Disparities in Health and Healthcare: Impact of Race on Resource Utilization and Costs Following Transcatheter Edge-to-Edge Repair.

BACKGROUND: This study sought to investigate health and healthcare disparities in the management of severe mitral regurgitation with transcatheter edge-to-edge repair using MitraClip and how racial differences impact resource utilization and costs. METHODS: We retrospectively analyzed the National Inpatient Sample (NIS) for patients who underwent Transcatheter Edge-to-Edge Repair (TEER) using MitraClip between 2016 and 2018. The patients were stratified into four racial cohorts and study outcomes included high resource utilization (HRU), periprocedural complications, and total procedural costs. High resource utilization (HRU) was defined as length of stay (LOS) ≥7 days or a nonhome disposition at discharge. Multivariate logistic regression models were utilized to determine independent predictors of HRU. RESULTS: 17,100 weighted TEER patients were segregated by race: Caucasian (n = 13,270), others (n = 1510), African Americans, AA (n = 1245) and Hispanics (n = 1075). More African Americans and Hispanics had TEER at Urban facilities (P < 0.001), which were teaching hospitals as well (P < 0.001) but were less likely to be covered by public insurance options -Medicare or Medicaid (P < 0.001). More AA (52.2 %) and Hispanics (27.6 %) were likely to be in the lowest median annual income quartile versus Caucasians (19.2 %) (P = 0.003). AA and Hispanics had higher resource utilization (HRU), prolonged length of stay, nonhome disposition at discharge, higher procedural costs and periprocedural complications versus Caucasians. The logistic regression model revealed acute kidney injury (AKI) and actual procedural costs as independent predictors of HRU in both African American and Hispanic groups. CONCLUSION: Significant Health and healthcare disparities do exist among underrepresented, racial minority patients undergoing transcatheter edge-to-edge repair in the US. These disparities were associated with higher resource utilization and actual costs in patients with mitral regurgitation treated with TEER.

Adverse Events Following Transcatheter Edge-to-Edge Repair (TEER) Using MitraClip: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Registry.

OBJECTIVE: The MitraClip from Abbott is FDA approved intracardiac implantable device for transcatheter edge-to-edge repair (TEER). Despite a few previously published studies, there is limited safety data for its use in clinical practice, hence, we designed this study using data obtained from a safety nationwide database to demonstrate the safety profile of MitraClip. METHODS: The first two of the five authors independently queried all reported adverse events from the United State Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] registry from January 2014 to December 2020. The primary end point was trend in reported fatal events obtained from this database. The secondary end points included the causes of reported nonfatal reports from the MAUDE registry. The trend of reported fatal events was assessed using the Cochran Armitage trend test over the period of the study. RESULTS: During the study period, subjects included 3370 patients whose MitraClip-associated adverse events were reported and captured by MAUDE registry. Of these, 211 were fatal and 3159 nonfatal events. Fatal event reports resulted deaths and reported nonfatal events were from injuries and device system malfunction. This study demonstrated an initial upward trend from 2014 to 2015 then a subsequent statistically significant downward trend in reported fatal events from 2015 to 2020 (Cochran-Armitage test P = 0.039). The peak proportion of reported fatal events occurred in 2015, (n = 44; representing 1.25% of reported adverse events) and lowest proportion of reported fatal events took place in 2020 (n = 19; representing 0.56% of reported adverse events). The most reported nonfatal events were from malfunctioning of MitraClip system (n = 1170; representing 37% of reported nonfatal events), new unremarkable repolarization abnormalities on periprocedural EKG (n = 864; representing 27% of reported nonfatal events), leaflet rupture (n = 651; representing 21% of reported nonfatal events), and cardiogenic shock (n = 170; representing 5% of reported nonfatal events). CONCLUSIONS: This analysis of the MAUDE Registry indicated, especially within the confines of this study's limitations and poor data quality of information, an apparent downward trend of reported fatal events over the study period. Even though conclusive attributions cannot be made regarding this important finding, perhaps, this points to early evidence of a potential institutional or operator learning curve with this device. However, in view of the inferior quality of the data accrued from the MAUDE Registry, more high-precision studies are needed to better understand these changes, as the utility of MitraClip, becomes more established in clinical practice.

Intermediate and Late Outcomes With PCI vs CABG for Left Main Disease - Landmark Meta-Analysis of Randomized Trials.

PCI to improve survival is currently recommended as a reasonable alternative to CABG in patients with unprotected left main disease. However, RCTs to support this recommendation has generated mixed results and recently published EXCEL trial has sparked debate about differences in late mortality. To address this point, we performed landmark meta-analysis of 4 RCTs with 5 year follow up data - EXCEL, NOBLE, PRECOMBAT and SYNTAX LEFT MAIN. Overall, there was no significant difference in all-cause mortality between PCI and CABG at 5 years (RR = 1.03 [95% CI = 0.79-1.33]). However, there was apparent change in the direction of association before and after the 1 year landmark that underscores the need for long term follow up in these trials. In addition, we found that PCI was associated with significantly lower rate of intermediate stroke at 1 year (RR = 0.44 [0.24-0.82]) but higher rate of late MI after 1 year (3.31 [2.11-5.18]) compared to CABG.

Aortic Valve Replacement for Severe Aortic Stenosis Before and During the Era of Transcatheter Aortic Valve Implantation.

Recent positive results of transcatheter aortic valve replacement (TAVI) in clinical trials have sparked debate on whether TAVI should be first line for all patients with aortic stenosis. However, limited evidence exists on the clinical impact of TAVI on a national level. Using the national inpatient sample (NIS) of hospital discharges in the United States from 2001 to 2016, we evaluated the rate of AVR and associated in-hospital outcomes in pre-TAVI and TAVI era. Hierarchical mixed effect modeling was used to assess for trend and calculate risk adjusted estimates. Annual volume of AVR increased from 49,357 in 2001 to 100,050 in 2016 (103% increase). Compared with the pre-TAVI era, mean annual change in volume of AVR was higher in the TAVI era (+2.9% vs +9.4%, respectively, p <0.001). In contrast, rate of in-hospital mortality decreased from 5.4% in 2001 to 2.7% in 2016 (50% decrease). Compared with the pre-TAVI era, magnitude of mean annual change in mortality was higher in TAVI era (-4.0% vs -6.7%, respectively, p = 0.04). Unlike SAVR for which risk-adjusted rate for most outcomes seems to have plateaued, TAVI demonstrated significant improvement from 2012 to 2016 for mortality (4.6% to 1.8%), acute kidney injury (15.1% to 2.6%) and nonroutine home discharge (63.6% to 44.6%). However, no significant change in the rate of stroke (2.4% to 2.1%) and pacemaker implantation remained high (8.1% to 9.4%). Lastly, median length of stay was shorter for TAVI compared with isolated SAVR (3 vs 8 days, respectively). In conclusion, the adoption of TAVI has led to increase in volume of AVR for severe aortic stenosis in the United States with favorable short-term outcome.

Missing Vitamin C: A Case of Scorbutic Cardiac Tamponade.

Scurvy is a disorder of vitamin C deficiency which leads to vascular fragility and multisystemic complications. The paper presents a case of scurvy resulting in cardiac tamponade in addition to its classic manifestations. Life-threatening tamponade is an extreme presentation of scurvy and has not been reported in modern publications to the best of the present authors' knowledge. (Level of Difficulty: Beginner.).

Relation of Higher Resting Heart Rate to Risk of Cardiovascular Versus Noncardiovascular Death.

Higher resting heart rate (RHR) is associated with increased risk of all-cause and cardiovascular mortality, with some reports showing the magnitude of association with all-cause mortality being stronger than that with cardiovascular mortality. This suggests that RHR association with mortality may not be limited to cardiovascular death. We compared the association between RHR with cardiovascular and noncardiovascular mortality in 6,743 participants (mean age 58.7 years, 52% women, 48% non-Hispanic whites) from the Third National Health and Nutrition Examination Survey (NHANES-III) after excluding those on antiarrhythmic drugs or with missing data. RHR data were obtained from standard 12-lead electrocardiogram recorded on the NHANES participants during a physical examination. National Death Index was used to identify the date and cause of death. Multivariable Cox proportional hazards analysis was used to calculate the hazard ratios (HRs) and 95% CIs for cardiovascular mortality and noncardiovascular mortality, separately, associated with 10 beats/min increase in RHR. During a median follow-up of 13.9 years, 906 cardiovascular deaths and 1,306 noncardiovascular deaths occurred. In models adjusted for age, gender, race, hypertension, diabetes, obesity, dyslipidemia, previous cardiovascular disease, smoking, cancer, chronic obstructive airway disease, thyroid disease, and serum creatinine, higher RHR was associated with increased risk of both cardiovascular mortality and noncardiovascular mortality with a relatively similar magnitude of risk (HR 1.19, 95% CI 1.12 to 1.26 and HR 1.23, 95% CI 1.17 to 1.29, respectively). In conclusion, higher RHR is associated with both cardiovascular mortality and noncardiovascular mortality suggesting that RHR is probably a marker of overall well-being rather than a marker of cardiovascular health.

Left ventricular hypertrophy by ECG versus cardiac MRI as a predictor for heart failure.

OBJECTIVE: To determine if there is a significant difference in the predictive abilities of left ventricular hypertrophy (LVH) detected by ECG-LVH versus LVH ascertained by cardiac MRI-LVH in a model similar to the Framingham Heart Failure Risk Score (FHFRS). METHODS: This study included 4745 (mean age 61±10 years, 53.5% women, 61.7% non-whites) participants in the Multi-Ethnic Study of Atherosclerosis. ECG-LVH was defined using Cornell voltage product while MRI-LVH was derived from left ventricular mass. Cox proportional hazard regression was used to examine the association between ECG-LVH and MRI-LVH with incident heart failure (HF). Harrell's concordance C-index was used to estimate the predictive ability of the model when either ECG-LVH or MRI-LVH was included as one of its components. RESULTS: ECG-LVH was present in 291 (6.1%), while MRI-LVH was present in 499 (10.5%) of the participants. Both ECG-LVH (HR 2.25, 95% CI 1.38 to 3.69) and MRI-LVH (HR 3.80, 95% CI 1.56 to 5.63) were predictive of HF. The absolute risk of developing HF was 8.81% for MRI-LVH versus 2.26% for absence of MRI-LVH with a relative risk of 3.9. With ECG-LVH, the absolute risk of developing HF 6.87% compared with 2.69% for absence of ECG-LVH with a relative risk of 2.55. The ability of the model to predict HF was better with MRI-LVH (C-index 0.871, 95% CI 0.842 to 0.899) than with ECG-LVH (C-index 0.860, 95% CI 0.833 to 0.888) (p<0.0001). CONCLUSIONS: ECG-LVH and MRI-LVH are predictive of HF. Substituting MRI-LVH for ECG-LVH improves the predictive ability of a model similar to the FHFRS.