Paravalvular Regurgitation and SAPIEN 3 1-Year Outcomes

Study Questions:

What is the incidence, evolution, and effect on 1-year outcomes of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) with a third-generation balloon-expandable transcatheter heart valve?

Methods:

A prespecified analysis of PVR was performed in the PARTNER (Placement of Aortic Transcatheter Valves) II SAPIEN 3 trial; a multicenter, nonrandomized registry of 1,661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3 valve conducted from October 1, 2013 to September 3, 2014. Patients with severe, symptomatic aortic stenosis and high/intermediate surgical risk were enrolled in the registry at 51 sites in the United States and Canada. PVR was assessed in a core laboratory at 30 days and 1 year according to a 5-class scheme: 0, none or trace; 1, mild; 2, mild to moderate; 3, moderate; 4, moderate to severe; and 5, severe. The effect of PVR on 1-year mortality and heart failure re-hospitalization was assessed.

Results:

Among 1,661 patients included in the registry, 1,592 received a SAPIEN 3 valve and had assessment of PVR. Of these patients, 55.7% had none-trace PVR, 32.6% had mild, 8.2% had mild to moderate, and 3.5% had at least moderate PVR at 30 days. At 1 year, 9.3% of patients had died and 14.2% had been re-hospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% confidence interval [CI], 1.30-4.43; p = 0.005) and composite of mortality/re-hospitalization (HR, 2.35; 95% CI, 1.52-3.62; p < 0.001). In a paired comparison including 1,213 patients, 73% of patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least 1 PVR class at 1 year.

Conclusions:

In this series of patients undergoing TAVR with the SAPIEN 3 valve, at least moderate PVR was rare, but associated with increased risk of death and heart failure re-hospitalization at 1 year. Even the upper range of the mild class in a 3-class grading scheme (mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or re-hospitalization. Most patients with at least moderate PVR at 30 days had a decrease of PVR severity grade at 1 year.

Perspective:

There are discrepant data regarding the association between paravalvular aortic regurgitation and adverse clinical outcomes after TAVR. These data, derived from the PARTNER II SAPIEN 3 registry, suggest that only moderate or more PVR was associated with an increased risk of death or re-hospitalization at 1 year after TAVR with a SAPIEN 3 valve; and (perhaps surprisingly with a balloon-expandable valve) that most patients with at least moderate PVR at 30 days had a decrease of PVR severity grade at 1 year. It remains unclear whether PVR is an independent risk for adverse outcomes or a marker of other disease (such as more advanced aortic annular calcification, and therefore, potentially more advanced vascular atherosclerotic disease).


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