Key result
ICD lead implantation in the right ventricular mid-septum demonstrated noninferior implant success rates compared to apical placement (89.7% vs 91.7%, ns).
Why the study?
Does right ventricular mid-septal ICD lead placement maintain implant success rates compared to apical placement in patients requiring an ICD?
RCT (n=215)
randomly assigned
Does right ventricular mid-septal ICD lead placement maintain implant success rates compared to apical placement in patients requiring an ICD?
Implantation of ICD leads in the RV mid-septum is technically feasible and demonstrates noninferior performance compared to the traditional RV apical position.
Answers are grounded in this paper and cite their sources.
Supports RV mid-septal ICD lead placement as viable alternative; extends positioning options beyond apical in this RCT.
Impact of Recalls on ICD Utilization . Introduction: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid‐septal versus apical implantable defibrillator (ICD) lead placement. Methods and 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). Conclusion: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid‐septum versus the apex. (J Cardiovasc Electrophysiol, Vol. 23, pp. 853‐860, August 2012)
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Mabo et al. (2012) conducted an RCT in Patients requiring implantable defibrillator (ICD) (n=215). ICD lead implantation in the right ventricular mid-septum vs. ICD lead implantation in the right ventricular apex was evaluated on implant success rate based on strict electrical predefined criteria (p=ns). ICD lead implantation in the right ventricular mid-septum demonstrated noninferior implant success rates compared to apical placement (89.7% vs 91.7%, ns).
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