Abstract 16152: Utility of Peak Systolic Velocity Ratio in Asymptomatic Patients With Restenosis After Endovascular Therapy for Femoro-Popliteal Lesion

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Shota Tohoku ◽  
Soga Yoshimitsu ◽  
Yusuke Tomoi

Introduction: The predictive factor of whether asymptomatic restenosis needs reintervention after initial therapy remains unclear. Objective: The aim of this study was to evaluate whether peak systolic velocity ratio (PSVR) is effective to predict target lesion revascularization (TLR) after endovascular therapy (EVT) for femoropopliteal (FP) lesion. Methods: From April 2007 to September 2013, 120 restenotic limbs without ischemic symptoms (mean age: 73.1±9.0, men: 75.0%, stent implantation: 57.5%) were selected and analyzed, 73 limbs underwent reintervention. Median follow-up period was 33.7 months (5.1-110.4 months). They were followed by serial duplex ultrasound (DUS). Restenosis was defined as peak systolic velocity (PSV) > 250cm/s or PSVR > 2.4 by using DUS. We divided them into two groups (High PSVR group (PSVR ≧3.63)and low PSVR group (PSVR < 3.63)). The ratio of TLR was compared between two groups by Kaplan-Meier survival curve. We also analyzed the TLR between balloon angioplasty (POBA) alone and stent implantation on initial EVT. Each cut off value of PSVR were 4.19 and 3.63. Results: At 1, 3 and 5 years after initial EVT, Freedom from TLR were significantly different between two groups (76.5%, 33.2% and 18.3% vs 90.7%, 75.4%, and 58.0%, p<0.001). Moreover, two groups were significantly different when analyzed about limbs performed POBA (86.9%, 67.0% and 35.7% vs 69.2%, 29.0% and 14.5%, p =0.048 ) and stenting on initial EVT (92.3%, 77.6% and 51.7% vs 83.8%, 35.2% and 12.0%, p < 0.01). After adjustment for use of cilostazol, use of proton pomp inhibitor , chronic total occlusion, history of EVT for aortoiliac disease, PSVR was an independent predictors of TLR. Conclusions: PSVR may be a predictive factor of performing reintervention for asymptomatic patient with restenosis after EVT of FP lesion.

2016 ◽  
Vol 35 ◽  
pp. 68-74 ◽  
Author(s):  
Steven A. Plato ◽  
Elizabeth A. Kudlaty ◽  
Matthew T. Allemang ◽  
Daniel E. Kendrick ◽  
Virginia L. Wong ◽  
...  

2012 ◽  
Vol 46 (5) ◽  
pp. 353-357 ◽  
Author(s):  
Donald T. Baril ◽  
Luke K. Marone

Surveillance following lower extremity bypass, carotid endarterectomy, and endovascular aortic aneurysm repair has become the standard of care at most institutions. Conversely, surveillance following lower extremity endovascular interventions is performed somewhat sporadically in part because the duplex criteria for recurrent stenoses have been ill defined. It appears that duplex surveillance after peripheral endovascular interventions, as with conventional bypass, is beneficial in identifying recurrent lesions which may preclude failure and occlusion. In-stent stenosis following superficial femoral artery angioplasty and stenting can be predicted by both peak systolic velocity and velocity ratio data as measured by duplex ultrasound. Duplex criteria have been defined to determine both ≥50% in-stent stenosis and ≥80% in-stent stenosis. Although not yet well studied, it appears that applying these criteria during routine surveillance may assist in preventing failure of endovascular interventions.


2017 ◽  
Vol 24 (3) ◽  
pp. 321-330 ◽  
Author(s):  
Gagan D. Singh ◽  
Ellen K. Brinza ◽  
Justin Hildebrand ◽  
Stephen W. Waldo ◽  
T. Raymond Foley ◽  
...  

Purpose: To analyze the relationship between the new TransAtlantic Inter-Society Consensus (TASC II) infrapopliteal classification and limb outcomes among patients with critical limb ischemia (CLI). Methods: A single-center retrospective study was performed on 166 consecutive CLI patients (mean age 71 years; 113 men) undergoing endovascular treatment of 244 infrapopliteal lesions from 2006 to 2013. Patient, procedural, angiographic, and limb outcomes were compared for the new TASC A/B vs C/D classification for infrapopliteal lesions. Binary restenosis was determined by a peak systolic velocity ratio >2.0 by duplex ultrasound on follow-up at 1, 3, 6, and 12 months. Results: Seventy-two (43.4%) patients had TASC A/B lesions, while 94 (56.6%) had TASC C/D patterns of infrapopliteal disease. Baseline demographics and tissue loss (93% vs 94%, p=0.59) were similar between the groups. TASC A/B lesions were shorter (53±35 vs 170±83 mm, p<0.001), less severely stenosed (77%±24% vs 93%±14%, p<0.001), had a larger target vessel diameter (2.9±0.5 vs 2.6±0.5 mm, p<0.001), and were less frequently chronic total occlusions (24% vs 64%, p<0.001) compared with the TASC C/D group. Three-year freedom from both amputation (85% vs 67%, p=0.02) and major adverse limb events (79% vs 61%, p=0.02) were significantly higher in the TASC A/B group. Technical success rates (95% vs 80%, p<0.001) and 1-year primary patency (58% vs 51%, p=0.04) were higher in the A/B group. Overall 3-year survival was similar between the groups (96% A/B vs 88% C/D, p=0.2). Conclusion: TASC C/D infrapopliteal lesions are associated with higher amputation and major adverse limb events rates and lower primary patency compared with TASC A/B infrapopliteal lesions. Further studies are needed to assess the association between TASC C/D infrapopliteal lesions and clinical outcomes in patients with CLI.


2019 ◽  
Vol 26 (1) ◽  
pp. 26-30 ◽  
Author(s):  
Eugenio Stabile ◽  
Donato Gerardi ◽  
Fabio Magliulo ◽  
Drago Zhelev ◽  
Vassil Chervenkoff ◽  
...  

Purpose: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. Methods: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. Results: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. Conclusion: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.


Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Douglas W Jones ◽  
Ashley Graham ◽  
Peter H Connolly ◽  
Darren B Schneider ◽  
Andrew J Meltzer

After endovascular therapy, duplex ultrasound surveillance to detect restenosis guides clinical decisions and defines treatment failure. However, the correlation between duplex ultrasound and symptom recurrence remains unclear. We reviewed our institutional experience (2007–2010) to identify patients undergoing endovascular therapy for claudication. The association between post-intervention systolic velocity ratio and patient-reported symptom recurrence was determined. We analyzed 183 follow-up visits following treatment in 88 limbs (femoropopliteal (56%) or iliac (44%) arteries). After femoropopliteal intervention, median systolic velocity ratio was higher in patients with symptom recurrence (2.99 symptomatic vs. 1.69 asymptomatic; p < 0.001). Elevated systolic velocity ratio or occlusion correlated with symptom recurrence (area under receiver operator characteristic curve = 0.82 [95% CI 0.74–0.83]), and systolic velocity ratio >2.5 was 71% sensitive and 72% specific for symptom recurrence. After femoropopliteal endovascular therapy for claudication, duplex ultrasound-detected restenosis is highly associated with clinical deterioration. This validates objective criteria for treatment failure in claudicants and suggests that symptom status can serve as a primary indicator of anatomic restenosis.


2007 ◽  
Vol 14 (4) ◽  
pp. 452-459 ◽  
Author(s):  
Oliver Schlager ◽  
Marcel Francesconi ◽  
Markus Haumer ◽  
Petra Dick ◽  
Schila Sabeti ◽  
...  

Purpose: To evaluate the agreement of duplex ultrasound (DUS) versus digital subtraction angiography (DSA) for assessment of femoropopliteal arterial disease in a real-world clinical setting. Methods: Consecutive patients with peripheral artery disease who were scheduled for a percutaneous intervention were included in this retrospective study. During an 18-month period, 491 patients (276 men; median age 73 years, interquartile range 64–81) were enrolled. A peak systolic velocity ratio (PSVR) >2.4 was the optimal cutoff for detecting a >50% stenosis by DSA. Findings of preprocedural DUS in the proximal, middle, and distal ipsilateral superficial femoral artery and in the popliteal segment were analyzed for agreement with preprocedural femoropopliteal DSA using kappa statistics. Only the target limb in each patient was analyzed, for a total of 1964 vascular segments. Results: Agreement for the degree of stenosis in 10% increments was only moderate (weighted kappa 0.67, 95% CI 0.65 to 0.69). Using the PSVR >2.4 cutoff, agreement between DUS and DSA for a >50% stenosis was good (kappa 0.79, 95% CI 0.77 to 0.81). Sensitivity, specificity, positive predictive value, and negative predictive value for correctly detecting a >50% stenosis by DUS were 0.81 (0.78 to 0.84), 0.93 (0.91 to 0.94), 0.84 (0.81 to 0.87), and 0.91 (0.87 to 0.95), respectively. Comparable findings were observed within different patient subgroups. Conclusion: Agreement between DUS and DSA in the femoropopliteal segment is only moderate with respect to the absolute degree of stenosis. However, detection of a >50% stenosis can be done with acceptable precision in routine clinical practice using PSVR >2.4 as a threshold.


2020 ◽  
Vol 27 (2) ◽  
pp. 296-303 ◽  
Author(s):  
Jaafer Golzar ◽  
Yoshimitsu Soga ◽  
Anvar Babaev ◽  
Osamu Iida ◽  
Daizo Kawasaki ◽  
...  

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.


2021 ◽  
pp. 1358863X2110112
Author(s):  
Heather L Gornik ◽  
Tatjana Rundek ◽  
Hannah Gardener ◽  
James F Benenati ◽  
Nirvikar Dahiya ◽  
...  

Diagnostic criteria to classify severity of internal carotid artery (ICA) stenosis vary across vascular laboratories. Consensus-based criteria, proposed by the Society of Radiologists in Ultrasound in 2003 (SRUCC), have been broadly implemented but have not been adequately validated. We conducted a multicentered, retrospective correlative imaging study of duplex ultrasound versus catheter angiography for evaluation of severity of ICA stenosis. Velocity data were abstracted from bilateral duplex studies performed between 1/1/2009 and 12/31/2015 and studies were interpreted using SRUCC. Percentage ICA stenosis was determined using North American Symptomatic Carotid Endarterectomy Trial (NASCET) methodology. Receiver operating characteristic analysis evaluated the performance of SRUCC parameters compared with angiography. Of 448 ICA sides (from 224 patients), 299 ICA sides (from 167 patients) were included. Agreement between duplex ultrasound and angiography was moderate (κ = 0.42), with overestimation of degree of stenosis for both moderate (50–69%) and severe (⩾ 70%) ICA lesions. The primary SRUCC parameter for ⩾ 50% ICA stenosis of peak-systolic velocity (PSV) of ⩾ 125 cm/sec did not meet prespecified thresholds for adequate sensitivity, specificity, and accuracy (sensitivity 97.8%, specificity 64.2%, accuracy 74.5%). Test performance was improved by raising the PSV threshold to ⩾ 180 cm/sec (sensitivity 93.3%, specificity 81.6%, accuracy 85.2%) or by adding the additional parameter of ICA/common carotid artery (CCA) PSV ratio ⩾ 2.0 (sensitivity 94.3%, specificity 84.3%, accuracy 87.4%). For ⩾ 70% ICA stenosis, analysis was limited by a low number of cases with angiographically severe disease. Interpretation of carotid duplex examinations using SRUCC resulted in significant overestimation of severity of ICA stenosis when compared with angiography; raising the PSV threshold for ⩾ 50% ICA stenosis to ⩾ 180 cm/sec as a single parameter or requiring the ICA/CCA PSV ratio ⩾ 2.0 in addition to PSV of ⩾ 125 cm/sec for laboratories using the SRUCC is recommended to improve the accuracy of carotid duplex examinations.


2020 ◽  
pp. 153857442096897
Author(s):  
Hanbee Hong ◽  
Ui Jun Park ◽  
Young Nam Roh ◽  
Hyoung Tae Kim

Purpose: The knowledge regarding the benefits of the scoring balloon (SB) in comparison to the plain balloon (PB) is limited. This study aims to elucidate the difference in efficacy between SB and PB as pre-balloon in superficial femoral artery angioplasty. Methods: We retrospectively analyzed angiographic images of 113 lesions in 98 patients treated with endovascular surgery. 37 lesions were prepared by SB and 76 lesions by PB. Lesions without significant residual stenosis nor a flow-limiting dissection were treated by drug-coated balloon and the others by drug-eluting stent. Severity of dissection was evaluated by Kobayashi dissection grade and NHLBI classification. The rate of stent implantation was compared between the 2 groups. Kaplan-Meier analysis estimated freedom from target lesion revascularization (TLR) rate at 12 months. Results: Severe dissections (>1/3 of lumen) occurred less frequently in the SB group (SB 40.5% vs. PB 75.0%, P = 0.001). Overall stent implantation rate was lower in the SB group (SB 27.0% vs. PB 55.3%, P = 0.005). In subgroup analysis for the complex lesions, the SB group had lower rate of severe dissection(>1/3 of lumen) in patients with long lesions(>15 cm) (SB 51.7% vs. PB 76.9%, P = 0.020) and lesions of calcium grade ≥2 (SB 43.8% vs. PB 72.5%, P = 0.009). SB group had lower stent implantation rate in patients with long lesions (SB 34.5% vs. PB 59.6%, P = 0.030), lesions of calcium grade ≥2 (SB 31.3% vs. PB 56.9%, P = 0.023), and total occlusion (SB 30.8% vs. PB 80.0%, P = 0.002). There were no procedure-related complications in either group except 1 case of puncture-site hematoma. There was no significant difference in TLR rate between both groups at 12 months (P = 0.509). Conclusion: SB reduces the incidence of severe dissection (>1/3 of lumen) and rate of overall stent implantation in comparison with PB. The use of SB is a safe and effective method of lesion preparation in SFA angioplasty.


2019 ◽  
Vol 26 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Yasuo Komura ◽  
Yoshimitsu Soga ◽  
Naoto Inoue ◽  
...  

Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. Materials and Methods: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. Results: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. Conclusion: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.


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