National registry data and record linkage to inform - PowerPoint Presentation

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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.

Study 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

Key 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

Limitations

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

Appendix: 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

This 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.

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