Kapadia, Samir

Abstract Background The management of patients with severe but asymptomatic aortic stenosis (AS) is a challenge of daily practice. Evidence on early aortic valve replacement (AVR) versus symptom-driven approach is controversial. Methods Electronic databases were searched and articles comparing early-AVR with conservative management for severe asymptomatic AS were identified. The pooled unadjusted odds ratio (OR) was computed using a random-effects model. Results A total of 10 studies (observational=9, and randomized clinical trials=1) consisting of 5,291 patients were included. On a mean follow up duration of 4 years, the odds of early-AVR vs conservative management were in favour for early intervention in terms of cardiovascular mortality (OR 0.26, 95% CI 0.13–0.53, p=0.0002, figure-1) and all-cause mortality (OR 0.27, 95% CI: 0.17–0.41, p≤00001). The number needed to treat (NNT) by performing early AVR (either SAVR or TAVR) to prevent one death secondary to either cardiovascular or all-cause was 8 (95% CI: 6–10), and 5 (95% CI, 4.2–5.4) respectively. The odds of all-cause mortality in a selected patient population undergoing surgical AVR (SAVR) (OR 0.17, 95% CI 0.10–0.29, p≤0.00001) or transcatheter AVR (TAVR) (OR 0.45, 95% CI 0.31–0.64, p≤0.0001) were significantly lower compared to patients who were managed conservatively. A subgroup sensitivity analysis based on severe vs. very severe AS and early vs. symptom based AVR also mirrored the findings of overall results. Conclusions Patients with asymptomatic aortic valve stenosis have lower odds of all-cause and cardiovascular mortality when managed with early-AVR compared to conservative management. Figure 1 Funding Acknowledgement Type of funding source: None

Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P <0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P <0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. Clinical Trial Registration : URL: http://www.clinicaltrials.gov . Unique identifier: NCT01314313.