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Calibrated cusp sizers to facilitate aortic valve repair: development and clinical application.

ABSTRACT: Based on the natural mathematical relationships between the components of the human tri-leaflet aortic valve, new calibrated cusp sizers were developed in order to facilitate aortic valve assessment in the operating room and enhance the chance for a perfect restoration of aortic valve competence. These sizers were used clinically to guide the implementation of established aortic valve repair techniques in 10 consecutive patients with severe aortic valve regurgitation. Valve repair was successful in all cases, and at a median follow-up was 5.5 months, aortic valve function remained stable, with aortic regurgitation ?1+ in every patient and no significant gradient across the aortic valves. This preliminary clinical experience indicates that the calibrated cusp sizers can provide reliable insight into the mechanism of aortic valve insufficiency, and can guide aortic valve repair techniques successfully. We hope that the simplicity and reproducibility of this method would assist in its dissemination and further increase the percentage of aortic valves that are repaired when compared with current practice.

SUBMITTER: Izzat MB

PROVIDER: S-EPMC3279973 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Calibrated cusp sizers to facilitate aortic valve repair: development and clinical application.

Izzat Mohammad Bashar MB

Interactive cardiovascular and thoracic surgery 20111129 2

Based on the natural mathematical relationships between the components of the human tri-leaflet aortic valve, new calibrated cusp sizers were developed in order to facilitate aortic valve assessment in the operating room and enhance the chance for a perfect restoration of aortic valve competence. These sizers were used clinically to guide the implementation of established aortic valve repair techniques in 10 consecutive patients with severe aortic valve regurgitation. Valve repair was successful ...[more]

PMID: 22159260

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Project description:ImportanceThe US Centers for Medicare and Medicaid Services recently released an updated national coverage determination proposal for transcatheter aortic valve replacement (TAVR) that maintains a focus on hospital TAVR volume and percutaneous coronary intervention (PCI) volume, and the national coverage determination for transcatheter mitral valve repair (TMVr) also has PCI volume requirements. However, the associations between hospital PCI volume and TAVR and TMVr outcomes are unknown.ObjectiveTo investigate whether hospital inpatient PCI volume is associated with rates of risk-adjusted in-hospital mortality and 30-day hospital readmission after TAVR and TMVr.Design, setting, and participantsThis population-based cross-sectional study of the 2016 Nationwide Readmissions Database included procedures completed in hospitals with a minimum of 5 TAVR or 5 TMVr procedures between January 1, 2016, and November 30, 2016.ExposuresHospitals were divided into quartiles based on annual inpatient PCI volumes.Main outcomes and measuresPrimary outcomes were in-hospital mortality and 30-day readmission rates. The associations between hospital inpatient PCI quartile and outcomes were evaluated using Kruskal-Wallis tests. Risk adjustment for in-hospital mortality rates was done through inclusion of variables based on the Elixhauser comorbidity classification, and risk adjustment for 30-day readmission rates was done in accordance with the Hospital-Wide Readmission Measure methodology used by the Centers for Medicare and Medicaid Services for public reporting.ResultsThere were 283 hospitals that performed at least 5 TAVRs, with a median inpatient PCI volume of 386 (interquartile range, 299-571) procedures, and 125 hospitals that performed at least 5 TMVr procedures, with a median inpatient PCI volume of 451 (interquartile range, 326-651) procedures. There was no association between hospital inpatient PCI volume and median TAVR risk-standardized in-hospital mortality (median [IQR] rates: bottom quartile, 1.82% [1.77%-1.90%]; second quartile, 1.81% [1.76%-1.86%]; third quartile, 1.81% [1.75%-1.90%]; top quartile, 1.82% [1.76%-1.91%]; P = .75) or the 30-day readmission (median [IQR] rates: bottom quartile, 13.6% [13.2%-14.3%]; second quartile, 13.3% [12.7%-14.0%]; third quartile, 13.5% [12.7%-14.3%]; top quartile, 13.8% [12.8%-14.3%]; P = .10) rates. Similarly, there was no association between hospital inpatient PCI volume and median TMVr risk-standardized in-hospital mortality rates (median [IQR] rates: bottom quartile, 1.84% [1.47%-2.53%]; second quartile, 1.65% [1.21%-3.02%]; third quartile, 1.80% [1.52%-3.58%]; top quartile, 1.76% [1.33%-4.20%]; P = .71) or 30-day readmission rates (median [IQR] rates: bottom quartile, 13.4% [13.1%-13.6%]; second quartile, 13.1% [12.9%-13.5%]; third quartile, 13.1% [12.9%-13.5%]; top quartile, 13.3% [12.8%-13.6%]; P = .30).Conclusions and relevanceIn this study, there was no association between inpatient PCI volume and TAVR or TMVr outcomes. Further evidence is needed to support inclusion of PCI volume minimums in national coverage determination requirements for hospital TAVR and TMVr programs.

Dataset Information

Calibrated cusp sizers to facilitate aortic valve repair: development and clinical application.

Publications

Calibrated cusp sizers to facilitate aortic valve repair: development and clinical application.

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