Usefulness of the “Non-Slip Element” Percutaneous Transluminal Angioplasty Balloon in the Treatment of Femoropopliteal Arterial Lesions

2019 ◽  
Vol 27 (1) ◽  
pp. 102-108 ◽  
Author(s):  
Eiji Karashima ◽  
Shunsuke Yoda ◽  
Shioto Yasuda ◽  
Shota Kajiyama ◽  
Hiroyuki Ito ◽  
...  

Purpose: To evaluate a new scoring balloon, the non-slip element (NSE) percutaneous transluminal angioplasty (PTA) balloon, in the treatment of femoropopliteal lesions by comparing angiographic dissection patterns to those of a conventional balloon. Methods: This retrospective, single-center study included 71 symptomatic patients (mean age 77.4±8.8 years; 33 men) with de novo femoropopliteal lesions <20 cm long treated with balloon angioplasty between January 2017 and May 2018. Thirty-four patients were treated with 3 inflations of an NSE balloon and 37 patients were treated with a conventional balloon. Results: Severe dissections were fewer (8.8% vs 29.7%, p=0.027) and the total dissection length was shorter (11.5±12.8 vs 35.7±24.1 mm, p=0.027) in the NSE group. The bailout stenting rate was also lower in the NSE group (17.6% vs 40.5%, p=0.035). There were no significant differences between the groups regarding lesion length (70.3±50.4 vs 77.8±56.6 mm, p=0.28), inflation time (294±162 vs 353±179 seconds, p=0.08), or inflation pressure (10.6±5.0 vs 11.3±5.3 atm, p=0.31). Conclusion: Three NSE balloon inflations may reduce severe dissections induced by balloon angioplasty in femoropopliteal lesions.

2020 ◽  
Vol 27 (3) ◽  
pp. 481-491
Author(s):  
Kazunori Horie ◽  
Akiko Tanaka ◽  
Masataka Taguri ◽  
Naoto Inoue

Purpose: To investigate the efficacy of scoring balloons for immediate success of percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions. Materials and Methods: Between 2013 and 2019, 398 consecutive patients with de novo femoropopliteal lesions were treated using PTA in our hospital. The procedure success rate was compared among patients undergoing PTA with vs without scoring balloons after 1:1 propensity score matching on hemodialysis, TransAtlantic Inter-Society Consensus II classification, Peripheral Arterial Calcium Scoring System (PACSS) grade, lesion length, and use of intravascular ultrasound. Propensity matching produced 84 patients (mean age 73.4±8.3; 65 men) treated with scoring balloons and 84 patients (mean age 75.6±8.7; 56 men) treated with plain balloons. Kaplan-Meier analysis investigated patency after the procedure in both groups; estimates are given with the 95% confidence interval (CI). Results: Residual stenosis <30% was achieved more often (77.4% vs 57.1%, p=0.005) and severe arterial dissection occurred less frequently (16.7% vs 29.8%, p=0.043) in the scoring balloon group vs the plain balloon group, respectively. The rate of provisional stenting was significantly lower after scoring balloon use (13.3% vs 29.8%, p=0.008). Multivariable analysis revealed that use of scoring balloons (p<0.001) and prolonged inflation time (p<0.001) were independent predictors of successful angioplasty, whereas chronic total occlusion (p=0.005) and longer lesion length (p=0.005) were predictors of an unsuccessful procedure. Among 108 patients with PACSS 0–3 lesions in the matched population, Kaplan-Meier analysis showed better primary patency at 18 months in the scoring balloon group in the intention to treat analysis [68.6% (95% CI 53.5% to 80.6%) vs 43.0% (95% CI 28.7% to 58.5%), p=0.044]. Conclusion: Scoring balloons may be effective in restoring acute lumen gain and preventing severe arterial dissection in femoropopliteal lesions. Moreover, scoring balloons might be associated with better primary patency at 18 months in PACSS 0–3 lesions.


2017 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.


2019 ◽  
Vol 26 (4) ◽  
pp. 479-489 ◽  
Author(s):  
Ehrin J. Armstrong ◽  
Marianne Brodmann ◽  
David H. Deaton ◽  
William A. Gray ◽  
Michael R. Jaff ◽  
...  

Purpose: To systematically review the literature and extract information on the definitions, prevalence, implications, and treatment of dissections after infrainguinal balloon angioplasty, with a goal of summarizing current data and identifying gaps in knowledge to help direct future research. Materials and Methods: A systematic review was performed according to the PRISMA guidelines. Medline (PubMed), Scopus, and Cochrane CENTRAL databases were reviewed for prospective and retrospective studies reporting dissection identification, characterization, incidence, severity, and/or outcomes after infrainguinal balloon angioplasty up to January 30, 2019. The electronic search resulted in 288 studies. From these, 153 full-text articles were assessed, and 51 published from 1964 to 2018 were selected as relevant to this systematic review. Because of the significant between-study differences in lesion characteristics, reporting methods, and lack of core laboratory adjudication, the findings were summarized from each study, but the results were not pooled. Results: The mechanism of percutaneous transluminal angioplasty (PTA) consists of adventitial stretching, medial necrosis, and controlled dissection or plaque fracture. PTA-induced dissections can precipitate pathological high and low shear hemodynamic defects and have been implicated as a contributing factor in procedural complications as well as restenosis at the treatment site. The development of significant dissection after PTA often leads to the use of adjunctive therapies, including stent placement. Despite the ubiquitous nature of dissection after balloon angioplasty (incidence 7.4% to 84%), limited data are available to categorize dissections in the peripheral arteries and direct subsequent treatments to improve vessel patency. With the increased utilization of drug-coated balloon angioplasty, understanding the outcomes of postangioplasty dissection has become increasingly important, as the decision to treat dissections with additional strategies has therapeutic and economic implications. Conclusion: All post-PTA dissections in the femoropopliteal arteries may benefit from a treatment approach that ensures optimal hemodynamics with long-term durability in treated lesions. Further understanding the importance of postangioplasty dissections, along with the development of new technologies, will help optimize the patency of endovascular interventions.


2019 ◽  
Vol 26 (05) ◽  
Author(s):  
Amber Malik ◽  
Muhammad Tufail ◽  
Arz Muhammad

Objective: To evaluate the treatment success rate of percutaneous transluminal angioplasty (balloon angioplasty) for peripheral and central venous stenosis in hemodialysis patients. Study Design: Retrospective/observational study. Place and Duration of Study: Department of Cardiology, Shaikh Zayed Hospital Lahore from 1st January 2018 to 30th June 2018. Methods: Thirteen patients of both genders presenting during from two years of hemodialysis failure and ipsilateral arm and neck swelling followed by peripheral and central venous stenosis were included in this study. Patients ages were ranging from 25 to 70 years. Patient’s detailed history including hemodialysis treatment, age, sex, socio-economic status was examined after taking informed consent from the patients. Percutaneous transluminal angioplasty (PTA) was performed at all the patients. Procedural success rate was examined. Results: There were 9 (69.23%) patients were men and rest (13.77%) were women. 5 (38.46%) patients were ages between 25 to 45 years, 6 (46.15%) patients had an ages 46 to 65 years and 2 (15.38%) patients were ages greater than 65 years. 10 (76.92%) had rural residency. 40 % patients had income >30000 PKR. Location and severity of lesions was examined as brachiocephalic vein, subclavian vein, Axillary vein, basilica, cephalic and median cubtal vein in 1,3,2,3,3 and 1 patients respectively. We determine priority patency rate in central lesion PTA was 82.7%, 62% and 38% at 3, 6 and 12 months and priority patency rate in peripheral lesions PTA was 87%, 79.5% and 67.8% at 3, 6 and 12 months. Conclusion: It is concluded that percutaneous transluminal angioplasty (balloon angioplasty) procedure for treatment of central and peripheral venous stenosis in hemodialysis patients was safe and effective with no procedural complications.


2010 ◽  
Vol 141 (3) ◽  
pp. e51-e53 ◽  
Author(s):  
Masamichi Takano ◽  
Masanori Yamamoto ◽  
Daisuke Murakami ◽  
Hitoshi Takano ◽  
Kuniya Asai ◽  
...  

Vascular ◽  
2020 ◽  
Vol 28 (6) ◽  
pp. 747-755
Author(s):  
Alexander Lam ◽  
Adam Schwertner ◽  
James Katrivesis ◽  
Dayantha Fernando ◽  
Kari Nelson ◽  
...  

Objectives To compare perioperative outcomes related to atherectomy with percutaneous transluminal angioplasty versus percutaneous transluminal angioplasty alone for the treatment of lower extremity chronic limb threatening ischemia using a national patient database. Methods Patients with chronic limb threatening ischemia treated with atherectomy and percutaneous transluminal angioplasty or percutaneous transluminal angioplasty alone from 2011 to 2016 in the National Surgical Quality Improvement Program database were identified. Primary outcomes were major adverse limb events (30-day untreated loss of patency, major reintervention, major amputation) and major adverse cardiac events (cardiac arrest, composite outcome of myocardial infarction or stroke). Secondary outcomes included 30-day mortality, length of stay, and any unplanned readmission within 30 days. Multivariate regression analyses were performed to determine independent predictors of outcome. Propensity score matched cohort analysis was performed. A p-value <0.05 was considered statistically significant. Subgroup analyses of femoropopliteal and infrapopliteal interventions were performed. Results In total, 2636 (77.2%) patients were treated with percutaneous transluminal angioplasty and 778 (22.8%) were treated with atherectomy and percutaneous transluminal angioplasty. Multivariate analyses of the unadjusted cohort revealed no significant differences in major adverse cardiac events or major adverse limb events between the two groups ( p-value >0.05). Subgroup analysis of femoropopliteal interventions demonstrated a significantly decreased likelihood of untreated loss of patency in 30 days in the atherectomy group compared to the percutaneous transluminal angioplasty group (1.1% vs. 2.7%, respectively; p-value = 0.034), which persisted on propensity score matched analysis (1.1% vs. 3.1%, respectively; p-value = 0.026). Conclusion Atherectomy with balloon angioplasty of femoropopliteal disease provides a significant decrease in untreated loss of patency compared to balloon angioplasty alone.


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