Percutaneous Microaxial Ventricular Assist Device Versus Intra-Aortic Balloon Pump for Nonacute Myocardial Infarction Cardiogenic Shock.

BACKGROUND: Evidence on the comparative outcomes following percutaneous microaxial ventricular assist devices (pVAD) versus intra-aortic balloon pump for nonacute myocardial infarction cardiogenic shock is limited. METHODS AND RESULTS: We included 704 and 2140 Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD and intra-aortic balloon pump, respectively, for nonacute myocardial infarction cardiogenic shock from 2016 to 2020. Patients treated using pVAD compared with those treated using intra-aortic balloon pump were more likely to be concurrently treated with mechanical ventilation, renal replacement therapy, and blood transfusions. We computed propensity scores for undergoing pVAD using patient- and hospital-level factors and performed a matching weight analysis. The use of pVAD was associated with higher 30-day mortality (adjusted odds ratio, 1.92 [95% CI, 1.59-2.33]) but not associated with in-hospital bleeding (adjusted odds ratio, 1.00 [95% CI, 0.81-1.24]), stroke (adjusted odds ratio, 0.91 [95% CI, 0.56-1.47]), sepsis (OR, 0.91 [95% CI, 0.64-1.28]), and length of hospital stay (adjusted mean difference, +0.4 days [95% CI, -1.4 to +2.3]). A quasi-experimental instrumental variable analysis using the cross-sectional institutional practice preferences showed similar patterns, though not statistically significant (adjusted odds ratio, 1.38; 95% CI, 0.28-6.89). CONCLUSIONS: Our investigation using the national sample of Medicare beneficiaries showed that the use of pVAD compared with intra-aortic balloon pump was associated with higher mortality in patients with nonacute myocardial infarction cardiogenic shock. Providers should be cautious about the use of pVAD for nonacute myocardial infarction cardiogenic shock, while adequately powered high-quality randomized controlled trials are warranted to determine the clinical effects of pVAD.

Cardiac Reoperation or Transcatheter Mitral Valve Replacement for Patients With Failed Mitral Prostheses.

BACKGROUND: Evidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. OBJECTIVES: The goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. METHODS: Medicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score-matched analysis was used. RESULTS: A total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). CONCLUSIONS: In this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.

Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review and Meta-analysis.

Importance: Evidence of the efficacy and safety of messenger RNA (mRNA) COVID-19 vaccines in children aged 5 to 11 years has been emerging. Collecting these data will inform clinicians, families, and policy makers. Objective: To evaluate the efficacy and safety of mRNA COVID-19 vaccines in children aged 5 to 11 years in a systematic review and meta-analysis. Data Sources: PubMed and Embase databases were searched on September 29, 2022, without language restrictions. Study Selection: Randomized clinical trials and observational studies comparing vaccinated vs unvaccinated children aged 5 to 11 years and reporting efficacy or safety outcomes were included. Studies reporting safety outcomes in vaccinated children only (ie, no control group) were also included. Data Extraction and Synthesis: Two investigators independently extracted relevant data from each study. Odds ratios (ORs) for efficacy and safety outcomes and incidences of adverse events (AEs) following vaccination were synthesized using a random-effects model. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses and Meta-analysis of Observational Studies in Epidemiology reporting guidelines. Main Outcomes and Measures: The primary outcome was SARS-CoV-2 infections with or without symptoms. The secondary outcomes included symptomatic SARS-CoV-2 infections, hospitalizations, and multisystem inflammatory syndrome in children. The incidences of each AE following vaccination were also evaluated. Results: Two randomized clinical trials and 15 observational studies involving 10 935 541 vaccinated children (median or mean age range, 8.0-9.5 years) and 2 635 251 unvaccinated children (median or mean age range, 7.0-9.5 years) were included. Two-dose mRNA COVID-19 vaccination compared with no vaccination was associated with lower risks of SARS-CoV-2 infections with or without symptoms (OR, 0.47; 95% CI, 0.35-0.64), symptomatic SARS-CoV-2 infections (OR, 0.53; 95% CI, 0.41-0.70), hospitalizations (OR, 0.32; 95% CI, 0.15-0.68), and multisystem inflammatory syndrome in children (OR, 0.05; 95% CI, 0.02-0.10). Two randomized clinical trials and 5 observational studies investigated AEs among vaccinated children. Most vaccinated children experienced at least 1 local AE following the first injection (32 494 of 55 959 [86.3%]) and second injection (28 135 of 46 447 [86.3%]). Vaccination was associated with a higher risk of any AEs compared with placebo (OR, 1.92; 95% CI, 1.26-2.91). The incidence of AEs that prevented normal daily activities was 8.8% (95% CI, 5.4%-14.2%) and that of myocarditis was estimated to be 1.8 per million (95% CI, 0.000%-0.001%) following the second injection. Conclusions and Relevance: In this systematic review and meta-analysis, COVID-19 mRNA vaccines among children aged 5 to 11 years were associated with measures of efficacy in preventing SARS-CoV-2 infection and severe COVID-19-related illnesses. While most children developed local AEs, severe AEs were rare, and most of AEs resolved within several days. These data provide evidence for future recommendations.

Assessment of Nonfatal Bleeding Events as a Surrogate for Mortality in Coronary Artery Disease.

Background: Bleeding events are frequently applied as safety end points for randomized controlled trials (RCTs) investigating the effect of antithrombotic agents in patients with coronary artery disease. However, whether a bleeding event is a valid surrogate for death remain uncertain. Objectives: This study aimed to assess the correlation between the treatment effect on bleeding events and mortality. Methods: Multiple databases were searched to identify RCTs studying antithrombotic agents for patients with coronary artery disease through August 2022. Major and minor bleeding events were defined in included trials, mostly defined with BARC (Bleeding Academic Research Consortium) or TIMI (Thrombolysis In Myocardial Infarction) criteria. Trial-level correlations between nonfatal bleeding events and mortality were assessed. We performed subgroup analyses by the definitions of bleeding (BARC vs TIMI criteria), study year, and follow-up duration. We used a cutoff with a lower limit of 95% confidence interval of R2 >0.72 as a strong correlation and with an upper limit of 95% confidence interval of R2 <0.50 as a weak correlation. Results: A total of 48 RCTs with 181,951 participants were analyzed. Overall, trial-level R2 for major and minor bleeding were 0.09 (95% CI: 0.00-0.26) and 0.09 (95% CI: 0.00-0.27) for all-cause or cardiovascular death, respectively. When confined to major bleeding, R2 were 0.03 (95% CI: 0.00-0.13) and 0.01 (95% CI: 0.00-0.05), respectively. All of the subgroup analyses did not show any significant correlations. Conclusions: We demonstrated a trial-defined bleeding event may not be a valid surrogate for mortality in RCTs investigating the effect of antithrombotic agents for coronary artery disease.

Transcatheter Versus Surgical Aortic Valve Replacement in the United States (From the Nationwide Readmission Database).

Clinical outcomes of transcatheter aortic valve implantation (TAVI) have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. There is limited data on TAVI outcomes compared with surgical aortic valve replacement (SAVR) in contemporary practice in the United States. We queried the 2018 Nationwide Readmission Database of the United States. International Classification Diagnosis code 10 was used to extract TAVI and SAVR admissions. A propensity-matched cohort was created to compare TAVI and SAVR outcomes. A weighted 48,349 TAVI and 24,896 SAVR for aortic stenosis were included and 4.9% of TAVI were performed with an embolic protection device. In propensity-matched cohort (12,708 TAVI and 12,708 SAVR), TAVI conferred lower in-hospital mortality (1.7% vs 3.8%), acute kidney injury (11.3% vs 22.9%), and transfusion rate (5.9% vs. 20.6%) whereas new pacemaker rate was higher in TAVI compared with SAVR (10.5% vs. 7.0%) (all p values < 0.001). Stroke rate was similar between TAVI and SAVR (1.5% vs. 1.5%) (p value = 0.79). The routine discharge was more frequent (66.9% vs 25.8%) and length of stay was shorter (4.8 vs. 9.8 days) in TAVI than SAVR. Hospitalization cost was higher in SAVR than TAVI (51,962 vs 57,754 U.S. dollars) (all p values < 0.001). In-hospital mortality was also lower in TAVI compared with isolated SAVR. TAVI was performed more frequently than SAVR in 2018 in the United States with lower in-hospital mortality of TAVI compared with both SAVR and isolated SAVR.

Racial disparities in in-hospital outcomes after left ventricular assist device implantation.

BACKGROUND: Previous studies of patients undergoing various cardiac surgeries demonstrated worse outcomes among African-American (AA) patients. It remains unclear if the race is a predictor of outcomes among left ventricular assist device (LVAD) recipients. METHODS: Patients who underwent LVAD implantation between 2010 and 2017 were identified using the National Inpatient Sample. The race was classified as Caucasians vs AA vs Hispanics, and endpoints were in-hospital outcomes, length of stay, and cost. Procedure-related complications were identified via the International Classification of Diseases-9 (ICD-9) and ICD-10 coding and analysis performed via mixed-effect models. RESULTS: A total of 27 132 adults (5114 unweighted) underwent LVAD implantation in the U.S. between 2010 and 2017, including Caucasians (63.8%), AA (23.8%), and Hispanics (6%). The number of LVAD implantations increased in both Caucasians and AA during the study period. AA LVAD recipients were younger, with higher rates of females and mostly comorbidities, but lower rates of coronary artery disease and bypass grafting compared to Caucasians and Hispanics. Medicaid and median income at the lowest quartile were more frequent among AA LVAD recipients. We did not identify differences in stroke, bleeding complications, tamponade, infectious complications, acute kidney injury requiring hemodialysis, and in-hospital mortality among racial groups. AA LVAD recipients had lower rates of routine discharge than Caucasians and Hispanics, longer length of stay than Caucasians, but similar cost of hospitalization. After adjustment for clinical comorbidities, race was not a predictor of in-hospital mortality. CONCLUSION: We identified differences in clinical characteristics but not in in-hospital complications among LVAD recipients of a different races.