Faculty Bibliography

BACKGROUND/UNASSIGNED:Despite recent improvements in radiation safety, interventionalists are increasingly exposed to radiation during cardiac catheterization laboratory (CCL) procedures. The RADPAD was designed as a protective scatter-radiation absorbing shield with early studies demonstrating a 20% to 62% reduction in scatter-radiation. The objective of this study was to examine the impact of the protective scatter-radiation absorbing shield in a large contemporary randomized controlled trial across multiple CCL procedures. METHODS/UNASSIGNED:The investigator-initiated, prospective, randomized, controlled ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) trial randomized CCL procedures 1:1 to use of the RADPAD vs no use of the RADPAD. The primary outcome of interest was the most proximal operator's dose area product (DAP)-normalized operator dose (E). RESULTS/UNASSIGNED:= .1094). CONCLUSIONS/UNASSIGNED:In the largest randomized controlled trial to date evaluating the RADPAD protective scatter-radiation absorbing shield, encompassing contemporary coronary and structural CCL procedures, use of the protective scatter-radiation absorbing shield led to a marked decrease in proximal operator radiation exposure when adjusted for the total radiation delivered during each procedure.

Current CardioMEMS HF System (Abbott) instructions for use recommend against implantation in obese patients (body mass index >35 kg/m²) whose chest circumference exceeds 165 cm, as placement can be technically challenging and remote interrogation can be unreliable. We present a case of successful CardioMEMS implantation in a patient with significant morbid obesity, exceeding previously reported body size limits, with a body mass index of 77.1 kg/m² and chest circumference of 178 cm. Outpatient device interrogation following implantation has been reliable in optimizing diuretic management and preventing readmissions in this patient.

BACKGROUND/UNASSIGNED:The American College of Cardiology (ACC) launched the Clinical Trials Research (CTR) program in 2019 to increase representation of historically underrepresented early-career investigators in cardiovascular research. In 2024, ACC introduced REACH (Research, Equity, and Access for Cardiac Health), a new subcohort within CTR focused on addressing disparities in structural heart disease research and recruitment. This analysis aimed to evaluate the diversity of the 2024-2025 CTR and REACH cohorts and assesses the program's short-term impact on research engagement, mentorship, and professional development. METHODS/UNASSIGNED:This was a cross-sectional voluntary survey of 22 items offered to all participants following completion of the program in March 2025. Responses were collected anonymously to ensure confidentiality, with data encrypted during transit and stored securely. RESULTS/UNASSIGNED:Among the 2024-2025 ACC CTR cohort, 48 of 51 participants (94.1%) completed the survey, with equal sex distribution (50% women, 50% men) and 25% identifying as Hispanic. Reported short-term outcomes included 52% gaining new mentorship outside their institution, 23% receiving speaking invitations to national meetings, 81% forming new collaborations, and 79% identifying new research opportunities. In the ACC CTR REACH cohort, 60% reported new external mentorship, 40% received national speaking invitations, 60% formed collaborations, and 88% accessed at least 1 new research opportunity. CONCLUSIONS/UNASSIGNED:The 2024-2025 ACC CTR and REACH programs fostered mentorship, collaboration, and research engagement among early-career investigators while advancing diversity in sex and ethnicity.

BACKGROUND:Despite recent improvements in radiation safety, interventionalists are increasingly exposed to radiation during cardiac catheterization laboratory (CCL) procedures. The RADPAD was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. Early studies demonstrated between a 20 and 62 % relative reduction in scatter radiation. The purpose of this study was to examine the impact of the RADPAD through a randomized controlled trial in a large contemporary CCL. DESIGN/METHODS:The ATTENUATE (v) Trial is an investigator-initiated, prospective, randomized controlled trial which will randomize 1000 CCL procedures 1:1 to use of the RADPAD vs. no use of the RADPAD. The primary outcome of interest is the most proximal operator's dose-area product (DAP)-normalized operator dose (E) defined as E divided by DAP. Additional subgroup analysis comparing types of procedure will also be performed. Every case will utilize contemporary radiation safety equipment. SUMMARY/CONCLUSIONS:The ATTENUATE Trial is the largest randomized controlled trial to evaluate the utility of the RADPAD in reducing relative operator exposure in a contemporary CCL including coronary and structural interventions.

BACKGROUND:Drug-coated balloons (DCBs) represent a novel treatment option for coronary in-stent restenosis (ISR). The AGENT DCB (Boston Scientific, Marlborough, MA) demonstrated superior efficacy in treating ISR compared to uncoated balloons in randomized controlled trials. However, real-world data on AGENT DCB safety remains limited. AIMS/OBJECTIVE:This study sought out to evaluate post-marketing adverse event reports related to the AGENT DCB. METHODS:This study analyzed post-marketing adverse event reports submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database between March 1, 2024, and March 1, 2025, specifically focusing on coronary interventions utilizing the AGENT DCB. Reports were independently reviewed and categorized by device-related complications, patient injuries, and device failures. Data were summarized descriptively, and limitations inherent to the MAUDE database were considered. RESULTS:After screening and excluding duplicates, 155 reports on the AGENT DCB were included. Among all reports, device malfunctions without injury were most common (56.77%), followed by patient injury (30.97%) and death (12.26%). Of the total reported device problems, balloon rupture (33.55%) and shaft breakage (10.32%) were predominant. Injuries reported included angina (32.84%), acute myocardial infarction (29.85%), and coronary perforation (8.95%). Notably, 30 MAUDE reports described off-label treatment of de novo lesions; these off-label cases exhibited similar injury rates compared to ISR-treated lesions (53.33% vs. 57.89%). CONCLUSION/CONCLUSIONS:Real-world analysis of FDA MAUDE reports revealed frequent device malfunctions, mainly balloon rupture and shaft breakage, and patient complications such as angina, myocardial infarction, and coronary perforation. The off-label use for de novo lesions highlights the need for caution and further clinical investigation.

BACKGROUND/UNASSIGNED:Patients with bicuspid aortic stenosis who receive transcatheter aortic valve replacement (TAVR) may require subsequent valve interventions in their lifetime; however, the feasibility of redo-TAVR in this population is uncertain. We aimed to assess redo-TAVR feasibility in bicuspid patients and develop a predictive virtual valve planning algorithm. METHODS/UNASSIGNED:We studied computed tomography scans of bicuspid patients who received a balloon-expandable transcatheter heart valve (THV) in the LRT trial (Low Risk TAVR). Redo-TAVR feasibility, determined by valve-to-coronary and valve-to-aorta measurements on 30-day computed tomography, was assessed according to raphe location and calcification. A virtual valve planning algorithm was developed using baseline and 30-day computed tomography scans. RESULTS/UNASSIGNED:<0.001) due to favorable shifting of the THV away from the coronary ostia. A bicuspid virtual planning algorithm accounting for 83.4% THV underexpansion, resulting in an 11.9% taller frame and translation of the THV away from the calcified raphe (mean valve shift 6.6 mm) achieved 86.7% sensitivity and 88.9% specificity for predicting redo-TAVR feasibility. CONCLUSIONS/UNASSIGNED:Calcified raphe in left/right cusp fusion shifts the THV away from the coronary ostia, reducing coronary obstruction risk during redo-TAVR. Underexpansion causing increased THV frame height and valve shifting is common in bicuspid patients; a virtual planning algorithm accounting for these aspects can accurately assess redo-TAVR risk. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02628899.