DOI: 10.25881/BPNMSC.2019.86.13.022

Authors

Markin S.M.1, Mazayshvili K.V.2, Agalarov R.M.2, Mordovin A.I.1, Gitsuk Ia.V.1, Mandzhikian O.P.3, Gustelev Yu.A.2

1 Saint-Petersburg Сlinical Hospital of Russian Academy of Sciences, Saint Petersburg

2 Surgut State University, Phlebological Center “Antireflux”, Surgut

3 City Hospital А.K. Eramishancev, Moscow

Abstract

The aim of the study is to clarify what stages of the life cycle of medical innovation, according to the model of McKinlay, the methods of mechanochemical (MOCA) and cyanacrylate obliteration (CAO) are at and to answer the question: is it the proper time for most phlebologists to start using them in their practice? The literature review using the PubMed database was performed including studies from January 2010 to December 2018. The inclusion criterion was the possibility to attribute the publication to any stage of the life cycle. Each article was related to the only one stage. Experimental studies on animals evaluating the safety of methods, as well as articles having the character of randomized clinical trials announcements were excluded from our study. The study included 93 publications, 48 of them were dedicated to mechanochemical ablation, 57 were dedicated to cyanoacrylate obliteration. The distribution of the articles describing stages of the life cycle: the first stage included 3 MOCA studies and 2 CAO studies; the second stage — 14 reports on mechanochemical obliteration and 12 publications about cyanoacrylate obliteration; the third stage — 7 and 14 publications, respectively; the fourth stage — 21 for MOCA and 24 for CAO; the fifth stage — 3 articles about MOCA and 5 articles about CAO. No publications were related to the sixth and seventh stages. The large number of publications devoted to cyanacrylate obliteration is associated with the three types of glue using in the practice: VariClose, VenaBlock and VenaSeal. The catheter with a cutting edge (Flebogrif system) as variation of the mechanochemical obliteration wasn’t presented in the PubMed database, therefore, we didn’t include it in our study. Thus, non-thermal non-tumescent methods have received public recognition and approval, and acquire the features of a standard procedure for the treatment of varicose veins.

Keywords: mechanochemical obliteration, cyanoacrylate obliteration, non-thermal non-tumescent methods, NTNT.

References

1. Mckinlay JB. From “Promising Report” to “Standard Procedure”: Seven Stages in the Career of a Medical Innovation. Source Milbank Meml Fund Q Heal Soc. 1981; 59:374–411. doi:10.2307.

2. Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27(2):67-72. doi:10.1258/ phleb.2011.010100

3. van Eekeren RRJP, Boersma D, de Vries JPPM, Reijnen MMPJ. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177.

4. Eekeren RRJP van, Boersma D, Elias S, et al. Endovenous Mechanochemical Ablation of Great Saphenous Vein Incompetence Using the ClariVein Device: A Safety Study. 2011;18(3):328-334. doi:10.1583/11-3394.1

5. Almeida JI, Javier JJ, Mackay E, et al. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. 2013. doi:10.1016/j.jvsv.2012.09.010

6. Proebstle TM, Alm J, Rasmussen L, et al. The European Multicenter Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins without Tumescent Anesthesia and without Compression Therapy. J Vasc Surg Venous Lymphat Disord. 2013;1(1):101. doi:10.1016/j.jvsv.2012.10.010

7. Bishawi M, Bernstein R, Boter M, et al. Mechanochemical ablation in patients with chronic venous disease: A prospective multicenter report. Phlebology. 2014. doi:10.1177/0268355513495830

8. Van Eekeren RRJP, Boersma D, Holewijn S, et al. Mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Vasc Surg. 2014. doi:10.1016/j.jvsv.2014.01.001

9. Boersma D, van Eekeren RRJP, Werson DAB, et al. Mechanochemical Endovenous Ablation of Small Saphenous Vein Insufficiency Using the ClariVein® Device: One-year Results of a Prospective Series. Eur J Vasc Endovasc Surg. 2013;45(3): 299-303. doi:10.1016/J.EJVS.2012.12.004

10. Witte ME, Holewijn S, Eekeren RR van, et al. Midterm Outcome of Mechanochemical Endovenous Ablation for the Treatment of Great Saphenous Vein Insufficiency. 2016;24(1):149-155. doi:10.1177/1526602816674455

11. Elias S, Lam YL, Wittens CHA. Mechanochemical ablation: status and results. 2013;28(1_suppl):10-14. doi:10.1177/0268355513477787

12. van Eekeren RRJP, Boersma D, Konijn V,et al. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013;57(2):445-450. doi:10.1016/J.JVS.2012.07.049

13. Sadek M, Kabnick LS. Are Non-Tumescent Ablation Procedures Ready to Take Over? Phlebol J Venous Dis. 2014;29(1_suppl):55-60. doi:10.1177/0268355514526681

14. Vun S V, Rashid ST, Blest NC, et al. Lower pain and faster treatment with mechanico-chemical endovenous ablation using ClariVein®. Phlebology. 2015;30(10): 688-692. doi:10.1177/0268355514553693

15. Tok M, Tüydeş O, Yüksel A, et al. Early-Term Outcomes for Treatment of Saphenous Vein Insufficiency with N-Butyl Cyanoacrylate: A Novel, Non-Thermal, and Non-Tumescent Percutaneous Embolization Technique. Heart Surg Forum. 2016;19(3):E118-22.

16. Eroglu E, Yasim A, Ari M, et al. Mid-term results in the treatment of varicose veins with N-butyl cyanoacrylate. Phlebology. 2017; Dec;32(10):665-669. doi:10.1177/ 0268355517718761

17. Almeida JI, Javier JJ, Mackay EG, et al. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015;Jul;30(6):397-404. doi:10.1177/0268355514532455

18. Proebstle TM, Alm J, Dimitri S, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015;3(1):2-7. doi:10.1016/j.jvsv.2014.09.001

19. Park I. Initial Outcomes of Cyanoacrylate Closure, VenaSeal System, for the Treatment of the Incompetent Great and Small Saphenous Veins. Vasc Endovascular Surg. 2017;51(8):545-549. doi:10.1177/1538574417729272

20. Sun JJ, Chowdhury MM, Sadat U, et al. Mechanochemical Ablation for Treatment of Truncal Venous Insufficiency: A Review of the Current Literature. J Vasc Interv Radiol. 2017;28(10):1422-1431. doi:10.1016/j.jvir.2017.07.002

21. Kugler NW, Brown KR. An update on the currently available nonthermal ablative options in the management of superficial venous disease. J Vasc Surg Venous Lymphat Disord. 2017;5(3):422-429. doi:10.1016/J.JVSV.2017.01.014

22. Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebol J Venous Dis. 2014;29(10):654-657. doi:10.1177/0268355513501301

23. Moore HM, Lane TR, Franklin IJ, et al. Retrograde mechanochemical ablation of the small saphenous vein for the treatment of a venous ulcer. Vascular. 2014;22(5): 375-377. doi:10.1177/1708538113516320

24. Toonder IM, Lam YL, Lawson J, et al. Cyanoacrylate adhesive perforator embolization (CAPE) of incompetent perforating veins of the leg, a feasibility study. Phlebology. 2014;May;29(1 suppl):49-54. doi:10.1177/0268355514529696

25. Prasad BP K, Joy B, Toms A, et al. Treatment of incompetent perforators in recurrent venous insufficiency with adhesive embolization and sclerotherapy. Phlebol J Venous Dis. 2018;33(4):242-250. doi:10.1177/0268355517696612

26. Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2016. doi:10.1177/1708538116651014

27. Park I. Successful use of VenaSeal system for the treatment of large great saphenous vein of 2.84-cm diameter. doi:10.4174/astr.2018.94.4.219

28. Bellam Premnath KP, Joy B, Raghavendra VA, Toms A, et al. Cyanoacrylate adhesive embolization and sclerotherapy for primary varicose veins. Phlebol J Venous Dis. 2018;33(8):547-557. doi:10.1177/0268355517733339

29. Koramaz İ, El Kılıç H, Gökalp F, et al. Ablation of the great saphenous vein with nontumescent n-butyl cyanoacrylate versus endovenous laser therapy. J Vasc Surg Venous Lymphat Disord. 2016. doi:10.1016/j.jvsv.2016.09.007

30. Kolluri R, Gibson K, Cher D, et al. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016. doi:10.1016/j.jvsv.2016.06.017

31. Boersma D, Kornmann VNN, Eekeren RRJP van, et al. Treatment Modalities for Small Saphenous Vein Insufficiency: Systematic Review and Meta-analysis. 2015;23(1):199-211. doi:10.1177/1526602815616375

32. Witte ME, Zeebregts CJ, de Borst GJ, et al. Reply to: Letter to Editor re: “Mechanochemical endovenous ablation of saphenous veins using the ClariVein: A systematic review” – MOCA data reporting needs to be tighter and standardized! Phlebol J Venous Dis. 2017;32(10):682-683. doi:10.1177/0268355517734953

33. Kiguchi MM, Dillavou ED. Thermal and Nonthermal Endovenous Ablation Options for Treatment of Superficial Venous Insufficiency. Surg Clin North Am. 2018;98(2):385-400. doi:10.1016/j.suc.2017.11.014

34. Bozkurt AK, Yılmaz MF. A prospective comparison of a new cyanoacrylate glue and laser ablation for the treatment of venous insufficiency. Phlebol J Venous Dis. 2016;31(1_suppl):106-113. doi:10.1177/0268355516632652

35. Chan YC, Law Y, Cheung GC, et al. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebol J Venous Dis. 2017;32(2):99-106. doi:10.1177/0268355516638200

36. Almeida JI, Javier JJ, Mackay EG, et al. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. 2017; Sep;5(5):658-666.doi:10.1016/j.jvsv.2017.03.016

37. Kendler M, Averbeck M, Simon JC, et al. Histology of saphenous veins after treatment with the ClariVein® device - an ex-vivo experiment. JDDG J der Dtsch Dermatologischen Gesellschaft. 2013. doi:10.1111/ddg.12022

38. van Eekeren RRJP, Hillebrands JL, van der Sloot K, et al. Histological observations one year after mechanochemical endovenous ablation of the great saphenous vein. J Endovasc Ther. 2014;21(3):429-433.

39. Tal MG, Dos Santos SJ, Marano JP, et al. Histologic findings after mechanochemical ablation in a caprine model with use of ClariVein. J Vasc Surg Venous Lymphat Disord. 2015;3(1):81-85. doi:10.1016/J.JVSV.2014.07.002

40. Kendler M, Kratzsch J, Schmidt R, et al. Serum endothelin 1 levels before, during and after mechanochemical endovenous ablation with foam and surgical correction of incompetent great saphenous veins. J Eur Acad Dermatology Venereol. 2016;30(3):546-547. doi:10.1111/jdv.12944

41. Shaidakov E V, Mel’tsova AZ, Porembskaia OI, et al. [Experience with using cyanoacrylate glue in endovascular treatment of varicose veins]. Angiologia i Sosudistaya Khirurgia. 2017;23(4):62-67.

42. Epstein D, Onida S, Bootun R, et al. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Heal. 2018;21(8):911-920. doi:10.1016/ J.JVAL.2018.01.012

43. Bootun R, Lane T, Dharmarajah B, et al. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre VenefitTM versus ClariVein® for varicose veins trial. 2014;31(1):61-65. doi:10.1177/0268355514551085

44. Lane T, Bootun R, Dharmarajah B, et al. A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins – Final results of the Venefit versus Clarivein for varicose veins trial. 2016;32(2):89-98. doi:10.1177/0268355516651026

45. Lam Y, Toonder IM, Wittens CH. Clarivein® mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study. 2015;31(3):170-176. doi:10.1177/0268355515599692

46. Eekeren RR van, Boersma D, Holewijn S, et al. Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial. Trials 2014 151. 2014;15(1):121. doi:10.1186/1745-6215-15-121

47. Boersma D, Eekeren RR van, Kelder HJ, et al. Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial. Trials 2014 151. 2014;15(1):421. doi:10.1186/1745-6215-15-421

48. Leung CCM, Carradice D, Wallace T, et al. Endovenous laser ablation versus mechanochemical ablation with ClariVein ® in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials 2016 171. 2016;17(1):421. doi:10.1186/s13063-016-1548-1

49. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). In: Journal of Vascular Surgery. ; 2015. doi:10.1016/j.jvs.2014.11.071

50. Morrison N, Gibson K, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017;5(3):321-330.
doi:10.1016/j.jvsv.2016.12.005

For citation

Markin S.M., Mazayshvili K.V., Agalarov R.M., Mordovin A.I., Gitsuk Ia.V., Mandzhikian O.P., Gustelev Yu.A. Evaluation of the life cycle of nonthermal non-tumescent methods by Mckinlay model. Bulletin of Pirogov National Medical & Surgical Center. 2019;14(3):110-115. (In Russ.) https://doi.org/10.25881/BPNMSC.2019.86.13.022