A comparison of quality-adjusted life years in older adults after heart transplantation versus long-term mechanical support: Findings from the SUSTAIN-IT study.

BACKGROUND: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up. METHODS: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models. RESULTS: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF. CONCLUSIONS: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF.

Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study.

BACKGROUND: Information about health-related quality of life (HRQOL) among caregivers of older patients with heart failure who receive heart transplantation (HT) and mechanical circulatory support (MCS) is sparse. We describe differences and factors associated with change in HRQOL before and early post-surgery among caregivers of older heart failure patients who underwent 3 surgical therapies: HT with pretransplant MCS (HT MCS), HT without pretransplant MCS (HT non-MCS), and long-term MCS. METHODS: Caregivers of older patients (60-80 years) from 13 US sites completed the EQ-5D-3 L visual analog scale (0 [worst]-100 [best] imaginable health state) and dimensions before and 3 and 6 months post-surgery. Analyses included linear regression, t tests, and nonparametric tests. RESULTS: Among 227 caregivers (HT MCS=54, HT non-MCS=76, long-term MCS=97; median age 62.7 years, 30% male, 84% White, 83% spouse/partner), EQ-5D visual analog scale scores were high before (84.8±14.1) and at 3 (84.7±13.0) and 6 (83.9±14.7) months post-surgery, without significant differences among groups or changes over time. Patient pulmonary hypertension presurgery (ß=-13.72 [95% CI, -21.07 to -6.36]; P<0.001) and arrhythmia from 3 to 6 months post-operatively (ß=-14.22 [95% CI, -27.41 to -1.02]; P=0.035) were associated with the largest decrements in caregiver HRQOL; patient marital/partner status (ß=6.21 [95% CI, 1.34-11.08]; P=0.013) and presurgery coronary disease (ß=8.98 [95% CI, 4.07-13.89]; P<0.001) were associated with the largest improvements. CONCLUSIONS: Caregivers of older patients undergoing heart failure surgeries reported overall high HRQOL before and early post-surgery. Understanding factors associated with caregiver HRQOL may inform decision-making and support needs. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02568930.

Caregiver burden before heart transplantation and long-term mechanical circulatory support: Findings from the sustaining quality of life of the aged: Transplant or mechanical support (SUSTAIN-IT) study.

BACKGROUND: Caregiving for heart failure (HF) patients is burdensome. We examined differences in caregiver burden for 3 groups of older advanced HF patients: (1) supported with mechanical circulatory support (MCS) before heart transplantation (HT MCS), (2) awaiting transplant without MCS (HT non-MCS), and (3) prior to long-term MCS and factors associated with burden. METHOD: From October 1, 2015 to December 31, 2018, we enrolled 276 caregivers for HF patients from 13 U.S. sites: 85 HT MCS, 96 HT non-MCS, and 95 prior to long-term MCS. At enrollment, caregivers completed the Oberst Caregiving Burden Scale (15 items, 2 subscales: time (range = 1-5; higher score = more time spent on task) and difficulty (range = 1-5; higher score = higher difficulty of task) and other measures. Statistical analyses included descriptive statistics, ANOVA, chi-square tests, and linear regression. RESULT: Overall, caregivers were aged 60.8 ± 9.8 years and predominantly white, female, spouses, well educated, and reported ≥1 comorbidities. Caregivers overall reported a moderate amount of time spent on tasks and slight task difficulty. Caregivers for HT non-MCS candidates reported significantly less perceived time spent on tasks than caregivers for HT MCS candidates and caregivers for patients prior to long-term MCS (2.2 ± 0.74 vs 2.4 ± 0.74 vs 2.5 ± 0.71, respectively, p = 0.02) and less perceived difficulty of tasks (1.2 ± 0.33 vs 1.4 ± 0.53 vs 1.4 ± 0.54, respectively, p = 0.01). Caregiver and patient factors were associated with caregiver burden. CONCLUSIONS: Prior to HT and long-term MCS, caregiver burden was low to moderate. Caregiver factors were predominantly associated with caregiver burden. Understanding caregiver burden and factors affecting caregiver burden may enhance preoperative advanced therapies discussions and guide caregiver support.

Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study.

BACKGROUND: Restoring health-related quality of life (HRQOL) is a therapeutic goal for older patients with advanced heart failure. We aimed to describe change in HRQOL in older patients (60-80 years) awaiting heart transplantation (HT) with or without pretransplant mechanical circulatory support (MCS) or scheduled for long-term MCS, if ineligible for HT, from before to 6 months after these surgeries and identify factors associated with change. METHODS: Patients from 13 US sites completed the EuroQol 5-dimension 3L questionnaire and Kansas City Cardiomyopathy Questionnaire-12 at baseline and 3 and 6 months after HT or long-term MCS. Analyses included univariate comparisons and multivariable linear regression. RESULTS: Among 305 participants (cohort mean age=66.2±4.7 years, 78% male, 84% White, 55% New York Heart Association class IV), 161 underwent HT (n=68 with and n=93 without pretransplant MCS), and 144 received long-term MCS. From baseline to 3 months, EuroQol 5-dimension visual analog scale scores improved in HT patients without pretransplant MCS (54.5±24.3 versus 75.9±16.0, P<0.001) and long-term MCS patients (45.7±22.9 versus 66.2± 20.9, P <0.001); while Kansas City Cardiomyopathy Questionnaire-12 overall summary scores improved in all 3 groups (HT without pretransplant MCS: 47.2±20.9 versus 77.4±20.1, P <0.001; long-term MCS: 35.3±20.2 versus 58.6±22.0, P <0.001; and HT with pretransplant MCS: 58.3±23.6 versus 72.1±23.5, P=0.002). No further HRQOL improvement was found from 3 to 6 months. Factors most significantly associated with change in HRQOL, baseline 3 months, were right heart failure and 3-month New York Heart Association class, and 3 to 6 months, were 6-month New York Heart Association class and major bleeding. CONCLUSIONS: In older heart failure patients, HRQOL improved from before to early after HT and long-term MCS. At 6 postoperative months, HRQOL of long-term MCS patients was lower than one or both HT groups. Understanding change in HRQOL from before to early after these surgeries may enhance decision-making and guide patient care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02568930.

Health-Related Quality of Life in Older Patients With Advanced Heart Failure: Findings From the SUSTAIN-IT Study.

Background There is a paucity of research describing health-related quality of life (HRQOL) in older adults considered for advanced heart failure surgical therapies. Using data from our SUSTAIN-IT (Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support) study, we aimed to compare HRQOL among 3 groups of older (60-80 years) patients with heart failure before heart transplantation (HT) or long-term mechanical circulatory support (MCS) and identify factors associated with HRQOL: (1) HT candidates with MCS, (2) HT candidates without MCS, or (3) candidates ineligible for HT and scheduled for long-term MCS. Methods and Results Patients from 13 US sites completed assessments, including self-reported measures of HRQOL (EuroQol-5 Dimension Questionnaire, Kansas City Cardiomyopathy Questionnaire-12), depressive symptoms (Personal Health Questionnaire-8), anxiety (State-Trait Anxiety Inventory-state form), cognitive status (Montreal Cognitive Assessment), and performance-based measures (6-minute walk test and 5-m gait speed). Analyses included ANOVA, χ2 tests, Fisher's exact tests, and linear regression. The sample included 393 patients; the majority of patients were White men and married. Long-term MCS candidates (n=154) were significantly older and had more comorbidities and a higher New York Heart Association class than HT candidates with MCS (n=118) and HT candidates without MCS (n=121). Long-term MCS candidates had worse HRQOL than HT candidates with and without MCS (EQ-5D visual analog scale scores, 46±23 versus 68±18 versus 54±23 [P<0.001] and Kansas City Cardiomyopathy Questionnaire-12 overall summary scores, 35±21 versus 60±21 versus 49±22 [P<0.001], respectively). In multivariable analyses, lower 6-minute walk distance, higher New York Heart Association class, depressive symptoms, and not being an HT candidate with MCS were significantly associated with worse overall HRQOL. Conclusions Our findings demonstrate important differences in overall and domain-specific HRQOL of older patients with heart failure before HT or long-term MCS. Understanding HRQOL differences may guide decisions toward more appropriate and personalized advanced heart failure therapies.

Proceedings from the metrics forum in heart transplantation for performance monitoring.

Regulatory oversight for heart transplant programs is currently under review by the United Network for Organ Sharing (UNOS). There is concern whether 1-year patient and graft survival truly represent heart transplant center performance. Thus, a forum was organized by the Thoracic and Critical Care Community of Practice (TCC COP) of the American Society of Transplantation (AST) for the heart transplant community to voice their opinions on matters involving program performance monitoring by UNOS. A TCC COP work group was formed to review outcome metrics for adult heart transplantation and culminated in a virtual community forum (72 participants representing 61 heart transplant programs) on November 12-13, 2020. One-year posttransplant survival is still considered an appropriate and important measure to assess program performance. Waitlist mortality and offer acceptance rate as pretransplant metrics could also be useful measures of program performance, recognizing that outside factors may influence these metrics. In depth discussion of these metrics and other issues including auditing thresholds, innovations to reduce risk-averse behavior and personally designed program scorecards are included in this meeting proceedings.

Amiodarone Use Prior to Cardiac Transplant Impacts Early Post-Transplant Survival.

PURPOSE: It remains unclear if use of amiodarone pre-cardiac transplantation impacts early post-transplant survival. METHODS: We selected all patients undergoing heart transplant from 2004 to 2006 with available information using the United Network for Organ Sharing database (n = 4057). Multivariable Cox models compared the risk of death within 30 days post-transplant in patients who were taking amiodarone at the time of transplant listing (n = 1227) to those who were not (n = 2830). RESULTS: Mean age was 52 (± 12) years, and 23% were women. Patients who died within 30 days (n = 168) were older; had higher panel reactive antibody levels, higher bilirubin levels, and higher prevalence of prior cardiac surgery; were often at status 1B; and had higher use of amiodarone at listing compared to those who survived (5.3% versus 3.6%; p = 0.02). Cause of death was unknown in 49% and was reported as graft failure in 43% of cases. In multivariable Cox models, patients on amiodarone at the time of listing had 1.56-fold higher risk of post-transplant death within 30 days (95% confidence intervals 1.08-2.27) compared to patients who were not on amiodarone at listing (C-statistic 0.70). CONCLUSION: In conclusion, patients who reported taking amiodarone at the time of listing for transplant had a higher risk of death within 30 days post-transplant.

Heart and kidney transplant: should they be combined or subsequent?

AIMS: End-stage heart failure patients often present with severe kidney failure and have limited treatment options. We compared the clinical characteristics and outcomes among end-stage heart and kidney failure patients who underwent combined heart and kidney transplant (HKTx) with those who underwent kidney transplant after heart transplant (KAH). METHODS AND RESULTS: All patients from 2007-2016 who underwent combined HKTx (n = 715) and those who underwent KAH (n = 130) using the United Network for Organ Sharing database were included. Kaplan-Meier curves and Cox models compared survivals and identified predictors of death. Number of combined HKTx performed annually in United States increased from 59 in 2007 to 146 in 2016 whereas KAH decreased from 34 in 2007 to 6 in 2016. Among KAH patients, average wait time for kidney transplant was 3.0 years, time to dialysis or to kidney transplant after heart transplant did not differ with varying severity of kidney disease at baseline (P for both >0.05). Upon follow-up (mean 3.5 ± 2.7 years), 151 patients died. In multivariable models, patients who underwent combined HKTx had 4.7-fold greater risk of death [95% confidence interval (CI) 2.4-9.4) than KAH patients upon follow up. A secondary analysis using calculation of survival only after kidney transplant for KAH patients still conferred higher risk for combined HKTx patients [hazard ratio (HR) 2.6 95% CI 1.33-5.15]. In subgroup analyses after excluding patients on dialysis (HR 3.99 95% CI 1.98-8.04) and analysis after propensity matching for age, gender, and glomerular filtration rate (HR 3.01 95% CI 1.40-6.43) showed similar and significantly higher risk for combined HKTx patients compared with KAH patients. Lastly, these results also remained unchanged after excluding transplant centres who performed only one type of procedure preferentially, i.e. HKTx or KAH (HR 4.70 95% CI 2.35-9.42). CONCLUSIONS: National registry data show continual increase in combined HKTx performed annually in the United States but inferior survival compared with KAH patients. Differences in patient characteristics or level of kidney dysfunction at baseline do not explain these poor outcomes among HKTx patients compared with KAH patients. Consensus guidelines are greatly needed to identify patients who may benefit more from dual organ transplants.

Evaluation for Heart Transplantation and LVAD Implantation: JACC Council Perspectives.

Timely referrals for transplantation and left ventricular assist device implantation play a key role in favorable outcomes in patients with advanced heart failure. Nonetheless, evaluation usually occurs at advanced heart failure centers and is obscured from referring physicians. The purposes of this review are to explain the decision-making process for candidacy for advanced therapies and to describe the potential impact of the new organ allocation algorithm on center decision making. The document first addresses the signs of advanced heart failure, specifically focusing on the importance of the syndrome of low cardiac output as a key feature of advanced heart failure, and then summarizes the evaluation as a 3-step process addressing the following questions: 1) Is transplantation or durable assist device placement indicated? 2) Are there contraindications to either intervention? 3) How can one choose between transplantation and left ventricular assist device implantation if advanced therapies are indicated and not contraindicated?

Activities and Compensation of Advanced Heart Failure Specialists: Results of the Heart Failure Society of America (HFSA) Survey.

BACKGROUND: In the current era, where advanced heart failure (AHF) has become an American Board of Internal Medicine-certified subspecialty, new data are needed to benchmark and value levels of clinical effort performed by AHF specialists (AHFMDs). METHODS AND RESULTS: A 36-question survey was sent to 728 AHFMDs, members of the Heart Failure Society of America, and 224 (31%) responded. Overall, 56% worked in academic medical centers (AMCs) and were younger (48 ± 9 y vs 52 ± 10 y; P < .01) and were represented by a higher proportion of women (34% vs 21%, P < .01) compared with non-AMCs. The percentage of time in clinical care was lower in AMCs (64 ± 19% vs 78 ± 18%; P = .002), with similar concentration on evaluation and management services (79 ± 18% in AMCs vs 72 ± 18 % in non-AMCs; P = NS). The majority of nonclinical time was spent in program administration (10% in both AMCs and non-AMCs) and education/research (15% in AMC vs 5% in non-AMCs). Although 69% of respondents were compensated by work-relative value units (wRVUs), only a small percentage knew their target or the amount of RVUs generated. The mean annual wRVUs generated were lower in AMCs compared to non-AMCs (5,452 ± 1,961 vs 9,071 ± 3,484; P < .001). The annual compensation in AMCs was lower than in non-AMCs (45% vs 10% <$250,000 and 17% vs 61% >$350,000; P < .001) and the satisfaction with compensation was higher in non-AMCs. CONCLUSIONS: AHFMDs' compensation is largely dependent by practice type (AMC vs non-AMC) and clinical productivity as measured by wRVUs. These data provide an opportunity for benchmarking work effort and compensation for AHFMDs, allowing distinction from segments of cardiologists with greater opportunity to accrue procedural wRVUs. They also show several differences between AMCs and non-AMCs that should be considered when formulating work assignment and compensation for AHFMDs.

A novel approach to prevent post-operative ileus after continuous-flow left ventricular assist device implantation: A retrospective cohort study.

INTRODUCTION: Patients with postoperative ileus (POI), a common post-surgical event, experience intense discomfort. Various treatments targeting prevention of POI have shown to have an unpredictable effect. We introduced a novel postoperative bowel management protocol in patients implanted with a continuous-flow left ventricular assist device (CF-LVAD). The effect of this protocol on POI was evaluated. METHODS: Patients receiving an old bowel management protocol (OBMP; 01/2007-03/2009) were compared with those receiving a new bowel management protocol (NBMP; 04/2009-12/2013). The OBMP consisted of advancing the diet as tolerated, bisacodyl suppositories and enemas with the goal of a bowel movement (BM) every 3 days. The NBMP consisted of clear liquids until first BM is achieved, then full liquids until the second BM, then advancing to goal diet. Docusate is given on postoperative day (POD) 1 and bisacodyl PR on POD2 with enemas if ileus develops. Enemas are added POD3 if no BM has occurred. Polyethylene glycol is considered daily for patients prone to constipation. The goal is a BM every 2 days. Patients were made nil per os (NPO) with any signs of ileus. RESULTS: One hundred eighteen patients were implanted with CF-LVADs during the study period. The incidence of ileus significantly decreased from 19% in the OBMP group to 4% percent in the NBMP group (p < 0.05). In-hospital mortality was not different between the two groups (6% vs. 2% p = 0.35). CONCLUSIONS: A novel postoperative bowel management protocol successfully decreased the incidence of POI following CF-LVAD implant surgery at our institution.