First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results.

OBJECTIVE: The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here. METHODS: The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites. RESULTS: At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported. CONCLUSION: The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.

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.

Hybrid Repair of an Aneurysm of the Innominate Artery.

INTRODUCTION: Innominate artery aneurysms (IAAs) are rare. They are notorious for causing thromboembolic events. Modern imaging modalities make early detection in an asymptomatic phase possible. In Kieffer group B aneurysms the origin of the innominate artery is affected. Thanks to the combination of open and endovascular techniques, off pump repair is feasible in patients with a fragile aortic arch. During this hybrid procedure the aortic arch is debranched and reinforced with a stent graft. REPORT: A 73 year old white man with a history of extensive thoraco-abdominal aortic reconstructions for aneurysmal disease presented with a progressive Kieffer B IAA of 35 mm. He underwent an off pump hybrid repair. A bifurcated Dacron prosthesis was used for the debranching. The main body originated from the ascending aorta. The right limb was anastomosed to the common ostium of the right carotid and subclavian arteries. The left limb was anastomosed to the left subclavian and carotid artery. The aortic arch was reinforced with a 40 × 162 mm Zenith TX2 endoprosthesis. The endoprosthesis was inserted through a temporary conduit on the main body and deployed during rapid ventricular pacing. The endoprosthesis lined the ascending aorta distal to the debranching up to Ishimaru zone 3. The antegrade insertion prevented excessive manipulation of the aortic arch and the tortuous aorta, which was lined with mural thrombus. Post-operative computed tomography showed a patent debranching with excellent alignment of the endoprosthesis without endoleak. DISCUSSION: Hybrid repair of the aortic arch is well described in literature. This technique was adapted in the treatment of a Kieffer group B IAA. The tortuous aorta and mural thrombus led to the antegrade placement of the endoprosthesis through the main body of the debranched aorta. This approach seems safe and feasible.

Salvage Lobectomy to Treat Necrotizing SARS-CoV-2 Pneumonia Complicated by a Bronchopleural Fistula.

We report a case of necrotizing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia complicated by a bronchopleural fistula and treated by decortication and salvage lobectomy. Owing to the unknown characteristics of the underlying SARS-CoV-2 infection, treatment of the abscess and bronchopleural fistula was delayed. This may have resulted in further deterioration of the patient, with ensuing multiple organ dysfunction. Complications of SARS-CoV-2 pneumonia, such as a bacterial abscess and a bronchopleural fistula, should be treated as if the patient were not infected with SARS-CoV-2.

Surgical rejoining of small arm veins to enhance dialysis fistula maturation.

Non-maturation of arteriovenous fistulas is a frequent problem after dialysis access creation, especially in the forearm. The presence of accessory veins may play an important role in the non-maturing fistula. Several surgical and endovascular techniques are described to deal with this problem. We describe a new surgical technique in which we perform a rejoining of the arm veins to create a single large run-off vessel with greater diameter and flow for haemodialysis.