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(R) Endovascular Technolog ies, Menlo Park, Calif, USA) in the Netherlands. The program was started in January 1994 and at the moment of writing consis ts 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 br eaks of the attachments system were reported and consequently the EVT progr am was discontinued from January 1995 through January 1996, pending renewal of FDA approval. From January 1996 through October 1997, another 24 patien ts were treated with the redesigned EGS-II (group II). Patient and aneurysm characteristics are summarized in the table I. All pat ients were ASA class I-III and were scheduled for elective repair of asympt omatic infrarenal AAA. No compassionate cases or high-risk patients were in cluded in this study. All patients were entered into a prospective follow-up program, including t he following studies postoperatively, at 6 weeks, 6 and 12 months, and year ly 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 1(st) postoperative day due to a significant prox imal 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 mo nths) due to persistent aneurysm growth with a distal endoleak and in the t hird case (at 3 years) due to a recurrent endoleak with aneurysm growth aft er initial spontaneous closure and shrinkage. These conversions and their p ostoperative courses were uneventful. In two cases, proximal hook breaks we re detected after 6 and 15 months, but in both patients the aneurysm diamet er has decreased and follow-up exceeds 3 years. Another 2 patients are aliv e more than 3 years after the procedure without signs of endoleak, but in o ne the aneurysm failed to shrink, probably due to complete circular calcifi cation. The other 3 patients have died during follow-up (6, 11, and 20 mont hs) from diseases unrelated to the aneurysm: one pancreatic carcinoma that had been missed on CT angiography, one respiratory failure and one myocardi a infarction. Overall, at three years 3 out of 11 Group I patients are aliv e and well, with an excluded aneurysm. In Group II, there were 17 bifurcated grafts, 5 tubes, and 2 patients in wh om a tube graft could not be placed because the introduction sheath could n ot pass the iliac artery. In one case, this was complicated by a tear in th e external iliac artery. At conversion, both patients needed a conventional bifurcated graft, one extending into the groin to bypass the damaged exter nal iliac artery. In a third patient, a tear in the distal aortic neck was detected intraoperatively after tube endograft placement. Conversion was pe rformed in the same session. Of the 21 endografts that left the operating r oom, 2 have been explanted. In one case (day 5) a tear of the proximal neck was detected. Conversion to conventional repair involved suprarenal clampi ng which led to multiple organ failure in this 82-y/o patient who ultimatel y died. In the other the bifurcated endograft showed a distal endoleak on o ne side, which was locally repaired by an iliac interposition graft. Three months later a proximal and left distal endoleak was diagnosed, his aneurys m 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 detecte d on the postoperative CTA. Five appeared to have closed spontaneously at 6 weeks, conversion has been scheduled in one, and 3 small endoleaks an bein g observed (2 weeks, 6 and 12 months). In all 35 attempts, there were four cases of injury to the common femoral a rtery at the introduction site, which was repaired locally in three. In add ition, there was one dissection of the iliac artery successfully treated wi th a Palmaz stent. No signs of distal emboli were found. Operative mortalit y was 1/35 (3 %). All in all, this series achieved a 22/35 (63 %) initial s uccess rate as defined by complete AAA exclusion at 6 weeks postoperatively on an intention to-treat basis. This is one of the oldest series worldwide. Nevertheless, follow-up is limi ted: 12 of 35 patients (34 %) have completed 12 months of follow-up of whom 2 have gone on to conversion due to incomplete AAA exclusion. Only 3 endog rafts are currently out more than 3 years. In conclusion, these results demonstrate endovascular AAA repair to be feas ible and effective if the operation results in complete aneurysm exclusion. Many important issues like endoleaks and device related problems remain un resolved and do not to justify widespread use of this technique outside a c ontrolled trial.