Femoropopliteal Disease Research Articles

Ambulatory Femoral Access Strategies for Endovascular Femoropopliteal Disease Treatment: Is that the Break-through?

Ambulatory Femoral Access Strategies for Endovascular Femoropopliteal Disease Treatment: Is that the Break-through?

2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions.

The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions. Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear. Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed. The majority of patients presented with lifestyle-limiting claudication (n=90 [69%]). The mean lesion length was 194 ± 108mm, 74% of the lesions (n=101) were chronic total occlusions, and 72% (n=99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n=67). At 24months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%). In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment.

An indirect comparison by Bayesian network meta-analysis of drug-coated devices versus saphenous vein graft bypass in femoropopliteal arterial occlusive disease

ObjectiveTo compare the efficacy and safety between drug-coated devices (DCDs) and bypass surgery with saphenous vein graft (BSV) in femoropopliteal arterial occlusive disease. MethodsA Bayesian network meta-analysis and indirect comparison were performed. Randomized controlled trials of BSV, bypass surgery with prosthetic graft, bare metal stents, endoluminal bypass (covered stent), percutaneous transluminal angioplasty, and DCDs treating femoropopliteal arterial occlusive disease were collected. The primary end point was target lesion revascularization/target vessel revascularization, and secondary end points were all-cause mortality, limb salvage, and early complications (PROSPERO registry number: CRD42019136530). ResultsForty-two trials and 6867 patients were included. The comparison of DCDs and BSV revealed no significant difference in the 1-year target lesion revascularization/target vessel revascularization (DCDs vs BSV: odds ratio [OR], 0.60; 95% credible interval [CrI], 0.16-2.39). Total early complications from BSV were significantly higher than those from DCDs (DCDs vs BSV: OR, 0.14; 95% CrI, 0.05-0.45), and the main complications of BSV were not death related. There was also no significant difference in systemic early complications (DCDs vs BSV: OR, 0.19; 95% CrI, 0.00-7.82) and 1-year amputation rate (DCDs vs BSV: OR, 2.81; 95% CrI, 0.16-89.53). The 30-day (DCDs vs BSV: OR, 0.38; 95% CrI, 0.00-110.46), 1-year (DCDs vs BSV: OR, 0.96; 95% CrI, 0.24-3.29), 2-year (DCDs vs BSV: OR, 1.60; 95% CrI, 0.64-4.95), and 5-year all-cause mortality rates (DCDs vs BSV: OR, 2.05; 95% CrI, 0.92-4.39) showed no significant differences between DCDs and BSV, although there was a noticeable tendency toward significant results of a higher 5-year mortality rate. ConclusionsThere is no significant difference between DCDs and BSV in short-term efficacy or short- and long-term mortality. Despite traditional BSV remaining the gold standard, DCDs provide a reasonable alternative therapy. In addition, the DCDs have a lower short-term morbidity associated with the procedure at the cost of the possible risk of higher long-term mortality. Clinical trials with more validity are required for a direct comparison between BSV and DCDs.

Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial

ObjectiveWe evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). MethodsIn this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. ResultsDuring the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. ConclusionsWe found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.

RAVS Study: A Single Center Experience with Turbo hawk Directional Atherectomy Device to analyze it as an Emerging Modality for Treatment of Long Segment Femoro-Popliteal Occlusive Disease

Background: Despite advances to prevent and better manage patients with established Peripheral Arterial Disease (PAD), the incidence of PAD continues to increase and morbidity remains high, especially as the population ages. For physicians treating PAD cases, an understanding of the various treatment options, along with their benefits and limitations is crucial. Endovascular treatment with Turbo hawk atherectomy device has promising technical and clinical success rates. Objective: To consider Turbo hawk directional atherectomy as an important and safer endovascular modality for treatment of long segment Femoro-popliteal occlusive disease. Methods: This is a retrospective study which included 40 patients diagnosed with PAD (long segment occlusion of Femoro-popliteal arteries), who came to Ramaiah medical college hospital, Bangalore from June 2014 to June 2018 and fit into specified inclusion criteria with mean age of the patients being 61.5 years. All these patients underwent endovascular therapy with turbo hawk atherectomy device and post intervention was followed for a period of one year. Results: Primary technical success rate was 97%. Pre-operatively mean ABI was 0.27 and post–operative mean ABI was 0.64. An average length of corrected lesion was 10.5cms. Post-operatively one patient had an episode of distal embolization, two patients had dissection and three had puncture site hematomas, all of which were managed conservatively. No vessel perforation was observed in our study. Patients were followed up at 1 month, 6 months and 12 months postoperatively. Primary vessel patency rates at 6 and 12 -months were 96% and 85%. Conclusion: Directional atherectomy using turbo hawk device is safe, effective at 12 months for medium and long segment femoro-popliteal lesions in claudicants as well as in patients with critical limb threatening ischemia and has a primary patency rates of 85 % over 1-year period. Further, complication rates that warrants a treatment is also very low with Turbo hawk as seen with our study.

Long-term clinical outcome and mortality risks after paclitaxel-coated balloon angioplasty in patients with peripheral artery disease: An observational clinical study.

Background and aimsDrug‐eluting devices (DEDs) are usually used as a standard therapy for revascularization in femoropopliteal artery disease. Randomized controlled trails have found that DEDs with paclitaxel result in superior patency rates and decreased target lesion revascularization. A meta‐analysis by Katsanos et al indicated an increased long‐term mortality in patients treated with paclitaxel‐coated devices. The aim of this observational clinical study was to assess the long‐term clinical outcomes and mortality risk after paclitaxel‐coated balloon angioplasty in patients with symptomatic peripheral artery disease.MethodsWe retrospectively evaluated 287 patients with peripheral interventions, including 173 drug‐coated balloon (DCB) angioplasties and 114 plain old balloon angioplasties (POBA), performed at our center between 2015 and 2018.ResultsThere were no significant differences in mortality rates between patients who received DCB angioplasty and those who received POBA. In the first year, the hazard ratio (HR) for DCB angioplasty was 0.59 (95% confidence interval [CI] 0.31 to 1.12, P = .104). After 2 years, this HR was 0.64 (95% CI 0.36‐1.17, P = .145), while the 3‐year and 4‐year HR increased to 0.71 and 1.30 (3‐year: 95% CI 0.37‐1.33, P = ,283; 4‐year: 95% CI 0.55‐3.08, P = .546). No paclitaxel dose‐response relationship with mortality rate was identified when adjusted for key predictors of mortality.ConclusionsAnalyses of patient level data identified no significant mortality differences between DCB angioplasty and POBA after 4 years of follow‐up. Furthermore, there was no dose‐response relationship between paclitaxel and mortality. These findings demonstrate that paclitaxel DCB is safe. Further long‐term multicenter studies are needed to determine the risk of late mortality.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

Efficacy of Rotational Atherectomy Followed by Drug-coated Balloon Angioplasty for the Treatment of Femoropopliteal Lesions—Comparison with Sole Drug–coated Balloon Revascularization: Two-year Outcomes

We aimed to evaluate the results of the combined use of rotational atherectomy (RA) followed by drug-coated balloon (DCB) treatment against DCB angioplasty alone in patients who had significantly calcified and symptomatic femoropopliteal peripheral arterial disease. Patients presented to the clinic with symptoms of chronic limb ischemia of femoropopliteal segment such as moderate or severe claudication and rest pain, who received endovascular therapy between January 2016 and January 2018 in our hospital comprised the study cohort and investigated, retrospectively. Patients with minor or major tissue loss were excluded from the study. We evaluated the effect of RA system followed by DCB with DCB alone in 121 patients and a total of 226 significantly calcified and symptomatic femoropopliteal lesions. Fifty-eight patients and 112 (49.5%) lesions were treated with RA+DCB, whereas 63 patients and 114 (50.5%) lesions were treated with DCB only. The mean age was 61.2±9.7years. Primary patency is evaluated with duplex ultrasound/angiography at 6, 12, and 24months and with angiography on 12 and 24months. Patients were followed up for 24months to assign clinically driven target lesion revascularization (TLR). Overall survival rates were 96.5% (56/58) in RA+DCB group and 93.6% (59/63) in DCB alone group both at one-year and two-year follow-up. Amputation-free survival rates of RA+DCB and DCB-only groups are 96.5% (56/58) to 87.3% (55/63) at one year, and 94.8% (55/58) to 82.5% (52/63) at two years, respectively. Baseline characteristics of groups were similar. The lesions were longer in the RA+DCB group than the DCB alone group (14.4±5.2cm vs. 10.2±3.1cm; P=0.05). The technical success rate in the RA+DCB group was superior to that of DCB-only group (95.4% vs. 84.8%, P=0.006). The 12-month and 24-month patency rates with angiography in the RA-DCB group were similar to those in the DCB-only group (85.7% vs. 74.6% and 73.2% vs. 62.7%, respectively). The rates of bailout stenting were significantly lower among patients treated with RA+DCB (n=3; 5.1% vs. n=13; 20.6%, P<0.001). The rates of flow-limiting dissections and vessel recoils after procedures were significantly in RA+DCB group (n=2; 3.4% vs. n=8; 12.6%, P<0.001) than DCB only (n=1; 1.7% vs. n=4; 6.3%, P<0.002). The freedom from TLR rate was significantly increased in the RA+DCB group at 12months (95.2% vs. 76.3%, P=0.002) and 24months (93.4% vs. 63.7%, P=0.002). The mean ankle brachial index at discharge in the RA-DCB group improved by 0.35±0.24, and in the DCB-only group, it was 0.30±0.23 (P=0.683). Combined use of RA and DCB treatment is an effective, safe, and durable method for the treatment of the complex femoropopliteal lesions. Combination of RA and DCB angioplasty reveals increased technical success, fewer flow-limiting dissections, significantly reduced TLR, and bailout stenting rates compared with sole DCB angioplasty.

Health Care Utilization Following Inpatient Femoropopliteal Revascularization With Drug-Coated Balloon Angioplasty: A Nationwide Cohort Analysis

Purpose To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization. Materials and Methods The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016–2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). Results Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure. Conclusion DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Primary Patency Rate of Superficial Femoral Artery Angioplasty in Patients with Stenosis/Occlusion of Femoropopliteal Artery

Background: The primary patency rate (PPR) is still controversial in angioplasty and heart bypass surgery for blood vessel repair and reconstruction in patients with femoropopliteal disease. Objectives: This study aimed to investigate the prolonged PPR rate in patients with stenosis/occlusion of the femoropopliteal artery undergoing superficial femoral artery (SFA) and popliteal angioplasty. Methods: A case series study population consisted of patients demonstrating femoropopliteal artery occlusion referred to Sina Hospital, Tehran, Iran for angiography during 2016-2018. After angiography, patients underwent either stent placement or balloon angioplasty in the case of stenosis/occlusion of femoropopliteal arteries. After angioplasty, patients were followed up in the 3rd, 12th, and 24th months for re-examination, and color Doppler ultrasonography of femoropopliteal arteries was also performed to measure the patency rate. The SPSS Statistics version 21.0 was used to analyze the data. The Kaplan–Meier method and a log-rank test were utilized to evaluate this rate. Results: Sixty patients were included in the study, from which 44 were women (73.3%) and 16 were men (26.6%) with a mean age of 69.9 years. Fifty-two, 41, and 29 patients were examined at intervals of 3, 12, 24 months, with PPRs of 86%, 79%, and 68%, respectively. There was a significant relationship between claudication degree and procedure success (P = 0.02). Conclusion: The prolonged PPR rate of patients after femoropopliteal artery angioplasty was acceptable and was a safe and effective treatment. For future studies, an increase in the number of study variables, a more comprehensive classification, and PPR-related variables are suggested.

Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass

ObjectiveThe DETOUR 1 study was performed to assess the safety of the femoral vein as a "pass through" conduit for covered stent placement during fully percutaneous femoropopliteal bypass, also known as the DETOUR procedure. MethodsAt eight participating centers in this prospective, single-arm, international trial, 78 patients (82 femoropopliteal lesions) were enrolled. All patients had patent femoral veins measuring ≥10 mm in diameter at baseline. The DETOUR procedure involved delivery of a series of TORUS stent grafts, deployed from contralateral common femoral artery access, to the ipsilateral proximal superficial femoral artery, with entry into the femoral vein and re-entry into the arterial vasculature at the above-the-knee popliteal artery. The TORUS stent grafts are deployed in an overlapping configuration as an arterial-arterial conduit. Due to this novel transvenous approach, we assessed specific considerations related to the venous system to analyze the risk of risk of venous thromboembolic complications. Symptomatic deep vein thrombosis, nonocclusive material associated with the graft such as benign endovenous graft-associated material, pulmonary embolism, Venous Clinical Severity Score (VCSS) and Villalta scores, and luminal occupancy by the stent graft were assessed as the ratio of cross-sectional areas of the stent graft to the native vein at baseline and 1 year after the procedure. ResultsA duplicate femoral vein was present in 20.7% of cases. The majority of patients (86.8%) had a femoral vein luminal area preservation of ≥55%. Thirty-two patients experienced an increase in the vein diameter over time after the procedure, but this pattern of venous remodeling was not uniform. The patients who had a compensatory increase in the vein diameter had a smaller average baseline vein diameter compared with the patients who did not have a compensatory increase in vein diameter (P = .0414). Only two patients (2.4%) developed ipsilateral symptomatic deep vein thrombosis) through 1 year of follow-up. There were no pulmonary embolism in any patient in the series. The overall VCSS and Villata scores did not change during follow-up. Mean VCSS and Villata were 0.8 ± 1.4 and 0.5 ± 1.1 at 1 year, compared with 0.6 ± 1.0 and 0.4 ± 0.9 at baseline, respectively. ConclusionsAs a percutaneous alternative to open surgical bypass for complex femoropopliteal peripheral arterial disease, the transvenous bypass has a low rate of deep venous thrombotic and obstructive complications. Cross-sectional vein area is preserved, and in some patients, the compensatory vein diameter increases with time, supporting the feasibility and safety of using the lower extremity deep venous system as a pass-through conduit for the DETOUR percutaneous femoropopliteal bypass. Trial RegistrationNCT02471638.

Comparison of Percutaneous Transluminal Angiography With or Without Catheter-Directed Thrombolysis for Chronic Femoropopliteal Occlusive Disease.

Background:Catheter-directed thrombolysis (CDT) is seldom used for chronic femoropopliteal occlusive disease.Methods:Patients with chronic femoropopliteal occlusive disease enrolled between January, 2011 and April, 2017. Hospitalization expense, limb salvage rate and survival rate were calculated.Results:Twenty-nine patients were treated with CDT (CDT group) and 31 patients without CDT (Non-CDT group).The mean hospitalization expense (5.2 ± 0.5), balloon catheter (1.0 ± 0.2) and stents number (0.8 ± 0.2) in CDT group were significantly less compared to Non-CDT group (P < 0.05). The short-term and long-term effect scales showed similar in both groups. The incidences of perioperative complications (10.3% vs. 19.4%), primary patency and second patency rate, limb salvage rate (14.8% vs. 16.1%) and survival rate were also similar (P > 0.05). Six patients died in each group and only 2 disease related deaths were found in Non-CDT group.Conclusion:CDT is a safe and economic strategy for patients with chronic femoropopliteal occlusive disease, and should be served as blanket treatment for every patient without thrombolytic contradictions or a remedy for failure PTA to achieve a comparable clinical effect.

Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty

<i>Backgroud</i>: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. <i>Objective</i>: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. <i>Patients and Methods</i>: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. <i>Results</i>: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. <i>Conclusion</i>: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.

Interventional Treatments for Femoropopliteal Arterial Disease and Recent Updates

대퇴슬와동맥의 말초동맥폐쇄질환은 일반적으로 죽상경화증에 의해 발생하며, 질병의 정도에 따라 간헐적 파행에서부터 심각한 사지 허혈 또는 조직 손상에 이르는 다양한 증상으로 나타날 수 있다. 따라서, 증상을 개선하고 사지를 형태적, 기능적으로 보존하기 위해서는 적절한 치료가 필요하다. 대퇴슬와동맥 질환에서 시행되는 대표적인 인터벤션 치료로는 혈관 성형술, 스텐트 삽입술, 죽종절제술 등이 있다. 수년에 걸쳐, 혈관 내 재개통술은 최소 침습적이라는 이점과 더불어 시술 방법 및 사용 기기의 지속적인 발전을 토대로 말초동맥폐쇄질환의 치료에 널리 시행되고 있다. 이번 종설에서는 대퇴슬와동맥 질환의 다양한 혈관 내 치료 방법에 대해 소개하고, 문헌 고찰을 통해 현재까지 나온 임상 연구의 결과들을 논의하며, 대퇴슬와동맥질환의 치료에 적용되는 시술 방법에 대한 영상을 제시하여 독자의 이해를 돕고자 한다.

Endovascular Treatment for Trans-Atlantic Inter-Society Consensus II D Femoropopliteal Arterial Disease in Elderly Patients with Ulcer and Gangrene: A Retrospective Analysis

Objective: The aim of this study was to analyze the middle-term results of endovascular treatment for Trans-Atlantic Inter-Society (TASC) II D femoropopliteal arterial disease in elderly patients with ulcer and gangrene.

General Treatment Strategy for Intervention in Lower Extremity Arterial Disease

하지동맥 질환의 유병률은 고연령 군에서 증가한다. 최근의 기술적 진보로 혈관 내 치료가 점점 더 많은 빈도로 시행되고 있다. 간헐적 파행의 치료 목표는 보행 능력을 향상시키고 증상을 완화시키는 것이다. 이를 위해 해부학적 내구성을 높이는 것이 중요한 전략이며 개통률이 치료 평가 기준이 된다. 임계 하지허혈을 가진 환자에서는 병변이 광범위하고 특히 무릎 아래동맥을 심하게 침범한다. 임계 하지허혈의 치료 목적은 상처 회복을 촉진하고 주요 절단을 예방하는데 있으며 사지 보존율이 평가의 기준이 된다. 장골동맥 협착의 치료에는 피복 혹은 비피복 스텐트 삽입술이 일차적 치료로 인정된다. 대퇴슬와동맥 질환은 죽종제거술과 함께 약물방출풍선 및 스텐트가 자주 사용되는 반면 무릎아래동맥 질환에서는 풍선확장술이 주요 치료 방법이다. 컴퓨터단층 혈관조영술은 절대적 금기증이 없는 환자에서 혈관 내 치료 계획 수립을 하는데 로드맵을 제공한다.

Image quality and safety of automated carbon dioxide digital subtraction angiography in femoropopliteal lesions: Results from a randomized single-center study

PurposeTo evaluate the image quality and the safety of automated carbon dioxide (CO2) digital subtraction angiography (DSA). Materials and MethodsFifty patients receiving DSA for femoropopliteal peripheral arterial disease (PAD) were enrolled in this single-center prospective study. All patients received iodinated contrast media (ICM) and CO2 as a contrast agent in the same target lesion. As a primary endpoint, four raters independently evaluated the angiography images based on overall image quality, visibility of collaterals, and assessment of stenoses/occlusions. Inter-rater agreement was assessed using the intraclass correlation coefficient (ICC) and differences between the raters were evaluated using Friedmann’s test. Secondary endpoints were procedure safety and patient pain assessment. ResultsInter-rater agreement between CO2-DSA and ICM-DSA images was fair to excellent for overall image quality (ICC: 0.399–0.748), fair to excellent for the visibility of collaterals (ICC: 0.513–0.691), and poor to excellent for the assessment of stenoses/occlusions (ICC: -0.065–0.762). There were no significant differences between the raters. Two patients had a hematoma, one reported pain related to puncture, one became nauseous, and one vomited. No other adverse events were observed. Reported pain scores were significantly higher for CO2-DSA vs. ICM-DSA (1.25 vs. 0625; p < 0.028). ConclusionCO2-DSA using automated injection system in combination with proprietary post-processing software is safe and comparable diagnostic test compared to ICM-DSA.

Significance of Distal Runoff Score as a Key Influencer on Clinical Outcomes after Endovascular Interventions for Superficial Femoral Artery Disease

Endovascular therapy (EVT) is being adopted by many surgeons as a suitable first choice in the treatment of most femoropopliteal disease when clinically indicated. However, there are multiple factors affecting the outcome of EVT including the anatomy of lesions and distal runoff status. The evidence of runoff effect on the outcome of superficial femoral artery (SFA) interventions is still scarce and not well studied in the current literature. The aim of this study was to investigate the effect of runoff score on the outcomes of SFA endovascular interventions. Retrospective analysis was carried out on prospectively collected data on patients who underwent SFA endovascular intervention for critical limb ischemia (CLI) in a single tertiary center. Patients with Rutherford categories 4, 5, and 6 who did not have any previous vascular interventions were included in the study. The modified SVS runoff score was used after calculating scores from popliteal and all tibial vessels. Runoff was stratified into good (score <5), compromised (score 5-10), and poor (score >10). Amputation-free survival, patency rates, and overall survival were compared between all groups at 5 years. Between 2011 and 2018, 254 procedures were performed in 220 patients. Technical success was >92%; 66 patients required SFA stents, and 55 had concomitant tibial angioplasty. There was no significant difference between good, compromised, or poor runoff groups regarding complication rates, with 3.5% overall perioperative mortality (5 cases in the compromised group and 4 in the poor runoff group). A runoff score of <5 was associated with significantly marked clinical improvement (P<0.001). Patency rates were significantly worse in the compromised and poor runoff groups, with 5-year cumulative primary patency rates of 80%, 50%, and 22% in the good, compromised, and poor runoff groups, respectively (P<0.001). Amputation-free survival worsened as the runoff got poorer with 98%, 91%, and 78% in the good, compromised, and poor runoff groups, respectively, at 5 years (P<0.001). SFA stenting and concomitant tibial angioplasty led to slight improvement in patency rates in the poor runoff group. Poor runoff with a score of >10 was associated with significantly reduced amputation-free survival and patency rates at 5 years in patients undergoing SFA endovascular intervention for CLI. Patients with a runoff score of <5 showed marked clinical improvement postoperatively when compared with patients with a runoff score of ≥5.

Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Comparison of Long Term Outcomes After Endovascular Treatment Versus Bypass Surgery in Chronic Limb Threatening Ischaemia Patients with Long Femoropopliteal Lesions

<h3>Objective</h3> There are currently two treatments available for patients with chronic limb threatening ischaemia (CLTI): open surgical bypass (OSB) and percutaneous transluminal angioplasty with/without stenting (PTA/S). The aim of this study was to compare short and long term outcomes between PTA/S and OSB in CLTI patients with long (GLASS grade III and IV) femoropopliteal disease. <h3>Methods</h3> This was a two centre retrospective study including all consecutive patients with CLTI undergoing first time lower extremity intervention at two distinct vascular surgical centres. Between 1 January 2012 and 1 January 2018, 1 545 CLTI consecutive limbs were treated for femoropopliteal GLASS grade III and IV lesions at two vascular surgical centres. Using covariables from baseline and angiographic characteristics, a propensity score was calculated for each limb. Thus, comparable patient cohorts (235 in PTA/S and 235 in OSB group) were identified for further analysis. The primary outcomes were freedom from re-intervention in the treated extremity and major amputation. Secondary outcomes were all hospital complications among the two patient groups. <h3>Results</h3> Total overall complication rates were significantly higher in the OSB group (20.42% <i>vs.</i> 5.96%, <i>p</i> < .001), especially wound infection/seroma rate that required prolonged hospitalisation and further treatment (7.65% <i>vs.</i> 0%, <i>p</i> < .001). After the median follow up of 61 months, re-intervention rates were significantly higher in the PTA/S group (log rank test, 44.68% <i>vs.</i> 29.79%, <i>p</i> = .002), but there was no significant difference in terms of major amputation rates between the two group of patients (log rank test, PTA/S 27.23% <i>vs.</i> OSB 22.13%, <i>p</i> = .17). <h3>Conclusion</h3> Bypass surgery seems to be superior to PTA/S for GLASS grade III and IV femoropopliteal lesions in patients with CLTI in terms of long term re-intervention rates, but with considerably higher rates of post-operative complications. A larger cohort of patients in currently ongoing randomised trials, as well as prospective cohort studies are necessary to confirm these findings.