The Trade-offs When Focusing on the Mortality Benefit

The Trade-offs When Focusing on the Mortality Benefit Opinion EDITORIAL Albert Liu, MD; Gregory Curfman, MD There is growing evidence that patients have varying priori- decision making is that clinicians are transparent with their rec- ties at the end of their life. Some want to focus on maximiz- ommendations—and their implications, both positive and nega- ing their quality of life, whereas others focus on living longer. tive. When survival benefit is overemphasized and risks are underestimated, patients risk deciding on therapies that are Current clinical practice prioritizes the latter. For example, most 8,9 cardiac device trials use over- inconsistent with their goals. all survival as the primary Left ventricular assist devices may provide symptom re- outcome, instead of quality- lief for patients and improve survival, but they continue to be Related article page 520 2-4 adjusted life years (QALYs). associated with considerable symptoms including pain, What is left unsaid is that these mortality benefits often come major depression, and organic mental syndromes. Device- at a cost: discomfort, loss of mobility, polypharmacy with its related adverse events include stroke, infection, bleeding, attendant adverse effects, procedural complications, device pump thrombosis, ventricular arrhythmias, and right failure, or loss of functional status. ventricular heart failure. Owing to the substantial risk of ma- The DECIDE-LVAD trial by Allen et al evaluates the effect jor morbidity, discussion with patients and their caregivers is of a shared decision support intervention on decision quality important prior to LVAD implantation so they understand what for patients considering destination therapy left ventricular as- life is like with an LVAD as well as having the opportunity to sist devices (DT LVAD). Their primary outcome, decision qual- express their treatment preferences. ity, considered both patients’ level of knowledge and how well Patients randomized to the shared decision support inter- their decisions matched their values. They found that patients vention arm in the DECIDE-LVAD trial were significantly less randomized to receive a pamphlet and video describing the risks likely to both want and receive an LVAD, with no significant and benefits of DT LVAD were more likely to make higher- differences in decision conflict, decision regret, illness accep- quality decisions. We applaud the author’s decision to focus on tance, or quality of life compared with the control arm. This the decision-making process prior to DT LVAD placement. reduction in choosing LVAD in the shared decision making arm Shared decision making means clinicians elicit patient val- raises the alarming possibility that many patients undergoing ues and use them to guide clinical recommendations. Pa- usual care are consenting to an LVAD without being fully aware tients hospitalized at the end of their life have identified shared of the risks and benefits, and may have chosen otherwise with decision making as one of the most important components more information. It is important for clinicians to be comfort- of their care. For patients with advanced heart failure, this is able discussing risks of complex medical decisions, even po- becoming ever more crucial owing to the growing number of tentially lifesaving ones such as DT LVAD, to be sure that pa- complex treatment options. Integral to the idea of shared tients are making choices consistent with their wishes. ARTICLE INFORMATION for the Treatment of Congestive Heart Failure 6. Allen LA, Stevenson LW, Grady KL, et al; (REMATCH) Study Group. Long-term use of a left American Heart Association; Council on Quality of Author Affiliations: University of California, San ventricular assist device for end-stage heart failure. Care and Outcomes Research; Council on Francisco, San Francisco (Liu); Division of N Engl J Med. 2001;345(20):1435-1443. Cardiovascular Nursing; Council on Clinical Pharmacoepidemiology and Pharmacoeconomics, Cardiology; Council on Cardiovascular Radiology Brigham and Women's Hospital, Boston, 3. Moss AJ, Zareba W, Hall WJ, et al; Multicenter and Intervention; Council on Cardiovascular Massachusetts (Curfman); Health Care Policy and Automatic Defibrillator Implantation Trial II Surgery and Anesthesia. Decision making in Law Editor, JAMA Internal Medicine (Curfman). Investigators. Prophylactic implantation of a advanced heart failure. Circulation. 2012;125(15): defibrillator in patients with myocardial infarction Corresponding Author: Albert Y. Liu, MD, 1928-1952. and reduced ejection fraction. N Engl J Med. 2002; University of California, San Francisco, 1237 Cole St, 346(12):877-883. 7. Virdun C, Luckett T, Davidson PM, Phillips J. San Francisco, CA 94117 (albert.liu@ucsf.edu). Dying in the hospital setting. Palliat Med. 2015;29 4. Leon MB, Smith CR, Mack MJ, et al; PARTNER 2 Published Online: February 26, 2018. (9):774-796. Investigators. Transcatheter or surgical aortic-valve doi:10.1001/jamainternmed.2018.0067 replacement in intermediate-risk patients. N Engl J 8. Hoffmann TC, Del Mar C. Patients’ expectations Conflict of Interest Disclosures: None reported. Med. 2016;374(17):1609-1620. of the benefits and harms of treatments, screening, and tests. JAMA Intern Med. 2015;175(2):274-286. 5. Allen LA, McIlvennan CK, Thompson JS, et al. REFERENCES Effectiveness of an intervention supporting shared 9. Hoffmann TC, Del Mar C. Clinicians’ expectations 1. Lewis EF, Johnson PA, Johnson W, et al. decision making for destination therapy left of the benefits and harms of treatments, screening, Preferences for quality of life or survival expressed ventricular assist device: the DECIDE-LVAD and tests. JAMA Intern Med. 2017;177(3):407-419. by patients with heart failure. J Heart Lung Transplant. randomized clinical trial [published online February 10. Enciso JS, Adler E, Greenberg BH. Current 2001;20(9):1016-1024. 26, 2018]. JAMA Intern Med. doi:10.1001 status of left ventricular device as a destination /jamainternmed.2017.8713 2. Rose EA, Gelijns AC, Moskowitz AJ, et al; therapy. US Cardiol Rev. 2016;10(2):85-90. Randomized Evaluation of Mechanical Assistance jamainternalmedicine.com (Reprinted) JAMA Internal Medicine April 2018 Volume 178, Number 4 455 © 2018 American Medical Association. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

The Trade-offs When Focusing on the Mortality Benefit

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Abstract

Opinion EDITORIAL Albert Liu, MD; Gregory Curfman, MD There is growing evidence that patients have varying priori- decision making is that clinicians are transparent with their rec- ties at the end of their life. Some want to focus on maximiz- ommendations—and their implications, both positive and nega- ing their quality of life, whereas others focus on living longer. tive. When survival benefit is overemphasized and risks are underestimated, patients risk deciding on therapies that are Current clinical practice prioritizes the latter. For example, most 8,9 cardiac device trials use over- inconsistent with their goals. all survival as the primary Left ventricular assist devices may provide symptom re- outcome, instead of quality- lief for patients and improve survival, but they continue to be Related article page 520 2-4 adjusted life years (QALYs). associated with considerable symptoms including pain, What is left unsaid is that these mortality benefits often come major depression, and organic mental syndromes. Device- at a cost: discomfort, loss of mobility, polypharmacy with its related adverse events include stroke, infection, bleeding, attendant adverse effects, procedural complications, device pump thrombosis, ventricular arrhythmias, and right failure, or loss of functional status. ventricular heart failure. Owing to the substantial risk of ma- The DECIDE-LVAD trial by Allen et al evaluates the effect jor morbidity, discussion with patients and their caregivers is of a shared decision support intervention on decision quality important prior to LVAD implantation so they understand what for patients considering destination therapy left ventricular as- life is like with an LVAD as well as having the opportunity to sist devices (DT LVAD). Their primary outcome, decision qual- express their treatment preferences. ity, considered both patients’ level of knowledge and how well Patients randomized to the shared decision support inter- their decisions matched their values. They found that patients vention arm in the DECIDE-LVAD trial were significantly less randomized to receive a pamphlet and video describing the risks likely to both want and receive an LVAD, with no significant and benefits of DT LVAD were more likely to make higher- differences in decision conflict, decision regret, illness accep- quality decisions. We applaud the author’s decision to focus on tance, or quality of life compared with the control arm. This the decision-making process prior to DT LVAD placement. reduction in choosing LVAD in the shared decision making arm Shared decision making means clinicians elicit patient val- raises the alarming possibility that many patients undergoing ues and use them to guide clinical recommendations. Pa- usual care are consenting to an LVAD without being fully aware tients hospitalized at the end of their life have identified shared of the risks and benefits, and may have chosen otherwise with decision making as one of the most important components more information. It is important for clinicians to be comfort- of their care. For patients with advanced heart failure, this is able discussing risks of complex medical decisions, even po- becoming ever more crucial owing to the growing number of tentially lifesaving ones such as DT LVAD, to be sure that pa- complex treatment options. Integral to the idea of shared tients are making choices consistent with their wishes. ARTICLE INFORMATION for the Treatment of Congestive Heart Failure 6. Allen LA, Stevenson LW, Grady KL, et al; (REMATCH) Study Group. Long-term use of a left American Heart Association; Council on Quality of Author Affiliations: University of California, San ventricular assist device for end-stage heart failure. Care and Outcomes Research; Council on Francisco, San Francisco (Liu); Division of N Engl J Med. 2001;345(20):1435-1443. Cardiovascular Nursing; Council on Clinical Pharmacoepidemiology and Pharmacoeconomics, Cardiology; Council on Cardiovascular Radiology Brigham and Women's Hospital, Boston, 3. Moss AJ, Zareba W, Hall WJ, et al; Multicenter and Intervention; Council on Cardiovascular Massachusetts (Curfman); Health Care Policy and Automatic Defibrillator Implantation Trial II Surgery and Anesthesia. Decision making in Law Editor, JAMA Internal Medicine (Curfman). Investigators. Prophylactic implantation of a advanced heart failure. Circulation. 2012;125(15): defibrillator in patients with myocardial infarction Corresponding Author: Albert Y. Liu, MD, 1928-1952. and reduced ejection fraction. N Engl J Med. 2002; University of California, San Francisco, 1237 Cole St, 346(12):877-883. 7. Virdun C, Luckett T, Davidson PM, Phillips J. San Francisco, CA 94117 (albert.liu@ucsf.edu). Dying in the hospital setting. Palliat Med. 2015;29 4. Leon MB, Smith CR, Mack MJ, et al; PARTNER 2 Published Online: February 26, 2018. (9):774-796. Investigators. Transcatheter or surgical aortic-valve doi:10.1001/jamainternmed.2018.0067 replacement in intermediate-risk patients. N Engl J 8. Hoffmann TC, Del Mar C. Patients’ expectations Conflict of Interest Disclosures: None reported. Med. 2016;374(17):1609-1620. of the benefits and harms of treatments, screening, and tests. JAMA Intern Med. 2015;175(2):274-286. 5. Allen LA, McIlvennan CK, Thompson JS, et al. REFERENCES Effectiveness of an intervention supporting shared 9. Hoffmann TC, Del Mar C. Clinicians’ expectations 1. Lewis EF, Johnson PA, Johnson W, et al. decision making for destination therapy left of the benefits and harms of treatments, screening, Preferences for quality of life or survival expressed ventricular assist device: the DECIDE-LVAD and tests. JAMA Intern Med. 2017;177(3):407-419. by patients with heart failure. J Heart Lung Transplant. randomized clinical trial [published online February 10. Enciso JS, Adler E, Greenberg BH. Current 2001;20(9):1016-1024. 26, 2018]. JAMA Intern Med. doi:10.1001 status of left ventricular device as a destination /jamainternmed.2017.8713 2. Rose EA, Gelijns AC, Moskowitz AJ, et al; therapy. US Cardiol Rev. 2016;10(2):85-90. Randomized Evaluation of Mechanical Assistance jamainternalmedicine.com (Reprinted) JAMA Internal Medicine April 2018 Volume 178, Number 4 455 © 2018 American Medical Association. All rights reserved.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Apr 26, 2018

References

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