Procedural Characteristics and Outcomes of Transcatheter Aortic Valve Implantation: A Single-Center Experience of the First 100 Inoperable or High Surgical Risk Patients with Severe Aortic Stenosis.

Abstract

This is the first study of a Taiwanese population reporting transcatheter aortic valve implantation (TAVI) outcomes of the first 100 cases from a single center offering two different transcatheter heart valve technologies via six types of approaches. We herein report the 30-day and one-year outcomes in our first 100 TAVI patients at Taipei Veterans General Hospital. From May 2010 to April 2016, 100 consecutive patients with severe aortic stenosis (AS) who were considered unsuitable or at high risk for surgical aortic valve replacement underwent TAVI. Patient outcomes were classified according to the Valve Academic Research Consortium-2 (VARC-2) definitions. The device performance was assessed using transthoracic echocardiography by independent investigators. The mean patient age was 81.1 years, where 54% were female, and the mean Logistic EuroSCORE was 21.5%. The Medtronic CoreValve was used in 84 patients and the Edwards Sapien or Sapien XT valve (ESV) in 16. The transfemoral approach was the most frequently used route (83%), followed by transapical (9%) access. Overall, there was no procedural death. The VARC-2 outcomes were as follows: device success, 95%; stroke, 1%; major vascular complication, 3%; a need for pacemaker implantation, 5.1%. At discharge, the incidence of postoperative mild, moderate or severe paravalvular leak was 30%, 3% and 0%, respectively. At one year, the all-cause mortality rate was 14.0%, and no valve-related dysfunction was observed. Through multivariable analysis, non-transfemoral access [hazard ratios (HR) 4.81; 95% confidence interval (CI) 1.66-14.09; p = 0.004] and advanced chronic kidney disease (stages 4-5), (HR 3.13; 95% CI 1.07-9.09; p = 0.036) were independently associated with an increased risk of one-year mortality. We demonstrated that TAVI shows good early and mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance in high-risk patients with severe AS.