Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study

2021 ◽  
Author(s):  
Krishna J. Rocha‐Singh ◽  
Ravish Sachar ◽  
Brian G. DeRubertis ◽  
Claus C. A. Nolte‐Ernsting ◽  
John G. Winscott ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Directional Atherectomy

Initial Clinical Experience with Percutaneous Atherectomy in the Infragenicular Arteries

2003 ◽  
Vol 10 (5) ◽  
pp. 987-993 ◽  
Author(s):  
Thomas Zeller ◽  
Ulrich Frank ◽  
Karlheinz Bürgelin ◽  
Uwe Schwarzwälder ◽  
Peter-Christian Flügel ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Ankle Brachial Index ◽  
Peroneal Artery ◽  
Lesion Length ◽  
Anterior Tibial Artery ◽  
Tibial Artery ◽  
Below The Knee ◽  
Directional Atherectomy ◽  
Mean Diameter ◽  
The Mean

Purpose: To evaluate the efficacy and safety of a new atherectomy device for the treatment of infragenicular lesions in arteries with a reference diameter of at least 2.5 mm. Methods: Twenty-seven below-the-knee lesions in 17 patients (12 men; mean age 69±12 years) with chronic peripheral arterial occlusive disease were treated with directional atherectomy. The target lesion was in the popliteal artery (segment 3) in 2 (7%) cases, the tibioperoneal trunk in 12 (44%), the peroneal artery in 8 (30%), the anterior tibial artery in 2 (7%), and the posterior tibial artery in 3 (11%). Six (22%) of the lesions were in-stent stenoses. The mean diameter stenosis was 87%±9%, and the mean lesion length was 34±24 mm. Results: All but 2 (7%) of the lesions could be treated successfully (residual stenosis <30%) with the atherectomy catheter (93% technical success) using an average of 5±2 (range 1–10) passes of the device. Six lesions (22%) were treated after predilation and 21 (78%) with primary atherectomy. In 8 (30%) lesions, additional balloon angioplasty was performed. The 2 failures were in heavily calcified lesions through which the device could not pass despite predilation. The mean diameter stenosis after atherectomy was 14%±22% (range 0%–90%); after additional balloon angioplasty, the mean residual stenoses reduced to 12%±21% (range 0%–100%). One (6%) of the 2 patients who failed atherectomy sustained a thrombotic occlusion of the target vessel. This complication was treated successfully with local lysis, but the vessel reoccluded 3 days later; a stent was implanted. The mean ankle-brachial index increased from 0.50±0.27 to 0.86±0.40 before discharge. Conclusions: Below-the-knee native vessel lesions and in-stent restenoses with a diameter of at least 2.5 mm can be treated successfully and safely with this new atherectomy catheter. Additional balloon angioplasty was necessary in only a few cases.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Aljoscha Rastan ◽  
Marianne Brodmann ◽  
Tanja Böhme ◽  
Roland Macharzina ◽  
Elias Noory ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Primary Study ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Infrapopliteal Artery ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

scholarly journals Embolic Protection in Complex Femoropopliteal Interventions: Safety, Efficacy and Predictors of Filter Macroembolization

2020 ◽  
Author(s):  
Michael Czihal ◽  
Zeynep Findik ◽  
Christoph Bernau ◽  
Max Seidensticker ◽  
Jens Ricke ◽  
...  
Keyword(s):  
Risk Factors ◽  
Balloon Angioplasty ◽  
Critical Limb Ischaemia ◽  
Lesion Length ◽  
Limb Ischaemia ◽  
Distal Embolization ◽  
Embolic Protection ◽  
Endovascular Interventions ◽  
Directional Atherectomy ◽  
Peripheral Embolization

Abstract Objectives To evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries. Methods Patients who underwent endovascular interventions of the femoropopliteal arteries between 2008 and 2016 and in whom the SpiderFXTM FEPD was applied were included in this retrospective study. Clinical and angiographic characteristics, filter macroembolization (FME), device-related complications, distal embolization, as well as the early clinical and hemodynamic outcome, were assessed. Potential risk factors for FME were evaluated by multivariate analysis. Results A total of 244 cases were identified (203 patients, claudication 60.4%, critical limb ischaemia 39.6%, mean lesion length 13.2 ± 12.9 cm, complete occlusions in 72.7%). Balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) and rotational thrombectomy ± balloon angioplasty ± stenting (RT) were performed in 141, 61 and 42 cases, respectively. FEPD placement and retrieval were successful in all but one case each. Permanent filter-related vessel damage was not observed. The rate of FME was 37.3% (BAP 36.2%, DA 32.8%, RT 47.7%). Risk factors for FME in the BAP- and DA-group were total occlusion, lesion length > 19 cm, visible thrombus and diabetes mellitus. The distal embolization rate despite filter protection was 4.1 % (BAP 4.9%, DA 1.6%, RT 4.8%) and was higher in cases with FME compared with those without FME (8.7% vs. 1.5%, p = 0.02). Conclusion The Spider FXTM device is safe and effective in capturing embolic debris during femoropopliteal interventions. A residual risk of peripheral embolization remains. Level of Evidence III, Cohort study

6111Optical coherence tomography derived predictors of restenosis after non-stenting coronary intervention with drug-coated balloon

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Nakagama ◽  
T Niida ◽  
Y Matsuda ◽  
T Nakamura ◽  
T Sasaoka ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Stent Implantation ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Coronary Intervention ◽  
Laser Angioplasty ◽  
Metallic Stents ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Abstract Background One of the limitations of metallic stents including contemporary drug eluting stents lies in the permanent existence of metallic materials within the coronary arteries, which may lead to neoatherosclerosis and a long-term use of dual antiplatelet therapy. Some reports have recently suggested the efficacy and safety of non-stent strategy with drug-coated balloon (DCB) angioplasty in combination with debulking devices for de novo lesions. However, little is known about the potential risk of restenosis after percutaneous coronary intervention (PCI) with DCB. Purpose We sought to assess the predictive factors of restenosis by optical coherence tomography (OCT) after PCI with DCB instead of metallic stents. Methods We retrospectively investigated 49 de novo lesions in 38 patients treated by DCB without stent implantation in whom OCT was performed immediately after PCI and follow-up angiography was performed at median of 5.6 (3.7–6.9) months. OCT findings after PCI and the incidence of restenosis at follow-up angiography were evaluated. By means of OCT images, medial coronary dissection was defined as a dissection which reached the medial layer of the vessel, and major dissection was defined as a dissection with more than 60 degrees of the circumference of the vessel or more than 3mm in length. Restenosis was defined as more than 50% diameter stenosis evaluated by Quantitative Coronary Angiography. Results Restenosis was observed in 13 of 49 lesions (27%). In univariate logistic regression analysis, major dissection and medial dissection at the final OCT were associated with restenosis (Odds ratio [OR] 10.0; 95% confidence interval [CI] 2.5–52.6; p<0.01 and OR 5.8; 95% CI 1.5–25.1; p=0.01, respectively). Lesion preparation prior to DCB were performed with rotational atherectomy (n=9), orbital atherectomy (n=2), directional atherectomy (n=4), excimer laser angioplasty (n=17), scoring balloon angioplasty (n=13), or balloon angioplasty (n=4). OCT-defined major dissection remained a significant predictor for restenosis independent of debulking devices used for the preparation (OR 8.1; 95% CI 1.2–70.2; p=0.03). Conclusions Major dissection was associated with restenosis after non-stenting PCI with DCB. Stent implantation should be considered in cases of OCT-defined major dissection. Acknowledgement/Funding None

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