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ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy

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. CLINICAL TRIAL: NCT01277783
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01263253
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Submitted on : Wednesday, January 27, 2016 - 3:43:00 PM
Last modification on : Sunday, October 25, 2020 - 7:05:58 AM

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John M. Morgan, Mauro Biffi, László Gellér, Christophe Leclercq, Franco Ruffa, et al.. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. European Heart Journal, Oxford University Press (OUP): Policy B, 2016, 37 (27), pp.2118-2127. ⟨10.1093/eurheartj/ehv723⟩. ⟨hal-01263253⟩

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