Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: FDA Patient-Level Meta-Analysis of Premarket Clinical Trials

2018 ◽  
Vol 27 (6) ◽  
pp. 808-814 ◽  
Author(s):  
Robbert Zusterzeel ◽  
Nishant K. Mishra ◽  
Hind Beydoun ◽  
John Laschinger ◽  
Changfu Wu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Meta Analysis ◽  
Patient Level ◽  
Transcatheter Aortic Valve

Epidemiology of infective endocarditis in transcatheter aortic valve replacement: systemic review and meta-analysis

2020 ◽  
Vol 21 (10) ◽  
pp. 790-801 ◽  
Author(s):  
Narut Prasitlumkum ◽  
Wasawat Vutthikraivit ◽  
Sittinun Thangjui ◽  
Thiratest Leesutipornchai ◽  
Jakrin Kewcharoen ◽  
...  
Keyword(s):  
Infective Endocarditis ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Meta Analysis ◽  
Systemic Review ◽  
Transcatheter Aortic Valve

scholarly journals Aortic Annular Sizing Using Novel Software in Three-Dimensional Transesophageal Echocardiography for Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Diagnostics ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 751
Author(s):  
Chanrith Mork ◽  
Minjie Wei ◽  
Weixi Jiang ◽  
Jianli Ren ◽  
Haitao Ran
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Transesophageal Echocardiography ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Meta Analysis ◽  
Three Dimensional ◽  
Minimum Diameter ◽  
Transcatheter Aortic Valve ◽  
Mean Differences

(1) Background: We performed this study to evaluate the agreement between novel automated software of three-dimensional transesophageal echocardiography (3D-TEE) and multidetector computed tomography (MDCT) for aortic annular measurements of preprocedural transcatheter aortic valve replacement (TAVR); (2) Methods: PubMed, EMBASE, Web of Science, and Cochrane Library (Wiley) databases were systematically searched for studies that compared 3D-TEE and MDCT as the reference standard for aortic annular measurement of the following parameters: annular area, annular perimeter, area derived-diameter, perimeter derived-diameter, maximum and minimum diameter. Meta-analytic methods were utilized to determine the pooled correlations and mean differences between 3D-TEE and MDCT. Heterogeneity and publication bias were also assessed. Meta-regression analyses were performed based on the potential factors affecting the correlation of aortic annular area; (3) Results: A total of 889 patients from 10 studies were included in the meta-analysis. Pooled correlation coefficients between 3D-TEE and MDCT of annulus area, perimeter, area derived-diameter, perimeter derived-diameter, maximum and minimum diameter measurements were strong 0.89 (95% CI: 0.84–0.92), 0.88 (95% CI: 0.83–0.92), 0.87 (95% CI: 0.77–0.93), 0.87 (95% CI: 0.77–0.93), 0.79 (95% CI: 0.64–0.87), and 0.75 (95% CI: 0.61–0.84) (Overall p < 0.0001), respectively. Pooled mean differences between 3D-TEE and MDCT of annulus area, perimeter, area derived-diameter, perimeter derived-diameter, maximum and minimum diameter measurements were −20.01 mm2 ((95% CI: −35.37 to −0.64), p = 0.011), −2.31 mm ((95% CI: −3.31 to −1.31), p < 0.0001), −0.22 mm ((95% CI: −0.73 to 0.29), p = 0.40), −0.47 mm ((95% CI: −1.06 to 0.12), p = 0.12), −1.36 mm ((95% CI: −2.43 to −0.30), p = 0.012), and 0.31 mm ((95% CI: −0.15 to 0.77), p = 0.18), respectively. There were no statistically significant associations with the baseline patient characteristics of sex, age, left ventricular ejection fraction, mean transaortic gradient, and aortic valve area to the correlation between 3D-TEE and MDCT for aortic annular area sizing; (4) Conclusions: The present study implies that 3D-TEE using novel software tools, automatically analysis, is feasible to MDCT for annulus sizing in clinical practice.

Abstract 381: Clinical Outcomes Following Transcatheter Aortic Valve Replacement Among US Hospitals

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Fenton McCarthy ◽  
Katherine M McDermott ◽  
Vinay Kini ◽  
Dale Kobrin ◽  
Nimesh D Desai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Clinical Outcomes ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Mortality Rates ◽  
Transcatheter Aortic Valve ◽  
Cardiovascular Interventions

Background: Transcatheter Aortic Valve Replacement (TAVR) demonstrated excellent outcomes in clinical trials of inoperable/high-risk patients. Subsequent approval by the Food and Drug Administration and National Coverage Determination by the Centers for Medicare and Medicaid Services established unique volume requirements for institutions and physicians to perform TAVR. Diffusion of prior cardiovascular interventions has involved less stringent policies and exhibited significant institutional variation in clinical outcomes. Our objective is to compare risk-standardized procedural outcomes across US hospitals performing TAVR to identify hospitals with outlying post-procedure mortality rates. Methods: All Medicare fee-for-service beneficiaries who underwent TAVR between January 1, 2011 and November 30, 2012 were identified. Thirty-day risk-standardized mortality rates (RSMR) were calculated using the Hospital Compare statistical method, a well-validated hierarchical generalized linear model. Results: Claims were examined from 5044 patients undergoing TAVR at 199 hospitals, with a crude 30-day mortality rate of 5.97%. RSMRs modeled using patient-level predictors varied from 4.5 % to 9.0 % (Figure 1). One hospital had a RSMR statistically lower than the national mean (4.5%, P<0.05), and two hospitals had RSMRs statistically higher than the national mean (8.5% and 6.9%, P<0.05). Conclusions: Clinical outcomes among TAVR hospitals in high-risk/inoperable patients demonstrated very little variability, few outliers, and excellent outcomes comparable to pre-approval clinical trials. This may be the result of the unique policy and regulatory environment governing the CMS coverage determination for TAVR institutions. As TAVR disseminates to additional hospitals and other new cardiovascular interventions are inevitably introduced, risk-standardized outcome comparisons across hospitals may facilitate ongoing surveillance to ensure high quality outcomes at all active centers.

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