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Ethics of Innovation in Surgery for Congenital Cardiac Diseases

Published online by Cambridge University Press:  01 November 2009

Constantine Mavroudis*
Affiliation:
Cleveland Clinic Children’s Hospital, Center for Pediatric and Adult Congenital Heart Diseases, Cleveland, Ohio, United States of America
Constantine D. Mavroudis
Affiliation:
Loyola University Stritch School of Medicine, Chicago, Illinois, United States of America
Marshall L. Jacobs
Affiliation:
Cleveland Clinic Children’s Hospital, Center for Pediatric and Adult Congenital Heart Diseases, Cleveland, Ohio, United States of America
Jeffrey P. Jacobs
Affiliation:
The Congenital Heart Institute of Florida (CHIF), Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital and Children’s Hospital of Tampa, University of South Florida College of Medicine, Cardiac Surgical Associates of Florida (CSAoF), Saint Petersburg and Tampa, Florida, United States of America
*
Correspondence to: Constantine Mavroudis, MD, Ross Chair, Pediatric and Adult Congenital Heart Diseases, Cleveland Clinic Children’s Hospital, 9500 Euclid Avenue/M41, Cleveland, Ohio 44195. Tel: 216.636.5288; Fax: 216.445.3692; E-mail: mavrouc@ccf.org

Abstract

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Type
Original Article
Copyright
Copyright © Cambridge University Press 2009

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References

1.Jatene, AD, Fontes, VF, Paulista, PP, Souza, LC, Neger, F, Galantier, M, Sousa, JE. Anatomic correction of transposition of the great vessels. J Thorac Cardiovasc Surg 1976; 72 (3): 364370.Google Scholar
2.Yacoub, MH, Radley-Smith, R, Maclaurin, R. Two-stage operation for anatomical correction of transposition of the great arteries with intact interventricular septum. Lancet 1977; 1 (8025): 12751278.Google Scholar
3.Riskin, DJ, Longaker, MT, Krummel, TM. The ethics of innovation in pediatric surgery. Semin Pediatr Surg 2006; 15 (4): 319323.CrossRefGoogle ScholarPubMed
4.Lillehei, CW, Cohen, M, Warden, HE, Ziegler, NR, Varco, RL. The results of direct vision closure of ventricular septal defects in eight patients by means of controlled cross circulation. Surg Gynecol Obstet 1955; 101 (4): 446466.Google ScholarPubMed
5.Lower, RR, Shumway, NE. Studies on orthotopic homotransplantation of the canine heart. Surg Forum 1960; 11: 1819.Google Scholar
6.Barnard, CN. The operation. A human cardiac transplant: an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J 1967; 41 (48): 12711274.Google Scholar
7. US Department of Health and Human Services. Food and Drug Administration. FDA Backgrounder: Milestones in US Food and Drug Law History. Available at: http://www.fda.gov/oc/history/default.htm.Google Scholar
8. University of Minnesota Department of Surgery. Owen H. Wangensteen, MD, PhD, Biography. Available at: http://www.surg.umn.edu/surgery/Education/OWSS/wangensteen_bio.html.Google Scholar
9.Gott, VL. Lillehei, Lewis, and Wangensteen: the right mix for giant achievements in cardiac surgery. Ann Thorac Surg 2005; 79 (6): S2210S2213.CrossRefGoogle ScholarPubMed
10.Shumway, NE. C. Walton and F. John. Ann Thorac Surg 1999; 68 (3 Suppl): S34S36.Google Scholar
11.Miller, GW. KING of Hearts: The True Story of the Maverick Who Pioneered Open Heart Surgery: Random House/Times Books; 2002.Google Scholar
12.Ramsey, PG. The Patient as Person: Explorations in Medical Ethics. New Haven, CONN: Yale University Press; 2002.Google Scholar
13.Mavroudis, C. Presidential address. A partnership in courage. Ann Thorac Surg 2003; 75 (5): 13661371.Google Scholar
14.Norwood, WI, Dobell, AR, Freed, MD, Kirklin, JW, Blackstone, EH. Intermediate results of the arterial switch repair. A 20-institution study. J Thorac Cardiovasc Surg 1988; 96 (6): 854863.CrossRefGoogle ScholarPubMed
15.Anderson, WF. Uses and abuses of human gene transfer. Hum Gene Ther 1992; 3 (1): 12.Google Scholar
16.Callahan, D. What Price Health? Hazards of the Research Imperative. Berkeley, CA: University of California Press; 2003.Google Scholar
17.Jonas, H. Philosophical reflection on experimenting with human subjects. Daedalus 1969; 98 (2): 219247.Google Scholar
18.Bailey, LL, Nehlsen-Cannarella, SL, Concepcion, W, Jolley, WB. Baboon-to-human cardiac xenotransplantation in a neonate. JAMA 1985; 254 (23): 33213329.CrossRefGoogle ScholarPubMed
19.Jonasson, O, Hardy, MA. The case of Baby Fae. JAMA 1985; 254 (23): 33583359.CrossRefGoogle ScholarPubMed
20.Katz, JJ. Experimentation With Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process. New York: Russell Sage Foundation; 1972.Google Scholar
21.Moore, FD. Therapeutic innovation: ethical boundaries in the initial clinical trials of new drugs and surgical procedures. CA Cancer J Clin 1970; 20 (4): 212227.Google Scholar
22.Aristotle. The Nichomachean Ethics Book III. [Translated by Sir David Ross]. London: Oxford University Press; 1954.Google Scholar
23.Kant, I . Grundlegung zur Metaphysik der Sitten [Foundations of the Metaphysics of Morals]. 1785.Google Scholar
24.Altman, DG, Schulz, KF, Moher, D, Egger, M, Davidoff, F, Elbourne, D, Gotzsche, PC, Lang, T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134 (8): 663694.CrossRefGoogle ScholarPubMed
25.Morreim, H, Mack, MJ, Sade, RM. Surgical innovation: too risky to remain unregulated? Ann Thorac Surg 2006; 82 (6): 19571965.CrossRefGoogle ScholarPubMed