TY - JOUR
T1 - Considerations and recommendations for the introduction of objective performance criteria for transcatheter aortic heart valve device approval
AU - Head, Stuart J.
AU - Mylotte, Darren
AU - Mack, Michael J.
AU - Piazza, Nicolo
AU - Van Mieghem, Nicolas M.
AU - Leon, Martin B.
AU - Kappetein, A. Pieter
AU - Holmes, David R.
N1 - Publisher Copyright:
© 2016 American Heart Association, Inc.
PY - 2016/5/24
Y1 - 2016/5/24
N2 - In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of new-generation THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and provides several considerations and recommendations. Factors to be taken into account in the construction of OPC include the maturity of THV technology, variability in transcatheter aortic valve replacement practice, end points included as OPC, follow-up terms for specific OPC, patient populations to which these OPC apply, and (statistical) methods for OPC development. We recommend that approval of THV devices in the United States for low- and intermediate-risk patients or for new indications should provisionally rely on data from randomized, clinical trials. However, it is recommended that formal OPC be applied for approval of new-generation THVs for use in high- and extreme-risk patient populations.
AB - In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of new-generation THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and provides several considerations and recommendations. Factors to be taken into account in the construction of OPC include the maturity of THV technology, variability in transcatheter aortic valve replacement practice, end points included as OPC, follow-up terms for specific OPC, patient populations to which these OPC apply, and (statistical) methods for OPC development. We recommend that approval of THV devices in the United States for low- and intermediate-risk patients or for new indications should provisionally rely on data from randomized, clinical trials. However, it is recommended that formal OPC be applied for approval of new-generation THVs for use in high- and extreme-risk patient populations.
KW - aortic valve
KW - aortic valve stenosis
KW - device approval
KW - heart valve prosthesis implantation
KW - transcatheter aortic valve replacement
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U2 - 10.1161/CIRCULATIONAHA.115.020493
DO - 10.1161/CIRCULATIONAHA.115.020493
M3 - Article
C2 - 27217434
AN - SCOPUS:84969921736
SN - 0009-7322
VL - 133
SP - 2086
EP - 2093
JO - Circulation
JF - Circulation
IS - 21
ER -