Purpose: The purpose of this study was to review the current literature of intravascular ultrasound (IVUS) use in real world cohorts inclusive of chronic limb threatening ischemia (CLTI) patients and compare the outcomes to patients imaged by angiography alone.
Methods: The systematic review was registered in Research Registry. A literature search was performed across 4 databases: PubMed, Medline/Embase, Cochrane Review, and Web of Science for eligible comparative studies. The primary outcomes examined were clinically driven target lesion revascularization (CD-TLR), amputation (including minor below the ankle and major above the ankle), all-cause mortality, limb salvage and mean balloon dilation. A random effects model was used when pooling outcomes to account for heterogeneity. Publication bias was determined using eggers test and illustrated on a funnel plot.
Main findings: Six studies were included in this review, with a total of 1883 subjects with Rutherford 1-6. Among the 1883 subjects, 940 had Rutherford 4-6. IVUS was used in 1294 subjects and angiography alone was used in 589 subjects. Pooled analysis determined no significant association in IVUS + angiography with CD-TLR (O.R = 1.43 [CI: 0.80, 2.58]), all-cause amputation (O.R = 0.63 [CI: 0.34, 1.17]), and all-cause mortality (O.R = 0.63 [CI: 0.34, 1.17]). Sub analysis of subjects with CLTI, Rutherford classes 4-6 showed an association between IVUS + angiography use with limb salvage at 1 year, O.R = 2.22 [1.24, 3.97].
Conclusion: The use of IVUS + angiography compared to angiography alone showed larger reference vessel diameter in both all-inclusive Rutherford classifications and the CLTI subset. The use of IVUS + angiography compared to angiography alone showed no difference in CD-TLR at 12 months, lower extremity amputation, and all-cause mortality for Rutherford 1-6. The use of IVUS + angiography compared to angiography alone in the CLTI subset analysis improved limb salvage.
Keywords: amputation; chronic limb threatening ischemia; intravascular ultrasound; limb salvage; peripheral artery disease; revascularization; stent.