Endovascular Treatment Of Femoropopliteal Disease Research Articles

Long-Term Effects of Acute Kidney Injury Following Endovascular Femoropopliteal Intervention: Insights From a Multicenter Trial

Purpose: To examine the association between acute kidney injury (AKI) severity and duration with cardiovascular mortality, following endovascular treatment of femoropopliteal disease, and whether it is AKI in itself that confers an increased risk of cardiovascular mortality. Methods: A retrospective analysis of prospectively collected data obtained between 2014 and 2019 from 3 vascular centers. Renal function was followed up for a minimum of 90 days. Electronic records were queried to establish a cause of death, where applicable. Patients were excluded if unable to provide written informed consent or if presenting with acute limb ischemia. Primary outcomes were the hazard ratios for cardiovascular death (AKI patients vs no AKI; no AKI vs stage 1 AKI vs stage 3 AKI; and no AKI vs transient AKI vs established AKI). Propensity score–matched analysis was used to establish whether developing AKI, in patients with similar demographics and procedural characteristics, is associated with a higher risk of cardiovascular death. Results: Overall 239 patients developed AKI, and this was associated with an increased risk of cardiovascular mortality (hazard risk [HR]: 4.3, 95% confidence intervals [CIs]: 2.1–6.8, pairwise comparison p value=0.006]. This was dependent on the severity of the AKI stage (HR 5.4, 95% CI: 2.4–7.3, pairwise comparison p value=0.01) and duration (HR 4.2, 95% CI: 2.3–6.2, pairwise comparison p value=0.04). The propensity score–matched analysis showed that even when patients are matched for comorbidity and procedural characteristics, AKI confers an increased risk of mortality (p=0.04). Conclusions: Acute kidney injury is common after femoropopliteal endovascular therapy. It confers an increased risk of long-term cardiovascular mortality, which is still present when renal decline is transient, and highest for patients with established decline in renal function. Clinical Impact This is the first study in the setting of peripheral arterial disease to show that acute kidney injury has an adverse effect on cardiovascular mortality, in the long-term, that is dependent on its severity, and present even when the AKI is transient. We have also shown that this difference in cardiovascular mortality becomes more pronounced from the medium-term, and thus closer follow-up of these patients is required.

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®

Purpose The excellent performance of the Supera Peripheral Stent System ® by Abbott Vascular in femoropopliteal interventions has already been proven through several trials. This retrospective study aims to evaluate the durability and long-term patency of the Supera stent for the treatment of severe femoropopliteal lesions in a real-world population. Methods A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis. Results Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively (p = 0.001). Overall freedom from TLR after 12 and 24 months was 73.8% and 62.8% respectively. No significant patency differences were observed based on calcification rate. Conclusion Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study.

Background: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), most of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature.Design and methods: In this study we enrolled only patients who satisfied the inclusion criteria: i) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; ii) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow- up at 12-24 and 36 months to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value.Results: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled).Conclusions: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease. Significance for public health Peripheral artery disease (PAD) is a benign multifactorial condition associated with high morbidity and mortality; the femoral-popliteal axis is one of the most critical vascular districts due to its complex biodynamic. Although balloon angioplasty represents the first line treatment, it is not uncommon the use of stents in order to preserve patency vessel. Among different stents available, however, Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) has the ability to fit better to the femoro-popliteal compartment which is subject to biomechanical stress. The aim of this paper is to retrospectively analyze a multicentric experience with the use of a specific device (Supera peripheral stent) for treatment of PAD in femoral-popliteal disease, comparing results with Literature. Through this paper, every interventional radiologist interested in PAD endovascular treatment could have an important reference in order to perform the best management in this chronic and complex benign pathology.

A Single-Center Experience of Paclitaxel in the Treatment of Femoropopliteal Disease-No Evidence for an Association With Mortality.

Paclitaxel-coated devices have been increasingly used in endovascular treatment of femoropopliteal disease as they limit recurrence of lesions and improve patient outcomes. However, a recent meta-analysis reported that these devices increase mortality risk at 2 years post-intervention but did not account for confounding variables. Therefore, our goal was to evaluate mortality after paclitaxel treatment of femoropopliteal disease using patient-level data. We performed a retrospective review of all patients who received endovascular treatment for femoropopliteal lesions at our center between December 2009 and July 2017. There were 388 patients in the paclitaxel group and 314 control patients. Survival analysis with hazard ratios showed no difference between mortality in the paclitaxel and control groups. Age, renal insufficiency, and chronic limb-threatening ischemia were significant predictors of mortality. We also used logistic regression to evaluate mortality at 1, 2, and 5 years post-intervention and found no difference between the paclitaxel and control groups at any time point, while age, renal insufficiency, and chronic limb-threatening ischemia at the time of intervention were all associated with the risk of death. Finally, we tallied the causes of death in our cohort and found no difference in the distribution of causes between groups. Our single-center, retrospective study provides no evidence of increased risk of death with paclitaxel treatment in femoropopliteal disease. Contrastingly, age, renal insufficiency, and chronic limb-threatening ischemia were the most important factors contributing to mortality and therefore should be included as potential confounders in future studies assessing mortality in femoropopliteal disease.

Drug coated balloons in the superficial femoral artery.

Despite the progress in endovascular treatment of patients with peripheral arterial disease, restenosis remains the major drawback, especially in patients with femoropopliteal lesions. To reduce neointimal proliferation and subsequent restenosis the use of antiproliferative drug eluting devices was implemented in the endovascular treatment of femoropopliteal disease. Aiming to use the favorable effects of these antiproliferative agents and to reduce foreign body exposure in affected arteries, drug coated balloons (DCB) have been developed. Up to now, several randomized controlled trials have consistently demonstrated the superiority of DCB over uncoated balloon angioplasty in the treatment of femoropopliteal lesions. Similarly, DCB appear to have favorable effects on vessel patency in the treatment of femoropopliteal in-stent restenosis. However, there still is a need for further studies, especially addressing different lesion characteristics as well as the combinations of particular treatment modalities.

Impact of Chronic Kidney Disease on Clinical Outcomes of Endovascular Treatment for Femoropopliteal Arterial Disease

PurposeTo evaluate effect of chronic kidney disease (CKD) on all-cause mortality, major adverse limb event (MALE), MALE and postoperative death (MALE + POD), and amputation after endovascular treatment of femoropopliteal disease. Materials and MethodsA retrospective review from January 2002 to October 2011 was performed of 440 patients who underwent endovascular treatment of symptomatic femoropopliteal disease for claudication (n = 251) or critical limb ischemia (CLI) (n = 267). CKD stage was divided based on Kidney Dialysis Outcomes Quality Initiative classification. Outcomes and factors associated with amputation, MALE, and MALE + POD were determined. ResultsPatients with diabetes (hazard ratio [HR] = 2.2; 95% confidence interval [CI], 1.3–3.6; P = .002) and runoff score of 0 or 1 (HR = 2.0; 95% CI, 1.2–3.4; P = .01) relative to runoff score of 3 were at increased risk of amputation. Patients with baseline glomerular filtration rate < 45 mL/min/1.73 m2 had a 17% increase in amputation for every 5-point decrease < 45 mL/min/1.73 m2 (95% CI, 1.09–1.26; P < .001). Increase of 10 years in age (HR = 1.9; 95% CI, 1.5–2.3; P < .001), TransAtlantic Inter-Society Consensus class of C/D relative to A/B (HR = 1.6; 95% CI, 1.1–2.2; P = .01), and CLI (HR = 2.4; 95% CI, 0.5–0.9; P < .001) were associated with increased mortality. Female sex was associated with decreased risk of mortality (HR = 0.7; 95% CI, 0.5–0.9; P = .01). ConclusionsWorsening CKD is associated with higher amputation rates, all-cause mortality, and MALE + POD in patients undergoing endovascular treatment of femoropopliteal disease.

Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence.

Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease in patients with disabling claudication or chronic limb ischemia. The femoropopliteal artery crosses two joint structures (hip and knee joints) and courses through the muscular adductor canal in the thigh, which places the artery at increased biomechanical stress. There is a critical need for stent platforms with a reduced risk of stent fracture while maintaining patency during long-term follow-up. The Supera peripheral stent system has a braided nickel–titanium alloy stent designed to withstand the unique stressors along the course of the femoropopliteal artery. This design may be associated with improved patency in association with reduced stent fracture rates on short- and medium-term follow-up. Further studies, including randomized controlled studies, comparing the Supera interwoven nickel–titanium alloy stent system with other stent platforms and angioplasty alone are needed.

Abstract No. 330 - The effects of chronic kidney disease on patients undergoing endovascular treatment of femoropopliteal disease

Patient factors predicting positive outcomes after femoropopliteal angioplasty and stenting remain poorly delineated. Few studies have investigated the predictive value of TASC (TransAtlantic Inter-Society Consensus) II classification on patient outcomes. Chronic kidney disease (CKD) has been implicated in poor outcomes. The purpose of our study is to understand the effect of chronic kidney disease on initial TASC II classifications in regard to patient outcomes.

Cilostazol

Summary The prospective STOP-IC trial confirms the results of the majority of previous retrospective studies. Cilostazol reduces the restenosis rate after endovascular treatment of femoro-popliteal disease in Asian people and improves quality of life independently of the effect of the revascularization. Disclosures Dr Zeller reports receiving advisory board fees from Medtronic-Invatec and lecture honoraria from Cook, Bard-Lutonix, Medtronic-Invatec, Biotronik, and Bayer-Medrad. His institution received study grants from Eurocor, Cook, Bard-Lutonix, Medtronic-Invatec, Biotronik, and Bayer-Medrad. Dr Trenk reports receiving consulting fees from Boehringer Ingelheim, Daiichi Sankyo, and Eli Lilly and lecture fees from AstraZeneca, Bayer Vital, Daiichi Sankyo, Eli Lilly, and MSD. His institution received a grant from Eli Lilly.