Balloon angioplasty with/without utilizing drug eluting technology or stenting constitutes the treatment of choice for a significant percentage of patients with peripheral artery disease requiring an intervention. However, in cases of diffuse disease and plaque complexity, angioplasty may lead to dissection, recoil, and/or early restenosis, making vessel preparation a key component for successful and durable endovascular revascularization outcome. This review of literature aims to present contemporary data for several commercially available specialty balloons that have been designed to minimize the arterial wall stress of conventional balloon angioplasty and facilitate technical success, as well as long-term patency.
Gerhard-HermanMDGornikHLBarrettC, et al.2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69(11):1465-1508.
2.
PandeRLPerlsteinTSBeckmanJACreagerMA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011;124(1):17-23.
3.
FowkesFGRudanDRudanI, et al.Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis. Lancet (London, England). 2013;382(9901):1329-1340.
4.
SampsonUKFowkesFGMcDermottMM, et al.Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014;9(1):145-158.e121.
5.
KimHKimSHanS, et al.Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors in Korea: A nationwide population-based study. BMC Publ Health. 2019;19(1):1112.
6.
GolombBADangTTCriquiMH. Peripheral arterial disease: Morbidity and mortality implications. Circulation. 2006;114(7):688-699.
7.
Peripheral arterial disease in people with diabetes. Diabetes Care. 2003;26(12):3333-3341.
8.
MahmoodSSLevyDVasanRSWangTJ. The Framingham Heart Study and the epidemiology of cardiovascular disease: A historical perspective. Lancet (London, England). 2014;383(9921):999-1008.
9.
McDermottMMLiuKGreenlandP, et al.Functional decline in peripheral arterial disease: Associations with the ankle brachial index and leg symptoms. JAMA. 2004;292(4):453-461.
10.
FowkesFGPriceJFStewartMC, et al.Aspirin for prevention of cardiovascular events in a general population screened for a low ankle brachial index: A randomized controlled trial. JAMA. 2010;303(9):841-848.
11.
CriquiMHNinomiyaJKWingardDLJiMFronekA. Progression of peripheral arterial disease predicts cardiovascular disease morbidity and mortality. J Am Coll Cardiol. 2008;52(21):1736-1742.
12.
CriquiMHLangerRDFronekA, et al.Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992;326(6):381-386.
13.
SaraidaridisJTErgulEPatelVIStoneDHCambriaRPConradMF. The Society for Vascular Surgery’s objective performance goals for lower extremity revascularization are not generalizable to many open surgical bypass patients encountered in contemporary surgical practice. J Vasc Surg. 2015;62(2):392-400.
14.
GoodneyPPBeckAWNagleJWelchHGZwolakRM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50(1):54-60.
15.
ConteMSBradburyAWKolhP, et al.Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019;69(6s):3S-125S.e140.
16.
AgarwalSSudKShishehborMH. Nationwide Trends of Hospital admission and outcomes among critical limb ischemia patients: From 2003-2011. J Am Coll Cardiol. 2016;67(16):1901-1913.
17.
GiannopoulosSMustaphaJGrayWA, et al.Three-year outcomes from the LIBERTY 360 study of endovascular interventions for peripheral artery disease stratified by rutherford category. J Endovasc Ther. 2021;28(2):262-274.
FarberAMenardMTConteMS, et al.Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med. 2022;387(25):2305-2316.
20.
BarilDTChaerRARheeRYMakarounMSMaroneLK. Endovascular interventions for TASC II D femoropopliteal lesions. J Vasc Surg. 2010;51(6):1406-1412.
21.
YinMYJiangMEHuangXT, et al.Endovascular interventions for TransAtlantic InterSociety Consensus II C and D femoropopliteal lesions. Chin Med J. 2013;126(3):415-420.
22.
GiannopoulosSArmstrongEJ. Clinical considerations after endovascular therapy of peripheral artery disease. Expert Rev Cardiovasc Ther. 2021;19:1-10.
23.
GiannopoulosSArmstrongEJ. Medical therapy for cardiovascular and limb-related risk reduction in critical limb ischemia. Vasc Med. 2021;26(2):210-224.
24.
GiannopoulosSVarcoeRLLichtenbergM, et al.Balloon angioplasty of infrapopliteal arteries: A systematic review and proposed algorithm for optimal endovascular therapy. J Endovasc Ther. 2020;27(4):547-564.
25.
FanelliFCannavaleAGazzettiM, et al.Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37(4):898-907.
26.
HalwaniDOAndersonPGBrottBCAnayiotosASLemonsJE. The role of vascular calcification in inducing fatigue and fracture of coronary stents. J Biomed Mater Res B Appl Biomater. 2012;100(1):292-304.
27.
AdlakhaSSheikhMWuJ, et al.Stent fracture in the coronary and peripheral arteries. J Intervent Cardiol. 2010;23(4):411-419.
28.
MattesiniADi MarioC. Calcium: A predictor of interventional treatment failure across all fields of cardiovascular medicine. Int J Cardiol. 2017;231:97-98.
29.
FitzgeraldPJPortsTAYockPG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64-70.
30.
KondapalliAJeon-SlaughterHLuH, et al.Comparative assessment of patient outcomes with intraluminal or subintimal crossing of infrainguinal peripheral artery chronic total occlusions. Vasc Med. 2018;23(1):39-45.
DeRubertisBGFariesPLMcKinseyJF, et al.Shifting paradigms in the treatment of lower extremity vascular disease: A report of 1000 percutaneous interventions. Ann Surg. 2007;246(3):415-422. discussion 422-414.
33.
KatsanosKKitrouPSpiliopoulosSDiamantopoulosAKarnabatidisD. 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: Off J Int Soc Endovasc Spec. 2016;23(6):851-863.
34.
MoherDLiberatiATetzlaffJAltmanDG. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med. 2009;6(7):e1000097.
35.
FaxonDPWeberVJHaudenschildCGottsmanSBMcGovernWARyanTJ. Acute effects of transluminal angioplasty in three experimental models of atherosclerosis. Arteriosclerosis. 1982;2(2):125-133.
36.
BlockPCBaughmanKLPasternakRCFallonJT. Transluminal angioplasty: Correlation of morphologic and angiographic findings in an experimental model. Circulation. 1980;61(4):778-785.
37.
HoshinoTYoshidaHTakayamaS, et al.Significance of intimal tears in the mechanism of luminal enlargement in percutaneous transluminal coronary angioplasty: correlation of histologic and angiographic findings in postmortem human hearts. Am Heart J. 1987;114(3):503-510.
38.
LyonRTZarinsCKLuCTYangCFGlagovS. Vessel, plaque, and lumen morphology after transluminal balloon angioplasty. Quantitative study in distended human arteries. Arteriosclerosis. 1987;7(3):306-314.
39.
BaughmanKLPasternakRCFallonJTBlockPC. Transluminal coronary angioplasty of postmortem human hearts. Am J Cardiol. 1981;48(6):1044-1047.
40.
Castaneda-ZunigaWRFormanekATadavarthyM, et al.The mechanism of balloon angioplasty. Radiology. 1980;135(3):565-571.
41.
SanbornTAFaxonDPHaudenschildCGottsmanSBRyanTJ. The mechanism of transluminal angioplasty: Evidence for formation of aneurysms in experimental atherosclerosis. Circulation. 1983;68(5):1136-1140.
42.
BotasJClarkDAPintoFChenzbraunAFischellTA. Balloon angioplasty results in increased segmental coronary distensibility: A likely mechanism of percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1994;23(5):1043-1052.
43.
DavidsonCJNewmanGESheikhKHKissloKStackRSSchwabSJ. Mechanisms of angioplasty in hemodialysis fistula stenoses evaluated by intravascular ultrasound. Kidney Int. 1991;40(1):91-95.
44.
ShanahanCMCaryNRSalisburyJRProudfootDWeissbergPLEdmondsME. Medial localization of mineralization-regulating proteins in association with Monckeberg’s sclerosis: Evidence for smooth muscle cell-mediated vascular calcification. Circulation. 1999;100(21):2168-2176.
45.
MustaphaJADiaz-SandovalLJSaabF. Infrapopliteal calcification patterns in critical limb ischemia: Diagnostic, pathologic and therapeutic implications in the search for the endovascular holy grail. J Cardiovasc Surg. 2017;58(3):383-401.
46.
SteenmanMEspitiaOMaurelB, et al.Identification of genomic differences among peripheral arterial beds in atherosclerotic and healthy arteries. Sci Rep. 2018;8(1):3940.
47.
HerissonFHeymannMFChetiveauxM, et al.Carotid and femoral atherosclerotic plaques show different morphology. Atherosclerosis. 2011;216(2):348-354.
48.
HeymannMFHerissonFDavaineJM, et al.Role of the OPG/RANK/RANKL triad in calcifications of the atheromatous plaques: Comparison between carotid and femoral beds. Cytokine. 2012;58(2):300-306.
49.
LondonGMGuerinAPMarchaisSJMetivierFPannierBAddaH. Arterial media calcification in end-stage renal disease: Impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003;18(9):1731-1740.
50.
TripodiA. Thrombin generation assay and its application in the clinical laboratory. Clin Chem. 2016;62(5):699-707.
51.
KuijpersMJEPEJvdMFeijgeMAH, et al.Factor XII regulates the pathological process of thrombus formation on ruptured plaques. Arterioscler Thromb Vasc Biol. 2014;34(8):1674-1680.
52.
de Athayde SoaresRMatieloMFBrochado NetoFC, et al.Impact of calcification and infrapopliteal outflow on the outcome of endovascular treatment of femoropopliteal occlusive disease. JRSM Cardiovasc Dis. 2019;8:2048004019828941.
53.
van der LugtAGussenhovenEJMaliWP, et al.Effect of balloon angioplasty in femoropopliteal arteries assessed by intravascular ultrasound. Eur J Vasc Endovasc Surg: Off J Eur Soc Vasc Surg. 1997;13(6):549-556.
54.
KashyapVSPavkovMLBishopPD, et al.Angiography underestimates peripheral atherosclerosis: Lumenography revisited. J Endovasc Ther: Off J Int Soc Endovasc Specialists. 2008;15(1):117-125.
55.
ArmstrongEJBrodmannMDeatonDH, et al.Dissections after infrainguinal percutaneous transluminal angioplasty: A systematic review and current state of clinical evidence. J Endovasc Ther: Off J Int Soc Endovascul Specialists. 2019;26(4):479-489.
56.
KaladjiAVentPADanvinA, et al.Impact of vascular calcifications on long femoropopliteal stenting outcomes. Ann Vasc Surg. 2018;47:170-178.
57.
TepeGBeschornerURuetherC, et al.Drug-eluting balloon therapy for femoropopliteal occlusive disease: Predictors of outcome with a special emphasis on calcium. J Endovasc Ther: Off J Int Soc Endovasc Specialists. 2015;22(5):727-733.
58.
RazaviMKMustaphaJAMillerLE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Intervent Radiol. 2014;25(10):1489-1496. 1496.e1481-1483.
59.
ShammasNWToreyJTShammasWJ. Dissections in peripheral vascular interventions: A proposed classification using intravascular ultrasound. J Invasive Cardiol. 2018;30(4):145-146.
60.
ArmstrongEJShishehborMH. Commentary: Contemporary outcomes of endovascular interventions for peripheral artery disease: The LIBERTY to determine optimal treatment strategies. J Endovasc Ther: Off J Int Soc Endovasc Specialists. 2019;26(2):155-157.
61.
TopferLASpryC. New Technologies for the Treatment of Peripheral Artery Disease. In: CADTH Issues in Emerging Health Technologies. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; 2016:172. Available fromhttps://www.ncbi.nlm.nih.gov/books/NBK519606/
62.
KokkinidisDGGiannopoulosSJawaidOCantuDSinghGDArmstrongEJ. Laser atherectomy for infrapopliteal lesions in patients with critical limb ischemia. Cardiovasc Revascularization Med. 2021;23:79-83.
63.
OrmistonWDyer-HartnettSFernandoRHoldenA. An update on vessel preparation in lower limb arterial intervention. CVIR Endovasc. 2020;3(1):86.
64.
LugenbielIGrebnerMZhouQ, et al.Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon - results from the Heidelberg PANTHER registry. Vasa. 2018;47(1):49-55.
65.
KronlageMWernerCDufnerM, et al.Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt™). Clin Res Cardiol. 2020;109(9):1177-1185.
HoldenAHillAWalkerA, et al.PRELUDE prospective study of the serranator device in the treatment of atherosclerotic lesions in the superficial femoral and popliteal arteries. J Endovasc Ther: Off J Int Soc Endovasc Specialists. 2019;26(1):18-25.
70.
TzafririARGarcia-PoliteFZaniB, et al.Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Contr Release. 2017;264:203-210.
DasTSMcNamaraTGrayB, et al.Primary cryoplasty therapy provides durable support for limb salvage in critical limb ischemia patients with infrapopliteal lesions: 12-month follow-up results from the BTK Chill Trial. J Endovasc Ther: Off J Int Soc Endovasc Specialists. 2009;16(2 suppl 2):II19-30.
73.
AnselGMSampleNSBottiICJr, et al.Cutting balloon angioplasty of the popliteal and infrapopliteal vessels for symptomatic limb ischemia. Cathet Cardiovasc Interv. 2004;61(1):1-4.
TepeGZellerTSchnorrB, 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: Off J Int Soc Endovasc Specialists. 2013;20(6):792-800.
78.
TepeGZellerTAlbrechtT, et al.Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689-699.
79.
KobayashiNHiranoKYamawakiM, et al.Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg. 2018;67(4):1151-1158.
80.
GiannopoulosSStrobelARudofkerEKovachCSchneiderPAArmstrongEJ. Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther. 2021;28(4):593-603.
MustaphaJALanskyAShishehborM, et al.A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry. Cathet Cardiovasc Interv. 2018;91(6):1144-1148.
83.
SirignanoPMansourWd’AdamoACuozzoSCapocciaLSpezialeF. Early experience with a new concept of angioplasty nitinol-constrained balloon catheter (Chocolate(®)) in severely claudicant patients. Cardiovasc Intervent Radiol. 2018;41(3):377-384.
84.
ShishehborMHZellerTWernerM, et al.Randomized trial of Chocolate touch compared with Lutonix drug-coated balloon in femoropopliteal lesions (Chocolate Touch Study). Circulation. 2022;145(22):1645-1654.
85.
ShiraiSMoriSYamaguchiK, et al.Impact of Chocolate percutaneous transluminal angioplasty balloon on vessel preparation in drug-coated balloon angioplasty for femoropopliteal lesion. CVIR Endovasc. 2022;5(1):46.
86.
BrodmannMWernerMBrintonTJ, et al.Safety and performance of lithoplasty for treatment of calcified peripheral artery lesions. J Am Coll Cardiol. 2017;70(7):908-910.
87.
BrodmannMWernerMHoldenA, et al.Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Cathet Cardiovasc Interv. 2019;93(2):335-342.
RastanATepeGKrankenbergH, et al.Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: A double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011;32(18):2274-2281.
90.
AdamsGSoukasPAMehrleABertoletBArmstrongEJ. Intravascular lithotripsy for treatment of calcified infrapopliteal lesions: Results from the Disrupt PAD III Observational Study. J Endovasc Ther. 2022;29(1):76-83.
