TransAtlantic Inter-Society Consensus Classification Research Articles

Staged versus non-staged elective hybrid iliofemoral revascularization – analysis of ten years of prospective data

Reports of large series of hybrid iliofemoral revascularization for chronic lower limb ischemia are scarce. The aims of this study were to evaluate outcomes for staged and non-staged procedures, and to evaluate risk factors for outcomes at 90 days. Patients were consecutively included between 2013 and 2023. Surgical site infection (SSI) was defined by the ASEPSIS criteria and major adverse limb events (MALE) as onset of acute or continuing or worsening chronic limb ischemia or major amputation. Factors associated with outcomes were tested in a multivariable logistic regression analysis and expressed in Odds ratios (OR) with 95% confidence intervals (CI). Patients undergoing non-staged procedures (n=124) had higher TASC (Trans-Atlantic Inter-Society Consensus) class representing anatomical occlusive complexity, more often through-and through femoral guidewire access, more endoprosthesis, more covered stents, longer procedure time with open groin wounds, and less contralateral femoral access, than those undergoing staged procedures (n=31). The median time interval between the staged procedures was one day, and iliac stenting was done first in 77%. The median in-hospital stay was non-significantly longer in staged procedure (8 versus 6 days, p=0.053). The overall SSI and MALE rates were 25.8% and 20.0%, respectively, without differences between groups. Diabetes mellitus (OR 3.7, 95% CI 1.2 - 7.2]) and presence of a foot ulcer (OR 3.7, 95% CI [1.5 - 9.4]) were independently associated with MALE at 90 days. Postoperative hyperglycemia was non-significantly associated with SSI (OR 2.1 [95% CI 1.0 - 4.5], p=0.066) in multivariable analysis. The risks of SSI and MALE after elective hybrid iliofemoral revascularization were high. There appears to be no benefit in performing staged as opposed to non-staged procedures. The extent of iliofemoral occlusive disease according to the TASC classification had little influence on outcomes whereas diabetes mellitus and presence of a foot ulcer had greater impact on MALE.

Triglyceride-glucose index for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

To evaluate the triglyceride-glucose index (TyG index) for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents. Subjects with iliac artery stenosis, who underwent an iliac stent intervention and were followed up for at least 2 years were included in the study. Subjects were grouped according to TyG index (Group A, TyG index ≤8.848; Group B 8.849 ≤TyG index ≤9.382 and Group C TyG index ≥9.383). The subject's baseline characteristics, blood parameters, claudication distance, Transatlantic Intersociety Consensus classification, target lesion localization, stent direction, number of stents that were applied, and stent type were noted. Pre- and 1st and 2nd-year post-procedure Rutherford statuses, ankle-brachial index, and stenosis degree were recorded. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), Group B and Group C were combined and compared with Group A. In total, 255 subjects were evaluated (female, n=77-30.2%, male, n=178-69.8%). The mean age of the subjects was 66.00±10.00 years (range from 39 to 90 years). The pre-procedure Rutherford measurements were significantly different among the groups (p=0.001). The rates of mild claudication and resting pain in Group A were higher than those in Groups B and C. The rate of moderate claudication in Group C was higher than that in Groups A and B. The rate of severe claudication in Group B was higher than that in Groups A and C. One year after the procedure, there were more asymptomatic cases in Group A than in Groups B and C (p=0.001). The rate of mild claudication in Group C was lower than that in Groups A and B. The rate of moderate claudication in Group C was higher than that in Group A. The rate of severe claudication in Group C was higher than that in Groups A and B. Two years after the procedure, the Rutherford measurements and the rates of mild claudication in Groups A and B were higher than those in Group C. The rate of severe claudication in Group C was higher than that in Groups A and B (p=0.001). One year after the procedure, the computed tomography angiography (CTA) measurements and the rate of full patency in Group A were higher than that in Groups B and C. The rate of 0-50% stenosis in Group B was higher than that in Groups A and C. The rate of 50-70% stenosis in Group C was higher than that in Group A. Two years after the procedure, the CTA measurements and the rates of 70-99% stenosis and 100% occlusion in Group C were higher than those in Groups A and B. The TyG index has high specificity and NPV. However, specificity and PPV levels were found to be quite low. The TyG index was found to be an easy-to-use marker for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

Endovascular retrieval of an elongated Supera stent

Stenting is used to achieve artery patency, and the Supera stent, a self-expanding interwoven nitinol stent, has produced good clinical outcomes. A 70-year-old woman with peripheral artery disease had experienced intermittent claudication (Fontaine stage IIb). Endovascular treatment was performed for a chronic total occlusion TransAtlantic InterSociety Consensus class II type B lesion. A Supera stent (Abbott Vascular, Santa Clara, CA) was used. However, it had become severely elongated to the proximal end in the superficial femoral artery and was removed using a balloon inserted from the side and trapped to the guide sheath with the distal end of the stent outside the sheath. After this bailout, an alternate stent could be placed through an antegrade approach to the contralateral common femoral artery.

Embolic Protection Devices are Not Associated with Improved Outcomes of Atherectomy for Lower Extremity Revascularization

Atherectomy is associated with a risk of distal embolization, but the role of embolic protection devices (EPDs) during atherectomy is not well-defined. This study examines the utilization and impact of EPD on the outcomes of atherectomy during peripheral vascular interventions (PVIs). The annual trend in utilization of EPD during atherectomy in the Vascular Quality Initiative PVI files (2010-2018) was derived. Patients with concomitant open surgery, acute limb ischemia, emergent-status, concomitant thrombolysis, missing indication, missing EPD use, and missing long-term follow-up data were excluded. The characteristics of patients undergoing atherectomy with and without EPD were compared. Propensity matching based on age, gender, race, chronic obstructive pulmonary disease, coronary artery disease, end-stage renal disease, prior PVI, indication, urgent-status, TransAtlantic interSociety Consensus classification, and anatomical location of lesion was performed. The perioperative and 1-year outcomes of the matched groups were compared. EPD was used in 23.3% of atherectomy procedures (n=5,013/21,500). The utilization of EPD with atherectomy increased from 8.8% to 22.7% (P=0.003) during the study period. Patients undergoing atherectomy without EPD were more likely to have ESRD (7.8% vs. 5.2%; P<0.001), tissue loss (31% vs. 23.1; P<0.001), tibial intervention (39.6% vs. 23.3%; P<0.001), higher number of arteries treated (1.78±0.92 vs. 1.68±0.93; P=0.001), and longer length of lesion (21.15±21.14 vs. 19±20.27cm; P=0.004). Conversely, patients undergoing atherectomy with EPD were more likely to be White (81.1% vs. 74%; P<0.001), have a history of smoking (80.6% vs. 74.5%; P<0.001), chronic obstructive pulmonary disease (24.8% vs. 21.6%; P<0.037), coronary artery disease (38.5% vs. 33.2%; P=0.002), prior percutaneous coronary intervention (24.3% vs. 19.9%, P=0.005), prior coronary artery bypass grafting (32.3% vs. 24.9%; P<0.001), and prior PVI (49.2% vs. 45.1%; P=0.023). After propensity matching, there were 1,007 patients in each group with no significant difference in baseline characteristics. There was no significant difference in short-term outcomes including the rate of distal embolization, technical success, dissection, perforation, discharge to home, and 30-day mortality. The use of EPD was, however, associated with longer fluoroscopy time. At 1-year, there was also no difference in primary patency, ipsilateral minor or major amputation, ankle brachial index improvement, reintervention, or mortality rate between patients who underwent atherectomy with and without EPD. EPD has been increasingly used in conjunction with atherectomy especially in patients with claudication and femoropopliteal disease. However, the use of EPD during atherectomy does not seem to impact the outcomes. Further research is needed to justify the additional cost and fluoroscopy time associated with the use of EPD during atherectomy.

Society for Vascular Surgery femoral runoff score is associated with limb-based patency after aortofemoral bypass

ObjectiveDespite advancements, aortofemoral bypass (AFB) remains the most durable option for aortoiliac occlusive disease. Although runoff has been shown to be associated with AFB patency, the association of the Society for Vascular Surgery (SVS) thigh runoff scoring system with patency has not been assessed. The aim of the present study was to evaluate the association between the SVS runoff scoring system and limb-based primary patency after AFB. MethodsInstitutional data for patients undergoing AFB with preoperative runoff imaging available from 2000 to 2017 were queried. Runoff scores were assigned according to the presence of occlusive disease in the superficial femoral artery and profunda femoris artery (minimum, 1; maximum, 10) as described by the 1997 SVS reporting standards for lower extremity ischemia. Limb-based patency was the primary endpoint. Kaplan-Meier analysis was used to compare the long-term limb-based patency and freedom from reintervention between limbs with runoff scores ≥6 and those with runoff scores <6. Propensity score-weighted Cox proportional hazards modeling was used to evaluate the association between a runoff score of ≥6 and primary patency loss, controlling for other factors associated with primary patency. ResultsIn 161 patients, 316 limbs had undergone revascularization. The mean patient age was 66.7 ± 11.3 years, and 51.6% were women. Most limbs had undergone revascularization for claudication (56.5%). Most (89.4%) had TransAtlantic InterSociety Consensus class D lesions, 27.3% had required suprarenal or higher clamping, and 11.2% had undergone concomitant mesenteric intervention. A femoral outflow adjunct and concurrent lower extremity bypass was required in 41.8% and 2.9% of limbs, respectively. Those with a runoff score of ≥6 had experienced greater rates of 30-day myocardial infarction (11% vs 1%; P = .005), respiratory failure (11% vs 1%; P = .005), and mortality (8% vs 0%; P ≤ .006). The median follow-up period was 4.0 years (interquartile range, 6.5 years). The 1-, 3-, and 5-year primary patency was 94.6% (95% confidence interval [CI], 91.9%-97.3%), 89.2% (95% CI, 85.4%-93.2%), and 81.4% (95% CI, 76.0%-87.1%), respectively. The 5-year primary-assisted patency, secondary patency, and freedom from reintervention were 84.9% (95% CI, 79.7%-90.5%), 91.7% (95% CI, 87.3%-96.3%), and 83.3% (95% CI, 78.3%-88.7%), respectively. Patients with a runoff score of ≥6 had lower primary (log-rank P < .01), primary-assisted (P < .01), and secondary patency (P = .01). The factors associated with the loss of primary patency included a high runoff score (runoff score of ≥6: hazard ratio [HR], 4.1; 95% CI, 2.1-8.0; P < .01), simultaneous mesenteric endarterectomy (HR, 13.5; 95% CI, 1.9-97.8; P = .01), and chronic kidney disease (HR, 4.6; 95% CI, 1.5-14.6; P = .01). Increasing age (HR, 0.94 per year; 95% CI, 0.91-0.97; P < .01) and hyperlipidemia (HR, 0.44; 95% CI, 0.23-0.85; P = .01) were protective. ConclusionsThe SVS femoral runoff score is an important factor associated with long-term AFB limb patency. Scores of ≥6 portend for worse limb outcomes and a greater incidence of operative complications. The SVS score can be determined from preoperative axial imaging studies and serve as a guide in decision-making and operative planning.

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions.

PurposeDrug-coated balloons have shown successful results in treating peripheral arterial occlusive disease. However, using multiple balloons for long femoropopliteal lesions (>15 cm) remains challenging; their safety and efficacy need to be explored. Therefore, we aimed to evaluate the outcomes of multiple drug-coated balloons for long femoropopliteal lesions in terms of the primary patency, freedom from clinically-driven target lesion revascularization, and mortality.MethodsBetween April 2015 and September 2018, 96 patients (117 limbs) who underwent balloon angioplasty using at least 2 drug-coated balloons for femoropopliteal lesions were retrospectively reviewed. Lesions were classified as Trans-Atlantic Inter-Society Consensus (TASC) classification C or D. The outcomes were analyzed using Kaplan-Meyer analysis.ResultsThe mean age of 96 enrolled patients was 70.8 ± 9.8 years, and 83 patients were males (86.5%). Critical limb-threatening ischemia was found in 29 cases (24.8%). The mean lesion and drug-coated balloon lengths per limb were 292.3 ± 77.8 mm and 325.0 ± 70.2 mm, respectively. The technical success rate was 99.2%. A total of 82.1% were followed-up for more than 6 months. The primary patency rates at 12 and 24 months were 71.4% and 41.7%, respectively; freedom from clinically-driven target lesion revascularization rates were 96.4% and 71.0% at 12 and 24 months, respectively. The Kaplan-Meier estimate of the 2-year overall cumulative mortality rate was 20.8%. All identified mortalities appeared to be less associated with paclitaxel.ConclusionDrug-coated balloons can be effectively used without drug-related mortality, even for long lesions, such as TASC classification C or D femoropopliteal lesions.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Outcomes of Treatment With Paclitaxel-Coated Devices for Peripheral Arterial Disease

Treatment of femoropopliteal peripheral artery disease using paclitaxel-coated devices (PCD) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with the use of this technology. Although subsequent studies have found no association with mortality, real-world data are lacking. Thus, the aim of this study is to investigate real-world outcomes and causes of mortality of patients treated with PCD. Patients who underwent endovascular interventions for peripheral artery disease from 2013 to 2016 at a single institution were reviewed. Patients were stratified based on the use of PCD. The cumulative dose of paclitaxel over a 3-year period was calculated among patients who received multiple interventions. Causes of mortality were identified and compared between the two groups. There were 138 (37.7%) patients who received an endovascular intervention with a PCD and 228 (62.3%) who received an endovascular intervention without paclitaxel. Patients treated with PCD were less likely to have prior open surgery compared to patients treated without paclitaxel. There were no differences in indication, TransAtlantic Inter-Society Consensus classification, or 30-day outcomes between the two groups. After 3-year follow-up, there was no difference in primary patency, reintervention rate, mean number of reinterventions, amputation (5.1% vs 3.5%; P = .465), or mortality (15.9% vs 19.7%; P = .363) between the PCD and non-PCD groups (Table). There was also no overall difference in the causes of mortality with and without PCD use or in the Kaplan-Meier survival curves (Figure). Furthermore, the use of PCD was not associated with an increased risk of mortality in Cox regression analysis. The cumulative dose of paclitaxel in patients treated with PCD ranged from 383 to 49,259 μg with a median dose of 7561 μg. Comparison of patients treated with cumulative doses of paclitaxel in the upper 50th percentile compared to the lower 50th percentile showed no significant difference in mortality (13.0% vs 19.1%; P = .333). PCD use is safe and not associated with an increased risk of long-term mortality in this study. However, PCD use was not associated with improved LER outcomes. Continued monitoring of PCD is warranted to ensure safety and efficacy of this new technology in a real-world setting.TableDemographics, comorbidities, procedural characteristics, and outcomesNon-PCD paclitaxelPCDP valueDemographics and comorbidities No. of patients228138 Age (years)69.7 ± 11.469.7 ± 11.6.866 Male sex148 (64.9)89 (64.5).935 Race.693White171 (77.0)102 (77.7)African American33 (14.9)16 (12.2)Other18 (8.1)13 (9.9) Body mass index27.5 ± 5.929.2 ± 6.4.015 Diabetes120 (52.6)73 (52.9).960 Hypertension205 (89.9)133 (96.4).024 Coronary artery disease133 (58.3)75 (54.4).456 Chronic renal insufficiency31 (13.7)26 (18.8).192 Smoking.250Nonsmoker37 (16.4)30 (21.7)Former116 (51.3)73 (52.9)Current73 (32.3)35 (25.4) Prior endovascular revascularization53 (23.4)31 (22.5).846 Prior open revascularization30 (13.2)8 (5.8).025 Preoperative ABI0.7 ± 0.30.8 ± 0.3.290 Indication.195Asymptomatic5 (2.2)1 (0.7)Claudication131 (57.5)91 (65.9)Chronic limb-threatening ischemia92 (40.4)46 (33.3)Medications Antiplatelet192 (84.2)109 (79.0).205 Statin161 (70.6)99 (71.7).818Procedure characteristics TASC classification.227TASC A24 (26.1)22 (23.4)TASC B29 (31.5)22 (23.4)TASC C12 (13.0)9 (9.6)TASC D27 (29.4)41 (43.6)30-Day outcomes Return to operating room16 (7.3)9 (6.8).872 Any complication34 (14.9)17 (12.3).487 Mortality4 (1.75)0 (0.0).1183-Year outcomes Primary patency73 (52.4)45 (42.9).150 Ipsilateral reintervention67 (29.4)53 (38.4).075 Ipsilateral major amputation8 (3.5)7 (5.1).465 All-cause mortality45 (19.7)22 (15.9).363Deaths.807 No. of patients4522 Cause of deathCardiovascular12 (26.7)9 (40.9)Cancer5 (11.1)1 (4.5)Respiratory2 (4.4)2 (9.1)Neurologic1 (2.2)0 (0.0)Gastrointestinal2 (4.4)1 (4.6)Renal0 (0.0)0 (0.0)Infectious8 (17.8)3 (13.6)Other/unspecified15 (33.3)6 (27.3)ABI, Ankle-brachial index; PCS, paclitaxel-coated device; TASC II, Inter-Society Consensus of the Management of Peripheral Artery Disease.Values are mean ± standard deviation or number (%), unless otherwise indicated. Open table in a new tab

The Correlation of the Trans-Atlantic Inter-Society Consensus Classification to Outcomes of Pedal Amputations

In an attempt at limb salvage for patients with peripheral arterial disease, revascularization is often performed prior to pedal amputation. The purpose of this study was to evaluate the association between proximal arterial lesions, based on Trans-Atlantic Inter-Society Consensus aortoiliac, femoropopliteal, and infrapopliteal classifications, and healing pedal amputations post endovascular revascularization. Patients with revascularization up to 90 days prior to pedal amputation with a minimum of 12 months postoperative follow-up were included. Each level of proximal disease was subdivided into Trans-Atlantic Inter-Society Consensus classifications A through D, which range in severity from a single short stenosis or occlusion to more complex stenoses and chronic total occlusion. For comparison, we categorized A and/or B lesions into Group 1 and C and/or D lesions into Group 2. The frequency of proximal lesions was recorded as either isolated, bi-level, or multilevel disease. Chi-square and Fisher's exact tests were used to compare categorical variables. Of the 310 patients, there were a total of 68 aortoiliac, 256 femoropopliteal, and 172 infrapopliteal lesions; 140 patients had isolated lesions, 154 had bi-level disease, and 16 had multilevel disease. Although not statistically significant, patients in Group 1 (A and/or B lesions) had higher proportion of failed amputation compared to Group 2 (C and/or D lesions) in either aortoiliac (84.4% vs 15.6%, p = .17), femoropopliteal (61.2% vs 38.8%, p = .72), or infrapopliteal (57.3% vs 42.7%, p = .44). Bi-level disease showed a higher proportion of failure (50.6%) compared to isolated lesions (43.8%) and multilevel disease (5.6%), (p = .86). To our knowledge, this is the first study to evaluate the association between Trans-Atlantic Inter-Society Consensus arterial lesions and incisional healing of pedal amputations. Despite our belief, there was no correlation between patients with simple, isolated lesions compared to either complex arterial lesions or multilevel disease in healing pedal amputations.

Outcome benefit of arterial duplex stent imaging after superficial femoral artery stent implantation

ObjectiveIn-stent stenosis is a frequent complication of superficial femoral artery (SFA) endovascular intervention and can lead to stent occlusion or symptom recurrence. Arterial duplex stent imaging (ADSI) can be used in the surveillance for recurrent stenosis; however, its uniform application is controversial. In this study, we aimed to determine, in patients undergoing SFA stent implantation, whether surveillance with ADSI yielded a better outcome than in those with only ankle-brachial index (ABI) follow-up. MethodsWe performed a retrospective analysis of all patients undergoing SFA stent implantation for occlusive disease at a tertiary care referral center between 2009 and 2016. The patients were divided into those with ADSI and those with ABI follow-up only. Life-table analysis comparing stent patency, major adverse limb events (MALEs), limb salvage, and mortality between groups was performed. ResultsThere were 248 patients with SFA stent implantation included, 160 in the ADSI group and 88 in the ABI group. Groups were homogeneous in clinical indications of claudication and critical limb-threatening ischemia (for ADSI, 39% and 61%; for ABI, 38% and 62%; P = .982) and TransAtlantic Inter-Society Consensus class A, B, C, and D lesions (for ADSI, 17%, 45%, 16%, and 22%; for ABI, 21%, 43%, 16%, and 20%; P = .874). Primary patency was similar between groups at 12, 36, and 56 months (ADSI, 65%, 43%, and 32%; ABI, 69%, 34%, and 34%; P = .770), whereas ADSI patients showed an improved assisted primary patency (84%, 68%, and 54%) vs ABI patients (76%, 38%, and 38%; P = .008) and secondary patency. There was greater freedom from MALEs in the ADSI group (91%, 76%, and 64%) vs the ABI group (79%, 46%, and 46%; P < .001) at 12, 36, and 56 months of follow-up. ADSI patients were more likely to undergo an endovascular procedure as their initial post-SFA stent implantation intervention (P = .001), whereas ABI patients were more likely to undergo an amputation (P < .001). ConclusionsIn SFA stent implantation, patients with ADSI follow-up demonstrate an advantage in assisted primary patency and secondary patency and are more likely to undergo an endovascular reintervention. These factors are likely to have effected a decrease in MALEs, indicating the benefit of a more universal adoption of post-SFA stent implantation follow-up ADSI.

From the Aortic Bifurcation to the Groin: Long-term Outcomes of Covered Kissing Stent Placement in Combination with Iliofemoral Reconstruction for Extensive Iliofemoral Occlusive Disease

The aim of this study was to evaluate outcomes of extensive iliofemoral reconstruction combining both iliac covered kissing stents (ICKS) with stenting of the external iliac artery (SEIA) and/or surgical femoral endarterectomy (SFE). From November 2010 to November 2017, patients with extensive iliofemoral occlusive disease-classified as Trans-Atlantic Inter-Society Consensus class D-treated by ICKS in combination with SEIA and/or SFE were included. Patients received ICKS+SEIA, ICKS+SFE, or ICKS+SEIA+SFE. Demographics, procedure details, and postoperative outcomes were recorded. Primary end points were primary patency (PP), primary assisted patency (PAP), and secondary patency (SP). Long-term patency was assessed by annual clinical and ultrasonographic examination. Among 156 consecutive ICKS procedures performed during the study period, 59 patients were included (81% men; median age, 65years). In all, 32 patients (54%) underwent ICKS+SEIA, 17 (29%) patients underwent ICKS+SFE, and 10 (17%) patients underwent ICKS+SEIA+SFE. Operative indication was either disabling claudication (n=46, 78%) or critical limb-threatening ischemia (n=13, 22%). A total of 92 limbs were revascularized, including 121 covered balloon-expandable stents and 65 self-expanding nitinol stents, with 100% technical success. Thirty-day mortality was 3% (2/59) and 5 (8%) patients suffered from local complications, with no early reintervention. Long-term patency rates were as follows: at 2years, overall PP, PAP, and SP were 82%, 86%, and 96%, respectively; at 5years, overall PP, PAP, and SP were 73%, 79%, and 95%, respectively. After a mean follow-up of 34±29months, 25% (15/59) patients underwent late reinterventions for either de novo iliac or femoral stenosis (n=9), iliac occlusion (n=4), or external iliac in-stent restenosis (n=2). Treatment of extensive iliofemoral occlusive disease involving ICKS in combination with SEIA and/or SFE is safe and effective, providing satisfactory long-term secondary patency, at the price of a significant reintervention rate.

Incidence of Distal Embolization during Peripheral Intervention using the NAV-6 Embolic Protection System

Purpose: To compare the rates of embolic debris (ED) generation during lower extremity arterial interventions and evaluate the safety and efficacy of the using an embolic protection device (EPD). Methods: This was a single-center retrospective review of 111 patients (114 vessels) having undergone peripheral arterial intervention with the use of an EPD (Emboshield NAV-6 device). A database was created through review of the electronic health record and images in PACS. The presence of ED was determined through visual inspection after retrieval of the device or from filling defects identified during digital subtraction angiography with the device deployed. Descriptive statistics were used to report the demographic and clinical information. Relative frequencies of debris generation were determined for vessel type, trans-atlantic inter-society consensus (TASC) classification, and type of intervention. Differences in frequencies between groups weer evaluated with the Chi-square test, and associations were examined using the logistic regression analysis. Results: Of the 114 vessels treated, 16 (14%) demonstrated true distal embolization (DE) past the filter basket and 58 (51%) demonstrated generation of ED as determined by filling of the filter basket. This was significantly higher in patients undergoing atherectomy (70%) compared with those undergoing thrombolysis (38%) or angioplasty with or without stenting (29%) (P &lt; 0.001). Of those patients undergoing atherectomy, laser atherectomy had the lowest rate of DE (26%) compared with either orbital (67%) or directional atherectomy (57%) (P &lt; 0.05). In regression analysis, atherectomy was the only factor with significant association with detection of ED (odds ratio: 4.52, P &lt; 0.0001). There was no statistically significant difference in the frequency of debris generated based on vessel type or TASC classification. Conclusion: The frequency of ED is higher in patients undergoing atherectomy versus patients undergoing lysis or percutaneous transluminal balloon angioplasty with or without stenting. Laser atherectomy has a lower frequency of debris generation when compared to either orbital or directional atherectomy.

Trans-Atlantic Inter-Society Consensus Class D Aortoiliac Lesions: A Comparison of Endovascular and Open Surgical Outcomes

OBJECTIVE. The purpose of this study is to compare the clinical and safety outcomes between two groups of patients with Trans-Atlantic Inter-Society Consensus class D (TASC II D) aortoiliac occlusive disease (AIOD): those with higher-risk comorbidity who underwent endovascular reconstruction and those with lower-risk comorbidity who underwent surgical bypass. MATERIALS AND METHODS. Thirty-two consecutive patients with symptomatic TASC II D AOID who underwent surgical bypass or endovascular reconstruction from 2012 to 2017 were retrospectively reviewed. Lesion characteristics, technical approach, survival, limb salvage, patency, and change in clinical symptoms were analyzed. RESULTS. Nineteen patients with higher comorbidity underwent endovascular reconstruction, whereas 13 patients with lower comorbidity underwent surgical bypass. Patients undergoing endovascular reconstruction had an older median age (67.0 vs 62.0 years; p = 0.007), higher rates of hypertension (94.7% vs 61.5%; p = 0.018) and coronary artery disease (26.3% vs 0%; p = 0.044), and advanced renal impairment (mean [± SD] chronic kidney disease stage, 1.4 ± 1.5 vs 0.7 ± 1.3; p = 0.005). There were no significant differences in Rutherford classification between the groups. During long-term follow-up of 2.76 years, endovascular reconstruction and surgical bypass showed equivalent rates of survival (89.5% vs 84.6%; p = 0.683), limb salvage (100.0% vs 92.3%; p = 0.219), and primary or primary-assisted patency (85% vs 85%; p = 0.98). Groups showed similar clinical improvements in walking distance, rest pain, and tissue loss at 30 days (95% vs 85%; p = 0.158) and at long-term follow-up (74% vs 62%; p = 0.599). CONCLUSION. For properly selected patients, the clinical outcomes of endovascular reconstruction versus surgical bypass for TASC II D AOID may be equivalent at 2.5 years after the procedure. The decreased operative risk associated with endovascular reconstruction suggests that it is the technique of choice for high-risk patients.

IP221. Updated Tibial TransAtlantic Inter-Society Consensus Classification System Fails to Show Improved Differentiation in Outcomes After Endovascular Intervention

IP221. Updated Tibial TransAtlantic Inter-Society Consensus Classification System Fails to Show Improved Differentiation in Outcomes After Endovascular Intervention

Outcomes of infrageniculate retrograde versus transfemoral access for endovascular intervention for chronic lower extremity ischemia

ObjectiveRetrograde infrageniculate access is an alternative treatment strategy for patients who have failed to respond to antegrade endovascular intervention. This study compares the outcomes of infrageniculate retrograde arterial access with the conventional transfemoral access for the endovascular management of chronic lower extremity ischemia. MethodsThis was a retrospective single-center review of retrograde endovascular intervention (REI) from 2012 to 2016. Indications for intervention, comorbidities, complications, procedural success, limb outcomes, and mortality were analyzed. Technical failure was defined as the inability to complete the procedure because of failed access or unsuccessful recanalization. Infrageniculate access and transfemoral access were obtained with ultrasound or angiographic roadmap guidance. Patency rates were calculated for technically successful interventions. ResultsThere were 47 patients (85% presenting with critical limb ischemia) who underwent sheathless REI after failed antegrade recanalization of TransAtlantic Inter-Society Consensus class D infrainguinal lesions, whereas 93 patients (83% with critical limb ischemia) underwent standard transfemoral access. There were 16 (34%) femoropopliteal, 14 (30%) tibial, and 17 (36%) multilevel interventions in the retrograde group compared with 41 (41%) femoropopliteal, 20 (20%) tibial, and 39 (39%) multilevel interventions in the transfemoral group. Access sites for the retrograde group included the dorsalis pedis (26%), midcalf peroneal (24%), anterior tibial (22%), posterior tibial (26%), and popliteal (2%) arteries. Overall technical success was achieved in 57% of the retrograde group compared with 78% of the transfemoral group. Mean follow-up was 20 months (range, 1-45 months). There were no significant differences in the primary patency rates between the two groups at 1 year and 2 years. The primary assisted patency rates were significantly better in the transfemoral group at 1 year (66% vs 46%; P = .031) and 2 years (56% vs 29%; P = .031). The secondary patency rates were higher in the transfemoral group at 1 year (93% vs 83%; P = .079) and 2 years (91% vs 76%; P = .079), although this did not reach statistical significance. The rate of reintervention was 41% for the retrograde group vs 40% for the transfemoral group. Most of the reinterventions (70% in the retrograde group and 61% in the transfemoral group) were endovascular interventions for a restenosis or occlusion. ConclusionsInfrageniculate access for REI can result in primary patency rates similar to those of antegrade interventions and does not compromise the access site. Technical failure is high in this initial experience and is mostly due to failed recanalization. Limb salvage may be achieved after technical failure with either repeated antegrade intervention or surgical bypass.

Recanalization of native superficial femoral artery chronic total occlusion after failed femoropopliteal bypass in patients with critical limb ischemia.

This study aimed to examine the outcomes of endovascular recanalization for native superficial femoral artery (SFA) chronic total occlusion (CTO) in patients with critical limb ischemia (CLI) after femoropopliteal bypass failure with limited surgical revascularization options. Endovascular recanalization of native artery occlusions has been recently used as a new alternative for threatened limbs after bypass graft occlusion. The feasibility and efficacy has not been widely reported. We retrospectively analyzed 45 consecutive patients (45 limbs) undergoing endovascular recanalization of native SFA occlusion following failed femoropopliteal bypass between June 2010 and December 2016. All limbs had Transatlantic Inter-Society Consensus class C (26.7%, 12/45) or D (73.3%, 33/45) lesions with a mean lesion length of 29.8 cm. The technical success rate was 95.6% (43/45 limbs). The ABI showed a significant increase from 0.3 ± 0.1 pre-procedure to 0.7 ± 0.1 post-procedure (P < 0.01). Two early (<30 days) below-knee amputations due to acute thrombotic ischemia occurred during perioperative period and resulted in one death due to myocardial infarction. The mean follow-up was 42.7 months (1-62 months). Two patients were lost to follow up. The primary patency rates at 12 and 36 months were 54% and 51%, respectively. Secondary patency rates at 12 and 36 months were 78% and 61%, respectively. Limb salvage rate was 95% and amputation-free survival rate was 88% at both 12 and 36 months. Recanalization of native SFA CTO due to failed femoropopliteal bypass offers a feasible and safe alternative to surgical reconstruction with acceptable limb salvage.

Retrograde Popliteal Access to Percutaneous Peripheral Intervention for Chronic Total Occlusion of Superficial Femoral Arteries.

The aim of this study is to present our initial experience with the use of the retrograde popliteal artery access in patients with chronic total occlusions of superficial femoral artery (SFA). From July 2012 to May 2014, a total of 28 patients (20 men, mean age 61.2 ± 11.5 years) with total occlusion of the SFA and good distal runoff were treated with percutaneous atherectomy, balloon angioplasty, and stenting (mean length 165.3 ± 57.5 mm, range 72-336 mm). All patients had severe claudication or critical limb ischemia, and most of the lesions were TransAtlantic Inter-Society Consensus classification type D (n = 21). Technical success was achieved in all cases. In majority (26, 92.8%) of the patients, endoluminal recanalization was possible from the popliteal access; SFA recanalization in the other 2 cases was obtained through the subintimal space. During a mean follow-up of 12.9 ± 2.5 months, claudication, severity, rest pain, and toe ulcers improved significantly. Ankle-brachial index changed from 0.54 ± 0.11 to 0.91 ± 0.2 at 1 year after intervention ( P < .001), and patency rates at 1, 6, and 12 months after interventions were 100%, 92.8%, and 85.7%, respectively. One pseudoaneurysm and 1 arteriovenous fistula were found in the popliteal region on duplex examinations. There were 2 in-stent restenosis and 3 occlusions during the 12-month follow-up. These occlusions were treated with reendovascular procedures. Our secondary patency rate was 96.4%. No stent fracture was observed. The retrograde popliteal artery approach under duplex guidance can be considered as safe, efficient, and the primary SFA recanalization strategy in carefully selected patients, with competitive immediate 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.

Elevated serum phosphate levels are associated with decreased amputation-free survival after interventions for critical limb ischemia

ObjectiveElevated serum phosphate levels have been associated with increased risks of cardiovascular events and death in several patient populations. The effects of serum phosphate on outcomes in patients with critical limb ischemia (CLI) have not been evaluated. In this study, we assessed the effect of abnormal phosphate levels on mortality and major limb events after surgical intervention for CLI. MethodsA retrospective review was undertaken to identify all patients at a single institution who underwent a first-time open or endovascular intervention for CLI between 2005 and 2014. Patients without recorded postoperative phosphate levels were excluded. Postoperative phosphate levels ≤30 days of the initial operation were recorded, and the mean was calculated. Patients were stratified according to mean phosphate levels (low: <2.5 mg/dL, normal: 2.5-4.5 mg/dL, and high: >4.5 mg/dL). Patient demographics, comorbidities, and operative details were compared in univariate analysis. Multivariable regression and Cox proportional hazard modeling were used to account for patient demographics and comorbid conditions. ResultsWe identified 941 patients, including 42 (5%) with low phosphate, 768 (82%) with normal phosphate, and 131 (14%) with high phosphate. Patients with elevated phosphate were younger and had higher rates of congestive heart failure, diabetes, and dialysis dependence. Bypass was more common among patients with normal phosphate compared with high or low phosphate levels. There was no difference in the Wound, ischemia, and Foot infection (WiFi) classification or TransAtlantic Inter-Society Consensus classification among the cohorts. There were significant differences in 1-year mortality (low: 19%, normal: 17%, high: 33%; P < .01) and 3-year mortality (low: 38%, normal: 34%, high: 56%; P < .01) between phosphate cohorts. Major amputation (low: 12%, normal: 12%, high: 15%) and restenosis (low: 21%, normal: 24%, high: 28%) tended toward worse outcomes among patients with elevated phosphate levels but did not reach statistical significance. After adjustment for baseline characteristics, mortality was higher (hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.3-2.2) and amputation-free survival was lower (HR, 1.5; 95% CI, 1.2-1.9) among patients with elevated compared with normal phosphate levels. A subgroup analysis was then performed to assess dialysis and nondialysis patients separately. Patients with elevated serum phosphate levels maintained a significantly higher risk of mortality in each group (dialysis: HR, 1.8; 95% CI, 1.2-2.6; nondialysis: HR, 1.5; 95% CI, 1.04-2.10). ConclusionsElevated phosphate levels are associated with increased mortality and decreased amputation-free survival after interventions for CLI. Future studies evaluating the effects of phosphate reduction in patients with CLI are warranted.

Outcomes of Critical Limb Ischemia in an Urban, Safety Net Hospital Population with High WIfI Amputation Scores

Patients presenting to a public hospital with critical limb ischemia (CLI) typically have advanced disease with significant comorbidities. The purpose of this study was to assess the influence of revascularization on 1-year amputation rate of CLI patients presenting to Los Angeles County USC Medical Center, classified according to the Society for Vascular Surgery Wound, Ischemia and foot Infection (WIfI). A retrospective review of patients who presented to a public hospital with CLI from February 2010 to July 2014 was performed. Patients were classified according to the WIfI system. Only patients with complete data who survived at least 12months after presentation were included. Ninety-three patients with 98 affected limbs were included. The mean age was 62.8 years. Eighty-two patients (84%) had hypertension and 71 (72%) had diabetes. Fifty (57.5%) limbs had Trans-Atlantic Inter-Society Consensus (TASC) C or D femoral-popliteal lesions and 82 (98%) had significant infrapopliteal disease. The majority had moderate or high WIfI amputation and revascularization scores. Eighty-four (86%) limbs underwent open, endovascular, or hybrid revascularization. Overall, one year major amputation (OYMA) rate was 26.5%. In limbs with high WIfI amputation score, the OYMA was 34.5%: 21.4% in those who were revascularized and 57% in those who were not. On univariable analysis, factors associated with increased risk of OYMA were nonrevascularization (P=0.005), hyperlipidemia (P=0.06), hemodialysis (P=0.005), gangrene (P=0.02), ulcer classification (P=0.05), WIfI amputation score (P=0.026), and WIfI wound grade (P=0.04). On multivariable analysis, increasing WIfI amputation score (odds ratio [OR] 1.84, 95% confidence interval [CI] 1.0-3.39) was associated with increased risk of OYMA while revascularization (OR 0.24, 95% CI 0.07-0.80) was associated with decreased risk of OYMA. The OYMA rates in this population were consistent with those predicted by the WIfI classification system. In this population, revascularization significantly reduced the risk of amputation. Comorbidities including diabetes mellitus and TASC classification did not moderate the association of WIfI amputation score with risk of 1-year major amputation.