Safety and efficacy of leadless pacemaker for cardioinhibitory vasovagal syncope

Mohit K. Turagam, Rakesh Gopinathannair, Peter H. Park, Rangarao V. Tummala, Chandrasekhar Vasamreddy, Alap Shah, Scott Koerber, Yoaav Krauthammer, Luigi Di Biase, Ghulam Murtaza, Krishna Akella, Donita Atkins, Sudharani Bommana, Naresh Kodwani, Jorge Romero, Amin Al-Ahmad, Prajwala Lakkireddy, Domenico G. Della Rocca, Sanghamitra Mohanty, Yeongjin GwonAndrea Natale, Dhanunjaya R. Lakkireddy

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1575-1581
Number of pages7
JournalHeart Rhythm
Issue number9
StatePublished - Sep 2020


  • Asystole
  • Leadless pacemaker
  • Syncope
  • Vasovagal syncope

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)


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