Transaortic transcatheter aortic valve implantation: experience from the Kiel study

ORIGINAL ARTICLE Interactive CardioVascular and Thoracic Surgery 24 (2017) 55–62 doi:10.1093/icvts/ivw277 Advance Access publication 5 September 2016 Cite this article as: Petzina R, Lutter G, Wolf C, Kühl C, Freitag-Wolf S, Panholzer B et al. Transaortic transcatheter aortic valve implantation: experience from the Kiel study. Interact CardioVasc Thorac Surg 2017;24:55–62. Transaortic transcatheter aortic valve implantation: experience from the Kiel study Rainer Petzinaa,*, Georg Luttera,b, Christin Wolfc, Constantin Kühlc, Sandra Freitag-Wolfd, Bernd Panholzera, Peter Bramlagee, Norbert Freyb,c, Jochen Cremera and Derk Frankb,c a Department for Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Germany DZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Hamburg, Germany c Department of Internal Medicine III (Cardiology and Angiology), University Hospital Schleswig-Holstein, Campus Kiel, Germany d Department of Medical Informatics and Statistics, University Hospital Schleswig-Holstein, Campus Kiel, Germany e Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany * Corresponding author. Tel: +49-431-5977319; fax: +49-431-5972836; e-mail: ; (R. Petzina). Received 4 January 2016; received in revised form 25 May 2016; accepted 19 July 2016 Abstract OBJECTIVES: To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access. METHODS: A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012–December 2014). Periprocedural and post-procedural outcomes were assessed. RESULTS: Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21–8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates. CONCLUSIONS: The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes. Keywords: Transcatheter heart valve • Transcatheter aortic valve implantation • Transaortic access • Aortic valve replacement • SAPIEN INTRODUCTION The prevalence of severe calcific aortic stenosis is rising as life expectancy increases and is progressively becoming a greater healthcare burden [1]. Although surgery is the standard of care in patients with acceptable surgical risk, transcatheter aortic valve implantation (TAVI) is a less invasive alternative for patients at high or prohibitive risk [2]. Typically, the femoral artery is used as the default access point; however, this route may bear a significant risk or be not feasible in a significant proportion of patients who have peripheral vascular disease or severe aortic calcification. Transapical access (TA) is the standard surgical approach for TAVI with very good results, but it is linked to a higher risk of bleeding complications and ventricular damage [3]. Furthermore, TA is not suitable for patients with respiratory disease or poor ventricular function or for frail patients [4, 5]. More recently, the use of transaortic (TAo) access has emerged, with preliminary results demonstrating good efficacy and safety [6, 7]. Bapat et al. [4] found similar 30-day mortality rates for TAo- and TA-TAVI and comparable complication rates in a small cohort of patients for whom a transfemoral (TF) procedure was not feasible. Similarly, Lardizabal et al. [8, 9] reported equivalent complication rates for these two procedures, whereas short- and long-term mortality rates were lower when TAo access was used. The present study was carried out to evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves (THVs) inserted via the TAo approach and to assess its potential as an alternative access site. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. ADULT CARDIAC b 56 R. Petzina et al. / Interactive CardioVascular and Thoracic Surgery MATERIALS AND METHODS Study design The present data are based on the experience of a single centre at the University Hospital Schleswig-Holstein (UKSH) in Kiel (Germany). All consecutive patients undergoing TAo-TAVI were enrolled from November 2012 to December 2014, irrespective of the valve to be deployed. All patients included in the registry provided written informed consent, and ethical approval was obtained from the institutional ethics board. The study was carried out in accordance with the Declaration of Helsinki. Patients Patients were included in this analysis if they were diagnosed with severe symptomatic calcific aortic stenosis and were at increased perioperative risk [elevated surgical risk scores such as the EuroSCORE I, EuroSCORE II and Society of Thoracic Surgeons (STS) score] as well-being at an advanced age (greater than 75 years) and/or having another factor precluding conventional aortic valve replacement. The final decision to schedule the patients to undergo TAo-TAVI was made by the institutional interdisciplinary heart team. Patients were excluded from undergoing the TAo-TAVI procedure if they had a congenital unicuspid or bicuspid aortic valve, evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis, or if they were unable to tolerate anticoagulation/antiplatelet therapy. Furthermore, patients with excessive calcification of the anterior part of the ascending aorta (access site) were excluded. All patients were examined preoperatively according to a standardized TAVI protocol, including transoesophageal echocardiography (TOE), a cardiac CT scan and a CT scan of the complete aorta and the peripheral arteries. general (...truncated)