The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions.

INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

Chimney technique in combination with a sac-anchoring endograft for juxtarenal aortic aneurysms: technical aspects and early results.

BACKGROUND: Juxtarenal aortic aneurysms (JAAs) pose clinical challenges for vascular specialists. Chimney endovascular sealing (Ch-EVAS) might be an ideal endovascular solution in the treatment of JAAs. We present technical aspects and early clinical results of a multicenter experience with Ch-EVAS. METHODS: This was a retrospective, multicenter study. Between November 2014 and March 2016, 16 patients underwent elective endovascular repair of JAAs with Ch-EVAS of 1 or 2 renal and/or superior mesenteric artery vessels. Essential technical steps, early complications, chimney stent patency, gutter formation, type IA endoleak, 30-day outcome, renal function, and neck characteristics were the endpoints. RESULTS: There were 26 chimney stents implanted with 100% technical success. The intraoperative death and 30 day mortality was 0%. Secondary interventions were required in 3 patients each due to type IA endoleak, limb occlusion and brachial dissection. The latter patient presented with renal chimney stent occlusion and required hemodialysis. One patient was known to have a pulmonary malignancy and left-sided carotid stenosis and sustained a left hemispheric stroke after the endovascular procedure. The preoperative median aortic neck length was 3 mm, after Ch-EVAS the median seal length between endobags and the aortic neck was 25 mm. No further significant changes in neck morphology were found at the one-month follow-up. CONCLUSIONS: Ch-EVAS is an off-the-shelf solution to treat JAAs with high technical success. Longer-term follow-up with a substantial number of patients can answer the question of whether Ch-EVAS is a sustainable technique that is preferred over open surgery or fenestrated endovascular aneurysm repair.

Secondary interventions in patients with autologous arteriovenous fistulas strongly improve patency rates.

BACKGROUND: Nowadays, as a result of more liberal selection criteria, dialysis-dependent patients have become substantially older, more likely to be female and diabetic, and have more comorbidity. The 1-year primary patency rates of arteriovenous fistulas (AVFs) are poor. To improve these results, several secondary interventions can be performed. The aim of this study was to evaluate the results after secondary interventions in patients with an upper extremity AVF. METHODS: Between January 2000 and December 2008, all consecutive patients who underwent construction of an autologous upper extremity AVF were included. Patient characteristics were collected retrospectively from digital patient files and a prospectively recorded database on hemodialysis patients. RESULTS: Between January 2000 and December 2008, 736 hemodialysis access procedures were performed. A total of 347 autologous arteriovenous fistulas (AVFs) were created in 294 patients. The mean age was 62.1 ± 14.7 years, and the majority (66%) of the patients was male. Mean follow-up of all 347 fistulas was 21.9 ± 21.6 months. During follow-up, failure occurred in 209 (60%) of the AVFs. A total of 133 of these failures were followed by a secondary intervention, of which 78 (59%) were endovascular interventions. Twenty-nine patients developed a third failure, and 25 of these patients underwent another intervention, of which 22 were percutaneous transluminal angioplasty for stenosis. Fifteen patients developed a fourth failure, and all of them underwent an intervention. One patient had 11 interventions. The 1- and 2-year primary patency rates were 46% and 36.8%, respectively. The 1- and 2-year primary assisted patency rates were 74.6% and 71.2%, respectively. The 1- and 2-year secondary patency rates were 79.2% and 77.8%, respectively. CONCLUSION: The primary patency rate of AVFs is disappointing. However, due to mostly endovascular secondary interventions, 2-year primary assisted and secondary patency rates of more than 70% can be obtained.

Endovascular management of traumatic ruptures of the thoracic aorta: a retrospective multicenter analysis of 28 cases in The Netherlands.

BACKGROUND: Minimally invasive endovascular treatment of a traumatic rupture of the thoracic aorta is a new strategy in the care of multitrauma patients. We report the experience in The Netherlands with endovascular management of patients with acute traumatic ruptures of the thoracic aorta. METHODS: We reviewed 28 patients with a traumatic thoracic aortic rupture treated with a thoracic aortic endograft between June 2000 and April 2004. All patients underwent treatment at one of the four participating level 1 trauma centers. Data collected included age, sex, injury severity score, type of endovascular graft, endovascular operation time, length of stay, length of stay in the intensive care unit, and mortality. Follow-up data consisted of computed tomographic angiography and plain chest radiographs at regular intervals. RESULTS: All patients (mean age, 40.9 years; SD, 18.5 years) experienced severe traumatic injury, and the mean injury severity score was 37.1 (SD, 7.8). All endovascular procedures were technically successful, and the median operating time for the endovascular procedure was 58 minutes (interquartile range, 47-88 minutes). The overall hospital mortality was 14.3% (n = 4), and all deaths were unrelated to the aortic rupture or stent placement. There was no intervention-related mortality during a median follow-up of 26.5 months (interquartile range, 10-34.6 months). Postoperative data showed no severe endovascular graft- or procedure-related morbidity, except for one patient with an asymptomatic collapse of the endovascular graft during regular follow-up. This was corrected by placing a second graft. CONCLUSIONS: This study shows that the results of immediate endovascular repair of a traumatic aortic rupture are at least equal to those of conventional open surgical repair. Especially in these multitrauma patients with traumatic ruptures of the thoracic aorta, endovascular therapy seems to be preferable to conventional open surgical repair.