Outcomes of Noncompliant Balloons in the Treatment of Lower Extremity Chronic Limb Threatening Ischemia: A Prospective Study.

PURPOSE: This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI). MATERIALS AND METHODS: This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis. RESULTS: From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively. CONCLUSION: Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency. CLINICAL IMPACT: There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.

Patients with venous leg ulcers can be managed safely in the community ----results of an observational comparison study in Singapore.

AIM: To examine the healing outcomes of patients with venous leg ulcers requiring compression bandaging in community care versus tertiary care. METHOD: This was an analytical observational cohort study. Venous leg ulcer (VLU) patients who required compression bandaging were recruited from an outpatient vascular clinic between May 2021 and August 2022. Eligible patients received two-or four-layer compression bandaging and followed up with the community care or tertiary care centre nurses. The primary outcome was the difference in the total surface area of the VLU after 12 weeks, and the secondary outcome was the patient's quality of life, as measured by the Cardiff Wound Impact Schedule (CWIS). RESULTS: Forty-seven VLU patients were recruited; 27 received compression bandaging in the community care and 20 by the tertiary care centre. Mean age 70 years old (SD 11.04). The two most prevalent comorbidities were hypertension (51.06 %) and diabetes mellitus (38.29 %). Among those who completed follow-up (12 weeks), the median difference of the total surface area of the VLU between community-based care (p = 0.02) versus tertiary-based care (0.003) was significant. However, there was no difference in the healing status between community and tertiary-based care (p = 0.68). There was no difference in the quality of life of patients between groups. CONCLUSION: This first tropical study comparing VLU healing outcomes between community and tertiary care found no significant difference in healing with compression bandaging by nurses in either setting. However, the small sample size and high dropout rate limit the generalizability of the findings, necessitating a larger-scale study with longer follow-up. Despite these limitations, the study is a crucial step toward improving wound care services in Singapore, and highlights the need for further research to guide future community wound care implementation.

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.

Common Designs of Custom-Made Fenestrated Arch Devices and Applicability of an Off-the-Shelf Design.

OBJECTIVES: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. MATERIALS AND METHODS: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. RESULTS: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. CONCLUSION: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. CLINICAL IMPACT: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.

Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population - 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III.

BACKGROUND: Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. METHODS: A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). RESULTS: AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months. CONCLUSION: Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.

Multi-Modality Imaging of Atheromatous Plaques in Peripheral Arterial Disease: Integrating Molecular and Imaging Markers.

Peripheral artery disease (PAD) is a common and debilitating condition characterized by the narrowing of the limb arteries, primarily due to atherosclerosis. Non-invasive multi-modality imaging approaches using computed tomography (CT), magnetic resonance imaging (MRI), and nuclear imaging have emerged as valuable tools for assessing PAD atheromatous plaques and vessel walls. This review provides an overview of these different imaging techniques, their advantages, limitations, and recent advancements. In addition, this review highlights the importance of molecular markers, including those related to inflammation, endothelial dysfunction, and oxidative stress, in PAD pathophysiology. The potential of integrating molecular and imaging markers for an improved understanding of PAD is also discussed. Despite the promise of this integrative approach, there remain several challenges, including technical limitations in imaging modalities and the need for novel molecular marker discovery and validation. Addressing these challenges and embracing future directions in the field will be essential for maximizing the potential of molecular and imaging markers for improving PAD patient outcomes.

A prospective study on the wound healing and quality of life outcomes of patients with venous leg ulcers in Singapore-Interim analysis at 6 month follow up.

Venous leg ulceration results in significant morbidity. However, the majority of studies conducted are on Western populations. This study aims to evaluate the wound healing and quality of life for patients with venous leg ulcers (VLUs) in a Southeast Asian population. This is a multi-centre prospective cohort study from Nov 2019 to Nov 2021. All patients were started on 2- or 4-layer compression bandage and were reviewed weekly or fortnightly. Our outcomes were wound healing, factors predictive of wound healing and the EuroQol 5-dimensional 5-level (EQ-5D-5L) health states. Within our cohort, there were 255 patients with VLU. Mean age was 65.2 ± 11.6 years. Incidence of diabetes mellitus was 42.0%. Median duration of ulcer at baseline was 0.30 years (interquartile range 0.136-0.834). Overall, the median time to wound healing was 4.5 months (95% confidence interval [CI]: 3.77-5.43). The incidence of complete wound healing at 3- and 6-month was 47.0% and 60.9%, respectively. The duration of the wound at baseline was independently associated with worse wound healing (Hazard ratio 0.94, 95% CI: 0.89-0.99, P = .014). Patients with healed VLU had a significantly higher incidence of perfect EQ-5D-5L health states at 6 months (57.8% vs 13.8%, P < .001). We intend to present longer term results in subsequent publications.

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.

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.

The modified frailty index-11 predicts medium-term outcomes after endovascular revascularisation for chronic limb threatening ischaemia in Asian patients.

OBJECTIVE: The aim was to evaluate the utility of frailty, as defined by the modified Frailty Index-1 1 (mFI-11) on predicting outcomes following endovascular revascularisation in Asian patients with chronic limb-threatening ischaemia (CLTI). METHODS: CLTI patients who underwent endovascular revascularisation between January 2015 and March 2017 were included. Patients were retrospectively scored using the mFI-11 to categorise frailty as low, medium or high risk. Observed outcomes included 30-day complication rate and unplanned readmissions, 1-, 6- and 12-month mortality, and ambulation status at 6- and 12 months post-intervention. RESULTS: A total of 233 patients (250 procedures) were included; 137 (58.8%) were males and the mean age was 69.0 (±10.7) years. 202/233 (86.7%) were diabetic and 196/233 (84.1%) had a prior diagnosis of peripheral arterial disease (PAD). The mean mFI-11 score was 4.2 (±1.5). 28/233 (12.0%), 155/233 (66.5%), and 50/233 (21.5%) patients were deemed low (mF-11 score 0-2), moderate (mFI-11 score 3-5) and high (mFI-11 score 5-7) frailty risk, respectively. High frailty was associated with an increased 12-month mortality (OR 8.54, 95% CI 1.05-69.5; p = 0.05), 30-day complication rate (OR 9.41, 95% CI 2.01-44.1; p < 0.01) and 30-day unplanned readmission (OR 5.06, 95% CI 1.06-24.2; p = 0.04). Furthermore, a high score was associated with a significantly worse 6- (OR 0.320, 95% CI 0.120-0.840; p = 0.02) and 12-month (OR 0.270, 95% CI 0.100-0.710; p < 0.01) ambulatory status. CONCLUSION: The mFI-11 is a useful, non-invasive tool that can be readily calculated using readily available patient data, for prediction of medium-term outcomes for Asian CLTI patients following endovascular revascularisation. Early recognition of short- and mid-term loss of ambulation status amongst high-frailty patients in this challenging cohort of patients could aid decision-making for whether a revascularisation or amputation-first policy is appropriate, and manage patient and caregiver expectations on potential improvement in functional outcome.

Maggot debridement therapy in the tropics - Preliminary outcomes from a tertiary hospital.

This paper aimed to describe the clinical outcomes and patients' acceptance of Maggot debridement therapy (MDT) at a tertiary hospital in Singapore. Patients with non-viable tissue (NVT) covering at least 25% of wound bed on lower limbs and/or unable to tolerate sharp debridement at the bedside were recruited between January and August 2021. Sterile medical-grade maggots of Lucilla Cuprina were used. Wound specialist nurses assessed the size and wound to determine the type of MDT, either Baggots or free-range larvae (FRL), and the number of maggots required prior to commencement of therapy. Wound sites were measured and photographed at multiple time points: before the start of MDT therapy, during the wound review at 48 or 72 h after each cycle of MDT and completion of therapy. Three patients received Baggot therapy, while the remaining 11 received FRL therapy. The mean age for patients receiving Baggot and FRL were 78.3 (SD = 10.6) and 63.6 (11.4), respectively. Each patient received three cycles of MDT treatment on average. The most common type of wound was ray amputated toe wounds (n = 8), while the most common wound aetiology was arterial ulcerations (n = 12). A reduction of NVT was observed in 11 out of 14 patients, and ten of these 11 patients achieved successful debridement (at least 25% reduction in NVT). Five out of 14 patients had to undergo amputation within the same admission due to poor wound healing, and 60% of these five patients failed to achieve successful debridement. MDT was quite well-accepted by the patients, and they felt some improvement in their wounds. MDT can facilitate wound healing through successful debridement and potentially reduce the need for amputation. Further research needs to be done regarding the type of MDT that is optimal to use in tropical countries with high humidity.

Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI Trial.

Background There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with -critical limb ischemia. Purpose To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months. Materials and Methods In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. The primary efficacy end point was angiographic primary patency at 6 months analyzed on an intention-to-treat basis. Secondary end points through 12 months were composed of major adverse events including death and major amputations, wound healing, limb salvage, clinically driven target-lesion revascularization, and amputation-free survival. Primary and binary secondary end points, analyzed by using generalized-linear model and time-to-event analyses, were estimated with Kaplan-Meier survival curves and hazard ratios (Cox regression). Results Seventy participants (mean age, 61 years ± 10 [standard deviation]; 43 men) in the DCBA group and 68 (mean age, 64 years ± 10; 50 men) in the PTA group were evaluated. The percentage of patients with angiographic primary patency at 6 months was 43% (30 of 70) in the DCBA group and 38% (26 of 68) in the PTA group (P = .48). Through 12 months, the percentage of deaths was similar: 21% in the DCBA group and 16% in the PTA group (P = .43). Amputation-free survival rate assessed with Kaplan-Meier curves differed through 12 months: 59% (41 of 70) in the DCBA group compared with 78% (53 of 68) in the PTA group (P = .01). Conclusion In participants with critical limb ischemia, the drug-coated balloon angioplasty group and the conventional percutaneous transluminal angioplasty group had similar primary patency rates at 6 months after treatment of below-the-knee arteries. Amputation-free survival rates through 12 months were higher in the percutaneous transluminal angioplasty group. © RSNA, 2021 Online supplemental material is available for this article.

World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study.

PURPOSE: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. MATERIALS AND METHODS: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). RESULTS: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (p<0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively. CONCLUSIONS: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results.

PURPOSE: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. MATERIALS AND METHODS: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. RESULTS: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). CONCLUSIONS: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft.

PURPOSE: To investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG). MATERIALS AND METHODS: A single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded. RESULTS: The primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194-376 days), 319 days (95% CI = 221-416 days), and 409 days (95% CI = 333-485 days). No adverse event directly related to sirolimus DCB use was observed. CONCLUSIONS: The results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.

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.

Effect of short-term low molecular weight heparin on patency following successful salvage of arteriovenous access with recurrent thrombosis.

AIM: This study aims to investigate the effect of low molecular weight heparin (LMWH) in maintaining the patency of arteriovenous (AV) access with recurrent thrombosis. METHODS: Following successful thrombectomy, 66 patients with recurrent thrombosis were included in the study. The primary, assisted primary and secondary patency rates of patients who received LMWH (n = 24) were compared with those who did not receive anticoagulant (n = 42) using Kaplan-Meier analysis. Cox-regression analysis was performed to investigate potential predictors of patency rates. RESULTS: The mean dose of enoxaparin used was 40 ± 13.1 mg or 0.74 ± 0.2 mg/kg daily for a median duration of 14 (IQR 7,28) days. The mean trough anti-Xa concentrations measured after two doses of LMWH was 0.17 ± 0.13 IU/mL. Kaplan-Meier analyses for mean primary, assisted primary and secondary patency rates of LMWH vs no anticoagulation groups were 149 (95% CI: 91 - 207) vs 87 (95% CI: 42-132) days (P < .006), 230 (95% CI: 142-320) vs 107 (95% CI: 62-150) days (P = .01) and 438 (299-579) vs 294 (95% CI: 197-392) days (P = .08) respectively. LMWH remained a significant protective predictor of primary (HR: 0.49; 95% CI: 0.25-0.86; P = .02) and assisted primary patency rates (HR: 0.51; 95% CI: 0.27-0.98; P = .04) after adjusting for patient age, access age, type of AV access, presence of peripheral vascular disease and haemoglobin levels. CONCLUSION: LMWH may improve short and mid-term patency rates for AV accesses with recurrent thrombosis.

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.

Outcomes of endovascular salvage of clotted arteriovenous access and predictors of patency after thrombectomy.

OBJECTIVE: This study aimed to report the outcomes of endovascular salvage of clotted arteriovenous (AV) accesses and to determine potential predictors of poor patency rates after thrombectomy. METHODS: Records of hemodialysis patients who underwent endovascular salvage of clotted AV access were reviewed retrospectively. Technical and clinical success rates, complication rates, and 3- and 6-month patency rates were determined. Multivariate analysis was performed to determine the predictors of patency after thrombectomy. RESULTS: A total of 294 patients underwent endovascular salvage of clotted AV access during the study period; 156 patients had arteriovenous fistula, whereas the remaining 138 were arteriovenous grafts (AVGs). The technical and clinical success rates were 96.3% and 93.2%; the major and minor complication rates were 0.7% and 9.9%. Post-thrombectomy primary, assisted primary, and secondary patency rates were 62.9%, 76.2%, and 77.6% at 3 months and 43.9%, 59.5%, and 61.6% at 6 months. The patency rates were significantly better for arteriovenous fistula than for AVG except for 6-month assisted primary and secondary patency. Multivariate Cox regression analysis showed that prior thrombosis within 90 days was significantly associated with loss of primary patency (hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.21-2.98; P < .01), assisted primary patency (HR, 2.42; 95% CI, 1.42-4.13; P < .01), and secondary patency (HR, 2.52; 95% CI, 1.40-4.53; P < .01). Having an AVG was also negatively associated with primary patency. CONCLUSIONS: Most clotted AV accesses can be salvaged by endovascular technique. Recurrent thrombosis within 90 days is associated with poor short- and long-term patency even after successful endovascular reinterventions.

Outcome and Distal Access Patency in Subintimal Arterial Flossing with Antegrade-Retrograde Intervention for Chronic Total Occlusions in Lower Extremity Critical Limb Ischemia.

PURPOSE: To report the outcome and distal access patency of the Subintimal Arterial Flossing with Antegrade-Retrograde Intervention (SAFARI) technique for chronic total occlusion (CTO) in critical limb ischemia (CLI). MATERIALS AND METHODS: From January 2009 to June 2015, 220 SAFARI procedures were performed for 200 limbs in 191 patients (108 males [56.5%]; median age, 70 years old; range, 36 to 97 years old) with CLI (9.4% were Fontaine classification 3; and 90.6% were Fontaine classification 4). Distal access was obtained from the distal superficial femoral artery (n = 6), popliteal artery (n = 49), anterior tibial artery (n = 56), dorsalis pedis (n = 51), peroneal artery (n = 12), posterior tibial artery (n = 45), and lateral plantar artery (n = 1). Distal access hemostasis was obtained with internal balloon tamponade in 71.4% (n = 157). Outcome measurements were technical success, freedom from major amputation and complications. Preprocedural angiograms of clinically driven repeat interventions were reviewed in 73 cases for distal access patency. RESULTS: Technical success was achieved in 80.5% (n = 177). Reasons for technical failure include inability to obtain distal access (n = 3), cross the occlusion retrogradely (n = 16), re-enter the true lumen (n = 9), and achieve antegrade blood flow after the procedure (n = 15). Freedom from major amputation for technically successful procedures was 84.7%, 82.9%, and 81.9% at 6, 12, and 24 months, respectively. There were 3 cases of distal access bleeding with 1case that required coil embolization. The distal access remained patent in 80.8% of observable cases with repeated endovascular intervention. CONCLUSIONS: Distal retrograde arterial access (SAFARI) technique is safe and effective in the treatment of CTOs in the context of CLI, after failure of antegrade revascularization.