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Randomized Controlled Trial
. 2016 Feb 1;37(5):473-83.
doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15.

Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study

Christophe Leclercq  1 , Nicolas Sadoul  2 , Lluis Mont  3 , Pascal Defaye  4 , Joaquim Osca  5 , Elisabeth Mouton  6 , Richard Isnard  7 , Gilbert Habib  8 , Jose Zamorano  9 , Genevieve Derumeaux  10 , Ignacio Fernandez-Lozano  11 ; SEPTAL CRT Study Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study

Christophe Leclercq et al. Eur Heart J. .

Abstract

Aims: Cardiac resynchronization therapy (CRT) is a recommended treatment of heart failure (HF) patients with depressed left ventricular ejection fraction and wide QRS. The optimal right ventricular (RV) lead position being a matter of debate, we sought to examine whether RV septal (RVS) pacing was not inferior to RV apical (RVA) pacing on left ventricular reverse remodelling in patients receiving a CRT-defibrillator.

Methods and results: Patients (n = 263, age = 63.4 ± 9.5 years) were randomly assigned in a 1:1 ratio to RVS (n = 131) vs. RVA (n = 132) pacing. Left ventricular end-systolic volume (LVESV) reduction between baseline and 6 months was not different between the two groups (-25.3 ± 39.4 mL in RVS group vs. -29.3 ± 44.5 mL in RVA group, P = 0.79). Right ventricular septal pacing was not non-inferior (primary endpoint) to RVA pacing with regard to LVESV reduction (average difference = -4.06 mL; P = 0.006 with a -20 mL non-inferiority margin). The percentage of 'echo-responders' defined by LVESV reduction >15% between baseline and 6 months was similar in both groups (50%) with no difference in the time to first HF hospitalization or death (P = 0.532). Procedural or device-related serious adverse events occurred in 68 patients (RVS = 37) with no difference between the two groups (P = 0.401).

Conclusion: This study demonstrates that septal RV pacing in CRT is non-inferior to apical RV pacing for LV reverse remodelling at 6 months with no difference in the clinical outcome. No recommendation for optimal RV lead position can hence be drawn from this study.

Clinicaltrials gov number: NCT 00833352.

Trial registration: ClinicalTrials.gov NCT00833352.

Keywords: Cardiac resynchronization therapy; Left ventricular end-systolic volume; Right ventricular defibrillation lead; Right ventricular lead position.

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Figures

Figure 1
Figure 1
Right ventricular lead apical and septal locations.
Figure 2
Figure 2
Population flowchart.
Figure 3
Figure 3
Kaplan–Meier analysis of survival free from death and heart failure hospitalization in the right ventricular septum vs. right ventricular apex lead implantation group.
See this image and copyright information in PMC

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