Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm.

BACKGROUND: The benefits of endovascular repair of ruptured abdominal aortic aneurysm remain controversial, without any strong evidence about advantages in specific subgroups. METHODS: An individual-patient data meta-analysis of three recent randomized trials of endovascular versus open repair of abdominal aortic aneurysm was conducted according to a prespecified analysis plan, reporting on results to 90 days after the index event. RESULTS: The trials included a total of 836 patients. The mortality rate across the three trials was 31.3 per cent for patients randomized to endovascular repair/strategy and 34.0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0.88, 95 per cent c.i. 0.66 to 1.18), and 34.3 and 38.0 per cent respectively at 90 days (pooled odds ratio 0.85, 0.64 to 1.13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8.2(1.9) cm and the overall in-hospital mortality rate was 34.8 per cent. There was no significant effect modification with age or Hardman index, but there was indication of an early benefit from an endovascular strategy for women. Discharge from the primary hospital was faster after endovascular repair (hazard ratio 1.24, 95 per cent c.i. 1.04 to 1.47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0.69 (95 per cent c.i. 0.53 to 0.89) per 15 mm), but aortic diameter was not associated with mortality for either type of repair. CONCLUSION: Survival to 90 days following an endovascular or open repair strategy is similar for all patients and for the restricted population anatomically suitable for endovascular repair. Women may benefit more from an endovascular strategy than men and patients are, on average, discharged sooner after endovascular repair.

Ruptured Aneurysm Trials: The Importance of Longer-term Outcomes and Meta-analysis for 1-year Mortality.

OBJECTIVE: To assess current knowledge for the management of ruptured abdominal aortic aneurysm (AAA), based on the 1-year outcomes of 3 recent randomised trials. METHODS: An individual patient data meta-analysis of three recent randomised trials of endovascular versus open repair, including 817 patients, was conducted according to a pre-specified analysis plan, report all-cause mortality and re-interventions at 1 year after the index event. RESULTS: Mortality across the 3 trials at 1-year was 38.6% for the EVAR or endovascular strategy patient groups and 42.8% for the open repair groups, pooled odds ratio 0.84 (95% CI 0.63-1.11), p = .209. There was no evidence of heterogeneity in the odds ratios between trials. When the patients in the endovascular strategy group of the IMPROVE trial were restricted to those with proven rupture who were anatomically suitable for endovascular repair, the pooled odds ratio reduced slightly to 0.80 (95% CI 0.56-1.16), p = .240. CONCLUSIONS: After 1 year there is a consistent but non-significant trend for lower mortality for EVAR or an endovascular strategy. Taken together with the recent gains in health economic outcomes demonstrated at 1 year in the IMPROVE trial, the evidence suggests that endovascular repair should be used more widely for ruptured aneurysms.

Early Results of Physician Modified Fenestrated Stent Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms.

OBJECTIVES: The aim was to determine whether physician modified stent grafts (PMSGs) are safe and effective for the treatment of high risk patients with thoraco-abdominal aortic aneurysms (TAAAs). DESIGN: This was a retrospective single institution study. MATERIAL: Consecutive patients with TAAA undergoing endovascular repair using a PMSG between January 2012 and June 2014 were evaluated. METHODS: Fenestrations to preserve branch vessels were created in TX2 thoracic (Cook Medical) stent grafts. Pre- intra- and post-operative data were recorded by means of a prospectively maintained database. RESULTS: Eleven high risk patients with TAAA (type I, n = 4; type III, n = 3; type IV, n = 3; type V, n = 1) underwent fenestrated endovascular repair using PMSGs. Indications were painful aneurysm (n = 5), >70 mm rapidly enlarging aneurysm (n = 4), saccular aneurysm (n = 1), and visceral patch false aneurysm after open repair of a type IV TAAA (n = 1). In four asymptomatic patients, an additional fenestration was created for temporary selective sac perfusion and occluded 2-4 weeks later. Median duration for stent graft modifications was 2 hours (range 1-3 hours). The median number of fenestrations was three (range 2-4). One patient died during the post-operative period from colonic ischemia, giving a 9% in hospital mortality rate. Four (36%) patients presented with moderate to severe complications. One (9%) patient presented with a paraparesis that resolved completely after spinal fluid drainage. Among surviving patients, four required early endovascular re-intervention for type III endoleak (n = 2), type Ia endoleak (n = 1), or target vessel cannulation failure (n = 1). The median follow up time was 6 months (range 3-20 months). During follow up, no other complications occurred and all target vessels remained patent. One patient presented with a persistent type II endoleak. CONCLUSION: PMSGs provided acceptable short-term results and may be a management option for the treatment of TAAA in selected high risk patients. Durability concerns need to be assessed in additional studies with long-term follow up.

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.

Inferior Mesenteric Artery Stenting as a Novel Treatment for Chronic Mesenteric Ischemia in Patients with an Occluded Superior Mesenteric Artery and Celiac Trunk.

INTRODUCTION: Chronic mesenteric ischemia (CMI) is a challenging problem, with revascularization the mainstay of treatment. Management of CMI is especially challenging in the patient with superior mesenteric artery (SMA) and celiac artery (CA) occlusions. REPORT: We report a case series of four patients with chronic mesenteric ischemia who were not candidates for CA or SMA revascularization who were successfully treated with inferior mesenteric artery (IMA) angioplasty and stent placement to improve collateral circulation and palliate symptoms. DISCUSSION: To our knowledge, this is the largest case series to date reporting the use of an IMA stent to improve collateral circulation in patients with CMI.

In situ reconstruction in native and prosthetic aortic infections using cryopreserved arterial allografts.

OBJECTIVES: To evaluate overall survival and complications of cryopreserved arterial allografts in aortic graft infections and infected aortic aneurysms. METHODS: A retrospective review of consecutive patients was conducted with native or prosthetic aortic infections, who underwent local debridement and in situ implantation of a cryopreserved aortic allograft from September 2004 to June 2012 at the Henri Mondor University Hospital. Patient characteristics, indications for allograft implantation, perioperative events, bacteriological data, and events related to follow-up were identified. The primary outcome was overall survival. Overall survival was estimated using the Kaplan-Meier method. Predictors of postoperative mortality were identified using uni- and multivariate analysis with a Cox proportional hazard regression. RESULTS: During the study period, 54 patients (45 [83%] men, mean age 66.2 ± 10.2 years) underwent aortic reconstruction using cryopreserved allografts. Indications were native aortic infection in 17 patients and prosthetic graft infection in 37 patients, including seven aortoenteric fistulae. Twelve aortic reconstructions (22%) were performed as emergency procedures. The median duration of follow-up was 12.1 months (range 0.4-83.6). The 30-day mortality rate was 28%. The overall mortality rate was 39% at a median follow-up of 12.1 months. Early significant postoperative complications occurred in 52% of patients. The graft-related mortality rate was 7%. The graft-related complication rate was 19%. During follow-up, there were two recurrences of aortic infection and two recurrences of allograft limb occlusion. Multivariate survival analysis identified age, chronic renal disease, prosthetic infection, emergent procedure, and coronary disease as independent predictors for postoperative mortality. CONCLUSION: This experience with cryopreserved aortic allografts in aortic reconstructions shows an unsatisfactory 30-day survival rate, as well as a substantial early graft-related complication rate. Longer follow-up is needed in order to support the preferential use of cryopreserved allografts based on their long-term behavior.

New bacteriological patterns in primary infected aorto-iliac aneurysms: a single-centre experience.

OBJECTIVES: To assess causative pathogens and surgical outcomes in patients with primary infected aorto-iliac aneurysms at our institution. DESIGN: Retrospective study of patients treated at a university hospital between 1992 and 2009. RESULTS: We identified 26 patients (median age, 63 years) with primary infected aneurysms on the aorta (descending thoracic, n = 2; thoraco-abdominal, n = 3; suprarenal, n = 2; infrarenal, n = 15) or iliac arteries (n = 4). Among them, 22 were symptomatic, including 13 with ruptured aneurysms. The causative organisms, identified in 25/26 patients, were Campylobacter fetus, n = 6; Streptococcus pneumoniae, n = 4; Listeria, n = 3; Salmonella, n = 2; Mycobacterium tuberculosis, n = 2; Staphylococcus aureus, n = 1; and other, n = 7. Immune suppression was a feature in 10 (38.4%) patients. Revascularisation was performed in situ in 23 patients (10 allografts, eight grafts, three superficial femoral veins, and 2 stentgrafts) and by extra-anatomic bypass in three patients. Hospital mortality was 23% (in situ group, 17.4%; extra-anatomic group, 66.7%; χ(2)(Yates), P = 0.24). During follow-up in the 20 survivors (median, 48.5 months), there were two non-infection-related deaths (five and 24 months) and six (30%) vascular complications. CONCLUSIONS: The bacteriological spectrum of primary infected aorto-iliac aneurysms was wider than previously reported. The availability of new diagnostic tests and increased prevalence of immunosuppression may explain this finding.

Virtual angioscopy and 3D navigation: a new technique for analysis of the aortic arch after vascular surgery.

PURPOSE: Anatomy of the aortic arch is highly variable and can be drastically altered by surgical or endovascular procedures. Detailed analysis of computed tomography (CT) scans is facilitated by reconstruction techniques such as virtual angioscopy (VA). In the present study, we have evaluated the benefit of VA for the assessment of aortic arch abnormalities in patients with prior surgical or endovascular procedures. MATERIAL AND METHODS: We analysed post-procedural CT scans available in 103 patients who underwent thoracic aortic procedures between 2006 and 2009 at our institution. Patients were classified into three groups: surgical (group A, n = 26), hybrid (group B, n = 27) and endovascular (group C, n = 50), procedures. A 64 LightSpeed volume computed tomography (VCT) multidetector-row computed tomography was used, allowing maximal intensity projection, maximal projection rendering imaging and three-dimensional (3D) rendering of images. VA reconstruction was performed by applying volume-rendered thresholds and spatial rendering to generate endoluminal views. RESULTS: Multiplanar reformations (MPRs) detected 46 abnormalities in 39 patients: inadequate apposition of the proximal rim of a stent-graft (n = 21), abnormalities of the stent-graft itself (n = 11), aortic aneurysm (n = 6), residual intimal tears (n = 5) and secondary dissection (n = 3). VA provided additional information in 76% of cases (35/46) and was more contributive after endovascular repair than after open repair (group A: 54% (7/14), group B: 75% (9/12), group C: 95% (19/20)). VA improved localisation of abnormalities with respect to supra-aortic vessels, measured inadequate stent-graft apposition in relation to the aortic wall and precisely analysed kinking or inadequate apposition of overlapping stent grafts. VA diagnosed three additional abnormalities: two false aneurysms and one retrograde dissection developed on a suture line. CONCLUSIONS: VA conceptualises planar images by 3D reconstruction. It provides additional information in comparison with conventional CT scans by allowing precise localisation of abnormalities with respect to the aortic wall itself and supra-aortic vessels. Furthermore, it facilitates analysis of abnormalities in case of overlapping stent grafts.

[Management of anastomotic stenosis after lower extremity bypass surgery with cutting balloon angioplasty]. / Traitement des sténoses anastomotiques des pontages des membres inférieurs par angioplastie au ballon coupant "Cutting Balloon"

PURPOSE: Conventional balloon angioplasty of anastomotic stenosis following bypass surgery is insufficient at mid- and long-term. However, short-term results with cutting balloon angioplasty (CBA) are satisfactory. The purpose of this study is to determine the long-term results using this technique. Materials and methods. Between January 2002 and January 2006, all patients with anastomotic stenosis more than one month after bypass surgery, shorter than 2 cm and>50%, were referred without randomisation to CBA. RESULTS: A total of 19 patients with mean age of 63.5 years (55-82 years), 14 males and 5 females, were included. Twenty stenoses (femoral n=15, popliteal n=4 and calf n=1) managed with CBA affected 17 infrainguinal and 2 suprainguinal bypasses. One patient had anastomotic stenoses at both extremities. The rate of technical success aws 100%. Mean follow-up was 32 months (12-42). Three deaths occurred during follow-up. One patient presented with restenosis at 3 months, successfully treated with repeat CBA. No thrombosis or infection was observed. CONCLUSION: The results with CBA appear persistent and compete favorably with results from surgical repair. A randomized trial would be necessary to confirm these results.

Immediate and 1-year success rate of type 2 endoleak treatment using three-dimensional image fusion guidance.

PURPOSE: To retrospectively assess immediate and 1-year success rate of type 2 endoleak (T2E) treatment with ethylene-vinyl-alcohol-polymer using three-dimensional (3D) image fusion guidance with cone beam computed tomography via trans-arterial embolization (TAE) or direct percutaneous sac injection (DPSI). MATERIALS AND METHODS: A total of 37 patients with T2E who were treated either using TAE (34/37; 92%) or DPSI (9/37; 8%) were included. There were 34 men and 3 women with a mean age of 86±9 (SD) years (range: 67-104years). Mean aneurysm diameter was 67±14 (SD) mm (range: 42-101mm) at pre-procedure evaluation. Immediate success was complete embolization of the sac and feeding artery. 1-year success was reduction or stability of the aneurysmal sac diameter based on pre-procedure and 12-month follow-up examinations. Safety (treatment-related complications), patient demographics, duration of procedure and contrast volume were reported. RESULTS: Immediate and 1-year successful outcomes were reported in 94% (n=32) and 88% (n=28) of patients after TAE and 100% (n=9) and 89% (n=8) after DPSI. T2E treatments were immediately successful for 95% of the procedures (41/43) and for 88% (36/41) at 1year. Overall, T2E treatment was effective in 33 patients (89%). No major complications occurred. Mean procedure time and contrast volume were significantly different between the 2 techniques with respectively 87±16 (SD) min (range: 65-120min) and 75±26 (SD) mL (range: 40-130mL) for TAE and 32±10 (SD) min (range: 20-50min) (P<0.01) and 6±6 (SD) mL (range: 2-22mL) (P<0.01) for DPSI. Mean aneurysm diameter at 1-year was 68±17 (SD) mm (range: 43-101mm). No significant differences in the pre-procedure sac diameter were found at long-term follow-up between patients without T2E and those with persistent T2E (P=0.1) in the successful embolization group (n=33). CONCLUSION: TAE or DPSI treatments of T2E with ethylene-vinyl-alcohol-polymer using 3D-image fusion guidance were immediately successful for 95% of the procedures and remained effective for 88%. Longer follow-up is necessary to assess sac stability in the case of persistent endoleak.

Is hypogastric artery embolization during endovascular aortoiliac aneurysm repair (EVAR) innocuous and useful?

INTRODUCTION: We hypothesized that the coverage of the hypogastric artery with a stent-graft causes an occlusion of the artery in its proximal segment, allowing collateral network formation in distal segments of the artery. In contrast, hypogastric embolisation may cause the formation of microthrombi that tend to disseminate leading to embolic occlusion of secondary branches and collaterals. This phenomenon worsens pelvic ischemia. To answer this question we compared two groups of patients with aortoiliac aneurysms treated with or without coil embolization to assess 1) The occurrence and evolution of buttock ischemia and 2) the effect on endoleak. MATERIALS/METHODS: Between October 1995 and January 2007, 147 out of 598 EVAR patients (24.6%) required occlusion of one or both hypogastric arteries. 101 were available for over one year of follow-up. Group A included 76 patients (75%) who underwent coil embolization before EVAR and group B 25 patients (25%) who had their hypogastric artery covered by the sole limb of the stent. Patient demographics, aneurysm characteristics, operative details, immediate and long term clinical outcomes, and CT-scan evaluation were stored prospectively in a specific data base and analyzed retrospectively. RESULTS: They were 96 males (95%). Mean age was 72.1+/-9.5 years. One month postoperatively, 51 patients (50.0%) suffered from buttock claudication. After six months, 34 patients were still disabled (34%), 32 in Group A (42%) and 2 in Group B (8%) (p=0.001). Post-operative sexual dysfunction occurred in 19 (19.6%) without statistical difference between the two groups. Type 2 endoleaks occurred in 12 patients (16.0%) in group A and 4 patients (16.0%) in group B (p=1). Endoleak from the hypogastric artery occurred in one patient in each group. Univariate analysis showed that predictive factors of long term (over six months) buttock claudication were embolization (p<0.001), younger age (p<0.03), coronary disease (p=0.06) and left ventricular dysfunction (p<0.01). The logistic regression analysis showed that buttock claudication was independently associated with embolization OR=9.1[95%CI=1.9-44] and left ventricular dysfunction OR=4.1[95%CI=1.3-12.7]. CONCLUSIONS: Coil embolization of hypogastric artery during EVAR is not an innocuous procedure and may not reduce the rate of type II endoleak.

Abdominal aortic aneurysm sac behavior following Cook Zenith graft implantation: a five-year follow-up assessment of 212 cases.

AIM: Aneurysm shrinkage is an expected outcome after stent-grafting for abdominal aortic aneurysm (AAA). A worrying problem following repair is progressive enlargement indicating persistent sac pressurization: in this setting not all grafts are equal. The Cook Zenith device (CZ) became available on the European market in 1999. While multicenter studies on the device have shown favorable clinical results at mid-term follow-up, few have focused on sac behavior. This study evaluated AAA sac behavior and predictive factors of its evolution by assessing the five-year results obtained with the CZ graft in a single-institution experience. METHODS: All consecutive elective surgery patients treated with a CZ graft for infrarenal aortic or aortoiliac aneurysm repair from January 2000 to November 2004 in our institution were included prospectively in the study and followed at 1, 6, 12, 18, 24 months and yearly thereafter. Pre-, intra- and postoperative data were recorded in a computerized database. Computed tomography (CT) scans were reviewed by a senior radiologist to identify any abnormalities including endoleak and graft malfunction. Pre- and postoperative maximum sac diameters were derived from measurements of CT findings and then compared. A change of at least 8 mm in sac size was considered significant. Overall results are expressed according to the Committee on Reporting Standards of AAA treatment. Factors that may have influenced sac behavior were analyzed by dividing the patients into 3 groups according to whether the sac diameter remained unchanged (group 1), had increased (group 2) or regressed (group 3). Statistical analysis of the demographic and CT-scan data was then performed. RESULTS: The study sample was 212 consecutive patients (mean age 72.8+/-9.0 years); the mean aneurysm diameter before treatment was 55.5+/-9.8 mm. All stent grafts were successfully implanted. The 30-day mortality rate was 0.94% (2/212); the morbidity rate was 11.7% (25/212). The primary technical success rate was 93.40%; the assisted primary technical success and secondary technical success rates were 96.63% and 99.52%, respectively. The mean follow-up period was 17.7+/-14.7 (1-60) months. The cumulative survival probability was 94%, 84.2%, and 72.9% at 12, 24, and 36 months, respectively. The endoleak-free survival probabilities at 12 and 24 months were 75.7% and 62.8%, respectively. The free of intervention survival rates were 82.1%, 68.9% and 60.6% at 12, 24 and 38 months, respectively. At five years follow-up, the overall clinical success rate was 49.5%. If changes in sac diameter occurred, they were noted at 13 months on average. Sac size remained unchanged in 115 (54.3%) patients (group 1), increased in 9 (4.2%) (group 2), and regressed in 88 (41.5%) (group 3). Neither preoperative patient demographics nor aneurysm characteristics were found to be predictive of sac behavior. Aortouniliac graft configuration was predictive of sac shrinkage (P=0.020). Endoleak was more frequent among patients in groups 1 (27/115; 23%) and 2 (5/9; 56%) than among those in group 3 (9/88;10%) (P=0.001). Reduction in aneurysm sac diameter was less marked in patients with any type of endoleak (P=0.0003). CONCLUSION: The CZ grafts offered satisfactory overall results up to five years of follow-up; nevertheless, sac diameter increased in 4.25% of patients. Endoleak was a predictive factor of a lack of sac shrinkage, while aortouniliac graft configuration was predictive of sac shrinkage.

Elective popliteal aneurysms: does venous availability has an impact on indications?

AIM: The aim of this retrospective study was to evaluate the patency and limb salvage rates after prosthetics or venous bypasses for asymptomatic or mildly symptomatic popliteal aneurysms, in order to determine if small uncomplicated aneurysms (caliber <300%) should be operated or periodically controlled when a venous conduit is not available. METHODS: During a 18 years period, 100 popliteal aneurysms, including 85 asymptomatic and 15 associated with intermittent claudication, were operated on: group I consisted of 80 venous bypasses, and group II consisted of 20 prosthetic bypasses. RESULTS: Demographics and risks factors were similar in both groups. Local complications were more frequent in group I (17% vs 10% p=NS). Early vascular complications were rare in both groups. Late arterial complications were more frequent in group II. Primary patency, assisted primary patency, and secondary patency rates at 2 years were 94.3%, 97.3% and 98.7% in group I, and 61.5%, 89% and 88.4% in group II (p<0.05). In contrast, the limbs salvage rates were not significantly different for each type of graft (98.7% vs 100% p=NS). CONCLUSIONS: Our data shows that aneurysms treated with a prosthetic graft are at higher risk of late occlusion than those operated with a vein graft. This should be taken into account when facing a small uncomplicated aneurysm without available venous conduit. The presence of a suitable vein should be checked before deciding to operate a small uncomplicated popliteal aneurysm.

Endovascular repair for ruptured AAA: a literature review.

The reduced physiological impact of endovascular aneurysm repair (EVAR) compared with conventional open repair has been demonstrated. If this technique could be used routinely in patients with ruptured abdominal aortic aneurysm (AAA) it may reduce the high peri-operative mortality. This review of the literature identified the current experience with EVAR of ruptured AAA. Only a small number of case series with selected patients are reported. These patients were selected for their haemodynamic stability, and their suitable aneurysm morphology. The overall anatomic suitability rates for EVAR reported, suggest an applicability of 58% to 80% from an intent-to-treat experience. The average post-operative mortality rate was 24%, ranging from 9 to 45% and may reflect increasing experience and patient selection. Important lessons have been learned from these first experiences that help to define a clear position of EVAR as an additional therapeutic option for ruptured AAA.

Management of radiation-induced occlusive arterial disease: a reassessment.

BACKGROUND: The goal of this study was to evaluate the operative hazards, therapeutic procedures, and late results of arterial reconstruction for radiation-induced occlusive disease. METHODS: Twenty-five patients were referred to our institution for radiation-induced occlusive arterial disease. Group 1: carotid artery stenosis or occlusion was encountered in seven patients. The nine procedures employed included percutaneous transluminal angioplasty (PTA) (n = 2), carotid endarterectomy (n = 3), vein or prosthetic bypass (n = 4). Group 2: four patients presenting with subclavian and axillary artery occlusion were treated with a common carotid to brachial artery vein bypass, one after unsuccessful PTA. Group 3: Thirteen patients had aorto-iliac occlusion. Initial management included medical treatment (n = 1), PTA (n = 2), aorto-bifemoral bypass (n = 4), aortofemoral and iliofemoral bypass (n = 1 each), axillofemoral bypass (n = 3), femorofemoral bypass (n = 1). Group 4: One patient had femoral artery occlusion treated with PTA. RESULTS: Group 1: One of two PTA was successful. Endarterectomy or bypass were successful in all cases. One late vein bypass stenosis was treated by venous patch angioplasty. Group 2: All vein bypasses were successful. Group 3: Limb salvage was achieved in all patients but eight required repeat operations for prosthetic sepsis (n = 3), restenosis (n = 3), or thrombosis (n = 12). Two patients died of late sepsis. Group 4: Outcome after PTA was successful. CONCLUSIONS: 1) Surgery for radiation-induced arterial lesions is difficult because of arterial, periarterial, and cutaneous sclerosis. Some patients, however, are amenable to PTA or endarterectomy. When bypass is necessary, anastomosis should be performed in healthy arteries, for instance, the thoracic aorta for the proximal anastomosis, or the brachial artery approached through a lateral mid-arm incision. 2) The risk of early or late graft infection is enhanced by the presence of tracheostomy, colostomy, or ureterostomy and by repeat operation for thrombosis. PTA, endarterectomy, or vein bypass should be preferred whenever feasible. When prosthetic material is unavoidable, prevention of infection should include the use of omentoplasty, remote bypass, antibiotic-bonded grafts or, in the case of major sepsis, allografts. 3) As restenosis remains a frequent complication, annual clinical and Duplex-scan surveillance is mandatory.

Are femoro-infrapopliteal bypasses worthwhile for limb salvage?

OBJECTIVE: This study was performed in order to determine if: 1-- femoral bypasses ending below the popliteal artery are justified in aged patients or in patients with poor general conditions, 2-- if the use of prosthetic material is justified when no vein is available, 3-- if reintervention is beneficial in case of bypass occlusion. EXPERIMENTAL DESIGN: Retrospective study of 162 infrapopliteal bypasses followed during 1 to 12 years (mean: 1.5). SETTING: Vascular Surgery Department of the University Hospital Henri Mondor based in a suburb of Paris, France. PATIENTS: All patients who underwent a femoral bypass ending below the popliteal artery for limb salvage from January 1984 to December 1995. INTERVENTION: These bypasses were performed with a vein in 131 cases and with a PTFE graft (with or without distal cuff) in 31 cases. MEASURES: All patients were followed with clinical evaluation and duplex scan. Primary and secondary patency, limb salvage and patient survival were studied. The survival rates at 1 and 5 years were 87+/-3.8% and 66+/-9.6% respectively. Preoperative mortality was 7.4%. Renal insufficiency requiring dialysis, not age over 80, was associated with high perioperative mortality. RESULTS: The primary patency rates of the total series at 1 and 5 years were 55 and 35% respectively for the total series. For venous bypasses, it was 58 and 37% while for prosthetic bypasses, it was 49 and 15%. The secondary patency rates at 1 and 5 years were 67 and 46% for the total series. For venous bypasses, it was 70 and 49% and for prosthetic bypasses, it was 53 and 21%. Limb salvage rates at 1 and 5 years were 65 and 61% for the total series, 73 and 65% for venous bypasses and 48 and 41% for prosthetic bypasses. CONCLUSION: 1-- Femorotibial or peroneal bypasses are worthwhile for limb salvage even in aged patients but renal insufficiency requiring dialysis may justify primary amputation. 2-- If no vein can be used, prosthetic or composite bypasses should be performed because they are associated with a 41% limb salvage rate at 5 years. 3-- If thrombosis occurs, the increase of patency after re-operation is 12% in case of venous bypass and 6% in case of prosthetic bypass.

Extracellular matrix covered biomaterials for human endothelial cell growth.

The aim of this study is to optimize conditions for growing endothelial cells on vascular biomaterials. Bovine cornea endothelial cells (BCEC), stimulated by basic Fibroblast Growth Factor (bFGF) secrete an extracellular matrix (ECM) similar to the Descemet membrane produced in vivo by these cells. This ECM, obtained by removing BCEC with an hypotonic shock can be used as a substratum for other endothelial cell growth. Human endothelial cells (HEC) were purified from omentum that was digested with a solution of collagenase-dispase, then filtered through nylon meshes. The cells were further purified by centrifugation onto a Percoll gradient. A comparative study on the attachment and growth of HEC on various coatings (laminin, poly-L-lysine, fibronectin or ECM) indicates that ECM is the most performing substratum. The quality of this endothelium was confirmed by the presence of factor VIII, and MHC class I and the absence of class II antigens.

Transmural endothelialization of vascular prostheses is regulated in vitro by Fibroblast Growth Factor 2 and heparan-like molecule.

Endothelialization of vascular prostheses may result from transmural migration of endothelial cells. Angiogenesis is controlled by growth factors like Fibroblast Growth Factor 2 (FGF2) and regulators like heparan-like molecules. To that end, we used heparan-like molecules named RGTA for ReGeneraTing Agent. The RGTA11 used was a chemically derived dextran obtained by successive substitutions with carboxymethyl, benzylamide, and benzylamide sulfonate groups on glucose residues. This agent was further selected for its ability to bind, stabilize and protect FGF2. We defined firstly the angiogenic capability of FGF2 in combination with RGTA11 on bovine aortic endothelial cells (BAEC) cultured on collagen I gels. Secondly, the role of FGF2 and RGTA11 in transmural endothelialization was assessed in a three-dimensional in vitro model using a polyethylene terephtalate prosthesis included in collagen gel. BAEC seeded on the external face can migrate to the luminal face of the prosthesis. Microscopic and histological evaluations were performed at 4 and 7 days. Results showed that the addition of RGTA11 alone did not promote angiogenesis while FGF2 alone did. However, RGTA11 combined with FGF2 produced a significant acceleration in angiogenesis compared to FGF2 alone. This combination magnifies and enhances the angiogenic processes leading to endothelialization of luminal face through transmural cellular migration. Our data demonstrates that in vitro transmural endothelialization of porous vascular prostheses by BAEC cultured on collagen I gels is upregulated by RGTA11 combined with FGF2.

Management of infected vascular prostheses. The vascular homograft revisited.

Treatment of infected aortic femoral grafts is difficult and controversial. We describe the case of a patient who presented for recurrent infections of an aorto-bifemoral prosthesis. An arterial homograft was used to replace the Dacron prosthesis. One year later, the patient is free of symptoms and is doing well. Although early experiences with long-term use of homografts showed late degeneration of the grafts, 2 points should now be raised in favor of homograft use: new techniques of fresh antibiotic storage of homografts appear to have improved durability; and if replacement of a homograft ever becomes necessary, implantation of a Dacron prosthesis could likely be performed in an aseptic environment. While the use of homografts may constitute a reasonable alternative for treating patients with infected vascular grafts, firm conclusions cannot be drawn until we have seen larger series of patients and longer follow-up periods than those few reported to date.