Outcomes of Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis: A Single Center Experience
Background:
Low-risk patients with severe aortic stenosis were excluded from recent transcatheter aortic valve replacement (TAVR) randomized clinical trials. Despite lack of data in outcomes from clinical trials, low-risk patients are being treated with TAVR. The safety and efficacy of TAVR in this population is unclear.
Methods:
This is a retrospective observational study of patients with severe aortic stenosis undergoing TAVR in a single cardiovascular center. From April 2012 to January 2017, a total of 568 consecutive patients were included. They were stratified according to their Society of Thoracic Surgeons (STS) score into high-risk (STS ≥8), intermediate-risk (STS 4 to 8), and low-risk (STS ≤4). Outcomes included 30-day and one-year mortality, 30-day stroke rate, length of stay and procedural complications.
Results:
There were 156 (27.5%) low-risk, 282 (49.6%) intermediate-risk, and 130 (22.9%) high-risk patients. Low-risk patients were significantly younger, more likely to be males compared to intermediate-risk and high-risk patients. Low-risk patients were more likely to undergo transfemoral route (87.8% vs. 74.8% vs. 60.0%, p<0.001), and had higher BMI (28.1 ± 5.4 vs. 26.9 ± 5.3 vs. 26.2 ± 5.2, p=0.013) compared to intermediate and high risks. There was no significant difference in 30-day mortality (1.3% vs. 5.3% vs. 5.4%, p=0.1). Low-risk patients had significantly lower one-year mortality (4.5% vs. 16.7% vs. 19.2%, p<0.001). There was no significant difference in 30-day stroke rate (3.6% vs. 5.0% vs. 0.8%, p=0.125), complete heart block (9.5% vs. 13.1% vs. 13.8%, p=0.494), vascular complication (10.2% vs. 13.3% vs. 16.9%, p=0.281), or new-onset atrial fibrillation (10.9% vs. 9.2% vs. 8.9%, p=0.817). Low-risk patients had significantly less acute kidney injury (19.0% vs. 29.5% vs. 35.0%, p=0.012), major bleeding (17.5% vs. 37.9% vs. 58.5%, p<0.001), and perivalvular leak (40.8% vs. 52.5% vs. 65%, p=0.006).
Conclusions:
Low-risk patients undergoing TAVR appear to have favorable outcomes compared with intermediate and high-risk patients. This study suggests under careful selection, TAVR can be offered to low-risk patients in contemporary practice.