Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions

Horie, Kazunori; Tanaka, Akiko; Taguri, Masataka; Inoue, Naoto

doi:10.1177/1526602820914618

Cited by 17 publications

(12 citation statements)

References 29 publications

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“…Vessel preparation with special balloons, as compared to conventional balloons, has recently been reported to be useful in achieving a larger acute gain in calcified lesions. 23 However, our results suggested that a larger acute gain might not directly improve vascular patency after DCB treatment of calcified lesions, and thus, careful postintervention follow-up is necessary.…”

Section: Discussionmentioning

confidence: 68%

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions

et al. 2021

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Purpose: Drug-coated balloons (DCBs) are commonly used for endovascular treatment of femoropopliteal lesions. Here, we employed intravascular ultrasound (IVUS) to investigate the predictors of restenosis after DCB treatment. Methods: This retrospective and single-center study was performed to examine 1-year primary patency after DCB treatment and to identify the risk factors for restenosis by analyzing clinical characteristics, angiographic findings, and IVUS measurements. We included 111 consecutive patients undergoing DCB treatment for de novo femoropopliteal lesions at our hospital from July 2018 to March 2020. Results: The primary patency rate was found to be 80.0% at 1 year. The Cox proportional hazard multivariate analysis revealed that restenosis was independently associated with chronic total occlusion (CTO; p < 0.001), circumferential calcification (p = 0.023), and smaller postprocedural minimum lumen area (MLA; p = 0.036). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of postprocedural MLA to prevent restenosis was 12.7 mm2, with an area under the curve of 0.774 (p< 0.001). The multivariate analysis indicated that patients with a postprocedural MLA below 12.7 mm2 (n = 44) had a significantly smaller distal reference vessel size (p < 0.001) compared to those with a postprocedural MLA over 12.7 mm2 (n = 67). Conclusions: Restenosis after DCB treatment was shown to correlate with CTO, circumferential calcification, and postprocedural MLA as evaluated by IVUS. Moreover, smaller vessel sizes might represent a particular challenge to the DCB strategy due to the difficulty of restoring a sufficient postprocedural lumen area by balloon dilatation.

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Section: Discussionmentioning

confidence: 68%

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions

et al. 2021

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“…Furthermore, this study found that the severity of calcification, as graded by the Peripheral Artery Calcium Scoring System, CTOs, and long lesions did not impact technical success, suggesting that the scoring element of the balloons used in this study was effective in treating complex lesions, consistent with the results of a previous study. 9 Drug-coated balloons (DCBs) have consistently demonstrated improved efficacy compared with standard balloon angioplasty in treating femoropopliteal lesions. [1][2][3] As such, DCB angioplasty is recommended as the first-line treatment for femoropopliteal lesions instead of uncoated balloon angioplasty.…”

Section: Discussionmentioning

confidence: 99%

Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions

Haraguchi¹,

Tsujimoto²,

Otake³

et al. 2023

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Combination angioplasty with paclitaxel-coated balloons (PCBs) and conventional scoring balloons for femoropopliteal lesions has demonstrated satisfactory results, even for complex lesions. The UltraScore balloon (Becton Dickinson, New Jersey, USA), which has a maximum length of 300 mm, has two longitudinal 0.010-inch stainless steel wires and is a new treatment option for complex femoropopliteal lesions. However, no studies have evaluated the effect of the UltraScore balloon on femoropopliteal lesions. This study aimed to compare the clinical efficacy of angioplasty over a six-month period using UltraScore balloons versus conventional scoring balloons for the treatment of atherosclerotic femoropopliteal lesions with PCBs. METHODSA retrospective single-center observational study enrolled 272 patients who underwent PCB angioplasty combined with an UltraScore balloon (n = 58) or conventional scoring balloon (n = 214) without bailout stenting. Propensity score matching was used to minimize intergroup differences in baseline characteristics, and six-month outcomes were compared between the two groups. The primary endpoint was a technical success (i.e., residual angiographic stenosis of <30% with non-severe dissection). The secondary endpoints were the incidences of periprocedural complications, restenosis, and target lesion revascularization (TLR). RESULTSAfter propensity score matching, 50 matched pairs of patients were selected for analysis. The Ultra-Score group had a significantly longer vessel length (192.8 ± 94.9 versus 36.6 ± 7.9 mm, P < 0.001), a lower frequency of non-compliant balloon (26.0% versus 56.0%, P = 0.002), and a smaller PCB diameter (5.32 ± 0.65 versus 5.66 ± 0.52 mm, P = 0.002) compared with the scoring group. The primary endpoint of technical success was significantly higher in the UltraScore group than in the scoring group (76.0% versus 56.0%, P = 0.035). There were no significant differences in periprocedural complications (4.0% versus 2.0%, P = 0.562), six-month restenosis (4.0% versus 8.0%, P = 0.339), and TLR (2.0% versus 4.0%, P = 0.500) between both groups. The multivariate logistic regression analysis showed that UltraScore use was independently associated with an increase in technical success (odds ratio: 2.58; 95% confidence interval: 1.05-6.36, P = 0.040). CONCLUSIONThe use of an UltraScore balloon during PCB angioplasty for femoropopliteal lesions significantly improved technical success compared with conventional scoring balloons. UltraScore use was an independent predictor of technical success, indicating its potential advantages in peripheral intervention procedures. KEYWORDSBalloon angioplasty, endovascular treatment, UltraScore balloon, conventional scoring balloon, cutting balloon, drug-coated balloon, femoropopliteal lesions, peripheral artery disease You may cite this article as: Haraguchi T, Tsujimoto M, Otake R, Kashima Y, Sato K, Fujita T. Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus convent...

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“…Some would suggest that cutting balloons, which longitudinally score the vessel, are more effective than any others, as they better prepare the vessel prior to stenting and thus help to reduce restenosis rates (Lee et al, 2002). However, some studies have shown that cutting balloons are not effective for TASC II type D lesions (Horie et al, 2020). Therefore, by creating a biomimetic with calcium deposits printed in a ceramic material, which more closely resembles the mechanical properties of true CTO calcification, there is potential to further investigate the interactions of current cutting balloons with severe calcification and improve their design so that they may be utilised for clinical treatment of such lesions in future.…”

Section: Discussionmentioning

confidence: 99%

A method of characterising the complex anatomy of vascular occlusions and 3D printing biomimetic analogues

et al. 2022

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Chronic total occlusions (CTOs) occur in approximately 40% of individuals with symptomatic peripheral arterial disease and are indicative of critical limb ischaemia. Currently, few medical devices can effectively treat CTOs long‐term, with amputation often required. This is due to a lack of knowledge of CTO anatomy, making device design and testing difficult. This study is a proof‐of‐concept study, which aimed to develop a workflow for further characterising the complex multi‐material anatomy of CTOs and creating 3D models of CTO components, which may be useful in producing a vascular CTO biomimetic for device testing. Here, we establish such a workflow using samples of atheromatous plaques. We focus on a high‐resolution, non‐destructive microcomputed tomography (μCT) technique which enables visualisation of occlusion anatomy at a greater resolution than computed tomography angiography (CTA), which is the typical modality used for CTO clinical visualisation. Four arteries (n = 2 superficial femoral; n = 2 popliteal) with evidence of atheromatous plaques were cut into 8 cm segments, which were then stained with iodine and scanned at low resolution, with calcified regions rescanned at high resolution. Resulting files were manually segmented to generate 3D models, which were then 3D printed in resin using a stereolithography printer to produce parts suitable for creating a biomimetic. In total, μCT files from three arterial segments (n = 2 high resolution, n = 1 low resolution) were deemed suitably calcified for segmentation, and thus were segmented to produce 3D models. 3D models of the arterial wall, intima and atheromatous calcium deposits from a high‐resolution popliteal artery scan were successfully 3D printed at several scales. While this research is at an early stage, it holds great promise. The workflow for segmentation and 3D printing various components of an atheromatous plaque established here is replicable and uses software and equipment which are accessible to research laboratories in both academia and industry. The ability to print detailed models on a desktop 3D printer is unprecedented and can be improved further, which is promising for future development of biomimetics with multi‐material detail of both soft tissue and calcified components of a vascular occlusion. Indeed, this workflow provides a solid foundation for future studies of CTO anatomy and the creation of true, multi‐material CTO biomimetics. Such biomimetics may enable the development of improved interventional devices, as they would mimic the general in vivo CTO environment. As this method cannot be applied in vivo, we cannot yet produce patient‐specific biomimetics, however, these analogues would still be important in device development, which would improve patient outcomes in critical limb ischaemia.

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Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions

Cited by 17 publications

References 29 publications

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions

Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions

A method of characterising the complex anatomy of vascular occlusions and 3D printing biomimetic analogues

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