Comparison of balloon-expandable valves versus self-expandable valves in high-risk patients undergoing transcatheter aortic valve replacement for severe aortic stenosis.

BACKGROUND Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis (AS) who have a high surgical risk. In Taiwan, this is the first study reporting TAVI outcomes at a single center offering two different transcatheter heart valve technologies via four types of approaches. Our aim was to compare 30-day and 6-month Valve Academic Research Consortium-2 (VARC-2) outcomes of the two valves. METHODS We reported the procedural, 30-day, and 6-month VARC-2 outcomes of high-risk patients who were consecutively treated with the Medtronic CoreValve (MCV) or with the Edwards SAPIEN valve or SAPIEN XT valve (ESV; Edwards Lifesciences, Irvine, CA, USA) delivered via four types of approaches. RESULTS From May 2010 to December 2013, 30 consecutive patients with severe AS underwent TAVI: 15 patients were treated with the MCV and 15 patients were treated with the ESV. The transfemoral approach was the most frequently used route (13 MCV and 6 ESV), followed by the transapical approach (9 ESV), trans-subclavian approach (1 MCV), and direct aortic approach (1 MCV). There were no procedural deaths. "Device success" was achieved in 29 (96.7%) patients, and is defined as the absence of procedural mortality, correct positioning of one prosthetic heart valve into the proper anatomical location, and intended performance of the heart valve without moderate or severe regurgitation. The VARC-2-defined combined safety endpoint at 30 days was comparable between patients treated with the ESV and the MCV (33.3% vs. 20%, respectively; group, p = 0.409). At the 6-month follow up, the combined efficacy endpoint was not significantly different between the two groups (13.3% in the ESV group vs. 20% in the MCV group; p = 0.624). There was only one (3.3%) patient who required permanent pacemaker implantation. CONCLUSION For the first time in Taiwan, we have demonstrated that TAVI using either device is complementary and feasible for treating a wide range of patients by using a careful selection of approaches. Favorable overall procedural success rates and 30-day and 6-month outcomes were achieved with both devices.