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.

Initial Experience with the Eclipse Double-Lumen Balloon Catheter for Embolization of Cranial Vascular Malformations.

BACKGROUND: Double lumen balloon catheters (DLBCs) have emerged as a potential alternative to single lumen balloon catheters for endovascular embolization of arteriovenous malformations (AVMs) and dural arteriovenous fistulas (dAVFs). This study describes our preliminary experience with the Eclipse 2L DLBC in treating AVMs and dAVFs. METHODS: Patients who underwent embolization of cranial dAVFs or AVMs at our institution from August 2021 to March 2024 were included. Spinal vascular malformations were excluded. Descriptive statistics were used to analyze procedural outcomes, technical nuances, and postoperative outcomes on follow-up. RESULTS: Twenty-five patients who underwent 38 embolization procedures (15 AVMs and 23 dAVFs) met criteria for inclusion in this study. The mean age of the cohort was 52.44 (standard deviation = 17.26), and 48% of the overall cohort (n = 13) was female. The average procedure times for AVMs and dAVFs were 80.4 minutes and 96.73 minutes, respectively. There was 1 instance of catheter entrapment. Two patients in the AVM cohort experienced mortality, and 1 experienced postoperative rupture. CONCLUSIONS: Our preliminary experience using the Eclipse 2L balloon catheter for Onyx embolization reported procedural outcomes comparable to other DLBCs despite relatively higher procedure times and radiation doses. Further long-term studies on its efficacy as primary modality in treating AVMs and dAVFs are encouraged.

Application of balloon occluder for specimen collection after descending duodenal ESD.

Endoscopic submucosal dissection (ESD) is a popular technique for resecting duodenal tumors. However, there is a risk of losing resected specimens during the procedure, particularly for lesions in the descending part of the duodenum. This study aims to introduce a simple and effective method for specimen collection after descending duodenal ESD using a self-made balloon occluder. The balloon occluder, made from a spray pipe and sterile rubber glove, is utilized to prevent the loss of resected specimens. The balloon is inflated under endoscopic visualization, occluding the descending lumen. With careful timing, the resected specimen can be safely collected by grasping it from the balloon using foreign forceps. This method has been successfully applied in several cases, demonstrating its practicality and efficacy. Further evaluation and validation of this technique in a larger patient population are warranted to establish its wider application in clinical practice.

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.

Use of the Scepter Dual-Lumen Balloon Catheter for Transarterial Onyx Embolization of Cranial Dural Arteriovenous Fistulas.

BACKGROUND: Dual-lumen balloon microcatheters allow for controlled anterograde flow of Onyx while providing proximal flow arrest, thereby obviating the need for a second microcatheter or Onyx plug formation. We sought to assess the safety and efficiency of the Scepter dual-lumen balloon microcatheter in trans arterial Onyx embolization of intracranial dural arteriovenous fistulas (DAVFs). METHODS: We conducted a retrospective study of 36 patients with cranial DAVFs in which a Scepter balloon microcatheter was used between 2016 and 2023. RESULTS: Our study comprised 36 patients, mostly male (n = 23, 63.8%) with a mean age of 60.8 years. Most DAVFs were in the occipital lobe (n = 24, 66.7%), and 50% had external carotid artery supply from the occipital artery. Eighteen (50%) of DAVFs were Cognard type III and IV, respectively. About one third (33.3%, n = 12) of the DAVFs drained into the transverse sigmoid junction, and 27.7% (n = 10) had direct cortical venous drainage into supratentorial or posterior fossa veins. Complete occlusion was obtained in 22 (61.1%) patients while partial occlusion was observed in 14 (38.9%) patients. One patient (2.8%) developed a retroperitoneal hematoma. At final follow-up, complete occlusion was observed in 21 (77.8%) and partial occlusion was observed in 8 (22.2%). Recurrence was observed in 4/30 (13.3%) patients, and retreatment was required in 6 (18.75%) cases. CONCLUSIONS: At midterm follow-up, our study showed low morbidity and modest complete occlusion rates using the Scepter for transarterial Onyx embolization of high-grade DAVFs.