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Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device
Accepted Manuscript Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device Sara E. Wordingham, MD, Colleen K. McIlvennan, DNP, ANP, Timothy J. Fendler, MD, Amy L. Behnken, APRN, CNP, Shannon M. Dunlay, MD, MS, James N. Kirkpatrick, MD, Keith M. Swetz, MD, MA PII:
S0885-3924(17)30270-1
DOI:
10.1016/j.jpainsymman.2017.07.007
Reference:
JPS 9432
To appear in:
Journal of Pain and Symptom Management
Received Date: 26 September 2016 Revised Date:
17 April 2017
Accepted Date: 6 July 2017
Please cite this article as: Wordingham SE, McIlvennan CK, Fendler TJ, Behnken AL, Dunlay SM, Kirkpatrick JN, Swetz KM, Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device, Journal of Pain and Symptom Management (2017), doi: 10.1016/ j.jpainsymman.2017.07.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Wordingham et. al 0 [Category. Curbside Rounds: State-of-the-Art in Palliative Care] Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device Sara E. Wordingham, MD1
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Colleen K. McIlvennan, DNP, ANP2 Timothy J. Fendler, MD3 Amy L. Behnken, APRN, CNP4
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Shannon M. Dunlay, MD, MS4 James N. Kirkpatrick, MD5
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Keith M. Swetz, MD, MA6,7
Author affiliations: 1Mayo Clinic, Phoenix, AZ, 2University of Colorado, Aurora, Colorado, 3
Midamerica Heart Institute, Kansas City, MO, 4Mayo Clinic, Rochester, MN, 5University of
Center, Birmingham, AL
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Washington, Seattle, WA, 6University of Alabama-Birmingham and 7Birmingham VA Medical
Corresponding author: Keith M. Swetz MD, MA, UAB Center for Palliative & Supportive Care,
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1720 2nd Avenue South, BDB 650, Birmingham, AL 35294-0012. Email: [email protected],
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Phone: 205-975-8197, Fax 205-975-8173
Text word count: 3952
Abstract: pending review regarding format Running title: Curbside Consult for Palliative Care and CF-LVADs Keywords: mechanical circulatory support; ventricular assist device; end-of-life; palliative care; medical ethics, advance care planning
ACCEPTED MANUSCRIPT Wordingham et. al 1 Abstract Left ventricular assist devices (LVADs) are an available treatment option for carefullyselected patients with advanced heart failure. Initially developed as a bridge to transplantation,
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LVADs are now also offered to patients ineligible for transplantation as destination therapy (DT). Individuals with a DT-LVAD will live the remainder of their lives with the device in place. While survival and quality of life improve with LVADs compared to medical therapy, complications
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persist including bleeding, infection, and stroke. There has been increased emphasis on
involving palliative care specialists in LVAD programs, specifically the DT-LVAD population,
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from the pre-implantation process through the end of life. Palliative care specialists are wellpoised to provide education, guidance and support to patients, families, and clinicians throughout the LVAD journey. This manuscript addresses the complexities of the LVAD population, describes key challenges faced by palliative care specialists, and discusses
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opportunities for building collaboration between palliative care specialists and LVAD teams.
ACCEPTED MANUSCRIPT Wordingham et. al 2 I. Introduction The use of mechanical circulatory support (MCS)—specifically durable continuous-flow left ventricular assist devices (CF-LVADs)—has become a mainstream treatment option for
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patients with end-stage heart failure. (1) While CF-LVAD is the major mechanism how the device delivers cardiac output, the rationale for placing the device or the implantation strategy focuses on whether or not heart transplant is anticipated for the patient. Initially, LVADs were
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developed as a “bridge” treatment to stabilize patients awaiting heart transplant. In this situation, patients receive their LVAD as a “bridge-to-transplant”, where supporting patients to allow future
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cardiac transplantation is the main goal of the therapy. However many patients with advanced heart disease may not be eligible for transplantation or do not wish to receive this treatment, and quality of life and mortality remain major issues in this group. In 2003, the Food and Drug Administration (FDA) approved LVADs as “destination therapy” (DT-LVAD) for patients with end-stage heart failure who are either too old or too sick from other medical problems to be
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considered for heart transplantation. By virtue of this, patients with DT-LVAD will live the rest of their lives with an LVAD, and die with the device in place, inexorably altering the end-of-life (EOL) experience. The consideration and use of DT-LVAD continues to grow, with estimates of
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150,000-250,000 patients annually who could be eligible for DT-LVAD (2) among the greater than six million patients in the U.S. with chronic heart failure. (3) While patients often experience
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improved survival and quality of life (QOL) with DT-LVAD compared to optimal medical management of heart failure, LVADs come with considerable risks and burdens that cannot be underestimated. (4) Most importantly, death remains inevitable despite DT-LVAD, with a current 1-year mortality of approximately 20% and average survival exceeding two years after implantation. (1) Over the past several years, there has been an increased emphasis on involving palliative care (PC) specialists in the care of patients with DT-LVAD, from the pre-implantation process through the EOL. Currently, the International Society of Heart and Lung Transplantation
ACCEPTED MANUSCRIPT Wordingham et. al 3 Guidelines for MCS include a Class IIa recommendation to consult PC specialists during the CF-LVAD pre-implantation evaluation period, noting that this consultation should explore goals and preferences for EOL care. (5) In 2013, The Joint Commission mandated that all accredited
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DT-LVAD programs must have a PC specialist as part of the team, in concert with the Centers for Medicare and Medicaid Services finalizing an update to the national coverage determination for bridge-to-transplant and DT-LVAD in 2014 that requires the MCS multidisciplinary team to
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include a PC expert. (6) While these actions have been fairly well-received by both cardiology and PC, there remains a lack of consensus on how and when to incorporate PC and the care
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process remains imprecise and limited by workforce challenges and PC clinician comfort and familiarity with CF-LVADs. Furthermore, there are unique aspects of PC for children and adolescents pursuing LVAD implantation, however, these are beyond the scope of this paper. There is substantial variability across institutions as to how PC specialists are included as part of MCS programs. (7) In some programs, PC specialists attend patient selection
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conferences and meet all patients and caregivers prior to CF-LVAD implant. Elsewhere PC clinicians are consulted only when a patient is nearing EOL. (8,9) At many institutions, PC providers not only address EOL care decisions and transitions to hospice, but forge active
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collaboration with patients, families, and clinicians in the implantation decision-making process, which we recommend. Depending on the relationship between PC and MCS programs, some
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PC providers may make recommendations about whether or not a patient seems to be a suitable candidate for CF-LVAD. PC teams often facilitate advance care planning (preparedness planning) (10) prior to CF-LVAD implantation, manage longitudinal QOL issues and assist with symptom management, especially the increasing burden of symptoms in an older patient population with multimorbidity. As the PC and heart failure communities continue to learn through experience, it is anticipated that the role for PC in this complex patient population will expand.
ACCEPTED MANUSCRIPT Wordingham et. al 4 Understanding the complexities and nuances of the CF-LVAD population is a crucial first step for PC specialists. Herein, we describe key challenges faced by patients with CF-LVAD and clinicians who care for them, and discuss opportunities for building collaboration between
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PC clinicians and MCS teams.
II. Key Challenges to Palliative Care Providers
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While MCS can improve functional capacity, QOL, and survival in selected patients, challenges exist in providing high quality care to this population. The unpredictable trajectory of
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advanced heart failure combined with distinct idiosyncrasies of MCS can complicate shareddecision making, advance care planning (ACP), and EOL care.
Preparedness Planning
Preparedness planning was initially developed in response to ethical dilemmas
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encountered in patients with DT-LVAD for whom ACP was incomplete or lacking altogether. (10) Many patients with CF-LVADs require rehospitalization and encounter a range of disease and device-specific complications portending morbidity and mortality. Aimed at eliciting patients’
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goals, preferences, and values in the setting of evidence-based medicine, preparedness planning has been developed as a technique to facilitate ACP specific to patients with CF-
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LVADs. Standard advance directives pose generic questions about EOL preferences but seldom mention LVADs while preparedness planning seeks to translate and document iterative, disease-specific patient preferences (11). With skills in communication, ACP and EOL care, PC clinicians are well poised to lead preparedness planning efforts, allowing for treatment goals to best align with patient preferences and values. While examples of preparedness planning discussions exist (12) the process should not be viewed as a checklist of points to be addressed, nor binary choices between aggressive interventions or death. The role of the PC clinician is to help transform a broad range of patient
ACCEPTED MANUSCRIPT Wordingham et. al 5 preferences into clinically relevant information in the event of catastrophic complications or progressive debility. The optimal timing of preparedness planning has not been established, nor has a standard format for documentation with the latter varying based on provider group,
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institution, and jurisdiction. It is recommended, however, that these discussions and any associated documents be completed prior to device implantation, after extensive counselling on risks, benefits and alternatives to CF-LVAD. Depending on the individual institution, the majority
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of the consent is usually obtained from the MCS team with information augmented and tailored by PC based on patient-specific factors. Concurrently, a medical power of attorney should be
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designated (who may or may not be the primary caregiver, or person who would assume the surrogate decision making role in that location), as it is anticipated that all patients undergoing device implantation will experience even a transient period of incapacity after the surgery. Importantly, preparedness plans, patients’ goals of care, and prognostication should be addressed iteratively throughout the CF-LVAD trajectory as patients’ preferences evolve over
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time. To be truly beneficial, preparedness plans must be readily accessible in the electronic health record since CF-LVAD complications often require swift decision making.
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Potential Complications
In order to engage effectively in preparedness planning, PC providers should be familiar
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with complication rates, implications, and interventions to best support decision making and foster patients’ trust in their expertise. Major CF-LVAD complications include bleeding and clotting, infections, end-organ failure, and cerebrovascular events. As a general rule, 1-year complication rates include serious device-related infection in 20%, stroke in 10%, and major bleeding (including gastrointestinal bleed) in about 30%. (4) Regardless of how well the left ventricle is being offloaded by the LVAD, there is still risk of progressive right heart failure, which is often a chronic complication that can contribute to morbidity and mortality for many patients with CF-LVAD. (4)
ACCEPTED MANUSCRIPT Wordingham et. al 6 Currently in the U.S. the only device approved by the FDA for DT-LVAD is the HeartMate II LVAD (Thoratec, Pleasanton, CA). Another commonly encountered device (although not yet FDA approved in the U.S. as DT-LVAD), the HVAD (HeartWare, Miami Lakes,
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FL) is smaller, allowing it to be used on a greater range of body habitus and has fewer parts to wear out, but reports have shown a higher stroke rate. (13) Rates of other complications are similar with use of the two devices. As the risk of complications may vary from patient to
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patient, PC clinicians are encouraged to collaborate with MCS teams to determine how best to counsel patients. PC teams may be called upon to refine goals of care in the face of repeated,
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debilitating, or prognostically significant events. In fact, patients may be concerned about disappointing the MCS team if opting to change the disease-directed plan of care and defer or discontinue CF-LVAD support. (14)
A decision aid is currently being tested as part of the DECIDE-LVAD trial (PCORI-131006998), and Figure 1 from a previously published systematic review is helpful in
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conceptualizing the commonly encountered complications. Impact of these complications is discussed in the next section. (4)
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Collaboration with MCS teams
In new or developing partnerships, PC providers should seek to explore and meet the
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needs of patients and MCS teams. Consultations without skilled communication and collaboration between teams may be ill-perceived; however, the unique skill set of PC teams can foster best supportive care practices across the continuum of care with CF-LVAD. PC clinicians are often engaged late in the care of patients with advanced illness, including CFLVAD, and despite this, hospice is often underutilized at the EOL for patients with CF-LVAD. (15) Therefore, PC teams consulted infrequently and only in EOL situations for patients with CF-LVAD may see only those who have protracted critical illness, poor QOL and/or unfortunate outcomes. However, it is critical for PC teams to understand and educate patients that most
ACCEPTED MANUSCRIPT Wordingham et. al 7 patients experience improvements in QOL and physical functioning by three months after implantation that persist unless limited by complications. (16) Critical to maximal supportive care of patients with CF-LVAD is close, ongoing collaboration with MCS teams—mutual respect,
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bidirectional education, and consistent engagement are essential. Both PC and MCS teams
successful partnership and foster patients’ trust.
III. Longitudinal Care Issues with CF-LVAD
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need a strong working knowledge of the fundamentals of the others’ practice to ensure
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While MCS technology may increase longevity and improve QOL, the device itself is not curative and is best considered aggressive palliation. Care must be taken to ensure that patients receive optimal supportive care throughout their advanced illness trajectory, which includes aligning treatment goals with patient preferences (as discussed in the preceding section), expert symptom control, psychosocial support, and anticipatory guidance nearing EOL.
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PC teams are distinctively equipped to collaborate with MCS teams to achieve optimal care for patients with this advanced technology, who remain at risk of life-limiting complications.
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CF-LVAD Outcomes as Destination Therapy
Essential to optimal care for patients with DT-LVAD is a detailed understanding of the
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prognostic implications, symptom burden, potential complications and caregiving needs associated with MCS. Prognostication can be exceptionally challenging in advanced heart failure, a trend which persists in DT-LVAD. The majority of patients will live for months to years with MCS. Nevertheless, the advanced illness trajectory for this population is punctuated with repeated hospitalizations, problems associated with aging-related comorbidities, increasing symptom burden, caregiver burnout and other challenges, which require longitudinal PC. As noted earlier, about 80% of patients receiving the HeartMate II will survive 1 year or more post-implantation; and approximately 10% die during the implantation hospitalization. (1,4)
ACCEPTED MANUSCRIPT Wordingham et. al 8 Patients may encounter extended stays in the intensive care unit, returns to the operating room, and the ongoing need for other life-sustaining therapies (i.e. hemodialysis)in the post-operative period and do not necessarily portend to an unacceptable or poor end outcome. PC teams may
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encounter challenges if called to see patients post-operatively and presume the intent of the consult is to assist with the decision about the ongoing role of DT-LVAD or other aggressive support. PC clinicians should view patients with DT-LVAD as having an advanced chronic
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illness with unique challenges and needs, and assumptions should not be made that the reason
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for consultation is EOL care.
Symptom Management
Longitudinal PC for patients with CF-LVAD requires honing of symptom management expertise with this population. Patients often experience pain, mood disorders and fatigue similar to other advanced illnesses. Careful attention to symptom burden and QOL issues can
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be the primary role of PC teams to augment the care provided by MCS teams. Notably, patients’ level of underlying debility or specific burdensome symptoms may have been masked or overlooked by pre-implantation critical illness, necessitating early PC involvement post-
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implantation. Symptom burden may escalate over time with aging, debility and complications underscoring the importance of ongoing, long-term PC involvement.
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Chronic pain encountered in this population is often multifactorial and associated with musculoskeletal sources. For example, pain may emanate from underlying degenerative joint disease and arthritis or preexisting neuropathy and is potentially exacerbated by carrying the CF-LVAD equipment. Similar to pain management in advanced heart failure, opioids have been proposed as perhaps the safest analgesic, as nonsteroidal anti-inflammatory drugs affect renal function and volume status and increase the risk of gastrointestinal bleeding. Gabapentin can be associated with edema and dosing also limited by edema and/or renal dysfunction. Analgesic management including opioids requires knowledge and skill that may be outside the
ACCEPTED MANUSCRIPT Wordingham et. al 9 scope or comfort level of some MCS providers, and PC clinicians can assist in the management to maximize QOL. Mood symptoms and depression are common in advanced heart failure and require
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close monitoring in DT-LVAD patients. PC clinicians can monitor for symptoms of anxiety and depression and assist in management with pharmacologic and non-pharmacologic
interventions, as well as referrals to mental health providers. Minimizing the risk of QT interval
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prolongation is often a concern of cardiologists, but may be less of an issue with DT-LVAD depending on the goals of care. Patients with potentially fatal cardiac rhythms, including
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ventricular tachycardia/fibrillation, may remain awake and alert as they maintain steady cardiac output with the LVAD operating independent of rhythm, while others may be more symptomatic although hemodynamically stable. Antidepressants can be chosen to optimize the anticipated treatment effect and side-effect profile with the target symptoms. Suicidality can be particularly concerning as patients have direct access to their own life-sustaining power supply.
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Furthermore, inpatient psychiatric facilities may be reluctant to care for patients with MCS due to lack of appropriate staffing or accreditation of care for such patients. Often, PC teams are asked to support patients, caregivers, and MCS teams in times of patient crisis which can be
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distressing to all.
Following LVAD implantation, patients and caregivers must adjust to a new lifestyle
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related to the device and associated equipment. Ordinary routines, such as sleeping and personal care must change, and changes in positioning and needing to be connected to a power supply at all times requires adaptation. Additionally, patients face changes in bathing and water-associated hobbies and issues of body image, sexuality, and intimacy may also arise. Longitudinal whole person care provided by PC teams may assist in the identification and management of issues stemming from these requisite adaptations and restrictions.
ACCEPTED MANUSCRIPT Wordingham et. al 10 Summary Regarding Longitudinal Care PC teams can support patients with MCS with longitudinal care beginning before device implantation by establishing rapport, preparedness planning, assisting with symptom
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management, and facilitating transitions in goals of care. Assistance with discussions regarding changes in clinical status and next steps tends to be more straightforward when patients and their loved ones are familiar with PC teams and concepts. Involvement of PC teams can be
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exceptionally valuable when MCS complications arise. The aim at times of complications or transition is to refer back to, and build upon, previous discussions and preparedness planning.
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Discussions regarding the care plan or anticipated outcomes should not be undertaken without collaboration with the MCS team. Strategies for management of various MCS-associated complications continue to evolve rapidly and novel approaches may be considered.
IV. End-of-Life Issues with CF-LVAD
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EOL care with CF-LVAD requires device-specific, physiologic, and symptom management considerations. A lack of protocols and evidence-based approaches to discontinuation of MCS therapy may complicate care. Furthermore, PC specialists may be
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engaged late or may be unfamiliar with CF-LVAD specifics. We propose that PC providers should be familiar with issues related to concurrent defibrillator management, the dynamics
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between their institution’s PC and MCS teams, and physiologic considerations including right and left heart function and aortic valve status.
General Considerations
As with any patient, location of anticipated death requires special consideration—as patients may wish to die at home. For hospitalized LVAD patients, transitioning to non-hospital based settings at EOL can be challenging as many hospices and skilled nursing facilities lack experience and training with MCS and may not feel comfortable caring for patients with LVADs.
ACCEPTED MANUSCRIPT Wordingham et. al 11 (17) The same holds true for many community care providers, such as home health nurses and home hospice providers. Even if family caregivers are available around the clock to assist with device-specific cares and tasks, agencies lacking experience may still decline to accept patients
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with MCS. Furthermore, caregivers may be anxious and overwhelmed with continuing to provide care to their loved one approaching EOL, and may be unable to assume these
responsibilities without additional support. Often, this additional support is provided by hospital-
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based MCS teams collaborating with local hospice agencies, which, when collaborating
effectively bring to bear knowledge, confidence, and experience to manage both the device and
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the EOL care of the patient. Further work is needed to develop systems of care to more optimally support the outpatient management of patients with MCS at EOL. Providing goal-aligned care is critically important. Goals, values, and preferences may vary among patients and may change over time—underscoring the important of iterative discussions. Importantly, the patient and MCS team’s approach to EOL care may differ by LVAD
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indication (i.e. bridge to transplantation or destination therapy) and the plan of care should be considered in the context of the patient’s individual goals and illness trajectory. Regardless of device indication, patients with LVAD may consider device deactivation
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when the LVAD is no longer consistent with their goals. (18) When considering device deactivation, collaboration between MCS and PC teams is critical. Although patients or their
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surrogate ultimately delineate what QOL is acceptable, multidisciplinary discussions should be ongoing to consider all potential opportunities to maximize QOL. Previously completed preparedness planning can help guide decision making approaching EOL. (11) If device deactivation is planned, a checklist (see Figure 2) can be utilized to ensure detailed plans are made for device and symptom management and maximal EOL and bereavement support. (19)
ACCEPTED MANUSCRIPT Wordingham et. al 12 Device-Specific and Physiologic Considerations PC teams should collaborate with MCS teams to develop a strong working knowledge of device management, physiologic changes, anticipated symptoms, and prognosis in the setting
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of device deactivation. When patients with MCS reach EOL, PC specialists and LVAD healthcare centers should have a protocol in place for addressing LVAD deactivation and providing comfort care that addresses ethical concerns regarding discontinuation of life-
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prolonging device therapy (20), minimizes fear and suffering for the patient and assuages anxiety and grief for loved ones. (17, 21)
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Discussions regarding defibrillator deactivation, as well as minimizing LVAD alarms, should occur in an anticipatory manner among the multidisciplinary teams. (20) When possible, a member of the MCS team should be present for device deactivation for expert device management, and in light of the extended relationship they have with CF-LVAD patients and families. If MCS team member are unavailable, such as in a planned deactivation at home or in
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a rural location, hospice and PC teams should be in direct contact with MCS teams to optimize device management at EOL. (17, 20)
The importance of device and physiologic considerations approaching EOL is
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paramount. Providers engaged in imminent EOL care for patients with CF-LVAD require working knowledge of the device itself including its functionality, anatomic positioning, alarms,
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power source, as well an understanding of the patient’s aortic valve status and native heart function. For example, knowledge of whether a patient has total artificial heart or an CF-LVAD is key to expert management of the device at the time of deactivation to best appreciate and anticipate how discontinuing the device will affect cardiac output and organ perfusion which affects prognosis. Knowledge of intrinsic left ventricular function can be beneficial to help gauge how long the patient may survive once the device is deactivated. If a patient has an aortic valve that was oversewn at the time of implantation due to aortic insufficiency, then the left ventricle is only able to eject blood through the CF-LVAD itself and death will be almost immediate after
ACCEPTED MANUSCRIPT Wordingham et. al 13 device deactivation. Lastly, changes in circulation are immediate when the device is deactivated, which can lead to challenges circulating parenterally administered medications needed for symptom management. (20) These device and physiologic considerations must be
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addressed prior to a planned deactivation so that patients, their loved ones, and bedside providers can be appropriately counseled and prepared for the patient’s EOL.
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V. Opportunities and Future Directions
Comprehensive care of patients with CF-LVAD, beginning at the pre-implant stage and
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extending through transplant or EOL, necessitates collaboration and coordination of care between many specialties, of which PC represents only one. There are currently a number of initiatives underway, which are vital to improving the processes of interdisciplinary care for patients with CF-LVAD and are, in fact, increasingly mandated. In addition to discussing ACP, PC specialists can play a role in meeting the psychosocial needs of patients before CF-LVAD
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implantation, (22) in conjunction with allied health specialists in psychology, nutrition and dietetics, physical and occupational therapy. (23) In the post-implantation setting, continuing psychosocial and adjustment needs exist, as
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do the risks of common adverse clinical events associated with CF-LVAD implantation, such as stroke, gastrointestinal bleeding and chronic driveline infection. (4) In caring for these needs, the
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PC clinician collaborates with a multitude of available specialty clinician services such as psychiatry, neurology, gastroenterology, infectious disease, primary care and internal medicine. Accordingly, an interdisciplinary, team-based approach to the care of patients with CF-LVAD underscores the importance of patient proximity to a comprehensive, tertiary or quaternary healthcare center. Furthermore, as an increasing number of local hospitals establish DT-LVAD programs, it is unclear what degree of subspecialist PC is available. Opportunities to collaborate and even provide tele-health consultation may be necessary to ensures that optimal patientcentered care is delivered in each unique situation.
ACCEPTED MANUSCRIPT Wordingham et. al 14 Lastly, caregivers necessitate special consideration in DT-LVAD and PC focuses to enhance the life of the patient as well as the family unit. Implanting centers may vary in their caregiving requirements; however, most patients are supported by unpaid family members or
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friends to assist with care. Caregivers perform a multitude of tasks—a role which often peaks in the post-implantation phase and when disease burdens escalate approaching EOL. (24)
Caregivers are often available 24 hours/day and are at risk for caregiver fatigue and burnout.
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Interdisciplinary PC teams can help normalize caregiver distress and assist in finding means to minimize the psychological and physical burden of caregiving.
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Within such a wide-ranging interdisciplinary care team for patients with CF-LVADs, involved specialists are bound to have differing views and approaches to the many ethical considerations surrounding LVAD therapy, especially among patients with CF-LVADs approaching EOL. (25) Even in the pre-implant, CF-LVAD candidacy stage, patients may express beliefs and decisions about pursuing CF-LVAD therapy that differ starkly from other
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patients and involved providers. After CF-LVAD implantation, individual patient trajectories and experiences will continue to vary greatly, and patients should be encouraged to continually explore their thoughts and desires regarding goals of care and aggressiveness of treatment,
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VI. Summary
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especially among patients receiving DT-LVAD.
In such a dynamically changing clinical setting, PC specialists, in particular, are well-
poised to provide education, guidance and support to patients, families, and clinicians. Furthermore, in addition to ensuring effective and meaningful communication with patients and their loved ones, PC specialists are uniquely positioned to engage other providers involved in the care of the patient in shared decision-making, who may have different levels of comfort with discussing EOL care and decisions with patients or each other.
ACCEPTED MANUSCRIPT Wordingham et. al 15 VII. Pearls •
Despite increasing regulatory requirements of palliative care specialists’ involvement in DTLVAD programs, there remains wide variability in integration among the LVAD team. Longitudinal involvement of palliative care specialists in patients with DT-LVADs is optimal, from
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•
pre-implantation through the end of life. •
LVADs prolong survival and improve quality of life; however, they are associated with significant
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risks including stroke, bleeding, infection and burdens such as driveline care and caregiver requirements.
Preparedness planning has been developed as a technique to facilitate advanced care planning
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•
for patients with LVADs in order to document iterative, disease and device-specific patient preferences.
End of life with an LVAD is a complicated process and requires collaboration with multiple disciplines; palliative care specialists are in an optimal position to provide coordination of goal-
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aligned care.
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•
ACCEPTED MANUSCRIPT Wordingham et. al 16 VIII. References 1. Kirklin JK, Naftel DC, Pagani FD, et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant 2015;34:1495-504.
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2. Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol 2013;61:1209-21. 3. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016;133:e38-e360 4. McIlvennan CK, Magid KH, Ambardekar AV, et al. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail 2014;7:1003-13
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5. Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 2013;32:157-87
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6. Centers for Medicare & Medicaid Services. Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R) 2013. Available from: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo.aspx?NCAId=268 7. Sagin A, Kirkpatrick JN, Pisani BA, et al. Emerging Collaboration Between Palliative Care Specialists and Mechanical Circulatory Support Teams: A Qualatative Study. J Pain Symptom Manage 2016;52(4): 491-7.
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8. Kirkpatrick JN, Hauptman PJ, Swetz KM, et al. Palliative Care for Patients With End-Stage Cardiovascular Disease and Devices: A Report From the Palliative Care Working Group of the Geriatrics Section of the American College of Cardiology. JAMA Intern Med 2016;176(7):1017-9. 9. Swetz KM, Bakitas MA, Tucker RO, et al. Abstract 123: Attitudes and Availability of Palliative Care Within Institutions Providing Mechanical Circulatory Support Device Implantation: A National Survey. Circ Cardiovasc Qual Outcomes 2016;9:A123.
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10. Swetz KM, Freeman MR, Abouezzeddine OF, et al. Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy. Mayo Clin Proc 2011;86:493-500.
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11. Verdoorn BP, Luckhardt AJ, Wordingham SE, Dunlay SM, Swetz KM. Palliative Medicine and Preparedness Planning for Patients Receiving Left Ventricular Assist Device as Destination Therapy: Challenges to Measuring Impact and Change in Insitutiional Culture. J Pain Symptom Manage 2017 Jan 16. [Epub ahead of print]. doi: 10/1016/j.jpainsymman.2016.10.372. 12. Swetz KM, Kamal AH, Matlock DD, et al. Preparedness planning before mechanical circulatory support: a "how-to" guide for palliative medicine clinicians. J Pain Symptom Manage 2014;47:926-935,e6. 13. Pagani FD, Milano CA, Tatooles AJ, et al. HeartWare HVAD for the Treatment of Patients With Advanced Heart Failure Ineligible for Cardiac Transplantation: Results of the ENDURANCE Destination Therapy Trial. J Heart Lung Transplant 2015;34:S9.
ACCEPTED MANUSCRIPT Wordingham et. al 17 14. Brush S, Budge D, Alharethi R, et al. End-of-life decision making and implementation in recipients of a destination left ventricular assist device. J Heart Lung Transplant 2010;29:1337-1341. 15. Dunlay SM, Strand JJ, Wordingham SE, et al. Dying With a Left Ventricular Assist Device as Destination Therapy. Circ Heart Fail. 2016;9:e003096.
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16. Maciver J, Ross HJ. Quality of life and left ventricular assist device support. Circulation 2012;126:866-74. 17. Panke JT, Ruiz G, Elliott T, et al. Discontinuation of a Left Ventricular Assist Device in the Home Hospice Setting. J Pain Symptom Manage 2016. 52(2):313-7.
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18. Mueller PS, Swetz KM, Freeman MR, Carter KA, Crowley ME, Severson CJ, Park SJ, Sulmasy DP. Ethical analysis of withdrawing ventricular assist device support. Mayo Clin Proc 2010 Sep;85(9):791-7. 19. Schaefer KG, Griffin L, Smith C, May CW, Stevenson LW. An interdisciplinary checklist for left ventricular assist device deactivation. J Palliat Med 2014;17:4-5.
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20. Gafford EF, Luckhardt AJ, Swetz KM. Deactivation of a left ventricular assist device at the end of life #269. J Palliat Med 2013;16:980-2. 21. Rossi Ferrario S, Omarini P, Cerutti P, Balestroni G, Omarini G, Pistono M. When LVAD Patients Die: The Caregiver’s Mourning. Artif Organs 2016;40(5):454-458. 22. Petty M, Bauman L. Psychosocial issues in ventricular assist device implantation and management. J Thorac Dis 2015;7:2181-7.
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23. Kugler C, Malehsa D, Schrader E, et al. A multi-modal intervention in management of left ventricular assist device outpatients: dietary counselling, controlled exercise and psychosocial support. Eur J Cardiothorac Surg 2012;42:1026-32. 24. McIlvennan CK, Jones J, Allen LA, Swetz KM, Nowels C, Matlock DD. Bereaved Caregiver Perspectives on the End-of-Life Experience of Patients With a Left Ventricular Assist Device. JAMA Intern Med 2016;176(4):534-9.
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25. Petrucci RJ, Benish LA, Carrow BL, et al. Ethical considerations for ventricular assist device support: a 10-point model. ASAIO J 2011;57:268-73.
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26. McIlvennan CK, Wordingham SE, Allen LA, Matlock DD, Jones J, Dunlay SM, Swetz KM. Deactivation of Left Ventricular Assist Devices: Differing Perspectives of Cardiology and Hospice/Palliative Medicine Clinicians. J Card Fail. 2016 Dec 5. [Epub ahead of print]. doi: 10/1016/j.cardfail.2016.12.001.
ACCEPTED MANUSCRIPT Wordingham et. al 18 Selected Annotated References 1. Swetz KM, Kamal AH, Matlock DD, et al. Preparedness planning before mechanical circulatory support: a "how-to" guide for palliative medicine clinicians. J Pain Symptom Manage 2014;47:926-935, e6. This “How To” guide was published in 2014 the Journal of Pain and Symptom Management and provides key highlights and suggestions on how to approach preparedness planning.
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2. Gafford EF, Luckhardt AJ, Swetz KM. Deactivation of a left ventricular assist device at the end of life #269. J Palliat Med 2013;16:980-2. This focused, concise information for palliative care providers in approaching end-of-life care with CF-LVAD.
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3. Schaefer KG, Griffin L, Smith C, May CW, Stevenson LW. An interdisciplinary checklist for left ventricular assist device deactivation. J Palliat Med 2014;17:4-5. High-yield, practical checklist that highlights key aspects of the device deactivation and surrounding care considerations.
4. Mcilvennan CK, Wordingham SE, Allen LA, Matlock DD, Jones J, Dunlay SM, Swetz KM. Deactivation of Left Ventricular Assist Devices: Differing Perspectives of Cardiology and Hospice/Palliative Medicine Clinicians. J Card Fail. 2016 Dec 5.. It is important to note that, in general, cardiology and MCS teams may have a different approach to EOL and device deactivation than PC providers. Recognizing these differences may help to improve collaboration between MCS and palliative care teams.
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5. Dunlay SM, Strand JJ, Wordingham SE, et al. Dying With a Left Ventricular Assist Device as Destination Therapy. Circ Heart Fail. 2016;9: e003096.
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This new single-center review looks extensively at the end-of-life experience amongst 89 patients with DT-LVAD teams.
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Figure 1: Pictogram showing most common occurring complications and rates for counselling patient with LVAD (4)
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Figure 2: LVAD Deactivation Checklist (19)
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Figure 3: Proposed roles for palliative care providers in caring for patients with DT-LVAD
S0885-3924(17)30270-1
DOI:
10.1016/j.jpainsymman.2017.07.007
Reference:
JPS 9432
To appear in:
Journal of Pain and Symptom Management
Received Date: 26 September 2016 Revised Date:
17 April 2017
Accepted Date: 6 July 2017
Please cite this article as: Wordingham SE, McIlvennan CK, Fendler TJ, Behnken AL, Dunlay SM, Kirkpatrick JN, Swetz KM, Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device, Journal of Pain and Symptom Management (2017), doi: 10.1016/ j.jpainsymman.2017.07.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Wordingham et. al 0 [Category. Curbside Rounds: State-of-the-Art in Palliative Care] Palliative Care Clinicians Caring for Patients Before and After Continuous Flow-Left Ventricular Assist Device Sara E. Wordingham, MD1
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Colleen K. McIlvennan, DNP, ANP2 Timothy J. Fendler, MD3 Amy L. Behnken, APRN, CNP4
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Shannon M. Dunlay, MD, MS4 James N. Kirkpatrick, MD5
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Keith M. Swetz, MD, MA6,7
Author affiliations: 1Mayo Clinic, Phoenix, AZ, 2University of Colorado, Aurora, Colorado, 3
Midamerica Heart Institute, Kansas City, MO, 4Mayo Clinic, Rochester, MN, 5University of
Center, Birmingham, AL
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Washington, Seattle, WA, 6University of Alabama-Birmingham and 7Birmingham VA Medical
Corresponding author: Keith M. Swetz MD, MA, UAB Center for Palliative & Supportive Care,
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1720 2nd Avenue South, BDB 650, Birmingham, AL 35294-0012. Email: [email protected],
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Phone: 205-975-8197, Fax 205-975-8173
Text word count: 3952
Abstract: pending review regarding format Running title: Curbside Consult for Palliative Care and CF-LVADs Keywords: mechanical circulatory support; ventricular assist device; end-of-life; palliative care; medical ethics, advance care planning
ACCEPTED MANUSCRIPT Wordingham et. al 1 Abstract Left ventricular assist devices (LVADs) are an available treatment option for carefullyselected patients with advanced heart failure. Initially developed as a bridge to transplantation,
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LVADs are now also offered to patients ineligible for transplantation as destination therapy (DT). Individuals with a DT-LVAD will live the remainder of their lives with the device in place. While survival and quality of life improve with LVADs compared to medical therapy, complications
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persist including bleeding, infection, and stroke. There has been increased emphasis on
involving palliative care specialists in LVAD programs, specifically the DT-LVAD population,
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from the pre-implantation process through the end of life. Palliative care specialists are wellpoised to provide education, guidance and support to patients, families, and clinicians throughout the LVAD journey. This manuscript addresses the complexities of the LVAD population, describes key challenges faced by palliative care specialists, and discusses
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opportunities for building collaboration between palliative care specialists and LVAD teams.
ACCEPTED MANUSCRIPT Wordingham et. al 2 I. Introduction The use of mechanical circulatory support (MCS)—specifically durable continuous-flow left ventricular assist devices (CF-LVADs)—has become a mainstream treatment option for
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patients with end-stage heart failure. (1) While CF-LVAD is the major mechanism how the device delivers cardiac output, the rationale for placing the device or the implantation strategy focuses on whether or not heart transplant is anticipated for the patient. Initially, LVADs were
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developed as a “bridge” treatment to stabilize patients awaiting heart transplant. In this situation, patients receive their LVAD as a “bridge-to-transplant”, where supporting patients to allow future
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cardiac transplantation is the main goal of the therapy. However many patients with advanced heart disease may not be eligible for transplantation or do not wish to receive this treatment, and quality of life and mortality remain major issues in this group. In 2003, the Food and Drug Administration (FDA) approved LVADs as “destination therapy” (DT-LVAD) for patients with end-stage heart failure who are either too old or too sick from other medical problems to be
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considered for heart transplantation. By virtue of this, patients with DT-LVAD will live the rest of their lives with an LVAD, and die with the device in place, inexorably altering the end-of-life (EOL) experience. The consideration and use of DT-LVAD continues to grow, with estimates of
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150,000-250,000 patients annually who could be eligible for DT-LVAD (2) among the greater than six million patients in the U.S. with chronic heart failure. (3) While patients often experience
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improved survival and quality of life (QOL) with DT-LVAD compared to optimal medical management of heart failure, LVADs come with considerable risks and burdens that cannot be underestimated. (4) Most importantly, death remains inevitable despite DT-LVAD, with a current 1-year mortality of approximately 20% and average survival exceeding two years after implantation. (1) Over the past several years, there has been an increased emphasis on involving palliative care (PC) specialists in the care of patients with DT-LVAD, from the pre-implantation process through the EOL. Currently, the International Society of Heart and Lung Transplantation
ACCEPTED MANUSCRIPT Wordingham et. al 3 Guidelines for MCS include a Class IIa recommendation to consult PC specialists during the CF-LVAD pre-implantation evaluation period, noting that this consultation should explore goals and preferences for EOL care. (5) In 2013, The Joint Commission mandated that all accredited
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DT-LVAD programs must have a PC specialist as part of the team, in concert with the Centers for Medicare and Medicaid Services finalizing an update to the national coverage determination for bridge-to-transplant and DT-LVAD in 2014 that requires the MCS multidisciplinary team to
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include a PC expert. (6) While these actions have been fairly well-received by both cardiology and PC, there remains a lack of consensus on how and when to incorporate PC and the care
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process remains imprecise and limited by workforce challenges and PC clinician comfort and familiarity with CF-LVADs. Furthermore, there are unique aspects of PC for children and adolescents pursuing LVAD implantation, however, these are beyond the scope of this paper. There is substantial variability across institutions as to how PC specialists are included as part of MCS programs. (7) In some programs, PC specialists attend patient selection
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conferences and meet all patients and caregivers prior to CF-LVAD implant. Elsewhere PC clinicians are consulted only when a patient is nearing EOL. (8,9) At many institutions, PC providers not only address EOL care decisions and transitions to hospice, but forge active
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collaboration with patients, families, and clinicians in the implantation decision-making process, which we recommend. Depending on the relationship between PC and MCS programs, some
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PC providers may make recommendations about whether or not a patient seems to be a suitable candidate for CF-LVAD. PC teams often facilitate advance care planning (preparedness planning) (10) prior to CF-LVAD implantation, manage longitudinal QOL issues and assist with symptom management, especially the increasing burden of symptoms in an older patient population with multimorbidity. As the PC and heart failure communities continue to learn through experience, it is anticipated that the role for PC in this complex patient population will expand.
ACCEPTED MANUSCRIPT Wordingham et. al 4 Understanding the complexities and nuances of the CF-LVAD population is a crucial first step for PC specialists. Herein, we describe key challenges faced by patients with CF-LVAD and clinicians who care for them, and discuss opportunities for building collaboration between
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PC clinicians and MCS teams.
II. Key Challenges to Palliative Care Providers
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While MCS can improve functional capacity, QOL, and survival in selected patients, challenges exist in providing high quality care to this population. The unpredictable trajectory of
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advanced heart failure combined with distinct idiosyncrasies of MCS can complicate shareddecision making, advance care planning (ACP), and EOL care.
Preparedness Planning
Preparedness planning was initially developed in response to ethical dilemmas
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encountered in patients with DT-LVAD for whom ACP was incomplete or lacking altogether. (10) Many patients with CF-LVADs require rehospitalization and encounter a range of disease and device-specific complications portending morbidity and mortality. Aimed at eliciting patients’
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goals, preferences, and values in the setting of evidence-based medicine, preparedness planning has been developed as a technique to facilitate ACP specific to patients with CF-
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LVADs. Standard advance directives pose generic questions about EOL preferences but seldom mention LVADs while preparedness planning seeks to translate and document iterative, disease-specific patient preferences (11). With skills in communication, ACP and EOL care, PC clinicians are well poised to lead preparedness planning efforts, allowing for treatment goals to best align with patient preferences and values. While examples of preparedness planning discussions exist (12) the process should not be viewed as a checklist of points to be addressed, nor binary choices between aggressive interventions or death. The role of the PC clinician is to help transform a broad range of patient
ACCEPTED MANUSCRIPT Wordingham et. al 5 preferences into clinically relevant information in the event of catastrophic complications or progressive debility. The optimal timing of preparedness planning has not been established, nor has a standard format for documentation with the latter varying based on provider group,
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institution, and jurisdiction. It is recommended, however, that these discussions and any associated documents be completed prior to device implantation, after extensive counselling on risks, benefits and alternatives to CF-LVAD. Depending on the individual institution, the majority
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of the consent is usually obtained from the MCS team with information augmented and tailored by PC based on patient-specific factors. Concurrently, a medical power of attorney should be
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designated (who may or may not be the primary caregiver, or person who would assume the surrogate decision making role in that location), as it is anticipated that all patients undergoing device implantation will experience even a transient period of incapacity after the surgery. Importantly, preparedness plans, patients’ goals of care, and prognostication should be addressed iteratively throughout the CF-LVAD trajectory as patients’ preferences evolve over
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time. To be truly beneficial, preparedness plans must be readily accessible in the electronic health record since CF-LVAD complications often require swift decision making.
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Potential Complications
In order to engage effectively in preparedness planning, PC providers should be familiar
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with complication rates, implications, and interventions to best support decision making and foster patients’ trust in their expertise. Major CF-LVAD complications include bleeding and clotting, infections, end-organ failure, and cerebrovascular events. As a general rule, 1-year complication rates include serious device-related infection in 20%, stroke in 10%, and major bleeding (including gastrointestinal bleed) in about 30%. (4) Regardless of how well the left ventricle is being offloaded by the LVAD, there is still risk of progressive right heart failure, which is often a chronic complication that can contribute to morbidity and mortality for many patients with CF-LVAD. (4)
ACCEPTED MANUSCRIPT Wordingham et. al 6 Currently in the U.S. the only device approved by the FDA for DT-LVAD is the HeartMate II LVAD (Thoratec, Pleasanton, CA). Another commonly encountered device (although not yet FDA approved in the U.S. as DT-LVAD), the HVAD (HeartWare, Miami Lakes,
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FL) is smaller, allowing it to be used on a greater range of body habitus and has fewer parts to wear out, but reports have shown a higher stroke rate. (13) Rates of other complications are similar with use of the two devices. As the risk of complications may vary from patient to
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patient, PC clinicians are encouraged to collaborate with MCS teams to determine how best to counsel patients. PC teams may be called upon to refine goals of care in the face of repeated,
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debilitating, or prognostically significant events. In fact, patients may be concerned about disappointing the MCS team if opting to change the disease-directed plan of care and defer or discontinue CF-LVAD support. (14)
A decision aid is currently being tested as part of the DECIDE-LVAD trial (PCORI-131006998), and Figure 1 from a previously published systematic review is helpful in
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conceptualizing the commonly encountered complications. Impact of these complications is discussed in the next section. (4)
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Collaboration with MCS teams
In new or developing partnerships, PC providers should seek to explore and meet the
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needs of patients and MCS teams. Consultations without skilled communication and collaboration between teams may be ill-perceived; however, the unique skill set of PC teams can foster best supportive care practices across the continuum of care with CF-LVAD. PC clinicians are often engaged late in the care of patients with advanced illness, including CFLVAD, and despite this, hospice is often underutilized at the EOL for patients with CF-LVAD. (15) Therefore, PC teams consulted infrequently and only in EOL situations for patients with CF-LVAD may see only those who have protracted critical illness, poor QOL and/or unfortunate outcomes. However, it is critical for PC teams to understand and educate patients that most
ACCEPTED MANUSCRIPT Wordingham et. al 7 patients experience improvements in QOL and physical functioning by three months after implantation that persist unless limited by complications. (16) Critical to maximal supportive care of patients with CF-LVAD is close, ongoing collaboration with MCS teams—mutual respect,
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bidirectional education, and consistent engagement are essential. Both PC and MCS teams
successful partnership and foster patients’ trust.
III. Longitudinal Care Issues with CF-LVAD
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need a strong working knowledge of the fundamentals of the others’ practice to ensure
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While MCS technology may increase longevity and improve QOL, the device itself is not curative and is best considered aggressive palliation. Care must be taken to ensure that patients receive optimal supportive care throughout their advanced illness trajectory, which includes aligning treatment goals with patient preferences (as discussed in the preceding section), expert symptom control, psychosocial support, and anticipatory guidance nearing EOL.
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PC teams are distinctively equipped to collaborate with MCS teams to achieve optimal care for patients with this advanced technology, who remain at risk of life-limiting complications.
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CF-LVAD Outcomes as Destination Therapy
Essential to optimal care for patients with DT-LVAD is a detailed understanding of the
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prognostic implications, symptom burden, potential complications and caregiving needs associated with MCS. Prognostication can be exceptionally challenging in advanced heart failure, a trend which persists in DT-LVAD. The majority of patients will live for months to years with MCS. Nevertheless, the advanced illness trajectory for this population is punctuated with repeated hospitalizations, problems associated with aging-related comorbidities, increasing symptom burden, caregiver burnout and other challenges, which require longitudinal PC. As noted earlier, about 80% of patients receiving the HeartMate II will survive 1 year or more post-implantation; and approximately 10% die during the implantation hospitalization. (1,4)
ACCEPTED MANUSCRIPT Wordingham et. al 8 Patients may encounter extended stays in the intensive care unit, returns to the operating room, and the ongoing need for other life-sustaining therapies (i.e. hemodialysis)in the post-operative period and do not necessarily portend to an unacceptable or poor end outcome. PC teams may
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encounter challenges if called to see patients post-operatively and presume the intent of the consult is to assist with the decision about the ongoing role of DT-LVAD or other aggressive support. PC clinicians should view patients with DT-LVAD as having an advanced chronic
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illness with unique challenges and needs, and assumptions should not be made that the reason
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for consultation is EOL care.
Symptom Management
Longitudinal PC for patients with CF-LVAD requires honing of symptom management expertise with this population. Patients often experience pain, mood disorders and fatigue similar to other advanced illnesses. Careful attention to symptom burden and QOL issues can
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be the primary role of PC teams to augment the care provided by MCS teams. Notably, patients’ level of underlying debility or specific burdensome symptoms may have been masked or overlooked by pre-implantation critical illness, necessitating early PC involvement post-
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implantation. Symptom burden may escalate over time with aging, debility and complications underscoring the importance of ongoing, long-term PC involvement.
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Chronic pain encountered in this population is often multifactorial and associated with musculoskeletal sources. For example, pain may emanate from underlying degenerative joint disease and arthritis or preexisting neuropathy and is potentially exacerbated by carrying the CF-LVAD equipment. Similar to pain management in advanced heart failure, opioids have been proposed as perhaps the safest analgesic, as nonsteroidal anti-inflammatory drugs affect renal function and volume status and increase the risk of gastrointestinal bleeding. Gabapentin can be associated with edema and dosing also limited by edema and/or renal dysfunction. Analgesic management including opioids requires knowledge and skill that may be outside the
ACCEPTED MANUSCRIPT Wordingham et. al 9 scope or comfort level of some MCS providers, and PC clinicians can assist in the management to maximize QOL. Mood symptoms and depression are common in advanced heart failure and require
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close monitoring in DT-LVAD patients. PC clinicians can monitor for symptoms of anxiety and depression and assist in management with pharmacologic and non-pharmacologic
interventions, as well as referrals to mental health providers. Minimizing the risk of QT interval
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prolongation is often a concern of cardiologists, but may be less of an issue with DT-LVAD depending on the goals of care. Patients with potentially fatal cardiac rhythms, including
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ventricular tachycardia/fibrillation, may remain awake and alert as they maintain steady cardiac output with the LVAD operating independent of rhythm, while others may be more symptomatic although hemodynamically stable. Antidepressants can be chosen to optimize the anticipated treatment effect and side-effect profile with the target symptoms. Suicidality can be particularly concerning as patients have direct access to their own life-sustaining power supply.
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Furthermore, inpatient psychiatric facilities may be reluctant to care for patients with MCS due to lack of appropriate staffing or accreditation of care for such patients. Often, PC teams are asked to support patients, caregivers, and MCS teams in times of patient crisis which can be
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distressing to all.
Following LVAD implantation, patients and caregivers must adjust to a new lifestyle
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related to the device and associated equipment. Ordinary routines, such as sleeping and personal care must change, and changes in positioning and needing to be connected to a power supply at all times requires adaptation. Additionally, patients face changes in bathing and water-associated hobbies and issues of body image, sexuality, and intimacy may also arise. Longitudinal whole person care provided by PC teams may assist in the identification and management of issues stemming from these requisite adaptations and restrictions.
ACCEPTED MANUSCRIPT Wordingham et. al 10 Summary Regarding Longitudinal Care PC teams can support patients with MCS with longitudinal care beginning before device implantation by establishing rapport, preparedness planning, assisting with symptom
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management, and facilitating transitions in goals of care. Assistance with discussions regarding changes in clinical status and next steps tends to be more straightforward when patients and their loved ones are familiar with PC teams and concepts. Involvement of PC teams can be
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exceptionally valuable when MCS complications arise. The aim at times of complications or transition is to refer back to, and build upon, previous discussions and preparedness planning.
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Discussions regarding the care plan or anticipated outcomes should not be undertaken without collaboration with the MCS team. Strategies for management of various MCS-associated complications continue to evolve rapidly and novel approaches may be considered.
IV. End-of-Life Issues with CF-LVAD
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EOL care with CF-LVAD requires device-specific, physiologic, and symptom management considerations. A lack of protocols and evidence-based approaches to discontinuation of MCS therapy may complicate care. Furthermore, PC specialists may be
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engaged late or may be unfamiliar with CF-LVAD specifics. We propose that PC providers should be familiar with issues related to concurrent defibrillator management, the dynamics
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between their institution’s PC and MCS teams, and physiologic considerations including right and left heart function and aortic valve status.
General Considerations
As with any patient, location of anticipated death requires special consideration—as patients may wish to die at home. For hospitalized LVAD patients, transitioning to non-hospital based settings at EOL can be challenging as many hospices and skilled nursing facilities lack experience and training with MCS and may not feel comfortable caring for patients with LVADs.
ACCEPTED MANUSCRIPT Wordingham et. al 11 (17) The same holds true for many community care providers, such as home health nurses and home hospice providers. Even if family caregivers are available around the clock to assist with device-specific cares and tasks, agencies lacking experience may still decline to accept patients
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with MCS. Furthermore, caregivers may be anxious and overwhelmed with continuing to provide care to their loved one approaching EOL, and may be unable to assume these
responsibilities without additional support. Often, this additional support is provided by hospital-
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based MCS teams collaborating with local hospice agencies, which, when collaborating
effectively bring to bear knowledge, confidence, and experience to manage both the device and
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the EOL care of the patient. Further work is needed to develop systems of care to more optimally support the outpatient management of patients with MCS at EOL. Providing goal-aligned care is critically important. Goals, values, and preferences may vary among patients and may change over time—underscoring the important of iterative discussions. Importantly, the patient and MCS team’s approach to EOL care may differ by LVAD
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indication (i.e. bridge to transplantation or destination therapy) and the plan of care should be considered in the context of the patient’s individual goals and illness trajectory. Regardless of device indication, patients with LVAD may consider device deactivation
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when the LVAD is no longer consistent with their goals. (18) When considering device deactivation, collaboration between MCS and PC teams is critical. Although patients or their
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surrogate ultimately delineate what QOL is acceptable, multidisciplinary discussions should be ongoing to consider all potential opportunities to maximize QOL. Previously completed preparedness planning can help guide decision making approaching EOL. (11) If device deactivation is planned, a checklist (see Figure 2) can be utilized to ensure detailed plans are made for device and symptom management and maximal EOL and bereavement support. (19)
ACCEPTED MANUSCRIPT Wordingham et. al 12 Device-Specific and Physiologic Considerations PC teams should collaborate with MCS teams to develop a strong working knowledge of device management, physiologic changes, anticipated symptoms, and prognosis in the setting
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of device deactivation. When patients with MCS reach EOL, PC specialists and LVAD healthcare centers should have a protocol in place for addressing LVAD deactivation and providing comfort care that addresses ethical concerns regarding discontinuation of life-
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prolonging device therapy (20), minimizes fear and suffering for the patient and assuages anxiety and grief for loved ones. (17, 21)
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Discussions regarding defibrillator deactivation, as well as minimizing LVAD alarms, should occur in an anticipatory manner among the multidisciplinary teams. (20) When possible, a member of the MCS team should be present for device deactivation for expert device management, and in light of the extended relationship they have with CF-LVAD patients and families. If MCS team member are unavailable, such as in a planned deactivation at home or in
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a rural location, hospice and PC teams should be in direct contact with MCS teams to optimize device management at EOL. (17, 20)
The importance of device and physiologic considerations approaching EOL is
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paramount. Providers engaged in imminent EOL care for patients with CF-LVAD require working knowledge of the device itself including its functionality, anatomic positioning, alarms,
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power source, as well an understanding of the patient’s aortic valve status and native heart function. For example, knowledge of whether a patient has total artificial heart or an CF-LVAD is key to expert management of the device at the time of deactivation to best appreciate and anticipate how discontinuing the device will affect cardiac output and organ perfusion which affects prognosis. Knowledge of intrinsic left ventricular function can be beneficial to help gauge how long the patient may survive once the device is deactivated. If a patient has an aortic valve that was oversewn at the time of implantation due to aortic insufficiency, then the left ventricle is only able to eject blood through the CF-LVAD itself and death will be almost immediate after
ACCEPTED MANUSCRIPT Wordingham et. al 13 device deactivation. Lastly, changes in circulation are immediate when the device is deactivated, which can lead to challenges circulating parenterally administered medications needed for symptom management. (20) These device and physiologic considerations must be
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addressed prior to a planned deactivation so that patients, their loved ones, and bedside providers can be appropriately counseled and prepared for the patient’s EOL.
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V. Opportunities and Future Directions
Comprehensive care of patients with CF-LVAD, beginning at the pre-implant stage and
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extending through transplant or EOL, necessitates collaboration and coordination of care between many specialties, of which PC represents only one. There are currently a number of initiatives underway, which are vital to improving the processes of interdisciplinary care for patients with CF-LVAD and are, in fact, increasingly mandated. In addition to discussing ACP, PC specialists can play a role in meeting the psychosocial needs of patients before CF-LVAD
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implantation, (22) in conjunction with allied health specialists in psychology, nutrition and dietetics, physical and occupational therapy. (23) In the post-implantation setting, continuing psychosocial and adjustment needs exist, as
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do the risks of common adverse clinical events associated with CF-LVAD implantation, such as stroke, gastrointestinal bleeding and chronic driveline infection. (4) In caring for these needs, the
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PC clinician collaborates with a multitude of available specialty clinician services such as psychiatry, neurology, gastroenterology, infectious disease, primary care and internal medicine. Accordingly, an interdisciplinary, team-based approach to the care of patients with CF-LVAD underscores the importance of patient proximity to a comprehensive, tertiary or quaternary healthcare center. Furthermore, as an increasing number of local hospitals establish DT-LVAD programs, it is unclear what degree of subspecialist PC is available. Opportunities to collaborate and even provide tele-health consultation may be necessary to ensures that optimal patientcentered care is delivered in each unique situation.
ACCEPTED MANUSCRIPT Wordingham et. al 14 Lastly, caregivers necessitate special consideration in DT-LVAD and PC focuses to enhance the life of the patient as well as the family unit. Implanting centers may vary in their caregiving requirements; however, most patients are supported by unpaid family members or
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friends to assist with care. Caregivers perform a multitude of tasks—a role which often peaks in the post-implantation phase and when disease burdens escalate approaching EOL. (24)
Caregivers are often available 24 hours/day and are at risk for caregiver fatigue and burnout.
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Interdisciplinary PC teams can help normalize caregiver distress and assist in finding means to minimize the psychological and physical burden of caregiving.
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Within such a wide-ranging interdisciplinary care team for patients with CF-LVADs, involved specialists are bound to have differing views and approaches to the many ethical considerations surrounding LVAD therapy, especially among patients with CF-LVADs approaching EOL. (25) Even in the pre-implant, CF-LVAD candidacy stage, patients may express beliefs and decisions about pursuing CF-LVAD therapy that differ starkly from other
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patients and involved providers. After CF-LVAD implantation, individual patient trajectories and experiences will continue to vary greatly, and patients should be encouraged to continually explore their thoughts and desires regarding goals of care and aggressiveness of treatment,
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VI. Summary
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especially among patients receiving DT-LVAD.
In such a dynamically changing clinical setting, PC specialists, in particular, are well-
poised to provide education, guidance and support to patients, families, and clinicians. Furthermore, in addition to ensuring effective and meaningful communication with patients and their loved ones, PC specialists are uniquely positioned to engage other providers involved in the care of the patient in shared decision-making, who may have different levels of comfort with discussing EOL care and decisions with patients or each other.
ACCEPTED MANUSCRIPT Wordingham et. al 15 VII. Pearls •
Despite increasing regulatory requirements of palliative care specialists’ involvement in DTLVAD programs, there remains wide variability in integration among the LVAD team. Longitudinal involvement of palliative care specialists in patients with DT-LVADs is optimal, from
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pre-implantation through the end of life. •
LVADs prolong survival and improve quality of life; however, they are associated with significant
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risks including stroke, bleeding, infection and burdens such as driveline care and caregiver requirements.
Preparedness planning has been developed as a technique to facilitate advanced care planning
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for patients with LVADs in order to document iterative, disease and device-specific patient preferences.
End of life with an LVAD is a complicated process and requires collaboration with multiple disciplines; palliative care specialists are in an optimal position to provide coordination of goal-
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ACCEPTED MANUSCRIPT Wordingham et. al 16 VIII. References 1. Kirklin JK, Naftel DC, Pagani FD, et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant 2015;34:1495-504.
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2. Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol 2013;61:1209-21. 3. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016;133:e38-e360 4. McIlvennan CK, Magid KH, Ambardekar AV, et al. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail 2014;7:1003-13
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5. Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 2013;32:157-87
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6. Centers for Medicare & Medicaid Services. Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R) 2013. Available from: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo.aspx?NCAId=268 7. Sagin A, Kirkpatrick JN, Pisani BA, et al. Emerging Collaboration Between Palliative Care Specialists and Mechanical Circulatory Support Teams: A Qualatative Study. J Pain Symptom Manage 2016;52(4): 491-7.
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8. Kirkpatrick JN, Hauptman PJ, Swetz KM, et al. Palliative Care for Patients With End-Stage Cardiovascular Disease and Devices: A Report From the Palliative Care Working Group of the Geriatrics Section of the American College of Cardiology. JAMA Intern Med 2016;176(7):1017-9. 9. Swetz KM, Bakitas MA, Tucker RO, et al. Abstract 123: Attitudes and Availability of Palliative Care Within Institutions Providing Mechanical Circulatory Support Device Implantation: A National Survey. Circ Cardiovasc Qual Outcomes 2016;9:A123.
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10. Swetz KM, Freeman MR, Abouezzeddine OF, et al. Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy. Mayo Clin Proc 2011;86:493-500.
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11. Verdoorn BP, Luckhardt AJ, Wordingham SE, Dunlay SM, Swetz KM. Palliative Medicine and Preparedness Planning for Patients Receiving Left Ventricular Assist Device as Destination Therapy: Challenges to Measuring Impact and Change in Insitutiional Culture. J Pain Symptom Manage 2017 Jan 16. [Epub ahead of print]. doi: 10/1016/j.jpainsymman.2016.10.372. 12. Swetz KM, Kamal AH, Matlock DD, et al. Preparedness planning before mechanical circulatory support: a "how-to" guide for palliative medicine clinicians. J Pain Symptom Manage 2014;47:926-935,e6. 13. Pagani FD, Milano CA, Tatooles AJ, et al. HeartWare HVAD for the Treatment of Patients With Advanced Heart Failure Ineligible for Cardiac Transplantation: Results of the ENDURANCE Destination Therapy Trial. J Heart Lung Transplant 2015;34:S9.
ACCEPTED MANUSCRIPT Wordingham et. al 17 14. Brush S, Budge D, Alharethi R, et al. End-of-life decision making and implementation in recipients of a destination left ventricular assist device. J Heart Lung Transplant 2010;29:1337-1341. 15. Dunlay SM, Strand JJ, Wordingham SE, et al. Dying With a Left Ventricular Assist Device as Destination Therapy. Circ Heart Fail. 2016;9:e003096.
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16. Maciver J, Ross HJ. Quality of life and left ventricular assist device support. Circulation 2012;126:866-74. 17. Panke JT, Ruiz G, Elliott T, et al. Discontinuation of a Left Ventricular Assist Device in the Home Hospice Setting. J Pain Symptom Manage 2016. 52(2):313-7.
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18. Mueller PS, Swetz KM, Freeman MR, Carter KA, Crowley ME, Severson CJ, Park SJ, Sulmasy DP. Ethical analysis of withdrawing ventricular assist device support. Mayo Clin Proc 2010 Sep;85(9):791-7. 19. Schaefer KG, Griffin L, Smith C, May CW, Stevenson LW. An interdisciplinary checklist for left ventricular assist device deactivation. J Palliat Med 2014;17:4-5.
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20. Gafford EF, Luckhardt AJ, Swetz KM. Deactivation of a left ventricular assist device at the end of life #269. J Palliat Med 2013;16:980-2. 21. Rossi Ferrario S, Omarini P, Cerutti P, Balestroni G, Omarini G, Pistono M. When LVAD Patients Die: The Caregiver’s Mourning. Artif Organs 2016;40(5):454-458. 22. Petty M, Bauman L. Psychosocial issues in ventricular assist device implantation and management. J Thorac Dis 2015;7:2181-7.
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23. Kugler C, Malehsa D, Schrader E, et al. A multi-modal intervention in management of left ventricular assist device outpatients: dietary counselling, controlled exercise and psychosocial support. Eur J Cardiothorac Surg 2012;42:1026-32. 24. McIlvennan CK, Jones J, Allen LA, Swetz KM, Nowels C, Matlock DD. Bereaved Caregiver Perspectives on the End-of-Life Experience of Patients With a Left Ventricular Assist Device. JAMA Intern Med 2016;176(4):534-9.
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25. Petrucci RJ, Benish LA, Carrow BL, et al. Ethical considerations for ventricular assist device support: a 10-point model. ASAIO J 2011;57:268-73.
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26. McIlvennan CK, Wordingham SE, Allen LA, Matlock DD, Jones J, Dunlay SM, Swetz KM. Deactivation of Left Ventricular Assist Devices: Differing Perspectives of Cardiology and Hospice/Palliative Medicine Clinicians. J Card Fail. 2016 Dec 5. [Epub ahead of print]. doi: 10/1016/j.cardfail.2016.12.001.
ACCEPTED MANUSCRIPT Wordingham et. al 18 Selected Annotated References 1. Swetz KM, Kamal AH, Matlock DD, et al. Preparedness planning before mechanical circulatory support: a "how-to" guide for palliative medicine clinicians. J Pain Symptom Manage 2014;47:926-935, e6. This “How To” guide was published in 2014 the Journal of Pain and Symptom Management and provides key highlights and suggestions on how to approach preparedness planning.
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2. Gafford EF, Luckhardt AJ, Swetz KM. Deactivation of a left ventricular assist device at the end of life #269. J Palliat Med 2013;16:980-2. This focused, concise information for palliative care providers in approaching end-of-life care with CF-LVAD.
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3. Schaefer KG, Griffin L, Smith C, May CW, Stevenson LW. An interdisciplinary checklist for left ventricular assist device deactivation. J Palliat Med 2014;17:4-5. High-yield, practical checklist that highlights key aspects of the device deactivation and surrounding care considerations.
4. Mcilvennan CK, Wordingham SE, Allen LA, Matlock DD, Jones J, Dunlay SM, Swetz KM. Deactivation of Left Ventricular Assist Devices: Differing Perspectives of Cardiology and Hospice/Palliative Medicine Clinicians. J Card Fail. 2016 Dec 5.. It is important to note that, in general, cardiology and MCS teams may have a different approach to EOL and device deactivation than PC providers. Recognizing these differences may help to improve collaboration between MCS and palliative care teams.
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5. Dunlay SM, Strand JJ, Wordingham SE, et al. Dying With a Left Ventricular Assist Device as Destination Therapy. Circ Heart Fail. 2016;9: e003096.
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This new single-center review looks extensively at the end-of-life experience amongst 89 patients with DT-LVAD teams.
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Figure 1: Pictogram showing most common occurring complications and rates for counselling patient with LVAD (4)
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Figure 2: LVAD Deactivation Checklist (19)
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Figure 3: Proposed roles for palliative care providers in caring for patients with DT-LVAD