One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair.

OBJECTIVE: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year. METHODS: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days. RESULTS: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients. CONCLUSIONS: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

Prediction of Survival after 48 Hours of Intensive Unit Care following Repair of Ruptured Abdominal Aortic Aneurysm-Multicentric Study for External Validation of a New Prediction Score for 30-Day Mortality.

BACKGROUND: Ruptured abdominal aortic aneurysm (rAAA) remains a critical life-threatening condition. We aimed to evaluate rAAA management in our center focusing on predictors of mortality at 48 hr of intensive care unit (ICU) and to develop a new mortality prediction score considering data at 48 hr postprocedure. External validation of the modified score with patient data from independent vascular surgery centers was subsequently pursued. METHODS: Clinical data of all patients admitted in our center from January 2010 to December 2017 with the diagnosis of rAAA were retrospectively reviewed for the development of the mortality prediction score. Subsequently, clinical data from patients admitted at independent centers from January 2010 to December 2017 were reviewed for external validation of the score. Statistical analysis was performed with SPSS Version 25. RESULTS: A total of 78 patients were included in the first part of the study: 21 endovascular aneurysm repairs (EVARs), 56 open repairs (ORs), and 1 case of conservative management. Intraoperative mortality in EVAR and OR groups was 0% vs. 24.6%, respectively (P = 0.012). Thirty-day mortality reached 50% and 33% in the OR and EVAR groups. For patients alive at 48 hr, 30-day mortality diminished to 27.6%. Several preoperative predictors of outcome were identified: smoking (P = 0.004), hemodynamic instability(P = 0.004), and elevated international normalized ratio (P < 0.0001). Dutch Aneurysm Score and Vascular Study Group of New England Score (VSGNE) were also significant predictors of outcome (area under the receiver operating characteristic curve [ROC AUC] 0.89 and 0.79, respectively; P < 0.0001). At 48 hr of ICU stay, high lactate level, high Sequential Organ Failure Assessment score, need for hemodyalitic technique, and hemodynamic instability were significant risk predictors for 30-day mortality (P < 0.05). VSGNE score was modified with the inclusion of 2 variables: hemodynamic instability and lactate level at 48 hr and a new score was attained-Postoperative Aneurysm Score (PAS). Comparing AUC for VSGNE and PAS for patients alive at 48 hr, the latter was significantly better (AUC 0.775 vs. 0.852, P = 0.039). The PAS was applied and validated in 3 independent vascular surgery centers (AUC VSGNE 0.782 vs. AUC PAS 0.820, P = 0.027). CONCLUSIONS: Despite recent evidence on preoperative predictors of survival in an era when both EVAR and OR are available, emergent decision to withhold life-saving treatment will always be extremely difficult. Therefore, the policy in our department is to try surgical repair in all cases. It remains important, however, to identify whether late deaths can be predicted, so that unnecessary prolonged treatment can be avoided. A PAS was delineated predicting 30-day mortality significantly better in patients alive at 48 hr. The score was externally applied and validated in independent centers, corroborating the score's usefulness.