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

Abstract

Post-market evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom (UK). Objective: To identify prosthetic aortic valve models that display unexpected patterns of mortality or re-intervention using routinely collected national registry data and record linkage. Design: Observational study using the UK National Adult Cardiac Surgery Audit (NACSA) registry for procedures performed between 1998 and 2013. 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 (pre-)operative covariates. Setting: All National Health Service and private hospitals in England and Wales who submit data to the NACSA registry. Patients and Interventions: All patients undergoing first-time elective and urgent aortic valve replacement surgery (± coronary artery bypass graft) with a mechanical (n=10 series) or biological (n=15 series) prosthetic valve from 5 primary suppliers, and satisfying pre-specified data quality criteria were included (n=43,782 biological, n=11,084 mechanical). Main Outcome Measures: Time to all-cause mortality or aortic valve re-intervention (surgical or trans-catheter). There were 13,104 deaths and 723 re-interventions during follow-up. Results: Two series of valves were associated with significantly increased hazard of death or reintervention were identified: Sorin Biological Series (frailty 1.18 [95%PI: 1.06 to 1.32]) and 4 Sorin Mitroflow series (frailty 1.19 [95%PI: 1.09 to 1.31]). These results were robust to covariate adjustment, and sensitivity analyses. Three biological valve series were associated with significantly decreased hazard. Conclusions: Meaningful evidence from the analysis of routinely-collected registry data can inform post-market surveillance of medical devices. Although the findings are associated with a number of caveats, two specific biological aortic valve series identified in this study may warrant further investigation.

Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

“…17 Notably, outcomes vary with different surgical bioprostheses as demonstrated in recent post-market surveillance of 43 782 valves in England and Wales. 20 …”

Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes

“…In recent years, in the prosthetic heart valve market there has been great heterogeneity of valve sub-models, with different post-market surveillance and effectiveness [1]. Therefore, replacement of native heart valves with either bioprosthetic or mechanical substitutes requires patients and clinicians to weigh the impact on long-term quality of life and patient satisfaction associated with each [2].…”

Calcification and Oxidative Modifications Are Associated With Progressive Bioprosthetic Heart Valve Dysfunction

“…Our study noted significantly earlier reoperation in BHV patients with either prior or concurrent CABG. Prior studies have reported concurrent CABG and BHV aortic valve replacement in ≥35% of BHV aortic valve replacement patients . However, the impact of this association on subsequent freedom from reoperation after BHV surgery has not been described in other observational studies.…”