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.

• MeSH
• defibrilátory implantabilní * škodlivé účinky   MeSH
• lidé MeSH
• náhlá srdeční smrt epidemiologie   etiologie   prevence a kontrola   MeSH
• následné studie MeSH
• srdeční arytmie MeSH
• tepový objem MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: The subcutaneous implantable defibrillator (S-ICD) provides an alternative to the transvenous ICD for the prevention of sudden cardiac death, but has not been well studied in the most commonly treated transvenous ICD patient population, namely, primary prevention (PP) patients with left ventricular dysfunction. OBJECTIVE: The analyses in the present study were designed to compare clinical outcomes for PP patients with and without a reduced ejection fraction (EF) and secondary prevention (SP) patients implanted with the S-ICD. METHODS: All patients 18 years and older from the S-ICD IDE study and the EFFORTLESS Registry with available data as of November 18, 2013, were included (n = 856; mean follow-up duration 644 days). Outcomes were evaluated in 2 analyses: (1) comparing all PP patients (n = 603, 70.4%) with all SP patients (n = 253, 29.6%) and (2) comparing all PP patients with an EF ≤35% (n = 379) with those with an EF >35% (n = 149, 17.4%). RESULTS: No differences were observed in mortality, complications, inappropriate therapy, or ability to convert ventricular tachyarrhythmias between SP and PP patients. However, SP patients had a higher incidence of appropriate therapy than did PP patients (11.9% vs 5.0%; P = .0004). In the PP subanalysis, the cohort with an EF ≤35% had significantly older patients with more comorbidities and higher mortality (3.0% annually vs 0.0%). Despite these differences, device-related complications, conversion efficacy, and incidence of inappropriate shock therapies were not significantly different between PP subgroups. CONCLUSION: The S-ICD performs well in protecting patients with either PP or SP implant indications from sudden cardiac death. Within PP patients, device performance was independent of EF.

• MeSH
• defibrilátory implantabilní * MeSH
• dospělí MeSH
• dysfunkce levé srdeční komory * diagnóza   patofyziologie   MeSH
• elektrická defibrilace * škodlivé účinky   přístrojové vybavení   metody   MeSH
• Kaplanův-Meierův odhad MeSH
• komorová tachykardie * mortalita   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhlá srdeční smrt prevence a kontrola   MeSH
• primární prevence metody   statistika a číselné údaje   MeSH
• protetické vybavení MeSH
• registrace MeSH
• sekundární prevence metody   statistika a číselné údaje   MeSH
• senioři MeSH
• tepový objem MeSH
• výsledky a postupy - zhodnocení (zdravotní péče) MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. OBJECTIVE: This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. METHODS: Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). RESULTS: Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. CONCLUSION: The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.

• MeSH
• analýza přežití MeSH
• defibrilátory implantabilní * škodlivé účinky   statistika a číselné údaje   MeSH
• dospělí MeSH
• elektrická defibrilace přístrojové vybavení   metody   MeSH
• implantace protézy * škodlivé účinky   metody   mortalita   MeSH
• infekce chirurgické rány * diagnóza   epidemiologie   terapie   MeSH
• komorová tachykardie terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• reoperace statistika a číselné údaje   MeSH
• selhání zařízení statistika a číselné údaje   MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

AIMS: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). METHODS AND RESULTS: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). CONCLUSION: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.

• MeSH
• databáze faktografické MeSH
• defibrilátory implantabilní * MeSH
• dospělí MeSH
• elektrická defibrilace * MeSH
• implantace protézy výchova   MeSH
• Kaplanův-Meierův odhad MeSH
• kardiochirurgické výkony výchova   MeSH
• křivka učení * MeSH
• lidé středního věku MeSH
• lidé MeSH
• multivariační analýza MeSH
• následné studie MeSH
• proporcionální rizikové modely MeSH
• registrace MeSH
• rizikové faktory MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH