Christian E Rex1,2, Johan Heiberg1,2, Kaj-Erik Klaaborg1,2, Vibeke E Hjortdal1,2. 1. a Deparment of Cardiothoracic & Vascular Surgery , Aarhus University Hospital , Aarhus , Denmark. 2. b Deparment of Clinical Medicine , Aarhus University Hospital , Aarhus , Denmark.
Abstract
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.
RCT Entities:
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.
Authors: Stephanie Louise Swift; Thomas Puehler; Kate Misso; Shona Helen Lang; Carol Forbes; Jos Kleijnen; Marion Danner; Christian Kuhn; Assad Haneya; Hatim Seoudy; Jochen Cremer; Norbert Frey; Georg Lutter; Robert Wolff; Fueloep Scheibler; Kai Wehkamp; Derk Frank Journal: BMJ Open Date: 2021-12-06 Impact factor: 2.692