12-Monats-Ergebnisse nach perkutaner Implantation einer neuartigen low-profile Aortenbifurkationsprothese zur Behandlung des infrarenalen Bauchaortenaneurysmas
Abstract: Objective: Clinical evaluation of safety and efficacy of the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ) after 12-months, a low-profile device for the treatment of abdominal aortic aneurysms. Methods: From September 2014 to October 2016 we treated 70 patients suffering from infrarenal aortic aneurysm with the low-profile Cordis INCRAFT™ stent-graft prosthesis (75.7 % male; mean age 75.9 ± 6.5 years). Main inclusion criteria included proximal aortic neck length of 10 mm or more with a diameter between 17 to 31 mm; distal iliac landing zones with a length greater than 15 mm and a diameter between 7 and 22 mm; infra- and suprarenal aortic neck angulation < 60°; minimal distance between proximal and distal landing zone >128 mm. The primary end point was technical success including the absence of device- or procedure-related major adverse events, absence of type I, III or IV endoleak, and maintenance of device integrity through a follow up of 12 months. Results: Technical success of the procedure was 100%, all 70 procedures were performed percutaneously. Two patients with ruptured aneurysm died immediately after their operation. CT-angiography control scans were performed on 68, 56 and 47 patients after 1 week, 3 and 12 months, respectively. During this follow up we observed no type I, III or IV endoleak. Type II endoleaks were detected after 1 week, 3 and 12 months in 36.8%, 28.6% and 21.3% of analyzed patients. None of these patients had to be reoperated during the study period. Evaluation of the CT-angiographies during the follow up documented absence of endograft migration and stent fractures in all patients. One patient required a reoperation after two months due to an acute iliac limb occlusion. CT-scans prior to patients` postoperative discharge revealed less perivascular hematoma in the vascular access region compared to standard profile stent-graft systems. Conclusion: The INCRAFT AAA Stent Graft System provides a safe and efficient solution for patients with abdominal aortic aneurysms with a low frequency of device-related events through a follow up of 12 months. Due to the low profile design it could be implanted with less vascular access trauma.
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