Massive Inguinoscrotal Bladder Herniation with Calculi, and Bladder Outlet Obstruction

Scrotal herniation of the bladder is a rare event and can be associated with bladder outlet obstruction, bladder infarction and renal impairment. This condition is also associated with a significant mortality rate. We present a case report of extensive scrotal cystocele involving 90% of the bladder in which the diagnosis was suggested by KUB, pelvic ultrasound, and pelvic CT imaging showing distorted bladder anatomy and the presence of several large bladder calculi

TCT-126 Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention of the Left Anterior Descending Artery

Background: Improvement of left ventricular ejection fraction (LVEF) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been modest in prior studies. Methods: Our cohort included patients who underwent LAD CTO PCI at a single center (Henry Ford Hospital) from 2014 to 2021. We evaluate the change in LVEF after LAD CTO PCI using the paired t test in all patients, those with ischemic cardiomyopathy (CM), and those who underwent a viability test. Results: From December 2014 to February 2022, a total of 237 LAD CTO PCI procedures were performed at Henry Ford Hospital (proximal LAD: 56.6%). In-hospital MACE occurred in 13 patients (5.5%; death: 1.3%). Landmark analysis after discharge showed an overall survival of the cohort was 92.7% and MACE-free survival of 85.0% over a median follow-up of 2 years. The median baseline EF was 50% (IQR 35%-55%). Only 51 patients had reduced baseline LVEF (40% or less). After a median follow-up of 9.2 months (IQR 3-28.6 months), there was a significant improvement in LVEF after LAD CTO PCI (mean 10.9%, 95% CI 7.1%-14.8%, P \u3c 0.001). When limiting the analysis to patients who had ischemic cardiomyopathy, proximal LAD CTO PCI, and were on optimal medical therapy (n = 29), LVEF was significantly improved (mean increase of 14%, 95% CI 9.5-18.5%, P \u3c 0.001) after a median follow-up period of 6.2 months (3-29.5 months). Conclusion: LAD CTO PCI was associated with a significant 10% improvement in LVEF in ICM patients and was more pronounced (14% improvement) in those who had proximal LAD treated and were on optimal medical therapy. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location

Objectives The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. Background The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. Methods The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. Results No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were −11.9 ± 2.4 mmHg (distal), −10 ± 1.6 mmHg (middle), and −10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). Conclusion In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months

Renal denervation in heart failure with preserved ejection fraction (RDT-PEF): a randomized controlled trial

Aim: Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RDT) might be helpful and there are no data currently in humans with HFpEF. Methods and results: In this single-centre, randomized, open-controlled study we included 25 patients with HFpEF [preserved left ventricular (LV) ejection fraction, left atrial (LA) dilatation or LV hypertrophy and raised B-type natriuretic peptide (BNP) or echocardiographic assessment of filling pressures]. Patients were randomized (2:1) to RDT with the Symplicity™ catheter or continuing medical therapy. The primary success criterion was not met in that there were no differences between groups at 12 months for Minnesota Living with Heart Failure Questionnaire score, peak oxygen uptake (VO2) on exercise, BNP, E/e′, LA volume index or LV mass index. A greater proportion of patients improved at 3 months in the RDT group with respect to VO2 peak (56% vs. 13%, P = 0.025) and E/e′ (31% vs. 13%, P = 0.04). Change in estimated glomerular filtration rate was comparable between groups. Two patients required plain balloon angioplasty during the RDT procedure to treat renal artery wall oedema. Conclusion: This study was terminated early because of difficulties in recruitment and was underpowered to detect whether RD improved the endpoints of quality of life, exercise function, biomarkers, and left heart remodelling. The procedure was safe in patients with HFpEF, although two patients did require intraprocedure renal artery dilatation

Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design.

BACKGROUND: The SPYRAL HTN clinical trial program was initiated with two 80-patient pilot studies, SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, which provided biological proof of principle that renal denervation has a blood pressure-lowering effect versus sham controls for subjects with uncontrolled hypertension in the absence or presence of antihypertensive medications, respectively. TRIAL DESIGN: Two multicenter, prospective, randomized, sham-controlled trials have been designed to evaluate the safety and efficacy of catheter-based renal denervation for the reduction of blood pressure in subjects with hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) or presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications. The primary efficacy endpoint is baseline-adjusted change from baseline in 24-h ambulatory systolic blood pressure. The primary safety endpoint is incidence of major adverse events at 1 month after randomization (or 6 months in cases of new renal artery stenosis). Both trials utilize a Bayesian design to allow for prespecified interim analyses to take place, and thus, the final sample sizes are dependent on whether enrollment is stopped at the first or second interim analysis. SPYRAL HTN-OFF MED Pivotal will enroll up to 300 subjects and SPYRAL HTN-ON MED Expansion will enroll up to 221 subjects. A novel Bayesian power prior approach will leverage historical information from the pilot studies, with a degree of discounting determined by the level of agreement with data from the prospectively powered studies. CONCLUSIONS: The Bayesian paradigm represents a novel and promising approach in device-based hypertension trials. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02439749 (SPYRAL HTN-OFF MED Pivotal) and NCT02439775 (SPYRAL HTN-ON MED Expansion)