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J Thorac Cardiovasc Surg 2002;123:830
© 2002 The American Association for Thoracic Surgery

Letters to the Editor

A question of terminology

Patrick M. McCarthy, MD, Anders Franco-Cerceda, MD, PhD, Eugene H. Blackstone, MD, Katherine Hoercher, RN, Jennifer A. White, MS, James B. Young, MD, Randall C. Starling, MD

Department of Thoracic/Cardiovascular Surgery, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195

To the Editor:

We are writing to clarify issues raised by McKneally's editorialGo 1 regarding our article on partial left ventriculectomy that reported on patients who underwent the Batista procedure at The Cleveland Clinic.Go 2 Some confusion has resulted from our use of certain words, commonly used in a research setting, and we want to clarify any misunderstandings. The Cleveland Clinic has "prospectively" collected clinical data and outcomes for all patients having cardiac surgery since 1973 and for patients having heart transplantation since 1984. For example, patients who underwent coronary artery bypass have been followed up through the years. Information generated from these data has been the subject of numerous important reports. The word prospective was used in our manuscript to indicate that data were collected concurrently with, or shortly after, the time of care. We also used other terms that may have created the impression for some readers that we had prospectively formulated a research protocol to evaluate the procedure when in fact we did not do so for the reasons described later in this letter. We published the data about the Batista procedure because we believed it was our obligation to tell the medical community that the procedure appeared to be less effective in late follow-up than was previously thought.

The Cleveland Clinic Institutional Review Board (IRB) was engaged in the review of ancillary projects involving the Batista procedure, but not the performance of the Batista procedure itself. Several forms of ventricular surgery have been used for decades to treat heart failure related to left ventricular aneurysms in nonresearch settings. Therefore, we concluded that it was not necessary to formulate a research protocol to evaluate the effectiveness of the procedure itself. We discussed this with others, including other members of the transplant team and the attorney member of the IRB. The data and interpretations contained in the report are accurate, but we did not believe it was important to clarify the use of certain words and the involvement of the IRB. We respect the critical role that the IRB serves, and we did not intend to "bypass" the IRB. We suggest that physicians consult their IRB if they have any questions regarding how innovative surgery should be evaluated.

We submit this clarification in the spirit of both accuracy and integrity.

12/8/121503

doi:10.1067/mtc.2002.121503

References

  1. McKneally MF. A bypass for the Institutional Review Board: reflections on the Cleveland Clinic study of the Batista operation. J Thorac Cardiovasc Surg. 2001;121:879-93.[Abstract/Free Full Text]
  2. Franco-Cerceda A, McCarthy PM, Blackstone EH, Hoercher KJ, White JA, Young JB, et al. Partial left ventriculectomy for dilated cardiomyopathy: Is this an alternative to transplantation? J Thorac Cardiovasc Surg. 2001;121:837-9.[Free Full Text]




This Article
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Patrick M. McCarthy
Eugene H. Blackstone
James B. Young
Randall C. Starling
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