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Background: The purpose of this study was to use 2003 nationwide United States data to determine the incidences of primary total hip replacement, partial hip replacement, and revision hip replacement and to assess the short-term patient outcomes and factors associated with the outcomes.Methods: We screened more than eight million hospital discharge abstracts from the 2003 Healthcare Cost and Utilization Project Nationwide Inpatient Sample and approximately nine million discharge abstracts from five state inpatient databases. Patients who had undergone total, partial, or revision hip replacement were identified with use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes. In-hospital mortality, perioperative complications, readmissions, and the association between these outcomes and certain patient and hospital variables were analyzed.Results: Approximately 200,000 total hip replacements, 100,000 partial hip replacements, and 36,000 revision hip replacements were performed in the United States in 2003. Approximately 60% of the patients were sixty-five years of age or older and at least 75% had one or more comorbid diseases. The in-hospital mortality rates associated with these three procedures were 0.33%, 3.04%, and 0.84%, respectively. The perioperative complication rates associated with the three procedures were 0.68%, 1.36%, and 1.08%, respectively, for deep vein thrombosis or pulmonary embolism; 0.28%, 1.88%, and 1.27% for decubitus ulcer; and 0.05%, 0.06%, and 0.25% for postoperative infection. The rates of readmission, for any cause, within thirty days were 4.91%, 12.15%, and 8.48%, respectively, and the rates of readmissions, within thirty days, that resulted in a surgical procedure on the affected hip were 0.79%, 0.91%, and 1.53%. The rates of readmission, for any cause, within ninety days were 8.94%, 21.14%, and 15.72%, and the rates of readmissions, within ninety days, that resulted in a surgical procedure on the affected hip were 2.15%, 1.61%, and 3.99%. Advanced age and comorbid diseases were associated with worse outcomes, while private insurance coverage and planned admissions were associated with better outcomes. No consistent association between outcomes and hospital characteristics, such as hip procedure volume, was identified.Conclusions: Total hip replacement, partial hip replacement, and revision hip replacement are associated with different rates of postoperative complications and readmissions. Advanced age, comorbidities, and nonelective admissions are associated with inferior outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery. Methods A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year. Results We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80). Conclusions The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.

Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry., Method: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication., Results: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification)., Conclusions: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these "Considerations" is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all., (© 2023. Springer Nature Limited.)

Background: Conflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of the current availability of data, the RoundTable concluded that a strategically Coordinated Registry Network (CRN) is needed to collect and generate accessible data on temporomandibular disorder (TMD) and its care. The aim of this study was therefore to advance the clinical understanding, usage, and adoption of a core minimum dataset for TMD patients as the first foundational step toward building the CRN., Methods: Candidate data elements were extracted from existing data sources and included in a Delphi survey administered to 92 participants. Data elements receiving less than 75% consensus were dropped. A purposive multi-stakeholder sub-group triangulated the items across patient and clinician-based experience to remove redundancies or duplicate items and reduce the response burden for both patients and clinicians. To reliably collect the identified data elements, the identified core minimum data elements were defined in the context of technical implementation within High-performance Integrated Virtual Environment (HIVE) web-application framework. HIVE was integrated with CHIOS™, an innovative permissioned blockchain platform, to strengthen the provenance of data captured in the registry and drive metadata to record all registry transaction and create a robust consent network., Results: A total of 59 multi-stakeholder participants responded to the Delphi survey. The completion of the Delphi surveys followed by the application of the required group consensus threshold resulted in the selection of 397 data elements (254 for patient-generated data elements and 143 for clinician generated data elements). The infrastructure development and integration of HIVE and CHIOS™ was completed showing the maintenance of all data transaction information in blockchain, flexible recording of patient consent, data cataloging, and consent validation through smart contracts., Conclusion: The identified data elements and development of the technological platform establishes a data infrastructure that facilitates the standardization and harmonization of data as well as perform high performance analytics needed to fully leverage the captured patient-generated data, clinical evidence, and other healthcare ecosystem data within the TMJ/TMD-CRN., Competing Interests: VS is employed by Embleema. IV-F is employed by SofThread. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Gressler, Cowley, Velezis, Aryal, Clare, Kusiak, Cowley, Sedrakyan, Marinac-Dabic, Reardon, Schmidt, Feldman, Difabio, Bergman, Simonyan, Yesha, Vasiliu-Feltes, Durham, Steen, Woods, Kapos and Loyo-Berrios.)

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies., Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved., Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes., Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The CathPCI Data Extraction and Longitudinal Trend Analysis study was designed to determine the feasibility of conducting prospective surveillance of a large national registry to perform comparative safety analyses of medical devices. We sought to determine whether the complementary use of retrospective case data could improve safety signal detection time., Design: We performed a simulated surveillance study of the comparative safety of the Mynx vascular closure device (VCD) with propensity score matched alternate VCD recipients, using both retrospective and prospective cohort data., Setting: Centers within the USA using the National Cardiovascular Data Registry (NCDR) CathPCI Registry., Participants: Percutaneous coronary intervention cases captured within the NCDR CathPCI Registry from July 1, 2009 to September 30, 2013 were included in the analysis., Interventions: None., Main Outcome Measures: Absolute and relative risk (RR) of any vascular complication (a composite of bleeding at access site, hematoma at access site, retroperitoneal bleeding, and other vascular complications requiring treatment); time to signal detection., Results: A safety alert was detected for the primary outcome of "any vascular complication" after 15 months of surveillance and was sustained for the study duration (absolute risk of any vascular complication, 1.20% vs 0.73%, RR, 1.63; 95% CI 1.50 to 1.79; p<0.001). The safety signal was identified 12 months earlier with the use of retrospective case data than during the initial study., Conclusions: Prospective, active surveillance of cardiovascular registries is feasible to perform comparative analyses of medical devices. Retrospective data may complement prospective surveillance to improve time to signal detection, indicating the need for earlier prospective application of safety surveillance for devices new to the market., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Translational multidisciplinary research is important for the Center for Devices and Radiological Health's efforts for utilizing real-world data (RWD) to enhance predictive evaluation of medical device performance in patient subpopulations. As part of our efforts for developing new RWD-based evidentiary approaches, including in silico discovery of device-related risk predictors and biomarkers, this study aims to characterize the sex/race-related trends in hip replacement outcomes and identify corresponding candidate single nucleotide polymorphisms (SNPs). Adverse outcomes were assessed by deriving RWD from a retrospective analysis of hip replacement hospital discharge data from the National Inpatient Sample (NIS). Candidate SNPs were explored using pre-existing data from the Personalized Medicine Research Project (PMRP). High-Performance Integrated Virtual Environment was used for analyzing and visualizing putative associations between SNPs and adverse outcomes. Ingenuity Pathway Analysis (IPA) was used for exploring plausibility of the sex-related candidate SNPs and characterizing gene networks associated with the variants of interest. The NIS-based epidemiologic evidence showed that periprosthetic osteolysis (PO) was most prevalent among white men. The PMRP-based genetic evidence associated the PO-related male predominance with rs7121 (odds ratio = 4.89; 95% confidence interval = 1.41-17.05) and other candidate SNPs. SNP-based IPA analysis of the expected gene expression alterations and corresponding signaling pathways suggested possible role of sex-related metabolic factors in development of PO, which was substantiated by ad hoc epidemiologic analysis identifying the sex-related differences in metabolic comorbidities in men vs. women with hip replacement-related PO. Thus, our in silico study illustrates RWD-based evidentiary approaches that may facilitate cost/time-efficient discovery of biomarkers for informing use of medical products., (© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals Inc. on behalf of the American Society of Clinical Pharmacology & Therapeutics. This article has been contributed to by US Government employees and their work is in the public domain in the USA.)

Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11% to 5.32% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78% to 10.18%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.

Background: Little is known about the effectiveness of recombinant human bone morphogenetic proteins (rhBMPs) in reducing the demand for opioids after surgery. We investigated the association between rhBMP use and the likelihood of achieving opioid independence and changes in opioid demand in the first postoperative year., Methods: Using the Multi-Payer Claims Database from 2007 to 2010, patients aged >20 years who had undergone a degenerative disc disease-indicated lumbar fusion procedure and had had ≥1 opioid prescription in the 3 months before surgery were identified. Propensity score matching (1:1) of rhBMP-exposed and rhBMP-unexposed patients was used to mitigate confounding. The outcomes of interest were opioid independence and decreases in opioid doses in morphine equivalent units, assessed at 3-6 and 9-12 months after the procedure. Logistic regression and analysis of covariance models were used., Results: The data from 318 patients were analyzed. Most patients were women (61%) and aged <65 years (68%). Few had achieved opioid independence at 3-6 (n = 71; 22.3%) or 9-12 (n = 115; 36.2%) months postoperatively. During the 3-6-month window, the rhBMP group reduced their opioid use rates (estimated mean difference. -28.4 vs. -19.5; P = 0.69) and achieved opioid independence (21.4% vs. 23.3%; odds ratio, 0.92; 95% confidence interval, 0.54-1.56; P = 0.74) at rates that were statistically comparable to their matched comparators. Similar patterns were observed during the 9-12-month window., Conclusion: We found no evidence to suggest that rhBMP use during spinal fusion procedures is associated with either the discontinuation or decrease of opioid analgesic therapy. The continued opioid use after surgery warrants further clinical and research attention., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI)., Methods: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion., Results: We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015., Conclusions: A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).

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.

Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS)., Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex., Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants., Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat.

Context: Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety., Objective: To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices., Design, Setting, and Patients: Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts., Main Outcome Measure: Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered., Results: We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device., Conclusion: Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.