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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

Endovascular devices have catalyzed a global industry for advanced technologies such as flow diverters and stent retrievers. Though adoption of these devices has skyrocketed over the past 30 years, the regulatory landscape for real‐world monitoring is constantly under revision. Postmarket surveillance is an area of Medical Device Regulation that monitors how devices perform in the real world after regulatory approval. This area of research is underdeveloped globally, with most surveillance relying on passive adverse event data collection from health care systems. The US Food and Drug Administration has not yet established a comprehensive postmarket surveillance strategy for neuroendovascular devices. Postmarket clinical surveillance data are rare; only 4 mandated 522 postmarket neuroendovascular trials exist, and 4 of 14 endovascular registries have published results per ClinicalTrials.gov. The European Union 2017 Medical Device Regulation describes a comprehensive regulatory strategy to address postmarket surveillance, yet it has faced difficult implementation due to resource constraints and concerns such as increased costs and reliance on foreign devices and regulators. More than 50% of manufacturers are planning portfolio reductions, with 33% of the devices from these manufacturers planned for discontinuation. As of April 2022, >85% of 500 000+ previously certified devices were without new certification. In this article, we describe the current regulatory landscape for postmarket surveillance and support the need for a comprehensive, cost‐efficient postmarket strategy for neurovascular devices while proposing several solutions and considerations. An effective postmarket strategy has numerous benefits, such as promoting patient safety, expanding real‐world data collection, and increased efficiency for approving future devices.

Abstract Background Validating new algorithms, such as methods to disentangle intrinsic treatment risk from risk associated with experiential learning of novel treatments, often requires knowing the ground truth for data characteristics under investigation. Since the ground truth is inaccessible in real world data, simulation studies using synthetic datasets that mimic complex clinical environments are essential. We describe and evaluate a generalizable framework for injecting hierarchical learning effects within a robust data generation process that incorporates the magnitude of intrinsic risk and accounts for known critical elements in clinical data relationships. Methods We present a multi-step data generating process with customizable options and flexible modules to support a variety of simulation requirements. Synthetic patients with nonlinear and correlated features are assigned to provider and institution case series. The probability of treatment and outcome assignment are associated with patient features based on user definitions. Risk due to experiential learning by providers and/or institutions when novel treatments are introduced is injected at various speeds and magnitudes. To further reflect real-world complexity, users can request missing values and omitted variables. We illustrate an implementation of our method in a case study using MIMIC-III data for reference patient feature distributions. Results Realized data characteristics in the simulated data reflected specified values. Apparent deviations in treatment effects and feature distributions, though not statistically significant, were most common in small datasets (n

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.

BackgroundConflicting 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.MethodsCandidate 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.ResultsA 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.ConclusionThe 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.

Background Stroke is a leading cause of death that disproportionately affects women. Treating carotid stenosis with carotid artery stenting (CAS) or carotid endarterectomy (CEA) can prevent ischemic stroke. Yet, the sex‐specific use and long‐term outcomes of these interventions remain unclear. Thus, we sought to investigate sex‐based differences in the treatment and outcomes of carotid stenosis. Methods We analyzed carotid revascularizations in the Vascular Quality Initiative, a national clinical registry. Patients were linked to Medicare claims to identify long‐term outcomes. Our study cohort included patients undergoing index CAS or CEA between 2005 and 2015 who were fee‐for‐service Medicare beneficiaries aged 65+. The primary exposure was sex, and the primary outcome was stroke. Using log‐binomial regression, we estimated the relative risk for CAS treatment accounting for clustering by center. Cox proportional hazards regression was used to estimate the hazard ratio for stroke. We used inverse probability‐weighted risk adjustment based on patient demographics, comorbidities, and disease severity for all analyses. Results In our cohort of 22 341 eligible patients, 39% were women, 13% underwent CAS, and the median survival time was 2.6 years (interquartile range: 1.0–3.4 years). After risk adjustment, women were less likely to undergo CAS than men (adjusted relative risk, 0.89; [95% CI, 0.83–0.96]; P=0.003). Women undergoing carotid revascularization had a 24% increased risk of stroke (adjusted HR, 1.24; [95% CI, 1.10–1.39]; P=0.001) within 5 years of surgery. The higher stroke rate in women was noted following both carotid endarterectomy (adjusted HR, 1.22; [95% CI, 1.07–1.38]; P=0.003) and CAS (adjusted HR, 1.40; [95% CI, 1.06–1.83]; P=0.014). This effect was most pronounced for symptomatic treatment, where women undergoing CEA had a 3% higher risk‐adjusted 5‐year cumulative incidence of stroke (13% versus 10%, Gray's P=0.002). Conclusion Compared with men, women had a higher incidence of postoperative stroke after carotid revascularization, regardless of treatment type. Sex disparities in postrevascularization stroke rates may give rise to concern given the widespread use of revascularization for managing carotid stenosis.

Objective To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft).Design Multicentre retrospective cohort study.Setting Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres.Participants In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other.Main outcome measures Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality.Results The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1–2). Median total LOS was 1 day (IQR: 1–2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths.Conclusions This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.

Objective Transesophageal echocardiography (TEE) is sometimes used to search for cardioembolic sources after ischemic stroke or transient ischemic attack (TIA). TEE visualizes some sources better than transthoracic echocardiography, but TEE is invasive and may cause aspiration. Few data exist on the risk of respiratory complications after TEE in patients who had stroke or TIA. Our objective was to determine whether TEE was associated with increased risk of respiratory failure in patients who had ischemic stroke or TIA.Design This is a retrospective cohort study using administrative data from inpatient and outpatient insurance claims collected by the US federal government’s Centers for Medicare and Medicaid Services.Setting Hospitals and outpatient clinics throughout the USA.Participants 99 081 patients ≥65 years old hospitalized for out-of-hospital ischemic stroke or TIA, defined by validated International Classification of Disease-9/10 diagnosis codes and present-on-admission codes, using claims data from 2008 to 2018 in a random 5% sample of Medicare beneficiaries.Main outcome measures Acute respiratory failure, defined as endotracheal intubation and/or mechanical ventilation, starting on the first day after admission through 28 days afterward.Results Of 99 081 patients included in this analysis, 73 733 (74.4%) had an ischemic stroke and 25 348 (25.6%) a TIA. TEE was performed in 4677 (4.7%) patients and intubation and/or mechanical ventilation in 1403 (1.4%) patients. The 28-day cumulative risk of respiratory failure after TEE (1.4%; 95% CI 0.8% to 2.7%) was similar to that seen in those without TEE (1.4%; 95% CI 1.4% to 1.5%) (p=0.84). After adjustment for age, sex, race, Charlson comorbidities, diagnosis of stroke versus TIA, intravenous thrombolysis, and mechanical thrombectomy, TEE was not associated with an increased risk of respiratory failure (HR, 0.9; 95% CI 0.6 to 1.2).Conclusions In a cohort of older patients who had ischemic stroke or TIA, TEE was not associated with an increased risk of subsequent respiratory failure.

Background:. 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 (

The combination of registry and administrative claims data have facilitated research and quality improvement efforts. Using Vascular Quality Initiative (VQI) registry data and Medicare claims we have generated centre-specific survival, reintervention and surveillance reports which benchmark participating centres’ performance to the VQI as a whole and to published guidelines. In 2021, we distributed these reports to 303 participating centres. These reports offer an opportunity for centres to evaluate their performance and identify focus areas for quality improvement work.

Background Real-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.Objectives To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.Methods We compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.Results We analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%–71%) were also realized compared with industry-based estimates.Conclusions The use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real‐world surveillance system exists to monitor their long‐term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee‐for‐service claims for patients aged ≥65 years who underwent PCI with drug‐eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in‐stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow‐up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real‐world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in‐depth examination to accurately assess stent safety.

Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan–Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1–3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74–0.82]; atherectomy risk ratio=0.69 [0.58–0.82]) and tibial arteries (stent risk ratio=0.70 [0.55–0.89]; atherectomy risk ratio=0.87 [0.70–1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17–1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12–1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06–1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence‐based guidelines are needed to guide optimal use of endovascular treatments for men and women.

This data article presents the supplementary material for the review paper “Healthcare Costs of Post-Prostate Biopsy Sepsis” (Gross et al., 2019). A general overview is provided of 18 papers, including the details about year and journal of publication, country of dataset, data population characteristics, cost basis, and potential for bias evaluation. Quality assessment and the risk of bias of the 18 papers are detailed and summarized. Keywords: Sepsis, Health care costs, Prostate, Biopsy, Prostatic neoplasms, Cost and cost analysis, Urology

Background The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.Objectives We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.Methods For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.Results We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.Conclusions The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.