1. The First International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in Heart Valve Disease: Moving From Device- to Patient-Centered Outcomes.
- Author
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Lansac E, Veen KM, Joseph A, Blancarte Jaber P, Sossi F, Das-Gupta Z, Aktaa S, Sádaba JR, Thourani VH, Dahle G, Szeto WY, Bakaeen F, Aikawa E, Schoen FJ, Girdauskas E, Almeida A, Zuckermann A, Meuris B, Stott J, Kluin J, Meel R, Woan W, Colgan D, Jneid H, Balkhy H, Szerlip M, Preventza O, Shah P, Rigolin VH, Medica S, Holmes P, Sitges M, Pibarot P, Donal E, Hahn RT, and Takkenberg JJM
- Abstract
Objective: Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD., Methods: A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition., Results: Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions., Conclusions: Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.A. has received research funding from the National Institutes of Health. S.A. has received meeting/travel support from the European Society of Cardiology; participated in Data Management and Analysis Group of the British Intervention Cardiovascular Society; and is a Leader of the Quality of Care group of the European Society of Cardiology. A.A.A. has received payment/honoraria fees from Abbott Medical Pty Ltd and Corcym Pty Ltd. H.H.B. has received consulting fees for being a proctor for Intuitive Surgical; has received lecture honoraria from Medtronic and Edwards Lifesciences; has served on a data safety monitoring board for Edwards Lifesciences; and has served in leadership positions for ISMICS, SRS, STS, and ACS. P.B.J., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. Z.D-S., via ICHOM, received funding from Adetec Coeur and Edwards Lifesciences for this project. D.E. has received research and advisory collaboration with GE Healthcare and Abbott Vascular. G.E. has received speaker honoraria (payments to the institution) from Edwards Lifesciences, Medela, and AstraZeneca. R.T.H. has received honoraria for lectures from Boston Scientific, Edwards Lifesciences, and Philips Healthcare; and Institutional Consulting Contracts (no direct compensation) from Abbott, Anteris, Boston Scientific, and Novartis. A.J. has been a senior project leader for the development of the standard set for heart valve disease, which entails development of study materials, leading the working group through the process, and quality assurance of all materials. E.L. has received a patent for extra aortic ring from Coroneo Inc; and has received royalties/licenses for a patent extra aortic ring from Coroneo Inc. B.M. has received consulting fees from Corcym, Edwards Lifesciences, and Novostia; and has received honoraria for lectures/presentations from Medtronic. P.P. has received institutional funding with no direct compensation from Novartis, Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; has received honoraria for lectures/presentations from Edwards Lifesciences; and has participated on an advisory board for Medtronic. O.P. has been co-chair of ACC/AHA guidelines on aortic disease (2022); has served as a member of the EACTS/STS guidelines on aortic disease (2024); and has been a consultant (no fees) for W.L. Gore and Associates, Terumo Aortic, Intressa Vasc, and AbioMed. V.R. has participated on an advisory board for Rednvia Co, Ltd (Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient’s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis [EVOID-AS]); has received stock from Amgen, Edwards Lifesciences, Intuitive Surgical, Inc, Bristol Myers Squibb, Merck-Schering Plough, Viatris, Organon, Regeneron, and AstraZeneca. F.J.S. has received consulting fees as a paid consultant and SAB member for Xeltis; and has received support for meetings/travel as a paid consultant and SAB member Xeltis. P.S. has received support (payments to institution) from Edwards Lifesciences and support (InstitutionEd) from Medtronic; has received honoraria for lectures/presentations from Edwards; has served on a data safety monitoring board for Anteris; and has received stock/stock options from Xenter. M. Sitges has received consulting fees from Edwards Lifesciences and Abbott; has received honoraria for lectures/presentations from Edwards Lifesciences, Abbott, Medtronic, General Electric, and Siemens Healthineers; has received payment for expert testimony from Abbott and General Electric; has received meeting/travel support from Abbott and Edwards Lifesciences; has served as past president of the Heart Valve Society; has been elected president of the Societat Catalana de Cardiologia; and has served with the Tricuspid Focus Group PCR. M. Szerlip has received honoraria for lectures/presentations from Edwards Lifesciences, CVI, SCAI, and Boston Scientific; has served on a data safety monitoring board for Abbott Vascular; and is a member of the Baylor Scott and White Heart Hospital Board, the SCAI Board of Trustees, and the IAGS Board. W.Y.S. has received honoraria for lectures/presentations from Edwards Lifesciences, Medtronic, Abbott, Terumo Aortic, and Artivion. J.J.M.T. is past president and senior advisor to Heart Valve Society Board. V.H.T. has received consulting fees from Abbott Vascular, Artivion, Boston Scientific, CroíValve, Edwards Lifesciences, Articure, and Egnite Medical; and has received equity from Dasi Simulations and Trisol. F.B., D.C., G.D., H.J., J.K., S.M., R.M., R.S., F.S., J.S., K.V., W.W., and A.Z. have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2025
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