Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy : The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study - 17/08/11
, Cord Paul Müller, MD b, Karl Heinz Seidl, MD c, Rainer Grove, MD d, Jürgen Vogt, MD e, Wilfried Danschel, MD f, Andreas Schuchert, MD g, Pierre Djiane, MD h, Mauro Biffi, MD a, Thorsten Becker, MD c, Christophe Bailleul, PhD i, Hans Joachim Trappe, MD bfor the Resynchronization for the HemodYnamic Treatment for Heart Failure Management II (RHYTHM II) investigators
Résumé |
Background |
The clinical value of interventricular (V-V) delay optimization in patients with chronic congestive heart failure (CHF) undergoing implantation of a device for cardiac resynchronization therapy (CRT) has not been clearly demonstrated.
Methods |
RHYTHM II was a single-blind randomized trial including 121 recipients of a device for CRT with cardioverter/defibrillator capabilities (CRT-D) randomly assigned in a 1:3 ratio to simultaneous (n = 30) versus optimized (OPT) (n = 91) biventricular pacing. V-V delay was optimized by echocardiography. The study end points were (1) freedom from CRT-D system–related complications and (2) changes between preimplant and 6 months of follow-up in (a) New York Heart Association CHF functional class, (b) distance covered during a 6-minute hall walk, and (c) quality of life (QOL).
Results |
In the OPT group, the V-V delay ranged from 0 to 80 milliseconds, with 28.4% of patients stimulated at an OPT V-V delay of 0 milliseconds. The overall 6-month survival free of adverse events requiring invasive interventions was 81.8%. In the whole cohort, 6 months of CRT-D was associated with a significant decrease in New York Heart Association class, increase in the distance covered during the 6-minute hall walk, and improvement in QOL (each P < .0001). The effects of CRT-D on these end points were similar in both study groups.
Conclusions |
Cardioverter-defibrillator capabilities was associated with a significant alleviation of CHF symptoms, increase in functional capacity, and improvement in QOL. The optimization of the V-V delay conferred no additional benefit compared with simultaneous biventricular stimulation.
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| This study was sponsored by SJM International, Inc. |
Vol 151 - N° 5
P. 1050-1058 - mai 2006 Retour au numéro
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