Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Clinical trials have demonstrated the efficacy and safety of mitral transcatheter edge-to-edge repair (M-TEER) for selected patients with severe mitral regurgitation. However, the generalizability of trial results to real-world patients remains uncertain. OBJECTIVES: The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER. METHODS: Using the National Inpatient Sample database years 2016-2020, M-TEER admissions were identified and categorized into trial participants vs none. We also identified a cohort of trial noneligible patients based on clinical exclusion criteria from pivotal trials. Multivariate regression analysis was performed to compare in-hospital outcomes. The primary outcome was in-hospital mortality, and secondary outcomes included in-hospital complications, length of stay, and hospitalization cost. RESULTS: Among 38,770 M-TEER admissions from 2016 to 2020, 11,450 (29.5%) were trial participants, 22,975 (59.3%) were eligible nonparticipants, and 2,960 (7.6%) were noneligible. Baseline characteristics and comorbidity profiles were mostly similar between trial participants vs eligible nonparticipants. In-hospital mortality (adjusted OR [aOR]: 0.98; 95% CI: 0.60-1.62), cardiogenic shock (aOR: 1.06; 95% CI: 0.80-1.42), mechanical circulatory support (aOR: 0.91; 95% CI: 0.58-1.41), mechanical ventilation (aOR: 1.03; 95% CI: 0.74-1.42), and conversion to mitral valve surgery (aOR: 1.08; 95% CI: 0.57-2.03) were not different between both groups. Conversely, M-TEER for noneligible patients was associated with higher rates of mortality (aOR: 6.27; 95% CI: 3.75-10.45) and complications. CONCLUSIONS: The majority of real-world M-TEER patients would have been eligible for clinical trial participation and had comparable clinical profiles and in-hospital outcomes to trial participants. However, noneligible patients had worse in-hospital outcomes compared with trial participants.

Association Between ß-thalassemia and Atrial Fibrillation: Insights from the United States National Inpatient Sample.

Transfusion-dependent ß-thalassemia (thalassemia major and thalassemia intermedia) (BT) requires repeated blood transfusions for survival due to ineffective erythropoiesis. Consequently, iron overload can predispose the patient to atrial fibrillation (AF) despite the improved prognosis achieved with transfusion and chelation therapy. We sought to study the impact of AF on BT patients through a large database analysis. The current study used data from the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project National Inpatient Sample collected from 2016-2019. A total of 17,150 admissions were included, of which 2100 (12.2%) admissions had a concomitant diagnosis of AF. Admissions with AF were older (mean age, 72.1 vs. 47.3 years; P < .001) and more likely to have congestive heart failure (CHF), hypertension, valvular heart disease, and renal disease. BT admission was associated with a higher AF prevalence than non-BT admission across all age groups. AF was not associated with an increased risk of in-hospital mortality (adjusted odds ratio [aOR], 1.36; 95% confidence interval [CI], 0.67-2.78; P = .398) or an increased length of stay (LOS) (aOR, 1.00; 95% CI, 0.78-1.29; P = .997) in the general cohort. In a subgroup analysis, AF was associated with increased in-hospital mortality in women (aOR, 2.73; 95% CI, 1.09-6.8; P = .031). Predictors of in-hospital mortality were increasing age, CHF, and liver disease, while predictors of prolonged LOS were diabetes mellitus, CHF, and increasing age. Further studies are warranted to develop strategies to improve the quality of care and outcome in this population.

Asymptomatic COVID-19 presenting with features of mixed pattern acute liver injury in a young healthy female, a case report.

COVID-19 associated severe acute liver injury in a young healthy patient has not been reported much in the literature. And currently, there are no standard management guidelines. We want to report a case of acute liver injury of mixed pattern in a young healthy female with asymptomatic COVID-19 infection. She presented with abdominal pain, nausea, vomiting and yellowish discoloration of her skin. Further laboratory investigations revealed mixed pattern liver injury with highly raised liver enzymes. She was managed with N-acetyl cysteine protocol and monitoring of her liver enzymes. Other causes of acute liver injury were ruled out. She remained stable during her hospital stay and follow up. Our aim is to highlight the significance of acute liver injury in COVID 19 patients that may lead to fatal outcomes if not managed and monitored accordingly.

Contemporary Trends, Characteristics, and Outcomes of Transcatheter Aortic Valve Implantation Among Extreme Elderly Patients.

Transcatheter aortic valve implantation (TAVI) has been increasingly performed among extreme elderly patients with symptomatic severe aortic stenosis. We aimed to study the trends, characteristics, and outcomes of TAVI among extreme elderly. The National Readmission Database for the years 2016 to 2019 was queried for extreme elderly who underwent TAVI. Linear regression analysis was used to calculate the temporal trends in outcomes. A total of 23,507 TAVI extreme elderly admissions (50.3% women and 95.9% Medicare insurance) were included. The in-hospital mortality and all-cause 30-day readmissions were 2% and 15% and have been stable over years of analysis (p trend = 0.79 and 0.06, respectively). We evaluated complications, such as permanent pacemaker implantation (12%) and stroke (3.2%). Stroke rates did not decrease (3.4% vs 2.9% in 2016 and 2019 [p trend = 0.24]). The mean length of stay improved from 5.5 days in 2016 to 4.3 days in 2019 (p trend <0.01). The rates of early discharge (day ≤3) has improved from 49% in 2016 to 69% in 2019 (p trend <0.01). In conclusion, this nationwide contemporary observational analysis showed that TAVI was associated with low rates of complications in the extreme elderly.

Trends and Predictors of Poor Outcomes in Patients With Right Heart Failure: Insights From the National Readmission Database.

Right heart failure (RHF) is a complex clinical syndrome that confers high risk of morbidity and mortality. We sought to study RHF using large national database. The study is a retrospective analysis of the National Readmission Database (NRD) of years 2017-2019. Admissions with a primary diagnosis of RHF were included. Study outcomes were temporal trends of RHF diagnosis and predictors of in-hospital mortality and 30-day readmission. Subgroup analysis according to co-presence of reduced or preserved left ventricular ejection fraction (LVEF). Multivariate logistic regression was utilized to detect predictors of poor outcome and difference between subgroups. A total of 127,503 admissions were identified from the database of which 4,717 primary RHF admissions were included in our cohort. There was a trend of increasing RHF diagnosis from 2017 4th Quarter to 2019 4th Quarter. Age, liver disease and reduced LVEF were amongst predictors of in-hospital mortality while iron deficiency anemia and a Charlson Comorbidity Score ≥ 3 were predictors of 30-day readmission. The study of real-world data contributes to a better understanding of RHF outcomes. Further studies are needed to investigate the association between RHF and different types of heart failure and its implications on clinical practice.

National Trends of Structural Heart Disease Interventions from 2016 to 2020 in the United States and the Associated Impact of COVID-19 Pandemic.

The Coronavirus Disease-2019 (COVID-19) pandemic placed an enormous strain on the healthcare system. Data on the impact of COVID-19 on the utilization and outcomes of structural heart disease interventions in the United States are scarce. The National Inpatient Sample from 2016 to 2020 was queried to identify adult admissions for transcatheter aortic valve replacement (TAVR), left atrial appendage occlusion (LAAO), and transcatheter end-to-end repair (TEER). The primary outcome was temporal trends of procedure utilization rate per 100,000 admissions over quarters from 2016 to 2020. The secondary outcomes were adjusted rates of in-hospital mortality, major complications, and length of stay (LOS). Among 434,630 weighted admissions (TAVR: 305,550; LAAO: 89,300; TEER: 40,160), 95,010 admissions (22%) were during the COVID-19 era. There was a decline during the second quarter of 2020 followed by an increase to the pre pandemic levels (TAVR: 220 to 253, LAAO: 57 to 109, and TEER: 31 to 36 per 100,000 admissions, Ptrend<0.001). There were no differences in the mortality or major complication rates. Median LOS has decreased in TAVR (4 days-1 day) and in TEER (3 days-1 day) but remained stable in LAAO (1 day). This nationwide analysis showed that structural heart disease interventions decreased during the early waves of COVID-19 pandemic. There was a significant reduction in hospital LOS without differences in in-hospital mortality or complication rates during the pandemic. These data suggest that hospitals adapted to the unprecedent challenges during the pandemic to provide advanced cardiac care to patients.

COVID-19 Myopericarditis With Pericardial Effusion Complicated With Cardiac Tamponade and Rhabdomyolysis.

COVID-19 infection is a complex multi-organ disease, including the cardiovascular system, which may present with myocarditis. A 42-year-old female presented to our ED with generalized weakness, myalgia, and epigastric pain. Laboratory workup showed a positive SARS-CoV-2 polymerase chain reaction (PCR). An ECG showed sinus tachycardia with low voltage. A bedside echocardiogram showed a pericardial effusion with cardiac tamponade. An emergent pericardiocentesis was performed with immediate hemodynamic improvement. The patient was admitted to the coronary care unit (CCU), and colchicine and ibuprofen were started for pericarditis. Pericardial fluid bacterial and fungal cultures were negative, and serum antinuclear antibodies were also negative. On day 5 of hospitalization, creatine kinase (CK) level was high compared to on presentation. COVID-induced rhabdomyolysis was suspected and was dramatically improved with IV fluids. The patient was discharged on day 7 of admission. Our case shows that COVID-19 can present with an uncommon presentation like cardiac tamponade. Further studies are warranted to better understand the pathogenesis and management of COVID-19 myopericarditis.

Clozapine-Induced Myocarditis in a Young Man with Refractory Schizophrenia: Case Report of a Rare Adverse Event and Review of the Literature.

BACKGROUND Myocarditis is cardiac muscle inflammation caused by infectious or noninfectious agents. Rarely, clozapine, an atypical antipsychotic drug used to treat resistant schizophrenia, has been reported to cause myocarditis, as we report in this case. CASE REPORT A 29-year-old man, who was known to have schizophrenia and was on olanzapine therapy, presented in our Emergency Department with active psychosis, and was subsequently admitted to the psychiatric ward for refractory schizophrenia. He was started on clozapine, which was cross-titrated with olanzapine. On day 20 of being treated with clozapine, he developed a high-grade fever and chest pain. EKG demonstrated new-onset prolonged QT corrected for heart rate (QTc), premature ventricular contractions, ST-T wave changes with an increased ventricular rate, and ventricular bigeminy with elevated troponin and inflammatory markers. Echocardiography showed a reduced left ventricular ejection fraction. Coronary angiography showed normal coronary arteries, low cardiac output, and cardiac index consistent with cardiogenic shock was also observed. Other pertinent laboratory results included negative respiratory viral panel, including COVID-19 PCR, negative blood cultures, and negative stool screen for ova and parasite. Clozapine was discontinued and the patient received management for heart failure with reduced ejection fraction. He improved clinically with return of EKG to normal sinus rhythm and improved left ventricular ejection fraction on repeat echocardiogram. CONCLUSIONS Acute myocarditis can occur due to a myriad of causes, both infectious and noninfectious; thus, determining the lesser-known causes, such as drug-related etiology, is essential to provide appropriate treatment for patients.

Pembrolizumab-Induced Myocarditis and Pancreatitis in a Patient With Colon Cancer: A Case Report.

We present a unique case of immune checkpoint inhibitor (ICI)-induced myocarditis and acute pancreatitis in a patient with metastatic colon cancer after seven cycles of pembrolizumab. A 43-year-old male with stage IV colon cancer on pembrolizumab presented with acute onset of heart failure with severely decreased ejection fraction (EF), conduction abnormalities, and normal coronary arteries on cardiac catheterization. He was started on high-dose steroids for grade 3 immune-related myocarditis. Four days later he presented with abdominal pain consistent with acute pancreatitis, likely related to the immune checkpoint inhibitors as well, Pembrolizumab was discontinued permanently. Pembrolizumab is currently used to treat many types of advanced cancers with promising results; thus, clinicians need to be aware of the multiple organs and systems that can be affected after using ICIs.

Characteristics and Outcomes of Critically Ill Patients with Raised Cardiac Troponins Admitted in the Intensive Care Unit: A single centre experience from Oman.

Objectives: Critically ill patients have raised troponins. This study aimed to assess the incidence of myocardial injury in the intensive care unit (ICU) at a tertiary care hospital and assess the management and prognosis. Methods: This retrospective study included adult patients who were admitted to the ICU of Sultan Qaboos University Hospital, Muscat, Oman, between January and December 2019 and had undergone a high-sensitive cardiac troponin (hs-cTn) assay. Patients admitted with a primary diagnosis of myocardial infarction were excluded. Results: A total of 264 patients had their hs-cTn measured during the study period. Of these, 128 (64.3 ± 17.1 years; 58.6% male) had elevated levels, giving an incidence rate of approximately 48.5%. Those with raised troponin were older and had more co-morbidities. These patients were also more critically ill with lower blood pressure, higher heart rates and increased hypotensive episodes. Of these, 47 were treated for acute coronary syndrome, 32 underwent coronary angiography and only three required stenting. Patients with raised troponin had a poor outcome with only 45 (35.2%) surviving to discharge compared to 101 (74.3%) with normal troponin. Patients with raised troponin had shorter hospital stays than those with normal troponin (16 versus 19 days; P = 0.017). Conclusion: A high proportion of critically ill patients showed evidence of myocardial injury without significant coronary artery disease, which is associated with a poor prognosis. Further prospective studies are required to ascertain the best course of treatment for these patients.

Abnormal diastolic function and Global longitudinal strain in patients with Thalassemia Major on long term chelation therapy.

Cardiac complications are the major cause of mortality in patients with Thalassemia major (TM). Cardiac T2* MRI is currently the gold standard for assessing myocardial iron concentration. The aim of our study was to assess whether any echocardiographic parameter would correlate with these findings in patients well established on chelation therapy. This was a prospective study on patients with TM who are regularly followed in our clinic. Patients had a cardiac MRI and echocardiogram within 2 months of each other. Echo parameters included global longitudinal strain and diastolic function. We also compared these findings with those from a cohort of thalassemia intermedia (TI) and normal controls. A total of 84 patients (mean age 26.3 ± 6.1 years, 42.8% male) with TM were enrolled. All had normal left ventricular ejection fraction and only 8 patients had MRI T2* < 10. As compared to 17 patients with TI and 53 controls, these patients had significantly higher E/E' and lower pulmonary vein s/dd ratio suggesting early diastolic dysfunction. 28 patients fulfilled criteria for diastolic dysfunction even in the presence of normal MRI T2*. Global longitudinal strain (GLS) was significantly lower in the TM group as compared to the TI and controls. We found no correlation between any of the echo findings and the MRI T2*in TM patients. In patients with thalassemia and MRI T2* > 20 ms features of diastolic dysfunction persist even in the presence of normal LV function and normal GLS. This suggests that diastolic function remains abnormal even when myocardial iron concentrations are normal and follow up therefore is essential.