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.

3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation.

INTRODUCTION: Medium-term clinical outcome data are lacking for cyanoacrylate glue (CAG) ablation for symptomatic varicose veins, especially from the Asian population. OBJECTIVES: Aim was to determine the 3-year symptomatic relief gained from using the VenaSeal™ device to close refluxing truncal veins from the Singaporean ASVS prospective registry. METHODS: The revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess clinical improvement in venous disease symptoms along with a dedicated patient satisfaction survey. 70 patients (107 limbs; 40 females; mean age of 60.9 ± 13.6 years) were included at 3 years. RESULTS: At 3 years, rVCSS showed sustained improvement from baseline (5.00 to 0.00; p < 0.001) and 51/70 (72.9%) had improvement by at least 2 or more CEAP categories. Freedom from reintervention was 90% and 85.7% patients were extremely satisfied with the treatment outcome. No further reports of further hypersensitivity reactions after one year. CONCLUSION: The 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions following CAG embolization in Asian patients with chronic venous insufficiency. TRIAL REGISTRATION: ClinicalTrials.gov Registration: NCT03893201.

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.

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.

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.

Cleaner XT Rotational Thrombectomy: An Efficacious Endovascular Technique for Salvage of Thrombosed Arteriovenous Access and a 12 Month Outcome Analysis.

PURPOSE: This study aims to describe an efficacious method using Cleaner XT rotational thrombectomy with catheter-directed thrombolysis and drug-eluting balloon angioplasty for the salvage of thrombosed arteriovenous fistulae and grafts. MATERIALS AND METHODS: Retrospective analysis of all patients with thrombosed hemodialysis accesses who underwent endovascular salvage using the Cleaner XT rotational thrombectomy system at a single institution between June 2019 and September 2020 was performed. Patency was presented as Kaplan-Meier survival curves, and regression analysis was performed to examine predictors of postintervention primary patency and assisted primary patency based on Cox proportional-hazards model. RESULTS: Thirty-four patients with thrombosed accesses underwent Cleaner XT rotational thrombectomy between June 2019 and September 2020. Technical and clinical success were both 100%. Mean procedure time was 62 ± 20 minutes. Mean postintervention primary patency time was 152 ± 51 days; 30, 90, 180, and 365 day postintervention primary patency rates were 89%, 80%, 68%, and 56%, respectively. Mean postintervention-assisted primary patency time was 157 ± 59 days; 30, 90, 180, and 365 day postintervention-assisted primary patency rates were 91%, 82%, 71%, and 59%, and 180 and 365 day secondary patency rates were 97.2% and 94.4%, respectively. CONCLUSION: The Cleaner XT rotational thrombectomy device demonstrates excellent clinical and technical success rates, with good patency results at all time points up to 12 months postintervention.

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.

Medium-Term Survival After Unrepaired Ruptured Abdominal Aortic Aneurysm.

PURPOSE: Ruptured abdominal aortic aneurysm (AAA) is almost always considered fatal without open surgical or endovascular repair. We report a case that has defied this norm and explore the possible factors involved in this exceedingly rare outcome. CASE REPORT: An 87 year old gentleman presented with an acute ruptured AAA with left retroperitoneal hematoma. He was counseled for emergent repair, but opted for conservative management instead. He has remained well at the time of writing, 13 months from the rupture, with clinical resolution of symptoms along with radiological resolution of the hematoma. CONCLUSION: Timely repair remains the mainstay of management for ruptured AAA, although this rare case highlights that it is possible for ruptured AAA to seal spontaneously with patient surviving up to 13 months. We have sought to hypothesize the factors in this case that may have contributed to prolonged survival following untreated ruptured AAA. CLINICAL IMPACT STATEMENT: While the overwhelming evidence is that a ruptured AAA left unrepaired is fatal, our case report illustrates a rare case that shows it is possible for ruptured AAA to seal spontaneously, with patient surviving up to 13 months. We seek to hypothesize the factors that may contribute to such prolonged survival.

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.

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.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months.

INTRODUCTION: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). MATERIAL AND METHODS: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. RESULTS: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). CONCLUSIONS: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial.

BACKGROUND: Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied. METHODS/DESIGN: This is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical. DISCUSSION: This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04409912 . Registered on 1 June 2020.