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.

Sex differences in myocarditis hospitalizations: Rates, outcomes, and hospital characteristics in the National Readmission Database.

Inflammation of the myocardium, or myocarditis, presents with varied severity, from mild to life-threatening such as cardiogenic shock or ventricular tachycardia storm. Existing data on sex-related differences in its presentation and outcomes are scarce. Using the Nationwide Readmission Database (2016-2019), we identified myocarditis hospitalizations and stratified them according to sex to either males or females. Multivariable regression analyses were used to determine the association between sex and myocarditis outcomes. The primary outcome was in-hospital mortality, and the secondary outcomes included sudden cardiac death (SCD), cardiogenic shock (CS), use of mechanical circulatory support (MCS), and 90-day readmissions. We found a total of 12,997 myocarditis hospitalizations, among which 4,884 (37.6 %) were females. Compared to males, females were older (51 ± 15.6 years vs. 41.9 ± 14.8 in males) and more likely to have connective tissue disease, obesity, and a history of coronary artery disease. No differences were noted between the two groups with regards to in-hospital mortality (adjusted odds ratio [aOR] 1.20; confidence interval [CI] 0.93-1.53; P = 0.16), SCD (aOR:1.18; CI 0.84-1.64; P = 0.34), CS (aOR: 1.01; CI 0.85-1.20;P = 0.87), or use of MCS (aOR: 1.07; CI:0.86-1.34; P = 0.56). In terms of interventional procedures, females had lower rates of coronary angiography (aOR: 0.78; CI 0.70-0.88; P < 0.01), however, similar rates of right heart catheterization (aOR 0.93; CI:0.79-1.09; P = 0.36) and myocardial biopsy (aOR: 1.16; CI:0.83-1.62; P = 0.38) compared to males. Additionally, females had a higher risk of 90-day all-cause readmission (aOR: 1.25; CI: 1.16-1.56; P < 0.01) and myocarditis readmission (aOR:1.58; CI 1.02-2.44; P = 0.04). Specific predictors of readmission included essential hypertension, congestive heart failure, malignancy, and peripheral vascular disease. In conclusion, females admitted with myocarditis tend to have similar in-hospital outcomes with males; however, they are at higher risk of readmission within 90 days from hospitalization. Further studies are needed to identify those at higher risk of readmission.

Mechanical Thrombectomy for Acute Ischemic Stroke in Metastatic Cancer Patients: A Nationwide Cross-Sectional Analysis.

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MT) is the standard treatment for large vessel occlusion (LVO) acute ischemic stroke. Patients with active malignancy have an increased risk of stroke but were excluded from MT trials. METHODS: We searched the National Readmission Database for LVO patients treated with MT between 2016-2018 and compared the characteristics and outcomes of cancer-free patients to those with metastatic cancer (MC). Primary outcomes were all-cause in-hospital mortality and favorable outcome, defined as a routine discharge to home (regardless of whether home services were provided or not). Multivariate regression was used to adjust for confounders. RESULTS: Of 40,537 LVO patients treated with MT, 933 (2.3%) had MC diagnosis. Compared to cancer-free patients, MC patients were similar in age and stroke severity but had greater overall disease severity. Hospital complications that occurred more frequently in MC included pneumonia, sepsis, acute coronary syndrome, deep vein thrombosis, and pulmonary embolism (P<0.001). Patients with MC had similar rates of intracerebral hemorrhage (20% vs. 21%) but were less likely to receive tissue plasminogen activator (13% vs. 23%, P<0.001). In unadjusted analysis, MC patients as compared to cancer-free patients had a higher in-hospital mortality rate and were less likely to be discharged to home (36% vs. 42%, P=0.014). On multivariate regression adjusting for confounders, mortality was the only outcome that was significantly higher in the MC group than in the cancerfree group (P<0.001). CONCLUSION: LVO patients with MC have higher mortality and more infectious and thrombotic complications than cancer-free patients. MT nonetheless can result in survival with good outcome in slightly over one-third of patients.

Temporal Trends and Sex Differences in Patients With Cardiac Amyloidosis and Heart Failure With Preserved Ejection Fraction: Retrospective Analysis of 22,015 Admissions From the National Inpatient Sample.

Cardiac amyloidosis (CA) often goes unrecognized as a cause of heart failure with preserved ejection fraction (HFpEF). There is paucity of contemporary data evaluating the trends of CA diagnosis and associated sex differences. Adult heart failure hospitalizations were identified from the National Inpatient Sample between 2016 and 2019. Hospitalizations with heart failure other than HFpEF were excluded. Hospitalizations with a diagnosis of CA were identified. A Linear regression was utilized to calculate the trend of CA diagnosis over time. A multivariate logistic regressions analysis was performed to analyze sex differences. There was an increasing trend of CA from 1.2 to 2.3 per 1000 HFpEF admission in the first quarter of 2016 to the fourth quarter of 2019 (Ptrend <0.001). In females, as compared to males, there was an increased risk of AIS (6% vs 3%, aOR: 1.68[1.24-2.27], P=0.001) and major bleeding events (10% vs 5%, aOR: 1.97[1.53-2.52], P<0.001). No difference was observed in the in-hospital mortality outcome (8% vs 7%, aOR: 1.2[0.95-1.53], P=0.12) between both groups. Our real-world contemporary analysis showed an increase in CA diagnosis from 2016 to 2019. Despite similar in-hospital mortality, females were associated with higher AIS and major bleeding events rates. Further prospective studies are needed to validate these results.

Outcomes of Coronary Artery Bypass Grafting in Patients With Previous Mediastinal Radiation.

Studies have shown that patients with radiation therapy-associated coronary artery disease tend to have worse outcomes with percutaneous revascularization. Previous irradiation has been linked with future internal mammary artery graft disease. Studies investigating the outcomes of coronary artery bypass surgery (CABG) among patients with previous radiation are limited. The Nationwide Readmission Database for the years 2016 to 2019 was queried for hospitalizations with CABG and history of mediastinal radiation. Complex samples multivariable logistic and linear regression models were used to determine the association between the history of mediastinal radiation and in-hospital mortality, 90 days all-cause unplanned readmission rates, and acute coronary syndrome readmission rates. A total of 533,702 hospitalizations (2,070 in the irradiation history group and 531,632 in the control group) were included in this analysis. Patients with radiation therapy history were less likely to have traditional coronary artery disease risk factors and more likely to have associated valvular disease. Patients with a history of irradiation had similar in-hospital mortality and 90-day readmission risk at the expense of higher hospitalizations costs (ß coefficient: $2,764; p = 0.005). They had a higher likelihood of readmission with acute coronary syndrome within 90 days (adjusted odds ratio 1.67, p = 0.02). In a conclusion, a history of mediastinal irradiation is not associated with increased rates of short-term mortality or increased all-cause readmission risk after CABG. However, it may be associated with increased acute coronary syndrome readmission rates.

Minimally Invasive Aortic Valve Replacement: Cost-Benefit Analysis of Ministernotomy Versus Minithoracotomy Approach.

BACKGROUND AND AIM OF THE STUDY: Minimally invasive aortic valve replacement via ministernotomy (ministernotomy-AVR) or minithoracotomy (minithoracotomy-AVR) is gaining popularity. To date, a direct comparison of ministernotomy-AVR versus minithoracotomy-AVR is lacking. The study aim was to compare these two procedures from a cost-benefit perspective. METHODS: Eight reports from the United States were selected from amongst 33,494 literature citations based on sample size and data completeness. Perioperative variables were collected for each surgical approach. Fixed and variable costs were estimated as cost per case in excess of full sternotomy AVR procedures. RESULTS: Ministernotomy-AVR patients were of a significantly lower mean age (59.8 years versus 67.9 years), ejection fraction (50.4-51.6% versus 56.1-57.8%), shorter cardiopulmonary bypass time (97.2 min versus 125.6 min) and cross-clamp time (69.9 min versus 87.9 min), a lower rate of blood transfusion (25.9% versus 64.4%), and a shorter length of hospital stay (5.7 versus 6.2 days). There were no significant inter-group differences in 30-day mortality, conversion to sternotomy, neurologic events, arrhythmia, wound infection, or postoperative bleeding. Assuming a volume of 50 cases per year, the added operative cost per case for a minithoracotomy-AVR was US$ 4,254 compared to US$ 290 for a ministernotomy-AVR. The added costs per case, assuming 200 cases per year, were US$ 4,209 and US$ 290, respectively. A minithoracotomy-AVR program performing 50 cases per year adds US$ 1,063,665 of operative costs over five years, compared to US$ 72,500 for a ministernotomy-AVR program. CONCLUSION: The present analysis suggested that the clinical benefits of ministernotomy-AVR are comparable or better than those of minithoracotomy-AVR, and at lower costs. Healthcare delivery organizations should consider the results of cost-benefit examinations when developing surgical valve replacement programs.