Clinical expert consensus document on standards for lower extremity artery disease of imaging modality from the Japan Endovascular Treatment Conference

Fujihara, Masahiko; Kurata, Naoya; Yazu, Yuko; Mori, Shinsuke; Tomoi, Yusuke; Horie, Kazunori; Nakama, Tatsuya; Tsujimura, Takuya; Nakata, Aya; Iida, Osamu; Shinjo, Samuel Katsuyuki; Torii, Sho; Ishihara, Takayuki; Azuma, Nobuyoshi; Urasawa, Kazushi; Ohki, Takao; Komori, Kimihiro; Kichikawa, Kimihiko; Yokoi, Hiroyoshi; Nakamura, Masato

doi:10.1007/s12928-022-00875-x

Cited by 31 publications

(18 citation statements)

References 39 publications

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“…After DCB treatment, the image slices were analyzed to evaluate the MLA. All parameters were analyzed by participating specialists at each hospital certified by the academic society in Japan according to the current clinical expert consensus document of the EVT imaging 16) .…”

Section: Ivus Analysis and Measurementmentioning

confidence: 99%

“…Third, angiographic and IVUS findings, baseline characteristics, and clinical events were not evaluated by an external core laboratory. However, to reduce the bias of measuring the parameters, the observers assessed the findings according to the current consensus document 16) . Fourth, the current guideline recommends bypass surgery for patients with FP lesion longer than 25 cm 4) ; however, 16.0% of patients with long FP lesions underwent EVT in this study because of poor general condition and comorbidities.…”

Section: Study Limitationsmentioning

confidence: 99%

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Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Horie

Takahara

Nakama³

et al. 2023

JAT

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Aim: This study aimed to reveal whether a larger postprocedural minimum lumen area (MLA) would reduce restenosis risk after endovascular therapy (EVT) using drug-coated balloons (DCBs) in femoropopliteal (FP) lesions. Methods: This retrospective, nonrandomized, single-arm, and multicenter registry analyzed patients with FP lesions undergoing intravascular ultrasound (IVUS)-guided EVT with DCB between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. The association between IVUS-based MLA and restenosis risk was investigated using a generalized propensity score (GPS) method to address imbalance of baseline covariates. The dose-response function of IVUS-measured MLA for restenosis risk was developed using the GPS-adjusted Cox proportional hazards regression model. Results:This study enrolled consecutive 489 patients with 595 lesions undergoing DCB treatment. The median MLA (interquartile range) was 13.20 (9.90-16.91) mm 2 . Kaplan-Meier estimates showed that freedom from restenosis was 84.4% at 1 year. The GPS-adjusted dose-response function showed that MLA was inversely associated with restenosis risk. The upper limit of 95% confidence interval (CI) of the slope was lower than 0 between 10.6 and 17.0 mm 2 of MLAs. The 1-year cumulative incidence of restenosis was estimated to be 9.8% (95% CI, 5.8%-13.7%) for the 3rd quartile of MLA (16.91 mm 2 ) versus 18.5% (12.3%-24.1%) for the 1st quartile (9.90 mm 2 ), with a hazard ratio of 0.51 (95% CI, 0.39-0.67; p＜0.001). Conclusions:The present GPS analysis suggested that larger IVUS-measured MLA might be associated with lower risk of 1-year restenosis after DCB treatment for FP lesions.

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Section: Ivus Analysis and Measurementmentioning

confidence: 99%

Section: Study Limitationsmentioning

confidence: 99%

Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Horie

Takahara

Nakama³

et al. 2023

JAT

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“…Angioscopic images were analyzed for each stent to determine: (1) the dominant degree of neointimal coverage over the stent; (2) the heterogeneity of neointimal coverage; (3) the yellow color grade of the stented segment; and (4) thrombus adhesion in the stented segment. Neointimal coverage over the stent was classified into 4 grades, as described previously: 10 Grade 0, stent struts fully visible, similar to the status observed immediately after implantation; Grade 1, stent struts bulging into the lumen, although covered, still visible; Grade 2, stent struts embedded in the neointima, but visible; and Grade 3, stent struts fully embedded and invisible on angioscopy.…”

Section: Angioscopic Analysis and Outcome Measuresmentioning

confidence: 99%

“…Heterogeneity of neointimal coverage has been previously defined. 10 Briefly, neointimal coverage was evaluated throughout the entire stented segments, and was judged as heterogeneous when differences in the neointimal coverage grade became apparent. Struts located in the overlapped segment were excluded from grading, as were stent edges.…”

Section: Angioscopic Analysis and Outcome Measuresmentioning

confidence: 99%

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions

Tsujimura

Iida

Ishihara

et al. 2023

Circ J

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After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study was an investigatorinitiated clinical study that examined the clinical outcomes of FP-DES for real-world femoropopliteal lesions and found an acceptable and consistent 1-year primary patency. 6 However, with regard to the morphology of restenosis after FP-DES implantation, the frequency of totally occlusive restenosis (including acute stent thrombosis) was remarkably high at 71.1%. Another study evaluating 2-year clinical outcomes after FP-DES implantation found a gradual reduction in primary patency and an increased frequency of vessel wall degeneration from 1 to 2 years of follow-up. 7 Based on these clinical scenarios, it is clinically important to determine the intravascular status after FP-DES implantation and whether the artery is optimally healed. With the development of antirestenotic devices, endovascular therapy (EVT) has been established as an option for the treatment of femoropopliteal lesions in patients with symptomatic lower extremity arterial disease. 1-3 IMPERIAL (A randomIzed trial coMParing the ELUVIA dRug-elutIng stent versus Zilver PTX stent for treatment of superficiAL femoral and/or proximal popliteal arteries) compared a fluoropolymer-based drug-eluting stent (FP-

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“…The treatment strategies were classified into plain old balloon angioplasty (POBA), bare nitinol stent (BNS), DCB, DES, CS, and spot bare nitinol stent implantation with POBA (spot). Technical success was defined as < 30% residual stenosis without flow-limiting severe dissection after stent implantation or after the balloon angioplasty strategy (Fujihara et al 2022). Follow-up clinical evaluations were conducted six and 12 months after the procedure.…”

Section: Endovascular Therapy Procedures and Follow-upmentioning

confidence: 99%

Intravascular ultrasound-based decision tree model for the optimal endovascular treatment strategy selection of femoropopliteal artery disease—results from the ONION Study-

Yazu

Fujihara²,

Takahara³

et al. 2022

CVIR Endovasc

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Background The role of catheter-based imaging in peripheral interventions for lower extremity artery disease (LEAD) has increased with percutaneous interventions. To clarify the relation between intravascular ultrasound (IVUS) information and procedure selection strategy for endovascular treatment therapy (EVT) of the femoropopliteal artery in the real-world clinical settings wherein new endovascular technologies (NETs), including drug-coated balloon (DCB), drug-eluting stent (DES), and covered stent-graft (CS). Our retrospective multicenter analysis examined symptomatic 970 patients treated by EVT for de novo femoropopliteal lesions with IVUS guidance. The decision tree analysis was performed retrospectively to determine the association of IVUS and angiography parameters with the strategy selection of endovascular procedures. We divided the study population according to the developed tree, and identified the most popular strategy selection in each subgroup. We finally examined whether the restenosis risk would be different among respective subgroups of the tree. Results During the study periods, plain old balloon angioplasty, DCB, and bare nitinol stent were most frequently selected (25.3%, 23.9%, and 23.8%, respectively). The drug-eluting stent (DES), covered stent (CS), and spot stent strategies were used in 7.3%, 11.5%, and 8.1%. NETs had the lowest restenosis risk in the overall population. The decision tree had a depth of six branches and divided the patients into 11 subgroups by IVUS and angiography parameters. The restenosis rate was similarly low among these 11 subgroups when the most popular NET in each subgroup was selected (P = 0.94). Conclusions The use of IVUS data along with angiography data would standardize the selection of endovascular procedures and can improve patency outcomes if NETs are used properly.

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Clinical expert consensus document on standards for lower extremity artery disease of imaging modality from the Japan Endovascular Treatment Conference

Cited by 31 publications

References 39 publications

Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions

Intravascular ultrasound-based decision tree model for the optimal endovascular treatment strategy selection of femoropopliteal artery disease—results from the ONION Study-

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