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CLINICAL RESEARCH: HEART RHYTHM DISORDER

A Randomized Comparison of Triple-Site Versus Dual-Site Ventricular Stimulation in Patients With Congestive Heart Failure

Christophe Leclercq, MD, PhD^_*,_*, Fredrik Gadler, MD, PhD, Wolfgang Kranig, MD, Sue Ellery, MD, Daniel Gras, MD^||, Arnaud Lazarus, MD^¶, Jacques Clémenty, MD^#, Eric Boulogne, MSc^_**, Jean-Claude Daubert, MD^_* for the TRIP-HF (Triple Resynchronization In Paced Heart Failure Patients) Study Group

^_* CHU Pontchaillou, Rennes, France
Karolinska Hospital, Stockholm, Sweden
Schüchtermann-Klinik, Bad Rothenfelde, Germany
Eastbourne District General Hospital, Eastbourne, United Kingdom
^|| NCN, Nantes, France
^¶ InParys, Paris, France
^# Hopital Cardiologique, Bordeaux, France
^_** St. Jude Medical, Zaventem, Belgium.

Manuscript received July 24, 2007; revised manuscript received October 26, 2007, accepted November 28, 2007.

^_* Reprint requests and correspondence: Dr. Christophe Leclercq, Department of Cardiology and Vascular Diseases, Centre Cardio-Pneumologique, Hôpital Pontchaillou, rue Henri Le Guilloux, 35033 Rennes Cedex 09, France. (Email: christophe.leclercq{at}chu-rennes.fr).

Objectives: We compared the effects of triple-site versus dual-site biventricular stimulation in candidates for cardiac resynchronization therapy.

Background: Conventional biventricular stimulation with a single right ventricular (RV) and a single left ventricular (LV) lead is associated with persistence of cardiac dyssynchrony in up to 30% of patients.

Methods: This multicenter, single-blind, crossover study enrolled 40 patients (mean age 70 ± 9 years) with moderate-to-severe heart failure despite optimal drug treatment, a mean LV ejection fraction of 26 ± 11%, and permanent atrial fibrillation requiring cardiac pacing for slow ventricular rate. A cardiac resynchronization therapy device connected to 1 RV and 2 LV leads, inserted in 2 separate coronary sinus tributaries, was successfully implanted in 34 patients. After 3 months of biventricular stimulation, the patients were randomly assigned to stimulation for 3 months with either 1 RV and 2 LV leads (3-V) or to conventional stimulation with 1 RV and 1 LV lead (2-V), then crossed over for 3 months to the alternate configuration. The primary study end point was quality of ventricular resynchronization (Z ratio). Secondary end points included reverse LV remodeling, quality of life, distance covered during 6-min hall walk, and procedure-related morbidity and mortality. Data from the 6- and 9-month visits were combined to compare end points associated with 2-V versus 3-V.

Results: Data eligible for protocol-defined analyses were available in 26 patients. No significant difference in Z ratio, quality of life, and 6-min hall walk was observed between 2-V and 3-V. However, a significantly higher LV ejection fraction (27 ± 11% vs. 35 ± 11%; p = 0.001) and smaller LV end-systolic volume (157 ± 69 cm³ vs. 134 ± 75 cm³; p = 0.02) and diameter (57 ± 12 mm vs. 54 ± 10 mm; p = 0.02) were observed with 3-V than with 2-V. There was a single minor procedure-related complication.

Conclusions: Cardiac resynchronization therapy with 1 RV and 2 LV leads was safe and associated with significantly more LV reverse remodeling than conventional biventricular stimulation.

Abbreviations and Acronyms   AF = atrial fibrillation   AV = atrioventricular   CHF = congestive heart failure   CRT = cardiac resynchronization therapy   CS = coronary sinus   LV = left ventricle/ventricular   LVEF = left ventricular ejection fraction   LVESV = left ventricular end-systolic volume   NYHA = New York Heart Association   QOL = quality of life   RV = right ventricle/ventricular   2-V = dual-site   3-V = triple-site   6-MHW = 6-min hall walk

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