The Utrecht endovascular technologies (EVT) experience.
The aim of this report is to review the single center, clinical experience with the Endovascular Grafting System (EGS/Ancure Endovascular Technologies, Menlo Park, Calif, USA) in the Netherlands. The program was started in January 1994 and at the moment of writing consists of 35 patients on an intention-to-treat basis. From January 1994 through January 1995, 11 patients (Group I) were treated. In January 1995, hook breaks of the attachments system were reported and consequently the EVT program was discontinued from January 1995 through January 1996, pending renewal of FDA approval. From January 1996 through October 1997, another 24 patients were treated with the redesigned EGS-II (group II). Patient and aneurysm characteristics are summarized in the table I. All patients were ASA class I-III and were scheduled for elective repair of asymptomatic infrarenal AAA. No compassionate cases or high-risk patients were included in this study. All patients were entered into a prospective follow-up program, including the following studies postoperatively, at 6 weeks, 6 and 12 months, and yearly thereafter. Duplex, plain X-rays and CT-angiography (CTA) with cine-mode post-processing. In Group I, there were 10 tubes and 1 one bifurcated system. The bifurcated EGS was explanted on the 1st postoperative day due to a significant proximal leak and lower back pain. Of the 10 tube grafts, 3 have been explanted. In one case (day 2) due to a proximal endoleak, in another case (at 12 months) due to persistent aneurysm growth with a distal endoleak and in the third case (at 3 years) due to a recurrent endoleak with aneurysm growth after initial spontaneous closure and shrinkage. These conversions and their postoperative courses were uneventful. In two cases, proximal hook breaks were detected after 6 and 15 months, but in both patients the aneurysm diameter has decreased and follow-up exceeds 3 years. Another 2 patients are alive more than 3 years after the procedure without signs of endoleak, but in one the aneurysm failed to shrink, probably due to complete circular calcification. The other 3 patients have died during follow-up (6, 11, and 20 months) from diseases unrelated to the aneurysm: one pancreatic carcinoma that had been missed on CT angiography, one respiratory failure and one myocardia infarction. Overall, at three years 4 out of 11 Group I patients are alive and well, with an excluded aneurysm. In Group II, there were 17 bifurcated grafts, 5 tubes, and 2 patients in whom a tube graft could not be placed because the introduction sheath could not pass the iliac artery. In one case, this was complicated by a tear in the external iliac artery. At conversion, both patients needed a conventional bifurcated graft, one extending into the groin to bypass the damaged external iliac artery. In a third patient, a tear in the distal aortic neck was detected intraoperatively after tube endograft placement. Conversion was performed in the same session. Of the 21 endografts that left the operating room, 2 have been explanted. In one case (day 5) a tear of the proximal neck was detected. Conversion to conventional repair involved suprarenal clamping which led to multiple organ failure in this 82-y/o patient who ultimately died. In the other the bifurcated endograft showed a distal endoleak on one side, which was locally repaired by an iliac interposition graft. Three months later a proximal and left distal endoleak was diagnosed, his aneurysm had not decreased in size, and his iliac interposition graft had occluded. He was then successfully converted to a conventional bifurcated graft. In 9 of the remaining 15 bifurcated and 4 tube grafts, endoleak was detected on the postoperative CTA. Five appeared to have closed spontaneously at 6 weeks, conversion has been scheduled in one, and 3 small endoleaks are being observed (2 weeks, 6 and 12 months). In all 35 attempts, there were four cases of injury to the common femoral artery at the introduction site, wh
Blankensteijn
J D
JD
Department of Surgery, University Hospital Utrecht, The Netherlands.
Mali
W P
WP
Eikelboom
B C
BC
D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D005500:Follow-Up Studies; D006801:Humans; D009426:Netherlands; D011183:Postoperative Complications; D011474:Prosthesis Design; D012189:Retrospective Studies; D016019:Survival Analysis