Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation

Bharath Yarlagadda, Mohit K. Turagam, Tawseef Dar, Pragna Janagam, Vaishnavi Veerapaneni, Donita Atkins, Sudharani Bommana, Paul Andrew Friedman, Abhishek J. Deshmukh, Rahul Doshi, Vivek Y. Reddy, Srinivas R. Dukkipati, Andrea Natale, Dhanunjaya Lakkireddy

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). Objectives: The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. Methods: We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. Results: A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12–18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P =.66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P =.30). Conclusion: Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.

Original languageEnglish (US)
Pages (from-to)994-1000
Number of pages7
JournalHeart Rhythm
Volume15
Issue number7
DOIs
StatePublished - Jul 1 2018

Fingerprint

Atrioventricular Node
Atrial Fibrillation
Safety
Multicenter Studies
Observational Studies
Equipment and Supplies

Keywords

  • Atrial fibrillation
  • AV node ablation
  • Leadless pacemakers
  • Nanostim
  • Transvenous pacemaker

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Yarlagadda, B., Turagam, M. K., Dar, T., Janagam, P., Veerapaneni, V., Atkins, D., ... Lakkireddy, D. (2018). Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. Heart Rhythm, 15(7), 994-1000. https://doi.org/10.1016/j.hrthm.2018.02.025

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. / Yarlagadda, Bharath; Turagam, Mohit K.; Dar, Tawseef; Janagam, Pragna; Veerapaneni, Vaishnavi; Atkins, Donita; Bommana, Sudharani; Friedman, Paul Andrew; Deshmukh, Abhishek J.; Doshi, Rahul; Reddy, Vivek Y.; Dukkipati, Srinivas R.; Natale, Andrea; Lakkireddy, Dhanunjaya.

In: Heart Rhythm, Vol. 15, No. 7, 01.07.2018, p. 994-1000.

Research output: Contribution to journalArticle

Yarlagadda, B, Turagam, MK, Dar, T, Janagam, P, Veerapaneni, V, Atkins, D, Bommana, S, Friedman, PA, Deshmukh, AJ, Doshi, R, Reddy, VY, Dukkipati, SR, Natale, A & Lakkireddy, D 2018, 'Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation', Heart Rhythm, vol. 15, no. 7, pp. 994-1000. https://doi.org/10.1016/j.hrthm.2018.02.025
Yarlagadda, Bharath ; Turagam, Mohit K. ; Dar, Tawseef ; Janagam, Pragna ; Veerapaneni, Vaishnavi ; Atkins, Donita ; Bommana, Sudharani ; Friedman, Paul Andrew ; Deshmukh, Abhishek J. ; Doshi, Rahul ; Reddy, Vivek Y. ; Dukkipati, Srinivas R. ; Natale, Andrea ; Lakkireddy, Dhanunjaya. / Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. In: Heart Rhythm. 2018 ; Vol. 15, No. 7. pp. 994-1000.
@article{6b384742107c41eeb495dc34ce708e2c,
title = "Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation",
abstract = "Background: Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). Objectives: The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. Methods: We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. Results: A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12–18 months). Ninety-five percent of the LP group and 97{\%} of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P =.66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P =.30). Conclusion: Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.",
keywords = "Atrial fibrillation, AV node ablation, Leadless pacemakers, Nanostim, Transvenous pacemaker",
author = "Bharath Yarlagadda and Turagam, {Mohit K.} and Tawseef Dar and Pragna Janagam and Vaishnavi Veerapaneni and Donita Atkins and Sudharani Bommana and Friedman, {Paul Andrew} and Deshmukh, {Abhishek J.} and Rahul Doshi and Reddy, {Vivek Y.} and Dukkipati, {Srinivas R.} and Andrea Natale and Dhanunjaya Lakkireddy",
year = "2018",
month = "7",
day = "1",
doi = "10.1016/j.hrthm.2018.02.025",
language = "English (US)",
volume = "15",
pages = "994--1000",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",
number = "7",

}

TY - JOUR

T1 - Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation

AU - Yarlagadda, Bharath

AU - Turagam, Mohit K.

AU - Dar, Tawseef

AU - Janagam, Pragna

AU - Veerapaneni, Vaishnavi

AU - Atkins, Donita

AU - Bommana, Sudharani

AU - Friedman, Paul Andrew

AU - Deshmukh, Abhishek J.

AU - Doshi, Rahul

AU - Reddy, Vivek Y.

AU - Dukkipati, Srinivas R.

AU - Natale, Andrea

AU - Lakkireddy, Dhanunjaya

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Background: Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). Objectives: The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. Methods: We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. Results: A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12–18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P =.66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P =.30). Conclusion: Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.

AB - Background: Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). Objectives: The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. Methods: We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. Results: A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12–18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P =.66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P =.30). Conclusion: Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.

KW - Atrial fibrillation

KW - AV node ablation

KW - Leadless pacemakers

KW - Nanostim

KW - Transvenous pacemaker

UR - http://www.scopus.com/inward/record.url?scp=85048415594&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85048415594&partnerID=8YFLogxK

U2 - 10.1016/j.hrthm.2018.02.025

DO - 10.1016/j.hrthm.2018.02.025

M3 - Article

VL - 15

SP - 994

EP - 1000

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

IS - 7

ER -