A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: The Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial

被引:68
|
作者
Boriani, Giuseppe [1 ]
Kranig, Wolfgang [2 ]
Donal, Erwan [3 ]
Calo, Leonardo [4 ]
Casella, Michela [5 ]
Delarche, Nicolas [6 ]
Fernandez Lozano, Ignacio [7 ]
Ansalone, Gerardo [8 ]
Biffi, Mauro [1 ]
Boulogne, Eric [9 ]
Leclercq, Christophe [3 ]
机构
[1] Univ Bologna, Inst Cardiol, Azienda Osped S Orsola Malpighi, I-40138 Bologna, Italy
[2] Schuchtermann Klin, Bad Rothenfelde, Germany
[3] CHU Pontchaillou, Rennes, France
[4] Policlin Casilino, Rome, Italy
[5] Policlin Univ A Gemelli, Rome, Italy
[6] CH President F Mitterand, Pau, France
[7] Hosp Univ Puerta de Hierro, Madrid, Spain
[8] Osped Madre G Vannini, Rome, Italy
[9] St Jude Med, Zaventem, Belgium
关键词
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR; RHYTHM-II ICD; CONDUCTION DELAY; HEMODYNAMICS; IMPROVEMENT;
D O I
10.1016/j.ahj.2010.03.008
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Biventricular (BiV) stimulation is the preferred means of delivering cardiac resynchronization therapy (CRT), although left ventricular (LV)-only stimulation might be as safe and effective. B-LEFT HF is a prospective, multicenter, randomized, double-blind study aimed to examine whether LV-only is noninferior to BiV pacing regarding clinical and echocardiographic responses. Methods B-LEFT HF randomly assigned 176 CRT-D recipients, in New York Heart Association class III or IV, with an LV ejection fraction <= 35% and QRS >= 130 milliseconds, to a BiV (n = 90) versus LV (n = 86) stimulation group. Clinical status and echocardiograms were analyzed at baseline and 6 months after CRT-D implant to test the noninferiority of LV-only compared with BiV stimulation. Results The proportion of responders was in line with current literature on CRT, with improvement in heart failure composite score in 76.2% and 74.7% of patients in BiV and LV groups, respectively. Comparing LV versus BiV pacing, the small differences in response rates and corresponding 95% CI indicated that LV pacing was noninferior to BiV pacing for a series of response criteria (combination of improvement in New York Heart Association and reverse remodeling, improvement in heart failure composite score, reduction in LV end-systolic volume of at least 10%), both at intention-to-treat and at per-protocol analysis. Conclusions Left ventricular-only pacing is noninferior to BiV pacing in a 6-month follow-up with regard to clinical and echocardiographic responses. Left ventricular pacing may be considered as a clinical alternative option to BiV pacing. (Am Heart J 2010; 159: 1052-1058.e1.)
引用
收藏
页码:1052 / U12
页数:8
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