Dataset Information

Paravalvular regurgitation after transcatheter aortic valve replacement in intermediate-risk patients: a pooled PARTNER 2 study.

ABSTRACT:

Background

Moderate or worse paravalvular regurgitation (PVR) post transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The mechanisms by which this occurs are not fully understood.

Aims

The aim of this study was to determine the mechanism by which PVR leads to worse outcomes.

Methods

A total of 1,974 intermediate-risk patients who received TAVR in the PARTNER 2 trial and registries were grouped by PVR severity. Clinical and echocardiographic outcomes were compared.

Results

Overall 1,176 (60%) patients had none/trace, 680 (34%) had mild, and 118 (6%) had ≥moderate PVR. At two years, ≥moderate PVR patients had increased risks of all-cause (HR 2.33 [1.41-3.85], p-value=0.001) and cardiovascular death (HR 3.30 [1.74-6.28], p-value <0.001), rehospitalisation (HR 2.68 [1.57-4.58], p-value <0.001), and reintervention (HR 14.72 [3.13-69.32], p-value <0.001). Moderate or worse PVR was associated with larger increases in left ventricular (LV) end-diastolic and systolic dimensions and volumes, LV mass indices, and reductions in LV ejection fractions (LVEFs) from 30 days to two years. Mild PVR was not associated with worse outcomes. Adjusting for LV dimensions and LVEF from the one-year echocardiogram, patients with ≥moderate PVR still had an increased risk of all-cause death or rehospitalisation at two years (HR 2.84 [1.25-5.78], p-value=0.009).

Conclusions

Moderate or worse PVR, but not mild PVR, is associated with an increased risk of all-cause and cardiovascular death, rehospitalisation, and reintervention at two years. Moderate or worse PVR is also associated with adverse LV remodelling, which partially mediates how ≥moderate PVR leads to worse outcomes. These results provide dual insights on the deleterious impact of ≥moderate PVR and the contributing mechanisms of poor clinical outcomes.

SUBMITTER: Chau KH

PROVIDER: S-EPMC9724907 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Paravalvular regurgitation after transcatheter aortic valve replacement in intermediate-risk patients: a pooled PARTNER 2 study.

Chau Katherine H KH Chen Shmuel S Crowley Aaron A Redfors Bjorn B Li Ditian D Hahn Rebecca T RT Douglas Pamela S PS Alu Maria C MC Finn Matthew T MT Kodali Susheel S Jaber Wael A WA Rodriguez Leonardo L Thourani Vinod H VH Pibarot Philippe P Leon Martin B MB

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20220101 13

<h4>Background</h4>Moderate or worse paravalvular regurgitation (PVR) post transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The mechanisms by which this occurs are not fully understood.<h4>Aims</h4>The aim of this study was to determine the mechanism by which PVR leads to worse outcomes.<h4>Methods</h4>A total of 1,974 intermediate-risk patients who received TAVR in the PARTNER 2 trial and registries were grouped by PVR severity. Clinical and echocardiographi ...[more]

PMID: 34483095

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Project description:ImportanceModerate/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.ObjectiveTo 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 participantsPrespecified 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.InterventionsTranscatheter aortic valve replacement with the SAPIEN 3 valve.Main outcomes and measuresParavalvular 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.ResultsAmong 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 relevanceIn 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 registrationclinicaltrials.gov Identifier: NCT01314313.

Project description:Aims: The study aimed to compare paravalvular leak (PVL) changes after a transcatheter aortic valve replacement (TAVR) with self-expandable prosthesis between different aortic valve morphologies and evaluate the impact of paravalvular leak regression on clinical prognosis. Methods: Patients with aortic stenosis (AS) successfully treated with a self-expandable TAVR who were followed up for at least 1 year at our centre were consecutively enrolled from January 2016 to August 2019. Paired serial changes in paravalvular leak and other haemodynamic parameters by echocardiography were collected and compared between the bicuspid valve (BAV) and tricuspid aortic valve (TAV). A logistic regression model was used to explore the predictors of paravalvular leak regression (<1 grade) 1 year after transcatheter aortic valve replacement, while its impact on subsequent clinical outcomes (all-cause mortality and rehospitalisation for heart failure (HF)) was further evaluated using Kaplan-Meier analysis. Results: A total of 153 bicuspid valve and 114 tricuspid aortic valve patients were finally enrolled; haemodynamic parameters and paravalvular leak severity were comparable before the discharge between the two groups. The peak transaortic velocity, mean transvalvular gradient, and effective orifice area all significantly improved (p < 0.05) without intergroup differences at all follow-up timepoints. Significant paravalvular leak reduction was observed only in the TAV group (1.75% vs. 4.39%, p = 0.029), while moderate paravalular leak was still more prevalent in BAV (7.19% vs. 1.75%, p = 0.041) at the 1-year follow-up. Multivariable analyses identified the bicuspid valve, asymmetric calcification, and undersizing as independent predictors of failure of the 1-year paravalvular leak reduction in patients with mild or moderate paravalvular leak after discharge. Patients without a paravalvular leak reduction within 1 year showed a relatively higher 2-year all-cause mortality and HF (HR: 5.994, 95% CI: 1.691-21.240, and p = 0.053) rates thereafter. Conclusion: In AS patients after self-expandable transcatheter aortic valve replacement, paravalvular leak regression within 1 year was less prevalent in bicuspid valve morphology. The failure of paravalvular leak reduction might lead to an increased risk of poorer prognosis in the long run.

Dataset Information

Paravalvular regurgitation after transcatheter aortic valve replacement in intermediate-risk patients: a pooled PARTNER 2 study.

Background

Aims

Methods

Results

Conclusions

Publications

Paravalvular regurgitation after transcatheter aortic valve replacement in intermediate-risk patients: a pooled PARTNER 2 study.

Similar Datasets

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