Joint STS/AATS/EACTS reportGuidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions
Section snippets
Purpose
These reporting guidelines are intended to facilitate analysis and reporting of clinical results of various therapeutic approaches to diseased heart valves such that meaningful comparisons can be made and inferences drawn from investigations of medical, surgical, and percutaneous interventional treatment of patients with valvular heart disease.
Early Mortality
Early mortality is to be reported as all-cause mortality at 30, 60, or 90 days and depicted by actuarial estimates (with number remaining at risk and confidence intervals [CIs]) or as simple percentages, regardless of the patient’s location, be it home or in a health care facility.
Structural Valve Deterioration
Structural valve deterioration includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by reoperation, autopsy, or clinical investigation. Clinical investigation should include periodic echocardiographic surveillance. Substantially increased regurgitation or stenosis of the operated valve over time should be reported with quantitative or semiquantitative methods. The term structural valve deterioration refers to changes intrinsic
Valve-Related Mortality
Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.
Sudden, Unexplained Death
A sudden, unexplained death is one in which the cause of death has not been determined by clinical investigation or autopsy findings and the relationship to the operated valve is undefined. These deaths should be reported as a separate category, but also included in valve-related mortality.
Cardiac Death
Cardiac death includes all deaths resulting from cardiac causes. This category includes valve-related deaths, sudden unexplained deaths, and deaths from non–valve-related cardiac causes (eg, from heart failure, acute myocardial infarction, or documented arrhythmias).
All-Cause Mortality
All-cause mortality includes all deaths from any cause after a valve intervention. Survival should be referenced to an age- and sex-matched sample from the representative general population being investigated whenever possible.
Permanent Valve-Related Impairment
Permanent valve-related impairment is any permanent neurologic or other functional deficit caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, operated valve endocarditis, or reintervention.
Major Adverse Valve-Related Event
Major adverse valve-related events include the following: (1) valve-related mortality, (2) all valve-related morbidity, and (3) need for new permanent pacemaker or defibrillator within 14 days after the valve intervention.
Data Collection
Data collection and reporting for all treated valves should include location (aortic, mitral, tricuspid, pulmonary, multiple), treatment method (repair, replacement, percutaneous catheter intervention), repair methods if valve preserved (including type of annuloplasty ring, suture annuloplasty, or coronary sinus cerclage), and, for valve replacement, prosthesis type (mechanical prosthesis, stented bovine pericardial or porcine bioprosthesis, stentless xenograft bioprosthesis, aortic or
Additional Pertinent Material
In addition, the report should specify the following:
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The patient population from which the study cohort was selected, preferably according to CONSORT (Consolidated Standards of Reporting Trials) recommendations (see http://www.consort-statement.org). Inclusive dates of operation and whether the series was consecutive should be stated. Criteria used to select patients should be defined and listed. If a subset of the sample population is reported, the total number of patients who underwent valve
Data Analysis and Reporting
The method of reporting data should facilitate comparison between reports and support the conclusions, inferences, and predictions made. Methods chosen to analyze the collected data depend on the purpose of the report and availability of analytic techniques. Methods used to collect and analyze data should be summarized in the Methods section, with references included or defined in an appendix.
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This article is being co-published in The Annals of Thoracic Surgery, The Journal of Thoracic and Cardiovascular Surgery, the European Journal of Cardio-Thoracic Surgery, and the Asian Cardiovascular & Thoracic Annals.