Abstract
Background:
Caregiver support is considered necessary after heart transplant (HT) and left ventricular assist device (LVAD) for patients with end-stage heart failure (HF). Few studies have demonstrated how caregivers differ by gender and race, and whether that impacts therapy eligibility.
Methods:
We examined caregiver relationships among 674 patients (32% women, 55% Black) evaluated at Emory University from 2011 to 2017. Therapy readiness was assessed using the Stanford Integrated Assessment for Transplant (SIPAT). Evaluation outcome according to caregiver relationship was compared using χ2 analysis. Multivariable logistic regression determined the association between caregiver and eligibility according to gender and race.
Results:
Women and Black patients were less likely to have spouses as their support person (P<0.001). Women were less likely to be considered eligible for advanced therapies (adjusted odds ratio [aOR] 0.64, 95% confidence interval [CI] 0.46-0.89; P=0.008), with Black women having lower eligibility than White women (aOR 0.28, 95% CI 0.11-0.72; P=0.008). Social support and SIPAT scores did not significantly influence eligibility by gender or race.
Conclusion:
Lack of caregiver support is considered a relative contraindication to advanced therapies. Type of caregiver in our cohort varied according to race and gender but did not explain differences in eligibility for advanced therapies.
Keywords: health disparities, race-ethnicity, gender, social support, social determinants
INTRODUCTION
Over 6 million Americans are estimated to have heart failure (HF), and the prevalence is expected to rise to nearly 8 million by 2030.1 Despite improvements in both medical and device therapies for patients with HF, important disparities persist by race/ethnicity and gender. Black Americans are at greater risk for developing HF than other race/ethnic groups, and are more likely to require hospitalization.1 While women make up approximately half of patients with HF, women are more likely to report lower quality of life compared to men and notable knowledge gaps exist regarding pathophysiology and sex-specific risk factors in women.2
Advanced therapies for HF, including heart transplantation (HT) and left ventricular assist device (LVAD), result in improved survival for HF patients. Accordingly, as the prevalence of HF increases, the demand for advanced HF therapies has also risen.1 Despite their higher incidence of HF, however, Black patients and women receive proportionally fewer HT and LVAD annually than White patients and men, respectively.3,4 The reasons for the underrepresentation of Black patients and women as recipients of advanced HF therapies are incompletely understood.
Candidates for advanced HF therapies must undergo a stringent screening process, with consideration of objective measures of disease severity (i.e. estimates of 1-year mortality, cardiopulmonary stress testing, right heart catheterization, etc.), assessment and screening of comorbid conditions, and psychosocial evaluation.5 Caregivers are an essential component of psychosocial eligibility, and lack of adequate caregiver support is a relative contraindication to LVAD and HT.5,6 Patients who receive advanced HF therapies rely on caregivers for assistance with managing post-operative care, transportation, medication adherence, and assistance completing other essential activities of daily living.6 Prior studies in patients with HF as well as solid-organ transplant recipients have shown superior survival in patients with dependable caregiver support, particularly spouses.7,8,9
Currently, there is little data examining if primary caregiver support differs based on the race/ethnicity and/or gender of the patient, and whether any differences influence eligibility for advanced HF therapies. Since Black patients develop HF at younger ages than other race-ethnic groups10,11, for example at ages where caregivers are still working or still have to provide care for minor children, the stringent requirements for HT and LVAD may present unique barriers in this population. The importance of adequate social support has been demonstrated in Black HF patients specifically, with married Black patients and those living with family having lower mortality and readmission rates than single Black patients or those who live alone.12 Similarly, older women with HF more often lack social support than men with HF, which may also be a barrier to HT and LVAD eligibility.13 In this single center, retrospective cohort analysis, we sought to 1) compare differences in primary caregiver support of advanced HF patients by race/ethnicity and gender, and 2) examine if primary caregiver support influences eligibility for advanced HF therapies.
MATERIALS AND METHODS
Study population.
We retrospectively examined all patients evaluated for advanced HF therapies at Emory University Hospital from January 1, 2011 to December 31, 2017 (N=682). All patients evaluated for HT and LVAD are recorded in the Emory HT database, and all decisions made regarding final candidacy for HT or LVAD are documented in the medical record. Patients who had previously received HT and were evaluated for retransplant during this period were excluded from the study (N=8). This study was approved by the Emory University Institutional Review Board.
Study endpoints.
The primary endpoint for this analysis was eligibility for HT/LVAD. Eligibility for HT or LVAD is determined using criteria specified in the Emory University Hospital Guidelines for Recipient Candidacy for HT and LVAD based on international guidelines.5,14 Decisions regarding eligibility are made by an advanced HF therapeutics committee, which includes HF/transplant cardiologists and surgeons, HT and LVAD nurse coordinators, biomedical engineers, pharmacists, social workers, financial counselors, dieticians, and physical therapists. A summary of the discussion by the multidisciplinary committee is documented in the medical record. Transplant centers are also required to provide a letter to all patients evaluated for HT that documents the specific reasons that a patient is not considered a HT candidate; these reasons are documented in the medical record. Those candidates who meet the specified criteria are “listed” for HT, while those candidates who do not meet the specified criteria for HT are considered for DT LVAD. All other patients are considered ineligible for advanced HF therapies. Our analysis captures the results of the final evaluation for patients referred for advanced HF therapies (i.e. the final outcome for patients who were initially deemed not a candidate for any reason, but were later re-evaluated at any time during the study period). Patients were censored at the time of loss to follow-up or at the last date of follow-up on December 31, 2017.
Demographic and clinical covariates.
Information on demographic and clinical covariates was documented at the time of the HT/LVAD evaluation. Covariates of interest included all of the demographic and clinical variables included in Table 1. Race and gender are recorded as self-reported by the patient. Specific reasons that a patient was not considered to be a HT or LVAD candidate were also considered as covariates.
Table 1.
Baseline characteristics of the study cohort.
| Participant Characteristics | Total Cohort N = 674 |
|---|---|
| Age | 51.8 ± 12.7 |
| Gender | |
| - Female | 209 (31) |
| - Male | 465 (69) |
| Race | |
| - Black | 370 (54.9) |
| - White | 275 (40.8) |
| - Other | 29 (4.3) |
| Insurance | |
| - Private | 325 (48.2) |
| - Medicare | 273 (40.5) |
| - Medicaid | 76 (11.3) |
| Heart failure type | |
| - Ischemic | 178 (26.4) |
| - Nonischemic | 390 (57.9) |
| - Peripartum | 28 (4.2) |
| - Restrictive | 4 (0.6) |
| - Other | 57 (8.5) |
| - Adult Congenital Heart Disease | 17 (2.5) |
| Employment Status at Time of Evaluation | |
| - Unemployed | 368 (54.6) |
| - Employed | 165 (24.5) |
| - Retired | 104 (15.4) |
| Supplemental Security Income / Social Security Disability Insurance | 416 (61.7) |
| VA Benefits | 34 (5.0) |
| Education Level* | |
| - Less than High School | 61 (9.0) |
| - High School | 206 (30.6) |
| - Some College | 176 (26.1) |
| - College/Graduate Degree | 164 (24.3) |
| Coronary artery disease | 296 (43.9) |
| Lung disease | 83 (12.3) |
| Diabetes mellitus | 236 (35) |
| Hypertension | 405 (60.1) |
| CKD categories | |
| - Stage 1-2 | 301 (44.7) |
| - Stage 3 | 301 (44.7) |
| - Stage 4-5 | 69 (10.2) |
| Left ventricular thrombus at time of evaluation | 83 (12.3) |
| Inotropes | 409 (60.7) |
| PRA Class I | 9.5 ± 22.8 |
| PRA Class II | 6.1 ± 19.9 |
| Allosensitization (PRA > 75%)* | 37 (5.5) |
| Body mass index (kg/m2) | 29.0 ± 6.8 |
| Right atrial pressure (mmHg)* | 12.1 ± 6.6 |
| Mean pulmonary artery pressure (mmHg)* | 36.1 ± 10.9 |
| Pulmonary capillary wedge pressure (mmHg)* | 25.0 ± 9.6 |
| Cardiac index (L/min/m2)* | 1.8 ± 0.9 |
| Hematocrit (%) | 36.9 ± 6.0 |
| Hemoglobin A1C (%)* | 6.4 ± 1.3 |
| Total bilirubin (mg/dL) | 1.6 ± 1.3 |
| Sodium (mmol/L) | 134.9 ± 4.9 |
| Blood urea nitrogen (mg/dL) | 29.7 ± 19.4 |
| Creatinine (mg/dL) | 1.5 ± 0.7 |
| Estimated glomerular filtration rate (mL/min/1.73 m2) | 58.1 ± 23.2 |
| Albumin (g/dL) | 3.5 ± 0.6 |
| Primary Caregiver Type | |
| - Spouse | 402 (59.6) |
| - Parent | 90 (13.4) |
| - Adult Offspring | 69 (10.2) |
| - Other Family Member | 48 (7.1) |
| - Friend | 22 (3.3) |
| - Missing | 43 (6.4) |
Values are mean standard deviation or percent by column.
Abbreviations: PRA: panel reactive antibodies, CKD: chronic kidney disease
Indicates >10% missing data for these variables
Psychosocial covariates.
The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) scoring system was used to quantitatively assess psychosocial variables in all patients evaluated for HT or LVAD after 2013 (N=392) and is missing for patients evaluated prior to 2013.15 Briefly, the score has four subscales: A=patient’s readiness for transplant, B=social support system, C=psychosocial stability, and D=substance abuse and lifestyle. Total scores can be categorized as excellent candidate (0-6), good candidate (7-20), minimally acceptable candidate (21-39), and high-risk candidate (≥40). Patients who were not evaluated using the SIPAT scoring system (N=282) were rigorously evaluated by our experienced mental health and social work team for their psychiatric history and stability, as well as their substance use history according to standard criteria16.
Statistical analysis.
Data are presented as mean ± standard deviation (SD), median (interquartile range [IQR]), or N (%) of patients. Baseline characteristics were compared between patients based on gender and race using Student’s t test for continuous variables and the chi-square or Fisher’s exact test for categorical variables. Reasons for ineligibility were compared using chi-square test. The association of gender and race with eligibility for HT and DT LVAD were examined using separate multivariable logistic regression models, adjusted for insurance type, age, body mass index (BMI), HF etiology, pulmonary capillary wedge pressure, cardiac index, severe allosensitization (defined by panel-reactive antibodies [PRA] levels > 75%), and estimated glomerular filtration rate (eGFR). In addition, to determine the presence of any effect modification of race on the association of gender with eligibility for HT and DT LVAD, a race*gender interaction term was added to the fully adjusted model. Additional sensitivity analyses were performed by 1) adding the total SIPAT score to stratified logistic regression models in a subset of patients (N=379) for which full data was available, and 2) stratifying the cohort into early (2011-2014) and late (2015-2017) evaluation periods to determine if any differences in the association of race or gender with eligibility for advanced therapies was changing with time. Data were analyzed with the use of SAS statistical software version 9.4 (SAS Institute Inc.) and visualization was carried out with RStudio version 1.3.1073 (The Comprehensive R Archive Network: https://cran.r-project.org).
RESULTS
Baseline characteristics.
The baseline characteristics of the 674 patients evaluated for primary HT and/or LVAD implantation during the study period are displayed in Table 1. The mean age was 51.8 ± 12.7 years, 209 (31%) patients were women, and 370 (55%) were Black. Compared to men, women were younger, and more likely to be Black, unemployed, and have nonischemic HF etiology (Supplemental Table 1). Women were less likely to have coronary artery disease (CAD) and hypertension, but were more likely to be allosensitized. There was no difference by gender in inotrope dependence or hemodynamics at the time of evaluation. Compared to White patients, Black patients were younger, and more likely to have nonischemic HF etiology, public insurance, and social security disability insurance (Supplemental Table 2). Compared to White patients, Black patients appeared to have a more severe level of illness, characterized by higher prevalence of inotrope dependence at the time of the initial evaluation, worse hemodynamics, and lower albumin.
Race and gender differences in caregiver type and psychosocial characteristics.
Compared to men, women were more likely to have parents and adult children as primary support, but less likely to have a spouse or friend as primary support (Table 2). Compared to non-Black patients, Black patients were more likely to have parents, children, and other family members as primary support, but less likely to have a spouse as primary support (Table 2).
Table 2.
Caregiver distribution of the study cohort by race and gender.
| Caregiver Type | Female (N=199) |
Male (N=432) |
P-value | Black (N=353) |
Non-Black (N=278) |
P-value |
|---|---|---|---|---|---|---|
| Spouse | 92 (46.2) | 310 (71.8) | <0.001 | 188 (53.3) | 214 (77.0) | <0.001 |
| Parent | 44 (22.1) | 46 (10.6) | <0.001 | 70 (19.8) | 20 (7.2) | <0.001 |
| Child | 44 (22.1) | 25 (5.8) | <0.001 | 49 (13.9) | 20 (7.2) | 0.008 |
| Other Family Member | 18 (9.0) | 30 (6.9) | 0.355 | 38 (10.8) | 10 (3.6) | 0.001 |
| Friend | 1 (0.5) | 21 (4.9) | 0.006 | 8 (2.3) | 14 (5.0) | 0.060 |
In those patients for whom SIPAT scores were available (N=392), total SIPAT scores were similar for those who were eligible for advanced HF therapies compared to those who were ineligible (10, IQR [6 – 14] vs 10, IQR [6 – 17], P=0.16). Comparisons by gender and race revealed relatively few differences in the total SIPAT score between men and women (Figure 1). Although most of the total SIPAT scores fell into the range of excellent or good candidate, comparisons by gender (Supplemental Figure 1) and race (Supplemental Figure 2) revealed some notable differences among SIPAT subscales. There was a trend toward higher Subscale C scores (psychiatric stability) in women considered eligible for advanced therapies (P=0.051). Black patients considered eligible for advanced therapies had higher SIPAT A scores (patient readiness) than non-Blacks, and Black patients considered ineligible for therapies had higher SIPAT B scores (social support). Non-Black patients considered ineligible had higher SIPAT C scores (psychiatric stability) compared to Black patients deemed ineligible.
Figure 1.
Total SIPAT scores and eligibility for advanced HF therapies by gender and race.
Abbreviations: NS: not significant.
*p-value<0.05
Association of race and gender with eligibility for advanced HF therapies.
Overall, 351 (52.1%) patients were considered eligible for advanced HF therapies. On univariate analysis, the outcome of the evaluation for HT/LVAD varied significantly according to gender but not race, with women being less likely than men to be eligible for advanced HF therapies (OR 0.64 95% CI 0.46-0.89, P=0.008). Documented reasons for ineligibility for advanced HF therapies were classified as medical, psychosocial, compliance, or too well for therapy, and were compared by gender and race (Figure 2). Notably, severe allosensitization and obesity class II or greater (body mass index >35 kg/m2) are specific exclusion criteria for HT, whereas the other reasons listed apply to both LVAD and HT eligibility. Black men and women were more likely to have psychosocial factors documented as a reason for ineligibility (P=0.021). Black women in particular were more likely to be considered ineligible for HT because of medical reasons, namely allosensitization (Table 3). Noncompliance was not considered a significant exclusion for advanced therapies by race or gender. Even with adjustment for clinical covariates, women were less likely to be eligible for advanced HF therapies (adjusted odds ratio [aOR] 0.45, 95% confidence interval [CI] 0.29-0.72, P=0.001). Further, there was a significant interaction between gender and race (P=0.03 for race*gender interaction term). Black women were less likely than non-Black women to be eligible for advanced therapies (aOR 0.28, 95% CI 0.11-0.72; P=0.008), however there was no difference in eligibility for advanced therapies between Black and non-Black men (OR 1.04, 95% CI 0.62-1.75; P=0.88) (Table 4, Supplemental Table 3). Further adjustment for caregiver type did not attenuate the lower odds of eligibility for advanced HF therapies in Black female candidates (Table 4). The sensitivity analysis incorporating the total SIPAT score for those with available data (N=379) showed a consistent direction of effect of the decreased eligibility for Black women (OR 0.30, 95% CI 0.09-1.06; P=0.062). In addition, the sensitivity analysis incorporating the early and late periods showed a consistent direction of effect of the decreased eligibility for Black women (Supplemental Tables 5 and 6).
Figure 2.
Reasons for ineligibility for advanced HF therapies by race and gender group
Table 3.
Comparison of reasons for ineligibility for advanced HF therapies by race and gender group.
| Reason | Non-Black Male N=110 |
Black Male N=97 |
Non-Black Female N=40 |
Black Female N=76 |
Total Cohort N=323 |
P-value |
|---|---|---|---|---|---|---|
|
Medical Overall - Age - Allosensitization† - Obesity† - Comorbidities - Death |
68 (61.8) | 56 (57.7) | 27 (67.5) | 59 (77.6) | 210 (65.0) | 0.042 |
| 7 (10.3) | 2 (3.6) | 1 (3.7) | 1 (1.7) | 11 (5.2) | 0.206 | |
| 4 (5.9) | 1 (1.8) | 5 (18.5) | 16 (27.1) | 26 (12.4) | <0.001 | |
| 6 (8.8) | 5 (8.9) | 3 (11.1) | 11 (18.6) | 25 (11.9) | 0.227 | |
| 25 (36.8) | 22 (39.3) | 7 (17.5) | 14 (23.7) | 68 (32.4) | 0.170 | |
| 11 (16.2) | 6 (10.7) | 2 (7.4) | 6 (10.2) | 25 (11.9) | 0.658 | |
| Psychosocial | 38 (34.5) | 46 (47.4) | 8 (20.0) | 28 (36.8) | 120 (37.2) | 0.021 |
| Compliance | 29 (26.4) | 24 (24.7) | 7 (17.5) | 17 (22.4) | 77 (23.8) | 0.704 |
| Too Well | 33 (30.0) | 17 (17.5) | 12 (30.0) | 17 (22.4) | 79 (24.5) | 0.158 |
Percentages do not add up to 100, as patients may have had more than one reason for ineligibility
Severe allosensitization and BMI>35 are a HT specific exclusion factors
Table 4.
Odds ratios of eligibility for advanced HF therapies by gender.
| Characteristics | Unadjusted OR (95% CI) |
P-value | Model 1 Adjusted OR (95% CI) |
Model 1 P-value |
Model 2 Adjusted OR (95% CI) |
Model 2 P-value |
Unadjusted OR (95% CI) |
P-value | Model 1 Adjusted OR (95% CI) |
Model 1 P-value |
Model 2 Adjusted OR (95% CI) |
Model 2 P-value |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female Cohort | Male Cohort | |||||||||||
| Race | ||||||||||||
| - Non-Black | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. | ||||||
| - Black | 0.76 (0.43-1.34) | 0.344 | 0.28 (0.11-0.72) | 0.008 | 0.32 (0.11-0.89) | 0.028 | 1.39 (0.96-2.00) | 0.080 | 1.04 (0.62-1.75) | 0.878 | 1.15 (0.67-1.97) | 0.609 |
| Insurance | ||||||||||||
| - Private | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. | ||||||
| - Medicare | 0.99 (0.56-1.77) | 0.76 (0.33-1.73) | 0.94 (0.39-2.29) | 0.54 (0.36-0.80) | 0.54 (0.32-0.92) | 0.53 (0.31-0.92) | ||||||
| - Medicaid | 0.35 (0.13-0.96) | 0.104 | 0.73 (0.20-2.71) | 0.769 | 1.05 (0.26-4.18) | 0.983 | 0.47 (0.26-0.87) | 0.003 | 0.37 (0.17-0.81) | 0.011 | 0.37 (0.17-0.83) | 0.014 |
| Age | 1.01 (0.99-1.03) | 0.210 | 1.04 (1.00-1.08) | 0.060 | 1.06 (1.01-1.11) | 0.015 | 0.98 (0.97-1.00) | 0.010 | 0.99 (0.97-1.02) | 0.541 | 1.00 (0.97-1.03) | 0.781 |
| Body mass index (kg/m2) | 0.99 (0.96-1.03) | 0.656 | 1.03 (0.96-1.09) | 0.426 | 1.02 (0.96-1.09) | 0.475 | 0.99 (0.96-1.02) | 0.481 | 0.99 (0.95-1.03) | 0.550 | 0.99 (0.94-1.03) | 0.541 |
| Heart failure type | ||||||||||||
| - Ischemic | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. | ||||||
| - Nonischemic | 1.36 (0.61-3.05) | 1.01 (0.34-3.04) | 1.17 (0.38-3.67) | 1.85 (1.23-2.77) | 1.09 (0.61-1.94) | 0.10 (0.61-1.99) | ||||||
| - Other | 1.25 (0.51-3.03) | 0.754 | 2.08 (0.53-8.21) | 0.379 | 2.10 (0.51-8.68) | 0.510 | 2.69 (1.34-5.39) | 0.002 | 1.82 (0.71-4.63) | 0.444 | 1.76 (0.67-4.60) | 0.509 |
| Pulmonary capillary wedge pressure (mmHg) | 1.01 (0.98-1.04) | 0.533 | 1.01 (0.96-1.06) | 0.734 | 1.01 (0.96-1.06) | 0.797 | 1.02 (1.00-1.00) | 0.045 | 1.03 (1.00-1.06) | 0.063 | 1.03 (1.00-1.06) | 0.026 |
| Cardiac index (L/min/m2) | 0.40 (0.21-0.76) | 0.005 | 0.22 (0.08-0.58) | 0.002 | 0.18 (0.06-0.51) | 0.001 | 0.45 (0.29-0.70) | <0.001 | 0.57 (0.34-0.98) | 0.04 | 0.55 (0.32-0.95) | 0.032 |
| Allosensitization (PRA>75%) | 1.99 (0.94-4.19) | 0.071 | 1.42 (0.43-4.64) | 0.563 | 1.41 (0.41-4.89) | 0.590 | N/A | N/A | N/A | N/A | N/A | N/A |
| Estimated glomerular filtration rate (mL/min/1.73 m2) | 1.00 (0.99-1.02) | 0.670 | 1.02 (1.00-1.05) | 0.042 | 1.03 (1.01-1.05) | 0.017 | 1.00 (0.99-1.01) | 0.575 | 1.00 (0.99-1.01) | 0.918 | 1.00 (0.99-1.01) | 0.695 |
| Primary Caregiver Type | ||||||||||||
| - Spouse | Ref. | Ref. | Ref. | Ref. | ||||||||
| - Parent | 0.55 (0.27-1.15) | 1.06 (0.28-4.00) | 0.99 (0.49-1.73) | 0.71 (0.28-1.79) | ||||||||
| - Adult Offspring | 0.50 (0.24-1.05) | 0.36 (0.12-1.11) | 0.31 (0.13-0.73) | 0.48 (0.15-1.57) | ||||||||
| - Other Family / Friend | 0.63 (0.24-1.73) | 0.307 | 0.69 (0.16-3.06) | 0.324 | 0.42 (0.23-0.77) | 0.007 | 0.33 (0.15-0.71) | 0.027 | ||||
Model 1: Adjusted for race, insurance, age, body mass index, heart failure type, pulmonary capillary wedge pressure, cardiac index, allosensitization, estimated glomerular filtration rate
Model 2: Model 1 components + primary caregiver type
DISCUSSION
In this single center, retrospective analysis of evaluations for advanced HF therapies, we demonstrate three main findings: 1) primary caregiver support for advanced HF therapies differs by race and gender. Compared to men and non-Black patients, women and Black patients were more likely to have parents and adult children as primary support, but less likely to have a spouse as their support person. 2) Women, particularly Black women, are less likely to be considered eligible for advanced HF therapies as compared to men and 3) incorporation of caregiver type attenuates but does not account for the decreased eligibility in women. Multivariable models incorporating clinical characteristics, lab values, and psychosocial factors did not fully resolve race- and gender-based differences in eligibility, suggesting unmeasured confounders still influence the exclusion of female patients from advanced HF therapies.
Social support has historically been an important determinant in eligibility for solid organ transplantation.17 Caregiver relationships may have influences on patient health behaviors, psychological well-being, and quality of life, although the nature of this impact in improving or diminishing patient well-being has conflicting results and is likely dependent on dyad-specific behaviors.18 Vulnerable groups, including women and Black patients, may be disproportionately excluded from solid organ transplantation due to lack of traditional caregiver support, and clinician bias in evaluating support systems may place further strain on these groups.17 A systematic review by Ladin et al. examined the association of social support with clinical outcomes after organ transplantation, and determined that marital status and medication adherence were not consistently influential, with most benefit seen in kidney transplant recipients but variation observed across other transplant types.19 The effects of marital status on post-transplant outcomes are nonuniform, with studies showing both patient improvement and decline among married couples. Studies focusing on non-marital relationships showed similar inconsistency of medication adherence, though a possible protective effect on post-transplant outcomes was observed. These findings challenge the weight that caregiver support should have in determining transplant listing, and suggest that exclusion based on strict social support criteria may exacerbate current disparities in solid organ transplantation.
Implicit bias may be a key unmeasured confounder in the evaluation process for advanced HF therapies, and understanding its role is critical in diminishing disparities in access by race and gender. Recent analyses document that Black patients are more likely to be referred for advanced HF therapies at a higher acuity of illness, which may influence providers’ perception of a patient’s need for therapies. Similarly, in our cohort, Black men and women were more likely than White men and women to be inotrope dependent at the time of the evaluation. Even in the face of objective criteria (i.e. hemodynamics, inotrope requirements, SIPAT scores, etc), however, decisions about treatment pathways may be subject to implicit bias. Breathett et al. performed a national survey of HF clinicians, where clinicians were presented with a clinical vignette describing a patient with advanced HF in need of advanced therapies. All aspects of the clinical presentation including details on medical comorbidities, hemodynamics, adherence with medical therapy, social support, and socioeconomic status were identical, except for the race or gender of the patient being evaluated.20,21 Discussions with clinicians revealed that women, particularly Black women, were perceived to have more barriers to eligibility for advanced HF therapies, including the assumed burden of childcare and lack of social support. The results of that analysis may be informative in the context of our current findings. Our study demonstrates that historical rates of noncompliance and SIPAT scores did not differ significantly among patient groups in our cohort, yet Black patients were still perceived to have a greater psychosocial burden that would make advanced therapies an unrealistic option for them. Black women in our cohort were particularly less likely to be eligible for advanced therapies, and since they more frequently identified non-spousal caregivers, it is possible that implicit bias may have been present during our evaluation process. Black patients being evaluated for advanced HF therapies may not necessarily fit a “traditional” family framework, as Black individuals are less likely to be married compared to other race-ethnic groups, and may be more likely to rely on help from multiple family members including those outside of the home.22,23 As Black patients often present at a later stage of illness than non-Black patients, providers’ assumptions regarding increased requirements of social support, combined with a non-traditional family support plan, may disadvantage Black patients undergoing evaluation.
As men make up the majority of HT and LVAD recipients, women, particularly spouses, are more likely than men to be caregivers to HF and LVAD patients.6,24 Consistent with this trend, our study found that men undergoing evaluation were most likely to list their female spouses as their primary support person. Female caregivers may be more likely to provide emotional care to male patients with HF, while male caregivers may be more responsible for physical support of female HF patients.25 These differences in the role of caregiver by gender may bias evaluator perception of a patient’s ability to manage the complex care after receipt of advanced therapy. In Breathett et al., social support assessments were more critical when the patient was female, particularly for Black women, and spouses were more often deemed inadequate forms of support when the patient was female.20 Our study also showed a trend toward higher scores on SIPAT Subscale C (psychiatric stability) for women patients with HF compared to men, consistent with prior data demonstrating more depression in women with HF.26,27 Evaluator perception of psychiatric instability combined with the apparent lack of an emotional support system may disproportionately impact eligibility for women.
Several tools have been developed to standardize in psychosocial evaluations for HT, including the Transplant Evaluation Rating Scale (TERS), the Psychosocial Assessment of Candidates for Transplantation, and the SIPAT tool.15,28,29 Social support, knowledge, and psychiatric history, and substance use are all substantial components of these scales, and the SIPAT score in particular has demonstrated a correlation between higher scores and increased clinical events in HT and LVAD patients.30,31 Studies analyzing SIPAT scores in demographic subgroups are limited. Our prior work showed that men were more likely to have higher SIPAT scores compared to women primarily due to substance use, but that this difference did not account for differences in advanced therapy eligibility.32 In the current study, we did not find significant differences in SIPAT scores between men and women, whether considered ineligible or eligible for advanced therapies. Notably, these scales are still subject to evaluator bias, relying on the evaluator’s perception of the patient’s support system, psychiatric health, and surrounding circumstances around transplantation.
Our study represents a single-center experience, and so our results may not be generalizable to other centers. Notably, our center cares for a very high proportion of Black patients, including a relatively large number of Black women with elevated panel-reactive antibodies (PRA) as their cause for medical ineligibility for HT. The racial composition of our cohort may not be generalizable to other regions of the country or other countries outside of the United States. Additionally, we are unable to address differences which may exist in referral for evaluation for advanced therapies. However, as our program is the largest HT/LVAD program in the state of Georgia, we feel that our experience is an important representation of HF care in a region with very high HF morbidity and mortality, and a high proportion of women and Black patients living with HF. Our center is often the terminal referral center for HF patient evaluation for advanced therapies, and so we cannot account for disparities in the external referral process and differences in patient characteristics that may make our results less generalizable. Since large national registries currently do not capture data on the evaluation process for advanced HF therapies, we feel that our analysis provides unique insights into variables implicated in the evaluation process that may influence disparities by gender and race. Additionally, although our analysis focused on the presence or absence of caregiver support, we did not have metrics to evaluate the competency of caregivers. Future directions in evaluating caregiver dependency may include more extensive interview of the reported caregiver.
In summary, we found that women, particularly Black women, are less likely to be considered eligible for advanced HF therapies, a finding which persisted despite adjustment for clinical, laboratory, and psychosocial variables. Our study exposes opportunities for improvement in the evaluation process for advanced HF therapies, both for our institution and other centers, in order to reduce the impact of implicit bias in the evaluation process. Future directions should focus on multicenter studies to address these questions in order to better characterize contributing factors to disparities in eligibility of these lifesaving therapies.
Supplementary Material
ACKNOWLEDGEMENTS
The project was supported by funding for RS from NIH/NIMHD U54 MD008173 and by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002378 & TL1TR002382. AAM is supported by NHLBI (R03 HL146874), AHRQ (HS026081), the Woodruff Foundation, and the Association of Black Cardiologists.
Footnotes
CONFLICTS OF INTEREST
None.
Publisher's Disclaimer: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi:10.1002/ctr.14502.
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