Incidence of ineffective safety margin testing (<10 J) and efficacy of routine subcutaneous array insertion during implantable cardioverter defibrillator implantation☆

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications.