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Purpose: Caregivers (CGs) provide essential support to older (60-80 years) patients with advanced heart failure (HF), yet caregiving may be burdensome. Understanding the caregivers time spent and difficulty in caring for patients may inform CG support needs before and after cardiac surgery. We compared CG burden before and 24 months after heart transplantation (HT), with or without baseline mechanical circulatory support (MCS), and long-term MCS as destination therapy (DT). Methods: Between 10/1/15-12/31/18, we enrolled 301 CGs of HF patients from 13 U.S. hospitals: 193 awaiting HT (92 with and 101 without MCS), and 108 scheduled for long-term MCS. At baseline (pre-surgery) and 24 months post-surgery, CGs completed the Oberst Caregiving Burden Scale (OCBS), which has 15 items with 2 subscales: (1) time: range=1-5, higher score=more time spent on task and (2) difficulty: range=1-5, higher score=higher task difficulty. Statistical analyses included t-tests and baseline-adjusted linear regression models. Results: CGs’ average age was 60.9±10 years, 83% were spouses, 85% female, and 85% white. Across all groups and both time points, time spent on caregiving tasks was moderate and task difficulty was rated low. Time spent on caregiving decreased significantly from baseline to 24-months for all groups (p-value Conclusions: CG time on tasks decreased from baseline to 24-months post-surgery in all groups, and both time and difficulty scores were persistently higher for CGs of DT patients. These results may inform identification of support options to reduce time and difficulty of CG tasks, particularly for those who care for destination therapy HF patients.

Supplemental Digital Content is available in the text., Background. We sought to compare change over time (baseline to 2 y) in health-related quality of life (HRQOL) between older (60–80 y) patients awaiting heart transplantation (HT) with mechanical circulatory support (MCS) versus without MCS and their caregivers and caregiver burden. Methods. This study was conducted at 13 United States sites. Patient HRQOL was examined using the EuroQol 5-dimensional questionnaire (EQ-5D-3L) and Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Caregiver measures included the EQ-5D-3L and Oberst Caregiving Burden Scale, measuring time on task and difficulty. Analyses included analysis of variance, χ2, and linear regression. Results. We enrolled 239 HT candidates (n = 118 with MCS and n = 121 without MCS) and 193 caregivers (n = 92 for candidates with MCS and n = 101 for candidates without MCS). Baseline differences in HRQOL were observed between HT candidates with and without MCS: EQ-5D-3L visual analog scale (VAS) score (67.7 ± 17.6 versus 54.1 ± 23.3, P < 0.001) and KCCQ-12 overall summary score (59.9 ± 21.0 versus 48.9 ± 21.6, P < 0.001), respectively. HT candidates with MCS had significantly higher EQ-5D-3L VAS scores and KCCQ-12 overall summary score across time versus without MCS. Baseline EQ-5D-3L VAS scores did not differ significantly between caregivers of HT candidates with and without MCS (84.6 ± 12.9 versus 84.3 ± 14.4, P = 0.9), respectively, nor were there significant between-group differences over time. Caregivers for HT candidates with MCS reported more task difficulty (range: 1 = not difficult to 5 = extremely difficult) versus caregivers for those without MCS at baseline (1.4 ± 0.5 versus 1.2 ± 0.3, P = 0.004) and over time. Conclusions. Understanding differences in HRQOL and caregiver burden among older HT candidates with and without MCS and their caregivers may inform strategies to enhance HRQOL and reduce burden.

Introduction: Caregivers (CGs) of heart failure (HF) patients (PTs) who undergo heart transplantation (HT) or Destination Therapy Mechanical Circulatory Support (DT MCS) provide support to PTs before and after surgery, which may affect their own health-related quality of life (HRQOL). In SUSTAIN-IT, we previously reported that CG HRQOL was good at baseline (i.e., before HT and DT MCS surgery) and was impacted by CG comorbidities and CG anxiety. This report explores change in CG overall HRQOL, depression, and anxiety from baseline to 12 months after HT or DT MCS surgery. Methods: From 10/1/15-12/31/18, 13 U.S. centers enrolled 301 CGs of HF PTs: 193 awaiting HT (92 HT with MCS as a bridge to transplant [HT BTT] and 101 HT without MCS [HT non-BTT]), and 108 awaiting DT MCS. At baseline, 3, 6, and 12 months post HT or DT MCS surgery, CGs completed the following instruments: EQ-5D-3L (Visual Analog Scale [VAS]: 0 [worst] to 100 [best] imaginable health state), PHQ-8 (range=0-24; score ≥10=depressive symptoms requiring evaluation), and STAI-State (range=20-80, higher score=more anxiety). Analyses included unadjusted and baseline-adjusted linear regression models. Results: CGs were age 61.0±10.3 years; the majority were Caucasian (86%), female (86%), spouses (85%) of enrolled HF PTs. At baseline, CG EQ-5D-3L VAS and PHQ-8 average scores were 83.8 ± 13.99 (high) and 2.6 ± 2.85 (low), respectively, for the entire cohort. No significant interval changes in CG HRQOL and depressive symptoms were found within or between groups. DT MCS and HT non-BTT CG anxiety significantly decreased over time (baseline to 12 months) (Figure). Levels of CG anxiety were similar among all groups at 12 months after HT or DT MCS surgery. Conclusions: The demonstrated reduction in anxiety among CGs in the post-operative period provides clinicians with important information to share with CGs when PTs are considering surgical treatment options for HF.

Purpose: Caregivers (CGs) for patients with advanced heart failure (HF) assist in HF-specific disease management. In the SUSTAIN-IT study, we reported CG perception of difficulty and time needed to perform tasks for patients awaiting surgery in 3 groups: HF patients awaiting heart transplant (HT) without mechanical support (HT-non-MCS), HF patients awaiting HT bridged with mechanical support (HT-MCS), and HF patient awaiting left ventricular device implantation as destination therapy (DT-MCS). In this report, we compare CG perceived burden from baseline to 1 year after surgery. Methods: We enrolled 301 CGs of HF patients between 10/1/15-12/31/18 from 12 U.S. hospitals: 193 awaiting HT (92 with and 101 without MCS), and 108 scheduled for DT-MCS. Prior to surgery and 3, 6, and 12 months after surgery, CGs completed the Oberst Caregiver Burden Scale (OCBS) which has 15 items with 2 subscales: (1) time and (2) difficulty: range=1-5, higher score=more time required for tasks and more task difficulty. Analyses included t-tests, chi-square tests, and baseline-adjusted linear regression models. Results: CGs were age 61.0±10.3 years, the majority were spouses (85%), female (86%), and white (86%). Average time spent on caregiving was moderate and decreased significantly from baseline to 12 months after surgery for all groups (Figure). DT-MCS CGs spent significantly more time than HT CGs on tasks 12 months after surgery. There were no significant differences in perceived difficulty (which was low) in performing CG tasks in all groups from baseline to 12 months. DT-MCS CGs did perceive tasks to be more difficult than HT CGs at 12 months. Conclusion: CGs of advanced HF patients adapted well to assisting with care, without increased burden, 1 year after HT and DT-MCS surgery. CGs of DT-MCS patients required more time and reported CG tasks to be more difficult than HT CGs. Understanding differences in CG burden will aid in pre surgical risk discussions and post-surgical follow-up.

Suicide is a major public health problem around the world. Case reports include extreme suicidal self-inflicted injuries, in which extensive damage to the abdominal wall associated with injury or even excision of fragments of the intestine and its fragmentation are present. These cases usually give rise to doubts of investigators as to the course of the incident, the circumstances of death and the possibility of participation of other people. At the same time they are interesting from the medico-legal and psychiatric perspective. The aim of this study is the presentation of two extremely rare cases of suicides through evisceration and intestinal injury from the clinical and opinioning practice of the authors, one of which ended with survival and the second one with death. Regardless of the final result of the suicide attempt (death or survival), good practice of the investigative teams in such cases should include a detailed examination of the place of the suicide attempt, obtaining opinion of an expert in the field of forensic medicine with full post-mortem diagnosis, and in-depth forensic psychological and psychiatric analysis of, among others, lifeline, mental state and suicidal motivation (so-called psychological autopsy).Samobójstwo stanowi poważny problem w zakresie zdrowia publicznego na całym świecie. Do kazuistycznych należą przypadki ekstremalnych samobójczych samookaleczeń, w których samobójca dokonuje rozległych uszkodzeń powłok brzusznych połączonych z uszkodzeniem lub nawet wycięciem fragmentów jelita i jego rozkawałkowaniem. Przypadki te zazwyczaj budzą wątpliwości śledczych co do przebiegu zdarzenia i okoliczności zgonu oraz możliwości udziału osób trzecich. Jednocześnie są one interesujące z perspektywy medyczno-sądowej i psychiatrycznej. Celem niniejszej pracy jest prezentacja dwóch niezwykle rzadkich przypadków działań samobójczych poprzez wytrzewienie i uszkodzenie jelita – z praktyki klinicznej i opiniodawczej autorów, z których jedno zakończyło się przeżyciem, a drugie śmiercią samobójcy. Niezależnie od końcowego efektu podjętej próby samobójczej (zgon lub przeżycie) optymalnym postępowaniem ze strony służb dochodzeniowo-śledczych w tego rodzaju przypadkach powinno być przeprowadzenie szczegółowych oględzin miejsca zdarzenia, zasięgnięcie dowodu z opinii biegłego z zakresu medycyny sądowej z wykonaniem pełnej diagnostyki pośmiertnej i pogłębiona analiza sądowo-psychologiczna oraz psychiatryczna m.in. linii życiowej, stanu psychicznego i motywacji samobójcy (tzw. autopsja psychologiczna).

Purpose Factors related to health-related quality of life (HRQOL) of older patients (pts) with advanced heart failure (HF) scheduled for left ventricular assist device (LVAD) implantation as destination therapy (DT) or while a candidate for heart transplantation (HT) with or without an LVAD, may guide therapeutic strategies. We sought to identify pt and caregiver (cg) factors related to HRQOL of pts (60-80 years) awaiting these surgeries. Methods From 10/1/15-12/31/18, we enrolled 302 pts with cgs (n=302) from 13 U.S. sites: 193 pts awaiting HT (92 with and 101 without LVAD) and 109 DT LVAD pts. Pts completed the EQ-5D-3L Visual Analog Scale (VAS): 0-100 (worst-best) health; KCCQ-12 summary score (SS), 0-100=low-high; PHQ-8 (0-24; score > 10=significant depressive symptoms) and STAI-state (20-80; higher score=more anxiety). Cgs completed the EQ-5D, STAI, PHQ-8 and Oberst Caregiving Burden Scale (OCBS): 2 subscales (time and difficulty, 1-5; higher score=more time and more task difficulty). Analyses included multivariable logistic regression models; the binary outcomes were whether individual EQ-5D VAS and KCCQ-12 SSs were higher than the cohort median of 60 and 46, respectively. Results Pts were 66.1±4.5 years, 82% male, and 86% white. Pts reported relatively low generic HRQOL (VAS mean=55.3±23.5) and low HF-specific HRQOL (SS mean=47.5±22.5), both with significant group differences. HT pts with LVADs were more likely to have higher EQ-5D VAS scores; DT pts had the lowest VAS scores (p > 10 was related to lower VAS scores (p > 10 was related to lower KCCQ-12 SSs (p Conclusion Implant strategy, pt depression, and cg time spent on care were significantly related to older advanced HF pt HRQOL. Findings may inform interventions for HF pts awaiting surgery.

Purpose Heart transplantation (HT) and mechanical circulatory support (MCS) has improved heart failure (HF) patient (PT) outcomes; it has also led to increased caregiver (CG) responsibility pre and post-surgery. We assessed whether PT and CG factors were related to baseline CG perceived burden in 3 groups of CGs of HF PTs (60-80 years): (1) PT supported with MCS as a bridge to HT (HT BTT), (2) PT awaiting HT without MCS (HT non BTT), and (3) PT prior to MCS for destination therapy (DT MCS). Methods Between 10/1/15-12/31/18, we enrolled 302 CGs from 13 U.S. sites: 92 HT BTT, 101 HT non BTT, and 109 DT MCS. CG burden was measured with the Oberst Caregiving Burden Scale (OCBS: [1] time: higher score=more time spent on task and [2] difficulty: higher score=more difficulty of task). CGs also completed the EQ-5D-3L (Visual Analog Scale [VAS]: 0 [worst] to 100 [best] imaginable health state and 5 dimensions); STAI-State (higher score=more anxiety); PHQ-8 (score ≥10=significant depressive symptoms), and demographic/health history/impact of caregiving on own health questions. PTs completed the KCCQ-12, MoCA (measure of cognitive dysfunction) and all above measures except the OCBS. Analyses included multivariable logistic regression models in which the binary outcomes were whether individual OCBS difficulty and time scores were higher than the cohort median values of 1.20 and 2.26, respectively. Results CGs were 61.1±9.7 years, 85% spouses, 85% female, and 85% white. Overall CG difficulty was low and CG time spent was moderate. CGs who reported more difficulty on tasks perceived more impact on their own health and had more anxiety, with no differences by PT implant strategy (table). CGs with Conclusion Only CG factors, and not PT factors, were related to CG perceived burden. Understanding factors that affect CG burden may aid in preoperative advanced therapies discussions.

Purpose While left ventricular assist devices (LVADs) are known to improve heart failure (HF) patient survival and health status (i.e., symptoms, function, and quality of life), they also require substantial support from caregivers (CG). In fact, excessive CG burden is a relative contraindication to LVAD implantation. Importantly, CG burden can be a transient state and whether or not this improves in patients’ whose health status improves from before to after LVAD implantation has not been described. Methods Between 10/1/15 and 12/31/18, 96 patients and their CGs were recruited from 13 U.S. sites; data through 1 year after LVAD implantation were used. Patient health status was defined by Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) Overall Summary score, where higher scores indicate better health status. CG burden was measured using the Oberst Caregiver Burden Scale (OCBS): 15 items (range=1-5), measuring perceived amount of time spent and difficulty of tasks (higher score=more time on task and more difficulty), respectively. Linear regression was used to identify patient and CG factors independently associated with change in CG burden. Results LVAD recipients were 67.5±5.4 years old, 86% male, and with an implant strategy of destination therapy (65%) and bridge to transplant (35%). Their baseline KCCQ score was 45.5±23.9. Their CGs were 60.7±10.3 years old, 91% female and had baseline OCBS time and burden scores of 2.4±0.7 and 1.4±0.5, respectively. Better baseline and greater improvements in patients’ health status was strongly associated with improvements in CG burden, both time and difficulty (Table). Conclusion This study highlights the complex dyadic relationship between HF patients and their CGs. After LVAD implantation, the greater the improvement in HF patient health status, the greater the reduction in CG burden. The likelihood of patient improvement with LVAD implantation should be considered when there is concern about CG burden prior to implantation.

Objectives Heart transplantation (HT) and mechanical circulatory support (MCS) as destination therapy (DT) are life-saving options for 60-80 year-old patients (pts) with advanced heart failure (HF). We compared pt health-related quality of life (HRQOL) before and 1 year (yr) after surgery in pts undergoing HT (with or without MCS) and DT MCS. Methods Among 393 pts at 13 US sites awaiting HT (n=239; 118 awaiting HT with MCS, 121 awaiting HT without MCS; 66% transplanted) and DT MCS (n=154) between 10/1/15-12/31/18, we collected self-report data on: HRQOL (EQ-5D-3L Visual Analog Scale [VAS]: 0-100=worst to best) and (KCCQ-12: 0-100=lowest to highest), depressive symptoms (PHQ-8: 0-24=fewer to more) and anxiety (STAI-state: 20-80=lower to higher]). There were 337 pts at 1 year follow up. Statistical analyses included paired t-tests, chi-square tests, and baseline-adjusted linear regression models. Results The majority of pts were white and male. DT pts were older than HT pts (DT = 68.6±5.2 vs HT with MCS = 64.4±3.3 vs HT without MCS = 64.0±2.9 years, p Conclusions HRQOL and mood improved in all 3 groups over time with better overall 1-yr scores observed in those undergoing HT. These unique findings may guide HRQOL-related therapeutic strategies.

Introduction: While health-related quality of life (HRQOL) for patients with advanced heart failure is improved after left ventricular assist device (LVAD) implantation, caregivers (CGs) may experience worse quality of life due to new roles and responsibilities. CG burden is associated with worse outcomes in patients with other chronic illnesses, but the association between caregiver burden and patient recovery following LVAD implant for destination therapy (DT) has not been described. Methods: Between 10/1/15 and 12/31/18, 154 DT LVAD patients (age=60-80 years) and 108 DT CGs from 13 U.S. sites were enrolled. Of these, data through 1 post-operative year from 64 patients and CGs were analyzed. CG burden was measured using the Oberst Caregiver Burden Scale (OCBS): 15 items (range=1-5), measuring perceived amount of time spent and difficulty of tasks (higher score=more time on task and more difficulty of task), respectively. High CG burden=scoring greater than the cohort median. Patient recovery post-LVAD implant was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), change in 6-minute walk distance (6MWD), and re-hospitalizations over 1 year. Proportional odds models for change in KCCQ-12 and 6MWD and linear regression for re-hospitalizations were used to assess for an association with CG burden. Results: Patients were 69.4±5.4 years, 86% male, and 91% White. Over the first year post-LVAD implant, 30% were hospitalized, 73% (47/64) had an improvement of at least 5 points on KCCQ-12 scores and 16% (10/64) a deterioration of at least 5 points. Mean 6MWD was 206.7 (SD, 133.9) meters at baseline and improved to 280.5 (SD, 102.5) meters at 1 year. CGs were 61.7±11.3 years, 94% female, 82% White, and 86% married. Median OCBS-difficulty score at baseline was 1.20 and median for time was 2.27. Higher CG burden was not associated with hospitalizations or changes in patient HRQOL or 6MWD over the first year following LVAD implant (table). Discussion: Higher CG burden at baseline was not associated with patient recovery in the first year post-LVAD implant. Understanding how CG burden is associated with patient outcomes following LVAD implant is important as lack of CG support is typically a contraindication for LVAD implantation.

Purpose Caregivers (CGs) of patients (PTs) with heart failure (HF) experience substantial CG burden. Poor PT health-related quality of life (HRQOL) correlates with increased CG burden in other chronic disease. We evaluated the relationship between PT HRQOL and CG burden in older PTs receiving left ventricular assist devices (LVAD) as destination therapy (DT) or awaiting heart transplant (HT) with or without an LVAD. Methods Data were from SUSTAIN-IT, a study of PT and CG HRQOL in adults age 60-80 receiving DT LVAD or HT. PT HRQOL was assessed by EQ-5D-3L Visual Analog Scale (VAS) score: 0-100 (worst-best) & HF-specific KCCQ-12 summary score (SS), 0-100=low-high. CG burden was assessed by Oberst Caregiving Burden Scale (OCBS) assessing perceptions of CG difficulty & time (1-5; higher score=more time & difficulty). Baseline CG burden, PT HRQOL, and changes from 0 to 6 months were compared by linear regression. Results Data from 302 PTs and CGs were analyzed: 109 DT LVAD, 193 HT (101 without LVAD & 92 with LVAD). KCCQ-12 and EQ-5D VAS scores increased significantly from 0 to 6 months (p Conclusion PT HRQOL generally correlated with CG burden in older HF PTs before and early after DT and HT. Improved PT HRQOL did not correlate with decreased CG burden in HT, but may be associated in DT LVAD. These findings may guide support needs of CGs of PTs undergoing advanced therapies.

Background The CTOT-11 (Prevention of Cardiac Allograft Vasculopathy Using Rituximab Therapy in Cardiac Transplantation [Clinical Trials in Organ Transplantation-11]) study was a randomized, placebo-controlled, multicenter, double-blinded clinical trial in nonsensitized primary heart transplant (HTX) recipients. Objectives The study sought to determine whether B cell depletion therapy would attenuate the development of cardiac allograft vasculopathy. Methods A total of 163 HTX recipients were randomized to rituximab 1,000 mg intravenous or placebo on days 0 and 12 post-transplant. Primary outcome was change in percent atheroma volume (PAV) from baseline to 1 year measured by intravascular ultrasound. Secondary outcomes included treated episodes of acute rejection, de novo anti-HLA antibodies (including donor-specific antibodies), and phenotypic differentiation of B cells. Results There were no significant differences at study entry between the rituximab and placebo groups. Paired intravascular ultrasound measures were available at baseline and 1 year in 86 subjects (49 rituximab, 37 placebo). The mean ± SD change in PAV at 12 months was +6.8 ± 8.2% rituximab versus +1.9 ± 4.4% placebo (p = 0.0019). Mortality at 12 months was 3.4% rituximab versus 6.8% placebo (p = 0.47); there were no retransplants or post-transplant lymphoproliferative disorder. The rate of treated rejection was 24.7% rituximab versus 32.4% placebo (p = 0.28). Rituximab therapy effectively eliminated CD20+/CD19+ B cells followed by a gradual expansion of a CD19– cell population in the rituximab-treated group. Conclusions A marked, unexpected increase in coronary artery PAV with rituximab was observed during the first year in HTX recipients. One-year mortality was not impacted; however, longer-term follow-up and mechanistic explanations are required. (Prevention of Cardiac Allograft Vasculopathy Using Rituximab [Rituxan] Therapy in Cardiac Transplantation; NCT01278745)