Lansac Emmanuel, Veen Kevin M, Joseph Andria, Blancarte Jaber Paula, Sossi Frieda, Das-Gupta Zofia, Aktaa Suleman, Sádaba J Rafael, Thourani Vinod H, Dahle Gry, Szeto Wilson Y, Bakaeen Faisal, Aikawa Elena, Schoen Frederick J, Girdauskas Evaldas, Almeida Aubrey, Zuckermann Andreas, Meuris Bart, Stott John, Kluin Jolanda, Meel Ruchika, Woan Wil, Colgan Daniel, Jneid Hani, Balkhy Husam, Szerlip Molly, Preventza Ourania, Shah Pinak, Rigolin Vera H, Medica Silvana, Holmes Philip, Sitges Marta, Pibarot Philippe, Donal Erwan, Hahn Rebecca T, Takkenberg Johanna J M
Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France; Department of Cardiothoracic Surgery, Erasmus MC, Rotterdam, the Netherlands; International Consortium for Health Outcomes Measurement, London, UK; Department of Cardiology, Leeds Teaching Hospitals NHS Foundation Trust and Leeds Institute of Cardiovascular and Metabolic Medicine, UK; Department of Cardiac Surgery, Navarra University Hospital, Pamplona, Spain; Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia, USA; Department of Cardiothoracic Surgery, Oslo University Hospital, Norway; Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Main Campus, Cleveland, Ohio, USA; Department of Medicine, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Cardiothoracic Surgery, Augsburg University Hospital, Germany; Monash Medical Centre, Melbourne, Victoria, Australia; Department of Cardiac Surgery, Medical University of Vienna, Austria; Department of Cardiovascular Sciences, KU Leuven, Belgium; Heart Valve Voice Canada, Toronto, Ontario, Canada; Department of Cardiothoracic Surgery, University Hospital Amsterdam, the Netherlands; Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa; Heart Valve Voice, Manchester, UK; University of Texas Medical Branch, Galveston, TX; Biological Sciences Division, Department of Surgery, University of Chicago Medicine, Chicago, Illinois, USA; Baylor Scott & White The Heart Hospital Plano, Plano, Texas, USA; Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, Texas, USA; Heart and Vascular Center, Brigham and Women's Hospital, Boston, Massachusetts, USA; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA; Hospital Clínic Cardiovascular Institute, Barcelona, Spain; Quebec Heart and Lung Institute, Quebec City, Québec, Canada; Cardiology Department, University Hospital of Rennes, France; Department of Cardiology, Columbia Structural Heart & Valve Center, Columbia University, New York, New York, USA.
JACC Adv. 2025 Apr;4(4):101059. doi: 10.1016/j.jacadv.2024.101059. Epub 2025 Feb 17.
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.
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.
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.
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.
全球范围内，心脏瓣膜病（HVD）的治疗方法和病程存在显著差异，且结果测量以手术操作为重点而非以患者为重点。本文描述了一套与患者相关的（国际健康结果测量协会）标准结局指标和病例组合，用于测量HVD患者的情况。
成立了一个多学会工作组，成员包括患者代表以及发表当前HVD指南的心血管内科和心胸外科学会的代表。制定该标准集是为了监测患者从诊断到接受外科手术或经导管手术治疗的全过程。通过基准分析和系统评价确定了候选临床和患者报告结局指标（PROMs）以及病例组合。工作组通过在线改良德尔菲法对最终结局指标/病例组合及其相应定义进行投票。
标准集中纳入了患有主动脉瓣/二尖瓣/三尖瓣疾病或主动脉根部/升主动脉直径>40mm的患者。当确诊为HVD时，患者进入数据集，从而能够在患者生命的术前、围术期和术后阶段进行结局测量。工作组定义了5个结局领域：生命状态、患者报告结局、疾病进展、心功能和耐久性以及治疗并发症。随后，选择了16项结局指标，包括2项患者报告结局，用于跟踪HVD患者。病例组合变量包括人口统计学因素、人口统计学变量、超声心动图变量、心导管检查变量以及主动脉瓣/二尖瓣/三尖瓣及其特定干预措施的具体细节。
通过患者与心血管内科和心胸外科学会之间独特的合作努力，制定了一套HVD的标准测量指标。该数据集侧重于无论治疗方式如何的结局测量，从以手术操作为中心的结局转向以患者为中心的结局。实施该数据集将促进结局测量的全球标准化，允许医疗保健系统之间进行有意义的比较，并评估临床实践指南，最终改善全球HVD患者的护理。
