A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure.
OBJECTIVE
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.
Leclercq
Christophe
C
CHU Pontchaillou, Rennes, France. christophe.leclercq@chu-rennes.fr
Gadler
Fredrik
F
Kranig
Wolfgang
W
Ellery
Sue
S
Gras
Daniel
D
Lazarus
Arnaud
A
Clémenty
Jacques
J
Boulogne
Eric
E
Daubert
Jean-Claude
JC
D000368:Aged; D001281:Atrial Fibrillation / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D018592:Cross-Over Studies; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000503:physiopathology*; D006352:Heart Ventricles / Q000503:physiopathology; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000517:prevention & control*; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D013318:Stroke Volume; D016896:Treatment Outcome