Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization.
BACKGROUND
The nonresponder rate to cardiac resynchronization therapy (CRT) may be due to incomplete resynchronization, with dyssynchrony persisting in approximately 30% of patients. We hypothesized that CRT with triple-site ventricular stimulation (TRIV) may improve resynchronization and its outcomes.


OBJECTIVE
The purpose of this study was to assess the feasibility and safety of TRIV and collected data on clinical outcomes to dimension future studies.


METHODS
Our pilot randomized trial was designed to assess the safety and feasibility of TRIV with 2 right ventricular leads and 1 left ventricular leads compared to conventional CRT. The primary end-point was the rate of severe adverse events at 6 months. Secondary end-points included functional improvement parameters, quality-of-life (QOL) score, and changes of echocardiographic indices at 6 and 12 months in a subset of patients.


RESULTS
Seventy-six patients were enrolled at 11 centers and randomized to control or TRIV arm. All implant procedures but one were successful. At 6 months, there was no statistical difference between proportions of patients with at least 1 severe adverse event in both groups (34.1% vs 25.7%, P = .425). There also was no difference between functional improvement parameters, 6-minute walking distances (P = .40), QOL scores (P = .27), and echographic indices. At 12 months, the proportions of patients with a left ventricular ejection fraction gain of more than 5%, 10%, or 15% were significantly superior with TRIV.


CONCLUSIONS
TRIV pacing is an effective and safe technique and may provide a greater benefit in ventricular remodeling than conventional CRT. Further studies are needed to assess its long-term benefit.
Charles Nicolle University Hospital, Rouen, France. Electronic address: frederic.anselme@chu-rouen.fr.
Frederic
F
Anselme
Haut Lévèque University Hospital, Pessac, France.
Pierre
P
Bordachar
Arnaud de Villeneuve University Hospital, Montpellier, France.
Jean Luc
JL
Pasquié
Cardiology Hospital, Lille, France.
Didier
D
Klug
Pontchaillou University Hospital, Rennes, France.
Christophe
C
Leclercq
Saint Louis Hospital, La Rochelle, France.
Antoine
A
Milhem
Ambroise Paré Clinic, Neuilly sur Seine, France.
Christine
C
Alonso
La Timone University Hospital, Marseille, France.
Jean Claude
JC
Deharo
Nouvelles Cliniques Nantaises-Le Confluent, Nantes, France.
Daniel
D
Gras
Laënnec University Hospital, Saint Herblain, France.
Vincent
V
Probst
Centre Cardiologique du Nord, Saint-Denis, France.
Olivier
O
Piot
Charles Nicolle University Hospital, Rouen, France.
Arnaud
A
Savouré
D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000379:methods; D058409:Cardiac Resynchronization Therapy Devices / Q000145:classification; D057186:Comparative Effectiveness Research; D004452:Echocardiography / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling
Cardiac resynchronization therapy; Congestive heart failure; Multisite pacing