Opinion
VIEWPOINT
James N. Kirkpatrick, MD Hospital of the University of Pennsylvania, Perelman School of Medicine, Philadelphia. Paul J. Hauptman, MD Saint Louis University School of Medicine, St Louis, Missouri. Sarah J. Goodlin, MD Oregon Health Sciences University, Portland; and Veterans Affairs Medical Center, Portland, Oregon.
Corresponding Author: James N. Kirkpatrick, MD, Echocardiography Laboratory, Hospital of the University of Pennsylvania, 3400 Spruce St, HUP 9021 Gates, Philadelphia, PA 19104 (james.kirkpatrick @uphs.upenn.edu). jamainternalmedicine.com
Bundling Informed Consent and Advance Care Planning in Chronic Cardiovascular Disease We Need to Talk Modern cardiovascular therapies offer unprecedented opportunities to improve survival and quality of life. Cardiovascular morbidity and mortality have significantly declined, owing in a large part to preventive therapies and technological advances such as coronary revascularization, implantable cardioverter defibrillators (ICDs), and ventricular assist devices (VADs). Newer therapies like transcatheter aortic valve replacement hold great promise. Nonetheless, cardiovascular disease remains a leading cause of death. Cardiovascular therapies delay but cannot avert dying. A view expressed in 1997 regarding coronary angioplasty remains applicable: “We rescue people from a relatively sudden death…only to inflict on them a more prolonged death from progressive heart failure.”1(p1484) This trade-off may be worth it for individual patients but also introduces complexities into end-of-life interventions (both in terms of whether to intervene at all and, if so, when and how to stop the interventions). The choice to implant an ICD in an octogenarian, for instance, begs the question “How do you want to die?” because sudden arrhythmic death may be preferable to most other ways to die. Conversely, the decision to deactivate a VAD in a young patient with a debilitating stroke draws on subjective assessments of quality of life and patient values. The federal Patient Self-Determination Act2 mandates that all patients be given the opportunity to execute an advance directive (living will, power of attorney for health care). Despite broad support, only a third of patients take this opportunity. Even elderly patients with highly mortal diseases like severe aortic stenosis often lack advance directives.3 Furthermore, advance directives may not impact end-of-life care,4 and few address important decisions like defibrillator deactivation.3,5 Advance directives are only 1 part of advance care planning—the process by which clinicians set a course of care by integrating the patient’s values and preferences with what is medically reasonable. Advance care planning should anticipate future decisions in care and approaches to care at the end of life. We need to talk with patients who have chronic cardiovascular diseases about these issues; we need to engage in advance care planning and promote advance directives. It is probably never too early to start these conversations; it can definitely be too late—after a patient has lost decision-making capacity. Naturally, patients seeking therapies such as valve replacement and cardiac assist devices are focused on life prolongation. They may be encouraged by “miracle stories” and sub-
scribe to a cultural phenomenon termed the technological imperative: we have the technology and therefore must use it.6 Nonetheless, even patients focused on life prolongation can understand the need to prepare for the worst while hoping for the best.7 There are multiple opportunities in the course of cardiovascular disease to evaluate treatments in light of patient preferences. Preferred times include “turning points” such as changes in symptoms, development of comorbidities, and new indications for interventions.7 These turning points provide an important opportunity to address larger issues. Informed consent must be obtained prior to most cardiovascular interventions. During the informed consent process, why not ask patients to put intervention decisions into the larger context of their values and goals? We suggest that informed consent and advance care planning be bundled. In addition to asking “do you understand the risks?” we need to understand how the intervention can achieve patient goals. We should ask “what should we do if things do not go as planned?” and “under what circumstances would you want us to allow you to die?” We need to let patients know that deactivation of ICDs or VADs may be a necessary step in allowing them to die. Incorporating advance care planning into informed consent allows clinicians to address preferences for management of undesired outcomes while simultaneously informing the patient of the possibility of those outcomes. Each new medical intervention that requires informed consent should be a time to confirm or reevaluate patient preferences. Some patients may decide to forgo interventions; more likely, they will opt to proceed but with a better sense of how their choices fit into the bigger picture of their lives. And they and their loved ones will be better prepared when confronted by end-of-life decisions. Ideally, we should talk with patients in the outpatient setting and in advance of critical points; however, many hospitalized patients are more motivated and have sufficient time to think about values and goals. Of course, advance care planning should not be added to urgent informed consent for percutaneous coronary intervention to treat ST elevation myocardial infarction, but it can happen the next day. We contend that advance care planning should also happen before every nonemergent cardiac device implant. Who should hold these conversations about endof-life issues? Cardiovascular specialists point to primary care clinicians because they are longitudinal care clinicians, but primary care clinicians may assert that adequately addressing issues like device deactivation reJAMA Internal Medicine January 2015 Volume 175, Number 1
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Nanyang Technological University User on 05/27/2015
5
Opinion Viewpoint
quires cardiovascular specialists’ knowledge and training. In the ideal, primary care physicians set general goals of care to be used as a platform to address specific cardiovascular issues. Our experience is that advance care planning is most effective when led by the physician managing the patient’s care. Complicated discussions can be facilitated by consultant experts in palliative care, geriatrics, or ethics, but cardiovascular physicians must provide the context and prognosis and answer technical questions. To participate effectively in these conversations, most cardiologists will need additional training. It is our view that specialty societies should take the lead in providing educational opportunities, though the best approach has not been determined. The American College of Cardiology established a Cardiovascular Palliative Care Working Group to explore these issues with the goal of informing educational offerings. It will certainly be necessary to require basic training in advance care planning during cardiology fellowship. Communication skills training has been successfully incorporated into some oncology fellowships. This “Oncotalk” program may provide a model for cardiology training programs. Reimbursing physicians to conduct combined informed consent–advance care planning sessions may also be necessary and should improve the quality of both. Admittedly, reimbursement to physicians for advance care planning has proven politically controversial (eg, “death panel” accusations). Some private insurers, however, have started reimbursing for advance care planning.8 MediARTICLE INFORMATION Published Online: November 24, 2014. doi:10.1001/jamainternmed.2014.6219. Conflict of Interest Disclosures: None reported. REFERENCES 1. Goodman NW. What is it acceptable to die of? BMJ. 1997;314(7092):1484. 2. The Patient Self Determination Act. Pub L No. 101-508, §§ 4206 & 4751, 104 Stat 1388 (codified at 42 USC §§ 1395cc[f], 1396a[w] [1994]). 3. Nkomo VT, Suri RM, Pislaru SV, et al. Advance directives of patients with high-risk or inoperable aortic stenosis. JAMA Intern Med. 2014;174(9):15161518. 4. Silveira MJ, Wiitala W, Piette J. Advance directive completion by elderly Americans: a decade of change. J Am Geriatr Soc. 2014;62(4):706-710.
6
care includes advance care planning in the reimbursed annual wellness visit. Asking patients to reflect on larger issues during informed consent should highlight the fact that advance care planning is not necessarily about forgoing life-sustaining treatment. Successful adoption in a specialty like cardiology that is replete with diagnostic and therapeutic interventions would commend extension to other areas of medicine. Marrying advance care planning to informed consent will require restructuring of both processes. Scientific statements by the Heart Rhythm Society (HRS)9 and the Canadian Cardiovascular Society10 provide frameworks to introduce advance care planning concepts when counseling patients prior to cardiac device implant. Introducing these concepts at the time of informed consent does not imply the requirement to execute an advance directive when signing an informed consent form. There must be adequate time for patients, families, and care partners to become informed and to explore alternatives, to consider each in light of patient goals, and in some cases to clarify values by probing life-and-death questions. For patients with stable preferences who have already thought through these issues, this process should take little time. For other patients, focusing on big picture issues may be challenging but nonetheless worthwhile. For clinicians, identifying patient values and setting goals are crucial steps in assessing what is reasonable for a given patient. In this sense, advance care planning might even put the “informed” back into “informed consent.”
5. Buchhalter LC, Ottenberg AL, Webster TL, Swetz KM, Hayes DL, Mueller PS. Features and outcomes of patients who underwent cardiac device deactivation. JAMA Intern Med. 2014;174(1):80-85. 6. Kaufman SR, Mueller PS, Ottenberg AL, Koenig BA. Ironic technology: Old age and the implantable cardioverter defibrillator in US health care. Soc Sci Med. 2011;72(1):6-14. 7. Goodlin SJ, Hauptman PJ, Arnold R, et al. Consensus statement: Palliative and supportive care in advanced heart failure. J Card Fail. 2004;10 (3):200-209. 8. Belluck P. Coverage for end-of-life talks gaining ground [published August 30, 2014]. New York Times;A1. http://www.nytimes.com/2014/08/31 /health/end-of-life-talks-may-finally-overcome -politics.html. Accessed September 10, 2014.
9. Lampert R, Hayes DL, Annas GJ, et al; American College of Cardiology; American Geriatrics Society; American Academy of Hospice and Palliative Medicine; American Heart Association; European Heart Rhythm Association; Hospice and Palliative Nurses Association. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7(7):1008-1026. 10. McKelvie RS, Moe GW, Cheung A, et al. The 2011 Canadian Cardiovascular Society heart failure management guidelines update: focus on sleep apnea, renal dysfunction, mechanical circulatory support, and palliative care. Can J Cardiol. 2011;27 (3):319-338.
JAMA Internal Medicine January 2015 Volume 175, Number 1
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Nanyang Technological University User on 05/27/2015
jamainternalmedicine.com
VIEWPOINT
James N. Kirkpatrick, MD Hospital of the University of Pennsylvania, Perelman School of Medicine, Philadelphia. Paul J. Hauptman, MD Saint Louis University School of Medicine, St Louis, Missouri. Sarah J. Goodlin, MD Oregon Health Sciences University, Portland; and Veterans Affairs Medical Center, Portland, Oregon.
Corresponding Author: James N. Kirkpatrick, MD, Echocardiography Laboratory, Hospital of the University of Pennsylvania, 3400 Spruce St, HUP 9021 Gates, Philadelphia, PA 19104 (james.kirkpatrick @uphs.upenn.edu). jamainternalmedicine.com
Bundling Informed Consent and Advance Care Planning in Chronic Cardiovascular Disease We Need to Talk Modern cardiovascular therapies offer unprecedented opportunities to improve survival and quality of life. Cardiovascular morbidity and mortality have significantly declined, owing in a large part to preventive therapies and technological advances such as coronary revascularization, implantable cardioverter defibrillators (ICDs), and ventricular assist devices (VADs). Newer therapies like transcatheter aortic valve replacement hold great promise. Nonetheless, cardiovascular disease remains a leading cause of death. Cardiovascular therapies delay but cannot avert dying. A view expressed in 1997 regarding coronary angioplasty remains applicable: “We rescue people from a relatively sudden death…only to inflict on them a more prolonged death from progressive heart failure.”1(p1484) This trade-off may be worth it for individual patients but also introduces complexities into end-of-life interventions (both in terms of whether to intervene at all and, if so, when and how to stop the interventions). The choice to implant an ICD in an octogenarian, for instance, begs the question “How do you want to die?” because sudden arrhythmic death may be preferable to most other ways to die. Conversely, the decision to deactivate a VAD in a young patient with a debilitating stroke draws on subjective assessments of quality of life and patient values. The federal Patient Self-Determination Act2 mandates that all patients be given the opportunity to execute an advance directive (living will, power of attorney for health care). Despite broad support, only a third of patients take this opportunity. Even elderly patients with highly mortal diseases like severe aortic stenosis often lack advance directives.3 Furthermore, advance directives may not impact end-of-life care,4 and few address important decisions like defibrillator deactivation.3,5 Advance directives are only 1 part of advance care planning—the process by which clinicians set a course of care by integrating the patient’s values and preferences with what is medically reasonable. Advance care planning should anticipate future decisions in care and approaches to care at the end of life. We need to talk with patients who have chronic cardiovascular diseases about these issues; we need to engage in advance care planning and promote advance directives. It is probably never too early to start these conversations; it can definitely be too late—after a patient has lost decision-making capacity. Naturally, patients seeking therapies such as valve replacement and cardiac assist devices are focused on life prolongation. They may be encouraged by “miracle stories” and sub-
scribe to a cultural phenomenon termed the technological imperative: we have the technology and therefore must use it.6 Nonetheless, even patients focused on life prolongation can understand the need to prepare for the worst while hoping for the best.7 There are multiple opportunities in the course of cardiovascular disease to evaluate treatments in light of patient preferences. Preferred times include “turning points” such as changes in symptoms, development of comorbidities, and new indications for interventions.7 These turning points provide an important opportunity to address larger issues. Informed consent must be obtained prior to most cardiovascular interventions. During the informed consent process, why not ask patients to put intervention decisions into the larger context of their values and goals? We suggest that informed consent and advance care planning be bundled. In addition to asking “do you understand the risks?” we need to understand how the intervention can achieve patient goals. We should ask “what should we do if things do not go as planned?” and “under what circumstances would you want us to allow you to die?” We need to let patients know that deactivation of ICDs or VADs may be a necessary step in allowing them to die. Incorporating advance care planning into informed consent allows clinicians to address preferences for management of undesired outcomes while simultaneously informing the patient of the possibility of those outcomes. Each new medical intervention that requires informed consent should be a time to confirm or reevaluate patient preferences. Some patients may decide to forgo interventions; more likely, they will opt to proceed but with a better sense of how their choices fit into the bigger picture of their lives. And they and their loved ones will be better prepared when confronted by end-of-life decisions. Ideally, we should talk with patients in the outpatient setting and in advance of critical points; however, many hospitalized patients are more motivated and have sufficient time to think about values and goals. Of course, advance care planning should not be added to urgent informed consent for percutaneous coronary intervention to treat ST elevation myocardial infarction, but it can happen the next day. We contend that advance care planning should also happen before every nonemergent cardiac device implant. Who should hold these conversations about endof-life issues? Cardiovascular specialists point to primary care clinicians because they are longitudinal care clinicians, but primary care clinicians may assert that adequately addressing issues like device deactivation reJAMA Internal Medicine January 2015 Volume 175, Number 1
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Nanyang Technological University User on 05/27/2015
5
Opinion Viewpoint
quires cardiovascular specialists’ knowledge and training. In the ideal, primary care physicians set general goals of care to be used as a platform to address specific cardiovascular issues. Our experience is that advance care planning is most effective when led by the physician managing the patient’s care. Complicated discussions can be facilitated by consultant experts in palliative care, geriatrics, or ethics, but cardiovascular physicians must provide the context and prognosis and answer technical questions. To participate effectively in these conversations, most cardiologists will need additional training. It is our view that specialty societies should take the lead in providing educational opportunities, though the best approach has not been determined. The American College of Cardiology established a Cardiovascular Palliative Care Working Group to explore these issues with the goal of informing educational offerings. It will certainly be necessary to require basic training in advance care planning during cardiology fellowship. Communication skills training has been successfully incorporated into some oncology fellowships. This “Oncotalk” program may provide a model for cardiology training programs. Reimbursing physicians to conduct combined informed consent–advance care planning sessions may also be necessary and should improve the quality of both. Admittedly, reimbursement to physicians for advance care planning has proven politically controversial (eg, “death panel” accusations). Some private insurers, however, have started reimbursing for advance care planning.8 MediARTICLE INFORMATION Published Online: November 24, 2014. doi:10.1001/jamainternmed.2014.6219. Conflict of Interest Disclosures: None reported. REFERENCES 1. Goodman NW. What is it acceptable to die of? BMJ. 1997;314(7092):1484. 2. The Patient Self Determination Act. Pub L No. 101-508, §§ 4206 & 4751, 104 Stat 1388 (codified at 42 USC §§ 1395cc[f], 1396a[w] [1994]). 3. Nkomo VT, Suri RM, Pislaru SV, et al. Advance directives of patients with high-risk or inoperable aortic stenosis. JAMA Intern Med. 2014;174(9):15161518. 4. Silveira MJ, Wiitala W, Piette J. Advance directive completion by elderly Americans: a decade of change. J Am Geriatr Soc. 2014;62(4):706-710.
6
care includes advance care planning in the reimbursed annual wellness visit. Asking patients to reflect on larger issues during informed consent should highlight the fact that advance care planning is not necessarily about forgoing life-sustaining treatment. Successful adoption in a specialty like cardiology that is replete with diagnostic and therapeutic interventions would commend extension to other areas of medicine. Marrying advance care planning to informed consent will require restructuring of both processes. Scientific statements by the Heart Rhythm Society (HRS)9 and the Canadian Cardiovascular Society10 provide frameworks to introduce advance care planning concepts when counseling patients prior to cardiac device implant. Introducing these concepts at the time of informed consent does not imply the requirement to execute an advance directive when signing an informed consent form. There must be adequate time for patients, families, and care partners to become informed and to explore alternatives, to consider each in light of patient goals, and in some cases to clarify values by probing life-and-death questions. For patients with stable preferences who have already thought through these issues, this process should take little time. For other patients, focusing on big picture issues may be challenging but nonetheless worthwhile. For clinicians, identifying patient values and setting goals are crucial steps in assessing what is reasonable for a given patient. In this sense, advance care planning might even put the “informed” back into “informed consent.”
5. Buchhalter LC, Ottenberg AL, Webster TL, Swetz KM, Hayes DL, Mueller PS. Features and outcomes of patients who underwent cardiac device deactivation. JAMA Intern Med. 2014;174(1):80-85. 6. Kaufman SR, Mueller PS, Ottenberg AL, Koenig BA. Ironic technology: Old age and the implantable cardioverter defibrillator in US health care. Soc Sci Med. 2011;72(1):6-14. 7. Goodlin SJ, Hauptman PJ, Arnold R, et al. Consensus statement: Palliative and supportive care in advanced heart failure. J Card Fail. 2004;10 (3):200-209. 8. Belluck P. Coverage for end-of-life talks gaining ground [published August 30, 2014]. New York Times;A1. http://www.nytimes.com/2014/08/31 /health/end-of-life-talks-may-finally-overcome -politics.html. Accessed September 10, 2014.
9. Lampert R, Hayes DL, Annas GJ, et al; American College of Cardiology; American Geriatrics Society; American Academy of Hospice and Palliative Medicine; American Heart Association; European Heart Rhythm Association; Hospice and Palliative Nurses Association. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7(7):1008-1026. 10. McKelvie RS, Moe GW, Cheung A, et al. The 2011 Canadian Cardiovascular Society heart failure management guidelines update: focus on sleep apnea, renal dysfunction, mechanical circulatory support, and palliative care. Can J Cardiol. 2011;27 (3):319-338.
JAMA Internal Medicine January 2015 Volume 175, Number 1
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Nanyang Technological University User on 05/27/2015
jamainternalmedicine.com
