Background: Transcatheter aortic valve implantation (TAVI) is currently recommended in European practice guidelines for patients with intermediate to high risk for surgical aortic valve replacement. Our aim was to compare the efficacy and safety of TAVI in patients with low versus intermediate and high surgical risk.
Methods: We performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers. We defined patients with low surgical risk (LSR) as patients with a Society of Thoracic Surgery (STS) score of under 4, and patients with intermediate and/or high surgical risk (I-HLR) as patients with STS score ≥4.
Results: The study population included 2,336 patients (LSR n=1198, I-HLR n=1138). As compared to LSR patients with I-HSR had significantly higher rates of baseline comorbidities including older age (85 vs. 81 years), renal failure (86% vs. 63%), ischemic heart disease (57% vs. 50%), prior stroke (17% vs. 13%), peripheral vascular disease (18% vs. 8%), diabetes mellitus (44% vs. 32%), chronic obstructive pulmonary disease (21% vs. 11%) and were more often considered frail (31% vs. 18%), respectively (all p<0.05). Alternative access was used more commonly in I-HSR patients (I-HSR 13% and LSR 5%; p<0.001). Procedural outcome were comparable between groups including devices success (95% vs. 96%), major vascular complications (4.7% vs. 4.2%), bleeding (6% vs. 6%), permanent pacemaker implantation (17% vs. 18%), and at least moderate paravalvular regurgitation (4% vs. 5%) for I-HSR versus LSR, respectively (all p>0.05). Patients at I-HSR had higher rates of acute kidney injury (15% vs. 11%, p=0.002) as well as the need for post procedural Dialysis (1.3% vs 0.1%, p=0.002) as compared to LSR patients, respectively. As expected, 1-month and 1-year all-cause mortality were higher for patients with I-HSR (3.9% versus 1.9%, p=0.005; and 14.5% vs. 6.9%, p<0.001; for I-HSR vs. LSR, respectively).
Conclusion: In spite of a higher calculated surgical risk for 30-d mortality, and higher rates of baseline co-morbidities, comparable rates of procedural and post procedural complications were observed for TAVI patients at LSR versus I-HSR.