Retrieval of Large Balloon Fragments During Transcatheter Pulmonary Valve Implantation Using a Novel Retrieval System
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SUBMITTER: Taylor A
PROVIDER: S-EPMC10715928 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Project description:Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval device. Results: A total of 11 patients from five institutions were gathered between 2019 and 2022 (age 68 ± 7.8, 63% women). The peak and mean transvalvular gradients were 27 ± 5 mmHg and 14.7 ± 2.3 mmHg, respectively, and the predicted neo-left ventricular outflow tract (neo-LVOT) area was 183.4 ± 56 mm2 (range: 171 to 221 mm2). The procedures were performed via transfemoral access in all cases (through echocardiography-guided transeptal puncture (81.8% transesophageal, 11.2% intracardiac)). Technical success was achieved in all cases, with no significant residual mitral stenosis in any of them (peak 7.2 ± 2.7 and mean gradient 3.4 ± 1.7 mmHg) and no complications during the procedure. There were no data of LVOT obstruction, migration, or paravalvular leak in any case. Mean hospital stay was 3 days, with one major vascular complication and no stroke. At 6-month follow-up, there was one case with suboptimal anticoagulation presenting an increase in the transmitral gradients (mean 15 mmHg) that normalized after optimization of the anticoagulation, but no other relevant events. Conclusions: Transseptal ViV mitral implantation with the balloon-expandable Myval device was feasible and safe avoiding redo surgery in high-risk patients with bioprosthesis degeneration.
| S-EPMC9457220 | biostudies-literature
Project description:Balloon aortic valvuloplasty (BAV) has historically been recommended prior to transcatheter aortic valve implantation (TAVI). Pre-implantation BAV (pBAV) creates fractures at the level of calcified leaflets, thereby facilitating delivery of the transcatheter valve system across the diseased aortic valve and, enhances prosthesis implantation and expansion within the calcified aortic valve annulus. New device designs, lower profile delivery systems and increasing operator experience have enabled direct-TAVI (without pBAV), and its appeal amongst TAVI operators enhanced the dissemination of a direct TAVI approach across many centres. In this review, we discuss contemporary evidence that inform the debate on the need for routine pBAV for TAVI candidates and present a framework that may assist operators in selecting patients for pBAV.
| S-EPMC6242918 | biostudies-literature
Project description: Not available
| S-EPMC10405301 | biostudies-literature
Project description:ObjectivePermanent pacemaker implantation (PPI) risk is higher following transcatheter aortic valve implantation (TAVI) than surgical valve replacement. Native aortic leaflets are retained in patients undergoing TAVI, unlike in surgical valve replacement. Whether the retained leaflets influence PPI risk because of their proximity to the conduction system is unknown. The study sought to determine the association between infra-annular extension of native right coronary cusp/noncoronary cusp (RCC/NCC) post balloon-expandable TAVI and PPI risk.MethodsWe performed a retrospective analysis of 190 patients undergoing balloon-expandable TAVI at a single center. Manifestation of infra-annular extension of RCC/NCC was considered to be present when part of leaflet extended below aortic-annular plane on post-implantation aortic-root angiography.ResultsInfra-annular extension of RCC/NCC was observed in 33 patients (17.37%). PPI incidence post-TAVI was higher in patients with infra-annular extension of RCC/NCC than in those without (36.36% versus 8.92%, relative-risk: 4.08, p˂0.0001). On logistic-regression analysis, preexisting right bundle-branch block (RBBB) (odds-ratio: 12.73, 95% confidence-interval: 2.16-74.93, p = 0.005), and infra-annular extension of RCC/NCC (odds-ratio: 5.63, 95% confidence-interval: 2.17-14.58, p < 0.0001) were independently associated with PPI risk. Preexisting RBBB (φ = +0.25, p = 0.001) and infra-annular extension of RCC/NCC (φ = +0.30, p < 0.0001) showed a positive-correlation with PPI risk. Infra-annular extension of RCC/NCC was a significant predictor of PPI risk on receiver-operating-characteristic curve analysis (area under-the-curve 0.67; 95% confidence-interval: 0.54-0.79, p = 0.006).ConclusionThe retained native aortic leaflets play a significant role in PPI risk following balloon-expandable TAVI. Infra-annular extension of RCC/NCC is a novel predictor, and is associated with a four-fold higher risk of PPI.
| S-EPMC10421988 | biostudies-literature
Project description: Not available
| S-EPMC10883288 | biostudies-literature
Project description: Not available
| S-EPMC11907267 | biostudies-literature
Project description:AimsTranscatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA).Methods and resultsParticipating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6 ± 6.7 years, 52% male) were enrolled in 80 centres from 10 European countries. At 1 year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1 year.ConclusionIn SOURCE 3, we observe a low complication rate and mortality at 1 year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956.
| S-EPMC5837400 | biostudies-literature
Project description:Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0-12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02-1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86-1.37, p = 0.48). This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.
| S-EPMC8432462 | biostudies-literature
Project description:BackgroundLeft ventricular (LV) mechanics are impaired in patients with severe aortic stenosis (AS); however, transcatheter aortic valve implantation (TAVI) may positively affect LV mechanics. Assessed herein is the performance of the SAPIEN 3 transcatheter heart valve (THV) and the effect of TAVI on LV function recovery, as assessed by global longitudinal strain (GLS).MethodsA subset of patients from the SOURCE 3 registry (n = 276) from 16 European centers received SAPIEN 3 balloon-expandable THV. Echocardiography was performed at baseline, postprocedure, and at 1 year, including assessment of GLS using standard two-dimensional images, and was analyzed in a core laboratory. Paired analyses between baseline and discharge, baseline and at 1 year were conducted.ResultsHemodynamic parameters were improved after TAVI and sustained to 1 year. At 1 year, the rate of moderate to severe paravalvular leaks (PVL), and moderate to severe mitral and tricuspid regurgitations were 1.8%, 1.7%, and 8.0%, respectively. The discharge GLS (-15.6 ± 5.1; p = 0.004; n = 149) improved significantly from baseline (-15.1 ± 4.8) following TAVI. This improvement was sustained at 1 year compared with baseline (-17.0 ± 4.6, p < 0.001; n = 100). Conversely, LV ejection fraction (LVEF) did not significantly change following TAVI (p = 0.47).ConclusionsFollowing TAVI with a third-generation THV, valve performances were good at 1 year with low PVL rate. The LV mechanics improved immediately after the procedure and were maintained at 1 year. These findings demonstrate the benefit of TAVI on LV mechanics, and suggests that GLS may be superior to LVEF in assessing this benefit. Clinicaltrial.gov number: NCT02698956.
| S-EPMC8079106 | biostudies-literature
Project description: Not available
| S-EPMC9361163 | biostudies-literature