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Background: Machine learning methods may complement traditional analytic methods for medical device surveillance. Methods and results Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=−0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=−0.042). Conclusion: Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

The article discusses a study that examined the association between elevated B-type natriuretic peptide (BNP) level with increased risk of in-hospital mortality or cardiac arrest in patients undergoing implantable cardioverter-defibrillator (ICD). Findings found an increase in the rate of in-hospital mortality or cardiac arrest with elevated BNP level. It also showed that the association was more significant in men, renal dysfunction patients, and those undergoing biventricular ICD implantation.

The aim of this study was to compare outcomes between total ankle replacement (TAR) and ankle arthrodesis (AA) for ankle osteoarthritis using real-world data., Methods: We used longitudinal claims data from New York State from October 2015 to December 2018, and from California from October 2015 to December 2017. The primary outcome was revision. Secondary outcomes were in-hospital complications and below-the-knee amputation. Propensity-score matching adjusted for differences in baseline characteristics. To determine predictors of the main outcome, each group was analyzed using multivariable Cox regressions., Results: There were 1,477 TAR procedures (50.2%) and 1,468 AA procedures (49.8%). Patients undergoing TAR were less likely to belong to a minority group and had fewer comorbidities compared with those undergoing AA. Crude analyses indicated that the TAR group had a lower risk of revision (5.4% versus 9.1%), in-hospital complications (<1% versus 1.8%), and below-the-knee amputation (<1% versus 4.9%) (p < 0.001 for all). However, in the propensity-score-matched analysis, the risk of revision was no longer significantly lower (TAR, 5.6% versus AA, 7.6%; p = 0.16). In the multivariable analyses, older age was predictive of a lower risk of revision after TAR (hazard ratio [HR], 0.96 [95% confidence interval (CI), 0.93 to 1.00]), but age was not predictive of revision after AA (HR, 0.99 [95% CI, 0.97 to 1.01]). Female patients were less likely to undergo revision after AA (HR, 0.61 [95% CI, 0.39 to 0.96]), but sex was not predictive of revision after TAR (HR, 0.90 [95% CI, 0.51 to 1.60])., Conclusions: The 2-year adjusted revision risk was 5.6% after TAR and 7.6% after AA. This difference did not reach significance. Older age was a predictor of lower revision risk after TAR. Men had a higher risk of revision than women after AA. The number of TAR procedures has now caught up with the number of AA procedures., Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence., (Copyright © 2022 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.)

Background and Aim of the Study: Since the voluntary recall of St. Jude Medical (SJM) Silzone impregnated heart valves, no large-scale study has examined their long-term outcomes., Methods: Using Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (1993-2004), the clinical outcomes were evaluated through eight years among those patients who received SJM mechanical heart valves during the Silzone era (March 1998 to December 1999; n = 3,775), relative to those in both the pre-Silzone era (January 1993 to February 1998; n = 13,570) and the post-Silzone era (January 2000 to December 2004; n = 6,882). An inverse probability weighting was used to balance the observed differences in case mix., Results: During the Silzone era, 79% of all implanted mechanical heart valves were manufactured by SJM. By eight years post-implantation, the most common adverse events in this Medicare-linked cohort (median age 71 years) were death (43.5%) and thromboembolism (14.7%), while valve reoperation (1.7%) and endocarditis (1.4%) were less common. Patients treated during the Silzone era experienced a lower associated risk of mortality to eight years than those in both the pre-Silzone era (adjusted hazards ratio (HR) 0.93, 95% confidence interval (CI) 0.88-0.98) and post-Silzone era (adjusted HR 0.92, CI 0.67-0.98), while the adjusted eight-year risks of reoperation, thromboembolism and endocarditis were similar across the three eras for the overall cohort and among both aortic valve and mitral valve patients., Conclusion: Medicare patients who received SJM mechanical heart valves during the Silzone era experienced similar clinical outcomes as those treated before or after the Silzone era. These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals.

Objective: To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants., Design: Systematic review of clinical trials, observational studies, and registries., Data Sources: Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration., Study Selection: Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed., Results: There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding., Conclusions: There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.