There is a risk of distal embolization lower extremity endovascular interventions. Possibly a drug-coating embolism caused by coating detachment from intravascular devices.
Methods
This review focuses on providing updated information on distal embolism in endovascular revascularization of lower extremity arteries, including the use of drug-coated balloons.
Results
Drug-coating embolism is a special case of distal embolization during recanalization of the arteries of the lower extremities. Preclinical studies have demonstrated embolization of drug-coated balloons during angioplasty of lower extremity arteries. However, the clinical role of drug-coating embolism is not completely clear. A 2020 meta-analysis found an increased risk of major lower extremity amputation after drug-coated balloon angioplasty in patients with critical limb ischemia. But long-term research is emerging to support the safety of using these devices. Perhaps a more thorough assessment of the quality of life and the degree of compensation of lower limb ischemia with an intraoperative assessment of the frequency of peripheral embolizations using ultrasound emboli detection, as well as microcirculation with transcutaneous oximetry and laser Doppler flowmetry of the operated lower limb will allow a more detailed study of the phenomenon of drug-coating embolism and its impact on long-term clinical outcomes.
Conclusion
According to the results of preclinical studies, the use of paclitaxel-coated balloons leads to an increase in the concentration of paclitaxel in distal skeletal muscles. However, paclitaxel concentration in skeletal muscle was significantly higher in first-generation DCBs. The non-target effects of drug-coating balloon are not fully understood and require further study. Understanding the phenomenon of drug-coating embolism can help physicians to better assess the patient risk and to minimize complications.
KatsanosKSpiliopoulosSParaskevopoulosI, et al.Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther2016; 23: 356–370.
2.
KatsanosKSpiliopoulosSKitrouP, 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. J Vasc Interv Radiol2020; 31: 202–212.
3.
Ochoa ChaarCISheblFSumpioB, et al.Distal embolization during lower extremity endovascular interventions. Journal of Vascular Surgery. Mosby Inc., 2017, pp. 143–150.
4.
MendesBCOderichGSFlemingMD, et al.Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices. J Vasc Surg2014; 59: 359–367. DOI: 10.1016/J.JVS.2013.07.119.
5.
KarnabatidisDKatsanosKKagadisGC, et al.Distal embolism during percutaneous revascularization of infra-aortic arterial occlusive disease: an underestimated phenomenon. J Endovasc Ther2006; 13: 269–280.
6.
LamRCLinSCDeRubertisB, et al.The impact of increasing age on anatomic factors affecting carotid angioplasty and stenting. J Vasc Surg2007; 45: 875–880.
7.
SpiliopoulosSTheodosiadouVKoukounasV, et al.Distal macro- and microembolization during subintimal recanalization of femoropopliteal chronic total occlusions. J Endovasc Ther2014; 21: 474–481.
8.
WangXNieS-P. The coronary slow flow phenomenon: characteristics, mechanisms and implications. Cardiovasc Diagn Ther2011; 1: 37–43.
SanatiHKianiRShakerianF, et al.Coronary slow flow phenomenon clinical findings and predictors. Res Cardiovasc Med2016; 5: e30296. DOI: 10.5812/CARDIOVASCMED.30296.
11.
KobayashiNHiranoKYamawakiM, et al.Clinical impact and predictors of the slow-flow phenomenon after endovascular treatment of infrapopliteal lesions using the crosser catheter in patients with critical limb ischemia. J Vasc Interv Radiol2020; 31: 141–149.
12.
TokudaTHiranoKSakamotoY, et al.Incidence and clinical outcomes of the slow-flow phenomenon after infrapopliteal balloon angioplasty. J Vasc Surg2017; 65: 1047–1054.
13.
AkşitEGaziEToprakCA, et al.Unilateral peripheral slow flow phenomenon without significant stenosis in lower extremity artery: can primary peripheral slow flow be a new phenomenon?BMJ Case Rep September 2020; 13: 23. DOI: 10.1136/BCR-2020-235686.
14.
ZellerTSchmidtARastanA, et al.New approach to protected percutaneous transluminal angioplasty in the lower limbs. J Endovasc Ther2013; 20: 409–419.
15.
ShrikhandeGVKhanSZHussainHG, et al.Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions. J Vasc Surg2011; 53: 347–352.
16.
YsaALobatoMArronizA, et al.Retrograde balloon-Assisted approach to prevent distal embolization during complex recanalization procedures. J Endovasc Ther2022; 5: 15266028221138024. DOI: 10.1177/15266028221138024.
17.
AlmeidaSOBudoffM. Effect of statins on atherosclerotic plaque. Trends Cardiovasc Med2019; 29: 451–455.
18.
LamRCShahSFariesPL, et al.Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery. J Vasc Surg2007; 46: 1155–1159.
19.
BrancaccioGLombardiRStefaniniT, et al.Comparison of embolic load in femoropopliteal interventions: percutaneous transluminal angioplasty versus stenting. Vasc Endovascular Surg2012; 46: 229–235.
20.
AngHKopparaTRCasseseS, et al.Drug-coated balloons: Technical and clinical progress. Vasc Med2020; 25: 577–587.
21.
GranadaJFVirmaniRSchulz-JanderD, et al.Rate of drug coating dissolution determines in-tissue drug retention and durability of biological efficacy. J Drug Deliv2019; 2019: 1–7.
22.
GongoraCAShibuyaMWesslerJD, et al.Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv2015; 8: 1115–1123.
23.
KolodgieFDPachecoEYahagiK, et al.Comparison of particulate embolization after femoral artery treatment with IN.PACT Admiral versus Lutonix 035 paclitaxel-coated balloons in Healthy swine. J Vasc Interv Radiol2016; 27: 1676–1685.
24.
KelschBSchellerBBiedermannM, et al.Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Invest Radiol2011; 46: 255–263.
25.
SpeckUCremersBKelschB, et al.Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel?Circ Cardiovasc Interv2012; 5: 392–400.
26.
StolzenburgNBreinlJBienekS, 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 Ther2016; 30: 263–270.
27.
SatoYKuntzSHSurveD, et al.What are the pathological concerns and limitations of current drug-coated balloon technology?Heart Int2019; 13: 15–22.
28.
ToriiSJinnouchiHSakamotoA, 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 Radiol2019; 30: 103–109.
29.
YoshikawaMToriiSAiharaK, et al.Differences in biologic drug effects and distal particulate embolization in three paclitaxel-coated balloons for femoropopliteal lesions in a rabbit model. J Endovasc Ther2023: 15266028231161215. DOI: 10.1177/15266028231161215.
ThomasSDMcDonaldRRAVarcoeRL. Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon. J Vasc Surg2014; 59: 520–523.
32.
GostevAAOsipovaOSKlinkovaAS, et al.Peripheral embolism and microcirculation during revascularization of the superficial femoral artery with native and drug-coated balloons over a one-year follow-up period. The Siberian Journal of Clinical and Experimental Medicine2024; 38: 202–212.
33.
ShiraiSHiranoKMoriS, et al.Frequency, predictors, and effect of the slow-flow phenomenon after drug-coated balloon angioplasty for femoropopliteal lesions. Heart Ves2021; 36: 1818–1824.
34.
TangTYSulaimanMSBSoonSXY, et al.Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia—a case series. Quant Imaging Med Surg2022; 12: 2058–2065.
35.
KatsanosKSpiliopoulosSTeichgräberU, 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. Eur J Vasc Endovasc Surg2022; 63: 60–71.
36.
CaiHDongJYeY, et al.Safety and efficacy of drug-coated balloon in the treatment of below-the-knee artery: a meta-analysis. J Surg Res2022; 278: 303–316.
37.
CannavaleASantoniMGazzettiM, et al.Current status of distal embolization in femoropopliteal endovascular interventions. Vasc Endovascular Surg2018; 52: 440–447.
38.
KatsanosKTepeGTsetisD, et al.Standards of practice for superficial femoral and popliteal artery angioplasty and stenting. Cardiovasc Intervent Radiol2014; 37: 592–603.
39.
OkazakiTSakamotoSShinagawaK, et al.Detection of in-stent protrusion (ISP) by intravascular ultrasound during carotid stenting: Usefulness of stent-in-stent placement for ISP. Eur Radiol2019; 29: 77–84.
40.
KonishiTFunayamaNYamamotoT, et al.Stabilization of symptomatic carotid atherosclerotic plaques by statins: a clinico-pathological analysis. Heart Ves2018; 33: 1311–1324.
41.
LeeSEChangHJSungJM, et al.Effects of statins on coronary atherosclerotic plaques: the PARADIGM study. JACC Cardiovasc Imaging2018; 11: 1475–1484.
ShammasNWDippelEJCoinerD, et al.Preventing lower extremity distal embolization using embolic filter protection: results of the protect registry. J Endovasc Ther2008; 15: 270–276.
44.
KrishnanPTarriconeAPurushothamanKR, et al.An algorithm for the use of embolic protection during atherectomy for femoral popliteal lesions. JACC Cardiovasc Interv2017; 10: 403–410.
45.
JaffMRNelsonTFerkoN, et al.Endovascular interventions for femoropopliteal peripheral artery disease: a network meta-analysis of current Technologies. J Vasc Interv Radiol2017; 28: 1617–1627.
46.
TeichgräberUKMKlumbC. [Drug-coated balloon angioplasty in femoropopliteal arteries - is there a class effect?]. Zentralbl Chir2017; 142: 470–480.
47.
AboyansVRiccoJBBartelinkMLEL, 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). Eur J Vasc Endovasc Surg2018; 55: 305–368.
48.
KatsanosKSpiliopoulosSKitrouP, et al.Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc December 2018; 7: e011245. DOI: 10.1161/JAHA.118.011245.
49.
ConteMSBradburyAWKolhP, et al.Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg2019; 69: 3S–125S. e40.
50.
ZellerTMicariAScheinertD, et al.The in.pact deep clinical drug-coated balloon trial: 5-year outcomes. JACC Cardiovasc Interv2020; 13: 431–443.
51.
StettlerCWandelSAllemannS, et al.Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet2007; 370: 937–948.
52.
PerezEASumanVJDavidsonNE, et al.Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central cancer treatment group N9831 adjuvant breast cancer trial. J Clin Oncol2008; 26: 1231–1238.
53.
HayesDFThorADDresslerLG, et al.HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med2007; 357: 1496–1506.
54.
PapoyanSAShchegolevAAGromovDG, et al.Drug-coated balloon angioplasty in peripheral arterial disease. Russian Medical Inquiry2022; 6: 177–181.
