TY - JOUR
T1 - Functional Status After Transcatheter and Surgical Aortic Valve Replacement
T2 - 2-Year Analysis From the SURTAVI Trial
AU - Tuttle, Mark K.
AU - Kiaii, Bob
AU - Van Mieghem, Nicolas M.
AU - Laham, Roger J.
AU - Deeb, G. Michael
AU - Windecker, Stephan
AU - Chetcuti, Stanley
AU - Yakubov, Steven J.
AU - Chawla, Atul
AU - Hockmuth, David
AU - Teefy, Patrick
AU - Li, Shuzhen
AU - Reardon, Michael J.
N1 - Funding Information:
The SURTAVI trial was funded by Medtronic. Dr Kiaii has served as a consultant for Medtronic, Boston Scientific, Johnson and Johnson, and LivaNova; as a speaker for Medtronic, Boston Scientific, and Johnson and Johnson; and as a proctor for Medtronic, Boston Scientific, and LivaNova. Drs Van Mieghem and Laham have received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr Deeb has served on the advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical with all fees paid to his institution. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson and Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; has served as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and has served as a member of the steering/executive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Chetcuti has received grant support and fees for proctoring from Medtronic; and has served as a consultant for JenaValve. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic; Dr Chawla has served as a proctor for Medtronic. Dr Teefy has received grant support from Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Reardon has received fees from Medtronic for providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022 American College of Cardiology Foundation
PY - 2022/4/11
Y1 - 2022/4/11
N2 - Objectives: This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery. Background: Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on “hard endpoints,” including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden. Methods: The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers. Results: Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve– and heart failure–related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years. Conclusions: In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)
AB - Objectives: This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery. Background: Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on “hard endpoints,” including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden. Methods: The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers. Results: Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve– and heart failure–related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years. Conclusions: In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)
KW - functional status
KW - quality of life
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jcin.2022.01.284
DO - 10.1016/j.jcin.2022.01.284
M3 - Article
C2 - 35393106
AN - SCOPUS:85126955200
VL - 15
SP - 728
EP - 738
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 7
ER -