Dataset Information

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

ABSTRACT:

Background

Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique.

Aims

This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes.

Methods

In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients with ≥moderate PVR were excluded. Mild PVR was categorised into mild and mild-to-moderate PVR using a recently proposed unifying 5-class grading scheme.

Results

A total of 1,128 patients undergoing TAVI between 2007 and 2015 were enrolled. Of these, 560 patients had mild PVR, including 433 with mild (5-class) PVR and 127 with mild-to-moderate PVR. Patients with mild PVR were older (83 years vs 82 years, p=0.013) and had a higher surgical risk compared to patients with none/trace PVR (STS-PROM: 6.49±4.68 vs 5.41±3.48, p<0.001). At five years, patients with mild PVR had a higher risk of mortality than those with none/trace PVR (54.6% vs 43.8%; HR_adjusted 1.26, 95% CI: 1.06-1.50). When applying the 5-class grading scheme, only mild-to-moderate PVR was associated with an increased risk of mortality at five years (mild PVR: HR_adjusted 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HR_adjusted 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups.

Conclusions

Mild PVR was associated with an increased risk of mortality at five years after TAVI. The detrimental effect was primarily driven by mild-to-moderate PVR using the 5-class grading scheme.

Clinical trial registration

https://www.

Clinicaltrials

gov. NCT01368250.

SUBMITTER: Okuno T

PROVIDER: S-EPMC9904370 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

Okuno Taishi T Tomii Daijiro D Heg Dik D Lanz Jonas J Praz Fabien F Stortecky Stefan S Reineke David D Windecker Stephan S Pilgrim Thomas T

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20220501 1

<h4>Background</h4>Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique.<h4>Aims</h4>This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes.<h4>Methods</h4>In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients ...[more]

PMID: 34930717

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Project description: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.

Project description:BACKGROUND:Three-dimensional (3D) models have the unique ability to replicate individualized cardiac anatomy and may therefore provide clinical benefit. Transcatheter aortic valve implantation (TAVI) currently relies on preoperative imaging for accurate valve sizing, type of valve used, and avoidance of complications. Three-dimensional (3D) modelling may provide benefit for optimal preoperative TAVI planning. The goal of this study is to assess the utility of 3D modelling in the prediction of paravalvular leak (PVL) post TAVI. METHODS:Retrospective analysis of five patients who underwent TAVI at our center. Pre-operative cardiac gated CT images were utilized to create a 3D printed model with true size aortic root dimensions, including the coronary artery ostium location and left ventricular outflow tract. Deployment of the corresponding model and size TAVI valve into the created 3D model at a similar depth of implantation via fluoroscopy was performed for each patient. Degree of PVL was assessed using a closed system with water infusion under pressure over a duration of 5 s. Correlation was made between the volume obtained in the closed loop model during the pressurized period and the degree of PVL reported on the patients post TAVI placement on transthoracic echocardiogram. RESULTS:One female, and four males (age in years ranged from 68 to 87) underwent successful TAVI (0% 30-day mortality). PVL on post procedure TTE ranged from none to trivial. Successful deployment of TAVI valves inside the 3D model occurred in all cases. The average volume of water collected on three trials over 5 s ranged between 19.1-24.1?ml A multivariate linear regression showed significant association between the degree of PVL reported on post-operative transthoracic echocardiogram and the amount of volume detected in the 3D model (difference: -3.9657, 95% CI: (-?4.6761,-3.2554), p?<?0.001). CONCLUSIONS:Our experiments show that replicated 3D models have potential clinical utilization in predicting PVL in the TAVI population. Future research into the role of 3D modelling in the field of TAVI should continue to be explored.

Project description:Background and aimsTranscatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years.MethodsThe NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD.ResultsBaseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4).ConclusionsIn patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.

Dataset Information

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

Background

Aims

Methods

Results

Conclusions

Clinical trial registration

Clinicaltrials

Publications

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

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