title: Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval.
abstract: 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.
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.). s.head@erasmusmc.nl.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Head
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: Darren
authors.initials: D
authors.lastname: Mylotte
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: van Mieghem
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: A Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.affiliation: From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.).
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
mesh_terms: D001024:Aortic Valve Stenosis / Q000453:epidemiology / Q000601:surgery*; D018795:Device Approval / Q000592:standards*; D006801:Humans; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods / Q000592:standards*; D014481:United States / Q000453:epidemiology
keywords: aortic valve; aortic valve stenosis; device approval; heart valve prosthesis implantation; transcatheter aortic valve replacement