Transcatheter Aortic and Mitral Valve-in-Valve Implantation Using the Edwards Sapien 3 Heart Valve.
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ABSTRACT:
SUBMITTER: Shivaraju A
PROVIDER: S-EPMC6064864 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
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Transcatheter Aortic and Mitral Valve-in-Valve Implantation Using the Edwards Sapien 3 Heart Valve.
Shivaraju Anupama A Michel Jonathan J Frangieh Antonio H AH Ott Ilka I Thilo Christian C Schunkert Heribert H Kastrati Adnan A Leon Martin B MB Dvir Danny D Kodali Susheel S Bapat Vinayak V Guerrero Mayra M Kasel Albert M AM
Journal of the American Heart Association 20180707 14
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Project description:We describe the case of a 57-year-old man who had severe mitral valve stenosis and regurgitation without significant annular calcification. He was not a candidate for surgical valve replacement or repair because of his substantial comorbid conditions, overall frailty, and elevated surgical risk. He underwent successful transcatheter mitral valve replacement of his native mitral valve with compassionate, off-label use of an Edwards Sapien 3 valve. A search of the literature produced no other cases like ours, which represents a further evolution of the transcatheter valve implantation concept. Further studies are needed to help define accurate valve sizing, intraprocedural positioning, and long-term device stability, as well as to determine which patients might benefit from this commercially available valve. In the meantime, our findings could present a means of treating patients who have no other options.
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Project description:ImportanceBioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients.ObjectiveTo assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.Design, setting, and participantsIn this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.ExposuresMitral valve-in-valve for degenerated bioprosthetic mitral valves.Main outcomes and measuresThe primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance.ResultsA total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.Conclusions and relevanceTranscatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.
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Project description:Transcatheter aortic valve implantation has emerged as a valuable option to treat patients with symptomatic severe aortic stenosis, who are not being considered for surgery because of significant comorbidities. Concerns exist over treating patients who have previously undergone mitral valve surgery for possible interference between the percutaneous aortic valve and the mitral prosthesis or ring.At our centre, from May 2008 to December 2012, 172 patients (76 male) with severe symptomatic aortic stenosis were eligible for transcatheter aortic valve implant. Nine patients, affected by severe aortic stenosis, had previously undergone mitral valve surgery (4 mono-leaflet, 3 bileaflet, 1 bioprosthesis, 1 mitral ring); they were considered high-risk surgical candidates following joint evaluation by cardiac surgeons and cardiologist and had undergone TAVI.Seven patients underwent standard femoral retrograde CoreValve(®) (Medtronic Inc., Minneapolis, USA) implantation, two patients underwent a direct aortic implantation through a mini-thoracotomy. All patients experienced immediate improvement of their haemodynamic status. No deformation of the nitinol tubing of the CoreValve, nor distortion or malfunction of the mechanical valve or mitral ring, occurred as assessed by echographical and fluoroscopic evaluation. No major postoperative complications occurred. In all patients , echocardiography indicated normal valve function during follow-up.Our experience confirms the feasibility of CoreValve implantation in patients with mechanical mitral valves or mitral annuloplasty ring.
| S-EPMC3686371 | biostudies-other
Project description:BackgroundNo comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV).AimsWe aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV.MethodsA total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs. Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups.ConclusionsShort-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.
| S-EPMC9853033 | biostudies-literature
Project description:BackgroundThe presence of aortic and mitral disease in a patient who is not a suitable candidate for surgical correction poses significant challenges in the diagnostic workup as well as management plans. Percutaneous treatment can be staged to fix the aortic valve with transcatheter aortic valve implantation (TAVI) as a first step, followed by reassessment and percutaneous correction of mitral regurgitation (MR).Case summaryA 65-year-old female with multiple co-morbidities presented with acute coronary syndrome and heart failure. She was diagnosed with three-vessel coronary artery disease and degenerative low-flow low-gradient severe aortic stenosis, along with severe degenerative MR with a left ventricular ejection fraction of 35%. Because of the high surgical risk, she underwent multi-vessel percutaneous coronary intervention with stenting. Transcatheter aortic valve implantation was done as a staged procedure, which partially improved her symptoms. Mitral regurgitation was not suitable for percutaneous mitral valve edge-to-edge repair. After a discussion by the heart team, she underwent transcatheter mitral valve implantation, for which the Tendyne mitral valve (Tendyne™; Abbott) was used through a transapical approach. There was no paravalvular leak, and the mean gradient across the valve was 2 mmHg. She was symptomatically better at follow-up and an echocardiogram showed a normally functioning aortic valve and Tendyne mitral valves.DiscussionTransapical transcatheter mitral valve implantation using the Tendyne valve is a feasible option for patients with prior TAVI. This can be considered an alternative treatment for MR in patients who are not suitable for edge-to-edge mitral repair.
| S-EPMC10583539 | biostudies-literature
Project description:BackgroundTranscatheter mitral valve-in-valve (TMVIV) procedure with aortic transcatheter heart valves has recently become a less invasive alternative for patients with mitral bioprosthetic dysfunction. This study reports the initial experience of TMVIV implantation using the J-Valve System (JieCheng Medical Technology Corporation Ltd., Suzhou, China).MethodsA retrospective observational multicenter study was conducted to evaluate the short-term outcomes of TMVIV. In total, 26 consecutive patients with symptomatic bioprosthetic failure at eight hospitals underwent TMVIV using the J-Valve System between May 2019 and June 2021. Procedural results and clinical outcomes were analyzed using the Mitral Valve Academic Research Consortium criteria.ResultsThe mean age was 75.3 ± 7.1 years and 69.2% of patients were female. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 12.3 ± 8.3%. The technical success rate was 96.2%. Nine of the 26 patients (34.6%) were implanted with a J-Valve of a size equal to the internal diameters of the deteriorated prostheses. At the 30-day and 1-year follow-ups, all-cause mortality was 3.8 and 16.0% and the stroke rates were 0 and 12.0%, respectively. Device-related mortality was 0% and the mean mitral valve gradient was 6.4 ± 2.7 mm Hg. No patient experienced device embolization, left ventricular outflow tract obstruction, or mitral valve reintervention. Postprocedural mitral regurgitation was none or trace in all the patients. All the patients were in the New York Heart Association (NYHA) class ≤ II at the last follow-up.ConclusionTranscatheter implantation of the J-Valve System in high-risk patients with mitral bioprosthetic dysfunction was found to be a reasonable alternative and associated with good short-term outcomes.
| S-EPMC8811914 | biostudies-literature
Project description:BackgroundConduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve.MethodsWe included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge.ResultsNo significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001).ConclusionNo significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.
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Project description: Not available
| S-EPMC10307587 | biostudies-literature
Project description:AimsThe third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.Methods and results235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low.ConclusionsIn patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes.Trial registrationClinicalTrials.gov NCT02162069.
| S-EPMC4803290 | biostudies-literature
Project description:Valve disease in the presence of porcelain aorta and severe peripheral artery disease challenge physicians in choosing the appropriate therapy. We used a total transcatheter approach, simultaneously implanting a dedicated mitral and aortic valve prosthesis treating a patient with mitral and aortic valve disease at an extremely high surgical risk. (Level of Difficulty: Advanced.).
| S-EPMC8302802 | biostudies-literature