A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure
Christophe Leclercq, Fredrik Gadler, Wolfgang Kranig, Sue Ellery, Daniel Gras, Arnaud Lazarus, Jacques Clémenty, Eric Boulogne, Jean-Claude Daubert, TRIP-HF (Triple Resynchronization In Paced Heart Failure Patients) Study Group, Jean-Claude Daubert, Christophe Leclercq, Daniel Gras, Jean-Pierre Cebron, Arnaud Lazarus, Philippe Ritter, Jacques Clementy, Stéphane Garrigue, Cecilia Linde, Fredrik Gadler, Wolfgang Kranig, Rainer Grove, Guido Lüdorff, Vince Paul, Sue Ellery, Christophe Leclercq, Fredrik Gadler, Wolfgang Kranig, Sue Ellery, Daniel Gras, Arnaud Lazarus, Jacques Clémenty, Eric Boulogne, Jean-Claude Daubert, TRIP-HF (Triple Resynchronization In Paced Heart Failure Patients) Study Group, Jean-Claude Daubert, Christophe Leclercq, Daniel Gras, Jean-Pierre Cebron, Arnaud Lazarus, Philippe Ritter, Jacques Clementy, Stéphane Garrigue, Cecilia Linde, Fredrik Gadler, Wolfgang Kranig, Rainer Grove, Guido Lüdorff, Vince Paul, Sue Ellery
Abstract
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 cm(3) vs. 134 +/- 75 cm(3); 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.
Source: PubMed