Experimental Assessment of Physician Modified Proximal Scalloped Stent Graft to Extend Proximal Landing Zone in the Aortic Arch.

OBJECTIVE/BACKGROUND: The aim of the study was to assess a model of physician modified scalloped stent graft (PMSG) on currently available thoracic aortic devices to extend the proximal landing zone in either zone 2, 1 or 0 of the aortic arch while preserving flow in the supra-aortic vessels on human cadaveric aorta. METHODS: Fresh human aortas were harvested at autopsy from adult subjects. A proximal scallop was made on the stent grafts based on direct measurements on the aortas to extend the proximal landing zone in zone 0 (n = 5), zone 1 (n = 5), and zone 2 (n = 5). A previously described benchtop closed system pulsatile flow model was used to mimic flow and pressure conditions in the aorta to deploy the stent graft as close to physiological conditions as possible. Deployment accuracy of the scallop opposite the aortic arch branch ostia was assessed by completion angiography and post-procedural analysis of the aortas. RESULTS: Fifteen proximal scalloped stent grafts were deployed in the aortic arch of 15 human cadaveric aortas under fluoroscopy. The expected proximal landing zone was achieved in all cases (zone 2 = 5; zone 1 = 5; zone 0 = 5). Post-procedural angiography and direct visual analysis showed supra-aortic vessel patency and deployment of the scallop opposite the aortic arch branch ostia in all cases. CONCLUSION: PMSG to extend the proximal landing zone in zone 2, 1, or 0 in order to treat urgent diseases of the proximal descending aorta or the inner circumference of the aortic arch by a totally endovascular approach while preserving flow in the supra-aortic trunks is experimentally feasible.

Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms.

OBJECTIVES/BACKGROUND: ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms (rAIA) eligible for treatment by either endovascular (EVAR) or open surgical repair (OSR). Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture. METHODS: Randomization was done by week, synchronously in all centers. The primary end point was 30 day mortality. Secondary end points were post-operative morbidity, length of stay in the intensive care unit (ICU), amount of blood transfused (units) and 6 month mortality. RESULTS: From January 2008 to January 2013, 107 patients (97 men, 10 women; median age 74.4 years) were enrolled in 14 centers: 56 (52.3%) in the EVAR group and 51 (47.7%) in the OSR group. The groups were similar in terms of age, sex, consciousness, systolic blood pressure, Hardman index, IGSII score, type of rupture, use of endoclamping balloon, and levels of troponin, creatinine, and hemoglobin. Delay to treatment was higher in the EVAR group (2.9 vs. 1.3 hours; p < .005). Mortality at 30 days and 1 year were not different between the groups (18% in the EVAR group vs. 24% in the OSR group at 30 days, and 30% vs. 35%, respectively, at 1 year). Total respiratory support time was lower in the EVAR group than in the OSR group (59.3 hours vs. 180.3 hours; p = .007), as were pulmonary complications (15.4% vs. 41.5%, respectively; p = .050), total blood transfusion (6.8 vs. 10.9, respectively; p = .020), and duration of ICU stay (7 days vs. 11.9 days, respectively; p = .010). CONCLUSION: In this study, EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality. However, EVAR was associated with less severe complications and less consumption of hospital resources than OSR.

Endovascular management of rupture in acute type B aortic dissections.

OBJECTIVE: Reports of thoracic endovascular aortic repair (TEVAR) for complicated acute type B aortic dissection (ABAD) bring together a large range of clinical presentations. With a 30 day mortality of 50% when managed with open surgery, rupture is the most devastating complication of ABAD. This study investigated the outcome of TEVAR for ABAD complicated by rupture (r-ABAD) to assess the results of this particularly critical subgroup. METHODS: A review of consecutive TEVAR for r-ABAD in two tertiary referral centers was performed using a prospectively maintained database. RESULTS: Between 2000 and 2013, 24 patients (mean age 71 years; 14 males) underwent TEVAR for r-ABAD. Sixteen (67%) were in shock (Systolic blood pressure <80 mmHg) before surgery. Seven patients had coverage of the left subclavian artery, of whom four had partial arch debranching procedures via cervical access concomitant with TEVAR. Median length of aortic coverage was 150 mm, median proximal oversizing was 13.3% (range 6.2-33.3%). Technical success was achieved in 100%. There were four in hospital deaths (16%). Two patients (8%) had paraplegia, but neither stroke nor renal insufficiency requiring dialysis occurred. During a mean follow up of 28 months, there was one aortic dissection related death and eight patients (40% of the surviving patients) required re-intervention. All re-interventions were managed endovascularly. At last follow up CT scan, eight patients (40%) had complete remodeling of the aortic wall. CONCLUSION: With 16% in hospital mortality and 8% early major complications, this study confirms the feasibility of TEVAR for r-ABAD with a lower peri-operative morbidity and mortality rate compared with open surgery. Given the high rate of re-intervention, close follow up is required in surviving patients.

Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial.

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

Open surgical secondary procedures after thoracic endovascular aortic repair.

OBJECTIVES: Improved outcomes of thoracic endovascular aortic repair (TEVAR) compared with open repair have changed the therapeutic paradigm of thoracic aortic lesions. As the number of TEVAR survivors has grown, reports of complications have similarly increased. Although secondary endovascular rescue measures are often undertaken, patients with serious complications are often converted, ultimately, to open repair. The aim of this study was to assess causes and midterm results of open surgical secondary procedures after thoracic endovascular aortic repair. METHODS: A total of 236 patients underwent TEVAR. Fourteen of these patients required open repair because of six aortobronchial fistulas, four retrograde type A dissections, two aneurysm enlargement without endoleak, one thoracic stent-graft collapse, and one aortoesophageal fistula. Eight (57.1%) patients underwent surgical repair using cardiopulmonary bypass. Six stent-grafts were totally removed, and eight stent-grafts were left in situ. Four patients underwent supracoronary ascending aorta replacement, and one an extensive replacement of the aortic arch through sternotomy. Three patients had descending aortic replacement through left thoracotomy combined with a total esophagectomy in one case. One patient was treated by ligation of the aortic arch, ascending to supraceliac abdominal aorta bypass and stent-graft explantation. One patient was treated by exclusion bypass of the descending thoracic aorta. Pulmonary resection and large pleural or intercostal muscle flap interposition to wrap the stent-graft left in situ was done in four cases of aortobronchial fistula. RESULTS: All patients survived the surgical procedure. Ten patients (71%) had an uneventful postoperative course. There were two in-hospital deaths (14.3%). Both died from multi-organ failure in the early postoperative course after surgical repair of a stent-graft infection and an aortoesophageal fistula. One patient suffered a definitive paraplegia and a secondary aortoesophageal fistula requiring reoperation for esophageal repair. One patient, treated by pulmonary resection and flap interposition to wrap the stent-graft, underwent stent-graft explantation and in situ descending aortic replacement because of stent-graft reinfection. Actuarial survival was 87.7% after a mean follow-up of 26.3 months (range 9-72 months). CONCLUSIONS: Complications or prevention of complications after TEVAR either due to device failure or adverse events may require conversion to open repair or additional open surgical procedure. Open repair can be performed by a team experienced in management of diseases of the thoracic aorta and a low mortality rate achieved despite the precarious preoperative conditions and complex aortic pathologies of patients.

Endovascular repair of aorto-iliac artery injuries after lumbar-spine surgery.

OBJECTIVE: This study aims to describe the endovascular management of abdominal-aortic- or common-iliac-artery injuries after lumbar-spine surgery. METHODS: Patients treated for abdominal-aortic- or common-iliac-artery injuries after lumbar-spine surgery during a 13-year period were identified from an endovascular database, providing prospective information on techniques and outcome. The corresponding patient records and radiographic reports were analysed retrospectively. RESULTS: Seven patients were treated with acute (n = 3) or subacute (n = 4) injuries of the common iliac artery (n = 6) or abdominal aorta (n = 1) after lumbar-spine surgery. Vascular injuries included arterial lacerations (n = 3), arteriovenous fistulas (n = 2) and pseudo-aneurysms (n = 2). The mean age of the patients was 51.7 years (30-60 years), 71.4% were women. These lesions were repaired by transluminal placement of stent grafts: Passager (n = 3), Viabahn (n = 1), Wallgraft (n = 1), Zénith (n = 1) and Advanta V12 (n = 1). Exclusion of the injury was achieved in all cases. Mortality was nil. There were no procedure-related complications. During a median follow-up of 8.7 years (range 0.3-13 years), all stent grafts remained patent. CONCLUSIONS: Sealing of common iliac artery or abdominal aortic lesions as a complication of lumbar-disc surgery with a stent graft is effective and is suggested as an excellent alternative to open surgery for iatrogenic great-vessel injuries, particularly in critical conditions.

Preoperative assessment of anatomical suitability for thoracic endovascular aortic repair.

Endovascular treatment of descending thoracic aortic pathologies requires a preoperatively determined interventional strategy. Its feasibility depends mainly on anatomic factors: the morphology of the proximal and distal fixation sites, the diameter and disease state of the access vessels. These factors represent important predictors of success and the most important exclusion criteria. Current diagnostic evaluation of aortic aneurysm for endovascular repair relies primarily on CT scan associated with 3D-reconstruction to assess the anatomical suitability for endograft implantation. In patients with an inadequate length of the proximal or distal neck, the left subclavian artery or the coeliac trunk can be overstented to effectively exclude thoracic aortic lesions. Deliberate coverage of aortic side branches should be decided prior to the procedure (guided by a extensive anatomical assessment) or carefully be avoided in order to reduce major morbidity, especially cerebral embolization, spinal cord ischemia and ischemic abdominal complications.