Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Two-Stage Endovascular Treatment of a Traumatic Pseudoaneurysm of Superior Mesenteric Artery Branch in a Soldier After a Military Combat Mission.

Aneurysms and pseudoaneurysms of the visceral arteries are a rare pathology with a prevalence of 0.1-2% in the general population, most common in men. Despite low prevalence, visceral aneurysms pose a significant threat to the patient's health and life; a ruptured superior mesenteric branch aneurysm carries mortality rates of 10-25% and up to 30-90%. This article presents a case of a 50-year-old former active duty soldier and veteran of a military combat mission in Afghanistan, during which he sustained a traumatic injury resulting from a mine explosion under a vehicle. After completing the mission and returning home, the patient developed abdominal pain. The diagnosis made in the general surgery department of the district hospital was upper gastrointestinal obstruction and aneurysmal rupture of the superior mesenteric branch with inflammatory infiltration of the pancreatic-intestinal area. The patient underwent emergency gastrointestinal anastomosis and Braun enteroenterostomy. The aneurysm was not resected. One month later, the patient underwent a follow-up abdominal angiotomography, which revealed an approximately 20-mm aneurysm of a branch of the superior mesenteric artery and celiac artery subocclusion (Dunbar syndrome) with extensive collateral circulation. A diagnosis of pseudoaneurysm/traumatic aneurysm was made, and the patient was referred to a vascular surgery center for endovascular treatment. Following CT angiography, a decision was made to perform a two-stage endovascular repair. The first stage was a bridge therapy aimed to release celiac artery subocclusion with a stent; after 3 weeks, pseudoaneurysm embolization was performed. The decision to use two-stage endovascular treatment was attributable to the risk of gastrointestinal ischemia that might result from intraoperative technical difficulties and complications, coil dislocation, and thrombosis of the superior mesenteric artery or its branch; the coexisting subocclusion of the celiac artery was also considered. The patient was discharged in good condition and returned to normal everyday activities. He also continued follow-up appointments with a vascular surgeon. An angiotomography performed at 1 year of endovascular treatment confirmed good effects of the embolization procedure and coagulation of the aneurysm. Visceral aneurysms are a rare vascular pathology but are associated with significant morbidity and mortality rates. The incidence of ruptured aneurysms is probably underestimated as some patients may be operated on for acute abdominal symptoms, e.g., bowel obstruction.

[Transcutaneal drainage intrahepatic biliary ducts as a method of paliative treatment of inoperative liver hilum tumours]. / Przezskbórny drena, wewnatrzwatrobowych dróg zolciowych jako metoda leczenia paliatywnego w nieoperacyjnych guzach wneki watroby.

The aim of the study is determine, that transhepatic,transcutaneal drainage of the bile ducts is the method of palliative treatment of inoperative liver hilum tumours. In the years 1998-2011, 211 patients with malignant obturation of the liver hilum were palliative treated by transcutanel, transhepatic drainage with US control. Patients with inoperative, malignant tumours of liver hilum in terminal state were included. More than 5 mm, minimal wideness of bile duct was the main term of qualification to procedure. The procedures were performed either with US puncture guide-line or with "free-hand" technique, using one or two steps Seldinger method drains. In cases of problem with US identification of the place of fixation of the drain, fluoroscopy examination was performed. Quality of life of the patients was increased. The icterus parameters were decreased, depends of the volume of drainage of the bile. Taking in account the improvement of overall patient status and relative prolongate of live, transcutaneal, transhepatic drainage of the bile ducts has a place as a method of palliative treatment of inoperative obturation of the liver hilum.

Prospective multicentre study of carotid artery stenting using the MER™ Stent - the OCEANUS study - 30-day and one-year follow-up results.

INTRODUCTION: Constant technological progress in the field of carotid stenting translates into improved short- and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. AIM: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation. MATERIAL AND METHODS: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. RESULTS: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. CONCLUSIONS: The OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.