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 ◽  
...  

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.

2016 ◽  
Vol 24 (2) ◽  
pp. 181-188 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Arne Stachmann ◽  
Christiane Hericks ◽  
...  

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.


2021 ◽  
pp. 152660282110348
Author(s):  
Grzegorz Halena ◽  
Dainis K. Krievins ◽  
Dierk Scheinert ◽  
Janis Savlovskis ◽  
Piotr Szopiński ◽  
...  

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.


2021 ◽  
Author(s):  
Roberto Minici ◽  
Michele Ammendola ◽  
Marisa Talarico ◽  
Maria Luposella ◽  
Marco Minici ◽  
...  

Abstract Background: The femoropopliteal bypass occlusion in patients with critical limb ischemia and chronic total occlusion of the native superficial femoral artery remains a significant problem, that hardly challenges vascular surgeons and interventional radiologists. Performing a secondary femoropopliteal bypass is still considered the standard of care, although it is associated with a higher complication rate and lower patency rate in comparison with primary bypass. Advanced age, lack of a good great saphenous vein, anastomosis’ pseudoaneurysms and high surgical risks make surgical approach not always suitable. Over the past few years, angioplasty has been commonly used, with the development in endovascular technologies, to treat chronic total occlusions of the native SFA, with a good technical success rate and clinical prognosis. Hence, the idea to recanalize the native SFA chronic total occlusions, in patients with critical limb ischemia (CLI) and femoro-popliteal bypass failure, has been born, limited to those patients unfit for surgery or refusing surgical reconstruction. Data regarding long-term outcomes of this approach in femoro-popliteal bypass failure are limited to few case-series studies.Results: Technical success was achieved in 51 (94.4%) of 54 limbs. Angiographically, 77.8% of the lesions were TASC II category D, while 22.2% TASC II category C. The average length of the native SFA lesions was 26.8 cm. Clinical success, with improved Rutherford classification staging, followed each case of technical success. The median follow-up value was 5.75 years (IQR, 1.5 – 7). By Kaplan-Meier survival analysis, primary patency rates were 61% (±0.07 SE) at 1 year and 46% (±0.07 SE) at 5 years. Secondary patency rates were 93% (±0.04 SE) at 1 year and 61% (±0.07 SE) at 5 years. Limb salvage rates were 94% (±0.03 SE) at 1 year and 88% (±0.05 SE) at 5 years.Conclusions: The endovascular recanalization of chronic total occlusions (CTO) of the native superficial femoral artery (SFA) after failed femoropopliteal bypass is a safe and effective therapeutic option in patients unfit for surgery with critical limb ischemia.


2012 ◽  
Vol 97 (1) ◽  
pp. 56-64 ◽  
Author(s):  
Junjie Zou ◽  
Yongxiang Xia ◽  
Hongyu Yang ◽  
Hao Ma ◽  
Xiwei Zhang

Abstract The objective of this study was to evaluate the feasibility and efficacy of hybrid therapy (combined endarterectomy-endovascular) in patients with complex peripheral multifocal steno-obstructive vascular disease involving the femoral artery bifurcation. Forty-one combined procedures were performed on 40 patients. Although the common femoral artery was usually treated with endarterectomy, endoluminal procedures were performed proximally in 12 patients (group 1), distally in 18 patients (group 2), and both upward and downward in 11 patients (group 3). Patients underwent clinical assessment and ankle-brachial index measurement thereafter. Primary, assisted-primary, and secondary patency rates at 24 months were 59%, 66%, and 72%, respectively. Primary patency rates were lower in group 3 compared with groups 1 and 2 (P  =  0.015). The limb salvage rate was 86.4% at the end of the follow-up period. Hybrid procedures provide feasible and effective treatment management of selected patients with multilevel lower extremity arterial disease involving the femoral artery bifurcation.


Vascular ◽  
2016 ◽  
Vol 24 (4) ◽  
pp. 404-413 ◽  
Author(s):  
Jonathan Bath ◽  
Efthymios Avgerinos

Background Atherosclerotic disease of common femoral and profunda femoris arteries has been historically treated with surgical endarterectomy. Endovascular treatment of common femoral artery and profunda femoris artery disease is increasingly reported in the recent literature. This review summarizes short- and mid-term outcomes of endovascular interventions to the common femoral artery and common femoral artery. Methods All published series in the English language were identified through a systematic PubMed search. Standard descriptive statistics, reported as mean ± SD, were applied to perform the pooled analysis and calculate the overall outcome measures. Combined overall effect sizes were calculated using fixed-effect meta-analysis. Results The analysis included 20 studies with a total of 836 patients (897 limbs, mean age of 70.5 ± 4.3 years, critical limb ischemia 39.6%). Technical success was 95%. Angioplasty alone was undertaken in 68.8% of cases and stenting in 22.3%. Access complications occurred in 2.4% of cases. Post-operative major adverse limb events occurred in 2% and major adverse cardiovascular events in 1% of cases. Primary patency at 6, 12 and 24 months was 87%, 77% and 73%, respectively. Subgroup analysis revealed a significantly higher mean primary patency at 12 months for routine stenting compared to a selective stenting strategy (91.4% versus 75%; p < 0.05). Conclusions Endovascular interventions to the common femoral artery and common femoral artery can be performed safely with high technical success. Endovascular therapy may be a favored approach over endarterectomy for highly selected patients of poor surgical risk, with limited life expectancy and those with wound-healing considerations such as re-operative fields or prone to infection.


2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Roberto Minici ◽  
Michele Ammendola ◽  
Marisa Talarico ◽  
Maria Luposella ◽  
Marco Minici ◽  
...  

Abstract Background Femoropopliteal bypass occlusions are a significant issue in patients with critical limb ischemia and chronic total occlusion of the native superficial femoral artery, which challenges vascular surgeons and interventional radiologists. Performing a secondary femoropopliteal bypass is still considered the standard of care, although it is associated with a higher complication rate and lower patency rate in comparison with primary bypass. Over the past few years, angioplasty has been commonly used, with the development in endovascular technologies, to treat chronic total occlusions of the native superficial femoral artery, with a good technical success rate and clinical prognosis. The purpose of the study is to assess the outcome of endovascular recanalization of chronic total occlusions of the native superficial femoral artery, in patients unfit for surgery with critical limb ischemia after failed femoropopliteal bypass. Results A total of 54 patients were treated. 77.8 % of the conduits were PTFE grafts; the remainder were single-segment great saphenous veins. The most common clinical presentation was rest pain. Technical success was achieved in 51 (94.4 %) of 54 limbs. Angiographically, 77.8 % of the lesions were TASC II category D, while 22.2 % were TASC II category C. The average length of the native SFA lesions was 26.8 cm. Clinical success, with improved Rutherford classification staging, followed each case of technical success. The median follow-up value was 5.75 years (IQR, 1.5–7). By Kaplan-Meier survival analysis, primary patency rates were 61 % (± 0.07 SE) at 1 year and 46 % (± 0.07 SE) at 5 years. Secondary patency rates were 93 % (± 0.04 SE) at 1 year and 61 % (± 0.07 SE) at 5 years. Limb salvage rates were 94 % (± 0.03 SE) at 1 year and 88 % (± 0.05 SE) at 5 years. Conclusions The endovascular recanalization of chronic total occlusions (CTO) of the native superficial femoral artery (SFA) after a failed femoropopliteal bypass is a safe and effective therapeutic option in patients unfit for surgery with critical limb ischemia.


Vascular ◽  
2020 ◽  
pp. 170853812097081
Author(s):  
Aysen Y Engin ◽  
Onur Saydam

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.


Vascular ◽  
2020 ◽  
pp. 170853812094331
Author(s):  
Iris PS van Wijck ◽  
Suzanne Holewijn ◽  
Laurens A van Walraven ◽  
Michel MPJ Reijnen

Background Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. Purpose The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. Method We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). Results A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). Conclusion The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.


2021 ◽  
pp. 153857442110104
Author(s):  
Rabellino Martin ◽  
Di Caro Vanesa G ◽  
Juan Valle Raleigh ◽  
Chas Jose ◽  
Kotowicz Vadim ◽  
...  

Background: Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis. Methods: A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates. Results: In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20–70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%. Conclusion: Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.


2021 ◽  
Vol 135 ◽  
pp. 175394472110469
Author(s):  
Prakash Krishnan ◽  
Arthur Tarricone ◽  
Simon Chen ◽  
Samin Sharma

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.


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