postmarket surveillance of prosthetic aortic valve models over 15 years Hickey GL et al JAMA Intern Med 2017 177 7986 Study details Aim To identify prosthetic valve models with unusual patterns of reinterventionfree survival after AVR using registry data and record linkage ID: 803123
Download The PPT/PDF document "National registry data and record linkag..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
National registry data and record linkage to inform postmarket surveillance of prosthetic aortic valve models over 15 years
Hickey GL
et al. JAMA Intern Med
. 2017;
177
: 79–86.
Slide2Study details
Aim:
To identify prosthetic valve models with unusual patterns of reintervention-free survival after AVR using registry data and record linkage for England and WalesStudy type: Retrospective cross-sectional analysisEndpoint: Time from surgery to death or aortic valve reintervention (surgical or transcatheter)Methods: Included NACSA data on first-time elective and urgent AVRs +/- CABG in England and Wales between April 1998 and March 2013Patient records linked to other routinely collected dataValves grouped into series of related models from a single manufacturerMechanical and biological valves analysed separately
AVR: aortic valve replacement; CABG: coronary artery bypass graft; NACSA: National Adult Cardiac Surgery Audit
Slide3Key study results
54,866 records from 37 hospitals and 344 consultant surgeons
Median follow-up 4.1 years
Rate of biological valve implantation increased from 59% to 86% over the study periodWithin type (biological/mechanical) patients were generally of similar age, regardless of valve series**Frailty >1 corresponds to increased hazard; frailty <1 corresponds to decreased hazard
Series
Frailty*
95% prediction interval
Sorin Mitroflow
1.191.09–1.31Sorin Biological1.181.06–1.32Edwards Lifesciences PERIMOUNT valve0.880.80–0.96Edwards Lifesciences PERIMOUNT Magna valve0.880.80–0.96Medtronic Hancock0.880.78–0.98
Significantly higher hazard of death or reintervention
Significantly lower hazard of death or reintervention
Slide4Limitations
Variable data quality and potential for data misclassification
Outcome may have varied for different models/generations in a series
Possible bias sources: institution effects, missing data imputation, change in risk profilesMissing patient identificationTracking stopped at different timepoints for TAVI, surgical reintervention and survivalVariable sample sizes for different valvesLimited follow-up period (4.1 years)Clinical outcomes lacking (other than mortality and reintervention)Patients with multiple surgical records within a single admission excluded (n=34)
Conclusion
A national clinical registry can inform
postmarket
surveillance programmes for medical devices. This analysis identified two prosthetic aortic valve series with larger than expected hazards of death or reintervention. These valve series may need further investigation.
Study limitations and conclusionTAVI: transcatheter aortic valve intervention
Slide5Appendix: All valves included in the study
Biological valve
Mechanical valve
Vascutek
Elan
Vascutek
Ultracor
Vascutek AspireSorin CarbomedicsSorin SuturelessSorin BicarbonSorin MitroflowSt. Jude Medical Standard MechanicalSorin BiologicalSt. Jude Medical RegentSt. Jude Medical TrifectaSt. Jude Medical MastersSt. Jude Medical TorontoMedtronic HallSt. Jude Medical EpicMedtronic ATS Open PivotSt. Jude Medical BiocorMedtronic Advantage
Medtronic MosaicEdwards Lifesciences Mechanical valveMedtronic Hancock
Medtronic ATS-3F
Edwards Lifesciences Porcine valve
Edwards Lifesciences PERIMOUNT Magna valve
Edwards Lifesciences PERIMOUNT valve
Slide6This document is a summary of the Hickey GL et al
. paper and covers key information including aim, type of study, methods, results, limitations and conclusions.
The full publication is available at:
http://bit.ly/hickey2017AbbreviationsAVR: aortic valve replacementCABG: coronary artery bypass graftNACSA: National Adult Cardiac Surgery AuditTAVI: transcatheter aortic valve interventionFor professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, Magna, Magna Ease, PERIMOUNT and PERIMOUNT Magna are trademarks
of Edwards
Lifesciences Corporation. All other trademarks are the property of their respective owners
.© 2019 Edwards Lifesciences Corporation. All rights reserved. E9139/02-19/SUR
Slide7