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Palliative Care Consultation and Associated End-of-Life Care After Pacemaker or Implantable Cardioverter-Defibrillator Deactivation
American Journal of Hospice & Palliative Medicine® 1-6 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1049909115595017 ajhpm.sagepub.com
Dario Pasalic, BS1, Halena M. Gazelka, MD2, Rachel J. Topazian, BA3,4,5, Lillian C. Buchhalter, MD, MPH1, Abigale L. Ottenberg, MA6,7, Tracy L. Webster, RN8, Keith M. Swetz, MD, MA3,4,9, and Paul S. Mueller, MD, MPH3,4,6
Abstract The presence of cardiac pacemakers and defibrillators complicates making end-of-life (EOL) medical decisions. Palliative care/ medicine consultation (PCMC) may benefit patients and primary providers, but data are lacking. We retrospectively reviewed 150 charts of patients who underwent device deactivation at our tertiary care center (between November 1, 2008, and September 1, 2012), assessing for PCMC and outcomes. Overall, 42% of patients received a PCMC, and 68% of those PCMCs specifically addressed device deactivation. Median survival following deactivation was 2 days, with 42% of deaths occurring within 1 day of deactivation. There was no difference in survival between the groups. The EOL care for patients with implanted cardiac devices is complex, but PCMC may assist with symptom management and clarification of goals of care for such patients. Keywords cardiac pacemaker, cardiovascular implantable electronic device, end of life, implantable cardioverter-defibrillator, medical ethics, palliative care
Introduction Hundreds of thousands of patients in the United States have cardiovascular implantable electronic devices (CIEDs), such as pacemakers and implantable cardioverter-defibrillators (ICDs).1 Although CIEDs prolong life, they also increase the complexity of medical decisions, particularly for patients approaching the end of life (EOL) for whom the therapies delivered by these devices may no longer be consistent with their goals of care.2-4 For those patients, the perceived and real burdens of an active CIED may outweigh its benefits (eg, ICD-delivered shocks compared with maximizing comfort).5,6 Indeed, emotional distress related to possible ICDdelivered shocks and perceived interference with the natural dying process are common reasons patients or their surrogates request CIED deactivation.4,5,7,8 Consensus statements by the Heart Rhythm Society9 and the European Heart Rhythm Association10 assert that ‘‘withdrawal of a treatment is a personal right of the patient’’ and is ethically and legally permissible.9 Patient education and effective communication with health care providers have been advocated to facilitate CIED deactivation discussions,11-13 with palliative
care consultation as needed9 and team-based approaches that include cardiology and palliative care consultants collaborating to improve EOL care.14-16 However, with palliative care workforce shortages coupled with the tens of thousands of patients undergoing CIED implantation annually, this approach may not be practical.17,18 Even with cooperative partnerships, some institutions lack CIED deactivation policies and procedures, and the result can be confusion among care providers.2,19 Some 1
Mayo Medical School, Mayo Clinic College of Medicine, Rochester, MN, USA Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA 3 Mayo Clinic Biomedical Ethics Program, Mayo Clinic, Rochester, MN, USA 4 Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA 5 Johns Hopkins Medical Institutes, Baltimore, MD, USA 6 Program in Professionalism and Ethics, Mayo Clinic, Rochester, MN, USA 7 SSH Health, Mission, Legal and Government Affairs, St Louis, MO, USA 8 Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA 9 Birmingham VA Medical Center, Birmingham, AL, USA 2
Corresponding Author: Halena M. Gazelka, MD, Division of Pain Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. Email: [email protected]
Downloaded from ajh.sagepub.com at University of Sussex Library on August 26, 2015
American Journal of Hospice & Palliative Medicine®
2 physicians may not perceive CIED deactivation as their concern,20 but others simply have little or no experience with the matter.14 Finally, little is known about the effect of palliative care/ medicine consultation (PCMC) on patients who request and undergo CIED deactivation. In this study, we sought to characterize PCMCs at our institution and retrospectively investigate how they affect patients’ EOL experiences.
Methods After obtaining approval from the Mayo Clinic Institutional Review Board, we conducted a retrospective review of the medical records of patients with CIEDs referred to the Mayo Clinic Division of Cardiovascular Diseases Heart Rhythm Service in Rochester, Minnesota, for CIED deactivation between November 1, 2008, and September 1, 2012. Referrals were made by health care providers after receiving a request for CIED deactivation from patients or their surrogates. At our institution, all CIED deactivations are carried out by nurses or physicians from the Heart Rhythm Service for hospitalized patients and sometimes by industry-employed allied professionals (IEAPs) for patients outside the hospital (eg, in nursing homes). Nonhospital-based deactivations are reported to the Heart Rhythm Service (compiled by TLW). The PCMCs were performed by board-eligible or board-certified hospice and palliative medicine physicians or health care practitioners with advanced palliative care/medicine experience. The medical records of patients who underwent CIED deactivation were retrospectively reviewed, and data regarding demographics, clinical outcomes, and care provided by the palliative care/medicine consultants were abstracted.
Patients Overall, 150 patients who underwent CIED deactivation at our institution were included in the study. The clinical features and outcomes of these patients were previously reported.5 Inclusion criteria required patients to be 18 years or older and to have previously undergone implantation of a CIED (permanent pacemaker or an ICD or both; some patients received concurrent left ventricular assist devices). Patients were excluded if they did not authorize use of their medical records for research purposes in accordance with state law.
Statistical Analysis The 150 patients who underwent CIED deactivations when approaching EOL were stratified into 2 groups: those who received a PCMC and those who did not. Categorical variables were analyzed with the Fisher exact test and continuous variables with the 2-sided t test. The log-rank test was used to evaluate survival comparison between the groups. The McNemar test was used for paired categorical variables testing for concordance of reasons for consultation and items addressed with consultation. All analyses were performed with JMP statistical
software version 10 (SAS Institute Inc., Cary N.C.). A P value less than .05 was considered statistically significant.
Results Demographic data and summary statistics are shown in Table 1. Of the 150 patients, 118 (79%) underwent deactivation of tachycardia therapies only, and 32 (21%) underwent deactivation of bradycardia therapies with or without tachycardia therapies. Of 10 patients who concurrently had left ventricular assist devices, 9 received a PCMC, and of these 9 patients, 7 underwent deactivation of the left ventricular assist device concurrently with deactivation of their CIED. Nearly, all patients (149; 99%) had poor or terminal prognoses related to a wide range of causes. (One patient who had Ebstein anomaly and a favorable prognosis requested ICD deactivation of tachycardia therapies only because of unacceptable shocks.) Overall, 63 (42%) patients received PCMCs. Of these, 43 (68%) consultations specifically addressed CIED management. Reasons for PCMC varied (Table 2). For several patients, the consultation requests asked that multiple topics be addressed, and in some instances, the services provided by the PCMC went beyond what was requested. Overall, statistically significant differences were found between the percentage of patients for whom a consultation was requested and the percentage for whom a consultation was performed, respectively, for goals of care discussions (67% vs 90%; P < .001); symptom management (37% vs 76%; P < .001); discussion of hospice, community resources, or disposition assistance (14% vs 38%; P < .001); and prognosis (0% vs 24%; P < .001). Patients who received a PCMC did not differ from those who did not receive PCMC by sex, age, race, or residence. However, patients who received a PCMC were significantly more likely to be Protestant than those who did not receive a PCMC. The median time from PCMC to CIED deactivation was 2 days. However, the interquartile range for time from PCMC to CIED deactivation was 0 days (ie, the day of CIED deactivation) to 23 days before CIED deactivation. Requests for CIED deactivation were made by 72 (48%) patients and 78 (52%) surrogates. Patients who were able to make decisions were significantly more likely to receive a PCMC than patients who were unable to make decisions and relied on surrogates requesting CIED deactivation (59% vs 41%; P ¼ .03). The PCMC differed according to the health care providers who actually deactivated the CIEDs. Among patients who received a PCMC, CIED deactivation was carried out by 43 (68%) nurses, 18 (29%) physicians, and 2 (3%) IEAPs, whereas among patients who did not receive a PCMC, CIED deactivation was carried out by 39 (45%) nurses, 28 (32%) physicians, and 20 (23%) IEAPs (P < .001). There was no statistically significant difference in survival between patients who received a PCMC and those who did not, with 42% of overall deaths occurring within 1 day of CIED deactivation. Kaplan-Meier survival outcomes are depicted in Figure 1.
Downloaded from ajh.sagepub.com at University of Sussex Library on August 26, 2015
Pasalic et al
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Table 1. Characteristics of 150 Patients Who Underwent CIED Deactivations and Received or Did Not Receive PCMC. Patientsa Received PCMC (n ¼ 63) Did not receive PCMC (n ¼ 87) P value
Total
Characteristic
Sex Male 102 (68) Female 48 (32) Age at CIED deactivation, median (IQR), years 79 (69-86) Race White 145 (97) Not white 5 (3) Religion Protestant 71 (47) Catholic 64 (43) Not Christian 15 (10) Residence Olmsted County, Minnesota 26 (17) Other Minnesota county 78 (52) Outside Minnesota 46 (31) No. of days from PCMC to CIED deactivation, median (IQR) NA Person requesting CIED deactivation Patient (patient able to make decisions) 72 (48) Surrogate (patient unable to make decisions) 78 (52) Person carrying out CIED deactivation Physician 46 (31) Nurse 82 (55) IEAP 22 (15) Ethics consultation 3 (2)
.86 42 (67) 21 (33) 78 (69-86)
60 (69) 27 (31) 79 (72-86)
62 (98) 1 (2)
83 (95) 4 (5)
46 (73) 13 (21) 4 (6)
25 (29) 51 (59) 11 (13)
10 32 21 2
16 (18) 46 (53) 25 (29) NA
.29 .40
Palliative Care Consultation and Associated End-of-Life Care After Pacemaker or Implantable Cardioverter-Defibrillator Deactivation
American Journal of Hospice & Palliative Medicine® 1-6 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1049909115595017 ajhpm.sagepub.com
Dario Pasalic, BS1, Halena M. Gazelka, MD2, Rachel J. Topazian, BA3,4,5, Lillian C. Buchhalter, MD, MPH1, Abigale L. Ottenberg, MA6,7, Tracy L. Webster, RN8, Keith M. Swetz, MD, MA3,4,9, and Paul S. Mueller, MD, MPH3,4,6
Abstract The presence of cardiac pacemakers and defibrillators complicates making end-of-life (EOL) medical decisions. Palliative care/ medicine consultation (PCMC) may benefit patients and primary providers, but data are lacking. We retrospectively reviewed 150 charts of patients who underwent device deactivation at our tertiary care center (between November 1, 2008, and September 1, 2012), assessing for PCMC and outcomes. Overall, 42% of patients received a PCMC, and 68% of those PCMCs specifically addressed device deactivation. Median survival following deactivation was 2 days, with 42% of deaths occurring within 1 day of deactivation. There was no difference in survival between the groups. The EOL care for patients with implanted cardiac devices is complex, but PCMC may assist with symptom management and clarification of goals of care for such patients. Keywords cardiac pacemaker, cardiovascular implantable electronic device, end of life, implantable cardioverter-defibrillator, medical ethics, palliative care
Introduction Hundreds of thousands of patients in the United States have cardiovascular implantable electronic devices (CIEDs), such as pacemakers and implantable cardioverter-defibrillators (ICDs).1 Although CIEDs prolong life, they also increase the complexity of medical decisions, particularly for patients approaching the end of life (EOL) for whom the therapies delivered by these devices may no longer be consistent with their goals of care.2-4 For those patients, the perceived and real burdens of an active CIED may outweigh its benefits (eg, ICD-delivered shocks compared with maximizing comfort).5,6 Indeed, emotional distress related to possible ICDdelivered shocks and perceived interference with the natural dying process are common reasons patients or their surrogates request CIED deactivation.4,5,7,8 Consensus statements by the Heart Rhythm Society9 and the European Heart Rhythm Association10 assert that ‘‘withdrawal of a treatment is a personal right of the patient’’ and is ethically and legally permissible.9 Patient education and effective communication with health care providers have been advocated to facilitate CIED deactivation discussions,11-13 with palliative
care consultation as needed9 and team-based approaches that include cardiology and palliative care consultants collaborating to improve EOL care.14-16 However, with palliative care workforce shortages coupled with the tens of thousands of patients undergoing CIED implantation annually, this approach may not be practical.17,18 Even with cooperative partnerships, some institutions lack CIED deactivation policies and procedures, and the result can be confusion among care providers.2,19 Some 1
Mayo Medical School, Mayo Clinic College of Medicine, Rochester, MN, USA Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA 3 Mayo Clinic Biomedical Ethics Program, Mayo Clinic, Rochester, MN, USA 4 Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA 5 Johns Hopkins Medical Institutes, Baltimore, MD, USA 6 Program in Professionalism and Ethics, Mayo Clinic, Rochester, MN, USA 7 SSH Health, Mission, Legal and Government Affairs, St Louis, MO, USA 8 Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA 9 Birmingham VA Medical Center, Birmingham, AL, USA 2
Corresponding Author: Halena M. Gazelka, MD, Division of Pain Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. Email: [email protected]
Downloaded from ajh.sagepub.com at University of Sussex Library on August 26, 2015
American Journal of Hospice & Palliative Medicine®
2 physicians may not perceive CIED deactivation as their concern,20 but others simply have little or no experience with the matter.14 Finally, little is known about the effect of palliative care/ medicine consultation (PCMC) on patients who request and undergo CIED deactivation. In this study, we sought to characterize PCMCs at our institution and retrospectively investigate how they affect patients’ EOL experiences.
Methods After obtaining approval from the Mayo Clinic Institutional Review Board, we conducted a retrospective review of the medical records of patients with CIEDs referred to the Mayo Clinic Division of Cardiovascular Diseases Heart Rhythm Service in Rochester, Minnesota, for CIED deactivation between November 1, 2008, and September 1, 2012. Referrals were made by health care providers after receiving a request for CIED deactivation from patients or their surrogates. At our institution, all CIED deactivations are carried out by nurses or physicians from the Heart Rhythm Service for hospitalized patients and sometimes by industry-employed allied professionals (IEAPs) for patients outside the hospital (eg, in nursing homes). Nonhospital-based deactivations are reported to the Heart Rhythm Service (compiled by TLW). The PCMCs were performed by board-eligible or board-certified hospice and palliative medicine physicians or health care practitioners with advanced palliative care/medicine experience. The medical records of patients who underwent CIED deactivation were retrospectively reviewed, and data regarding demographics, clinical outcomes, and care provided by the palliative care/medicine consultants were abstracted.
Patients Overall, 150 patients who underwent CIED deactivation at our institution were included in the study. The clinical features and outcomes of these patients were previously reported.5 Inclusion criteria required patients to be 18 years or older and to have previously undergone implantation of a CIED (permanent pacemaker or an ICD or both; some patients received concurrent left ventricular assist devices). Patients were excluded if they did not authorize use of their medical records for research purposes in accordance with state law.
Statistical Analysis The 150 patients who underwent CIED deactivations when approaching EOL were stratified into 2 groups: those who received a PCMC and those who did not. Categorical variables were analyzed with the Fisher exact test and continuous variables with the 2-sided t test. The log-rank test was used to evaluate survival comparison between the groups. The McNemar test was used for paired categorical variables testing for concordance of reasons for consultation and items addressed with consultation. All analyses were performed with JMP statistical
software version 10 (SAS Institute Inc., Cary N.C.). A P value less than .05 was considered statistically significant.
Results Demographic data and summary statistics are shown in Table 1. Of the 150 patients, 118 (79%) underwent deactivation of tachycardia therapies only, and 32 (21%) underwent deactivation of bradycardia therapies with or without tachycardia therapies. Of 10 patients who concurrently had left ventricular assist devices, 9 received a PCMC, and of these 9 patients, 7 underwent deactivation of the left ventricular assist device concurrently with deactivation of their CIED. Nearly, all patients (149; 99%) had poor or terminal prognoses related to a wide range of causes. (One patient who had Ebstein anomaly and a favorable prognosis requested ICD deactivation of tachycardia therapies only because of unacceptable shocks.) Overall, 63 (42%) patients received PCMCs. Of these, 43 (68%) consultations specifically addressed CIED management. Reasons for PCMC varied (Table 2). For several patients, the consultation requests asked that multiple topics be addressed, and in some instances, the services provided by the PCMC went beyond what was requested. Overall, statistically significant differences were found between the percentage of patients for whom a consultation was requested and the percentage for whom a consultation was performed, respectively, for goals of care discussions (67% vs 90%; P < .001); symptom management (37% vs 76%; P < .001); discussion of hospice, community resources, or disposition assistance (14% vs 38%; P < .001); and prognosis (0% vs 24%; P < .001). Patients who received a PCMC did not differ from those who did not receive PCMC by sex, age, race, or residence. However, patients who received a PCMC were significantly more likely to be Protestant than those who did not receive a PCMC. The median time from PCMC to CIED deactivation was 2 days. However, the interquartile range for time from PCMC to CIED deactivation was 0 days (ie, the day of CIED deactivation) to 23 days before CIED deactivation. Requests for CIED deactivation were made by 72 (48%) patients and 78 (52%) surrogates. Patients who were able to make decisions were significantly more likely to receive a PCMC than patients who were unable to make decisions and relied on surrogates requesting CIED deactivation (59% vs 41%; P ¼ .03). The PCMC differed according to the health care providers who actually deactivated the CIEDs. Among patients who received a PCMC, CIED deactivation was carried out by 43 (68%) nurses, 18 (29%) physicians, and 2 (3%) IEAPs, whereas among patients who did not receive a PCMC, CIED deactivation was carried out by 39 (45%) nurses, 28 (32%) physicians, and 20 (23%) IEAPs (P < .001). There was no statistically significant difference in survival between patients who received a PCMC and those who did not, with 42% of overall deaths occurring within 1 day of CIED deactivation. Kaplan-Meier survival outcomes are depicted in Figure 1.
Downloaded from ajh.sagepub.com at University of Sussex Library on August 26, 2015
Pasalic et al
3
Table 1. Characteristics of 150 Patients Who Underwent CIED Deactivations and Received or Did Not Receive PCMC. Patientsa Received PCMC (n ¼ 63) Did not receive PCMC (n ¼ 87) P value
Total
Characteristic
Sex Male 102 (68) Female 48 (32) Age at CIED deactivation, median (IQR), years 79 (69-86) Race White 145 (97) Not white 5 (3) Religion Protestant 71 (47) Catholic 64 (43) Not Christian 15 (10) Residence Olmsted County, Minnesota 26 (17) Other Minnesota county 78 (52) Outside Minnesota 46 (31) No. of days from PCMC to CIED deactivation, median (IQR) NA Person requesting CIED deactivation Patient (patient able to make decisions) 72 (48) Surrogate (patient unable to make decisions) 78 (52) Person carrying out CIED deactivation Physician 46 (31) Nurse 82 (55) IEAP 22 (15) Ethics consultation 3 (2)
.86 42 (67) 21 (33) 78 (69-86)
60 (69) 27 (31) 79 (72-86)
62 (98) 1 (2)
83 (95) 4 (5)
46 (73) 13 (21) 4 (6)
25 (29) 51 (59) 11 (13)
10 32 21 2
16 (18) 46 (53) 25 (29) NA
.29 .40
