Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Y-shaped stenting of brachiocephalic vein in a symptomatic hemodialysis patient.

Stenosis or obstruction of neck great veins represent a frequent and severe complication in hemodialysis patients. Endovascular treatment with percutaneous transluminal angioplasty and/or stenting of these veins is the gold standard to restore patency. However, the jugular vein is frequently overstented in these cases and this might lead to persistent symptomatology of those patients also losing an access for future catheter placement. Herein, we present the 6-months performance of a Y-shaped stenting of the brachiocephalic and internal jugular vein leading to complete resolution of the symptoms, and maintenance of the jugular vein access.

Hybrid angioplasty-catheter placement procedure performed in a hemodialysis patient with central venous obstruction disease. Presentation of a case.

Obstruction or occlusion of the central veins (Central venous disease, CVD) represents a major complication in hemodialysis patients (HD) limiting central venous access available for a central venous catheter placement. Endovascular treatment with percutaneous transluminal angioplasty (PTA) is the first therapeutic option to restore patency and gain access. This case presents our initial experience of a HD patient with CVD treated with a combination therapy of a balloon PTA to the left brachiocephalic trunk, through the right hepatic vein and standard catheter placement technique to the previously occluded junction of the left internal jugular vein to the left subclavian vein.

Combined Type III and Type II Endoleaks after Endovascular Aneurysm Repair: Presentation of 2 Cases and a Literature Review.

Although endovascular aneurysm repair is a feasible option for high-risk patients resulting in lower perioperative mortality when compared with open repair, the need for reintervention and long-term follow-up affects its use. The aim of the current report is to present 2 cases of patients with type IIIa endoleak from limb disconnection (one patient with double-bilateral endoleak) combined with a late type II endoleak and symptomatic sac growth treated in our department. We also performed a literature review about type III endoleaks and their treatment options.

Thrombolysis in Acute Lower Limb Ischemia: Review of the Current Literature.

BACKGROUND: Catheter-directed thrombolysis (CDT) is a therapeutic option with acceptable results in patients with acute limb ischemia (ALI) but with severe systemic or intracranial bleeding being the most significant clinical complication. The aim of the study is to collect and present direct results of CDT in patients treated for ALI. METHODS: Reports on CDT treatment in ALI until December 2016 were searched in PubMed using the keywords catheter direct thrombolysis, acute lower limb ischemia, and any combination. RESULTS: A total of 256 clinical trials were identified. After the exclusion criteria were applied, 10 articles were selected including 1,249 patients and 1,361 lower extremities treated for ALI. Acute thrombosis of a limb artery or bypass graft was the main cause of ischemia ranging from 77.7% to 98.0%. The overall technical success rate of the applied method reached 79.3% (1,079 successful cases). Complications of any type occurred in 358 (28.7%) patients. Of them, 72 (20.1%) experienced a minor complication while 286 (79.9%) had a major life-threatening complication. The need for secondary interventions was 77.8% (935 patients). The death rate during the first month was 4.2% (56 patients), while the percentage of patients who suffered amputation because of a failed thrombolysis during the same period was 11.5% (156 patients). Finally, the survival rate without amputation within 30 days was 88.5% (1.105 out of a total of 1,249 patients studied). CONCLUSIONS: Results confirm the high direct technical success rate of CDT and the high percentage of patients survived without amputation within 30 days, although major complications are a great disadvantage of the method.

AAA Rupture and Psoas Hematoma due to Type II Endoleak from Inferior Mesenteric Artery "Unusual" Collaterals.

Although endovascular aneurysm repair (EVAR) in the abdominal aorta has reduced the perioperative mortality when compared with open repair, the need for reintervention after complications such as endoleak may be presented in up to 20% of the cases. Type II endoleak from branch vessels is often benign but can potentially be associated with progressive abdominal aortic aneurysm growth and sac expansion. We present a rare case of a patient who presented with sac expansion and psoas hematoma due to Type II endoleak from "unusual" collaterals of IMA and was treated successfully with endoleak microembolization and percutaneous decompression of the hematoma.

Fenestrated and Branched Stent Grafting in Complex Aneurysmatic Aortic Disease: A Single-Center Early Experience.

BACKGROUND: The aim of this study is to present our early experience and highlight the technical difficulties associated with the use of fenestrated and branched stent grafts to treat patients with juxtarenal abdominal aortic aneurysm (AAA), pararenal AAA, and thoracoabdominal aortic aneurysms (TAAAs). METHODS: A prospectively held database maintained at our department was queried for patients who have undergone branched and fenestrated stent grafting for AAA or TAAA treatment. Indication for repair, comorbidity precluding open repair, technical challenges associated with the repair, as well as operative mortality, morbidity, and reintervention rate were evaluated. RESULTS: A total of 8 patients underwent repair with a fenestrated or branched stent graft. All patients had aneurysmal degeneration of the juxtarenal aorta, pararenal aorta, and thoracoabdominal aorta not suitable to standard endovascular techniques. Two patients had a prior aortic repair, a failed migrated stent graft, and an old surgical tube graft after an open repair. One patient had a type III TAAA and 1 patient had a postdissection TAAA type I. For all patients, target vessel success rate was 96.4% (27/28) and mean hospital stay was 6.0 days (range 3-21). Thirty-day and 1-year mortality were 0%. Mean follow-up was 23 months (range 7-45). Two endoleaks occurred, 1 type III and 1 type II, which were treated endovascularly. No death or major complication occurred during follow-up. CONCLUSIONS: Fenestrated and branched endovascular stent grafts can be used to repair juxtarenal AAA, pararenal AAA, and TAAA in patients with significant comorbidities. However, several technical challenges have to be overcome due to the unique complex aortic pathology of each patient.

Endovascular Treatment of Type Ib Endoleak after Evar Using the IBD Device: A Case Report.

In the modern endovascular era, abdominal aortic aneurysm repair is still not free of complications with re-interventions following endovascular aneurysm repair (EVAR) being more common than with open surgical repair. A variety of endovascular, open surgical and combined techniques were described according to the anatomical considerations and general health of the patient to achieve the best possible result after these complications. In cases of type Ib endoleak following aorto-uni-lateral EVAR for an abdominal aortic aneurysm, the use of the internal branched device (IBD) constitutes a safe and effective technique.