Publications by authors named "Kenneth A Ellenbogen"

458 Publications

Eccentric hypertrophy in an animal model of mid- and long-term premature ventricular contraction-induced cardiomyopathy.

Heart Rhythm O2 2021 Feb 8;2(1):80-88. Epub 2021 Jan 8.

Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia.

Background: Tachycardia and heart rate irregularity are proposed triggers of premature ventricular contraction-induced cardiomyopathy (PVC-cardiomyopathy). Bigeminal premature atrial and ventricular contractions (PACs and PVCs) increase heart rate and result in rhythm irregularities but differ in their effects on ventricular synchrony. Comparing chronic bigeminal PACs with PVCs would provide insights into mechanisms of PVC-cardiomyopathy.

Objective: To compare the impact of chronic PACs and PVCs on ventricular hemodynamics, structure, and function.

Methods: Pacemakers were implanted in 27 canines to reproduce atrial (PACs, n = 7) or ventricular bigeminy (PVCs, n = 11) for 12 weeks, and compared to sham-operated animals (n = 9). Four additional animals were exposed to long-term bigeminal PVCs (48 weeks). Hemodynamic changes were assessed using a pressure-transducing catheter at baseline and 12 weeks. Cardiac remodeling was monitored by transthoracic echocardiography throughout the 12- and 48-week protocols in the respective groups.

Results: PVC group demonstrated a significant decrease in left ventricular (LV) ejection fraction and contractility (max dP/dt), impaired LV lusitropy (min dP/dt), and increase in LV dimensions and LV mass at 12 weeks without further deterioration beyond 16 weeks. Despite increased LV mass, relative wall thickness decreased, consistent with eccentric hypertrophy. No significant cardiac remodeling was noted in either sham or PAC groups at 12 weeks.

Conclusion: In contrast to bigeminal PACs, PVCs result in a cardiomyopathy characterized by reduced LV ejection fraction, LV dilation, and eccentric hypertrophy that plateaus between 12 and 16 weeks. The lack of remodeling in chronic PACs suggests that tachycardia and heart rate irregularity do not play a significant role on the development of PVC-cardiomyopathy.
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http://dx.doi.org/10.1016/j.hroo.2020.12.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183810PMC
February 2021

Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation.

Heart Rhythm O2 2020 Aug 28;1(3):173-179. Epub 2020 May 28.

Virginia Commonwealth University Medical Center, Richmond, Virginia.

Background: Although there are considerable data on the safety of cryoablation, data on the rare but severe complication of atrioesophageal fistula (AEF) following cryoballoon ablation are limited.

Objective: To report the global, user-reported incidence of AEF associated with cryoballoon ablation for the treatment of atrial fibrillation using Medtronic's complaint database.

Methods: User-reported cryoballoon ablation complications occurring between July 1, 2009, and March 31, 2019, were reviewed to identify cases of AEF. A global event rate of AEF was calculated by dividing the event count by total catheter utilization over the same period. Data on symptoms and patient sequalae were reported as available.

Results: More than 500,000 Arctic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, Arctic Front Advance ST, and Arctic Front Advance Pro; Medtronic, Inc) were distributed globally during the 9.75-year study period. During this time, 18 confirmed AEF, 1 suspected AEF, and 1 pericardial esophageal fistula were identified; therefore, global incidence of AEF associated with the Arctic Front family of ablation catheters was 0.00396%. Patients most commonly presented with fever (88.2%), and initial symptoms were reported a median of 21 (interquartile range: 4-30) days after the ablation. Although rare, the development of an AEF resulted in death in 68.8% (11/16) of patients with known outcomes.

Conclusions: AEF is a possible but rare complication of cryoballoon ablation with a reported frequency of 1 in every 25,000 patients treated. Awareness of the prevalence and manifestation of AEF associated with cryoballoon ablation is critical for early identification and treatment of this complication.
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http://dx.doi.org/10.1016/j.hroo.2020.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183952PMC
August 2020

Left bundle branch pacing is the best approach to physiological pacing.

Heart Rhythm O2 2020 Apr 27;1(1):59-67. Epub 2020 Apr 27.

Department of Cardiac Electrophysiology, Virginia Commonwealth University, Richmond, Virginia.

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http://dx.doi.org/10.1016/j.hroo.2020.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183895PMC
April 2020

Pursue physiological pacing therapy: A better understanding of left bundle branch pacing and left ventricular septal myocardial pacing.

Heart Rhythm 2021 May 13. Epub 2021 May 13.

Division of Cardiology, Virginia Commonwealth University Medical Center, Richmond, Virginia.

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http://dx.doi.org/10.1016/j.hrthm.2021.05.013DOI Listing
May 2021

Impact of His bundle pacing on right ventricular performance in patients undergoing permanent pacemaker implantation.

Pacing Clin Electrophysiol 2021 Jun 7;44(6):986-994. Epub 2021 May 7.

Department of Cardiology, Policlinico Casilino of, Rome, Rome, Italy.

Background: His-Bundle pacing (HBP) is an emerging technique for physiological pacing. However, its effects on right ventricle (RV) performance are still unknown.

Methods: We enrolled consecutive patients with an indication for pacemaker (PM) implantation to compare HBP versus RV pacing (RVP) effects on RV performance. Patients were evaluated before implantation and after 6 months by a transthoracic echocardiogram.

Results: A total of 84 patients (age 75.1±7.9 years, 64% male) were enrolled, 42 patients (50%) underwent successful HBP, and 42 patients (50%) apical RVP. At follow up, we found a significant improvement in RV-FAC (Fractional Area Change)% [baseline: HBP 34 IQR (31-37) vs. RVP 33 IQR (29.7-37.2),p = .602; 6-months: HBP 37 IQR (33-39) vs. RVP 30 IQR (27.7-35), p < .0001] and RV-GLS (Global Longitudinal Strain)% [baseline: HBP -18 IQR (-20.2 to -15) vs. RVP -16 IQR (-18.7 to -14), p = .150; 6-months: HBP -20 IQR(-23 to -17) vs. RVP -13.5 IQR (-16 to -11), p < .0001] with HBP whereas RVP was associated with a significant decline in both parameters. RVP was also associated with a significant worsening of tricuspid annular plane systolic excursion (TAPSE) (p < .0001) and S wave velocity (p < .0001) at follow up. Conversely from RVP, HBP significantly improved pulmonary artery systolic pressure (PASP) [baseline: HBP 38 IQR (32-42) mmHg vs. RVP 34 IQR (31.5-37) mmHg,p = .060; 6-months: HBP 32 IQR (26-38) mmHg vs. RVP 39 IQR (36-41) mmHg, p < .0001] and tricuspid regurgitation (p = .005) irrespectively from lead position above or below the tricuspid valve.

Conclusions: In patients undergoing PM implantation, HBP ensues a beneficial and protective impact on RV performance compared with RVP.
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http://dx.doi.org/10.1111/pace.14249DOI Listing
June 2021

Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathy.

Prog Cardiovasc Dis 2021 Apr 20. Epub 2021 Apr 20.

Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, United States of America.

The medical community's understanding of the consequences of premature ventricular contractions (PVCs) and PVC-induced cardiomyopathy has been derived mostly from observational and large population-based studies. Due to the difficulty of predicting the development of PVC-cardiomyopathy, the acute and chronic cardiac effects of PVCs and the mechanism of PVC-cardiomyopathy have been derived from pre-clinical studies with large animal models. Recently, these studies have described myocardial substrates that could potentially increase morbidity and mortality in patients with frequent PVCs and PVC-cardiomyopathy. In this paper, we provide an up-to-date comprehensive review of these pre-clinical and clinical studies.
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http://dx.doi.org/10.1016/j.pcad.2021.04.001DOI Listing
April 2021

Spectrum of arrhythmogenic substrate post minimally invasive maze surgery in patients with recurrent.

Pacing Clin Electrophysiol 2021 Jun 23;44(6):1054-1061. Epub 2021 Apr 23.

Division of Cardiology, Pauley Heart Center, Virginia Commonwealth University Medical Center, Richmond, Virginia, USA.

Background: Advancements in minimally invasive surgical ablation (MISA) have focused on improving pulmonary vein isolation. Additional ablation targets have been developed (such as posterior wall isolation). The mid- and long-term effects of current techniques (including electrophysiologic findings and recurrent arrhythmia mechanisms) have not previously been reported.

Methods: Twenty eight patients with recurrent atrial arrhythmias after bipolar clamp ablation of the pulmonary vein antrum, ganglionated plexi, posterior wall isolation (roof and floor lines to create a posterior box), and ligament of Marshall ligation/cauterization and left atrial appendage clipping underwent follow up electrophysiology study including left atrial mapping an average of 2.3 years postoperatively.

Results: Atrial fibrillation was the most common recurrent arrhythmia (n = 18) followed by micro-reentrant atrial tachycardia (n = 5), macro-reentry left atrial flutter (n = 3), and typical cavo-tricuspid isthmus atrial flutter (n = 2). Eighty six of 112 (77%) PVs mapped were electrically isolated, 16 (57%) patients had all four pulmonary veins (PVs) isolated. The posterior wall (PW) was completely isolated in only four (14%) patients, seven (25%) patients had normal PW voltage, while 17 (61%) patients had abnormal delayed or fractionated electrograms in the posterior wall (incomplete isolation). Abnormal PW electrograms were more frequently found in patients with complex recurrent left atrial arrhythmia (micro-reentry or left atrial macro-reentry flutter).

Conclusion: With current surgical techniques PV isolation has improved, but PW isolation remains challenging. Incomplete PW isolation may produce arrhythmogenic substrate.
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http://dx.doi.org/10.1111/pace.14242DOI Listing
June 2021

Outcomes of Premature Ventricular Contraction-Cardiomyopathy in the Veteran Population: A Secondary Analysis of the CHF-STAT Study.

JACC Clin Electrophysiol 2021 03 25;7(3):380-390. Epub 2020 Nov 25.

Washington Veterans Affairs Medical Center, Washington, DC, USA.

Objectives: This study sought to assess the rate and outcomes of premature ventricular contractions (PVC)-cardiomyopathy from the CHF-STAT (Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure) trial, a population with cardiomyopathy (left ventricular [LV] ejection fraction of <40%) and frequent PVCs (>10 PVCs per hour).

Background: PVCs are associated with heart failure and PVC-cardiomyopathy. The prevalence of PVC-cardiomyopathy and outcome benefits of PVC suppression are not clear.

Methods: A secondary analysis of the CHF-STAT study was performed to compare the rate of successful PVC suppression (≥80% PVC reduction), LV recovery (defined as improvement in LV ejection fraction of ≥10% points), and PVC-cardiomyopathy between amiodarone and placebo groups at 6 months. PVC-cardiomyopathy was defined if both PVC reduction of ≥80% and LV ejection fraction improvement of ≥10% were present at 6 months. Cardiac events (death or resuscitated cardiac arrest) were compared between PVC-cardiomyopathy versus non-PVC-cardiomyopathy during a 5-year follow-up.

Results: The rates of successful PVC suppression and LV recovery were significantly higher in the amiodarone (72% and 39%, respectively) when compared to the placebo group (12% and 16%, respectively; p < 0.001), regardless of cardiomyopathy etiology. PVC-cardiomyopathy was present in 29% and 1.8% of patients in the amiodarone and placebo groups, respectively (p < 0.001). Similar PVC-cardiomyopathy rates were found in ischemic (24% amiodarone vs. 2% placebo; p < 0.001) and nonischemic populations (41% amiodarone vs. 1.5% placebo; p < 0.001). Death and resuscitated cardiac arrest were significantly lower in patients with PVC-cardiomyopathy and those treated with amiodarone.

Conclusions: The overall prevalence of PVC-cardiomyopathy in the CHF-STAT study was significant regardless of ischemic substrate (29%, overall population; 41%, nonischemic cardiomyopathy). Treatment of PVC-cardiomyopathy with amiodarone is likely to improve survival in this high-risk population.
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http://dx.doi.org/10.1016/j.jacep.2020.08.028DOI Listing
March 2021

A Tale of 2 Blocks.

Circulation 2021 Mar 8;143(10):1062-1065. Epub 2021 Mar 8.

Division of Cardiac Electrophysiology, Pauley Heart Center, Virginia Commonwealth University, Richmond.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052981DOI Listing
March 2021

Coronary Artery Laceration During Epicardial Ablation.

JACC Clin Electrophysiol 2021 02;7(2):273-274

Virginia Commonwealth University, Pauley Heart Center, Richmond, Virginia, USA.

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http://dx.doi.org/10.1016/j.jacep.2020.11.011DOI Listing
February 2021

Arrhythmias in Cardiac Sarcoidosis Bench to Bedside: A Case-Based Review.

Circ Arrhythm Electrophysiol 2021 02 16;14(2):e009203. Epub 2021 Feb 16.

University of Washington School of Medicine, Seattle (L.L.V., K.K.P., R.K.C.).

Cardiac sarcoidosis is a component of an often multiorgan granulomatous disease of still uncertain cause. It is being recognized with increasing frequency, mainly as the result of heightened awareness and new diagnostic tests, specifically cardiac magnetic resonance imaging and F-fluorodeoxyglucose positron emission tomography scans. The purpose of this case-based review is to highlight the potentially life-saving importance of making the early diagnosis of cardiac sarcoidosis using these new tools and to provide a framework for the optimal care of patients with this disease. We will review disease mechanisms as currently understood, associated arrhythmias including conduction abnormalities, and atrial and ventricular tachyarrhythmias, guideline-directed diagnostic criteria, screening of patients with extracardiac sarcoidosis, and the use of pacemakers and defibrillators in this setting. Treatment options, including those related to heart failure, and those which may help clarify disease mechanisms are included.
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http://dx.doi.org/10.1161/CIRCEP.120.009203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8142901PMC
February 2021

A deeper look into conduction system pacing: From the bench to the bedside.

Heart Rhythm 2021 May 19;18(5):822-823. Epub 2021 Jan 19.

Division of Cardiology, Department of Medicine, Virginia Commonwealth University School of Medicine, Richmond, Virginia.

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http://dx.doi.org/10.1016/j.hrthm.2021.01.015DOI Listing
May 2021

Determinants of outcome impact of vein of Marshall ethanol infusion when added to catheter ablation of persistent atrial fibrillation: A secondary analysis of the VENUS randomized clinical trial.

Heart Rhythm 2021 Jan 19. Epub 2021 Jan 19.

Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas. Electronic address:

Background: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial demonstrated that adding vein of Marshall (VOM) ethanol infusion to catheter ablation (CA) improves ablation outcomes in persistent atrial fibrillation (AF). There was significant heterogeneity in the impact of VOM ethanol infusion on rhythm control.

Objective: The purpose of this study was to assess the association between outcomes and (1) achievement of bidirectional perimitral conduction block and (2) procedural volume.

Methods: The VENUS trial randomized patients with persistent AF (N = 343) to CA combined with VOM ethanol or CA alone. The primary outcome (freedom from AF or atrial tachycardia [AT] lasting longer than 30 seconds after a single procedure) was analyzed by 2 categories: (1) successful vs no perimitral block and (2) high- (>20 patients enrolled) vs low-volume centers.

Results: In patients with perimitral block, the primary outcome was reached 54.3% after VOM-CA and 37% after CA alone (P = .01). Among patients without perimitral block, freedom from AF/AT was 34.0% after VOM-CA and 37.0% after CA (P = .583). In high-volume centers, the primary outcome was reached in 56.4% after VOM-CA and 40.2% after CA (P = .01). In low-volume centers, freedom from AF/AT was 30.77% after VOM-CA and 32.61% after CA (P = .84). In patients with successful perimitral block from high-volume centers, the primary outcome was reached in 59% after VOM-CA and 39.1% after CA (P = .01). Tests for interaction were significant (P = .002 for perimitral block and P = .04 for center volume).

Conclusion: Adding VOM ethanol infusion to CA has a greater impact on outcomes when associated with perimitral block and performed in high-volume centers. Perimitral block should be part of the VOM procedure.
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http://dx.doi.org/10.1016/j.hrthm.2021.01.005DOI Listing
January 2021

Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study.

JACC Clin Electrophysiol 2021 01 30;7(1):73-84. Epub 2020 Sep 30.

Department of Cardiology, Division of electrophysiology Virginia Commonwealth University, Richmond, Virginia, USA.

Objectives: This study sought to evaluate the correlation between His bundle (HB) pacing (HBP) implantation characteristics, lead-tip location, and association of intraprocedural His recordings with approximated HB anatomic landmarks using computed tomography (CT) imaging.

Background: HBP continues to grow in clinical practice due to offering true physiological pacing. However, a clear understanding of HB anatomy and the lead-tip location's influence on pacing characteristics is lacking.

Methods: The IMAGE-HBP study (Imaging Study of Lead Implant for His Bundle Pacing) was a prospective, multicenter study designed to assess implantation characteristics of the SelectSecure Model 3830 lead placed at the HB, evaluate protocol-specified HBP success (His recording present on electrogram and HBP threshold ≤2.5 V at 1 ms), and correlation between lead-tip location by CT imaging and HBP characteristics as well as lead-related complications through 12 months.

Results: Sixty-nine patients underwent a lead implantation attempt at the HB. Of these, 61 patients (88%) had a lead successfully implanted at the HB, and 52 patients (75%) met the pre-specified definition of successful HBP. In 51 patients with CT imaging, 11 leads (22%) were placed in the atrial aspect of the HB region (36% selective HBP), and 40 leads (78%) were placed in the ventricular aspect (28% selective HBP). Four of the 51 patients had P-wave oversensing, all with leads in the atrium. Freedom from lead-related complication at 12 months was 93%.

Conclusions: Successful HBP could be achieved at lead-tip locations in the atrium or ventricle but is preferable in the ventricle to eliminate risk of oversensing. The IMAGE-HBP study offers better insight into approximated HB anatomic landmarks, lead-tip location, and correlation with pacing characteristics. (Imaging Study of Lead Implant for His Bundle Pacing [IMAGE-HBP]; NCT03294317).
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http://dx.doi.org/10.1016/j.jacep.2020.07.026DOI Listing
January 2021

Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study.

Circ Arrhythm Electrophysiol 2021 02 9;14(2):e009261. Epub 2021 Jan 9.

Department of Cardiology, the First Affiliated Hospital of Wenzhou Medical University, China (L.S., S. Wang, S. Wu, L.X., Z.H., X.C., R.Z., L.J., W.H.).

Background: Left bundle branch pacing (LBBP) is a novel pacing method and has been observed to have low and stable pacing thresholds in prior small short-term studies. The objective of this study was to evaluate the feasibility and safety of LBBP in a large consecutive diverse group of patients with long-term follow-up.

Methods: This study prospectively enrolled 632 consecutive pacemaker patients with attempted LBBP from April 2017 to July 2019. Pacing parameters, complications, ECG, and echocardiographic measurements were assessed at implant and during follow-up of 1, 6, 12, and 24 months.

Results: LBBP was successful in 618/632 (97.8%) patients according to strict criteria for LBB capture. Mean follow-up time was 18.6±6.7 months. Two hundred thirty-one patients had follow-up over 2 years. LBB capture threshold at implant was 0.65±0.27 mV at 0.5 ms and 0.69±0.24 mV at 0.5 ms at 2-year follow-up. A significant decrease in QRS duration was observed in patients with left bundle branch block (167.22±18.99 versus 124.02±24.15 ms, <0.001). Postimplantation left ventricular ejection fraction improved in patients with QRS≥120 ms (48.82±17.78% versus 58.12±13.04%, <0.001). The number of patients with moderate and severe tricuspid regurgitation decreased at 1 year. Permanent right bundle branch injury occurred in 55 (8.9%) patients. LBB capture threshold increased to >3 V or loss of bundle capture in 6 patients (1%), 2 patients of them had a loss of conduction system capture. Two patients required lead revision due to dislodgement.

Conclusions: This large observational study suggests that LBBP is feasible with high success rates and low complication rates during long-term follow-up. Therefore, LBBP appears to be a reliable method for physiological pacing for patients with either a bradycardia or heart failure pacing indication.
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http://dx.doi.org/10.1161/CIRCEP.120.009261DOI Listing
February 2021

Intermediate-term performance and safety of His-bundle pacing leads: A single-center experience.

Heart Rhythm 2021 May 5;18(5):743-749. Epub 2021 Jan 5.

Division of Cardiac Electrophysiology, Virginia Commonwealth University, Richmond, Virginia. Electronic address:

Background: The short-term safety, feasibility, and performance of His-bundle pacing (HBP) leads have been reported; however, their longer-term performance beyond 1 year remains unclear.

Objective: The purpose of this study was to examine the intermediate-term performance and safety of HBP.

Methods: All HBP lead implants at Virginia Commonwealth University between January 2014 and January 2019 were analyzed. HBP was performed using a Medtronic SelectSecure 3830-69 cm pacing lead.

Results: Of 295 attempts, successful HBP implantation (selective or nonselective) was seen in 274 cases (93%). Mean follow-up duration was 22.8 ± 19.5 months (median 19.5; interquartile range 11-33). Mean age was 69 ± 15 years; 58% were males; and ejection fraction <50% was noted in 30%. Indications for pacemaker included sick sinus syndrome in 41%, atrioventricular block in 36%, cardiac resynchronization therapy in 7%, and refractory atrial fibrillation in 15%. Selective HBP was achieved in 33%. Mean HBP capture threshold at implant was 1.1 ± 0.9 V at 0.8 ± 0.2 ms, which significantly increased at chronic follow-up to 1.7 ± 1.1 V at 0.8 ± 0.3 ms (P <.001). Threshold was ≥2.5 V in 24% of patients, and 28% had an increase in HBP threshold ≥1 V. Loss of His-bundle capture at follow-up (septal right ventricular pacing) was seen in 17%. There was a total of 31 (11%) lead revisions, primarily for unacceptably high thresholds.

Conclusion: Although HBP can prevent or improve pacing-induced cardiomyopathy, the elevated capture thresholds, loss of His-bundle capture, and lead revision rates at intermediate follow-up are of concern. Longer-term follow-up data from multiple centers are needed.
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http://dx.doi.org/10.1016/j.hrthm.2020.12.031DOI Listing
May 2021

Impact of QRS morphology on response to conduction system pacing after atrioventricular junction ablation.

ESC Heart Fail 2021 Apr 4;8(2):1195-1203. Epub 2021 Jan 4.

Department of Cardiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.

Aims: His-Purkinje conduction system pacing (HPCSP) utilizing His (HBP) or left bundle branch pacing (LBBP) in patients with atrial fibrillation (AF) and wide QRS duration has not been well studied. We assessed the benefit of left bundle branch block (LBBB) correction during HPCSP in AF patients undergoing atrioventricular junction (AVJ) ablation with LBBB, compared with those with narrow QRS duration.

Methods And Results: This is an observational study in consecutive patients with typical LBBB or narrow QRS duration in whom we attempted HPCSP after AVJ ablation for refractory AF with a left ventricular ejection fraction (LVEF) ≤ 50%. Echocardiographic responses and clinical outcomes were assessed at baseline and during 1 year of follow-up. A total of 178 patients were enrolled, of which 170 achieved AVJ ablation + permanent HPCSP (age 69.3 ± 10.1 years; LVEF 34.3 ± 7.7%), 133 (78.2%) patients had a narrow QRS duration, and 37 (21.2%) had an LBBB. The QRS duration changed from a baseline of 159.7 ± 16.6 ms to a paced QRS duration of 110.4 ± 12.7 ms in the LBBB cohort and from 95.6 ± 10.4 to 100.8 ± 14.5 ms (both P < 0.001) in the narrow QRS cohort after AVJ ablation and pacing. Compared with the narrow QRS cohort, the LBBB cohort showed a greater absolute increase in LVEF (+22.3% vs. +14.2%, P < 0.001), higher super responder rate (71.4% vs. 49.2%, P = 0.011), and greater New York Heart Association (NYHA) class improvement (-1.9 vs. -1.4, P < 0.001) at 1 year.

Conclusion: Patients with LBBB have greater improvement in LVEF and NYHA class function than patients with narrow QRS from HPCSP after AVJ ablation.
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http://dx.doi.org/10.1002/ehf2.13181DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006676PMC
April 2021

Procedure characteristics and outcomes of atrial fibrillation ablation procedures using cryoballoon versus radiofrequency ablation: A report from the GWTG-AFIB registry.

J Cardiovasc Electrophysiol 2021 Feb 6;32(2):248-259. Epub 2021 Jan 6.

Duke Clinical Research Institute, Durham, North Carolina, USA.

Introduction: Cryoballoon ablation (CBA) is an alternative to radiofrequency ablation (RFA) for ablation of atrial fibrillation (AF) and real-world comparisons of this strategy are lacking. As such, we sought to compare patient and periprocedural characteristics and outcomes of CBA versus RFA in the Get With the Guidelines AFIB Registry.

Methods: Categorical variables were compared via the χ test and continuous variables were compared via the Wilcoxon rank-sum test. Adjusted analyses were performed using overlap weighting of propensity scores.

Results: A total of 5247 (1465 CBA, 3782 RFA) ablation procedures were reported from 33 sites. Those undergoing CBA more often had paroxysmal AF (60.0% vs. 48.8%) and no prior AF ablation (87.5% vs. 73.8%). CHA DS -VASc scores were similar. Among de novo ablations, most ablations involved intracardiac echocardiography and electroanatomic mapping, but both were less common with CBA (87.3% vs. 93.9%, p < .0001, and 87.7% vs. 94.6%, p < .0001, respectively). CBA was associated with shorter procedures (129 vs. 179 min, p < .0001), increased fluoroscopy use (19 vs. 11 min, p < .0001), and similar ablation times (27 vs. 35 min, p = .15). Nonpulmonary vein ablation was common with CBA: roof line 38.6%, floor line 20.4%, cavotricuspid isthmus 27.7%. RFA was associated with more total complications compared to CBA (5.4% vs. 2.3%, p < .0001), due to more volume overload and "other" events, although phrenic nerve injury was more common with CBA (0.9% vs 0.1%, p = .0001). In the adjusted model, any complication was less common among CBA cases (odds ratio, 0.45; confidence interval, 0.25-0.79, p = .0056).

Conclusion: CBA was associated with fewer complications, and shorter procedure times, and greater fluoroscopy times, compared to RFA. Nonpulmonary vein ablation and electroanatomic mapping system use was common with CBA.
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http://dx.doi.org/10.1111/jce.14858DOI Listing
February 2021

Permanent His Bundle Pacing in Patients With Congenital Complete Heart Block: A Multicenter Experience.

JACC Clin Electrophysiol 2021 04 24;7(4):522-529. Epub 2020 Dec 24.

Division of Cardiology, Geisinger Heart Institute, Wilkes-Barre, Pennsylvania, USA.

Objectives: This study retrospectively assessed the safety and efficacy of permanent His bundle pacing (HBP) in patients with congenital complete heart block (CCHB).

Background: HBP has become an accepted form of pacing in adults. Its role in CCHB is not known.

Methods: Seventeen patients with CCHB who underwent successful HBP were analyzed at 6 academic centers between 2016 and 2019. Nine patients had de novo implants, and 8 patients had previous right ventricular (RV) leads. Three RV paced patients had reduced left ventricular ejection fractions at the time of HBP. Implant/follow-up device parameters, New York Heart Association functional class, QRS duration, and left ventricular ejection fraction data were analyzed.

Results: Patients' mean age was 27.4 ± 11.3 years, 59% were women, and mean follow-up was 385 ± 279 days. The following parameters were found to be statistically significant between implant and follow-up, respectively: impedance, 602 ± 173 Ω versus 460 ± 80 Ω (p < 0.001); and New York Heart Association functional class, 1.7 ± 0.9 versus 1.1 ± 0.3 (p = 0.014). In patients with previous RV pacing, HBP resulted in a significant decrease in QRS duration: 167.1 ± 14.3 ms versus 118.3 ± 13.9 ms (p < 0.0001). In de novo implants, HBP resulted in increases in QRS duration compared with baseline: 111.1 ± 19.4 ms versus 91.0 ± 4.8 ms (p = 0.016). Other parameters exhibited no statistically significant differences. During follow-up, 2 patients required lead revision due to elevated pacing thresholds.

Conclusions: HBP seems to be safe and effective, with improvement in clinical outcomes in patients with CCHB. Larger studies with longer follow-up periods are required to confirm our findings.
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http://dx.doi.org/10.1016/j.jacep.2020.09.015DOI Listing
April 2021

Initial Experience, Safety, and Feasibility of Left Bundle Branch Area Pacing: A Multicenter Prospective Study.

JACC Clin Electrophysiol 2020 12 16;6(14):1773-1782. Epub 2020 Sep 16.

Division of Cardiology, Southlake Regional Health Center, University of Toronto, Toronto, Ontario, Canada.

Objectives: This study sought to evaluate the safety and feasibility of conduction system pacing by performing left bundle branch area pacing (LBBAP).

Background: There are limited data from single centers showing that LBBAP may circumvent the technical and electrophysiological challenges encountered with His bundle pacing.

Methods: Patients referred for pacemaker implantation at 2 centers between February 1, 2019, and March 31, 2020, were considered for LBBAP. LBBAP was performed by implanting a lumen-less, exposed helix lead approximately 2 cm distal to the His bundle and deep into the septum using a specialized delivery sheath. Implant success rates, complications, and electrophysiological parameters were assessed.

Results: LBBAP was successful in 305 of 341 patients (89%). Mean age was 72 ± 12 years; 45% were women; and 39% had QRS duration (QRSd) >130 ms, 22% right bundle branch block, 11% left bundle branch block, and 6% intraventricular conduction defect. Pacing indications were sinus node dysfunction in 28.7%, atrioventricular block in 52.5%, cardiac resynchronization therapy in 8.8%, and refractory atrial fibrillation in 10% of patients. Procedural duration was 74.7 ± 34 min and fluoroscopic time was 10.4 ± 8.1 min. The mean baseline QRSd and paced QRSd in the overall cohort was 114 ± 29.8 ms versus 112 ± 11.7 ms (p < 0.001) and in patients with infra-Hisian disease was 144.5 ± 19 ms versus 115 ± 12 ms (p < 0.001), respectively. Mean left ventricular activation time was 71.7 ± 11 ms at high output and 74.7 ± 11 ms at low output. LBB potentials were noted in 41% patients. Pacing threshold and R waves were 0.74 ± 0.3 V at 0.4 ms and 10.7 ± 4.9 mV at time of implantation and were stable at 1-, 3-, 6-, and 12-month follow-ups. The only major complications were 3 LBBAP lead dislodgements, 2 within 24 h and 1 at 2 weeks.

Conclusions: LBBA pacing is safe, feasible, and a reliable alternative to His bundle pacing for providing physiological pacing. Randomized controlled studies are needed to confirm the safety, feasibility, and clinical outcomes of LBBAP.
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http://dx.doi.org/10.1016/j.jacep.2020.07.004DOI Listing
December 2020

Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study.

Circ Arrhythm Electrophysiol 2021 01 8;14(1):e008867. Epub 2020 Dec 8.

Massachusetts General Hospital, Boston (M.M.).

Background: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation.

Methods: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score.

Results: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline.

Conclusions: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.
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http://dx.doi.org/10.1161/CIRCEP.120.008867DOI Listing
January 2021

Is PVC-Induced Cardiomyopathy Truly Reversible?: A Deep Dive Into Questions That Remain Unanswered.

JACC Clin Electrophysiol 2020 10;6(11):1377-1380

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia, USA; Virginia Commonwealth University/Pauley Heart Center, Richmond, Virginia, USA.

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http://dx.doi.org/10.1016/j.jacep.2020.06.034DOI Listing
October 2020

Anatomy of the cardiac conduction system.

Pacing Clin Electrophysiol 2021 01 12;44(1):15-25. Epub 2020 Nov 12.

Division of Cardiology, Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia.

The specialized cardiomyocytes that constitute the conduction system in the human heart, initiate the electric impulse and result in rhythmic and synchronized contraction of the atria and ventricles. Although the atrioventricular (AV) conduction axis was described more than a century ago by Sunao Tawara, the anatomic pathway for propagation of impulse from atria to the ventricles has been a topic of debate for years. Over the past 2 decades, there has been a resurgence of conduction system pacing (CSP) by implanting pacing leads in the His bundle region in lieu of chronic right ventricular pacing that is associated with worse clinical outcomes. The inherent limitations of implanting the leads in the His bundle region has led to the emergence of left bundle branch area pacing in the past 3 years as an alternative strategy for CSP. The clinical experience from performing CSP has helped electrophysiologists gain deeper insight into the anatomy and physiology of cardiac conduction system. This review details the anatomy of the cardiac conduction system, and highlights some of the recently published articles that aid in better understanding of the AV conduction axis and its variations, the knowledge of which is critical for CSP. The remarkable evolution in technology has led to visualization of the cardiac conduction system using noninvasive, nondestructive high-resolution contrast-enhanced micro-computed tomography imaging that may aid in future CSP. We also discuss from anatomical perspective, the differences seen clinically with His bundle pacing and left bundle branch area pacing.
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http://dx.doi.org/10.1111/pace.14107DOI Listing
January 2021

Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial.

JAMA 2020 10;324(16):1620-1628

Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.

Importance: Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion.

Objective: To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation.

Design, Setting, And Participants: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N = 350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019.

Interventions: Patients were randomly assigned to catheter ablation alone (n = 158) or catheter ablation combined with vein of Marshall ethanol infusion (n = 185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures.

Main Outcomes And Measures: The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others.

Results: Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P = .04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P = .01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P = .04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P < .001) were significantly improved in vein of Marshall-treated patients. Adverse events were similar between groups.

Conclusions And Relevance: Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy.

Trial Registration: ClinicalTrials.gov Identifier: NCT01898221.
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http://dx.doi.org/10.1001/jama.2020.16195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592031PMC
October 2020

Show Me the P Wave: An Old Tool to Discern Atrioventricular Relationships.

Circulation 2020 Oct 19;142(16):1596-1598. Epub 2020 Oct 19.

Division of Clinical Cardiac Electrophysiology(K.A.E., S.K.P.), Virginia Commonwealth University, Richmond.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050260DOI Listing
October 2020

Separating the Forest From the Trees: New Tools for a Personalized Sudden Cardiac Death Risk Stratification.

J Am Heart Assoc 2020 10 7;9(20):e018957. Epub 2020 Oct 7.

Pauley Heart Center Virginia Commonwealth University Richmond VA.

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http://dx.doi.org/10.1161/JAHA.120.018957DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763384PMC
October 2020

Long-term durability of posterior wall isolation using the cryoballoon in patients with persistent atrial fibrillation: a multicenter analysis of repeat catheter ablations.

J Interv Card Electrophysiol 2020 Sep 30. Epub 2020 Sep 30.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, USA.

Purpose: There is a growing interest in performing pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) using the cryoballoon for the treatment of patients with persistent atrial fibrillation (AF). However, there is little known about the long-term durability of PWI using this approach.

Methods: In this multicenter study, we retrospectively examined the durability of PVI + PWI using the 28-mm cryoballoon by investigating the outcomes from consecutive patients referred for repeat catheter ablation.

Results: Altogether, 81/519 patients (15.6%) were referred for repeat catheter ablation. Repeat ablation was associated with a longer AF duration, hypertension, heart failure, multiple cardioversions, and antiarrhythmic therapy as well as larger left atrial (LA) diameters (49 ± 4 mm versus 43 ± 5 mm; P < 0.001) and greater need for "touch-up" (adjunct) radiofrequency ablation (44.4% versus 18.3%; P < 0.001). LA diameter also emerged as a significant predictor for adjunct radiofrequency ablation (P < 0.001). Durable PVI was observed in 66/81 patients (81.5%) and PWI in 67/81 patients (82.7%). Those with incomplete PWI exhibited larger LA diameters, particularly > 48 mm (negative predictive value = 89.7%). Lastly, an atypical LA posterior wall/roof flutter represented the third most common cause of arrhythmia recurrence and essentially every patient with incomplete PWI exhibited such an arrhythmia.

Conclusion: PWI performed using a 28-mm cryoballoon in conjunction with PVI exhibits long-term durability in the vast majority of patients with persistent AF. While LA diameter (particularly > 48 mm) is a significant predictor for the need for adjunct radiofrequency ablation when performing this technique, those with incomplete PWI invariably present with an atypical flutter using this substrate.
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http://dx.doi.org/10.1007/s10840-020-00887-8DOI Listing
September 2020

Comparison of Frequency of Atrial Fibrillation in Blacks Versus Whites and the Utilization of Race in a Novel Risk Score.

Am J Cardiol 2020 11 28;135:68-76. Epub 2020 Aug 28.

Pauley Heart Center, Division of Cardiovascular Diseases, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.

Blacks have a lower prevalence of atrial fibrillation (AF) compared with Whites. We sought to confirm previously reported ethnic trends in AF in Blacks and Whites in a large database, and develop a prediction score for AF. Over 330 million hospital discharges between the years 2003 to 2013 from the National Inpatient Sample database were analyzed. All hospitalizations with a diagnosis of AF formed the study cohort. Traditional risk factors for the development of AF were compared between Blacks and Whites. Univariate and multiple logistic regression analyses were used to formulate a risk score to predict AF-CHADSAVES (Congestive heart failure, Hypertension, Age>65 years, Diabetes Mellitus, prior Stroke, Age>75 years, Vascular disease, White Ethnicity, and previous cardiothoracic Surgery). AF prevalence in Whites was 11.3% vs 4.6% in Blacks (p < 0.001). Blacks were younger (33.8% vs 14.4% patients <65 years, p < 0.01) and had less males (46.3% vs 49.4%, p < 0.01). Blacks had more hypertension (71.3% vs 64.1%, p < 0.01), congestive heart failure (24.8% vs 22.6%, p < 0.01), diabetes mellitus with (7.5% vs 4.7%, p < 0.01) or without complications (30.3% vs 23.1%, p < 0.01), renal failure (29.7% vs 17.1%, p < 0.01), and obesity (13.1% vs 8.7%, p < 0.01). CHADSAVES predicted AF in the study population (NIS 2003 to 2013) with an AUC of 0.82 and verified in a validation cohort (NIS 2014) with an AUC of 0.85. In conclusion, our data confirm a significant AF ethnicity paradox. Despite a higher prevalence of traditional risk factors for AF, Blacks had >2-fold lower prevalence of AF compared with Whites. CHADSAVES can be used effectively to predict AF in inpatients.
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http://dx.doi.org/10.1016/j.amjcard.2020.08.029DOI Listing
November 2020

Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial.

JACC Clin Electrophysiol 2020 08;6(8):958-969

Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, USA.

Objectives: This study sought to evaluate the safety and effectiveness of catheter ablation of persistent atrial fibrillation (PsAF) using a porous tip contact force-sensing catheter.

Background: Although the safety and effectiveness of catheter ablation of paroxysmal atrial fibrillation are established, there are limited data on outcomes in patients with PsAF. As such, no ablation catheter is currently approved by the Food and Drug Administration for PsAF ablation.

Methods: The prospective, multicenter, nonrandomized PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). An individualized treatment approach was used including pulmonary vein isolation with ablation of additional targets permitted at the investigators' discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiography, and Holter monitoring for up to 15 months after ablation.

Results: Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event rate was 4.1% (15 events in 14 participants). Kaplan-Meier analyses estimated a primary effectiveness success rate of 61.7% and a clinical success rate of 80.4% at 15 months.

Conclusions: The results demonstrate the clinical safety and effectiveness of PsAF ablation using contact force-sensing technologies. The primary adverse event was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation. (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF; NCT02817776).
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http://dx.doi.org/10.1016/j.jacep.2020.04.024DOI Listing
August 2020

Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker.

Heart Rhythm 2020 12 4;17(12):2056-2063. Epub 2020 Aug 4.

Department of Cardiac Electrophysiology, Virginia Commonwealth University/Pauley Heart Center, Richmond, Virginia. Electronic address:

Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood.

Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM.

Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM.

Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40).

Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status.

Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.
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http://dx.doi.org/10.1016/j.hrthm.2020.07.035DOI Listing
December 2020