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Purpose To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life. Methods A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5–22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire. Results Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months’ follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % ( p  = 0.84) and 40.8 versus 46.7 % ( p  = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p  = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life. Conclusion Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.

Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients “crossed over” to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower ( p  = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

Excellent results with small stents in coronary arteries have led endovascular therapists to their use in infrapopliteal vessels. However, to date no level I evidence exists to recommend primary stenting over infrapopliteal angioplasty alone. The aim of this randomized single-center trial was to compare their 1-year outcome. A total of 38 limbs in 35 patients with critical limb ischemia were randomized to angioplasty (22 pts) or primary stenting (16 pts). Target lesions were infrapopliteal occluded (36) or stenotic (20) lesions ranging from <2 to >15 cm in length. The mean age was 72 years. At 12 months, there was no statistical difference in survival (angioplasty, 69.3%; primary stenting, 74.7%), in limb salvage (angioplasty, 90%; primary stenting, 91.7%), or in primary and secondary patency (angioplasty, 66 and 79.5%; primary stenting, 56 and 64%) between the groups Renal insufficiency was the only significant negative predicting factor for limb salvage in both groups. In conclusion, the 1-year results for both groups were broadly similar. Stenting has its place in infrapopliteal angioplasty if the procedure is jeopardized by a dissection or recoil, but our results do not support primary stenting in all cases.

Purpose: To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST). Methods: Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68±9 years) with a single de novo >70% SFA lesion <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received (“on treatment” analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study. Results: Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75±0.79 to 0.94±1.38 (p<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62±0.15 to 0.85±0.20 (p<0.0001). Conclusion: This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.

Abstract We determined whether higher levels of physical activity in daily life are associated with better brachial artery flow-mediated dilation (FMD) among individuals with lower extremity peripheral arterial disease (PAD). Participants were 111 men and women with PAD (ankle–brachial index (ABI) ≤ 0.95) who completed baseline testing in the Study to Improve Leg Circulation (SILC). We evaluated FMD of the brachial artery at baseline and at 60 seconds following 4 minutes of suprasystolic blood pressure cuff inflation. Physical activity was measured continuously over 7 days using a vertical accelerometer (Caltrac) and a pedometer (Digiwalker). Adjusting for age, sex, race, ABI, cardiovascular risk factors and other potential confounders, higher levels of physical activity were associated with a greater percent change in brachial artery FMD at 60 seconds post cuff deflation for both Caltrac (1st tertile of activity +4.81% change; 2nd tertile +4.60% change; 3rd tertile +7.23% change; p-trend = 0.018) and the Digiwalker (1st tertile of activity +3.76% change; 2nd tertile +6.25% change; 3rd tertile +7.25% change; p-trend = 0.001). Similar findings were observed for absolute change in brachial artery FMD 60 seconds after cuff deflation. In conclusion, higher levels of physical activity during daily life are associated significantly and independently with better brachial artery FMD among individuals with PAD, even after adjusting for confounders. ClinicalTrials.gov Identifier: NCT00106327.

Purpose: To report a 5-year observational parallel group study comparing the effectiveness of subintimal angioplasty (SIA) to bypass grafting (BG) for treatment of TASC II type C/D lesions in the lower limb arteries of patients with critical limb ischemia (CLI). Methods: Of 1076 patients referred with PVD from 2002 to 2007, 206 SIAs in 190 patients (104 women; mean age 73±13 years) and 128 bypass grafts in 119 patients (77 men; mean age 70±14 years) were enrolled in the study. All patients had Rutherford classification 4–6 ischemia manifested as rest pain and/or tissue loss. Primary endpoints were (1) survival free from amputation and (2) sustained clinical improvement [+2 Rutherford category and/or ABI increase >0.15 without target lesion revascularization (TLR)]. Secondary endpoints were major adverse events (MAE), the binary restenosis rate, freedom from TLR, and a special quality-adjusted life year (QALY) endpoint (Q-TWiST) that incorporated both length and quality of life to evaluate treatments. A cost analysis was also performed. Results: At 5 years, clinical improvement was sustained in 82.8% of the SIA group versus 68.2% of the BG patients (p=0.106). Five-year all-cause survival was similar for SIA (78.6%) and BG (80.1%; p=0.734), as was amputation-free survival (SIA 72.9% versus BG 71.2%; p=0.976). Hyperfibrinogenemia (p=0.009) and C-reactive protein (p=0.019) had negative effects on survival without amputation. Five-year freedom from binary restenosis rates were 72.8% for SIA versus 65.3% for BG (p=0.700). While the 5-year freedom from TLR rates (SIA 85.9% versus BS 72.1%, p=0.262) were not statistically significant, the risk of MAE (p<0.002) and length of hospital stay (p<0.0001) were significantly reduced in the SIA group. Q-TWiST significantly improved (p<0.001) and cost-per-QALY (SIA €5663 versus BG €9172, p<0.002) was reduced with SIA. The 5-year risk of re-intervention (p>0.05) and mean number of procedures (p=0.078) were similar. Conclusion: Five-year freedom from MAE was enhanced by 20% in the SIA group, with substantial cost reduction and better Q-TWiST. SIA is a minimally invasive technique that expands amputation-free and symptom-free survival. SIA is poised to bring about a paradigm shift in the management of CLI.

Purpose This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. Results Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.

Background Worldwide, at least 200 million people are affected by peripheral vascular diseases (PVDs), including peripheral arterial disease (PAD), chronic venous insufficiency (CVI) and deep vein thrombosis (DVT). The high prevalence and serious consequences of PVDs have led to the development of several diagnostic tools and clinical guidelines to assist timely diagnosis and patient management. Given the increasing number of diagnostic methods available, a comprehensive review of available technologies is timely in order to understand their limitations and direct future development effort. Main body This paper reviews the available diagnostic methods for PAD, CVI, and DVT with a focus on non-invasive modalities. Each method is critically evaluated in terms of sensitivity, specificity, accuracy, ease of use, procedure time duration, and training requirements where applicable. Conclusion This review emphasizes the limitations of existing methods, highlighting a latent need for the development of new non-invasive, efficient diagnostic methods. Some newly emerging technologies are identified, in particular wearable sensors, which demonstrate considerable potential to address the need for simple, cost-effective, accurate and timely diagnosis of PVDs.

Non-invasive lower limb vascular assessment in people at risk of peripheral arterial disease (PAD) including those with diabetes is crucial. There is evidence that standard assessment techniques such as the ankle–brachial index (ABI) may be less effective in people with diabetes. However there is limited evidence for other frequently used tests including continuous wave Doppler (CWD), and the toe–brachial index (TBI). The aim of this study was to determine the sensitivity and specificity of, ABI, CWD and TBI in a population with, and without diabetes. Participants with and without diabetes who met current guidelines for vascular screening were recruited, and CWD waveforms, an ABI and a TBI were obtained from the right lower limb. Diagnostic accuracy was determined using colour duplex ultrasound (CFDU). Receiver operating characteristic curves were calculated. 117 participants were recruited, seventy-two with diabetes and forty-five without diabetes. CWD had the highest sensitivity in people with diabetes (74%) and without (84%). CWD also had the highest specificity in people with diabetes (74%) and without (84%) compared to both TBI and ABI. In participants with diabetes, the ABI was a poor test, area under the curve: 0.58 (p=0.27). CWD waveform is more likely to detect significant PAD compared to ABI and TBI in people with and without diabetes.

The objective of this study was to summarize outcomes of subintimal angioplasty (SA) for peripheral arterial occlusive disease. The Cochrane Library, Medline and Embase databases were searched to perform a systematic review of the literature from 1966 through May 2007 on outcomes of SA for peripheral arterial occlusive disease of the infrainguinal vessels. The keywords “percutaneous intentional extraluminal revascularization,” “subintimal angioplasty,” “peripheral arterial disease,” “femoral artery,” “popliteal artery,” and “tibial artery” were used. Assessment of study quality was done using a form based on a checklist of the Dutch Cochrane Centre. The recorded outcomes were technical and clinical success, primary (assisted) patency, limb salvage, complications, and survival, in relation to the clinical grade of disease (intermittent claudication or critical limb ischemia [CLI] or mixed) and location of lesion (femoropopliteal, crural, or mixed). Twenty-three cohort studies including a total of 1549 patients (range, 27 to 148) were included in this review. Methodological and reporting quality were moderate, e.g., there was selection bias and reporting was not done according to the reporting standards. These and significant clinical heterogeneity obstructed a meta-analysis. Reports about length of the lesion and TASC classification were too various to summarize or were not mentioned at all. The technical success rates varied between 80% and 90%, with lower rates for crural lesions compared with femoral lesions. Complication rates ranged between 8% and 17% and most complications were minor. After 1 year, clinical success was between 50% and 70%, primary patency was around 50% and limb salvage varied from 80% to 90%. In conclusion, taking into account the methodological shortcomings of the included studies, SA can play an important role in the treatment of peripheral arterial disease, especially in the case of critical limb ischemia. Despite the moderate patency rates after one year, SA may serve as a “temporary bypass” to provide wound healing and limb salvage.