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.

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.

Open repair for juxtarenal aortic aneurysms.

Abdominal aortic aneurysms (AAAs) are classified as juxtarenal if their proximal extent is next to the origin of the renal arteries but does not involve them. An AAA is suprarenal if it extends above at least one renal artery and ends below the celiac axis. Juxtarenal AAAs need inter-renal or suprarenal clamping, with the aortic reconstruction usually made at the infrarenal level. Aneurysms requiring suprarenal clamping, often supraceliac, and the reconstruction (direct attachment or bypass) of at least one renal artery, are often defined as suprarenal AAAs. Endovascular aortic repair (EVAR) is feasible in most of cases of infrarenal AAAs and has been shown to be as effective as open repair (OR) in reducing aneurysm-related mortality and perioperative mortality with shorter length of stay. However, the feasibility of standard EVAR with an on-label use of commercially available devices is limited in the juxtarenal aorta. In our series, approximately, 20% to 30% of patients with an AAA are considered not eligible for standard EVAR owing to their anatomy, and in the most of the cases are patients with juxtarenal AAAs. Fenestrated and branched endografts and newer "off the shelf" techniques (such as chimney, periscope, sandwich) have been recently described, all with the purpose of widening the therapeutic range of EVAR to the treatment of aneurysms with involvement of renal and visceral arteries. However, safety, efficacy, long-term results, and cost-effectiveness of these expensive techniques have still to be carefully assessed. For these reasons, the OR is currently still considered the gold standard for treatment of juxtarenal AAAs, reserving endovascular strategies mainly for high-risk patients having comorbidities or other contraindications for conventional repair. If compared to open repair of infrarenal AAAs, juxtarenal AAA OR is technically more complex and might require specific organ-protection strategies in order to minimize ischemia-reperfusion injury to kidneys and visceral organs. Because of the complexity of the surgical procedure and of the multiple clinical problems, an optimal operative strategy for the treatment of juxtarenal AAAs has not been established yet. The choice of the surgical access, clamping level, methods of organ protection and their impact on renal, respiratiry, cardiac and gastrointestinal morbidity are still debated issues.

Open repair for infrarenal AAA: technical aspects.

The aim of this study was to describe the technique and report our single center experience of abdominal aortic aneurysm (AAA) open surgical repair over the last 17 years. From 1993 to 2010, a total of 4347 open surgical procedures for repair of AAA were performed in our center. The details of 3857 (88.7%) patients undergoing infrarenal AAA open repair were analyzed; mean age at the time of surgery was 71.8 years ranging from 58 to 89 years. Among all repairs, 23.7% (914) were performed in women and 24.3% (937) in octogenarians; 3587 (93.0%) procedures were performed for degenerative aneurysms, 146 (3.8%) for inflammatory aneurysms, 100 (2.6%) for dissecting aneurysms, and 19 (0.5%) for other pattern of disease. In 162 cases (4.2%) surgery was performed for ruptured aneurysm. In most cases (N.=2596; 67.3%) infrarenal AAA open repair was performed by means of aorto-aortic bypass using a tube graft. A total of 1261 patients were treated using a bifurcated graft: 417 (33.1%) aorto-iliac bypasses, 530 (42.0%) aorto-femoral bypasses and 314 (24.9%) aorto-iliac-femoral bypasses were performed. In elective aorto-aortic bypass, mean aortic clamping time was 21.3+6.7 minutes. The average duration of the procedure was 126+84 minutes (range, 42-410 minutes). Mean intraoperative bleeding was 803.4+422.7 mL (range 250-3,100). Overall intraoperative mortality was 0.2%. Intraoperative mesenteric ischemia was observed in 3% of cases, all treated with inferior mesenteric artery reimplantation. The rate of intraoperative lower limbs ischemia was 2.2%. One intraoperative acute type A aortic dissection occurred. The overall 30-day mortality was 0.6%. Permanent renal function impairment occurred in 4.3% of cases. The rate of pulmonary complications was 9.8%. Other complications were myocardial infarction, congestive heart failure, late ischemic colitis, late leg ischemia, wound infection, urinary tract infection, and sepsis. Although endovascular techniques have emerged as a less invasive alternative to open repair, short- and long-term outcomes associated to the surgery of infrarenal AAAs remain satisfactory for a large range of patients.

Hybrid procedures for the treatment of thoracoabdominal aortic aneurysms and dissections.

The search for less invasive therapeutic approaches to thoracoabdominal aortic aneurysms (TAAAs) brought endovascular procedures to establish themselves as alternatives to open surgery in high-risk patients. Aim of this study is to illustrate the hybrid - open and endovascular - treatment of dissecting and non-dissecting TAAAs, and to analyze short and midterm results at our Center. We analyzed 41 high-risk patients who underwent hybrid TAAA repair (dissecting TAAA in 17% of cases) with a variety of visceral rerouting configuration and of commercially available thoracic endografts. Thirty-one simultaneous (76%) and 10 staged procedures (24%) were performed with a four-vessel revascularization in 13 cases (32%), a three-vessel in 9 (22%) and a two-vessel in 19 (46%). No intraoperative deaths were observed in our series, with a technical success in endovascular TAAA repair of 100%. Two patients died in the intersurgical time. A perioperative mortality of 13% and a perioperative morbidity of 32% were recorded, including one case (2.4%) of permanent paraplegia. At a median follow-up of 23.3 months, we observed a visceral graft occlusion rate of 6%, three type II endoleak and one endograft migration. Six patients died for unrelated events. Typical complications of conventional TAAA open surgery have been not eliminated by hybrid repair and still significant mortality and morbidity have been reported. Dissecting etiology did not negatively affect the outcome of hybrid repair in our experience. Fate of visceral bypasses and incidence of endoleak and other endograft-related complications need to be carefully assessed. Hybrid TAAA repair should nowadays be limited as alternative to simple observation in patients unfit for the conventional open repair.

Endovascular treatment of descending thoracic aneurysms.

INTRODUCTION: Current strategies for repair of descending thoracic aortic aneurysms consist of open repair with surgical graft replacement or thoracic endovascular aortic repair. We review and update our overall experience in aortic thoracic diseases and specifically analyzed our outcomes with thoracic endovascular aortic repair in patients with descending thoracic aortic aneurysms. METHODS: From 1993 to present a total of 1144 patients were treated in our Center for pathology involving the thoracic aorta. Since 1998, 322 patients underwent thoracic endovascular aortic repair, and among this group, in 188 cases the descending aorta was involved. In 74% of patients treated for a descending thoracic aortic lesion, a degenerative aneurysm was observed. RESULTS: In patients with descending thoracic aortic aneurysms receiving thoracic endovascular aortic repair, our technical success rate, i.e. deployment of endograft with complete exclusion of the lesion/minimal endoleak, was 99.5% (one case required emergent open conversion) with a perioperative mortality of 2.6% (five patients). The rate of spinal cord ischemia, manifesting either as paraplegia or paraparesis, was 4.7%. Delayed onset spinal cord ischemia ameliorated with adequate arterial pressure and cerebrospinal fluid drainage. CONCLUSIONS: Our experience of selected patients undergoing thoracic endovascular aortic repair of descending thoracic aorta aneurysms is satisfactory with very low mortality and morbidity. A large use of thoracic endovascular aortic repair is foreseen in the next future.

Open repair of descending thoracic aneurysms.

INTRODUCTION: Current strategies for operative treatment of a thoracic aortic aneurysm consist of open repair with surgical graft replacement or endovascular exclusion. To reduce mortality and morbidity of open repair, a multimodal approach has gradually evolved by maximizing organ protection. METHODS: On a total of 1108 patients treated in our Center from 1993 for pathology involving the thoracic aorta, we reviewed the prospectively collected data of 194 consecutive patients who underwent open thoracic aortic aneurysm repair, 104 (54%) for degenerative aneurysms, 65 (34%) for dissections, 25 (12%) for other pattern of disease. Left Heart Bypass was used in 82% of cases, clamp and sew technique in 16%, hypotermic circulatory arrest in 2%. RESULTS: Overall perioperative mortality was 4.1%. The rate of pulmonary complications was 8.8%. The rate of cardiac complications, i.e. new onset myocardial necrosis demonstrated by positive blood tests, was 6.2%. The rate of renal complications was 7.2%. Cerebrovascular accident, defined as a new neurologic deficit lasting more than 24 hours confirmed by imaging, occurred in 2.0% of patients. The rate of spinal cord ischemia, manifesting either as paraplegia or paraparesis, was 4.6%. CONCLUSIONS: Mortality and morbidity rates of open thoracic aortic aneurysm repair are currently satisfactory especially in fit patients. In order to define surgical indications and the role of endovascular repair, consideration of age of the patient, comorbidity, symptoms, life expectancy, likely quality of life (if asymptomatic), aortic diameter, aneurysm morphology, aneurysm extent, suitability of landing zones, and operator experience are all distinctly relevant.

Is hybrid procedure the best treatment option for thoraco-abdominal aortic aneurysm?

OBJECTIVE: Hybrid thoraco-abdominal aortic aneurysm (TAAA) repair, consisting in re-routing of abdominal aortic visceral branches followed by TAAA endograft exclusion has been shown to be a feasible strategy, especially appealing in high-risk patients. PATIENTS AND METHODS: We analysed 31 high-risk patients who underwent hybrid TAAA repair in our centre with a variety of visceral re-routing configuration and of commercially available thoracic endografts. Twenty-three simultaneous (74.2%) and eight staged procedures (25.8%) were performed with a four-vessel re-vascularisation in 10 cases (32.3%), a three-vessel in six (19.4%) and a two-vessel in 15 (48.4%). We also performed a literature review of major single-centre series of TAAA hybrid repair. RESULTS: No intra-operative deaths were observed in our series, with a technical success in endovascular TAAA repair of 100%, an overall perioperative mortality of 19.4% and a perioperative morbidity of 35.5%, including one case (3.2%) of permanent paraplegia. At a median follow-up of 11.9 months, we observed a visceral graft occlusion rate of 6.8%, one type II endoleak and one endograft migration. From the literature review, six other single-centre series with more than 10 hybrid TAAA repairs were found. From data available of 107 patients, we observed a mean perioperative mortality of 15.6%, the rate of primary endoleaks was 17.9%, paraplegia/paraparesis 7.2% and renal failure 9.9%, with other major perioperative complications reported in the 50.6% of cases. At the follow-up period visceral graft occlusion rate was 5.1%. CONCLUSION: Typical complications of conventional TAAA open surgery have been not eliminated by hybrid repair and significant mortality and morbidity have been reported till date. The fate of visceral bypasses and incidence of endoleak and other endograft-related complications need to be carefully assessed. Hybrid TAAA repair should nowadays be limited as alternative to simple observation in patients unfit for the conventional open repair.

Management of thoracoabdominal aortic aneurysms.

Conventional treatment of thoracoabdominal aortic aneurysms (TAAAs) consists of graft replacement with reattachment of the main aortic branches. Over the past 20 years a multimodal approach has gradually evolved to reduce the trauma of surgery by maximizing organ protection, allowing experienced surgical Centers to have better outcomes than previously reported. However, mortality and morbidity associated to TAAA open repair remain significant. Hybrid repair, consisting of open aortic debranching and revascularization followed by endovascular exclusion of the aneurysm, may extend the indications of TAAA repair to high-risk patients that cannot benefit from surgery, however results are still under evaluation. Aim of this paper is to illustrate the management and results of thoracoabdominal aortic aneurysms surgery with open techniques of organ protection and hybrid approach in our Center.