drug coated balloon
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2022 ◽  
Vol 3 (1) ◽  
Author(s):  
Jessica DeLong ◽  
Michael J. Ehlert ◽  
Bradley A. Erickson ◽  
Kaiser J. Robertson ◽  
Ramón Virasoro ◽  
...  

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P < 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P < 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.


2022 ◽  
Vol 8 ◽  
Author(s):  
Yuxi Li ◽  
Xinyan Wen ◽  
Bo Zheng ◽  
Ming Chen ◽  
Wei Ma ◽  
...  

Fibromuscular dysplasia (FMD) is the second common cause of renovascular hypertension. With the advent of endovascular therapy, angiography has become a diagnostic gold standard for FMD. Optical coherence tomography (OCT) by reflecting in vivo histology may improve diagnostic and classification accuracy. Renal fractional flow reserve (rFFR), measured by pressure guidewire, may distinguish the patients who may benefit from revascularization by identifying physiologically significant stenoses. However, the role of usage of both OCT and rFFR is not well-studied. We herein report a 17-year-old male with renovascular hypertension due to FMD. Angioplasty of drug-coated balloon (DCB) guided by OCT and FFR favorably achieved blood pressure (BP) control. In conclusion, the utility of both OCT and FFR may be useful for the appropriate selection of patients with renal FMD.


2022 ◽  
Vol 2022 ◽  
pp. 1-7
Author(s):  
Hengdao Liu ◽  
Hailong Tao ◽  
Xufei Han ◽  
Yang Lu ◽  
Xiaofei Xue ◽  
...  

Background. Drug-eluting stent (DES) plus drug-coated balloon (DCB) is a safe and effective treatment strategy for coronary artery bifurcation lesions, but there is no report about this strategy being used for left main (LM) bifurcation lesions. We aim to explore the efficacy and safety of DES plus DCB in the treatment of LM bifurcation lesions. Methods. A total of 100 patients diagnosed with LM bifurcation lesions by coronary angiography were retrospectively enrolled at our center from January 2018 to December 2019. They received either a two-stent strategy or a main branch (MB) stenting plus side branch (SB) DCB strategy and were accordingly divided into the 2-DES group and the DES + DCB group. Patients treated with DES + DCB were compared with a cohort of matched patients treated with a 2-DES strategy. Clinical data was collected and quantitative coronary analysis was performed. Results. For immediate postoperative angiography, though the two groups had no differences in the minimal luminal diameter (MLD) and luminal stenosis of MB, the DES + DCB group had significantly lower SB ostial MLD and a higher degree of residual lumen stenosis than the 2-DES group ( P < 0.05 ). At the time of follow-up, the SB ostial MLD of the DES + DCB group was higher than that of the 2-DES group, but lumen stenosis, late lumen loss (LLL), and LLL at the distal end of the left MB were all smaller than those of the 2-DES group ( P s < 0.05 ). Furthermore, the incidence of lumen restenosis and MACE between the two groups had no significance. Conclusion. The combination of DES and DCB is relatively safe and effective for the treatment of LM bifurcation lesions, and this strategy seems to have advantages in reducing LLL at the SB ostium.


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.


2022 ◽  
Vol 11 (2) ◽  
pp. 299
Author(s):  
Sunwon Kim ◽  
Jong-Seok Lee ◽  
Yong-Hyun Kim ◽  
Jin-Seok Kim ◽  
Sang-Yup Lim ◽  
...  

Balloon-injured coronary segments are known to harbor abnormal vasomotion. We evaluated whether de novo coronary lesions treated using drug-coated balloon (DCB) are prone to vasospasm and how they respond to ergonovine and nitrate. Among 132 DCB angioplasty recipients followed, 89 patients underwent ergonovine provocation test at 6–9 months follow-up. Within-subject ergonovine- and nitrate-induced diameter changes were compared among three different sites: DCB-treated vs. angiographically normal vs. segment showing prominent vasoreactivity (spastic). No patient experienced clinically refractory vasospastic angina or symptom-driven revascularization during follow-up. Ergonovine induced vasospasm in seven patients; all were multifocal spasm either involving (n = 2) or rather sparing DCB-treated segments (n = 5). None showed focal spasm that exclusively involved DCB-treated lesions. Among 27 patients with vasospastic features, DCB-treated segments showed less vasoconstriction than spastic counterparts (p < 0.001). A total of 110 DCB-treated lesions were analyzed to assess vasomotor function. Vasomotor function, defined as a combined constrictor and dilator response, was comparable between DCB-treated and angiographically normal segments (p = 0.173), while significant differences were observed against spastic counterparts (p < 0.001). In our study, DCB-treated lesions were not particularly vulnerable to vasospasm and were found to have vasomotor function similar to angiographically normal segments, supporting safety of DCB-only strategy in treating de novo native coronary lesions.


2022 ◽  
Vol 52 ◽  
Author(s):  
Jung-Joon Cha ◽  
Jae-Hwan Lee ◽  
Young-Guk Ko ◽  
Jae-Hyung Roh ◽  
Yong-Hoon Yoon ◽  
...  

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Zeki Temiztürk ◽  
Davut Azboy ◽  
Fevzi Sarper Türker

Purpose. Native arteriovenous fistulas (AVFs) are the most effective vascular access (VA) for haemodialysis. We aimed to evaluate the results of balloon angioplasty (fistuloplasty) from drainage vein performed for the treatment of AVF dysfunction in haemodialysis patients and examine potential patient and AVF-associated factors that might affect such results. Methods. This is a nonrandomized, retrospective, and single-centred study. A total of 105 balloon fistuloplasties were performed for dysfunctional AVFs of 82 haemodialysis patients. Patients were treated with a drug-coated balloon according to standard procedures. Evaluations were performed by physical examinations and if needed by color Doppler imaging in every 6 months. The primary endpoint was patency by balloon fistuloplasty. Patency was evaluated clinically by detecting the thrill in AVF and by the adequacy of the dialysis. Multidimensional scaling (MDS) technique was used as a method for the statistical analysis. Results. The success of the procedure after the first attempt was 85.3% with 70 patients. Patency in the 6th, 12th, 18th, and 24th months were 63 (76.8%), 60 (73.1%), 53 (64.6%), and 44 (54%), respectively. The procedure was considered successful when the thrill was detected in AVF and when dialysis was adequate. The statistical analysis by MDS revealed that patients’ age was the most effective factor acting on the procedure success followed by the age of AVF. Other patient-associated and AVF-associated factors were not found as effective statistical evaluation. Conclusions. Haemodialysis through native AVFs with restored functionality contributes positively to the life span and the quality of life of the patient. Probably, advanced age and high fistula age are unfavourable factors leading to the development of neointimal hyperplasia and venous stenosis. Balloon fistuloplasty of the draining vein is an effective and safe method regardless of patient age and the age of AVF.


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