SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis: One-Year Clinical Outcomes
Reporter: Aviva Lev-Ari, PhD, RN
The registry study — the preliminary results of which were presented at the Transcatheter Cardiovascular Therapeutics meeting in 2015 — included 583 high-risk (65%) or inoperable patients (35%) who got TAVR with the Sapien 3 device between 2013 and 2014. Procedures were performed via the transfemoral (84%) or transapical/transaortic routes (16%).
On multivariable adjustment, the predictors of 1-year mortality were
- alternative access (hazard ratio [HR] 2.06, 95% CI 1.26-3.36),
- moderate paravalvular leak (HR 3.75, 95% CI 1.57-8.96), and
- disabling stroke (HR 10.33, 95% CI 4.62-233.09).
“Even with the low rate of moderate paravalvular leak rate, they found an association with 1 year mortality,” commented Kappetein. “Moderate paravalvular leak is bad for a patient!”
Within 30 days, overall stroke and disabling stroke occurred at frequencies of 1.4% and 0.9%, respectively. Between 1 month and 1 year, these rates were 4.3% and 2.4%.
Généreux appeared to be at ease with the 1-year stroke rate, adding that “this reflects it being a high-risk population.”
In order to bring mortality and stroke rates even lower, he suggested that clinicians “focus on other strategies such as anticoagulation and other medical or device therapies like left atrial appendage closure.”
Nearly all patients improved enough to move out of New York Heart Association class three and four after the procedure (90.1% at baseline versus 7.7% at 1 year, P<0.0001). Self-reported quality of life similarly improved on the Kansas City Cardiomyopathy Questionnaire, with average scores rising from 46.9 to 72.4 at 1 year (P<0.0001).
“A high-risk population is difficult because patients may have mortality related to a comorbidity such as infection and heart failure. That being said, there is still room for improvement in the care of patients beyond the device choice,” Généreux said, suggesting that appropriate anticoagulation is key.
For now, “the combination of new design features of Sapien 3, procedural improvements, operator experience and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in high-risk and inoperable patients with severe aortic stenosis,” Herrmann and colleagues concluded.
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.