Purpose: To assess the utility of intravascular ultrasound (IVUS) during below-the-knee (BTK) interventions for patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: This retrospective single-center study included 216 symptomatic patients (mean age 74.2±9.5 years; 167 men) with CLTI and BTK steno-occlusive disease who underwent successful balloon angioplasty between January 2016 and August 2018. Data from 88 vessels (58 patients) treated with IVUS-guided procedures were compared with corresponding values from 242 vessels (158 patients) treated with angiography-guided procedures. The primary outcomes included procedure-related variables of balloon size, contrast dose, and complication rates, as well as changes in ankle-brachial index (ABI) and skin perfusion pressure (SPP). Secondary outcomes included IVUS determination of vessel size, wire route, and calcification severity, as well as technical success and clinically-driven target lesion revascularization (TLR), limb salvage, and wound healing rates in the Rutherford category 5/6 patients as evaluated by propensity score matching analysis. Results: The patient and lesion characteristics were similar in both groups. The mean balloon size for IVUS-guided procedures was significantly larger (2.45±0.4 mm) compared with that for angiography-guided procedures (2.23±0.4 mm; p<0.001). The technical success (p=0.56) and complication rates (p=0.16) were similar between the groups. The postprocedure dorsal and plantar SPP and change in dorsal SPP improved more in the IVUS-guided group (p<0.001, p=0.015, and p=0.02, respectively). The IVUS-guided group had a significantly better wound healing rate than the angiography-guided group (p=0.006), although the freedom from TLR and limb salvage rates were similar between the groups (p=0.16 and p>0.99, respectively). Conclusion: IVUS-guided interventions for BTK lesions were safe and effective in accurately assessing the lesions. The results suggest that IVUS guidance of endovascular procedures has the potential to influence better clinical outcomes than angiography-guided angioplasty.
HirschATHartmanLTownRJ, et al. National health care costs of peripheral arterial disease in the Medicare population. Vasc Med. 2008;13:209–215.
2.
NorgrenLHiattWRDormandyJA, et al. Inter-society consensus for the management of peripheral arterial disease. Eur J Vasc Endovasc Surg. 2007;33:S1–S75.
3.
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;69:1465–1508.
4.
ConteMSBradburyAWKolhP, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019;69(6S):3S–125S.e40.
5.
MarstonWADaviesSWArmstrongB, et al. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg. 2006;44:108–114.
6.
IidaONakamuraMYamauchiY, et al. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Circ Cardiovasc Interv. 2013;6:68–76.
7.
IidaOTakaharaMSogaY, et al. Impact of angiosome-oriented revascularization on clinical outcomes in critical limb ischemia patients without concurrent wound infection and diabetes. J Endovasc Ther. 2014;21:607–615.
8.
ReijnenMMPJvan WijckIZellerT, et al. Outcomes after drug-coated balloon treatment of femoropopliteal lesions in patients with critical limb ischemia: a post hoc analysis from the IN.PACT Global Study. J Endovasc Ther. 2019;26:305–315.
9.
SinghGDBrinzaEKHildebrandJ, et al. Midterm outcomes after infrapopliteal interventions in patients with critical limb ischemia based on the TASC II classification of below-the-knee arteries. J Endovasc Ther. 2017;24:321–330.
10.
SogaYIidaOTakaharaM, et al. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014;7:1444–1449.
11.
IidaOSogaYKawasakiD, et al. Angiographic restenosis and its clinical impact after infrapopliteal angioplasty. Eur J Vasc Endovasc Surg. 2012;44:425–431.
12.
BaumannFFustJEngelbergerRP, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther. 2014;21:44–51.
13.
TeichgräberULehmannTThiemeM, et al. Drug-coated balloon angioplasty of infrapopliteal lesions in patients with critical limb ischaemia: 1-year results of the APOLLO trial. Cardiovasc Intervent Radiol. 2019;42:1380–1390.
14.
ShammasNWRadaidehQShammasWJ, et al. The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions. Vasc Health Risk Manag. 2019;15:283–290.
15.
IidaOTakaharaMSogaY, et al. Efficacy of intravascular ultrasound in femoropopliteal stenting for peripheral artery disease with TASC II class A to C lesions. J Endovasc Ther. 2014;21:485–492.
16.
ShammasNWShammasWJJones-MillerS, et al. Optimal vessel sizing and understanding dissections in infrapopliteal interventions: data from the iDissection Below-the-Knee Study. J Endovasc Ther. May 18, 2020. doi:10.1177/1526602820924815
17.
NguyenPSetoA.Contemporary practices using intravascular imaging guidance with IVUS or OCT to optimize percutaneous coronary intervention. Expert Rev Cardiovasc Ther. 2020;18:103–115.
18.
FujiharaMHaramitsuYOhshimoK, et al. Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous revascularization. Cardiovasc Interv Ther. 2017;32:233–240.
19.
KawaradaOFujiharaMHigashimoriA, et al. Predictors of adverse clinical outcomes after successful infrapopliteal intervention. Catheter Cardiovasc Interv. 2012;80:861–871.
20.
FujiharaMKozukiATsubakimotoY, et al. Lumen gain after endovascular therapy in calcified superficial femoral artery occlusive disease assessed by intravascular ultrasound (CODE Study). J Endovasc Ther. 2019;26:322–330.
21.
CastronuovoJJJrAderaHMSmiellJM, et al. Skin perfusion pressure measurement is valuable in the diagnosis of critical limb ischemia. J Vasc Surg. 1997;26:629–637.
22.
YamadaTOhtaTIshibashiH, et al. Clinical reliability and utility of skin perfusion pressure measurement in ischemic limbs comparison with other noninvasive diagnostic methods. J Vasc Surg. 2008;47:318–323.
23.
RosenbaumPRRubinDB.The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70:41–55.
NakamaTWatanabeNHaraguchiT, et al. Clinical outcomes of pedal artery angioplasty for patients with ischemic wounds: Results from the multicenter RENDEZVOUS registry. JACC Cardiovasc Interv. 2017;10:79–90.
26.
ShahSMBortnickABertrandOF, et al. Transpedal vs. femoral access for peripheral arterial interventions-A single center experience. Catheter Cardiovasc Interv. 2019;93:1311–1314.
27.
ChinCYMaeharaAFallK, et al. Imaging comparisons of coregistered native and stented coronary segments by high-definition 60-MHz intravascular ultrasound and optical coherence tomography. JACC Cardiovasc Interv. 2016;9:1305–1306.
28.
ArmstrongEJAlamSHenaoS, et al. Multidisciplinary care for critical limb ischemia: current gaps and opportunities for improvement. J Endovasc Ther. 2019;26:199–212.
29.
MizobuchiKJujoKMinamiY, et al. The baseline nutritional status predicts long-term mortality in patients undergoing endovascular therapy. Nutrients. 2019;11:1745.
30.
KatsanosKKitrouPSpiliopoulosS, et al. 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. 2016;23:851–863.
31.
ZellerTBaumgartnerIScheinertD, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64:1568–1576.
32.
MustaphaJABrodmannMGeraghtyPJ, et al. Drug-coated vs uncoated percutaneous transluminal angioplasty in infra-popliteal arteries: six-month results of the Lutonix BTK Trial. J Invasive Cardiol. 2019;31:205–211.
33.
SiablisDKitrouPM, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014;7:1048–1056.
34.
BrodmannMHoldenAZellerT.Safety and feasibility of intravascular lithotripsy for treatment of below-the-knee arterial stenoses. J Endovasc Ther. 2018;25:499–503.
35.
AdamsGShammasNMangalmurtiS, et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020;27:473–481.
