Rutherford-Becker Class Research Articles

Evaluation of acute and midterm outcomes after complex combined antegrade/retrograde recanalization for occlusions of the femoropopliteal and infrapopliteal arteries

IntroductionWhen antegrade recanalization of femoro- and/or infrapopliteal occlusions fails, retrograde access has become an established option. To evaluate the results of combined antegrade and retrograde recanalization of femoropopliteal and infrapopliteal occlusions, patients undergoing secondary retrograde recanalization attempts were analyzed retrospectively. MethodsPrimary endpoint was the success of the procedure (successful occlusion crossing using the ante-/retrograde technique). Secondary endpoints include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index (ABI), and Rutherford-Becker class (RBC). Predictors for procedure failure and TLR were analyzed. ResultsWe included 888 patients: 362 with femoropopliteal (group 1), 353 with infrapopliteal (group 2), and 173 with multi-level (group 3) recanalization. Critical limb threatening ischemia (CLTI) was present in group 1, 2, and 3 in 36%, 62%, and 76%, respectively. The intervention was successful in 92.5%, 93.8%, 90.8% of respective cases (p=0.455). The overall peri-interventional complication rate was 7.2%.At 6, 12 and 24 months, primary patency was highest in group 1 (63.9%, 45.8%, 33.3%), followed by group 3 (59.8%, 46.1%, 33.3%), and group 2 (58.5%, 43.1%, 30.4%), p=0.537).The risk of undergoing repeated TLR within 24 months was 31.4% for group 1, 39.1% for group 2, and 45.7% for group 3.At 24 months, the survival rate in groups 1, 2, 3 was 93.8%, 79.4% and 87.5%, respectively. During 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ABI and RBC were present at discharge as well as at 6, 12 and 24 months (p<0.001).Dialysis dependency was a predictor of unsuccessful ante/retrograde recanalization (p=0.048).Lesion length (p=0.0043), dialysis (p=0.033) and recanalization level (p=0.013) increase the risk of TLR. ConclusionUsing a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Due to the high rate of repeated TLR across all lesion localizations, the indication for ante- and retrograde recanalization may be limited to patients with CLTI.

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial

BackgroundEndovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.MethodsThis prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.DiscussionEndovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a “leaving nothing behind” endovascular approach combining directional atherectomy and DCB compared to surgical therapy.Trial registrationClinicalTrials.gov NCT02517827.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting

ObjectiveTo evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BackgroundThe benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. MethodsThis retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). ResultsOne hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172).After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline.Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. ConclusionAfter one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.

Effect of Limb Salvage by Excimer Laser Angioplasty Plus Low-Pressure Balloon Inflation in Chronic Limb-Threatening Ischemia Patients with Infrapopliteal Vessel Disease.

Patients with chronic limb-threatening ischemia (CLTI) often exhibit long, diffuse, totally occluded and heavily calcified infrapopliteal (IP) lesions. This study evaluated limb salvage after peripheral excimer laser atherectomy (PELA) plus low-pressure balloon inflation (LPBI) without stent deployment in CLTI patients with severe IP disease. We retrospectively evaluated 70 consecutive patients with 109 IP vessels who underwent PELA plus LPBI from 2010 to 2013. Technical success was defined as at least one IP straight-line flow being achieved below the malleolus. Binary logistic regression was performed to identify factors associated with 6-month limb salvage. Of the 109 IP vessels, 100 (91.7%) were totally occluded, and none of the patients received a stent. Of the 70 patients, 20% were octogenarians, and 85.8% had a Rutherford-Becker class 5 and 6. The technical success rate was 87.1% and 6-month limb salvage rate was 78.6%. Rutherford score was negatively correlated with clinical success (adjusted odds ratio 0.24; p = 0.028). No immediate major cardiovascular events were recorded during admission. PELA plus LPBI may be a treatment option for complex IP lesions in patients with CLTI. Higher Rutherford class was correlated with a lower 6-month limb salvage rate. However, a large-scale study with a control group is needed to clarify our results.

Evaluation of Stent Angioplasty in the Treatment of Arteriosclerotic Lesions of the Common Femoral Artery.

In many vascular segments, endovascular therapy is the treatment of choice for arteriosclerotic lesions. For the treatment of common femoral artery (CFA) lesions, surgical reconstruction is still considered the gold standard. The purpose of this study is to evaluate the safety and efficacy of stent angioplasty for the treatment of common femoral artery (CFA) lesions in a real-world population during a two-year follow up. This retrospective, single-center study includes 250 patients requiring treatment with stent angioplasty of CFA lesions. The primary end point was the target lesion revascularization (TLR) rate. Secondary end points were the overall procedural complication rate, the rate of ipsilateral CFA punctures during follow-up, changes in the Rutherford–Becker class (RBC) and ankle–brachial index (ABI), primary patency rates, amputation rate, time to and the type of TLR. A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR. Stent angioplasty for the treatment of CFA lesions is safe and effective. Further studies are needed to compare this endovascular option with surgical therapy.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone (P=0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P=0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P=0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P=0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P=0.618) in the DA+DCB group and the DCB group, respectively. Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. https://www.clinicaltrials.gov; Unique identifier: NCT01763476.

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World

ObjectivesThis study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice. BackgroundA recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices. MethodsA retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. ResultsOverall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007). ConclusionsIn this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.

Outcomes of directional atherectomy for common femoral artery disease.

Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard. The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions. A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up. This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR. The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.

Directional Atherectomy of the Common Femoral Artery: Complications and Outcomes

The use of directional atherectomy (DA) with or without drug-coated balloon (DCB) may be considered for the management of common femoral artery (CFA) occlusive disease because of its minimally invasive nature with early mobilization, reduced incision complications, and infection rates. However, it has recognized complications, which may be related to the learning curve. We present our initial experience using DA and suggest changes that may, based on our practice, improve outcomes. Retrospective analysis with a prospective data collection from 2 centers to analyze outcomes in all consecutive patients treated during 1 year (n=25). Patients who underwent CFA DA with/without DCB for CFA >70% stenosis. Primary end points include technical success, primary patency of the CFA, morbidity, and mortality. Secondary end points include change in Rutherford-Becker class, length of stay, and target lesion revascularization rate. Between July 2017 and December 2018, 25 patients underwent CFA DA. Two had an occluded CFA, and 23 had >70% CFA stenosis as determined by ultrasound scan (USS) and/or computed tomography angiogram (CTA) preoperatively. There were no deaths within 30days. Procedure-related complications included 2 cases of CFA pseudoaneurysm (one of them repaired by open surgery) and 1 CFA perforation (repaired with covered stent). No distal embolization or limb loss occurred. Mean length of stay was 1.9days. Primary and secondary patency at 3 and 6months was 100%. At 12months, it was 96%. Early results suggest that CFA DA with/without DCB is safe and effective. Previous CTA, focused USS, and/or intravascular USS may be useful to minimize the risk of pseudoaneurysm or perforation by excessive thinning of the media. Experience is required to prevent localized dilatation over time.

Directional Atherectomy of the Common Femoral Artery. Learning Curve and One Year Follow up

Introduction: The use of Directional Atherectomy (DA) with or without anti-restenotic therapy (ART) may be considered for the management of common femoral artery (CFA) occlusive disease because of its minimally invasive nature with early mobilisation, reduced incision complications and infection rates [1-5]. However, it has recognised complications, which may be related to the learning curve. We present our initial experience using DA and suggest changes that may, based on our practice, improve outcomes. Methods: A consecutive series of patients who underwent CFA DA +/- ART for chronic limb ischemia with > 70 % CFA stenosis in two tertiary hospitals between June 2017 and December 2018 are described here. All of them had Ultrasound (USS) and /or Computerised Tomography Angiogram (CTA) before the procedure. Data were collected prospectively and retrospectively evaluated. The primary endpoints were technical success (< 50% residual stenosis in the CFA measured by USS after the procedure), primary patency of the CFA measured by USS at 1, 3, 6 and 12 months and also morbidity and mortality. Secondary endpoints were change in Rutherford-Becker class, target lesion revascularisation rate and length of stay post-procedure. Patients were selected for DA by the treating surgeon based on IFU and significant comorbidities. CFA DA was performed in isolation or in conjunction with other endovascular treatment of the iliac/ipsilateral femoral or tibial vessels Results: Between July 2017 and December 2018, 25 patients underwent CFA DA. Two had an occluded CFA and 23 had >70% CFA stenosis as determined by USS [6, 7] and CTA preop. There were no deaths within 30 days. Procedure-related complications included 2 cases of CFA pseudoaneurysm (one of them repaired by open surgery) (Figure 1 and Figure 2) and 1 CFA perforation (repaired with covered stent). No distal embolisation or limb loss occurred. The mean length of stay was: 1.96 days. The primary and secondary patency at 3 and 6 months was 100%. At 12 months it was 96%. Conclusion: Early results suggest that CFA DA ± ART is safe & effective and may be advantageous over open endarterectomy in some patients. However preoperative imaging or intravascular USS (IVUS) may be required to ensure that the device passes are in areas of highest plaque burden to avoid early complications and localised dilatation over time.Figure 2A: Pre DA. B: Post CFA DA + EIA Viabahn. C: Duplex USS 6 month later. D: 6 months later.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Disclosure: Nothing to disclose

Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon - results from the Heidelberg PANTHER registry.

Treatment of calcified femoropopliteal lesions remains challenging, even in the era of drug-eluting balloon angioplasty. Lesion recoil and dissections after standard balloon angioplasty in calcific lesions often require subsequent stent implantation. Additionally, poor patency rates in calcified lesions despite the use of drug-eluting balloons may be due to the limited penetration depth of the antiproliferative drug in the presence of vascular calcium deposits. Therefore, preparation of calcified lesions with the AngioSculpt™ scoring balloon might be a valuable option either as a stand-alone treatment, followed by drug-eluting balloon angioplasty or prior to subsequent stent deployment. In this retrospective, single centre registry, 124 calcified femoropopliteal lesions were treated in 101 subsequent patients. All patients were treated with scoring balloon angioplasty, either alone, in combination with drug-eluting balloons, or prior to stent deployment. The primary outcome was safety and technical success during the index procedure as well as patency at six and 12 months, as evaluated by duplex sonography. Successful scoring was safely performed in all 124 lesions with the AngioSculpt™ balloon. Overall primary patency after 12 months was 81.2 %. Patency rates did not differ significantly between the three treatment strategies. Degree of calcification did not predict patency. Improved clinical outcomes (Rutherford-Becker class and ankle-brachial index) were also observed in the study cohort. Preparation with the AngioSculpt™ scoring balloon offers a safe and valuable treatment option for calcified femoropopliteal lesions.

Endovascular treatment of atherosclerotic popliteal artery disease based on dynamic angiography findings

ObjectiveTo evaluate efficacy, safety, and midterm patency of endovascular treatment of obstructive popliteal artery (PA) disease. MethodsA retrospective evaluation of patients with atherosclerotic PA disease who underwent percutaneous transluminal balloon angioplasty and provisional stent, based on both conventional and dynamic angiographies, was conducted from June 2011 to June 2014. Forty-three patients were included in the study, and most patients had limited surgical revascularization options. Demographic characteristics, angiographic findings, interventional data, complications, vessel patency, limb salvage rates, and survival rates were analyzed. ResultsThe median lesion length was 5 cm with 72.1% having total occlusions. The second popliteal segment (P2) was involved most frequently (60.5%, n = 26). Critical limb ischemia was present in 69.8%. The technical success rate was 92.9% (42/43 limbs), with 29 cases requiring adjunctive nitinol stents after balloon angioplasty (47.6% based on conventional angiography, 21.4% based on dynamic angiography, and 4.8% additional stents based on dynamic angiography). Complications included thromboembolism (2.3%), perforation (2.3%), pseudoaneurysm (2.3%), and myocardial infarction (2.3%). Stent fracture was present in three cases (7.1%) during the mean follow-up period of 18.3 months. The baseline ankle-brachial index significantly improved after the intervention, from 0.49 ± 0.11 to 0.92 ± 0.14 (P < .01). The Rutherford-Becker class decreased from 3.95 ± 0.76 to 1.76 ± 0.95 (P < .01) at 12 months. The 1-year primary, primary-assisted, and secondary patency rates were 75.2% ± 6.8%, 82.4% ± 6.0%, and 89.9% ± 4.8%, respectively. The limb salvage and amputation-free survival rates at 12 months were 91.6% and 87.0%, respectively. ConclusionsBalloon angioplasty with a provisional stent based on dynamic angiography is a feasible, safe, and effective therapy for patients with obstructive PA disease. Although the occurrence of stent fracture is still inevitable, patients with critical limb ischemia who have limited surgical options may get more benefits from the endovascular treatment of PA obstructive diseases.

Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry

To examine the efficacy and durability of an interwoven self-expanding nitinol stent in the treatment of complex femoropopliteal artery lesions in unselected patients. Five hundred and twenty-seven limbs in 470 patients with femoropopliteal arterial disease were treated with SUPERA stents. Follow-up data were prospectively collected in a single-centre registry and were available for 439 patients (492 limbs). The patients were followed by Doppler ultrasound, stent roentgenograms, estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). Total occlusions were present in 277 limbs (52.6%) and 52.4% had either moderate or severe calcification. The mean lesion length was 126.4 mm. The primary patency (PP) rates were 83.3% after 12 months and 72.8% at two years. The secondary patency rates were 98.1% after 12 months and 92.0% at two years. Patency rates did not differ between superficial femoral artery (SFA) and popliteal lesions. Between baseline and a mean of 21 months of follow-up, mean ABI increased from 0.53 to 0.91, and mean RBC decreased from 3.0 to 1.9 (p<0.001 for both comparisons). Radiographs performed on 229 patients at a mean of 16.6 months confirmed the absence of stent fractures in all patients. Over a two-year surveillance period, the patency rate and fracture resistance of SUPERA stents implanted for complex femoropopliteal artery disease were high.

Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Background— Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery. Methods and Results— This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P =0.002). Target-lesion revascularization rates were 14.7% and 44.1%, respectively ( P =0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P =0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class ( P =0.31). Conclusions— Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00712309.

Bifurcation stenting after failed angioplasty of infrapopliteal arteries in critical limb ischemia: Techniques and short‐term follow‐up

To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infrapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 ± 0.10 to 0.68 ± 0.16, and mean Rutherford-Becker class decreased from 4.73 ± 0.20 to 3.00 ± 1.41 (P < 0.001 for both comparisons). Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered.

Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES. PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported. Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7). DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.

Treatment of Complex Atherosclerotic Popliteal Artery Disease With a New Self-Expanding Interwoven Nitinol Stent: 12-Month Results of the Leipzig SUPERA Popliteal Artery Stent Registry

We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients. The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known. We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations. Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.