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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).
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Failure, Heart Valve Diseases, Hospital Mortality, Outcome Assessment, Health Care, Risk, Transcatheter Aortic Valve Replacement
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