Femoropopliteal Segment Research Articles

Comparison of safety and efficacy of femoropopliteal arterial disease using different dose drug-coated balloons: Systematic review and meta-analysis.

Endovascular therapy with balloon percutaneous angioplasty (PTA) in the femoro-popliteal segment is frequently performed, however, long-term favorable outcomes and patency remain challenging, with restenosis rates reaching 60% post-standard balloon angioplasty. Drug-coated balloons (DCBs) have shown promise in improving these outcomes; Paclitaxel, used in DCBs, inhibits hyperplasia and smooth muscle cell proliferation, reducing restenosis; however, the optimal dose of Paclitaxel remains unclear, with high-dose (HD-DCB [>3mg/mm2]) and low-dose (LD-DCB [<2.0mg/mm2]) options available. This meta-analysis aims to compare the efficacy and safety of HD-DCB and LD-DCB in treating femoropopliteal arterial disease. We followed PRISMA guidelines and conducted a comprehensive search of PubMed, EMBASE, Cochrane, Scopus, and Mendeley up to May 27, 2024. We included randomized controlled trials and cohort studies comparing HD-DCB and LD-DCB in patients with femoropopliteal arterial disease. Data were extracted on baseline characteristics, outcomes, and study quality. The Newcastle-Ottawa Scale and ROB2 tool were used for bias assessment. Outcomes included overall survival (OS), limb salvage (LS), freedom from clinically driven target lesion revascularization (CD-TLR), and major amputation. Six studies comprising 2563 patients were included. HD-DCB showed a significant benefit in limb salvage at 6 months (RR = 0.38, 95% CI = 0.18-0.78, p = .009) but not at 12 months (RR = 3.08, 95% CI = 0.14-67.13, p = .47). No significant difference was observed in overall survival between HD-DCB and LD-DCB at either 6 months (RR = 1.53, 95% CI = 0.25-9.57, p = .65) or 12 months (RR = 1.21, 95% CI = 0.17-8.84, p = .85). HD-DCB was associated with an increased risk of perioperative complications (RR = 1.90, 95% CI = 1.14-3.17, p = .01) and a higher, though not statistically significant, risk of major amputation (RR = 4.73, 95% CI = 0.54-41.52, p = .16). HD-DCB may offer advantages in limb salvage over LD-DCB in the short term, but this comes with an increased risk of perioperative complications. These findings underscore the need for careful patient selection when considering HD-DCB for femoropopliteal artery disease.

Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients. We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention. Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions. The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

Directional Atherectomy for Critical Lower Limb Ischemia: A Retrospective Observational Study.

Chronic arterial obstructive disease of the lower limbs is a significant global health issue. Directional atherectomy offers advantages in treating critical ischemia. The objective of this study is to determine the clinical outcomes of patients with critical ischemia who underwent directional atherectomy using the TurboHawkdevice. A retrospective review was conducted at Alma Mater Hospital in Medellín, Colombia, on all medical records of patients with critical limb ischemia (Rutherford Classes V and VI) who underwent directional atherectomy for infra-inguinal arterial disease. A total of 42 atherectomies were performed in 41 patients, with 61% classified as Rutherford V and 24.4% as Rutherford VI. The average lesion length to be treated was 60 mm. Calcifications were found in 45.2% of cases, and predilatation angioplasty was used in 42.9% of cases. Atherectomy sites included femoropopliteal segment (40%), superficial femoral (29%), infrapopliteal vessels (14.2%), and more than one vessel in 50% of cases. Technical success was achieved in 78.6% of cases and procedural success in 97.6%, and the need for adjunctive conventional balloon angioplasty was 21.4%, while drug-coated balloon angioplasties were performed in 50% of limbs. The overall complication rate was 14.4%, with embolism at 4.8%, dissection at 4.8%, puncture at 2.4%, and perforation at 2.4%. The average follow-up duration was 12 months, and major amputations were required in 23.8% of cases. Improvement in ankle-brachial index to ≥0.1 was seen in 77% of limbs. Limb survival at 30 days was 85%, and at 90 days, it was 83%. The overall survival rate in the study was 79%. Directional atherectomy is a safe alternative for managing critical ischemia in Rutherford V and VI patients.

Analysis of Deep Vein Thrombosis: A Prospective Observational Study.

Objective This prospective observational study aimed to investigate the prevalence, acquired risk factors, and treatment outcomes of deep vein thrombosis (DVT) at a tertiary care center in India. Materials and methods Conducted from 2022 to 2024, the study included 100 patients diagnosed with lower extremity DVT. The study subjects included patients visiting the general surgery, vascular surgery, surgical gastroenterology, general medicine, emergency medicine, and obstetrics and gynecology departments with symptoms suggestive of DVT. The primary objectives were to evaluate the effectiveness of conventional anticoagulation and thrombolytic therapy as well as to assess the various acquired risk factors for DVT. Patients underwent comprehensive clinical and biochemical evaluations, including venous Doppler ultrasound, and were treated based on their clinical presentations. The study's primary end outcome was early recanalization rates on day 14 post-initiation of treatment and occurrence of post-thrombotic syndrome (PTS). Secondary outcome measures included duration of hospital stay, time taken to return to workand early complications. Results The highest incidence of DVT was in individuals in their forties, with a mean age of 44.84+/-11.71 years and a female preponderance of 58% (n=58). Key acquired risk factors identified included hypertension (25%; n=25), diabetes mellitus (20%; n=20), obesity (16%; n=16), and smoking (34%; n=34). Obesity (16%; n=16), a history of DVT (25%; n=25), trauma/immobilization (9%; n=9), pregnancy (10%; n=10), smoking (34%; n=34), and cancer (20%; n=20) were also identified as important acquired risk factors contributing to the occurrence of DVT. Amongst the study participants, 28% (n=28) had femoro-popliteal segment involvement, 36% (n=36) had calf vein thrombosis, and the remaining 36% (n=36) showed femoro-iliac segment thrombosis. Conventional anticoagulation was administered to 69% (n=69) of patients, while 31% (n=31) received thrombolytic therapy. Both treatments showed similar recanalization rates, but thrombolytic therapy was associated with a longer hospital stay (8.61+/-1.65 days; p=0.024; p<0.05) and return to work period (14.65+/-2.31 days; p=0.012; p<0.05). Post-thrombotic syndrome was less common in the thrombolytic therapy group (3%; n=3). Three patients died in the study, with the cause being pulmonary embolism. The descriptive statistics were computed to delineate the study sample. After completion of data collection, data analysis was achieved using SPSS for Windows, Version 16 (Released 2007; SPSS Inc., Chicago, United States), and the correlations sought after were achieved using the chi-square test of significance. Conclusion The study underscores the importance of recognizing and managing acquired risk factors for DVT, thereby facilitating early diagnosis and ultimately reducing morbidity and mortality. Understanding these factors and employing effective treatment strategies are crucial for better management and prevention of DVT, enhancing patient outcomes.

Long-term comparison of rotational and directional atherectomy outcomes in patients with femoropopliteal lesions.

Objective: This study aims to elucidate the differences in vessel patency rates, procedural complications, and the need for repeat interventions between these two techniques, thereby providing insights into the optimal atherectomy strategy for managing peripheral arterial disease in the femoropopliteal segment. Material and Methods: This retrospective study investigated the long-term effectiveness of two atherectomy techniques, rotational atherectomy (RA) and directional atherectomy (DA), in treating lower extremity peripheral artery disease (LE-PAD) affecting the superficial femoral artery (SFA) and popliteal arteries. A total of 134 patients with symptomatic LE-PAD and significant stenosis (70%-99%) were included and divided into two groups based on the atherectomy method used. Both groups underwent similar pre- and post-atherectomy procedures, including drug-coated balloon angioplasty. The primary outcome measure was clinical success, defined as procedural success and an improvement in Rutherford classification at 1year. Results: Baseline characteristics were similar between the two groups, with no significant differences in demographics or lesion characteristics, except for a higher proportion of right-sided lesions in the DA group. While both RA and DA effectively improved ankle-brachial index (ABI) and Rutherford classification at 12 months, RA demonstrated superior long-term benefits, with significantly higher ABI at 24 months and a greater proportion of asymptomatic patients. Although RA had a longer procedural duration and a higher incidence of dissection, it resulted in lower residual stenosis and fewer cases of treated segment thrombosis than DA. Both RA and DA are effective treatment options for femoropopliteal lesions, but RA may offer advantages in long-term symptom management and vessel patency. Conclusion: Both rotational and directional atherectomy effectively treat femoropopliteal lesions, with rotational atherectomy demonstrating superior long-term outcomes in terms of symptom management and vessel patency. Despite longer procedural times and a slightly higher risk of dissection, rotational atherectomy resulted in lower residual stenosis and fewer cases of treated segment thrombosis than directional atherectomy.

The Impact of Knee Bending on the Superficial Femoral Artery and Popliteal Artery Morphology Before and After Endovascular Repair of Popliteal Aneurysm.

The aim of this study is to evaluate the deformations of the femoropopliteal (FP) arterial segment due to knee flexion in patients suffering from popliteal aneurysm before and after endovascular treatment (ET). Nine patients were prospectively evaluated. Pre-operative and post-operative computed tomography angiography (CTA) scans were performed on the leg of each patient in both a flexed and extended knee position. The images were employed to reconstruct the FP segment through segmentation and the resulting models were subsequently used to calculate the average diameter, length, and tortuosity of both the superficial femoral artery (SFA) and popliteal artery (PA). Furthermore, the overall PA tortuosity was decomposed into 2 components, ie, antero-posterior and lateral direction. Following knee flexion, both arterial segments experienced shortening in the pre-operative and post-operative phases. Specifically, the SFA was shortened by 3.5% in pre (p<0.001) and 1.21% in post-stenting (p<0.001), while the PA was shortened by 4.8% (p<0.001) and 5.63% (p<0.001), respectively. Tortuosity significantly increased in all considered segments; in particular, in SFA there was a pre-intervention increase of 85.2% (p=0.002) and an increase of 100% post-intervention (p=0.004), whereas in the PA, there was an increase of 128.9% (p<0.001) and 254.8% (p<0.001), respectively. The only diameter variation occurred in the SFA pre-operatively with an increase of 11.9% (p=0.007). Tortuosity decomposition revealed significant differences between the 2 planes during the pre-operative and post-operative phases in both extended and flexed configurations, confirming a change in artery position and geometry due to treatment. Knee flexion induces arterial shortening and increased tortuosity in both the pre- and post-operative configuration. Stent placement does not induce significant geometric differences between pre-treatment and post-treatment. These results seem to indicate that the geometry of the covered stent is not affected by the flexion of the knee joint. Despite this, a more detailed analysis of arterial tortuosity showed a change in artery deformation following treatment. This study aimed to evaluate femoropopliteal arterial deformations in nine patients with popliteal aneurysm before and after endovascular treatment (ET) during knee flexion, using a standardized protocol for CTA acquisition and analysis. The result can be useful in procedure planning and have shown that the Viabahn stent used can adapt to the morphological variations induced by limb flexion. Consequently, device failure does not be attributed to stent compression but rather to other factors, such as alterations in hemodynamic and biomechanical forces on the implant due to the significant changes in tortuosity observed, or biological causes.

Femoro-popliteal bypass versus remote endarterectomy: a propensity matched analysis.

The purpose of this study was to compare femoropopliteal bypass (FPB) and remote endarterectomy (RE) for long femoropopliteal lesions. Single center retrospective propensity matching analysis of the symptomatic patients with long occlusion of the femoro-popliteal segment (>250 mm), who underwent femoro-popliteal bypass above the knee or remote endarterectomy from 2014 to 2020. Primary endpoints: primary patency (PP), secondary patency (SP), target lesion revascularization (TLR). Secondary endpoints: MALE, MACE, clinical improvement and survival. Four hundred patients were divided into two groups: 200 in the FPB group and 200 in the RE group. As a result of propensity score matching, 110 (FPB) and 109 (RE) patients remained. Three-year primary patency rates were 62% for FPB vs. 53% for RE, P=0.16. Secondary patency rates were 84% for FPB vs. 75% for RE, P=0.10. Freedom from TLR were 61% for FPB vs. 71% for RE P=0.21. Survival and amputation-free survival (AFS) also did not differ (93% vs. 94%, P=0.81 and 87% vs. 92%, P=0.19 respectively). Primary patency of the GSV higher than RE (P=0.00) and PTFE (P=0.00). It was established statistically advantages of RE and great saphenous vein (GSV) bypass over a PTFE bypass in SP (P=0.01 P=0.03), TLR (P=0.02 P=0.00) and AFS (P=0.03 P=0.01). Surgical treatment of long femoropopliteal occlusions with an autovenous bypass or remote endarterectomy showed significantly better results in secondary patency, TLR and AFS than the use of PTFE prostheses. GSV remains the gold standard for femoropopliteal bypass surgery.

Comparative Study between Rate of Stenting after Mechanical Rotational Thrombectomy Using Rotarex® System versus Balloon Angioplasty for Treatment of Critical Limb Ischemia in the Femoropopliteal Segment

Comparative Study between Rate of Stenting after Mechanical Rotational Thrombectomy Using Rotarex® System versus Balloon Angioplasty for Treatment of Critical Limb Ischemia in the Femoropopliteal Segment

Advances in Vascular Imaging: A Comparative Analysis of Doppler Ultrasound and Multidetector CT for Lower Limb Peripheral Arterial Disease Diagnosis.

Background This study explores the comparison between Doppler ultrasound and multidetector CT angiography (MDCTA) in diagnosing peripheral arterial disease (PAD), emphasizing the urgent need for precise and minimally invasive methodologies in vascular medicine. PAD, stemming from atherosclerosis, manifests as reduced blood flow and symptoms, such as claudication, requiring timely and accurate diagnosis for optimal treatment outcomes. Doppler ultrasound emerges as an option, offering a non-invasive and cost-effective approach. Conversely, MDCTA provides intricate images, albeit with associated risks, such as radiation exposure and potential complications from contrast agents. This research rigorously evaluates the efficacy, safety, and cost-efficiency of these modalities, aiming to provide clinicians with valuable insights for informed decision-making, ultimately enhancing standards of patient care. Methodology In this prospective study conducted at Saveetha Medical College, Chennai, 34 patients diagnosed with PAD were enrolled to compare the efficacy of duplex ultrasound and MDCTA in identifying arterial lesions. Statistical analysis comprised kappa statistics and contingency tables to evaluate the concordance between the modalities, with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) being calculated. Exclusions were made for patients with contraindications to MDCTA, those under 18 years of age, severe renal impairment, and allergies to contrast agents. This research examined the diagnostic accuracy of both imaging techniques, aiming to provide valuable insights into their effectiveness in identifying arterial lesions associated with PAD. Statistical analysis This investigation studied the efficacy of Doppler ultrasound and MDCTA in diagnosing PAD, with a particular focus on comparing the accuracy of Doppler ultrasonography (DUS) against MDCTA using sensitivity, specificity, and Cohen's kappa coefficient. Through segmental analysis, valuable insights were garnered into the diagnostic precision of DUS across various arterial segments. The results underscored the significance of DUS as a safe, cost-effective, and non-invasive alternative that complements the utility of MDCTA. This comprehensive assessment sheds light on the comparative strengths of both modalities, offering invaluable guidance for clinicians in selecting optimal diagnostic approaches for PAD assessment. Statistical analysis was conducted using the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Version 24.0, Armonk, NY). Results The sensitivity of ultrasonography (USG) arterial Doppler in evaluating the supra-inguinal, femoropopliteal segments, and infrapopliteal segments was 87.5%, 100%, and 75.32%, respectively. The specificity in evaluating supra-inguinal, femoropopliteal segments, and infrapopliteal segments was 100%, 96.01%, and 83.06%, respectively. The agreement between the two modalities (USG arterial Doppler and CT angiography) obtained by Cohen's kappa analysis with respect to the aortoiliac region and femoropopliteal region was very good (0.91). For infrapopliteal vessels, it was only moderate (0.76). Conclusion Duplex ultrasound emerges as an indispensable tool in the investigation of PAD, offering safety, affordability, and non-invasiveness alongside high diagnostic accuracy and substantial concordance with MDCTA.

The Association between Major Adverse Cardiovascular Events and Peripheral Artery Disease Burden.

The aim of the present study was to investigate the possible relationship between the segmental burden of lower limb atherosclerosis and Major Adverse Cardiovascular Events (MACEs). All the consecutive symptomatic peripheral artery disease (PAD) patients admitted for digital subtraction angiography (DSA) at Turku University Hospital department of Vascular Surgery between 1 January 2009 and 30 July 2011 were retrospectively analyzed. Angiography due to symptomatic PAD was used as the index date for the inclusion in the study. The segmental burden of atherosclerosis based on DSA was divided into three categories according to the highest disease burden of the defined artery segment: aorto-iliac, femoropopliteal, or tibial segments. The major association for the study was MACEs (defined as a cerebrovascular event, heart failure (HF) and myocardial infarction requiring hospital admission). Demographic data and MACEs were obtained from the hospital electronic medical records system. The lower limb atherosclerosis burden of tibial vessels was related to an increased probability for HF (OR 3.9; 95%CI 2.4-6.5) and for MACEs overall (OR 2.3; 95%CI 1.4-3.6). The probability of both HF and MACEs overall rose with the increasing severity of the atherosclerosis burden. Moreover, the more severe the tibial vessel atherosclerosis, the higher the risk of HF and MACEs. The most extensive tibial atherosclerosis patients had an OR 4.5; 95%CI 2.6-8.0 for HF and an OR 3.1; and 95%CI 1.7-5.6 for MACEs overall. The femoropopliteal disease burden was also associated with an increased risk of HF (OR 2.3; 95%CI 1.6-3.2) and MACE (OR 1.9; 95%CI 1.3-2.7). However, the increasing extent of atherosclerosis of the femoropopliteal segment solely increased the risk of MACEs. PAD patients with severe tibial atherosclerosis are likely to present with MACEs. The risk is further enhanced as the extent of tibial vessel atherosclerosis is increased. An association between MACE and severe atherosclerosis on the aortoiliac segment was not detected. However, when the femoropopliteal segment was the most affected artery segment, the risk of MACEs was increased.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study

BackgroundThe optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. MethodsWe retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups—group A (with an intact GSV) and group B (with a stripped or ablated GSV)—were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. ResultsThere were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. ConclusionsOur findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.

Predictors of Crossing Failure in Femoropopliteal Lesions: The Importance of Length of the Lesion and Calcification

IntroductionEndovascular therapy is nowadays the first choice for most patients with peripheral artery disease. The most important cause of technical failure is failure to cross the lesion with a wire. In this retrospective study we explore possible risk factors of crossing failure. PatientsWe included all consecutive patients in whom the lesion could not be crossed in the period of the 1th January 2017 to 1th January 2022. The lesions of these patients were compared with patients in whom the lesion could be crossed (2:1). The following potential anatomical risk factors were compared: location of the lesion, occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, circumferential characterization classification and the TASC II classification. ResultsIn 71 patients the lesion could not be crossed, these patients were compared with 142 patients. There were significantly more patients with hypertension and hyperlipidemia in the group with crossing failure. The following factors were risk factors for crossing failure: occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium and circumferential characterization classification. Discussions and conclusionAlthough conclusions should be carefully drawn from this retrospective study, calcification and length of the lesion are associated with crossing failure in the femoropopliteal segment. The Trans-Atlantic Inter-Society Consensus (TASC) II classification was the best predictor of crossing failure.

Mechanical, structural, and physiologic differences between above and below-knee human arteries

Peripheral Artery Disease (PAD) affects the lower extremities and frequently results in poor clinical outcomes, especially in the vessels below the knee. Understanding the biomechanical and structural characteristics of these arteries is important for improving treatment efficacy, but mechanical and structural data on tibial vessels remain limited. We compared the superficial femoral (SFA) and popliteal (PA) arteries that comprise the above-knee femoropopliteal (FPA) segment to the infrapopliteal (IPA) anterior tibial (AT), posterior tibial (PT), and fibular (FA) arteries from the same 15 human subjects (average age 52, range 42–67 years, 87 % male). Vessels were imaged using μCT, evaluated with biaxial mechanical testing and constitutive modeling, and assessed for elastin, collagen, smooth muscle cells (SMCs), and glycosaminoglycans (GAGs). IPAs were more often diseased or calcified compared to the FPAs. They were also twice smaller, 53 % thinner, and significantly stiffer than the FPA longitudinally, but not circumferentially. IPAs experienced 48 % higher physiologic longitudinal stresses (62 kPa) but 27 % lower circumferential stresses (24 kPa) and similar cardiac cycle stretch of <1.02 compared to the FPA. IPAs had lower longitudinal pre-stretch (1.12) than the FPAs (1.29), but there were no differences in the stored elastic energy during pulsation. The physiologic circumferential stiffness was similar in the above and below-knee arteries (718 kPa vs 754 kPa). Structurally, IPAs had less elastin, collagen, and GAGs than the FPA, but maintained similar SMC content. Our findings contribute to a better understanding of segment-specific human lower extremity artery biomechanics and may inform the development of better medical devices for PAD treatment. Statement of significancePeripheral Artery Disease (PAD) in the lower extremity arteries exhibits distinct characteristics and results in different clinical outcomes when treating arteries above and below the knee. However, their mechanical, structural, and physiologic differences are poorly understood. Our study compared above- and below-knee arteries from the same middle-aged human subjects and demonstrated distinct differences in size, structure, and mechanical properties, leading to variations in their physiological behavior. These insights could pave the way for creating location-specific medical devices and treatments for PAD, offering a more effective approach to its management. Our findings provide new, important perspectives for clinicians, researchers, and medical device developers interested in treating PAD in both above- and below-knee locations.

Arterial histology in amputated limbs with chronic limb-threatening ischemia and cadaver limbs

ObjectiveThe study objectives were to: (1) elucidate the histopathological and structural alterations in the femoral to popliteal arteries and tibial or more distal arteries in patients with chronic limb-threatening ischemia through detailed histomorphological and histopathological examinations of the lower limb arteries in the amputated limbs; and (2) elucidate the basic structure of the entire lower extremity, from the external iliac artery to the digital artery, based on histomorphological examinations of cadaver limbs. MethodsWe examined the histopathology and histomorphology of lower limb arteries harvested from 22 amputated limbs and that from 11 cadavers without lower limb issues. Sixty-three sections from the amputated limbs were categorized into femoropopliteal, tibial, and distal segments. Five hundred ten sections (from the external iliac artery to the digital artery) from the cadavers were categorized as femoropopliteal segments, tibial and distal segments, and others. The modified American Heart Association classification was used for the histopathological analysis, and the advanced lesion was defined as the presence of progressive atherosclerotic lesion. In the histomorphological analyses, we calculated % stenosis, % medial area as the medial area divided by the area within the external elastic lamina × 100, and % intimal area as the intimal area divided by the area within the external elastic lamina × 100. ResultsIn amputated limbs, advanced lesions and calcification in the medial area were more prevalent in the femoropopliteal segments than in the tibial and distal segments (advanced lesion: 8/10 vs 18/42; P = .048; calcification: 10/10 vs 28/42; P = .037), whereas % stenosis and prevalence of luminal thrombi were comparable. Significant inverse correlations were noted between % medial area and external elastic lamina diameter in both amputated (r = −0.641; P < .001) and cadaver limbs (r = −0.775; P < .001). In the femoropopliteal segments of the amputated limbs, luminal stenosis was solely caused by intimal lesions, whereas in the tibial and distal segments, medial area thickening contributed to luminal stenosis when intimal lesions were less pronounced. When the external elastic lamina diameter was entered as a covariate, the medial area of the 178 cadaver tibial and distal segments with minimal intimal lesions (<40% intimal area) was significantly greater when >75% stenosis was present in the femoropopliteal segments (P < .001). ConclusionsAdvanced lesions in the tibial and distal segments are less prevalent compared with the femoropopliteal segments. Medial area thickening may contribute to luminal stenosis in the tibial and distal segments when intimal lesions were less pronounced, which may be secondary to a significant proximal occlusive lesion.

Predicting the Development of Thrombosis of the Femoral-Popliteal Bypass in the Long-Term Follow-Up Period

Aim of study. The development of a program for predicting thrombosis with subsequent amputation of a limb in the long-term period after femoral-popliteal bypass (FPB).Material and methods. This is a retrospective open comparative study performed from January 10, 2016 to December 25, 2019 at Research Institute – Professor S.V. Ochapovsky Regional Clinical Hospital No. 1 of the Ministry of Health of the Krasnodar Territory, Krasnodar, which included 473 patients who underwent FPB. Depending on the type of bypass, five groups were formed: Group 1 (n=266), reversed vein (great saphenous vein (GSV); Group 2 (n=59), autovenous vein (GSV), prepared in situ; Group 3 (n=66), autovenous vein (GSV), prepared ex situ; Group 4 (n=9) synthetic graft (Jotec, Germany); Group 5 (n=73), veins of the upper limb (forearm and shoulder). In all cases of observation, multislice computed tomography with angiography revealed an extensive (25 cm or more) atherosclerotic occlusive lesion of the superficial femoral artery, corresponding to type D according to the transatlantic consensus (TASC II). The long-term followup period was 16.6±10.3 months.Results. During the hospital postoperative period, all complications developed in groups 1, 2, 3 and 5. However, no significant intergroup statistical differences were found. In the long-term follow-up period, according to the mortality rate (group 1: 4.6%; group 2: 1.7%; group 3: 4.6%; group 4: 0%; group 5: 2.8%; p=0.78), myocardial infarction (group 1: 1.9%; group 2: 0%; group 3: 1.5%; group 4: 0%; group 5: 0%; p=0.62), ischemic stroke (group 1: 0.8%; group 2: 1.7%; group 3: 1.5%; group 4: 0%; group 5: 0%; p=0.8) and bybass thrombosis (group 1: 14.5%; group 2: 19.3%; group 3: 18.5%; group 4: 44.4%; group 5: 19.7%; p=0.16), no significant intergroup differences were identified. However, the largest number of limb amputations (group 1: 4.2%; group 2: 5.3%; group 3: 9.2%; group 4: 22.2%; group 5: 1.4%; p=0.03) and the maximum composite endpoint (sum of all complications) (group 1: 26.0%; group 2: 28.1%; group 3: 35.4%; group 4: 66.7%; group 5: 23 .9%; p=0.05) were observed after the use of a synthetic graft. Using “random forest” analysis, a model and computer program was created that allows, the risk (low, medium, high) of developing bypass thrombosis to be assessed interactively, based on clinical, anamnestic, demographic and perioperative data, with subsequent amputation after FPB in the long-term follow-up period.Conclusions. Revascularization strategy for patients with extended atherosclerotic lesions of the femoropopliteal segment should be determined individually and only by a multidisciplinary council. The conduit of choice for femoral-popliteal bypass surgery is an autovenous graft. Synthetic prostheses can only be used in the absence of the latter. To identify a group of patients with a high risk of thrombosis of the femoral-popliteal bypass and limb amputation in the long-term follow-up period, the created risk stratification program for the development of these complications can be used. Precision supervision of these patients in the postoperative period will make it possible to prevent these adverse events in time.

Arterial dissection during peripheral vascular interventions

ObjectiveArterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. MethodsThe Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. ResultsThere was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. ConclusionsAD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.

Angioplasty with Sirolimus-coated Balloon: the New Standard in the Treatment of PAD?

Endovascular revascularisation with paclitaxel-coated balloons for the treatment of peripheral artery disease has been shown to be an effective therapeutic option in the femoropopliteal segment. The antiproliferative effect of paclitaxel prevents restenosis. In contrast, in the infra-popliteal segment, the evidence is currently conflicting. However, there is evidence of an increased risk of amputation and mortality from the second year after angioplasty with paclitaxel-coated balloons. This may be due to a dose-dependent cytotoxic effect of paclitaxel. Sirolimus-coated balloons might therefore be an alternative because sirolimus is cytostatic rather than cytotoxic and thus has a wide therapeutic window.Three single-arm pilot studies (50, 25, and 50 patients, respectively) show that angioplasty with sirolimus-coated balloons leads to comparable results to those reported from paclitaxel-coated balloons (late lumen loss at 6 months: 0.29mm; primary patency at 12 months: femoropopliteal 79%-82%, infra-popliteal 59%; freedom from target lesion revascularization at 12 months: femoropopliteal 83%-94%, infra-popliteal 86%). Randomised controlled trials comparing standard balloon angioplasty and paclitaxel-coated balloons for the treatment of intermittent claudication or chronic limb-threatening ischaemia are active and are expected to provide efficacy and safety results from mid 2024.This review presents the results of pilot studies on angioplasty with sirolimus-coated balloons for the treatment of peripheral artery disease and reviews currently ongoing randomised controlled trials.

Endovascular Revascularisation versus Open Surgery with Prosthetic Bypass for Femoro-Popliteal Lesions in Patients with Peripheral Arterial Disease.

Aim: Complex atherosclerotic femoro-popliteal lesions have traditionally been treated with bypass surgery. A prosthetic graft is used to save the vein graft for more distal revascularisations or when a vein graft is unavailable. The endovascular approach has gained popularity and is offered as a first-line strategy for complex lesions. This study aimed to evaluate whether endovascular procedures can be used as a first-line treatment strategy for complex native femoro-popliteal lesions over open surgery with prosthetic bypass in patients with peripheral arterial disease (PAD). Methods: This single-centre retrospective observational study was conducted between 2013 and 2021; it included patients with symptomatic PAD who required limb revascularisation at the femoro-popliteal segment and who had complex lesions. The primary endpoints analysed were technical success, primary patency, freedom from clinically driven target lesion revascularisation (cdTLR), freedom from major adverse limb and cardiovascular events (MALE and MACE, respectively), freedom from limb loss, and survival. The secondary endpoints were length of in-hospital stay, and duration and costs of the procedure. Results: We identified 185 limbs among 174 suitable candidates for comparison, wherein 105 were treated with an endovascular procedure and 80 with a femoro-popliteal prosthetic bypass. Most patients in both groups presented with chronic limb-threatening ischaemia, and >90% of them had an American Society of Anesthesiologists (ASA) physical status classification of >3. The endovascular group had more octogenarians (p = 0.02) and patients with coronary disease (p = 0.004). The median follow-up was 30 months. The technical failure rate for endovascular procedures was 4.7%, versus 0% in the open group (p = 0.047). Freedom from MACE was similar in both groups. The endovascular group showed superior primary patency (p < 0.0001), cdTLR (p < 0.0001), MALE (p < 0.0001), and freedom from limb loss (p = 0.0018) at 24 and 48 months. Further analysis performed for the open above-the-knee sub-group showed that the aforementioned endpoints were similar between the groups at 12 months and were better in the endovascular group at 24 and 48 months. Procedural time and in-hospital stay were longer in the open group than in the endovascular group (p < 0.0001 and p < 0.001, respectively). The procedural cost in the endovascular group was 10-fold lower than that in the prosthetic bypass group. Conclusions: Endovascular procedures are safe for treating complex femoro-popliteal lesions in patients at a high risk for surgery and show better outcomes at 24 months than prosthetic bypasses do. The latter may be considered as an alternative should endovascular treatment fail.

Retrograde tibial access for revascularization of chronic total occlusions in patients with chronic limb-threatening ischemia.

To evaluate tibial single access in treatment of chronic total occlusions (CTO) in patients with ipsilateral chronic-limb ischemia (CLTI). In this retrospective study, data was collected on patients treated for ipsilateral CTO via a tibial artery access between March 2017 and March 2021. Fifty-nine limbs in 57 patients, (42 men, average age 73years; range 47-96) were treated. Patient's symptoms were classified in accordance with the Rutherford category. The end points were freedom from major amputation and the need for reintervention up to 1year of follow up. Out of the 59 treated limbs, technical success was achieved in 57 (97%). The treated multilevel segments involved 5 common and 12 external iliac arteries, 23 common and 37 superficial femoral arteries, 23 femoropopliteal segments, 14 popliteal arteries, and 4 bypasses. Mean length of occlusion was 186 mm (range 7-670). Rutherford classification of the treated limbs was category 5 and 6 in 45 patients and category 4 in 14 patients. Three procedural complications occurred and were successfully treated during the same procedure. No immediate post-procedural complication was encountered. Median follow-up was 13months (range 1-45.3). Reintervention was required in 9 limbs, after an average of 6months. One year free from amputation rate was 91.2%. Single access via the ipsilateral tibial artery can be a useful, effective, and safe approach for treating CTO in CLTI patients.