Why the study?
Does TA-TAVI improve long-term health-related quality-of-life compared to SAVR in low-risk patients with aortic valve stenosis?
RCT (n=58)
randomized
Does TA-TAVI improve long-term health-related quality-of-life compared to SAVR in low-risk patients with aortic valve stenosis?
Answers are grounded in this paper and cite their sources.
In low-risk patients with aortic valve stenosis, TA-TAVI provides similar long-term health-related quality of life and survival compared to SAVR over 5 years, with a transient early benefit in physical recovery at 1 year.
PURPOSE: Transcatheter aortic valve implantation (TA-TAVI) is a well-established treatment for aortic valve stenosis in high-risk patients and indications have been continuously expanding to also include intermediate-risk patients. However, in low-risk patients, experiences are still sparse and although clinical outcomes have been shown favorable results, HRQoL has remained unexplored. The aim of this report was to describe the long-term health-related quality-of-life (HRQoL) in low-risk patients randomized to TA-TAVI or surgical aortic valve replacement (SAVR). METHODS: In a prospective, randomized trial, patients with aortic valve stenosis were randomized to either TA-TAVI or SAVR. TA-TAVI was performed through a mini thoracotomy with the introduction of prosthesis via the apex of the heart and antegradely advancement over the pre-dilated native valve. SAVR was performed during cardiopulmonary bypass with resection of the native valve and replacement with a prosthesis valve through a median sternotomy. Afterwards, patients were followed yearly with echocardiography and HRQoL assessment. RESULTS: A total of 58 patients were included; 29 patients for TA-TAVI and 29 patients for SAVR. The only difference in HRQoL was found in the physical component summary after 1 year; 44 ± 9 in the TA-TAVI group compared with 36 ± 9 in the SAVR group, p = .03. There were no differences in any of the remaining timepoints in neither physical nor mental component summary, p = .19 and p = .98, respectively, and there were no differences in survival during the 5 years. CONCLUSIONS: In low-risk patients with aortic valve stenosis undergoing TA-TAVI, no differences appeared in HRQoL compared with SAVR during a 5-year follow-up period.
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Rex et al. (2016) conducted an RCT in aortic valve stenosis (n=58). Transapical transcatheter aortic valve implantation (TA-TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated on Health-related quality-of-life (HRQoL) physical component summary at 1 year (p=.03).
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