scholarly journals Impact of Peak Systolic Velocity Ratio after Drug-Coated Balloon for Femoropopliteal Disease: Three-Month Serial Observation Vessel Echo Study

Author(s):  
Daizo Kawasaki ◽  
Aya Nakata ◽  
Kunihiko Nishian ◽  
Machiko Nishimura ◽  
Reiko Fujiwara ◽  
...  
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.


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.


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

2019 ◽  
Vol 43 (4) ◽  
pp. 182-185
Author(s):  
Alex Polak ◽  
Joseph F. Polak

The association between internal carotid artery/peak systolic velocity and stenosis severity as measured by the North American Symptomatic Carotid Endarterectomy Trial is known. The association of internal carotid artery peak systolic velocity to common carotid artery peak systolic velocity ratio is less well studied. We use a machine learning algorithm to study this association. We performed a meta-analysis of papers with point data showing graphs of internal carotid artery/peak systolic velocity ratio versus North American Symptomatic Carotid Endarterectomy Trial percent stenosis. We used a neural net algorithm to derive an equation relating internal carotid artery/common carotid artery peak systolic velocity to % stenosis in a derivation group (two thirds of the data points) and applied it to a validation subset (one third of the data points). Model performance was assessed by correlation coefficients and Bland-Altman analyses. We found 4 papers with appropriate data for a total of 775 data points. The mean % stenosis was 53% (26% SD) with a mean internal carotid artery/common carotid artery peak systolic velocity ratio of 3.9 (2.9 SD). The derivation data set (n = 516) showed an association with an r value of 0.76 ( P < .0001) between predicted and measured stenosis. Applying the derived equation to the validation subset (n = 259) showed a similar association ( r = 0.8; P < .0001). A machine learning algorithm gave a good approximation of the association between internal carotid artery/common carotid artery peak systolic velocity ratio and % stenosis on a continuous scale for the aggregate data of 4 published studies. These data could be used to study the accuracy of different cut-points for 50% and 70% stenosis in an unbiased fashion.


2020 ◽  
Vol 27 (2) ◽  
pp. 287-295 ◽  
Author(s):  
Marc Bosiers ◽  
Carlo Setacci ◽  
Gianmarco De Donato ◽  
Giovanni Torsello ◽  
Pierre Galvagni Silveira ◽  
...  

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.


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.


1994 ◽  
Vol 35 (3) ◽  
pp. 270-274 ◽  
Author(s):  
J. Zeuchner ◽  
J. T. Geitung ◽  
P. Lukes ◽  
J. H. Göthlin

Colour flow duplex ultrasonography (CFDUS) was performed in 50 patients with advanced peripheral ischaemic disease scheduled for conventional angiography. Atherosclerosis was diagnosed by the appearance of plaque and spectral broadening. Haemodynamically significant stenosis was represented as a doubling of peak systolic velocity expressed as peak velocity ratio. Occlusion was diagnosed by the lack of colour saturation and absence of Doppler wave form. In the pelvis and thigh/knee region the sensitivity and specificity exceeded 90% except for stenoses, where the sensitivity was lower. The run-off was evaluated by examination of the tibial and peroneal arteries to at least midcalf. If 2 open arteries were identified, or, if only the posterior tibial artery was patent, the run-off was considered good. Compared to angiography the sensitivity and specificity exceeded 90%. We conclude that CFDUS is an accurate non-invasive method for preoperative screening of patients with peripheral ischaemic disease.


Author(s):  
Colin Honish ◽  
Venkatraman Sadanand ◽  
Derek Fladeland ◽  
Vance Chow ◽  
Fahrad Pirouzmand

ABSTRACT:Objective:Carotid ultrasound (US) is a screening test for patients with transient ischemic attacks (TIAs) or stroke who then undergo Digital Subtraction Angiogram (DSA) or Magnetic Resonance Angiography (MRA). Gold standard DSA is invasive with inherent risks and costs. MRA is an evolving technology. This study compares reliability of MRA and US modes with DSA in determining degree of internal carotid artery stenosis.Methods:A five year retrospective analysis of 140 carotid arteries from patients who had carotid US and DSA, and possibly Magnetic Resonance Angiography was undertaken. Recorded US parameters were peak systolic velocity (PSV), end diastolic velocity (EDV), and ICA/CCA peak systolic velocity ratio. The MRA and DSA parameters used NASCET technique for measuring stenosis. Statistical analysis included ROC curves and Kappa computation.Results:US grading of carotid stenosis can be made more reliable by choosing appropriate parameters. The best combination of sensitivity and specificity for stenosis > 70% in our hospital was seen at PSV > 173cm/s (sensitivity 0.87, specificity 0.8, Positive Predictive Value (PPV) 0.70, Negative Predictive Value (NPV) 0.93, kappa 0.64 and weighted kappa 0.71). MRA kappa was 0.78, (sensitivity 0.75, specificity 1.0, PPV 1.0, NPV 0.85).Conclusions:US parameters should be validated in each centre. At best, US can only approximate the accuracy of DSA, probably due to inherent limitations of this modality. Magnetic Resonance Angiography has a perfect specificity and PPV but this technique needs to be standardized. Simultaneous use of MRA and US for screening increases sensitivity to over 0.9 without compromising specificity in > 70% stenosis.


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