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

Giuseppe Boriani, Wolfgang Kranig, Erwan Donal, Leonardo Calo, Michela Casella, Nicolas Delarche, Ignacio Fernandez Lozano, Gerardo Ansalone, Mauro Biffi, Eric Boulogne, Christophe Leclercq

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Abstract

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.

Original languageEnglish
JournalAmerican Heart Journal
Volume159
Issue number6
DOIs
Publication statusPublished - Jun 2010

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Cardiac Resynchronization Therapy
Heart Failure
Stroke Volume
Double-Blind Method

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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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. / Boriani, Giuseppe; Kranig, Wolfgang; Donal, Erwan; Calo, Leonardo; Casella, Michela; Delarche, Nicolas; Lozano, Ignacio Fernandez; Ansalone, Gerardo; Biffi, Mauro; Boulogne, Eric; Leclercq, Christophe.

In: American Heart Journal, Vol. 159, No. 6, 06.2010.

Research output: Contribution to journalArticle

Boriani, Giuseppe ; Kranig, Wolfgang ; Donal, Erwan ; Calo, Leonardo ; Casella, Michela ; Delarche, Nicolas ; Lozano, Ignacio Fernandez ; Ansalone, Gerardo ; Biffi, Mauro ; Boulogne, Eric ; Leclercq, Christophe. / 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. In: American Heart Journal. 2010 ; Vol. 159, No. 6.
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abstract = "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.",
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T1 - A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy

T2 - The Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial

AU - Boriani, Giuseppe

AU - Kranig, Wolfgang

AU - Donal, Erwan

AU - Calo, Leonardo

AU - Casella, Michela

AU - Delarche, Nicolas

AU - Lozano, Ignacio Fernandez

AU - Ansalone, Gerardo

AU - Biffi, Mauro

AU - Boulogne, Eric

AU - Leclercq, Christophe

PY - 2010/6

Y1 - 2010/6

N2 - 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.

AB - 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.

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