Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.

BACKGROUND: Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group. CONCLUSIONS: Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.).

Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.

BACKGROUND: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups. METHODS: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m2, New York Heart Association class II-IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatment effects was assessed across subgroups of interest. We assessed safety in all participants who received at least one dose of study drug. FINDINGS: Between March 19, 2021 and March 9, 2022, 529 people were randomly assigned in STEP-HFpEF, and between June 27, 2021 and Sept 2, 2022, 616 were randomly assigned in STEP-HFpEF DM. Overall, 1145 were included in our pooled analysis, 573 in the semaglutide group and 572 in the placebo group. Improvements in KCCQ-CSS and reductions in bodyweight between baseline and week 52 were significantly greater in the semaglutide group than in the placebo group (mean between-group difference for the change from baseline to week 52 in KCCQ-CSS 7·5 points [95% CI 5·3 to 9·8]; p<0·0001; mean between-group difference in bodyweight at week 52 -8·4% [-9·2 to -7·5]; p<0·0001). For the confirmatory secondary endpoints, 6-min walk distance (mean between-group difference at week 52 17·1 metres [9·2 to 25·0]) and the hierarchical composite endpoint (win ratio 1·65 [1·42 to 1·91]) were significantly improved, and CRP concentrations (treatment ratio 0·64 [0·56 to 0·72]) were significantly reduced, in the semaglutide group compared with the placebo group (p<0·0001 for all comparisons). For the dual primary endpoints, the efficacy of semaglutide was largely consistent across multiple subgroups, including those defined by age, race, sex, BMI, systolic blood pressure, baseline CRP, and left ventricular ejection fraction. 161 serious adverse events were reported in the semaglutide group compared with 301 in the placebo group. INTERPRETATION: In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction. These effects were largely consistent across patient demographic and clinical characteristics. Semaglutide was well tolerated. FUNDING: Novo Nordisk.

Semaglutide and Diuretic Use in Obesity-Related Heart Failure with Preserved Ejection Fraction: A Pooled Analysis of the STEP-HFpEF and STEP-HFpEF-DM trials.

BACKGROUND AND AIMS: In the STEP-HFpEF trial program, treatment with semaglutide resulted in multiple beneficial effects in patients with obesity-related heart failure with preserved ejection fraction (HFpEF). Efficacy may vary according to baseline diuretic use, and semaglutide treatment could modify diuretic dose. METHODS: In this pre-specified analysis of pooled data from the STEP-HFpEF and STEP-HFpEF-DM trials (n=1145), which randomized participants with HFpEF and body mass index ≥30 kg/m2 to once weekly semaglutide 2.4 mg or placebo for 52 weeks, we examined whether efficacy and safety endpoints differed by baseline diuretic use, as well as the effect of semaglutide on loop diuretic use and dose changes over the 52-week treatment period. RESULTS: At baseline, across no diuretic (n=220), non-loop diuretic only (n=223), and loop diuretic (<40 [n=219], 40 [n=309], and >40 [n=174] mg/day furosemide-equivalents) groups, there was progressively higher prevalence of hypertension and atrial fibrillation; and severity of obesity and heart failure. Over 52 weeks of treatment, semaglutide had a consistent beneficial effect on change in body weight across diuretic use categories (adjusted mean difference vs. placebo ranged from -8.8% [95% CI -10.3, -6.3] to -6.9% [95% CI -9.1, -4.7] from no diuretics to the highest loop diuretic dose category; interaction P=0.39). Kansas City Cardiomyopathy Questionnaire clinical summary score improvement was greater in patients on loop diuretics compared to those not on loop diuretics (adjusted mean difference vs. placebo: +9.3 [6.5; 12.1] vs. +4.7 points [1.3, 8.2]; P=0.042). Semaglutide had consistent beneficial effects on all secondary efficacy endpoints (including 6-min walk distance) across diuretic subgroups (interaction P=0.24-0.92). Safety also favored semaglutide versus placebo across the diuretic subgroups. From baseline to 52 weeks, loop diuretic dose decreased by 17% in the semaglutide group vs. a 2.4% increase in the placebo group (P<0.0001). Semaglutide (vs. placebo) was more likely to result in loop diuretic dose reduction (odds ratio [OR] 2.67 [95% CI 1.70, 4.18]) and less likely dose increase (OR 0.35 [95% CI 0.23, 0.53]; P<0.001 for both) from baseline to 52 weeks. CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide improved heart failure-related symptoms and physical limitations across diuretic use subgroups, with more pronounced benefits among patients receiving loop diuretics at baseline. Reductions in weight and improvements in exercise function with semaglutide versus placebo were consistent in all diuretic use categories. Semaglutide also led to a reduction in loop diuretic use and dose between baseline and 52 weeks. CLINICALTRIALS.GOV REGISTRATION: NCT04788511 and NCT04916470.

Improvement in Echocardiographic Indexes of Systolic Heart Failure Post Kidney Transplantation - a retrospective analysis.

INTRODUCTION: End-stage renal disease (ESRD) is a major risk factor for cardiovascular morbidity and mortality, which can be partially eliminated by kidney transplantation. Systolic heart failure might be considered as contraindication for kidney transplant although some patients demonstrate myocardial recovery post-transplant. We aim to identify and characterize the phenomenon of reverse myocardial remodelling in kidney transplanted patients. METHODS: The study is a retrospective cohort of patients undergoing kidney transplant between 2016-2019 (n=604) at Rabin Medical Center. Patients were assessed according to availability of two echocardiographic examinations: pre- and post-kidney transplant. The change in estimated ejection fraction (EF) and possible predictors of myocardial recovery were examined. RESULTS: Data of 293 patients was available for the final analysis. Eighty-one (28%) patients had a LVEF improvement equal or above 5%, whereas 36 (12%) patients had a LVEF improvement 10% or more post transplantation. Twenty-five patients (8.5%) had moderate or severe systolic heart failure with LVEF reduced to 40% or less at baseline. 13 of them (52%) had a LVEF improvement of ≥5% and 10 patients (40%) had an improvement of ≥10% in their EF. Cox regression analyses identified female gender as the only independent variable associated with LVEF improvement of at least 10%. Conclusion Renal transplantation might lead to improved LV systolic function in some patients.

Couples' Coping Strategies with Left Ventricular Assist Device Implantation: A Qualitative Dyadic Study.

A left ventricular assist device (LVAD) is a mechanical device that treats advanced heart failure. Patients coping with an LVAD need extensive instrumental and medical support, which is usually provided by the spouse. Therefore, it seems that dyadic coping strategies play a crucial role as either mitigators or hinderers of couples' illness management in the context of LVADs. The aim of this research was to formulate a typology of dyadic coping strategies applied by these couples, as unfolded in their mutual and individual subjective experiences. The research was performed in collaboration with an LVAD implantation unit at a medium-sized hospital in Israel. Couples (N = 17) participated in an in-depth dyadic interview using a semi-structured interview guide, and the data collected were analyzed using content analysis. Our findings suggest that couples coping with an LVAD develop strategies for handling fear, processing and accepting their illness narratives, adjusting their level of independence and intimacy, and utilizing humor. Moreover, our analysis showed that each couple utilized a unique mix of dyadic coping strategies. To the best of our knowledge, the current study is the first to explore the dyadic coping strategies of couples coping with an LVAD. Our results may constitute a base for developing dyadic intervention programs and clinical recommendations to improve the quality of life and relationships of patients and their spouses while coping with LVAD implementation.

The Effect of Tafamidis on Circulating Endothelial Progenitor Cells in Patients with Transthyretin Cardiac Amyloidosis.

AIMS: Endothelial microvascular dysfunction is a known mechanism of vascular pathology in cardiac amyloidosis (CA). Scientific evidence regarding the possible protective role of the amyloid transthyretin (ATTR) stabilizer, tafamidis, is lacking. Circulating endothelial progenitor cells (cEPCs) have an important role in the process of vascular repair. We aimed to examine the effect of tafamidis on cEPCs. METHODS AND RESULTS: Study population included patients with ATTR-CA. cEPCs were assessed using flow cytometry by the expression of CD34(+)/CD133(+) and vascular endothelial growth factor receptor (VEGFR)-2(+) and by the formation of colony-forming units (CFUs) and production of VEGF. Tests were repeated at pre-specified time-points up to 12 months following the initiation of tafamidis. Included were 18 ATTR-CA patients at a median age of 77 (IQR 71, 85) years and male predominance (n = 15, 83%). Following the initiation of tafamidis and during 12 months of drug treatment, there was a gradual increase in the levels of CD34(+)/VEGFR-2(+) (0.43 to 2.42% (IQR 1.53, 2.91)%, p = 0.002) and CD133(+)/VEGFR-2(+) (0.49 to 1.64% (IQR 0.97, 2.90)%, p = 0.004). Functionally, increase in EPCs-CFUs was microscopically evident following treatment with tafamidis (from 0.5 CFUs (IQR 0.0, 1.0) to 3.0 (IQR 1.3, 3.8) p < 0.001) with a concomitant increase in EPC's viability as demonstrated by an MTT assay (from 0.12 (IQR 0.03, 0.16) to 0.30 (IQR 0.18, 0.33), p < 0.001). VEGF levels increased following treatment (from 54 (IQR 52, 72) to 107 (IQR 62, 129) pg/ml, p = 0.039). CONCLUSIONS: Tafamidis induced the activation of the cEPCs pathway, possibly promoting endothelial repair in ATTR-CA.

Management of Patients with Left Ventricular Assist Device during the COVID-19 Pandemic.

The novel coronavirus disease 2019 (COVID-19) is an infectious disease with multi-organ involvement, including the cardiovascular system. The disease may cause several cardiovascular complications, and may increase morbidity and mortality among patients with background cardiovascular disease. Patients with advanced heart failure are often treated with left ventricular assist device (LVAD), and represent a unique population mandating multi-disciplinary approach. Several aspects of COVID-19 should be taken into account in LVAD implants, including right ventricular involvement, hemodynamic alterations, thromboembolic and haemorrhagic complications, and the psychological effects of social isolation. Patients with VAD and suspected COVID-19 should be transferred to specialized centers for better management of complications. Here, we review the implications of COVID-19 pandemic on LVAD patients with our recommendations for appropriate management.

Trends in Kaposi's Sarcoma Morbidity: A Retrospective Cohort Study of Heart and Lung Transplant Recipients.

Data on post-transplant Kaposi's sarcoma in heart and lung transplant recipients are sparse. This study examined the incidence of biopsy-proven post-transplant Kaposi's sarcoma in thoracic organ recipients over a period of 20 years. As mammalian target of rapamycin inhibitors were introduced in 2006 as optional maintenance immunosuppressive therapy, the overall results were analysed and stratified into 2 groups: 1996 to 2005 and 2006 to 2016. A total of 867 transplant recipients met the study criteria. Post-transplant Kaposi's sarcoma was diagnosed in 7 (0.81%) patients. Five cases (0.19% of transplant recipients) were recorded in 1996 to 2005 and 2 (0.03% of transplant recipients) in 2006 to 2016 (p = 0.04). Multivariable logistic regression analyses identified the following as risk factors: period of transplantation (odds ratio (OR) 4.844, 95% confidence interval (95% CI) 1.156-20.291), age at transplantation (OR 1.066, 95% CI 0.992-1.145), and North African origin (OR 7.282, 95% CI 12.55-42.254). This study found a decreased incidence of post-transplant Kaposi's sarcoma over the last 20 years, mainly attributed.

Depression and Anxiety Moderate the Relationship Between Body Image and Personal Well-being Among Patients With an Implanted Left Ventricular Assist Device.

BACKGROUND: Left ventricular assist devices (LVADs) support the diseased heart of patients with advanced heart failure and are used as a bridge to heart transplantation or as destination therapy for patients ineligible for heart transplantation. Body image changes, as well as anxiety and depression, are prevalent among patients with an implanted LVAD. OBJECTIVE: The aim of this study was to investigate whether a relationship exists between body image and personal well-being among patients with an implanted LVAD and, if it does, whether it is moderated by anxiety and depression. METHODS: In this cross-sectional correlational study, a convenience sample of 30 adult patients with an implanted LVAD (mean age, 63 ± 10; 90% male) from the outpatient facility of a tertiary medical center completed validated instruments including the Body Image Scale, Cosmetic Scale, Hospital Anxiety and Depression Scale, and Personal Well-being Index, from October 2017 to February 2018. Results were subjected to multivariate linear regression and bootstrap moderation analyses. RESULTS: Eleven patients (37%) had below-average personal well-being scores, and 14 patients (47%) had below-average body image scores. Seven (23%) had either anxiety or depression, and 11 (37%) had both anxiety and depression. Body image was found to be a significant predictor of personal well-being (t = 2.16, P = .04). When anxiety and depression were present, body image (t = 2.08, P = .049), depression (t = 2.53, P = .018), and the interaction between body image and depression (t = -2.1, P = .047) were significantly associated with personal well-being. CONCLUSIONS: Body image significantly predicted personal well-being among patients with an implanted LVAD. Depression alone, or depression combined with anxiety, moderated the relationships between body image and personal well-being. The current results may help to heighten healthcare providers' awareness of body image perception among patients with an implanted LVAD.

Abdominal Surgery in Patients with a Ventricular Assist Device: A Single Center Experience in Israel.

BACKGROUND: Left ventricular assist devices (LVADs) are used more commonly in patients with advanced-stage heart failure. Some of these patients may require elective or urgent abdominal surgical procedures. OBJECTIVES: To determine the outcomes of the management of LVAD-supported patients who underwent elective and urgent abdominal surgical procedures in our institution. METHODS: A retrospective review was conducted on 93 patients who underwent LVAD implantation between August 2008 and January 2017. All abdominal surgeries in these patients were studied, and their impact on postoperative morbidity and mortality Ten patients underwent abdominal surgical procedures. Of these procedures, five were emergent and five were elective. The elective cases included one bariatric surgery for morbid obesity, one hiatal hernia repair, two cholecystectomies, and one small bowel resection for a carcinoid tumor. The emergency cases included suspected ischemic colitis, right colectomy for bleeding adenocarcinoma, laparotomy due to intraabdominal bleeding, open cholecystectomy for gangrenous cholecystitis, and laparotomy for sternal and abdominal wall infection. All patients undergoing elective procedures survived. Of the five patients who underwent emergency surgery, three died (60%, P = 0.16) and one presented with major morbidity. One of the two survivors required reintervention. In total, 12 interventions were performed on this group of patientswas evaluated. RESULTS: Ten patients underwent abdominal surgical procedures. Of these procedures, five were emergent and five were elective. The elective cases included one bariatric surgery for morbid obesity, one hiatal hernia repair, two cholecystectomies, and one small bowel resection for a carcinoid tumor. The emergency cases included suspected ischemic colitis, right colectomy for bleeding adenocarcinoma, laparotomy due to intraabdominal bleeding, open cholecystectomy for gangrenous cholecystitis, and laparotomy for sternal and abdominal wall infection. All patients undergoing elective procedures survived. Of the five patients who underwent emergency surgery, three died (60%, P = 0.16) and one presented with major morbidity. One of the two survivors required reintervention. In total, 12 interventions were performed on this group of patients. CONCLUSIONS: It is safe to perform elective abdominal procedures for LVAD-supported patients. The prognosis of these patients undergoing emergency surgery is poor and has high mortality and morbidity rates.

Psychometric Testing of the Hebrew Version of the European Heart Failure Self-Care Behaviour Scale.

BACKGROUND: The assessment of self-care behaviour is important for tailoring care to patients and evaluating the effectiveness of heart failure (HF) disease-management programmes. The European HF Self-care Behaviour (EHFScB) scale is a validated instrument used worldwide. AIM: The purpose of the study was to evaluate psychometric properties of the Hebrew version of the nine-item EHFScB scale in Israeli patients with HF. METHOD: To develop the Hebrew version of the EHFScB scale, forward and back translation was performed. The psychometric evaluation was based on data from 102 patients with HF (mean age 61±12 yr, male 75%, New York Heart Association [NYHA] class II 42% and NYHA class III 51%) included in two cross-sectional studies performed in 2007 and 2015-2017 in an Israeli hospital. Content validity, construct validity, known-groups validity, and discriminant validity were assessed. Reliability was evaluated with internal consistency. RESULTS: Content validity and useability were confirmed by HF experts and patients with HF. Construct validity was tested using factor analysis and two factors were extracted (factor 1: consulting behaviour; factor 2: adherence to the regimen). Known-groups validity testing revealed a significant difference before and after an educational intervention in the total score (n=40 [41.6±23.8] vs [67.6±21.8]; p<0.01). A weak correlation between the self-care score and health-related quality of life (r= -0.299, p<0.01) was observed, showing that these concepts were related but not overlapping. Cronbach's alpha was 0.78 for the total scale, 0.76 for factor 1, and 0.68 for factor 2, suggesting that the internal consistency of this scale was acceptable. CONCLUSIONS: Our study provides support for the useability, validity, and reliability of the nine-item Hebrew version of the EHFScB scale.

The Effect of Mineralocorticoid Receptor Antagonists on Recruitment and Function of Endothelial Progenitor Cells in Patients with Congestive Heart Failure.

BACKGROUND: Circulating endothelial progenitor cells have an important role in the process of vascular repair. Impaired recruitment and function of endothelial progenitor cells is related to the pathophysiology of congestive heart failure. Endothelial progenitor cells have been shown to express the mineralocorticoid receptor. OBJECTIVES: To investigate the effect of mineralocorticoid receptor antagonists on endothelial progenitor cells in patients with heart failure. METHODS: Twenty-four patients with compensated heart failure, who were not under mineralocorticoid receptor antagonist therapy, were recruited. Either eplerenone (n=8) or spironolactone (n=16) therapy was initiated. Circulating endothelial progenitor cell level, identified as the proportion of mononuclear cells expressing vascular endothelial growth factor receptor 2 (VEGFR-2), CD133, and CD34, was evaluated by flow cytometry at baseline and after 8 weeks. Following 7 days of culture, colonies were counted by microscopy and MTT assay was performed on randomly selected patients (n=12) to estimate viability. RESULTS: Both median CD34+/VEGFR2+ and median CD133+/VEGFR2+ increased significantly (P = 0.04 and 0.02, respectively). However, the number of colonies and viability of the cells after therapy (as assessed by the MTT assay) was not significantly different compared with the baseline. CONCLUSIONS: These preliminary results suggest that mineralocorticoid receptor blockade may enhance endothelial progenitor cells recruitment in patients with compensated heart failure.

The Management and Outcome of Hospitalized and Ambulatory Israeli Heart Failure Patients Compared to European Heart Failure Patients: Results from the ESC Heart Failure Long-Term Registry.

BACKGROUND: The treatment of patients hospitalized with heart failure (HHF) and ambulatory chronic heart failure (CHF) differs in various countries. OBJECTIVES: To evaluate the management and outcomes of patients with HFF and CHF in Israel compared to those in other European countries who were included in the ESC-HF Long-Term Registry. METHODS: From May 2011 to April 2013, heart failure patients - 467 Israelis and 11,973 from other countries - were evaluated. The Israeli patients included 178 with HHF and 289 with CHF. One year outcomes, including all-cause and cardiovascular mortality as well as HHF, were evaluated. RESULTS: The HHF Israeli patients were older than their CHF Israeli counterparts, had more co-morbidities, included more women, and were treated less frequently with medications suggested by European guidelines. The Israeli HHF patients had similar all-cause 1 year mortality rates compared to HHF patients from other participating countries, but their cardiovascular (CV) mortality was lower, while a significantly higher rate of all-cause and HHF was noted. The Israeli CHF patients were older, suffered from more co-morbidities and had prior cardio-electronic implantable devices. In addition, they had higher mortality rates, especially non-CV, and were more frequently hospitalized, compared to CHF patients from other countries. CONCLUSIONS: The Israeli patients with heart failure differed in their baseline characteristics and the therapeutic approach. Despite high usage of treatments recommended by official guidelines, especially among CHF patients, mortality, particularly in HHF patients, remained high.

[LAPAROSCOPIC "SLEEVE" GASTRECTOMY POST HEART TRANSPLANTION].

Morbid obesity affects the function of the transplanted heart either directly, by damaging many elements that affect cardiac function or indirectly, by the initial appearance or worsening of co-morbidities that affect the heart. Bariatric surgery is the most effective treatment for a significant and sustained decrease in weight and it leads to the disappearance of co-morbidities such as diabetes, hypertension and dyslipidemia in high rates. These diseases can damage the blood vessels of the graft and impair its function. We report a case study of a 47-year-old morbidly obese male (BMI 36 kg/m2] who underwent heart transplantation three years previously, developed gradual weight gain and symptoms of aggravating heart failure. Coronary artery disease in the implanted heart was diagnosed. Clinically, he started suffering from shortness of breath and chest pain during minimal effort. In addition, he also suffered from high blood pressure and kidney failure. Laparoscopic sleeve gastrectomy was successfully performed and he was discharged four days later. On follow-up the patient has lost 35 kg. His present weight is 74 kg (BMI 25.7). All symptoms of heart failure improved and oral medications for hypertension and heart failure were withdrawn. Our conclusion is that it is justified to consider bariatric surgery in heart transplant recipients suffering from morbid obesity, as long as the long-term benefit outweighs the surgical risk. The decision to perform bariatric surgery should be made by a multidisciplinary team and the operation should take place at a center with extensive experience in bariatric surgery.

Utility of immune monitoring in heart transplant recipients on everolimus-based immune suppression.

BACKGROUND: Everolimus provides effective immune suppression (IS) after heart transplant (HTx). Its pharmacologic properties differentiate everolimus from other IS drugs. A non-invasive immune monitoring (IM) assay test appears to predict the immune state in HTx recipients on standard calcineurin-inhibitor-based IS. The utility of IM in HTx recipients on everolimus-based IS was evaluated. METHODS: Between June 2005 and June 2011, 34 adult HTx recipients followed up at our center received everolimus and had 381 IM assays that were performed at six months to 16-yr post-transplant. Results of the IM assay were correlated with infection and rejection episodes that occurred during the IM testing. RESULTS: In the everolimus-based IS group, there were 18 infectious episodes and four rejection episodes. The average IM score was significantly lower during infection than at steady state (188 ± 122 vs. 338 ± 137 ng/mL ATP, p < 0.001) and not significantly different during rejection when compared with steady state (430 ± 132 vs. 338 ± 137 ng/mL ATP, p = 0.5). CONCLUSIONS: The non-invasive IM assay predicts infectious risk in HTx recipients on everolimus-based IS. Its inconclusive association with rejection was probably due to the small number of rejections. Serial longitudinal IM may allow proper adjustment of everolimus doses.

Cardiac function recovery following LVAD implantation and bariatric surgery in a morbidly obese patient.

We present a morbidly obese 44-year-old female who underwent Thoratec HeartMate II left ventricular assist device implantation. The patient subsequently underwent laparoscopic sleeve gastrectomy and removal of the LVAD following improvement in her cardiac function.

Learning self-care after left ventricular assist device implantation.

The number of heart failure (HF) patients living with a left ventricular assist device (LVAD) as destination therapy is increasing. Successful long-term LVAD support includes a high degree of self-care by the patient and their caregiver, and also requires long-term support from a multidisciplinary team. All three components of self-care deserve special attention once an HF patient receives an LVAD, including activities regarding self-care maintenance (activities related both to the device and lifestyle), self-care monitoring (e.g., monitoring for complications or distress), and self-care management (e.g., handling alarms or coping with living with the device). For patients to perform optimal self-care once they are discharged, they need optimal education that focuses on knowledge and skills through a collaborative, adult learning approach.

Changes over time in patient-reported outcomes in patients with heart failure.

AIM: This paper describes the trajectory during 1 year of four patient-reported outcomes (PROs), namely, sleep, depressive symptoms, health-related quality of life (HrQoL), and well-being, in patients with heart failure (HF), their relationship and the patient characteristics associated with changes in these PROs. METHODS AND RESULTS: Data analyses of PROs from 603 patients (mean age 67 years; 29% female, 60% NYHA II) enrolled in the HF-Wii study. On short term, between baseline and 3 months, 16% of the patients experienced continuing poor sleep, 11% had sustained depressive symptoms, 13% had consistent poor HrQoL, and 13% consistent poor well-being. Across the entire 1-year period only 21% of the patients had good PRO scores at all timepoints (baseline, 3, 6, and 12 months). All others had at least one low score in any of the PROs at some timepoint during the study. Over the 12 months, 17% had consistently poor sleep, 17% had sustained symptoms of depression, 15% consistently rated a poor HrQoL, and 13% poor well-being. Different patient characteristics per PRO were associated with a poor outcomes across the 12 months. Age, education, New York Heart Association, and length of disease were related to two PRO domains and submaximal exercise capacity (6 min test), co-morbidity, and poor physical activity to one. CONCLUSION: In total, 79% of the patients with HF encountered problems related to sleep, depressive symptoms, HrQoL, and well-being at least once during a 1-year period. This underscores the need for continuous monitoring and follow-up of patients with HF and the need for dynamic adjustments in treatment and care regularly throughout the HF trajectory.