Safety and feasibilty of transfemoral aortic valve implantation (CoreValve) in local anesthesia

Abstract

Aims: The aim of this study was to investigate the safety and feasibilty of transfemoral aortic valve implantation (CoreValve) in local anaesthesia without deep sedation and without anaesthesiological standby. Methods and results: From April 2010 until November 2012 in total 247 inoperable patients or patients with high surgical risk underwent transfemoral TAVI in local anaesthesia at our hospital using the CoreValve Revalving system (26/29/31 mm). There was no anaesthesiological assistance, but a cardiology fellow with experience in intensive care was present. For local anaesthesia 20 ml of 1% lidocaine was injected subcutaneously into the groin. The CoreValve prothesis was inserted retrogradely via an 18 F sheath. Before introducing the 18-F-sheath, 2-7,5 mg of Piritramid was given iv for analgesia. Closure of the arterial access site was done using the ProStar XL 10F- percutaneous suture device. At our hospital 247 patients (age 81.2+0.4 years, 129 male) with severe aortic stenosis (pmax 74.8+1.4 mmHg, pmean 44.2+0.9 mmHg, aortic valve area 0.6+0.01 cm2, left ventricular ejection fraction (LVEF) 51.1+0.7 %) with high surgical risk (logistic Euroscore 24.3+0.8)underwent the TAVI procedure in local anaesthesia. Only one patient had to be converted to general anaesthesia because of the development of a pulmonary oedema due to a intermittent postinterventional aortic insuffiency grade III, which could be successfully treated by post-dilatation with a 28 mm Balloon. Only 4 patients needed conversion to deep sedation using midazolame/Propofol. There were no in-lab deaths and no in-lab strokes or TIAs . Mean intervention time was 74+3.4 min, the mean fluoroscopy time 13.3 min and the amount of contrast was 167+5.3 ml. In-Lab vascular complications occurred in 8 pts (3.2%); 1 vessel closure of the arteria femoralis communis (AFC) due to the Prostar system, 4 sheath induced dissections of the iliac artery treated by stenting, two iliac perforations treated with covered stents and 1 unremovable Solopath sheath. Two of these 8 pts (Prostar vessel closure, unremovable sheath) needed surgical repair. Thirty-day all-cause mortality was 4.9 % (n=12;cardiac mortality 41.6%) and long-term all-cause mortality (1-year) 14.6% (n=36; cardiac mortality 41.7%). There were 2 strokes during the observation period of 30 days resulting in a stroke rate of 0.8% and 4 TIAs (1.6%). Conclusions: TAVI in local anaesthesia represents a feasible and safe option with low (0%) In-Lab stroke/TIA rate. Acute-, intermediate and longtermoutcome is excellent