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Mechanical recanalization of subacute arterial vessel occlusions using the SilverHawk atherectomy catheter Poster No.: C-2112 Congress: ECR 2010 Type: Scientific Exhibit Topic: Interventional Radiology Authors: A. Massmann, M. Katoh, P. Minko, S. Jaeger, G. K. Schneider, A. Bücker; Homburg/DE Keywords: peripheral artery disease, atherectomy, silverhawk DOI: 10.1594/ecr2010/C-2112 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. www.myESR.org Page 1 of 18 Purpose To demonstrate the technical feasibility and safety of mechanical recanalization of subacute peripheral arterial vessel occlusions using the SilverHawk atherectomy device (ev3 endovascular, MN, USA) (figure 1-3). The SilverHawk atherectomy device is typically used in patients with peripheral arterial disease (PAD) and its related clinical complaints. It is used as an endovascular procedure to remove occluding atheromatous plaque material (figure 4-5). As yet, only patients with chronic arterial stenosis or occlussion were treated with the SilverHawk device in large register studies. A hallmark of the intervention was the very high initial success rate. Until now, reports concerning the treatment of subacute arterial vessel occlusion with the SilverHawk device are not available. Images for this section: Fig. 1: Silverhawk atherectomy device (ev3 endovascular, MN, USA) Page 2 of 18 Page 3 of 18 Fig. 2: close-up view of the cutting blade of the Silverhawk atherectomy device (ev3 endovascular, MN, USA) Fig. 3: visualization of the mechanism of the atherectomy with the Silverhawk device (ev3 endovascular, MN, USA) Page 4 of 18 Fig. 4: macroscopic view of the excised and extracted typical red thrombus material after removal of a subacute vessel occlusion Page 5 of 18 Fig. 5: macroscopic view of the excised and extracted typical white material after atherectomy of intimal hyperplasia Page 6 of 18 Methods and Materials Overall, five patients (female 1, male 4, age 51-81 years, average 64 ± 12.6 years) with subacute arterial vessel occlusion were treated with the SilverHawk atherectomy device. Patients suffered from a sudden worsening of their known PAD related complaints within 2 - 6 weeks. The arterial occlusion was located in four patients within the popliteal artery. One patient suffered from an in-stent occlusion located in the distal superficial femoral artery. In every patient, excised occluding material consisted of macroscopic red thrombus material (figure 1). In contrast, removal of intimal hyperplasia typically consists of white tissue cylinders (figure 2). A histological proof of subacute occluding thrombus material was verified in only one patient. The diameter of treated arterial vessels was 5.1 ± 1.0 mm. The length of the arterial vessel occlusion was 2- 14 cm. Images for this section: Page 7 of 18 Fig. 1: macroscopic view of the excised and extracted typical red thrombus material after removal of a subacute vessel occlusion Page 8 of 18 Fig. 2: macroscopic view of the excised and extracted typical white material after atherectomy of intimal hyperplasia Page 9 of 18 Results Diagnostic angiography depicted 4 subacute peripheral vessel occlusions in four patients within the PA and in one patient an in-stent occlusion within the distal superficial femoral artery (SFA) (figure 1). The length of the occlusion ranged from 2 - 14 cm. The mean diameter of the treated vessel was 5.1 mm ± 1mm. Every patient underwent a mechanical recanalization of a subacute arterial vessel occlusion of a femoropopliteal segment. A successful treatment needed 2 - 3 atherectomy maneuvers, consisting of 3 - 4 cutting procedures, which immediately yielded to a substantial initial reduction of the occlusion (figure 2-3). The primary technical success rate was 100%. Histological analysis of excised material proved the presence of typical subacute, partially organized red thrombus (figure 4) in all cases. A residual stenosis <20% was seen in four of five patients of an initially occluded PA and a 30% stenosis in one patient with an initial in-stent occlusion of the SFA. A mechanic recanalization of an in-stent occlusion showed a very good hemodynamic result at a residual stenosis of 40%. In this case, atherectomy was terminated at this point, to prevent a stent injury or entanglement within the stent braces. There were no procedure related complications such as peripheral emboli, dissection or vessel perforation. One female patient underwent a surgical intervention during the hospitalization due to a previously unknown HIT-syndrome with a consecutive reocclusion after an initial technical success. After the atherectomy, one patient showed again a 3-vessel supply, three patients a 2vessel and two patients a 1-vessel supply of the lower leg. Within the re-evaluation period after 6 months till now, there was no need for (surgical) re-intervention. Images for this section: Page 10 of 18 Page 11 of 18 Fig. 1: The digital substraction angiography shows a new occlusion of the distal superficial femoral artery and popliteal artery. The patient reported a substantial increase of his PAD related claudicatio since 3 weeks. Page 12 of 18 Page 13 of 18 Fig. 2: After initial successful mechanic recanalization with the SilverHawk atherectomy device only discrete irregularities within the P2-segment of the popliteal artery could be delineated. Page 14 of 18 Page 15 of 18 Fig. 3: Another atherectomy manoeuvre in the same session yields to a nearly complete removal of the subacute arterial vessel occlusion. Fig. 4: macroscopic view of the excised and extracted typical red thrombus material after removal of a subacute vessel occlusion Page 16 of 18 Conclusion Until now, usage of the SilverHawk atherectomy device was only described for the treatment of chronic arterial vessel stenosis or occlusion. To treat subacute arterial vessel occlusion the same mechanic recanalization technique is applied. Based on symptomatic clinical complaints related to PAD in our patients, subacute occlusions could definitely be assumed. This implements a substantial inferior response to a thrombolysis therapy. As a possible therapeutic option primary stent-PTA after vessel recanalization was avoided due to occlusion of the popliteal artery. So, technical successful mechanic recanalization of the popliteal artery could be performed in four patients without the need for stentimplantation within the region of the popliteal artery. As well as another stent implantation in a patient with a previous stent-PTA within a superficial femoral artery could be avoided. The evaluation of the treated subacute arterial vessel occlusions reveals an initial technical success in 100% combined with a very good morphologic and hemodynamic result. In one patient re-intervention was necessary due to an previously unknown HITsyndrome. Apart from that, mechanic recanalization of subacute arterial vessel occlusion with the SilverHawk atherectomy device showed no procedure-associated complications in any patient. Notably, there was no angiographic visible or clinically symptomatic peripheral embolization. In summary, according to our initial results, mechanic recanalization of subacute arterial vessel occlusion with the SilverHawk atherectomy device is feasible with a very high technical success rate and without clinically symptomatic complications. It may be considered as an alternative to conventional thrombolytic or thrombectomy procedures. As a limitation of our study, there is still a lack for long-term success rates for this particular indication. References 1. Ramaiah V, Gammon R, Kiesz S, et al. Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection. J Endovasc Ther. 2006 Oct;13(5):592-602. 2. McKinsey JF, Goldstein L, Khan HU, et al. Novel treatment of patients with lower extremity ischemia: use of percutaneous atherectomy in 579 lesions. Ann Surg. 2008 Oct;248(4):519-28. 3. Zeller T, Krankenberg H, Reimers B, et al. Erste klinische Erfahrungen mit einem neuen Atherektomiekatheter zur Behandlung femoro-poplitealer Stenosen. Röfo. 2004 Jan;176(1):70-5. Page 17 of 18 4. Zeller T, Rastan A, Schwarzwälder U et al. Percutaneous Peripheral Atherectomy of Femoropopliteal Stenoses Using a New-Generation Device: Six-Month Results From a Single-Center Experience. J Endovasc Ther 2004; 11: 676-685. 5. Zeller T, Sixt S, Schwarzwälder U, et al. Two-year results after directional atherectomy of infrapopliteal arteries with the SilverHawk device. J Endovasc Ther. 2007 Apr;14(2):232-40. 6. Garcia LA, Lyden SP. Atherectomy for infrainguinal peripheral artery disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II105-15. 7. Lam RC, Shah S, Faries PL, et al. Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery. J Vasc Surg. 2007 Dec;46(6):1155-9. Personal Information Saarland University Hospital Clinic for Diagnostic and Interventional Radiology 66421 Homburg/Saar Germany Dr. med. Alexander Maßmann PD Dr. med. Marcus Katoh Dr. med. Peter Minko Dr. med. Sabine Jäger PD. Dr. med. Dr. rer. nat. Günther Karl Schneider Prof. Dr. med. Arno Bücker Page 18 of 18