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Aims To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. Methods and results Kaplan–Meier, trend and multivariable analyses were performed for mortality and late (years 2–5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7–5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2–11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS. Conclusion In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.

[Figure][1] The Heart Research Follow-up Program at the University of Rochester Medical Center has an ongoing record of successfully carrying out large-scale clinical cardiovascular studies and randomized clinical trials for >35 years, and nearly all of the original executive committee

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up.The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate.This is the first report on the full patient cohort and study endpoints with follow-up ≥1 year. The predefined endpoints are 30- and 360-day complications, and shocks for atrial fibrillation or supraventricular tachycardia.Patients were followed for 3.1 ± 1.5 years and 82 completed the study protocol 5-year visit. Average age was 48 years, 28% were women, ejection fraction was 43 ± 18%, and 65% had a primary prevention indication. The S-ICD system and procedure complication rate was 4.1% at 30 days and 8.4% at 360 days. The 1-year complication rate trended toward improvement from the first to last quartile of enrollment (11.3% [quartile 1]) to 7.8% [quartile 2], 6.6% [quartile 3], and 7.4% [quartile 4]; quartile 1 vs. quartiles 2 to 4; p = 0.06). Few device extractions occurred due to need for antitachycardia (n = 5), or biventricular (n = 4) or bradycardia pacing (n = 1). Inappropriate shocks occurred in 8.1% at 1 year and 11.7% after 3.1 years. At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year rates of appropriate shock were 5.8% and 13.5%, respectively. Conversion success for discrete spontaneous episodes was 97.4% overall.This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD [The EFFORTLESS S-ICD Registry]; NCT01085435).

The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming.The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT-RIT. The secondary end points are all-cause shock-free rate at 18 months, and system- and procedure-related complication-free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points.This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs.

Introduction: The fully Subcutaneous Implantable Cardioverter Defibrillator (SICD) has been introduced as a less invasive option for the prevention of Sudden Cardiac Death (SCD). According to the labeling, the implantation of the device requires three incisions: one pocket incision for the pulse generator and two parasternal incisions to tunnel the lead. These parasternal incisions are a potential source of discomfort and infection. Also the superior parasternal incision leaves a cosmetically notable scar on the upper chest. A less invasive, two incision, implantation technique has recently been introduced that omits the superior parasternal incision. Short term follow-up in a small patient cohort has shown that it is a safe and efficacious alternative for S-ICD implantation and may help to reduce complications. No long term follow up data is available on this technique. Hypothesis: Long term follow up in a large patient cohort continues to show the safety and effectiveness of the two incision technique for S-ICD implantation. Methods: The two incision technique has been described previously. It makes use of a peelable sheeth to avoid the superior parasternal incision. We performed a retrospective analysis of all the patients in our center that have been implanted with this technique. Results: A total of 107 S-ICD patients were implanted with the two incision technique (56% male, mean age 40±16, BMI 25 (16.6-37.3). During a total follow up of 180 years patient years (mean 12 months, range 1-48) no dislocations were observed. One S-ICD system was repositioned due to DFT failure. First shock efficacy during DFT was 96% and 75% (6/8) for spontaneous episodes (100% efficacy with multiple shocks). The 1 year inappropriate shock rate was 7.4%. Device function was normal in all patients, and no inappropriate sensing occurred related to the implantation technique. Four infections occurred of which one originated from the parasternal incision. Conclusions: Long term follow up in a large patient cohort continues to show the safety and effectiveness of the two incision technique for S-ICD implantation. This technique offers physicians a less invasive and simplified implantation procedure for the S-ICD.

Introduction: In pediatric patients prevention of Sudden Cardiac Death (SCD) using Implantable Cardioverter Defibrillators (ICD) is associated with a higher risk of complications than in the adult population. Surgical re-interventions due to infection, lead dislocation or migration and inappropriate shocks on intra and extracardiac oversensing are the most prevalent complications. The Subcutaneous ICD (S-ICD) has been introduces as a less invasive and extravascular alternative to overcome some of these complications. The scientific data that has led to the approval of the S-ICD did not include pediatric patients. Contradicting reports in small cohorts have been published on the effectiveness of S-ICD therapy in the pediatric population. We here report the largest pediatric cohort with the longest follow up to date where the S-ICD has been used for SCD prevention. Hypothesis: The S-ICD is safe and effective for the prevention of SCD in a diverse pediatric population. Methods: We retrospectively studied all consecutive pediatric patients (age Results: Fifteen S-ICDs were implanted in 14 patients (mean age 14, range 8-17), 71% were male, mean BMI was 18.8 (range 17.2-28.8), 57% had a secondary prevention indication, 77% had a genetic arrhythmia diagnosis and the median follow up was 21 months (range 1- 57). The first shock efficacy of induced and spontaneous episodes was 100% (n=13 and n =2 respectively). Inappropriate shocks due to intracardiac oversensing occurred in 3 (21%) patients. No lead failures or dislocations were observed. Two patients (14%) experienced a complication requiring re-intervention: one infection and one pocket erosion. After the pocket erosion the S-ICD has been successfully re-implanted. In one patient the S-ICD was removed after cardiac transplantation. None of the patients died during follow up. Conclusions: The S-ICD is safe and effective in a diverse pediatric populations. There was a very high efficacy of defibrillation therapy (100%) and a relative low and mild occurrence of complications. The S-ICD should be considered as a viable alternative for transvenous ICD's in pediatric patients.