Art Sedrakyan

Background: The use of antibiotic-loaded bone cement (ALBC) in primary total knee arthroplasty (TKA) is debated. Some argue that ALBC might only be justified in high-risk patients. This study assessed the effectiveness of ALBC vs. plain bone cement (PBC) in reducing risk of revision for periprosthetic joint infection (PJI) in TKA patients considered to have a high risk of infection. Methods: Cohort study of primary TKAs in 11 national or regional arthroplasty registries from 2010 to 2020. The 1-year risk of revision for PJI in TKAs with ALBC vs. PBC among patients with high American Society of Anesthesiologists (ASA) classification, body mass index (BMI), and/or diabetes was compared. Cumulative percent revision (1 minus Kaplan-Meier) based on 685,818 TKAs and Cox regression analyses (adjusted Hazard Rate Ratios [aHRRs]) were performed for TKAs with ALBC (reference) vs. PBC restricted to the following high-risk subgroups of patients: (1) ASA ≥3 (n = 335,612 vs. 35,997), (2) BMI ≥35 (n = 278,927 vs. 24,737), (3) ASA ≥3 and BMI ≥35 (n = 99,407 vs. 11,407), (4) diabetes (n = 38,341 vs. 21,838), and (5) ASA ≥3, BMI ≥35, and diabetes (n = 3,347 vs. 4,261). Advanced distributed meta-analyses were performed to combine all aggregate data and assess 1-year risk of revision for PJI. Results: Each registry reported a 1-year cumulative percent revision of ≤1.6% for PJI following TKAs both for ALBC and PBC in all high-risk subgroups. Similar 1-year risks of revision for PJI were found in TKAs with ALBC (reference) and PBC among patients with ASA ≥3 (aHRR: 1.09; 95% CI, 0.90-1.31); BMI ≥35 (1.06; 0.54-2.12); ASA ≥3 and BMI ≥35 (1.12; 0.83-1.50); diabetes (0.95; 0.74-1.20); and ASA ≥3, BMI ≥35, and diabetes (1.40; 0.86-2.29). Conclusions and Relevance: Similar 1-year revision risk of PJI was found for TKAs with ALBC vs. PBC in high-risk patients. Confirmation of the efficacy of ALBC in high-risk TKA patients needs to be evaluated in clinical trials. Level of Evidence: Level III. See Instructions for Authors for a complete description of levels of evidence.

Objectives: To evaluate the feasibility for use of electronic health record (EHR) data in conducting adverse event surveillance among women who received mid-urethral slings (MUS) to treat stress urinary incontinence (SUI) in five health systems. Design: Retrospective observational study using EHR data from 2010 through 2021. Women with a history of MUS were identified using common data models; a common analytic code was executed at each site. A manual chart review was conducted in a per-site random patient subset to establish a reference standard. Automated text processing (Text Processed Integrated (TPI)) was developed and evaluated at each site to determine the surgical approach and synthetic mesh implantation. Patients were characterized and surgical outcomes were ascertained over 730 subsequent days. Setting: Five large tertiary care academic medical centers. Participants: Across five health systems, 9,906 eligible patients (mean age 57–60 per site) were identified. Main outcome measures: Determination of surgical approach, synthetic mesh implantation, and assessment of the duration of surveillance for mortality and reoperation rates following MUS implantation. Results: In the TPI cohort analysis, 3,331 patients were identified. Surgical approach per site was retropubic (42% to 77%), transobturator (6% to 44%), single incision (0% to 24%), and adjustable sling (0% to <4%). Concordance rates for TPI using chart review were 71%–90% at each site for the surgical approach and 28%–85% for synthetic mesh implantation. Patient follow-up observation rates for mortality and reoperation ranged from 22% to 36% at 90 days, 15% to 30% at 365 days, and 8% to 19% at 730 days. Conclusion: Using EHR data alone, identification of medical devices and surgical approaches was feasible among women with MUS surgery for SUI, but long-term follow-up ascertainment rates were low. Medical device surveillance using EHR data should be evaluated in the context of the clinical use case, as applicability may vary.

Background: The use of systemic antibiotic prophylaxis (SAP) and antibiotic-loaded bone cement (ALBC) is the accepted practice to reduce the risk of periprosthetic joint infection (PJI) in primary total knee arthroplasty (pTKA). However, practice varies internationally. This study's primary aim was to compare the risk of PJI revision after pTKA with ALBC + SAP vs. plain bone cement (PBC) + SAP, and the secondary aim was to assess whether the risk of PJI revision varies with the number of SAP doses. Methods: Cohort of 289,926 pTKAs for osteoarthritis from arthroplasty registries in Denmark, New Zealand, Norway, Romania, and United States registered from 2010 to 2020. One-year revision for PJI following pTKA with ALBC + SAP vs. PBC + SAP, and single vs. multiple SAP doses was compared. We computed cumulative percent revision (1 minus Kaplan-Meier) using distributed analysis method and adjusted hazard rate ratios (HRRs) using Cox regression analyses within each registry. Advanced distributed meta-analysis was performed to summarize HRRs from all countries. Results: Among all pTKAs, 64.4% were performed with ALBC + SAP. Each registry reported a 1-year cumulative percent revision for PJI of <1.00% for both pTKAs with ALBC + SAP (0.34%-0.80%) and with PBC + SAP (0.54%-0.69%). The distributed meta-analysis showed HRR = 1.21; (95% confidence interval [CI], 0.79-1.87) for ALBC + SAP compared with PBC + SAP. Similar risk of PJI revision was observed between pTKAs with ALBC + single vs. multiple doses of SAP: 2 doses (0.95; 95% CI, 0.68-1.33), 3 doses (1.09; 95% CI, 0.64-1.87), and 4 doses (1.23; 95% CI, 0.69-2.21). Comparable results were found for the PBC + SAP group except for higher risk of PJI revision with 4 doses of SAP (2.74; 95% CI, 1.11-6.75). Conclusions: ALBC and PBC entailed similar risk of PJI revision when patients received SAP in pTKA, regardless of number of SAP doses. ALBC or PBC used in combination with SAP in pTKAs, with one single preoperative dose of SAP may be sufficient without compromising the patient safety. Level of evidence: Level III. See Instructions for Authors for a complete description of levels of evidence.

Objectives To assess the feasibility of assessing long-term outcomes of peripheral vascular intervention (PVI) by linking data from a clinical registry to electronic health records (EHR) data from a clinical research network. Design Observational cohort study. Setting Vascular Quality Initiative registry linked to INSIGHT Clinical Research Network, which aggregated EHR data from multiple institutions in New York City. Participants Patients receiving PVI during 1 January 2013–30 November 2021 in four centres in New York City. Primary and secondary outcome measures We examined the proportion of registry patients retained in EHR over time and predictors of EHR retention after year 1. We evaluated the implications of EHR attrition by examining amputation-free survival (AFS) in the observed data and predicted data when patients discontinued in the EHR were hypothesised to have increased risks of events than the observed average. Results We included 1405 patients receiving PVI (age=70.8±11.2 years, 51.3% male). Among eligible patients, 75.2% were retained in EHR through year 3. Patients who aged 75 years or above (vs Conclusions Studies using registry-EHR data may benefit from the timeliness of the data but may be most appropriate to focus on short-term to intermediate-term outcomes of interventions and devices. Future research is needed to investigate the value of registry-EHR linkage in facilitating short-term to intermediate-term outcome assessment following vascular interventions and advanced statistical approaches to account for non-random missing long-term data.

Objective To avoid the need for extensive adhesiolysis in patients with small bowel obstruction (SBO). We evaluated the feasibility of using advanced imaging, percutaneous access, and endoscopy as alternative therapies for SBO. Design Retrospective case series (IDEAL [Idea, Development, Exploration, Assessment, and Long-term Study Collaborative] stages 1 and 2a). Setting Single tertiary referral center. Participants Twelve adults with chronic SBO resulting from inflammatory bowel disease, disseminated cancer, radiation, and/or adhesive disease. Participants were included if they underwent one of three novel access procedures. There were no exclusion criteria. The median age of participants was 67.5 years (range 42–81); two-thirds were women; and median American Society of Anesthesiology class was 3. Interventions All participants underwent one of three novel access methods, followed by wire-guided balloon dilation of a narrowed area of small bowel. These methods combined endoscopic, fluoroscopic, and surgical techniques. The techniques were (1) a purely endoscopic approach aided by an over-the-scope double-balloon device, (2) a combined endoscopic and percutaneous approach, and (3) a cut-down approach. Main outcome measures Procedural success (defined as successful access to the small bowel and successful balloon dilation of the stenotic area). Secondary outcomes included major complications, recurrence, length of stay, and procedure time. Results Procedural success was achieved in 10 of 12 patients (83%). At the time of median follow-up of 10 months, recurrence of SBO was observed in two patients. In only one patient, the novel method did not change the treatment plan. No major complications occurred. Conventional operative intervention was avoided in all patients who achieved technical success with one of the novel approaches. The median postprocedure length of hospital stay was 4 days. Median procedure time was 135 min. Conclusions Novel minimally invasive approaches to SBO represent feasible alternatives to surgical procedures in select patients. Further study should compare these approaches to standard ones as new methods are refined.

Background: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). Methods: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. Results: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). Conclusion: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.

Stroke is the leading cause of disability with treatment costs exceeding $46 billion between 2014 and 2015 in the USA alone.1 2 Every year, approximately 795 000 Americans suffer a new or recurrent stroke resulting in nearly 140 000 deaths, with 87% being ischemic strokes.1 Device-assisted interventions, such as endovascular mechanical thrombectomy, can be used for the emergent treatment of acute ischemic stroke. The comprehensive assessment of safety and effectiveness of device-assisted treatments is complicated by several factors, including complex and unique neurovascular anatomy, the timing of stroke presentations, and variable tissue tolerability to ischemia.

Objectives The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies. Design A Delphi method approach was employed to achieve consensus on a core minimum data set for the 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. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved. Results Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data. Conclusions The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.