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.
Project description:This report describes a successful transcatheter aortic valve replacement in an older patient with severe aortic stenosis, mitral paravalvular leak, and associated hemolytic anemia. Transcatheter aortic valve replacement is worth considering as a first-line procedure in this high-risk patient because of its beneficial impact on reducing shear forces at the mitral valve. (Level of Difficulty: Intermediate.).
Project description:BackgroundPost-transcatheter aortic valve replacement (TAVR), paravalvular leak (PVL) is a quality metric associated with worse clinical outcomes. Transcatheter heart valve (THV) sizing is based primarily on the systolic annular size without regard to the left ventricular outflow tract (LVOT), which also lies within the THV landing zone. We hypothesized that LVOT size relative to the annulus is associated with post-TAVR PVL.MethodsData from consecutive patients undergoing TAVR in a single high-volume center from January 2018 to March 2019 were used. Pre-TAVR data from multidetector computed tomography (MDCT) were collected. Relative LVOT area was defined as LVOT area/annular area during systole. Logistic regression analysis was used to evaluate association with post-TAVR mild or greater PVL by transthoracic echocardiography before discharge.ResultsAmong 293 patients (median age, 81.1 years; female, 49.5%; White, 88.0%), 81.6% received SAPIEN 3 and 18.4% received CoreValve THV models. Aortic valve morphology was bicuspid in 10.9% of patients. Prevalence of mild or greater PVL was 23.5% (mild in 20.1%). Relative LVOT area had a significant inverse association such that the odds of mild or greater PVL decreased significantly with every 1% increase in relative LVOT area (adjusted odds ratio, 0.96; 95% CI, 0.93-0.98; P = .002). There was no interaction between the type of implanted valve and the relative LVOT area. Patients in the highest relative LVOT tertile had significantly lower odds of mild or greater PVL (adjusted odds ratio, 0.42; 95% CI, 0.21-0.87; P = .018 vs first tertile).ConclusionsIn patients undergoing TAVR with the newer generation of THV (SAPIEN 3 and CoreValve models), a relatively narrower LVOT area vs annular area was independently associated with increased odds of mild or greater PVL before discharge.
Project description:A patient with severe bioprosthesic patient-prosthesis mismatch, severe paravalvular leak, and symptoms of heart failure New York Heart Association functional class III was successfully treated using valve cracking followed by valve-in-valve transcatheter aortic valve implantation with excellent results at 1-year follow-up. (Level of Difficulty: Advanced.).
Project description:Background: Paravalvular leak (PVL) was initially recognized as one of the most common complications after transcatheter aortic valve implantation (TAVI) and has been linked to adverse clinical outcomes, including mortality. This study aims to assess the long-term clinical effects of PVL in patients undergoing TAVI with the latest generation of transcatheter aortic valves, as part of the national observational prospective multicenter study OBSERVANT II. Methods: OBSERVANT II included all consecutive patients with severe aortic stenosis who underwent TAVI across 28 Italian centers from December 2016 to September 2018. A total of 2125 patients were included in this analysis and stratified according to the presence of moderate-to-severe PVL (significant PVL, n = 155) versus no/trace-to-mild PVL (no significant PVL, n = 1970). The primary endpoint was 5-year major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, myocardial infarction, and coronary revascularization. Five-year all cause death and re-hospitalization for heart failure (HF) were the secondary endpoints. Results: In our cohort, the incidence of moderate-to-severe PVL was 7%. Age, aortic anulus perimeter, and self-expandable valves were determinants of PVL. The risk of MACCE, all-cause death, and re-hospitalization for HF at the 5-year follow-up were not different between the study groups [HR = 1.07 (95% CI: 0.85-1.34) p = 0.571; HR = 1.10 (95% CI: 0.87-1.39) p = 0.435; HR = 1.20 (95% CI: 0.88-1.62) p = 0.245, respectively]. Conclusions: In this analysis of the OBSERVANT II study, moderate/severe PVL was not associated with a higher incidence of MACCE and re-hospitalization for heart failure at the 5-year follow-up.
Project description:Transcatheter aortic valve replacement (TAVR) is becoming increasingly prevalent worldwide and is now more common than surgical aortic valve replacement. It is expanding into all patient subsets including younger and lower risk patients. Bicuspid aortic valve (BAV) accounts for a significant proportion of TAVR, but due to heterogenous anatomy, it is of increased complexity. One of the greatest challenges in BAV is the selection of the correct TAVR size. Transcatheter aortic valve replacement sizing is based upon computed tomography-derived annular measurements. There are a number of sizing algorithms for BAV based upon anatomical characteristics, often yielding different results. This is noted especially when a patient falls near the borderline between two valve sizes, an anatomical grey zone. Complementary to the algorithm approach is the use of pre-procedural patient-specific computer simulation using finite-element modelling. An 86-year-old female was treated for heart failure secondary to severe and calcific BAV aortic stenosis with TAVR. Due to anatomical difficulty and grey-zone valve sizing, we demonstrate the use of pre-procedural patient-specific computer simulation with the novel Medtronic Evolut PRO+ platform to achieve a good result. Using patient-specific computer simulation, we were able to safely select the valve and the deployment height and then accurately predict the result in a difficult, severely calcified BAV. In addition to improving outcome, this allows for patient-specific, tailored discussion to occur at heart team meetings.
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:BackgroundData regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce.AimsThis study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure.MethodsAll patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included.ResultsOverall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%).ConclusionsPercutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.