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.

Editor's Choice - Decrease in Mortality from Abdominal Aortic Aneurysms (2001 to 2015): Is it Decreasing Even Faster?

OBJECTIVE: The early twenty first century witnessed a decrease in mortality from abdominal aortic aneurysms (AAA), which was associated with variations in the prevalence of cardiovascular risk factors. This study investigated whether these trends continued into the second decade of the twenty first century. METHODS: Information on AAA mortality (2001 - 2015) using International Classification of Diseases codes was extracted from the World Health Organization (WHO) mortality database. Data on risk factors were extracted from the Institute of Health Metrics and Evaluation and WHO InfoBase, and data on population from the World Development Indicators database. Regression analysis of temporal trends in cardiovascular risk factors was done independently for correlations with AAA mortality trends. RESULTS: Seventeen countries across four continents met the inclusion criteria (Australasia, two; Europe, 11; North America, two; Asia, two). Male AAA mortality decreased in 13 countries (population weighted average: -2.84%), while female AAA mortality decreased in 11 countries (population weighted average: -1.64%). The decrease in AAA mortality was seen in both younger (< 65 years) and older (> 65 years) patients. The decrease in AAA mortality was more marked in the second decade of the twenty first century (2011 - 2015) compared with the first decade (2001 - 2005 and 2006 - 2010). Trends in AAA mortality positively correlated with smoking (males: p = .03X, females: p = .001) and hypertension (males: p = .001, females: p = .01X). Conversely, AAA mortality negatively correlated with obesity (males: p = .001, females: p = .001), while there was no significant correlation with diabetes. CONCLUSION: AAA mortality has continued to decline and seems to have declined at an even faster rate in the second decade of the twenty first century, albeit with heterogeneity among countries. These variations are multifactorial in origin but further efforts targeting smoking cessation and blood pressure control will probably contribute to continued reductions in AAA mortality.

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.

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.

Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial.

BACKGROUND: The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention. METHODS: Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months. RESULTS: 47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients' underlying co-morbidities. CONCLUSIONS: SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.

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.

Treatment of lower limb ischaemia in patients with diabetes.

Diabetic chronic limb-threatening ischaemia is a challenging clinical problem with patients at high risk of diabetic foot ulceration (DFU) and limb loss. Patients often remain asymptomatic even in the presence of severe pedal ischaemia until first presenting with tissue loss such as DFU or frank gangrene. Limb salvage units should have the facilities and expertise to provide multidisciplinary team-based holistic care through best medical therapy, rapid diagnosis, prompt revascularisation with endovascular or open surgical techniques and expert wound management. Endovascular revascularisation has become the first line strategy in contemporary clinical practice because of similar outcomes in wound healing and amputation rates in most patients when compared with open surgery. The primary goal is restoration of pulsatile in-line blood flow to the ankle or foot, with an angiosome-directed approach possibly achieving superior outcomes especially in diabetics with poor collaterals. A comprehensive overview of conventional endovascular techniques (such as antegrade true lumen and subintimal approaches), advanced techniques for complex disease (such as retrograde subintimal and pedal-plantar loop approaches or even deep venous arterialisation) and the various treatment options are described. Diabetic limb salvage rates can be excellent with suitable multidisciplinary expertise and care.