Successful percutaneous implantation of Symetis ACURATE neo transcatheter aortic bioprosthesis in a patient with existing mechanical mitral valve.
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SUBMITTER: Ali S
PROVIDER: S-EPMC5324907 | biostudies-literature | 2016 Nov
REPOSITORIES: biostudies-literature
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Successful percutaneous implantation of Symetis ACURATE neo transcatheter aortic bioprosthesis in a patient with existing mechanical mitral valve.
Ali Sina S Alsancak Yakup Y Duran Mustafa M Bilge Mehmet M
Anatolian journal of cardiology 20161101 11
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Project description:A 76-year-old woman had received surgical mitral valve replacement with Magna Mitral Ease (Edwards Lifesciences, Irvine, CA, USA) 25 mm for functional severe mitral regurgitation 6 years previously. She presented recurrence of heart failure due to severe stenotic and moderate regurgitant degeneration of the implanted mitral bioprosthesis. Considering her comorbidities and left ventricular systolic dysfunction, our heart valve team eventually decided to perform percutaneous transseptal transcatheter mitral valve-in-valve replacement instead of surgical redo mitral valve replacement, using a 26 mm SAPIEN 3 valve (Edwards Lifesciences) via trans-femoral approach. Post-procedural course was uneventful and she was discharged on post-procedural day 2. This is, to the best of our knowledge, the first case of successful percutaneous transseptal transcatheter mitral valve-in-valve replacement in Japan. Further large-scale prospective studies are warranted to validate its long-term safety and efficacy, particularly by comparing with the redo surgery. <Learning objective: We experienced an off-label transseptal mitral valve-in-valve replacement using SAPIEN 3 to treat degenerative mitral bioprosthesis for the first time in Japan. Although further large-scale prospective studies are warranted, this procedure should be a promising therapeutic alternative to conventional redo-surgery, particularly for elderly patients with multiple comorbidities.>.
| S-EPMC7783651 | biostudies-literature
Project description:BackgroundFailed mitral bioprosthesis has conventionally been treated with redo surgical mitral valve replacement (SMVR). Transcatheter mitral valve-in-valve implantation (TM-VIVI) is emerging as an alternative to SMVR in high-risk patients. We report our experience with transapical TM-VIVI using the J-Valve system.MethodsFrom May 2020 to January 2021, 21 patients with a failed mitral bioprosthesis underwent transapical TM-VIVI without concomitant procedures at Guangdong Provincial People's hospital. The mean age was 74.62 years. All patients were heavily symptomatic with severe mitral regurgitation and increased trans-prosthetic gradient. The Society of Thoracic Surgeons predicted risk of mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroScore II) scores were used and predicted high mortality (STS PROM, 12.91%±9.94%; EuroScore II, 12.04%±10.5%). All the procedures were performed in a hybrid room.ResultsThe success rate was 100% with no conversion to median sternotomy and no intraprocedural death. The mean ventilation time and intensive care unit (ICU) stay were 25±21.44 minutes and 4.14±7.08 days, respectively. No major postoperative complications were observed, except 1 patient suffered pneumonia and required tracheostomy. All patients recovered well. Postoperative echocardiography revealed excellent hemodynamics with no residual mitral regurgitation in 19 patients and mild regurgitation in 2 patients. In a subgroup analysis, no significant differences among procedural and postoperative outcomes were detected in patients with previous aortic-mitral double valve replacement (DVR) compared to other patients.ConclusionsOur results demonstrate the safety and feasibility of transapical TM-VIVI using the J-Valve system, even in patients following DVR.
| S-EPMC8411171 | biostudies-literature
Project description:ObjectivesThe PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve.BackgroundWhile clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL.MethodsThe primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo.ResultsThe rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P < 0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months.ConclusionsResults from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.
| S-EPMC9252754 | biostudies-literature
Project description:BackgroundCoronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis.AimsTo evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve.Materials and methodsSixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans.ResultsDiagnostic angiography and PCI were feasible for 97 and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic "chimney" stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30 vs. 35 mm, p < 0.01), STJ width (28 vs. 32 mm, p < 0.05) and shorter STJ height (15 vs. 17 mm, p < 0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28 vs. 32 mm, p < 0.05), smaller transcatheter-to-coronary distance (5 vs. 9.2 mm, p < 0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6 o , p < 0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases.ConclusionIn this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation.
| S-EPMC9515364 | biostudies-literature
Project description:Transcatheter aortic valve replacement (TAVR) is a treatment of choice in patients with symptomatic severe aortic valve stenosis (AS) and intermediate-to-high surgical risk. The presence of a small aortic annulus (SAA) has been associated with a higher incidence of prosthesis-patient mismatch (PPM) when surgical aortic valve replacement (sAVR) is performed. TAVR might be a treatment option offering better hemodynamics with a lower incidence of PPM. When a severe AS with a SAA is treated, TAVR-related risk as the coronary obstruction and the annulus rupture, must be also prevented. We present a case of a TAVR in a very small aortic annulus; to our knowledge, this is the smallest native aortic annulus treated percutaneously in a tricuspid stenotic aortic valve with a Self-Expanding Transcatheter Heart Valve (THV) Acurate Neo 2.
| S-EPMC10545879 | biostudies-literature
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:BackgroundTranscatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty.Methods and materialBetween March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria.ResultsThe mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups.ConclusionDespite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.
| S-EPMC8386843 | biostudies-literature
Project description:BackgroundTranscatheter implantation of the Edwards Sapien 3 valve (Edwards Lifesciences, Irvine CA) within the bioprosthetic mitral valve (MV) is an established method of treatment in adults. However, it has not been well studied in the pediatric age group.MethodsTranscatheter mitral valve-in-valve implantation was attempted in 4 symptomatic pediatric patients with a dysfunctional MV bioprosthesis implanted at an earlier stage due to severe MV stenosis or regurgitation. We reviewed our experience with MV implantation in this cohort.ResultsThe mean age and weight of the patients at the time of the procedure were 11.4 years (range: 10-14 years) and 36 kg (range: 31-44 kg), respectively. The transmitral mean gradient dropped from a mean of 19.75 mm Hg (range: 15-22 mm Hg) to a mean of 1 mm Hg (range: 0-3 mm Hg) after the procedure. The mean fluoroscopy time was 55.25 minutes (range: 40-72 minutes), and the mean hospital length of stay was 4 days (range: 3-7 days). The patients' functional class improved from New York Heart Association class IV to class I during the follow-up period.ConclusionsTranscatheter mitral valve-in-valve implantation can be performed safely for dysfunctional bioprosthetic MVs in the pediatric age group with favorable early and midterm outcomes. This procedure offers a viable alternative in patients who have high surgical risk or are deemed unfit for conventional surgery. However, we still recommend a long-term study of this approach in a large cohort, multicentre study.
| S-EPMC8767141 | biostudies-literature
Project description:BackgroundConcomitant structural degeneration of surgical mitral bioprostheses and paravalvular leak (PVL) is rare but potentially fatal. Data pertaining to simultaneous transcatheter mitral valve implantation (TMVI) and percutaneous PVL closure are limited, and the optimal treatment strategy remains undetermined. We report a case of simultaneous TMVI and double percutaneous PVL closure in a patient with a degenerated bioprosthetic mitral valve and associated medial and lateral PVLs.Case summaryA 75-year-old woman who underwent combined aortic (Edwards Perimount Magna 19 mm) and mitral (Edwards Perimount Magna 25 mm) surgical valve replacement 6 years ago was referred for treatment of new-onset orthopnoea and severely reduced exercise capacity. Transoesophageal echocardiography revealed severe mitral stenosis and concomitant moderate to severe mitral regurgitation, originating from two PVLs located medial and lateral from the surgical bioprosthesis. Due to high surgical risk, we performed successful transseptal mitral valve-in-valve (ViV) implantation combined with the closure of two PVLs during the same procedure.DiscussionAlthough surgery should be considered as a first-line treatment in this setting, most patients have extremely high or prohibitive surgical risk inherent to repeat open heart surgery. Mitral ViV implantation appears a reasonable treatment option for patients with failed mitral bioprostheses. Furthermore, a recent study of percutaneous PVL closure showed no significant difference in long-term all-cause mortality compared with redo open-heart surgery. Simultaneous TMVI and percutaneous PVL closure appears feasible in selected high-risk patients.
| S-EPMC6764577 | biostudies-literature
Project description:Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.
| S-EPMC6058955 | biostudies-literature