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.

Endovascular Transcatheter Aortic Valve Replacement Outcomes in Hypertrophic Cardiomyopathy: Insights from the National Inpatient Sample (2014-2018).

BACKGROUND: Outcomes of patients with hypertrophic cardiomyopathy (HCM) following transcatheter aortic valve replacement (TAVR) remain largely unknown. OBJECTIVES: This study sought to assess the clinical characteristics and outcomes of HCM patients following TAVR. METHODS: We queried the National Inpatient Sample from 2014 to 2018 for TAVR hospitalizations with and without HCM, creating a propensity-matched cohort to compare outcomes. RESULTS: 207,880 patients that underwent TAVR during the study period, 810 (0.38%) had coexisting HCM. In the unmatched population, TAVR patients with HCM compared to those without HCM, were more likely to be female, had a higher prevalence of heart failure, obesity, cancer, and history of pacemaker/implantable cardioverter defibrillation, and were more likely to have nonelective and weekend admissions (p for all <0.05). TAVR patients without HCM had higher prevalence of coronary artery disease, prior percutaneous coronary intervention, prior coronary artery bypass grafting, and peripheral arterial disease compared to their counterparts (p for all <0.05). In the propensity-matched cohort, TAVR patients with HCM had significantly higher incidence of in-hospital mortality, acute kidney injury/hemodialysis, bleeding complications, vascular complications, permanent pacemaker requirement, aortic dissection, cardiogenic shock, and mechanical ventilation requirement. CONCLUSION: Endovascular TAVR in HCM patients is associated with an increased incidence of in-hospital mortality and procedural complications.

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.

Cryoablation versus antiarrhythmic therapy for initial treatment of atrial fibrillation: a systematic review and meta-analysis.

BACKGROUND: Atrial fibrillation is a common cardiac arrhythmia that affects approximately 2% of the overall population. Current guidelines suggest the use of antiarrhythmic agents as initial therapy in patients with symptomatic atrial fibrillation; however, using cryoablation as a first-line therapy might provide increased efficacy. METHODS: We conducted a systematic review from inception to March 2021 to find randomized controlled trials (RCT) that directly compared cryoablation therapy versus antiarrhythmic therapy as initial treatment for atrial fibrillation. RESULTS: The primary outcome of our meta-analysis was recurrence of atrial arrhythmias. The secondary outcome evaluated serious adverse events of each therapy. Three RCTs involving 724 patients were included in the meta-analysis. The results showed a statistically significant reduction in recurrence of atrial arrhythmias in patients receiving cryoablation compared to antiarrhythmic therapy [RR 0.60, 95% CI (0.50, 0.72), P < 0.00001, I2 = 0%]. There was no significant difference in serious adverse events between patients receiving cryoablation compared to patients receiving antiarrhythmic therapy [RR 0.80, 95% CI (0.57, 1.13), P = 0.21, I2 = 0%]. CONCLUSION: Our meta-analysis showed that cryoablation therapy as initial therapy is more efficacious than antiarrhythmic therapy in patients with atrial fibrillation without an increased risk of serious adverse events.

Meta-Analysis Comparing Multiple Arterial Grafts Versus Single Arterial Graft for Coronary-Artery Bypass Grafting.

Observational studies and randomized controlled trials (RCTs) have shown conflicting outcomes for multiple arterial graft (MAG) coronary artery bypass graft surgery compared with single arterial grafts (SAGs). The predominant evidence supporting the use of MAGs is observational. The aim of this meta-analysis of RCTs is to compare outcomes following MAG and SAG. We searched multiple databases for RCTs comparing MAG versus SAG. The clinical outcomes studied were all-cause mortality, cardiac mortality, myocardial infarction (MI), revascularization, stroke, sternal wound complications, and major bleeding. We used hazard ratio (HR), relative risk (RR), and corresponding 95% confidence interval (CI) for measuring outcomes. Ten RCTs (6392 patients) were included. The average follow-up in the studies was 4.2 years. The average age of the patients in the studies ranged from 56.3 years to 74.6. No significant difference was seen between MAG and SAG groups for all-cause mortality (11.8% vs 12.7%, HR 0.94, 95% CI 0.81 to 1.09, p 0.36), cardiac mortality (4.1% vs 4.5%, HR 0.96 95% CI 0.74 to 1.26, p 0.77), MI (3.5% vs 5.1%, HR 0.87 95% CI 0.67 to 1.12, p 0.28), and major bleeding (3.3% vs 4.9%, RR 0.85 95% CI 0.64 to 1.13, p 0.26). Repeat revascularization in MAG showed a lower RR than SAG when one of the confounding studies was excluded (RR 0.63, 95% CI 0.4 to 0.99, p 0.04). The incidence of stroke was lower in MAG than SAG (2.9% vs 3.9%, RR 0.74 95% CI 0.56 to 0.98, p 0.03). MAG had higher incidence of sternal wound complications than SAG (2.9% vs 1.7%, RR 1.75 95% CI 1.19 to 2.55, p 0.004). In conclusion, MAG does not have a survival advantage compared with SAG but is better in revascularization and risk of stroke. This benefit may be set off by a higher incidence of sternal wound complications in MAG.

Interarterial course of anomalous right coronary artery: role of symptoms and surgical outcomes.

Anomalous origin of right coronary artery with interarterial course (ARCA-IA) is a risk factor for sudden death and other cardiac complications. Surgical correction remains its gold standard treatment. We describe clinical characteristics, workup, surgical techniques and outcomes of ARCA-IA at our center. A retrospective analysis of cardiovascular database was performed. From March 2005 through January 2011, 11 patients with mean age of 53 ± 18 years were diagnosed with ARCA-IA. Reported symptoms included chest pain (64%), arrhythmia [27%; i.e. atrial flutter (9%), recurrent supraventricular tachycardia (9%), ventricular tachycardia (9%)], syncope (18%), dyspnea (9%) and aborted sudden cardiac death (9%). Chest pain (n = 7) was episodic and lasted longer than 6 months before diagnosis. Initial diagnosis was made at coronary computed tomography in two patients and at cardiac catheterization in nine patients. Four patients had positive stress test and were subsequently found to have ARCA-IA at cardiac catheterization. There was no operative mortality. Surgery (bypass with ligation of native vessel or translocation and reimplantation) was performed in seven patients. Three patients refused surgery, and in one patient, surgery was not considered due to comorbidities. Symptom relief was noted in all surgical patients. At mean follow-up of 36 months, two patients had noncardiac-related deaths whereas nine were asymptomatic. There were no deaths reported in patients treated surgically. Definitive surgery is indicated in symptomatic ARCA-IA and is associated with excellent long-term outcome. RCA dominance in ARCA-IA is an adverse marker with increased symptoms; this hypothesis should be tested in larger studies.