Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results
| Autor: | Jose Maria Egaña Barrenechea, Gerhard Rümenapf, Mariano de Blas Bravo, Cetin Kocaer, Kornelia Hirsch, Gerard Mertikian, Alexander Oberhuber, Eliza Pleban, Carlos Vaquero Puerta, Sven Seifert, Jan Brunkwall, Thorsten Theis, Afshin Assadian, Piotr Szopiński, Jost-Philipp Schäfer, Mirko Esche, Alvaro Revilla Calavia, Jasper Schupp, Payman Majd, Joerg Heckenkamp, Semih Buz, Spyridon N. Mylonas |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Computed Tomography Angiography medicine.medical_treatment 030204 cardiovascular system & hematology Prosthesis Design Blood Vessel Prosthesis Implantation 03 medical and health sciences Postoperative Complications 0302 clinical medicine medicine.artery Humans Medicine Radiology Nuclear Medicine and imaging Prospective Studies 030212 general & internal medicine Iliac Aneurysm Survival rate Vascular Patency Aged Aged 80 and over business.industry Endovascular Procedures Stent External iliac artery General Medicine Middle Aged medicine.disease Common iliac artery Internal iliac artery Blood Vessel Prosthesis Surgery Stenosis Treatment Outcome Feasibility Studies Female Stents medicine.symptom Cardiology and Cardiovascular Medicine business Claudication Aortic Aneurysm Abdominal |
| Zdroj: | Vascular. 26:647-656 |
| ISSN: | 1708-539X 1708-5381 |
| DOI: | 10.1177/1708538118789510 |
| Popis: | Objectives To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. Methods A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. Results Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53–90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. Conclusions The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194. |
| Databáze: | OpenAIRE |
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