Transcatheter aortic valve replacement (TAVR), a groundbreaking medical development, has removed the need for open-heart surgery for patients with severe, symptomatic aortic stenosis. TAVR has gained universal acceptance as a result of a decade of clinical evidence from randomized trials.
In randomized controlled trials utilizing both balloon-expandable and self-expanding TAVR valves, TAVR was found to be as successful as, if not more effective than, surgical aortic valve replacement in patients at intermediate or high risk. Â
The Placement of Aortic Transcatheter Valves (PARTNER) 3 experiment, the results of which were just recently made public, represent a watershed moment in medical history. In terms of mortality, stroke, and readmission rates, the trial’s composite outcome revealed no significant difference between the TAVR and surgical groups.
Death from any cause, disability from a stroke, and readmission to the hospital occurred at about the same rates in both groups, as did the other major outcome components. The bulk of the 5-year limited mean event-free survival time difference between the TAVR and control groups was accounted for by differences in readmission rates. Â
An essential aspect, aortic-valve durability, was shown to be the same in both groups at the 5-year mark, as determined by VARC-3 criteria of bioprosthetic-valve failure. Secondary outcomes showed that TAVR was linked with a lower incidence of atrial fibrillation and bleeding. In contrast, surgery was associated with a lower incidence of paravalvular aortic regurgitation, valve thrombosis, and pacemaker implantation. Indicators of functional and health status, such as NYHA class and KCCQ-OS score, showed comparable among groups. Â
The study did, however, shed light on a few wrinkles. After the first year, there was less of a difference in the nonhierarchical composite primary endpoint between the TAVR and surgical groups, with more fatalities in the TAVR group from year 1 to year 5. The possible influence of the Covid-19 epidemic on negative follow-up findings is unknown at this time. The incidence of stroke was comparable after five years in both groups, demonstrating the importance of this complication following aortic valve replacement. Â
After five years, there was no difference in durability between TAVR and surgical valves, which is especially important in younger patients. While TAVR was related to an early improvement in functional status and quality of life, both groups improved to a similar level by the end of the trial period. TAVR appeared to increase the likelihood of clinically severe valve thrombosis but not valve durability. Â
Two possible sources of bias in the current study include dropouts and the need for a more broadly representative trial group. Despite these constraints, the findings shed light on how TAVR and surgery influence low-risk individuals over time. Following transcatheter and surgical bioprosthetic valves over ten years will shed light on their longevity, paving the way for future advances in cardiovascular treatment. Â
News Reference Â
Mack, Michael J., et al. New England Journal of Medicine, vol. 389, no. 21, 23 Nov. 2023, pp. 1949–1960, doi:10.1056/nejmoa2307447.Â
