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The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) dataset represents a unique source for post-market surveillance data on adverse events (AE). An analysis of AE with percutaneous mechanical circulatory support (pMCS) devices has previously been reported specifically for microaxial flow pumps. The characteristic AE for the intra-aortic balloon pump (IABP) have not been similarly analyzed or reported. All events in the MAUDE dataset between January 1, 2016 and December 31, 2021 were reviewed involving the Linear, Mega and Sensation devices (Datascope/Getinge, Wayne New Jersey). Data was analyzed by two authors and categorized based on AE type, date, event type and device-related or patient-related AE. A total of 2795 AE were reported over five years. Device malfunction (91.4 %) was the most frequent classification followed by death (5.6 %) and injury (3.0 %). Catheter deformation/fracture/leak accounted for 37.9 % of total AEs. The most common patient event categorization was asymptomatic (90.8 %). Vessel damage/hemorrhage occurred in 1.4 % of reports. Death occurred in 5.6 % of reports and was associated with cardiac arrest in 110 of 156 events. Thrombus formation was described in 1.1 % of AEs. Device optic AE were common and unique to Sensation catheters. Calibration errors were also more common with Sensation (4.6 % versus 1.3 %) compared to other models. Publicly reported AE with IABPs are predominantly device malfunctions without clinical sequelae. Injury, vascular damage, bleeding and thrombosis AEs are not frequent amongst reported AEs. Emphasis should be placed on understanding mechanisms of device malfunction in order to improve both reliability and user experience. • Review of adverse events for Intra-Aortic Balloon Pumps from 2016 to 2021 • Adverse events for IABP mainly device malfunction without clinical sequelae. • Clinically important adverse events are infrequent but life threatening. [ABSTRACT FROM AUTHOR]

Introduction: Frailty is a well-documented risk factor for increased morbidity and mortality among patients undergoing percutaneous coronary intervention (PCI). There remains a lack of knowledge regarding the impact of patient frailty in cardiac patient management and outcomes. Thus, this study examined whether the Heart Team, without using frailty assessments, made decisions regarding coronary interventions [medical management (MM) vs. PCI vs. coronary artery bypass grafting (CABG)] that aligned with formally quantified frailty status.Material and Methods: This cross-sectional quality-improvement (QI) study was performed at a single, large, urban Veterans Affairs Hospital. From September 2019 to November 2020, heart team nurses approached patients prior to coronary angiograms and assessed for frailty using the Risk Analysis Index Questionnaire (RAIC). Interventional cardiologists were blinded to the results. This study's independent variable was RAI-C score. The outcome variables were "intervention performed" (MM, PCI, or CABG) and presence of a "reduced invasiveness intervention" (RI).Results: Ninety-five of the 182 participants had obstructive coronary artery disease. Among them, there were 69 PCIs, 10 CABGs, and 16 MMs. 26 received RIs. The primary outcomes demonstrated that frailty score was positively associated with receiving RI [adjusted OR = 1.13, 95% CI = 1.02-1.24, p = 0.02] and MM [adjusted OR = 1.13, CI = 1.02-1.25, p = 0.02], and negatively associated with receiving PCI [adjusted OR = 0.94, CI = 0.88-0.998, p = 0.04]. There was no significant association between frailty and the likelihood of undergoing CABG [AOR = 0.95, CI = 0.81-1.10, p = 0.47].Conclusion: This study demonstrated that the Heart Team and patients at baseline reduced high-risk interventions in frailer patients. A Heart Team, shared-decision-making model utilizing the RAI-C was found to be efficient and effective at measuring frailty in coronary angiogram patients and should be considered for use in the clinical setting. [ABSTRACT FROM AUTHOR]

Single-port (SP) robot-assisted laparoscopic prostatectomy (RALP) appears to be a safe and feasible approach for radical prostatectomy, but no prior studies have compared SP-RALP to a multiport (MP) platform. Using retrospective data from a single-center tertiary institution we compare 50 consecutive SP-RALP patients (da Vinci SP) to a contemporary cohort of 113 patients who underwent MP-RALP (da Vinci Xi). We found no significant differences in surgical or total operating room time. Pain scores were measured on a scale from 0 to 10. There were more pain-free patients on postoperative day 1 (18% difference, 95% confidence interval [CI] 9.9–27%) and there were shorter hospital stays (−1 d, 95% CI −1.0 to 0) in favor of SP. There were no significant differences in inpatient total morphine equivalents used, complication rates, or stress incontinence determined at a minimum of 90 d. These findings show that the learning curve for SP-RALP is relatively short for an experienced robotic surgeon and may favor better pain control and shorter hospitalization. We analyzed the differences in robotic surgery for localized prostate cancer using a single-port robotic platform compared to the traditional multiport robotic platform. We did not find significant differences in operative times, but significantly more patients were pain-free on the first postoperative day and had shorter hospital stays. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether total serum PSA, free-PSA ratio and PSA density have similar diagnostic properties for detecting prostate cancer (PCa) and clinically-significant (cs) PCa in men with normal testosterone compared to men with low testosterone with a prior negative biopsy.Methods: We conducted a retrospective analysis of 3295 men undergoing a 2-year prostate biopsy following a negative prestudy biopsy in the placebo arm of the Reduction by Dutasteride of PCa Events (REDUCE) study. Men were divided in 2 groups based on testosterone level < or ≥300 ng/dL. Diagnostic properties of total serum PSA, free-PSA ratio, and PSA density to predict PCa and csPCa, defined as Gleason score ≥7, were determined for several thresholds and plotted as receiver operator characteristic curves.Results: A total of 603 men (18.3%) had low testosterone. The prevalence of PCa and csPCa was 92 (15.3%) and 27 (4.5%), respectively, for low testosterone men compared to 458 (17.0%) and 138 (5.1%), correspondingly, for normal testosterone men. Total PSA, free-PSA ratio and PSA density showed similar sensitivity, specificity, and accuracy to predict PCa and csPCa among low testosterone men compared to normal testosterone men.Conclusion: Among subjects in a clinical trial with a prior negative biopsy, total PSA, free-PSA ratio and PSA density have comparable diagnostic characteristics for PCa screening in low and normal testosterone men. [ABSTRACT FROM AUTHOR]