title: A randomized study of defibrillator lead implantations in the right ventricular mid-septum versus the apex: the SEPTAL study.
abstract: BACKGROUND
  The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid-septal versus apical implantable defibrillator (ICD) lead placement.
  
  
  RESULTS
  SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid-septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all-cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid-septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1-year rate of lead-related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid-septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All-cause mortality was 7.9% in the RV mid-septal versus 2.9% in the RV apical group (ns).
  
  
  CONCLUSIONS
  This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid-septum versus the apex.
authors.affiliation: Centre Hospitalier Universitaire, Rennes, France. philippe.mabo@chu-rennes.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Mabo
authors.forename: Pascal
authors.initials: P
authors.lastname: Defaye
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Mouton
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cebron
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Davy
authors.forename: Aude
authors.initials: A
authors.lastname: Tassin
authors.forename: Dominique
authors.initials: D
authors.lastname: Babuty
authors.forename: Pierre
authors.initials: P
authors.lastname: Mondoly
authors.forename: Olivier
authors.initials: O
authors.lastname: Paziaud
authors.forename: Frederic
authors.initials: F
authors.lastname: Anselme
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Daubert
mesh_terms: D000328:Adult; D000368:Aged; D002304:Cardiac Pacing, Artificial; D017147:Defibrillators, Implantable; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D004562:Electrocardiography; D005240:Feasibility Studies; D005260:Female; D005602:France; D006352:Heart Ventricles / Q000503:physiopathology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D016037:Single-Blind Method; D017180:Tachycardia, Ventricular / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D054088:Ventricular Septum / Q000503:physiopathology*