Hashem, Anas

ABSTRACT Objective This study compared the effects of phentermine‐topiramate‐ER (mid‐dose 7.5/46 mg) versus placebo on weight loss and cardiovascular disease (CVD) risk outcomes when used as an adjunct to a digitally enhanced lifestyle intervention (DELI). Methods We conducted a 12‐month, randomized, double‐blind, placebo‐controlled trial at a single tertiary academic center in the United States (June 2020–June 2022). Eighty participants with obesity (BMI ≥ 30 kg/m 2 ) were enrolled in the DELI program, consisting of in‐person and telehealth modalities, dietary and physical activity goals, and use of a smartphone application integrated with digital devices (Apple Watch and Bluetooth‐enabled weight scale and blood pressure monitor). Participants were randomized 1:1 to receive either phentermine‐topiramate‐ER ( n = 42) or placebo ( n = 38) in addition to the DELI. Results At 3 months, the phentermine‐topiramate group lost a mean of 10.82 kg versus 4.04 kg in the placebo group (mean difference −6.78 kg; p = 0.002). At 12 months, weight loss was 15.32 kg versus 5.85 kg, respectively (mean difference −9.48 kg; p < 0.001). Participants receiving phentermine‐topiramate‐ER experienced a 3.35% reduction in the estimated atherosclerotic CVD risk compared to baseline ( p = 0.004). Conclusions Phentermine‐topiramate‐ER, when combined with a DELI, produced significant and sustained weight loss and reduced CVD risk in adults with obesity. Trial Registration ClinicalTrials.gov : NCT04408586

Introduction: Infective endocarditis (IE) is a severe intracardiac infection, often requiring intensive care unit (ICU) admission. Despite early surgical intervention, mortality remains high. Data for patients admitted to the cardiac intensive care unit (CICU) is especially limited. Research Question: We aimed to investigate the short and long-term outcomes of patients with IE admitted to the CICU. Methods: We conducted a retrospective cohort study of adult patients admitted to the Mayo Clinic CICU (2007-2018) with confirmed acute IE, identified via database query and manual chart review. Patients were further categorized by cardiac surgery status: performed, indicated but declined, or not indicated. Primary outcomes were all-cause mortality at 30-days and 1-year, analyzed using Kaplan-Meier and Cox proportional-hazard analysis. Models were adjusted for known predictors. Results: Overall, 233 CICU patients met criteria for IE. Median age was 64.0 years; 49 were female. In total, 104 patients had native valve IE; 128 had prosthetic or implantable device-associated IE. Staphylococcus aureus was the most prevalent organism (42.7%) and was present in 72.4% of 30-day deaths. Cardiac surgery was indicated in 182 (78.1%) patients - 129 patients underwent surgery, while 53 declined; 48 patients did not have indications. By 30 days, 58 (24.9%) patients died; significant predictors included older age, higher illness severity scores, and greater need for critical care therapies. The 30-day mortality estimates were markedly higher for patients who declined surgery (60.4%, adj. HR 4.17, 95% CI 2.02-8.52, p <0.001), and lower for those who received surgery vs those without surgical indications (11.9% vs 23.8%, adj. HR 0.44, 95% CI 0.20-0.98, p=0.04) (Figure 1). By 1-year, 93 (39.9%) patients died, including 36 (20.5%) hospital survivors. The 1-year mortality estimates were markedly higher for patients who declined surgery (85.1%, adj. HR 5.46, 95% CI 2.87-10.39, p <0.001), but was similar for patients who received surgery to those without surgical indications (31.8% vs 29.3%, adj. HR 0.94, 95% CI 0.49-1.78, p=0.84) (Figure 2). Conclusion: IE requiring CICU admission carries substantial mortality despite acute management. Higher severity scores, comorbidities, and intensive care interventions predict mortality. Early cardiac surgery improved short-term outcomes, but long-term mortality remains high.

Background: Clinical outcomes of catheter-based thrombectomy (CBT) compared with surgical embolectomy (SE) in patients with massive pulmonary embolism (mPE) have not been previously examined. Methods: We conducted a retrospective cohort study using the 2016-2020 National Inpatient Sample database to compare the outcomes of CBT versus SE in patients with mPE. Outcomes of interest included risk-adjusted in-hospital mortality, major bleeding, stroke, acute kidney injury (AKI), hospital length of stay (LOS), and total cost. Results: The total cohort included 5,845 patients with mPE, of which 5,490 (93.9%) underwent CBT and 215 (3.7%) underwent SE. After risk-adjustment, CBT had similar odds of in-hospital mortality (adjusted odds ratio [aOR] 1.49, 95% confidence interval [CI] 0.60-3.66, p=0.37) and stroke (aOR 1.49, 95% CI 0.30-7.38, p=0.62), lower odds of major bleeding (aOR 0.28, 95% CI 0.13-0.63, p<0.01), and higher odds of AKI (aOR 2.40, 95% CI 1.11-5.17, p=0.02) compared with SE. CBT had a similar LOS (p=0.58) and total cost (p=0.23) compared with SE. Between 2016 and 2020, there was a temporal increase in the performance of CBT in patients with mPE (p trend <0.01). Conclusions: In patients with massive PE, CBT was associated with similar in-hospital mortality, stroke, LOS, and total cost, lower major bleeding, and higher AKI compared with SE. Randomized controlled trials are indicated to confirm our findings.

Introduction: Data on use of ICE guidance in TEER procedure is limited to case reports and small case series. Our study aims to assess the feasibility, safety, utilization patterns and clinical outcomes of mitral TEER procedure with ICE guidance using a nationally representative real-world cohort of patients.Hypothesis: There is no difference between ICE-guided TEER and TEE-guided TEER in the clinical outcomes and complications. Methods: This study used the National Inpatient Sample database from quarter 4 of 2015 to 2020. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of <0.05 was considered significant. Results: A total of 38,770 weighted cases of mitral TEER were identified. Of the included patients 665 patients underwent ICE-guided TEER while 38,105 had TEE-guided TEER. There were no differences in the in-hospital mortality between both groups (2.5% vs. 3.0%, p=0.58). Adjusted odds of in-hospital mortality (aOR 0.83, 95%CI [0.42-1.64]) were not significantly different. There were no differences in periprocedural complications including cardiac (aOR 0.85, 95%CI [0.54-1.35]), bleeding (aOR 1.45, 95%CI [0.93-2.33]), respiratory (aOR 0.88, 95%CI [0.61-1.25]), and renal (aOR 0.89, 95%CI [0.66-1.20]) complications between patients undergoing ICE-guided versus TEE-guided TEER. There was no difference in GI complications between both groups (aOR 1.11, 95%CI [0.46-2.70]). The adjusted length of stay was less among ICE-guided TEER (median: 1 vs. 2, p<0.01) with no differences in costs of hospitalization ($137,312 vs. $153,773, p=0.06), Conclusions: In conclusion, ICE-guided mitral TEER is safe when compared with TEE guided TEER with no significant differences in in-hospital mortality, cardiac, bleeding, respiratory, and renal complications. The length of stay in ICE group is shorter as compared with the TEE group.

Introduction: Data on clinical outcomes of percutaneous closure of iatrogenic atrial septal defect (PC-ASD) in patients undergoing transcatheter edge-to-edge repair (TEER) or mitral valve replacement (TMVR) remains limited. We used a real-world USA database to evaluate the differences in the in-hospital outcomes between both groups. Hypothesis: Is there a clinical significance for PC-ASD in patients undergoing TEER or TMVR? Methods: We used the National Inpatient Sample (2015-2020) by utilizing ICD-10 codes to identify all patients who underwent TEER or TMVR with or without PC-ASD. Multivariate logistic regression was used for adjusted outcomes (adjusted odds ratio [aOR]). Results: A total of 44,065 eligible weighted hospitalizations were included: 39,625 (89.9%) of the patients underwent TEER and 4,440 (10.1%) underwent TMVR. Rates of PC-ASD were higher in TMVR group compared to TEER group (10.7% vs. 2.0%, p<0.01). In patients who underwent TEER without PC-ASD, PC-ASD was more associated with acute heart failure (AHF) (aOR 1.42 [1.19-1.68], p<0.01) and longer hospitalizations (aOR 1.64 [1.41-1.89], p<0.01), without significant difference in inpatient mortality (aOR 0.97 [0.61-1.54], p<0.01), cardiogenic shock (aOR 1.13 [0.85-1.51], p=0.21), need for mechanical circulatory support (MCS) (aOR 0.98 [0.61-1.54], p=0.18), and stroke. Compared to patients who underwent TMVR without PC-ASD, PC-ASD was associated with higher inpatient morality (aOR 1.65 [1.13-2.4], p<0.01), need for MCS (aOR 1.91 [1.33-2.73], p<0.01) without significant difference in AHF (aOR 1.19 [0.94-1.51], p=0.18] and cardiogenic shock (aOR 0.83 [0.56-1.22], p=0.43). Remarkably, PC-ASD was less associated with stroke (aOR 0.27 [0.10-0.72], p<0.01). Conclusions: Rates of PC-ASD after TEER were lower than after TMVR and were associated with worse in-hospital mortality and need for MCS in TMVR but not in TEER. Also, PC-ASD was less associated with stroke after TMVR.

Introduction: Data on clinical outcomes of early transcatheter aortic valve replacement (TAVR) (<48 hours) compared to late (≥48 hours) TAVR in patients hospitalized with acute heart failure (AHF) and aortic stenosis (AS) remains limited. We aim to evaluate the differences between early vs. late TAVR regarding major clinical outcomes using a real-world US database. Hypothesis: There is no differences in the clinical outcomes based on the timing of TAVR procedural intervention in patients with acute heart failure. Methods: We used the National Inpatient Sample database by utilizing ICD-10 codes to identify all hospitalizations with a diagnosis of AHF and TAVR (2015-2020). The associations between the time of TAVR and outcomes were examined using multivariable logistic regression. Propensity-score matched (PSM) analysis was utilized to determine the adjusted odds ratio (aOR) of major clinical outcomes. Results: A total of 25,285 weighted hospitalizations of AHF were identified, of which 6,855 patients (27.1%) underwent early TAVR and 18,430 (72.9%) had late TAVR. Compared with early TAVR, Late TAVR was associated with less need for mechanical circulatory support (MCS) (aOR 0.97 [0.96-0.98], p<0.01) and acute hypoxic respiratory failure (aOR 0.99 [0.98-0.99], p<0.01), but higher odds of developing septic shock (aOR 2.06 [1.52-2.80], p <0.01). However, there was no significant difference between both procedures regarding in-hospital mortality (aOR 1.01 [1.00-1.02], p=0.14), cardiac arrest (aOR 0.99 [0.98-1.00], p=0.21), and stroke (aOR 1.01 [1.00-1.02], p=0.18). Conclusions: Most patients with AHF and AS undergo TAVR after 48 hours of their presentation. After PSM, there was no difference in inpatient mortality, cardiac arrest, and stroke between both procedures. Late TAVR was associated with lower odds for MCS and acute hypoxic respiratory failure. The optimal timing of TAVR in patients with AHF and AS needs further study.

Introduction: Patients with acute heart failure (AHF) exacerbation are susceptible to complications in the setting of COVID-19 infection. Data regarding the clinical outcomes of COVID-19 in patients admitted with AHF is limited. Methods: We used the national inpatient sample database by utilizing ICD-10 codes to identify all hospitalizations with a diagnosis of AHF in 2020. We classified the sample into AHF with COVID-19 infection versus those without COVID-19. Primary outcome was in-hospital mortality. Secondary outcomes were acute myocardial infarction, need for pressors, mechanical cardiac support, cardiogenic shock, and cardiac arrest. Also, we evaluated for acute pulmonary embolism (PE), bacterial pneumonia, need for a ventilator, and acute kidney injury (AKI). Results: We identified a total of 694,920 of AHF hospitalizations, 660,463 (95.04%) patients without COVID-19 and 34,457 (4.96%) with COVID-19 infection. For baseline comorbidities, diabetes mellitus, chronic heart failure, ESRD, and coagulopathy were significantly higher among AHF patients with COVID-19 ( P < .01). While CAD, prior MI, percutaneous coronary intervention, and coronary artery bypass graft, atrial fibrillation, chronic obstructive pulmonary disease, and peripheral vascular disease were higher among those without COVID-19. After adjustment for baseline comorbidities, in-hospital mortality (aOR 5.08 [4.81 to 5.36]), septic shock (aOR 2.54 [2.40 to 2.70]), PE (aOR 1.75 [1.57 to 1.94]), and AKI (aOR 1.33 [1.30 to 1.37]) were significantly higher among AHF with COVID-19 patients. The mean length of stay (5 vs 7 days, P < .01) and costs of hospitalization ($42,143 vs $60,251, P < .01) were higher among AHF patients with COVID-19 infection. Conclusion: COVID-19 infection in patients with AHF is associated with significantly higher in-hospital mortality, need for mechanical ventilation, septic shock, and AKI along with higher resource utilization. Predictors for mortality in AHF patients during the COVID-19 pandemic, COVID-19 infection, patients with end-stage heart failure, and atrial fibrillation. Studies on the impact of vaccination against COVID-19 in AHF patients are needed

Introduction: Persons who conceived through Assisted Reproductive Technology (ART) have an increased risk of obstetric-associated complications. Hypothesis: ART is associated with increased acute cardiovascular (CV) complications during delivery admissions. Methods: We used data from the National Inpatient Sample (2008-2019) while utilizing ICD-9 or ICD-10 codes to identify delivery hospitalizations and ART procedure. Results: A total of 45,867,086 weighted delivery cases were identified, of which 0.24% were among individuals who conceived through ART (n=108,542). Persons with an ART history were older at the time of delivery (median 35 vs. 28 years, p<0.01) and had higher prevalence of hypertension, gestational diabetes, and dyslipidemia (all, p<0.01). After adjustment for age, race/ethnicity, comorbidities, multiple gestation, insurance, and income, ART remained an independent predictor of peripartum CV complications including preeclampsia (aOR 1.48 [1.45-1.51], p<0.01), heart failure (aOR 1.94 [1.10-3.40], p<0.01), and cardiac arrhythmias (aOR 1.39 [1.30-1.48], p<0.01) compared to natural conception. Likewise, the risk of acute kidney injury (aOR 2.57 [2.25-2.92], p<0.01), stroke (aOR 1.57 [1.23-2.01], p<0.01), pulmonary edema (aOR 2.29 [2.02-2.61], p<0.01), and venous thromboembolism (aOR 1.92 [1.63-2.25], p<0.01) were higher with ART. However, higher odds of developing peripartum cardiomyopathy or acute coronary syndrome were not associated with ART. Length of stay (3 vs. 2 days, p<0.01) and cost of hospitalization ($5,903 vs. $3,922, p<0.01) were higher for deliveries among persons with history of ART. Conclusions: Persons who conceived with ART had higher risk of preeclampsia, heart failure, cardiac arrhythmias, pulmonary edema, AKI, stroke, and VTE during their delivery hospitalizations. This may in part contribute to increased resource utilization seen in patients conceiving with ART

We show how switching from a regular diet to an HCHF increases cholesterol absorption in patients with normal weight and obesity. The decrease in cholesterol absorption from an HCHF to an LCLF, on the other hand, was only seen in normal-weight controls, underlining the importance of body weight in this regulation. In addition, changes in caloric and fat content had an immediate and direct effect on hepatic bile acid production.