First in man evaluation of the new APICA ASC™ access and closure device

J Blumenstein; J Kempfert; A Van Linden; A Mani; H Moellmann; WK Kim; V Thourani; T Walther

doi:10.1055/s-0032-1332318

The Thoracic and Cardiovascular Surgeon, Table of Contents

First in man evaluation of the new APICA ASC™ access and closure device

J Blumenstein ¹, J Kempfert ¹, A Van Linden ¹, A Mani ¹, H Moellmann ², WK Kim ³, V Thourani ⁴, T Walther ¹

¹Kerckhoff-Klinik, Heart Center, Herzchirurgie, Bad Nauheim, Germany
²Kerckhoff-Klinik, Heart Center, Kardiologie, Bad Nauheim, Germany
³Kerckhoff-Klinik, Heart Center, Herzchirurgie/Kardiologie, Bad Nauheim, Germany
⁴Emory University School of Medicine, Cardiothoracic Surgery, Atlanta, United States

Abstract

Objective: The aim of this study was to evaluate the APICA ACS^™ access, stabilization, and closure system which aims to facilitate and standardize the transapical (TA) approach for transcatheter aortic valve implantation (TAVI).

Methods: TAVI candidates were included into the trial after informed consent and heart team decision. The Apica ASC™ introducer was anchored by rotational motion the titanium coil across the epicardium into the myocardium. Following the TA-AVI procedure, the cap was delivered through the system for final closure.

Results: A total of 17 high risk patients (82.7 ± 5.2 years, EuroSCORE I: 26 ± 14%, EuroSCORE II: 6 ± 5%, STSscore: 7 ± 3%) were included. In three patients perioperatively the APICA system was not used due to excessive epicardial fatty tissue according to the protocol. In the remaining 14 patients the ACS System provided sufficient sealing during the whole procedure and no relevant bleeding was observed at final cap closure. Pericardial drainages were removed within 24 hours in all patients. One patient suffered from non device related pericardial effusion requiring surgical decompression on postoperative day six. Two patients suffered from delayed minor strokes most likely due to pre-existing atrial fibrillation; complete functional recovery was achieved. One patient required short period of resuscitation due to asystolie under betablocker therapy. All patients received Aspirin, clopidogrel and low molecular heparin after procedure. Discharge echoes revealed well preserved left-ventricular function as compared to baseline. All patients were alive at 30 days follow-up.

Conclusion: TA access and closure is feasible and safe using the APICA ASC™ device. The system facilitates and standardizes TA access and closure by providing a sufficient and secure sealing during and after TA-AVI procedure.