High-pressure, non compliant balloon angioplasty for long and calcified infrapopliteal and inframalleolar lesions is feasible

Background: To evaluate the safety, feasibility and effectiveness of high-pressure, noncompliant balloon angioplasty in the management of long infrapopliteal calcified lesions. Methods: Consecutive patients, presenting with chronic limb-threatening ischemia (CLTI) and long (>100 mm) calcified infrapopliteal lesions who were treated with a high pressure, noncompliant balloon (JADE, OrbusNeich, Hong Kong) between January 2016 and July 2016 were retrospectively analyzed. Angioplasty was performed by inflating the balloon to a pressure of 22 to 24 atm for 90 seconds. Primary outcome was technical success. Secondary outcomes were procedure-related complications, limb salvage, amputation-free survival (AFS), wound healing, overall survival, freedom from clinically driven target lesion reintervention (CD-TLR), and resolution of CLTI at 2 and 3 years. Results: Overall, 23 lesions in 21 limbs of 20 patients were treated. All patients had tissue loss (Rutherford 5 or 6). The mean lesion length was 374.8 mm. Of all lesions, 56.5% were occlusions, 91.3% were classified as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, and 78.3% had severe calcification classification. Of all lesions, 52.2% extended into the below-the-ankle arteries. Technical success was achieved in 22 lesions (95.7%). There were no procedure-related complications. No bailout stenting was required. At 2 and 3 years, limb salvage was 84.7% and 78.7%, AFS was 71.4% and 56.1%, wound healing was 81.0% and 85.7%, overall survival was 75.0% and 64.3% and freedom from CD-TLR was 77.6% and 63.5%, respectively. Resolution of CLTI without TLR was 81.0% at 2 and 3 years. Conclusions: This study is the first to analyze safety and feasibility of a high-pressure, noncompliant balloon for long, calcified infrapopliteal and inframalleolar lesions

Covered Stents vs. Angioplasty for Common Iliac Artery In Stent Restenosis:A Retrospective Comparison

Objective: The optimal endovascular treatment for common iliac artery in stent re-stenosis has yet to be assessed. Treatment options include, among others, angioplasty alone and repeated stenting with covered stents. Methods: This study retrospectively compared patency and target lesion revascularisation of these treatments. All patients who underwent endovascular treatment of common iliac artery in stent re-stenosis between 2007 and 2017 were included retrospectively. The primary end point was freedom from re-stenosis. Secondary endpoints were target lesion revascularisation rate (TLR) and freedom from occlusion during follow up. Results: Seventy-four interventions were included, consisting of 37 angioplasties and 37 covered stent placements in 57 patients. Freedom from re-stenosis at four years was 72.6% (95% confidence interval [CI] 51.8% – 88.7%) in the covered stent group vs. 43.5% (95% CI 25.9% – 59.8%) in the percutaneous transluminal angioplasty (PTA) group (p = .003). The target lesion revascularisation (TLR) rate was 16.4% (95% CI 7.1% – 35.6%) and 43.6% (95% CI 28.0% – 63.2%) respectively (p = .020). There was no difference in freedom from occlusion; this was 90.8% (95% CI 73.9% – 97.0%) in the covered stent group and 79.1% (95% CI 58.4% – 90.3%) in the PTA group (p = .49). The difference in freedom from re-stenosis and TLR remained significant after sensitivity and multivariable analyses. Conclusion: Covered stents offer better outcomes for common iliac artery in stent re-stenosis than angioplasty alone

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Objective: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. Methods: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. Results: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. Conclusions: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years

Design and Evaluation of a Magnetic Rotablation Catheter for Arterial Stenosis

Arterial stenosis is a high-risk disease accompanied by large amounts of calcified deposits and plaques that develop inside the vasculature. These deposits should be reduced to improve blood flow. However, current methods used to reduce stenosis require externally-controlled actuation systems resulting in limited workspace or patient risks. This results in an unexplored preference regarding the revascularization strategy for symptomatic artery stenosis. In this paper, we propose a novel internally-actuated solution: a magnetic spring-loaded rotablation catheter. The catheter is developed to achieve stenosis-debulking capabilities by actuating drill bits using two internal electromagnetic coils and a magnetic reciprocating spring-loaded shaft. The state-space model of the catheter is validated by comparing the simulation results of the magnetic fields of the internal coils with the experimental results of a fabricated prototype. Contact forces of the catheter tip are measured experimentally, resulting in a maximum axial force of 2.63 N and a torque of 5.69 mN-m. Finally, we present interventions in which the catheter is inserted to a vascular target site and demonstrate plaque-specific treatment using different detachable actuator bits. Calcified deposits are debulked and visualized via ultrasound imaging. The catheter can reduce a stenosis cross-sectional area by up to 35%, indicating the potential for the treatment of calcified lesions, which could prevent restenosis

Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery:an observational pilot study

Background: Telemonitoring during the perioperative trajectory may improve patient outcomes and self-management. The aim of this study is to assess the feasibility of and patient’s experiences with telemonitoring before and after major abdominal surgery to inform future study design. Methods: Patients planned for elective major abdominal surgery wore a sensor and answered well-being questions on a tablet daily for at least 2 weeks preoperatively up to 30-days postoperatively. Feasibility was assessed by participation and completion rate, compliance per day, weekly satisfaction scores, and reasons for nonscheduled contact. Results: Twenty-three patients were included (participation rate of 54.5%) with a completion rate of 69.6%. Median compliance with the wearable sensor and well-being questions was respectively: 94.7% and 83.3% preoperatively at home; 100% and 66.7% postoperatively in-hospital; and 95.4% and 85.8% postoperatively at home. Median weekly satisfaction scores for both wearing the sensor and well-being questions were 5 (IQR, 4–5). Contact moments were related to absence of sensor data and technological issues (76.0%) or patient discomfort and insecurity (24.0%). Conclusions: In this study, telemonitoring showed high satisfaction and compliance during the perioperative trajectory. Future trial design regarding the effectiveness of telemonitoring requires embedding in clinical practice and support for patients, relatives, and healthcare personnel

3D virtual pre-operative planning may reduce the incidence of dorsal screw penetration in volar plating of intra-articular distal radius fractures

Purpose: To evaluate the effect of three-dimensional virtual pre-operative planning (3DVP) on the incidence of dorsal screw penetration after volar plating of distal radius fractures. Methods: A cross-sectional diagnostic imaging study was performed. Twenty out of 50 patients were randomly selected from our index prospective cohort (IPC): a prior study evaluating dorsal tangential views (DTVs) in reducing dorsal screw penetration in internal fixation of intra-articular distal radius fractures using post-operative CT scans to quantify screw protrusion. Pre-operative CTs from this cohort were now used for 3DVP by three experienced orthopaedic trauma surgeons (supplementary video). 3DVP was compared with the corresponding post-operative CT for assessing screw lengths and incidence of dorsal penetration. The Wilcoxon Signed Ranks test was used to compare screw lengths and the Fishers’ exact for incidence of penetration. Results: Three surgeons performed 3DVP for 20 distal radius fractures and virtually applied 60 volar plates and 273 screws. Median screw length was shorter in the 3DVP when compared to IPC: 18 mm (range, 12–22) versus 20 mm (range, 14–26) (p < 0.001). The number of penetrating screws was 5% (13/273 screws) in the 3DVP group compared to 11% (10/91 screws) in the IPC (p = 0.047). Corresponding to a reduction in incidence of at least one dorsally penetrating screw in 40% of patients in the IPC group, to 18% in the 3DVP group (p = 0.069). Conclusion: Three-Dimensional Virtual Pre-Operative Planning (3DVP) may reduce the incidence of dorsally penetrating screws in patients treated with volar plating for intra-articular distal radius fractures. Level of evidence: II, diagnostic imaging study

Atherosclerotic Plaque Biomarkers: Beyond the Horizon of the Vulnerable Plaque

Cardiovascular disease (CVD) is the number one cause of death globally, and the majority of CVD is caused by atherosclerosis. Atherosclerosis is a systemic inflammatory disease that leads to myocardial infarction, stroke and lower limb ischemia. Pathological studies have given insight to development of atherosclerosis and the importance of local plaque vulnerability, leading to thrombus formation and cardiovascular events. Due to the burden of cardiovascular disease, identification of patients at risk for cardiovascular events and treatment stratification is needed. The predictive power of classical risk factors is limited, especially in patients with manifest atherosclerosis. Imaging modalities have focused on the characteristics of the vulnerable plaque. However, it has become evident that not all so-called vulnerable plaques lead to rupture and subsequent thrombosis. The latter obviously limits the positive predictive value for imaging assessment of plaques and patients at risk. Serum biomarkers have also been studied extensively, but have very limited application in a clinical setting for risk stratification. In line with the important relation between vulnerable plaques and cardiovascular events, plaque biomarker studies have been initiated. These longitudinal studies are based on the concept, that a vulnerable plaque contains predictive information for future cardiovascular events, also in other territories of the vascular tree. Results look promising and plaque markers can be used to develop imaging modalities to identify patients at risk, or to monitor treatment effect. Plaque biomarker studies do not challenge the definition of the vulnerable plaque, but use its concept in favor of prediction improvement for vascular patients

Continuous monitoring of vital signs with the Everion biosensor on the surgical ward:a clinical validation study

Background: Wearable sensors enable continuous vital sign monitoring, although information about their performance on nursing wards is scarce. Vital signs measured by telemonitoring and nurse measurements on a surgical ward were compared to assess validity and reliability. Methods: In a prospective observational study, surgical patients wore a wearable sensor (Everion, Biovotion AG, Zürich, Switzerland) that continuously measured heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature during their admittance on the ward. Validity was evaluated using repeated-measures correlation and reliability using Bland-Altman plots, mean difference, and 95% limits of agreement (LoA). Results: Validity analyses of 19 patients (median age, 68; interquartile range, 62.5–72.5 years) showed a moderate relationship between telemonitoring and nurse measurements for HR (r = 0.53; 95% confidence interval, 0.44–0.61) and a poor relationship for RR, SpO2, and temperature. Reliability analyses showed that Everion measured HR close to nurse measurements (mean difference, 1 bpm; LoA, −16.7 to 18.7 bpm). Everion overestimated RR at higher values, whereas SpO2 and temperature were underestimated. Conclusions: A moderate relationship was determined between Everion and nurse measurements at a surgical ward in this study. Validity and reliability of telemonitoring should also be assessed with gold standard devices in future clinical trials