Kapadia, Samir

Background: Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip. Methods: Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months. Results: Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06–1.64], P =0.01) and adjusted (HR, 1.30 [1.03–1.64], P =0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46–0.82]) and without (HR, 0.46 [0.33–0.66]) a history of AF ( P int =0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04–0.86]) but not in those without a history of AF (HR, 1.64 [0.58–4.62]; P int =0.02). Conclusions: In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01626079.

Aim We sought to determine the racial and ethnical disparities in the delivery of TAVR and to evaluate the in-hospital outcomes and utilization of TAVR stratified by patient ethnicity. Method Using a national inpatient sample database between 2011 and 2015, we identified all adult patients who had TAVR. Races were identified and white race was set as control. Multiple logistic regression analysis was performed for the primary outcome of in-hospital mortality. Results Out of 58 174 patients who underwent TAVR, 50 809 (87.3%) were white, 2327 (4.0%) were black, 2311 (4.0%) were Hispanic, 640 (1.1%) Asian, 105 (0.2%) Native American and 1982 (3.4%) of other ethnicities. We found a statistically significant linear uptrend in the utilization of TAVR in patients of all races between the years 2011 and 2015. White, black, Hispanic and Native American patients had a downward linear trend for mortality during the studied years ( P ≤ 0.005 for all). Black patients had lower in-hospital mortality [2.8 vs. 3.6%, odds ratio (OR) = 0.62; 95% confidence interval (CI) 0.44, 0.81 P < 0.001] compared with white patients, whereas Hispanic patients and Native Americans had higher in-hospital mortality compared with white patients (4.5% OR 1.26; 95% CI 1.01, 1.56 P = 0.041), (9.5% OR 4.44; 95% CI 2.25, 8.77 P < 0.001), respectively. Conclusion Overall, TAVR utilization is associated with lower mortality. There is a rising trend in utilization of TAVR in the black population with a significantly favorable mortality trend compared with the white population.

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.

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: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Background— Diabetes mellitus (DM) adversely affects morbidity and mortality for cardiovascular diseases and procedures. Data evaluating the outcomes of transcatheter aortic valve replacement (TAVR) in diabetic patients are limited by small sample size and contradictory results. We aimed to establish the magnitude of risk and the incremental influence of insulin dependency by examining short- and long-term adverse outcomes according to DM status and therapy in the world’s largest TAVR registry. Methods and Results— We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. In-hospital mortality, 30-day mortality, and 1-year mortality after TAVR in patients with and without DM were evaluated using multivariate modeling. Among 47 643 patients treated with TAVR from November 2011 through September 2015 at 394 US hospitals, there were 17 849 (37.5%) patients with DM. Overall, 6600 of the diabetic patients were insulin treated (IT). Thirty-day mortality was 5.0% in patients with DM (6.1% in IT DM and 4.4% in non-IT DM; P <0.001) versus 5.9% in patients without DM ( P <0.001). Overall, 1-year mortality was 21.8% in patients with DM (24.8% in IT DM and 20.1% in non-IT DM; P <0.001) versus 21.2% in patients without DM ( P =0.274). In a multivariable model, DM was associated with increased 1-year mortality (hazard ratio, 1.30; 95% confidence interval, 1.13–1.49; P <0.001). Subgroup multivariable analysis showed stronger mortality association in IT diabetics (hazard ratio, 1.57; 95% confidence interval, 1.28–1.91; P <0.001) than in non-IT diabetics (hazard ratio, 1.17; 95% confidence interval, 1.00–1.38; P =0.052). Conclusions— Our data establish the magnitude of short- and long-term risk conferred by DM and the incremental risk conferred by insulin dependency in the performance of TAVR. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT01737528.