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Original Investigation
January 2017

National Registry Data and Record Linkage to Inform Postmarket Surveillance of Prosthetic Aortic Valve Models Over 15 Years

Author Affiliations
  • 1University of Liverpool, Department of Biostatistics, Liverpool, L69 3GL, England
  • 2University College London, National Institute for Cardiovascular Outcomes Research (NICOR), London, EC1A 4NP, England
  • 3Computer Science Corporation, Kings Cross, London, N1C 4AG, England
  • 4Academic Surgery Unit, University of Manchester, Manchester Academic Health Science Centre, University Hospital of South Manchester, Manchester, M23 9LT, UK
  • 5Department of Cardiac Surgery, Bristol Heart Institute, Bristol Royal Infirmary, Bristol, BS2 8HW, England
  • 6South West Cardiothoracic Centre, Derriford Hospital, Derriford, Plymouth, PL68DH, England
  • 7Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, SW3 6NP, England
  • 8University of Manchester, Manchester Academic Health Science Centre, Centre for Health Informatics, Vaughan House, Manchester, M13 9GB, England
  • 9Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, TS4 3BW, England
JAMA Intern Med. 2017;177(1):79-86. doi:10.1001/jamainternmed.2016.6936
Key Points

Question  Do prosthetic aortic valves implanted in patients operated on in England and Wales display unexpected patterns of reintervention-free survival?

Findings  Using a UK national clinical registry, records for more than 54 000 aortic valve replacement procedures were mapped to implanted prosthetic valves; 2 biological valves displayed patterns of increased hazard, and 3 displayed decreased hazard.

Meaning  In the absence of alternative data sources, clinical registry data should be used to inform postmarket surveillance of cardiovascular devices.

Abstract

Importance  Postmarket evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom.

Objective  To identify prosthetic aortic valve models that display unexpected patterns of mortality or reintervention using routinely collected national registry data and record linkage.

Design, Setting, and Participants  This observational study used data from all National Health Service and private hospitals in England and Wales that submit data to the National Adult Cardiac Surgery Audit (NACSA). All patients undergoing first-time elective and urgent aortic valve replacement surgery (with or without coronary artery bypass grafting) with a biological (n = 15 series) or mechanical (n = 10 series) prosthetic valve from 5 primary suppliers, and satisfying prespecified data quality criteria (n = 43 782 biological; n = 11 084 mechanical) between 1998 and 2013 were included. Valves were classified into series of related models. Outcome tracking was performed using multifaceted record linkage. The median follow-up was 4.1 years (maximum, 15.3 years). Cox proportional hazards regression with random effects (frailty models) were used to model valve effects on the outcomes, with and without adjustment for preoperative and intraoperative covariates.

Main Outcomes and Measures  Time to all-cause mortality or aortic valve reintervention (surgical or transcatheter). There were 13 104 deaths and 723 reinterventions during follow-up.

Results  Of 79 345 isolated aortic valve replacement procedures with or without coronary artery bypass grafting, 54 866 were analyzed. Biological valve implantation rates increased from 59% in 1998 and 1999 to 86% in 2012 and 2013. Two series of valves associated with significantly increased hazard of death or reintervention were identified (first series: frailty, 1.18; 95% prediction interval [PI], 1.06-1.32 and second series: frailty, 1.19; 95% PI, 1.09-1.31). These results were robust to covariate adjustment and sensitivity analyses. There were 3 prosthetic valves with a significant reduction in hazard (valve 1: frailty, 0.88; 95% PI, 0.80-0.96; valve 2: frailty, 0.88; 95% PI, 0.80-0.96; and valve 3: frailty, 0.88; 95% PI, 0.78-0.98).

Conclusions and Relevance  Meaningful evidence from the analysis of routinely collected registry data can inform postmarket surveillance of medical devices. Although the findings are associated with a number of caveats, 2 specific biological aortic valve series identified in this study may warrant further investigation.

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