Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: Bench test using a three-dimensional printer and computer simulation with the finite element method

Song, Xiaoyang; Adachi, Taiji; Kawase, Yoshiaki; Kimura, Takeshi; Saito, Naritatsu

doi:10.1007/s12928-020-00739-2

Cited by 9 publications

(5 citation statements)

References 11 publications

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“…At low pressure, cutting and inflating the balloon promoted more uniform angiectasis, reducing the risk of widespread air pressure injury and maximizing vascular resource protection. Cutting balloon angioplasty under low pressure can reduce the inflammatory response and the risks of cell proliferation and restenosis [ 31 ]. However, this study found that cutting balloon angioplasty and high-pressure angioplasty were not significantly different in terms of the technical and clinical success rates, possibly due to the heterogeneity among the studies and limited number of patients included.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of cutting balloon angioplasty versus high-pressure balloon angioplasty for the treatment of arteriovenous fistula stenoses in patients undergoing hemodialysis: Systematic review and meta-analysis

Pang,

Chang,

Chang

et al. 2024

PLoS ONE

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This systematic review and meta-analysis aimed to assess and compare the therapeutic outcomes of cutting balloon angioplasty and high-pressure balloon angioplasty for arteriovenous fistula stenosis in hemodialysis patients. All studies indexed in PubMed, Embase, and Cochrane Library Web of Science were retrieved. The retrieval deadline was July 15, 2023. Risk of bias 2.0 was used to evaluate the quality of the included studies. Revman 5.4 software was used for data analysis. This review included three studies and 180 patients, with 90 patients in the cutting balloon angioplasty group and 90 patients in the high-pressure balloon angioplasty group. The results of the meta-analysis suggested that compared with high-pressure balloon angioplasty, cutting balloon angioplasty can improve primary lesion patency rates of internal arteriovenous fistulas at 6 months (relative risk, 1.45; 95% confidence interval, 1.08–1.96; P = 0.01). However, there were no significant differences between the technical success rate (relative risk, 0.99; 95% confidence interval, 0.93–1.05; P = 0.72) and clinical success rate (relative risk, 1.01; 95% confidence interval, 0.95–1.07; P = 0.73). Therefore, cutting balloon angioplasty is likely to increase primary lesion patency rates at 6 months. However, more high-quality, large-sample, multicenter, randomized controlled trials are needed for further validation due to the limited number of included studies.

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Section: Discussionmentioning

confidence: 99%

Efficacy of cutting balloon angioplasty versus high-pressure balloon angioplasty for the treatment of arteriovenous fistula stenoses in patients undergoing hemodialysis: Systematic review and meta-analysis

Pang,

Chang,

Chang

et al. 2024

PLoS ONE

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“…Although some studies exist [4][5][6], the contact pressure when a balloon or stent is expanded in a blood vessel is not sufficiently clarified. Normal blood vessels rupture at several 100 kPa when fluid pressure is directly applied [18].…”

Section: Capacitance Change During Balloon Dilationmentioning

confidence: 99%

“…Contact pressure is a load that acts directly on the vessel wall, and it can serve as a useful indicator for understanding the relationships between device dilation conditions and actual expansion results or postoperative negative events. Therefore, the con tact force or pressure on a vessel wall was evaluated by numerical simulations [4,5]. In the experimental method, flexible film sensors are used for force or pressure evalua tion [6,7].…”

Section: Introductionmentioning

confidence: 99%

Experimental study on the effects of dielectric layer thickness and elastic modulus on the performance of flexible capacitive sensor films

Moriwaki,

Nakano

2023

J Biorheol

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A stenosed blood vessel with a calcified part has complex shape and deformation properties. When using a catheter device in the blood vessel, a large deformation occurs, so the sensor needs to be flexible, and film sensors are used for contact force and pressure measurements dur ing in vitro evaluations. Various flexible film sensors are available. However, capacitive sensors are widely used because of their simple structure and low power consump tion. When using a balloon catheter in a calcified vessel, wide range of contact pressure may act on blood vessels, such as poor contact (less than the order of 1 kPa) and stress concentration areas (more than the order of 100 kPa). In this study, the performance of a capacitive film sensor is investigated over a wide pressure range 1-1000 kPa by focusing on the thickness and elastic modulus of its dielec tric layer. The sensitivity of capacitance change is high for sensors with thin and soft dielectric layers. However, the sensor is considered to be more affected by creep deforma tion. The sensor can detect the contact pressure between the balloon catheter and the model vessel during balloon dilation. During the use of catheter devices through in vitro experi ments using flexible film sensors, quantitative mea surement of the load on blood vessels is useful for acquiring knowl edge for application in clinical device selection and mechan ical evaluation testing during new device development.

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“…MB create a discrete longitudinal incision in the atherosclerotic target coronary segment during balloon inflation. MB may reduce the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty balloons or noncompliant balloon catheters ( 8 , 9 ). Nevertheless, several trials have failed to demonstrate an advantage of MB over conventional balloon angioplasty, non-compliant, or super high-pressure balloon dilatation ( 8 , 10 , 11 ).…”

Section: Introductionmentioning

confidence: 99%

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

Leick

Rheude

Denne

et al. 2023

Front. Cardiovasc. Med.

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BackgroundThe aim of this two-center, all-comers registry was to compare the effectiveness and safety of intravascular lithotripsy (IVL) to that of modified balloon angioplasty (MB). MB angioplasty using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare MB with IVL.MethodsThe cohort included all patients treated by MB angioplasty or IVL between 2019 and 2021. The primary endpoint was strategy success (<20% residual stenosis). The secondary endpoint was long-term safety outcomes [cardiac death, acute myocardial infarction (AMI), target lesion failure/revascularization (TVR)]. Quantitative coronary angiography (QCA) was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.ResultsA total of n = 86 patients were treated by IVL and n = 92 patients by MB angioplasty. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; p = 0.001) in QCA. Weighted multivariable regression analysis revealed that IVL had a significant positive effect on reaching the primary endpoint of strategy success [odds ratio (OR) 24.58; 95% confidence interval (95% CI) 7.40–101.86; p = 0.001]. In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02–0.24; p = 0.001). During the follow-up period (450 days) there was no difference in cardiovascular mortality rate [IVL (n = 5) 2.8% vs. MB (n = 3) 1.7%; p = 0.129]. Patients with unstable angina at the time of the index procedure had the highest probability of cardiovascular death [hazard ratio (HR) 7.136; 95% CI 1.248–40.802; p = 0.027]. No differences were found in long-term rates of AMI (IVL 1.7% vs. MB 2.8%; p = 0.399; IVL HR 2.73; 95% CI 0.4–17.0; p = 0.281) or TVR (IVL 5.6% vs. MB 9%; p = 0.186; IVL HR 0.78; 95% CI 0.277–2.166; p = 0.626).ConclusionIVL leads to a significantly better angiographic intervention outcome compared to MB angioplasty in our cohort. During long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction, or target lesion failure/revascularization were observed.

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Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: Bench test using a three-dimensional printer and computer simulation with the finite element method

Cited by 9 publications

References 11 publications

Efficacy of cutting balloon angioplasty versus high-pressure balloon angioplasty for the treatment of arteriovenous fistula stenoses in patients undergoing hemodialysis: Systematic review and meta-analysis

Efficacy of cutting balloon angioplasty versus high-pressure balloon angioplasty for the treatment of arteriovenous fistula stenoses in patients undergoing hemodialysis: Systematic review and meta-analysis

Experimental study on the effects of dielectric layer thickness and elastic modulus on the performance of flexible capacitive sensor films

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

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