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OUR MISSION: TO REDUCE THE BURDEN OF CARDIOVASCULAR DISEASE
Prof. Christophe Leclercq,
Dr. Jagmeet Singh
By Christophe Leclercq, FESC (Rennes, France)View Discussant reportRead the press releaseOpen the PresentationWatch the Webcast
List of AuthorsChristophe Leclercq, Nicolas Sadoul, Luis Mont, Pascal Defaye, Joaquím Osca, Marc Delay, Gilbert Habib, Elisabeth Mouton, Jose Zamorano, Igniacio Lozano, on behalf of the Septal CRT Study investigators.
PurposeCardiac resynchronization therapy (CRT) is a recommended therapeutic strategy in the treatment of symptomatic heart failure patients with depressed left ventricular ejection fraction (LVEF) and wide QRS. The location of the right ventricular lead, septal versus apical, impacting biventricular pacing is still a matter of debate. We conducted a prospective randomized European multicenter (25 centers) non inferiority trial comparing the septal RV pacing to the apical RV pacing on the LV reverse remodeling in CRT defibrillator (CRT-D) patients.MethodsPatients included in the trial fulfilled the ESC guidelines for CRT. They were all in sinus rhythm at implant and were randomly assigned in a 1:1 ratio to septal RV pacing or to apical RV pacing. The RV lead location was assessed using predefined anatomical and electrical parameters. The LV lead was positioned on the lateral LV wall whenever possible. The primary endpoint was to demonstrate that RV septal pacing was not inferior to RV apical pacing in terms of changes in LV end systolic volume (LVESV) between baseline and 6 months at echocardiography. The primary endpoint of non-inferiority was defined with a safety margin of 20 ml for the LVESV. The main secondary objective was to assess the percentage of “echo-responders” defined by a > 15% reduction in the LVESV between baseline and 6 months. All echocardiographic analyses were performed on the PP population according to implanted sites. All echocardiographic recordings were analyzed by an independent core lab.ResultsA total of 182 patients (mean age = 63.3 ± 9.8 y, 73% male, LVEF = 0.30 ± 0.08, 69% non-ischemic cardiomyopathy, 88% in NYHA class III), were randomized (90 septal, 92 apex). The QRS duration was 160 ± 22 ms. RV implant success rate fulfilling the pre-required anatomical lead position and electrical parameters, including one defibrillation test at 21J, was not statistically different in both groups. The non-inferiority of septal vs. apical pacing was reached with a difference of -4.72 ml (95% CI = -16.54; 7.10). Changes in LVESV are given in the table. The percentage of "echo-responders" was similar in both groups (50%). During a 11.7 months mean follow-up, the proportion of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, cardiac and procedure-related or device-related MAE was not different (p=0.437) between RV septal pacing (37.8%) and the RV apical pacing (31.5%).ConclusionThis first randomized prospective trial comparing RV apical and RV septal pacing in CRT-D recipients demonstrates the non-inferiority of RV septal pacing when compared to conventional RV apical pacing.
By Jagmeet Singh, (Boston, United States of America)See Presenter abstractOpen the presentationWatch the Webcast
Hot Line: Heart failure: devices and interventions
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