Tack Provisional Stenting for Arterial Dissection Following Balloon Angioplasty

VASCULAR DISEASE MANAGEMENT 2019;16(8):E103-E106

The utilization of percutaneous methods for the treatment of peripheral arterial disease (PAD) is an increasing national trend, aided by advances in technology that help improve clinical outcomes. Interventionalists are increasingly willing to attempt revascularization of more complex lesions that have traditionally been treated with open surgical procedures..^1-6 Balloon angioplasty is commonly accepted as the first-line treatment for PAD because of its proven effectiveness in disrupting atherosclerotic plaque, as well as its cost efficiency compared to other percutaneous revascularization methods.^2,7-11 However, acute arterial injury from balloon angioplasty can lead to unwanted sequelae. Balloon angioplasty that results in arterial dissection causes a reactive inflammatory response that can lead to the development of neointimal hyperplasia and long-term arterial restenosis.^2,7,8,12-15 Arterial dissections are a common sequela of balloon angioplasty, with incidence rates as high as 84%, regardless of lesion type classification. Arterial segments that experience dissections have target lesion revascularization rates 3.5-fold higher (10.5% vs 37%) than lesions without identifiable acute dissections.^6,7,12,16-18 

The development of drug-eluting technology effectively addressed the reactive inflammatory response to arterial trauma by suppressing the development of neointimal hyperplasia with anti-proliferative drugs such as paclitaxel.^19-31 The U.S. FDA has since issued a statement of safety concern regarding a potential increased mortality risk from use of paclitaxel for treatment of PAD, which has led many interventionalists to exercise caution in their use of drug-eluting technology.^32-34 This shift highlights the need to address dissection in the current landscape of PAD treatment.

Due to increased risk factors for restenosis after dissection, provisional stenting is generally performed in order to act as a mechanical scaffold that assists in the vessel wall apposition of the dissected tissue.^6,8,28,35 Provisional stenting provides optimal short-term hemodynamic outcomes; however, the insertion of a rigid foreign body into the vasculature initiates an inflammatory response similar to what was previously discussed, negatively affecting the long-term patency of the treated segment.^4,14,36-46 A novel re-design of the traditional nitinol stent may offer better clinical outcomes for arterial dissections following balloon angioplasty.^6,7,35 The Tack implant (Intact  Vascular) minimizes many of the factors that increase the risk of in-stent restenosis, such excessive outward radial force that results in adventitial stretching, long stented segments, and dynamic frictional forces between the artery and stent.^4,38-44 The Tack implants achieve the same mechanical scaffold effect as traditional self-expanding nitinol stents. However, the Tack implants have lower radial force and 70% less of a metallic imprint, and they demonstrate reduced short-term neointimal proliferation, inflammation, and restenosis rates when compared to a traditional self-expanding nitinol stent.^6,35 

The case herein describes a 64-year-old man with lifestyle-limiting right lower extremity claudication. This case highlights the use of Tack implants to address two grade D dissections of the mid-right superficial femoral artery (SFA) following balloon angioplasty.  

Case Report

A 64-year-old man with a history of coronary artery disease, hyperlipidemia, and hypertension presented in clinic with right calf pain upon walking approximately 100 meters that resolved with rest (Rutherford 3). Bilateral abdominal aortography with runoff was performed, revealing a severe stenosis (80%) of the mid-right SFA. 

During the index procedure for the right lower extremity, an OmniFlush catheter (AngioDynamics) was positioned at the level of the right common femoral artery (CFA) for selective angiography with runoff (Figure 1). A Runthrough NS Extra Floppy guidewire (Terumo) was used to traverse the diseased segment. The Runthrough guidewire was exchanged for an .018-inch NiT-Vu guidewire (AngioDynamics) through a Glidecath support catheter (Terumo), and the lesion was prepared with a 5 × 80 mm Armada PTA balloon (Abbott Vascular). After vessel preparation, another balloon angioplasty was performed with a 6 × 120 mm Lutonix drug-coated balloon PTA catheter (BD). Angiography demonstrated less than 10% residual stenosis, but there were two grade D, flow-limiting dissections that were located in the mid-right SFA (Figure 2), disrupting an optimal hemodynamic result.   

A .035-inch Rosen guidewire (Cook Medical) was exchanged through a Glidecath support catheter to accommodate the Tack implant .035-inch platform. The 6-French delivery catheter with the six preloaded, self-expanding Tack implants was loaded over the wire and positioned at the distal edge of the most distal dissection. Three Tack implants were deployed, with approximately 5 mm of distance between the stent edges. The remaining three Tack implants were deployed to resolve the proximal dissection (Figure 3). An additional balloon angioplasty with a 6 × 100 mm Armada PTA balloon was performed to seat the Tack implants in the desired location to optimize vessel flap apposition to the intima. Final angiography demonstrated resolution of the flow-limiting dissections, and post-intervention imaging confirmed less than 10% residual stenosis of the mid-right SFA (Figure 4).

Discussion

Arterial dissections are an undesirable outcome of balloon angioplasty, but with new balloon technologies such as low-pressure cutting/scoring and intravascular lithotripsy, there is promise for better clinical outcomes in the treatment of PAD. The recently commercially available Tack implants offer several advantages over traditional provisional stenting for arterial dissection following balloon angioplasty. As the arterial vascular tree tapers in the more distal segments, a uniform stent exerts greater radial force in segments of the vessel for which the stent is oversized. Tack implants self-size for vessel diameters 3.5 mm to 6 mm, and the 6-mm length allows for focal treatment of dissections. The smaller metallic imprint of the Tack implants permits earlier discontinuation of dual-antiplatelet therapy at the 30-days post-operative interval. A smaller metallic imprint also preserves healthy tissue for future potential treatment options. The Tack implants are an ideal treatment solution for patients who have a satisfactory angiographic result post-balloon angioplasty but have poor hemodynamic results due to arterial dissection, as in the case herein. At a 2-year follow-up post intervention, our patient reported resolution of claudication symptoms (Rutherford 0). An arterial duplex ultrasound demonstrated a widely patent mid-right SFA segment with no evidence of stenosis. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Gabriel T. Brandner, BS, has no disclosures. George L. Adams, MD, MHS, FACC, is a trainer and consultant for Cook Medical, as well as a consultant for Abbott Vascular. 

Manuscript submitted on June 24, 2019; accepted on June 30, 2019.

Address for correspondence: George L.  Adams, MD, MHS, FACC, Rex Hospital in Raleigh, North Carolina, and the University of North Carolina in Chapel Hill, North Carolina. Email: george.adams@unchealth.unc.com

REFERENCES

1. Friedell ML, Stark KR, Kujath SW, Carter RR. Current status of lower-extremity revascularization. Curr Probl Surg. 2014;51(6):254-290.

2. Spiliopoulos S, Karamitros A, Reppas L, Brountzos E. Novel balloon technologies to minimize dissection of peripheral angioplasty. Expert Rev Med Devices. 2019;16(7):581-588.

3. Goodney PP, Tarulli M, Faerber AE, Schanzer A, Zwolak RM. Fifteen-year trends in lower limb amputation, revascularization, and preventive measures among medicare patients. JAMA Surg. 2015;150(1):84-86.

4. Ho KJ, Owens CD. Diagnosis, classification, and treatment of femoropopliteal artery in-stent restenosis. J Vasc Surg. 2017;65(2):545-557.

5. Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996-2005. J Vasc Surg. 2009;49(4):910-917.

6. Kokkinidis DG, Armstrong EJ. Emerging and future therapeutic options for femoropopliteal and infrapopliteal endovascular intervention. Interv Cardiol Clin. 2017;6(2):279-295.

7. Bosiers M, Scheinert D, Hendriks JM, et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg. 2016;64(1):109-116.

8. Fanelli F, Cannavale A, Gazzetti M, D'Adamo A. Commentary: how do we deal with dissection after angioplasty? J Endovasc Ther. 2013;20(6):801-804.

9. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. J Vasc Surg. 2011;54(5):e32-e58.

10. Tendera M, Aboyans V, Bartelink ML, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851-2906.

11. Brandner GT, Adams GL, Hurst RC, Nagel M. Exotic access for a bilateral above-knee amputee with critical limb ischemia. Vascular Disease Management. 2019;16(6):e82-e84.

12. Kobayashi N, Hirano K, Yamawaki M, et al. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg. 2018;67(4):1151-1158.

13. Armstrong EJ, Brodmann M, Deaton DH, et al. Dissections after infrainguinal percutaneous transluminal angioplasty: a systematic review and current state of clinical evidence. J Endovasc Ther. 2019;26(4):479-489.

14. Bennett MR. In-stent stenosis: pathology and implications for the development of drug eluting stents. Heart (British Cardiac Society). 2003;89(2):218-224.

15. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64-70.

16. Fujihara M, Takahara M, Sasaki S, et al. Angiographic dissection patterns and patency outcomes after balloon angioplasty for superficial femoral artery disease. J Endovasc Ther. 2017;24(3):367-375.

17. TASC Steering Committee, Jaff MR, White CJ, et al. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Vasc Med. 2015;20(5):465-478.

18. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-Society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5-S67.

19. Cassese S, Ndrepepa G, Liistro F, et al. Drug-coated balloons for revascularization of infrapopliteal arteries: a meta-analysis of randomized trials. JACC Cardiovasc Interv. 2016;9(10):1072-1080.

20. Herten M, Torsello GB, Schonefeld E, Stahlhoff S. Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease. Vasc Health Risk Manag. 2016;12:341-356.

21. Tepe G, Zeller T, Schnorr B, et al. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013;20(6):792-800.

22. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689-699.

23. Thukkani Arun K, Kinlay S. Endovascular intervention for peripheral artery disease. Circ Res. 2015;116(9):1599-1613.

24. Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014;7(9):1048-1056.

25. Chen X, Li J, Zheng C, et al. Drug-delivering endovascular treatment versus angioplasty in artery occlusion diseases: a systematic review and meta-analysis. Curr Med Res Opin. 2018;34(1):95-105.

26. Antoniou GA, Georgakarakos EI, Antoniou SA, Georgiadis GS. Does endovascular treatment of infra-inguinal arterial disease with drug-eluting stents offer better results than angioplasty with or without bare metal stents? Interact Cardiovasc Thorac Surg. 2014;19(2):282-285.

27. Katsanos K, Kitrou P, Spiliopoulos S, Diamantopoulos A, Karnabatidis D. Comparative effectiveness of plain balloon angioplasty, bare metal stents, drug-coated balloons, and drug-eluting stents for the treatment of infrapopliteal artery disease: systematic review and bayesian network meta-analysis of randomized controlled trials. J Endovasc Ther. 2016;23(6):851-863.

28. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19(1):1-9.

29. Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial. J Endovasc Ther. 2012;19(5):571-580.

30. Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5(6):831-840.

31. Micari A, Cioppa A, Vadala G, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv. 2012;5(3):331-338.

32. UPDATE: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality - letter to health care providers. US Food and Drug Administration. https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting. Published March 15, 2019. Accessed August 6, 2019.

33. Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality - letter to health care providers. US Food and Drug Administration. https://www.fda.gov/medical-devices/letters-health-care-providers/treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting-stents. Published  January 17, 2019. Accessed August 6, 2019.

34.    UPDATE: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality. https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel. Published August 7, 2019. Accessed August 20, 2019.

35. Schneider PA, Giasolli R, Ebner A, Virmani R, Granada JF. Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection. JACC Cardiovasc Interv. 2015;8(2):347-354.

36. Hoffmann R, Mintz GS, Dussaillant GR, et al. Patterns and mechanisms of in-stent restenosis. Circulation. 1996;94(6):1247-1254.

37. Schwartz RS, Huber KC, Murphy JG, et al. Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol. 1992;19(2):267-274.

38. Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009;32(4):720-726.

39. Saguner AM, Traupe T, Raber L, et al. Oversizing and restenosis with self-expanding stents in iliofemoral arteries. Cardiovasc Intervent Radiol. 2012;35(4):906-913.

40. Ihnat DM, Duong ST, Taylor ZC, et al. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg. 2008;47(5):967-974.

41. Choi G, Cheng CP, Wilson NM, Taylor CA. Methods for quantifying three-dimensional deformation of arteries due to pulsatile and nonpulsatile forces: implications for the design of stents and stent grafts. Ann Biomed Eng. 2009;37(1):14-33.

42. Choi G, Shin LK, Taylor CA, Cheng CP. In vivo deformation of the human abdominal aorta and common iliac arteries with hip and knee flexion: implications for the design of stent-grafts. J Endovasc Ther. 2009;16(5):531-538.

43. Early M, Lally C, Prendergast PJ, Kelly DJ. Stresses in peripheral arteries following stent placement: a finite element analysis. Comput Methods Biomech Biomed Engin. 2009;12(1):25-33.

44. Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation.1999;100(18):1872-1878.

45. Komatsu R, Ueda M, Naruko T, Kojima A, Becker AE. Neointimal tissue response at sites of coronary stenting in humans: macroscopic, histological, and immunohistochemical analyses. Circulation. 1998;98(3):224-233.

46. Farb A, Sangiorgi G, Carter AJ, et al. Pathology of acute and chronic coronary stenting in humans. Circulation. 1999;99(1):44-52.