Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

Aortic balloon occlusion (REBOA) in pelvic ring injuries: preliminary results of the ABO Trauma Registry.

EndoVascular and Hybrid Trauma Management (EVTM) has been recently introduced in the treatment of severe pelvic ring injuries. This multimodal method of hemorrhage management counts on several strategies such as the REBOA (resuscitative endovascular balloon occlusion of the aorta). Few data exist on the use of REBOA in patients with a severely injured pelvic ring. The ABO (aortic balloon occlusion) Trauma Registry is designed to capture data for all trauma patients in hemorrhagic shock where management includes REBOA placement. Among all patients included in the ABO registry, 72 patients presented with severe pelvic injuries and were the population under exam. 66.7% were male. Mean and median ISS were respectively 43 and 41 (SD ± 13). Isolated pelvic injuries were observed in 12 patients (16.7%). Blunt trauma occurred in 68 patients (94.4%), penetrating in 2 (2.8%) and combined in 2 (2.8%). Type of injury: fall from height in 15 patients (23.1%), traffic accident in 49 patients (75.4%), and unspecified impact in 1 patient (1.5%). Femoral access was gained pre-hospital in 1 patient, in emergency room in 43, in operating room in 12 and in angio-suite in 16. REBOA was positioned in zone 1 in 59 patients (81,9%), in zone 2 in 1 (1,4%) and in zone 3 in 12 (16,7%). Aortic occlusion was partial/periodical in 35 patients (48,6%) and total occlusion in 37 patients (51,4%). REBOA associated morbidity rate: 11.1%. Overall mortality rate was 54.2% and early mortality rate (≤ 24 h) was 44.4%. In the univariate analysis, factors related to early mortality (≤ 24 h) are lower pH values (p = 0.03), higher base deficit (p = 0.021), longer INR (p = 0.012), minor increase in systolic blood pressure after the REBOA inflation (p = 0.03) and total aortic occlusion (p = 0.008). None of these values resulted significant in the multivariate analysis. In severe hemodynamically unstable pelvic trauma management, REBOA is a viable option when utilized in experienced centers as a bridge to other treatments; its use might be, however, accompanied with severe-to-lethal complications.

Feasibility and Clinical Outcome of Reboa in Patients with Impending Traumatic Cardiac Arrest.

BACKGROUND: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) may improve Systolic Blood Pressure (SBP) in hypovolemic shock. It has, however, not been studied in patients with impending traumatic cardiac arrest (ITCA). We aimed to study the feasibility and clinical outcome of REBOA in patients with ITCA using data from the ABOTrauma Registry. METHODS: Retrospective and prospective data on the use of REBOA from 16 centers globally were collected. SBP was measured both at pre- and post-REBOA inflation. Data collected included patients' demography, vascular access technique, number of attempts, catheter size, operator, zone and duration of occlusion, and clinical outcome. RESULTS: There were 74 patients in this high-risk patient group. REBOA was performed on all patients. A 7-10Fr catheter was used in 66.7% and 58.5% were placed on the first attempt, 52.1% through blind insertion and 93.2% inflated in Zone I, 64.8% for a period of 30 to 60 min, 82.1% by ER doctors, trauma surgeons, or vascular surgeons. SBP significantly improved to 90 mm Hg following the inflation of REBOA. 36.6% of the patients survived. CONCLUSIONS: Our study has shown that REBOA may be performed in patients with ITCA, SBP can be elevated, and 36.6% of the patients survived if REBOA placement is successful.

EndoVascular and Hybrid Trauma Management (EVTM) for Blunt Innominate Artery Injury with Ongoing Extravasation.

Innominate artery (IA) traumatic injuries are rare but life-threatening, with high mortality and morbidity. Open surgical repair is the treatment of choice but is technically demanding. We describe a case of blunt trauma to the IA with ongoing bleeding, treated successfully by combined (hybrid) endovascular and open surgery. The case demonstrates the immediate usage of modern endovascular and surgical tools as part of endovascular and hybrid trauma management.

Onyx Embolization as Single Rescue Treatment for Ruptured Abdominal Aortic Aneurysm After EVAR.

A 76-year-old man who had undergone endovascular repair for an infrarenal aortic aneurysm, presented with a late type Ia endoleak 3 years after his operation. Deployment of an aortic cuff did not achieve a better seal at the proximal neck, and the aneurysm developed a rupture. We successfully treated the ruptured aneurysm using transcatheter Onyx embolization only. At 6-month and 1-year follow-ups with contrast-enhanced duplex scanning, no endoleak was seen and sac shrinkage was observed. Onyx is a relatively new liquid embolic agent that is slowly transformed into a solid state by contact with blood. Owing to this unique characteristic, Onyx embolization can be a useful technique for stopping bleeding from an aneurysm in an emergency situation. This is a unique case of the use of an embolization agent in the treatment of aortic aneurysm rupture.

Endovascular Repair of a Ruptured Aortic Extra-anatomic Bypass Pseudoaneurysm After Previous Coarctation Surgery.

We present a short case of a total endovascular repair of a ruptured thoracic pseudoaneurysm after previous coarctation aortic conduit bypass surgery. A 67-year-old man with two previous coarctation repairs many years ago was admitted with chest pain, dyspnea, and hemoptysis. Computed tomography showed a rupture in the distal anastomosis of the thoracic extra-anatomic graft. Successful treatment was achieved by placement of an endovascular stent graft between the old graft and the native aorta and with a vascular plug occlusion of the native aorta.

Embolization with Onyx in iatrogenic bleeding of the gluteal region.

We report a unique method using transcatheter Onyx embolization in a bleeding due to morphine injection in the gluteal region. A 47-year-old man with a rare blood type presented a painful gluteal hematoma due to iatrogenic injury. A computed tomographic angiography verified bleeding from a suspected branch of the deep femoral artery. Because of the unbearable pain, the hematoma was evacuated by means of computed tomography (CT)-guided puncture and the insertion of a pigtail catheter combined with the injection of a human plasminogen activation agent (t-PA). The initial result was positive. To stop the bleeding, angiographic embolization with Onyx was successfully used. Onyx can be used in small vessel bleedings and might offer the advantage of selective embolization in cases where the access to the bleeding vessel is challenging or time-consuming.