Lumen Loss at 1 Year After Bare Nitinol Stent Implantation in the Superficial Femoral Artery

2020 ◽  
pp. 152660282095026
Author(s):  
Nobuhiro Ito ◽  
Mitsuyoshi Takahara ◽  
Yoshimitsu Soga ◽  
Seiichi Hiramori ◽  
Kaoru Hirose ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Failure Time ◽  
De Novo ◽  
Vessel Diameter ◽  
Accelerated Failure Time Model ◽  
Lesion Length ◽  
Time Model ◽  
Nitinol Stent ◽  
The Mean

Purpose To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions. Materials and Methods The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model. Results Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%). Conclusion Mean LL progressed by at least 1.6 mm at 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.

Abstract 1788: Clinical Impact of the Diameter of a Self-expandable Stent in the Superficial Femoral Artery

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Yoshimitsu Soga ◽  
Hiroyoshi Yokoi ◽  
Tomoko Urakawa ◽  
Kenji Ando ◽  
Shinichi Shirai ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Chronic Total Occlusion ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Total Occlusion ◽  
Kaplan Meier ◽  
The Mean ◽  
Stent Diameter

Background Factors associated with patency of self-expandable stents placed in the superficial femoral artery (SFA) have not been clarified. In this study, we investigated the impact of stent diameter in patients who implanted self-expandable stents in the SFA. Methods Self-expandable stents were placed in SFA lesions in 80 patients (84 limbs) at our hospital between January 2003 and December 2005 and we investigated prospectively for 18 months. A total of 144 stents were used: The mean vascular diameter at sites proximal and distal to the stent-placement region on angiography was defined as the vessel diameter, and the stent diameter/vessel diameter (S/V) ratio was calculated. Results The age of the patients ranged from 44 to 88 years old (mean: 70.3 ± 6.8 years old), and 68 patients were male (85%). The mean diameter of the treated vessels was 5.1 ± 0.7 mm, the mean lesion length was 93.8 ± 43.8 mm, and 1.7 ± 0.6 stents were used per lesion. Chronic total occlusion was noted in 24 cases (30%). The primary (secondary) patency rates at 6, 12, and 18 months were 91.2% (97.5%), 74.5% (87.2%), and 63.6% (79.1%), respectively as estimated by the Kaplan-Meier method. An S/V ratio >1.3 was noted in 16 of the 80 patients (20%). There was a high percentage of patients with renal dysfunction and a smoking habit in this group, and the length of the treated lesion was long. In contrast, there were fewer patients with a high cholesterol level in this group. Other baseline parameters were similar between the two groups. A Kaplan-Meier estimate showed that the restenosis rate after 18 months was significantly higher in the S/V >1.3 group (87.5% vs. 35.5%, p<0.0001), whereas the primary patency was lower (31.3% vs. 73.4%, p<0.0001). Multivariate analysis indicated that lesion length >100 mm (Hazard ratio (HR) 6.6, p=0.015), chronic total occlusion (HR 6.0, p=0.035), stent fracture(HR 17.5, p=0.022), and S/V >1.3(HR 29.0, p=0.0014) were independent predictors of primary patency at 18 months. conclusion The stent diameter of self-expandable stent was strongest predictor in primary patency at 18 months. The stent diameter of self-expandable stent can affect patency in the chronic phase.

One-Year Follow-up after Implantation of the EverFlex Nitinol Stent in Long Lesions of the Superficial Femoral Artery

Angiology ◽  
2008 ◽  
Vol 60 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Johannes Ruef
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Clinical Stage ◽  
Clinical Results ◽  
Long Term Results ◽  
Lesion Length ◽  
Secondary Patency ◽  
Nitinol Stent

For treatment of complex superficial femoral artery lesions, suitable stent devices are required. The present study details the first long-term results with the long EverFlex nitinol stent. Forty-one EverFlex stents were implanted in 32 patients with either superficial femoral artery occlusions (n = 20) or stenoses (n = 12); mean lesion length was 13.3 cm (range = 8.0–39.0). Patients presented with clinical stage Fontaine IIb (n = 27), III (n = 4), or IV (n = 1). Stent lengths were 10 cm (n = 18), 12 cm (n = 6), or 15 cm (n = 17). Follow-up after 2 months indicated primary and secondary patency rates of 96.9% (n = 31) and 100% (n = 32); ABI improved from 0.57 to 0.91 ( P < .001). After 1 year, revascularization was performed in 6 patients (18.8%). Primary and secondary patency rates were 81.3% (n = 26) and 93.8% (n = 30). In this first long-term evaluation, the long EverFlex nitinol stent achieves excellent clinical results after implantation into complex superficial femoral artery lesions.

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

2022 ◽  
pp. 152660282110677
Author(s):  
Marcus Thieme ◽  
Jarwed Arjumand ◽  
Markus Spanagel ◽  
Gunnar Tepe ◽  
Erwin Blessing ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
De Novo ◽  
Safety Concern ◽  
Occlusive Disease ◽  
Surveillance Study ◽  
Lesion Length ◽  
Torsional Strength ◽  
Procedural Success

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

scholarly journals Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

2021 ◽  
Author(s):  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Mitsutoshi Asai ◽  
Masaharu Masuda ◽  
Shin Okamoto ◽  
...  
Keyword(s):  
Intravascular Ultrasound ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Distal Part ◽  
De Novo ◽  
Vessel Diameter ◽  
Implantation Site ◽  
Severe Stenosis ◽  
Distal Edge ◽  
The Right

Abstract Background: Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia™; Boston Scientific, Marlborough, MA, USA) implantation, aneurysmal degeneration after implanting Eluvia™ has raised clinical concerns. Here, we report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for a superficial femoral artery lesion.Case presentation: A 79-year-old woman with claudication in the right lower extremity decreasing her quality of life was referred to our hospital. Pre-procedural angiography showed severe stenosis from the middle-to-distal part of the right superficial femoral artery, and Eluvia™ was implanted with optimal expansion. However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months thereafter. Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal stent edge restenosis at the Eluvia™ implantation site. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed vessel enlargement with a mean vessel diameter of 7.2-9.9 mm at the distal edge of the Eluvia™ implantation site. However, intermittent claudication on the right side recurred again 50 months after Eluvia™ implantation. Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Furthermore, peri-stent contrast staining was found at the distal part of the Eluvia™ implantation site. Intravascular ultrasound showed a further enlargement of mean vessel diameter to 11.9 mm at the distal edge of the Eluvia™ stent. Moreover, enlargement of the lumen and stent malapposition were also found, suggesting exacerbated aneurysmal degeneration 50 months after Eluvia™ implantation.Conclusions: We report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for an SFA lesion. Long-term follow-up should be mandatory for patients receiving Eluvia™ implants.

Angiographic Dissection Patterns and Patency Outcomes After Balloon Angioplasty for Superficial Femoral Artery Disease

2017 ◽  
Vol 24 (3) ◽  
pp. 367-375 ◽  
Author(s):  
Masahiko Fujihara ◽  
Mitsuyoshi Takahara ◽  
Shinya Sasaki ◽  
Kiyonori Nanto ◽  
Makoto Utsunomiya ◽  
...  
Keyword(s):  
Predictive Factors ◽  
Femoral Artery ◽  
Balloon Angioplasty ◽  
Superficial Femoral Artery ◽  
Stent Implantation ◽  
Significant Risk ◽  
Vessel Diameter ◽  
Lesion Length ◽  
Type C ◽  
Vessel Dissection

Purpose: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and the predictive factors for severe dissection. Methods: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR). Results: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C–F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection. Conclusion: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency.

scholarly journals Aneurysmal degeneration of fluoropolymer-coated paclitaxel-eluting stent in the superficial femoral artery: a rising concern

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Mitsutoshi Asai ◽  
Masaharu Masuda ◽  
Shin Okamoto ◽  
...  
Keyword(s):  
Intermittent Claudication ◽  
Intravascular Ultrasound ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Distal Part ◽  
De Novo ◽  
Vessel Diameter ◽  
Drug Eluting Stent ◽  
Drug Eluting ◽  
The Right

Abstract Background Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia; Boston Scientific, Marlborough, MA, USA) placement, aneurysmal degeneration after drug-eluting stent (Eluvia) placement has raised clinical concerns. Here, we report a case with progressive aneurysm formation on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery atheromatous plaque. Case presentation A 79-year-old woman with right leg intermittent claudication at 100 m distance was referred to our hospital. Pre-procedural angiography showed long-segment severe stenosis from the middle-to-distal part of the right superficial femoral artery, and a 7 mm wide drug-eluting stent (Eluvia) was placed. However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months thereafter. Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal superficial femoral artery in-stent restenosis. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed femoral artery enlargement with a maximum vessel diameter of 10.0 mm at the distal edge of the stent. Intermittent claudication on the right side recurred again 50 months after drug-eluting stent (Eluvia). Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Peri-stent contrast staining was found at the distal part of the drug-eluting stent (Eluvia) site. Intravascular ultrasound showed a further enlargement of maximum vessel diameter to 12.0 mm at the distal edge of the stent. Conclusions We report a case with progressive aneurysm degeneration on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery stenosis.

Crush implantation of a self-expanding interwoven stent over a subintimally recanalized standard stent in a TASC D lesion of the superficial femoral artery

VASA ◽  
2012 ◽  
Vol 41 (6) ◽  
pp. 458-462 ◽  
Author(s):  
Vogel ◽  
Strothmeyer ◽  
Cebola ◽  
A. Katus ◽  
Blessing
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Popliteal Artery ◽  
Duplex Ultrasound ◽  
Stent Fracture ◽  
Nitinol Stent ◽  
Nitinol Stents ◽  
Walking Capacity ◽  
Radial Strength ◽  
Good Treatment Option

We demonstrate feasibility of implantation of a self-expanding interwoven nitinol stent in a claudicant, where recanalization attempt of a heavily calcified, occluded superficial femoral artery (TASC D lesion) was complicated by a previously implanted, fractured standard stent. Wire passage through the occlusion and beyond the fractured stent could only be achieved through the subintimal space. A dedicated reentry device was used to allow distal wire entry into the true lumen at the level of the popliteal artery. Despite crushing of the fractured stent with a series of increasingly sized standard balloons, a significant recoil remainded in the area of the crushed stent. To secure patency of the femoro-popliteal artery we therefore decided to implant the novel self-expanding interwoven nitinol stent (Supera Veritas (TM), IDEV), whose unique feature is an exceptional high radial strength. Patient presented asymptomatic without any impairment of his walking capacity at three month follow up and duplex ultrasound confirmed patency of the stent. Subintimal recanalizations can be complicated by previously implanted stents, in particular in the presence of stent fracture, where intraluminal wire passage often can not be achieved. Considering the high radial strength and fracture resistance, interwoven nitinol stents represent a good treatment option in those challenging cases and they can be used to crush standard nitinol and ballonexpandable stents.

Clinical Experience with a New Nitinol Self-Expanding Stent in Peripheral Arteries

1996 ◽  
Vol 3 (4) ◽  
pp. 369-379 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Rafael Beyar ◽  
Isabelle Henry ◽  
Jean-Marc Porte ◽  
...  
Keyword(s):  
Long Term Results ◽  
Lesion Length ◽  
Secondary Patency ◽  
Peripheral Arteries ◽  
External Compression ◽  
Nitinol Stent ◽  
Nitinol Stents ◽  
The Mean

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

scholarly journals Impact of chronic outward force on arterial responses of proximal and distal of long superficial femoral artery stent

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hu Li ◽  
Seung-Woon Rha ◽  
Byoung Geol Choi ◽  
Se Yeon Choi ◽  
Sang Ki Moon ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Distal Segment ◽  
Vessel Diameter ◽  
Distal Portion ◽  
Control Group ◽  
Stent Restenosis ◽  
Histopathologic Analysis ◽  
Stent Diameter ◽  
The Impact

Abstract Background Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR). This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA. Methods In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. Excised stented arteries were evaluated by histopathologic analysis. Results We analyzed 65 SENS in 61 patients with follow-up angiography at 6 months to 1 year. The baseline diameter was 6.8 ± 0.71 mm and length were 97.0 ± 33.8 mm for the SENS. The ratio of the diameter of the stent to the reference vessel was 1.3 ± 0.24 at the proximal portion and 1.53 ± 0.27 at the distal portion (P < 0.001). In the long SFA stent, stent-to-vessel ratio was significantly higher in the distal stent than in the proximal stent (1.3 ± 0.2 vs. 1.55 ± 0.25, P = 0.001). ISR incidence was higher at the distal stent (37.3% vs 52.6%, P = 0.029). All 11 pigs survived for 4 weeks after SENS implantation. The vessel diameter was 4.04 ± 0.40 mm (control group) vs 4.45 ± 0.63 mm (oversized group), and the implanted stent diameter was 5.27 ± 0.46 mm vs. 7.18 ± 0.4 mm (P = 0.001). The stent-to-vessel diameter ratio was 1.31 ± 0.12 versus 1.63 ± 0.20 (P < 0.001). After 4 weeks, restenosis % was 29.5 ± 12.9% versus 46.8 ± 21.5% (P = 0.016). The neointimal area was 5.37 ± 1.15 mm2 vs. 8.53 ± 5.18 mm2 (P = 0.05). The restenosis % was 39.34 ± 8.53% versus 63.97 ± 17.1% (P = 0.001). Conclusions COF is an important cause of restenosis in the distal portion of the SFA stent. Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. Therefore, COF was an important factor of restenosis following distal SFA stenting.

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