Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).

OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. RESULTS: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. CONCLUSION: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. TRIAL REGISTRATION: German Clinical Trials Register DRKS 00004900.

Modelling regional cropping patterns under scenarios of climate and socio-economic change in Hungary.

Impacts of socio-economic, political and climatic change on agricultural land systems are inherently uncertain. The role of regional and local-level actors is critical in developing effective policy responses that accommodate such uncertainty in a flexible and informed way across governance levels. This study identified potential regional challenges in arable land use systems, which may arise from climate and socio-economic change for two counties in western Hungary: Veszprém and Tolna. An empirically-grounded, agent-based model was developed from an extensive farmer household survey about local land use practices. The model was used to project future patterns of arable land use under four localised, stakeholder-driven scenarios of plausible future socio-economic and climate change. The results show strong differences in farmers' behaviour and current agricultural land use patterns between the two regions, highlighting the need to implement focused policy at the regional level. For instance, policy that encourages local food security may need to support improvements in the capacity of farmers to adapt to physical constraints in Veszprém and farmer access to social capital and environmental awareness in Tolna. It is further suggested that the two regions will experience different challenges to adaptation under possible future conditions (up to 2100). For example, Veszprém was projected to have increased fallow land under a scenario with high inequality, ineffective institutions and higher-end climate change, implying risks of land abandonment. By contrast, Tolna was projected to have a considerable decline in major cereals under a scenario assuming a de-globalising future with moderate climate change, inferring challenges to local food self-sufficiency. The study provides insight into how socio-economic and physical factors influence the selection of crop rotation plans by farmers in western Hungary and how farmer behaviour may affect future risks to agricultural land systems under environmental change.

Transcarotid Artery Revascularization With Flow Reversal.

PURPOSE: To report a study evaluating the safety and efficacy of stenting via direct carotid access with flow reversal using the ENROUTE Transcarotid Neuroprotection System. METHODS: Between March 2009 and June 2012, 75 patients (mean age 72.6 years; 45 men) underwent carotid artery stenting with the ENROUTE System; the majority of patients (63, 84%) were asymptomatic. The primary safety endpoint was the composite of major stroke, myocardial infarction, or death at 30 days. Efficacy outcomes included acute device success, procedure success, and tolerance to flow reversal. Fifty-six (74.7%) patients underwent diffusion-weighted magnetic resonance imaging (DW-MRI) before and after the procedure to assess the development of new ischemic brain lesions. RESULTS: Acute device and procedure success were achieved in 68 (90.6%) patients. The reverse flow circuit was established in 71 (94.6%) patients; only 5 patients demonstrated transient intolerance to flow reversal that did not interfere with completion of the procedure. The mean time on flow reversal was 19.1 minutes. In the DW-MRI substudy, 10 (17.9%) of 56 patients had ipsilateral new white lesions with a mean volume of 0.17 mL. At 30 days, no major stroke, myocardial infarction, or death occurred; 1 patient had experienced a minor stroke that was adjudicated as not related to either the device or procedure. CONCLUSION: Results of the PROOF study demonstrate the safety and efficacy of transcarotid revascularization with the ENROUTE Transcarotid Neuroprotection System.

Relating farmer's perceptions of climate change risk to adaptation behaviour in Hungary.

Understanding how farmers perceive climate change risks and how this affects their willingness to adopt adaptation practices is critical for developing effective climate change response strategies for the agricultural sector. This study examines (i) the perceptual relationships between farmers' awareness of climate change phenomena, beliefs in climate change risks and actual adaptation behaviour, and (ii) how these relationships may be modified by farm-level antecedents related to human, social, financial capitals and farm characteristics. An extensive household survey was designed to investigate the current pattern of adaptation strategies and collect data on these perceptual variables and their potential antecedents from private landowners in Veszprém and Tolna counties, Hungary. Path analysis was used to explore the causal connections between variables. We found that belief in the risk of climate change was heightened by an increased awareness of directly observable climate change phenomena (i.e. water shortages and extreme weather events). The awareness of extreme weather events was a significant driver of adaptation behaviour. Farmers' actual adaptation behaviour was primarily driven by financial motives and managerial considerations (i.e. the aim of improving profit and product sales; gaining farm ownership and the amount of land managed; and, the existence of a successor), and stimulated by an innovative personality and the availability of information from socio-agricultural networks. These results enrich the empirical evidence in support of improving understanding of farmer decision-making processes, which is critical in developing well-targeted adaptation policies.

A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR (RADial access for CARotid artery stenting) study.

AIMS: Limited data exist on radial access in carotid artery stenting. This multicentre prospective randomised study was performed to compare the outcome and complication rates of transradial and transfemoral carotid artery stenting. METHODS AND RESULTS: The clinical and angiographic data of 260 consecutive patients with high risk for carotid endarterectomy, treated between 2010 and 2012 by carotid stenting with cerebral protection, were evaluated. Patients were randomised to transradial (n=130) or transfemoral (n=130) groups and several parameters were evaluated. Primary combined endpoint: major adverse cardiac and cerebral events, rate of access-site complications. Secondary endpoints: angiographic outcome of the procedure, fluoroscopy time and X-ray dose, procedural time, crossover rate to another puncture site and hospitalisation in days. Procedural success was achieved in all 260 patients (100%), the crossover rate was 10% in the TR and 1.5% in the TF group (p<0.05). A major access-site complication was encountered in one patient (0.9%) in the TR group and in one patient (0.8%) in the TF group (p=ns). The incidence of major adverse cardiac and cerebral events was 0.9% in the TR and 0.8% in the TF group (p=ns). Procedure time (1,620 [1,230-2,100] vs. 1,500 [1,080-2,100] sec, p=ns) and fluoroscopy time (540 [411-735] vs. 501 [378-702] sec, p=ns) were not significantly different, but the radiation dose was significantly higher in the TR group (195 [129-274] vs. 148 [102-237] Gy*cm2, p<0.05) by per-protocol analysis. Hospitalisation days were significantly lower in the TR group (1.17±0.40 vs. 1.25±0.45, p<0.05). By intention-to-treat analysis there was a significantly higher radiation dose in the TR group (195 [130-288] vs. 150 [104-241], p<0.05), but no difference in major events (0.9 vs. 0.8, p=ns) and length of hospitalisation in days (1.4±2.6 vs. 1.25±0.45, p=ns). CONCLUSIONS: The transradial approach for carotid artery stenting is safe and efficacious; however, the crossover rate is higher with transradial access. There are no differences in the total procedure duration and fluoroscopy time between the two approaches but the radiation dose is significantly higher in the radial group, and the hospitalisation is shorter with the use of transradial access by per-protocol analysis. By evaluating the patient data according to intention-to-treat analysis we found no difference in major adverse events and hospitalisation. In both groups, vascular complications rarely occurred.

Retrograde transpedal stenting of the tibioperoneal trunk in critical limb ischemia.

Management of critical limb ischemia (CLI) requires a combined treatment approach: optimal medical therapy and revascularization procedures are both essential for favorable outcome. With the development of endovascular interventions these new modalities took the primary role in limb revascularization, especially in CLI patients, where the culprit lesion is often located below the knee (BTK) level, making the surgical procedure unfeasible. In our present case report, we demonstrate a successful percutaneous recanalization of a surgically non-treatable tibioperoneal trunk occlusion. The procedure was performed with dual access from anterograde and retrograde transpedal approach, and modified "V stenting" technique was used. We describe feasibility of bail out stenting using retrograde posterior tibial artery access after failed retrograde guidewire externalization. Our report discusses the feasibility, safety, and efficacy of the retrograde approach applying 4F compatible devices.

Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.

BACKGROUND: Randomized controlled trials have shown that periprocedural rates of stroke and death are higher with carotid artery stenting (CAS) than with carotid endarterectomy (CEA) in the treatment of carotid artery stenosis. Diffusion-weighted magnetic resonance imaging (DW-MRI) has shown higher rates of clinically silent new ischemic brain lesions when CAS is performed as compared with CEA. The Silk Road Medical Embolic PROtectiOn System: First-In-Man (PROOF) Study is a single-arm first-in-man study using the MICHI Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcervical access and cerebral embolic protection system. This system enables stent implantation under controlled blood flow reversal of the carotid artery, also known as Flow Altered Short Transcervical Carotid Artery Stenting (FAST-CAS). METHODS: Between March 2009 and February 2010, a total of 44 subjects were enrolled into the study. The primary composite endpoint was major stroke, myocardial infarction, or death within 30 days. Forty-three patients (97.7%) completed the study through the 30-day endpoint. One patient was lost to follow-up. In a subgroup of consecutive subjects, DW-MRI examinations were performed preprocedure and within 24 to 48 hours after the stent implantation. Blinded independent neuroradiologists reviewed all DW-MRI studies and confirmed the absence or presence of new ischemic brain lesions. RESULTS: All enrolled patients were successfully treated, and no major adverse events were seen through the follow-up period. Thirty-one subjects had DW-MRI examinations. Of these, five patients (16%) had evidence of new ischemic brain lesions but no clinical sequelae. Transient intolerance to reverse flow was reported in 9% of cases, but in all cases, a stent was successfully placed, and the intolerance was managed by minimizing the duration of reverse flow during the procedure. CONCLUSION: In this first-in-man experience, FAST-CAS using the MICHI Neuroprotection System was shown to be a safe and feasible method for carotid revascularization. DW-MRI findings suggest controlled reverse flow provides cerebral embolic protection similar to that seen with CEA.

Anterograde recanalisation of the radial artery followed by transradial angioplasty.

We report a patient with critical hand ischemia after transradial coronary angioplasty. The radial artery occlusion was confirmed by angiography. The report discusses the role of angioplasty for the treatment of symptomatic radial artery occlusion.

Hybrid treatment of common carotid artery occlusion with ring-stripper endarterectomy plus stenting.

Symptomatic occlusion of the common carotid artery with preserved circulation in the internal carotid artery is an uncommon occurrence. We describe a hybrid technique whereby a patient was treated with eversion carotid bifurcation endarterectomy, fluoroscopically guided retrograde ring-stripper common carotid endarterectomy, and stenting of residual stenosis in the disobliterated artery. Successful recanalization was achieved without adverse anatomic or neurologic sequelae. The patient remains asymptomatic with a radiographically patent reconstruction at 1 year. This combination of endovascular and open surgery enables the surgeon to address long occlusions of the common carotid arteries with control of the distal and proximal endarterectomy margins and obviates the need for general anesthesia or sternotomy.

Report on initial experience with transradial access for carotid artery stenting.

OBJECTIVE: Carotid artery stenting is emerging as an attractive alternative to surgical endarterectomy for the treatment of carotid artery disease. This study reports our initial experience using the radial artery as access for carotid stenting. METHODS: A retrospective study was performed in which 20 consecutive patients at high risk for carotid endarterectomy underwent carotid stenting with cerebral protection using radial artery access. All procedures were performed in the operating room from March 2006 to December 2006. Seven lesions were symptomatic, and 13 lesions were asymptomatic. Patients were evaluated for development of stroke or transient ischemic attacks, myocardial infarction, access site complications, procedural success, time to patient mobilization, and need for intravenous analgesia. RESULTS: Procedural success was achieved in 18 patients (90%). Intense radial artery vasospasm resulted in one failure, and the second failure occurred in a patient with a left-sided carotid lesion and type I arch. The 30-day incidence of stroke, transient ischemic attacks, myocardial infarction, and death was 0%. Radial artery occlusion only occurred in the one patient because of the development of intense vasospasm during the procedure. One patient had persistent local pain requiring intravenous medication for relief. All patients were mobilized

Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.

This prospective cohort study was taken to determine whether transcervical carotid artery stenting (CAS) with internal carotid artery (ICA) flow reversal is associated with a lower incidence of embolization and femoral access complication when compared with protected, transfemoral CAS in selected, high-risk patients. From 2002 to October 2004, the authors performed 55 carotid stentings and angioplasties. Among the 24 cases via transfemoral approach, 1 developed transient ischemic attack (TIA), 1 stroke, 1 asystolic cardiac arrest, 2 groin hematoma, 2 technical failure, and 1 restenosis. Among the 31 cases via transcervical approach, 2 patients developed TIAs, 4 bradycardia, 2 cervical hematoma, and 3 technical failures leading to open conversion and carotid endarterectomy. Transcervical CAS with ICA flow reversal eliminates the risk of aortic arch emboli, provides cerebral protection during predeployment manipulation across the carotid lesion, negates preprocedure mapping of the aortic arch configuration, and surpasses difficult aortic arch or transfemoral access.

Combining open and endovascular surgery for the treatment of infrarenal abdominal aortic aneurysm: a case report using a hybrid vascular graft.

Migration and endoleaks after endovascular exclusion of an infrarenal abdominal aortic aneurysm may lead to long-term failure of the stent graft. We report a successful case of a novel technique that combined open and endovascular surgery to address the issues of migration and endoleak in the repair of an abdominal aortic aneurysm. The hybrid graft, consisting of a proximal, conventional Dacron graft and two distal endoprosthesis limbs, was designed to reduce aortic cross-clamp time in aortic procedures. This is the first reported clinical experience with this new hybrid vascular graft for the treatment of an abdominal aortic aneurysm.

Totally laparoscopic explantation of migrated stent graft after endovascular aneurysm repair: a report of two cases.

This report describes the removal of two migrated stent grafts and the repair of abdominal aortic aneurysms by laparoscopic technique. In these two cases, endovascular treatment was not indicated because of device migration into the aneurysm and the presence of thrombus within the endografts. Operative times were 245 and 230 minutes, with aortic clamp times of 95 and 66 minutes. The patients were extubated immediately after the procedure, resumed a normal diet on postoperative day 2, and were discharged home on postoperative days 5 and 6. We believe these are the first reported cases of laparoscopic explantation of migrated aortic stent grafts in the literature.