[Incidence of major amputations, bypass procedures and percutaneous transluminal angioplasties (PTA) in the treatment of peripheral arterial occlusive disease in a German referral center 1996-2003] ***

Rofo. 2006 Sep;178(9):906-10. Epub 2006 Aug 7.

[Article in German]

Wohlgemuth WA, Freitag MH, Wolfle KD, Bohndorf K, Kirchhof K.

Klinik fur Diagnostische Radiologie und Neuroradiologie, Zentralklinikum Augsburg.

PURPOSE: To determine the current incidence of major amputations, bypass procedures and percutaneous transluminal angioplasties (PTA) in a study population of patients with peripheral arterial occlusive disease in a German referral center. MATERIALS AND METHODS: In a retrospective study, we recruited patients with peripheral arterial occlusive disease who underwent an amputation, bypass procedure, or PTA in the region of the pelvis or lower limbs between 1996 and 2003 at the Augsburg Medical Center. Patients were identified via the hospital database. This was performed with the help of the International Classification of Diseases (ICD 9 and 10), the operation code (OPS), and appropriate invoices. The incidence of PTAs was further estimated with 200 charts. RESULTS: Of 5379 patients, 627 underwent amputation, 1832 a bypass procedure, and 2920 a PTA. The incidence of PTAs increased during the study period from 51.3/100 000/year to 64.4/100 000/year (p < 0.01), while the number of amputations and bypass procedures remained stable. The incidence of PTAs was exceeded by that of bypass procedures only in patients older than 85 years. The age of the amputees decreased during the study period from 72.2 to 70.5 years (p < 0.01). The age of patients who underwent a bypass procedure increased from 67.2 to 69.4 years, and the age of patients who underwent PTA increased from 66.3 to 69.8 years (p < 0.01). Bypass procedures and PTAs were performed in men 6.3 years earlier than in women (p < 0.01). CONCLUSION: The result is a population-corrected need of 8.4/100 000/year major amputations, 23/100 000/year bypass procedures and 64.4/100 000/year PTAs for patients with peripheral arterial occlusive disease within the referral area of our hospital. The performance of major amputations and bypass procedures stagnates, while the incidence of PTAs is increasing.

PreMedline Identifier: 16894498

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Factors Affecting Patency of Subintimal Infrainguinal Angioplasty in Patients with Critical Lower Limb Ischemia. ***

Eur J Vasc Endovasc Surg. 2006 Sep 9; [Epub ahead of print]

Lazaris AM, Salas C, Tsiamis AC, Vlachou PA, Bolia A, Fishwick G, Bell PR.

Attikon Teaching Hospital, 3rd Surgical Department, Athens, Greece; Leicester Royal Infirmary, Department of Surgery, UK.

BACKGROUND: Because subintimal angioplasty (SA) is a technique that can achieve recanalization of long arterial occlusions, it is considered an alternative to lower limb bypass operations. The aim of this prospective study was to identify the risk factors that affect patency of SA in patients suffering from critical limb ischemia (CLI). METHODS AND RESULTS: 51 consecutive infrainguinal SA were done in 46 patients suffered from CLI. The patients were followed-up with regular duplex scans up to 12 months post-intervention. Sex, atherosclerosis risk factors, and some technical details of the procedure (number of patent run-off vessels after the procedure, length and re-entry point of angioplasty) were examined as potential risk factors of patency, using survival analysis statistical techniques. The overall patency rate at 12 months post-intervention was 50%. According to Cox-regression analysis, the factors that affect patency were the number of run-off vessels and the length of occlusion. Patients with two or three run-off vessels had a hazard of occlusion of 0.30 (P=.027) compared to those who had one run-off vessel. The 12-months patency in patients with more than one run-off vessels was 81% vs. 25% in patients with one run-off vessel. Regarding the length of angioplasty, the hazard of reocclusion was 1.02 for every centimeter of occlusion (P=.049). CONCLUSIONS: The number of patent run-off crural vessels after the angioplasty and the length of occlusion are significant risk factors for reocclusion of infrainguinal SA in patients with CLI. Trying to recanalize more than one run-off vessels could raise the SA patency.

PreMedline Identifier: 16968668

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The Occurrence of Arterio-venous Fistula during Lower Limb Subintimal Angioplasty: Treatment and Outcome.***

Eur J Vasc Endovasc Surg. 2006 Sep 9; [Epub ahead of print]

Ananthakrishnan G, Denunzio M, Bungay P, Pollock G, Fishwick G, Bolia A.

Departments of Surgery, Derbyshire Royal Infirmary, UK.

OBJECTIVES: To describe our experience with iatrogenic arterio-venous fistula (AVF) occurring during lower limb subintimal angioplasty, their management and the final clinical, radiological outcome. DESIGN: Retrospective review of case series from two centres, from a computerised database over a period of five years. MATERIAL: Twelve patients whose lower limb subintimal angioplasty was complicated by Iatrogenic AVF. RESULTS: The Majority of AVF occurred at the popliteal trifurcation vessels. And the incidence of this complication in our case series was 0.8%. This was managed with a variety of techniques-Coil embolisation, balloon tamponade, alternative dissection and stent placement. In one patient, the fistula was left open intentionally. All twelve patients had a successful angioplasty. The overall technical success rate for AVF ablation was eighty percent. CONCLUSIONS: AVF is a potential complication of angioplasty. The majority can be managed by endovascular means during the angioplasty procedure with good technical success.

PreMedline Identifier: 16968667

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PTA and stent placement distal to the superficial femoral artery.***

Radiologe. 2006 Oct 12; [Epub ahead of print]

[Article in German]

Rand T, Haumer M, Stadler A, Schoder M, Kettenbach J.

Klinische Abteilung fur Angiographie und Interventionelle Radiologie, Medizinische Universitat Wien, Wahringer Gurtel 18-20, 1090 , Wien, Osterreich, Thomas.rand@meduniwien.ac.at.

Although angioplasty and stent applications in the iliac vessels and the superficial femoral artery have become routine procedures, their usefulness for the treatment of lesions of the popliteal artery and the lower leg arteries is still under discussion. For the popliteal artery, limitations are mainly due to the high mechanical stress in this area, causing high traction forces. Moreover, beyond the occlusive atherosclerotic changes, specific pathological entities such as aneurysms, emboli, entrapment syndromes, and cystic adventitial disease have to be differentiated. There is hope that the development of innovative stent designs with high flexibility might overcome the limitations. For lesions of the lower leg arteries treatment with percutaneous transluminal angioplasty (PTA) has become the method of choice. However, stent designs as used for cardiac interventions have been adapted for their application below the knee, and first encouraging results may help to justify their broad use in the future. Regarding PTA, innovative equipment and techniques for the treatment of arterial lesions below the knee include dedicated, long, and very flexible balloons, cutting balloon cryoplasty, and laser angioplasty. Regarding stents, bare metal stents, stents with passive or active coatings, and bioabsorbable stents have all been successfully used.

PreMedline Identifier: 17036248

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Rational minimally invasive treatment of pAOD: when should a conservative approach, PTA, or stent be chosen?***

Radiologe. 2006 Oct 11; [Epub ahead of print]

[Article in German]

Muller-Hulsbeck S.

Klinik fur Diagnostische Radiologie, Universitatsklinikum Schleswig-Holstein der Christian-Albrechts-Universitat zu Kiel, Arnold-Heller-Strasse 9, 24105 , Kiel, Deutschland, muehue@rad.uni-kiel.de.

In order to obtain optimal results and satisfied patients, rational therapy of pAOD should strictly follow national and international society guidelines. In particular cases an individual therapeutic concept seems justified beyond these guidelines. Based on clinical data and driven by costs, aortic and iliac lesions may be treated by PTA or selective stent placement with equal results; however, long-term data justify also primary, direct stenting. For treatment of infrainguinal and popliteal stenotic lesions primary stenting should be restricted to PTA failure (dissection, recoil, occlusion); except for treatment of extended lesions, primary stenting compared to PTA alone seems beneficial in terms of midterm patency. Endovascular procedures below the knee and at the toe should be limited to existing limb-threatening ischemia in order to save the extremity; whether PTA or stenting is advantageous has not yet determined.

PreMedline Identifier: 17033776

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Fluoropolymer-coated Dacron Versus PTFE Grafts for Femorofemoral Crossover Bypass: Randomised Trial. ***

Eur J Vasc Endovasc Surg. 2006 Oct;32(4):431-8. Epub 2006 Jun 27.

Eiberg JP, Roder O, Stahl-Madsen M, Eldrup N, Qvarfordt P, Laursen A, Greve M, Florenes T, Nielsen OM, Seidelin C, Vestergaard-Andersen T, Schroeder TV.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark.

OBJECTIVES: To investigate whether patency of a thin walled 8mm fluoropassivated Dacron graft was similar to that of a standard 8mm PTFE graft for femorofemoral crossover bypass surgery. DESIGN: A randomised multicentre clinical trial comparing two vascular grafts with participation of 10 departments of vascular surgery in Denmark, Sweden and Norway. PATIENTS AND METHODS: 198 patients were randomised to PTFE (n=107) or fluoropolymer-coated Dacron grafts (n=91), 63% underwent surgery for claudication, 27% for ischaemic rest pain and 10% for tissue loss. The median follow-up time was 24 months (IQR 19-26 months). RESULTS: The primary patency rate of the two grafts was similar (log rank test: p=0.35). The primary patency rates (95% CI) for coated Dacron and PTFE grafts were 92% (86-98) and 94% (89-99) at 12 months and 87% (74-95) and 93% (87-99) at 24 months, respectively. CONCLUSION: In patients with unilateral iliac artery disease not amenable to angioplasty, the femoral-femoral bypass is durable and effective. No difference in patency was found between the two graft materials (fluoropolymer coated Dacron and PTFE).

PreMedline Identifier: 16807001

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[Guidance of interventions in subintimal recanalization and fenestration of dissection membranes using a novel dual-lumen intravascular ultrasound catheter] ***

Rofo. 2006 Sep;178(9):898-905. Epub 2006 Aug 21.

[Article in German]

Kickuth R, Ludwig KC, Do DD, Husmann M, Baumgartner I, Triller J.

Departement Radiologie, Neuroradiologie und Nuklearmedizin (DRNN), Institut fur Diagnostische, Interventionelle und Padiatrische Radiologie. ralph.kickuth@insel.ch

PURPOSE: To evaluate the feasibility and effectiveness of IVUS-guided puncture for gaining controlled target lumen reentry in subintimal recanalization of chronic iliac/femoral artery occlusions and in fenestration of aortic dissections. MATERIALS AND METHODS: Between 5/2004 and 12/2005 12 consecutive patients (7 male, 5 female; mean age 64.6 +/- 12.0 years) with chronic critical limb ischemia and ischemic complications of aortic dissection were treated using the Pioneer catheter. This 6.2-F dual-lumen catheter combines a 20-MHz IVUS transducer with a pre-shaped extendable, hollow 24-gauge nitinol needle. This coaxial needle allows real-time IVUS-guided puncture of the target lumen and after successful reentry a 0.014" guidewire may be advanced through the needle into the target lumen. 7 patients were treated for aortic dissection and 5 patients (with failed previous attempts at subintimal recanalization) for chronic arterial occlusion. Patients with aortic dissection (5 type A dissections, 2 type B dissections) had developed renal ischemia (n = 2), renal and mesenteric ischemia (n = 2), or low extremity ischemia (n = 3). Patients with chronic arterial occlusions (2 common iliac artery occlusions, 3 superficial femoral artery occlusions) experienced ischemic rest pain (n = 4), and a non-healing foot ulcer (n = 1). RESULTS: The technical success rate using the Pioneer catheter was 100%. The recanalization/fenestration time was 37 +/- 12 min. Procedure-related complications did not occur. In 10 cases a significant improvement of clinical symptoms was evident. One patient with aortic dissection and ischemic paraplegia required subsequent surgical intervention. One patient had persistent ischemic rest pain despite successful recanalization of a superficial femoral artery occlusion. CONCLUSION: The Pioneer catheter is a reliable device which may be helpful for achieving target lumen reentry in subintimal recanalization of chronic occlusions and in fenestration of aortic dissections.

PreMedline Identifier: 16921463

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Endofibrosis of iliac arteries in high-performance athletes: diagnostic approach and minimally invasive endovascular treatment.***

Cardiovasc Intervent Radiol. 2006 Sep-Oct;29(5):866-9.

Giannoukas AD, Berczi V, Anoop U, Cleveland TJ, Beard JD, Gaines PA.

Sheffield Vascular Institute, Northern General Hospital, Sheffield, S5 7AU, UK. agiannoukas@hotmail.com

The aim of this article is to report our experience in the diagnosis of two cases of iliac artery endofibrosis or arteriopathy, a rare entity occurring in high-performance athletes, presenting with intermittent claudication (right-sided in both) after maximal exercise. External iliac artery endofibrosis or arteriopathy is a likely diagnosis in competitive athletes free of cardiovascular risk factors who present with leg claudication. Arteriography and a papaverine-assisted mean pressure gradient across the iliac arteries of more than 10 mmHg is a useful diagnostic approach. Moreover, balloon angioplasty of the iliac artery in that patient, in whom a pressure gradient was detected, resulted in symptomatic relief for 2 months followed by mild symptom recurrence. Thus, although balloon angioplasty is feasible and safe, it might not be adequate to treat this entity and, thus, its value remains undefined.

PreMedline Identifier: 16565800

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Hybrid approach to complex thoracic aortic aneurysms in high-risk patients: surgical challenges and clinical outcomes. ***

J Vasc Surg. 2006 Oct;44(4):688-93. Epub 2006 Aug 22.

Zhou W, Reardon M, Peden EK, Lin PH, Lumsden AB.

Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX 77030, USA. wzhou1@bcm.edu

BACKGROUND: Endovascular therapy is a less invasive alternative treatment for high-risk patients with thoracic aortic aneurysms. However, this technology alone is often not applicable to complex aneurysmal morphology. The purpose of this study was to evaluate the utility of hybrid strategies in high-risk patients who are otherwise unsuitable for endovascular therapy alone. METHODS: During an 18-month period, 31 high-risk patients (mean age, 69 years; range, 52-89 years) underwent combined open and endovascular approaches for complex aneurysms, including 16 patients with ascending and arch aneurysms and 15 patients with aneurysms involving visceral vessels. Among them, 11 patients had histories of aneurysm repairs. To overcome the anatomic limitations of endovascular repairs, various adjunctive surgical maneuvers were used, including aortic arch reconstruction in 3 patients, supra-aortic trunk debranching in 13 patients (including 8 patients who required aortas as inflow sources), and visceral vessel bypasses in 15 patients (including 10 patients who required bypasses to all 3 visceral branches). Additionally, carotid artery access was obtained in 1 patient, and iliac artery conduits were created in 12 patients. RESULTS: Technical success was achieved in all patients. There was one perioperative death (3.2%) due to postoperative bleeding. Two patients (6.4%) had immediate type II endoleaks, which were resolved by the 1-month follow-up. Other procedure-related complications occurred in three patients (9.6%), including renal bypass thromboses in two patients and retroperitoneal hematoma, which was successfully managed conservatively, in one patient. During a mean follow-up of 16 months, two patients died of unrelated causes, whereas the remainder of patients were asymptomatic, without aneurysm enlargement. CONCLUSIONS: Our study highlights how hybrid strategies incorporating surgical and endovascular approaches can be used successfully in treating patients with complex thoracic aortic aneurysms. This combined approach potentially expands the field of endovascular stent grafting and is an attractive solution for patients with poor cardiopulmonary reserves.

PreMedline Identifier: 16926086

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Percutaneous removal of two self-expanding stent grafts following failed deployment. ***

Acta Radiol. 2006 Sep;47(7):667-71.

Ferguson E, Cwikiel W.

Section of Vascular Surgery and Department of Interventional Radiology, University of Michigan Hospital, Ann Arbor, Mich., USA.

Insertion of self-expanding stent grafts was attempted in two patients with venous obstruction following unsuccessful venoplasty. One patient with end-stage renal disease had stenosis at the caudal end of the previously placed stent in the right external iliac vein. The second patient was treated for occlusion of multiple stents in the left iliac vein. Two of the stent grafts failed deployment and were subsequently removed percutaneously. New stent grafts were inserted in the intended positions. Despite additional venous access sites with large caliber sheaths, required for retrieval of the failed stent grafts, there were no major complications.

PreMedline Identifier: 16950702

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A third-generation, long-acting, dihydropyridine calcium antagonist, azelnidipine, attenuates stent-associated neointimal formation in non-human primates. ***

J Hypertens. 2006 Sep;24(9):1881-9.

Nakano K, Egashira K, Tada H, Kohjimoto Y, Hirouchi Y, Kitajima S, Endo Y, Li XH, Sunagawa K.

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

BACKGROUND: Calcium antagonists have been shown to reduce atherogenesis and improve clinical outcomes in atherosclerotic vascular disease. No study has so far, however, addressed the effects of calcium antagonists on stent-associated neointimal formation. We therefore investigated whether a third-generation calcium antagonist, azelnidipine, attenuates in-stent neointimal formation in non-human primates. METHOD: Male cynomolgus monkeys were fed a high cholesterol diet for 4 weeks, and were randomly assigned to three groups: a vehicle group and two other groups treated with azelnidipine at 3 and 10 mg/kg per day for an additional 24 weeks (n = 12 each). Multi-link stents were then implanted in the iliac artery. RESULTS: Azelnidipine at the high dose reduced neointimal thickness (0.25 +/- 0.02 versus 0.19 +/- 0.02 mm; P < 0.05). Azelnidipine also reduced local oxidative stress and monocyte chemoattractant protein 1 (MCP-1) expression. No difference was found between the three groups in the degrees of injury score, inflammation score, plaque neovascularization, or plasma lipid levels. Azelnidipine also reduced MCP-1-induced proliferation/migration of vascular smooth muscle cells in vitro. CONCLUSIONS: This study demonstrated for the first time that azelnidipine attenuates in-stent neointimal formation associated with the reduced expression of MCP-1 and smooth muscle proliferation/migration in the neointima. These data in non-human primates suggest potential clinical benefits of azelnidipine as a 'vasculoprotective calcium antagonist' in patients undergoing vascular interventions.

 

PreMedline Identifier: 16915039

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Isolated spontaneous dissection of the common iliac artery: percutaneous stent placement in two patients. ***

Cardiovasc Intervent Radiol. 2006 Sep-Oct;29(5):883-5.

Kwak HS, Han YM, Chung GH, Yu HC, Jeong YJ.

Department of Diagnostic Radiology, Chonbuk National University Medical School, 634-18 Keumam-Dong, Chonju-shi, Chonbuk 561-712, South Korea.

Isolated spontaneous dissection of the common iliac artery (CIA) is a rare entity. Two patients with this condition were successfully treated by percutaneous stent placement. We emphasize the feasibility of nonsurgical management by percutaneous stent placement for isolated spontaneous dissection of the CIA.

PreMedline Identifier: 16328683

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Adiponectin and inflammatory markers in peripheral arterial occlusive disease.***

Atherosclerosis. 2006 Oct;188(2):384-90.

Iwashima Y, Horio T, Suzuki Y, Kihara S, Rakugi H, Kangawa K, Funahashi T, Ogihara T, Kawano Y.

Department of Geriatric Medicine, Osaka University Graduate School of Medicine, Japan.

This study was designed to examine the plasma levels of adiponectin as well as markers of inflammation and endothelial function in peripheral arterial occlusive disease (PAOD), and to investigate the pathophysiological significance of adiponectin in this disease. Eighty-eight subjects with (n=40) and without PAOD (n=48) were enrolled. Multiple regression analysis including age, sex, body mass index, hypertension, diabetes, triglycerides, high-density lipoprotein cholesterol, creatinine, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cellular adhesion molecules-1 (sVCAM-1), von Willebrand factor, and high-sensitive C reactive protein (Hs-CRP) showed that adiponectin concentration was significantly lower in PAOD subjects (PAOD: 7.9+/-0.7 microg/mL versus without PAOD: 9.5+/-0.6 microg/mL, F=4.94, p<0.03). Furthermore, concentrations of adiponectin (F=8.5, p<0.01) as well as sICAM-1 (F=5.8, p<0.02), sVCAM-1 (F=5.9, p<0.02), and Hs-CRP (F=3.8, p=0.05) were independently associated with ankle-brachial index. In 27 subjects (10 with PAOD and 17 without PAOD), adiponectin levels in the femoral artery and saphenous vein were measured. A significant step-up of adiponectin from the artery to the vein was observed in subjects without PAOD (+13.0%, p<0.01), but not in subjects with PAOD (+0.4%, NS). Plasma adiponectin as well as Hs-CRP were followed before and after percutaneous transluminal angioplasty (PTA) in eight patients. Adiponectin showed a tendency to decrease after PTA (day 6, -30.6%), although Hs-CRP significantly increased. Adiponectin is decreased in patients with PAOD in proportion to the severity of the disease. Adiponectin concentration could be a marker of the existence of atherosclerosis, and measurement of its concentration may be helpful in assessment of the progress of atherosclerosis.

PreMedline Identifier: 16321391

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Aggravation of Pre-Existing Atrioventricular Block, Wenckebach Type, Provoked by Application of X-Ray Contrast Medium. ***

Cardiovasc Intervent Radiol. 2006 Sep 19; [Epub ahead of print]

Brodmann M, Seinost G, Stark G, Pilger E.

Division of Angiology, Department of Internal Medicine, Medizinische Universitat Graz, Auenbruggerplatz 15, 8036, Graz, Austria, marianne.brodmann@meduni-graz.at.

BACKGROUND: Significant bradycardia followed by cardiac arrest related to single bolus administration of X-ray contrast medium into a peripheral artery has not, to our knowledge, been described in the literature. METHODS AND RESULTS: While performing a percutaneous transluminal angioplasty of the left superficial femoral artery in a 68-year old patient with a pre-existing atrioventricular (AV) block, Wenckebach type, he developed an AV block III after a single bolus injection of intra-arterial X-ray contrast medium. CONCLUSION: We believe that application of contrast medium causes a transitory ischemia in the obstructed vessel and therefore elevation of endogenous adenosine. In the case of a previously damaged AV node this elevation of endogenous adenosine may be responsible for the development of a short period of third-degree AV block.

PreMedline Identifier: 16988879

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Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage. ***

J Vasc Surg. 2006 Sep;44(3):503-9.

Yancey AE, Minion DJ, Rodriguez C, Patterson DE, Endean ED.

University of Kentucky Medical Center and the Veteran's Affairs Medical Center, Lexington, 40536, USA.

BACKGROUND: The optimal therapy for TransAtlantic Societal Consensus (TASC) type C femoropopliteal lesions remains a critical issue in the treatment of infrainguinal occlusive disease. The purpose of this study was to evaluate the outcome of limbs with TASC C femoropopliteal lesions and critical limb ischemia treated with the FoxHollow SilverHawk atherectomy catheter. METHODS: From September 2004 to September 2005, 18 consecutive femoropopliteal procedures performed in 17 limbs in 16 patients were reviewed. Demographic data, baseline angiographic findings, and indications for the procedures were recorded. Clinical outcomes including symptom resolution and limb salvage were determined for the 17 primary procedures. Hemodynamic improvement was compared by using the paired Student t test. Stenosis-free patency was determined by the Kaplan-Meier method. RESULTS: The mean age was 72.5 years (range, 47-88 years). Fifty percent of the patients had four or more of the following risk factors: hypertension, diabetes, tobacco use, hyperlipidemia, renal insufficiency, and coronary artery disease. The indication was tissue loss in 13 limbs and rest pain in 4. All patients had a second level of disease, either inflow or tibial/pedal, which was treated concurrently when appropriate. Initial resolution of symptoms was achieved in 12 limbs, and partial healing was achieved in 2 others. Early amputation was necessary in the remaining three patients, but this was likely due to severe inframalleolar disease and advanced forefoot ischemia at the time of presentation. Five patients have remained symptom-free without restenosis at a mean follow-up of 6 months. Two patients have required late amputation for hemodynamic failure. The ankle-brachial index improved from 0.39 +/- 0.08 (mean +/- SEM) before surgery to 0.75 +/- 0.08 in the immediate postoperative period (P = .02). However, it returned toward baseline at 6 months after surgery, with a mean of 0.48 +/- 0.07. Stenosis-free patency of the femoropopliteal segment was 22% at 12 months. CONCLUSIONS: Peripheral atherectomy can achieve good early clinical and hemodynamic success in patients with TASC C lesions and critical limb ischemia. However, mid-term restenosis rates are high in this challenging cohort of patients.

PreMedline Identifier: 16950425

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Retrograde rotablator in limb salvage: a new technique using an open approach. ***

Cardiovasc Intervent Radiol. 2006 Sep-Oct;29(5):854-6.

Tamashiro A, Villegas M, Tamashiro G, Enterrios D, Dini A, Balestrini A, Diaz JA.

Hospital Nacional Alejandro Posadas, Illia s/n y Marconi, El Palomar (1706), Pcia de Buenos Aires, Argentina.

Conventional vascular surgery and balloon angioplasty have poor results in severe and diffuse atherosclerotic disease of the infrapopliteal arteries. High-speed rotational atherectomy (Auth Rotablator) has not succeeded either, because of poor long-term patency and the non-reflow phenomenon. We report a case of limb salvage with long occlusion of the three infrapopliteal vessels. The anterior tibial artery was treated with retrograde Auth Rotablator atherectomy by an open approach through the pedal artery, resulting in full patency of the anterior tibial artery and healing of the skin lesions. The microparticulate debris from the ablation was drained out through the pedal arteriotomy, avoiding the complications associated with conventional antegrade high-speed rotational atherectomy.

PreMedline Identifier: 16802076

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FDA APPROVES EXPANSION OF CSI OASIS CLINICAL TRIAL

Biotech Equipment Update. Boston: Sep 1, 2006. Vol. 14, Iss. 9;  pg. N.A

Cardiovascular Systems, Inc. (CSI), St. Paul, has announced that the FDA has approved the expansion of the OASIS clinical trial following review of the safety data from the feasibility phase of the study. The OASIS trial, sponsored by CSI, is being conducted to gather safety and effectiveness data on the Orbital Atherectomy System (OAS). OAS is a catheter-based system that uses a diamond coated crown to remove plaque from peripheral arteries. The novel design of the OAS allows the crown to create a final lumen about twice the size of the crown.

Michael J. Kallok, PhD, CSI's CEO said, "OASIS is the first prospective multi center clinical trial for an atherectomy device treating Peripheral Arterial Disease (PAD). We are excited to expand the OASIS trial to new centers and begin the process of enrolling the remaining patients. CSI is committed to putting clinical rigor in the data we collect during the OASIS trial as well as other trials we have planned for the future."

Over 12 million people in the US alone suffer from PAD which can cause debilitating pain in the legs. If allowed to progress, PAD can lead to Critical Limb Ischemia which may result in amputation of the leg if not treated. It is estimated that less than two million people are actually diagnosed with PAD and less than 700,000 are treated therapeutically each year.

Dr. Richard R. Heuser, of Phoenix Heart Center and Co-Principal Investigator of OASIS said, "We are excited about the eventual availability of this new therapy for the 12 million US sufferers of PAD. The OAS shows great potential and the expansion of the OASIS trial will give us the data physicians need to make informed decisions on treatment alternatives."

The first US patient was treated in January of this year by Dr. Robert D. Safian, Co-Principal Investigator of OASIS, at William Beaumont Hospital in Royal Oak, Michigan. As stated by Dr Safian, "The initial experience with orbital atherectomy has been extremely positive. The setup and utilization of the device have been very straightforward and simple. The technology can be easily incorporated into interventional practice after a very brief learning curve. The initial results are characterized by excellent angiographic appearance, excellent lumen enlargement, and lack of device-related complications, which is especially notable in this patient population with advanced peripheral arterial disease and high incidence of critical limb ischemia."

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