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.

Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia.

Background: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. Patients and methods: Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. Results: 86 patients (63% males, mean age 68.9 ± 9.9 years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6 = 91% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate/severe vessel wall calcification. 90% had > = 1 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower baseline toe pressure (OR 1.03, 95%CI 1.00-1.05) and elastic recoil post angioplasty (OR 0.20, 95%CI 0.05-0.79) were associated with a worse 6 month tibial patency. One-year AFS was 67%. 47/66 (71%) patients had a clinical improvement of at least one Rutherford class at 6 months and 52/59 (88%) experienced complete wound healing at 12 months. Conclusions: Use of a high pressure non-compliant balloon is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging population of CLTI patients with a high incidence of DM and ESRF. It is associated with highly satisfactory acute technical success, 6-month target lesion patency and one-year limb salvage.

Treatment of an Aortic Arch Aneurysm with Scalloped and Fenestrated Thoracic Stent Graft and Left Carotid to Subclavian Artery Bypass.

We report a successful treatment of thoracic arch aneurysm using a combination of hybrid approach and a customized stent graft in a frail patient with challenging anatomy and concomitant large retrosternal goiter. The patient is an 82-year-old lady with multiple comorbidities who presented to her general practitioner for anorexia and significant weight loss. She was incidentally found to have a 6.6-cm saccular distal aortic arch aneurysm, a 5.5-cm infrarenal abdominal aortic aneurysm, and a large goiter adjacent to the left common carotid artery (CCA) with retrosternal extension. The arch aneurysm was successfully managed with an open left common carotid to left subclavian bypass followed by thoracic endovascular aneurysm repair (EVAR) with a Cook stent graft customized to the patient's anatomy incorporating a proximal scallop for the brachiocephalic artery and a fenestration for the left CCA, and Amplatzer plug for occlusion of the ostium of the left subclavian artery. There was no endoleak and she was discharged uneventfully. She is planned for staged EVAR of her abdominal aortic aneurysm at a later date. In the presence of difficult arch aneurysm anatomies, the hybrid approach with bespoke stent grafts is a feasible alternative to open aortic arch replacement.

Fast-Access Multidisciplinary Approach to Management of Diabetic Foot Ulcers: The Diabetic Rapid Evaluation and Lower Limb Amputation Management (DREAM) Clinic.

Background: Diabetic foot ulcers (DFUs) are debilitating to the patient and costly for the healthcare system. We set up the Diabetic Rapid Evaluation and lower limb Amputation Management (DREAM) clinic with the aim of providing early directed specialist care to patients with DFUs. With early management, we hope to treat DFUs in its early stages, reducing the need for and associated morbidity of major and minor lower limb amputations. Objectives: We evaluated the outcomes of the fast-access DREAM clinic with multi-disciplinary evaluation for patients with DFUs. Outcomes include time from the point of referral to DREAM clinic evaluation, amputation rates and wound healing rates. Design: Patients presenting with DFU to the DREAM clinic were enrolled. A podiatrist made the first assessment, followed by immediate specialist consultation with Endocrinologists, Vascular surgeons or Orthopaedic surgeons as required. Methods: Data on baseline demographics and DFU characteristics were collected. Outcomes evaluated were wound healing at 12 weeks, wound salvage rates, time to DREAM clinic access and time to specialist referral. Results: Sixty-eight patients were enrolled, with 57.3% males, and mean age of 63 ± 13.0 years. Majority of ulcers were classified as neuropathic (41.3%) and located at the digits (40%). At 12-weeks follow-up, 1 had undergone major amputation, 9 minor amputations and 4 surgical debridements. The median time to DREAM clinic evaluation from first presentation was 3 days (IQR 7). Eleven (16.2%) required >1 specialist consult. Twenty (29.4%) were hospitalised for treatment. Twelve underwent revascularisation within 4 days (IQR 3.5). Twenty-four patients (35.3%) continued podiatry follow-up, having 28 DFUs in which 20 (71.4%) healed within 12 weeks. Conclusion: The fast-access multidisciplinary DREAM clinic shows promising outcomes with lower major amputation rates and exemplary DFU healing outcomes.

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.

Use of the helical SUPERA™ stent and Passeo-18 Lux™ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the Arch V SUPERA-LUX study.

BACKGROUND: Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ (Abbott Vascular, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ (Biotronik Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction. METHODS: Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months. RESULTS: There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients' underlying co-morbidities. CONCLUSION: Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.

Two-year clinical outcomes following lower limb endovascular revascularisation for chronic limb-threatening ischaemia at a tertiary Asian vascular centre in Singapore.

INTRODUCTION: Percutaneous transluminal angioplasty (PTA) is commonly used to treat patients with chronic limb-threatening ischaemia (CLTI). This study aimed to examine the mortality and functional outcomes of patients with CLTI who predominantly had diabetes mellitus in a multi-ethnic Asian population in Singapore. METHODS: Patients with CLTI who underwent PTA between January 2015 and March 2017 at the Vascular Unit at Singapore General Hospital, Singapore, were studied. Primary outcome measures were 30-day unplanned readmission, two-year major lower extremity amputation (LEA), mortality rates, and ambulation status at one, six and 12 months. RESULTS: A total of 221 procedures were performed on 207 patients, of whom 184 (88.9%) were diabetics. The one-, six- and 12-month mortality rate was 7.7%, 16.4% and 21.7%, respectively. The two-year LEA rate was 30.0%. At six and 12 months, only 96 (46.4%) and 93 (44.9%) patients were ambulant, respectively. Multivariate analysis revealed that preoperative ambulatory status, haemoglobin, Wound Ischaemia and foot Infection (WIfI) score, and end-stage renal failure (ESRF) were independent predictors of one-year ambulatory status. Predictors of mortality at one, six and 12 months were ESRF, preoperative albumin level, impaired functional status and employment status. CONCLUSION: PTA for CLTI was associated with low one-year mortality and two-year LEA rates but did not significantly improve ambulation status. ESRF and hypoalbuminaemia were independent predictors of mortality. ESRF/CKD and WIfI score were independent predictors of loss of ambulation at six months and one year. We need better risk stratification for patients with CLTI to decide between initial revascularisation and an immediate LEA policy.

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.

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.

Non-randomized safety and performance evaluation of the av-Guardian vascular access system.

INTRODUCTION: The ability to successfully cannulate the arteriovenous fistula reliably is a critical step in the delivery of hemodialysis therapy. The av-Guardian vascular access system (Advent Access, Singapore) is designed to overcome the technical barrier to establishing reliable blunt needle access in patients with mature arteriovenous fistula. METHODS: This was a first-in-man, prospective, non-randomized trial (registered on the Australian New Zealand Clinical Trial Registry (ACTRN12617000501347)) performed to assess the safety and feasibility of achieving repeatable successful cannulation via av-Guardian vascular access system to facilitate blunt needling in patients with mature arteriovenous fistula. The primary endpoints of the study included rate of successful hemodialysis sessions via av-Guardian vascular access system cannulation over 3 months and safety of the implants. RESULTS: A total of six patients (four patients with brachiocephalic and two with radiocephalic arteriovenous fistula) were enrolled in the study. A pair of av-Guardian vascular access system were implanted, one each at the arterial and venous cannulation sites, under local anesthesia. Overall, the rate of successful cannulation through the av-Guardian vascular access system over 3 months in 216 hemodialysis sessions was 98.1% (212/216) at the arterial site and 94.4% (204/216) at the venous site. Significantly, 90% and 85.5% of the cannulations at the arterial and venous site, respectively, were successful at first attempt. Blood flow rates within the arteriovenous fistula were unaffected by the devices. CONCLUSION: The results demonstrated the safety and feasibility of a subcutaneously implanted, extravascular device in achieving repeatable successful cannulation via a constant site, to facilitate blunt needling in matured arteriovenous fistula in limited number of patients.