First-in-man evaluation of the transapical APICA ASC™ access and closure device: the initial 10 patients

The aim of this study was to evaluate the initial and short-term results of a new apical access and closure device to facilitate and standardize the transapical (TA) approach to transcatheter aortic valve implantation (TAVI). The apical access, stabilization and closure (ASC (TM)) device consists of three components: an introducer system, a left ventricular low-profile titanium coil and a closure cap. The ASC (TM) introducer system is anchored and rotated into the myocardium almost like a corkscrew, using the titanium coil. Following the TA-AVI procedure, the closure cap is introduced and delivered through the system into the titanium coil for final sealing. A total of 11 high-risk elderly patients (EuroSCORE I: 27.8 +/- 16.7; EuroSCORE II: 6.6 +/- 5.0 and The Society of Thoracic Surgeons (STS) score: 5.9 +/- 2.7%) were evaluated for TA-AVI by our interdisciplinary Heart Team and subsequently included in the trial after informed consent was obtained. One patient was excluded due to the presence of deep epicardial fat tissue. In all other cases, the titanium coil provided sufficient sealing throughout the procedure without the presence of perisheath bleeding. After delivery of the closure cap, no relevant bleeding was observed in any patient. Pericardial drainages were removed early in all patients. One patient suffered from non-device-related pericardial effusion requiring surgical decompression on postoperative day 6. Two patients suffered from delayed minor strokes, most likely due to arrhythmia. All patients received aspirin, clopidogrel and low molecular heparin after the procedure. Discharge echocardiography revealed no changes in left ventricular function when compared with baseline and no new onset wall motion abnormalities. All 10 patients were alive at 30 days. TA access and closure are both feasible and safe using the APICA ASC (TM) device. The system facilitates and standardizes TA access and closure by providing a sufficient and secure sealing during and after the TA-AVI procedure.