PMID- 32389681
OWN - NLM
STAT- MEDLINE
DCOM- 20210906
LR  - 20210906
IS  - 1556-3871 (Electronic)
IS  - 1547-5271 (Linking)
VI  - 17
IP  - 9
DP  - 2020 Sep
TI  - Safety and efficacy of leadless pacemaker for cardioinhibitory vasovagal syncope.
PG  - 1575-1581
LID - S1547-5271(20)30427-6 [pii]
LID - 10.1016/j.hrthm.2020.05.006 [doi]
AB  - BACKGROUND: Single-chamber leadless pacemakers (LPs) have been shown to be an 
      effective alternative to conventional transvenous pacemakers (CTPs), but their 
      benefit in the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown. 
      OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of 
      LP compared with dual-chamber CTP for CI-VVS. METHODS: We conducted a 
      multicenter, retrospective study comparing patients who received LP or 
      dual-chamber CTP for drug-refractory CI-VVS. CI-VVS was diagnosed clinically and 
      supported by cardiac monitoring and head-up tilt table testing. The primary 
      efficacy endpoint was freedom from syncope during follow-up. Secondary endpoints 
      included device efficacy and safety estimated by device-related major and minor 
      adverse events (AEs). RESULTS: Seventy-two patients (24 LP, 48 CTP; age 32 +/- 5.5 
      years; 90% female; syncope frequency 7.6 +/- 3.4 per year) were included. At 1 
      year, 91% of patients (22/24) in the LP group and 94% of patients (43/48) in the 
      CTP group met the primary efficacy endpoint (P = .7). Device efficacy endpoint 
      was met in 92% of the LP group and 98% of the CTP group (P = .2). Early major AEs 
      occurred in 2 of 24 in the LP group and 3 of 48 in the CTP group (P = .4). Late 
      major AEs occurred in 0 of 24 in the LP group and 2 of 48 in the CTP group (P = 
      1). CONCLUSION: In patients with CI-VVS, single-chamber LP demonstrated 
      equivalent efficacy in reducing syncopal events compared to dual-chamber CTP, 
      with a similar safety profile.
CI  - Copyright (c) 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights 
      reserved.
FAU - Turagam, Mohit K
AU  - Turagam MK
AD  - Department of Cardiovascular Medicine, Icahn School of Medicine at Mount Sinai, 
      New York, New York.
FAU - Gopinathannair, Rakesh
AU  - Gopinathannair R
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Park, Peter H
AU  - Park PH
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Tummala, Rangarao V
AU  - Tummala RV
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Vasamreddy, Chandrasekhar
AU  - Vasamreddy C
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Shah, Alap
AU  - Shah A
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Koerber, Scott
AU  - Koerber S
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Krauthammer, Yoaav
AU  - Krauthammer Y
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Di Biase, Luigi
AU  - Di Biase L
AD  - Division of Cardiac Electrophysiology, Montefiore/Albert Einstein College of 
      Medicine, New York, New York.
FAU - Murtaza, Ghulam
AU  - Murtaza G
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Akella, Krishna
AU  - Akella K
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Atkins, Donita
AU  - Atkins D
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Bommana, Sudharani
AU  - Bommana S
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Kodwani, Naresh
AU  - Kodwani N
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas.
FAU - Romero, Jorge
AU  - Romero J
AD  - Division of Cardiac Electrophysiology, Montefiore/Albert Einstein College of 
      Medicine, New York, New York.
FAU - Al-Ahmad, Amin
AU  - Al-Ahmad A
AD  - Texas Cardiac Arrhythmia Institute, Austin, Texas.
FAU - Lakkireddy, Prajwala
AU  - Lakkireddy P
AD  - Apollo School of Medical Sciences, Hyderabad, India.
FAU - Della Rocca, Domenico G
AU  - Della Rocca DG
AD  - Texas Cardiac Arrhythmia Institute, Austin, Texas.
FAU - Mohanty, Sanghamitra
AU  - Mohanty S
AD  - Texas Cardiac Arrhythmia Institute, Austin, Texas.
FAU - Gwon, Yeongjin
AU  - Gwon Y
AD  - Department of Biostatics, University of Nebraska Medical Center, Omaha, Nebraska.
FAU - Natale, Andrea
AU  - Natale A
AD  - Texas Cardiac Arrhythmia Institute, Austin, Texas.
FAU - Lakkireddy, Dhanunjaya R
AU  - Lakkireddy DR
AD  - Kansas City Heart Rhythm Institute, Overland Park, Kansas. Electronic address: 
      dlakkireddy@kchrf.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200508
PL  - United States
TA  - Heart Rhythm
JT  - Heart rhythm
JID - 101200317
SB  - IM
MH  - Adult
MH  - Cardiac Pacing, Artificial/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - *Pacemaker, Artificial
MH  - Recurrence
MH  - Retrospective Studies
MH  - Syncope, Vasovagal/diagnosis/physiopathology/*therapy
MH  - Tilt-Table Test
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Asystole
OT  - Leadless pacemaker
OT  - Syncope
OT  - Vasovagal syncope
EDAT- 2020/05/12 06:00
MHDA- 2021/09/07 06:00
CRDT- 2020/05/12 06:00
PHST- 2020/03/24 00:00 [received]
PHST- 2020/04/27 00:00 [revised]
PHST- 2020/05/04 00:00 [accepted]
PHST- 2020/05/12 06:00 [pubmed]
PHST- 2021/09/07 06:00 [medline]
PHST- 2020/05/12 06:00 [entrez]
AID - S1547-5271(20)30427-6 [pii]
AID - 10.1016/j.hrthm.2020.05.006 [doi]
PST - ppublish
SO  - Heart Rhythm. 2020 Sep;17(9):1575-1581. doi: 10.1016/j.hrthm.2020.05.006. Epub 
      2020 May 8.