Oct 16th 2020

SOLVE-TAVI—coverage of TCT Connect 2020

A 2x2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation: 1-year Results

SOLVE-TAVI used a 2x2 factorial design to randomize 447 patients over the age of 75 (mean 81.6 years; 48% male) undergoing transfemoral TAVR for symptomatic severe aortic stenosis to either: a.) TAVR with Edwards Sapien S3 valve (n =  219) or the Medtronic CoreValve Evolut R (n = 219), or b.) conscious sedation with local anesthesia (n = 218) versus general anesthesia (n = 220). Median STS risk score was 4.8. The primary endpoint of all-cause mortality, stroke, moderate or severe aortic regurgitation and permanent pacemaker implantation at 30 days, was present in 25.9 percent and 28.4 percent, respectively (P = 0.04 for equivalence). Secondary endpoints comparing Sapien 3 and Evolut R, including device success (91.7% vs 94.0%), major vascular complications (6.4% vs 5.1%) and mean gradient >20 mmHg at 30 days (3.3% vs 2.0%), were similar. Looking at conscious sedation vs general anesthesia, the primary composite endpoint of all-cause mortality, stroke, myocardial infarction (MI), infection and acute kidney injury at 30 days were equivalent (25.5 % vs 27.0%, p for equivalence = 0.02). Of note, hospital length of stay, intensive care unit stay and rates of moderate to severe PVL were all similar.