balloon angioplasty
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Author(s):  
Cynthia B. Zevallos ◽  
Mudassir Farooqui ◽  
Darko Quispe‐Orozco ◽  
Alan Mendez‐Ruiz ◽  
Andres Dajles ◽  
...  

Background Despite thrombectomy having become the standard of care for large‐vessel occlusion strokes, acute endovascular management in tandem occlusions, especially of the cervical internal carotid artery lesion, remains uncertain. We aimed to compare efficacy and safety of acute carotid artery stenting to balloon angioplasty alone on treating the cervical lesion in tandem occlusions. Similarly, we aimed to explore those outcomes’ associations with technique approaches and use of thrombolysis. Methods and Results We performed a systematic review and meta‐analysis to compare functional outcomes (modified Rankin Scale), reperfusion, and symptomatic intracranial hemorrhage and 3‐month mortality. We explored the association of first approach (anterograde/retrograde) and use of thrombolysis with those outcomes as well. Two independent reviewers performed the screening, data extraction, and quality assessment. A random‐effects model was used for analysis. Thirty‐four studies were included in our systematic review and 9 in the meta‐analysis. Acute carotid artery stenting was associated with higher odds of modified Rankin Scale score ≤2 (odds ratio [OR], 1.95 [95% CI, 1.24–3.05]) and successful reperfusion (OR, 1.89 [95% CI, 1.26–2.83]), with no differences in mortality or symptomatic intracranial hemorrhage rates. Moreover, a retrograde approach was significantly associated with modified Rankin Scale score ≤2 (OR, 1.72 [95% CI, 1.05–2.83]), and no differences were found on thrombolysis status. Conclusions Carotid artery stenting and a retrograde approach had higher odds of successful reperfusion and good functional outcomes at 3 months than balloon angioplasty and an anterograde approach, respectively, in patients with tandem occlusions. A randomized controlled trial comparing these techniques with structured antithrombotic regimens and safety outcomes will offer definitive guidance in the optimal management of this complex disease.


2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.


Author(s):  
Hoang Van

Background: Chronic lower extremity arterial disease, mostly caused by atherosclerotic etiology, has been increasing in recent years. Currently, there has been a shift in the treatment chronic lower extremity arterial disease from open surgical treatment to endovascular intervention. According to the TASC classification, surgical treatment is preferred for patients with complex lesions of TASC C, D but recent studies have shown that endovascular intervention has had good results for high-grade lesions. Objective: To determine the efficacy, short-term results of endovascular intervention in patients with symptomatic lower extremity artery disease Methods: From January to December 2021, the cross sectional, descriptive study was carried out on 38 patients with lower limb artery disease, treated by endovascular intervetion in Interventional Department, Hanoi Heart hospital. All patients were evaluated by clinical symptoms, ankle- brachial index and lesion characteristic before and after the intervention to determine the initial success Results: Majority of lesions belong to TASC II C and D (78,9%). Injured arteries can be isolated in the aortoiliac (21,1%), femoropopliteal (21,1%), below-knee artery (21,1%) or combine aortoiliac and femoropopliteal (10,5%), femoropopliteal and BTK (15,8%). The ankle- brachial index before and after the intervention respectively 0,57 and 0.83 (p<0,001). The technical successful rate was 94,7%. Balloon angioplasty and stent placement were in 21 patients (55,3%) and balloon angioplasty in 17 patients (44,7%). Post-procedural complications included stent thrombosis (2.6%), amputation (2.6%), pseudoaneurysm at the puncture site (2.6%). Conclusion: Endovascular intervention is a safe, effective, minimally invasive method in the treatment of chronic lower extremity arterial disease


2021 ◽  
pp. 112972982110670
Author(s):  
Tjun Y Tang ◽  
Shereen XY Soon ◽  
Charyl JQ Yap ◽  
Ru Yu Tan ◽  
Suh Chien Pang ◽  
...  

Background: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. Methods: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. Results: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients’ underlying co-morbidities. Conclusions: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.


2021 ◽  
pp. 112972982110667
Author(s):  
Alexandra M Riding ◽  
Ahmed Al-Nowfal ◽  
Siva Ramanarayanan ◽  
Oscar Swift ◽  
Suresh Mathavakkannan ◽  
...  

Aim: Percutaneous transluminal angioplasty (PTA) is a standard treatment for arteriovenous fistula (AVF) stenosis to preserve haemodialysis vascular access, promoting improved dialysis adequacy and better outcomes for those dependent on renal replacement therapy. Drug coated balloons (DCB) may help reduce the rate of neointimal hyperplasia and recurrent stenosis, but their use in femoropopliteal angioplasty has been associated with increased mortality at 2 and 5 year follow-up. This study aims to address the long-term safety of PTA for AVF stenosis with clinical correlation to participant co-morbidity and mortality. Methods: All patients undergoing PTA for AVF stenosis at a single centre between 2013 and 2017 were identified and grouped according to the use of DCB versus standard balloon angioplasty. All data was anonymised and correlated to verify independent predictors of mortality. Results: 481 (400 standard balloon; 81 DCB) procedures were performed in 313 patients (250 standard balloon; 63 DCB). Follow-up at 80 months did not show any difference in mortality ( p = 0.546). Multivariate analysis identified time on dialysis ( p < 0.001), age ( p = 0.001) and Charlson comorbidity index ( p = 0.02) as independent predictors of mortality. Conclusions: In this study, mortality was not associated with the use of DCBs, but was related to established factors of dialysis longevity, age and comorbidity.


2021 ◽  
pp. 112972982110670
Author(s):  
Shereen XY Soon ◽  
Ru Yu Tan ◽  
Suh Chien Pang ◽  
Charyl JQ Yap ◽  
Ankur Patel ◽  
...  

Background: Aim was to compare the safety and patency efficacy outcomes between Ranger™ paclitaxel-coated balloon (PCB)- versus conventional balloon angioplasty (POBA) in the treatment of haemodialysis access-related conduit stenosis. Methods: Retrospective single-centre, multi-investigator, consecutive, double-arm comparative cohort study. About 130 end-stage renal failure Asian patients with dysfunctional arteriovenous fistula (AVF) or arteriovenous graft underwent PCB or POBA fistuloplasty between November 2018 and June 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to PCB angioplasty. All patients received at least one antiplatelet agent for 3 months duration post procedure. Results: Mean age was 66.0 ± 10 years and 79/130 (61%) were males. PCB arm ( n = 65) versus POBA arm ( n = 65). Majority were AVFs circuits (122/130, 94%). Main indication for intervention was dropping access flow (98/130, 76%). About 172 lesions were treated (56% POBA, 44% PCB), and the juxta-anastomosis (JAS) was the main target lesion (87/172, 51%). There were no significant differences in safety outcomes (30-day adverse events, access thrombosis, abandoned AVF and death) between treatment groups. Mean time to target lesion reintervention (TLR) was longer in PCB-treated lesions (7.1 ± 2.7 vs 5.8 ± 3.2 months, p = 0.03), especially amongst recurrent lesions (7.3 ± 2.4 vs 5.7 ± 3.2, p = 0.02). Mean time to circuit reintervention was also longer in PCB-treated circuits (6.9 ± 2.8 vs 5.8 ± 3.7months, p = 0.04). There were 16 deaths (12%), all attributed to patient’s underlying comorbidities. Conclusions: Fistuloplasty with Ranger™ PCB for failing arteriovenous circuits in end-stage renal failure patients, is a safe and efficacious modality compared to POBA in terms of longer freedom from TLR.


2021 ◽  
Author(s):  
Liqiang Li ◽  
Zhu Tong ◽  
Shijun Cui ◽  
Lianrui Guo ◽  
Yongquan Gu

Abstract Background: Femoropopliteal (FP) Tosaka Class III in-stent restenosis (ISR) Lesions remain a significant clinical problem and optimal revascularization management including the use of drug-coated balloon (DCB) and debulking devices have the potential to improve the outcomes for these patients. However, few studies have been published comparing the debulking plus DCB with DCB alone in Tosaka III FP-ISR treatment. This study was to compare debulking plus DCB versus DCB alone for the treatment of Tosaka III FP-ISR lesions in patients.Methods: This was a single-center retrospective study of patients Tosaka III FP-ISR who underwent endovascular interventions of debulking plus DCB or DCB alone for Tosaka III FP-ISR lesions. One-year primary patency was the main outcome. Other outcome measures are 12-month freedom from clinical-driven target lesion revascularization (f-CD-TLR), technical success rate, and periprocedural complications.Results: A total of 70 patients with Tosaka III FP-ISR were included; 29 were treated with debulking plus DCB, in which 13 were treated with laser atherectomy (LA) plus DCB and 16 were treated with rotational atherectomy (RA) plus DCB. 41 were treated with DCB alone. Lesions in the debulking plus DCB group were significantly longer (16.45±4.40mm vs. 14.04±3.67mm, p=0.015). the 12-month primary patency was not significant different in the comparison of debulking+DCB with DCB group (75.9% vs. 73.2%, p=0.798). in the subgroup comparison, no significant difference was found in the LA+DCB and RA+DCB group (69.2% vs. 81.3%, p=0.544). There were also no significant differences in the group and subgroup comparison of 12-month f-CD-TLR, technical success rate, and periprocedural complications.Conclusions: Debulking plus DCB or DCB alone are both safe and effective for Tosaka III FP-ISR lesions. Although no significant difference was seen, lesions in the debulking+DCB group were significantly longer, suggesting that debulking plus DCB treatment has possible superiority for longer lesions than DCB alone management.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Suh Chien Pang ◽  
Ru Yu Tan ◽  
Edward Choke ◽  
Jackie Ho ◽  
Kiang Hiong Tay ◽  
...  

Abstract Background Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied. Methods/design This is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical. Discussion This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients. Trial registration ClinicalTrials.govNCT04409912. Registered on 1 June 2020


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