John M Morgan1, Mauro Biffi2, László Gellér3, Christophe Leclercq4, Franco Ruffa5, Stanley Tung6, Pascal Defaye7, Zhongping Yang8, Bart Gerritse9, Mireille van Ginneken9, Raymond Yee10, Pierre Jais11. 1. Cardiac Rhythm Management, Faculty of Medicine, University Hospital Southampton, Tremona Road, Southampton SO16 6YD, UK jmm@hrclinic.org. 2. S Orsola-Malpighi University Hospital, Bologna, Italy. 3. Semmelweis University Heart Center, Budapest, Hungary. 4. University Hospital, Rennes, France. 5. Alessandro Manzoni Hospital, Lecco, Italy. 6. St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada. 7. University Hospital, Grenoble, France. 8. Medtronic Plc, Minneapolis, MN, USA. 9. Medtronic Bakken Research Center, Maastricht, The Netherlands. 10. London Health Sciences Center, London, ON, Canada. 11. CHU Bordeaux, Bordeaux University, Bordeaux, France.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Benjamin J Sieniewicz; Jonathan M Behar; Manav Sohal; Justin Gould; Simon Claridge; Bradley Porter; Steve Niederer; James H P Gamble; Tim R Betts; Pierre Jais; Nicolas Derval; David D Spragg; Paul Steendijk; Berry M van Gelder; Frank A Bracke; Christopher A Rinaldi Journal: Europace Date: 2018-12-01 Impact factor: 5.214