Randomized Study of Noninferiority Comparing Prosthetic and Autologous Vein Above-Knee Femoropopliteal Bypasses.

BACKGROUND: The main aim of this study was to compare the 5 years rates of secondary patency of above-knee femoropopliteal revascularizations with autologous veins or prosthetic grafts. The secondary objectives were to compare the rates of primary patency, limb salvage, morbidity, and mortality between the 2 groups. METHODS: This was a single-blind randomized study of noninferiority (ratio 1:1), carried out in 11 centers of vascular surgery with 2 parallel groups between July 2002 and November 2005. Follow-up finished in May 2011. The monitoring protocol included a clinical examination and an ultrasound control at 1 month, 3 and 6 months, then annually. RESULTS: One hundred patients were included and randomized in the study, 52 in the prosthetic group and 48 in the autologous vein group. Four patients randomized in the vein group received a prosthetic graft. No patient was excluded from the analysis. In the in intent-to-treat analysis, the 5 years secondary patency was 84.6% in the prosthetic group (IC 95%, 71.9-93.1) and 70.8% in the autologous vein group (IC 95%: 55.9-83.1), and the difference in secondary patency between the prosthetic and the autologous vein groups was 13.8% (IC 95%, -4.4 to 32.0). In the under treatment analysis, the 5 years secondary patency was 96.2% among patients receiving a prosthesis (IC 95%, 80.4-99.9) and 90.5% among patients receiving an autologous vein (IC 95%, 66.9-98.9), and the difference in the rate of patency between prostheses and veins was 5.7% (IC 95%, -13.2 to 24.6). Although there was no significant difference at 5 years, the death rate and the rate of amputation were higher in the prosthetic group. CONCLUSIONS: Although it is impossible to conclude definitely to the noninferiority of prosthetic bypass compared with venous bypass because of the insufficient number of inclusions, this randomized study nevertheless showed at 5 years the satisfactory results obtained with prostheses compared with autologous vein for above-knee femoropopliteal bypasses.

Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.

BACKGROUND: Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). METHODS/DESIGN: A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. DISCUSSION: This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Primary stenting of TASC C and D femoropopliteal lesions: results of the STELLA register at 30 months.

BACKGROUND: The 1-year results of the prospective register STELLA suggested that primary stenting of long femoropopliteal (FP) lesions (≥15-cm) was a sure and effective treatment. However, the long-term results of this technique remain unknown. METHODS: STELLA is a prospective monocentric register of patients treated for FP lesions ≥15-cm (Trans-Atlantic Inter-Society Consensus [TASC] C and D) by direct stenting (Flexstar(®), Bard). The patients with de novo atheromatous lesions were included between November 2008 and October 2009 when the guidewire had crossed the lesion. Restenoses were excluded. The follow-up was coordinated by a clinical research assistant. Clinical and ultrasound evaluation were carried out every 3 months for 12 months, then every 6 months up to 30 months. Restenosis was defined by an index of peak systolic velocity >2.4. RESULTS: Among the 58 patients (62 limbs) included, 40.3% presented an effort ischemia and 59.7% a critical ischemia (CI). The mean age was 71 ± 12 years. The lesions were classified as TASC D in 37.1% of the cases. The median length of the stenting was 26 ± 18 cm. The average follow-up was 26.1 months (1-30). At 30 months, a complete follow-up was obtained in 55 patients (58 limbs). The rate of survival was 79.6%. Nine of the 11 patients deceased presented initially with CI. Death was in connection with CI in 2 cases. At the date of latest news, 98.3% of the patients were under antiaggregating treatment, 20% received antivitamin K treatment, 75% received statins, and 75% received angiotensin-converting-enzyme inhibitors. The rates of maintenance of the primary and secondary clinical improvement were 68.6 ± 6.0% and 82.6 ± 5.1% at 12 months and 65.1 ± 6.2% and 78.4 ± 5.6% at 30 months, respectively. The mean Rutherford index was 4.1 ± 1.0 in preoperative, 0.7 ± 1.2 at 12 months, and 0.6 ± 1.1 at 30 months (P < 0.001). Two major amputations were carried out at 9 and 28 months for patients initially with CI. The mean systolic pressure index was 0.6 ± 0.1 in preoperative and 1.0 ± 0.2 at 1-year and 0.9 ± 0.3 at 30 months (P < 0.001). The rates of primary and secondary patency were 66 ± 6.3% and 80.9 ± 9.5% at 12 months and 62.2 ± 6.6% and 77.2 ± 5.9% at 30 months, respectively. Between 0 and 12 months, 12 (19.3%) intrastent restenosis (ISR) were noted. One ISR was observed after 12 months. At the same period, we observed 11 and 1 target lesion revascularization, respectively. CONCLUSIONS: In the long run, the primary stenting of long FP lesions (≥15-cm) is a safe and durable treatment. A strong clinical and ultrasound monitoring is indicated during the first year to maintain the clinical improvement.

Clinical and economic evaluation of ambulatory endovascular treatment of peripheral arterial occlusive lesions.

BACKGROUND: Ambulatory management of patients is an alternative to conventional hospitalization. In this study we evaluate the results of a prospective cohort study of patients receiving ambulatory endovascular treatment for peripheral arterial lesions. METHODS: From June 2008 to October 2010, ambulatory management was proposed for endovascular treatment of peripheral arterial lesions. An arterial closure device (Angio-Seal(®); St. Jude Medical) was used. For ambulatory treatment, patients were prohibited from driving a vehicle at discharge, had to be accompanied the first night after the procedure, had to live <1 hour from a medical facility, had to be reachable by telephone the day after the intervention, and had to remain hospitalized in the event of a complication. The principal criterion was morbimortality at 1 month. Secondary criteria were clinical improvement, patency, complications related to the arterial closure, and costs evaluation at 1 month. RESULTS: Forty-five patients were included and 50 ambulatory procedures were carried out. The patients presented with claudication (92%) or a critical ischemia (8%) of the lower extremities. All procedures were carried out by femoral puncture (retrograde in 94% and anterograde in 6% of the cases). The patients presented with iliac (68%) and femoropopliteal (64%) lesions. Lesions included stenoses (70%), thromboses (16%), and intrastent restenoses (14%). The rate of failure of ambulatory hospitalization was 16% (n = 8) without a serious undesirable event: 2 patients were hospitalized after a surgical conversion for iliac rupture and disinsertion of stent; 3 patients developed a hematoma during the intervention at the point of puncture; and in 3 cases the system of percutaneous closure failed. The mean duration of hospitalization was 1.36 ± 1.33 days. At 1 month, clinical improvement was observed in 97.5% of cases, with a primary patency of 100%. No perioperative rehospitalization or puncture site complications were observed. Ambulatory management made it possible to save 42 days of hospitalization, with associated costs of 10,971€, compared with conventional hospitalization. The additional costs related to use of the Angio-Seal amounted to 7427€. CONCLUSION: Ambulatory endovascular treatment of patients presenting with peripheral arterial lesions is reliable and effective and may contribute to savings in healthcare spending.

Acute compartment syndrome of the thigh secondary to isolated common femoral vessel injury: an unusual etiology.

We report a case of acute compartment syndrome of the thigh secondary to common femoral vessel injury. The lesion was associated with common femoral artery dissection and common femoral vein rupture. Emergency surgical treatment consisted of resection-anastomosis of the arterial dissection, vein ligature, and fasciotomies. The patient is symptom-free after 15 months of follow-up. Isolated vascular injury is an unusual cause of acute compartment syndrome of the thigh. This case serves to increase awareness that isolated vascular injury, without femoral fracture or multiple injury, can result in thigh compartment syndrome. Early recognition and treatment of vascular involvement contributes to better functional outcome of this rare condition, but treatment modalities remain subject to discussion.

Long-term influence of suprarenal or infrarenal fixation on proximal neck dilatation and stentgraft migration after EVAR.

BACKGROUND: We evaluated the influence of the proximal fixation systems of stentgrafts on proximal inter-renal or infrarenal aneurysm neck dilatation after endovascular repair of abdominal aortic aneurysms. Anatomic and clinical predictive factors of neck dilatation and stentgraft proximal migration were searched for. MATERIAL AND METHODS: Taking account of a prospective and monocenter register, 58 patients' files, with a complete minimum 3-year follow-up, were analyzed after treatment with stentgrafts with a suprarenal fixation (SRF: 33 Talent) or an infrarenal fixation (IRF: 25 AneuRx). Both groups were compared in terms of inter-renal neck dilatation (D1: diameter between the two renal arteries), infrarenal neck dilatation (D2: 7-mm diameter under the lowest renal artery), and specific complication (proximal migration, endoleak). The diameter measured on the last control computed tomography scan was compared with the postoperative diameter. Neck dilatation was defined by a diameter increase exceeding 3 mm and by the proximal migration due to a caudal displacement of the stentgraft ≥10 mm. Predictive factors of proximal migration or neck dilatation were searched for (anatomy of the neck, aneurysm anatomy, stent graft oversize percentage, demographic factors). RESULTS: Preoperatively, both groups were comparable in terms of anatomic and demographic characteristics of the aneurysm. Mean follow-up was longer in the AneuRx group (62 ± 17 months vs. 53 ± 13 months, p = 0.045) and the percentage of stent graft oversize was greater in the Talent group (18 ± 6% vs. 13 ± 5%, p < 10(-4)). Freedom from a dilatation exceeding 3 mm in D1 and D2 did not bring any significant difference between the two groups. In each group, the remodeling of the aneurysmal sac (AneuRx median = -4 mm, Talent median = -5 mm, p > 0.05) was only moderately related to proximal neck remodeling. A small angulation of the neck and a smaller neck were the only predictive factors of neck dilatation found respectively in D1 (p = 0.007) and in D2 (p = 0.022). Stent graft proximal migration was more frequent in the AneuRx group (p = 0.031) and was more frequent with large aneurysms (p = 0.029). CONCLUSION: In the long term, the absence of proximal stent graft fixation system on the dilatation of the aneurysm proximal neck enhances proximal migration. Conversely, the inter-renal or infrarenal proximal neck dilatation does not depend on the type of proximal fixation but on anatomic factors and on the natural evolution of the aneurysmal disease.

Prognostic factors of ischemic colitis after infrarenal aortic surgery.

BACKGROUND: Postoperative ischemic colitis (POIC) remains a frequent and extremely severe complication of infrarenal abdominal aorta surgery. However, its diagnosis and treatment are not always consensual because the incidence is very small. The aim of this retrospective study was to evaluate the prognostic factors of severe colitis after infrarenal aorta surgery. MATERIALS AND METHODS: We analyzed peroperative and perioperative data of the patients who, between 1998 and 2004, underwent infrarenal abdominal aorta surgery and were presented with confirmed POIC. We set two distinct groups: acute colitis group (operated POIC, perioperative deaths, or evolution toward a colic stenosis secondarily operated on) and a moderate colitis group (recovery without aftereffects and no surgery). The main goal was to individualize the prognostic factors of acute colitis. Using the Student's t-test or the Fisher's exact test, the potential prognostic factors were compared between these two groups. RESULTS: Between 1998 and 2004, 679 patients underwent infrarenal abdominal aorta surgery. Among these patients, 28 POIC cases were confirmed: 20 patients had acute POIC and eight had moderate POIC. Demographic and peroperative data were similar in the two groups. Among the 20 patients with acute POIC, 17 were operated on with a postoperative mortality rate of 58.8%. All the patients had at least a left colitis. In 59% of the cases, Hartmann's procedure was performed with a mortality rate of 50%. Early digestive symptoms (p = 0.05), use of vasopressors (p = 0.0377), diagnosis in intensive care unit (p = 0.0095), and a pH <7.35 at D1 (p = 0.0261) were independently associated with acute ischemic colitis. Moreover, we could observe the important role of endoscopy aiming at making diagnosis and prognosis. CONCLUSION: This study highlighted significant prognosis factors of severe colitis. These factors could help take the decision to operate POIC, especially to lower the effect of multiple organ failure syndrome (MOFS).

Hyaluronan induces vascular smooth muscle cell migration through RHAMM-mediated PI3K-dependent Rac activation.

OBJECTIVE: Hyaluronan (HA) is an important constituent of the extracellular matrix and is known to regulate cellular events through binding to CD44 and the receptor for HA-mediated motility (RHAMM). Here we investigated the role of these receptors and the signaling pathways involved in HA-mediated effects in arterial smooth muscle cells (ASMC). METHODS: Effects of high-molecular weight HA (1 to 5 mg/ml) were analyzed in cultured ASMC from rat aorta. RESULTS: HA promoted actin stress fiber and lamellipodia formation and dose-dependently induced ASMC migration without effect on proliferation. Pull-down assay of Rho protein activity indicated that HA activated RhoA and Rac. HA-induced ASMC migration was not affected by the RhoA inhibitor Tat-C3 (10 microg/ml), the Rho kinase inhibitor Y-27632 (10 microM) and blocking anti-CD44 antibody ,but was reduced by the non-selective Rho protein inhibitor simvastatin (10 microM), the Rac inhibitor LT-toxin (1 mug/ml), small interfering RNA (siRNA) targeting Rac and the phosphatidyl inositol 3-kinase (PI3K) inhibitor LY294002 (25 microM), which also blocked HA-induced Rac activation. CD44 knockdown by siRNA inhibited HA-mediated RhoA activation without effect on ASMC migration. In contrast, siRNA targeting RHAMM inhibited both HA-induced migration and Rac activation. CONCLUSIONS: High-molecular weight HA independently activates RhoA and Rac through CD44 and RHAMM, respectively. HA-induced migration depends exclusively on RHAMM-mediated PI3K-dependent Rac activation.

Evidence for early nasogastric tube removal after infrarenal aortic surgery: a randomized trial.

OBJECTIVE: Nasogastric tube (NGT) decompression after abdominal surgery is still largely used to prevent nausea and vomiting. However, indications are based more on practice than on studies. Moreover, prolonged NGT decompression can lead to complications. In this prospective and randomized study, we evaluated the effects of early withdrawal of NGTs in patients undergoing surgery of the infrarenal aorta. METHODS: Between October 2001 and May 2002, consecutive patients underwent scheduled infrarenal aortic operations. Patients were prospectively randomised into two groups: group 1, NGT maintenance until the passage of flatus; and group 2, NGT removal at the time of tracheal extubation. Preoperative and perioperative data were collected. The main end point was the occurrence of nausea and vomiting. Secondary end points were tolerance of NGT withdrawal and postoperative complications. Criteria were compared between groups by using Mann-Whitney or Fisher exact tests. RESULTS: Forty-six patients underwent aortic operations. Six patients were subsequently excluded from the study. Of the 40 randomized subjects, 20 patients were included in each group. Preoperative and intraoperative data were similar in both groups. There was no statistical difference between groups regarding nausea and vomiting. In group 1, the occurrence of respiratory complications was more frequent compared with group 2 (5 vs 0 complications; P = .023). There was no significant difference in intensive care unit stay, but the hospital stay was shorter in group 2 (mean, 9 +/- 3 days vs 15 +/- 9 days; P = .016). There were no differences in other adverse events. CONCLUSIONS: This study does not support a significant effect of early removal of NGTs on nausea and vomiting in patients undergoing open repair of the infrarenal aorta. However, these findings suggest that NGT maintenance increases the risk of respiratory complications and the length of hospital stay.

Association of aneurysmal and occlusive lesions in Behçet's disease.

Arterial involvement in Behçet's disease is rare, occurring in various locations with multiple clinical expressions. When Behçet's disease is associated with large arteries, lesions are usually in the form of aneurysms or occlusions. The simultaneous occurrence of these two lesions is even more unusual. We present a case of Behçet's disease in which arterial involvement included an iliac artery thrombosis and an asymptomatic aneurysm of the infrarenal abdominal aorta. Behçet's disease must be considered in the diagnosis of any unexplained inflammatory arteriopathy. Surgery is indicated for the majority of aneurysms and severe symptoms. The postoperative follow-up is based on noninvasive radiologic examinations.

Surgical treatment of nonaneurysmal aortic arch lesions in patients with systemic embolization.

PURPOSE: Atherosclerotic lesions of the aortic arch are potential sources of arterial embolism. Here we investigate whether surgery, with the necessary circulatory supports, can be proposed as a good option for treatment of this problem. Study of these lesions on a national scale in France has made possible the assessment for future indications of techniques and results of the surgical management of aortic arch lesions, which retrospectively proved to be embolic. METHODS: Thirty-eight patients, (19 men and 19 women) underwent surgery between 1976 and 1996 in 17 French cardiovascular surgical centers. The average age at the time of surgery was 49 +/- 12 years (range, 31 to 82 years). Atherosclerotic lesions were detected with transesophagial echocardiography (n = 19), angiography of the aortic arch (n = 16), computed tomography (n = 9), and magnetic resonance imaging (n = 10). Surgery consisted of thrombectomy and endarterectomy (n = 22), aortic resection and graft replacement (n = 10), and patch aortoplasty (n = 5; one thrombus disappeared spontaneously before surgery was performed). RESULTS: The average postoperative period was 30 months (range, 3 to 82 months). Contact was lost with four patients after a follow-up period of 12 months. On pathologic specimens obtained at surgery, an atherosclerotic plaque was found in 73% of the cases (n = 28). In 15% of the cases, the aorta appeared normal (n = 6) and four other types of lesion were identified: angiosarcoma (n = 1), ectasia at the insertion of the remains of the ductus arteriosus (n = 1), rupture of tunica intima (n = 1), and a fibroblastic plaque (n = 1). A thrombus was identified in 26 cases, attached to the arterial wall in 18 cases. When transesophagial echocardiographic results showed mobile lesions (n = 22), histopathologic examination of specimens allowed the detection of a thrombus in 18 cases and an atherosclerotic plaque with a mobile projection in four cases. The postoperative mortality rate was 2.6%. The morbidity rate (28.9%; n = 11) was related to neurologic complications (n = 6), vascular complications (n = 4), and infection (n = 1). Four cases (12%) were reoperated. CONCLUSION: Nonaneurysmal aortic arch lesions are a frequent and still underestimated source of stroke and peripheral embolization. Surgery with circulatory support can be recommended in good operative candidates with recurrent critical events despite medical management and with high embolic potential (young patients with no calcified plaques).

Superior mesenteric artery dissection: case report.

Spontaneous dissections of the superior mesenteric artery are exceptional events because only 26 reports have been published. We present a new case, revealed with an acute abdominal syndrome. Computed tomographic angiography and arteriography allowed a rapid diagnosis and urgent surgical intervention. Progress in imagery makes diagnosis and follow-up examination easier. Surgery is indicated for acute symptomatic forms with suspicion of mesenteric ischemia. In the other cases, a simple follow-up examination may be appropriate.