Abstract
Background: Subcutaneous implantable cardioverter defibrillator (S-ICD) system has been proven to be an effective therapy for prevention of sudden cardiac death (SCD) in selected patients. Although the Shockless IMPLant Evaluation (SIMPLE) trial has shown that defibrillation threshold (DFT) testing is not necessary for transvenous ICD (TV-ICD) systems, it is still recommended for S-ICD systems. We aimed to study the efficacy and safety of S-ICD implantation without DFT in our Heart Center with the comparison of S-ICD patients' outcome to those with a single chamber TV-ICD without DFT in the same period.
Methods: A retrospective analysis of patients underwent S-ICD without DFT from December 2014 to May 2016 with the comparison to single chamber TV-ICD patients implanted during the same period.
Results: Thirty consecutive patients (23 males (76.7%); mean age 41 +/- 13 years; mean left ventricular ejection fraction 30 +/- 12%) received a S-ICD for primary (25 patients, 83.3%) or secondary prevention (five patients, 16.7%) of SCD. During a mean follow-up of 710.6 +/- 190 days, three patients received 38 appropriate ICD shocks (90.5%), and two patients received four inappropriate shocks (9.5%). There were two mortalities (6.7%): one cardiac and one non-cardiac. When compared to 30 consecutive who received a single chamber TV-ICD during the same period, there was no significant difference in mortality.
Conclusions: Implantation of S-ICD using intermuscular approach without DFT seems to be safe and effective. Data from large S-ICD registries with long-term follow-up, and preferably randomized controlled studies, are needed to confirm this finding.