Comparison of Therapeutic Efficacy of Debulking Plus Drug-coated Balloon Angioplasty Versus Drug-coated Balloon Angioplasty Alone for Femoropopliteal Tosaka Class Iii in-stent Restenosis Lesions

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.

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Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Vascular ◽

10.1177/1708538120970817 ◽

2020 ◽

pp. 170853812097081

Author(s):

Aysen Y Engin ◽

Onur Saydam

Keyword(s):

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Primary Patency ◽

Rotational Atherectomy ◽

Secondary Patency ◽

Technical Success ◽

Technical Success Rate ◽

The Mean ◽

Drug Coated Balloon

Objectives The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. Methods Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. Results Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. Conclusions Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

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Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

Frontiers in Surgery ◽

10.3389/fsurg.2021.671849 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ming-Yuan Liu ◽

Wenrui Li ◽

Xiaobo Guo ◽

Zhiwen Zhang ◽

Bin Liu ◽

...

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Primary Patency ◽

Secondary Patency ◽

Single Center ◽

Technical Success ◽

Clinical Trial Registration ◽

Technical Success Rate ◽

Stent Restenosis ◽

In Stent Restenosis

Background: Studies investigating debulking devices with drug-coated balloons (DCBs) in the treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) are limited. We aimed to evaluate the safety and midterm outcome of percutaneous mechanical atherectomy plus thrombectomy (MATH) using the Rotarex®S (Straub Medical, Wangs, Switzerland) catheter followed by a DCB in the treatment of FP-ISR.Methods: This study was a single-center single-arm trial. Patients with symptomatic (Rutherford category 2–5) de novo restenosis lesions of FP-ISR were treated with MATH and subsequent DCB. From June 2016 to May 2018, 59 patients with FP-ISR were enrolled. The primary endpoint was target lesion revascularization (TLR) and changes in the Rutherford category of the target limb at 12 months. Secondary endpoints included primary and secondary patency at 12 months, technical success rate, major adverse events, and ankle-brachial index (ABI). Risk factors for TLR were analyzed using Cox proportional hazard model.Results: The average follow-up time was 33 ± 8 months. The rate of technical success was 88.1% (52/59). Nine patients received bailout stenting. The rate of freedom from TLR was 84.7% (50/59) at 1 year, the Rutherford category changed at 12 months were significantly improved from baseline (p < 0.01). The primary patency rates and the secondary patency at the 12-month follow-ups were 82.5 and 92.5%, respectively. The ABI changed at 12 months were significantly improved from baseline (p < 0.01). Global limb anatomic staging system (GLASS) classification III [hazard ratio (HR) 18.44, 95% CI (1.57–215.99), p = 0.020] and postoperative Rutherford classification ≥4 [HR 8.28, 95% CI (1.85–37.06), p = 0.006] were identified as independent predictors of TLR.Conclusion: Our preliminary data suggested that MATH using a Rotarex®S catheter combined with DCB angioplasty is a safe, minimally invasive, and effective treatment for FP-ISR with favorable, immediate, and midterm outcomes.Clinical Trial Registration:http://www.chictr.org.cn, identifier [ChiCTR2000041380].

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Drug-Coated Balloon for the Treatment of Femoropopliteal Tosaka Class III In-stent Restenosis Lesions

Frontiers in Surgery ◽

10.3389/fsurg.2020.616414 ◽

2021 ◽

Vol 7 ◽

Author(s):

Bihui Zhang ◽

Guochen Niu ◽

Ziguang Yan ◽

Yinghua Zou ◽

Xiaoqiang Tong ◽

...

Keyword(s):

Clinical Symptoms ◽

Ankle Brachial Index ◽

Primary Patency ◽

Lesion Length ◽

Efficacy And Safety ◽

Class Iii ◽

Stent Restenosis ◽

Drug Coated Balloon ◽

In Stent Restenosis

Background: To date, there have been few studies examining the efficacy and safety of drug-coated balloon (DCB) angioplasty in the treatment of Tosaka class III in-stent restenosis (ISR) lesions in the clinical setting. Therefore, this study aimed to investigate the clinical efficacy and safety of DCBs in patients with Tosaka class III ISR femoropopliteal lesions.Methods: This single-center study enrolled 28 femoropopliteal ISR Tosaka III patients who were treated by DCB angioplasty from September 2016 to September 2018. The patency, the freedom from target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints were analyzed during a 14-month follow-up period.Results: Out of the 28 patients, 32.1% presented with critical limb ischemia. The mean lesion length was 250.4 ± 93.9 mm. Technical success was achieved in all lesions (100%). Debulking devices were used in 50% of lesions, and bailout stents were performed in 3.6% of patients. Kaplan Meier estimates that the 14-month primary patency was 79.2% (95% CI 60.6–97.8%), whereas the freedom from TLR rate was 91.5% (95% CI 80.1–100%). Clinical symptoms improved by at least 1 Rutherford category in 82.1% of limbs. The ankle-brachial index (ABI) values improved from 0.51 ± 0.30 to 1.05 ± 0.22 at the final follow-up (P < 0.001). The rate of freedom from 30-day major adverse limb events (MALEs) was 100%. The mortality rate was 7.1%.Conclusion: These results suggested that the use of DCBs is safe and effective in treating femoropopliteal Tosaka class III ISR lesions.

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Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

The Journal of Vascular Access ◽

10.1177/11297298211070125 ◽

2022 ◽

pp. 112972982110701

Author(s):

Yunfeng Li ◽

Zhenwei Shi ◽

Yunyun Zhao ◽

Zhanjiang Cao ◽

Zhengli Tan

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Primary Patency ◽

Controlled Trials ◽

Technical Success ◽

Randomized Controlled ◽

All Cause Mortality ◽

Drug Coated Balloon

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.

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Serial Observations of In-Stent Restenosis Treated With Drug-Coated Balloon Angioplasty by Optical Coherence Tomography and Coronary Angioscopy

International Heart Journal ◽

10.1536/ihj.16-277 ◽

2017 ◽

Vol 58 (1) ◽

pp. 134-139 ◽

Cited By ~ 5

Author(s):

Nobuhiro Murata ◽

Tadateru Takayama ◽

Takafumi Hiro

Keyword(s):

Optical Coherence Tomography ◽

Balloon Angioplasty ◽

Optical Coherence ◽

Stent Restenosis ◽

Coronary Angioscopy ◽

Drug Coated Balloon ◽

In Stent Restenosis

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Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries: a meta-analysis

EuroIntervention ◽

10.4244/eij-d-16-00735 ◽

2017 ◽

Vol 13 (4) ◽

pp. 483-489 ◽

Cited By ~ 8

Author(s):

Salvatore Cassese ◽

Gjin Ndrepepa ◽

Sebastian Kufner ◽

Robert Byrne ◽

Daniele Giacoppo ◽

...

Keyword(s):

Balloon Angioplasty ◽

Meta Analysis ◽

Stent Restenosis ◽

Drug Coated Balloon ◽

In Stent Restenosis

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Long-term outcomes of tracheal stents removal under fluoroscopy guidance: comparison of tracheal fistulas with tracheal stenosis

10.21203/rs.2.24504/v1 ◽

2020 ◽

Author(s):

Yonghua Bi ◽

Jianzhuang Li ◽

Liangliang Bai ◽

Gang Wu ◽

Xinwei Han ◽

...

Keyword(s):

Success Rate ◽

Tracheal Stenosis ◽

Survival Rates ◽

Technical Success ◽

Technical Success Rate ◽

Stent Removal ◽

Total Incidence ◽

Significant Difference ◽

Routine Removal ◽

Fluoroscopy Guidance

Abstract Background: No study compared the techniques and complications of stent removal under fluoroscopy guidance for tracheal fistula and tracheal stenosis.Methods: We conducted a retrospective analysis of 152 patients who underwent fluoroscopy-guided stent removal from January 2011 to June 2017. Eighty-five patients underwent stent removal for tracheal fistula (TF group), and 67 patients for tracheal stenosis (TS group). All patients underwent tracheal CT scans before stent removal and during follow up. The technical success rate, complications, survival rate were compared between the two groups.Results: The technical success rate of stent removal was 98.9% and 97.4% for tracheal fistula and tracheal stenosis, respectively. Except for the routine removal for half of patients, excessive granulation tissue was the common indications for stent removal, which was found 142.1±25.9 days later for tracheal fistula, and 89.9±15.0 day for tracheal stenosis. The total incidence of complications was 21.1% and 22.4% for tracheal fistula and tracheal stenosis, respectively. One perioperative death of asphyxia was found in TF group, and 2 deaths in TS group. Recurrence of fistula or stenosis requiring stenting was the most comment complication in both groups. The 0.5-, 3-, 6-year survival rates were 90.3%, 59.6%, and 36.1% for TF group, and 80.4%, 75.7%, 75.7% for TS group.Conclusions: Fluoroscopic removal of tracheal stent is safe and effective for both tracheal fistula and tracheal stenosis, with no significant difference. Recurrence of fistula or stenosis requiring stenting was the most comment complication.

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Ultrasound-guided lung biopsy with coaxial technique: pleural contact length affects the occurrence of pneumothorax after first puncture

Japanese Journal of Radiology ◽

10.1007/s11604-021-01213-6 ◽

2021 ◽

Author(s):

Rinpei Imamine ◽

Takeshi Kubo ◽

Keizo Akuta ◽

Hisato Kobayashi ◽

Yoshiharu Yamamoto ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Success Rate ◽

Lung Biopsy ◽

Regression Tree ◽

Contact Length ◽

Classification And Regression Tree ◽

Technical Success ◽

Technical Success Rate ◽

Significant Difference ◽

Pleural Contact

Abstract Purpose To assess prebiopsy characteristics influencing the occurrence of pneumothorax after first puncture of ultrasound (US)-guided lung biopsy with coaxial technique. Materials and methods From January 2007 to September 2018, 180 peripheral lung lesions in 174 patients who underwent B-mode US-guided lung biopsy with coaxial technique at single institution were included in this study. Technical success was defined as the ability to make a diagnosis using the acquired sample with/without an adverse event of pneumothorax. Statistical analyses of prebiopsy characteristics were performed to identify the most important cutpoint and to evaluate the effect on diagnostic accuracy. Results Of the 180 lesions (mean size, 37 mm ± 26.2; mean pleural contact length, 38.2 mm ± 34.4), technical success rate was 97.2% (175/180 lesions) and diagnostic accuracy rate was 91.6% (165/180 lesions). Pneumothorax occurred immediately after first puncture for seven of 180 lesions. Classification and regression tree analysis and Fisher’s exact test showed the proportion of the pneumothorax immediately after first puncture was higher in lesions with pleural contact length less than 9.78 mm (p = 0.002). No significant difference was shown between the pneumothorax and non-pneumothorax after first puncture in technical success and final diagnosis success rate. Conclusion Pleural contact length affects the occurrence of pneumothorax after first puncture of US-guided lung biopsy with coaxial technique.

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Long-term outcomes of fluoroscopy-guided tracheal stents removal under fluoroscopy guidance: comparison of tracheal fistulas and tracheal stenosis

10.21203/rs.2.24504/v2 ◽

2020 ◽

Author(s):

Yonghua Bi ◽

Jindong Li ◽

Liangliang Bai ◽

Xinwei Han ◽

Jianzhuang Ren

Keyword(s):

Success Rate ◽

Tracheal Stenosis ◽

Survival Rates ◽

Technical Success ◽

Technical Success Rate ◽

Stent Removal ◽

Total Incidence ◽

Significant Difference

Abstract Background: Endoscopic removal is the most common method for removal of tracheal stents. Few studies have reported the technique of fluoroscopy-guided stent removal for tracheal fistula and tracheal stenosis. We aimed to study the safety and efficacy of fluoroscopy-guided stent removal as well as the optimal duration for stent usage.Methods: We conducted a retrospective analysis of 152 patients who underwent fluoroscopy-guided stent removal from January 2011 to June 2017. Reasons for stent implantation were tracheal fistula in 85 patients (TF group), and tracheal stenosis in 67 patients (TS group). All patients underwent tracheal CT scans before stent removal and during follow up. The technical success rate, complications, and survival rate were compared between the two groups.Results: The technical success rate of stent removal was 98.9% and 97.4%, respectively for the TF and TS group. Removal was routine for half of patients, and in the remainder, excessive granulation tissue was the common indications for stent removal, which was found after stenting at 142.1±25.9 days in the TF group, and at 89.9±15.0 day in the TS group. The total incidence of complications was 21.1% and 22.4%, respectively, for the TF and TS groups. Perioperative death occurred in one patient in the TF group, and two patients in the TS group. Recurrence of fistula or stenosis requiring re-stenting was the most comment complication in both groups. The 0.5-, 3-, 6-year survival rates were 90.3%, 59.6%, and 36.1% for TF group, and 80.4%, 75.7%, 75.7% for TS group.Conclusions: Fluoroscopic removal of tracheal stents is safe and effective for both tracheal fistula and tracheal stenosis, with no significant difference in outcomes. Recurrence of fistula or stenosis requiring re-stenting was the most common complication.

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