Association of Paravalvular Regurgitation With 1-Year Outcomes After Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve

Abstract

Importance: Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves.

Objective: To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve.

Design, setting, and participants: Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014. Multicenter, nonrandomized registry of 1661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3. 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.

Interventions: Transcatheter aortic valve replacement with the SAPIEN 3 valve.

Main outcomes and measures: Paravalvular regurgitation 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. We assessed the effect of PVR on 1-year mortality and heart failure rehospitalization.

Results: Among the 1661 included in the registry, 1592 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 rehospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% CI, 1.30-4.43; P = .005) and composite of mortality/rehospitalization (HR, 2.35; 95% CI, 1.52-3.62; P < .001). In a paired comparison including 1213 patients, 73% of the 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 and relevance: 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 rehospitalization at 1 year. Even the upper range of the mild class in the 3-class grading scheme (ie, mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or rehospitalization. Most patients with at least moderate PVR at 30 days showed a decrease of PVR severity grade at 1 year.

Trial registration: clinicaltrials.gov Identifier: NCT01314313.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Pibarot holds the Canada Research Chair in Valvular Heart Disease and his research program is funded by grant FDN-143225 from the Canadian Institutes of Health Research. Dr Pibarot has Core Lab contracts with Edwards Lifesciences for which he receives no direct compensation. Dr Hahn has Core Lab contracts with Edwards Lifesciences for which she receives no direct compensation and has speaker honoraria for Philips Healthcare, St Jude Medical, Boston Scientific, and Abbott Structural. Drs Weissman and Asch have Core Lab contracts with Edwards Lifesciences, St Jude Medical, Boston Scientific, Medtronic, Biostable, Sorin/Livanova, Symetis, Biotronik, JenaValve, Abbott Vascular, Direct Flow, GDS, MValve, Xeltis, and Mitralign, for which they receive no direct compensation. Dr Dahou is a reader for a Core Lab, which has contracts with Edwards Lifesciences, for which he receives no direct compensation. Dr Khalique receives speaker honoraria from Edwards Lifesciences, Boston Scientific, and is a reader for a Core Lab which has contracts with Edwards Lifesciences, for which he receives no direct compensation. Drs Leipsic and Blanke are consultants for Edwards Lifesciences and provide CT Core Lab services for Edwards Lifesciences, Medtronic, Neovasc, GDS, and Tendyne Holdings, for which they receive no direct compensation. Drs Leon and Mack are members of the PARTNER Trial Executive Committee, with no compensation. Dr Herrmann has received research funding from Edwards Lifesciences, Medtronic, St Jude, Boston Scientific, and Abbott Vascular and is a consultant for Edwards Lifesciences. Dr Makkar has received grants from Edwards Lifesciences and St Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr Herrmann has received grants from Edwards Lifesciences, St Jude Medical, Medtronic, Boston Scientific, Abbott Vascular, Gore, Siemens, Cardiokinetix, and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and holds equity in Microinterventional Devices. Dr Thourani is a member of the PARTNER Trial Steering Committee and is a consultant for Edwards Lifesciences, Sorin Medical, St Jude Medical, and DirectFlow. Dr Kodali consults with Edwards Lifesciences and Medtronic, and has ownership interest in Thubrikar Aortic Valve Inc. No other disclosures were supported.

Figures

Figure 1.. Incidence of Paravalvular Regurgitation (PVR) at 30 Days

In the ≥moderate column, the dark blue indicates moderate PVR (n = 47), and the light blue indicates moderate to severe PVR (n = 8).

Figure 2.. One-Year Outcomes According to Presence and Severity of Paravalvular Regurgitation (PVR) at 30 Days

Time-to-event curves for PVR stratified in 4 groups of PVR severity at 30-day echocardiography (none/trace; mild; mild to moderate; and ≥moderate) for death from any cause (A), cardiovascular death (B), composite of death and rehospitalization (C), and valve reintervention (D).

Figure 3.. Paired Comparison of Paravalvular Regurgitation (PVR) at 30 Days vs 1 Year

A, Paired comparison of PVR grading class at 30 days and 1 year in the subset of 1213 patients who had echocardiographic assessment of PVR available at both times and who did not undergo aortic valve reintervention between 30 days and 1 year. B, Comparison of the distribution of PVR severity at 30 days vs 1 year in this subset of patients.