title: ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy.
abstract: 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.
  
  
  
  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.
  
  
  
  The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP.
  
  
  
  NCT01277783.
authors.affiliation: Cardiac Rhythm Management, Faculty of Medicine, University Hospital Southampton, Tremona Road, Southampton SO16 6YD, UK jmm@hrclinic.org.
authors.forename: John M
authors.initials: JM
authors.lastname: Morgan
authors.affiliation: S Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Biffi
authors.affiliation: Semmelweis University Heart Center, Budapest, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Gellér
authors.affiliation: University Hospital, Rennes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Leclercq
authors.affiliation: Alessandro Manzoni Hospital, Lecco, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Ruffa
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Stanley
authors.initials: S
authors.lastname: Tung
authors.affiliation: University Hospital, Grenoble, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Defaye
authors.affiliation: Medtronic Plc, Minneapolis, MN, USA.
authors.forename: Zhongping
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Medtronic Bakken Research Center, Maastricht, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: Gerritse
authors.affiliation: Medtronic Bakken Research Center, Maastricht, The Netherlands.
authors.forename: Mireille
authors.initials: M
authors.lastname: van Ginneken
authors.affiliation: London Health Sciences Center, London, ON, Canada.
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.affiliation: CHU Bordeaux, Bordeaux University, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Jais
mesh_terms: D058406:Cardiac Resynchronization Therapy; D006333:Heart Failure; D006352:Heart Ventricles; D006801:Humans; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: Heart failure; Left ventricular endocardial pacing; Prospective clinical trial; Safety