Pediatric tricuspid valve replacement with a transcatheter aortic valve (SAPIEN 3).
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ABSTRACT:
SUBMITTER: Kalangos A
PROVIDER: S-EPMC8300567 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:to investigate the factors implied in the development of postoperative complications in both self-expandable and balloon-expandable transcatheter heart valves by means of finite element analysis (FEA). FEA was integrated into CT scans to investigate two cases of postoperative device failure for valve thrombosis after the successful implantation of a CoreValve and a Sapien 3 valve. Data were then compared with two patients who had undergone uncomplicated transcatheter heart valve replacement (TAVR) with the same types of valves. Computational biomechanical modeling showed calcifications persisting after device expansion, not visible on the CT scan. These calcifications determined geometrical distortion and elliptical deformation of the valve predisposing to hemodynamic disturbances and potential thrombosis. Increased regional stress was also identified in correspondence to the areas of distortion with the associated paravalvular leak. the use of FEA as an adjunct to preoperative imaging might assist patient selection and procedure planning as well as help in the detection and prevention of TAVR complications.
| S-EPMC8146716 | biostudies-literature
Project description: Not available
| S-EPMC9706736 | biostudies-literature
Project description:ObjectivesThe study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR).BackgroundThe new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited.MethodsA total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation.ResultsBetween June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm2 ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra.ConclusionsIn this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.
| S-EPMC8247002 | biostudies-literature
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.
| S-EPMC5577954 | biostudies-literature
Project description:Background: Subclinical leaflet thrombosis (SLT) is an important sequela that compromises the durability of the bioprosthetic valve. Objectives: To better determine the effect of SLT in bicuspid aortic valve (BAV), we performed a retrospective assessment of CT-defined SLT in BAV and tricuspid aortic valve (TAV) stenotic patients. Methods: We consecutively collected patients undergoing the TAVR between August 2015 and March 2020 in our center. A total of 170 BAV and 201 TAV cases were enrolled. Multidetector computed tomography was performed within 30 days and at 1-year. Results: Twenty cases in the BAV group and 19 cases in the TAV group had hypoattenuated leaflet thickening (HALT) in 30 days (12.5 vs. 9.9%, p = 0.449), and 52 cases in BAV and 61 cases in TAV had the HALT (34.9 vs. 36.7%, p = 0.733) at 1-year follow-up. The mean aortic gradient (MAG) and effective orifice areas (EOA) values were comparable between the two groups at 30 days (HALT vs. no HALT; 10.8 ± 4.8 vs. 11.3 ± 6.0, p = 0.638; 1.6 ± 0.4 vs. 1.6 ± 0.3, p = 0.724), and still, no difference was observed in the MAG at 1-year (11.5 ± 5.6 vs. 10.6 ± 5.1, p = 0.164). However, the EOA at 1-year was statistically different between the two groups (1.5 ± 0.3 vs. 1.6 ± 0.4, p = 0.004). The multivariate logistic regression analysis demonstrated the anticoagulation and age as independent predictors both in the BAV and TAV groups at 1-year. There was no difference in clinical events between the HALT and no HALT group in relevant to BAV or TAV at 1-year follow-up. Conclusions: The presence of subclinical leaflet thrombosis defined by the CT was comparable between the BAV and TAV in the first year after the TAVR procedure. Age and anticoagulation were the independent predictors of the subclinical leaflet thrombosis at 1 year after the TAVR. There was no difference in relevant clinical events between the BAV and TAV groups at 1-year follow-up.
| S-EPMC8727537 | biostudies-literature
Project description:Importance:Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves. Objective:To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve. Design, Setting, and Participants:Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014. Multicenter, nonrandomized registry of 1661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3. Patients with severe, symptomatic aortic stenosis and high/intermediate surgical risk were enrolled in the registry at 51 sites in the United States and Canada. Interventions:Transcatheter aortic valve replacement with the SAPIEN 3 valve. Main Outcomes and Measures:Paravalvular regurgitation was assessed in a core laboratory at 30 days and 1 year according to a 5-class scheme: 0, none or trace; 1, mild; 2, mild to moderate; 3, moderate; 4, moderate to severe; and 5, severe. We assessed the effect of PVR on 1-year mortality and heart failure rehospitalization. Results:Among the 1661 included in the registry, 1592 received a SAPIEN 3 valve and had assessment of PVR. Of these patients, 55.7% had none-trace PVR, 32.6% had mild, 8.2% had mild to moderate, and 3.5% had at least moderate PVR at 30 days. At 1 year, 9.3% of patients had died and 14.2% had been rehospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% CI, 1.30-4.43; P?=?.005) and composite of mortality/rehospitalization (HR, 2.35; 95% CI, 1.52-3.62; P?<?.001). In a paired comparison including 1213 patients, 73% of the patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least 1 PVR class at 1 year. Conclusions and Relevance:In this series of patients undergoing TAVR with the SAPIEN 3 valve, at least moderate PVR was rare but associated with increased risk of death and heart failure rehospitalization at 1 year. Even the upper range of the mild class in the 3-class grading scheme (ie, mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or rehospitalization. Most patients with at least moderate PVR at 30 days showed a decrease of PVR severity grade at 1 year. Trial Registration:clinicaltrials.gov Identifier: NCT01314313.
| S-EPMC5710359 | biostudies-literature
Project description:BackgroundThere is a lack of available data on specific prognostic comparisons between transcatheter aortic valve replacement (TAVR) using self-expandable valves (SEV) in patients with stenotic Type 0, Type 1 bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).ObjectivesTo evaluate the association between aortic valve morphology and outcomes following self-expandable TAVR.MethodsConsecutive patients with aortic stenosis(AS) undergoing self-expandable TAVR were enrolled and categorized into three groups (Type 0/Type 1 BAV or TAV) according to the Sievers classification. The primary endpoint was a composite of all-cause mortality and rehospitalization for heart failure (HF) within 2 years. Secondary outcomes included procedural complications and major cardiovascular events observed in clinical follow-ups. Clinical outcomes at 2 years following TAVR were compared among three groups using Kaplan-Meier curve and multivariable Cox proportional hazards regression models.ResultsA total of 344 AS patients (Type 0: 86; Type 1: 109; TAV: 149) were enrolled. The presence of moderate or severe paravalvular leak (PVL) was significantly higher in patients with Type 0 and Type 1 BAV versus TAV (10.47% vs. 16.51% vs. 6.71%, p = 0.043). All-cause 30-day mortality (2.33% vs. 0.92% vs. 2.68%, p = 0.626) and 2-year mortality (3.49% vs. 5.50% vs. 6.71%, p = 0.657) was comparable among the three groups. However, rehospitalization for HF within 2 years was significantly higher in Type 1 BAV (11.63% vs. 20.18% vs. 8.72%, p = 0.020). Multivariate Cox analysis showed that a higher STS score, Type 1 BAV morphology and excess leaflet calcification (≥ median calcium volume (CV) of the entire population) were independent predictors for HF rehospitalization. Additional intragroup Kaplan‒Meier analysis showed that excess leaflet calcification could predict higher long-term mortality and rehospitalization risk for HF(HR (95% CI): 3.430 (1.166-10.090), log rank p = 0.017) in Type 1 BAV patients.ConclusionOutcomes of self-expandable TAVR in BAV-AS patients might vary depending on valve subtypes. BAV patients with excess leaflet calcification and a raphe, especially calcified, had an increased risk of moderate PVL and HF readmission in mid-to-long term follow-ups.
| S-EPMC9743542 | biostudies-literature
Project description:Tricuspid regurgitation (TR) may affect as much as 65-85% of the population with the prevalence of moderate-to-severe TR in the United States reported at greater than 1.6 million. However, only 8,000 tricuspid valve operations are performed annually in the United States. As severe TR is associated with poor outcomes, there is an unmet clinical need for surgical or percutaneous transcatheter based treatment of TR. Over the last two decades there have been significant developments in percutaneous transcatheter based therapies for valvular disease. However, this progress has not been mirrored for the tricuspid valve until recently; we are now at a cross-roads of new transcatheter devices becoming available for treatment of TR. In this review, we discuss the principles of performing transcatheter tricuspid valve replacement, analyze the devices that can be utilized and outline the challenges related to this procedure.
| S-EPMC6156134 | biostudies-literature
Project description:Severe tricuspid regurgitation is relatively common, especially in the elderly, and portends poor survival. Neither medical therapy nor conventional surgery is efficacious for most patients. In contrast, transcatheter tricuspid valve interventions are showing promise to improve quality of life and mortality. Although there is more clinical experience with transcatheter tricuspid valve repair, there are many patients for which repair is either not possible or cannot optimally reduce the severity of tricuspid regurgitation. Transcatheter tricuspid valve replacement is rapidly emerging and may ultimately become the preferred treatment option. In this review, we discuss transcatheter tricuspid valve replacement, analyze the devices in development and in clinical trials, and highlight the advantages and drawbacks of transcatheter tricuspid valve replacement vs. repair.
| S-EPMC7917079 | biostudies-literature
Project description: Not available
| S-EPMC7451866 | biostudies-literature