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Transcatheter Aortic Valve Replacement: Clinical Aspects and Ethical Considerations

2012; Elsevier BV; Volume: 94; Issue: 6 Linguagem: Inglês

10.1016/j.athoracsur.2012.09.047

1552-6259

Matthew L. Stone, John A. Kern, Robert M. Sade,

Cardiac pacing and defibrillation studies

Mary Ann Moses is 84 years old and has been known to have aortic stenosis for many years. She now has dyspnea due to heart failure, which has been increasing in recent weeks. She is in a nursing home and has borderline renal function, urinary incontinence, and limited mobility due to hemiplegia and mild dementia from a previous stroke. Despite her previous strokes, she can still communicate orally with her large family: 6 children, their spouses, and many grandchildren. Her oldest daughter sums up the family's view: "Grandma has a pretty good existence, and if it just weren't for this worsening heart failure, she would be fine." Mrs Moses' family physician agrees with this assessment, but is not sure whether she is a suitable candidate for aortic valve replacement (AVR). He refers the patient to Dr Iva Hart, a highly respected cardiac surgeon, who has much experience with transcatheter AVR (TAVR), to be considered for AVR. Cardiology, neurology, and internal medicine consultations conclude that Mrs Moses probably has less than 1 year to live if nothing is done for her heart disease. Considering currently available data, Dr Hart believes that she is not a reasonable candidate for open surgical AVR (SAVR), and that if she survives TAVR, she is likely to survive for 2 additional years. Should he offer TAVR to this patient? Aortic stenosis is the most common valvular heart disease of advanced age: prevalence is 2.5% at age 75 years and 8.1% at 85 years [1Lindroos M. Kupari M. Heikkila J. Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample.J Am Coll Cardiol. 1993; 21: 1220-1225Abstract Full Text PDF PubMed Scopus (937) Google Scholar]. Randomized screening has identified critical aortic stenosis (valve area ≤0.8 cm2 and velocity ratio ≤0.35) in 2.2% of patients aged 75 years and older [1Lindroos M. Kupari M. Heikkila J. Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample.J Am Coll Cardiol. 1993; 21: 1220-1225Abstract Full Text PDF PubMed Scopus (937) Google Scholar]. Patients with severe symptomatic aortic stenosis have a dismal prognosis, with an estimated mortality of 75% at 3 years after onset of symptoms [2Carabello B.A. Paulus W.J. Aortic stenosis.Lancet. 2009; 373: 956-966Abstract Full Text Full Text PDF PubMed Scopus (538) Google Scholar]. Sudden cardiac death within 3 months after symptomatic presentation is a known threat to survival, prompting early intervention in symptomatic patients [3Pellikka P.A. Nishimura R.A. Bailey K.R. Tajik A.J. The natural history of adults with asymptomatic, hemodynamically significant aortic stenosis.J Am Coll Cardiol. 1990; 15: 1012-1017Abstract Full Text PDF PubMed Scopus (288) Google Scholar]. Asymptomatic patients with severe aortic stenosis who do not undergo SAVR face a 2% increase in mortality per month of life [2Carabello B.A. Paulus W.J. Aortic stenosis.Lancet. 2009; 373: 956-966Abstract Full Text Full Text PDF PubMed Scopus (538) Google Scholar]. Yet, SAVR can impose significant postoperative morbidity and mortality, particularly in the setting of substantial concomitant comorbidities and advanced age. TAVR offers a treatment option for high-risk patients who are not candidates for SAVR, introducing a critical need for determination of operative candidacy, optimal strategies for replacement, and cost-effectiveness. A substantial number of patients with severe aortic stenosis (30% to 40%) are considered for SAVR but are denied the procedure [4Iung B. Cachier A. Baron G. et al.Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?.Eur Heart J. 2005; 26: 2714-2720Crossref PubMed Scopus (911) Google Scholar, 5Bouma B.J. van Den Brink R.B. van Der Meulen J.H. et al.To operate or not on elderly patients with aortic stenosis: the decision and its consequences.Heart (British Cardiac Society). 1999; 82: 143-148PubMed Google Scholar]. In patients with New York Heart Association class III or IV symptoms and severe single-valve disease, multivariate analysis found that reasons for precluding SAVR included medical regression of symptoms (39.9%), end-stage disease (18.4%), coronary artery disease symptoms (14.9%), and recent myocardial infarction (7.9%). Noncardiac reasons included advanced age (27.6%), chronic obstructive pulmonary disease (13.6%), renal failure (6.1%), and short life expectancy (19.3%) [6Iung B. Baron G. Butchart E.G. et al.A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease.Eur Heart J. 2003; 24: 1231-1243Crossref PubMed Scopus (2584) Google Scholar]. These results indicate that age alone has been considered a contraindication to SAVR. TAVR using the Edwards SAPIEN heart-valve system (Edwards Lifesciences, Irvine, CA) has been largely validated by the Placement of Aortic Transcatheter Valve (PARTNER) trial. Inclusion criteria for the PARTNER trial were high-risk patients with a surgeon-predicted operative mortality of 15% or higher or a Society of Thoracic Surgeons (STS) mortality score of 10 or higher [7Shroyer A.L. Coombs L.P. Peterson E.D. et al.The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models.Ann Thorac Surg. 2003; 75 (discussion 1864–5): 1856-1864Abstract Full Text Full Text PDF PubMed Scopus (506) Google Scholar, 8Smith C.R. Leon M.B. Mack M.J. et al.Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4712) Google Scholar]. For inoperable patients, all-cause mortality at 1-year was 20% lower for patients undergoing TAVR compared with standard medical therapy [9Reiss G.R. Smith C.R. PARTNER B: where will it take us?.Semin Thorac Cardiovasc Surg. 2011; 23: 85-86Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar]. High-risk patients receiving TAVR also achieved significant improvement in health-related quality of life [10Reynolds M.R. Magnuson E.A. Lei Y. et al.Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.Circulation. 2011; 124: 1964-1972Crossref PubMed Scopus (246) Google Scholar]. The PARTNER trial demonstrates that TAVR is a promising treatment for selected high-risk patients; however, a better definition of selection criteria is needed as experience with this technique is gained. This is particularly important because the U.S. Food and Drug Administration has approved the Edwards SAPIEN transcatheter heart valve for use in inoperable patients with severe aortic stenosis. The use of TAVR has focused on high-risk patients with aortic stenosis, so little evidence supports using TAVR in lower-risk surgical candidates. The PARTNER 2 trial is presently underway to evaluate the efficacy of the Edwards SAPIEN transcatheter aortic valve in moderate-risk patients. In low-risk elderly patients with aortic stenosis, the Surgical Aortic Valve Replacement (AVR) in Operable Elderly Patients With Aortic Stenosis (STACCATO) trial compared transapical aortic valve implantation with SAVR; TAVR was associated with complication and device success rates similar or inferior to that demonstrated in high-risk patients [11Nielsen H.H. Klaaborg K.E. Nissen H. et al.A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial.EuroIntervention. 2012; 8: 383-389Crossref PubMed Scopus (157) Google Scholar]. These findings suggest the need for further research in low-risk patient populations before applying the technology to acceptable SAVR candidates. Predictive mortality models in cardiac surgery have variable power. The European System for Cardiac Operative Risk Evaluation (EuroSCORE) and the STS Predicted Risk of Mortality score were developed using data from low-to-intermediate surgical risk patients, so their application to high-risk surgical patients is uncertain [12Piazza N. Lange R. Martucci G. Serruys P.W. Patient selection for transcatheter aortic valve implantation: Patient risk profile and anatomical selection criteria.Arch Cardiovasc Dis. 2012; 105: 165-173Crossref PubMed Scopus (42) Google Scholar]. After isolated SAVR, the EuroSCORE significantly underestimates [13Kamiya H. Akhyari P. Pedraza A. et al.High mortality in late octogenarians undergoing isolated aortic valve replacement for aortic valve stenosis: EuroSCORE underestimates mortality in this cohort.Thorac Cardiovasc Surg. 2012; 60: 343-350Crossref PubMed Scopus (3) Google Scholar] and the STS mortality score overestimates mortality risk [8Smith C.R. Leon M.B. Mack M.J. et al.Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4712) Google Scholar]. The EuroSCORE effectively predicts mortality in low and high-risk populations undergoing TAVR [14Schymik G. Schrofel H. Schymik J.S. et al.Acute and late outcomes of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk.J Interv Cardiol. 2012; 25: 364-374Crossref PubMed Scopus (24) Google Scholar]. Perhaps surprisingly, the mortality rate after TAVR in patients aged 80 to 84 years is only 6% but is 21% in patients aged 85 to 89 years; thus, age 85 might be a break point for higher risk of TAVR. Many TAVR-specific baseline variables are independent risk factors for death and morbidity [12Piazza N. Lange R. Martucci G. Serruys P.W. Patient selection for transcatheter aortic valve implantation: Patient risk profile and anatomical selection criteria.Arch Cardiovasc Dis. 2012; 105: 165-173Crossref PubMed Scopus (42) Google Scholar, 15D'Onofrio A. Gasparetto V. Napodano M. et al.Impact of preoperative mitral valve regurgitation on outcomes after transcatheter aortic valve implantation.Eur J Cardiothorac Surg. 2012; 41: 1271-1277Crossref PubMed Scopus (51) Google Scholar, 16Gotzmann M. Pljakic A. Bojara W. et al.Transcatheter aortic valve implantation in patients with severe symptomatic aortic valve stenosis-predictors of mortality and poor treatment response.Am Heart J. 2011; 162: 238-245 e1Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar, 17Tamburino C. Capodanno D. Ramondo A. et al.Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.Circulation. 2011; 123: 299-308Crossref PubMed Scopus (983) Google Scholar, 18Buellesfeld L. Wenaweser P. Gerckens U. et al.Transcatheter aortic valve implantation: predictors of procedural success—the Siegburg-Bern experience.Eur Heart J. 2010; 31: 984-991Crossref PubMed Scopus (90) Google Scholar]. Age 85 to 89 years and poor left ventricular function are principle predictors for 30-day death [13Kamiya H. Akhyari P. Pedraza A. et al.High mortality in late octogenarians undergoing isolated aortic valve replacement for aortic valve stenosis: EuroSCORE underestimates mortality in this cohort.Thorac Cardiovasc Surg. 2012; 60: 343-350Crossref PubMed Scopus (3) Google Scholar]. Yet, increasing numbers of patients are being referred for TAVR who would have been excluded from the PARTNER trial due to advanced age, comorbidities, or poor left ventricular function. Cardiothoracic surgeons and cardiologists alike must be knowledgeable about exclusion criteria founded on current clinical experience with TAVR. The Edwards SAPIEN balloon-expandable prosthesis (23 and 26 mm) and the Medtronic CoreValve (Medtronic, Minneapolis, MN) self-expanding device (26 and 29 mm) have a technical success rate of 97% to 99% [19Eltchaninoff H. Prat A. Gilard M. et al.Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.Eur Heart J. 2011; 32: 191-197Crossref PubMed Scopus (458) Google Scholar, 20Zahn R. Gerckens U. Grube E. et al.Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.Eur Heart J. 2011; 32: 198-204Crossref PubMed Scopus (546) Google Scholar, 21Gilard M. Eltchaninoff H. Iung B. et al.Registry of transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715Crossref PubMed Scopus (1037) Google Scholar]. Although these data are encouraging, TAVR is also associated with a 3% to 4% incidence of stroke and a 12% and 24% mortality rate at 30 days and 1 year, respectively [21Gilard M. Eltchaninoff H. Iung B. et al.Registry of transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715Crossref PubMed Scopus (1037) Google Scholar]. All available data show that the principle complications that threaten short-term and long-term survival in patients undergoing TAVR are postoperative stroke and paravalvular regurgitation. In the Observational Study of Appropriateness, Efficacy and Effectiveness of AVR-TAVI Procedures for the Treatment of Severe Symptomatic Aortic Stenosis (OBSERVANT) propensity-matched study, the low-risk TAVR and SAVR groups had similar rates of mortality, stroke, and myocardial infarction [22D'Errigo P. Barbanti M. Ranucci M. et al.Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: results from an intermediate risk propensity-matched population of the Italian OBSERVANT study.Int J Cardiol. 2012; ([http://dx.doi.org/10.1016/j.ijcard.2012.05.028])PubMed Google Scholar]. SAVR patients had a greater requirement for blood transfusion, and patients undergoing TAVR had higher rates of major vascular damage, permanent atrioventricular block, and residual aortic valve regurgitation [22D'Errigo P. Barbanti M. Ranucci M. et al.Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: results from an intermediate risk propensity-matched population of the Italian OBSERVANT study.Int J Cardiol. 2012; ([http://dx.doi.org/10.1016/j.ijcard.2012.05.028])PubMed Google Scholar]. In the PARTNER trial, the 1-year incidence of transient ischemic attacks or stroke and major vascular complications was higher in TAVR than in SAVR patients [8Smith C.R. Leon M.B. Mack M.J. et al.Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4712) Google Scholar]. A cerebral magnetic resonance imaging study demonstrated new defects in 84% of patients undergoing TAVR [23Kahlert P. Knipp S.C. Schlamann M. et al.Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.Circulation. 2010; 121: 870-878Crossref PubMed Scopus (425) Google Scholar]. The lesions in this screening study were not associated with clinical symptoms at the 3-month follow-up; nevertheless, this finding suggests the need for a heightened awareness for the embolic risks associated with balloon dilation and in-valve prosthesis deployment. Major vascular complications after TAVR warrant long-term follow-up study. Insertion of a prosthetic valve without removal of the native valve creates an irregular paravalvular zone that may predispose to thrombus formation, requiring dual antiplatelet therapy, whereas aspirin alone is recommended for most SAVR patients [23Kahlert P. Knipp S.C. Schlamann M. et al.Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.Circulation. 2010; 121: 870-878Crossref PubMed Scopus (425) Google Scholar]. The well-established increased risk of bleeding in elderly patients with long-term dual antiplatelet therapy may affect candidacy for TAVR [24Berger P.B. Bhatt D.L. Fuster V. et al.Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial.Circulation. 2010; 121: 2575-2583Crossref PubMed Scopus (197) Google Scholar]. Cost estimates are about $43,000 for the initial TAVR procedure and $79,000 for hospitalization [25Reynolds M.R. Magnuson E.A. Wang K. et al.Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).Circulation. 2012; 125: 1102-1109Crossref PubMed Scopus (222) Google Scholar]. The survival benefit of TAVR is 1.9 years compared with standard nonsurgical treatment, and the incremental cost-effectiveness ratio for TAVR compared with standard medical treatment is estimated at $50,200 per year of life gained or approximately $62,000 per quality-adjusted life-year (QALY). No explicit policy for a cost-effectiveness threshold exists in the United States. Depending on the method of evaluation, estimates of the value of 1 QALY in 1997 dollars ranged from $25,000 to $428,000 and in 2010 dollars from $34,000 to $582,000 [26Hirth R.A. Chernew M.E. Miller E. Fendrick A.M. Weissert W.G. Willingness to pay for a quality-adjusted life year: in search of a standard.Med Decis Making. 2000; 20: 332-342Crossref PubMed Scopus (723) Google Scholar, 27Mark D.B. Hlatky M.A. Califf R.M. et al.Cost effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction.N Engl J Med. 1995; 332: 1418-1424Crossref PubMed Scopus (479) Google Scholar], but these costs are well within the cost-effectiveness range of other cardiovascular technologies such as implantable defibrillators, catheter ablation for atrial fibrillation, percutaneous coronary intervention, and left ventricular assist devices for destination therapy. The data upon which these calculations were based have been challenged [28Watt M. Mealing S. Eaton J. et al.Cost-effectiveness of transcatheter aortic valve replacement in patients ineligible for conventional aortic valve replacement.Heart (British Cardiac Society). 2012; 98: 370-376Crossref PubMed Scopus (94) Google Scholar], so further analysis regarding cost-effectiveness is needed. Incremental cost per QALY is likely to increase during long-term follow-up. It also seems clear, however, that determination of cost-effectiveness for TAVR should be patient-specific and guided by the projected risk-benefit of intervention. Mrs Moses is 84 years old, has lived a full life that is nearing its end, and now has significant comorbidities, including borderline renal function and urinary incontinence along with hemiplegia and mild dementia from a previous stroke. In this situation, TAVR can extend her life by perhaps 2 years. If TAVR is not offered to the patient, it will be because of her advanced age and the likelihood of a relatively small survival benefit. Is it right for Dr Hart to withhold an offer of TAVR from Mrs Moses? Major cardiothoracic operations in the elderly are well tolerated. Many studies have shown that the octogenarians have good quality of life after major cardiothoracic operations [29Hecker S. Sade R.M. Ethical issues in cardiothoracic surgery for the elderly.in: Katlic Mark R. Cardiothoracic surgery in the elderly. Springer, New York2011: 89-104Crossref Google Scholar]. In several studies, in fact, it was equal to the quality of life after major cardiothoracic operations in younger patients. Moreover, Mrs Moses' symptoms of heart failure and her quality of life are likely to improve if she undergoes TAVR. Under the conditions described, the balance of benefits and harms for Mrs Moses favor TAVR. Most medical societies that have a code of ethics consider discrimination for nonmedical reasons to be unethical. Of the many codes of ethics that are available, the American Medical Association's Code of Medical Ethics is the one that is most often used by medical licensure boards and by courts in various jurisdictions as a standard of proper ethical behavior for physicians. The Code provides guidance on allocation of limited medical resources: "Nonmedical criteria, such as ability to pay, age, social worth, perceived obstacles to treatment, potential contribution to illness, or past use of resources, should not be considered" [30Council on Ethical and Judicial Affairs, American Medical AssociationEthical considerations in the allocation of organs and other scarce medical resources among patients.Arch Intern Med. 1995; 155: 29-40Crossref PubMed Scopus (75) Google Scholar]. The American Association for Thoracic Surgery, the STS, and the American College of Cardiology each has a code of ethics, and all prohibit medically unjustified discrimination. Thus, according to these associations, medical decisions using criteria other than medical facts are not ethical. To clarify Mrs Moses' situation, we propose a parallel case, that of Mrs White, a 40-year-old woman in the room adjacent to Mrs Moses. Mrs White has had scleroderma with pulmonary fibrosis and aortic stenosis for many years. She has a devoted husband and 2 teenaged daughters. Her pulmonary fibrosis has worsened in recent years, and she now has severe fixed pulmonary artery hypertension. She has had a series of small strokes, so has limited mobility and mild dementia. Despite this, she communicates clearly with her family. Her aortic stenosis is now severe, and she has progressive symptoms of heart failure. She is not a candidate for open SAVR because of her pulmonary hypertension but is a candidate for TAVR. Like Mrs Moses, her life expectancy is less than 1 year without intervention, but if she undergoes TAVR, her life expectancy gains 2 years. The patient and her family would like her to live as long as possible. Should Dr Hart offer the option of TAVR? We believe it likely that almost all physicians would say yes. Physicians should treat every human life as having the same value as every other human life. The 1930s and 1940s were dark years for the medical profession; at that time, some physicians in Europe accepted and acted upon the concept of "Lebensunwertes Leben": a life not worthy of life, or a life not worth living [31Annas G.J. Grodin M.A. The Nazi Doctors and the Nuremberg Code: human rights in human experimentation. Oxford University Press, New York1992Google Scholar]. They participated in destroying the lives of such individuals. The experience of that era has led us to reject the idea of physicians making judgments about which treatments to offer or to withhold from a patient on the basis of the perceived value of that particular patient's life. On these grounds, the value of Mrs Moses' life should be considered virtually identical to the value of Mrs White's life. Medically, their clinical conditions and their prognoses are similar; the important difference is their age, one advanced and the other in the prime of life. This suggests that if a physician would offer TAVR to Mrs White, he or she is ethically obligated to offer it also to Mrs Moses. A disturbing trend in medicine in recent years is a shift in professional focus from primary attention to the needs of patients to greater attention to social needs. This is evident at every level of medicine and is perhaps best exemplified by pressures on practicing physicians to pay more attention to social needs and less to individual patients; for example, our dysfunctional health care financing system has placed physicians in the role of stewards of public expenditures for health care [32Brody H. From an ethics of rationing to an ethics of waste avoidance.N Engl J Med. 2012; 366: 1949-1951Crossref PubMed Scopus (128) Google Scholar]. In effect, this exhorts physicians to make the cost of an expensive treatment course an important determinant of whether a patient is declared inoperable or whether the therapy is mentioned to the patient at all. Mrs Moses' situation is a case in point: although the net balance of benefits and harms favors providing TAVR, many physicians would consider it reasonable for Dr Hart to withhold the therapy because it is expensive and the patient has already lived a full life. We mention this trend to indicate the dangers of the many factors that, in our opinion, move our professional focus away from our patients toward social considerations. When we make decisions that are not in the patient's best interest but in the interests of others, we may be engendering a loss of trust in us as individual physicians as well as in our profession. Patients lose trust when they cannot clearly distinguish between physicians' advice primarily aimed at their benefit vs advice aimed at what is good for society, even if contrary to the patients' best interests. Trust is the central core of the physician–patient relationship [33Cripe L.D. Trustworthiness.J Clin Oncol. 2011; 29: 3483-3486Crossref PubMed Scopus (1) Google Scholar]. Without it, the primary goal of the physician—amelioration of disease and relief of suffering—is undermined, because patients who lack trust are less likely to follow their physicians' advice, negatively affecting the healing process. Even more threatening, in our view, is the erosion of professional identity that is likely to result from making decisions based on considerations other than those in the patient's best interests. Aristotle's writings on ethics are essentially correct, in our view, because of his clear understanding of human nature. According to philosopher Will Durant, Aristotle said this: "Excellence is an art won by training and habituation. We do not act rightly because we have virtue or excellence, but we rather have those because we have acted rightly" [34Durant W. The story of philosophy: the lives and opinions of the world's greatest philosophers. Simon and Schuster, New York1961Google Scholar]. We are what we repeatedly do. The more we make decisions based on social needs rather than on the needs of the individual patient before us, the easier it becomes to make many kinds of decisions that are not consistent with the interests of the patient. In conclusion, health care resources are finite; individuals, insurance companies, and government cannot possibly pay for every potentially beneficial treatment for every malady of every patient. In managing finitude, however, we should keep a proper perspective of decision-making roles. On the basis of the calculations presented above, the cost of providing 84-year-old Mrs Moses 2 QALYs of life will be about $124,000, approximately the same cost of providing 40-year-old Mrs White 2 QALYs of life. As physicians, we should not attempt to distinguish between the two on grounds other than medical fact. Hospital administrators, insurance companies, or government regulators could legitimately write a set of rules that require selection of patients for expensive procedures [35McCarthy P. Lamm R. Sade R. Medical ethics collides with public policy: LVAD for a patient with leukemia.Ann Thorac Surg. 2005; 80: 793-798Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar], perhaps based on calculations of a specific monetary value for each QALY, perhaps based on an age cutoff beyond which only palliative treatment would be permitted (this view has been advocated for decades by philosopher and well-known bioethicist Daniel Callahan) [36Callahan D. Must we ration health care for the elderly?.J Law Med Ethics. 2012; 40: 10-16Crossref PubMed Scopus (20) Google Scholar]. But until external guidelines or standards are available, we believe that only one calculation is necessary for physicians at the bedside: the benefit-to-harm ratios of potentially beneficial therapies that will enable the patient, making decisions jointly with her physician, to choose the treatment that best serves her medical needs in the context of her personal values, including quality of life and cost considerations.