MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

A case of severe polyarteritis nodosa with critical limb threatening ischemia-promising treatment with sirolimus drug-coated angioplasty.

Polyarteritis nodosa (PAN) is a rare form of vasculitis. Acute limb ischemia is a rare presentation and complication of PAN. Plain old balloon angioplasty (POBA) is one of the treatment strategies for addressing PAN-related critical limb threatening ischemia (CLTI). However, recurrence of stenosis and occlusion is frequent, making POBA a poor treatment choice, as evidenced in our described clinical case. Consequently, with consideration of sirolimus's anti-inflammatory and immunosuppressive properties, we used a sirolimus-coated balloon in the treatment of PAN-induced CLTI. A 37-year-old woman first presented with acute limb ischemia as her initial symptom. Diagnostic angiography demonstrated occlusion of her tibial vessels, and POBA was performed to restore perfusion. Later in the course of her illness, she developed foot gangrene despite multiple courses of immunosuppressive drugs and several attempts with POBA to achieve limb salvage. Because of her disease trajectory, a MagicTouch (Concept Medical) sirolimus-coated balloon was deployed to her anterior tibial artery during her third angioplasty. At 17 months after her last angioplasty, she remained ulcer free, and surveillance scans demonstrated occlusion-free tibial vessels. The use of sirolimus-coated balloon angioplasty is a promising treatment approach for successful limb salvage in patients with PAN vasculitis and CLTI.

Treatment of a Delayed Type IIIb Endoleak 20 Years Post EVAR With Inverted Contralateral Limb Custom-Made Device: A Case Report.

PURPOSE: Type III endoleak can be difficult to distinguish from Type I endoleak. Depending on the stent graft anatomy, the use of standard bifurcated endografts may not be technically feasible, and patients may have to be subject to an aorto-uni-iliac repair with femoral-femoral bypass or open surgery. CASE REPORT: We report a case of an 86-year-old male who had a Type IIIb endoleak 20 years post EVAR which was characterized on angiography to be from a hole close to the bifurcation limb origin. The initial Talent (Medtronic, Santa Rosa, California) device had a 50 mm main body common trunk, which was not amenable to treatment with standard devices. He was successfully treated with a custom-made device with an inverted contralateral limb. CONCLUSIONS: Our case highlights the need for lifelong surveillance post EVAR as endoleak may present decades post initial EVAR. It also demonstrates that many Type III endoleak which were otherwise deemed unsuitable for treatment with standard devices may potentially be treatable with custom-made device (CMD). This solution preserves a percutaneous option in a now older person which avoids surgical bypass. Further studies are required to establish the durability of this treatment and survey for recurrence.

Pilot single-arm study to investigate the efficacy and safety of endovenous Microwave ablations for treatment of varicose veins in Singapore - one year results of the MAESTRO registry.

OBJECTIVES: Aim was to report a prospective two-centre Singaporean experience using Endovenous Microwave Ablation (EMA) to treat symptomatic primary great saphenous vein reflux. We evaluated 1-year safety, efficacy and patient satisfaction. METHODS: 50 patients (63 limbs; 29 females; mean age 58.0 ± 12.1 years) were included. Patients were reviewed at 2-weeks, 3-, 6- and 12-months and underwent Duplex ultrasound assessment. Three quality of life (QoL) questionnaires were completed. RESULTS: The truncal closure rates at 2-weeks, 3-, 6- and 12-months were 63/63 (100%), 59/59 (100%), 58/58 (100%) and 59/60 (98.3%), respectively. There was 100% technical success and no serious adverse events. There were sustained improvement of QoL questionnaire scores from 2 weeks to 12 months. CONCLUSION: EMA is a safe and efficacious venous ablative technology at 12 months and is associated with a high rate of target vein occlusion and sustained QoL improvement.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.

Importance: Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE). Objective: To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. Design, Setting, and Participants: The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months. Interventions: Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. Main Outcomes and Measures: The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores. Results: Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). Conclusions and Relevance: To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. Trial Registration: ClinicalTrials.gov Identifier: NCT03392753.

Diabetes and other vascular risk factors in association with the risk of lower extremity amputation in chronic limb-threatening ischemia: a prospective cohort study.

BACKGROUND: Patients with diabetes are at increased risk of developing chronic limb-threatening ischemia (CLTI) due to peripheral arterial disease, and this often results in lower extremity amputation (LEA). Little is known of the interaction between diabetes and other vascular risk factors in affecting the risk of CLTI. METHODS: We investigated the association of diabetes, and its interaction with hypertension, body mass index (BMI) and smoking, with the risk of LEA due to CLTI in the population-based Singapore Chinese Health Study. Participants were interviewed at recruitment (1993-1998) and 656 incident LEA cases were identified via linkage with nationwide hospital database through 2017. Multivariate-adjusted Cox proportional hazards models were used to compute hazard ratios (HRs) and 95% CIs for the associations. RESULTS: The HR (95% CI) for LEA risk was 13.41 (11.38-15.79) in participants with diabetes compared to their counterparts without diabetes, and the risk increased in a stepwise manner with duration of diabetes (P for trend < 0.0001). Hypertension and increased BMI independently increased LEA risk in those without diabetes but did not increase the risk in those with diabetes (P for interaction with diabetes ≤ 0.0006). Conversely, current smoking conferred a risk increment of about 40% regardless of diabetes status. CONCLUSIONS: Although diabetes conferred more than tenfold increase in risk of LEA, hypertension and increased BMI did not further increase LEA risk among those with diabetes, suggesting a common mechanistic pathway for these risk factors. In contrast, smoking may act via an alternative pathway and thus confer additional risk regardless of diabetes status.

Health Services Use and Functional Recovery Following Blunt Trauma in Older Persons - A National Multicentre Prospective Cohort Study.

OBJECTIVE: Frailty is associated with morbidity and mortality in older injured patients. However, for older blunt-trauma patients, increased frailty may not manifest in longer length of stay at index admission. We hypothesized that owing to time spent in hospital from readmissions, frailty would be associated with less total time at home in the 1-year postinjury period. DESIGN: Prospective, nationwide, multicenter cohort study. SETTING AND PARTICIPANTS: All Singaporean residents aged ≥55 years admitted for blunt trauma with an Injury Severity Score (ISS) or New Injury Severity Score (NISS) ≥10 from March 2016 to July 2018. METHODS: Frailty (by modified Fried criteria) was assessed at index admission, based on questions on preinjury weight loss, slowness, exhaustion, physical activity, and grip strength at the time of recruitment. Low time at home was defined as >14 hospitalized days within 1 year postinjury. The contribution of planned and unplanned readmission to time at home postinjury was explored. Functional trajectory (by Barthel Index) over 1 year was compared by frailty. RESULTS: Of the 218 patients recruited, 125 (57.3%) were male, median age was 72 years, and 48 (22.0%) were frail. On univariate analysis, frailty [relative to nonfrail: odds ratio (OR) 3.45, 95% confidence interval (CI) 1.33-8.97, P = .01] was associated with low time at home. On multivariable analysis, after inclusion of age, gender, ISS, intensive care unit admission, and surgery at index admission, frailty (OR 5.21, 95% CI 1.77-15.34, P < .01) remained significantly associated with low time at home in the 1-year postinjury period. Unplanned readmissions were the main reason for frail participants having low time at home. Frail participants had poorer function in the 1-year postinjury period. CONCLUSIONS AND IMPLICATIONS: In the year following blunt trauma, frail older patients experience lower time at home compared to patients who were not frail at baseline. Screening for frailty should be considered in all older blunt-trauma patients, with a view to being prioritized for postdischarge support.

Endoleak Complicated by communicating psoas abscess and aorto-enteric fistula in an immunocompromised patient.

PURPOSE: While endovascular repair of aortic aneurysm (EVAR) has become the mainstay treatment for abdominal aortic aneurysm (AAA), it is not without its disadvantages. Feared complications include graft infections, fistulation and endoleak, the outcomes of which may be life limiting. CASE REPORT: We present a case of a 57 year-old patient with human immunodeficiency virus (HIV) previously treated with EVAR for AAA complicated by endoleak post treatment. He developed an aorto-psoas abscess 2 years later which harboured Mycobacterium avium complex, and medical therapy was unsuccessful. He eventually underwent an extra-anatomical bypass and graft explant, for which an aortoenteric fistula was also discovered and repaired. CONCLUSION: Infection of endografts post EVAR is relatively rare, and there are presently no guidelines concerning its management. The concomittance of aorto-psoas abscess and aortoenteric fistula is even more uncommon, and necessitated surgical explant for source control purposes in our patient. Lifelong surveillance is required for complications of the aortic stump and bypass patency.

Innovative solutions for endovascular aneurysm sealing-delayed Nellix type 1a endoleak.

A delayed Nellix (Endologix, Irvine, Calif) type 1a endoleak from endovascular aneurysm sealing (EVAS) is particularly challenging to treat owing to the restrictions and scarcity of the technical options available. We have described two viable endovascular solutions, with and without the availability of the Nellix endograft inventory. A Nellix-in-Nellix apparatus with multivisceral chimney, covered stent extensions and internal reinforcements can be used if Nellix endografts are available (patient 1). In the absence of Nellix endografts, we used a Viabahn-in-Nellix apparatus, also with multiple chimney stents, as an alternative and timely treatment for patient 2. Our patients remained well and free of endoleaks at 19 and 11 months after treatment.

Spontaneous Superficial Femoral Artery Mycotic Aneurysm.

Peripheral artery mycotic aneurysms are rare occurrences. In this case, we review a 52-year-old lady with poorly controlled diabetes who developed a spontaneous left superficial artery mycotic aneurysm. She underwent excision and subsequent extra-anatomic bypass with a great saphenous vein graft. She had full functional recovery after a short period of rehabilitation.

Single Asian Center Experience Using the Flixene™ Early Cannulation Graft for Hemodialysis Access Creation.

BACKGROUND: The aim of this study was to review the efficacy of the Flixene™ (Atrium™, Hudson, NH, USA) hemodialysis arterio-venous graft (AVG) in a multiethnic Asian cohort of patients with end-stage renal failure (ESRF). Primary outcome was graft primary patency rate and secondary end points included graft usability, time to cannulation, reinterventions required for access salvage, complications, and patient mortality. METHODS: Single-center, single-arm, multi-investigator nonrandomized retrospective study. Patients with ESRF who underwent Flixene™ graft implantation over a two-year period (January 2017 - December 2018) were included to allow at least one-year follow-up. Demographics, procedural and follow-up data were collected from the hospital electronic medical records. RESULTS: About 48 patients (49 AVG) were included. There were 24 (50%) men; mean age 63.7 (IQR 58.2-71.3) years. Technical success rate was 45/49 (91.8%); 4/49 (8.2%) AVG created did not reach cannulation. 11/49 (22.4%) and 28/49 (57.1%) achieved cannulation within 1 and 2 weeks, respectively. 6- and 12- month primary patencies were 33.5% and 19.6%, respectively. Primary-assisted patency rates were 46.6% and 29.6% at the same time intervals. Secondary patency rate was 77.6% and 63.9% at 6 and 12 months, respectively. There were 6 (12.2%) graft infections requiring explant and one-year mortality was 14%. CONCLUSIONS: Our experience with the Flixene™ early cannulation graft is comparable with other AVGs in terms of patency and infection rates. However, early cannulation rates are lower than in other case series.

Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins.

OBJECTIVE: The aim of A Singapore VenaSeal Real-World Post-Market Evaluation Study (ASVS) was to evaluate the performance of cyanoacrylate closure (CAC) for varicose veins in a prospective multiracial Singaporean Asian cohort. We report early clinical and patient satisfaction outcomes at 3 months after intervention. METHODS: There were 100 patients (151 legs; 156 truncal veins) who underwent CAC between April and December 2018. Of the 151 legs, 49 (32.5%) were treated for great saphenous vein (GSV) incompetence, 96 (63.6%) for bilateral GSV incompetence, 1 (0.7%) for small saphenous vein (SSV) incompetence, and 5 (3.3%) for combined unilateral GSV and SSV reflux. At baseline, 68 legs (45.0%) had C4 to C6 disease, and 67 legs (44.4%) had concomitant multiple stab avulsions. Patients were reviewed at 2 and 12 weeks by duplex ultrasound to check for venous recanalization (defined as ≥5 cm in length), pain score, revised Venous Clinical Severity Score, EuroQol-5 Dimension questionnaire score, Aberdeen Varicose Vein Questionnaire score, 14-item Chronic Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life measures, and patient satisfaction. Time to return to work and normal activities were also recorded. RESULTS: There were 59 female patients, and mean age was 60.1 ± 12.7 years. There was 100% technical success. Patients tolerated the procedure well and reported low periprocedural pain (mean pain score, 2.9 [range, 0-9]). Patient surveys at the 3-month interval showed high satisfaction rates, with 72 of 91 (79.1%) being extremely or very satisfied. By day 10, of 100 patients, 93 (93%) resumed daily activities, whereas 36 (36%) had returned to work. At 2 weeks, GSV and SSV were completely occluded in 150 of 150 (100%) and 6 of 6 (100%) veins, respectively. At 3 months, GSV and SSV occlusion rates were 140 of 141 (99.3%) and 6 of 6 (100%), respectively. Transient superficial phlebitis was reported in 27 of 151 (18 %) legs, which was self-limited. At 3 months, revised Venous Clinical Severity Score improved from 5.00 (range, 1.00-18.00) to 1.00 (0.00-10.00; P < .001); EuroQol-5 Dimension score, from 0.686 (-0.382 to 1.00) to 1.00 (0.12-1.00; P < .001); Aberdeen Varicose Vein Questionnaire score, from 17.14 (1.29-61.15) to 4.83 (0.00-57.12; P < .001); and 14-item Chronic Venous Insufficiency Questionnaire, from 19.64 (1.79-73.21) to 7.14 (0.00-51.79; P < .001). CONCLUSIONS: CAC has a high safety profile and is an effective way to block refluxing truncal veins in Asian patients at early follow-up. Patients are highly satisfied and report low postoperative pain. There is significant continued quality of life improvement at 3 months. Early results are encouraging, but we await further prospective long-term follow-up from the study.

Exit site complications following cyanoacrylate glue endovenous ablation of incompetent truncal veins for chronic venous insufficiency.

In the last 5 years, the use of nonthermal, nontumescent endovenous ablation such as cyanoacrylate glue (CAG) for treatment of chronic venous insufficiency has gained global popularity. This case series discusses the presentation and management of delayed access sheath site infections in patients who have undergone CAG therapy. The authors believe such adverse effects are related to granuloma formation owing to a hypersensitivity reaction to CAG at the puncture exit site. The endovenous surgeon should be aware of preventing glue spillage into the subcutaneous space at the access site during treatment, to minimize the risk of this complication developing.

Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft.

BACKGROUND: In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term patency rates have been suboptimal. Drug-coated balloon (DCB) has been used to treat stenosed arteriovenous access in recent years with encouraging results but data on its effect in clotted AVG is unavailable. METHODS: This is an investigator-initiated, single-center, single-arm prospective pilot study to determine the safety and outcome of the sirolimus-coated balloon (SCB) in the salvage of thrombosed AVG. Twenty patients who undergo successful percutaneous thrombectomy will receive treatment with SCB at the graft vein junction. The patients will be followed-up for 6-months. The primary endpoint is the patency rates at 3-month while the secondary endpoints are the patency rates and the number of interventions needed to maintain patency at 6-month. DISCUSSION: Unremitting efforts have been made to prolong the patency of AV accesses over the years. DCB angioplasty combines mechanical and biological treatment for vascular stenosis. Sirolimus, being a cystostatic anti-proliferative agent, has been successfully used in coronary artery interventions. As the primary pathology of vascular stenosis in the dialysis circuit is neointimal hyperplasia, the use of sirolimus in balloon angioplasty may be effective. With this prospective study, we evaluate the efficacy and safety of SCB in patients with clotted AVG. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03666208 on 11 September 2018.

The Modified Frailty Index Does Not Predict Mortality After Major Lower Extremity Amputation for Peripheral Arterial Disease in an Asian Population.

BACKGROUND: Patients with critical limb ischemia (CLI) who undergo major lower extremity amputation (LEA) have been associated with high one-year mortality rates. Previous western-based studies have identified risk factors that exponentiate these poor outcomes, including nonambulatory status and cardiovascular morbidity. We assessed the effect of frailty, using the modified frailty index (mFI) in a cohort undergoing major LEA for CLI to predict mortality, perioperative complications, and unplanned readmissions in a tertiary institution from Singapore. METHODS: Data on patients who had undergone major LEA from January 2016 to December 2017 were collected retrospectively. Inclusion criteria were below-knee amputations (BKAs) or above-knee amputations (AKAs) performed for peripheral arterial disease-related tissue loss or sepsis only. Patients were categorized into 3 risk groups based on the 11-variable mFI: low mFI, 0-0.27; moderate mFI, 0.36-0.54; and high mFI ≥0.63. Univariate and multivariate analysis was performed using logistic regression analysis. RESULTS: 211 patients underwent major LEA, of whom 133 (63.0%) had undergone BKA. The mean mFI was 0.41 (range 0-0.81). 84/211 (39.8%) died within 1 year after the procedure, with mortality rates of 25/65 (38.4%), 49/127 (38.6%), and 10/19 (52.6%) in the low-, moderate-, high-mFI categories, respectively. High and moderate mFI had failed to demonstrate an increased risk of mortality when compared with the low-mFI group (P > 0.05). 91/211 (43.1%) patients had perioperative complications, whereas 27/211 (12.8%) patients were readmitted within 30 days of discharge. Myocardial infarction, chronic kidney disease, and atrial fibrillation were found to be predictive of poor outcomes after major LEA. CONCLUSIONS: Frailty as measured with the mFI did not predict outcome after major LEA. This could be due to confounding effects such as high prevalence of renal dysfunction and the constancy of diabetes and peripheral vascular disease in this population that would reduce the differentiation of patients using the mFI.

The utility of endovenous cyanoacrylate glue ablation for incompetent saphenous veins in the setting of venous leg ulcers.

OBJECTIVE: Patients with venous leg ulcers (VLUs) represent the worse spectrum of chronic venous insufficiency (CVI). The Early Venous Reflux Ablation (EVRA) landmark trial published in 2018 demonstrated that early endovenous intervention results in faster healing of VLUs. We describe our post-EVRA experience using endovenous cyanoacrylate glue ablation (ECGA) to treat superficial venous reflux on an early basis and assess its efficacy and safety in the setting of VLUs. METHODS: There were 37 patients (39 legs, 43 truncal veins) with 43 discrete venous ulcers who underwent ECGA for CVI symptoms and VLUs. They received compression therapy and regular dressings for the VLUs postoperatively and were reviewed at 1 week, 3 months, 6 months, and 12 months after the procedure. Postoperative healing time for VLUs and complications were recorded along with the patient's satisfaction and postprocedure pain scores. RESULTS: The venous ulcers were all <30 cm2 before ECGA. The mean time for VLU healing from operation was 73.6 ± 21.9 days, and the primary occlusion rate of the CVI at both 1 week and 3 months was 100%. No major adverse events were observed except for one case of deep venous thrombosis. There was significant improvement in the revised Venous Clinical Severity Score postoperatively from 11 ± 1.63 (baseline) to 5.6 ± 1.37 (P < .001) at 3-month follow-up (on a scale of 0 to 27, with the severity of symptoms at a maximal 27). The visual analog scale scores for pain were low postoperatively, decreasing from a preoperative score of 6.84 ± 1.42 to 2.72 ± 1.59 (P < .001) at the 3-month follow-up (on a scale of 1-10, with 10 being the most severe pain). The median time to return to normal activities was 7 days (interquartile range, 5-7 days). CONCLUSIONS: ECGA together with compression therapy for VLUs is both safe and effective in this population of Asian patients. ECGA for patients with VLUs has excellent patient acceptability, minimal morbidity, and low recanalization rates at 12 months. Larger extensive studies and longer follow-up periods are required to validate the preliminary outcomes of this paper, and if it is proven to significantly improve ulcer healing rates, this will change the way we approach chronic venous ulceration.

A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation.

OBJECTIVE: The percutaneous endovascular approach to arteriovenous fistula (AVF) creation is a minimally invasive alternative to surgical AVF creation. This systematic review and meta-analysis aimed to investigate the efficacy and safety of endovascular AVF creation in patients with end-stage renal disease. METHODS: This study conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search was performed on major databases to identify relevant articles. Meta-analysis of proportions and meta-regression were conducted. RESULTS: Seven studies totaling 300 patients were included, of which four evaluated the everlinQ (TVA Medical, Austin, Tex) and three employed the Ellipsys (Avenu Medical, San Juan Capistrano, Calif) systems. The overall technical success rate was 97.50% (95% confidence interval [CI], 94.98-99.31%; I2 = 0.00%; P = .487). The 90-day maturation rate was 89.27% (95% CI, 84.00-93.66%; I2 = 21.29%; P = .283), and the 6-month patency and 12-month patency were 91.99% (95% CI, 87.98-95.35%; I2 = 0.00%; P = .780) and 85.71% (95% CI, 79.90-90.71%; I2 = 0.00%; P = NS), respectively. The overall procedure-related complication rate was 5.46% (95% CI, 0.310-14.42%; I2 = 81.21%; P = .000). Meta-regression was conducted on the pooled rates of technical success and complication, showing that age, diabetes, white race, hypertension, on dialysis, and body mass index were not significant sources of heterogeneity. CONCLUSIONS: Current endovascular AVF systems appear to be effective and safe. However, given the lack of head-to-head comparative analyses with surgical AVF creation, superiority cannot be established.