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Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves for Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry.

ABSTRACT: Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes were based on the Society of Thoracic Surgeons-American College of Cardiology-Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty-day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all-cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all-cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all-cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all-cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self-expandable supra-annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

SUBMITTER: Dallan LAP

PROVIDER: S-EPMC8649494 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThere is a lack of available data on specific prognostic comparisons between transcatheter aortic valve replacement (TAVR) using self-expandable valves (SEV) in patients with stenotic Type 0, Type 1 bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).ObjectivesTo evaluate the association between aortic valve morphology and outcomes following self-expandable TAVR.MethodsConsecutive patients with aortic stenosis(AS) undergoing self-expandable TAVR were enrolled and categorized into three groups (Type 0/Type 1 BAV or TAV) according to the Sievers classification. The primary endpoint was a composite of all-cause mortality and rehospitalization for heart failure (HF) within 2 years. Secondary outcomes included procedural complications and major cardiovascular events observed in clinical follow-ups. Clinical outcomes at 2 years following TAVR were compared among three groups using Kaplan-Meier curve and multivariable Cox proportional hazards regression models.ResultsA total of 344 AS patients (Type 0: 86; Type 1: 109; TAV: 149) were enrolled. The presence of moderate or severe paravalvular leak (PVL) was significantly higher in patients with Type 0 and Type 1 BAV versus TAV (10.47% vs. 16.51% vs. 6.71%, p = 0.043). All-cause 30-day mortality (2.33% vs. 0.92% vs. 2.68%, p = 0.626) and 2-year mortality (3.49% vs. 5.50% vs. 6.71%, p = 0.657) was comparable among the three groups. However, rehospitalization for HF within 2 years was significantly higher in Type 1 BAV (11.63% vs. 20.18% vs. 8.72%, p = 0.020). Multivariate Cox analysis showed that a higher STS score, Type 1 BAV morphology and excess leaflet calcification (≥ median calcium volume (CV) of the entire population) were independent predictors for HF rehospitalization. Additional intragroup Kaplan‒Meier analysis showed that excess leaflet calcification could predict higher long-term mortality and rehospitalization risk for HF(HR (95% CI): 3.430 (1.166-10.090), log rank p = 0.017) in Type 1 BAV patients.ConclusionOutcomes of self-expandable TAVR in BAV-AS patients might vary depending on valve subtypes. BAV patients with excess leaflet calcification and a raphe, especially calcified, had an increased risk of moderate PVL and HF readmission in mid-to-long term follow-ups.

Project description:BackgroundLimited studies have focused on the performance of self-expandable valves (SEVs) and balloon-expandable valves (BEVs) in patients with dilatated ascending aorta (AA) undergoing transcatheter aortic valve replacement (TAVR). The present study compared the performance of widely used Edwards BEVs and domestic SEVs in patients with dilatated AA among Chinese population.MethodsWe identified and reviewed 207 patients who had baseline AA diameter ≥40 mm and underwent transfemoral TAVR. Patients were divided into two groups: SEV and BEV. The SEVs were locally manufactured valves that have received Chinese regulatory approval (Venus-A, Taurus One, and VitaFlow), while the BEVs were Edwards Sapien XT and Sapien3. Procedural device success and post-procedural changes of AA diameters were compared.ResultsThe sample size of SEV group was larger than that of BEV group because BEVs were not available in China in the early clinical practice. The overall device success was slightly lower in SEV group compared with BEV group (84.2% vs. 95.8%, P=0.213). However, in the univariable and multivariable logistic regression analyses, only bicuspid aortic valve (BAV) was found to be an independent risk factor for device failure (OR: 2.632, CI: 1.107-6.257, P=0.029). During the median follow-up of 21 months, no statistical difference was found between the two groups regarding the overall survival (83.1%±4.7% vs. 95.8%±4.1%, P=0.533), and no aortic dissection nor rupture was observed. In a subgroup of patients who had follow-up CTs ≥12-month intervals, the AA diameter appeared to remain stable in SEV group with an aortic expansion rate of 0 (-0.4 to 0.8) mm (P=0.102), while it slightly enlarged in BEV group with an aortic expansion rate of 0.4 (-0.4 to 0.6) mm/y (P=0.038). In addition, the AA diameter also slightly enlarged in patients with BAV [0.2 (0 to 1.0) mm/y, P=0.015], while it remained stable in patients with tricuspid aortic valve (TAV) [0 (-0.8 to 0.6) mm/y, P=0.640].ConclusionsIn patients with dilatated AA who underwent TAVR, the type of THVs did not affect the procedural device success. BAV appeared to be a risk factor for both device failure and higher aortic expansion rate in these patients.

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Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves for Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry.

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