Femoropopliteal Angioplasty Research Articles

Comparison of angiography and ultrasound for femoropopliteal angioplasty: decision-making and 12-month outcomes.

This study aimed to investigate whether intravascular ultrasound (IVUS) combined with angiography during percutaneous transluminal angioplasty impacts treatment strategies and the 12-month patency of the femoropopliteal artery, compared to angiography alone. This retrospective, single-center study enrolled 137 patients who underwent a femoropopliteal endovascular intervention between February 2020 and May 2021. Among these interventions, 43 were guided by IVUS combined with angiography and the remaining 94 were guided by angiography only. Treatment strategies and 12-month patency were analyzed in both groups. Multivariable analysis was performed to clarify the predictors of restenosis within 12 months. Primary patency at 12 months was significantly higher in the IVUS group than in the angiography group (56.4% vs. 76.7%, P=0.047). The reference diameter on IVUS images was greater than that on angiography images. Therefore, the IVUS group presented a higher balloon-to-vessel ratio [1.0 (0.97, 1.01) vs. 1.06 (1.0.1.25)]. More adjunctive stents were required in the angiography group. However, more dissections were performed in the IVUS group, with no difference in flow-limiting dissections between groups. Target disease length (odds ratio 1.02, P=0.021) and balloon-to-vessel ratio (odds ratio 0.01, P=0.021) were independent predictors of restenosis. Compared with angiography guidance alone, IVUS guidance for femoropopliteal artery-related treatment can significantly increase primary patency. This finding may be explained by the selection of larger balloons in IVUS and the resulting sufficient plaque compression and elastic membrane stretch. Moreover, IVUS was shown to detect more non-flow-limiting dissections than angiography.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

PurposeThis study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).Materials and MethodsThe EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.ResultsKaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34).ConclusionsPrimary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

Changes in the National Endovascular Management of Femoropopliteal Arterial Disease: An Analysis of the 2011–2019 Medicare Data

PurposeTo describe national trends in the utilization of endovascular approaches (including balloon angioplasty, atherectomy, and stent placement) for the management of femoropopliteal peripheral arterial disease (PAD). Materials and MethodsThe Medicare Physician/Supplier Procedure Summary dataset containing 100% of Part B claims was interrogated for years 2011–2019. The Current Procedural Terminology codes specific for femoropopliteal angioplasty, stent placement, and atherectomy were used to create summary statistics for utilization by year, place of service (hospital inpatient, hospital outpatient, and office-based laboratory), and provider specialty (cardiology, radiology, and surgery). ResultsThe use of atherectomy increased from 34,732 (33%) procedures in 2011 to 75,435 (53%) procedures in 2019, and atherectomy became the dominant treatment strategy for femoropopliteal PAD. The relative utilization of stent placement (36,793 [35%] to 28,899 [20%]) and angioplasty only (34,398 [32%] to 38,228 [27%]) decreased concomitantly from 2011 to 2019. By 2019, the use of atherectomy was twofold higher in office-based laboratories than in the outpatient hospital setting (44,767 and 20,901, respectively). Treatment strategy varied by provider specialty in 2011 when cardiologists used atherectomy most frequently (17,925 [43%]), whereas radiologists used angioplasty alone (5,928 [6%]) and surgeons stented (18,009 [37%]) most frequently. By 2019, all specialties utilized atherectomy most frequently (29,564 [59%] for cardiology, 10,912 [58%] radiology, and 33,649 [47%] surgery). ConclusionsThe national approach to endovascular management of femoropopliteal PAD has changed since 2011 toward an implant-free strategy, including a multifold increase in the use of atherectomy. Discordant rates of atherectomy use between the ambulatory hospital and office-based settings highlight the need for comparative effectiveness studies to guide management.

Comparison of Interwoven Nitinol and Drug-Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease.

Interwoven nitinol stents (INS) and drug-eluting stents (DES) were designed to improve the mid- and long-term results of femoropopliteal (F-P) angioplasty. The aim of this study was to systematically compare these stents. Between 2015 and 2017, 62 patients with symptomatic peripheral artery disease of the F-P segment treated by INS or DES were identified from a prospectively maintained institutional database. The primary outcome measure was one-year primary patency; secondary outcomes were in-stent restenosis (ISR), stent occlusion, target lesion revascularization (TLR) and mortality. The mean follow-up was 26.9 ± 11.2 months. No statistically significant difference in primary patency at one year was observed (88.6% vs. 88.9%). Throughout follow-up, overall rates of ISR (5.7% vs. 11.1%, p = 0.645), stent occlusion (25.7% vs. 7.4%, p = 0.094) and TLR (25.7% vs. 18.5%, p = 0.505) were statistically equivalent between the groups. Mortality reached 14.3% in the INS group and 3.7% in the DES group, but this difference was not statistically significant (p=0.196). Multivariable analysis revealed significant correlations between ISR and stent occlusions; popliteal lesion localization (p = 0.016) and poor below the knee vessel outflow (p < 0.001). In the short- and mid-term, the use of an INS or DES in the F-P arterial segment did not result in a difference in primary patency rate, stent occlusion, restenosis, re-intervention or mortality. The overall data do not provide any evidence to favor one stent over the other.

A single-centre, retrospective analysis of mortality over 80 months comparing paclitaxel-coated balloon versus standard balloon angioplasty in the treatment of dysfunctional arteriovenous access.

Percutaneous transluminal angioplasty (PTA) is a standard treatment for arteriovenous fistula (AVF) stenosis to preserve haemodialysis vascular access, promoting improved dialysis adequacy and better outcomes for those dependent on renal replacement therapy. Drug coated balloons (DCB) may help reduce the rate of neointimal hyperplasia and recurrent stenosis, but their use in femoropopliteal angioplasty has been associated with increased mortality at 2 and 5 year follow-up. This study aims to address the long-term safety of PTA for AVF stenosis with clinical correlation to participant co-morbidity and mortality. All patients undergoing PTA for AVF stenosis at a single centre between 2013 and 2017 were identified and grouped according to the use of DCB versus standard balloon angioplasty. All data was anonymised and correlated to verify independent predictors of mortality. 481 (400 standard balloon; 81 DCB) procedures were performed in 313 patients (250 standard balloon; 63 DCB). Follow-up at 80 months did not show any difference in mortality (p = 0.546). Multivariate analysis identified time on dialysis (p < 0.001), age (p = 0.001) and Charlson comorbidity index (p = 0.02) as independent predictors of mortality. In this study, mortality was not associated with the use of DCBs, but was related to established factors of dialysis longevity, age and comorbidity.

Angioplasty of Flow-Limiting Stenosis Reduces Aortic and Brachial Blood Pressure in Patients With Peripheral Artery Disease.

BackgroundArterial hypertension affects cardiovascular outcome in patients with peripheral artery disease (PAD). We hypothesized that angioplasty of peripheral arterial stenoses decreases aortic (aBP) and brachial blood pressure (bBP).Methods and ResultsIn an index cohort (n=30), we simultaneously measured aBP, bBP, augmentation index (AIx), and aortic pulse wave velocity (PWV) before and after angioplasty of the iliac and femoropopliteal arteries; diagnostic angiography served as a control. In an all‐comer registry cohort (n=381), we prospectively measured bBP in patients scheduled for angioplasty of the iliac, femoral, and crural arteries or diagnostic angiography. Systolic aBP decreased after iliac (Δ−25 mmHg; 95% CI, −30 to −20; P<0.0001) and femoropopliteal angioplasty (Δ−12 mmHg; 95% CI, −17 to −5; P<0.0001) as compared with diagnostic angiography. Diastolic aBP decreased after iliac (Δ−9 mmHg; 95% CI, −13 to −1; P=0.01) but not femoropopliteal angioplasty. In parallel, AIx significantly dropped, whereas PWV remained stable. In the registry cohort, systolic bBP decreased after angioplasty of the iliac (Δ−17 mmHg; 95% CI, −31 to −8; P=0.0005) and femoropopliteal arteries (Δ−10 mmHg; 95% CI, −23 to −1; P=0.04) but not the crural arteries, as compared with diagnostic angiography. Diastolic bBP decreased after iliac (Δ−10 mmHg; 95% CI, −17 to −2; P=0.01) and femoropopliteal angioplasty (Δ−9 mmHg; 95% CI, −15 to −1; P=0.04). Multivariate analysis identified baseline systolic bBP and site of lesion as determinants of systolic bBP drop after endovascular treatment.ConclusionsAngioplasty of flow‐limiting stenoses in patients with peripheral artery disease lowers aortic and brachial blood pressure with more pronounced effects at more proximal lesion sites and elevated baseline systolic blood pressure. These data indicate a role of endovascular treatment to acutely optimize blood pressure in patients with peripheral artery disease.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT02728479.

Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. Patients and methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. Results: Overall 624 patients with femoropopliteal lesions were included in this study. Of those, 197 patients were treated with POBA without crossover to a paclitaxel coated device during follow-up and 427 patients with DCB angioplasty. Mean follow-up time was 33.3±25.4 months. Mortality incidence was 81.7% (95% confidence interval [95% CI]: 76.1-86.8) after POBA and 59.0% (95% CI: 54.6-63.9) after DCB (p<0.001). Multivariate logistic regression analysis revealed type of treatment (POBA vs. DCB, (hazard ratio [HR]: 0.332, 95% CI: 0.215-0.514, p<0.001), age per year (HR: 1.065, 95% CI: 1.046-1.087, p<0.001), coronary heart disease (HR: 1.969, 95% CI: 1.323-2.930, p=0.001), renal insufficiency (HR: 1.583, 95% CI: 1.079-2.323, p=0.019), stroke (HR: 2.505, 95% CI: 1.431-4.384, p=0.001) as predictors for all-cause mortality. In the subgroup excluding octogenarians, mortality predictors were type of treatment (HR: 0.463, 95% CI: 0.269-0.796, p=0.005), age per year (HR: 1.035, 95% CI: 1.002-1.069, p=0.038), coronary heart disease (HR: 2.082, 95% CI: 1.274-3.400, p=0.003), stroke (HR: 2.203, 95% CI: 1.156-4.197, p=0.016) and renal insufficiency (HR: 2.201, 95% CI: 1.357-3.571, p<0.001). Conclusions: This monocentric retrospective analysis showed no survival disadvantage for patients in Rutherford-Becker stage 5 after treatment with paclitaxel-coated balloons.

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.

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

PurposeThe post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.MethodsIn the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.ResultsA total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI − 0.04 to 1.3], p = 0.06 and − 0.3 per 10 years [95% CI − 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: − 0.1 per 10 mm [95% CI − 0.1 to − 0.03], p = 0.001 and − 0.1 [95% CI − 1.7 to − 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).ConclusionDCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.

Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial.

Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA). This multicentre trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with a novel DCB or uncoated POBA. The primary endpoint, late lumen loss at six months, was 0.92 mm lower in the DCB group (95% CI: -1.36 to -0.49 mm, p<0.001). Patients showed improved walking after DCB treatment at six months (p=0.021). In the DCB group, 44.6% and 50% of the patients improved by three Rutherford-Becker classification stages after six to 12 months, respectively (POBA: 27.8% and 36.8%, respectively). Only one patient needed TLR (1.3%) in the DCB group, compared to 14 patients (18.7%) in the POBA group after 12 months (relative risk [RR]=0.08, 95% CI: 0.01-0.53, p<0.001). Primary patency was 90.3% (DCB group) versus 65.3% (POBA group) after 12 months (RR=1.38, 95% CI: 1.14-1.67, p<0.001). The novel DCB was effective and safe for inhibiting restenosis. Moreover, it demonstrated a better improvement in walking than POBA and showed no mortality concerns due to paclitaxel application after 12 months. Clinical Trials Identifier: NCT02540018

Clinical Outcomes Following Femoro-Popliteal Angioplasty for Severe Limb Ischaemia (SLI) are Worse Now (2009-2014) than They were in the Basil-1 Trial (1999-2004)

Introduction - Despite the only available level 1 evidence (from the UK NIHR HTA- funded BASIL-1 trial, B-1) showing superior outcomes from bypass, in recent years, there has been an increasing trend towards treating patients with severe limb ischaemia (SLI) due to femoro-popliteal (FP) disease by angioplasty+/-stenting. This is frequently justified by claiming the results of endovascular revascularisation (ER) are likely to be significantly better now than in 1999-2004, when B-1 patients were randomised.

P4702Blood pressure lowering by peripheral arterial angioplasty

Abstract Objective We hypothesized that the endovascular treatment of flow limiting peripheral stenosis may decrease arterial blood pressure (BP). Methods We prospectively enrolled 381 consecutive patients with PAD scheduled for PTA. Clinical baseline characteristics and BP responses to PTA or angiography were analyzed. In a subgroup of 30 patients, we analyzed intra-procedural central aortic BP before and after PTA of iliac (n=15) and femoropoliteal arteries (n=10) and diagnostic angiography (n=5). Results Systolic BP (SBP) decreased after PTA of iliac (−19 mmHg, 95% CI: −15, −23 mmHg), femoropopliteal (−12 mmHg, 95% CI: −9, −15 mmHg), and BTK arteries (−7 mmHg, 95% CI: −1, −14 mmHg) but not after diagnostic angiography (−2 mmHg, 95% CI: 2, −6 mmHg) as compared to baseline. Diastolic BP (DBP) decreased after iliac (−5 mmHg, 95% CI: −2, −9 mmHg) and femoropopliteal (−4 mmHg, 95% CI: −1, −6 mmHg) angioplasty, but not after BTK PTA (1 mmHg, 95% CI: 6, −8 mmHg) or angiography (5 mmHg, 95% CI: −10, 12 mmHg). Mean central BP (CBP) acutely decreased after iliac (−20 mmHg [95% CI: −12, −32 mmHg] / −7 mmHg [95% CI: −6, −9 mmHg]) and femoropopliteal artery PTA (−9 mmHg [95% CI: −8, −12 mmHg] / −4 mmHg [95% CI: −3, −6 mmHg]) but not after diagnostic angiography. Iliac PTA achieved the most pronounced peripheral and central SBP lowering effect (p&lt;0.05, iliac PTA vs. all other). Baseline clinical and demographic characteristics of overall study population and break-down according to most proximal flow limiting stenosis (a) Baseline characteristics Total Iliac Fempop. BTK Diagnostic n (%) 381 (100) 119 (31) 208 (55) 39 (10) 15 (4) Age (yrs) 70±11 66±11 74±9 70±12 67±12 Male (%) 275 (72) 85 (71) 146 (70) 32 (82) 12 (80) Smoker (%) 241 (63) 98 (83) 114 (55) 20 (50) 9 (60) Hypertension (%) 337 (88) 106 (89) 187 (90) 32 (82) 12 (80) Hyperlipidemia (%) 290 (76) 100 (84) 149 (71) 29 (75) 12 (80) CAD (%) 268 (70) 91 (76) 144 (69) 24 (61) 9 (60) Diabetes (%) 207 (54) 30 (25) 142 (68) 26 (68) 9 (60) Renal failure (%) 167 (44) 38 (32) 101 (48) 22 (57) 6 (40) Antihypertensive treatment (%) 350 (92) 108 (90) 194 (93) 33 (86) 15 (100) Baseline ABI 0.53±0.10 0.56±0.12 0.53±0.1 0.48±0.09 0.54±0.14 ABI before discharge 0.9±0.12 0.94±0.12 0.92±0.11 0.86±0.14 0.54±0.14 pBP baseline vs. post PTA/Angio Conclusion Endovascular treatment of proximal PAD lowers significantly central and peripheral blood pressure. Effect size increases with more proximal lesions.

Benefit and Risk from Paclitaxel-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Background: Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of all-cause death. Methods: Randomised trials published between Jan 1, 2005 and Feb 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus plain old balloon angioplasty (POBA) for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality. Findings: Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the probability of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1·24 [95% CI 1·14- 2·27], I2 = 66%; 24-month RR 1·39 [95% CI 1·39-1·52], I2 = 21%). The risk of all-cause mortality was similar between groups at 12 months (RR 0·87 [95% CI 0·48-1·59]), and non-significantly increased after DCB angioplasty at 24 months (RR 1·53 [95% CI 0·94-2·50]). Interpretation: Efficacy of DCB for femoropopliteal angioplasty differs substantial across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of all-cause death at two years tended to be increased after DCB without evidence of causation. Trial Registration Number: This study is registered with ClinicalTrials.gov (NCT02927574). Funding Statement: The authors stated: There was no funding source for this study. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: This systematic review and meta-analysis was conducted according to the Preferred Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.

An Experimental Study of Paclitaxel Embolisation During Drug Coated Balloon Angioplasty

Drug coated balloons (DCB) improve the patency of femoropopliteal angioplasty but their use in infrapopliteal lesions is debateable as paclitaxel (PTX) particle embolisation has been suspected in some trials. The aim of this study was to compare experimentally five DCBs in terms of distal embolism of PTX. Twenty-five New Zealand rabbits were divided into five groups according to the DCB used: Lutonix (Bard), In.Pact (Medtronic), Passeo-18 Lux (Biotronik), Ranger (Boston Scientific), and Stellarex (Spectranetics) (n=5 in each group). After ligation of the right common iliac artery, a 4×40mm DCB was inflated in the infrarenal aorta for 180 seconds. Rabbits were euthanised two hours after inflation of the DCB. The infrarenal aorta, a blood sample and three left hind leg muscles (tensor fasciae latae [TFL], vastus lateralis [VL], and tibialis anterior [TA] muscles) were harvested for blind measurement of PTX concentrations and histological analysis (PTX emboli count). In the TA muscle (the most distal), concentrations of PTX were significantly lower for the Ranger (0.067ng/mg) than for the Lutonix (0.342ng/mg; p=.008), In.Pact (0.370ng/mg; p=.012), and Passeo-18-Lux (0.160ng/mg; p=.021) DCBs. Similarly, concentrations of PTX were significantly lower for the Passeo-18-Lux than for the In.Pact (p=.028). Concentrations of PTX were not significantly different between DCBs in the TFL and VL muscles. Concentrations of PTX were found to be significantly higher in the plasma and lower in the aorta and on the DCBs after use of Lutonix compared with the four other DCBs. Histological analysis revealed evidence of embolised PTX crystals in small arterioles of all muscle tissue samples without any significant difference between the DCBs. This study suggests some differences regarding distal embolisation profiles between the five assessed DCBs. Although clinical implications remain to be demonstrated, the present results may have implications when choosing a DCB, especially in a critical limb ischaemia setting.

Impact of calcification and infrapopliteal outflow on the outcome of endovascular treatment of femoropopliteal occlusive disease.

ObjectivesIn this paper, we report the long-term outcomes of the endovascular treatment of femoropopliteal occlusive disease, focusing on the importance of calcification and runoff outflow on limb salvage and patency, and the factors associated with these outcomes at a single center.MethodsThis retrospective cohort study included consecutive patients with femoropopliteal occlusive who underwent femoropopliteal angioplasty at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between January 2015 and July 2017.ResultsIn total, 86 femoropopliteal occlusive angioplasties were performed in 86 patients, with an initial technical success rate of 95.34%. The mean ± standard deviation follow-up time was 880 ± 68.84 days. The analysis was performed at 720 days. Technical failure occurred in four patients, who were excluded from the analysis, leaving 82 patients and 82 femoropopliteal occlusive angioplasties. The estimated primary patency, secondary patency, limb salvage, and overall survival rates at 720 days were 60%, 96%, 90%, and 82.5%, respectively. In univariate and multivariate analyses, Cox regression showed worse primary patency rates in patients with one tibial vessel or isolated popliteal artery runoff (p = 0.005), calcification grade 4 (p = 0.019), calcification grade > 2 (p = 0.017), small vessel diameter < 4 mm (p = 0.03) or primary angioplasty without stenting (p = 0.021). A univariate analysis showed worse limb salvage in patients with one tibial vessel or isolated popliteal artery runoff (p = 0.039).ConclusionsIn this study, the main factors associated with worse outcomes in the endovascular treatment of femoropopliteal occlusive in terms of loss of primary patency were one tibial vessel or isolated popliteal artery runoff, calcification grade 4, or calcification grade > 2, small vessel diameter < 4 mm, and no stents use. One tibial vessel or isolated popliteal artery runoff was also associated with limb loss in a univariate Cox regression analysis.

Safety and Outcomes of Ipsilateral Antegrade Angioplasty for Femoropopliteal Disease

Previous reports have suggested higher periprocedural complications after ipsilateral antegrade femoral arterial access (AA). We looked at a contemporary series comparing complication rates between AA and contralateral retrograde femoral arterial access (RA) for femoropopliteal angioplasty. A prospective review of all cases between 2010 and 2015 in a United Kingdom tertiary vascular center. Demographical and procedural data were obtained for those undergoing percutaneous femoropopliteal angioplasty. The primary outcome looked at periprocedural complications including retroperitoneal hematoma, pseudoaneurysm, hematoma requiring transfusion, arteriovenous fistulation, and surgical intervention. Secondary outcomes included contrast and radiation doses in addition to procedural failure leading to major amputation. A total of 556 (66% male) patients underwent femoropopliteal angioplasty, 461 (82%) via AA. Groups were of comparable age, sex, comorbidity, and symptomatology. AA patients had a lower body mass index, 26 versus 29 ( P = .005). No significant difference was seen in periprocedural (15.8% AA vs 11.6% RA; P = 0.292) or access site complications (3.7% AA vs 1.1% RA; P = 0.186). There was less need for a closure device, 40.3% AA vs 73% RA ( P < .01), less contrast, 94 mL AA: 114 mL RA ( P < .001), and less radiation, 3487 cGy cm2 AA: 9697 cGy cm2 RA ( P < .001). Arterial access was also associated with greater technical success of 83.8%: 73.3% RA ( P = .002). Arterial access is associated with higher technical success and reduced contrast/radiation doses with no significant difference in complications compared to RA contrary to previous reports.

Complex femoropopliteal angioplasty: short and mid term results

Complex femoropopliteal angioplasty: short and mid term results

Femoropopliteal angioplasty: Short- and mid-term results

Percutaneous endovascular therapy is becoming a primary option for managing femoropopliteal occlusive disease. The purpose of this study was to evaluate the mid-term results of endovascular treatment of femoropopliteal arterial disease. Femoropopliteal percutaneous transluminal angioplasty was performed on 162 consecutive limbs (160 patients) from January 2006 to January 2016. In our study, 87.6% of patients had critical limb ischemia. Lesions were classified as Trans-Atlantic Inter-Society Consensus (TASC) A (43%), B (43%), C (7%), and D (7%). Femoropopliteal interventions included angioplasty only in 70 cases (43.2%), and the remaining 92 (56.8%) received at least one stent. Technical success was achieved in 98.7% of patients, with three deaths and a major morbidity rate of 15%. The actuarial primary patency at 12 and 36 month was 65.4% and 40.2%, respectively, 33 peripheral reinterventions were performed after femoropopliteal axis occlusion, resulting in an actuarial primary limb preservation rate of 94.4 at 12 months. Comparison between angioplasty only and the use of stent show no difference in primary patency (P=0.832) and limb salvage (P=0.67). Negative predictors of primary patency determined by univariate analysis included popliteal location (P<0.001) and TASC D (P<0.001). However, diabetes mellitus (P=0.001) and poor run off (P<0.001) were the principal predictive factors of limb loss. Femoropopliteal angioplasty can be performed with a low morbidity and mortality. Intermediate primary patency is directly related to TASC classification and popliteal localization.

Intraprocedural Distal Embolization After Femoropopliteal Angioplasty: Is There a Role for Below-the-Knee Stents?

Intraprocedural distal embolization is an accepted complication of femoropopliteal angioplasty. The purpose of this study is to assess the use of below-the-knee stents in the "bail-out" of conventional methods. We retrospectively reviewed 1485 of femoropopliteal angioplasties that were performed in our centre in a 4-year period and analysed 12 cases (<1%) where distal embolization that required further intervention occurred. In all cases lesions were chronic and 75% suffered from critical limb ischaemia. The target vessel was the SFA in all of the cases with a long (>10cm) occlusion in 50%. A three-vessel run-off was present in only 25%. Patients that received a stent as a limb salvage attempt were analysed. Outcome measures were technical success, clinical success and procedure-related complications. Multivariate regression analysis of the factors related to stenting was also performed. In 41% of the cases with distal embolization, recanalization with aspiration, thrombolysis or angioplasty offered a satisfactory result. In 59%, conventional methods were ineffective; a stent was deployed in 85%, whereas in 15% surgical embolectomy was required. Technical and clinical success of the stent cases was 100% without any procedure-related complications. There was significance (p<0.05) between critical limb ischaemia and stenting; single-vessel run-off has also shown a positive trend (p=0.88). Stents appear as a valid salvage option for infragenicular distal embolization when conventional methods fail; the likelihood of having to use a stent is higher for patients with critical limb ischaemia and a single-vessel run-off.

Increased intermediate CD14++CD16++ monocyte subset levels associate with restenosis after peripheral percutaneous transluminal angioplasty

Background and aimsWe aimed at studying the association of three major human monocyte subsets after percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. MethodsWe prospectively studied 67 sequential patients (40 male, 27 female; mean age 71 ± 11 years) treated with femoropopliteal angioplasty. Multi-color flow cytometry characterized monocyte subsets from venous blood for expression of CD14 and CD16 and intracellular myeloperoxidase (MPO) prior to, and 3, 6 and 12 months post PTA. Analyses tested associations between monocyte subsets and risk for restenosis. Results16/67 patients (24%) developed restenosis within 12 months after PTA. Patients with hyperlipidemia had increased risk for restenosis (HR = 1.7, 95% CI 0.7–2.9, p = 0.001). Increased baseline monocytes associated with an increased risk of late restenosis (HR = 4.9, 95% CI: 1.3–18.6, p = 0.047). CD14++CD16++ ‘intermediate’ monocytes assessed at baseline, and after 3, 6, and 12 months significantly associated with the risk for subsequent restenosis: HR = 3.9 (95% CI: 2.4–6.5, p = 0.029), HR = 5.7 (95% CI = 0.7–44.7, p = 0.013), HR = 6.5 (95% CI: 2.5–16.9, p = 0.001) and HR = 1.5 (95% CI = 1.4–15.5 p = 0.001), respectively. Moreover, the probability for freedom of restenosis decreased with increased levels of intermediate subsets at 12 months after PTA. Additionally, intracellular MPO expression in CD14++CD16++ measured at 3, 6 and 12 months associated with an increased restenosis risk (HR = 1.5, 95% CI: 0.8–2.1, p = 0.214, HR = 1.9, 95% CI: 1.0–2.3 p = 0.051 and HR = 1.4, 95% CI: 1.0–1.8, p = 0.052). ConclusionsOur results imply altered innate immunity after angioplasty. Elevated CD14++CD16++ intermediate monocyte frequencies and increased MPO expression may identify individuals at heightened risk for restenosis.