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National registry data may inform postmarket surveillance for medical devices

Recent findings published in JAMA Internal Medicine suggest that data from national clinical registries can be utilized to advise surveillance programs on the safety and effectiveness of medical devices after they are released to the market.

“In recent years there has been a shift in emphasis from establishing device safety and effectiveness before marketing to postmarket evidence generation and surveillance,” Graeme L. Hickey, PhD, from the department of biostatistics at the University of Liverpool, United Kingdom, and colleagues wrote. “The FDA system for postmarket surveillance has been found to be in need of strengthening.”

Hickey and colleagues performed a retrospective cross-sectional analysis to determine whether prosthetic aortic valve models implanted into patients are associated with unexpected patterns of mortality or reintervention. They extracted data from the National Adult Cardiac Surgery Audit which included all adult cardiac surgeries conducted in UK National Health Service hospitals, as well as private hospitals in England and Wales and hospitals in the Republic of Ireland.

The researchers identified and enrolled patients with a biological (n = 15 series) or mechanical (n = 10 series) prosthetic valve from five primary suppliers who were undergoing first-time elective and urgent aortic valve replacement surgery with or without coronary artery bypass grafting. A total of 79,345 of these surgeries were completed, of which 54,866 were analyzed. Satisfying prespecified data quality criteria from 1998 to 2013 were also included (n = 43,782 biological; n = 11,084 mechanical). In addition, the researchers conducted multiple record linkages to monitor patient and valve status. Follow-up was performed at a median of 4.1 years. During the follow-up period, 13,104 deaths and 723 reinterventions were reported.

Results showed an increase in the rate of biological valve implantation from 59% to 86% between 1998 and 2013. Increased hazard of death or reintervention was significantly associated with two series of valves. The first series had a frailty of 1.18 (95% prediction interval [PI], 1.06-1.32) and the second series had a frailty of 1.19 (95% PI, 1.09-1.31). These data correlated to covariate adjustment and sensitivity analyses. Hazard was significantly reduced in three prosthetic valves each with a frailty of 0.88 (valves 1 and 2: 95% PI, 0.80-0.96; valve 3: 95% PI, 0.78-0.98).

“We have shown that a national clinical registry, linked to other routinely collected data, might be used to inform postmarket surveillance programs,” Hickey and colleagues concluded. “By analyzing 15 years of data on [aortic valve replacement] procedures in England and Wales, we identified two prosthetic valves that may warrant further scrutiny through additional studies. Given the limitations of the study, the signals shown here should only serve as hypothesis generating and not misinterpreted as causal effects.” – by Alaina Tedesco

Disclosure: Hickey reports support by the Medical Research council. Please see full study for complete list of all other author’s relevant financial disclosures.