Snare-Assisted Valve Positioning of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.
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ABSTRACT:
SUBMITTER: Kunkel KJ
PROVIDER: S-EPMC8302783 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and objectivesTranscatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus.MethodsA total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared.ResultsBetween the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm², p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm²/m², p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up.ConclusionsTAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.
| S-EPMC7925971 | biostudies-literature
Project description:Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.
| S-EPMC8649510 | biostudies-literature
Project description:BackgroundThe choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV).MethodsElectronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs).ResultsThe meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV.ConclusionIn this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV.
| S-EPMC11308705 | biostudies-literature
Project description:BackgroundPrevious studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.ObjectivesThe goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.MethodsWe performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.ResultsRelative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.ConclusionsIn a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.StandardsWith expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).
| S-EPMC4959424 | biostudies-literature
Project description:BackgroundBalloon-expandable valves (BEV) and self-expanding valves (SEV) for transcatheter aortic valve replacement (TAVR) have shown promising results in Western populations. Herein, we comparatively evaluated their hemodynamics and early clinical outcomes in a Chinese population.MethodsOne hundred seventy-eight patients with symptomatic aortic stenosis who had undergone transfemoral TAVR using SEV (n=153; Venus-A, 97; VitaFlow, 56) or BEV (n=25; Sapien3) from September 2020 to April 2021 were retrospectively enrolled, and 25 pairs were propensity-score matched for 10 baseline variables. The primary study outcomes were aortic valve hemodynamics and postoperative complications at discharge and 3-month follow-up.ResultsTAVR was successful in all patients. Compared with SEV group, the BEV group had similarly distributed baseline characteristics, procedural time, hospital stay, new pacemaker implantation, and paravalvular regurgitation grade. We also observed that the BEV group had lower rates of balloon pre-dilation (60% vs. 92%, P=0.018), post-dilation (0 vs. 20%, P=0.050) and second valve implantation (0 vs. 24%, P=0.022); higher mean transaortic gradient (14.3±6.1 vs. 10.8±4.9, P=0.030) and proportion of patients with elevated gradients (20% vs. 0, P=0.050) at discharge; and similar rehospitalization, mean transaortic gradient, new pacemaker implantation, and paravalvular regurgitation grade than the SEV group at the 3-month follow-up. There were no deaths in either group. However, the proportion of patients with elevated gradients in SEV group was higher at 3 months than before discharge (24% vs. 0, P=0.022).ConclusionsBEV and SEV for transfemoral TAVR appear comparably safe and effective, with high device success and favorable 3-month clinical outcomes. However, the transaortic gradient and new pacemaker implantation in the SEV group increased during follow-up, warranting larger studies with longer-term follow-up.
| S-EPMC8848425 | biostudies-literature
Project description:Importance:To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic). Objective:To evaluate outcomes of Lotus vs CoreValve after 2 years. Design, Setting, and Participants:A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years. Main Outcomes and Measures:All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs). Results:Of 912 participants, the mean (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%]). Conclusions and Relevance:After 2 years, all-cause mortality rates, mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm. Trial Registration:clinicaltrials.gov Identifier: NCT02202434.
| S-EPMC6439548 | biostudies-literature
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.
| S-EPMC9743542 | biostudies-literature
Project description:Since the first-in-man transcatheter delivery of an aortic valve prosthesis in 2002, the landscape of aortic stenosis therapeutics has shifted dramatically. While initially restricted to non-surgical cases, progressive advances in transcatheter aortic valve replacement and our understanding of its safety and efficacy have expanded its use in intermediate and possibly low surgical risk patients. In this review, we explore the past, present, and future of transcatheter aortic valve replacement.
| S-EPMC5943666 | biostudies-literature
Project description:In this case, we successfully repositioned the transcatheter heart valve (THV) by pulling it with a snare inserted via the right brachial artery. Attempting to pull the THV via the femoral approach was not successful, due to the vector of the pulling force not being coaxial. Changing the direction of the force by switching to an approach from the right brachial artery successfully prevented perivalvular leakage. While there are previous case reports of repositioning an implanted transcatheter valve in a native valve using a gooseneck snare, to our knowledge, this is the first case of successfully repositioning an implanted transcatheter valve in a valve-in-valve procedure using the precise assessment that can be achieved with intra-procedural transesophageal echocardiography.Learning objectivePerivalvular leakage (PVL) is a major problem after transcatheter aortic valve replacement. In this case, we experienced PVL after implantation of self-expandable transcatheter heart valve (THV) inside the previously inserted Mosaic bioprosthetic valve. Depth of the implanted valve was too low into left ventricle accessed with transesophageal echocardiogram. It is barely known whether THV in surgical implanted aortic valve could be repositioned using snare maneuver, but we successfully pulled the valve via brachial artery and PVL was controlled.
| S-EPMC10730269 | biostudies-literature
Project description:Novel dedicated devices allow transcatheter treatment of pure aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System was introduced as the first dedicated and on-label AR transcatheter aortic valve replacement system, implementing a locator-based and calcium-independent anchoring mechanism. Here, we present the first-in-human transcatheter aortic valve replacement for pure AR via a transcaval access in a patient with prohibitive alternative arterial accesses.
| S-EPMC11002802 | biostudies-literature