Citations

Background: Readmission rates are a widely accepted quality indicator. Our objective was to study characteristics of readmissions at 30 and 180 days after Transcatheter Aortic Valve Replacement (TAVR). Methods: Patients undergoing TAVR between 2016 and 2017 in the U.S. Nationwide Readmission Database were evaluated for the rates, causes, predictors, and mortality of readmission at 30 and multiple readmission within 180 days after index discharge. Results: This analysis included 89601 hospitalizations; 13% were readmitted within 30 days and 8.7% were readmitted multiple times within 180 days. Most important predictors of readmissions, were Length of stay >5 days during index hospitalization (hazard ratio [HR], 1.59; 95% confidence interval [CI], 1.47-1.71 at 30 days & HR 1.72; 95% CI 1.58-1.87 at 180 days), > 4 Charlson comorbidities (HR 1.27; 95% CI, 1.19-1.34 at 30 days & HR, 1.54; 95% CI, 1.44-1.65 at 180 days), discharge to skilled nursing facility (HR, 1.34; 95% CI, 1.24-1.44 at 30 days & HR, 1.49; 95% CI, 1.36-1.65 ), atrial fibrillation (HR, 1.25; 95% CI, 1.18-1.32 at 30 days & HR, 1.35; 95% CI, 1.26-1.45 at 180 days), Transapical TAVR approach (HR, 1.21; 95% CI, 1.04-1.42 & HR, 1.20; 95% CI, 1.01-1.43 at 180 days), and acute kidney injury (HR, 1.22; 95% CI, 1.12-1.32 at 30 days & HR, 1.1; 95% CI, 1.01-1.21 at 180 days)(Figure 1 A,B). 67% patients were readmitted at least 1 time within 180 days, 22% were readmitted 2 times within 180days and 11% were readmitted more than 3 times within 180 days. Readmissions were because of noncardiac causes in 67.8% of cases and because of cardiac causes in 32.2% of cases. Conclusion: The study demonstrates that baseline comorbidities alongside non-cardiac causes contributed significantly to readmissions after TAVR at both 30 days and 180 days. The results help to target the susceptible patients in both short as well as long term and to provide evidence-based interventions to reduce the risk and financial burden associated with readmissions.

Background Aortic stenosis–related mortality might vary across demographic subsets, regions, and states in the United States. Methods and Results We reviewed the death certificate data from the Centers for Disease Control and Prevention Wide‐Ranging OnLine Data for Epidemiologic Research database to examine aortic stenosis–related mortality trends from 2008 to 2018. Crude and age‐adjusted mortality rates (AAMRs) per 100 000 people and annual percentage change with 95% CIs were calculated. Between 2008 and 2018, AAMR reduced from 12.7 to 11.5 (average annual percentage change, −1.0 [95% CI, −1.5 to −0.5]), because of an accelerated decline between 2015 and 2018 (annual percentage change, −4.4 [95% CI, −6.0 to −2.7]). Older (aged >85 years), male, and White patients had higher death rates than younger, female, and non‐White patients, respectively. Although mortality reduction was similar across sexes, significant mortality reduction was limited to White patients only. The AAMRs were higher in rural than urban areas. States with AAMRs >90th percentile were distributed in the West and the Northeast, and <10th percentile in the South. The AAMRs for sex and race were highest in the West and lowest in the South. None of the states located in the Midwest showed a significant reduction in mortality. Mortality remained stable for hospital setting and nursing home/long‐term care facility, except that the number of deaths increased at home and hospice facility since 2014. Conclusions The reduction in mortality in patients with aortic stenosis was not consistent among demographic subsets and states. The substantial public health and economic implications call for determination of underlying clinical and socioeconomic factors to narrow the gap.

AbstractObjectives and BackgroundThere is insufficient current evidence about whether sex impacts outcomes of percutaneous left atrial appendage occlusion (LAAO). The aim of this study was to investigate the association between sex and short‐term outcomes of LAAO.MethodsPatients who were hospitalized and underwent LAAO from October 2015 to December 2017 in the National Readmission Database were queried. The primary endpoint of interest was major in‐hospital adverse events. Secondary endpoints included, 30‐day readmission rate, nonhome discharge, and cost of hospitalization. Propensity score matching (1:1) was performed to compare the outcomes among women and men.ResultsA total of 9,281 patients were included in the current analysis [women = 3,659 (39%); men = 5,622 (61%)]. Comparing women to men, women had lower prevalence of diabetes mellitus (30.6% vs 35.7%, p < .01), heart failure (28.6% vs 30.8%, p = .03), vascular disease (55.5% vs 69.6%, p < .01) and renal failure (18.3% vs 21.2%, p < .01), and higher CHA2DS2VASc score (5 [IQR4‐6] vs 4 [IQR3‐6], p < .01). After propensity‐score matching, women had higher rate of major in‐hospital adverse events (2.8% vs 1.9%; p < .01), and nonhome discharges (11.4% vs 6.7%; p < .01). Additionally, 30‐day readmission rate was higher among women (10% vs 8.6%, p = .03).ConclusionAmong hospitalized patients undergoing LAAO, women carry higher risk for major in‐hospital adverse events, nonhome discharge, and 30‐day readmission rates.

AbstractObjectivesThe aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G‐BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G‐BEV) (SAPIEN 3).BackgroundThe incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies.MethodsPatients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G‐BEV has been utilized since 2/2019, and, after this date, 3G‐BEV and 4G‐BEV were simultaneously used. 4G‐BEV had three sizes (20, 23, and 26 mm) while 3G‐BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post‐TAVR with a transthoracic echocardiogram to assess for PVL.ResultsA total of 260 consecutive patients were included. Of these, 101 patients received a 4G‐BEV and 159 patients received a 3G‐BEV. There were more females (p = .0005) and a lower aortic valve calcium score (p = .02) in the 4G‐BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G‐BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G‐BEV at 30 days. There was no association between PVL and valve size in either cohort.ConclusionsUtilization of 4G‐BEV is associated with reduced PVL at 30 days post‐TAVR compared with 3G‐BEV.

AbstractObjectivesWe aimed to investigate the invasive hemodynamic changes with transcatheter mitral valve replacement (TMVR) in patients with severe mitral stenosis due to severe mitral annular calcification.BackgroundThe hemodynamic response to TMVR in patients with mitral stenosis related to degenerative mitral annular calcification has not been fully elucidated.MethodsWe conducted retrospective review of patients who underwent successful transseptal TMVR with balloon‐expandable valves for symptomatic severe mitral stenosis due to mitral annular calcification at our institution between January 2014 and February 2020. Invasive hemodynamic measurements were obtained both before valve implantation (predeployment) and after (postdeployment).ResultsEighteen patients (age 72 ± 10 years, 44% female) were included for the analysis. There was a significant reduction in mean left atrial pressure (23.7 ± 5.6 mmHg versus 20.6 ± 4.8 mmHg; p = .01), left atrial v‐wave (mean 39.3 ± 10.2 mmHg versus 32.9 ± 9.9 mmHg; p = .01), and an increase in systemic mean blood pressure (72.6 mmHg ±11.2 versus 79.5 ± 9.9 mmHg; p = .02) postdeployment compared to predeployment. Patients who had symptom improvement at 30‐day follow‐up tended to have greater reduction in mean left atrial pressure (4.4 ± 4.4 mmHg versus 0.5 ± 5.2 mmHg; p = .16) and v‐wave (8.6 ± 9.0 mmHg versus 0.7 ± 8.4 mmHg; p = .10) compared to those who did not experience improvement of symptoms.ConclusionsTransseptal TMVR for severe mitral stenosis due to mitral annular calcification is associated with reductions in mean left atrial pressure and left atrial v‐wave, and an increase in systemic arterial pressure.

AbstractObjectivesTo assess the Usefulness of oral anticoagulation therapy (OAT) in patients with coronary artery aneurysm (CAA).BackgroundData on the most adequate antithrombotic CAA management is lacking.MethodsPatients included in CAAR (Coronary Artery Aneurysm Registry, Clinical Trials.gov: NCT02563626) were selected. Patients were divided in OAT and non‐OAT groups, according to anticoagulation status at discharge and 2:1 propensity score matching with replacement was performed. The primary endpoint of the analysis was a composite and mutual exclusive endpoint of myocardial infarction, unstable angina (UA), and aneurysm thrombosis (coronary ischemic endpoint). Net adverse clinical events, major adverse cardiovascular events, their single components, cardiovascular death, re‐hospitalizations for heart failure, stroke, aneurysm thrombosis, and bleeding were the secondary ones.ResultsOne thousand three hundred thirty‐one patients were discharged without OAT and 211 with OAT. In the propensity‐matched sample (390 patients in the non‐OAT group, 195 patients in the OAT group), after 3 years of median follow‐up (interquartile range 1–6 years), the rate of the primary endpoint (coronary ischemic endpoint) was significantly less in the OAT group as compared to non‐OAT group (8.7 vs. 17.2%, respectively; p = .01), driven by a significant reduction in UA (4.6 vs. 10%, p < .01) and aneurysm thrombosis (0 vs. 3.1%, p = .03), along with a non‐significant reduction in MI (4.1 vs. 7.7%, p = .13). A non‐significant increase in bleedings, mainly BARC type 1 (55%), was found in the OAT‐group (10.3% in the non‐OAT vs. 6.2% in the OAT group, p = .08).ConclusionOAT decreases the composite endpoint of UA, myocardial infarction, and aneurysm thrombosis in patients with CAA, despite a non‐significant higher risk of bleeding.

Background The management of patients with severe but asymptomatic aortic stenosis is challenging. Evidence on early aortic valve replacement (AVR) versus symptom-driven intervention in these patients is unknown. Methods Electronic databases were searched, articles comparing early-AVR with conservative management for severe aortic stenosis were identified. Pooled adjusted odds ratio (OR) was computed using a random-effect model to determine all-cause and cardiovascular mortality. Results A total of eight studies consisting of 2201 patients were identified. Early-AVR was associated with lower all-cause mortality [OR 0.24, 95% confidence interval (CI) 0.13–0.45, P ≤ 0.00001] and cardiovascular mortality (OR 0.21, 95% CI 0.06–0.70, P = 0.01) compared with conservative management. The number needed to treat to prevent 1 all-cause and cardiovascular mortality was 4 and 9, respectively. The odds of all-cause mortality in a selected patient population undergoing surgical AVR (SAVR) (OR 0.16, 95% CI 0.09–0.29, P ≤ 0.00001) and SAVR or transcatheter AVR (TAVR) (OR 0.53, 95% CI 0.35–0.81, P = 0.003) were significantly lower compared with patients who are managed conservatively. A subgroup sensitivity analysis based on severe aortic stenosis (OR 0.24, 95% CI 0.11–0.52, P = 0.0004) versus very severe aortic stenosis (OR 0.20, 95% CI 0.08–0.51, P = 0.0008) also mirrored the findings of overall results. Conclusion Patients with asymptomatic aortic valve stenosis have lower odds of all-cause and cardiovascular mortality when managed with early-AVR compared with conservative management. However, because of significant heterogeneity in the classification of asymptomatic patients, large scale studies are required.

Background Nationwide studies documenting temporal trends in permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) are limited. Methods and Results We selected patients who underwent TAVR between 2012 and 2017 in the National Readmission Database. The primary end point was the 6‐year trend in post‐TAVR PPMI at index hospitalization and at 30, 90, and 180 days after discharge. The secondary end point was the association between PPMI and in‐hospital mortality, stroke, cost, length of stay, and disposition. Among the 89 202 patients who underwent TAVR, 77 405 (86.8%) with no prior pacemaker or defibrillator were included. Patients who required PPMI had a higher prevalence of atrial fibrillation (43.6% versus 38.7%, P <0.001) and conduction abnormalities (28.4% versus 15.3%, P <0.001). The incidence of PPMI during index admission increased from 8.7% in 2012 to 13.2% in 2015, and then decreased to 9.6% in 2017. The incidence of inpatient PPMI within 30 days after discharge increased from 0.5% in 2012 to 1.25% in 2017 ( P trend <0.001). Inpatient PPMI beyond 30 days remained rare (<0.5%) during the study period. After risk adjustment, PPMI was not associated with in‐hospital mortality or stroke but was associated with increased nonhome discharge, longer hospitalization, and higher cost. The incremental expenditure associated with post‐TAVR PPMI during index admission increased from $9.6 million to $72.2 million between 2012 and 2017. Conclusions After an upward trend, rates of PPMI after TAVR in the United States stabilized at ~10% in 2016 to 2017, but there was a notable increase in PPMI within 30 days after the index admission. PPMI was not associated with increased in‐hospital morbidity or mortality but led to longer hospitalization, higher cost, and more nonhome discharges.

Background: Representation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain. Methods: We systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥ 75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease. Results: Only 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. In RCTs, proportions of women, Hispanics, Blacks, American Indian/Alaskan patients, Asians, native Hawaiian/Pacific Islanders and non-Whites were 35.2%, 11.9%, 1.2%, 0.2%, 14.2%, 0.05%, and 19.5%, respectively. The corresponding proportions in general population were 35.1%, 5.2%, 5.7%, 0.2%, 2.4%, 0.1%, and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data. Conclusion: The reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF. In nearly all studied RCTs, the reporting of racial demographics did not start until later part of last decade.