Clinical experience with a novel subcutaneous implantable defibrillator system in a single center

Abstract

BackgroundImplantable cardioverter-defibrillators (ICDs) reduce mortality in both primary and secondary prevention, but are associated with substantial short- and long-term morbidity. A totally subcutaneous ICD (S-ICD) system has been developed. We report the initial clinical experience of the first 31 patients implanted at our hospital.MethodsAll patients had an ICD indication according to the ACC/AHA/ESC guidelines. The first 11 patients were part of the reported CE trial. The implantation was performed without fluoroscopy. The device was implanted subcutaneously in the anterior axillary line, with a parasternal lead tunneled from the xiphoid to the manubrial–sternal junction. Ventricular fibrillation (VF) was induced to assess detection accuracy and defibrillation efficacy using 65 J shocks.ResultsPost-implant, 52 sustained episodes of VF were induced. Sensitivity was 100% and induced conversion efficacy was 100% (with standard polarity in 29 patients). Mean time to therapy was 13.9 ± 2.5 s (range 11–21.6 s). Late procedure-related complications were observed in 2 of the first 11 implantations (lead migration). During follow-up, spontaneous ventricular arrhythmias occurred in four patients, with accurate detection of all episodes. Inappropriate therapy was observed in five patients. Recurrences were prevented with reprogramming.ConclusionsThe S-ICD system can be implanted without the use of fluoroscopy by using anatomical landmarks only. Episodes of VF were accurately detected using subcutaneous signals, and all induced and clinical episodes were successfully converted. The S-ICD system is a viable alternative to conventional ICD systems for selected patients.

2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death

“…W trakcie obserwacji trwającej średnio 18 miesięcy odnotowano 317 incydentów samoistnej arytmii u 85 pacjentów. Terapia z powodu VT lub VF została zastosowana w 169 z tych przypadków (53%) i tylko 1 pacjent zmarł z powodu nawracającego VF i znacznej bradykardii [161]. Próby kliniczne z użyciem podskórnych ICD podsumowano w dodatkowej tabeli 6 [157][158][159][160][161][162][163][164][165].…”

Sudden Cardiac Death Early After Myocardial Infarction

“…[35][36][37][38] The subcutaneous ICD delivers highenergy (80-J) shock therapy with no pacing capabilities (apart from 30 seconds of postshock demand pacing). Therefore, it is unable to treat slow or recurrent VT and is not appropriate for patients requiring antibradycardia or cardiac resynchronization pacing.…”

“…Subkutánní ICD byl hodnocen v nerandomizovaných studiích, v nichž úspěšně detekoval a rušil komorové tachyarytmie. [35][36][37][38] Subkutánní ICD vydává výboje o vysoké energii (80-J) a není schopen stimulace (kromě 30sekundové synchronní stimulace po výboji). Nemůže proto léčit / zrušit pomalé nebo rekurentní KT a není vhodný pro pacienty s nutnou antibradykardickou nebo resynchronizační kardiostimulací.…”

The subcutaneous implantable cardioverter-defibrillator: pros and cons

“…Current evidence is based on a certain number of regulatory studies [15,22] as well as several post-marketing studies, mostly multicentric [16,19,21,[27][28][29]. Follow-up remains relatively short, the longest being the pooled analysis of the EFFORTLESS and IDE registries with a mean follow-up of less than 2 years [20].…”

“…Modern programming seems to have greatly reduced the rate of IAS in TV-ICDs to around 2-3% over 1 year [37][38][39]. Regarding S-ICDs, in five multicentric studies, the rate of IAS was 9.2% after a mean follow-up of around 1 year [19,[27][28][29]40]. In the EFFORTLESS registry, the IAS rate was 7%/year [16].…”