The prevalence of heart failure (HF) is projected to steadily increase incurring the highest burden of cost to the healthcare system.1,2 Advanced HF therapies such as left ventricular assist device (LVAD) support are associated with improved survival and quality of life.1 In light of the complex and multifaceted nature of the care needed to support a patient with an LVAD, current guidelines require a comprehensive psychosocial assessment. The absence of a caregiver is a relative contraindication to LVAD support.1 Small studies have shown that a caregiver, particularly a spouse, may improve medical adherence and reduce 30-day hospital readmission and mortality.1 Despite these findings, perceptions of caregiver support requirements can vary significantly across LVAD programs. Patients with limited social support are more likely to be from a lower socioeconomic status, less likely to be married, nonwhite, and supported with public insurance.3 Inadequate or vague caregiver guidelines exacerbate current inequities by promoting inconsistent decision-making and increase implicit bias against those who are under supported.
We sought to better understand various current programmatic policies and recommendations for the need, number of caregivers, and duration of support across various VAD programs across North America.
Physician (surgical or medical) representatives of mechanical cardiac support programs across North America were invited by email to participate in an online six-question survey (Supplemental Digital Content 1, https://links.lww.com/ASAIO/A642) using a Qualtrics survey platform from October 22, 2019 for a 6-week period. Data were summarized descriptively.
A total of 20 respondents were surveyed from three Canadian (Programs A1–C1) and 14 American centers (A–N) (Table 1). Among the surveyed centers, 9 of 17 (53%) do not have a written policy on the need for social support for VAD eligibility. Three programs require a 24/7 live-in caregiver for variable durations of 2–6 weeks. All programs deem social support important ranging from extremely important (35%), very important (47%) to moderately important (18%). Flexible programs consider the patient’s health literacy, financial resources, and ability to travel in evaluating the need to have a live-in caregiver. Comments regarding the importance of social supports are summarized in Table 1. All programs surveyed educate patients and caregivers on how to perform a controller swap. Before coronavirus disease 2019 (COVID-19), only a third of programs provided some form of telemonitoring of VAD patients with home monitoring of hemodynamics with the use of a Cardiomems device, home international normalized ratio, periodic weight measurements, and blood pressure monitoring with the use of a Doppler device.
Table 1. -
Summary of Program-specific Policies on the Need for Social Support for Left Ventricular Assist Device Candidacy
|Program* (N = 17)
||No formal policy. Social supports remain incredibly important, particularly early after implant. In the long run social support becomes less critical, but only in those doing well.
||Informal process. Social support is a major consideration but the program will search alternatives when possible.
||No written policy but require the availability of a live-in caregiver for a minimum of 30 days.
||Formal policy in place which requires 24/7 live-in caregiver.
||No official policy but a member needs to be identified.
||The requirements are highly dependent on the patient. There is an intense screening of caregivers to ensure that at least 1 person is committed to spending the majority of time with the patient, particularly early after implant.
||No official policy. We ask that a 24/7 caregiver be present for a minimum of 2-4 weeks, or until the physician feels that the person is safe to be alone.
||Written policy on caregiver for dressing changes and transportation, live in for first two weeks at home.
||Written policy with strong preference towards live-in support for 30 days, but the program does make exceptions
||No official policy. Patient should have a caregiver that can assist in the event of emergency
||Written policy with the need of a caregiver for 6 weeks following discharge.
||There is a written statement to identify a primary caregiver and a back-up caregiver. Importance is emphasized early after implant, but once recovered and if the patient is able to care for themselves, somewhat less important to have someone 24 hours/day.
||The program does not require 24/7 live-in.
||The program requires a live-in caregiver for the first 1–3 months.
||The program requires the need of a primary and backup caregiver plan. Primary needs to be local and available for first 3 months
||No formal policy but specifics not detailed.
||No formal policy, but two caregivers need to be identified who are available and live in the area within the first 3 months.
*All US programs were involved in multicenter VAD trials with Joint Commission Certification. All 17 centers included are established VAD programs with heterogeneity in implants including low (11–30 implants/year), medium (31–50 implants/year, and high (>50 implants/year) volume centers.
VAD, ventricular assist device.
The findings of this survey highlight the heterogeneity in the need for social supports in evaluating LVAD candidacy. Most of the surveyed programs do not have a written policy on the number of caregivers required, the need for 24/7 support or the exact duration of support needed, as patients vary in their own personal needs.
A recent INTERMACS analysis found that 20% of patients supported with an LVAD had at least one or more psychosocial risk factors.1 Domains of psychosocial risk factors included limited social supports, limited cognition, substance abuse, psychiatric disease, and noncompliance. Among those patients who had a risk factor of limited social supports (4.9%), they had a higher likelihood for a 30-day readmission and device infection but a comparable survival compared with those without a risk factor. Importantly, patients with psychosocial risk were more likely to be nonwhite.1 Compared with Caucasians, African Americans have lower rates of VAD implantation compared with the expected rates, driven in part by racial bias in the assessment of social supports.4 Conversely, women have lower rates of advanced therapies, where the lack of a caregiver has contributed to the inequality.5
Although there were a number of limitations and biases in the analysis, the findings are provocative and emphasize the need for the VAD community to re-evaluate our current assessment of psychosocial risk factors.6
Although the role of psychosocial risk criteria needs to be examined further, social workers (or those in a similar role) play an integral part in understanding patients’ living conditions. This assessment typically includes determining living arrangements (number of family members living nearby, whether a live-in caregiver is feasible), caregiver understanding (what is an LVAD, duration of support, understanding and the ability to perform basic LVAD care), conflicting obligations (do the caregiver take care of other sick family members), and financial issues. Importantly, knowledge of the patient’s living arrangements should not preclude LVAD candidacy but set in motion strategies to support a patient who may not have any caregivers. Moreover, having explicit caregiver policies, which exist only in the minority of the programs surveyed, may limit the risk of inconsistent decision-making and the impact of implicit bias on an already vulnerable population who by definition lack supportive advocacy.
One of the few silver linings in the COVID-19 pandemic has been our advancements in connecting with patients remotely. Our current technologies provide unprecedented connectivity, with the potential 24 hours continuous access to patients. Given the evolution of care that we have seen within the last 6 months, is there an absolute need for a live-in or any caregiver at all? Our program has successfully pivoted an HF platform (Medly) to facilitate following all our LVAD patients.
The main limitation of this study was that it was a voluntary survey based on a list of programs that were involved in larger LVAD trials along with higher volume Canadian centers. This list may not be representative of the North American LVAD programs. This survey was conducted before COVID-19 and may not represent the resources now available for remote monitoring of LVAD patients.
Our findings suggest that LVAD programs have heterogeneous requirements for LVAD candidacy and the need for a caregiver.
It is our responsibility as an LVAD community to provide life-saving technologies to all patients regardless of their socioeconomic status to eliminate health inequities. In patients who do not have access to a caregiver, we need to think creatively to support this demographic, design creative efforts to improve candidacy, and not exclude this potentially vulnerable demographic.
1. DeFilippis EM, Breathett K, Donald EM, et al.: Psychosocial risk and its association with outcomes in continuous-flow left ventricular assist device patients. Circ Heart Fail. 13: e006910, 2020.
2. Kormos RL, Cowger J, Pagani FD, et al.: The Society of Thoracic Surgeons Intermacs Database Annual Report: Evolving indications, outcomes, and scientific partnerships. Ann Thorac Surg. 107: 341–353, 2019.
3. Clemons AM, Flores RJ, Blum R, et al.: Effect of socioeconomic status on patients supported with contemporary left ventricular assist devices. ASAIO J. 66: 373–380, 2020.
4. Breathett K, Yee E, Pool N, et al.: Does race influence decision making for advanced heart failure
therapies? J Am Heart Assoc. 8: e013592, 2019.
5. Moayedi Y, Fan CPS, Cherikh WS, et al.: Survival outcomes after heart transplantation: Does recipient sex matter? Circ Heart Fail. 12: e006218, 2019.
6. Eckman PM, Cogswell R: Is it time to reexamine psychosocial criteria for left ventricular assist device candidacy? Circ Heart Fail. 13: e007478, 2020.