SOLACE AU Registry: Interim Results at One Year of the Edwards SAPIEN XT TM Transcatheter Heart Valve in Intermediate Risk Patients with Severe Aortic Stenosis in Australia

Background: We report the interim clinical outcomes of intermediate-risk patients from the SOLACE AU Registry who received the Edwards SAPIEN XT ™ Transcatheter Heart Valve (THV) in 11 centres throughout Australia. Methods: This is a single arm multi-centre study of select symptomatic patients with severe aortic stenosis (mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of < 0.8 cm2 or indexed EOA < 0.5 cm2/m2) of at least intermediate risk (STS≥4), undergoing transcatheter valve implantation (TAVI) with Heart Team agreement. This study will also evaluate cost utilisation and will ultimately be case controlled with the PARTNERS 2 study in the USA. Results: The total enrolment for the study to date is 172 patients, the mean ages: 85.3 ± 4.4 years, female: 56.4%, STS score: 7.5 ± 6.02, Logistic Euroscore : 18.7 ± 12.7, with insertion of 23mm (24%), 26 mm (53%) and 29 mm (23%) valves. At 30 days the primary outcomes according to VARC definitions included mortality 3.2%, major vascular complications 3.2% and life threatening bleeding 0.6%. There were no major strokes, no acute kidney injury and no peri-procedural myocardial infarctions. The pacemaker implantation rate was 5.0%. The valve was deployed in the optimal position in 98.7% of cases. Conclusion: In this cohort of intermediate risk patients undergoing TAVI with the SAPIEN XT THV we demonstrated excellent 30-day outcomes with high rates of optimal deployment and low rates of morbidity and mortality.