Transcarotid transcatheter aortic valve implantation with a novel balloon expandable Myval® THV under the local anesthesia.
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ABSTRACT:
SUBMITTER: Ayhan H
PROVIDER: S-EPMC9361163 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
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Transcarotid transcatheter aortic valve implantation with a novel balloon expandable Myval<sup>®</sup> THV under the local anesthesia.
Ayhan Hüseyin H Karaduman Bilge Duran BD Keleş Telat T Uğuz Emrah E Boysan Emre E Bozkurt Engin E
Journal of geriatric cardiology : JGC 20220701 7
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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: Not available
| S-EPMC7791291 | biostudies-literature
Project description:BackgroundIn the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).Materials and methodsA total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.ResultsThe mean age of the study population was 83 (75-87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3-7) days.ConclusionBased on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.
| S-EPMC8512594 | 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:ObjectivesThis study analyzes neocommissural alignment and the clinical and hemodynamic outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve.MethodsWe performed a retrospective, single-center analysis of early outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Primary outcomes were neocommisural alignment, in-hospital mortality, and valve hemodynamic performance. Commissural alignment between native and transcatheter heart valves was assessed by transesophageal echocardiogram before and after the procedure.ResultsBetween October 2021 and November 2022, 40 consecutive patients were treated with the Acurate neo2 through a transaxillary or transcarotid approach. Access was achieved via the left subclavian artery in 30 cases and the left common carotid artery in 10 cases, with a mean vessel diameter of 6.7 mm. Implants most commonly used were size M (37.5%), L (35%), and S (27.5%). On the basis of transesophageal echocardiogram analysis, there was no significant difference in mean commissural orientation between native (mean, 65.1°; SD, 41.3°) and neocommissures (mean, 64°; SD, 44.1°) (P = .661). Mean commissural orientation did not significantly differ between native and neocommissures (P = .661). Optimal alignment or mild commissural misalignment was achieved in 99.5% of cases. There were no cases of severe commissural misalignment. Postprocedural mean values for peak and mean gradients were 12.7 mm Hg and 5.2 mm Hg, respectively. There were 2 cases of moderate paravalvular leak and 4 cases of mild paravalvular leak.ConclusionsThis patient-specific technique for transaxillary and transcarotid insertion of the Acurate neo2 delivery system prevents implantations with more than mild commissural misalignment and with a high device success rate.
| S-EPMC10750428 | 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:AimsThe aim of this study was to report the predictors and clinical impact of transcatheter heart valve (THV) thrombosis in patients undergoing transcatheter mitral valve implantation (TMVI).Methods and resultsWe included 130 patients who consecutively underwent TMVI. Transoesophageal echocardiography (TOE) and/or computed tomography (CT) were performed in 91.7% of patients at discharge, in 73.3% at three months and in 72% beyond three months. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion confirmed by TOE or contrast CT and classified as immediate, early, or late according to the timing of diagnosis. THV thrombosis was observed in 16 (12.3%) patients: immediate in 43.7%, early in 37.5% and late in 18.8%. Most of these thromboses were subclinical (93.7%) and non-obstructive (87.5%). No thromboembolic event occurred. After optimisation of antithrombotic treatment, THV thromboses resolved in all but one patient. Predictors were shock for immediate (p<0.001), male sex for early (p=0.045) and absence of anticoagulation for both early (p=0.018) and late (p=0.023) THV thromboses.ConclusionsTHV thrombosis is frequent after TMVI, occurs mainly within the first three months, is mostly subclinical and resolves after optimisation of antithrombotic treatment. An anticoagulation therapy for at least three months after the procedure is mandatory.
| S-EPMC9724835 | biostudies-literature
Project description:The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon-expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium-2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61-1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64-1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97-3.87 [P<0.001]). The repositionable LOTUS valve system and the balloon-expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium-2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.
| S-EPMC5210340 | biostudies-literature