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.

Common Designs of Custom-Made Fenestrated Arch Devices and Applicability of an Off-the-Shelf Design.

OBJECTIVES: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. MATERIALS AND METHODS: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. RESULTS: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. CONCLUSION: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. CLINICAL IMPACT: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.

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.

Pre-Loaded Fenestrated Thoracic Endografts for Distal Aortic Arch Pathologies: Multicentre Retrospective Analysis of Short and Mid Term Outcomes.

OBJECTIVE: To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies. METHODS: This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan-Meier survival analysis. RESULTS: One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 - 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively. CONCLUSION: This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates.

Treatment of iliac artery bifurcation aneurysms with the second-generation straight iliac bifurcated device.

BACKGROUND: There are few long term studies to show the safety and efficacy of iliac artery aneurysm exclusion, especially in regards to the straight iliac branched device. The objective of our study was to add our data with a mean follow-up of 32 months to the existing data available. METHODS: Patients undergoing iliac bifurcation procedure either as standalone or in combination with abdominal aortic aneurysm exclusion at two vascular centers had data prospectively gathered between 2004 and 2014. Collected data was analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) closure. RESULTS: A total of 45 iliac vessels in 41 patients (36 male) with a mean age of 70.4 years were treated with the iliac branched device. Procedural success was achieved in 85% (35/41) of patients and 87% (39/45) vessels with no intraoperative death. Of the six technical failures, three occurred due to failure to place the straight iliac branched device or stent properly. Two occurred because of endoleaks at the end of the procedure, and one occurred because the IIA side-branch occluded and could not be reopened. The mean patient follow-up was 32.0 ± 27.3 months (range, 0-109 months). During this time period, the IIA patency rate on an intention-to-treat basis was 81%, and the freedom from endoleak rate on an intention-to-treat basis was 76% per patient. The freedom from reintervention per patient was 75%. No patient reported symptoms of pelvic ischemia and permanent buttock claudication. CONCLUSIONS: In this study with mean follow-up of 32 months, treatment with iliac bifurcated devices is a safe and durable option in a carefully selected population of patients with iliac artery bifurcation aneurysms.

Hemangiosarcoma after endovascular aortic aneurysm repair.

PURPOSE: To report a rare case of hemangiosarcoma after endovascular aneurysm repair (EVAR). CASE REPORT: A 50-year-old man with Klinefelter syndrome presented 5 years after EVAR with a mass at the infrarenal aorta outside the stent-graft. Radiomorphologic and clinical signs were misleading because there had been evidence of an inflammatory process for more than a year. The stent-graft with the surrounding aorta was removed and replaced by a conventional tube graft. Systemic chemotherapy followed. The tumor recurred after 12 months, with pulmonary metastases and tumor embolic occlusion of his left femoral artery. Thrombectomy was performed, and a second course of chemotherapy was administered. The patient died 24 months after the conversion procedure. CONCLUSION: Morphological changes of the aneurysm wall seen on computed tomographic scans of EVAR patients may not be incidental or signs of infection; rather, a malignant tumor of the aorta or lymphatic disease, although rare, have to be taken into consideration as well.