A new standard of care for inoperable, severe aortic stenosis: implications of the PARTNER trial

摘要

Calcific aortic stenosis (AS) is the most common form of valvular heart disease requiring intervention in the developed world. Although indolent early in its course, the disease becomes extremely malignant following the development of symptoms with an average survival of only 2-3 years and a high rate of sudden death. Until recently, surgical aortic valve replacement (AVR) had been the only therapy demonstrated to alter the natural history of AS and improve mortality. Standard medical therapy, including balloon aortic valvuloplasty, can lead to a short-term improvement in symptoms, but does not improve survival. The Placement of Aortic Transcatheter Valves (PARTNER) trial compared transcatheter aortic valve replacement (TAVR) with standard therapy in patients with symptomatic, severe AS who were inoperable (cohort B) or high-risk (cohort A) candidates for AVR. In cohort B of the trial, TAVR with the Edwards SAPIEN valve significantly reduced the primary end point of overall mortality at 1 year among patients who were deemed to be too high risk to undergo AVR. TAVR was also superior to standard therapy with respect to death from cardiovascular causes, death from any cause or repeat hospitalization, and death or major stroke, despite being associated with higher 30-day rates of major stroke, major vascular complications, and major bleeding. Assessment at 1 year showed that the initial favorable hemodynamic results of TAVR were durable and there was no evidence of valve deterioration or restenosis. Importantly, TAVR was superior to standard therapy at 1 year with respect to improving symptoms and quality of life. This trial establishes TAVR as the new standard of care in appropriate patients with symptomatic severe AS who are not candidates for surgical AVR. Ongoing technological advances and additional trials will likely lead to further expansion of the population of patients with AS who are candidates for TAVR.