Alkhouli, Mohamad

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.

AbstractTranscatheter mitral valve replacement (TMVR) with off‐label use of aortic balloon‐expandable transcatheter heart valves has emerged as a therapeutic option in high‐surgical risk patients with severe mitral annular calcification. Left ventricular outflow tract (LVOT) obstruction post valve deployment is a major limitation. We describe a case of septal reduction therapy using radiofrequency ablation (RFA) when established methods of septal reduction were either ineffective or not feasible. RFA permitted successful enlargement of the LVOT area and subsequent TMVR.

Background Heart failure (HF) imparts a significant clinical and economic burden on the health system in the United States. Methods and Results We used the National Inpatient Sample database between September 2002 and December 2016. We examined trends of comorbidities, inpatient mortality, and healthcare resource use in patients admitted with acute HF. Outcomes were adjusted for demographic variables, comorbidities, and inflation. A total of 11 806 679 cases of acute HF hospitalization were identified. The burden of coronary artery disease, peripheral vascular disease, valvular heart disease, diabetes mellitus, hypertension, anemia, cancer, depression, and chronic kidney disease among patients admitted with acute HF increased over time. The adjusted mortality decreased from 6.8% in 2002 to 4.9% in 2016 ( P‐ trend<0.001; average annual decline, 1.99%), which was consistent across age, sex, and race. The adjusted mean length of stay decreased from 8.6 to 6.5 days ( P <0.001), but discharge disposition to a long‐term care facility increased from 20.8% to 25.6% ( P <0.001). The inflation adjusted mean cost of stay increased from $14 301 to $17 925 ( P <0.001) (average annual increase, 1.52%), which was partially explained by the higher proportion of procedures (echocardiogram, right heart catheterization, use of ventricular assist devices, coronary artery bypass grafting) and the higher incidence of HF complications (cardiogenic shock, respiratory failure, ventilator, and renal failure requiring dialysis). Conclusions This national data set showed that despite increasing medical complexities, there was significant reduction in inpatient mortality and length of stay. However, these measures were counterbalanced by a higher proportion of discharge disposition to long‐term care facilities and expensive cost of care.

Abstract The emergence of the COVID-19 epidemic posed unprecedented challenges to the cardiology community. In this perspective, we review the major changes associated with the COVID-19 crisis on major domains of cardiology.