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Medicine › Cardiology and Cardiovascular Medicine

Cardiac pacing and defibrillation studies

Works Count: 78499

Description

This cluster of papers focuses on the use of Cardiac Resynchronization Therapy (CRT) in the management of heart failure, particularly in patients with left ventricular dysfunction and ventricular arrhythmias. The cluster covers topics such as the use of implantable cardioverter-defibrillators, echocardiography-guided lead placement, remote monitoring, and the impact of CRT on dyssynchrony and sudden cardiac death.

Keywords

Cardiac Resynchronization Therapy; Implantable Cardioverter-Defibrillator; Heart Failure; Ventricular Arrhythmias; Left Ventricular Dysfunction; Echocardiography; Pacemaker Therapy; Remote Monitoring; Dyssynchrony; Sudden Cardiac Death

Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator

2002-12-25
Bruce L. Wilkoff , James R. Cook , Andrew E. Epstein +5 more
ContextImplantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid … ContextImplantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure.ObjectiveTo determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing.DesignThe Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial.Setting and ParticipantsA total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40% or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias.InterventionsAll patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n = 256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n = 250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and β-blockers, was prescribed to all patients.Main Outcome MeasureComposite end point of time to death or first hospitalization for congestive heart failure.ResultsOne-year survival free of the composite end point was 83.9% for patients treated with VVI-40 compared with 73.3% for patients treated with DDDR-70 (relative hazard, 1.61; 95% confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5% for VVI-40 vs 10.1% for DDDR-70 (relative hazard, 1.61; 95% CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3% for VVI-40 vs 22.6% for DDDR-70 (relative hazard, 1.54; 95% CI, 0.97-2.46), also trended in favor of VVI-40 programming.ConclusionFor patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40% or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.
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Effect of Pacing Chamber and Atrioventricular Delay on Acute Systolic Function of Paced Patients With Congestive Heart Failure

1999-06-15
Angelo Auricchio , Christoph Stellbrink , Michael S. Block +7 more
Background —Previous studies of pacing therapy for dilated congestive heart failure (CHF) have not established the relative importance of pacing site, AV delay, and patient heterogeneity on outcome. These variables … Background —Previous studies of pacing therapy for dilated congestive heart failure (CHF) have not established the relative importance of pacing site, AV delay, and patient heterogeneity on outcome. These variables were compared by a novel technique that evaluated immediate changes in hemodynamic function during brief periods of atrial-synchronous ventricular pacing. Methods and Results —Twenty-seven CHF patients with severe left ventricular (LV) systolic dysfunction and LV conduction disorder were implanted with endocardial pacing leads in the right atrium and right ventricle (RV) and an epicardial lead on the LV and instrumented with micromanometer catheters in the LV, aorta, and RV. Patients in normal sinus rhythm were stimulated in the RV, LV, or both ventricles simultaneously (BV) at preselected AV delays in a repeating 5-paced/15-nonpaced beat sequence. Maximum LV pressure derivative (LV+dP/dt) and aortic pulse pressure (PP) changed immediately at pacing onset, increasing at a patient-specific optimal AV delay in 20 patients with wide surface QRS (180±22 ms) and decreasing at short AV delays in 5 patients with narrower QRS (128±12 ms) ( P <0.0001). Overall, BV and LV pacing increased LV+dP/dt and PP more than RV pacing ( P <0.01), whereas LV pacing increased LV+dP/dt more than BV pacing ( P <0.01). Conclusions —In this population, CHF patients with sufficiently wide surface QRS benefit from atrial-synchronous ventricular pacing, LV stimulation is required for maximum acute benefit, and the maximum benefit at any site occurs with a patient-specific AV delay.
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Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms

2008-11-09
Cecilia Linde , William T. Abraham , Michael R. Gold +3 more

Adverse Effect of Ventricular Pacing on Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction

2003-06-04
Michael O. Sweeney , Anne S. Hellkamp , Kenneth A. Ellenbogen +4 more
Background— Dual-chamber (DDDR) pacing preserves AV synchrony and may reduce heart failure (HF) and atrial fibrillation (AF) compared with ventricular (VVIR) pacing in sinus node dysfunction (SND). However, DDDR pacing … Background— Dual-chamber (DDDR) pacing preserves AV synchrony and may reduce heart failure (HF) and atrial fibrillation (AF) compared with ventricular (VVIR) pacing in sinus node dysfunction (SND). However, DDDR pacing often results in prolonged QRS durations (QRSd) as the result of right ventricular stimulation, and ventricular desynchronization may result. The effect of pacing-induced ventricular desynchronization in patients with normal baseline QRSd is unknown. Methods and Results— Baseline QRSd was obtained from 12-lead ECGs before pacemaker implantation in MOST, a 2010-patient, 6-year, randomized trial of DDDR versus VVIR pacing in SND. Cumulative percent ventricular paced (Cum%VP) was determined from stored pacemaker data. Baseline QRSd <120 ms was observed in 1339 patients (707 DDDR, 632 VVIR). Cum%VP was greater in DDDR versus VVIR (90% versus 58%, P =0.001). Cox models demonstrated that the time-dependent covariate Cum%VP was a strong predictor of HF hospitalization in DDDR (hazard ratio [HR], 2.99 [95% CI, 1.15 to 7.75] for Cum%VP >40%) and VVIR (HR 2.56 [95% CI, 1.48 to 4.43] for Cum%VP >80%). The risk of AF increased linearly with Cum%VP from 0% to 85% in both groups (DDDR, HR 1.36 [95% CI, 1.09, 1.69]; VVIR, HR 1.21 [95% CI 1.02, 1.43], for each 25% increase in Cum%VP). Model results were unaffected by adjustment for known baseline predictors of HF hospitalization and AF. Conclusions— Ventricular desynchronization imposed by ventricular pacing even when AV synchrony is preserved increases the risk of HF hospitalization and AF in SND with normal baseline QRSd.
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Cardiovascular Magnetic Resonance, Fibrosis, and Prognosis in Dilated Cardiomyopathy

2006-11-01
Ravi Assomull , Sanjay Prasad , Jonathan Lyne +6 more

Association of Fibrosis With Mortality and Sudden Cardiac Death in Patients With Nonischemic Dilated Cardiomyopathy

2013-03-06
Ankur Gulati , Andrew Jabbour , Tevfik F. Ismail +7 more
<h3>Importance</h3>Risk stratification of patients with nonischemic dilated cardiomyopathy is primarily based on left ventricular ejection fraction (LVEF). Superior prognostic factors may improve patient selection for implantable cardioverter-defibrillators (ICDs) and other … <h3>Importance</h3>Risk stratification of patients with nonischemic dilated cardiomyopathy is primarily based on left ventricular ejection fraction (LVEF). Superior prognostic factors may improve patient selection for implantable cardioverter-defibrillators (ICDs) and other management decisions.<h3>Objective</h3>To determine whether myocardial fibrosis (detected by late gadolinium enhancement cardiovascular magnetic resonance [LGE-CMR] imaging) is an independent and incremental predictor of mortality and sudden cardiac death (SCD) in dilated cardiomyopathy.<h3>Design, Setting, and Patients</h3>Prospective, longitudinal study of 472 patients with dilated cardiomyopathy referred to a UK center for CMR imaging between November 2000 and December 2008 after presence and extent of midwall replacement fibrosis were determined. Patients were followed up through December 2011.<h3>Main Outcome Measures</h3>Primary end point was all-cause mortality. Secondary end points included cardiovascular mortality or cardiac transplantation; an arrhythmic composite of SCD or aborted SCD (appropriate ICD shock, nonfatal ventricular fibrillation, or sustained ventricular tachycardia); and a composite of HF death, HF hospitalization, or cardiac transplantation.<h3>Results</h3>Among the 142 patients with midwall fibrosis, there were 38 deaths (26.8%) vs 35 deaths (10.6%) among the 330 patients without fibrosis (hazard ratio [HR], 2.96 [95% CI, 1.87-4.69]; absolute risk difference, 16.2% [95% CI, 8.2%-24.2%]; P &lt; .001) during a median follow-up of 5.3 years (2557 patient-years of follow-up). The arrhythmic composite was reached by 42 patients with fibrosis (29.6%) and 23 patients without fibrosis (7.0%) (HR, 5.24 [95% CI, 3.15-8.72]; absolute risk difference, 22.6% [95% CI, 14.6%-30.6%]; P &lt; .001). After adjustment for LVEF and other conventional prognostic factors, both the presence of fibrosis (HR, 2.43 [95% CI, 1.50-3.92]; P &lt; .001) and the extent (HR, 1.11 [95% CI, 1.06-1.16]; P &lt; .001) were independently and incrementally associated with all-cause mortality. Fibrosis was also independently associated with cardiovascular mortality or cardiac transplantation (by fibrosis presence: HR, 3.22 [95% CI, 1.95-5.31], P &lt; .001; and by fibrosis extent: HR, 1.15 [95% CI, 1.10-1.20], P &lt; .001), SCD or aborted SCD (by fibrosis presence: HR, 4.61 [95% CI, 2.75-7.74], P &lt; .001; and by fibrosis extent: HR, 1.10 [95% CI, 1.05-1.16], P &lt; .001), and the HF composite (by fibrosis presence: HR, 1.62 [95% CI, 1.00-2.61], P = .049; and by fibrosis extent: HR, 1.08 [95% CI, 1.04-1.13], P &lt; .001). Addition of fibrosis to LVEF significantly improved risk reclassification for all-cause mortality and the SCD composite (net reclassification improvement: 0.26 [95% CI, 0.11-0.41]; P = .001 and 0.29 [95% CI, 0.11-0.48]; P = .002, respectively).<h3>Conclusions and Relevance</h3>Assessment of midwall fibrosis with LGE-CMR imaging provided independent prognostic information beyond LVEF in patients with nonischemic dilated cardiomyopathy. The role of LGE-CMR in the risk stratification of dilated cardiomyopathy requires further investigation.

Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction

2002-03-21
Arthur J. Moss , Wojciech Zaręba , William J. Hall +7 more
Patients with reduced left ventricular function after myocardial infarction are at risk for life-threatening ventricular arrhythmias. This randomized trial was designed to evaluate the effect of an implantable defibrillator on … Patients with reduced left ventricular function after myocardial infarction are at risk for life-threatening ventricular arrhythmias. This randomized trial was designed to evaluate the effect of an implantable defibrillator on survival in such patients.
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Improved Left Ventricular Mechanics From Acute VDD Pacing in Patients With Dilated Cardiomyopathy and Ventricular Conduction Delay

1999-03-30
David A. Kass , Chen-Huan Chen , Cecilia W. Curry +4 more
Background —Ventricular pacing can improve hemodynamics in heart failure patients, but direct effects on left ventricular (LV) function from varying pacing site and atrioventricular (AV) delay remain unknown. We hypothesized … Background —Ventricular pacing can improve hemodynamics in heart failure patients, but direct effects on left ventricular (LV) function from varying pacing site and atrioventricular (AV) delay remain unknown. We hypothesized that the magnitude and location of basal intraventricular conduction delay critically influences pacing responses and that single-site pacing in the delay-activated region yields similar or better responses to biventricular pacing. Methods and Results —Aortic and LV pressures were measured in 18 heart failure patients (mean±SD: LV ejection fraction, 19±7%; LV end-diastolic pressure, 25±8 mm Hg; QRS duration, 157±36 ms). Data under normal sinus rhythm were compared with ventricular pacing (VDD) at varying sites and AV delays (randomized order). Right ventricular (RV) apical or midseptal pacing had negligible contractile/systolic effects. However, LV free-wall pacing raised dP/dt max by 23.7±19.0% and pulse-pressure by 18.0±18.4% ( P &lt;0.01). Biventricular pacing yielded less change (+12.8±9.3% in dP/dt max , P &lt;0.05 versus LV). Pressure-volume analysis performed in 11 patients consistently revealed minimal changes with RV pacing but increased stroke work and lower end-systolic volumes with LV pacing. Optimal AV intervals averaged 125±49 ms, and within this range, AV delay had less influence on LV function than pacing site. Basal QRS duration positively correlated with %ΔdP/dt max ( P &lt;0.005), but pacing efficacy was not associated with QRS narrowing. Conduction delay pattern generally predicted pacing sites with most effect. Conclusions —VDD pacing acutely enhances contractile function in heart failure patients with intraventricular conduction delay. Single-site pacing at the site of greatest delay achieves similar or greater benefits to biventricular pacing in such patients. These data clarify pacing-effect mechanisms and should help in candidate identification for future studies.
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Chronic Rapid Atrial Pacing

1995-03-01
Carlos A. Morillo , George J. Klein , Douglas L. Jones +1 more
Background Despite the clinical importance of atrial fibrillation (AF), the development of chronic nonvalvular AF models has been difficult. Animal models of sustained AF have been developed primarily in the … Background Despite the clinical importance of atrial fibrillation (AF), the development of chronic nonvalvular AF models has been difficult. Animal models of sustained AF have been developed primarily in the short-term setting. Recently, models of chronic ventricular myopathy and fibrillation have been developed after several weeks of continuous rapid ventricular pacing. We hypothesized that chronic rapid atrial pacing would lead to atrial myopathy, yielding a reproducible model of sustained AF. Methods and Results Twenty-two halothane-anesthetized mongrel dogs underwent insertion of a transvenous lead at the right atrial appendage that was continuously paced at 400 beats per minute for 6 weeks. Two-dimensional echocardiography was performed in 11 dogs to assess the effects of rapid atrial pacing on atrial size. Atrial vulnerability was defined as the ability to induce sustained repetitive atrial responses during programmed electrical stimulation and was assessed by extrastimulus and burst-pacing techniques. Effective refractory period (ERP) was measured at two endocardial sites in the right atrium. Sustained AF was defined as AF ≥15 minutes. In animals with sustained AF, 10 quadripolar epicardial electrodes were surgically attached to the right and left atria. The local atrial fibrillatory cycle length (AFCL) was measured in a 20-second window, and the mean AFCL was measured at each site. Marked biatrial enlargement was documented; after 6 weeks of continuous rapid atrial pacing, the left atrium was 7.8±1 cm 2 at baseline versus 11.3±1 cm 2 after pacing, and the right atrium was 4.3±0.7 cm 2 at baseline versus 7.2±1.3 cm 2 after pacing. An increase in atrial area of at least 40% was necessary to induce sustained AF and was strongly correlated with the inducibility of AF ( r =.87). Electron microscopy of atrial tissue demonstrated structural changes that were characterized by an increase in mitochondrial size and number and by disruption of the sarcoplasmic reticulum. After 6 weeks of continuous rapid atrial pacing, sustained AF was induced in 18 dogs (82%) and nonsustained AF was induced in 2 dogs (9%). AF occurred spontaneously in 4 dogs (18%). Right atrial ERP, measured at cycle lengths of 400 and 300 milliseconds at baseline, was significantly shortened after pacing, from 150±8 to 127±10 milliseconds and from 147±11 to 123±12 milliseconds, respectively ( P &lt;.001). This finding was highly predictive of inducibility of AF (90%). Increased atrial area (40%) and ERP shortening were highly predictive for the induction of sustained AF (88%). Local epicardial ERP correlated well with local AFCL ( R 2 =.93). Mean AFCL was significantly shorter in the left atrium (81±8 milliseconds) compared with the right atrium 94±9 milliseconds ( P &lt;.05). An area in the posterior left atrium was consistently found to have a shorter AFCL (74±5 milliseconds). Cryoablation of this area was attempted in 11 dogs. In 9 dogs (82%; mean, 9.0±4.0; range, 5 to 14), AF was terminated and no longer induced after serial cryoablation. Conclusions Sustained AF was readily inducible in most dogs (82%) after rapid atrial pacing. This model was consistently associated with biatrial myopathy and marked changes in atrial vulnerability. An area in the posterior left atrium was uniformly shown to have the shortest AFCL. The results of restoration of sinus rhythm and prevention of inducibility of AF after cryoablation of this area of the left atrium suggest that this area may be critical in the maintenance of AF in this model.

The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure

2005-03-08
John G.F. Cleland , Jean‐Claude Daubert , Erland Erdmann +4 more
Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. We evaluated its effects on morbidity … Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. We evaluated its effects on morbidity and mortality.Patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony who were receiving standard pharmacologic therapy were randomly assigned to receive medical therapy alone or with cardiac resynchronization. The primary end point was the time to death from any cause or an unplanned hospitalization for a major cardiovascular event. The principal secondary end point was death from any cause.A total of 813 patients were enrolled and followed for a mean of 29.4 months. The primary end point was reached by 159 patients in the cardiac-resynchronization group, as compared with 224 patients in the medical-therapy group (39 percent vs. 55 percent; hazard ratio, 0.63; 95 percent confidence interval, 0.51 to 0.77; P<0.001). There were 82 deaths in the cardiac-resynchronization group, as compared with 120 in the medical-therapy group (20 percent vs. 30 percent; hazard ratio 0.64; 95 percent confidence interval, 0.48 to 0.85; P<0.002). As compared with medical therapy, cardiac resynchronization reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and the quality of life (P<0.01 for all comparisons).In patients with heart failure and cardiac dyssynchrony, cardiac resynchronization improves symptoms and the quality of life and reduces complications and the risk of death. These benefits are in addition to those afforded by standard pharmacologic therapy. The implantation of a cardiac-resynchronization device should routinely be considered in such patients.
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Left ventricular dyssynchrony predicts response and prognosis after cardiac resynchronization therapy

2004-11-01
Jeroen J. Bax , Gabe B. Bleeker , Thomas H. Marwick +5 more

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management

2009-05-23
Bruce L. Wilkoff , Charles J. Love , CHARLES L. BYRD +7 more

Canadian Implantable Defibrillator Study (CIDS)

2000-03-21
Stuart J. Connolly , Michael Gent , Robin S. Roberts +7 more
Background —Patients surviving ventricular fibrillation (VF) or sustained ventricular tachycardia (VT) are at a high risk of death due to a recurrence of arrhythmia. The implantable cardioverter defibrillator (ICD) terminates … Background —Patients surviving ventricular fibrillation (VF) or sustained ventricular tachycardia (VT) are at a high risk of death due to a recurrence of arrhythmia. The implantable cardioverter defibrillator (ICD) terminates VT or VF, but it is not known whether this device prolongs life in these patients compared with medical therapy with amiodarone. Methods and Results —A total of 659 patients with resuscitated VF or VT or with unmonitored syncope were randomly assigned to treatment with the ICD or with amiodarone. The primary outcome measure was all-cause mortality, and the secondary outcome was arrhythmic death. A total of 328 patients were randomized to receive an ICD. A thoracotomy was done in 33, no ICD was implanted in 18, and the rest had a nonthoracotomy ICD. All 331 patients randomized to amiodarone received it initially. At 5 years, 85.4% of patients assigned to amiodarone were still receiving it at a mean dose of 255 mg/day, 28.1% of ICD patients were also receiving amiodarone, and 21.4% of amiodarone patients had received an ICD. A nonsignificant reduction in the risk of death was observed with the ICD, from 10.2% per year to 8.3% per year (19.7% relative risk reduction; 95% confidence interval, −7.7% to 40%; P =0.142). A nonsignificant reduction in the risk of arrhythmic death was observed, from 4.5% per year to 3.0% per year (32.8% relative risk reduction; 95% confidence interval, −7.2% to 57.8%; P =0.094). Conclusions —A 20% relative risk reduction occurred in all-cause mortality and a 33% reduction occurred in arrhythmic mortality with ICD therapy compared with amiodarone; this reduction did not reach statistical significance.

Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure

2005-01-19
Gust H. Bardy , Kerry L. Lee , Daniel B. Mark +7 more
Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to … Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to improve the prognosis in such patients.We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause.The median LVEF in patients was 25 percent; 70 percent were in NYHA class II, and 30 percent were in class III CHF. The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent. The median follow-up was 45.5 months. There were 244 deaths (29 percent) in the placebo group, 240 (28 percent) in the amiodarone group, and 182 (22 percent) in the ICD group. As compared with placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5 percent confidence interval, 0.86 to 1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23 percent (0.77; 97.5 percent confidence interval, 0.62 to 0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population. Results did not vary according to either ischemic or nonischemic causes of CHF, but they did vary according to the NYHA class.In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent.
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Hemodynamic determinants of the time-course of fall in canine left ventricular pressure.

1976-09-01
James L. Weiss , James W. Frederiksen , Myron L. Weisfeldt
The hemodynamic determinants of the time-course of fall in isovolumic left ventricular pressure were assessed in isolated canine left ventricular preparations. Pressure fall was studied in isovolumic beats or during … The hemodynamic determinants of the time-course of fall in isovolumic left ventricular pressure were assessed in isolated canine left ventricular preparations. Pressure fall was studied in isovolumic beats or during prolonged isovolumic diastole after ejection. Pressure fall was studied in isovolumic relaxation for isovolumic and ejecting beats (r less than or equal to 0.98) and was therefore characterized by a time constant, T. Higher heart rates shortened T slightly from 52.6 +/- 4.5 ms at 110/min to 48.2 +/- 6.0 ms at 160/min (P less than 0.01, n = 8). Higher ventricular volumes under isovolumic conditions resulted in higher peak left ventricular pressure but no significant change in T. T did shorten from 67.1 +/- 5.0 ms in isovolumic beats to 45.8 +/- 2.9 ms in the ejecting beats (P less than 0.001, n = 14). In the ejecting beats, peak systolic pressure was lower, and end-systolic volume smaller. To differentiate the effects of systolic shortening during ejection from those of lower systolic pressure and smaller end-systolic volume, beats with large end-diastolic volumes were compared to beats with smaller end-diastolic volumes. The beats with smaller end-diastolic volumes exhibited less shortening but similar end-systolic volumes and peak systolic pressure. T again shortened to a greater extent in the beats with greater systolic shortening. Calcium chloride and acetylstrophanthidin resulted in no significant change in T, but norepinephrine, which accelerates active relaxation, resulted in a significant shortening of T (65.6 +/- 13.4 vs. 46.3 +/- 7.0 ms, P less than 0.02). During recovery from ischemia, T increased significantly from 59.3 +/- 9.6 to 76.8 +/- 13.1 ms when compared with the preischemic control beat (P less than 0.05). Thus, the present studies show that the time-course of isovolumic pressure fall subsequent to maximum negative dP/dt is exponential, independent of systolic stress and end-systolic fiber length, and minimally dependent on heart rate. T may be an index of the activity of the active cardiac relaxing system and appears dependent on systolic fiber shortening.
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Ventricular Pacing or Dual-Chamber Pacing for Sinus-Node Dysfunction

2002-06-13
Gervasio A. Lamas , Kerry L. Lee , Michael O. Sweeney +7 more
Dual-chamber (atrioventricular) and single-chamber (ventricular) pacing are alternative treatment approaches for sinus-node dysfunction that causes clinically significant bradycardia. However, it is unknown which type of pacing results in the better … Dual-chamber (atrioventricular) and single-chamber (ventricular) pacing are alternative treatment approaches for sinus-node dysfunction that causes clinically significant bradycardia. However, it is unknown which type of pacing results in the better outcome.
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Results of the Predictors of Response to CRT (PROSPECT) Trial

2008-05-06
Eugene Chung , Angel R. León , Luigi Tavazzi +7 more
Background— Data from single-center studies suggest that echocardiographic parameters of mechanical dyssynchrony may improve patient selection for cardiac resynchronization therapy (CRT). In a prospective, multicenter setting, the Predictors of Response … Background— Data from single-center studies suggest that echocardiographic parameters of mechanical dyssynchrony may improve patient selection for cardiac resynchronization therapy (CRT). In a prospective, multicenter setting, the Predictors of Response to CRT (PROSPECT) study tested the performance of these parameters to predict CRT response. Methods and Results— Fifty-three centers in Europe, Hong Kong, and the United States enrolled 498 patients with standard CRT indications (New York Heart Association class III or IV heart failure, left ventricular ejection fraction ≤35%, QRS ≥130 ms, stable medical regimen). Twelve echocardiographic parameters of dyssynchrony, based on both conventional and tissue Doppler–based methods, were evaluated after site training in acquisition methods and blinded core laboratory analysis. Indicators of positive CRT response were improved clinical composite score and ≥15% reduction in left ventricular end-systolic volume at 6 months. Clinical composite score was improved in 69% of 426 patients, whereas left ventricular end-systolic volume decreased ≥15% in 56% of 286 patients with paired data. The ability of the 12 echocardiographic parameters to predict clinical composite score response varied widely, with sensitivity ranging from 6% to 74% and specificity ranging from 35% to 91%; for predicting left ventricular end-systolic volume response, sensitivity ranged from 9% to 77% and specificity from 31% to 93%. For all the parameters, the area under the receiver-operating characteristics curve for positive clinical or volume response to CRT was ≤0.62. There was large variability in the analysis of the dyssynchrony parameters. Conclusion— Given the modest sensitivity and specificity in this multicenter setting despite training and central analysis, no single echocardiographic measure of dyssynchrony may be recommended to improve patient selection for CRT beyond current guidelines. Efforts aimed at reducing variability arising from technical and interpretative factors may improve the predictive power of these echocardiographic parameters in a broad clinical setting.
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Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial

2011-02-01
William T. Abraham , Philip B. Adamson , Robert C. Bourge +7 more

Reduction in Inappropriate Therapy and Mortality through ICD Programming

2012-11-06
Arthur J. Moss , Claudio Schuger , Christopher A. Beck +7 more
The implantable cardioverter–defibrillator (ICD) is highly effective in reducing mortality among patients at risk for fatal arrhythmias, but inappropriate ICD activations are frequent, with potential adverse effects. The implantable cardioverter–defibrillator (ICD) is highly effective in reducing mortality among patients at risk for fatal arrhythmias, but inappropriate ICD activations are frequent, with potential adverse effects.
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Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart Failure

2003-05-27
James B. Young
Cardiac resynchronization therapy (CRT) through biventricular pacing is an effective treatment for heart failure (HF) with a wide QRS; however, the outcomes of patients requiring CRT and implantable cardioverter defibrillator … Cardiac resynchronization therapy (CRT) through biventricular pacing is an effective treatment for heart failure (HF) with a wide QRS; however, the outcomes of patients requiring CRT and implantable cardioverter defibrillator (ICD) therapy are unknown.To examine the efficacy and safety of combined CRT and ICD therapy in patients with New York Heart Association (NYHA) class III or IV congestive HF despite appropriate medical management.Randomized, double-blind, parallel-controlled trial conducted from October 1, 1999, to August 31, 2001, of 369 patients with left ventricular ejection fraction of 35% or less, QRS duration of 130 ms, at high risk of life-threatening ventricular arrhythmias, and in NYHA class III (n = 328) or IV (n = 41) despite optimized medical treatment.Of 369 randomized patients who received devices with combined CRT and ICD capabilities, 182 were controls (ICD activated, CRT off) and 187 were in the CRT group (ICD activated, CRT on).The primary double-blind study end points were changes between baseline and 6 months in quality of life, functional class, and distance covered during a 6-minute walk. Additional outcome measures included changes in exercise capacity, plasma neurohormones, left ventricular function, and overall HF status. Survival, incidence of ventricular arrhythmias, and rates of hospitalization were also compared.At 6 months, patients assigned to CRT had a greater improvement in median (95% confidence interval) quality of life score (-17.5 [-21 to -14] vs -11.0 [-16 to -7], P =.02) and functional class (-1 [-1 to -1] vs 0 [-1 to 0], P =.007) than controls but were no different in the change in distance walked in 6 minutes (55 m [44-79] vs 53 m [43-75], P =.36). Peak oxygen consumption increased by 1.1 mL/kg per minute (0.7-1.6) in the CRT group vs 0.1 mL/kg per minute (-0.1 to 0.8) in controls (P =.04), although treadmill exercise duration increased by 56 seconds (30-79) in the CRT group and decreased by 11 seconds (-55 to 12) in controls (P<.001). No significant differences were observed in changes in left ventricular size or function, overall HF status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired.Cardiac resynchronization improved quality of life, functional status, and exercise capacity in patients with moderate to severe HF, a wide QRS interval, and life-threatening arrhythmias. These improvements occurred in the context of underlying appropriate medical management without proarrhythmia or compromised ICD function.

Prophylactic Use of an Implantable Cardioverter–Defibrillator after Acute Myocardial Infarction

2004-12-09
Stefan H. Hohnloser , Karl Heinz Kuck , Paul Dorian +6 more
Implantable cardioverter–defibrillator (ICD) therapy has been shown to improve survival in patients with various heart conditions who are at high risk for ventricular arrhythmias. Whether benefit occurs in patients early … Implantable cardioverter–defibrillator (ICD) therapy has been shown to improve survival in patients with various heart conditions who are at high risk for ventricular arrhythmias. Whether benefit occurs in patients early after myocardial infarction is unknown.
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Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy

2004-05-19
Alan H. Kadish , Alan R. Dyer , James P. Daubert +7 more
Patients with nonischemic dilated cardiomyopathy are at substantial risk for sudden death from cardiac causes. However, the value of prophylactic implantation of an implantable cardioverter–defibrillator (ICD) to prevent sudden death … Patients with nonischemic dilated cardiomyopathy are at substantial risk for sudden death from cardiac causes. However, the value of prophylactic implantation of an implantable cardioverter–defibrillator (ICD) to prevent sudden death in such patients is unknown.
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Instantaneous Pressure-Volume Relationships and Their Ratio in the Excised, Supported Canine Left Ventricle

1974-07-01
Hiroyuki Suga , K Sagawa
We have previously shown in the normally ejecting canine left ventricle that E ( t ), the time-varying ratio of instantaneous pressure, P ( t ), to instantaneous volume, V … We have previously shown in the normally ejecting canine left ventricle that E ( t ), the time-varying ratio of instantaneous pressure, P ( t ), to instantaneous volume, V ( t ), is little affected by end-diastolic volume or aortic pressure. The present study on an excised, supported canine heart preparation indicates that the thesis on E ( t ) is also valid for either totally isovolumic or auxobaric beats. Intraventricular volume was measured more accurately than it was in the previous study by a new volumetric system. Regression analysis of the data showed that the instantaneous pressure-volume relationship could be approximated by the equation P ( t ) = E ( t ).[ V ( t ) - V d ], where V d is an empirical constant, over a wide range of intraventricular volume. Similar E ( t ) curves were obtained from both isovolumic and auxobaric beats for a given contractile state. When the contractile state of the preparation was enhanced by a constant-rate infusion (0.2 µg/min) of norepinephrine or isoproterenol into the coronary artery, the peak magnitude of E ( t ) increased 63% from 3.6 mm Hg/ml and the time to peak E ( t ) shortened 10% from 175 msec. We conclude that the present investigation substantiates our earlier study which established a link between E ( t ) and the contractile state of the heart.
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Effect of Cardiac Resynchronization Therapy on Left Ventricular Size and Function in Chronic Heart Failure

2003-04-21
Martin G. St. John Sutton , Ted Plappert , William T. Abraham +7 more
Cardiac resynchronization therapy (CRT) has recently emerged as an effective treatment for patients with moderate to severe systolic heart failure and ventricular dyssynchrony. The purpose of the present study was … Cardiac resynchronization therapy (CRT) has recently emerged as an effective treatment for patients with moderate to severe systolic heart failure and ventricular dyssynchrony. The purpose of the present study was to determine whether improvements in left ventricular (LV) size and function were associated with CRT.Doppler echocardiograms were obtained at baseline and at 3 and 6 months after therapy in 323 patients enrolled in the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) trial. Of these, 172 patients were randomized to CRT on and 151 patients to CRT off. Measurements were made of LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, severity of mitral regurgitation (MR), peak transmitral velocities during early (E-wave) and late (A-wave) diastolic filling, and the myocardial performance index. At 6 months, CRT was associated with reduced end-diastolic and end-systolic volumes (both P<0.001), reduced LV mass (P<0.01), increased ejection fraction (P<0.001), reduced MR (P<0.001), and improved myocardial performance index (P<0.001) compared with control. beta-Blocker treatment status did not influence the effect of CRT. Improvements with CRT were greater in patients with a nonischemic versus ischemic cause of heart failure.CRT in patients with moderate-to-severe heart failure who were treated with optimal medical therapy is associated with reverse LV remodeling, improved systolic and diastolic function, and decreased MR. LV remodeling likely contributes to the symptomatic benefits of CRT and may herald improved longer-term survival.
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Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure

2004-05-19
Michael R. Bristow , Leslie A. Saxon , John Boehmer +7 more
We tested the hypothesis that prophylactic cardiac-resynchronization therapy in the form of biventricular stimulation with a pacemaker with or without a defibrillator would reduce the risk of death and hospitalization … We tested the hypothesis that prophylactic cardiac-resynchronization therapy in the form of biventricular stimulation with a pacemaker with or without a defibrillator would reduce the risk of death and hospitalization among patients with advanced chronic heart failure and intraventricular conduction delays.A total of 1520 patients who had advanced heart failure (New York Heart Association class III or IV) due to ischemic or nonischemic cardiomyopathies and a QRS interval of at least 120 msec were randomly assigned in a 1:2:2 ratio to receive optimal pharmacologic therapy (diuretics, angiotensin-converting-enzyme inhibitors, beta-blockers, and spironolactone) alone or in combination with cardiac-resynchronization therapy with either a pacemaker or a pacemaker-defibrillator. The primary composite end point was the time to death from or hospitalization for any cause.As compared with optimal pharmacologic therapy alone, cardiac-resynchronization therapy with a pacemaker decreased the risk of the primary end point (hazard ratio, 0.81; P=0.014), as did cardiac-resynchronization therapy with a pacemaker-defibrillator (hazard ratio, 0.80; P=0.01). The risk of the combined end point of death from or hospitalization for heart failure was reduced by 34 percent in the pacemaker group (P<0.002) and by 40 percent in the pacemaker-defibrillator group (P<0.001 for the comparison with the pharmacologic-therapy group). A pacemaker reduced the risk of the secondary end point of death from any cause by 24 percent (P=0.059), and a pacemaker-defibrillator reduced the risk by 36 percent (P=0.003).In patients with advanced heart failure and a prolonged QRS interval, cardiac-resynchronization therapy decreases the combined risk of death from any cause or first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.
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ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices—Summary Article

2002-11-01
Gabriel Gregoratos , Jonathan Abrams , Andrew E. Epstein +7 more

Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure

2010-11-14
Anthony Tang , George A. Wells , Mario Talajic +7 more
Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding … Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients.We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure.We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD-CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD-CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD-CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P = 0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001).Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.).
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Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events

2009-09-02
Arthur J. Moss , William J. Hall , David S. Cannom +7 more
This trial was designed to determine whether cardiac-resynchronization therapy (CRT) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms, a reduced … This trial was designed to determine whether cardiac-resynchronization therapy (CRT) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms, a reduced ejection fraction, and a wide QRS complex.During a 4.5-year period, we enrolled and followed 1820 patients with ischemic or nonischemic cardiomyopathy, an ejection fraction of 30% or less, a QRS duration of 130 msec or more, and New York Heart Association class I or II symptoms. Patients were randomly assigned in a 3:2 ratio to receive CRT plus an implantable cardioverter-defibrillator (ICD) (1089 patients) or an ICD alone (731 patients). The primary end point was death from any cause or a nonfatal heart-failure event (whichever came first). Heart-failure events were diagnosed by physicians who were aware of the treatment assignments, but they were adjudicated by a committee that was unaware of assignments.During an average follow-up of 2.4 years, the primary end point occurred in 187 of 1089 patients in the CRT-ICD group (17.2%) and 185 of 731 patients in the ICD-only group (25.3%) (hazard ratio in the CRT-ICD group, 0.66; 95% confidence interval [CI], 0.52 to 0.84; P=0.001). The benefit did not differ significantly between patients with ischemic cardiomyopathy and those with nonischemic cardiomyopathy. The superiority of CRT was driven by a 41% reduction in the risk of heart-failure events, a finding that was evident primarily in a prespecified subgroup of patients with a QRS duration of 150 msec or more. CRT was associated with a significant reduction in left ventricular volumes and improvement in the ejection fraction. There was no significant difference between the two groups in the overall risk of death, with a 3% annual mortality rate in each treatment group. Serious adverse events were infrequent in the two groups.CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complex. (ClinicalTrials.gov number, NCT00180271.)
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Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials

2000-12-15
Stuart J. Connolly
Aims Three randomized trials of implantable cardioverter defibrillator (ICD) therapy vs medical treatment for the prevention of death in survivors of ventricular fibrillation or sustained ventricular tachycardia have been reported … Aims Three randomized trials of implantable cardioverter defibrillator (ICD) therapy vs medical treatment for the prevention of death in survivors of ventricular fibrillation or sustained ventricular tachycardia have been reported with what might appear to be different results. The present analysis was performed to obtain the most precise estimate of the efficacy of the ICD, compared to amiodarone, for prolonging survival in patients with malignant ventricular arrhythmia. Methods and Results Individual patient data from the Antiarrhythmics vs Implantable Defibrillator (AVID) study, the Cardiac Arrest Study Hamburg (CASH) and the Canadian Implantable Defibrillator Study (CIDS) were merged into a master database according to a pre-specified protocol. Proportional hazard modelling of individual patient data was used to estimate hazard ratios and to investigate subgroup interactions. Fixed effect meta-analysis techniques were also used to evaluate treatment effects and to assess heterogeneity across studies. The classic fixed effects meta-analysis showed that the estimates of ICD benefit from the three studies were consistent with each other (P heterogeneity=0·306). It also showed a significant reduction in death from any cause with the ICD; with a summary hazard ratio (ICD:amiodarone) of 0·72 (95% confidence interval 0·60, 0·87;P=0·0006). For the outcome of arrhythmic death, the hazard ratio was 0·50 (95% confidence interval 0·37, 0·67;P<0·0001). Survival was extended by a mean of 4·4 months by the ICD over a follow-up period of 6 years. Patients with left ventricular ejection fraction ≤35% derived significantly more benefit from ICD therapy than those with better preserved left ventricular function. Patients treated before the availability of non-thoracotomy ICD implants derived significantly less benefit from ICD therapy than those treated in the non-thoracotomy era. Conclusion Results from the three trials of the ICD vs amiodarone are consistent with each other. There is a 28% reduction in the relative risk of death with the ICD that is due almost entirely to a 50% reduction in arrhythmic death.
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Long-term benefits of biventricular pacing in congestive heart failure: results from the MUltisite STimulation in cardiomyopathy (MUSTIC) study

2002-07-01
Cecilia Linde , Christophe Leclercq , S. Rex +7 more

Prognostic Importance of Defibrillator Shocks in Patients with Heart Failure

2008-09-03
Jeanne E. Poole , George Johnson , Anne S. Hellkamp +7 more
Patients with heart failure who receive an implantable cardioverter-defibrillator (ICD) for primary prevention (i.e., prevention of a first life-threatening arrhythmic event) may later receive therapeutic shocks from the ICD. Information … Patients with heart failure who receive an implantable cardioverter-defibrillator (ICD) for primary prevention (i.e., prevention of a first life-threatening arrhythmic event) may later receive therapeutic shocks from the ICD. Information about long-term prognosis after ICD therapy in such patients is limited.Of 829 patients with heart failure who were randomly assigned to ICD therapy, we implanted the ICD in 811. ICD shocks that followed the onset of ventricular tachycardia or ventricular fibrillation were considered to be appropriate. All other ICD shocks were considered to be inappropriate.Over a median follow-up period of 45.5 months, 269 patients (33.2%) received at least one ICD shock, with 128 patients receiving only appropriate shocks, 87 receiving only inappropriate shocks, and 54 receiving both types of shock. In a Cox proportional-hazards model adjusted for baseline prognostic factors, an appropriate ICD shock, as compared with no appropriate shock, was associated with a significant increase in the subsequent risk of death from all causes (hazard ratio, 5.68; 95% confidence interval [CI], 3.97 to 8.12; P<0.001). An inappropriate ICD shock, as compared with no inappropriate shock, was also associated with a significant increase in the risk of death (hazard ratio, 1.98; 95% CI, 1.29 to 3.05; P=0.002). For patients who survived longer than 24 hours after an appropriate ICD shock, the risk of death remained elevated (hazard ratio, 2.99; 95% CI, 2.04 to 4.37; P<0.001). The most common cause of death among patients who received any ICD shock was progressive heart failure.Among patients with heart failure in whom an ICD is implanted for primary prevention, those who receive shocks for any arrhythmia have a substantially higher risk of death than similar patients who do not receive such shocks.
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long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay

2002-06-01
Angelo Auricchio , Christoph Stellbrink , Stefan Sack +7 more

Update on Cardiovascular Implantable Electronic Device Infections and Their Management

2010-01-05
Larry M. Baddour , Andrew E. Epstein , Christopher C. Erickson +7 more
Despite improvements in cardiovascular implantable electronic device (CIED) design, application of timely infection control practices, and administration of antibiotic prophylaxis at the time of device placement, CIED infections continue to … Despite improvements in cardiovascular implantable electronic device (CIED) design, application of timely infection control practices, and administration of antibiotic prophylaxis at the time of device placement, CIED infections continue to occur and can be life-threatening. This has prompted the study of all aspects of CIED infections. Recognizing the recent advances in our understanding of the epidemiology, risk factors, microbiology, management, and prevention of CIED infections, the American Heart Association commissioned this scientific statement to educate clinicians about CIED infections, provide explicit recommendations for the care of patients with suspected or established CIED infections, and highlight areas of needed research.

Tissue Doppler Echocardiographic Evidence of Reverse Remodeling and Improved Synchronicity by Simultaneously Delaying Regional Contraction After Biventricular Pacing Therapy in Heart Failure

2002-01-29
Cheuk‐Man Yu , Elaine Chau , John E. Sanderson +7 more
Background — Biventricular pacing has been proposed to improve symptoms and exercise capacity in patients with advanced heart failure and wide electrocardiographic wave complexes. This study investigated the effect of … Background — Biventricular pacing has been proposed to improve symptoms and exercise capacity in patients with advanced heart failure and wide electrocardiographic wave complexes. This study investigated the effect of biventricular pacing on reverse remodeling and the underlying mechanisms. Methods and Results — Twenty-five patients with NYHA class III to IV heart failure and electrocardiographic wave complex duration &gt;140 ms receiving biventricular pacing therapy were assessed serially up to 3 months after pacing and when pacing was withheld for 4 weeks. Tissue Doppler echocardiography was performed using a 6-basal, 6-mid segmental model to assess the time to peak sustained systolic contraction (T S ). There was significant improvement of ejection fraction, dP/dt, and myocardial performance index; decrease in mitral regurgitation, left ventricular (LV) end-diastolic (205±68 versus 168±67 mL, P &lt;0.01) and end-systolic volume (162±54 versus 122±42 mL, P &lt;0.01); and improved 6-minute hall-walk distance and quality of life score after pacing for 3 months. The mechanisms of benefits were as follows: (1) improved LV synchrony, as evident by homogeneous delay of T S to a timing close to the latest (usually the lateral) segment abolishing the intersegmental difference in T S and decreasing the standard deviation of T S within the left ventricle (37.7±10.9 versus 29.3±8.3 ms, P &lt;0.05); (2) improved interventricular synchrony; and (3) shortened isovolumic contraction time (122±57 versus 82±36 ms, P &lt;0.05) but increased diastolic filling time. These benefits are pacing dependent, because withholding the pacing resulted in varying speeds in the loss of cardiac improvements. Conclusions — Biventricular pacing reverses LV remodeling and improves cardiac function. Improvement of LV mechanical synchrony seems to be the predominant mechanism.
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Prophylactic Use of Implanted Cardiac Defibrillators in Patients at High Risk for Ventricular Arrhythmias after Coronary-Artery Bypass Graft Surgery

1997-11-27
J. Thomas Bigger
Patients with coronary heart disease, left ventricular dysfunction, and abnormalities on signal-averaged electrocardiograms have an increased risk of sudden death. We evaluated the effect on survival of the prophylactic implantation … Patients with coronary heart disease, left ventricular dysfunction, and abnormalities on signal-averaged electrocardiograms have an increased risk of sudden death. We evaluated the effect on survival of the prophylactic implantation of cardioverter–defibrillators in such patients at the time of coronary-artery bypass surgery.
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Improved Survival with an Implanted Defibrillator in Patients with Coronary Disease at High Risk for Ventricular Arrhythmia

1996-12-26
Arthur J. Moss , William J. Hall , David S. Cannom +7 more
Unsustained ventricular tachycardia in patients with previous myocardial infarction and left ventricular dysfunction is associated with a two-year mortality rate of about 30 percent. We studied whether prophylactic therapy with … Unsustained ventricular tachycardia in patients with previous myocardial infarction and left ventricular dysfunction is associated with a two-year mortality rate of about 30 percent. We studied whether prophylactic therapy with an implanted cardioverter–defibrillator, as compared with conventional medical therapy, would improve survival in this high-risk group of patients.
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Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

2016-08-28
Lars Køber , Jens Jakob Thune , Jens Cosedis Nielsen +7 more
The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of … The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT).In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death.After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29).In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).
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Effects of Multisite Biventricular Pacing in Patients with Heart Failure and Intraventricular Conduction Delay

2001-03-22
Serge Cazeau , Christophe Leclercq , Thomas Lavergne +7 more
One third of patients with chronic heart failure have electrocardiographic evidence of a major intraventricular conduction delay, which may worsen left ventricular systolic dysfunction through asynchronous ventricular contraction. Uncontrolled studies … One third of patients with chronic heart failure have electrocardiographic evidence of a major intraventricular conduction delay, which may worsen left ventricular systolic dysfunction through asynchronous ventricular contraction. Uncontrolled studies suggest that multisite biventricular pacing improves hemodynamics and well-being by reducing ventricular asynchrony. We assessed the clinical efficacy and safety of this new therapy.
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2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death

2015-08-29
Silvia G. Priori , C. Blomström‐Lundqvist , Andrea Mazzanti +7 more
The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their … The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication.The ESC is not responsible in the event of any contradiction, discrepancy and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies.Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver.Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations.It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.
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Randomized Comparison of Antiarrhythmic Drug Therapy With Implantable Defibrillators in Patients Resuscitated From Cardiac Arrest

2000-08-15
Karl-Heinz Kuck , Riccardo Cappato , Jürgen Siebels +1 more
Background —We conducted a prospective, multicenter, randomized comparison of implantable cardioverter-defibrillator (ICD) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. Methods and Results —From … Background —We conducted a prospective, multicenter, randomized comparison of implantable cardioverter-defibrillator (ICD) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. Methods and Results —From 1987, eligible patients were randomized to an ICD, amiodarone, propafenone, or metoprolol (ICD versus antiarrhythmic agents randomization ratio 1:3). Assignment to propafenone was discontinued in March 1992, after an interim analysis conducted in 58 patients showed a 61% higher all-cause mortality rate than in 61 ICD patients during a follow-up of 11.3 months. The study continued to recruit 288 patients in the remaining 3 study groups; of these, 99 were assigned to ICDs, 92 to amiodarone, and 97 to metoprolol. The primary end point was all-cause mortality. The study was terminated in March 1998, when all patients had concluded a minimum 2-year follow-up. Over a mean follow-up of 57±34 months, the crude death rates were 36.4% (95% CI 26.9% to 46.6%) in the ICD and 44.4% (95% CI 37.2% to 51.8%) in the amiodarone/metoprolol arm. Overall survival was higher, though not significantly, in patients assigned to ICD than in those assigned to drug therapy (1-sided P =0.081, hazard ratio 0.766, [97.5% CI upper bound 1.112]). In ICD patients, the percent reductions in all-cause mortality were 41.9%, 39.3%, 28.4%, 27.7%, 22.8%, 11.4%, 9.1%, 10.6%, and 24.7% at years 1 to 9 of follow-up. Conclusions —During long-term follow-up of cardiac arrest survivors, therapy with an ICD is associated with a 23% (nonsignificant) reduction of all-cause mortality rates when compared with treatment with amiodarone/metoprolol. The benefit of ICD therapy is more evident during the first 5 years after the index event.

2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy

2013-06-24
Authors Task Force Members , Michele Brignole , Angelo Auricchio +7 more
The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written.Health professionals are encouraged to … The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written.Health professionals are encouraged to take them fully into account when exercising their clinical judgement.The guidelines do not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient and, where appropriate and necessary, the patient's guardian or carer.It is also the health professional's responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription.
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2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

2017-09-15
Fred Kusumoto , Mark H. Schoenfeld , Bruce L. Wilkoff +7 more

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

2008-05-16
Andrew E. Epstein , John Dimarco , Kenneth A. Ellenbogen +7 more
37.6% VVI(R) to DDD(R): 3.1% DDD(R) dropout: 8.3% R*added to pacing mode designation indicates rate-responsive pacemakers implanted in all patients.(R) 37.6% VVI(R) to DDD(R): 3.1% DDD(R) dropout: 8.3% R*added to pacing mode designation indicates rate-responsive pacemakers implanted in all patients.(R)
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2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death

2015-08-29
Silvia G. Priori , C. Blomström‐Lundqvist , Andrea Mazzanti +7 more
ACC : American College of Cardiology ACE : angiotensin-converting enzyme ACS : acute coronary syndrome AF : atrial fibrillation AGNES : Arrhythmia Genetics in the Netherlands AHA : American Heart … ACC : American College of Cardiology ACE : angiotensin-converting enzyme ACS : acute coronary syndrome AF : atrial fibrillation AGNES : Arrhythmia Genetics in the Netherlands AHA : American Heart Association AMIOVIRT : AMIOdarone Versus Implantable cardioverter-defibrillator:
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2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy

2021-08-29
Michael Glikson , Jens Cosedis Nielsen , Mads Brix Kronborg +7 more
The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their … The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication.The ESC is not responsible in the event of any contradiction, discrepancy, and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies.Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgement, as well as in the determination and the implementation of preventive, diagnostic, or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver.Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations.It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.
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2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA)

2013-06-24
Michele Brignole , Angelo Auricchio , Gonzalo Barón‐Esquivias +7 more
The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written.Health professionals are encouraged to … The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written.Health professionals are encouraged to take them fully into account when exercising their clinical judgement.The guidelines do not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient and, where appropriate and necessary, the patient's guardian or carer.It is also the health professional's responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription.
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A Randomized Trial of Propranolol in Patients With Acute Myocardial Infarction

1982-03-26
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ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

2006-08-26
Douglas P. Zipes , A. John Camm , Martin Borggrefe +7 more
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Depression and Anxiety in Patients Who Received a CRT Device and Did Not Have Shock Therapy During a 12‐Month Follow‐Up

2025-06-25
Elizabeth Florou , Dimitrios Sfairopoulos , Sofia Plakoutsi +5 more | Pacing and Clinical Electrophysiology
ABSTRACT Introduction Cardiac resynchronization therapy (CRT) may affect the patients’ psychological status differently in various populations. There are limited data regarding depression and anxiety in this setting, while there are … ABSTRACT Introduction Cardiac resynchronization therapy (CRT) may affect the patients’ psychological status differently in various populations. There are limited data regarding depression and anxiety in this setting, while there are no data regarding Greek patients. Methods We studied heart failure with reduced ejection fraction (HFrEF) patients, without conditions affecting psychological status, undergoing CRT. We used the Minnesota Living with Heart Failure Questionnaire (MLHFQ), the 9‐item Patient Health Questionnaire (PHQ‐9), and the 7‐item Generalized Anxiety Disorder Scale (GAD‐7) at baseline and 6‐ and 12‐month postimplantation. Results After excluding seven patients who experienced defibrillator shocks, we analyzed 99 patients (median age: 72 years, 77% men). The baseline MLHFQ score was 37 (interquartile range [IQR]: 36); at 6 months, 1 (IQR: 8); and at 12 months, 0.5 (IQR: 10); p &lt; 0.01. The baseline PHQ‐9 score was 9 (IQR: 11); at 6 months, 0 (IQR: 2); and at 12 months, 0 (IQR: 2); p &lt; 0.01. The baseline GAD‐7 score was 8 (IQR: 16); at 6 months, 0 (IQR: 1.5); and at 12 months, 0 (IQR: 3); p &lt;0.01. At baseline, 44% of patients had clinically significant depression (PHQ‐9 score ≥10), and 45% clinically significant anxiety (GAD‐7 score ≥10). The baseline PHQ‐9 and GAD‐7 scores correlated with the MLHFQ score. The logistic regression analysis revealed that clinically substantial depression at baseline (PHQ‐9 ≥ 10) had a negative association with chronic kidney disease [OR: 0.55; p &lt; 0.01]. Conclusions Depression and anxiety markedly improved during the 12‐month follow‐up period after CRT device implantation in HFrEF patients who did not receive shock therapy.

Renal Considerations in Sacubitril/Valsartan Uptitration for Heart Failure Patients

2025-06-25
Hiroki Ito , Takefumi Mori | Circulation Journal

Hitting the Wall: The Hidden Challenge of 2:1 Block in Pacemaker Patients

2025-06-25
Marc Strik , Sylvain Ploux , Anand Thiyagarajah +2 more | Pacing and Clinical Electrophysiology
ABSTRACT Introduction Dual‐chamber pacemakers incorporate proprietary algorithms to optimize atrioventricular (AV) synchronization and prevent pacemaker‐mediated arrhythmias. Patients have recently presented to our center with severe exercise intolerance due to the … ABSTRACT Introduction Dual‐chamber pacemakers incorporate proprietary algorithms to optimize atrioventricular (AV) synchronization and prevent pacemaker‐mediated arrhythmias. Patients have recently presented to our center with severe exercise intolerance due to the early onset of 2:1 AV block caused by Biotronik's Auto‐PVARP and 2:1 Lock‐in protection algorithms. This study evaluates the relationship of these algorithms to low 2:1 block rates in a large cohort of remotely monitored pacemaker patients. Methods We troubleshooted the patients with symptomatic exercise intolerance. We then performed an observational study using remote monitoring data from 895 patients implanted with Biotronik pacemakers, programmed in DDD(R) mode with the Auto‐PVARP algorithm activated. We analyzed PVARP settings, 2:1 block rates, and their relationship with age‐predicted maximal sinus rates. Results Among the 895 remotely monitored patients, the majority had significantly prolonged PVARP settings, lowering their 2:1 block rate. At the most recent transmission, only 37% had a PVARP ≤225 ms, while 63% had longer values (275–375 ms), leading to lower 2:1 block thresholds. The 2:1 block rate was below the age‐predicted maximal sinus rate in 48% of patients, suggesting a high risk of pacing‐induced exercise limitations. The prolonged PVARP was largely driven by Auto‐PVARP extensions, often without documented pacemaker‐mediated tachycardia (PMT). These findings indicate that a significant proportion of pacemaker‐dependent patients may unknowingly experience pacing‐related exercise intolerance. Conclusion The Biotronik Auto‐PVARP algorithm frequently extends the refractory period, lowering the threshold for 2:1 block and potentially limiting exercise capacity in active patients. Disabling Auto‐PVARP and setting a fixed, shorter PVARP may improve exercise tolerance.

Renal Considerations in Sacubitril/Valsartan Uptitration for Heart Failure Patients ― Reply ―

2025-06-25
Shunichi Doi , Keisuke Kida , Koshiro Kanaoka +1 more | Circulation Journal

Predicting the risk of motor vehicle crash in the first year after cardioverter-defibrillator implantation

2025-06-24
John A. Staples , Daniel Daly‐Grafstein , Mayesha Khan +6 more | Heart
Background Baseline health and driving data might allow clinicians to personalise medical driving restrictions after implantable cardioverter-defibrillator (ICD) implantation. Methods Using 22 years of population-based administrative data from British Columbia, … Background Baseline health and driving data might allow clinicians to personalise medical driving restrictions after implantable cardioverter-defibrillator (ICD) implantation. Methods Using 22 years of population-based administrative data from British Columbia, Canada, we identified licensed drivers with a first ICD implantation between 1998 and 2018. After stratifying by ICD indication (primary vs secondary prevention of sudden cardiac death), we used baseline health and driving data and logistic regression to estimate each driver’s 1-year crash risk. We assessed optimism-corrected discrimination and calibration of the final model using 200 bootstrapped samples. Results In the first year after implantation, there were 352 crashes among 3652 primary prevention ICD recipients and 270 crashes among 3408 secondary prevention ICD recipients. Crash prediction models exhibited poor discrimination (c-statistics 0.60 and 0.61, respectively) but good calibration (calibration slopes 1.14 and 1.07). The strongest predictors of crash among primary prevention ICD recipients were male sex, active vehicle insurance in the past year and the number of crashes in the past year. The strongest predictors of crash among secondary prevention ICD recipients were male sex, no history of seizure, an active prescription for opioids and active vehicle insurance in the past year. Conclusions Crash prediction models based on health and driving data had a limited ability to distinguish individuals who subsequently crashed from individuals who did not. Observed crash risks are likely to be strongly influenced by unobserved changes in road exposure (the hours or miles of driving per week), limiting the application of these risk scores by clinicians and policy-makers.

Implementation of transcutaneous ultrasound-guided axillary vein access for implantations, revisions and upgrades of cardiac implantable electronic devices in a large tertiary care center

2025-06-24
Julius Nikorowitsch , Tahsin Üctas , Katrin Borof +7 more | Clinical Research in Cardiology
Abstract Background Central venous access for cardiac implantable electronic device (CIED) implantations is conventionally acquired via the cephalic or subclavian vein. Controlled data suggest that axillary vein access may reduce … Abstract Background Central venous access for cardiac implantable electronic device (CIED) implantations is conventionally acquired via the cephalic or subclavian vein. Controlled data suggest that axillary vein access may reduce complications. Objectives We, therefore, shifted institutional practice from subclavian vein access to ultrasound (US)-guided axillary vein access for new implantations and revisions or upgrades and report on implant success rates, learning curves and periprocedural complications. Methods Between January 2021 and August 2023, all patients undergoing CIED implantations, revisions or upgrades were analyzed. US-guided axillary access was introduced starting with one operator and spreading to most operators and trainees thereafter. Periprocedural outcomes and complications (pocket hematoma, hemothorax, and pneumothorax) of transcutaneous US-guided axillary vein access were compared to the subclavian vein access. Results In this study, 986 patients (median age: 75 years, interquartile range (IQR) 64–82 years, 35% women) with 87% new implantations and 13% revisions or upgrades were included. Transcutaneous US-guided axillary access was successful in 535/578 patients (93%), subclavian vein access in 400/408 patients (98%) ( p &lt; 0.001). For device upgrades or revisions specifically, axillary access was successful in 69/79 patients (87%), versus 45/47 patients (96%) with subclavian access ( p = 0.208). The learning curve for axillary access was steep with success rates of 93 after 30 cases per operator. Complications occurred in 2/578 patients (0.3%) undergoing axillary vein access versus 17/408 patients (4.2%) ( p &lt; 0.001) undergoing subclavian vein access. Conclusion The implementation of transcutaneous US-guided axillary vein access for implantation, revisions and upgrades of cardiac electronic devices is feasible in a large tertiary care center. The periprocedural complications are rare. Graphical abstract CIED cardiac implantable electronic device, US ultrasound

Pacemakers

2025-06-24
Omar M. Aldaas , Anne-Sophie Roberge-Lacharite , Ulrika Birgersdotter‐Green | NEJM Evidence
AbstractPacemakers are critical in the management of bradyarrhythmias. The authors review pacemaker fundamentals, indications, and device types, as well as the role of pacemakers in heart failure, emerging advancements, and … AbstractPacemakers are critical in the management of bradyarrhythmias. The authors review pacemaker fundamentals, indications, and device types, as well as the role of pacemakers in heart failure, emerging advancements, and current limitations.

CardioMEMS device impact on heart failure hospitalization rates: A pre- and post-implantation analysis

2025-06-23
Gurpreet Singh , Rajveer Sangera , P De Saint Maur +5 more | World Journal of Biology Pharmacy and Health Sciences
Introduction : The CardioMEMS HF System proactively manages heart failure by addressing hemodynamic congestion before overt symptoms appear. This device provides daily pulmonary artery pressure readings, enabling tailored medical therapy. … Introduction : The CardioMEMS HF System proactively manages heart failure by addressing hemodynamic congestion before overt symptoms appear. This device provides daily pulmonary artery pressure readings, enabling tailored medical therapy. This study investigates CardioMEMS' impact on heart failure hospitalization rates in a community hospital setting. Methods: A retrospective analysis was conducted on 58 heart failure patients who underwent CardioMEMS implantation. Heart failure-related hospitalization rates were compared one year before and after implantation using electronic health records and paired t-tests. Results: A statistically significant reduction in heart failure hospitalization rates was observed following CardioMEMS implantation (t-statistic: 3.7540265, p-value: 0.0004156). The average number of heart failure-related hospitalizations per patient per year decreased by 0.67. Discussion: The findings align with previous studies demonstrating the device's efficacy in proactively managing hemodynamic congestion and preventing hospitalizations. Remote monitoring technologies, like CardioMEMS, facilitate communication between physicians and patients, encouraging active participation. Integrating CardioMEMS into heart failure management programs optimizes its capabilities and promotes timely interventions. Conclusion: CardioMEMS is associated with a significant reduction in heart failure hospitalization rates in a community hospital, improving patient outcomes and community health.

Outcomes of Micra Leadless Pacemaker Implants in Centers With and Without Cardiac Surgery

2025-06-23
Gildardo Manzo , G. Giannola , Gerardo Nigro +7 more | Journal of Cardiovascular Electrophysiology

How to Improve Safety and Efficacy of Micra Leadless Pacemakers

2025-06-23
Naoya Kataoka , Teruhiko Imamura | Journal of Cardiovascular Electrophysiology

Acute Effects of Fusion Pacing Versus Standard CRT on Myocardial Function in Heart Failure Patients with LBBB

2025-06-22
Michał Kucio , Andrzej Kułach , Tomasz Skowerski +3 more | Journal of Clinical Medicine
Background/Objectives: Although cardiac resynchronization therapy (CRT) plays an established role in the management of heart failure, a significant proportion of patients do not respond despite appropriate candidate selection. The optimization … Background/Objectives: Although cardiac resynchronization therapy (CRT) plays an established role in the management of heart failure, a significant proportion of patients do not respond despite appropriate candidate selection. The optimization of CRT pacing is one strategy to enhance response. Fusion pacing algorithms aim to synchronize intrinsic right ventricular (RV) conduction with paced left ventricular (LV) activation, resulting in a more physiological ventricular depolarization pattern. This approach may improve electrical synchrony and enhance left ventricular contraction compared to conventional simultaneous biventricular pacing. The aim of this study was to compare the acute, beat-to-beat effects of standard biventricular pacing versus fusion pacing on myocardial function, using both conventional and speckle-tracking echocardiography in heart failure patients with left bundle branch block (LBBB). Methods: In total, 27 heart failure patients (21 men and 6 women) with reduced ejection fraction (EF &lt; 35%), left bundle branch block (QRS &gt; 150 ms), and newly implanted CRT-D systems (Abbott) underwent echocardiographic assessment immediately after device implantation. Echocardiographic parameters—including left atrial strain, left ventricular strain, TAPSE, mitral and tricuspid valve function, and cardiac output—were measured at 5 min intervals under three different pacing conditions: pacing off, simultaneous biventricular pacing, and fusion pacing using Abbott’s SyncAV® algorithm. Results: In our study, CRT led to a significant shortening of the QRS duration from 169 ± 19 ms at baseline to 131 ± 17 ms with standard biventricular pacing, and further to 118 ± 16 ms with fusion pacing (p &lt; 0.05). Despite the electrical improvement, no significant changes were observed in global longitudinal strain (GLS: −9.15 vs. −9.39 vs. −9.13; p = NS), left ventricular stroke volume (67.5 mL vs. 68.4 mL vs. 68.5 mL; p = NS), or left atrial parameters including strain, area, and ejection fraction. However, fusion pacing was associated with more homogeneous segmental strain patterns, improved aortic valve closure time, and enhanced right ventricular function as reflected by tissue Doppler-derived S’. Conclusions: Immediate QRS narrowing observed in CRT patients—particularly with fusion pacing optimization—is associated with a more homogeneous pattern of left ventricular contractility and improvements in selected measures of mechanical synchrony. However, these acute electrical changes do not translate into immediate improvements in stroke volume, global LV strain, or left atrial function. Longer-term follow-up is needed to determine whether the electrical benefits of CRT, especially with fusion pacing, lead to meaningful hemodynamic improvements.

Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis

2025-06-21
Bassel Almarie , Kevin Pacheco‐Barrios , Anna Carolyna Gianlorenço +3 more | Expert Review of Medical Devices
Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices. From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 … Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices. From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed. Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of studies. Efficacy analyses showed small Cohen's d effect sizes in 65.85% of outcomes, medium in 24.39%, and large in 9.76%, with a median NNT of 4.65. Industry funded 87.5% of randomized trials, and conflicts of interest were disclosed in 92.2% of publications. Approximately 20% of devices were recalled - exclusively invasive. Randomized trials had larger sample sizes (median 152 subjects) than nonrandomized studies (median 53; p < 0.001), and study duration varied significantly by indication (p < 0.001). Our findings reveal considerable heterogeneity in the evidence supporting neuromodulation devices, with trials showing systematic safety documentation but modest efficacy. Industry-funded trials dominate the evidence base, with recalls primarily limited to invasive technologies. Evidence gaps persist in minority representation and longitudinal data.

Gender and age differences in ICI-related cardiac irAEs

2025-06-21
| Reactions Weekly

Risk Factors for Mortality in Patients Undergoing Permanent Pacemaker Implant

2025-06-20
Gaurav Mittal , Dhivya Priya , Avinash Anantharaj +2 more | Indian Journal of Clinical Cardiology
Introduction Demographics, comorbidities, and pacemaker-related factors may affect survival in patients having permanent pacemakers. This study reports the mortality risk predictors in patients undergoing pacemaker implants. Methods This retrospective single-cohort … Introduction Demographics, comorbidities, and pacemaker-related factors may affect survival in patients having permanent pacemakers. This study reports the mortality risk predictors in patients undergoing pacemaker implants. Methods This retrospective single-cohort observational study was conducted in permanent pacemaker implant patients from January 2015 to March 2021 in a tertiary care center in India. Survival was assessed during follow-up. Independent risk predictors for mortality were identified by multivariate Cox regression analysis. Using these, a risk score was derived to categorize patients into different risk groups. Results A total of 683 patients were included. 16.1% of patients died during a mean of 3 years follow-up. Independent mortality risk predictors were age &gt;60 years at implant, diabetes mellitus, hemoglobin &lt;11 g/dL, baseline left ventricular ejection fraction &lt;50%, and presence of structural heart diseases. Sex, history of hypertension, atrial arrhythmias, indication for an implant, and higher serum creatinine value did not significantly affect survival. The preimplant mortality risk score showed patients with scores of 0-1 had 3.9% mortality, 2-3 had 18.6%, and scores of 4-6 had 35.4% mortality risk over 3 years of mean follow-up. Conclusion Poor survival in patients undergoing pacemaker implant was independently associated with older age at implant, history of diabetes mellitus, presence of anemia, baseline left ventricular systolic dysfunction, and presence of structural heart diseases. Our preimplant mortality risk score can help to categorize implant patients as low, intermediate, or high-risk groups.

Effects of phantom shocks on anxiety levels, coping skills and sleep quality in patients with implantable cardioverter/defibrillators

2025-06-20
Gözde Yontar , Neriman Aras | Kastamonu Medical Journal
Aims: This study aimed to investigate the effects of phantom shocks on anxiety levels, coping skills, and sleep quality in patients with implantable cardioverter defibrillators (ICDs). Specifically, it examined the … Aims: This study aimed to investigate the effects of phantom shocks on anxiety levels, coping skills, and sleep quality in patients with implantable cardioverter defibrillators (ICDs). Specifically, it examined the relationship between phantom shocks and these psychological variables by comparing ICD recipients who had experienced phantom shocks with those who had not. Methods: This observational study included 66 patients with ICDs, divided into two groups: those who had experienced phantom shocks (PS+) and those who had not (PS-). An additional control group of 66 participants without heart failure or ICD implantation was also included. Participants completed the Beck Depression Inventory, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and Florida Shock Anxiety Scale. Data were analyzed using SPSS software to compare psychological outcomes across the groups. Results: Patients in the PS+ group demonstrated significantly poorer sleep quality, higher levels of general anxiety, and greater ICD-related anxiety compared to the PS- group. Furthermore, the PS+ group had a significantly higher prevalence of prior psychiatric diagnoses, including anxiety and depression, compared to both the PS- and control groups. The control group reported the best sleep quality and the lowest anxiety levels overall. Conclusion: Phantom shocks are associated with impaired sleep quality, elevated anxiety, and increased ICD-related distress in patients with ICDs. These findings underscore the psychological burden faced by ICD recipients, particularly those experiencing phantom shocks. A multidisciplinary approach addressing both physical and psychological aspects is crucial for enhancing the overall well-being of these patients.

Implantable cardioverter‐defibrillators in ischaemic versus non‐ischaemic heart failure: Insights from the <scp>VICTORIA</scp> trial

2025-06-20
Pishoy Gouda , Wendimagegn Alemayehu , Adriaan A. Voors +7 more | European Journal of Heart Failure
Abstract Aims Guidelines recommend the use of implantable cardioverter‐defibrillators (ICDs) to reduce the risk of sudden cardiac death (SCD) among individuals with heart failure (HF) with reduced ejection fraction (HFrEF). … Abstract Aims Guidelines recommend the use of implantable cardioverter‐defibrillators (ICDs) to reduce the risk of sudden cardiac death (SCD) among individuals with heart failure (HF) with reduced ejection fraction (HFrEF). However, the magnitude of benefit from ICD therapy remains unclear in those with a non‐ischaemic aetiology of HF. Methods and results Participants with HFrEF and recent HF decompensation in the VICTORIA trial were categorized based on the utilization of a baseline ICD and HF aetiology. A propensity‐score adjusted model was used to assess the effect of the presence of an ICD on SCD, cardiovascular death (including SCD) and all‐cause death. Of 5040 participants with HFrEF (53.6% ischaemic; 46.4% non‐ischaemic), 1399 (27.8%) had an ICD. Over a median of 10.8 months, pre‐existing ICD was associated with an overall reduction in SCD (adjusted hazard ratio [aHR] 0.64, 95% confidence interval [CI] 0.43–0.96), but no difference in cardiovascular death (aHR 0.99, 95% CI 0.83–1.18) or all‐cause death (aHR 1.02, 95% CI 0.87–1.19). HF aetiology did not modify the effects of ICD on SCD (ischaemic HF: aHR 0.61, 95% CI 0.38–0.98; non‐ischaemic HF: aHR 0.72, 95% CI 0.36–1.43; p interaction = 0.69). Despite relative underuse of ICDs in women as compared to men (16.4% vs. 26.8%), women with an ischaemic cause of their HF had a significant reduction in SCD (aHR 0.2, 95% CI 0.05–0.82; p interaction = 0.029). The presence of atrial fibrillation modulated ICD treatment effect on SCD ( p interaction = 0.015), with no benefit observed in those with atrial fibrillation. Conclusions Among patients with HFrEF with recent decompensation, presence of an ICD was associated with a reduction in SCD, but did not translate to a reduction in the risk of cardiovascular or all‐cause death. Future research is required to evaluate which patients with HFrEF benefit from ICD implantation.

Atypical Lead Pathway Leading to Vocal Cord Paralysis and Tracheostomy Following Pacemaker Implantation

2025-06-20
Dariusz Jagielski , Jagoda Jacków‐Nowicka , Bruno Hrymniak +2 more | Journal of Clinical Medicine
The axillary and cephalic veins are commonly utilized for transvenous pacemaker lead access. They typically advance to the heart through the subclavian, brachiocephalic, and superior vena cava veins. Anatomical variations … The axillary and cephalic veins are commonly utilized for transvenous pacemaker lead access. They typically advance to the heart through the subclavian, brachiocephalic, and superior vena cava veins. Anatomical variations such as a persistent left superior vena cava (PLSVC) may pose a challenge, necessitating an alternative approach for lead placement. This anomaly can often be identified during venographic contrast imaging or by visualizing atypical venous courses during the procedure. Another challenge occurs when the venous pathway is tortuous. Careful monitoring during the procedure is crucial to ensure that the lead follows the intended path. If not, the lead may inadvertently enter a collateral, such as the inferior thyroid vein, which drains into the internal jugular or left brachiocephalic vein. Despite these deviations, the lead may eventually reach the heart, although via an unusual course. If such a lead is left in place, even in the absence of immediate complications, long-term outcomes are unpredictable and carry the risk of unforeseen complications.

Real-World Efficacy and Safety of the Subcutaneous Implantable Cardioverter Defibrillator: Insights from the GASP Registry

2025-06-20
Nikias Milaras , Evangelos Oikonomou , Κonstantinos P. Letsas +7 more | Biomedicines
Background: The advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) marked a significant milestone in the course of cardiac rhythm devices, particularly for patients who are deemed at high risk for … Background: The advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) marked a significant milestone in the course of cardiac rhythm devices, particularly for patients who are deemed at high risk for ventricular arrhythmias and sudden cardiac death. This extracardiac approach makes the S-ICD an especially valuable option for young patients, those with difficult venous access, or those at high risk of infection. Although the S-ICD does not provide pacing for bradycardia or heart failure, it has shown efficacy in treating ventricular arrhythmias while minimizing complications associated with transvenous systems. Methods: The purpose of this multicenter retrospective analysis was to assess the real-world efficacy and safety of the S-ICD in a heterogeneous population. Results: The GASP registry consisted of 114 patients, 68% male, aged 41 ± 15 years, with a mean LVEF of 50%. In the follow-up of 35 months, inappropriate shocks occurred in 7% while appropriate shocks occurred in 6.2%. The most common reasons for inappropriate shocks were myopotentials and atrial tachyarrhythmias. Thirty-day complication-free rates were 97.3%, with the majority of patients requiring device extraction due to infection. Over the longer term, four patients required re-intervention due to local discomfort, while one device was extracted for infection. In a multivariate analysis, complications were not significantly higher in the sicker population, such as those with diabetes, kidney disease requiring dialysis, or heart failure. Conclusions: These findings support the growing role of the S-ICD as an alternative to the TV-ICD, especially in patients without pacing indications.

Virtual cardiac resynchronization therapy using the patient-specific heart model can predict the clinical response

2025-06-19
Daishi Nakagawa , Ruriko Hayakawa , Seiryo Sugiura +6 more | Next research.

Intriguing pacing spike

2025-06-19
Luis Cerdán , Carlos Ruben Lopez-Perales | Emergency Medicine Journal

Quality of Life, Mood Disturbance, and Sexual Health in Implantable Cardioverter Defibrillators Recipients

2025-06-19
Rosa Amelia Herrera Viancha , S. Santos , Orestes Román Ortega +3 more | Clinical Nursing Research
Implantable Cardioverter Defibrillators (ICDs) are essential for managing life-threatening arrhythmias but can impact patients’ quality of life (QoL), mood, and sexual health. Although QoL may improve shortly after implantation, factors … Implantable Cardioverter Defibrillators (ICDs) are essential for managing life-threatening arrhythmias but can impact patients’ quality of life (QoL), mood, and sexual health. Although QoL may improve shortly after implantation, factors such as age, psychological state, and ICD shocks can influence long-term outcomes. Anxiety, depression, and fears around physical and sexual activity are common among ICD patients, yet the depth of these effects remains underexplored. This cross-sectional, correlational study examined associations between QoL, mood, and sexual health in 30 adult ICD patients (ages 27–83) within 3 years postimplantation, recruited from a Southeastern U.S. academic medical center. Participants completed the SF-36, Profile of Mood States, and Multidimensional Sexuality Questionnaire. Spearman’s correlations indicated that lower QoL was significantly associated with higher mood disturbance (rho = −0.645, p &lt; .001) and lower sexual health (rho = 0.535, p = .005), though no significant link was found between mood disturbance and sexual health (rho = −0.279, p = .168). Multiple linear regression confirmed that QoL was influenced by both mood and sexual health. Post-hoc power analysis using EpiData verified that the sample size ( n = 30) provided 90% power with a 5% error rate. These findings underscore the importance of addressing emotional and sexual well-being in ICD patient care. Targeted interventions could improve outcomes, but further research with larger samples is needed to deepen understanding of these relationships.

Impact of ventricular pacing modalities and pacing percentage on new-onset atrial fibrillation after dual-chamber pacemaker implantation

2025-06-19
Meng Zhang , Jian Xu , Jianhua Wang +4 more | Frontiers in Cardiovascular Medicine
Objective To investigate the impact of the ventricular pacing modalities and ventricular pacing percentage (VP) on the incidence of new-onset atrial fibrillation (AF) following dual-chamber pacemaker implantation. We aim to … Objective To investigate the impact of the ventricular pacing modalities and ventricular pacing percentage (VP) on the incidence of new-onset atrial fibrillation (AF) following dual-chamber pacemaker implantation. We aim to explore how these factors, along with left atrial diameter (LAD), contribute to AF development, providing insights into optimizing pacemaker settings to potentially reduce AF risk in pacemaker patients. Methods Between January 1, 2020, and December 31, 2022, a total of 371 patients who underwent initial dual-chamber pacemaker implantation at the Second Affiliated Hospital of Harbin Medical University were enrolled. These patients were categorized into two groups: the non-AF group and the AF group, based on the presence of new-onset AF during one-year follow-up. Regular remote follow-up visits were conducted postoperatively, with endpoint events defined as the detection of AF. A comparative analysis was performed to evaluate the differences in basic characteristics, implantation site of the ventricular lead, and pacemaker programming settings between the two groups. Results The AF group exhibited a significantly higher prevalence of hypertension and a greater proportion of left bundle branch pacing (LBBP) compared to the non-AF group. Additionally, the AF group had a lower proportion of patients with ventricular pacing (VP) in the 0%–39% range, but a higher proportion of patients in the 40%–79% range. Notably, the LBBP cohort demonstrated a significantly lower incidence of AF. The AF group also presented with a larger left atrial diameter (LAD). Multivariate analysis revealed that LBBP and VP in the 0%–39% range were independently associated with a reduced risk of new-onset atrial fibrillation AF. Among the predictive indicators for new-onset AF, both LBBP and LAD demonstrated notable sensitivity and specificity. Conclusions Ventricular pacing modalities and percentage significantly impact new-onset AF after dual-chamber pacemaker implantation. LBBP and lower VP percentages are associated with a lower risk of AF development, whereas a larger LAD may be linked to an increased likelihood of its onset. Optimizing these factors could potentially reduce the risk of AF in pacemaker patients.

Revisiting Abnormalities of Ventricular Depolarization: Redefining Phenotypes and Associated Outcomes Using Tree‐Based Dimensionality Reduction

2025-06-18
Mehak Gurnani , Konstantinos Patlatzoglou , Joseph Barker +7 more | Journal of the American Heart Association
Background Abnormal ventricular depolarization, evident as a broad QRS complex on an ECG, is traditionally categorized into left bundle‐branch block (LBBB) and right bundle‐branch block or nonspecific intraventricular conduction delay. … Background Abnormal ventricular depolarization, evident as a broad QRS complex on an ECG, is traditionally categorized into left bundle‐branch block (LBBB) and right bundle‐branch block or nonspecific intraventricular conduction delay. This categorization, although physiologically accurate, may fail to capture the nuances of diseases subtypes. Methods We used unsupervised machine learning to identify and characterize novel broad QRS phenogroups. First, we trained a variational autoencoder on 1.1 million ECGs and discovered 51 latent features that showed high disentanglement and ECG reconstruction accuracy. We then extracted these features from 42 538 ECGs with QRS durations &gt;120 milliseconds and employed a reversed graph embedding method to model population heterogeneity as a tree structure with different branches representing phenogroups. Results Six phenogroups were identified, including phenogroups of right bundle‐branch block and LBBB with varying risk of cardiovascular disease and mortality. The higher risk right bundle‐branch block phenogroup exhibited increased risk of cardiovascular death (adjusted hazard ratio [aHR], 1.46 [1.30–1.63], P &lt;0.0001) and all‐cause mortality (aHR, 1.24 [1.16–1.33], P &lt;0.0001) compared with the baseline phenogroup. Within LBBB ECGs, tree position predicted future cardiovascular disease risk differentially. Additionally, for subjects with LBBB undergoing cardiac resynchronization therapy, tree position predicted cardiac resynchronization therapy response independent of covariates, including QRS duration (adjusted odds ratio [aOR], 0.47 [0.25–0.86], P &lt;0.05). Conclusions Our findings challenge the current paradigm, highlighting the potential for these phenogroups to enhance cardiac resynchronization therapy patient selection for subjects with LBBB and guide investigation and follow‐up strategies for subjects with higher risk right bundle‐branch block.

Predictors of Atrial Fibrillation in Heart Failure Patients with Indications for ICD Implantation

2025-06-18
Т. A. Atabekov , Р. Е. Баталов , Е. А. Арчаков +5 more | Journal of Clinical Medicine
Background/Objectives: Atrial fibrillation (AF) is a prevalent arrhythmia that significantly complicates the management of heart failure (HF) patients, particularly those who have implantable cardioverter-defibrillators (ICDs). The interplay between AF and … Background/Objectives: Atrial fibrillation (AF) is a prevalent arrhythmia that significantly complicates the management of heart failure (HF) patients, particularly those who have implantable cardioverter-defibrillators (ICDs). The interplay between AF and inappropriate ICD therapy poses a critical challenge in optimizing patient outcomes, as inappropriate shocks can lead to increased morbidity, psychological distress, and a reduced quality of life. We aimed to explore the various clinical and demographic predictors of AF in HF patients with indications for ICD implantation. Methods: This study included 122 patients who were indicated for ICD implantation and had undergone transthoracic echocardiography (TE). We evaluated the relationships between clinical and demographic factors and the occurrence of AF, which was recorded either before ICD implantation or during the follow-up period afterward. From our findings, we established predictors and a risk model for AF. Results: Out of 122 HF patients with ICDs, 52 (42.6%) experienced an episode of AF either prior to ICD implantation or during a follow-up period of 20.5 [6.0; 53.0] months, as recorded by the ICDs' endogram. Patients with AF were older compared to those without AF (p < 0.001). Additionally, they exhibited a higher left ventricular early diastolic filling rate (LVE) (p = 0.006) and a greater left atrial index (LAI) (p = 0.002). These three factors-age, LVE and LAI-were found to be independently associated with AF in both univariable and multivariable logistic regression analyses. The final model, including age, LVE, and LAI, showed a good discrimination capability with an AUC of 0.775. At a cutoff value of >0.47, the model achieved a sensitivity of 67.3% and a specificity of 77.2% in identifying HF patients with ICDs at risk for AF. Conclusions: This study found that 42.6% of HF patients with ICDs experienced AF, with older age, higher LVE, and greater LAI identified as significant predictors.

Incidences and clinical outcomes of patients with a single or dual chamber implantable cardioverter‐defibrillator developing an indication for cardiac resynchronization therapy

2025-06-18
Ines Quataert , Maarten Blondeel , Sander Trenson +7 more | European Journal of Heart Failure

Resincronización cardíaca: una oportunidad para el momento oportuno

2025-06-18
Julián Aristizábal | Revista Colombiana de Cardiología

Electrocardiostimulation in modern cardiology

2025-06-17
Natal'ya Kinyasheva , E.S. Malyutina | Clinical Medicine and Pharmacology
From the moment the first pacemaker appeared to its improvement and widespread use in modern cardiology, more than 100 years of hard work, scientific experiments and research by a huge … From the moment the first pacemaker appeared to its improvement and widespread use in modern cardiology, more than 100 years of hard work, scientific experiments and research by a huge number of cardiologists, cardiac surgeons, physiologists and engineers have passed. The article is devoted to electrocardiostimulation, interventional manipulation, which is the most effective and, in most cases, the only method of treating clinically significant bradyarrhythmias. Information is provided on the types of modern pacemakers, their differences and application features in different clinical situations, the technique of resynchronization therapy, as well as the possibilities of pacemakers for the treatment and prevention of tachyarrhythmias.

Implante de resincronizador cardíaco en pacientes con alto porcentaje de estimulación en el ventrículo derecho e insuficiencia cardíaca refractaria

2025-06-17
Gastón Albina , Santiago Rivera , Ignacio Mondragón +3 more | Revista Argentina de Cardiología
Introducción: El implante de un resincronizador cardíaco en pacientes que presentan marcapasos o cardiodesfibrilador y que desarrollan insuficiencia cardíaca con disfunción sistólica es controvertido. Objetivo: Evaluar la evolución de estos … Introducción: El implante de un resincronizador cardíaco en pacientes que presentan marcapasos o cardiodesfibrilador y que desarrollan insuficiencia cardíaca con disfunción sistólica es controvertido. Objetivo: Evaluar la evolución de estos pacientes (upgrade). Métodos: Se analizaron los pacientes a quienes se les realizó upgrade durante el período 2011 a 2015. Resultados: Se incluyeron 21 pacientes, cuya edad promedio era de 70,7 ± 10,8 años. La duración del QRS fue de 180,9 ± 23,2 ms y la FEVI de 26,8 ± 7,7%. En cuanto a la estimulación del ventrículo derecho el resultado fue de 90,5 ± 19,3%. Diez pacientes fueron clasificados en clase funcional II y 11, en CF III. Se lograron implantes exitosos en 18 pacientes (85,7%). La FEVI al año de realizado el upgrade fue de 33,9 ± 10,4% (p = 0,028). Del total de pacientes, trece mejoraron al menos en una clase funcional, y solo cuatro volvieron a ser internados por IC (p = 0,048). El porcentaje de complicaciones fue del 14,28%. Conclusiones: La terapia de upgrade permitió mejorar los síntomas y reducir internaciones por insuficiencia cardíaca.

Chronic Cardiac Resynchronization Therapy-Defibrillator Infection Leading to Sepsis and Bilateral Septic Pulmonary Emboli: A Case Report

2025-06-16
T Makaridze , Tinatin Jomidava , Nikoloz Kvaratskhelia +3 more | Cureus

Coronary Sinus Venoplasty Using Cutting Balloon for Left Ventricular Lead Placement

2025-06-16
Pooja Shah , Jyotika Gupta , Niraj Yadav +1 more | Journal of Cardiovascular Electrophysiology
ABSTRACT Background Coronary Sinus Venous stenosis is rare; however, it is often encountered during left ventricular (LV) lead implantation, which is the cornerstone of cardiac resynchronization therapy (CRT). Plain balloon … ABSTRACT Background Coronary Sinus Venous stenosis is rare; however, it is often encountered during left ventricular (LV) lead implantation, which is the cornerstone of cardiac resynchronization therapy (CRT). Plain balloon angioplasty and anchor balloon technique have been described for LV lead implantation in patients with venous stenosis and tortuous anatomy. We investigate the efficacy of coronary vein angioplasty using a cutting balloon to facilitate the implantation of LV lead. Methods 452 patients who underwent standard CRT implantation from 2015 to 2024 were studied retrospectively. 21 patients (4.64%) had significant venous stenosis in the posterolateral vein, which required venous intervention to facilitate lead placement. Seven patients required cutting balloon dilatation for focal venous stenosis in which balloon dilation and anchor balloon technique failed. Results All seven patients had successful LV lead implantation in the target vein following cutting balloon venoplasty. There was no complication during the procedure and long‐term lead parameters were excellent. Conclusion Coronary vein angioplasty using a cutting balloon is an effective and safe technique to facilitate LV pacing lead placement in case of target vein stenoses.

How the wearable cardioverter defibrillator helps as temporary sudden cardiac death protection and a monitoring tool during pregnancy

2025-06-16
Karolina Kryczka , Zofia Dzielińska , Maciej Sterliński +2 more | Kardiologia Polska

Aveir Pacemaker

2025-06-16
| Biomedical Safety & Standards

Enhancing Heart Failure Management: A Systematic Review and Meta-Analysis of Continuous Remote Telemedical Management vs. In-Person Visit in Patients with Cardiac Implantable Electronic Devices

2025-06-16
B Veres , Boldizsár Kiss , Péter Fehérvári +5 more | Journal of Clinical Medicine
Background/Objectives: Remote telemedical management (RTM) in heart failure (HF) patients with cardiac implantable electronic devices (CIED) is a reliable approach to follow device-specific and heart failure-related parameters. However, while some … Background/Objectives: Remote telemedical management (RTM) in heart failure (HF) patients with cardiac implantable electronic devices (CIED) is a reliable approach to follow device-specific and heart failure-related parameters. However, while some positive outcome data is available, results are inconclusive. We aimed to assess the benefits of continuous remote telemonitoring (RTM) compared to the in-person visit (IPV) in reducing all-cause mortality, heart failure hospitalizations (HFH), cardiovascular (CV) deaths, and the occurrence of inappropriate therapy. Methods: The study comprised a systematic review and meta-analysis of randomized controlled trials (RCTs) testing RTM (device-related or other non-invasive telemonitoring systems) vs. IPV for the management of HF patients. The main endpoints were all-cause and CV mortality. Risk of bias and level of evidence were assessed. Hazard ratios (HRs), odds ratios (ORs) and 95% confidence intervals (CI) were calculated. CENTRAL, EMBASE and MEDLINE were searched, and only randomized controlled studies were included. Results: Sixteen RCTs were identified, comprising a total of 11,232 enrolled patients. Seven studies evaluated all-cause mortality, resulting in an OR 0.83 (95% CI 0.72 to 0.96). When CV mortality was assessed, the RTM group showed a significant benefit compared to the IPV group (OR 0.81, 95% CI 0.67 to 0.97). The risk of bias ranged from "low" to "some concerns" for most outcomes, and the certainty was low to moderate depending on the specific outcomes. Conclusions: RTM proved to be superior in reducing all-cause and CV mortality compared to IPV; however, there is a clear need to have standardized alert actions to achieve the mortality benefit.

An Absorbable Antibacterial Envelope Promotes Development of a Healthy Device Pocket: Results of the TYRX Pocket Health Study

2025-06-16
François Philippon , Elena Ladich , Renu Virmani +7 more | Journal of Cardiovascular Electrophysiology
ABSTRACT Introduction Creation of a pocket and implant of a cardiac implantable electronic device (CIED) elicits a foreign body response in the presence of the normal wound healing process. An … ABSTRACT Introduction Creation of a pocket and implant of a cardiac implantable electronic device (CIED) elicits a foreign body response in the presence of the normal wound healing process. An absorbable antibacterial envelope (TYRX™, Medtronic Inc.) was developed to stabilize CIEDs and reduce infections. However, characterization of its impact on pocket healing is limited. We aimed to characterize histological and morphometric features of device capsules in patients previously implanted with an absorbable TYRX. Methods The TYRX Pocket Health Study (NCT05356546) was a prospective, observational study conducted from June 2022 to July 2023 at 9 sites. The study evaluated characteristics in existing CIED pockets of patients previously implanted with an absorbable TYRX returning for device replacement. Tissue sections were obtained, stained, and evaluated for adhesions, capsule thickness, inflammation, neovascularization, and calcification and compared to a historical control. Results The mean time between procedures was 6.8 years. TYRX pockets had significantly decreased adhesions ( p &lt; 0.05) with no clinically significant calcification. TYRX capsules contained predominantly Type I collagen and were significantly thinner (0.33 ± 0.16 mm TYRX, 0.8 ± 0.3 mm controls, p &lt; 0.0001). TYRX pockets had low inflammation with 96% of TYRX pockets (26/27) having absent to mild inflammation. Conclusion In this prospective evaluation of long‐term pocket healing with an absorbable TYRX, reduced adhesions, low inflammation, and well‐formed capsules were observed with no clinically significant calcification. This suggests that TYRX may promote creation of a well‐healed pocket desirable for subsequent procedures.

Floating to Find Rhythm: Assessing Procedural Confidence and Competence in a Novel Transvenous Pacemaker Simulation

2025-06-16
Sachin Parikh , Cosimo Laterza , Benjamin Gilbert | Western Journal of Emergency Medicine

Cost-Effectiveness of an Intraoperative Antibacterial Envelope in Preventing Cardiac Implantable Device Associated Infections: A Systematic Review

2025-06-16
Sathvika Mudigonda , Eileen Hagarty , Lucy Y. Lei +6 more | EP Europace
Abstract Background and Aims Intraoperative use of an antibacterial envelope during surgery for cardiac implantable electronic device surgery reduces infection risk at increased procedural costs. The objective of this systematic … Abstract Background and Aims Intraoperative use of an antibacterial envelope during surgery for cardiac implantable electronic device surgery reduces infection risk at increased procedural costs. The objective of this systematic review was to synthesize the published economic literature on the cost-effectiveness of the antibacterial envelope. Methods A systematic review of the published literature was conducted to identify economic evaluations (i.e. cost-utility, cost-effectiveness, cost-benefit studies) comparing the antibacterial envelope compared with standard of care in preventing post-operative CIED infection. Systematic review best practices were followed, and study quality was assessed. Results Of 142 unique citations, 7 studies met the inclusion criteria for qualitative synthesis. All cost-effectiveness studies were conducted from the health care payer perspective of high-income countries. The base case analysis of most economic studies (5/7) reported a cost per quality-adjusted life year gained that exceeded country-specific societal thresholds for good value in health care. Cost-effectiveness was highly dependent on the baseline infection risk. That is, at current pricing, the antibacterial envelope may be cost-effective at base infection rates of greater than 3%, and cost-savings at infection rates than exceed 6%. Conclusions Routine use of an antibacterial envelope in patients undergoing CIED procedures (implantation or revision) is unlikely to be cost-effective except among those at high risk. Individualized risk assessment may help guide efficient and value-based use of this technology.

Comparing Efficacy and Complications Between Stylet‐Driven Leads and Lumenless Leads in Left Bundle Branch Area Pacing

2025-06-15
Adivitch Sripusanapan , Nicha Wareesawetsuwan , Natee Deepan +4 more | Pacing and Clinical Electrophysiology
ABSTRACT Background Left bundle branch area pacing (LBBAP) is an emerging technique in conduction system pacing (CSP) that may offer improved outcomes over traditional methods. Typically, lumenless leads are used; … ABSTRACT Background Left bundle branch area pacing (LBBAP) is an emerging technique in conduction system pacing (CSP) that may offer improved outcomes over traditional methods. Typically, lumenless leads are used; however, stylet‐driven leads have recently been considered. This study conducts a systematic review and meta‐analysis evaluating the efficacy and complications of stylet‐driven leads versus lumenless leads. Method Databases including PubMed, Embase, and Scopus were searched from inception to June 2024 for relevant studies. We included published prospective or retrospective randomized controlled trials and cohort studies using stylet‐driven leads or lumenless leads for LBBAP. Data were combined using a random‐effects, generic inverse variance method of DerSimonian and Laird. Results Sixty‐eight studies involving 8996 patients from 2016 to 2023 were included. From eight head‐to‐head studies, the stylet‐driven leads group had a comparable success rate (OR = 1.46, 95% CI: 0.89, 2.39) but showed shorter procedural time (weighted mean difference [WMD] = −16.82 min, 95% CI: −24.42, −9.21). Stylet‐driven leads had a higher pacing threshold at implantation (WMD = 0.09 V, 95% CI: 0.00, 0.17) and lower lead impedance (WMD = −86.13 ohms, 95% CI: −129.46, −42.80). QRS duration and R wave amplitude were comparable initially, but at follow‐up (1–12 months), stylet‐driven leads had a lower R wave amplitude (WMD = −1.92 mV, 95% CI: −3.33, −0.51). Complication rates were higher with stylet‐driven leads (OR = 1.80, 95% CI: 1.34, 2.41), particularly lead dislodgement (OR = 3.26, 95% CI: 1.75, 6.07) and helix damage (OR = 11.46, 95% CI: 3.58, 36.63). Conclusion In this meta‐analysis of 8996 patients, stylet‐driven leads for LBBAP showed a comparable success rate to lumenless leads but was associated with a higher complication risk.

Psychometric Performance of Florida Patient Acceptance Survey in Danish Implantable Cardioverter Defibrillator Patients.

2025-06-15
Ole Skov , Jørgen Johansen , Jens Cosedis Nielsen +7 more | PubMed
Patient device acceptance reflects the psychological adjustment to living with an implantable cardioverter defibrillator (ICD) and is an important outcome for ICD patients. The Florida Patient Acceptance Survey (FPAS) is … Patient device acceptance reflects the psychological adjustment to living with an implantable cardioverter defibrillator (ICD) and is an important outcome for ICD patients. The Florida Patient Acceptance Survey (FPAS) is the gold standard for assessing patient device acceptance; however, the most optimal factor structure of the FPAS is an open question. This study aimed to evaluate the psychometric properties of FPAS by conducting head-to-head comparison tests between the proposed factor structures using prospective data from a national, Danish randomized controlled trial (ACQUIRE-ICD). The sample included 478 first-time ICD recipients (mean age 59.6 ± 11.6 years), predominantly male (83.1%), assessed at ICD implantation and at 1-year follow-up (n = 364; 76.2%), completing the FPAS and measures of anxiety, depression, and Type D personality. Confirmatory factor analyses showed that the abbreviated 12-item, three-factor version had the best fit to the data (CFI = 0.929), shortly followed by the original 15-item, four-factor version (CFI = 0.917, Δχ2 (33) = 125.05, p < 0.001). Both were superior to the two-factor versions (CFI = 0.707 and 0.843). The psychometric properties of the abbreviated 12-item version and original 15-item version were satisfactory with a moderate fit to the data at both ICD implantation and at 1-year follow-up, along with good internal reliability and divergent validity. In a large prospective cohort from a national Danish ICD study, the shortened, three-factor, 12-item version of the FPAS appears to be the most suitable version. The FPAS demonstrated satisfactory psychometric properties at both ICD implantation and 1-year follow-up.

Safety and performance of the Medtronic 3830 lead in His-bundle and Left bundle branch area pacing: A single-center experience

2025-06-14
Alejandro Sánchez-Nadales , Abdullah Sarkar , Jose Sleiman +6 more | Journal of Interventional Cardiac Electrophysiology
Abstract Background Conduction system pacing (CSP) using His Bundle Pacing (HBP) and Left Bundle Branch Area Pacing (LBAP) is an evolving alternative to traditional right ventricular pacing (RVP), promising better … Abstract Background Conduction system pacing (CSP) using His Bundle Pacing (HBP) and Left Bundle Branch Area Pacing (LBAP) is an evolving alternative to traditional right ventricular pacing (RVP), promising better physiological outcomes. This study evaluates the safety, feasibility, and performance of HBP and LBAP with Medtronic SelectSecure 3830 leads. Methods We conducted a single-center retrospective analysis of 490 patients undergoing HBP or LBAP. The study assessed implant success rates, pacing thresholds, device longevity, and complication rates over an average follow-up of 28 months for HBP and 14 months for LBAP. Results The implantation success rate was 85% for HBP and 97.4% for LBAP. LBAP demonstrated lower and more stable pacing thresholds, with initial values of 0.8V at 0.5 ms rising slightly to 0.9V at 0.5 ms, and fewer device revisions compared to HBP, whose initial pacing threshold of 1.3V at 0.8ms increased to 1.68 V at 0.7ms. Complications were minimal and similar across both groups. The need for fewer device revisions and potential for prolonged device life highlighted LBAP as potentially more cost-effective. Cardiac function measured by LVEF remained stable across both groups. Conclusions Both HBP and LBAP are safe and feasible with comparable safety profiles. LBAP may offer advantages in terms of stability, fewer revisions, and extended device longevity. The study underscores the need for further research into optimal lead positioning and long-term outcomes of CSP, particularly for LBAP. Graphical Abstract

Unraveling Mitral Annular Disjunction: A Case Report of Ventricular Arrhythmia Detected via Smartwatch

2025-06-14
Samantha Lo , Sanjay Sivalokanathan , Nina Kukar | Reports — Medical Cases Images and Videos
Background and Clinical Significance: Mitral valve prolapse (MVP) is commonly benign, but may result in life-threatening arrhythmias and sudden cardiac death (SCD). Mitral annular disjunction (MAD) often coexists with mitral … Background and Clinical Significance: Mitral valve prolapse (MVP) is commonly benign, but may result in life-threatening arrhythmias and sudden cardiac death (SCD). Mitral annular disjunction (MAD) often coexists with mitral valve prolapse (MVP) and has been implicated in the development of ventricular arrhythmias through myocardial stretch and fibrosis. Case Presentation: Here, we present a case that highlights the diagnostic value of multimodal imaging in evaluating ventricular ectopy in the context of MVP and MAD. A 72-year-old male presented to the cardiology clinic with palpitations and fatigue, compounded by an arrhythmia identified by his Apple Watch. Holter monitoring revealed premature ventricular contractions (PVCs), with cardiac magnetic resonance imaging (CMR) demonstrating MAD and basal inferolateral scarring. Despite minimal symptoms and normal echocardiographic imaging, CMR findings highlight the utility of advanced cardiovascular imaging in patients with newly detected ventricular arrhythmias. Conclusion: This case highlights the importance of integrating consumer wearables and advanced imaging in evaluating ventricular ectopy and its evolving role in risk stratification for patients with MVP, even in the absence of overt symptoms.

Heart Failure and Wide QRS: Clinical and Pharmacological Perspectives

2025-06-13
Alfredo Mauriello , Adriana Correra , Gerardo Elia Del Vecchio +7 more | Biomedicines
Heart failure (HF) is a highly prevalent cardiovascular clinical syndrome. Health care spending on HF treatment is high. Therefore, its treatment has generated a great deal of interest in pharmacological … Heart failure (HF) is a highly prevalent cardiovascular clinical syndrome. Health care spending on HF treatment is high. Therefore, its treatment has generated a great deal of interest in pharmacological research in recent years. Recent guidelines have introduced several molecules for the treatment of HF that have demonstrated safety, and above all, efficacy. One of the worst aspects of HF is ventricular dyssynchrony (VD) with a wide QRS interval. Currently, the cornerstone of VD therapy is cardiac resynchronization therapy (CRT). Our comprehensive review aims to analyze the effects of new molecules on QRS width and understand whether these molecules can provide benefits.

Selective and non-selective left bundle branch pacing

2025-06-13
T. A. Pavlenko , Yu. Yu. Gulyaev , M. V. Gorev | Journal of Arrhythmology
Left bundle branch (LBB) pacing is a novel method of cardiac pacing, which can prevent development of interventricular dyssynchrony, and also could be used as a resynchronization therapy in patients … Left bundle branch (LBB) pacing is a novel method of cardiac pacing, which can prevent development of interventricular dyssynchrony, and also could be used as a resynchronization therapy in patients with low ejection fraction and LBB block. Demonstration of the specific electrocardiographic criteria is essential to confirm LBB capture.

Comparative assessment of cardiac arrhythmias and clinical and economic analysis using remote telemetry in elderly and senile patients following dual-chamber pacemaker implantation

2025-06-13
S. A. Peshkov , Д. С. Титов , V.O. Povarov +1 more | Journal of Arrhythmology
Aim . To compare the frequency and timing of cardiac arrhythmia detection and conduct a clinical and economic analysis of remote telemetry (RT) in elderly and senile patients following dual-chamber … Aim . To compare the frequency and timing of cardiac arrhythmia detection and conduct a clinical and economic analysis of remote telemetry (RT) in elderly and senile patients following dual-chamber pacemaker (PM) implantation compared to in-person clinical follow-up over a 12-month period. Methods . A prospective study was conducted involving 92 patients (50% female), with a mean age of 71,5 years. The intervention group (n=39) was monitored remotely using the Medtronic CareLink Network, USA, with patients transmitting data monthly for one year. The control group (n=53) underwent in-person clinical follow-ups at one month and one year post-implantation. The groups were comparable in age, sex, clinical diagnoses, and complications (p&gt;0,05). A cost-effectiveness analysis (CEA) was performed, and the cost-effectiveness ratio (CER) was calculated. Results . No statistically significant differences were observed between the experimental and control groups in the frequency of cardiac arrhythmias. However, significant differences were found in the timing of arrhythmia detection (p&lt;0,001), with earlier detection in the experimental group. According to the results of the clinical and economic costeffectiveness analysis, the CER value for the remote monitoring method (33226,30 [33226,30; 33226,30]) is statistically significantly lower than the similar coefficient for in-person diagnostics (373542,00 [3735,42; 373542,00]). Conclusion . The use of RT in elderly and senile patients following dual-chamber PM implantation did not show a statistical difference in arrhythmia detection rates. However, cardiac arrhythmias were diagnosed earlier in the experi­ mental group. The cost-effectiveness analysis demonstrated that RT requires lower financial costs to achieve a unit of effectiveness compared to in-person monitoring.

Cardiac resynchronization therapy: towards personalized device selection. Results of a two-year prospective study

2025-06-13
D. А. Zorin , Н. Н. Илов , I. R. Karimov +2 more | Journal of Arrhythmology
Aim . To conduct a comparative analysis of clinical, instrumental, and laboratory diagnostic methods and to identify factors determining the likelihood of sustained paroxysmal ventricular tachyarrhythmias (VT) in patients with … Aim . To conduct a comparative analysis of clinical, instrumental, and laboratory diagnostic methods and to identify factors determining the likelihood of sustained paroxysmal ventricular tachyarrhythmias (VT) in patients with indications for cardiac resynchronization therapy (CRT). Methods . The study included 124 patients with chronic heart failure (CHF) and an implanted CRT-D system. The median age was 58 (52-63) years. Patients were followed for 24 months. Clinical and demographic characteristics, electrocardiographic data, speckle-tracking echocardiographic parameters, and blood biomarker levels were assessed. The primary endpoint was the occurrence of sustained VT episodes recorded by the implanted device. A multivariate logistic regression model was developed to predict the two-year probability of VT occurrence. Results . During the follow-up period, 29 patients (23.3%) experienced episodes of sustained VT. Univariate analysis identified seven candidate predictors with the highest potential for reaching the endpoint. These included: clinical factors (presence of coronary artery disease and atrial fibrillation); ECG parameters (modified QRS index &gt;0.6, presence of left bundle branch block (LBBB) according to Strauss criteria); echocardiographic findings (global longitudinal strain ≥ -6%, mitral regurgitation of grade 2 or higher); and laboratory markers (galectin-3 ≥ 12 ng/mL). Based on these variables, a predictive model was developed using binary logistic regression to estimate the two-year risk of VT in patients with CRT indications. The Strauss LBBB criterion, although statistically significant in univariate analysis, was not included in the final model. At a regression function cut-off value of 0.228, the model demonstrated a diagnostic accuracy of 73.6% (sensitivity - 86.2%, specificity - 69.6%). The area under the ROC curve was 0.779, which, according to expert grading, indicates good model performance. Conclusion . The study identified several independent predictors of sudden cardiac death risk in patients with implanted CRT-D devices and enabled the construction of a multifactorial prognostic model. The findings suggest the potential for developing a personalized algorithm for device selection.

Follow-up telefonico infermieristico e outcome degli assistiti con scompenso cardiaco: studio osservazionale retrospettivo

2025-06-13
Ivana Srđan Janjić , Alessandro Caldarola , Giuseppina Graceffa +3 more | Scenario - Il Nursing nella sopravvivenza
Introduzione: lo Scompenso Cardiaco (SC) è associato ad elevati tassi di riammissione ospedaliera e mortalità. Il follow-up telefo- nico infermieristico è riconosciuto come efficace nel garantire un’adeguata continuità assistenziale e … Introduzione: lo Scompenso Cardiaco (SC) è associato ad elevati tassi di riammissione ospedaliera e mortalità. Il follow-up telefo- nico infermieristico è riconosciuto come efficace nel garantire un’adeguata continuità assistenziale e ridurre le complicanze post dimissione. Obiettivo: valutare l’impatto di un programma di follow-up telefonico infermieristico sulla diminuzione delle riammissioni ospeda- liere e della mortalità a 6 e 12 mesi dalla dimissione per SC. Materiali e Metodi: lo studio osservazionale retrospettivo di coorte si è svolto presso l’ambulatorio Cardiologico di un ospedale spoke del Nord-est Italia. Sono stati confrontati due gruppi di pazienti affetti da SC, dei quali uno solo sottoposto al follow-up telefo- nico. Risultati: nei primi 6 mesi, il gruppo senza follow-up ha avuto una media di 0,56 riammissioni ospedaliere rispetto a 0,2 del gruppo con follow-up (P=0.004). La mortalità a 6 mesi era del 20% nel gruppo senza follow-up e del 4% nel gruppo con follow-up (P=0.014). Nel secondo semestre le differenze nelle riammissioni e nella mortalità non sono risultate statisticamente significative. Conclusioni: il follow-up telefonico da parte di personale infermieristico esperto, nell’ottica di una presa in carico completa che pre- vede monitoraggio dei sintomi e coaching infermieristico, effettuato nei 6 mesi successivi a un ricovero per SC acuto, ha un impatto positivo significativo sul numero di riammissioni ospedaliere e mortalità.

Transvenous Lead Extraction in Patients with Congenital Heart Disease

2025-06-12
Andrea Csillik , Rita B. Gagyi , Attila Kardos +4 more | Journal of Clinical Medicine
Background/Objectives: A significant subset of congenital heart disease (CHD) patients undergo a transvenous pacemaker (PM)/implantable cardioverter defibrillator (ICD) lead extraction (TLE) in their lifetime. We aimed to report on the … Background/Objectives: A significant subset of congenital heart disease (CHD) patients undergo a transvenous pacemaker (PM)/implantable cardioverter defibrillator (ICD) lead extraction (TLE) in their lifetime. We aimed to report on the outcome and complexity of TLEs in CHD patients for whom a powered mechanical sheath was used. Methods: This retrospective study included 175 consecutive TLEs performed at our centre. Overall, 13 TLEs in CHD patients and 162 TLEs in non-CHD patients were performed. A total of 264 leads were extracted. Results: CHD patients were younger than non-CHD patients at the time of their first lead implant (21.2 ± 17 vs. 57.1 ± 18 years; p &lt; 0.01) and at the time of lead extraction (33.38 ± 13 vs. 63.31 ± 16 years; p &lt; 0.01). The leads extracted from CHD patients were significantly older than the leads extracted from non-CHD patients (median: 8.0 vs. 4.0 years; p &lt; 0.01). CHD patients and non-CHD patients did not differ in terms of the procedural (92% vs. 87%; p = 0.581) and clinical success rates (100% vs. 91%; p = 0.269). The two patient groups did not differ in terms of their procedural complication rate (0% vs. 11%; p = 0.191). There were no differences in the extraction techniques used, i.e., rotational mechanical sheaths were used in 61% of CHD extractions and in 38% of non-CHD extractions; p = 0.11. Conclusions: TLEs that use rotational mechanical sheaths as an advanced technique can be safely and effectively performed in CHD patients. The outcome and complexity of TLEs in CHD patients are comparable with those in non-CHD patients that undergo this procedure.