Infrainguinal Arterial Disease Research Articles

Shockwave™ Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience

BackgroundCalcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. MethodsThis is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). ResultsA total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. ConclusionThe combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

Endovascular Therapy Provides Similar Results of Bypass Graft Surgery in the Treatment of Infrainguinal Multilevel Arterial Disease in Patients with Chronic Limb-Threatening Ischemia in All GLASS Stages

Extensive infrainguinal arterial disease still pose a challenge for technical and clinical success of percutaneous angioplasty. The purpose of this study was to compare the results of concomitant femoropopliteal and infrapopliteal percutaneous angioplasty/stenting (PTA/S) with distal bypass graft surgery (BGS) in patients with chronic limb-threatening ischemia (CLTI). In a single-center retrospective investigation between 2011 and 2017, 668 revascularization procedures for CLTI were reviewed. Concomitant femoropopliteal and infrapopliteal disease was identified in 153 CLTI patients, treated with BGS (48) using autogenous veins as substitute or PTA/S in a single procedure (105). A subgroup of patients with complex, extensive arterial lesions (GLASS stage III) received additional analysis. Primary outcomes were limb salvage and survival. The mean follow-up time was 21.4months. Patients treated with PTA/S were significantly older and with predominance of females, diabetes and chronic kidney disease. Smoking was more common in patients treated with BGS. The BGS group showed a 36-month survival rate of 73.4%, whereas the PTA/S group presented a survival of 61.3% in the same interval (P=0.25). The 36-month cumulative limb salvage rate was 53.3 and 59.7% for BGS and PTA/S, respectively (P=0.24). For GLASS stage III patients, 36-month limb salvage rates were 54.4% for the PTA/S group and 50.2% for the BGS group (P=0.29). Multivariate analysis pointed poor runoff status (all endovascular patients) and diabetes (GLASS III endovascular patients) as risk factors for limb loss. PTA/S and BGS presented similar results of limb salvage and survival in the treatment of concomitant femoropopliteal and infrapopliteal arterial disease in patients with CLTI, even for patients with extensive and complex arterial disease.

MORTALITY ANALYSIS IN PATIENTS UNDERGOING REVASCULARIZATION FOR INFRAINGUINAL ARTERY: INSIGHTS FROM NETWORK META-ANALYSIS

Risk of death after paclitaxel related devices for infrainguinal artery disease is actively debated and current evidences are conflicting regarding the association with mortality and paclitaxel. Our aim of this study was elucidating whether paclitaxel related devices increased the risk of death of

Effects of high-speed rotational atherectomy in peripheral artery disease patients with calcified lesions: a retrospective multicenter registry.

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12months compared to those who did not even after failed balloon angioplasty.

CRT-200.13 Shockwave Peripheral Intravascular Lithotripsy in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience.

Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. We present acute and intermediate outcome data from patients

Endovascular revascularisation in patients with necrotic wounds and extended infrainguinal arterial disease

To report own experience of endovascular interventions in patients with extended occlusive lesion (TASC II D) of the femoral-popliteal and tibial arteries and concomitant purulent-necrotic wounds. We have analyzed literature data and own experience of endovascular interventions in patients with extended occlusive lesion (TASC II D) of the femoral-popliteal and tibial arteries and concomitant purulent-necrotic wounds. Endovascular strategy is preferable in a certain subgroup of patients with extended infrainguinal lesions. Considering own data, we assumed the need for routine correction of outflow pathways (simultaneous angioplasty of at least 2 tibial arteries). Primary results are encouraging, but further research is required.

A Propensity-Matched Comparison for Bare Metal Stent and Covered Stent in the Management of Infrainguinal Arterial Obstructive Disease

Introduction - The aim of the study was to compare early and late results of bare metal stents and covered stents in the management of infrainguinal peripheral arterial obstructive disease (PAOD) in a retrospective single-centre matched case control study

Retrograde insertion of the outback reentry device from a tibial artery for complex infrainguinal recanalization

IntroductionRecanalization in an antegrade fashion in complex infrainguinal arterial disease can prove challenging and use of the Outback re-entry device via a retrograde approach may be an option.Case presentationUsing an antegrade approach we were unable to cross the native occluded superficial femoral artery in a patient after two occluded bypasses, with ulcers and was unfit for general anaesthesia.We successfully attempted retrograde re-entry using an Outback device via a phantom segment of the anterior tibial artery. After angioplasty and stenting a satisfactory result was achieved with one artery runoff.ConclusionsAt the 24 months follow up reconstruction was patent and ulcers were healed after 4 months.The outcome of more cases will be decisive for the broader applicability of this technique.

Duplex Surveillance after Primary Balloon Angioplasty or Directional Atherectomy for Treating Infrainguinal Arterial Disease

Duplex Surveillance after Primary Balloon Angioplasty or Directional Atherectomy for Treating Infrainguinal Arterial Disease

Influence of the metabolic syndrome on the results of the reconstructions in patients with infrainguinal artery disease

Summary. The aim of the study was to compare open and endovascular interventions in patients with infrainguinal arterial disease (IAD) against a metabolic syndrome (MS).
 Materials and methods. Results of treatment of 73 patients with IAD on MS background were studied. Patients were divided into two groups: 48 patients made up the basic group, they underwent endovascular interventions; 25 patients entered the control group they performed open operations. The value of bed-day, the degree of oxygenation of tissues, the dynamics of trophic disorders were analyzed. The duration of hospitalization of patients in the main group was less than in patients with open surgery. The dynamics of elimination of trophic disorders is more pronounced in patients of the main group.
 Conclusion. Endovascular interventions have a number of advantages over open operations in the treatment of IAD patients against the background of the metabolic syndrome: in relation to the number of so-called. “Large” complications, shunt interventions look less preferable.

Revascularization method for patients with infrainguinal arterial disease

Vessel Plus is an open acccess journal, which publishes articles related to vascular diseases, including acute respiratory distress syndrome, aneurysm, atherosclerosis, hypertension, stroke, peripheral vascular or pulmonary vascular diseases, etc.

IP191. Bare-Metal Stent and Covered Stent in the Management of Infrainguinal Arterial Obstructive Disease: A Case-Control Study∗

IP191. Bare-Metal Stent and Covered Stent in the Management of Infrainguinal Arterial Obstructive Disease: A Case-Control Study∗

Stent graft treatment for infra-inguinal arterial disease for either instent-restenosis and denovo lesions associated with very high rates of failure.

FDA approved the Gore Viabahn (WL Gore, Flagstaff, AZ, USA) stent for both femoro-popliteal arterial denovo and instent restenosis (ISRS) lesions. To date there is little data on Viabahn stent graft outcomes in ISRS arterial disease. Between 2007 and 2014 we identified 734 patients who underwent 1573 endovascular interventions in our institution for infra-inguinal revascularization. Among these, 48 patients had 143 Viabahn stents placed. Of these, 26 patients had 94 stents placed for ISRS and 22 patients had 49 stents placed for denovo lesions. The patients in the ISRS group were younger and more likely to have hypertension, hyperlipidemia, coronary artery disease, compared to the patients in the denovo group. Stents were placed principally for femoro-popliteal lesions, with mean length of 21 ± 12.5 cm (19.2 ± 14, ISRS vs. 22.1 ± 11, denovo; P = 0.2). Both groups had low primary patency rates during one year follow up (54% vs. 33%, OR = 2.3 (0.9-2.2). Target lesion revascularization (TLR) (57% vs. 27%, P < 0.0001, OR = 3.7, CI = 1.8-8) and surgical revascularization (21% vs. 4%, OR = 6.3, CI = 1.4-28) occurred more frequently in the ISRS group than in the denovo group. Amputation rate (17% vs. 31%, OR 0.7, CI = 0.2-1), cumulative blockage (defined as ISRS and thrombosis) (62% vs. 47%, P = 0.09, OR = 1.8, CI = 0.9-3.6), and Restenosis (40% vs. 31%, OR 1.5, CI = 0.7-3.2) were not statistically different between the two groups. Mean duration of follow-up was 12.8 ± 13 months. Stent graft treatment using the Gore Viabahn for denovo and ISRS in femoro-popliteal arterial obstructive disease have high restenosis and failure rates, of both stent patency and limb outcomes, which is consistent with existed literature.

Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease

ObjectiveThe optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. MethodsPatients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. ResultsOf 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). ConclusionsAn endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.

Endoluminal stents for iliac and infrainguinal arterial disease

Endoluminal stents for iliac and infrainguinal arterial disease

Fate of Immediately Failed Angioplasty for Infra-inguinal Arterial Disease

Background: Peripheral angioplasty for arterial disease is associated with low morbidity and mortality, short hospital stay and reduced cost. Concern exists about possible compromise of future bypass options if required. The objectives of this study were to determine the fate of the immediately failed angioplasty in our cohort of patients.

Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: the Belgian diabetic IN.PACT Trial

Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population. Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim. The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm. The treatment of diabetic PAD of the infra-inguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.

Endovascular Therapy for Infrainguinal Artery Disease With Coronary Devices: A Retrospective Observational Study Comparing Drug-Eluting Stents Versus Bioresorbable Vascular Scaffolds.

Several devices are available for infrainguinal endovascular therapy, with drug-eluting stents (DES) among the most promising. Bioresorbable vascular scaffolds (BVS) may further improve outcomes. We have liberally used in our practice coronary DES and BVS for infrainguinal endovascular therapy and hereby report our preliminary results. We conducted an observational study by retrospectively identifying characteristics of patients undergoing infrainguinal implantation of coronary DES or BVS. We compared the risk of major adverse events (MAE: death, amputation, or target vessel revascularization [TVR]) and components of MAE in the overall sample and after propensity matching. We included a total of 204 patients (207 limbs), 148 (72.5%) treated with DES and 56 (27.5%) with BVS. Bivariate analysis showed that TVR was less common in the DES group (41.9% vs 18.4%, P = .014). However, propensity-matched analysis showed nearly identical risks of MAE, amputation, TVR, or symptom burden with DES and BVS (all P > .05). In conclusion, the present pilot experience with coronary BVS suggests that they could provide acceptable results for infrainguinal endovascular procedures, comparable to those obtained by their metallic counterpart.

Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis

Rotational atherectomy with the use of the JetStream XC device is indicated for treatment of infrainguinal arterial obstructive disease. The number of blades-up (BU) runs needed for optimal tissue debulking in femoropopliteal in-stent restenosis (ISR) is unknown. In the present series, 6 patients (15 lesions) were treated for femoropopliteal ISR with the JetStream XC device. Minimal luminal diameter or percent stenosis improved significantly from baseline after 2 BU runs, but no further gain was seen between 2 and 4 BU runs (P > .05). However, adjunctive balloon angioplasty reduced percent stenosis significantly following BU runs. In conclusion, the JetStream XC device achieved optimal acute angiographic results in treating femoropopliteal ISR following 2 BU runs and adjunctive balloon angioplasty.

TCT-775 Rates, Predictors, and Risk Stratification of Mortality after Endovascular and Surgical Revascularization for Octogenarian Patients with Critical Limb Ischemia due to Infrainguinal Artery Disease

TCT-775 Rates, Predictors, and Risk Stratification of Mortality after Endovascular and Surgical Revascularization for Octogenarian Patients with Critical Limb Ischemia due to Infrainguinal Artery Disease