Trans Atlantic Inter-Societal Consensus Research Articles

Long-Term Results of Endovascular Femoropopliteal Interventions.

Background and Objective Short-term results of endovascular intervention for femoropopliteal lesions have been extensively reported; however, there exists a paucity of long-term objective data related to outcomes of these interventions. We sought to characterize these long-term results including patency, limb salvage, and mortality. Methods From May 2003 to July 2009, all patients who underwent technically successful endovascular balloon angioplasty and/or stenting for Trans-Atlantic Inter-Societal Consensus (TASC) II B, C, and D lesions were identified in a retrospective fashion. Patient demographics, clinical characteristics, arterial noninvasive data, and angiographic anatomic data were evaluated. Results A total of 236 limbs in 186 patients (mean age 74, range 37-94) were treated. Lesion distributions by TASC II classification B, C, and D were 121 (51.3%), 37 (15.7%), and 78 (33%), respectively. Critical limb ischemia (CLI) was the indication for intervention in 42.4% of patients. Five-year primary and primary-assisted patency rates stratified by TASC II classification were B: 55.1%, 91.9%; C: 37.4%, 74.6%; D: 35.5%, 67%, respectively ( p = 0.23). Secondary patency based on TASC II classification was B: 92.9%, C: 83%, and D: 75.9%, respectively. Univariate analysis identified age > 75, CLI, and cerebrovascular disease as predictors for loss of patency. Reinterventions to maintain patency were required in 26.5% of TASC II B, 43.2% of TASC II C, and 25.6% of TASCII D lesions ( p = NS) and mean time to reintervention ranged from 22 to 29 months with no significant difference related to TASC II classification. A total of eight limbs (3.38%) were converted to open revascularization with two (0.85%) having a change in their initial preoperatively identified bypass target site. Three limbs (1.27%) required a major amputation during follow-up. Survival at 5 years was 44.3%; CLI and smoking were identified as risk factors for death (hazard ratio [HR] 2.6, 1.75-3.84, p < 0.001, HR 3.33, 1.70-6.52, p < 0.001), respectively. Conclusion Long-term patency of endovascular interventions for complicated femoropopliteal lesions is acceptable across TASC II classification and is associated with excellent limb salvage. Mortality in this patient cohort is significant with CLI and smoking being identified as predictors of death.

The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.

Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039). Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.

Perioperative Complications After Aorto-iliac Stenting: Associated Factors and Impact on Follow-up Cardiovascular Prognosis

To investigate factors associated with 30-day perioperative complications (POC) after aorto-iliac (AI) stenting, and to compare follow-up cardiovascular prognosis between patients with and without POC. This was a retrospective multicenter study. We used a multicenter database of 2012 consecutive patients who successfully underwent AI stenting for peripheral arterial disease in 18 centers in Japan from January 2005 to December 2009 to analyze independent predictors of POC and impact of POC on prognosis by logistic regression and a Cox proportional hazard regression model, respectively. Mean age was 71 ± 9 years (median: 72 years; range: 37-98 years), and 1,636 patients (81%) were men. POC occurred in 126 patients (6.3%). In multivariate logistic regression analysis, old age (≥80 years), critical limb ischemia (CLI), and Trans Atlantic Inter-Societal Consensus (TASC) II class C/D were independently associated with POC with adjusted odds ratios and 95% confidence intervals (CI) of 1.9 (1.3-2.9), 2.3 (1.5-3.4), and 2.4 (1.6-3.4), respectively. Out of 2012 patients, 1995 were followed up for more than 30 days (mean: 2.6 ± 1.5 years; range: 2-2,393 days). In a Cox hazard regression model adjusted for baseline clinical characteristics, POC was positively and independently associated with follow-up major adverse cardiac events (adjusted hazard ratio [HR]: 1.9; 95% CI: 1.3-2.8; p = .002), but not with major adverse limb events and target lesion revascularization (adjusted HR: 1.4; 95% CI: 0.7-2.7; p = .25; and adjusted HR: 1.2; 95% CI 0.6-2.6; p = .568), respectively. Age >80 years, CLI, and TASC C/D lesion were positively associated with POC after AI stenting. Occurrence of POC appears to adversely affect follow-up cardiovascular, but not limb and vessel prognosis.

Randomized controlled trial of remote endarterectomy versus endovascular intervention for TransAtlantic Inter-Society Consensus II D femoropopliteal lesions

This study evaluated outcomes of remote endarterectomy (RE) vs endovascular (ENDO) interventions on TransAtlantic Inter-Societal Consensus (TASC)-II D femoropopliteal lesions and identified factors predictive of restenosis. From October 2004 to December 2008, 95 patients with TASC-II D lesions were randomized 1:1 to receive RE of the superficial femoral artery (SFA) with end point stenting (51 patients) or ENDO, consisting of subintimal angioplasty with stenting (44 patients). The groups were balanced for age, sex, atherosclerotic risk factors, and comorbidities. Categoric data were analyzed with χ2 tests, and time to event provided two-sided P values with a level of significance at .05 and 95% confidence intervals (CIs). Survival curves for primary patency were plotted using the Kaplan-Meier method. Univariate analysis for diabetes, hypertension, dyslipidemia, smoking, and critical ischemia was performed according to the Cox proportional hazards model. The mean follow-up was 52.5 months (range, 35-75 months). Five RE patients and four ENDO patients were lost to follow-up (censored). Primary patency was 76.5% (39 of 51) in RE and 56.8% (25 of 44) in ENDO (hazard ratio [HR], 2.6; 95% CI, 0.99-4.2; P=.05) at 24 months and was 62.7% (32 of 46) in RE and 47.7% (21 of 40) in ENDO (HR, 1.89; 95% CI, 0.94-3.78; P=.07) at 36 months. Assisted primary patency was 70.6% (36 of 51) in RE and 52.3% (23 of 44) in ENDO (HR, 2.45; 95% CI, 1.20-5.02; P=.01). Secondary patency overlapped the primary comparison data at 12 and 24 months; at 36 months, there was a slight but significative advantage for RE (HR, 2.26; 95% CI, 1.05-4.86; P=.03). Univariate analysis demonstrated that hypercholesterolemia and critical limb ischemia (CLI) were significantly related to patency failure, whereas diabetes was significant only in ENDO. These factors (hypercholesterolemia and CLI) were independent predictors of patency on Cox multivariate analysis. RE is a safe, effective, and durable procedure for TASC-II D lesions. Our data demonstrate a significantly higher primary, assisted primary, and secondary patency of RE vs ENDO procedures. Furthermore, overall secondary patency rates remain within the standard limits, although preoperative CLI and dyslipidemia continue to be associated with worse outcomes. Taken together, these data suggest that RE should be considered better than an endovascular procedure in SFA long-segment occlusion treatment.

Isolated femoral endarterectomy: Impact of SFA TASC classification on recurrence of symptoms and need for additional intervention

Atherosclerotic occlusive disease of the femoral artery is associated with symptoms ranging from claudication to tissue loss. This study examined the clinical and hemodynamic outcomes of isolated femoral endarterectomy (FEA) as well as the predictors of symptom recurrence and need for further intervention. Patients who underwent an isolated FEA between January 2001 and June 2008 were reviewed. Concurrent superficial femoral artery (SFA) disease was classified into Trans Atlantic Inter-Societal Consensus (TASC) II categories based upon angiographic findings. Hemodynamic success (HS) was defined as a postoperative ankle-brachial index (ABI) increase of >or=0.15. Clinical improvement was classified by Rutherford criteria. Multivariate analysis was used to identify predictors of clinical failure and need for additional intervention (AI). Kaplan-Meier estimates were used to determine the likelihood of both over time. Ninety-five patients (105 limbs) with a mean age of 68.3 +/- 10.2 years were reviewed. Indications were severe claudication in 68 (64.8%) limbs and critical limb ischemia (CLI) in 37 (35.2%). Mean preprocedural ABI was 0.57 +/- 0.25. The SFA-popliteal segment was classified as: normal in 34% of limbs, TASC A 23%, B 19%, C 9%, and D in 15%. One fatal myocardial infarction accounted for a procedural mortality of 0.95%. Morbidity was 6.7% (four hematomas and three wound infections) and mean hospital stay was 2.5 +/- 3.1 days. Patency was 100% with a mean follow-up of 11 months (1-72). Complete resolution of symptoms was noted in 73.4% with some clinical improvement noted in 91% of limbs. HS was achieved in 85.1% with a mean ABI increase of 0.27 +/- 0.20, and this correlated with >or=2 runoff vessels (odds ratio [OR] 0.20; 95% confidence interval [CI] 0.04-0.96; P = .045). Kaplan-Meier estimates revealed that 83.8% of patients with marked initial clinical improvement remained symptom free at 2 years, whereas only 28.6% in the group with mild and moderate initial response maintained their clinical status. Freedom from AI at 2 years was 61.8%. Multivariate analysis revealed that TASC C and D lesions (OR 9.3 [2.43-35.63] P = .001) and diabetes (OR 3.64 [1.01-13.15] P = .048) were predictive of recurrent symptoms while extensive endarterectomy and >or=2 vessel tibial runoff decreased the need for AI. FEA can achieve excellent immediate clinical and hemodynamic outcome in patients with claudication and CLI; however, patients with diabetes and femoropopliteal TASC C and D lesions are likely to experience recurrent symptoms. Long-term symptomatic improvement is associated with the degree of immediate clinical success as well as the status of the run-off vessels. Limited FEA and poor tibial runoff are associated with the need for AI.

Use of Extraperitoneal Iliac Artery Endarterectomy in the Endovascular Era

Although iliac artery (IA) endarterectomy has largely been replaced by bypass and endovascular options, open endarterectomy continues to play an important role in selected patterns of occlusive disease. The objective of this report is to present a contemporary clinical series of patients having undergone IA endarterectomy. Specifically, we define patterns of disease amenable to open endarterectomy and provide an updated technical note of this procedure. A retrospective study on 23 patients with IA occlusions unsuitable for radiologic intervention (TransAtlantic Inter-Societal Consensus [TASC] C and D lesions) underwent extraperitoneal IA endarterectomy. Twenty-five primary IA endarterectomies were performed. Of these, five required more extensive endarterectomy, three of the distal aorta and two of the contralateral IA. Sixteen of the 25 endarterectomies required common femoral artery endarterectomy and 6 required iliofemoral bypass. The average follow-up was 26 months. Procedure-related mortality occurred in one patient (4.3%). Within 4 months, one patient underwent an aortofemoral bypass and two patients required major amputation. Primary patency rates were 96% at 3 months and 88% at 1, 2, and 3 years. This series shows that in selected patterns of aortoiliac occlusive disease, endarterectomy remains an important alternative to consider.

Infrainguinal cutting balloon angioplasty in de novo arterial lesions

This prospective, non-randomized study evaluated the short- and mid-term feasibility, safety, primary patency, and limb salvage of cutting balloon percutaneous transluminal angioplasty (CB-PTA) for the treatment of peripheral arterial occlusive disease (PAOD). All data were collected for 128 consecutive patients who underwent CB-PTA to improve infrainguinal arterial circulation between January 2003 and July 2007. One-hundred thirty-five limbs with PAOD (claudication, n = 19; critical limb ischemia [CLI], n = 116) were treated. Patency was evaluated by clinical examination and duplex ultrasonography. A total of 203 lesions (183 stenoses, 20 occlusions) were treated in 66 femoropopliteal and 69 infrapopliteal arterial segments. The TransAtlantic Inter-Societal Consensus (TASC) classification of the primary lesions was A in 41.5%, B in 45.2%, C in 8.2%, and D 5.1%. Mean follow-up was 16.1 +/- 9.7 months. The overall technical success rate was 96.3% and the complication rate was 8.9%. There were two (1.5%) perioperative deaths. The primary patency rate was 82.1% at 12- and 24-months in patients with claudication (femoropopliteal lesions). The 1- and 2-year results for femoropopliteal and infrapopliteal lesions in patients with CLI were: primary patency 64.4% and 51.9 %, respectively; limb salvage 84.2% and 76.9%; survival 92.6% and 88.5%. More distal lesions and TASC classification were significant independent risk factors for outcome (P < .05). Treatment of multiple segment lesions was an independent predictor of a favorable outcome (P = .04). CB-PTA is safe and feasible for the treatment of infrainguinal arterial occlusive disease, with relatively low mid-term restenosis rates compared to other endovascular treatments. However, these data cannot be extrapolated to potential outcomes for lesions >10 cm in length. Further follow-up will be necessary to evaluate the long-term results of CB-PTA.

Outcomes of endovascular interventions for TASC II B and C femoropopliteal lesions

To evaluate outcomes of endovascular interventions on femoropopliteal occlusive disease and determine predictors of restenosis of Trans Atlantic Inter-Societal Consensus (TASC) II B and C lesions. All patients undergoing endovascular interventions for femoropopliteal occlusive disease between May 2003 and July 2007 were reviewed. Patient demographics, pre- and post-procedure ankle-brachial indices (ABI), and anatomic factors (including categorization by TASC II classification, lesion length, and runoff vessel status) were analyzed. Outcomes evaluated included freedom from restenoses, freedom from re-intervention, overall patency, and assisted-patency. A total of 237 total limbs were treated during the period reviewed. The study group included 108 TASC B and 32 TASC C limbs in 125 patients (mean age 73.1 +/- 10.4 years, male sex: 59%). Seventy-one percent of patients were Rutherford classification 2/3 while the remaining 29% were Rutherford classification 4/5. Mean follow-up period was 12.7 months (range, 1-52 m). Forty-one (41) limbs experienced restenosis or occlusion at a mean time of 8 months (range, 1-24 m). Freedom from restenosis/occlusion was 58.9% at 12 months and 47.9% at 24 months. Predictors of restenosis included a preoperative ABI <0.5 (hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.36-6.86, P = .007) and hypercholesterolemia (HR 2.42, 95% CI 1.11-5.25, P = .025). Lesion length as a continuous variable (per centimeter) also correlated with a higher risk of restenosis (HR 1.06, 95% CI 1.00-1.12, P = .057). The overall assisted-primary and secondary-patency rates were 87% and 94% respectively at 3 years with no significant differences between TASC B and TASC C limbs. Endovascular interventions for TASC II B and C lesions are associated with restenosis/occlusion rates that are at least as good as those of open femoropopliteal bypass surgery from historical, previously published series. Furthermore, overall assisted-patency rates are excellent, although low preoperative ABIs continue to be associated with worse outcomes.

Midterm outcome predictors for lower extremity atherectomy procedures

The performance of atherectomy devices has been variable. The purpose of this study was to evaluate our experience using the SilverHawk atherectomy (Fox Hollow Technologies, Redwood City, Calif) device for lower extremity procedures to determine predictors of midterm success. Records of all patients who underwent lower extremity atherectomy with the SilverHawk atherectomy catheter were reviewed. Patient demographics, vessel treated, number of vessels treated, lesion characteristics, and postoperative courses were analyzed. Cumulative patency rates, limb salvage, mortality, and factors associated with outcomes were determined using the Kaplan-Meier Method with Cox Proportional Hazards modeling. Between January 2004 and January 2006, 167 vessels were atherectomized with the SilverHawk in 73 patients. There were 42 men and 31 women treated, and the mean age was 68.8 +/- 13.8. Five patients had both legs treated for a total of 78 legs treated. Of the 78 legs intervened on, 25.6% (20/78) had 1 vessel treated, 51.3% (40/78) had 2 vessels treated, 11.5% (9/78) had 3 vessels treated, 9% (7/78) had 4 vessels treated, and 2.6% (2/78) had 5 vessels treated. A total of 78% (61/78) of patients had intermittent claudication, 71% (56/78) had rest pain, and 58% (45/78) had tissue loss. Adjunctive procedures were performed in 63 vessels in 33 patients (61 percutaneous transluminal angioplasty [PTA] and 2 PTA + stent). Eighty-four vessels treated were totally occluded and 83 stenotic. Cumulative 1-year primary, primary assisted, secondary patency, limb salvage, and survival rates with confidence intervals, respectively, are: 43% (30,57), 49% (36,63), 57% (43,71), 75% (57,92), and 90% (80,100). Multivariable analysis demonstrated tobacco use, renal disease, diabetes, and tissue loss are all predictors of patency loss, while only diabetes and tissue loss were associated with greater limb loss. There was no difference in patency rates irrespective of location of Trans Atlantic Inter-Societal Consensus (TASC) classification, vessel treated (femoral vs tibial), or degree of stenosis (occluded vs stenotic). Also, multiple vessels treated in the same patients had no affect on patency. The mean ankle brachial index (ABI) pre-op was 0.57 +/- 0.19, and this increased to 0.81 +/- 0.21 (P < .001) at 30 days post-op. Lower extremity atherectomy procedures with the SilverHawk device are safe and effective means in improving symptoms. However, there is decreased durability and significant patency and limb loss over time. Diabetes, renal disease, tobacco use, and tissue loss are all associated with inferior outcomes.

Quantifying improvement in symptoms, functioning, and quality of life after peripheral endovascular revascularization

Conclusion: In about 80% of a cohort of patients treated for intermittent claudication with peripheral endovascular revascularization (PER) techniques, there will be improvement in symptoms and quality of life at 1 year. Summary: This was a longitudinal follow-up study of patients treated with PER for symptomatic peripheral arterial disease (PAD). Approximately 94% of the patients were treated for intermittent claudication. There were 477 consecutive patients who underwent PER for symptomatic PAD eligible for the study. Of these, 300 participated in a longitudinal follow-up study of their health status. Health status was quantified using the disease-specific peripheral arterial questionnaire and the generic Short Form 12 in EuroQual-5 dimensions (EQ5D) questionnaire. Higher scores on these questionnaires represent fewer symptoms and better health status and quality of life. The average age of the patients was 68 ± 11 years, with 62% male and 96% white, and 39% of the cohort had diabetes. In the patients who consented to participate in the study, clinical follow-up was obtained in 99%, and 86% completed questionnaires. Peripheral revascularization procedures were technically successful in 98% of the patients. Ninety-five percent of iliac and femoropopliteal lesions revascularized were Transatlantic Intersocietal Consensus type A or B lesions. When an 8-point change in the peripheral arterial questionnaire summary was used as evidence of improved health-related quality of life, 79% of the patients treated had improvement in health-related quality of life at 1 year, but 21% did not. Overall, mean peripheral artery questionnaire summary scores improved from 31 ± 19 to 62 ± 27 at 1 year (P < .0001). Generic health status scores also improved significantly at 1 year (P < .001). Comment: This study indicates the difficulties of treating patients with claudication. Of the patients in this study, 94% were actually treated for claudication, with 98% having technically successful procedures and 96% having favorable lesions for percutaneous revascularization. Despite this, 21% of the patients did not have sustained benefit at 1 year. Further follow-up and cost analysis and comparisons with nonoperative treatment are needed to determine in what categories of patients percutaneous revascularization for claudication is a reasonable and cost-effective therapy.

The treatment of disabling intermittent claudication in patients with superficial femoral artery occlusive disease—Decision analysis

To determine the preferred approach to superficial femoral artery (SFA) revascularization of Trans-Atlantic Inter-Societal Consensus (TASC) B and C lesions in claudicants requiring intervention based on a review of published data. Decision analysis, Markov state transition model. Hypothetical cohorts of claudicants with TASC B or TASC C superficial femoral artery lesions considered candidates for either angioplasty with selective stenting (PTA/S) or greater saphenous vein bypass (GSVB). Quality adjusted life years (QALYs). For a 65-year-old man with disabling claudication, percutaneous transluminal angioplasty and selective stenting (PTA/S) was preferred over GSVB for a TASC B SFA lesion. In an otherwise identical patient with a TASC C lesion, bypass was the preferred therapy. Treating PTA/S failures with subsequent bypass increased the utility of PTA/S but bypass remained the preferred initial therapy for TASC C lesions. Sensitivity analysis showed that PTA/S surpasses bypass efficacy for TASC C lesions if PTA/S primary patency is >32% at 5 years, patient age is >80 years, or GSVB operative mortality is >6%. PTA/S is the preferred initial therapy over GSVB for TASC B SFA lesions in patients with disabling intermittent claudication who require intervention. Given contemporary published outcomes for TASC C lesions, GSVB is the preferred therapy in operative candidates. In elderly patients or patients at high risk for bypass, PTA/S should be considered over GSVB. Improved technology that results in a 5-year primary patency of 32% would also justify PTA/S for TASC C SFA lesions.

Progress in the Endovascular Treatment of Intermittent Claudication: Rationale for Changes in the TASC Classification

Published in 2000, the TransAtlantic Inter-Societal Consensus (TASC) guidelines contained a new classification system for treatment of peripheral arterial disease. The classification was based upon response to intervention and was independent of technology and techniques. The goal of this system was to indicate the best form of treatment, endovascular (TASC A) or surgical (TASC D), for patients with lower-extremity arterial occlusive disease based upon highest levels of evidence in published reports. Those lesions without strongly supportive evidence, but with a greater likelihood of good response to endovascular (TASC B) or surgery (TASC C), were noted as critical issues requiring additional assessment. It was the intent of the TASC Working Group that this classification be periodically updated. Lesion location, length, calcification, and occlusion have each posed significant challenges to the successful and enduring endovascular treatment of peripheral arterial disease. Since 2000, vascular specialists have systematically addressed these variables with new technology and techniques to improve results. These improvements have been reflected in changes to lesions included in each category of the initial TASC classification system as listed in TASC II. This review provides an evidence-based rationale for these changes.