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

Christophe Leclercq, Nicolas Sadoul, Lluis Mont, Pascal Defaye, Joaquim Osca, Elisabeth Mouton, Richard Isnard, Gilbert Habib, Jose Zamorano, Genevieve Derumeaux, Ignacio Fernandez-Lozano, SEPTAL CRT Study Investigators, Jean-Marc Dupuis, Frédéric Rouleau, Aude Tassin, Pierre Bordachar, Jacques Clémenty, Stephane Lafitte, Sylvan Ploux, Patricia Reant, Philippe Ritter, Pascal Defaye, Peggy Jacon, Blandine Mondesert, Carole Saunier, Estelle Vautrin, Salem Kacet, Laurence Guedon-Moreau, Didier Klug, Claude Kouakam, Sylvestre Marechaux, Christelle Marquie, Anne Sophie Polge, Marjorie Richardson, Philippe Chevallier, Brigitte De Breyne, Marcin M Lotek, Emilie Nonin, Julien Pineau, Jean-Claude Deharo, Emilie Bastard, Frédéric Franceschi, Gilbert Habib, Christophe Jego, Eric Peyrouse, Sebastien Prevot, Hôpital Saint-Joseph, Michel Bremondy, Jacques Faure, Ange Ferracci, Jean Lefevre, Andre Pisapia, Jean-Marc Davy, Frederic Cransac, Tien Tri Cung, Frederic Georger, Jean-Luc Pasquie, Franck Raczka, Catherine Sportouch-Dukhan, Nicolas Sadoul, Hugues Blangy, Jean-François Bruntz, Luc Freysz, Laurent Groben, Olivier Huttin, Antoine Bammert, Marc Burban, Jean-Pierre Cebron, Daniel Gras, Robert Frank, Guillaume Duthoit, Françoise Hidden-Lucet, Caroline Himbert, Richard Isnard, Jérôme Lacotte, Françoise Pousset, Thierry Zerah, Christophe Leclercq, Annaïk Bellouin, Christophe Crocq, Christian Deplace, Erwan Donal, Cécile Hamon, Philippe Mabo, Olivier Romain, Aude Solnon, Anselme Frederic, Fabrice Bauer, Mathieu Bernard, Benedicte Godin, Baptiste Kurtz, Arnaud Savoure, Xavier Copie, Gilles Lascault, Olivier Paziaud, Olivier Piot, Thierry Touche, Toulouse Marc Delay, Talia Chilon, Nicolas Detis, Alexandre Duparc, Aurélien Hebrard, Pierre Massabuau, Philippe Maury, Pierre Mondoly, Philippe Rumeau, Clinique Pasteur, Serge Boveda, Laurence Adrover, Nicolas Combes, Antoine Deplagne, Isabelle Marco-Baertich, Olivier Fondard, Juan Gabriel Martínez, José Luis Ibañez Criado, Diego Ortuño, Lluis Mont, Antonio Berruezo, Belu Eduard, Ana Martín, Franco M Merschon, Marta Sitges, José María Tolosana, Bárbara Vidal, H Valle Hebron, Angel Moya I Mitjans, Oscar Alcalde Rodriguez, José Fernando Rodriguez Palomares, Nuria Rivas, Gisela Teixidó, H Puerta de Hierro, Ignacio Fernández Lozano, Maria Lorena Ruiz Bautista, Victor Castro, Miguel Angel Cavero, Carlos Gutierrez, Natalia Ros, H Virgen de la Victoria, Francisco Javier Alzueta Rodriguez, Fernando Cabrera, Alberto Barrera Cordero, José Luis Peña, H de Valme Sevilla, Juan Lealdel Ojo Gonzáles, M Dolores Garcia Medina, Ricardo Pavón Jiménez, David Villagomez, H Virgen de la Salud Toledo, Eduardo Castellanos Martinez, Juan Alcalá, Carolina Maicas, Miguel Angel Arias Palomares, Alberto Puchol, H La Fé Valencia, Joaquim OscaAsensi, Anastasio Quesada Carmona, M José Sancho-Tello De Carranza, José Olagüe De Ros, Enrique Castro Pareja, Oscar Cano Pérez, Ana Osa Saez, H Rio Hortega, Benito Herreros Guilarte, Juan Francisco Muñoz San Jose, Teresa Myriam Pérez Sanz, Damien Logeart, Maria Lopez Gil, Christophe Leclercq, Ignacio Fernandez Lozano, H Puerta de Hierro, Genevieve Derumeaux, Christophe Leclercq, Nicolas Sadoul, Lluis Mont, Pascal Defaye, Joaquim Osca, Elisabeth Mouton, Richard Isnard, Gilbert Habib, Jose Zamorano, Genevieve Derumeaux, Ignacio Fernandez-Lozano, SEPTAL CRT Study Investigators, Jean-Marc Dupuis, Frédéric Rouleau, Aude Tassin, Pierre Bordachar, Jacques Clémenty, Stephane Lafitte, Sylvan Ploux, Patricia Reant, Philippe Ritter, Pascal Defaye, Peggy Jacon, Blandine Mondesert, Carole Saunier, Estelle Vautrin, Salem Kacet, Laurence Guedon-Moreau, Didier Klug, Claude Kouakam, Sylvestre Marechaux, Christelle Marquie, Anne Sophie Polge, Marjorie Richardson, Philippe Chevallier, Brigitte De Breyne, Marcin M Lotek, Emilie Nonin, Julien Pineau, Jean-Claude Deharo, Emilie Bastard, Frédéric Franceschi, Gilbert Habib, Christophe Jego, Eric Peyrouse, Sebastien Prevot, Hôpital Saint-Joseph, Michel Bremondy, Jacques Faure, Ange Ferracci, Jean Lefevre, Andre Pisapia, Jean-Marc Davy, Frederic Cransac, Tien Tri Cung, Frederic Georger, Jean-Luc Pasquie, Franck Raczka, Catherine Sportouch-Dukhan, Nicolas Sadoul, Hugues Blangy, Jean-François Bruntz, Luc Freysz, Laurent Groben, Olivier Huttin, Antoine Bammert, Marc Burban, Jean-Pierre Cebron, Daniel Gras, Robert Frank, Guillaume Duthoit, Françoise Hidden-Lucet, Caroline Himbert, Richard Isnard, Jérôme Lacotte, Françoise Pousset, Thierry Zerah, Christophe Leclercq, Annaïk Bellouin, Christophe Crocq, Christian Deplace, Erwan Donal, Cécile Hamon, Philippe Mabo, Olivier Romain, Aude Solnon, Anselme Frederic, Fabrice Bauer, Mathieu Bernard, Benedicte Godin, Baptiste Kurtz, Arnaud Savoure, Xavier Copie, Gilles Lascault, Olivier Paziaud, Olivier Piot, Thierry Touche, Toulouse Marc Delay, Talia Chilon, Nicolas Detis, Alexandre Duparc, Aurélien Hebrard, Pierre Massabuau, Philippe Maury, Pierre Mondoly, Philippe Rumeau, Clinique Pasteur, Serge Boveda, Laurence Adrover, Nicolas Combes, Antoine Deplagne, Isabelle Marco-Baertich, Olivier Fondard, Juan Gabriel Martínez, José Luis Ibañez Criado, Diego Ortuño, Lluis Mont, Antonio Berruezo, Belu Eduard, Ana Martín, Franco M Merschon, Marta Sitges, José María Tolosana, Bárbara Vidal, H Valle Hebron, Angel Moya I Mitjans, Oscar Alcalde Rodriguez, José Fernando Rodriguez Palomares, Nuria Rivas, Gisela Teixidó, H Puerta de Hierro, Ignacio Fernández Lozano, Maria Lorena Ruiz Bautista, Victor Castro, Miguel Angel Cavero, Carlos Gutierrez, Natalia Ros, H Virgen de la Victoria, Francisco Javier Alzueta Rodriguez, Fernando Cabrera, Alberto Barrera Cordero, José Luis Peña, H de Valme Sevilla, Juan Lealdel Ojo Gonzáles, M Dolores Garcia Medina, Ricardo Pavón Jiménez, David Villagomez, H Virgen de la Salud Toledo, Eduardo Castellanos Martinez, Juan Alcalá, Carolina Maicas, Miguel Angel Arias Palomares, Alberto Puchol, H La Fé Valencia, Joaquim OscaAsensi, Anastasio Quesada Carmona, M José Sancho-Tello De Carranza, José Olagüe De Ros, Enrique Castro Pareja, Oscar Cano Pérez, Ana Osa Saez, H Rio Hortega, Benito Herreros Guilarte, Juan Francisco Muñoz San Jose, Teresa Myriam Pérez Sanz, Damien Logeart, Maria Lopez Gil, Christophe Leclercq, Ignacio Fernandez Lozano, H Puerta de Hierro, Genevieve Derumeaux

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.

© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

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.

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