Infrapopliteal Arterial Disease Research Articles

Long-term Outcomes of the AcoArt II-BTK Trial: Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons for the Treatment of Infrapopliteal Artery Lesions.

Previous studies have indicated mixed short-term outcomes between drug-coated balloon (DCB) angioplasty and percutaneous transluminal angioplasty (PTA) in the treatment of infrapopliteal lesions. However, the long-term durability of DCB angioplasty remains uncertain. The objective of this study is to present the long-term outcomes of DCB angioplasty for infrapopliteal lesions in patients with critical limb ischemia (CLI). The AcoArt II-BTK Trial was a prospective, multicenter, randomized, single-blinded trial that enrolled 120 patients with CLI. The patients were randomized 1:1 to DCB angioplasty or PTA. Assessments over 5 years included freedom from all-cause death, freedom from clinically driven target lesion revascularization, and occurrence of major amputation. Additional endpoints included the rate of composite major adverse events. Over 5 years, patients treated with DCB angioplasty demonstrated a higher rate of freedom from all-cause death than patients treated with PTA (Kaplan-Meier estimate 74.6% vs 57.2%; log-rank p=0.04). The major amputation rate was 5.2% for DCB angioplasty compared with 1.8% for PTA (log-rank p=0.347). Freedom from clinically driven target lesion revascularization was 70.5% and 53.7%, respectively (log-rank p=0.058). The rate of composite major adverse events was 34.5% for DCB angioplasty and 56.1% for PTA (log-rank p=0.013), and this statistically significant difference persisted throughout the 5-year follow-up period. Conclusion:Infrapopliteal artery revascularization in patients with CLI using Litos/Tulip DCB angioplasty showed superior 5-year overall survival compared with PTA. The DCB angioplasty group had a consistently lower rate of major adverse events within 5 years of follow-up. The use of DCB in infrapopliteal arterial lesions has been controversial regarding both early and mid-term outcomes, with limited data on long-term results. However, this article demonstrates that the Litos/Tulip DCB exhibits favorable long-term outcomes in infrapopliteal artery lesions. These positive findings provide robust evidence supporting the use of DCB in treating infrapopliteal artery disease.

Drug-eluting devices versus angioplasty in infrapopliteal artery disease:an updated systematic review and meta-analysis

Abstract Background Clinically driven target lesion revascularization (CD-TLR) and restenosis are common complications in individuals with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease undergoing percutaneous transluminal angioplasty (PTA). Drug-eluting balloons, stents, and resorbable scaffolds have emerged as an alternative therapy that may decrease the recurrence of these complications compared to PTA. However, their efficacy and safety are still controversial. Purpose This study aims to update and provide new insights about coated balloons, stents, and resorbable scaffolds as drug-eluting devices compared to PTA in patients with CLTI and infrapopliteal artery disease. Methods We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing drug-eluting devices, such as stents, coated balloons, and resorbable scaffolds, to PTA in patients with CLTI and infrapopliteal artery disease. The primary endpoint of interest was (1) CD-TLR. We only included trials defining this outcome as angiographically confirmed restenosis associated with wound changes or change in Rutherford classification at 12 months follow-up. This study also reported the following secondary outcomes: (2) binary restenosis and (3) amputation. We performed a subgroup analysis of the drug-eluting devices and between the drug-eluting pharmacological class, comparing the limus drug family subgroup and Pactlitaxel subgroup. Results We included 6 RCTs, encompassing 1263 patients, of whom 761 (60.2%) received a drug-eluting device. The mean age was 70.94 years. In the pooled analysis, the primary endpoint of CD-TLR was not statistically significant(OR 0.79; 95% CI 0.56-1.12; p=0.64; figure 1A). Although binary restenosis (OR: 0.62; 95% CI 0.36-1.05; p= 0.04; Fig.1B) was not statistically significant, our subgroup analysis of different drug-eluting pharmacological classes was significantly different(p<0.01; Fig.1B). Furthermore, the -limus family subgroup presented with a significant lower (OR 0.39; 95% CI 0.25 - 0.61; p<0.01; Fig. 1B) binary restenosis. There was no significant difference in the amputation endpoint (OR: 1.12; 95% CI 0.52 - 2.49; p= 0.74) and among the drug-eluting devices subgroup (p=0.63; Fig. 1A) for the CD-TLR endpoint. Conclusion In this updated meta-analysis of patients with CLTI and infrapopliteal artery, drug-eluting devices were not associated with CD-TLR compared to PTA. However, the -limus drug family is associated with a more significant reduction in the binary restenosis endpoint.

The Efficacy of Drug-Coated Balloons and Drug-Eluting Stents in Infrapopliteal Revascularization: A Meta-analysis.

The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease. Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the "-limus" devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study's secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038. Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar. Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures. The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.

Early outcomes of drug-coated balloon angioplasty of infrapopliteal lesions in diabetic foot

Abstract: PURPOSE: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with diabetic foot. METHODS: We analyzed 6-month follow-up data from the prospective PRIME-WIFI study with 203 consecutive patientswith diabetic foot who underwent DCB angioplasty for infrapopliteal arterial occlusive disease. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, and complete wound healing. RESULTS: The mean age was 69.78 ± 9.50 years and 61 were female. A total of 271 lesions, with an average length of 26.02 ± 12.94 cm, accepted DCB angioplasty. Both infrapopliteal runoff score and pedal runoff score improved significantly after procedure compared with baseline. The score changes were − 5.73 and − 0.39, respectively (P < 0.001 for both). Within 6-month follow-up, 16 of the 203 patients died and 32 (15.76%) were lost to follow-up. By Kaplan–Meier analysis, at 6 months postprocedure, freedom from MAE was 85.77% (95% confidence interval [CI], 80.92%–90.91%); AFS was 88.88% (95% CI, 84.49%–93.49%); and freedom from major amputation, all-cause death, and CD-TLR were 95.65% (95% CI, 92.73%–98.65%), 92.57% (95% CI, 88.88%–96.4%), and 95.51% (95% CI, 92.51%–98.61%), respectively. During the 6-month follow up, complete wound healing was achieved in 67.11% patients. CONCLUSION: In patients with diabetic foot, DCB angioplasty of infrapopliteal lesions was effective and safe.

A Systematic Review and Meta-analysis of Atherectomy Plus Balloon Angioplasty Versus Balloon Angioplasty Alone for Infrapopliteal Arterial Disease.

The article aimed to compare the efficiency and safety of atherectomy plus balloon angioplasty (BA) with BA alone for the treatment of infrapopliteal arterial disease. According to the inclusion and exclusion criteria, PubMed, Embase, and Cochrane Library database were searched for studies comparing atherectomy plus angioplasty and angioplasty alone in treating infrapopliteal artery lesions until November 2022. The endpoints included technical success, primary patency, clinically-driven target lesion revascularization (CD-TLR), periprocedural complications, distal embolization, target limb major amputation, and all-cause mortality. Ten studies met the requirements of our meta-analysis, including 7723 patients in the atherectomy plus BA group and 2299 patients in the BA alone group. The meta-analysis showed that atherectomy plus BA was associated with reduced CD-TLR (odds ratio [OR]: 0.51, 95% confidence interval [CI]: 0.34, 0.78, p=0.002) and target limb major amputation (OR: 0.43, 95% CI: 0.19, 1.01, p=0.05) at 12-month follow-up. No statistically significant difference was found in technical success, primary patency, periprocedural complications, distal embolization, or all-cause mortality. Subgroup analysis found a higher rate of primary patency at 6 and 12 months (6 months: OR: 2.26, 95% CI: 1.11, 4.60, p=0.02; 12 months: OR: 2.38, 95% CI: 1.16, 4.86, p=0.02), and lower rates of CD-TLR (OR: 0.45, 95% CI: 0.25, 0.82, p=0.009) and target limb major amputation (OR: 0.43, 95% CI: 0.19, 1.01, p=0.05) at 12 months in patients treated with atherectomy plus drug-coated balloon (DCB) but not in patients treated with atherectomy plus plain old balloon angioplasty (POBA). This meta-analysis suggests that compared with BA alone, atherectomy plus BA may reduce the need for CD-TLR and the incidence of target limb major amputation at 12-month follow-up in the treatment of infrapopliteal artery occlusive lesions, even though there are no significant advantages in technical success, primary patency, periprocedural complications, distal embolization, or all-cause mortality. To go further, atherectomy plus DCB shows significant benefits in primary patency, CD-TLR, and target limb major amputation rate but atherectomy plus POBA does not'. However, due to the limitations of this article, more randomized controlled trials (RCTs) are needed to confirm these conclusions. According to our research, atherectomy combined with BA has the advantages of higher primary patency rate, lower CD-TLR and target limb significant amputation rate in treating infrapopliteal artery occlusive lesions, which may replace the current mainstream surgical method ---BA alone. For the clinician, although the surgery may take longer, it will significantly improve the prognosis and quality of life of patients and hold considerable significance for the management of patients with infrapopliteal arterial disease. Based on the characteristics of infrapopliteal artery disease, this study explored the feasibility of atherectomy combined with BA for infrapopliteal artery disease. Moreover, we found that atherectomy combined with DCB had better clinical efficacy, which should be the innovation of this study.

Drug-eluting resorbable scaffolds are superior to angioplasty for infrapopliteal artery disease.

Drug-eluting resorbable scaffolds are superior to angioplasty for infrapopliteal artery disease.

Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease

BackgroundAmong patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown.MethodsIn this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death.ResultsThe primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, −3 percentage points; 95% CI, −6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.ConclusionsAmong patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.)

Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

WTP1.10 Infra-malleolar bypass in patients with chronic limb threatening ischaemia

Abstract Introduction There is clinical equipoise surrounding the optimal strategy for revascularisation of infra-popliteal arterial disease. The BASIL-2 trial is attempting to address this. The trial has been designed to try and define whether a ‘vein bypass first’ or ‘best endovascular first’ strategy is superior. We have sought to explore the outcomes associated with ultra-distal bypass in a single Scottish Health Board. Methods This was a retrospective review of a single surgeon’s ultra-distal bypass practice over a 7 year period. Index cases were identified from a prospectively maintained logbook. Outcomes included were primary graft patency and amputation free survival. Results There were 22 procedures performed over the 7-year period of interest. Mean age of 66 years. 15/22 (68%) were diabetic. The dorsalis pedis was the most common arterial target (n=14). The primary graft patency at 3-years was 54%. During the follow-up period 50% of the patients had a major limb amputation. There was 1 death in the post-operative period prior to discharge. Discussion Primary patency and limb salvage at 3-years are acceptable, although they are less than that described in the contemporary literature. It is likely that this may a consequence of selection bias given the local prejudice for an endovascular ‘first strategy’.

Usefulness of Off-Label Use of Coronary Drug-Eluting Stents as Bailout for Patients with Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

Background: Infrapopliteal arterial disease is the most common finding in patients presenting with critical limb-threatening ischemia (CLTI) majority of whom also present with tissue loss. Vein bypass has been the gold standard of treatment in these patients. Nowadays, because of high peri-operative mortality and morbidity in these high-risk patients, endovascular treatment is offered first. Vascular restenosis, caused by intimal hyperplasia due to vessel injury during percutaneous transluminal angioplasty (PTA), remains the main limitation of infrapopliteal PTA and bare metal stent with clinical relapse and reinterventions. Drug-eluting stents (DES) are considered a possible solution to the problem of restenosis by reducing neointimal hyperplasia, after promising results in coronary arteries. Materials and Methods: Coronary DES was used as a bail out in patients undergoing below the knee (BTK) angioplasty. Those who developed dissection or recoil were stented with coronary stents. Multiple stents were used in patients with a long segment recoil of the artery. None of the stents were placed 2 or 3 cm beyond the origin of the tibial artery. The primary patency at 6 and 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on clinical assessment and duplex scan, limb salvage and time taken to complete wound healing were assessed. Results: A total of 26 patients underwent drug-eluting stenting of the infra-popliteal vessels for CLTI during a period of 32 months. Technical success was possible in 92.3% patients (n = 24), however two patients had on table thrombosis of the stent. These two patients went on to have surgical bypass and their limbs could be salvaged. Wound healing was seen in 13 of 18 (72.2%) patients at 6 months and 11/12 (91.6%) patients at 1 year. Most patients took an average of 5 months to heal. Limb salvage was 11/12 (91.6%) at 1 year. Two patients underwent below-knee amputation for severe worsening sepsis due to uncontrollable foot infection. In both these patients’ stents were patent at the time of amputation. Primary patency was 92.3% at 6 months and at 1 year. None of the patients required re-intervention. Mortality was 15.3% at 1 year. Conclusion: Off-label use of cardiac stents in the infra-popliteal segment seems a viable bailout option in patients undergoing revascularization. DES helps to achieve early technical success, longer patency, better wound healing, and improves limb salvage in these patients.

Below-the-Knee Stents and Scaffolds: A Comprehensive Review.

Below-the-knee intervention of chronic limb-threatening ischemia is an area of increasing interest. Due to lower morbidity and possibly better clinical outcomes, endovascular techniques have become increasingly important in this patient population many of who have limited surgical options. This article serves as a review of existing stent and scaffolding devices utilized for infrapopliteal disease. The authors will additionally discuss current indications and review studies that are investigating novel materials used in treating infrapopliteal arterial disease.

Inframalleolar thrice distal puncture in a single endovascular treatment session for successful revascularization

BackgroundMost patients with chronic limb-threatening ischemia (CLTI) have infrapopliteal arterial disease, which are often challenging to treat. In endovascular treatment (EVT) for these complex lesions, establishing retrograde access is an essential option not only for guidewire crossing but also for device delivery. However, no EVT case has yet been reported requiring inframalleolar thrice distal puncture in a single EVT session so far.Case presentationA 60-year-old CLTI patient with grade 3 Wound, Ischemia and foot Infection (WIfI) classification underwent EVT for occluded dorsal artery and posterior tibial artery. First, we conducted successful balloon angioplasty of the posterior tibial artery by establishing a retrograde approach via the lateral plantar artery. To treat the occlusion of the dorsal artery, we punctured the first dorsal metatarsal artery, and retrogradely advanced a guidewire to the dorsal artery occlusion; however, the microcatheter could not follow the guidewire. Therefore, we punctured the occluded distal anterior tibial artery and introduced the retrograde guidewire into the puncture needle. After guidewire externalization, we pulled up the retrograde microcatheter into the occlusion of dorsal artery using the “balloon deployment using forcible manner” technique. Thereafter, we were able to advance the antegrade guidewire into the retrograde microcatheter. After guidewire externalization, an antegrade balloon catheter was delivered and inflated for the purpose of dorsal artery dilation and hemostasis at the “needle rendezvous” point. Consecutively, balloon dilation was performed for puncture site hemostasis of the first dorsal metatarsal artery and complete hemostasis was achieved. Finally, we confirmed good vascular patency and favorable blood flow. After revascularization, transmetatarsal amputation was performed and the wound healed favorably.ConclusionsWe can markedly increase the success rate of revascularization by effectively utilizing the retrograde approach in EVT for complex chronic total occlusions in infrapopliteal arterial diseases.

The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions.

Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium.

Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5-6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.

The Impact of Diabetes in Intermittent Claudication: A Prospective Cohort Study.

The aim of this study was to determine the lower-limb outcome in patients with intermittent claudication (IC) and to identify predictors for deterioration. This study employed a prospective observational cohort single-centre design. One hundred fifty patients with IC attending a vascular surgery unit for the first time were recruited. Lower limb perfusion was assessed utilising ankle brachial index (ABI) measures, toe-brachial index (TBI) measures, Doppler waveform analysis and the walking impairment questionnaire. Follow-up was conducted after 1 year and 2 years following recruitment to assess haemodynamic parameters, symptom severity and outcome. Recruited participants had a mean age of 69.7 (±9.3) years, BMI 27.8(±4.2) and 79.3% were men. Significant haemodynamic decline (decline in ABPI by ≥0.15 and/or decline in TBPI by ≥0.1) occurred in 50.6% of the cohort within 2 years of whom 23.3% developed chronic limb threatening ischaemia (CLTI) with rest pain and/or tissue loss. Baseline ABPI, ABPI ≤ 0.5, TBPI ≤ 0.39, infrapopliteal artery (IPA) disease and high Haemoglobin A1c were identified as significant predictors for deterioration to CLI. (P < .05, binomial logistic regression). Patients with IC are at a high risk of developing CLTI within 2 years. Risk of lower limb adverse events is tripled in patients with IPA disease, low ankle and toe pressures and poorly controlled diabetes. Early identification of those at high risk for early deterioration may justify a paradigm shift in the management of this subgroup.

Patterns of Infra-Popliteal Arterial Disease for CME credit December 2022

Patterns of Infra-Popliteal Arterial Disease for CME credit December 2022

Clinical outcomes in patients with infrapopliteal arterial occlusive disease treated by lower extremity bypass surgery: a comparison of atherosclerosis and thromboangiitis obliterans.

Surgical bypasses are commonly utilized for the treatment of infrapopliteal arterial occlusive disease resulting from atherosclerosis (ASO) and thromboangiitis obliterans (TAO), especially when endovascular procedures fail. The aim of this study is to compare the in-hospital and follow-up outcomes of ASO and TAO patients treated with infrapopliteal bypass surgery. A total of 32 infrapopliteal bypasses were analyzed in 18 TAO patients and 14 ASO patients. Preoperative and postoperative arterial Doppler ultrasonography was performed in all patients. The ankle-brachial index (ABI) was calculated preoperatively and postoperatively in all cases. All patients were followed-up for at least one year and clinical outcomes were recorded. Within 1-7 days postoperatively, 4 grafts in TAO patients occluded; nevertheless, 1 graft occlusion occurred in ASO patients. Patency rates at in-hospital were 77.8% and 92.9% in TAO and ASO patients, respectively. In 27 patients with successful infrapopliteal bypass, ABIs and crural peak arterial flow velocities significantly increased at 1-7 days postoperatively. During the period of follow-up, 6 graft occlusions occurred in TAO patients, and one ASO patient died of myocardial infarction. Patency rates at follow-up were 44.5% and 85.7% in TAO and ASO patients. For TAO patients with graft failure, ABIs at follow-up did not statistically differ from those postoperatively; however, they were significantly higher than those preoperatively. Infrapopliteal bypass surgery is a feasible and effective procedure for ASO and TAO patients. Patency rates are lower in TAO than those in ASO during the in-hospital and follow-up period. However, TAO patients had the ischemic symptom relief and the improvement in ABI despite graft occlusion one year postoperatively.

Patterns of Infra-Popliteal Arterial Disease

Introduction The growth of the diabetic population and the increased prevalence of peripheral arterial disease (PAD) below the knee has created an increased demand for duplex ultrasound (DUS) evaluation of the infra-popliteal arteries. The purpose of this study is to show how DUS can be used to identify the patterns of infra-popliteal arterial occlusive disease. Methods: We performed infra-popliteal duplex ultrasound scans on 100 consecutive patients (199 limbs) with suspected PAD. Peak systolic velocity (PSV) was obtained from the anterior tibial artery (ATA) and posterior tibial artery (PTA) at the distal, mid, and proximal calf levels. The acceleration time (AT) was measured in the distal ATA and PTA segments. Results: The PTA was the infra-popliteal artery that was most often totally occluded (21% of limbs). Segmental PTA occlusions occurred predominantly in the proximal and distal segments. The ATA was totally occluded in 8% of limbs, with segmental occlusions located predominantly in the mid segment. We also confirmed that proximal PAD prolongs distal infra-popliteal artery AT and reduces distal PSV. Conclusion: These data add to our understanding of the patterns of infra-popliteal arterial disease and should be of interest to sonographers who perform DUS of the lower extremity arteries.

Intravascular Lithotripsy for Optimal Angioplasty of Infrapopliteal Calcified Lesions.

Infrapopliteal arterial disease results from 2 major etiologies: medial calcification and intimal atheromatous plaque. Lesion calcification constitutes one of the most widely encountered risk factors for percutaneous transluminal angioplasty failure. Intravascular lithotripsy (IVL) creates selective fracturing of calcium deposits in the arterial wall, increasing the compliance of the target artery and facilitating angioplasty. Results regarding IVL utilization at femoropopliteal and infrapopliteal lesions have been very promising in terms of safety and efficacy. This review presents currently available data on IVL outcomes for infrapopliteal lesions and provides technical information for optimal use of IVL in these challenging lesions.

Excimer laser atherectomy combined with drug-coated balloon versus drug-eluting balloon angioplasty for the treatment of infrapopliteal arterial revascularization in ischemic diabetic foot: 24-month outcomes.

There are few studies on excimer laser (308nm) atherectomy in the treatment ofinfrapopliteal artery disease. The purpose of this retrospective clinical study was to assess the efficacy and safety of excimer laser atherectomy (ELA)in combination with adjuvant drug-coated balloon angioplasty (DCB) compared to DCB for infrapopliteal arterial revascularization in patients with ischemic diabetic foot. From September 2018 to February 2019, a total of 79 patients with diabetic foot were treated for infrapopliteal arterial revascularization at Tianjin First Central Hospital (Tianjin, China). In this project, 35 patients were treated with ELA combined with DCB angioplasty, and 44 patients were treated with DCB angioplasty. The patients' baseline characteristics were similar between the 2 groups. The primary efficacy endpoints through 24months were clinically driven target lesion revascularization (CD-TLR), wound healing rate, major amputation rate, and target vessel patency rate.The primary safety endpoint through 24months was all-cause mortality.The primary efficacy results at 24months of ELA + DCB versus DCB were CD-TLR of 14.3% versus 34.1% (p = 0.044), wound healing rate of 88.6% versus 65.9% (p = 0.019), target vessel patency rate of 80.0% versus 52.3% (p = 0.010), and major amputations rate of 5.7% versus 22.7% (p = 0.036). The safety signal at 24months of all-cause mortality rate was 2.9% for ELA + DCB group and 4.5% for DCB group (p = 0.957). ELA combined with DCB angioplasty is more effective than DCB in the treatment of infrapopliteal artery disease in patients with ischemic diabetic foot, which can improve the wound healing rate and target vessel patency rate. There was no statistical difference in the safety results between the two groups.