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The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.

The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders.

Importance: The role of sex in relationship to implant failure after total hip arthroplasty (THA) is important for patient management and device innovation. Objective: To evaluate the association of sex with shortterm risk of THA revision after adjusting for patient, implant, surgery, surgeon, and hospital confounders. Design and Setting: A prospective cohort of patients enrolled in a total joint replacement registry from April 1, 2001, through December 31, 2010. Participants: Patients undergoing primary, elective, unilateral THA. Main Outcome Measures: Failure of THA, defined as revision procedure for (1) any reason, (2) septic reason, or (3) aseptic reason after the index procedure Results: A total of 35 140 THAs with 3.0 years of median follow-up were identified. Women constituted 57.5% of the study sample, and the mean (SD) patient age was 65.7 (11.6) years. A higher proportion of women received 28-mm femoral heads (28.2% vs 13.1%) and had metal on highly cross-linked polyethylene-bearing surfaces (60.6% vs 53.7%) than men. Men had a higher proportion of 36-mm or larger heads (55.4% vs 32.8%) and metal on metal-bearing surfaces (19.4% vs 9.6%). At 5-year follow-up, implant survival was 97.4% (95% CI, 97.2%- 97.6%). Device survival for men (97.7%; 95% CI, 97.4%- 98.0%) vs women (97.1%; 95% CI, 96.8%-97.4%) was significantly different (P=.01). After adjustments, the hazards ratios for women were 1.29 (95% CI, 1.11-1.51) for allcause revision, 1.32 (95% CI, 1.10-1.58) for aseptic revision, and 1.17 (95% CI, 0.81-1.68) for septic revision. Conclusions: After considering patient-, surgery-, surgeon-, volume-, and implant-specific risk factors, women had a 29% higher risk of implant failure than men after THA in this community-based sample. Refereed/Peer-reviewed

Purpose: The purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. Conclusions: Clinically rich data from a registry with linkages to electronic health records and other administrative databases improve identification of exposures, outcomes, and patient subgroups in medical device evaluation. These various data sources facilitate refined adjustment for potential confounders such as hospital, surgeon, and patient factors and ensure comprehensive device performance evaluation within registries. Methods: Using a large integrated healthcare system innovative infrastructure including electronic health record data, administrative data sources, and registry data collection, we evaluated device choice and outcomes of total hip arthroplasty (THA). Devices were classified into type of bearing surface (alternative versus traditional). Multiple imputation was used to accommodate missing data, and a logistic regression model was applied to assess the impact of patient and surgeon factors on choice of bearing surface. A Cox regression model was used to evaluate risk of aseptic revision while controlling for surgeon, site, and patient characteristics. Adjusted cumulative probability-of-event curves were created, comparing survival of alternative against traditional bearings of devices, with aseptic revision as the outcome of interest. Results: The study sample consisted of 25 377 primary THAs with an average follow-up of 2.7 years. Choice of bearing surface varied by surgeon and patient characteristics. After adjusting for patient, surgeon, and hospital covariates, results showed that the risk of aseptic revision associated with alternative bearings did not differ significantly from traditional bearing surfaces (hazard ratio = 1.33; 95% confidence interval: 0.90, 1.98). Refereed/Peer-reviewed