Self-Expanding Transfemoral TAVR at 2 Years
What are the 2-year safety and efficacy data for transfemoral CoreValve self-expanding transcatheter aortic valve replacement (TAVR) among patients with severe aortic stenosis (AS) at extreme risk for surgical AVR?
The CoreValve US Extreme Risk Pivotal Trial was a prospective, multicenter, controlled, nonrandomized single-arm investigation of the CoreValve self-expanding TAVR performed at 41 clinical sites in the United States. Included patients had severe (aortic valve area ≤0.8 cm2 or indexed aortic valve area ≤0.5 cm2, and mean gradient >40 mm Hg or Vmax >4.0 m/s) symptomatic (New York Heart Association [NYHA] class ≥II) AS, and were considered to be at extreme risk based on ≥50% risk at 30 days for mortality or irreversible morbidity with surgical AVR. All-cause mortality or stroke was assessed at 2 years using Valve Academic Research Consortium (VARC)-1 criteria. Major adverse cardiovascular and cerebral events (VARC-1 criteria) comprised all-cause death; myocardial infarction; all stroke; and re-intervention to alter, adjust, or replace a previously implanted valve.
A total of 489 extreme-risk patients were treated at 41 sites with transfemoral self-expanding CoreValve. The rate of all-cause mortality or major stroke was 38.0% at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included presence of coronary artery disease, and admission from an assisted living center. A Society of Thoracic Surgeons (STS) score >15% also trended to be predictive of 2-year all-cause mortality. At 2 years, 94% of patients had NYHA class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year and 4.4% at 2 years) was unchanged between the first and second year after TAVR.
The authors concluded that patients with severe AS and extreme surgical risk treated with transfemoral self-expanding TAVR continued to show good clinical outcomes and good hemodynamic valve performance at 2 years. In these patients, the presence of comorbid conditions rather than valve performance affected 2-year outcomes.
Among symptomatic patients with severe AS thought to be unsuitable for surgical AVR, good survival and low stroke rates at 1 year were sustained at 2 years after transfemoral self-expanding CoreValve TAVR, and the degree of significant paravalvular regurgitation remained unchanged between 1 and 2 years after valve implantation. Data from outside the United States suggest durable performance through 5 years. TAVR has allowed intervention for inoperable patients with severe symptomatic AS, and provides an alternative to surgical intervention for some high-risk patients.
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