Clinical Protocol for Left Ventricular Assist Device Deactivation at End of Life

Abstract

As patients live longer with left ventricular assist device (LVAD) support, many will either suffer an acute event or develop a gradual, progressive disease that results in a terminal prognosis. At the end-of-life, patients, and more often, their families, will be faced with the decision to deactivate the LVAD to allow natural death. The process of LVAD deactivation carries some distinct features that distinguish it from withdrawal of other forms of life-sustaining medical technology: multidisciplinary collaboration is paramount; prognosis after deactivation is short, typically minutes-hours; and premedication doses of symptom-focused medications are typically higher than other situations involving withdrawal of life-sustaining medical technologies given the precipitous decline in cardiac output following LVAD deactivation. In this Case Discussion, we introduce the complexity of planned in-hospital LVAD deactivation through a clinical case, share our detailed institutional checklist and order set for LVAD deactivation, and broach multidisciplinary clinical protocol development processes.

Introduction

The advent of the left ventricular assist device (LVAD) has transformed the care of patients with end-stage heart failure (HF). Over 27,000 patients received LVADs in the decade from 2012 to 2021, with the annual volume of LVAD implantation peaking in 2019 at 3198.¹ LVAD technology can be used as short-term (formerly bridge-to-transplantation) or as long-term (formerly destination) therapy and has been shown to improve both quality of life and survival.^2,3 Reflecting evolving patient and clinician preferences, a majority of LVADs, nearly 80%, are now being implanted with the intention to provide long-term support.¹ Moreover, compared to previous generations of LVAD technology, survival is improving with the newest generation of LVAD (five-year survival of 58.4%).⁴ These trends have resulted in a growing number of patients who are aging with their LVADs and are experiencing age-related illnesses such as malignancy and dementia.

LVAD deactivation is the process of disconnecting the driveline of the LVAD from the external controller and power source, thereby causing the LVAD to stop functioning. For some patients, LVAD explant occurs with successful orthotopic heart transplantation; for others, LVAD “decommissioning” heralds the improvement in cardiac function so significant that the device is no longer needed to support cardiac output. But for most patients living with long-term LVAD support, there comes a time when the LVAD carries greater burden than benefit, prompting consideration of withdrawal of this technology to allow natural death.

For patients living with LVADs, several pathways leading to end-of-life exist, including gradual decline (due to progression of HF, worsening frailty, and/or a parallel progressive illness such as cancer) or an acute illness (such as a debilitating stroke or sepsis).⁵ In addition, some patients experience unforeseen complications from LVAD implant surgery, leading to death during the index hospital admission.⁶ LVAD deactivation and death at home have been described and may be preferred by some patients and families.^7–9 However, at present, the complexity of end-of-life care while on device support generally encourages in-hospital deactivation.

Although much attention in the medical literature is understandably given to LVAD implantation and postoperative care, few specific protocols exist to guide clinicians on how to provide care at the end-of-life, particularly pertaining to the preparation for and the specific clinical processes of planned LVAD deactivation.^10,11 Developing best practices for this increasingly common scenario will achieve several critical outcomes, including optimization of patient comfort, engagement of patient/family in shared decision-making, and support to patient/family and to multidisciplinary clinical team members involved in care.^6,12,13

In this Case Discussion, we introduce the complexity of planned in-hospital LVAD deactivation through a clinical case, share our detailed institutional protocol for LVAD deactivation, and broach multidisciplinary clinical protocol development processes.

Case Description

Mr. B.W. was a 63-year-old gentleman who first presented to our hospital in 2013 for work up of newly diagnosed nonischemic cardiomyopathy, with an ejection fraction of 25%. He was treated with guideline directed medical therapies, with stable functional status and end-organ function for the next two years. In 2015, he was admitted to the hospital in cardiogenic shock. His condition was stabilized with inotropic support. He was evaluated for LVAD implantation and agreed to undergo surgery. He had a HeartMate II™ LVAD (Abbott) placed in the summer of 2015. After an unremarkable postoperative course, the patient was discharged home.

The patient did well for two years after his LVAD surgery, and then developed an acute LVAD pump thrombosis. This required exchange of his HeartMate II LVAD in the fall of 2017. The following year, the patient suffered from an electrical malfunction of his LVAD, termed short-to-shield, which required yet another exchange of his LVAD, this time from a HeartMate II to a HeartMate 3™. Following this third open heart surgery, the patient required a prolonged admission to a rehabilitation facility before returning home.

Once at home, the patient described feeling weak, chronically fatigued, with occasional low-grade fevers. He reported poor appetite and had a steady decline in his weight. He was admitted to the hospital in 2019 for these symptoms. Blood cultures were collected on admission, which ultimately revealed a nontuberculous mycobacterial infection called Mycobacterium chimaera. In discussion with Infectious Diseases colleagues, the patient learned that his LVAD was likely infected and that his infection would be incurable. He was started on a three-drug antibiotic regimen with the intention of palliating symptoms related to chronic infection and extending life.

He was hospitalized several times over the next year, with worsening organ failure, functional status, debility, malnutrition, escalating side effects from chronic antibiotic exposure, and antibiotic resistance. He was readmitted in November, of 2020 due to ototoxicity and visual impairment, felt to be side effects of his antibiotics. This prompted the clinical team to organize a family meeting with the patient and his surrogates to review the burdens and benefits of continued antibiotic therapy. During this meeting, the patient elected to forego further antibiotic therapy given lack of efficacy and burdensome side effects. Antibiotics and anticoagulation were deprescribed, and the patient was closely followed by the Palliative Care team to assist with symptom management.

Soon thereafter, he began to have signs of worsening hypoactive delirium, and lost capacity to participate in medical decision making. His oral intake diminished to the point of taking in only sips and chips. He became oliguric and his LVAD began to have low-flow alarms, suggestive of dehydration. Before this terminal decline, the patient had not completed an Advance Directive, but had verbally communicated to several clinicians over the years that his preferred surrogate decision maker was his mother.

A multidisciplinary team meeting with clinical representatives from palliative care, infectious diseases, advanced heart failure (AHF) (including an LVAD nurse coordinator), and nursing leadership was held to discuss the pros and cons of LVAD deactivation. The infectious diseases team believed the patient's infection to be terminal, with an expected prognosis of days-weeks with current treatments. The clinicians in the multidisciplinary meeting decided that it was ethically appropriate to offer deactivation of the patient's LVAD to allow natural death (Table 1, Section A). A family meeting was organized to discuss this with the patient's mother (Section B). The family ultimately felt that the patient would not have wanted to have his life prolonged if he had no meaningful chance of improvement. They requested the opportunity for family visitation, spiritual care, and memory making and suggested deactivation of LVAD on a day when the close relatives could be at bedside.

Table 1.

Checklist for Steps Leading Up to Left Ventricular Assist Device Deactivation

Team Planning for Deactivation (Section A)
Clinician (with Palliative Care) conducts care plan huddle to discuss deactivation plan: 1. Anticipated arrival of family 2. Contacted spiritual care as per patient/family wishes 3. Time of anticipated deactivation of LVAD 4. If ICD present: initiate plan to reprogram or obtain magnet
Clinician/AHF attending to notify LVAD implanting cardiothoracic surgeon of end-of-life plan.
Clinician to initiate Withdrawal Order using LVAD order set and to discontinue orders inconsistent with LVAD deactivation. Ensure DNR/DNI code status order is in place.
Family Planning for Deactivation (Section B)
Clinician to notify/call family with plan.
Inquire if there are specific family requests for timing of removal of support (e.g., extubation first to allow family to potentially talk with patient and/or be close without the endotracheal tube). Allow for family requests for spiritual support/cultural practices.
Ensure team establishes shared expectation of timing of deactivation as it may take hours to gather identified persons and administer adequate premedication to ensure good symptom control at end of life.
Nurse to Prep Room/Patient for EOL Care (Section C)
Bedside nurse/patient care technician provides hygiene/oral care and clean linens/blanket.
Bedside nurse administers premedication with anxiolytics, opioids, and adjuvants to achieve RASS and respiratory rate goals. It is important to ensure patient is at goal PRIOR to deactivation of VAD. Deactivation results in limited circulation of medications.
1. RASS goal: −1 to −2 2. Respiratory rate goal: fewer than 18 breaths/min
Deactivation Plan (Section D)
Clinician huddle to include available team members, as appropriate: 1. LVAD Coordinator 2. Clinician: Critical Care/AHF clinician 3. Bedside nurse 4. Palliative care team member if available 5. Social Work 6. Clinical Bioethicist if circumstances merit 7. Charge Nurse
Clinician verifies documentation of end-of-life conversation with patient/caregivers in the electronic medical record. Ensure that expectations are discussed, and anticipated signs/symptoms are reviewed with family.
Nurse to notify spiritual care and other disciplines regarding timing of LVAD deactivation.
Procedure Pause: (Section E) Clinician and Nurse MUST Be at Bedside for Procedure Pause and Deactivation
Time out to assure goals are clear. Introductions of care team.
Clinician to place magnet on ICD (if necessary).
Deactivation of LVAD performed as per competency with clinician at bedside.
Time of deactivation of LVAD is documented by nurse
Clinician to document time of death.

AHF, advanced heart failure; DNR/DNI, do not resuscitate/do not intubate; EOL, end of life; ICD, implantable cardioverter defibrillator; LVAD, left ventricular assist device; RASS, Richmond Agitation Sedation Scale.

On the day of deactivation, palliative care team members joined with the AHF cardiologist and bedside nurse to review the process of LVAD deactivation with the patient's surrogates (Sections C and D). The patient had hypoactive delirium and was unable to participate in complex medical decision making or discussions regarding prognosis. Before deactivation, the patient appeared to be in no physical or emotional distress. A procedural pause was conducted by the LVAD coordinator (Section E). Following premedication per the protocol described herein, the patient's LVAD was deactivated by the LVAD coordinator.

The patient's respiratory pattern acutely changed following deactivation; his prior shallow, regular breathing pattern transitioned to a cyclical Cheyne-Stokes pattern, with accessory muscle use noted during periods of rapid, deep breathing. Parenteral fentanyl was administered resulting in diminished accessory muscle use and a decrease in the respiratory rate. The patient was pronounced dead 25 minutes after LVAD deactivation. Bereavement support was offered to the patient's wife and mother.

Discussion

In this article, we describe the creation and implementation of a rigorous protocol for safe and effective deactivation of LVAD. Although the protocol reflects the experience of a multidisciplinary team participating in in-hospital LVAD deactivation, elements of the checklist and order set can readily translate to home and inpatient hospice settings.

In patients whose goals are no longer served by LVAD therapy or are experiencing more burdens than benefits of LVAD therapy, LVAD deactivation is ethically and morally supportable, and is akin to withdrawal of life-sustaining medical therapy in other contexts.^14,15 A recent review of literature on end-of-life care for patients with LVADs emphasized the need for a robust multidiscipline-driven protocol for LVAD deactivation.¹⁶

Given the medical complexity inherent to LVAD technology, patients often experience a highly medicalized end-of-life experience. In a case series of patients who died following in-hospital deactivation, most patients died in the intensive care unit.⁶ Often, patients dying with an LVAD have concomitant multiorgan system failure, and the proximal events leading to death include the withdrawal of one or more life-sustaining measures aside from the LVAD itself (e.g., hemodialysis, vasoactive medications, mechanical ventilator, etc.). A minority of patients are actually able to participate in the decision to deactivate their LVAD.¹⁷

Dunlay and colleagues described four clinical trajectories of patients dying with LVADs: early postoperative death, persistent and progressive organ failure, improvement in condition followed by an acute event, or improvement in condition followed by a terminal decline.⁵ We expanded on these clinical trajectories in our article, which specifically described the circumstances around in-hospital LVAD deactivation.⁶ Our case patient presented here followed the “gradual decline” trajectory due to an incurable infection. Following several meetings between the family and the care team, the family assented to deactivation of the LVAD based on their knowledge of the patient's wishes in context of the prognosis.

At our institution, a high-volume LVAD implant center, clinical and administrative stakeholders representing AHF, critical care, palliative care, nursing, pharmacy, spiritual care, and clinical ethics met approximately once monthly over a period of one year to develop an institutional protocol for planned LVAD deactivation at end-of-life. Initial stakeholder meetings determined the importance of implementing two discrete steps to a planned LVAD deactivation. For Step 1, a multidisciplinary conference with patient and/or surrogate decision-maker to reassess care preferences and assure patient/surrogate have adequate disease state and prognostic awareness and an understanding of the processes and timing of LVAD deactivation; a member of the AHF team is responsible for documenting this conference before initiating Step 2 (Table 1). Subsequently, clinicians implement a detailed clinical order set that includes detailed symptom management strategies for the LVAD deactivation (Table 2).

Table 2.

Detailed Order Set for Left Ventricular Assist Device Deactivation

Patient Care
Parameters and goals before deactivation of durable LVAD RASS goal: −1 to −2 Respiratory rate goal: Fewer than 18 breaths/min After LVAD deactivation: check RASS, nonverbal pain score, and respiratory rate q10min × 3 and PRN.
Medications
If high symptom burden is present before LVAD deactivation and there is reasonable expectation that symptoms could be alleviated with additional medication doses, provider to collaborate with team to DELAY LVAD deactivation until adequate symptom relief is achieved.
Medications—NON-Opioid Medications
Premedication Anxiolytic Dose
Lorazepam 1 mg, Inj, IV Push, One Time, PRN For patients not at RASS −1 to −2, this premedication dose is to be administered when the opioid premedication LOADING dose is given (30–45 minutes before LVAD deactivation)
PRN Doses
Select PRN anxiolytic and PRN antisecretory agent for ALL patients. Anxiolytic Lorazepam 1 mg, Inj, IV Push, q30min PRN anxiety Antisecretory agent Glycopyrrolate: 0.4 mg, Inj. IV Push q4h PRN excessive orotracheal secretions Antipsychotic Haloperidol 1 mg, Inj, IV Push, q4h PRN agitation Antiemetic Ondansetron 4 mg, Inj, IV Push, q4h PRN nausea and/or vomiting
Opioid Medications—For Opioid NAÏVE Patients
IV route is preferred for ALL patients. Note that CONTINUOUS Infusion is NOT generally NEEDED or recommended for Opioid NAÏVE patients. Opioids constitute mainstay therapy for prevention and management of dyspnea. Co-administration of anticholinergic agents for secretions and anxiolytics/antipsychotics are recommended but should never be used in lieu of an opioid.
Use of PCA for LOADING Dose and PRN Doses
Fentanyl Loading Dose (mcg): 50, Patient Administered Bolus (mcg): 25, Lockout Interval (minutes): 10 RN to administer LOADING Dose as Premedication 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3). Hydromorphone Loading Dose (mg): 1, Patient Administered Bolus (mg): 0.5, Lockout Interval (minutes): 10 RN to administer LOADING Dose 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate greater than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3).

Use of IV PUSH Route for LOADING Dose and PRN Doses
LOADING dose (IV Push) Fentanyl 50 mcg, Inj, IV Push, One Time, Indication: Other pain/dyspnea RN to administer LOADING Dose: give 30–45 minutes before LVAD Deactivation. Hydromorphone 1 mg, Inj, IV Push, One Time, Indication: Other pain/dyspnea RN to administer LOADING Dose: give 30–45 minutes before LVAD Deactivation. PRN Doses (IV Push) Fentanyl 25 mcg, Inj, IV Push, q10min PRN Give for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3). Hydromorphone 0.5 mg, Inj, IV Push, q10min PRN Give for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3).
Opioid Medications—For Opioid TOLERANT Patients
IV route is preferred for ALL patients. Opioids constitute mainstay therapy for prevention and management of dyspnea. Co-administration of anticholinergic agents for secretions and anxiolytics/antipsychotics are recommended but should never be used in lieu of an opioid. If EXISTING Opioid Doses EXCEED the doses included in orders below, CONSULT Palliative Care service for assistance with opioid regimen. Consider increasing previously tolerated bolus dose by 50–100%. Consider the addition of continuous infusion initiated at least eight hours before LVAD Deactivation. Hourly rate should approximate at least 50% of average daily opioid requirements/24.
Use of PCA for CONTINUOUS Infusion, LOADING Dose, and PRN Doses
Fentanyl Continuous Dose (mcg/h): 50, Loading Dose (mcg): 100, Patient Administered Bolus (mcg): 100; Lockout Interval (minutes): 10 RN to administer LOADING Dose 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3). Hydromorphone Continuous Dose (mg/h): 1, Loading Dose (mg): 2, Patient Administered Bolus (mg): 2, Lockout Interval (minutes): 10 RN to administer LOADING Dose 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3).
Use of PCA for LOADING Dose and PRN Doses ONLY (WITHOUT Continuous Infusion)
Fentanyl Loading Dose (mcg): 100, Patient Administered Bolus (mcg): 100, Lockout Interval (minutes): 10 RN to administer LOADING Dose 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3). Hydromorphone Loading Dose (mg): 2, Patient Administered Bolus (mg): 2, Lockout Interval (minutes): 10 RN to administer LOADING Dose 30–45 minutes before LVAD Deactivation. RN to administer “Patient Administered Bolus” for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3).
Use of IV PUSH Route for LOADING Dose and PRN Doses
LOADING Dose (IV Push) Fentanyl 100 mcg, Inj, IV Push LOADING Dose: give 30–45 minutes before LVAD Deactivation. Hydromorphone 2 mg, Inj, IV Push LOADING Dose: give 30–45 minutes before LVAD Deactivation. PRN Doses (IV Push) Fentanyl 100 mcg, Inj, IV Push, q10min PRN Give for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3). Hydromorphone 2 mg, Inj, IV Push, q10min PRN Give for Respiratory Rate GREATER than 16 or pain behaviors (moaning, facial grimace, NVPS greater than 3).

This order set was created jointly by members of the MedStar Washington Hospital Center Advanced Heart Failure Service, Palliative Care Service, Department of Nursing, and Department of Pharmacy. They serve as recommendations to promote best symptom management for patients who are undergoing deactivation of durable LVAD, in either a hospice or inpatient setting. They should be considered as expert opinion and should not be implemented as clinical orders at your institution without your own institutional review. These guidelines should only be followed in line with your institutional pharmacy policies.

NVPS, nonverbal pain scale; PAV, patient-controlled analgesia; RASS, Richmond Agitation Sedation Scale.

LVAD deactivation is a multidisciplinary endeavor. Typical participants at bedside include an AHF cardiologist, a clinician with advanced training in care for patients with LVADs termed “LVAD coordinator”,¹⁸ members of the palliative care and spiritual care teams, and the bedside nurse. The patient and family are counseled on expectations regarding LVAD deactivation and prognosis following deactivation. In our institution's protocols, patients who are alert are offered sedative anxiolytic medications to assuage impending anxiety before or at the time of deactivation. Some patients may elect to decline premedication with benzodiazepines but are encouraged to accept an opioid to mitigate the rapid onset of dyspnea that accompanies acute pulmonary edema from cardiogenic shock. The LVAD deactivation is performed by a trained clinician, typically a nurse or LVAD coordinator. In brief, shrill alarms are to be expected.

In expert hands, the alarms are quickly silenced to limit anxiety to the patient and family. Subsequently, repeat bolus doses of opioids and benzodiazepines (typically administered at higher doses to compensate for impaired systemic circulation) are administered to treat nonverbal signs of dyspnea and anxiety. Family members are offered the opportunity to remain at bedside throughout the process, given the mean duration of survival following LVAD deactivation is about 60 minutes.⁶

Select components of our LVAD deactivation order set are depicted in Table 2. In the lead-up to deactivation, the clinical team deprescribes medications that are not expected to contribute to symptomatic relief. If the patient is on multiple forms of life-sustaining medical treatments, a plan is formulated with the other clinical teams involved in the patient's care to withdraw life-sustaining treatments in a stepwise manner.

The anxiolytic and anterograde amnestic properties of benzodiazepines are of particular importance in patients who are awake and alert before deactivation. In our protocol, we use a short-intermediate-duration parenteral benzodiazepine, typically lorazepam, around 30–45 minutes before deactivation, with a goal Richmond Agitation Sedation Scale (RASS) score of −1 to −2, indicating drowsiness to light sedation. Concomitantly, patients are administered a bolus dose of opioid, typically fentanyl or hydromorphone (morphine is rarely used given patients frequently have comorbid renal dysfunction). Dosing suggestions for opioid naive and opioid tolerant patients are provided in Table 2.

If patients are already on an opioid infusion, for analgosedation related to being on a ventilator, for example, the infusion is continued at the effective dose. However, given acute cardiogenic shock precipitated by LVAD deactivation, and the abrupt change in pharmacodynamics that accompanies this change, all patients are administered a bolus dose of opioid before deactivation to increase serum levels of the drug. Following LVAD deactivation, subsequent bolus doses of opioids are not expected to circulate as well, so more aggressive dosing than clinicians may typically be accustomed to is advised.

In some cases, a patient-controlled analgesia is recommended to allow for frequent opioid dosing and the option of rapid opioid titration. Depending on the institution, a separate clinician order may be needed for the nurse to be able to administer the “patient administered bolus.” Adjuvant medications and doses for treatment of nausea, agitation, or excessive orotracheal secretions can be used as needed for these symptoms. All medications are administered parenterally to ensure rapid and complete onset of activity.

Conclusion

As more patients age with LVAD therapy, more patients and families will inevitably approach a point in their life where they must contemplate LVAD deactivation. Specific clinical guidelines and protocols are necessary to support HF and palliative care clinicians navigating this challenging clinical circumstance. We hope that our LVAD deactivation protocol, which was developed after engagement of stakeholders from multiple disciplines, can serve as a resource for hospice and palliative care clinicians to improve the end-of-life experience of patients with LVADs.

Footnotes

Acknowledgments

The authors thank Rose Dunkle, Shawn Glocker, Shadiya Henson, Karen Kelleher, Lisa Peters, Michelle Peters, Rusa Reimnitz, Jessica Rice, Tasha Wright, and other members of the Advanced Heart Failure, Palliative Care, Pharmacy, Nursing, and Surgical Critical Care departments who were instrumental in the development and implementation of these protocols.

Funding Information

No funding was received for this article.

Author Disclosure Statement

No competing financial interests exist.

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