Preview

Minimally Invasive Cardiovascular Surgery

Advanced search

Material embolization of the distal arterial channel during endovascular and open revascularization of total occlusions of the superficial femoral artery complemented by drug-coated balloon angioplasty Distal embolism in infrainguinal revascularizations augmented by drug-coated balloon angioplasty.

Abstract

Aim: The purpose of our clinical study is to compare the incidence of peripheral embolism during endovascular recanalization with a paclitaxel-coated balloon angioplasty versus open endatherectomy with a paclitaxel-coated balloon angioplasty.

Materials and methods: Prospective, randomized, single-center pilot study of patients with superficial femoral artery occlusive lesions. Patients of group 1 (PTA+DCB) underwent recanalization of the superficial femoral artery (SFA) with drug-coated balloon angioplasty. Patients of group 2 (RE+DCB) underwent remote semi-closed endarterectomy from the SFA with drug-coated balloon angioplasty. Doppler emboldetection was performed during the revascularization procedure.

Results: The study included 10 patients in each group. The patients did not differ in age, comorbidity, and severity of lower extremity ischemia. The majority were patients with intermittent claudication. In the PTA+DCB group, the median number of ebmols during the procedure was 200.0 [100.0; 200.0], and in the group RE+DCB 7 [6;8], p= 0.0002. Moreover, in the PTA+DCB group, peripheral embolism occurred both during the passage of the target artery lesion (in 100% of cases) and during drug-coated balloon angioplasty (in 60% of cases), while in the RE+DCB group peripheral embolism occurred only during drug-coated balloon angioplasty (100% of cases).

Conclusion: There was a higher incidence of material distal embolism with PTA+DCB compared with RE+DCB.

About the Authors

A. A. Gostev
Federal State Budgetary Institution “National Medical Research Centre named after Academician E.N. Meshalkin” of the Ministry of Health of the Russian Federation. Meshalkin National Medical Research Centre, Ministry of Health of the Russian Federation
Russian Federation

Gostev Alexander A.: Candidate of Medical Sciences, researcher at the Research Department of Vascular and Hybrid Surgery of the Institute of Circulatory Pathology, cardiovascular surgeon at the Cardiac Surgery Department of Vascular Pathology and Hybrid Technologies

 630055, Novosibirsk, 15 Rechkunovskaya str.



O. S. Osipova
Federal State Budgetary Institution “National Medical Research Centre named after Academician E.N. Meshalkin” of the Ministry of Health of the Russian Federation. Meshalkin National Medical Research Centre, Ministry of Health of the Russian Federation
Russian Federation

Osipova Olesia S.: junior researcher of the Research Department of Vascular and Hybrid Surgery of the Institute of Circulatory Pathology, cardiovascular surgeon of the Cardiac Surgery Department of Vascular Pathology and Hybrid Technologies

630055, Novosibirsk, 15 Rechkunovskaya str.



A. V. Cheban
Federal State Budgetary Institution “National Medical Research Centre named after Academician E.N. Meshalkin” of the Ministry of Health of the Russian Federation. Meshalkin National Medical Research Centre, Ministry of Health of the Russian Federation
Russian Federation

Cheban Alexey V.: junior researcher of the Research Department of Vascular and Hybrid Surgery of the Institute of Circulatory Pathology, cardiovascular surgeon of the Cardiac Surgery Department of Vascular Pathology and Hybrid Technologies

630055, Novosibirsk, 15 Rechkunovskaya str.



A. A. Karpenko
Federal State Budgetary Institution “National Medical Research Centre named after Academician E.N. Meshalkin” of the Ministry of Health of the Russian Federation. Meshalkin National Medical Research Centre, Ministry of Health of the Russian Federation
Russian Federation

Karpenko Andrey A.: Dr. Sci. (Med.), Professor, Head of the Research Department of Vascular and Hybrid Surgery of the Institute of Circulatory Pathology

630055, Novosibirsk, 15 Rechkunovskaya str.



References

1. Nakamura S. et al. Endovascular Treatment of Long Superficial Femoral Artery-Chronic Total Occlusions Using the Gogo Catheter With IVUS Via a Popliteal Puncture Method Is Effective, Safe, and Useful // Vasc Endovascular Surg. Vasc Endovascular Surg, 2020. Vol. 54, № 3. P. 225–232.

2. Gostev A.A. et al. Treatment of Long Femoropopliteal Occlusive Lesions With Selfexpanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial // J Endovasc Ther. J Endovasc Ther, 2023.

3. Gostev A.A. et al. Bypass Versus Interwoven Nitinol Stents for Long Femoro-Popliteal Occlusions: A Propensity Matched Analysis // Cardiovasc Intervent Radiol. Cardiovasc Intervent Radiol, 2022. Vol. 45, № 7. P. 929–938.

4. Aboyans V. et al. Editor’s Choice – 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS) // European Journal of Vascular and Endovascular Surgery. W.B. Saunders Ltd, 2018. Vol. 55, № 3. P. 305–368.

5. Katsanos K. et al. Editor’s Choice – Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled Trials // European Journal of Vascular and Endovascular Surgery. W.B. Saunders Ltd, 2022. Vol. 63, № 1. P. 60–71.

6. Katsanos K. et al. Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials // Journal of Vascular and Interventional Radiology. Elsevier Inc., 2020. Vol. 31, № 2. P. 202–212.

7. Conte M.S. et al. Global vascular guidelines on the management of chronic limb-threatening ischemia // J Vasc Surg. J Vasc Surg, 2019. Vol. 69, № 6S. P. 3S-125S.e40.

8. Torii S. et al. Comparison of Biologic Effect and Particulate Embolization after Femoral Artery Treatment with Three Drug-Coated Balloons in Healthy Swine Model // J Vasc Interv Radiol. J Vasc Interv Radiol, 2019. Vol. 30, № 1. P. 103–109.

9. Kolodgie F.D. et al. Comparison of Particulate Embolization after Femoral Artery Treatment with IN.PACT Admiral versus Lutonix 035 PaclitaxelCoated Balloons in Healthy Swine // J Vasc Interv Radiol. J Vasc Interv Radiol, 2016. Vol. 27, № 11. P. 1676-1685.e2.

10. Lake E., Twigg M., Farquharson F. Acute hypersensitivity reaction to femoral drug-coated balloons // https://doi.org/10.1024/0301-1526/a000604. Hogrefe AG , 2017. Vol. 46, № 3. P. 223–225.

11. Thomas S.D., McDonald R.R.A., Varcoe R.L. Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon // J Vasc Surg. Mosby, 2014. Vol. 59, № 2. P. 520–523.

12. Gostev А.А. et al. Evaluation of embologenicity in endovascular treatment of peripheral arteries using drug-coated balloons: interim results // Angiology and vascular surgery. 2023. Vol. 29, № 3. P. 99–108.

13. Karnabatidis D. et al. Distal embolism during percutaneous revascularization of infra-aortic arterial occlusive disease: an underestimated phenomenon // J Endovasc Ther. J Endovasc Ther, 2006. Vol. 13, № 3. P. 269–280.

14. Lam R.C. et al. The impact of increasing age on anatomic factors affecting carotid angioplasty and stenting. // J Vasc Surg. 2007. Vol. 45, № 5. P. 875–880.

15. Shrikhande G. V. et al. Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions // J Vasc Surg. J Vasc Surg, 2011. Vol. 53, № 2. P. 347–352.

16. Ochoa Chaar C.I. et al. Distal embolization during lower extremity endovascular interventions // Journal of Vascular Surgery. Mosby Inc., 2017. Vol. 66, № 1. P. 143–150.

17. Cheban A.V. et al. Semiclosed endarterectomy compared with semiclosed endarterectomy and drugcoated balloons in patients with total occlusion of the superfi cial femoral artery // Angiology and vascular surgery. 2022. Vol. 28, № 2. P. 132–140.

18. Saaya S. et al. A prospective randomized trial on endovascular recanalization with stenting versus remote endarterectomy for the superficial femoral artery total occlusive lesions // J Vasc Surg. J Vasc Surg, 2022. Vol. 76, № 1. P. 158–164.

19. Zeller T. et al. New approach to protected percutaneous transluminal angioplasty in the lower limbs // J Endovasc Ther. J Endovasc Ther, 2013. Vol. 20, № 3. P. 409–419.

20. Mendes B.C. et al. Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices // J Vasc Surg. J Vasc Surg, 2014. Vol. 59, № 2.

21. Shammas N.W. et al. Preventing lower extremity distal embolization using embolic filter protection: Results of the PROTECT registry // Journal of Endovascular Therapy. 2008. Vol. 15, № 3. P. 270– 276.

22. Speck U. et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? // Circ Cardiovasc Interv. Circ CardiovascInterv, 2012. Vol. 5, № 3. P. 392–400.

23. Stolzenburg N. et al. Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries - First Experimental Results in Rabbits at Low Inflation Pressure // Cardiovasc Drugs Ther. Cardiovasc Drugs Ther, 2016. Vol. 30, № 3. P. 263–270.

24. Kelsch B. et al. Dose response to Paclitaxelcoated balloon catheters in the porcine coronary overstretch and stent implantation model // Invest Radiol. Invest Radiol, 2011. Vol. 46, № 4. P. 255–263.

25. Cheban A.V. et al. Modern approaches to femoropopliteal bypass surgery: Achievements and future prospects // Cardiovascular Therapy and Prevention (Russian Federation). 2020. Vol. 19, № 2.


Review

For citations:


Gostev A.A., Osipova O.S., Cheban A.V., Karpenko A.A. Material embolization of the distal arterial channel during endovascular and open revascularization of total occlusions of the superficial femoral artery complemented by drug-coated balloon angioplasty Distal embolism in infrainguinal revascularizations augmented by drug-coated balloon angioplasty. Minimally Invasive Cardiovascular Surgery. 2024;3(3):66-77. (In Russ.)

Views: 23


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.