Point-of-care 3D printing: a low-cost approach to teaching carotid artery stenting.

BACKGROUND: Carotid Artery Stenting (CAS) is increasingly being used in selected patients as a minimal invasive approach to carotid endarterectomy. Despite the long standing tradition of endovascular treatments, visual feedback during stent-deployment is impossible to obtain as deployment is performed under fluoroscopic imaging. Furthermore, the concept of stent-placement is often still unclear to patients. 3D Printing allows to replicate patient-specific anatomies and deploy stents inside them to simulate procedures. As such these models are being used for endovascular training as well as patient education. PURPOSE: To our knowledge, this study reports the first use of a low-cost patient-specific 3D printed model for teaching CAS deployment under direct visualization, without fluoroscopy. METHODOLOGY: A CT-angiogram was segmented and converted to STL format using Mimics inPrint™ software. The carotid arteries were bilaterally truncated to fit the whole model on a Formlabs 2 printer without omitting the internal vessel diameter. Next, this model was offset using a 1 mm margin. A ridge was modelled on the original vessel anatomy which was subsequently subtracted from the offset model in order to obtain a deroofed 3D model. All vessels were truncated to facilitate post-processing, flow and guide wire placement. RESULTS: Carotid artery stents were successfully deployed inside the vessel. The deroofing allows for clear visualization of the bottlenecks and characteristics of CAS deployment and positioning, including stent foreshortening, tapering and recoil. This low-cost 3D model provides visual insights in stent deployment and positioning, and can allow for patient-specific procedure planning. CONCLUSIONS: The presented approach demonstrates the use of low-cost 3D Printed CAS models in teaching complex stent behavior as observed during deployment. Two main findings are illustrated. On one hand, the feasibility of low-cost in-hospital model production is shown. On the other hand, the teaching of CAS deployment bottlenecks at the carotid level without the need for fluoroscopic guidance, is illustrated. The observed stent characteristics as shown during deployment are difficult to assess in radiologic models. Furthermore, printing patient-specific 3D models preoperatively could possibly assist in accurate patient selection, preoperative planning, case-specific training and patient education.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

PURPOSE: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). MATERIALS AND METHODS: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. RESULTS: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). CONCLUSION: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

BACKGROUND: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions. METHODS: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. RESULTS: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year. CONCLUSIONS: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

EVOLUTION Study: 12-month results.

BACKGROUND: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months. METHODS: Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%). RESULTS: Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%. CONCLUSIONS: These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

BeGraft Peripheral PMCF Study: 12-month results.

BACKGROUND: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months. METHODS: Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%. RESULTS: Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%. CONCLUSIONS: These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.

Health Outcomes for Definite Concurrent Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study.

BACKGROUND: In patients with locally advanced lung cancer treated with concurrent chemoradiation, outcome measurements have been mostly limited to survival. OBJECTIVES: We aimed to measure outcomes that matter to these patients beyond survival in a general clinical practice. METHODS: In a prospective single-centre study, consecutive patients with locally advanced non-small cell lung cancer reported their own outcomes using the EORTC Quality of Life Questionnaire Core 30 at baseline, during therapy, at therapy stop and till 1 year after therapy end every 3 months. Survival, complications, quality of death and case-mix variables were measured. RESULTS: There were 32 consecutive patients included prospectively from June 2013 until September 2016. Median overall survival was 24.3 months (95% CI 12.7-35.9). Severe toxicity (grade III-IV) was frequent (haematologic toxicity III-IV in 59%). Patient-reported outcomes (PROs) documented the burden on global health status and on functional domains (physical, role, social, emotional and cognitive functioning). Deterioration was pronounced during and after treatment with drops over 20 up to 40% points from baseline for physical, role and social functioning. Clinically meaningful negative effects did persist up to 6 and 9 months for physical and role functioning. Fifty-six percent of the deceased patients died in hospital. CONCLUSIONS: The assault on health-related quality of life during concurrent chemoradiation for locally advanced lung cancer is considerable. Loss of physical and role functioning persists up to 6 and 9 months after therapy end, respectively. Measuring PROs can help to identify issues for improvement of the value of care delivered.

Robotically Assisted Transthoracic Cervical Rib Resection.

Several different approaches to surgical decompression of the thoracic outlet have been described. This report describes a unique case of robotically assisted transthoracic cervical rib resection for neurogenic thoracic outlet syndrome. This minimally invasive technique offers delicate tissue manipulation under optimal visualization of the thoracic outlet structures. Hence it promotes patients' safety and complete surgical decompression.

Plasma citrulline levels are increased in patients with multiple sclerosis.

BACKGROUND: Multiple sclerosis is an inflammatory demyelinating disorder of the central nervous system (CNS). Myelin basic protein (MBP), which is one of the main compounds of CNS myelin, appears to be hypercitrullinated in the brain of patients with MS. We hypothesized that MS is associated with an increased release of citrulline from the brain. METHODS: Twenty-five patients with MS, 25 controls without neurological disease (CwND) and 25 subjects with non-MS cerebral white matter lesions were included in this study. Groups were matched for age and gender. Clinical MS disability measures were recorded by means of Expanded Disability Status Scale (EDSS) scores and Multiple Sclerosis Severity Scores (MSSS). Citrulline was assessed in plasma obtained from an antecubital peripheral vein (PV) in all participants. Additional internal jugular vein (IJV) samples were examined in 10 patients with MS and 10 CwND. Twelve patients with MS underwent brain magnetic resonance imaging to determine total brain and T2 fluid-attenuated inversion recovery lesion volume. RESULTS: Median [IQR] PV citrulline levels were increased in patients with MS (50.47 [86.61] µM), as compared to CwND (33.58 [43.65] µM, P = 0.042) and subjects with non-MS cerebral white matter lesions (32.41 [28.86] µM, P = 0.006). Citrulline IJV levels and IJV/PV ratios were comparable between patients with MS and CwND. No significant correlations were found between PV citrulline levels and any of the clinical, nor radiological, disease measures. CONCLUSION: PV plasma levels of citrulline are elevated in patients with MS but this does not seem to result from an augmented release from the brain. Increased plasma citrulline may be a promising new biomarker in MS but the origin and significance need to be further elucidated.

Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study.

A quarter of patients with clinical N1 (cN1) non-small cell lung cancer (NSCLC) based on positron emission tomography-computed tomography (PET-CT) imaging have occult mediastinal nodal involvement (N2 disease). In a prospective study, endosonography alone had an unsatisfactory sensitivity (38%) in detecting N2 disease. The current prospective multicentre trial investigated the sensitivity of preoperative mediastinal staging by video-assisted mediastinoscopy (VAM) or VAM-lymphadenectomy (VAMLA).Consecutive patients with operable and resectable (suspected) NSCLC and cN1 after PET-CT imaging underwent VAM(LA). The primary study outcome was sensitivity to detect N2 disease. Secondary endpoints were the prevalence of N2 disease, negative predictive value (NPV) and accuracy of VAM(LA).Out of 105 patients with cN1 on imaging, 26% eventually developed N2 disease. Invasive mediastinal staging with VAM(LA) had a sensitivity of 73% to detect N2 disease. The NPV was 92% and accuracy 93%. Median number of assessed lymph node stations during VAM(LA) was 4 (IQR 3-5), and in 96%, at least three stations were assessed.VAM(LA) has a satisfactory sensitivity of 73% to detect mediastinal nodal disease in cN1 lung cancer, and could be the technique of choice for pre-resection mediastinal lymph node assessment in this patient group with a one in four chance of occult-positive mediastinal nodes after negative PET-CT.

Total Percutaneous Cardiopulmonary Bypass for Robotic and Endoscopic Atrioventricular Valve Surgery.

Continuous technological advances in endoscopic-, robotic- and catheter-based cardiac interventions are paralleled by rapid evolution in cannulation strategies for circulatory support. The recent introduction of suture-based percutaneous vascular closure devices resulted in innovative strategies to deliver peripheral endovascular therapeutic devices through the iliac and femoral arteries. Percutaneous access allows rapid postoperative mobilization and potentially avoids the devastating neuro-lympho-vascular- and wound infection morbidities associated with conventional open surgical exposure. We routinely perform endoscopic port access surgery for all isolated atrioventricular valve pathology and extended the application of suture-based percutaneous vascular closure device to establish total percutaneous peripheral cardiopulmonary bypass in disabled, immune-suppressed, and morbidly obese patients at risk neuro-lympho-vascular- and wound infection. In this report, we provide a stepwise description of our total percutaneous peripheral cardiopulmonary bypass technique.

One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

PURPOSE: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. METHODS: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). RESULTS: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. CONCLUSION: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Robotically enhanced mediastinal teratoma resection: a case report and review of the literature.

Mediastinal teratomata are rare, extragonadal germ cell tumors, which can occur at any age and are often asymptomatic. We present the case of a 57-year-old female with chronic cough diagnosed with a mass in the anterior mediastinum. The mass was successfully resected using the Intuitive Da Vinci® robotic system. The patient had an uneventful recovery. Review of the literature demonstrates that robotic surgery of the mediastinum is a safe and feasible alternative in selected cases.

Single-Stage Minimally Invasive Surgery for Synchronous Primary Pulmonary Adenocarcinoma and Left Atrial Myxoma.

We report the first successful short-term outcome of single-stage combined video-assisted thoracoscopic surgery lobectomy and port access surgery in a patient with operable primary right lower lobe adenocarcinoma and a synchronous cardiac myxoma. The video-assisted thoracic surgery right lower lobectomy with systematic lymph node dissection was performed first, followed by myxoma excision by port access surgery through the same working port incision. The histopathologic analysis confirmed a pT2a N0 M0 R0 (TNM 7th edition) primary poorly differentiated pulmonary adenocarcinoma and a completely excised cardiac myxoma. Postoperative recovery was uneventful, and follow-up at 6 weeks confirmed an excellent surgical and oncologic outcome.

Complete Endovascular Treatment of Saccular Aneurysm of the Aortic Arch by Coiling and ch-EVAR.

Saccular aneurysm of the aortic arch is a condition with a high associated mortality. Open surgery is often complicated with poor outcome and high postoperative morbidity and mortality. In this case report, we describe an alternative stepwise endovascular repair: coiling of the aneurysm followed by covering of the ostium of the saccular aneurysm by chimney endovascular aortic repair. In our opinion, this technique could be an alternative for a fully customized branched or fenestrated endoprosthesis to treat these kind of aneurysms.

Minimally invasive primary aortic valve surgery: the OLV Aalst experience.

BACKGROUND: The purpose of this study was to evaluate our in-hospital outcomes with primary J-sternotomy aortic valve surgery since the initiation of our program in 1997. METHODS: Between October 1(st) 1997 and August 31(st) 2014, 768 patients (mean age: 69.1±11.2 years, 46.6% females, 15.6% aged greater than 80 years) underwent primary JS-AVS. Additional risk factors included diabetes mellitus (n=98, 12.2%), peripheral vascular disease (n=42, 5.5%) and body mass index greater than 30 (n=144, 18.8%). The mean logistical EuroSCORE I was 5.46%±4.5%. RESULTS: Aortic valve replacement and repair were performed in 758 (98.7%) and 10 (1.3%) patients respectively, for isolated valve stenosis (n=472, 61.8%), incompetence (n=56, 7.3%) and mixed valve disease (n=236, 30.9%). Valve pathology included sclerosis (n=516, 67.2%), rheumatic disease (n=110, 14.3%) and endocarditis (n=10, 1.3%). Reasons for conversion to full sternotomy (n=23, 3.0%) included porcelain ascending aorta (n=3, 0.4%), inadequate visualization (n=2, 0.3%) and intra-operative complications (n=18, 2.3%). Mean length of hospital stay was 11.0±7.4 days. Morbidity included stroke (n=15, 2.0%), revision or re-exploration (n=52, 6.8%), atrial fibrillation (n=201, 26.2%) and sternitis (n=5, 0.7%). In-hospital mortality was 1.6% (n=12). Overall survival at 30 days was 98.0%. CONCLUSIONS: JS-AVS is safe and is our routine approach for isolated aortic valve disease. Procedure related mortality is lower than predicted, conversion rates limited and significant morbidity minimal.

Endosonography for mediastinal nodal staging of clinical N1 non-small cell lung cancer: a prospective multicenter study.

BACKGROUND: Patients with clinical N1 (cN1) lung cancer based on imaging are at risk for malignant mediastinal nodal involvement (N2 disease). Endosonography with a needle technique is suggested over surgical staging as a best first test for preoperative invasive mediastinal staging. The addition of a confirmatory mediastinoscopy seems questionable in patients with a normal mediastinum on imaging. This prospective multicenter trial investigated the sensitivity of preoperative linear endosonography and mediastinoscopy for mediastinal nodal staging of cN1 lung cancer. METHODS: Consecutive patients with operable and resectable cN1 non-small cell lung cancer underwent a lobe-specific mediastinal nodal staging by endosonography. The primary study outcome was sensitivity to detect N2 disease. The secondary end points were the prevalence of N2 disease, the negative predictive value (NPV) of both endosonography and endosonography with confirmatory mediastinoscopy, and the number of patients needed to detect one additional N2 disease with mediastinoscopy. RESULTS: Of the 100 patients with cN1 on imaging, 24 patients were diagnosed with N2 disease. Invasive mediastinal nodal staging with endosonography alone has a sensitivity of 38%, which can be increased to 73% by adding a mediastinoscopy. NPV was 81% and 91%, respectively. Ten mediastinoscopies are needed to detect one additional N2 disease missed by endosonography. CONCLUSIONS: Endosonography alone has an unsatisfactory sensitivity to detect mediastinal nodal metastasis in cN1 lung cancer, and the addition of a confirmatory mediastinoscopy is of added value. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01456429; URL: www.clinicaltrials.gov.

Femoro-saphenous arteriovenous access-related lower limb ischemia treated by distal arteries percutaneous angioplasty.

This is the first reported case of transposed femoro-saphenous angio-access complicated after four years by distal ischemia, which was successfully treated by percutaneous transluminal angioplasty (PTA) of the distal femoral and popliteal artery. Endovascular recanalization and angioplasty of the distal vessels offers a minimally invasive approach with preservation of the angio-access in these patients with high comorbidities.

Cerebral hypoperfusion in multiple sclerosis is reversible and mediated by endothelin-1.

Decreased cerebral blood flow (CBF) may contribute to the pathology of multiple sclerosis (MS), but the underlying mechanism is unknown. We investigated whether the potent vasoconstrictor endothelin-1 (ET-1) is involved. We found that, compared with controls, plasma ET-1 levels in patients with MS were significantly elevated in blood drawn from the internal jugular vein and a peripheral vein. The jugular vein/peripheral vein ratio was 1.4 in patients with MS vs. 1.1 in control subjects, suggesting that, in MS, ET-1 is released from the brain to the cerebral circulation. Next, we performed ET-1 immunohistochemistry on postmortem white matter brain samples and found that the likely source of ET-1 release are reactive astrocytes in MS plaques. We then used arterial spin-labeling MRI to noninvasively measure CBF and assess the effect of the administration of the ET-1 antagonist bosentan. CBF was significantly lower in patients with MS than in control subjects and increased to control values after bosentan administration. These data demonstrate that reduced CBF in MS is mediated by ET-1, which is likely released in the cerebral circulation from reactive astrocytes in plaques. Restoring CBF by interfering with the ET-1 system warrants further investigation as a potential new therapeutic target for MS.

Pacemaker insertion in a patient with persistent left superior vena cava.

A persistent left superior vena cava (PLSVC) is a rare and usually unnoticed congenital anomaly. However, clinicians must be conscious of its existence as a PLSVC can be associated with other anomalies of cardiovenous morphology with significant clinical implications for transvenous procedures. We report a case of a double superior vena cava with absent innominate vein found during catheterization for cardiac resynchronization pacemaker therapy implantation (CRT-P). We also describe a technique used for successful positioning of the leads into the right atrium and right ventricle.