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J Thorac Cardiovasc Surg 2001;121:837-839
© 2001 The American Association for Thoracic Surgery

Editorials

A bypass for the Institutional Review Board: Reflections on the Cleveland Clinic study of the Batista operation

From the Department of Surgery and Joint Centre for Bioethics, University of Toronto, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.

Received for publication Aug 11, 2000. Revisions requested Aug 22, 2000; revisions received Sept 12, 2000. Accepted for publication Sept 15, 2000. Address for reprints and suggestions: Martin F. McKneally, MD, 77 Forest Grove Dr, Toronto, Ontario, Canada M2K 1Z4 (E-mail: martin.mckneally@utoronto.ca).

For related article, see p. 879.

When I heard the oral presentation of the study of the Batista operation conducted by Patrick McCarthy and his colleagues last May, I shared in the thrill that was palpable in the audience. Chosen by the program committee as one of the first presentations at the meeting of The American Association for Thoracic Surgery, the study delivered a clear and practical surgical judgment about the validity of left ventricular reduction, a new procedure widely regarded as radically innovative.

We learned that the investigators removed part of the ventricle in patients judged ill enough to have their whole heart removed and replaced. The physiological effects of remodeling the heart were clearly described. Best of all, the operation was performed in a setting that could offer the patients a safe fallback procedure, either mechanical assistance or transplantation.

It seemed an ideal way to "try the treatment out," testing its efficacy and appropriateness. McCarthy and his colleagues had built a reliable safety net for their patients, which would protect them from the substantially higher mortality associated with the operation in other settings.

When the manuscript describing The Cleveland Clinic study reached the Journal's reviewers, it prompted them to ask several questions that focused on ethical issues: (1) Were the patients sufficiently informed about the study? (2) Shouldn't the study have been reviewed by a research ethics board such as the Institutional Review Board (IRB) of The Cleveland Clinic? (3) What is the Journal's role in setting or enforcing ethical standards of patient care and research?

Our Editor, Andrew Wechsler, asked me to comment on some of the ethical issues and to provide a definition of ethics. I will begin with the definition: Ethics is a plural noun, ¹ referring to various systems of principles and values . . . [Full Text of this Article]

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Partial left ventriculectomy for dilated cardiomyopathy: Is this an alternative to transplantation?

Anders Franco-Cereceda, Patrick M. McCarthy, Eugene H. Blackstone, Katherine J. Hoercher, Jennifer A. White, James B. Young, and Randall C. Starling
J. Thorac. Cardiovasc. Surg. 2001 121: 879-893. [Abstract] [Full Text] [PDF]

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