Below-the-knee (BTK) targeted re-entry using the Outback catheter in subintimal angioplasty: Success rate and complications

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1 Below-the-knee (BTK) targeted re-entry using the Outback catheter in subintimal angioplasty: Success rate and complications Poster No.: C-0734 Congress: ECR 2016 Type: Scientific Exhibit Authors: S. M. Santonocito 1, L. Patrone 2, S. Ilyas 3, I. Paraskevopoulos 4, A. Diamantopoulos 3, R. Dourado 3, N. Karunanithy 3, K. Katsanos 3 ; 1 Catania/IT, 2 Genova/IT, 3 London/UK, 4 Patras/GR Keywords: DOI: Arteries / Aorta, Interventional vascular, Extremities, Catheter arteriography, CT-Angiography, Angioplasty, Catheters, Recanalisation, Arteriosclerosis, Obstruction / Occlusion, Outcomes /ecr2016/C-0734 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 Page 1 of 11

2 available in the pdf version of presentations. Page 2 of 11

3 Aims and objectives Re-entry devices have been engineered to help cross CTO in a reproducible subintimal manner when the initial spontaneous re-entry fails, offering not only a high success rate of recanalization but also accuracy and precision of the distal re-entry point sparing the maximum possible healthy vessel [1]. The OUTBACK re-entry catheter (OUTBACK LTD, Cordis, Miami Lakes, Florida) is one of the most popular devices to date. It is easy to use (0.014-inch platform) and may facilitate true lumen re-entry both in aorto-iliac (AOI) and infrainguinal (INI) occluded vascular segments with reported success rates ranging between 65% and 100% [2-6]. The aim of our study is to evaluate the immediate outcomes in 10 patients where the OUTBACK re-entry device was used to assist targeted subintimal re-entry to the true lumen in BTK chronic total occlusions. There was particular interest to demonstrate that despite the lower diameter of BTK arteries compared to the bigger aorto-iliac (AOI) and infrainguinal (INI) vessels and considering the increased difficulty to operate in this region, there is an high technical success rate (if some small measures are taken into account), a good angiographic and clinical result and a low complication rate. Page 3 of 11

4 Images for this section: Fig. 1: Dorsalis Pedis re-entry by using Outback Catheter following unsuccessful subintimal recanalisation. Department of Interventional Radiology, Guy's and St Thomas Hospital Foundation Trust - London/UK Page 4 of 11

5 Methods and materials We retrospectively looked into our department's database for cases that the OUTBACK re-entry device was applied in order to facilitate distal BTK re-entry at the targeted artery due to unsuccessful spontaneous re-entry following subintimal crossing of a chronic total occlusion. We reserved the OUTBACK catheter in case of unsuccessful intraluminal lesion crossing, after unsuccessful spontaneous true lumen re-entry with the subintimal approach with a looped 0.035" J-shaped half-stiff hydrophilic wire. In all cases, eventual deployment of the OUTBACK device was decided either because of failure of the aforementioned methods or due to inadvertent extension of subintimal lumen. The OUTBACK device was advanced over a 0,014" guidewire and two plane fluoroscopy images were acquired to properly orientate the tip of the device as per instructions for use. Once re-entry was accomplished, the 0.014" guidewire was advanced into the true lumen and confirmed with selective angiography. A pre-dilation was always performed at the point of reentry followed by definitive lesion treatment. Treatment options included plain balloon angioplasty or stent deployment (bare or covered). Page 5 of 11

6 Images for this section: Fig. 1: Dorsalis Pedis re-entry by using Outback Catheter following unsuccessful subintimal recanalisation. Department of Interventional Radiology, Guy's and St Thomas Hospital Foundation Trust - London/UK Page 6 of 11

7 Fig. 2: recanalisation of a chronic total occlusion in a proximal anterior tibial artery by using the Outback catheter. Department of Interventional Radiology, Guy's and St Thomas Hospital Foundation Trust - London/UK Page 7 of 11

8 Results From January 2014 to May 2015, 10 OUTBACK-assisted angioplasty cases (8 men, 2 women) were treated. Overall, 3 re-entry attempts were made in the peroneal artery (PER), 3 attempts in the distal popliteal (POP), 2 attempts in the tibio-peroneal trunk (TPT), 2 in the anterior tibial artery (ATA), while 2 were made in the posterior tibial artery (PT). In 2 cases, however, lesions included more than one anatomical region. In one case PT and PER were involved; in other 2 cases (the 2 that failed) the distal POP, TPT and PER were involved. Overall technical success was 80% (8/10 cases). In 2 cases, failure to re-enter the true lumen with the OUTBACK device was due to heavy cylindrical calcifications at the vessel re-entry site; in 1 case, the outback was successfully used to pass the wire into the true lumen, but it was not possible to complete the recanalisation with the angioplasty because the heavy calcifications [7, 8]. Page 8 of 11

9 Images for this section: Fig. 3: sequential images of a correct use of the Outback catheter after unsuccessful spontaneous recanalisation with a subintimal approach in an anterior tibial artery: find the right angulation with the tip of the device, open the device's needle, push the 0.014" wire into the true lumen and confirm with a double projection angiography. Department of Interventional Radiology, Guy's and St Thomas Hospital Foundation Trust - London/UK Page 9 of 11

10 Conclusion The OUTBACK catheter is safe and easy to use in aorto-iliac (AOI) and infrainguinal (INI) vascular segments, but its use could be extended also in below-the-knee arteries (with appropriate measures). There's still no evidence on Literature and there are not enough data that effectiveness and safety of Outback catheter in BTK vessels is comparable to its use above the knee, but this could be a positive initial study that can stimulate the scientific community to keep in consideration the extension of its use in a so difficult and delicate vascular region. Page 10 of 11

11 References 1. Kitrou P, Parthipun A, Diamantopoulos A, Paraskevopoulos I, Karunanithy N, Katsanos K. Targeted True Lumen Re-Entry With the Outback Catheter: Accuracy, Success, and Complications in 100 Peripheral Chronic Total Occlusions and Systematic Review of the Literature. J Endovasc Ther Aug;22(4): Gandini R, Fabiano S, Spano S, Volpi T, Morosetti D, Chiaravalloti A, Nano G, Simonetti G. Randomized control study of the outback LTD reentry catheter versus manual reentry for the treatment of chronic total occlusions in the superficial femoral artery. Catheter Cardiovasc Interv 2013;82(3): Abisi S, Kapur R, Braithwaite B, Habib S. The feasibility of reentry device in recanalization of TASC C and D iliac occlusions. Vasc Endovascular Surg 2011;45(4): Aslam MS, Allaqaband S, Haddadian B, Mori N, Bajwa T, Mewissen M. Subintimal angioplasty with a true reentry device for treatment of chronic total occlusion of the arteries of the lower extremity. Catheter Cardiovasc Interv 2013;82(5): Etezadi V, Benenati JF, Patel PJ, Patel RS, Powell A, Katzen BT. The reentry catheter: a second chance for endoluminal reentry at difficult lower extremity subintimal arterial recanalizations. J Vasc Interv Radiol 2010;21(5): Shin SH, Baril D, Chaer R, Rhee R, Makaroun M, Marone L. Limitations of the Outback LTD re-entry device in femoropopliteal chronic total occlusions. J Vasc Surg 2011;53(5): Hausegger KA, Georgieva B, Portugaller H, Tauss J, Stark G. The outback catheter: a new device for true lumen re-entry after dissection during recanalization of arterial occlusions. Cardiovasc Intervent Radiol 2004;27(1): x600 Normal 0 14 false false false IT JA X-NONE 8. Setacci C, Chisci E, de Donato G, Setacci F, Iacoponi F, Galzerano G. Subintimal angioplasty with the aid of a re-entry device for TASC C and D lesions of the SFA. Eur J Vasc Endovasc Surg 2009;38(1): Page 11 of 11

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