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Guidelines for heart failure management commonly focus on mortality, hospitalization, or surrogate measures such as change in ejection fraction as outcome parameter. Reducing symptoms and increasing functional capacity and quality of life are commonly articulated goals, but there is no consensus on how best to achieve these outcomes. We aimed to evaluate the feasibility of routinely measurement of a defined standard pragmatic patient-reported outcome set. We assessed a panel of PROM assessment tools proposed by the International Consortium for Health Outcomes Measurement (ICHOM) in patients with advanced heart failure three months after discharge from Heart failure unit. Patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), PROMIS Physical Function Short Form 4a as (PROMIS-4a) well as EQ 5D and Patient Health Questionnaire-2 (PHQ-2). We included n=99 patients (33% female; mean age 64 years ±16 SD) into the study. Three months later, n=79 (80%) participated in PROM assessment. Eight patient died, ten patients were lost to follow-up and two patient were still at the ward. Nearly all patients (97%) suffered from systolic heart failure and two thirds had a reduced right ventricular function. Patients reported a mean KCCQ-12 overall score of 29.7 points (±12.0 SD). PHQ-2 score ≥3 points was found in 20 patients (25%). Further, patients reported a mean PROMIS-4a sum score of 12.6 (±4.8 SD) and a mean EQ-5D VAS of 56.8 points (±21.1 SD). In all questionnaires, we found <10% missing values. A vast majority of patients (73%) agreed that their responses provided good insight into their health state and limitations due to heart failure. 71% of patients would approve adjusting heart failure treatment based on their responses. We measured relatively low mean scores of all PROM assessment tools, underpinning the burden of disease in advanced heart failure. Low percentage of missing data hallmarks the feasibility of PROM assessment. We conclude that routinely PROM assessment and standardization might improve heart failure care, monitor quality of life and therefore permit comparison across several therapeutic strategies. [ABSTRACT FROM AUTHOR]

Background Ventricular assist devices (VADs) have improved survival among end-stage heart disease patients. Since 2002, heart transplant candidates with VADs have been afforded 30 days of elective time at the highest urgency category (Status 1A) under Organ Procurement and Transplantation Network (OPTN) policy. We aimed to determine the effect of increasing elective time at the highest urgency category for heart transplant candidates with VADs. This analysis was requested by OPTN during its evaluation of heart allocation policy. Methods We simulated several allocation schemes wherein elective Status 1A time was increased to 45, 60, and 90 days; results were compared with a baseline simulation of 30 days and with the actual observed heart transplant waiting list cohort. Results The simulations showed that increasing elective Status 1A time for candidates with VADs did not substantially change waiting list mortality overall or for sub-groups of concern, which were candidates with VADs listed at a lower-urgency category (Status 1B), those with with VAD complications, total artificial heart, or intraaortic balloon pump support; or those with extracorporeal membrane oxygenation. Across the different time allowances, the average post-transplant death rate remained stable. It also remained stable for recipients previously listed as Status 1A or 1B categories for VAD and for recipients with VAD complications or an intraaortic balloon pump at transplant, on extracorporeal membrane oxygenation, and those without devices. Conclusions Our results suggest that increasing time in the highest urgency category for candidates with VADs would not improve waiting list mortality or post-transplant outcomes for heart transplant candidates overall. [ABSTRACT FROM AUTHOR]

Background With increasing age of patients with heart failure, it is important to understand the potential role for orthotopic heart transplant (OHT) in elderly patients. We examined recipient and donor characteristics and long-term outcomes of older recipients of OHT in the United States. Methods Using the United Network for Organ Sharing database, we identified OHT recipients from the years 1987–2014 and stratified them by age 18–59 years old, 60–69 years old, and ≥70 years old. We compared baseline characteristics of recipients and donors and assessed outcomes across groups. Results During this period, 50,432 patients underwent OHT; 71.8% ( n = 36,190) were 18–59 years old, 26.8% ( n = 13,527) were 60–69 years old, and 1.4% ( n = 715) were ≥70 years old. Comparing the ≥70 years old group and 60–69 years old group, older patients had higher rates of ischemic etiology (53.6% vs 44.9%) and baseline renal dysfunction (61.4% vs 56.4%) and at the time of OHT were less likely to be currently hospitalized (45.0% vs 50.9%) or supported with left ventricular assist device therapy (21.0% vs 28.3%). Older recipients received organs from older donors (median age 36 years old vs 30 years old) who were more likely to have diabetes and substance use. After OHT, the median length of stay was similar between groups. At 1 year, of patients alive, patients ≥70 years old had fewer rejection episodes (17.8%) compared with patients 60–69 years old (29.5%). The 5-year mortality was 26.9% for recipients 18–59 years old, 29.3% for recipients 60–69 years old, and 30.8% for recipients ≥70 years old. Conclusions Despite advanced age and less ideal donors, OHT recipients in their 70s had similar outcomes to recipients in their 60s. Selected older patients should not routinely be excluded from consideration for OHT. [ABSTRACT FROM AUTHOR]

Background Advanced heart failure teams are often faced with the decision of whether or not to offer a left ventricular assist device (LVAD) to patients who have end-stage heart failure and recent or ongoing substance abuse. The outcomes of these patients after LVAD implantation are unknown. Methods Baseline predictors and outcomes were collected and analyzed from patients with active substance abuse and a cohort of patients without active substance abuse matched for age, INTERMACS profile and year of implantation. The primary outcome was all-cause mortality. Secondary outcomes included rates of listing for cardiac transplantation, transplantation and chronic drive-line infection. Results The cohort consisted of 20 consecutive LVAD recipients with active substance abuse and 40 recipients without active substance abuse. During a median follow-up period of 2.3 years (IQR 1.4 to 3.6), the substance abuse group had 3.2 times the rate (hazard) of death compared with a matched cohort (HR 3.2, 95% CI 1.2 to 8.0, p < 0.05). Furthermore, the rate of listing for transplant was 69% lower (rate ratio 0.31, p < 0.0005), rate of cardiac transplant was 89% lower (rate ratio 0.11, p < 0.0005), and risk of chronic drive-line infection was 5.4 times higher (rate ratio 5.4, p < 0.0005) in the substance abuse group. Conclusions Active substance abuse in patients who received an LVAD was associated with increased mortality and overall poor outcomes. Larger scale data will be needed to confirm these findings and to inform decision-making in this population. [ABSTRACT FROM AUTHOR]

Background: Elevated pulmonary vascular resistance (PVR) in heart transplant (HT) candidates is associated with poor survival after HT. This study assessed the effect of peri-operative sildenafil administration on pulmonary hemodynamics and clinical outcomes in patients with advanced heart failure who were considered high-risk for HT because of elevated PVR and transpulmonary gradient (TPG). Methods: The study included 119 consecutive patients who underwent HT between 2004 and 2011. Fifteen patients (Group A) had severe pulmonary hypertension (PH), defined as mean pulmonary pressure (MPAP)>25 mm Hg and PVR>2.5 Wood units (WU), and/or TPG>12 mm Hg after vasodilator test or the continuous administration of inotropics drugs, and 104 patients (Group B) were without severe PH. Group A received sildenafil therapy. Pulmonary hemodynamics were evaluated before HT with and without sildenafil therapy. Right catheterization was performed early after HT with sildenafil therapy and late after HT without sildenafil. Survival after HT was compared between the groups. Results: The sildenafil dosage was 109±42 mg/day during 163±116 days before HT. After sildenafil therapy MPAP, PVR, and TPG decreased from 43.9±12.5 to 33.4±5.8 mm Hg, 5.0±1.1 to 3.0±1.6 WU, and 17.3±3.2 to 10.2±4.1 mm Hg, respectively (p<.01). All patients underwent successful HT. Sildenafil dosage was 140±70 mg/day for 43±45 days after HT. There were no differences in PVR and TPG with sildenafil therapy early after HT and without sildenafil 6 months after HT. Survival after HT was similar between the groups. Conclusion: Sildenafil therapy before and after HT in patients with severe PH is associated with improved pulmonary hemodynamics and successful HT, without an increase in post-HT mortality. [Copyright &y& Elsevier]

Background: Liver dysfunction increases post-surgical morbidity and mortality. The Model of End-stage Liver Disease (MELD) estimates liver function but can be inaccurate in patients receiving oral anti-coagulation. We evaluated the effect of liver dysfunction on outcomes after ventricular assist device (VAD) implantation and the dynamic changes in liver dysfunction that occur during VAD support. Methods: We retrospectively analyzed 255 patients (147 with pulsatile devices and 108 with continuous-flow devices) who received a long-term VAD between 2000 and 2010. Liver dysfunction was estimated by MELD and MELD-eXcluding INR (MELD-XI), with patients grouped by a score of ≥ 17 or < 17. Primary outcomes were on-VAD, after transplant, and overall survival. Results: MELD and MELD-XI correlated highly (R ≥ 0.901, p < 0.0001) in patients not on oral anti-coagulation. Patients with MELD or MELD-XI < 17 had improved on-VAD and overall survival (p < 0.05) with a higher predictive power for MELD-XI. During VAD support, cholestasis initially worsened but eventually improved. Patients with pre-VAD liver dysfunction who survived to transplant had lower post-transplant survival (p = 0.0193). However, if MELD-XI normalized during VAD support, post-transplant survival improved and was similar to that of patients with low MELD-XI scores. Conclusions: MELD-XI is a viable alternative for assessing liver dysfunction in heart failure patients on oral anti-coagulation. Liver dysfunction is associated with worse survival. However, if MELD-XI improves during VAD support, post-transplant survival is similar to those without prior liver dysfunction, suggesting an important prognostic role. We also found evidence of a transient cholestatic state after LVAD implantation that deserves further examination. [ABSTRACT FROM AUTHOR]

Background: Risk stratification for mechanical circulatory support (MCS) has emerged as an important tool in patient selection and outcomes assessment. Most studies examining risk stratification have been limited to pulsatile devices. We use the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to stratify patients with continuous-flow devices and assess outcomes in less severe, but functionally impaired, heart failure patients. Methods: This study included 101 bridge-to-transplant and destination-therapy patients at 3 centers. Three groups were studied: Group 1, cardiogenic shock (INTERMACS Profile 1); Group 2, inotrope-dependent (INTERMACS Profile 2 or 3); and Group 3, ambulatory advanced heart failure (INTERMACS Profiles 4 to 7). The outcomes of interest were actuarial survival, survival to discharge and length of stay. Results: Survival at 36 months was better in Group 3 than in Group 1 (95.8% vs 51.1%, p = 0.011), but not between Groups 2 and 3 (68.8 vs 95.8%, p = 0.065). Lengths of stay for Groups 1 to 3 were 44, 41 and 17 days: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.62. Lengths of stay for survivors were 49, 39 and 14 for the 3 groups: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.28. Conclusion: INTERMACS classification is a useful metric for risk-stratifying candidates for MCS. Less acutely ill but functionally impaired heart failure patients receiving continuous-flow LVADs had longer short- and long-term survival and shorter lengths of stay compared with patients who were more acutely ill. [ABSTRACT FROM AUTHOR]

Background: Advanced age is considered a relative contraindication to heart transplantation, but there is no published consensus on critical age in the case of mechanical circulatory support (MCS). This single-center study investigated outcomes of elective versus emergent implementation of permanent MCS in the elderly. Methods: Between January 1, 2006 and April 1, 2009, 31 patients, >65 years of age, were supported with a ventricular assist device (VAD), intended for permanent support, at our institution. The 28 left VAD (LVAD) recipients were divided into two groups: a survival group, n = 13 (ongoing MCS at 180 days or weaned); and a non-survival group, n = 15 (death on device within 180 days). In addition, the survival rate of LVAD recipients according to pre-operative INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) status was analyzed. Results: The cumulative survival rates for the LVAD patients were 75% at 30 days, 46% at 180 days and 39% at 1 year after VAD implantation. The cumulative survival rates at 30 days, 180 days and 1 year were 71%, 47% and 35% for INTERMACS Level I to III (n = 17) patients vs 81%, 45% and 45% for INTERMACS Level IV to V (n = 11) patients (p = 0.9), respectively. Median age of LVAD recipients was 69 (range 66 to 80) years; 4 were women. Median support time was 565 (range 228 to 1,257) days. In 9 recipients support is ongoing. Both complications profiles and causes of death are reported. Conclusions: Our experience indicates that permanent MCS may be successful in highly selected elderly patients with terminal heart failure, especially when elective implantation is performed before development of inotropic dependency or cardiogenic shock. However, outcomes at 12 months in this selective elderly population remain uniformly poor. [Copyright &y& Elsevier]

Background: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scale classifies advanced heart failure patients according to hemodynamic status. This study assessed the usefulness of the INTERMACS scale to predict outcomes in advanced heart failure patients undergoing mechanical circulatory support (MCS). Methods: Fifty-four patients underwent MCS implantation from 2001 to 2007. Group A included 27 patients at INTERMACS level 1 and 2. Group B included 27 at INTERMACS level 3 and 4. Patient characteristics pre-MCS implant, incidence of complications during support, and survival between groups were compared. Results: Before MCS implantation, Group A had significantly lower cardiac index, mean arterial blood pressure, systolic pulmonary pressure, higher central venous pressure, and lower urine output (p < .05). After MCS, Group A had a lower incidence of infections (17% vs 46%; odds ratio [OR], 0.25, 95% confidence interval [CI], 0.06–0.6) and a higher incidence of liver injury (39% vs 11%; OR 5, 95% CI, 1.15–25). Mortality at 30 days was higher in Group A (38% vs 11%; OR, 4.8; 95% CI, 1.1–21); however, the mortality after 30 days post-MCS support was significantly higher in Group B (0% vs 18%, p < .05). Cox model showed overall survival was poorer in Group A (hazard ratio, 2.7; 95% CI, 1.1–7). Conclusion: INTERMACS levels identified patients at risk for developing complications after MCS support. INTERMACS is a valid score system that should be considered as a tool to assess patient profile and predict complications and mortality after MCS implantation. [Copyright &y& Elsevier]

Objective: The effect of age on outcomes after continuous-flow left ventricular assist device (LVAD) implantation as a bridge to transplantation (BTT) was determined. Methods: From November 1998 to July 2007, 86 patients with advanced heart failure underwent continuous-flow LVAD implantation as BTT and were retrospectively analyzed. Patients were categorized into 2 groups by age at LVAD implantation: 56 patients (65.1%) younger than 60, Group 1; and 30 (34.9%) aged 60 years or older, Group 2. Results: Group 2 patients had a higher incidence of heart failure caused by ischemic heart disease (63.3% vs 32.1%, p = 0.005) and more severely impaired renal function by Modification of Diet in Renal Disease-derived glomerular filtration rates (51.9 ± 15.9 vs. 68.0 ± 20.5 ml/min/1.73 m2, p < 0.001) than Group 1. Age was the only independent predictor of post-LVAD death (hazard ratio, 1.4 p = 0.003). The BTT rate was lower (33.3% vs 62.5%, p = 0.010), and incidence of post-LVAD renal failure was higher (53.3% vs 30.4%, p = 0.037) in Group 2 vs Group 1. Post-LVAD survival at 1, 3, and 6 months was 92.9%, 79.9%, and 74.0% for Group 1 and 90.0%, 62.0%, and 37.0% for Group 2 (p = 0.007). Post-transplant survival at 1, 3, and 5 years was 87.8%, 82.3%, and 76.0% for Group 1 and 90.0%, 67.5%, 67.5% for Group 2 (p = 0.517). Conclusions: Patients aged 60 years and older have inferior post-LVAD survival; however, post-transplant survival is excellent. We advocate LVAD placement as bridge-to-transplant therapy only in carefully selected older patients most well suited for transplantation. [Copyright &y& Elsevier]