TY - JOUR
T1 - Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement
AU - Rogers, Jason H.
AU - Sorajja, Paul
AU - Thourani, Vinod H.
AU - Sharma, Rahul Prakash
AU - Chehab, Bassem
AU - Cowger, Jennifer
AU - Heimansohn, David
AU - Badhwar, Vinay
AU - Guerrero, Mayra
AU - Ailawadi, Gorav
N1 - Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/9/27
Y1 - 2021/9/27
N2 - Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.
AB - Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.
KW - mitral regurgitation
KW - randomized trial
KW - transcatheter edge-to-edge repair
KW - transcatheter mitral valve replacement
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U2 - 10.1016/j.jcin.2021.06.014
DO - 10.1016/j.jcin.2021.06.014
M3 - Review article
C2 - 34556279
AN - SCOPUS:85115736440
SN - 1936-8798
VL - 14
SP - 2039
EP - 2046
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 18
ER -