Characteristic adverse events with intra-aortic balloon pumps: An analysis of the U.S. Food and Drug Administration MAUDE database from 2016 to 2021.

INTRODUCTION: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A Rare Case of Radiation-Associated Aortic and Mitral Valve Stenosis Treated With Transcatheter Valve Replacements.

Radiation therapy is the standard of care for achieving cure for many thoracic malignancies, but it can result in long-term cardiovascular sequelae such as valve disease. We describe a rare case of severe aortic and mitral stenosis due to prior radiation therapy for giant cell tumor treated successfully with percutaneous aortic and off-label mitral valve replacements. (Level of Difficulty: Intermediate.).

A Heart Team Approach to Assessing Frailty in the Cardiac Catheterization Laboratory.

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.

Coronary Artery Radial Deformation and Velocity in Native and Stented Arteries.

Introduction: Coronary arteries are exposed to a variety of complex biomechanical forces during a normal cardiac cycle. These forces have the potential to contribute to coronary stent failure. Recent advances in stent design allow for the transmission of native pulsatile biomechanical forces in the stented vessel. However, there is a significant lack of evidence in a human model to measure vessel motion in native coronary arteries and stent conformability. Thus, we aimed to characterize and define coronary artery radial deformation and the effect of stent implantation on arterial deformation. Materials and Methods: Intravascular ultrasound (IVUS) pullback DICOM images were obtained from human coronary arteries using a coronary ultrasound catheter. Using two-dimensional speckle tracking, coronary artery radial deformation was defined as the inward and outward displacement (mm) and velocity (cm/s) of the arterial wall during the cardiac cycle. These deformation values were obtained in native and third-generation drug-eluting stented artery segments. Results: A total of 20 coronary artery segments were independently analyzed pre and poststent implantation for a total of 40 IVUS runs. Stent implantation impacted the degree of radial deformation and velocity. Mean radial deformation in native coronary arteries was 0.1230 mm ± 0.0522 mm compared to 0.0775 mm ± 0.0376 mm in stented vessels (p=0.0031). Mean radial velocity in native coronary arteries was 0.1194 cm/s ± 0.0535 cm/s compared to 0.0840 cm/s ± 0.0399 cm/s in stented vessels (p=0.0228). Conclusion: In this in vivo analysis of third-generation stents, stent implantation attenuates normal human coronary deformation during the cardiac cycle. The implications of these findings on stent failure and improved clinical outcomes require further investigation.

An association between electronic nicotine delivery systems use and a history of stroke using the 2016 behavioral risk factor surveillance system.

ABSTRACT: Electronic nicotine delivery systems (ENDS) are growing in use and many of the health implications with these devices remain unknown. This study aims to assess, using a survey representative of the USA general population, if an association exists between a history of ENDS use and a history of stroke.This cross-sectional study was a secondary data analysis using the 2016 behavioral risk factor surveillance system survey. The main exposure variable of the study was a self-reported history of ENDS use. The main outcome was a self-reported history of stroke. Covariates included sex, race, traditional cigarette use, smokeless tobacco use, chronic kidney disease, diabetes, myocardial infarction, and coronary artery disease. Unadjusted and adjusted logistic regression analyses were done. Adjusted odds ratios (AOR) and their corresponding 95% confidence intervals (CI) were calculated.Of the 486,303 total behavioral risk factor surveillance system survey participants, 465,594 met the inclusion criteria for this study of ENDS use and stroke. This study shows that current ENDS use was positively associated with a history of stroke. AOR of some daily ENDS use with stroke was 1.28 (95% CI: 1.02-1.61) and AOR of current daily ENDS use with stroke was 1.62 (95% CI: 1.18-2.31). The majority (55.9%) of current daily ENDS users reported former traditional cigarette smoking. Female sex, non-white ethnicity, elderly age, chronic kidney disease, coronary artery disease, diabetes, and traditional cigarette use characteristics were all also associated with increased odds of reporting a stroke.This study found a statistically significant and positive association between ENDS use and a history of stroke. Further research is warranted to investigate the reproducibility and temporality of this association. Nevertheless, this study contributes to the growing body of knowledge about the potential cardiovascular concerns related to ENDS use and the need for large cohort studies.

Cardiac MRI and Myocardial Injury in COVID-19: Diagnosis, Risk Stratification and Prognosis.

Myocardial injury is a common complication of the COVID-19 illness and is associated with a worsened prognosis. Systemic hyperinflammation seen in the advanced stage of COVID-19 likely contributes to myocardial injury. Cardiac magnetic resonance imaging (CMR) is the preferred imaging modality for non-invasive evaluation in acute myocarditis, enabling risk stratification and prognostication. Modified scanning protocols in the pandemic setting reduce risk of exposure while providing critical data regarding cardiac tissue inflammation and fibrosis, chamber remodeling, and contractile function. The growing use of CMR in clinical practice to assess myocardial injury will improve understanding of the acute and chronic sequelae of myocardial inflammation from various pathological etiologies.

Morbidity and Mortality of Total Pelvic Exenteration for Malignancy in the US.

BACKGROUND: Total pelvic exenterations (TPEs) for malignancies are complex operations often performed by multidisciplinary teams. The differences among primary cancer for TPE and multicentered results are not well described. We aimed to describe TPE outcomes for different malignant origins in a national multicentered sample. METHODS: Patients from the National Surgical Quality Improvement Program (NSQIP) database who underwent TPE between 2005 and 2016 for all malignant indications (colorectal, gynecologic, urologic, or other) were included. Chi square and Kruskal-Wallis tests were used to compare patient characteristics by primary malignancy. Multivariate logistic and linear regression models were used to determine factors associated with any 30-day Clavien-Dindo grade 3 or higher complication, length of hospital stay (LOS; days), 30-day wound infection, and 30-day mortality. RESULTS: Overall, 2305 patients underwent TPE. Indications for surgery included 33% (749) colorectal, 15% (335) gynecologic, 9% (196) other, and 45% (1025) urologic malignancies. Median LOS decreased from 10 to 8 days during the study period (p < 0.001), 36% were males, and 50% required blood transfusion. High-grade complications occurred in 15% of patients and were associated with bowel diversion [odds ratio (OR) 1.6, 95% confidence interval (CI) 1.1-2.4], disseminated cancer (OR 1.8, 95% CI 1.4-2.3), and gynecologic cancers (OR 2.9, 95% CI 1.8-4.7). Mortality was 2% and was associated with disseminated cancer (OR 2.2, 95% CI 1.1-4.3) and male sex (OR 2.4, 95% CI 1.3-4.4). CONCLUSIONS: TPE is associated with high rates of complications, however mortality rates remain low. Preoperative and perioperative outcomes differ depending on the origin of the primary malignancy.

A Comparison of Perioperative Outcomes Between Single-port and Multiport Robot-assisted Laparoscopic Prostatectomy.

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. PATIENT SUMMARY: 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.

A systematic review of upper extremity neuropathy following total hip arthroplasty.

BACKGROUND: There is a paucity of literature describing upper extremity neuropathy following the procedure. We performed a systematic review of upper extremity neuropathy following total hip arthroplasty (THA) to provide characteristics regarding the incidence, suspected aetiology, and outcomes of such complications. METHODS: A systematic review of the literature was performed which investigated the COCHRANE and Medline databases regarding "peripheral neuropathy total hip arthroplasty" and "nerve palsy associated total hip arthroplasty." Studies were excluded if they were not Level I, II, or III of evidence or had incomplete reported data. Studies were evaluated and data was extracted for the analysis if they met all inclusion criteria. Data extracted was compiled to assess nerve injury, aetiology, and resolution of symptoms. RESULTS: The search included 77 articles and 4 were selected for inclusion. A total of 21,346 patients underwent a THA with 40 of those cases resulting in an upper extremity nerve injury yielding a complication rate of 0.20%. The most likely aetiology of the upper extremity neuropathy was a compression neuropathy related to improper patient positioning of the contralateral/ipsilateral arm. Full resolution was reported in 74.42% of these cases (32 of 43 cases). CONCLUSIONS: Upper extremity neuropathy following THA is a rare complication that presents with variations of sensory and motor deficits. A thorough attention to proper positioning of the upper extremity is necessary to mitigate this risk.

Diagnostic Properties of Total and Free Prostate-Specific Antigen to Predict Overall and Clinically Significant Prostate Cancer Among Men With Low Testosterone and Prior Negative Biopsy.

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.

The Association of Previous Prostate Biopsy Related Complications and the Type of Complication with Patient Compliance with Rebiopsy Scheme.

PURPOSE: Prostate biopsy complications have important consequences that may affect patient compliance with rebiopsy schemes. However, to our knowledge this has not been studied in earnest. Thus, we evaluated whether previous prostate biopsy related complications and the type of complication were associated with repeat prostate biopsy compliance in a clinical trial with study mandated systematic biopsies. MATERIALS AND METHODS: We retrospectively analyzed the records of 4,939 men 50 to 75 years old who underwent 2-year prostate biopsy and were recommended to undergo 4-year prostate rebiopsy in the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study. The analyzed biopsy complications were hematuria, urinary tract infection, acute urinary retention and hemospermia. RESULTS: A total of 260 men (5.3%) had a 2-year prostate biopsy related complication, including hematuria in 180 (3.6%), urinary tract infection in 36 (0.7%), acute urinary retention in 26 (0.5%) and hemospermia in 102 (2.1%). A total of 474 men (9.6%) were noncompliant with 4-year rebiopsy. On univariable analysis any previous complication (OR 1.56, 95% CI 1.08-2.24, p = 0.018), urinary tract infection (OR 2.72, 95% CI 1.23-6.00, p = 0.013), acute urinary retention (OR 4.24, 95% CI 1.83-9.81, p = 0.016) and hemospermia (OR 1.78, 95% CI 1.03-3.06, p = 0.037) were associated with rebiopsy noncompliance. Hematuria was not associated with rebiopsy noncompliance (OR 1.19, 95% CI 0.74-1.91, p = 0.483). Results were unchanged on multivariable analysis, including for any complication (OR 1.65, 95% CI 1.08-2.26, p = 0.018), for urinary tract infection (OR 2.62, 95% CI 1.07-3.21, p = 0.029), for acute urinary retention (OR 4.51, 95% CI 1.93-10.54, p = 0.001), for hemospermia (OR 1.85, 95% CI 1.07-3.21, p = 0.029) and for hematuria (OR 1.19, 95% CI 0.74-1.93, p = 0.472). CONCLUSIONS: In men who undergo repeat prostate biopsy a previous biopsy related complication and the type of complication were associated with lower compliance with rebiopsy schemes. Patients who experience biopsy related complications are ideal candidates to receive intervention regarding the importance of prostate rebiopsy to prevent noncompliance.