Long-term mortality, stroke similar in TAVR vs. surgery, but need for pacemaker elevated
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Key takeaways:
- TAVR was tied to similar long-term mortality vs. surgical AVR for severe aortic stenosis.
- But use of self-expanding TAVR valves elevated risk for pacemaker implant.
Transcatheter aortic valve replacement was associated with similar long-term mortality and stroke risk vs. surgery for severe aortic stenosis, but with greater risk for pacemaker implant with self-expanding TAVR valves, a speaker reported.
The results of a TAVR vs. surgical AVR meta-analysis were presented at EuroPCR and simultaneously published in the Journal of the Society for Cardiovascular Angiography and Interventions.
“We decided to perform a large-scale meta-analysis of randomized trials comparing long-term outcomes at the longest available term outcomes of patients undergoing TAVR vs. surgical AVR in cases of severe aortic stenosis,” Eliano P. Navarese, MD, PhD, FESC, FACC, head of clinical experimental cardiology in the department of clinical interventional cardiology at the University of Sassari, Italy, said during a press conference. “We have prespecified the trials to be categorized into three groups based on surgical risk. ... But importantly, we also prespecified the differences in terms of percutaneous device vs. the common comparator, which was surgical AVR.”
The meta-analysis assessed seven trials that compared TAVR with surgical AVR, including 7,785 patients at low, intermediate and high surgical risk. The weighted mean follow-up was nearly 6 years.
The prespecified primary endpoint was death or disabling stroke. Secondary endpoints of interest included pacemaker implantation, valve thrombosis and valve gradient.
Navarese reported there was no significant difference in the primary endpoint between TAVR and surgical AVR (HR = 1.02; 95% CI, 0.93-1.11; P = .7), and the results were consistent across the prespecified surgical risk profiles.
TAVR was associated with greater risk for pacemaker implantation (HR = 1.98; 95% CI, 1.34-2.91; P < .01) compared with surgical AVR, which was mainly driven by self-expanding TAVR use (HR for self-expanding TAVR valves vs. surgery = 2.83; 95% CI, 2.27-3.54; HR for balloon-expandable TAVR valves vs. surgery = 1.19; 95% CI, 0.98-1.44; P for interaction between TAVR valve types < .01), according to the presentation.
Compared with surgery, self-expanding TAVR valves were associated with lower risk for the following outcomes to a greater degree than ballon-expandable TAVR valves: death and disabling stroke (P for interaction = .06) and valve thrombosis (P for interaction= .06) and lower valve gradients (P for interaction < .01).
“These findings, as we expect, support the comparable long-term safety and efficacy of TAVR in comparison to surgical AVR,” Navarese said during the press conference.
“This meta-analysis may help us to better reflect on the potential selection of the TAVR device, especially now that we’re moving toward long-term implantation,” he said. “We should reflect also on the best patients suited for the better valve.”
Reference:
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Navarese EP, et al. TAVI hotline: long-term registry data. Presented at: EuroPCR; May 14-17, 2024; Paris.
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