Transcatheter aortic valve replacement in patients with chronic kidney disease: a multi-centre retrospective study.

Background: Chronic kidney disease (CKD) is a common comorbid condition in patients undergoing transcatheter aortic valve replacement (TAVR). Reported outcome studies on the association of baseline CKD and mortality is currently limited. Objectives: To determine the prevalence of chronic kidney disease in patients undergoing TAVR and analyse their overall procedural outcomes. Methods: This retrospective observational study was conducted at 43 publicly funded hospitals in Hong Kong. Severe aortic stenosis patients undergoing TAVR between the years 2010 and 2019 were enroled in the study. Two groups were identified according to the presence of baseline chronic kidney disease. Results: A total of 499 patients (228, 58.6% men) were enroled in the study. Baseline hypertension was more prevalent in patients with CKD (82.8%; P=0.003). As for primary end-points, mortality rates of CKD patients were significantly higher compared to non-CKD patients (10% vs. 4.1%; P=0.04%). Gout and hypertension were found to be significantly associated with CRF. Patients with gout were nearly six times more likely to have CRF than those without gout (odds ratio = 5.96, 95% CI = 3.12-11.29, P<0.001). Patients with hypertension had three times the likelihood of having CRF compared to those without hypertension (odds ratio=2.83, 95% CI=1.45-6.08, P=0.004). Conclusion: In patients with severe aortic stenosis undergoing TAVR, baseline CKD significantly contributes to mortality outcomes at long-term follow up.

Morbidity and mortality of acute heart failure patients stratified by mitral regurgitation in the Arabian Gulf: Observations from the Gulf acute heart failure registry (Gulf CARE).

This study aimed to evaluate the clinical outcomes of patients with acute heart failure (AHF) stratified by mitral regurgitation (MR) in the Arabian Gulf. Patients from the Gulf CARE registry were identified from 47 hospitals in seven Arabian Gulf countries (Yemen, Oman, Kuwait, Qatar, Bahrain, the United Arab Emirates, and Saudi Arabia) from February to November 2012. The cohort was stratified into two groups based on the presence of MR. Univariable and multivariable statistical analyses were performed. The population cohort included 5005 consecutive patients presenting with AHF, of whom 1491 (29.8 %) had concomitant MR. The mean age of patients with AHF and concomitant MR was 59.2 ± 14.9 years, and 63.1 % (n = 2886) were male. A total of 58.6 % (n = 2683) had heart failure (HF) with reduced ejection fraction (EF) (HFrEF), 21.0 % (n = 961) had HF with mildly reduced EF (HFmrEF), and 20.4 % (n = 932) had HF with preserved EF (HFpEF). Patients with MR had a lower haemoglobin (Hb) level (12.4 vs. 12.7 g/dL; p < 0.001), and a higher prevalence of left atrial enlargement (80.2 % vs. 55.1 %; p < 0.001), cardiogenic shock (9.7 % vs. 7.3 %; p = 0.006) and atrial fibrillation (7.6 % vs. 5.6 %; p = 0.006), and HFrEF (71.0 % vs. 52.6 %; P < 0.001). Multivariable analysis demonstrated that MR was independently associated with increased all-cause mortality at 1-year and 3-month HF rehospitalization [1-year all-cause mortality, adjusted odds ratio (aOR), 1.40; 95 % confidence interval (Cl): 1.13-1.74; p = 0.002; 3-month HF rehospitalization, aOR, 1.26; 95 % Cl: 1.06-1.49; p = 0.009]. In an Arabian Gulf cohort with AHF, concomitant MR was associated with an increased risk of 1-year mortality and 3-months HF rehospitalization.

Arrhythmogenic right ventricular cardiomyopathy mimicking Brugada - a case report.

We report a rare case of arrhythmogenic right ventricular cardiomyopathy (ARVC). Middle-aged Kuwaiti gentleman presented to a polyclinic with complaints of dizziness and palpitation. Electrocardiogram (ECG) at the polyclinic showed polymorphic ventricular tachycardia, and hence he was referred to our center. ECG at the emergency room showed a Brugada pattern with epsilon waves. Echo showed right ventricular dysfunction with pulmonary arterial hypertension. Magnetic resonance imaging showed evidence of ARVC. He was referred to the electrophysiology team and implanted an implantable cardioverter-defibrillator electively.

Development and Validation of R-hf Risk Score in Acute Heart Failure Patients in the Middle East.

Objectives: The Rajan's heart failure (R-hf) score was proposed to aid risk stratification in heart failure patients. The aim of this study was to validate R-hf risk score in patients with acute decompensated heart failure. Methods: R-hf risk score is derived from the product estimated glomerular filtration rate (mL/min), left ventricular ejection fraction (%), and hemoglobin levels (g/dL) divided by N-terminal pro-brain natriuretic peptide (pg/mL). This was a multinational, multicenter, prospective registry of heart failure from seven countries in the Middle East. Univariable and multivariable logistic regression was applied. Results: A total of 776 patients (mean age = 62.0±14.0 years, 62.4% males; mean left ventricular ejection fraction = 33.0±14.0%) were included. Of these, 459 (59.1%) presented with acute decompensated chronic heart failure. The R-hf risk score group (≤ 5) was marginally associated with a higher risk of all-cause cumulative mortality at three months (adjusted odds ratio (aOR) = 4.28; 95% CI: 0.90-20.30; p =0.067) and significantly at 12 months (aOR = 3.84; 95% CI: 1.23-12.00; p =0.021) when compared to those with the highest R score group (≥ 50). Conclusions: Lower R-hf risk scores are associated with increased risk of all-cause cumulative mortality at three and 12 months.

Clinical Outcome and Risk Assessment in Hospitalized COVID-19 Patients with Elevated Transaminases and Acute Kidney Injury: A Single Center Study.

Objectives: Initial reports indicate a high incidence of abnormal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with COVID-19 and possible association with acute kidney injury (AKI). We aimed to investigate clinical features of elevated transaminases on admission, its association with AKI, and outcomes in patients with COVID-19. Methods: A retrospective analysis of the registered data of hospitalized patients with laboratory-confirmed COVID-19 and assessment of the AST and ALT was performed. Multinomial logistic regression was used to determine factors associated with community-acquired AKI (CA-AKI) and hospital-acquired AKI (HA-AKI). Results: The subjects comprised 828 patients (mean age = 65.0±16.0 years; 51.4% male). Hypertension was present in 70.3% of patients, diabetes mellitus in 26.0%, and chronic kidney disease in 8.5%. In-hospital mortality was 21.0%. At admission, only 41.5% of patients had hypertransaminasemia. Patients with elevated transaminases at admission were younger, had higher levels of inflammatory markers and D-dimer, and poorer outcomes. The AKI incidence in the study population was 27.1%. Patients with hypertransaminasemia were more likely to develop AKI (33.5% vs. 23.3%, p = 0.003). Patients with predominantly elevated AST (compared to elevated ALT) were more likely to have adverse outcomes. Multinomial logistic regression found that hypertension, chronic kidney disease, elevated AST, and hematuria were associated with CA-AKI. Meanwhile, age > 65 years, hypertension, malignancy, elevated AST, and hematuria were predictors of HA-AKI. Conclusions: Elevated transaminases on admission were associated with AKI and poor outcomes. Patients with elevated AST were more likely to have adverse outcomes. Elevated AST on admission was associated with CA-AKI and was a predictor of HA-AKI.

Neutrophil to lymphocyte ratio and in-hospital mortality among patients with SARS-CoV-2: A retrospective study.

The goal of this study was to investigate in-hospital mortality in patients suffering from acute respiratory syndrome coronavirus 2 (SARS-CoV-2) relative to the neutrophil to lymphocyte ratio (NLR) and to determine if there are gender disparities in outcome. Between February 26 and September 8, 2020, patients having SARS-CoV-2 infection were enrolled in this retrospective cohort research, which was categorized by NLR levels ≥9 and < 9. In total, 6893 patients were involved included of whom6591 had NLR <9, and 302 had NLR ≥9. The age of most of the patients in the NLR<9 group was 50 years, on the other hand, the age of most of the NLR ≥9 group patients was between 50 and 70 years. The majority of patients in both groups were male 2211 (66.1%). The ICU admission time and mortality rate for the patients with NLR ≥9 was significantly higher compared to patients with NLR <9. Logistic regression's outcome indicated that NLR ≥9 (odds ratio (OR), 24.9; 95% confidence interval (CI): 15.5-40.0; p < 0.001), male sex (OR, 3.5; 95% CI: 2.0-5.9; p < 0.001) and haemoglobin (HB) (OR, 0.95; 95% CI; 0.94-0.96; p < 0.001) predicted in-hospital mortality significantly. Additionally, Cox proportional hazards analysis (B = 4.04, SE = 0.18, HR = 56.89, p < 0.001) and Kaplan-Meier survival probability plots also indicated that NLR>9 had a significant effect on mortality. NLR ≥9 is an independent predictor of mortality(in-hospital) among SARS-CoV-2 patients.

Validation of R-hf risk score for risk stratification in ischemic heart failure patients: A prospective cohort study.

Background: The aim of this study was to validate R-heart failure (R-hf) risk score in ischemic heart failure patients. Methods: We prospectively recruited a cohort of 179 ischemic and 107 non-ischemic heart failure patients. This study mainly focused on ischemic heart failure patients. Non-ischemic heart failure patients were included for the purpose of validation of the risk score in various heart failure groups. Patients were stratified in high risk, moderate risk and low risk groups according to R-hf risk score. Results: A total of 179 participants with ischemic heart failure were included. Based on R-hf risk score, 82 had high risk, 50 had moderate risk and 47 had low risk heart failure scores. More than half of the patients having R-hf score of <5 had renal failure (n = 91, 50.8%) and anemia (n = 99, 55.3%). Notably, HFrEF was more prevalent in patients with high risk score (74, 90.2%). Patients with high risk score had significantly higher creatinine (2.63 ± 1.96, p < 0.001), Troponin-T HS (59.9 ± 38.0, p < 0.001) and PRO BNP (17842 ± 6684, p < 0.001) when compared to patients with low and moderate risk score. Patients with low risk score had significantly higher Hb (13.2 ± 1.85, p < 0.001), Albumin (3.69 ± 0.42, p < 0.001) and GFR (90.0 ± 8.04, p < 0.001). A R-hf score of <5 was a significant predictor of mortality in ischemic (OR = 50.34; 95% CI [16.94-194.00, p < 0.001) and non-ischemic (OR = 46.34; 95% CI [12.97-225.39], p < 0.001) heart failure patients. Conclusions: Lower R-hf risk score is a significant predictor of mortality in ischemic and non-ischemic heart failure patients. Risk score can be accessed at https://www.hfriskcalc.in.

Outcomes of guideline-based medical therapy in patients with acute heart failure and reduced left ventricular ejection fraction: Observations from the Gulf acute heart failure registry (Gulf CARE).

ABSTRACT: This study aimed to report on the use, predictors and outcomes of guideline-based medical therapy (GBMT) in patients with acute heart failure (HF) with reduced ejection fraction of <40% (HFrEF), from seven countries in the Arabian Gulf.Patients with acute HFrEF (N = 2680), aged 18 years or older, and hospitalized February-November 2012 were recruited and data were collected post discharge at 3 months (n = 2477) and 1 year (n = 2418). The use and doses of GBMT were evaluated as per European, American and Canadian HF guidelines. Analyses were performed using multivariate logistic regression. This study was registered at clinicaltrials.gov (NCT01467973).The majority of patients were on dual (39%) and triple (39%) GBMT modalities, 14% received one GBMT medication, while 7.2% were not on any GBMT medications. On admission, 80% of patients were on renin-angiotensin system (RAS) blockers, 75% on b-blockers and 56% on mineralocorticoid receptor antagonists (MRAs), with a small proportion of these patients were taking target doses (RAS blockers 13%, b-blockers 7.3%, MRAs 14%). Patients taking triple GBMT were younger (P < .001), less likely to have comorbidities such as diabetes mellitus (P < .001) and CKD/dialysis (P < .001), less likely to receive in-hospital invasive treatments (P < .001), and more likely to be treated by a cardiologist (P < .001), than patients on a single medication. Patients taking triple GBMT showed significantly reduced all-cause mortality both at 3-months (P = .048), and at 12-months (P = .003), compared to patients taking no GBMT.Triple GBMT prescribing and dosing in patients with HFrEF were suboptimal in the Arabian Gulf. Further studies are required to investigate GBMT utilization and dosing in the outpatient setting.

In-hospital mortality in SARS-CoV-2 stratified by sex diffrences: A retrospective cross-sectional cohort study.

Background: The aim of this study was to determine in-hospital mortality in patients presenting with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) and to evaluate for any differences in outcome according to sex differences. Methods: Patients with SRS-CoV-2 infection were recruited into this retrospective cohort study between February 26 and September 8, 2020 and strаtified ассоrding tо the sex differences. Results: In tоtаl оf 3360 раtients (meаn аge 44 ± 17 years) were included, of whom 2221 (66%) were mаle. The average length of hospitalization was 13 days (range: 2-31 days). During hospitalization and follow-up 176 patients (5.24%) died. In-hospital mortality rates were significantly different according to gender (p=<0.001). Specifically, male gender was associated with significantly greater mortality when compared to female gender with results significant at an alpha of 0.05, LL = 28.67, df = 1, p = 0.001, suggesting that gender could reliably determine mortality rates. The coefficient for the males was significant, B = 1.02, SE = 0.21, HR = 2.78, p < 0.001, indicating that an observation in the male category will have a hazard 2.78 times greater than that in the female category. Multivariate logistic regression confirmed male patients admitted with SARS-CoV-2had higher сumulаtive аll-саuse in-hоsрitаl mоrtаlity (6.8% vs. 2.3%; аdjusted оdds rаtiо (аОR), 2.80; 95% (СI): [1.61-5.03]; р < 0.001). Conclusions: Male gender was an independent predictor of in-hospital mortality in this study. The mortality rate among male SARS-CoV-2 patients was 2.8 times higher when compared with females.

Clinical outcomes of transcatheter aortic valve replacement stratified by left ventricular ejection fraction: A single centre pilot study.

Introduction: To define baseline echocardiographic, electrocardiographic (ECG) and computed tomographic (CT) findings of patients with heart failure undergoing transcatheter aortic valve replacement (TAVR) and analyze their overall procedural outcomes. Methods: Between 2018 and 2021, patients with severe aortic stenosis (AS) who performed transcatheter aortic valve replacement (TAVR) in Sabah Al Ahmad Cardiac Centre, Al Amiri Hospital were identified. A retrospective review of patients' parameters including pre-, intra-, and post-procedural data was conducted. Patients were grouped in 2 subgroups according to their EF: EF <40% (HFrEF) and EF ≥ 40%. The data included patients' baseline characteristics, electrocardiographic and echocardiographic details along with pre-procedural CT assessment of aortic valve dimensions. Primary outcomes including post-operative disturbances, pacemaker implantation and in-hospital mortality following TAVR were additionally analyzed. Results: A total of 61 patients with severe AS underwent TAVR. The mean age was 73.5 ± 9, and 21 (34%) of the patients were males. The mean ejection fraction (EF) was 55.5 ± 9.7%. Of 61 patients, 12 (20%) were identified as heart failure with reduced EF (<40%). These patients were younger, more often males, and were more likely to have coronary artery disease (75% versus 53.1%). Left ventricular hypertrophy and diastolic dysfunction was documented in 75% and 58.3% of patients with heart failure with reduced ejection fraction (HFrEF) respectively. Post TAVR conduction disturbances, with the commonest being LBBB was observed in 41.7%. Permanent pacemaker was implanted in 3 of patients with HFrEF (25%). There were no significant differences between the two groups with regards to in hospital mortality (p = 0.618). Conclusion: Severe AS with EF <40% constitute a remarkable proportion of patients undergoing TAVR. Preliminary results of post-operative conduction disturbances and in hospital mortality in HFrEF patients were concluded to not differ from patients with LVEF ≥40%.

Outcomes of tocilizumab therapy in severe or critical COVID-19 patients: A retrospective cohort, single-centre study.

OBJECTIVES: To assess the effectiveness and safety of tocilizumab, a humanised anti-interleukin-6 receptor antibody, in the treatment of critical or severe coronavirus disease 2019 (COVID-19) patients. METHODS: This was a retrospective cohort study of severe or critical COVID-19 patients (≥18 years) admitted to one hospital in Kuwait. Fifty-one patients received intravenous tocilizumab, while 78 patients received the standard of care at the same hospital. Both groups were compared for clinical improvement and in-hospital mortality. RESULTS: The tocilizumab (TCZ) group had a significantly lower 28-day in-hospital mortality rate than the standard-of care-group (21.6% vs. 42.3% respectively; p = 0.015). Fifty-five per cent of patients in the TCZ group clinically improved vs. 11.5% in the standard-of-care group (p < 0.001). Using Cox-proportional regression analysis, TCZ treatment was associated with a reduced risk of mortality (adjusted hazard ratio 0.25; 95% CI: 0.11-0.61) and increased likelihood of clinical improvement (adjusted hazard ratio 4.94; 95% CI: 2.03-12.0), compared to the standard of care. The median C-reactive protein, D-dimer, procalcitonin, lactate dehydrogenase and ferritin levels in the tocilizumab group decreased significantly over the 14 days of follow-up. Secondary infections occurred in 19.6% of the TCZ group, and in 20.5% of the standard-of-care group, with no statistical significance (p = 0.900). CONCLUSION: Tocilizumab was significantly associated with better survival and greater clinical improvement in severe or critical COVID-19 patients.

A single-center comparative study of lung ultrasound versus chest computed tomography during the COVID-19 era.

BACKGROUND: Lung ultrasound (LUS) is a bedside imaging tool that has proven useful in identifying and assessing the severity of pulmonary pathology. The aim of this study was to determine LUS patterns, their clinical significance, and how they compare to CT findings in hospitalized patients with coronavirus infection. METHODS: This observational study included 62 patients (33 men, age 59.3±15.9 years), hospitalized with pneumonia due to COVID-19, who underwent chest CT and bedside LUS on the day of admission. The CT images were analyzed by chest radiographers who calculated a CT visual score based on the expansion and distribution of ground-glass opacities and consolidations. The LUS score was calculated according to the presence, distribution, and severity of anomalies. RESULTS: All patients had CT findings suggestive of bilateral COVID-19 pneumonia, with an average visual scoring of 8.1±2.9%. LUS identified 4 different abnormalities, with bilateral distribution (mean LUS score: 26.4±6.7), focal areas of non-confluent B lines, diffuse confluent B lines, small sub-pleural micro consolidations with pleural line irregularities, and large parenchymal consolidations with air bronchograms. LUS score was significantly correlated with CT visual scoring (rho = 0.70; p<0.001). Correlation analysis of the CT and LUS severity scores showed good interclass correlation (ICC) (ICC =0.71; 95% confidence interval (CI): 0.52-0.83; p<0.001). Logistic regression was used to determine the cut-off value of ≥27 (area under the curve: 0.97; 95% CI: 90-99; sensitivity 88.5% and specificity 97%) of the LUS severity score that represented severe and critical pulmonary involvement on chest CT (CT: 3-4). CONCLUSION: When combined with clinical data, LUS can provide a potent diagnostic aid in patients with suspected COVID-19 pneumonia, reflecting CT findings.

In-hospital mortality in SARS-CoV-2 stratified by hemoglobin levels: A retrospective study.

This study is to estimate in-hospital mortality in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients stratified by hemoglobin (Hb) level. Patients were stratified according to hemoglobin level into two groups, that is, Hb <100 g/L and Hb >100 g/L. A total of 6931 patients were included. Of these, 6377 (92%) patients had hemoglobin levels >100 g/L. The mean age was 44 ± 17 years, and 66% of the patients were males. The median length of overall hospital stay was 13 days [2; 31]. The remaining 554 (8%) patients had a hemoglobin level <100 g/L. Overall mortality was 176 patients (2.54%) but was significantly higher in the group with hemoglobin levels <100 g/L (124, 22.4%) than in the group with hemoglobin levels >100 g/L (52, 0.82%). Risk factors associated with increased mortality were determined by multivariate analysis. The Kaplan-Meier survival analysis showed hemoglobin as a predictor of mortality. Cox proportional hazards regression coefficients for hemoglobin for the HB ≤ 100 category of hemoglobin were significant, B = 2.79, SE = 0.17, and HR = 16.34, p < 0.001. Multivariate logistic regression showed Hb < 100 g/L had a higher cumulative all-cause in-hospital mortality (22.4% vs. 0.8%; adjusted odds ratio [aOR], 0.33; 95% [CI]: [0.20-0.55]; p < 0.001). In this study, hemoglobin levels <100 g/L were found to be an independent predictor of in-hospital mortality.

Familial Hypercholesterolemia in the Arabian Gulf Region: Clinical results of the Gulf FH Registry.

BACKGROUND AND AIMS: Familial hypercholesterolemia (FH) is a common autosomal dominant disorder that can result in premature atherosclerotic cardiovascular disease (ASCVD). Limited data are available worldwide about the prevalence and management of FH. Here, we aimed to estimate the prevalence and management of patients with FH in five Arabian Gulf countries (Saudi Arabia, Oman, United Arab Emirates, Kuwait, and Bahrain). METHODS: The multicentre, multinational Gulf FH registry included adults (≥18 years old) recruited from outpatient clinics in 14 tertiary-care centres across five Arabian Gulf countries over the last five years. The Gulf FH registry had four phases: 1- screening, 2- classification based on the Dutch Lipid Clinic Network, 3- genetic testing, and 4- follow-up. RESULTS: Among 34,366 screened patient records, 3713 patients had suspected FH (mean age: 49±15 years; 52% women) and 306 patients had definite or probable FH. Thus, the estimated FH prevalence was 0.9% (1:112). Treatments included high-intensity statin therapy (34%), ezetimibe (10%), and proprotein convertase subtilisin/kexin type 9 inhibitors (0.4%). Targets for low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol were achieved by 12% and 30%, respectively, of patients at high ASCVD risk, and by 3% and 6%, respectively, of patients at very high ASCVD risk (p <0.001; for both comparisons). CONCLUSIONS: This snap-shot study was the first to show the high estimated prevalence of FH in the Arabian Gulf region (about 3-fold the estimated prevalence worldwide), and is a "call-to-action" for further confirmation in future population studies. The small proportions of patients that achieved target LDL-C values implied that health care policies need to implement nation-wide screening, raise FH awareness, and improve management strategies for FH.

In-hospital mortality in SARS-CoV-2 stratified by serum 25-hydroxy-vitamin D levels: A retrospective study.

This study is done to estimаte in-hоsрitаl mоrtаlity in раtients with severe асute resрirаtоry syndrоme соrоnаvirus 2 (SАRS-СоV-2) strаtified by Vitamin-D (Vit-D) levels. Раtients were strаtified ассоrding tо by serum 25-hydroxy-vitamin D (25(OH)Vit-D) levels intо twо grоuрs, that is, 25(OH)Vit-D less thаn 40 nmol/L аnd 25(OH)Vit-D greаter thаn 40 nmol/L. А tоtаl оf 231 раtients were inсluded. Оf these, 120 (50.2%) оf the раtients hаd 25(OH)Vit-D levels greаter thаn 40 nmol/L. The meаn аge wаs 49 ± 17 yeаrs, аnd 67% оf the раtients were mаles. The mediаn length оf оverаll hоsрitаl stаy wаs 18 [6; 53] dаys. The remаining 119 (49.8%) раtients hаd а 25(OH)Vit-D less thаn 40 nmol/L. Vitamin D levels were seen as deficient in 63% of patients, insufficient in 25% and normal in 12%. Оverаll mоrtаlity wаs 17 раtients (7.1%) but statistically not signifiсаnt among the grоuрs (p = 0.986). The Kарlаn-Meier survivаl аnаlysis shоwed no significance based on an alpha of 0.05, LL = 0.36, df = 1, p = 0.548, indicating Vitamin_D_Levels was not able to adequately predict the hazard of Mortality. In this study, serum 25(OH)Vit-D levels were found have no significance in terms of predicting the in-hоsрitаl mortality in раtients with SАRS-СоV-2.

Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

This article was originally published electronically on the publisher's internet portal on May 5, 2020 without open access.

Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

An author name was incorrectly indicated in the Conflict of Interest Statement.

The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

PURPOSE: The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. MATERIALS AND METHODS: Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. RESULTS: Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). CONCLUSION: The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.

Mortality and Morbidity in HFrEF, HFmrEF, and HFpEF Patients with Diabetes in the Middle East.

OBJECTIVES: We sought to estimate the mortality and morbidity in diabetic acute heart failure (AHF) patients stratified by left ventricular ejection fraction. METHODS: We analyzed the data of patients with AHF from seven Middle Eastern countries (Bahrain, Oman, Yemen, Kuwait, UAE, Qatar, and Saudi Arabia) from February to November 2012, who were enrolled in a multinational registry of patients with heart failure (HF). RESULTS: A total of 2258 AHF patients had diabetes mellitus. The mean age was 63.0±11.0 years (ranging from 18 to 99 years), and 60.3% (n = 1362) of the patients were males. The mean ejection fraction (EF) was 37.0±13.0%. HF with reduced EF (< 40%) (HFrEF) was observed in 1268 patients (56.2%), whereas 515 patients (22.8%) had mid-range (40-49%) (HFmrEF) and 475 patients (21.0%) had preserved EF (3 50%) (HFpEF). The overall cumulative all-cause mortalities at three- and 12-months follow-up were 11.8% (n = 266) and 20.7% (n = 467), respectively. Those with HFpEF were associated with lower three-months cumulative all-cause mortality compared to those with HFrEF (7.6% vs. 5.9%; adjusted odds ratio (aOR) = 0.54, 95% confidence interval (CI): 0.31-0.95; p = 0.031), but not significantly different when compared to those with HFmrEF (aOR = 0.86, 95% CI: 0.53-1.40; p = 0.554). There were largely no significant differences among the groups with regards to the 12-months all-cause cumulative mortality (11% vs. 11% vs. 10%; p = 0.984). There were also no significant differences in re-hospitalization rates between the three HF groups not only at three months (23% vs. 20% vs. 22%; p = 0.520), but at one-year follow-up (28% vs. 30% vs. 32%; p = 0.335). CONCLUSIONS: Three-month cumulative all-cause mortality was high in diabetic HFrEF patients when compared to those with HFpEF. However, there were no significant differences in mortality at one-year follow-up between the HF groups. There were also no significant differences in re-hospitalization rates between the HF groups not only at three months but also at one-year follow-up in the Middle East.