A Bridge to Heart Transplantation
http://www.100md.com
《新英格兰医药杂志》
To the Editor: In the Perspective article by Renlund (Aug. 26 issue)1 on the use of a total artificial heart as a bridge to transplantation, the author's contention that a physician should do whatever is necessary to save an individual human life raises several questions. In a medical system that appears to be financially nonsustainable,2 should physicians continue largely to ignore escalating treatment costs, even at the peril of that system? If a large monetary outlay for one patient limits medical care for others, how should a physician seek the greater good? If, because of cost, a certain treatment is available only to a privileged few (i.e., if tiering exists),3 is it ethical to provide such treatment?
Chester M. Boltwood, Jr., M.D.
Valley Heart Associates Medical Group
Modesto, CA 95350
chester@vhamg.com
References
Renlund DG. Building a bridge to heart transplantation. N Engl J Med 2004;351:849-851.
Sandy LG. Homeostasis without reserve -- the risk of health system collapse. N Engl J Med 2002;347:1971-1975.
Reinhardt UE. Rationing health care: what it is, what it is not, and why we cannot avoid it. Baxter Health Policy Rev 1996;2:63-99.
To the Editor: That Copeland and colleagues (Aug. 26 issue)1 included retrospective control patients in their study of cardiac replacement with a total artificial heart as a bridge to transplantation is perplexing. Intuitively, such patients would have a higher mortality than would patients offered sophisticated mechanical assist devices, clearly evidenced by the fact that 19 percent of the latter were on cardiopulmonary bypass and unable to be weaned, as compared with no such patients in the control group. One is tempted to speculate that the authors added the control group to create an "evidence base" for the benefit of their device. The commentary by Renlund unfortunately suggests that they have been successful, and no doubt the authors will now also claim that their "lifesaving" device (in which they have a financial interest) should not be subjected to testing in a randomized, controlled trial, because to do so would be unethical.
Michael J. O'Leary, F.J.F.I.C.M.
St. George Hospital
Kogarah, Sydney NSW 2217, Australia
m.oleary@unsw.edu.au
References
Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004;351:859-867.
Dr. Copeland replies: O'Leary's confusion stems from design problems that have chronically plagued artificial-heart research, yet he has answered his own question, just as it has been answered in every bridge-to-transplantation study reported to date. No studies were prospectively randomized because it is not ethical to ask dying patients to be randomly assigned to a nondevice group (i.e., a group that receives no additional treatment). In the report on our study, Figure 2 demonstrates the dramatic early mortality in the retrospectively matched control group. As we stated in the article, controls were used to provide "a rough approximation of the natural history of patients with cardiogenic shock."
O'Leary's confusion continues with his reference to the 19 percent of patients on cardiopulmonary bypass, as if these patients were safer than the controls. In those patients who could not be weaned, the absence of cardiac function prevented discontinuation of bypass and led to implantation of the CardioWest Total Artificial Heart, thus averting death. It would be difficult to find a sicker group.
A randomized trial comparing this technology with another would be welcome. In the meantime, there is no doubt that the CardioWest Total Artificial Heart saves lives.
Jack G. Copeland, M.D.
University of Arizona Sarver Heart Center
Tucson, AZ 85724-5071
jgcbriez@aol.com
Dr. Renlund and colleagues reply: Contrary to O'Leary's contention, randomized, controlled trials are not the only means of establishing an evidence base for clinical practice. Reputable medical organizations have promulgated definitive guidelines "based on years of clinical experience and . . . supported only by historical data."1 Mechanical circulatory support as a bridge to heart transplantation in selected patients is too effective to ration its use in pursuit of some idealized controlled trial.2 The suggestion that such a study be conducted indicates a lack of understanding of the patient population in question. However, if O'Leary is advocating a trial in which patients are randomly assigned to various mechanical-circulatory-support devices before transplantation, we have no disagreement.
Boltwood makes a good point about the inherent tensions between individual patient advocacy and societal responsibility, even though his questions bespeak a broader scope than was addressed in the Perspective article. Indeed, care should be taken as the technology for mechanical circulatory support is extended to destination therapy. Nevertheless, pretransplantation use of the total artificial heart instead of other currently available extracorporeal devices is probably neutral in terms of cost and will not imperil the U.S. health care system. Furthermore, Boltwood seems to suggest that an effective treatment should not be used in anyone unless it can be used in everyone. Despite its admirable egalitarian qualities, this principle would preclude the use of any effective treatment, pending equal access to it.
As the medical community discusses the ethical implications of new forms of technology, let us be wary of simplified and extreme language. Such polemics oversimplify the issues, speciously polarize the debate, and discourage genuine dialogue. In short, they are as unproductive in medicine as they are ugly in politics.
Dale G. Renlund, M.D.
Abdallah G. Kfoury, M.D.
Ashley R. Renlund, B.A.
LDS Hospital
Salt Lake City, UT 84143
References
Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the evaluation and management of chronic heart failure in the adult: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2001;38:2101-2113.
Stevenson LW, Kormos RL. Mechanical cardiac support 2000: current applications and future trial design. J Heart Lung Transplant 2001;20:1-38.
Chester M. Boltwood, Jr., M.D.
Valley Heart Associates Medical Group
Modesto, CA 95350
chester@vhamg.com
References
Renlund DG. Building a bridge to heart transplantation. N Engl J Med 2004;351:849-851.
Sandy LG. Homeostasis without reserve -- the risk of health system collapse. N Engl J Med 2002;347:1971-1975.
Reinhardt UE. Rationing health care: what it is, what it is not, and why we cannot avoid it. Baxter Health Policy Rev 1996;2:63-99.
To the Editor: That Copeland and colleagues (Aug. 26 issue)1 included retrospective control patients in their study of cardiac replacement with a total artificial heart as a bridge to transplantation is perplexing. Intuitively, such patients would have a higher mortality than would patients offered sophisticated mechanical assist devices, clearly evidenced by the fact that 19 percent of the latter were on cardiopulmonary bypass and unable to be weaned, as compared with no such patients in the control group. One is tempted to speculate that the authors added the control group to create an "evidence base" for the benefit of their device. The commentary by Renlund unfortunately suggests that they have been successful, and no doubt the authors will now also claim that their "lifesaving" device (in which they have a financial interest) should not be subjected to testing in a randomized, controlled trial, because to do so would be unethical.
Michael J. O'Leary, F.J.F.I.C.M.
St. George Hospital
Kogarah, Sydney NSW 2217, Australia
m.oleary@unsw.edu.au
References
Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004;351:859-867.
Dr. Copeland replies: O'Leary's confusion stems from design problems that have chronically plagued artificial-heart research, yet he has answered his own question, just as it has been answered in every bridge-to-transplantation study reported to date. No studies were prospectively randomized because it is not ethical to ask dying patients to be randomly assigned to a nondevice group (i.e., a group that receives no additional treatment). In the report on our study, Figure 2 demonstrates the dramatic early mortality in the retrospectively matched control group. As we stated in the article, controls were used to provide "a rough approximation of the natural history of patients with cardiogenic shock."
O'Leary's confusion continues with his reference to the 19 percent of patients on cardiopulmonary bypass, as if these patients were safer than the controls. In those patients who could not be weaned, the absence of cardiac function prevented discontinuation of bypass and led to implantation of the CardioWest Total Artificial Heart, thus averting death. It would be difficult to find a sicker group.
A randomized trial comparing this technology with another would be welcome. In the meantime, there is no doubt that the CardioWest Total Artificial Heart saves lives.
Jack G. Copeland, M.D.
University of Arizona Sarver Heart Center
Tucson, AZ 85724-5071
jgcbriez@aol.com
Dr. Renlund and colleagues reply: Contrary to O'Leary's contention, randomized, controlled trials are not the only means of establishing an evidence base for clinical practice. Reputable medical organizations have promulgated definitive guidelines "based on years of clinical experience and . . . supported only by historical data."1 Mechanical circulatory support as a bridge to heart transplantation in selected patients is too effective to ration its use in pursuit of some idealized controlled trial.2 The suggestion that such a study be conducted indicates a lack of understanding of the patient population in question. However, if O'Leary is advocating a trial in which patients are randomly assigned to various mechanical-circulatory-support devices before transplantation, we have no disagreement.
Boltwood makes a good point about the inherent tensions between individual patient advocacy and societal responsibility, even though his questions bespeak a broader scope than was addressed in the Perspective article. Indeed, care should be taken as the technology for mechanical circulatory support is extended to destination therapy. Nevertheless, pretransplantation use of the total artificial heart instead of other currently available extracorporeal devices is probably neutral in terms of cost and will not imperil the U.S. health care system. Furthermore, Boltwood seems to suggest that an effective treatment should not be used in anyone unless it can be used in everyone. Despite its admirable egalitarian qualities, this principle would preclude the use of any effective treatment, pending equal access to it.
As the medical community discusses the ethical implications of new forms of technology, let us be wary of simplified and extreme language. Such polemics oversimplify the issues, speciously polarize the debate, and discourage genuine dialogue. In short, they are as unproductive in medicine as they are ugly in politics.
Dale G. Renlund, M.D.
Abdallah G. Kfoury, M.D.
Ashley R. Renlund, B.A.
LDS Hospital
Salt Lake City, UT 84143
References
Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the evaluation and management of chronic heart failure in the adult: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2001;38:2101-2113.
Stevenson LW, Kormos RL. Mechanical cardiac support 2000: current applications and future trial design. J Heart Lung Transplant 2001;20:1-38.