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Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients

  • Clinical Investigation
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Abstract

Background

To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol.

Methods

Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.

Results

Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs < 150 mm, PP was 100%, while in CTOs > 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p < 0.001).

Conclusions

In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.

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Fig. 1

Reprinted with permission from Trireme Medical. Ward and Mena-Hurtado [15]

Fig. 2

Reprinted with permission from Trireme Medical. Ward and Mena-Hurtado [15]

Fig. 3

Reprinted with permission from Trireme Medical. Ward and Mena-Hurtado [15]

Fig. 4
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References

  1. Newman AB, Shemanski L, Manolio TA, et al. Ankle–arm index as a predictor of cardiovascular disease and mortality in the cardiovascular health study group. Arterioscler Thromb Vasc Biol. 1999;19:538–45.

    Article  CAS  PubMed  Google Scholar 

  2. Diehm C, Schuster A, Allenberg JA, et al. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: a cross-sectional study. Atherosclerosis. 2004;172:95–105.

    Article  CAS  PubMed  Google Scholar 

  3. Zeller T. Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med. 2007;12(3):223–34.

    Article  PubMed  Google Scholar 

  4. Lawall H, Huppert P, Espinola-Klein C, et al. German guideline on the diagnosis and treatment of peripheral artery disease—a comprehensive update 2016. Vasa. 2017;46(2):79–86.

    Article  PubMed  Google Scholar 

  5. European Stroke O, Tendera M, Aboyans V, 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;32:2851–906.

    Article  Google Scholar 

  6. 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. J Am Coll Cardiol. 2011;58:2020–45.

    Article  PubMed  Google Scholar 

  7. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR, et al. Inter-society consensus for management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(1 suppl):S1–75.

    Article  PubMed  Google Scholar 

  8. Yokoi Y. How should recent endovascular trials for femoropopliteal artery disease be interpreted? Cardiovasc Interv Ther. 2017;32(2):106–13.

    Article  PubMed  Google Scholar 

  9. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.

    Article  CAS  PubMed  Google Scholar 

  10. Dick P, Wallner H, Sabeti S, et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090–5.

    Article  PubMed  Google Scholar 

  11. Laird JR, Katzen BT, Scheinert D, et al. RESILIENT investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267–76.

    Article  PubMed  Google Scholar 

  12. Dake MD, Ansel GM, Jaff MR, et al. Zilver PTX investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.

    Article  CAS  PubMed  Google Scholar 

  13. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–5.

    Article  PubMed  Google Scholar 

  14. Sirignano P, Citone M, Menna D, et al. Superficial femoral artery stent disruption treated by peripheral endograft. Ann Vasc Surg. 2015;29(8):1661.e5–8.

    Article  Google Scholar 

  15. Ward C, Mena-Hurtado C. Novel use of pillows and grooves: the Chocolate® PTA balloon catheter. Endovasc Today 2014;24–8. (http://evtoday.com/2014/05/novel-use-of-pillows-and-grooves-the-chocolate-pta-balloon-catheter/).

  16. Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Interv Radiol. 2014;37(4):898–907.

    Article  CAS  Google Scholar 

  17. London NJ, Srinivasan R, Naylor AR, et al. Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results. Eur J Vasc Surg. 1994;8(2):148–55.

    Article  CAS  PubMed  Google Scholar 

  18. Stoner MC, Calligaro KD, Chaer RA, et al. Reporting standards of the society for vascular surgery for endovascular treatment of chronic lower extremity peripheral artery disease. J Vasc Surg. 2016;64(1):e1–21.

    Article  PubMed  Google Scholar 

  19. Cheng CP, Wilson NM, Hallett RL, et al. In vivo MR angiographic quantification of axial and twisting deformations of the superficial femoral artery resulting from maximum hip and knee flexion. J Vasc Interv Radiol. 2006;17(6):979–87.

    Article  PubMed  Google Scholar 

  20. Antonopoulos CN, Mylonas SN, Moulakakis KG, et al. A network meta-analysis of randomized controlled trials comparing treatment modalities for de novo superficial femoral artery occlusive lesions. J Vasc Surg. 2017;65(1):234–45.

    Article  PubMed  Google Scholar 

  21. Schillinger M, Sabeti S, Dick P, et al. Sustained benefit a 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745–9.

    Article  PubMed  Google Scholar 

  22. 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;1:1–9.

    Article  Google Scholar 

  23. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773–80.

    Article  CAS  PubMed  Google Scholar 

  24. Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13:701–10.

    Article  PubMed  Google Scholar 

  25. Dake MD, Ansel GM, Jaff MR, et al. For the Zilver PTX investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.

    Article  CAS  PubMed  Google Scholar 

  26. Schillinger M, Exner M, Mlekusch W, et al. Inflammatory response to stent implantation: differences in femoropopliteal, iliac, and carotid arteries. Radiology. 2002;224(2):529–35.

    Article  PubMed  Google Scholar 

  27. Rosenfield K, Jaff MR, White CJ, et al. LEVANT 2 investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.

    Article  CAS  PubMed  Google Scholar 

  28. Tepe G, Laird J, Schneider P, et al. IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131(5):495–502.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Micari A, Vadalà G, Castriota F, et al. 1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-long study. JACC Cardiovasc Interv. 2016;9(9):950–6.

    Article  PubMed  Google Scholar 

  30. Bishu K, Armstrong EJ. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. Vasc Health Risk Manag. 2015;13(11):387–95.

    Google Scholar 

  31. Bhat TM, Afari ME, Garcia LA. Atherectomy in peripheral artery disease: a review. J Invasive Cardiol. 2017;29(4):135–44.

    PubMed  Google Scholar 

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Authors and Affiliations

  1. Vascular and Endovascular Surgery Division, Department of Surgery “Paride Stefanini”, Policlinico Umberto I, “Sapienza” University of Rome, Viale del Policlinico, 155, 00161, Rome, Italy

    Pasqualino Sirignano, Wassim Mansour, Alessandro d’Adamo, Simone Cuozzo, Laura Capoccia & Francesco Speziale

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  1. Pasqualino Sirignano
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  2. Wassim Mansour
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  3. Alessandro d’Adamo
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  4. Simone Cuozzo
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Correspondence to Pasqualino Sirignano.

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Sirignano, P., Mansour, W., d’Adamo, A. et al. Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients. Cardiovasc Intervent Radiol 41, 377–384 (2018). https://doi.org/10.1007/s00270-017-1840-9

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  • DOI: https://doi.org/10.1007/s00270-017-1840-9

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