ALternate Site Cardiac ResYNChronization (ALSYNC)

A prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy

John M. Morgan, Mauro Biffi, L. Gellér, Christophe Leclercq, Franco Ruffa, Stanley Tung, Pascal Defaye, Zhongping Yang, Bart Gerritse, Mireille Van Ginneken, Raymond Yee, Pierre Jais

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

Aims The ALternate Site Cardiac ResYNChronization (ALSYNC) study evaluated the feasibility and safety of left ventricular endocardial pacing (LVEP) using a market-released pacing lead implanted via a single pectoral access by a novel atrial transseptal lead delivery system. Methods and results ALSYNC was a prospective clinical investigation with a minimum of 12-month follow-up in 18 centres of cardiac resynchronization therapy (CRT)-indicated patients, who had failed or were unsuitable for conventional CRT. The ALSYNC system comprises the investigational lead delivery system and LVEP lead. Patients required warfarin therapy post-implant. The primary study objective was safety at 6-month follow-up, which was defined as freedom from complications related to the lead delivery system, implant procedure, or the lead ≥70%. The ALSYNC study enrolled 138 patients. The LVEP lead implant success rate was 89.4%. Freedom from complications meeting the definition of primary endpoint was 82.2% at 6 months (95% CI 75.6-88.8%). In the study, 14 transient ischaemic attacks (9 patients, 6.8%), 5 non-disabling strokes (5 patients, 3.8%), and 23 deaths (17.4%) were observed. No death was from a primary endpoint complication. At 6 months, the New York Heart Association class improved in 59% of patients, and 55% had LV end-systolic volume reduction of 15% or greater. Those patients enrolled after CRT non-response showed similar improvement with LVEP. Conclusions The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP.

Original languageEnglish
Pages (from-to)2118-2127
Number of pages10
JournalEuropean Heart Journal
Volume37
Issue number27
DOIs
Publication statusPublished - Jul 14 2016

Fingerprint

Cardiac Resynchronization Therapy
Multicenter Studies
Prospective Studies
Safety
Transient Ischemic Attack
Feasibility Studies
Warfarin
Lead
Stroke

Keywords

  • Heart failure
  • Left ventricular endocardial pacing
  • Prospective clinical trial
  • Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

ALternate Site Cardiac ResYNChronization (ALSYNC) : A prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. / Morgan, John M.; Biffi, Mauro; Gellér, L.; Leclercq, Christophe; Ruffa, Franco; Tung, Stanley; Defaye, Pascal; Yang, Zhongping; Gerritse, Bart; Van Ginneken, Mireille; Yee, Raymond; Jais, Pierre.

In: European Heart Journal, Vol. 37, No. 27, 14.07.2016, p. 2118-2127.

Research output: Contribution to journalArticle

Morgan, JM, Biffi, M, Gellér, L, Leclercq, C, Ruffa, F, Tung, S, Defaye, P, Yang, Z, Gerritse, B, Van Ginneken, M, Yee, R & Jais, P 2016, 'ALternate Site Cardiac ResYNChronization (ALSYNC): A prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy', European Heart Journal, vol. 37, no. 27, pp. 2118-2127. https://doi.org/10.1093/eurheartj/ehv723
Morgan, John M. ; Biffi, Mauro ; Gellér, L. ; Leclercq, Christophe ; Ruffa, Franco ; Tung, Stanley ; Defaye, Pascal ; Yang, Zhongping ; Gerritse, Bart ; Van Ginneken, Mireille ; Yee, Raymond ; Jais, Pierre. / ALternate Site Cardiac ResYNChronization (ALSYNC) : A prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. In: European Heart Journal. 2016 ; Vol. 37, No. 27. pp. 2118-2127.
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abstract = "Aims The ALternate Site Cardiac ResYNChronization (ALSYNC) study evaluated the feasibility and safety of left ventricular endocardial pacing (LVEP) using a market-released pacing lead implanted via a single pectoral access by a novel atrial transseptal lead delivery system. Methods and results ALSYNC was a prospective clinical investigation with a minimum of 12-month follow-up in 18 centres of cardiac resynchronization therapy (CRT)-indicated patients, who had failed or were unsuitable for conventional CRT. The ALSYNC system comprises the investigational lead delivery system and LVEP lead. Patients required warfarin therapy post-implant. The primary study objective was safety at 6-month follow-up, which was defined as freedom from complications related to the lead delivery system, implant procedure, or the lead ≥70{\%}. The ALSYNC study enrolled 138 patients. The LVEP lead implant success rate was 89.4{\%}. Freedom from complications meeting the definition of primary endpoint was 82.2{\%} at 6 months (95{\%} CI 75.6-88.8{\%}). In the study, 14 transient ischaemic attacks (9 patients, 6.8{\%}), 5 non-disabling strokes (5 patients, 3.8{\%}), and 23 deaths (17.4{\%}) were observed. No death was from a primary endpoint complication. At 6 months, the New York Heart Association class improved in 59{\%} of patients, and 55{\%} had LV end-systolic volume reduction of 15{\%} or greater. Those patients enrolled after CRT non-response showed similar improvement with LVEP. Conclusions The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP.",
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AU - Gellér, L.

AU - Leclercq, Christophe

AU - Ruffa, Franco

AU - Tung, Stanley

AU - Defaye, Pascal

AU - Yang, Zhongping

AU - Gerritse, Bart

AU - Van Ginneken, Mireille

AU - Yee, Raymond

AU - Jais, Pierre

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N2 - Aims The ALternate Site Cardiac ResYNChronization (ALSYNC) study evaluated the feasibility and safety of left ventricular endocardial pacing (LVEP) using a market-released pacing lead implanted via a single pectoral access by a novel atrial transseptal lead delivery system. Methods and results ALSYNC was a prospective clinical investigation with a minimum of 12-month follow-up in 18 centres of cardiac resynchronization therapy (CRT)-indicated patients, who had failed or were unsuitable for conventional CRT. The ALSYNC system comprises the investigational lead delivery system and LVEP lead. Patients required warfarin therapy post-implant. The primary study objective was safety at 6-month follow-up, which was defined as freedom from complications related to the lead delivery system, implant procedure, or the lead ≥70%. The ALSYNC study enrolled 138 patients. The LVEP lead implant success rate was 89.4%. Freedom from complications meeting the definition of primary endpoint was 82.2% at 6 months (95% CI 75.6-88.8%). In the study, 14 transient ischaemic attacks (9 patients, 6.8%), 5 non-disabling strokes (5 patients, 3.8%), and 23 deaths (17.4%) were observed. No death was from a primary endpoint complication. At 6 months, the New York Heart Association class improved in 59% of patients, and 55% had LV end-systolic volume reduction of 15% or greater. Those patients enrolled after CRT non-response showed similar improvement with LVEP. Conclusions The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP.

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