Publications

BACKGROUND: Recent data support both surgical-first and endovascular-first revascularization approaches for chronic limb-threatening ischemia (CLTI), but hospital-based practices are poorly described.

OBJECTIVES: This aim of this study was to characterize contemporary variations and outcomes associated with each strategy among U.S. hospitals providing both approaches.

METHODS: Medicare beneficiaries ≥66 years of age with CLTI treated at institutions offering both strategies between October 1, 2015 to December 31, 2021 were analyzed. A marginal Cox regression approach was used, and models were adjusted for patient-level covariates.

RESULTS: Among 196,070 patients at 1,832 institutions, 82.5% underwent endovascular treatment. Patients undergoing endovascular revascularization were older and had a higher comorbidity burden. The adjusted median OR for receiving an endovascular procedure was 2.32 among hospitals (Q1-Q3: 2.24-2.40; P < 0.01), demonstrating high variability in intervention use. Patients undergoing endovascular revascularization at the highest quintile hospitals had a lower rate of major amputation (adjusted HR [aHR]: 0.82; 95% CI: 0.77-0.88; P < 0.01) and a higher rate of repeat procedures (aHR: 1.37; 95% CI: 1.32-1.43; P < 0.01). Patients undergoing surgical bypass at the highest quintile hospitals had a higher rate of major amputation (aHR: 1.21; 95% CI: 1.13-1.29; P < 0.01) and a lower rate of repeat procedures (aHR: 0.73; 95% CI: 0.70-0.76; P < 0.01).

CONCLUSIONS: This study showed large interhospital variability in revascularization strategies, as well as improved outcomes for patients receiving endovascular treatment at higher volume sites. Further work is needed to standardize treatments with the goal of improving limb salvage rates.

Endovascular operators experience elevated rates of occupational orthopedic injuries and persistent radiation exposure with current lead shielding. Novel shielding systems eliminate the need to wear lead aprons while also mitigating occupational radiation exposure, but real-world evidence of their efficacy remains needed. This study evaluated consecutive endovascular procedures requiring fluoroscopy at U.S. and international institutions following installation of a commercially available portable shielding system consisting of interlocking radiation-attenuating acrylic and soft shielding components. Live dosimeters were placed at the left shoulder of the main and assistant operators for quantification of radiation exposure. In total, 1,712 endovascular procedures performed by 671 operators at 153 sites (19% non-U.S.). In 1,712 (99.4%), radiation exposure was recorded. A majority of procedures (83.6%) were coronary interventions including diagnostic angiography (43.8%), nonchronic total occlusion PCI (27.6%), and chronic total occlusion PCI (6.7%). Median fluoroscopy time was 7.7 mins (IQR 3.9 to 15.3 min), and median radiation exposure to the main operator and first assistant was 2 μSv and 1 μSv. This was comparable to historical measurements of under-lead radiation exposure. In conclusion, the Rampart system effectively reduced radiation exposure in real-world practice, enabling a safe lead-free procedure lab.

BACKGROUND: Isolated subsegmental pulmonary embolism (issPE) is a commonly encountered diagnosis. Although the International Classification of Diseases (ICD)-10 codes are used for research, their validity for identifying issPE is unknown. Moreover, issPE diagnosis is challenging, and the findings from radiology reports may conflict with those from expert radiologists.

METHODS: Based on prespecified criteria, 1734 medical records of adult patients hospitalized within the Mass General Brigham health system (2016-2021) were selected in three equal groups: (1) patients with principal discharge diagnosis codes for PE, (2) patients with secondary discharge diagnosis codes for PE, and (3) patients with no PE codes. The accuracy of ICD-10 codes for issPE was verified by two independent physicians and weighted by total hospitalizations. In a randomly selected sample of 70 patients, the accuracy of initial radiology reports was determined through a blinded re-evaluation by two expert radiologists.

RESULTS: In weighted estimates, ICD-10 codes in primary or secondary discharge positions, compared with chart reviews, showed a low sensitivity (7.0 %) and positive predictive value (25.2 %). Evaluation by two expert radiologists noted that initial radiology reports were sensitive (97.1 %) for issPE but had a low specificity (40.0 %). Two (3.6 %) out of 55 patients with initial issPE reports did not have PE, while 19 (34.5 %) had more proximal PE.

CONCLUSIONS: ICD-10 codes for issPE have poor sensitivity and positive predictive value and should not be used for research or quality improvement. Radiology reports for issPE may be inaccurate regarding the location or, less often, the presence of PE.

Despite advancements in diagnostics and therapeutics for cardiovascular disease, significant health disparities persist among patients from historically marginalized racial and ethnic groups, women, individuals who are socioeconomically under-resourced or underinsured, and those living in rural communities. While transcatheter interventions have revolutionized the treatment landscape in cardiology, populations bearing the greatest burden of disease continue to face inequitable access and poorer outcomes. A notable gap in the literature concerns the role of modern approaches to cardiovascular device innovation in shaping and perpetuating health disparities. Health equity has been declared one of the top strategic initiatives for 2022 to 2025 by the Food and Drug Administration Center for Devices and Radiological Health, underscoring the need for greater attention, dialogue, and targeted interventions in this space. This narrative review uses the cardiovascular device life cycle as a conceptual framework to enhance understanding and guide future efforts to mitigate disparities in the field of interventional cardiology. Drawing on illustrative examples from interventional cardiology, we examine current practices in cardiovascular device regulation and approval, clinical trial evaluation, adoption patterns, and postprocedural outcomes with the aim of uncovering potential mechanisms of disparities and identifying opportunities for targeted interventions.