Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR). METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion. RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1). CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

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.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

OBJECTIVES: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). BACKGROUND: Drug-eluting BVS has shown promise in coronary arteries. METHODS: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. RESULTS: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. CONCLUSIONS: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).

Tracheotomy: clinical review and guidelines.

Tracheotomy is a commonly performed procedure. The Belgian Society of Pneumology (BVP-SBP) and the Belgian Association for Cardiothoracic Surgery (BACTS) developed guidelines on tracheotomy for mechanical ventilation in adults. The levels of evidence as developed by the American College of Chest Physicians (ACCP) were used. The members of the guideline committee reviewed peer-reviewed publications on this subject. After discussion, a proposal of guidelines was placed on the website for remarks and suggestions of the members. Remarks and suggestions were discussed and used to adapt the guidelines when judged necessary. The different techniques of tracheotomy are described. The potential advantages and disadvantages of surgical and percutaneous tracheotomy versus endotracheal intubation are discussed. An overview of early and late complications is given. Low-pressure, high-volume cuffs should be used. The cuff pressure should be monitored with calibrated devices and recorded at least once every nursing shift and after manipulation of the tracheotomy tubes. Inspired gas should be humidified and heated. Regarding the timing of tracheotomy there are not enough well-designed studies to establish clear guidelines. Therefore, the timing of tracheotomy should be individualised. In critically ill adult patients requiring prolonged mechanical ventilation, tracheotomy performed at an early stage (within the first week) may shorten the duration of artificial ventilation and length of stay in intensive care. Percutaneous dilatational tracheotomy (PDT) appears to be at least as safe as surgical tracheotomy (ST) as measured in terms of peri-procedural complications. With PDT, less wound infection is observed. When PDT is compared to ST performed in the operating room, PDT is less expensive, reduces the time between the decision and the performance of tracheotomy and has a lower mortality rate. Different techniques of PDT are discussed. We recommend performing PDT under bronchoscopic guidance. Because of its technical simplicity and short procedure time, the modified Ciaglia Blue Rhino technique is advocated as technique of choice. PDT should be considered the procedure of choice in elective non-urgent tracheotomy. There are some relative contraindications for PDT, but with growing experience, they become less frequent.

Heparin-bonded expanded polytetrafluoroethylene vascular graft for femoropopliteal and femorocrural bypass grafting: 1-year results.

OBJECTIVE: Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency. METHOD: From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses. RESULTS: All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%. CONCLUSIONS: In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.

Belgian experience with FilterWire EX in the prevention of embolic events during carotid stenting.

PURPOSE: To evaluate the performance of the FilterWire EX for the capture and removal of debris and prevention of embolic events during endovascular carotid interventions. METHODS: In the period from October 2001 to May 2002, 100 patients (60 men; mean age 72 years, range 48-90), 69 symptomatic with >or=50% internal carotid artery (ICA) stenosis and 31 asymptomatic with >or=70% stenosis were scheduled for carotid stenting with cerebral protection provided by the FilterWire EX system. Satisfactory performance of the filter was defined as effectiveness in preventing intraprocedural embolic events shown by visible debris in the filter and unchanged neurological status assessed by an independent neurologist. RESULTS: The placement and retrieval of the FilterWire EX was technically successful in 93 of 100 patients. Five delivery failures were due to severe ICA angulation; one stenosis was underestimated on preprocedural imaging, and one case was aborted following a major stroke during sheath manipulation before filter introduction. In 56.9% of the protected cases, the filter contained debris. One neurological event occurred 6 hours after the procedure: a transient ischemic attack from which the patient recovered fully after 2 hours. No other procedure-related events were recorded within 30 days of the procedure. The procedural success among the 93 patients stented under FilterWire EX protection was 98% (92% by intention to treat). CONCLUSION: The FilterWire EX appears to be an effective tool in the prevention of embolic events and in preserving neurological status during endovascular treatment of carotid artery stenosis.