Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use.

PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). RESULTS: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. CONCLUSION: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft.

OBJECTIVE: Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. METHODS: This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. RESULTS: Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). CONCLUSIONS: No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

Initial single-site experience with the Ovation abdominal stent-graft system in patients with challenging aortoiliac anatomy.

BACKGROUND: Aim of the study was to evaluate the initial results of endovascular aneurysm repair with the Ovation abdominal stent-graft system in patients with challenging aortoiliac anatomy. METHODS: The Ovation stent-graft is an ultra-low profile, modular endovascular graft characterized by a 14F OD delivery system, active suprarenal fixation, and polymer-filled proximal rings that allow sealing in short (≥7 mm) proximal necks. Between November 2010 and January 2012, 14 patients with abdominal aortic aneurysms (AAA) (male: 100%, mean age: 76 years, mean AAA diameter: 54 mm) and challenging aortoiliac anatomy were treated with the Ovation endograft at a single centre. Mean patient follow-up was 5 months. RESULTS: All cases were performed under local or epidural anesthesia. No operative deaths or major complications were noted. A type I endoleak was detected on final angiogram in one case, which was successfully treated with additional ballooning and Palmaz stenting of the hooking landing zone. One patient died at 2 months due to myocardial infarction unrelated to the device or procedure. AAA-related mortality was 0%. No AAA rupture, AAA enlargement, type I or III endoleak, stent migration, access site complication, or conversion to open surgery was reported during follow-up. A type II endoleak was successfully treated with a right lumbar artery embolization at 4 months. Occlusion of an iliac axis was successfully managed with local fibrinolysis and implantation of a covered stent in the external iliac artery. CONCLUSIONS: Initial outcomes of this single-center experience suggest that the Ovation abdominal stent-graft system is a promising treatment in AAA patients with challenging aortoiliac anatomy.

Transplantation of human fetal biliary tree stem/progenitor cells into two patients with advanced liver cirrhosis.

BACKGROUND: Efforts to identify cell sources and approaches for cell therapy of liver diseases are ongoing, taking into consideration the limits recognized for adult liver tissue and for other forms of stem cells. In the present study, we described the first procedure of via hepatic artery transplantation of human fetal biliary tree stem cells in patients with advanced cirrhosis. METHODS: The cells were immune-sorted from human fetal biliary tree by protocols in accordance with current good manufacturing practice (cGMP) and extensively characterized. Two patients with advanced liver cirrhosis (Child-Pugh C) have been submitted to the procedure and observed through a 12 months follow-up. RESULTS: The resulting procedure was found absolutely safe. Immuno-suppressants were not required, and the patients did not display any adverse effects correlated with cell transplantation or suggestive of immunological complications. From a clinical point of view, both patients showed biochemical and clinical improvement during the 6 month follow-up and the second patient maintained a stable improvement for 12 months. CONCLUSION: This report represents proof of the concept that the human fetal biliary tree stem cells are a suitable and large source for cell therapy of liver cirrhosis. The isolation procedure can be carried out under cGMP conditions and, finally, the infusion procedure is easy and safe for the patients. This represents the basis for forthcoming controlled clinical trials.

Re-TEVAR for complications after blunt aortic traumatic injury stenting.

We report an endovascular approach that was used to treat two patients with previous thoracic aortic repair or endovascular repair (TEVAR) for blunt thoracic aortic injury. The first patient was a 38-year-old man who presented with distal intragraft thrombosis 24 months after TEVAR. The second patient, a 32-year-old man, developed a symptomatic distal device collapse at 39th month follow-up, associated with buttock claudication. Both patients were offered an endograft relining, complicated in the first case by distal embolization.

Outcomes in the emergency endovascular repair of blunt thoracic aortic injuries.

Thoracic aorta blunt injury (BAI) is a highly lethal lesion. A large number of victims die before obtaining emergency care. Thoracic endovascular aneurysm repair (TEVAR) is a less invasive method compared with open surgery and may change protocols for BAI treatment. This retrospective study was developed to evaluate the potential issues about thoracic endografting in the management of these patients. Twenty-seven patients with a BAI underwent aortic stent grafting. Intervention was preceded by the treatment of more urgent associated lesions in nine cases. In-hospital mortality was 7.4%. No paraplegia or ischemic complications developed because of the coverage of the left subclavian artery. In one case (3.2%), a type I endoleak was detected, proximal endograft infolding in two cases (7.4%) and endograft distal migration in further two cases were detected during follow-up (6-110 months). Thoracic endovascular aneurysm repair of BAI showed encouraging results in terms of perioperative mortality and morbidity. Concerns still remain about the potential mid- and long-term complications in younger patients.

Intraoperative aorta balloon occlusion: fertility preservation in patients with placenta previa accreta/increta.

OBJECTIVE: To evaluate whether aorta balloon occlusion decreases the rate of hysterectomies and maternal morbidity during extirpative surgery of placenta previa accreta or increta. METHODS: We prospectively assessed 33 consecutive patients with placenta praevia and MRI diagnosis of multifocal accreta or increta. Manual removal of the placenta was performed during a scheduled caesarean delivery. In 15 patients, surgery was preceded by balloon catheterization of the abdominal aorta (Intra Abdominal Balloon Occlusion: IABO); 18 patients refusing IABO were considered as controls. We used Fisher's exact test for categorical variables and Mann-Whitney test for continuous variables. RESULTS: In the IABO group we observed significant decreases in incidence of hysterectomy, estimated blood loss, number of transfused units of red blood cells, postoperative stay and admission to Intensive Care Unit. No IABO-related complications were reported. CONCLUSIONS: During scheduled caesarean section for placenta previa multifocally accreta or increta, IABO can prevent hysterectomy in many cases and improves perioperative outcome as it gives the operator time to achieve the haemostasis via curettage and oversewing of the implantation site with acceptable blood loss.

Mid- and long-term results of endovascular treatment in thoracic aorta blunt trauma.

STUDY AIM: Evaluation of results in blunt injury of the thoracic aorta (BAI) endovascular treatment. MATERIALS AND METHODS: Sixteen patients were treated for BAI. Thirteen patients had associated polytrauma, 4 of these had a serious hypotensive status and 4 had an hemothorax. In the remaining 3, two had a post-traumatic false aneurysm of the isthmus and 1 had a segmental dissection. In those 13 patients a periaortic hematoma was associated to hemothorax in 4. All patients were submitted to an endovascular treatment, in two cases the subclavian artery ostium was intentionally covered. RESULTS: One patient died for disseminated intravascular coagulation. No paraplegia was recorded. No ischemic complications were observed. A type I endoleak was treated by an adjunctive cuff. During the followup (1-9 years) 3 patients were lost. A good patency and no endoleaks were observed in all cases. One infolding and 1 migration of the endografts were corrected by an adjunctive cuff. CONCLUSION: The medium and long term results of the endovascular treatment of BAI are encouraging with a low incidence rate of mortality and complications. More suitable endo-suite and endografts could be a crucial point for the further improvement of these results.

Treatment of high-flow arteriovenous malformations (AVMs) of the head and neck with embolization and surgical resection.

AIM: Arteriovenous malformations (AVMs) with a high flow of the head and neck are quite rare compared to their low-flow counterparts, but when they do occur they are often accompanied by massive bleeding or present with significant esthetic defects. The treatment of these high-flow vascular anomalies is often highly risky. The multidisciplinary approach required for the assessment and treatment of these lesions should include angioradiology with preoperative superselective embolization, followed by surgical resection of the lesion within 24 hours and esthetic reconstruction. MATERIALS OF STUDY: We studied a series of 55 patients with AVMs of the head and neck that were treated surgically between 1999 and 2009. RESULTS: Of the 55 patients with AVMs, 7 had hemangiomas and 48 had vascular malformations, of which 28 were low-flow lesions and 20 were high-flow lesions (AVMs). The high-flow lesions were most commonly located on the lip. All 48 AVMs underwent surgical resection for concerning symptoms, diagnostic purposes, or esthetic problems. Of the 20 high-flow AVMs, 20% were classified as Schöbinger stage I, 55% as stage II, and 25% as stage III. A combined treatment of embolization and resection was used to resolve 13 of the high-flow AVMs (stages II and III), of which 4 required a flap reconstruction. CONCLUSION: Recent advances in microsurgery and interventional angioradiology have greatly improved the prognosis for patients with these malformations. Combined embolization-resection is the treatment of choice for high-flow AVMs, and esthetic reconstruction with flaps can prevent their recurrence.