Objectives
The purpose of this study was to assess the safety and performance of Stellarex Drug‐coated balloon (DCB).
Background
DCB coatings differ in excipients, paclitaxel dose, and coating ...morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results.
Methods
The ILLUMENATE Global Study is a prospective, multicenter, single‐arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically‐driven target lesion revascularization (CD‐TLR) at 12 months. The primary safety endpoint was freedom from device and procedure‐related death through 30 days postprocedure and freedom from target limb major amputation and CD‐TLR through 12 months.
Results
In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD‐TLR was 94.8% day 365 per Kaplan‐Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.
Conclusions
This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.
IntroductionDiabetic foot disease is a common condition globally and is over-represented in indigenous populations. The propensity for patients with diabetic foot disease to undergo minor or major ...limb amputation is a concern. Diabetic foot disease and lower limb amputation are debilitating for patients and have a substantial financial impact on health services. The purpose of this multicentre study is to prospectively report the presentation, management and outcomes of diabetic foot disease, to validate existing scoring systems and assess long term outcomes for these patients particularly in relation to major limb amputation.Methods and analysisThis is a multisite, international, prospective observational study, being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth Hospital, Australia. Consecutive participants with diabetic foot disease that meet inclusion criteria and agree to participate will be recruited from multidisciplinary team diabetic foot clinic, vascular clinic, dialysis and admission to hospital. Follow-up of participants will occur at 1, 3, 6 and 12 months. At recruitment and follow-up reviews, information about service details, demographic and clinical history, wound data and discharge information will be recorded. The primary outcomes are the time to wound healing, major amputation, overall mortality and amputation-free survival at 12 months. This study started in NZ in August 2020 and will commence in Australian sites in early 2021.Ethics and disseminationNew Zealand Central Health and Disability Ethics Committee (20/CEN/122), Waikato DHB Research Department (RDO020044), Quality Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (13928). Results will be presented at international conferences and published in peer-reviewed journals.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000337875).
Extracranial atherosclerotic carotid stenosis is associated with inadequate cerebral blood flow (CBF) and cognitive dysfunction. The impact of extracranial carotid revascularization on cognition and ...how any cognitive change relates to changes in CBF are less clear. This review examines the effects of revascularization of extracranial carotid disease by carotid endarterectomy (CEA) or carotid stenting (CAS) on cognition, and how this relates to changes in CBF.
A systematic review of existing reports in the Medline, Embase, and Cochrane databases was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement recommendations. All original retrospective or prospective studies and clinical trials that compared pre- and postoperative cognitive function and CBF in patients with extracranial carotid stenosis who underwent CEA or CAS versus a control group, published between January 1985 and December 2022, were identified and considered eligible for inclusion in this study.
Seven studies (661 participants; 460 CEA or CAS) were identified. All were observational studies and of moderate to good methodologic quality. Six studies (619 participants; follow-up range 1 month to 2 years) demonstrated improvement in some cognitive domains following CEA or CAS, improvement in CBF following revascularization, and correlated some of these cognitive changes with changes in CBF. One study (42 participants; 3 months follow-up) found cognitive improvement following CEA, but found no improvement in CBF or any correlation between cognitive and CBF change. The literature however represented heterogenous study populations examining asymptomatic and/or symptomatic carotid stenosis, differing in treatment modality and criteria for control groups ranging from healthy volunteers to those with stenosis but not who underwent surgical revascularization, and finally, differing reporting methods. This heterogeneity precluded meta-analysis.
Definitive conclusions are limited by variation in cognitive function assessment, timing of testing, and how these are correlated to CBF. However, research suggests a potential improvement in cognition which may be associated with improvement in CBF, particularly in those patients who have more significant CBF deficit at baseline. Further studies are required to better understand this association and provide a clearer picture of the cognitive effects of carotid revascularization.
Synchrotron-radiation-computed tomography (SRCT) allows more accurate calcified plaque and coronary stenosis assessment as a result of its superior spatial resolution; however, typical micro-computed ...tomography (micro-CT) systems have even higher resolution. The purpose of this study was to compare the performance of high-resolution micro-CT with SRCT in the assessment of calcified plaques and a previously published dataset of coronary stenosis assessment. This experimental study involved micro-CT scanning of three-dimensional printed coronary artery models with calcification in situ used in our previously published SRCT study on coronary stenosis assessment. Measurements of coronary stenosis utilizing both modalities were compared using a paired sample t-test. The degrees of stenosis measured on all but one micro-CT dataset were statistically significantly lower than the corresponding SRCT measurements reported in our previous paper (p < 0.0005–0.05). This indicates that the superior spatial resolution of micro-CT was able to further reduce over-estimation of stenosis caused by extensive calcification of coronary arteries and, hence, false positive results. Our results showed that the high-resolution micro-CT used in this study outperformed the Australian Synchrotron SRCT in both calcified plaque and coronary stenosis assessment. These findings will become clinically important for cardiovascular event prediction and enable reclassification of individuals with low and intermediate risk into appropriate risk categories when the technical challenges of micro-CT in clinical practice such as the small field of view and demanding on image processing power are addressed.
Background
Diabetes‐related foot disease (DFD) is a common, costly, and severe complication of diabetes mellitus. DFD is associated with high rates of morbidity and mortality and poses a significant ...burden on patients, healthcare systems and society. While the detrimental impact of DFD is widely recognised, the precise financial implications of its management in Australia remain unclear due to inconsistent and inconclusive contemporary data. Therefore, the aim of this review was to identify, summarise and synthesise existing evidence to estimate the costs associated with DFD management in Australia.
Methods
Searches were conducted in MEDLINE, Embase, AMED, CINAHL, Joanna Briggs Institute EBP, and the Cochrane Library from November 2011 to July 2023. Australian studies investigating costs associated with DFD management were eligible for inclusion. Two independent reviewers performed the study selection, data extraction and quality assessment steps. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) checklist was used to assess study quality. A descriptive analysis was performed due to limited existing evidence and large heterogeneity between study populations to conduct meta‐analyses.
Results
Three economic evaluations were included in the review. One study was rated as ‘poor’, one as ‘very good’ and one as ‘excellent’ when assessed against the CHEERS checklist. The estimated cost of DFD management varied between studies and comparisons were not possible due to the different methodological approaches and data sources. The studies were unable to provide an overall cost of DFD with respect to all aspects of care as they did not capture the multi‐faceted level of care throughout the entire patient journey between sectors and over time.
Conclusion
There is limited contemporary evidence for the costs associated with DFD management within Australia, particularly related to direct costs and resource utilisation. Further research into the economic impact of DFD management is needed to inform optimisation of national service delivery and improve health outcomes for individuals with DFD in Australia. Integrating real‐world data on impact of clinical interventions with parallel economic evaluation could be a valuable approach for future research, which would offer a more comprehensive understanding of the clinical and economic outcomes beyond solely model‐based evaluations.
Trial registration
PROSPERO Registration No. CRD42022290910.
The pathophysiology and time course of impairment in cutaneous microcirculatory function and structure remain poorly understood in people with diabetes, partly due to the lack of investigational ...tools capable of directly imaging and quantifying the microvasculature in vivo. We applied a new optical coherence tomography (OCT) technique, at rest and during reactive hyperemia (RH), to assess the skin microvasculature in people with diabetes with foot ulcers (DFU,
= 13), those with diabetes without ulcers (DNU,
= 9), and matched healthy controls (CON,
= 13). OCT images were obtained from the dorsal part of the foot at rest and following 5 min of local ischemia induced by inflating a cuff around the thigh at suprasystolic level (220 mmHg). One-way ANOVA was used to compare the OCT-derived parameters (diameter, speed, flow rate, and density) at rest and in response to RH, with repeated-measures two-way ANOVA performed to analyze main and interaction effects between groups. Data are means ± SD. At rest, microvascular diameter in the DFU (84.89 ± 14.84 µm) group was higher than CON (71.25 ± 7.6 µm,
= 0.012) and DNU (71.33 ± 12.04 µm,
= 0.019) group. Speed in DFU (65.56 ± 4.80 µm/s,
= 0.002) and DNU (63.22 ± 4.35 µm/s,
= 0.050) were higher than CON (59.58 ± 3.02 µm/s). Microvascular density in DFU (22.23 ± 13.8%) was higher than in CON (9.83 ± 2.94%,
= 0.008), but not than in the DNU group (14.8 ± 10.98%,
= 0.119). All OCT-derived parameters were significantly increased in response to RH in the CON group (all
< 0.01) and DNU group (all
< 0.05). Significant increase in the DFU group was observed in speed (
= 0.031) and density (
= 0.018). The change in density was lowest in the DFU group (44 ± 34.1%) compared with CON (199.2 ± 117.5%,
= 0.005) and DNU (148.1 ± 98.4,
= 0.054). This study proves that noninvasive OCT microvascular imaging is feasible in people with diabetes, provides powerful new physiological insights, and can distinguish between healthy individuals and patients with diabetes with distinct disease severity.
Aortoduodenal fistula (ADF) is a rare cause of upper gastrointestinal (GI) bleeding and is usually fatal without intervention. A high index of suspicion is required to identify and successfully ...manage this condition.
Three cases of ADF following duodenal stent insertion for gastric outflow obstruction secondary to metastatic adenocarcinoma are presented. All presented with upper GI bleeding and underwent emergency percutaneous endovascular aortic stent graft repair (EVAR), with temporary aortic balloon occlusion in one case. All were successful in achieving haemostasis. The first case, although initially complicated by acute stent thrombosis of the right iliac limb, was discharged to a rehabilitation facility and survived for two years. The second patient died two days after the procedure from sepsis related complications. The third was discharged home six days post-procedure with a three month follow up.
A high suspicion for ADF in patients with previous duodenal stents is required for prompt diagnosis and management. EVAR may increase short to midterm life expectancy.
•Aortoduodenal fistula following duodenal stent for malignant gastric obstruction•Cases underwent percutaneous endovascular stent graft repair and achieved haemostasis•In cases of ADF secondary to duodenal stenting, tube endografting may prolong life.
Thoracic endovascular aortic repair (TEVAR) is a life-saving therapy for type B aortic dissection (TBAD). However, surveillance computed tomography (CT) scans in post-TEVAR patients are associated ...with high radiation dose, thus resulting in potential risk of radiation-induced malignancy. In this study, we developed a patient-specific three-dimensional (3D) printed phantom with stent grafts in situ, then scanned the phantom with different CT protocols to determine the optimal scanning parameters for post-treatment patients. The CT scans were conducted with different kVp and pitch values (80, 100, 120 kVp and pitch of 1.2, 1.5, 2.0, 2.5), resulting in a total of 12 datasets. Signal-to-noise ratio (SNR) was measured to determine and compare the image quality between different datasets. Results showed no significant differences in SNR between different kVp when the pitch value was 1.2. At low pitch values, a decrease in kVp from 120 to 80 led to a significant effective dose reduction by more than 20%. SNR decreased by 30% when pitch was increased from 1.2 to 2.5 at 80 kVp, and 20% at 120 kVp. In contrast, there was only a 3.9% decrease in SNR when kVp was reduced from 120 to 80 at pitch 1.2, and 15.9% at pitch 2.5. High pitch with 100 kVp can effectively reduce the dose while maintaining image quality.
A novel roller pump for physiological flow Chong, Albert; Sun, Zhonghua; van de Velde, Lennart ...
Artificial organs,
August 2020, Letnik:
44, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Having physiological correct flow waveforms is a key feature for experimental studies of blood flow, especially in the process of developing and testing a new medical device such as stent, mechanical ...heart valve, or any implantable medical device that involves circulation of blood through the device. It is also a critical part of a perfusion system for cardiopulmonary bypass and extracorporeal membrane oxygenation procedures. This study investigated the feasibility of a novel roller pump for use in experimental flow phantoms. Flow rates of carotid flow profile measured directly with the ultrasonic flow meter matched well with the reference flow rates programmed into the machine with similarity index of 0.97 and measured versus programmed flow rates at specific time‐points of peak systolic velocity (PSV): 0.894 vs 0.880, end systolic velocity (ESV): 0.333 vs 0.319, and peak diastolic velocity (PDV): 0.514 vs 0.520 L/min. Flow rates derived from video analysis of the pump motion for carotid, suprarenal, and infrarenal flows also matched well with references with similarity indices of 0.99, 0.99, and 0.96, respectively. Measured flow rates (mean/standard deviation) at PSV, ESV, and PDV time‐points for carotid: 0.883/0.016 vs 0.880, 0.342/0.007 vs 0.319, and 0.485/0.009 vs 0.520; suprarenal: 3.497/0.014 vs 3.500, 0.004/0.003 vs 0, and 1.656/0.073 vs 1.453; infrarenal: 4.179/0.024 vs 4.250, −1.147/0.015 vs −1.213, and 0.339/0.017 vs 0.391 L/min, respectively. The novel roller pump is suitable for benchtop testing of physiological flow.
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