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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.
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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.
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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.
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OBJECTIVE: To estimate the 'cost of illness' arising from chronic wounds in Singapore. DESIGN: Incidence-based cost of illness study using evidence from a range of sources. SETTING: Singapore health services. PARTICIPANTS: We consider 3.49 million Singapore citizens and permanent residents. There are 16 752 new individuals with a chronic wound in 2017, with 598 venous ulcers, 2206 arterial insufficiency ulcers, 6680 diabetic ulcers and 7268 pressure injuries.Primary outcome measures expressed in monetary terms are the value of all hospital bed days lost for the population; monetary value of quality-adjusted life years (QALYs) lost in the population; costs of all outpatient visits; and costs of all poly clinic, use of Community Health Assist Scheme (CHAS) and emergency departments (EDs) visits. Intermediate outcomes that inform the primary outcomes are also estimated. RESULTS: Total annual cost of illness was $350 million (range $72-$1779 million). With 168 503 acute bed days taken up annually (range 141 966-196 032) that incurred costs of $139 million (range 117-161 million). Total costs to health services were $184 million (range $120-$1179 million). Total annual costs of lost health outcomes were 2077 QALYs (range -2657 to 29 029) valued at $166 million (range -212 to 2399 million). CONCLUSIONS: The costs of chronic wounds are large to Singapore. Costs can be reduced by making positive investments for comprehensive wound prevention and treatment programmes.
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Asiático , Costo de Enfermedad , Úlcera , Humanos , Instituciones de Atención Ambulatoria , Asiático/etnología , Asiático/estadística & datos numéricos , Servicio de Urgencia en Hospital , Emigrantes e Inmigrantes , Úlcera/economía , Úlcera/epidemiología , Úlcera/etnología , Úlcera/terapia , Enfermedad Crónica/economía , Enfermedad Crónica/epidemiología , Enfermedad Crónica/etnología , Enfermedad Crónica/terapia , Singapur/epidemiologíaRESUMEN
BACKGROUND: This study aims to evaluate the safety and efficacy of a short-term, low dose, weight-based subcutaneous enoxaparin protocol (SEP) in maintaining the patency of arteriovenous (AV) access with recurrent thrombosis. METHODS: Prospective follow-up of 25 patients who presented to a tertiary institution with recurrent AV access thrombosis and treated with anticoagulation according to SEP following successful thrombectomy. Patency and safety outcomes of SEP were studied. RESULTS: The participants were 66.4 ± 10.2 years old and predominantly male (60%) and of Chinese ethnicity (72%). The AV accesses had a median age of 1.4 (0.6, 5.6) years with 60% being non-autogenous arteriovenous access while 40% were autogenous arteriovenous access. Thrombolytic agents (urokinase (72%) or alteplase (28%)) were used in all procedures while adjunct thrombectomy device was used in only four procedures. The mean dose of enoxaparin was 36.0 ± 8.2 mg or 0.64 ± 0.1 mg/kg/day for a mean duration 30.0 days (Interquartile range: 27.5, 31.0). One patient developed minor bleeding episode. Kaplan-Meier analysis demonstrated that the mean thrombosis-free survival pre- versus post-SEP adoption was 27.3 (95% CI 17.9-36.7) versus 183.5 (95% CI 100.1-266.9) days (p < 0.001). After adjusting for the type of thrombolytic agent, use of adjunct thrombectomy device, cutting balloon, drug-coated balloon, and stent graft, SEP remained a significant factor associated with longer thrombosis-free patency (HR 0.166: 95% CI 0.070-0.392, p < 0.001). DISCUSSION: SEP appears to be a feasible and safe thromboprophylaxis method to improve thrombosis-free patency for AV access with recurrent thrombosis.
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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.
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Aterosclerosis , Enfermedad Arterial Periférica , Placa Aterosclerótica , Humanos , Placa Aterosclerótica/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Aterosclerosis/diagnóstico por imagen , Aterosclerosis/patología , Tomografía Computarizada por Rayos X/métodos , Imagen por Resonancia Magnética , Imagen Multimodal , Tomografía de Emisión de Positrones/métodosRESUMEN
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.
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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.
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Calidad de Vida , Úlcera Varicosa , Humanos , Persona de Mediana Edad , Anciano , Estudios Prospectivos , Estudios de Seguimiento , Singapur/epidemiología , Úlcera Varicosa/terapia , Vendajes de Compresión , Cicatrización de HeridasRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Resultado del Tratamiento , Stents/efectos adversos , Procedimientos Endovasculares/efectos adversos , Estudios RetrospectivosRESUMEN
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.
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Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Arteria Poplítea , Resultado del Tratamiento , Paclitaxel/efectos adversos , Grado de Desobstrucción Vascular , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Sistema de Registros , Materiales Biocompatibles Revestidos , Arteria FemoralRESUMEN
BACKGROUND: The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage. METHODS AND RESULTS: This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution™ sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution™ coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects. DISCUSSION: Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.
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Angioplastia de Balón , Fístula Arteriovenosa , Humanos , Fístula Arteriovenosa/etiología , Materiales Biocompatibles Revestidos , Constricción Patológica/etiología , Paclitaxel , Estudios Prospectivos , Diálisis Renal/efectos adversos , Sirolimus/efectos adversos , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Proyectos PilotoRESUMEN
Identification of patients with high-risk asymptomatic carotid plaques remains a challenging but essential step in stroke prevention. Current selection criteria for intervention in carotid disease are still determined by symptomatology and degree of luminal stenosis. This strategy has been less effective in identifying the high-risk asymptomatic individual patients. Inflammation is the key factor that drives plaque instability causing clinical sequelae. Currently, there is no imaging tool in routine clinical practice to assess the inflammatory status within atherosclerotic plaques. Herein we describe the development of a novel molecular magnetic resonance imaging (MRI) strategy to interrogate plaque inflammation, and hence its vulnerability in vivo, using dual-targeted iron particle-based probes and fast imaging with steady-state precession (FISP) sequence, adding further prognostic information to luminal stenosis alone. A periarterial cuff was used to generate high-risk plaques at specific timepoints and location of the carotid artery in an apolipoprotein-E-deficient mouse model. Using this platform, we demonstrated that in vivo dual-targeted iron particles with enhanced FISP can (i) target and characterise high-risk vulnerable plaques and (ii) quantitatively report and track the inflammatory activity within carotid plaques longitudinally. This molecular imaging tool may permit (i) accurate monitoring of the risk of carotid plaques and (ii) timely identification of high-risk asymptomatic patients for prophylactic carotid intervention, achieving early stroke prevention.
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Enfermedades de las Arterias Carótidas , Estenosis Carotídea , Placa Aterosclerótica , Accidente Cerebrovascular , Animales , Ratones , Estenosis Carotídea/complicaciones , Constricción Patológica/complicaciones , Constricción Patológica/patología , Enfermedades de las Arterias Carótidas/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Placa Aterosclerótica/patología , Arterias Carótidas/patología , Accidente Cerebrovascular/etiología , Hierro , Inflamación/complicacionesRESUMEN
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.
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Angioplastia de Balón , Fístula , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Grado de Desobstrucción Vascular , Constricción Patológica/etiología , Estudios Prospectivos , Proyectos Piloto , Diálisis Renal , Resultado del Tratamiento , Stents , Angioplastia de Balón/efectos adversos , Fístula/etiología , Materiales Biocompatibles RevestidosRESUMEN
BACKGROUND: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. METHODS: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. RESULTS: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients' underlying co-morbidities. CONCLUSIONS: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.
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Angioplastia de Balón , Fístula Arteriovenosa , Derivación Arteriovenosa Quirúrgica , Anciano , Humanos , Masculino , Persona de Mediana Edad , Angioplastia de Balón/efectos adversos , Fístula Arteriovenosa/etiología , Derivación Arteriovenosa Quirúrgica/efectos adversos , Materiales Biocompatibles Revestidos , Estudios Prospectivos , Diálisis Renal/efectos adversos , Sirolimus , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Aim was to compare the safety and patency efficacy outcomes between Ranger™ paclitaxel-coated balloon (PCB)- versus conventional balloon angioplasty (POBA) in the treatment of haemodialysis access-related conduit stenosis. METHODS: Retrospective single-centre, multi-investigator, consecutive, double-arm comparative cohort study. About 130 end-stage renal failure Asian patients with dysfunctional arteriovenous fistula (AVF) or arteriovenous graft underwent PCB or POBA fistuloplasty between November 2018 and June 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to PCB angioplasty. All patients received at least one antiplatelet agent for 3 months duration post procedure. RESULTS: Mean age was 66.0 ± 10 years and 79/130 (61%) were males. PCB arm (n = 65) versus POBA arm (n = 65). Majority were AVFs circuits (122/130, 94%). Main indication for intervention was dropping access flow (98/130, 76%). About 172 lesions were treated (56% POBA, 44% PCB), and the juxta-anastomosis (JAS) was the main target lesion (87/172, 51%). There were no significant differences in safety outcomes (30-day adverse events, access thrombosis, abandoned AVF and death) between treatment groups. Mean time to target lesion reintervention (TLR) was longer in PCB-treated lesions (7.1 ± 2.7 vs 5.8 ± 3.2 months, p = 0.03), especially amongst recurrent lesions (7.3 ± 2.4 vs 5.7 ± 3.2, p = 0.02). Mean time to circuit reintervention was also longer in PCB-treated circuits (6.9 ± 2.8 vs 5.8 ± 3.7months, p = 0.04). There were 16 deaths (12%), all attributed to patient's underlying comorbidities. CONCLUSIONS: Fistuloplasty with Ranger™ PCB for failing arteriovenous circuits in end-stage renal failure patients, is a safe and efficacious modality compared to POBA in terms of longer freedom from TLR.
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Angioplastia de Balón , Fístula Arteriovenosa , Derivación Arteriovenosa Quirúrgica , Fallo Renal Crónico , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Paclitaxel/efectos adversos , Estudios Retrospectivos , Estudios de Cohortes , Resultado del Tratamiento , Derivación Arteriovenosa Quirúrgica/efectos adversos , Angioplastia de Balón/efectos adversos , Diálisis Renal , Fallo Renal Crónico/terapia , Constricción Patológica/etiología , Fístula Arteriovenosa/etiología , Grado de Desobstrucción Vascular , Materiales Biocompatibles RevestidosRESUMEN
Background: Little is known about stage 1 and 2 pressure injuries that are health care-acquired. We report incidence rates of health care-acquired stage 1 and stage 2 pressure injuries, and, estimate the excess length of stay using four competing analytic methods. We discuss the merits of the different approaches. Methods: We calculated monthly incidence rates for stage 1 and 2 health care-acquired pressure injuries occurring in a large Singapore acute care hospital. To estimate excess stay, we conducted unadjusted comparisons with a control cohort, performed linear regression and then generalized linear regression with a gamma distribution. Finally, we fitted a simple state-based model. The design for the cost attribution work was a retrospective matched cohort study. Results: Incidence rates in 2016 were 0.553% (95% confidence interval [CI] 0.55, 0.557) and 0.469% (95% CI 0.466, 0.472) in 2017. For data censored at 60 days' maximum stay, the unadjusted comparisons showed the highest excess stay at 17.68 (16.43-18.93) days and multi-state models showed the lowest at 1.22 (0.19, 2.23) days. Conclusions: Poor-quality methods for attribution of excess length of stay to pressure injury generate inflated estimates that could mislead decision makers. The findings from the multi-state model, which is an appropriate method, are plausible and illustrate the likely bed-days saved from lowering the risk of these events. Stage 1 and 2 pressure injuries are common and increase costs by prolonging the length of stay. There will be economic value investing in prevention. Using biased estimates of excess length of stay will overstate the potential value of prevention.
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Introduction: The global burden of peripheral artery disease (PAD) has been increasing. Guidelines for PAD recommend evidence-based medical therapy (EBMT) to reduce the risks of cardiovascular events and death but the implementation of this is highly variable. This study aimed to understand the current practices regarding EBMT prescription in PAD patients and the key barriers and facilitators for implementing PAD guidelines. Method: A qualitative study was conducted in the largest tertiary hospital in Singapore from December 2021 to March 2023. The participants included healthcare professionals and in-patient pharmacists involved in the care of PAD patients, as well as patients with PAD who had undergone a lower limb angioplasty revascularisation procedure. Data were collected through in-depth, individual semi-structured interviews conducted face-to-face or remotely by a trained research assistant. Interviews were audio-recorded, transcribed and systematically coded using data management software NVivo 12.0. The Tailored Implementation for Chronic Diseases (TICD) framework was used to guide the interviews and analysis. Results: Twelve healthcare professionals (4 junior consultants, 7 senior consultants, and 1 senior in-patient pharmacist) and 4 patients were recruited. Nine themes in 7 domains emerged. Only a small proportion of doctors were aware of the relevant guidelines, and the generalisability of guidelines to patients with complicated conditions was the doctors' main concern. Other barriers included cost, frequent referrals, lack of interprofessional collaboration, not being the patients' long-term care providers, short consultation time and patients' limited medication knowledge. Conclusion: Findings from this study may inform strategies for improving healthcare professionals' adherence to guidelines and patients' medication adherence.
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Medicina Basada en la Evidencia , Enfermedad Arterial Periférica , Investigación Cualitativa , Humanos , Enfermedad Arterial Periférica/terapia , Singapur , Masculino , Femenino , Farmacéuticos , Persona de Mediana Edad , Anciano , Enfermedad Crónica , Adhesión a Directriz , Guías de Práctica Clínica como Asunto , Entrevistas como Asunto , Angioplastia/métodos , Personal de SaludAsunto(s)
Angioplastia , Extremidad Inferior , Enfermedad Arterial Periférica , Humanos , Singapur , Extremidad Inferior/irrigación sanguínea , Masculino , Angioplastia/métodos , Anciano , Femenino , Enfermedad Arterial Periférica/terapia , Persona de Mediana Edad , Cumplimiento de la Medicación/estadística & datos numéricosRESUMEN
Identification of high-risk carotid plaques in asymptomatic patients remains a challenging but crucial step in stroke prevention. The challenge is to accurately monitor the development of high-risk carotid plaques and promptly identify patients, who are unresponsive to best medical therapy, and hence targeted for carotid surgical interventions to prevent stroke. Inflammation is a key operator in destabilisation of plaques prior to clinical sequelae. Currently, there is a lack of imaging tool in routine clinical practice, which allows assessment of inflammatory activity within the atherosclerotic plaque. Herein, we have used a periarterial cuff to generate a progressive carotid atherosclerosis model in apolipoprotein E-deficient mice. This model produced clinically relevant plaques with different levels of risk, fulfilling American Heart Association (AHA) classification, at specific timepoints and locations, along the same carotid artery. Exploiting this platform, we have developed smart molecular magnetic resonance imaging (MRI) probes consisting of dual-targeted microparticles of iron oxide (DT-MPIO) against VCAM-1 and P-selectin, to evaluate the anti-inflammatory effect of statin therapy on progressive carotid atherosclerosis. We demonstrated that in vivo DT-MPIO-enhanced MRI can (i) quantitatively track plaque inflammation from early to advanced stage; (ii) identify and characterise high-risk inflamed, vulnerable plaques; and (iii) monitor the response to statin therapy longitudinally. Moreover, this molecular imaging-defined therapeutic response was validated using AHA classification of human plaques, a clinically relevant parameter, approximating the clinical translation of this tool. Further development and translation of this molecular imaging tool into the clinical arena may potentially facilitate more accurate risk stratification, permitting timely identification of the high-risk patients for prophylactic carotid intervention, affording early opportunities for stroke prevention in the future.
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BACKGROUND: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. METHODS: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. DISCUSSION: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.