A PROMPT Update on Partial REBOA: Initial Clinical Data and Overview of the DoD-Funded Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study.

INTRODUCTION: Retrograde Endovascular Balloon Occlusion of the Aorta (REBOA) is an effective management for the transient responder, but the ischemic consequences of complete aortic occlusion currently limit its use. Multiple DoD-funded preclinical studies have clearly demonstrated that partial REBOA reduces distal ischemia to potentially extend safe occlusion times, while still providing effective temporization of noncompressible torso hemorrhage. Early versions of REBOA devices were designed to completely occlude the aorta and had little ability to provide partial occlusion. Recently, a new REBOA device (pREBOA-PRO) was designed specifically to allow for partial occlusion, with the hypothesis that this may reduce the complications of aortic occlusion and extend safe occlusion times while maintaining the benefits on cardiac and cerebrovascular circulation as well as reductions in resuscitation requirements. MATERIALS AND METHODS: To ascertain the impact of a new purpose-built partial REBOA device on the extension of safe occlusion time, the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) trial compared available data from the pREBOA-PRO with existing data from 200 clinical uses of pREBOA-PRO and available data in the AAST AORTA Registry were reviewed to design primary endpoints and clinical evidence for a prospective multi-center trial, the PROMPT Study. Together with the endpoints identified in preclinical studies of partial REBOA, primary endpoints for the PROMPT study were identified and power analyses were conducted to determine the target patient enrollment goals. RESULTS: Results from the clinical implementation of partial REBOA at a single trauma center were used to conduct the initial power analysis for the primary endpoint of Acute Kidney Injury (AKI) after prolonged occlusion. The rate of AKI after complete REBOA was 55% (12/20) compared to 33% (4/12) after partial REBOA (Madurska et al., 2021). With an alpha of 0.05 and power (ß) of 0.8, the projected sample size for comparison on a dichotomous outcome is 85 patients for the assessment of AKI. Initial power and endpoint analyses have been confirmed and extended with the ongoing analysis of partial and complete REBOA reported in the AORTA database. These analyses confirm preclinical findings which show that compared to complete REBOA, partial REBOA is associated with extended occlusion time in zone 1 (complete: 31 min vs. partial: 45 min, P = 0.003), lower rates of AKI after zone 1 occlusion (complete: 33% vs. partial: 19%, P = 0.05) and reduced resuscitation requirements (e.g., 25% reduction in pRBC administration: complete: 18 units vs. partial: 13 units, P = 0.02). CONCLUSIONS: The DoD-funded PROMPT study of partial REBOA will provide prospective observational clinical data on patients being treated with pREBOA-PRO. Outcomes will be stratified based on partial or complete occlusion to address whether partial REBOA has additional clinical benefits over complete REBOA, such as decreased distal ischemia, extension of safe occlusion time, improved hemodynamics during transition to and from occlusion, and reduced interoperative bleeding and blood product use. The results from this study are expected to confirm previous data demonstrating reduction of ischemic sequalae, improved transition to reperfusion, and reduced resuscitative requirements compared to complete REBOA.

Temporary Ureter Occlusion with Simultaneous Urinary Diversion via a Single-Access Route Using a 4-French Balloon Catheter and a Pigtail Nephrostomy Drainage Catheter.

Background and Objectives: This study evaluated the efficacy and safety of temporary ureteral occlusion combined with urinary diversion using a single-access route created by inserting a balloon catheter through a pigtail nephrostomy drainage catheter. With this approach, we aimed to offer an alternative for patients with ureteral leaks who are suboptimal surgical candidates. Materials and Methods: This retrospective study included nine patients (eight of which were bilateral cases and one was unilateral, totaling seventeen cases) who underwent the surgery between September 2023 and March 2024. The method involved gaining percutaneous access to the pelvicalyceal system, inserting a 4-French Fogarty balloon catheter through a pigtail nephrostomy catheter, and inflating the balloon at the proximal or mid-ureter. Results: All 17 cases achieved technical successful with no major complications. The procedure effectively relieved symptoms associated with urinary leakage in most patients. However, the significant deflation of the balloon catheter occurred in five cases (29.4%), with three (17.6%) experiencing complete deflation. In these five cases, the final balloon size was 5.81 mm (range: 0-8.9 mm), confirming a 25.0% decrease in size from pre- to post-procedure. Ureteral occlusion was 28.3 d long on average (range: 8-57 d). All patients experienced symptom relief during temporary ureteral occlusion. Except for two patients lost to follow-up, three patients showed symptom improvement with only PCN and four patients underwent surgical closure of the fistula tract before or after balloon catheter removal. Conclusions: This study confirms that this approach is safe and effective.

Conversión y explantación de endoprótesis aórticas / Conversion and explantation of aortic endografts

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Uso de balões intrauterinos em pacientes com hemorragia pós-parto / Use of intrauterine balloons in patients with postpartum haemorrhage

A hemorragia pós-parto é uma complicação presente em mais de 18% dos nascimentos e responsável por cerca de 25 a 30% das mortes maternas no mundo. No Brasil, apesar da ampliação do acesso aos serviços de saúde e da melhoria em praticamente todos os indicadores de saúde materna, esta etiologia continua se apresentando entre os três principais grupos de causas de morte no ciclo grávido-puerperal. Nas últimas décadas, várias técnicas conservadoras visando o controle hemorrágico no período pós-parto têm sido relatadas, com destaque para as técnicas de desvascularização uterina, suturas compressivas, embolização arterial, balões intrauterinos e a interrupção do ato operatório com laparostomia, empacotamento pélvico e posterior reabordagem cirúrgica. O presente artigo apresenta uma revisão do uso de balões intrauterinos no controle hemorrágico com destaque para os tipos, aplicabilidades e cronologia de invenção e publicações. Foram avaliados os balões de Sengstaken-Blakemore, os artesanais, as sondas de Foley, balão de Rusch, de Bakri e o BT-cath. Detalhou-se também o teste do tamponamento e a técnica do "sanduíche uterino".(AU)

Postpartum hemorrhage is present in over 18% of births and accounts for 25-30% of maternal deaths worldwide. In Brazil, despite the expansion of access to health care and the improvement of virtually all maternal health indicators, such etiology is still present among the three main causes of death during pregnancy and childbirth. In the last decades, several conservative techniques direct at controlling hemorrhage in the postpartum period have been reported, principally techniques of uterine devascularization, compression sutures, arterial embolization, intrauterine balloons and surgery interruption with laparostomy, pelvic packing and subsequent surgical intervention. This article presents a review of the use of intrauterine balloons in controlling hemorrhage especially types, applicability and chronology of invention and publications. Sengstaken-Blakemore balloons, the artisanal, Foley probes, Rusch balloon, Bakri and BT-cath were reviewed. The tamponade test and the "uterine sandwich" technique were also detailed.(AU)

Initial Experience with the New Double-lumen Scepter Balloon Catheter for Treatment of Wide-necked Aneurysms

OBJECTIVE: A new double-lumen balloon catheter was being developed for the treatment of cerebral aneurysms. The purpose of this study is to report our initial experience of a double-lumen balloon catheter for the treatment of wide-necked aneurysms. MATERIALS AND METHODS: Seventeen patients (mean age, 63 years; range, 45-80 years) with wide-necked, with or without a branch-incorporated aneurysms, (10 ruptured and 9 unruptured) were treated with balloon-assisted coil embolization using a double-lumen balloon catheter (Scepter C(TM) or Scepter XC(TM)) for 7 months after being introduced to our country. Locations of the aneurysms were posterior communicating artery (n = 7), anterior communicating artery or A2 (n = 7), middle cerebral artery (MCA) bifurcation (n = 3), basilar artery tip (n = 1) and anterior choroidal artery (n = 1). The initial clinical and angiographic outcomes were retrospectively evaluated. RESULTS: Coil embolization was successfully completed in all 19 aneurysms, resulting in complete occlusions (n = 18) or residual neck (n = 1). In one procedure, a thrombus formation was detected at the neck portion of the ruptured MCA bifurcation aneurysm near to the end of the procedure. It was completely resolved with an intra-arterial infusion of Glycoprotein IIb/IIIa inhibitor (Tirofiban, 1.0 mg) without any clinical sequela. There were no treatment-related events in the remaining 18 aneurysms. At discharge, functional neurological state improved in 11 patients (10 patients with ruptured aneurysm and 1 with unruptured aneurysm presenting with mass symptoms) and 6 patients with unruptured aneurysms had no newly developed symptoms. CONCLUSION: In this preliminary case series, the newly developed double-lumen Scepter balloon appears to be a safe and convenient device for coil embolization of wide-necked aneurysms.