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Cary W. Akins
D. Craig Miller
Marko I. Turina
Nicholas T. Kouchoukos
Eugene H. Blackstone
Gary L. Grunkemeier
Johanna J.M. Takkenberg
Tirone E. David
Eric G. Butchart
David H. Adams
David M. Shahian
Siegfried Hagl
John E. Mayer
Bruce W. Lytle
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J Thorac Cardiovasc Surg 2008;135:732-738
© 2008 The American Association for Thoracic Surgery

Guidelines for reporting mortality and morbidity after cardiac valve interventions

Cary W. Akins, MDa,*, D. Craig Miller, MDa, Marko I. Turina, MDc, Nicholas T. Kouchoukos, MDb, Eugene H. Blackstone, MDa, Gary L. Grunkemeier, PhDb, Johanna J.M. Takkenberg, MD, PhDc, Tirone E. David, MDa, Eric G. Butchart, MDc, David H. Adams, MDb, David M. Shahian, MDb, Siegfried Hagl, MDc, John E. Mayer, MDb, Bruce W. Lytle, MDa

a The American Association for Thoracic Surgery
b The Society of Thoracic Surgeons
c European Association for Cardio-Thoracic Surgery

Received for publication December 11, 2007; accepted for publication December 11, 2007.

* Address for reprints: Cary W. Akins, MD, Cardiac Surgery, Cox 648, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114. (Email: cakins@partners.org).

The first 300 words of the full text of this article appear below.


    Introduction
 
Since the initial publication of "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" in 1988,1Go followed by a revised version in 1996,2Go valvular heart surgery has evolved to include an enhanced understanding of patient- and disease-related factors affecting outcomes, increased numbers of valve repairs, more operations performed for patients with minimal symptoms, new prostheses, novel repair methods, and the emergence of percutaneous interventional (catheter-based) valve repair and replacement. To adapt to this changing environment, the Councils of the American Association for Thoracic Surgery, The Society of Thoracic Surgeons, and The European Association for Cardio-Thoracic Surgery have directed an Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity to review current clinical practice to update and clarify these reporting guidelines. The guidelines are intended to cover treatment of all four cardiac valves in both adult and pediatric patients. Further, these guidelines apply uniformly, irrespective of whether the therapy was carried out as a conventional open operation, as a minimally invasive (video-assisted or robotic) surgical procedure, or with percutaneous interventional catheter techniques.


    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.


    Definitions of Morbidity
 
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 . . . [Full Text of this Article]




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