Chronic limb-threatening ischemia:Optimizing endovascular and medical treatment

Peripheral arterial disease is a problem that affects many people. The therapy often consists of endovascular treatment combined with medical treatment. Despite the fact that there have been many developments in the endovascular field, many patients develop vascular disease again after treatment or still need to be amputated. Regarding endovascular treatment, drug-coated balloons do not show any advantage over standard endovascular treatment. Bioresorbable vascular scaffolds, however, may be a good option; comparative studies are needed to better investigate this. 2D perfusion angiography software could be used to better predict the outcome of treatment already during the endovascular intervention.Regarding medical treatment, it is particularly striking that hardly any good quality studies have been carried out. As a result, treatment options are limited and there is often no international consensus. For example, this is reflected in the prescription of platelet aggregation inhibitors, where there is uncertainty which type and duration give the best result. Dual platelet aggregation inhibition may have a better effect than single platelet aggregation inhibition, but a well-powered, comparative study is necessary to further investigate this.In conclusion, the technique of endovascular treatment shows promising developments. High quality research is of great importance to better explore the medical treatment options

Medical adjunctive therapy for patients with chronic limb-threatening ischemia:a systematic review

INTRODUCTION: To systematically review the literature on medical adjunctive therapy for patients with chronic limb-threatening ischemia (CLTI). EVIDENCE ACQUISITION: MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched for studies published between January 1, 2009, and June 1, 2019. Articles that studied medical treatment of CLTI patients and reported clinical outcomes were eligible. Main exclusion criteria were case reports <20 patients, incorrect publication type, and CLTI caused by Buerger disease. The primary end point was major amputation (above the ankle) in studies with a follow-up of ≥6 months. Secondary end points were other clinical end points such as death and wound healing. Study quality was assessed according to the Downs and Black checklist. EVIDENCE SYNTHESIS: Included were 42 articles; 4 focused on antiplatelet therapy, 5 on antihypertensive medication, 6 on lipid-lowering therapy, 16 on stem cell therapy, 3 on growth factors, 5 on prostanoids, and 1 study each on cilostazol, glucose-lowering therapy, spinal cord stimulation, sulodexide, and hemodilution. Calcium channel blockers, iloprost, cilostazol, and hemodilution showed significant improvement of limb salvage, but data are limited. Stem cell therapy showed no significant improvement of limb salvage but could potentially improve wound healing. Antiplatelets, antihypertensives, and statins showed significantly lower cardiovascular events rates but not evident lower major amputation rates. The quality of the studies was fair to good. CONCLUSIONS: Certain medical therapies serve to improve limb salvage next to revascularization in CLTI patients, whereas others are important in secondary prevention. Because high quality evidence is limited, further research is needed

Comparing Venous Reconstructions and Antimicrobial Graft Reconstructions in Mycotic Abdominal Aortic Aneurysms and Aortic Graft Infections

Background: The perioperative mortality and morbidity rates of surgical repair of mycotic abdominal aortic aneurysms and aortic graft infections are high, and the appropriate treatment is debated. This retrospective study compared venous and antimicrobial prosthetic aortic graft reconstructions. Methods: All patients of the Northwest Clinics and St. Antonius Hospital who were treated for mycotic abdominal aortic aneurysms or aortic graft infections between January 1, 2008, and January 1, 2018, were analyzed. Exclusion criterion was treatment other than venous or antimicrobial reconstructions. Primary end points were 30-day complications and mortality rates and 3-year overall survival. Secondary end points were reintervention-free survival, persistent infection and reinfection rates, and hospital length of stay. Results: Fifty-one patients met the inclusion criteria, of whom 32 underwent venous reconstructions and 19 antimicrobial prosthetic aortic graft reconstructions. Baseline characteristics did not differ significantly between these groups, except for duration of surgical repair, which was longer in the venous group. The 30-day and 1-year mortality rates, reinfection rates, complication rates, and hospital length of stay did not significantly differ between the groups. The 3-year overall survival was 77% for venous reconstruction compared with 66% for antimicrobial reconstruction (P = 0.781). The 30-day reintervention rate was 19% for the venous group compared with 42% for the prosthetic group (P = 0.071). Reintervention-free survival at 3 years was 46% for the venous group compared with 52% for the prosthetic group (P = 0.615). Conclusions: Venous reconstruction tends to have better 3-year overall survival and lower 30-day reintervention rates compared with antimicrobial prosthetic graft reconstruction in patients with mycotic abdominal aortic aneurysms or abdominal aortic graft infections. In the acute setting, antimicrobial prosthetic graft reconstruction is a valuable solution due to the shorter operation time and similar 30-day mortality and complication rates

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease:A pooled analysis of individual patient data

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease

Short-Term Clinical Outcomes of Single Versus Dual Antiplatelet Therapy after Infrainguinal Endovascular Treatment for Peripheral Arterial Disease

After infrainguinal endovascular treatment for peripheral arterial disease (PAD), it is uncertain whether single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) should be preferred. This study investigated major adverse limb events (MALE) and major adverse cardiovascular events (MACE) between patients receiving SAPT and DAPT. Patient data from three centers in the Netherlands were retrospectively collected and analyzed. All patients treated for PAD by endovascular revascularization of the superficial femoral, popliteal, or below-the-knee (BTK) arteries and who were prescribed acetylsalicylic acid or clopidogrel, were included. End points were 1-, 3-, and 12-month MALE and MACE, and bleeding complications. In total, 237 patients (258 limbs treated) were included, with 149 patients receiving SAPT (63%) and 88 DAPT (37%). No significant differences were found after univariate and multivariate analyses between SAPT and DAPT on 1-, 3-, and 12-month MALE and MACE, or bleeding outcomes. Subgroup analyses of patients with BTK treatment showed a significantly lower 12-month MALE rate when treated with DAPT (hazard ratio 0.33; 95% confidence interval 0.12-0.95; p = 0.04). In conclusion, although patient numbers were small, no differences were found between SAPT and DAPT regarding MALE, MACE, or bleeding complications. DAPT should, however, be considered over SAPT for the subgroup of patients with below-the-knee endovascular treatment

A systematic review and meta-analysis of bioresorbable vascular scaffolds for below-the-knee arterial disease

INTRODUCTION: Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease. EVIDENCE ACQUISITION: MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score. EVIDENCE SYNTHESIS: Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality. CONCLUSIONS: This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold

Repeatability, and Intra-Observer and Interobserver Agreement of Two Dimensional Perfusion Angiography in Patients with Chronic Limb Threatening Ischaemia

Objective. Two dimensional (2D) perfusion angiography is a method that provides quantitative foot perfusion information from standard digital subtraction angiography acquisitions. The aim of this study was to test the reliability of this method in patients with chronic limb threatening ischaemia (CLTI) by investigating repeatability, and intra-observer and interobserver agreement. Methods: Twenty patients with CLTI and a below the knee endovascular revascularisation were included in a prospective clinical study. Prior to treatment two perfusion angiography runs were acquired with a five minute interval without performing an intervention. In these recordings, regions of interest were selected and time density curves and perfusion parameters were determined. To investigate intra-observer agreement one observer performed five measurements on the same acquisition for each patient. To investigate interobserver agreement three observers performed measurements on the same acquisition for each patient. Results were presented in Bland-Altman plots and as the intraclass correlation coefficient per parameter. Results: Two patients were excluded from repeatability analyses because of major motion artefacts. Repeatability analyses of the 18 remaining patients showed excellent correlation for every parameter (> .96). Intra-observer and interobserver agreement for all 20 patients were excellent for all parameters (1.00). Conclusion: Repeatability and intra-observer and interobserver agreement of 2D perfusion angiography in patients with CLTI were found to be excellent. It is therefore a reliable tool when used according to the standardised methods described in this study

Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease:A Systematic Review and Meta-Analysis

Objective: The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. Methods: This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. Results: Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39-2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39-1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83-9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90-8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23-2.75). No statistically significant differences were found. Conclusion: Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA

Antiplatelet and anticoagulation therapy after revascularization for lower extremity artery disease:a national survey and literature overview

BACKGROUND: Antiplatelet therapy (APT) after interventions for lower extremity artery disease (LEAD) is recommended. However, (inter)national guidelines vary on type and duration of APT. This report aimed to present the results of a survey on antithrombotic prescribing patterns after lower limb interventions in the Netherlands and an overview of the available literature on this topic. METHODS: Vascular surgeons from the Dutch Society for Vascular Surgery and interventional radiologists from the Dutch Society for Interventional Radiology received an online survey on the type and duration of antithrombotic medication after lower limb interventions. RESULTS: Surveys were completed by 139 of 285 vascular surgeons (49%) and 24 of 288 (8%) interventional radiologists. Clopidogrel was the most prescribed drug after iliac percutaneous transluminal angioplasty (PTA) (77%), femoral PTA (77%), femoral PTA with drug-coated balloon (66%), and femoropopliteal (80%) and femorocrural (51%) prosthetic bypasses. Dual APT (DAPT), consisting of aspirin and clopidogrel, was most often prescribed after femoral PTA with stenting (56%) and crural PTAs (55% without stent, 73% with stent). Vitamin K antagonists were most often prescribed after femoropopliteal (83%) and femorocrural (80%) venous bypasses. Aspirin monotherapy prescription varied from 1% to 8% after interventions. Many interventional radiologists responded that they only advise in medication prescription but do not prescribe themselves. CONCLUSIONS: Prescription of antiplatelet and anticoagulation therapy in LEAD patients after femoral and crural interventions varies widely among Dutch vascular surgeons, mostly between clopidogrel and DAPT. The duration of DAPT is also highly variable. These results reflect low-level evidence and discrepancy in current guideline recommendations