First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries

2021 ◽  
pp. 152660282110659
Author(s):  
Olaf Bakker ◽  
Yvonne Bausback ◽  
Tim Wittig ◽  
Daniela Branzan ◽  
Sabine Steiner ◽  
...  
Keyword(s):  
Lower Limb ◽  
De Novo ◽  
Target Lesion ◽  
Lesion Length ◽  
Minor Bleeding ◽  
Technical Success ◽  
Entry Site ◽  
Chronic Total Occlusions ◽  
Technical Success Rate ◽  
Tibial Arteries

Purpose: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. Materials and Methods: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. Results: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). Conclusion: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

scholarly journals World’s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study

2021 ◽  
pp. 152660282110074
Author(s):  
Tjun Yip Tang ◽  
Charyl Yap ◽  
Shereen Xue Yun Soon ◽  
Sze Ling Chan ◽  
QingWei Shaun Lee ◽  
...  
Keyword(s):  
Renal Failure ◽  
Clinical Success ◽  
Target Lesion ◽  
Lesion Length ◽  
Success Rates ◽  
Technical Success ◽  
Free Survival ◽  
End Stage Renal Failure ◽  
Technical Success Rate ◽  
End Stage

Purpose: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. Materials and Methods: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). Results: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (p<0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively. Conclusions: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.

scholarly journals PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries

2018 ◽  
Vol 26 (1) ◽  
pp. 18-25 ◽  
Author(s):  
Andrew Holden ◽  
Andrew Hill ◽  
Andrew Walker ◽  
Brendan Buckley ◽  
Stephen Merrilees ◽  
...  
Keyword(s):  
De Novo ◽  
Balloon Catheter ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
The Core ◽  
Safety Endpoint ◽  
Exciting Potential ◽  
Primary Safety Endpoint

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Extravascular Recanalization of Chronic Total Occlusions

2018 ◽  
Author(s):  
S. Lowell Kahn
Keyword(s):  
Lower Extremity ◽  
Success Rate ◽  
Technical Failure ◽  
Technical Success ◽  
Contrast Injection ◽  
True Lumen ◽  
Chronic Total Occlusions ◽  
Technical Success Rate ◽  
The Wire

Subintimal revascularization is a mainstay of therapy for lower extremity interventions. This stems from the realization that true lumen traversal is not always possible, subintimal revascularization has a high technical success rate, and the subintimal space may confer advantages over a heavily calcified true lumen. Most commonly in the tibial vasculature, there are times when subintimal recanalization is not possible because the wire and catheter may leave the subintimal plane and enter the periadventitial tissue. Although this is not intentional, exit from the vessel historically results in a technical failure because future passes of the wire and catheter are likely to follow suit, as evidenced by extravasation on contrast injection. This chapter describes two techniques to salvage this scenario and accept an extravascular tract for revascularization: the Outback® extravascular revascularization technique and the percutaneous gun-sight extravascular revascularization technique.

scholarly journals Tibiopedal and distal femoral retrograde vascular access for challenging chronic total occlusions: predictors for technical success, and complication rates in a large single-center cohort

2020 ◽  
Vol 31 (1) ◽  
pp. 535-542
Author(s):  
Gerd Grözinger ◽  
Jan Hallecker ◽  
Ulrich Grosse ◽  
Roland Syha ◽  
Dominik Ketelsen ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Success Rate ◽  
Vascular Access ◽  
Chronic Total Occlusion ◽  
Lesion Length ◽  
Complication Rates ◽  
Technical Success ◽  
Total Occlusion ◽  
Femoral Access ◽  
Technical Success Rate

Abstract Objective To evaluate the safety and effectiveness of tibiopedal and distal femoral access for retrograde crossing of chronic total occlusion (CTO) in Rutherford stage III to VI peripheral arterial occlusive disease, and to determine factors that correlate with technical success. Material and methods One hundred seventy-one consecutive patients were included in this retrospective study. Rutherford stages were III, IV, and V/VI in 24%, 8%, and 67% of patients. Inclusion criteria were CTO at the superficial femoral (SFA), popliteal (PA), and/or below-the-knee (BTK) level, and a failed antegrade treatment followed by a distal retrograde approach. The numbers of occluded vascular levels (OVL), lesion length, degree of calcification, technical success rate, complications, and clinical outcome were noted. Results OVL were 1 in 72%, 2 in 20%, and 3 in 8% of patients. CTOs were longer than 20 cm in 45.6% of cases and showed severe calcifications in 50.3%. Target vessels for distal access were the distal SFA/PA in 17% and BTK in 83%. The overall technical success rate was 82%. Severe calcification decreased technical success (p = 0.01) despite lesion length and Rutherford stage. Clinical outcome improved in 123/152 patients with a significant increase of the median ABI (N = 158) from 0.53 (interquartile range 0.39 to 0.61) to 0.85 (0.59 to 1.03; p < 0.001). Complications were reported in 7.6% cases with 2.3% related to the distal vascular access. Conclusion The tibiopedal and distal femoral retrograde access presents a safe and effective treatment option of CTOs at the thigh and/or BTK after a failed antegrade attempt improving clinical outcome. Technical success decreased with lesion’s degree of calcification. Key Points • Safety and effectiveness of the tibiopedal and distal femoral access for retrograde crossing of chronic total occlusion. • Target lesion’s degree of calcification decreases technical success. • Complications related to the distal vascular access were rare.

Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 225-230 ◽  
Author(s):  
Pasi Karjalainen ◽  
Tuomas Paana ◽  
Jussi Sia ◽  
Wail Nammas
Keyword(s):  
Optical Coherence Tomography ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Lesion Length ◽  
Optical Coherence ◽  
Flow Reserve ◽  
Coronary Lesions

Objectives: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. Methods: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. Conclusions: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

scholarly journals Safety and Efficacy of Guidezilla Extension Catheter for the Percutaneous Treatment of Complex Coronary Lesions

2020 ◽  
Vol 23 (2) ◽  
pp. E147-E150
Author(s):  
Tao Chen ◽  
Weihao Xu ◽  
Yulun Cai ◽  
Qi Wang ◽  
Jun Guo ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Percutaneous Treatment ◽  
Target Lesion ◽  
Lesion Length ◽  
Circumflex Artery ◽  
Chronic Total Occlusions ◽  
Left Circumflex Artery ◽  
Coronary Lesions ◽  
Procedural Success ◽  
The Right

Background: The GuidezillaTM support extension catheter is designed to provide extra back-up support and efficient device delivery during complex percutaneous coronary interventions (PCIs), such as in treatment of severe calcification, tortuous chronic total occlusions (CTOs), and coronary anomalies. The aim of this study was to describe our initial experience with the GuidezillaTM extension catheter in the treatment of complex coronary artery lesions. Methods: This study retrospectively analyzed data from 165 PCI cases that used the GuidezillaTM guide extension catheter between March 2015 and August 2017. We collected patient clinical characteristics, target lesion characteristics, and procedural details. Results: Eighty-six percent of patients had complex Type C lesions, and 13.9% had Type B lesions. Lesion length ranged from 8 mm to 130 mm (≤ 20 mm, 15.4%; 20–40 mm, 35.8%; > 40 mm, 49.1%). The right coronary artery (59.2%) was the most common intervention vessel followed by the left ascending artery (30.6%) and the left circumflex artery (10.2%). CTO accounted for 38% of all lesions, followed by distortions (28%), heavy calcification (24%), proximal stent thrombosis (9%), and coronary artery origin anomalies (1%). A total of 142 patients underwent successful PCI using the GuidezillaTM extension catheter. The success rate was 86%. Conclusion: The GuidezillaTM guide extension catheter was an effective and safe technique in the transradial treatment of complex coronary lesions. Use of the GuidezillaTM guide extension catheter can shorten the procedure time and ensure overall procedural success with a reduced complication rate in cases where adequate progress using angioplasty devices has not been achieved.

scholarly journals Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
De Novo ◽  
Target Lesion ◽  
Major Amputation ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Lesion Length ◽  
Japanese Cohort ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

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.

scholarly journals Transradial Approach for Aortoiliac and Femoropopliteal Interventions: A Systematic Review and Meta-analysis

2018 ◽  
Vol 25 (5) ◽  
pp. 599-607 ◽  
Author(s):  
Max M. Meertens ◽  
Eugene Ng ◽  
Stanley E. K. Loh ◽  
Miny Samuel ◽  
Barend M. E. Mees ◽  
...  
Keyword(s):  
Systematic Review ◽  
Lower Limb ◽  
Meta Analysis ◽  
Hospital Length Of Stay ◽  
Cochrane Library ◽  
Technical Success ◽  
Access Methods ◽  
Transradial Approach ◽  
Technical Success Rate ◽  
Transradial Access

Purpose: To present a systematic review and meta-analysis comparing the transradial approach for aortoiliac and femoropopliteal interventions to the traditional transfemoral access. Methods: A search of the public domain databases MEDLINE, SCOPUS, Web of Science, and Cochrane Library Databases was performed to identify studies related to the use of the transradial approach for infra-aortic procedures. Meta-analysis was used to compare the transradial to the transfemoral route in terms of procedure success, complications, procedure parameters, and hospital length of stay. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). Results: Nineteen studies containing 638 patients with transradial access for lower limb interventions were selected. Lesions were treated from the aortic bifurcation down to the popliteal artery. The mean technical success rate was 90.9%, conversion to a transfemoral approach was necessary in 9.9%, and complications were reported in 1.9%. The meta-analysis included 4 comparative studies involving 114 transradial and 208 transfemoral procedures. There was no significant advantage of either approach in terms of procedure success (OR 5.0, 95% CI 0.49 to 50.83, p=0.17), but the risk of developing a complication was significantly lower (OR 0.25, 95% CI 0.07 to 0.86, p=0.03) with the transradial approach. Conclusion: Transradial access for lower limb endovascular interventions can be performed with comparable technical success and a lower overall complication profile compared to transfemoral access.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease

2017 ◽  
Vol 25 (1) ◽  
pp. 92-99 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Efthymios Beropoulis ◽  
Arne Stachmann ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Success Rates ◽  
Technical Success ◽  
Chronic Total Occlusions ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II–BTK)

2020 ◽  
pp. 152660282096968
Author(s):  
Xin Jia ◽  
Baixi Zhuang ◽  
Feng Wang ◽  
Yongquan Gu ◽  
Jiwei Zhang ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
De Novo ◽  
Randomized Study ◽  
Balloon Catheter ◽  
Target Lesion ◽  
Primary Patency ◽  
Control Group ◽  
Lesion Length ◽  
Significant Difference ◽  
Drug Coated Balloon

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

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