Publications by Year: 2025

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.

Most of the 800 000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this article, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis, using data from 2 international, multicenter, randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and CIs were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; their median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6 to 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6-4.8) after heparin and 5.3% (3.4-7.4) without heparin at 14 days (risk ratio = 0.72; 95% CI, 0.50-0.98). Trial registration: ClinicalTrials.gov. Identifiers: NCT02110901 and NCT02414841.

A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.