Multicenter pivotal trial results of the Lifepath System for endovascular aortic aneurysm repair.

This study was undertaken to assess the results of endovascular aortic aneurysm repair with the Lifepath abdominal aortic aneurysm (AAA) graft system. In a prospective clinical trial, 23 centers used the Lifepath System balloon-expandable, modular bifurcated stent graft for elective endovascular aortic aneurysm repair. Stent grafts were sized according to computed tomographic angiography-based diameter measurements. All repairs were performed in the operating room through bilateral surgically exposed femoral arteries. Results were assessed with contrast agent-enhanced computed tomography scans and plain abdominal x-ray films at 1, 6, 12, 24, 36, and 48 months postoperatively. Over 52 months (mean follow-up, 11 months), 227 patients (206 men, 21 women) were enrolled. Technical implant success rate was 98.7%. There were five (2.2%) conversions to open surgery: two emergently because of aortic perforation; to treat refractory endoleak, immediate in one and at 12 months in one; and to replace a device with wireform fractures that had migrated at 12 months, resulting in a proximal endoleak. The perioperative mortality rate was 1.3%. There was one operative death during a secondary procedure to repair perforation of the aorta. There were two perioperative deaths, from postoperative myocardial infarction (n = 1) and pulmonary embolus (n = 1). There were 12 late deaths, from coronary artery disease (n = 4), cancer (n = 2), respiratory failure (n = 2), sepsis (n = 1), or unknown cause (n = 3). Median length of stay was 2 days (mean, 4 days). There have been no AAA ruptures after successful implantation of the device, no graft limb thromboses, and no limb dislocations. At the time of operation endoleak was noted in 43 (19%) patients, but by 6 months this was reduced to 8 (5.9%) patients (type I, n = 1; type II, n = 7). There were no type III or type IV endoleaks. Secondary interventions to treat endoleaks included open conversion (n = 2), placement of extension cuffs (n = 4), repeated balloon dilation (n = 3), and coil embolization (n = 6). The two remaining secondary interventions were emergent treatment of postoperative bleeding from a groin incision, and a colon resection because of postoperative colonic ischemia, for a 12-month secondary intervention rate of 7.5%. Wireform fractures were noted in the first generation Lifepath device in 37 of 79 (47%) patients. Graft migration (>10 mm) was observed in five patients (2.2%), each of whom also had two or more fractures of the proximal anchoring wireforms. Migration resulted in a proximal attachment endoleak in one patient. In response to wireform fractures, the device was modified after the initial 79 patients were enrolled. Wireform fracture has been observed in six patients since this modification (4%), and in only one patient did this involve fracture of a proximal anchoring wireform; none of these patients has had endoleak or graft migration. By 12 months, mean aneurysm diameter was noted to decrease by 9 mm (P <.0001), and mean aneurysm volume by 42 mL (P <.0001) from the preoperative visit. The Lifepath System demonstrates a low endoleak and secondary intervention rate and high sac regression rate, compared with other devices. The unique balloon-expandable design offers the advantages of precise placement and high radial force. The device appears to be highly resistant to limb thrombosis and modular component separation. Patients were protected from AAA rupture after successful device implantation, and demonstrated significant reduction in AAA diameter and volume. Fractures of the wireforms of the main body of the device have been observed. Careful long-term follow-up is necessary.

Carpenter JP ，Anderson WN ，Brewster DC ，Kwolek C ，Makaroun M ，Martin J ，McCann R ，McKinsey J ，Beebe HG ，Lifepath Investigators ... -  《JOURNAL OF VASCULAR SURGERY》

Midterm results of the multicenter trial of the powerlink bifurcated system for endovascular aortic aneurysm repair.

Carpenter JP ，Endologix Investigators 《JOURNAL OF VASCULAR SURGERY》

Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair.

We assessed the distribution of secondary interventions after aortic stent grafting (EVAR) performed to treat infrarenal abdominal aortic aneurysm (AAA), and evaluated clinical success and survival in patients who underwent a secondary procedure (group 2) compared with patients who did not undergo a secondary procedure (group 1). Two hundred fifty patients (mean age, 71.3 years) with asymptomatic AAAs (mean aneurysm diameter, 54.5 mm) underwent treatment with commercially available stent grafts. Mean follow-up was 28 months (median, 25 months). Secondary procedures were defined as any additional procedures performed after initial graft placement to treat endoleak, migration, kinking, stenosis, or occlusion. Overall clinical success was defined according to reporting standards of the Society for Vascular Surgery/American Association for Vascular Surgery. Sixty-eight patients (27%) required 112 secondary procedures, with a mean time from initial graft placement of 18.2 months. Patients who received grafts since removed from the market required more secondary procedures (59%, procedure:patient ratio) compared with patients who received devices still on the market (21%; P =.001). Thirty-six patients (53%) required a single secondary procedure, 24 patients (35%) required two procedures, 5 patients (10%) required three procedures, 2 patients (3%) required four procedures, and 1 patient required five secondary procedures. Ninety-eight procedures (87%) were performed with endovascular methods, including placement of 42 additional covered stent grafts (36 iliac, 6 aortic), with a success rate of 85%; 35 embolization procedures (21 lumbar, 9 internal iliac artery, 5 mesenteric), with only 23 (65%) successful; 14 angioplasty procedures, with 85% successful; 4 thrombolysis procedures, 2 of them successful (50%); and 3 successfully placed new endografts within a previous endovascular graft. Surgical secondary operations included nine femorofemoral bypass procedures and three femoral thromboendarterectomies, all of which remain patent; one cerclage of an external iliac limb; and one laparoscopic repair of a type II endoleak, which was successful. Overall clinical success rate for EVAR was 84% (211 of 250) in this series. Clinical success rate in groups 1 and 2 was 91% (166 of 182) versus 66% (45 of 68; P =.001) if all endoleaks on the most recent computed tomography scans are taken into account, and 94% (171 of 182) versus 76% (52 of 68; P =.001) if type II endoleak without aneurysm growth is not considered failure. The survival rate and rupture-free survival in groups 1 and 2 were, respectively, 97.7% +/- 1.0% and 98.5% +/- 1.4% at 1 month, 95.9% +/- 1.5% and 96.9% +/- 2.1% at 6 months, 94.4% +/- 2.0% and 93.2% +/- 3.4% at 1 year, and 80.8% +/- 5.2% and 88.5% +/- 5.0% at 3 years (P =.273, log-rank test). With close follow-up and a significant number of secondary operations, this 8-year experience has not included any aneurysm ruptures to date. Secondary operations did not lead to increased mortality, but were associated with more surgical conversions and with a higher clinical failure rate.

Becquemin JP ，Kelley L ，Zubilewicz T ，Desgranges P ，Lapeyre M ，Kobeiter H ... -  《JOURNAL OF VASCULAR SURGERY》

[Endovascular therapy of abdominal aortic aneurysm: results of a mid-term follow-up].

Prospective study to evaluate clinical results and complications of endovascular abdominal aortic aneurysm treatment in a mid-term follow-up. A total of 122 patients (9 females, 113 males, average age 70.9 +/- 7.9 years) with abdominal aortic aneurysms were treated with stent grafts (53 Vanguard or Stentor endografts, 69 Talent endografts). Group I consisted of 40 patients who had all aortic tributaries of the aneurysm sac occluded prior to endovascular grafting, either spontaneously by parietal thrombosis or by selective coil embolization of the respective ostia preserving collateral circulation distal to the vessel occlusion. Group II consisted of 82 patients and included all cases without or with incomplete coil embolization with at least one patent vessel. Stent grafting was performed in general anesthesia in the first 21 patients, followed by peridural anesthesia in 15 cases, and local anesthesia with conscious sedation in 86 cases. The results were evaluated with Spiral-CT, MRI and radiographs of the endovascular graft, with follow-up examinations obtained at 3, 6, 12 months, and every year. Implantation was successfully completed in all cases without primary conversion surgery, laparotomy, or any significant complication. Mean follow-up was 29 +/- 21 months (maximum 84 months). The 30-day mortality was 0.8 % due to a myocardial infarction 3 days after discharge from the hospital. A total of 47 re-interventions were performed in 29 patients (23.8 %), with 35 re-interventions in 18 cases with Vanguard or Stentor endografts and 12 re-interventions in 11 patients with Talent endografts. 23 percutaneous re-interventions included distal graft extension (n = 11), Wallstents for kinking and limb stenosis (n = 3), and secondary coil embolization of collateral vessels (n = 9). 24 surgical re-interventions included proximal graft extension (n = 6), new endovascular grafts (n = 3), surgical clipping of lumbar and mesenteric artery branches for type-II endoleaks following ineffective secondary coil embolization (n = 1), and femorofemoral crossover bypasses (n = 4). A total of 10 secondary conversion operations were performed because of damage to the membrane (n = 4; 3 Vanguard endografts, 1 Talent endograft), significant caudal migrations (n = 5; 4 Vanguard endografts, 1 Talent endograft) associated with type-I endoleaks (n = 2), limb occlusion (n = 1), disconnection of graft components (n = 1), and significant endoluminal thrombus deposits (n = 1). One patient, who was followed for 82 months, suffered from a significant endoleak for 10 months with increasing aneurysm diameter but he refused surgery. He was admitted with aneurysm perforation and was successfully operated with aortic graft replacement. Compared to group II, the incidence and size of endoleaks was reduced in group I (incidence 19.2 % versus 29.9 %, p < 0.05). Group I demonstrated significantly better aneurysm shrinkage at 36 months follow-up (Delta sagittal diameter - 11.1 +/- 8.4 mm versus - 4.9 +/- 6.2 mm, p < 0.05). In selected patients, endovascular aneurysm treatment is an effective alternative to open surgery. It is safely performed in local anesthesia with low mortality rate and a low number of acute complications. Intermediate follow-up revealed re-interventions in around one quarer of all patients, especially when Vanguard or Stentor endografts were implanted. Primary coil embolization of all aortic branches prior to endovascular grafting improves clinical outcome. Insufficient proximal fixation and its consecutive complications remains a major problem of this method.

Pitton MB ，Schweitzer H ，Herber S ，Schmiedt W ，Neufang A ，Düber C ，Thelen M ... -  《-》

Lessons learned from the long-term follow-up of a first-generation aortic stent graft.

Alric P ，Hinchliffe RJ ，Wenham PW ，Whitaker SC ，Chuter TA ，Hopkinson BR ... -  《JOURNAL OF VASCULAR SURGERY》