Single and multicentre TAVI registries
The Swedish TAVI registry: all 566 procedures in 2008-2011
Aims: To describe the total nationwide experience of TAVI including follow-up to one year.
Methods and results: The Swedish TAVI registry is a part of the Swedeheart group of registries. It covers all seven centres and all procedures since the first TAVI case in our country in 2008. Procedural and clinical data are entered into a central database prospectively. Mortality is collected from the national civil registry, with 100% coverage. Five hundred and sixty-six TAVI procedures were performed in 565 patients from 2008 to 2011. Mean age was 82 years, and mean logistic EuroSCORE was 26%. There is no trend for younger patients or a lower EuroSCORE from 2008 to 2011. Most patients had NYHA Class III symptoms before the procedure. The aortic mean pressure gradient was on average 50 mmHg before the procedure and 10 mmHg two to three months later. Transfemoral access was used in 385 cases, transapical access in 159 cases and subclavian access in 22 cases. The Medtronic CoreValve system was used in 314 cases and the Edwards SAPIEN system in 252 cases. The mortality at 30 days was 6.4%, and at one year (in patients treated in 2008-2010) 14%. In-hospital stroke was 2.2% (2008-2011). The median hospital stay was six days. In transfemoral cases, the 30-day and one-year mortality was 5.5% and 12%, respectively, compared to 8.8% and 19% in transapical cases (unadjusted). In CoreValve cases, the 30-day mortality and one-year mortality was 5.4% and 13%, respectively, compared to 7.5% and 17% in SAPIEN cases (unadjusted). Forty patients aged 90 or over were treated, with a 5% 30-day mortality and 4% one-year mortality (the latter in the 23 patients treated 2008-2010). Among the 209 cases performed in 2011, in-hospital complications included stroke (1.5%), vascular complication (11%), major bleeding (8%), new permanent pacemaker (8%) and new need for dialysis (1%). The technical success rate was 97%. General anaesthesia was used in 99% of the SAPIEN cases compared to 13% of the CoreValve cases. The mean procedural time was 1:35 with the CoreValve system and 1:59 with the SAPIEN system. On the postoperative echocardiogram, grade 0-1 aortic regurgitation was found in 86%, grade 2 regurgitation in 10% and grade 3 regurgitation in 3%. Comparing different counties in the country, there was a fourfold difference in the number of treated patients per 100,000 inhabitants in 2011.
Conclusions: A nationwide TAVI registry is feasible and is able to give valuable data. For Sweden, we found a rather low short-term and long-term mortality and a low stroke rate.