Initial clinical experience with the modified Zenith "Pro-Form" TX2 thoracic endograft

Purpose: To assess the safety and efficacy of thoracic aortic endovascular repair (TEVAR) with the newly introduced Zenith TX2 thoracic stent-graft with Pro-Form. Methods: From March 2009 to present, the Zenith TX2 with Pro-Form was used to treat 27 patients (23 men; median age 65 years, range 22-77) suffering from descending thoracic aortic disease: 20 degenerative aneurysms, 3 chronic type B dissections, 2 type I endoleaks following previous endograft repair, 1 aortic ulcer, and 1 traumatic isthmic rupture. According to Ishimaru's classification, the distribution of the proximal landing zone was zone 0 in 4 cases, zone 1 in 2 cases, zone 2 in 9 cases, zone 3 in 7 cases, and zone 4 in 5 cases. One aneurysm distally involved the thoracoabdominal aorta. An acutely angulated (<90°) proximal landing zone was found in 9 patients. Results: The device was safely and effectively deployed in all cases, with no problems during sheath retrieval. The postoperative course was free from major complications in all cases, and there was no perioperative mortality. Postoperative morbidity included respiratory failure in 1 case, transient acute renal failure in 3 cases, and post-implantation syndrome in 2 cases. Postoperative computed tomography at 1 and 6 months confirmed 100% clinical success with the absence of device-related complications. No type I endoleak was documented. The proximal sealing stent fitted well with the aortic profile in all cases except one, in which malapposition was seen in a severely angulated aorta at 6-month follow-up. Conclusion: Based on this preliminary experience, the TX2 thoracic stent-graft with Pro-Form can be safely and effectively deployed to satisfactorily repair thoracic aortic pathology, including lesions in the arch. Stent-graft conformance to the aorta was excellent even in cases with unfavorable anatomy. These encouraging results will need to be confirmed in larger series with larger follow-u

The Bolton Treovance endograft: Single center experience

Aim: In the last two decades, results of endovascular aortic repair (EVAR) for the treatment of infrarenal abdominal aortic aneurysms (AAAs) have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary reinterventions. We present our initial experience with the Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain), a new-generation trimodular endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. Methods: We treated 8 patients with anatomically suitable non-ruptured AAA. Results: Primary technical success was obtained in all patients, and no 30-day device-related complications nor deaths were reported. One patient experienced graft limb occlusion at 3 months, and underwent surgical conversion. At 1-year follow-up (completed in 6 patients), no device-related complications nor type I or III endoleak were observed. Conclusion: Initial personal experience with the Treovance abdominal stent-graft was satisfactory with regard to technical success and short-term clinical results. This new-generation endovascular device performed well even in angulated or heavily calcified anatomies

Technical features of the INCRAFT (R) AAA Stent Graft System

The INCRAFT (R) AAA Stent Graft System is the advanced endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal abdominal aneurysms. This new system is designed to address the unmet needs of current endografts by combining unique features and adding new refinements compared to existing endografts delivered through a flexible 14-Fr ultralow system. The INCRAFT (R) AAA Stent Graft System introduces innovative features without deviating from proven stent-graft design principles. It is a three-piece modular system, made of low porosity polyester and segmented nitinol stents. However, the introduction of cap-free delivery and partial proximal repositioning enhances the ability of the device to better match individual aortoiliac anatomy with a high deliverability and placement accuracy in a easy to use system. Moreover, the INCRAFT (R) System allows a "customization" of the implant during the procedure with bilateral in-situ length adjustment features. The present data from the ongoing clinical trials confirm excellent results with this system, but postmarket studies will be necessary to verify the effectiveness of this system in the real-world setting

The Bolton Treovance endograft: Single center experience

Aim: In the last two decades, results of endovascular aortic repair (EVAR) for the treatment of infrarenal abdominal aortic aneurysms (AAAs) have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary reinterventions. We present our initial experience with the Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain), a new-generation trimodular endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. Methods: We treated 8 patients with anatomically suitable non-ruptured AAA. Results: Primary technical success was obtained in all patients, and no 30-day device-related complications nor deaths were reported. One patient experienced graft limb occlusion at 3 months, and underwent surgical conversion. At 1-year follow-up (completed in 6 patients), no device-related complications nor type I or III endoleak were observed. Conclusion: Initial personal experience with the Treovance abdominal stent-graft was satisfactory with regard to technical success and short-term clinical results. This new-generation endovascular device performed well even in angulated or heavily calcified anatomies

Technical features of the INCRAFT AAA Stent Graft System

The INCRAFT® AAA Stent Graft System is the advanced endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal abdominal aneurysms.This new system is designed to address the unmet needs of current endografts by combining unique features and adding new refinements compared to existing endografts delivered through a flexible 14-Fr ultra-low system. The INCRAFT® AAA Stent Graft System introduces innovative features without deviating from proven stent-graft design principles. It is a three-piece modular system, made of low porosity polyester and segmented nitinol stents. However, the introduction of cap-free delivery and partial proximal repositioning enhances the ability of the device to better match individual aortoiliac anatomy with a high deliverability and placement accuracy in a easy to use system. Moreover, the INCRAFT® System allows a "customization" of the implant during the procedure with bilateral in-situ length adjustment features. The present data from the ongoing clinical trials confirm excellent results with this system, but postmarket studies will be necessary to verify the effectiveness of this system in the real-world setting

Aortobifemoral bypass grafting using expanded polytetrafluoroethylene stretch grafts in patients with occlusive atherosclerotic disease

The aim of this retrospective study was to evaluate the performance of bifurcated, longitudinally extensible (stretch), expanded polytetrafluoroethylene (ePTFE) grafts implanted in patients with aortoiliac or aortofemoral occlusive atherosclerotic disease. Between October 1991 and December 2005, 822 consecutive patients (708 men, 114 women; mean age 63.8 years) underwent aortoiliac or aortofemoral reconstruction using a bifurcated ePTFE stretch graft. Preoperatively, all patients had ultrasonographic and arteriographic evaluations and were divided into groups according to the TASC II morphological stratification of iliac lesions. Seventy-seven patients (9.4%) had type B lesions, 314 (38.2%) had type C lesions, and 431 (52.4%) were classified as type D lesions. Endarterectomy of the aorta was required in 172 patients (21%); femoral arteries were endarterectomized in 222 (27%). Femoropopliteal bypass grafting was performed in 18 patients, aortorenal bypass in 12, and mesenteric artery grafting in one. One patient died perioperatively of a myocardial infarction. Perioperative morbidity included cardiac (2.2% of patients), respiratory (0.9%), and gastrointestinal (1.2%) complications, as well as acute renal insufficiency (1.3%). Seven patients had bleeding requiring surgical revision within the first 24 hr after surgery. There were four cases (0.5%) of immediate graft thrombosis and five (0.6%) of single-limb graft thrombosis. During a mean follow-up time of 72 months (range 28-170), 58 patients (7.1%) were lost to follow-up and 205 patients (24.9%) died. The primary and secondary graft-patency rates during the observation period were 90.6% and 97.9%, respectively. Twelve late graft occlusions resolved after thrombectomy alone. Eleven cases of single-limb late thrombosis resolved after thrombectomy and profundoplasty. The limb-salvage rate during the observation period in patients who underwent operation for critical limb ischemia was 84.5%. There were nine postoperative graft infections (1.1% infection rate) in the series. Our long-term experience with ePTFE stretch grafts in aortoiliac and aortofemoral reconstruction shows that these prostheses have a high rate of patency and a low rate of graft-related complications. © Annals of Vascular Surgery Inc