scholarly journals Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Pierfrancesco Veroux ◽  
Alessia Giaquinta ◽  
Carla Virgilio ◽  
Davide Danilo Zani ◽  
Giuliano Ravasio ◽  
...  
Keyword(s):  
Porcine Model ◽  
Femoral Vein ◽  
Primary Patency ◽  
Venous Disease ◽  
Jugular Veins ◽  
Safety And Efficacy ◽  
Model Study ◽  
Venous Diseases ◽  
Brachiocephalic Trunk ◽  
Efficacy Profile

Background. Stenting has become the first-line treatment of obstructive venous disease because of poor results of balloon angioplasty. This preclinical study aimed to investigate the safety and efficacy profile of a novel compliant venous scaffold (CVS) denominated Petalo CVS, specifically designed for venous diseases. Materials and Methods. Twelve healthy pigs weighing 90 kg were used to test Petalo CVS. The devices were implanted into the internal jugular veins (IJVs) using a femoral vein percutaneous approach. The safety profile including the success rate of device releasing, anchoring, and positioning was evaluated immediately. Fracture, migration, primary patency, and endothelial response were assessed at 1, 2, 3, and 6 months after the study procedure. Results. A total of 32 devices were successfully released in both IJVs. No procedure- or device-related complications were reported, and all pigs successfully completed the different scheduled follow-up periods. The primary patency rate was 100%, and no fracture or migration of the device into the brachiocephalic trunk was reported. Histological examination revealed only minimal lesions with minimal or absent inflammatory reaction surrounding the incorporated metallic rods. Conclusions. This porcine model study showed a promising safety and efficacy profile of Petalo CVS, a novel endovenous device based on specific concepts.

scholarly journals Using Non-Contrast MRA to Discriminate between Obstructive and Nonobstructive Venous Diseases of the Legs

Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1392
Author(s):  
Chien-Wei Chen ◽  
Yuan-Hsi Tseng ◽  
Min Yi Wong ◽  
Yu-Hui Lin ◽  
Teng-Yao Yang ◽  
...  
Keyword(s):  
Great Saphenous Vein ◽  
Femoral Vein ◽  
Area Under The Curve ◽  
Iliac Vein ◽  
Venous Disease ◽  
Flow Volume ◽  
Mean Velocity ◽  
P Values ◽  
Venous Diseases ◽  
Venous Interventions

Background: Venous interventions of the legs are less predictable owing to a lock of objective tools. Methods: One hundred and twenty patients with lower extremity venous disease were evaluated anatomically using TRANCE MRI. Then, a QFlow analysis was performed in 53 patients with only one leg affected for hemodynamic evaluation. Those patients with complete QFlow were classified into obstructive and nonobstructive. Results: The QFlow—namely, stroke volume, forward flow volume, mean flux, stroke distance (SD), and mean velocity (MV) in the external iliac vein (EIV), femoral vein (FV), popliteal vein (PV), and great saphenous vein (GSV). The obstructed group had a shorter SD and lower MV in the EIV, EIV/FV, and GSV/PV (SD: p-values of 0.025, 0.05, and 0.043, respectively; MV: p-values of 0.02, 0.05, and 0.048, respectively). A good performance in discriminating obstructive venous disease was reported for SD in the EIV (area under the curve (AUC) = 67.9%, 95% confidence interval (CI) = 53.2–82.7%), EIV/FV (AUC = 72.4%, 95% CI = 58.2–86.5%), and GSV/PV (AUC = 67.9%, 95% CI = 51.7–84.1%). The SD in the EIV, EIV/FV, and GSV/PV had the ability to discriminate between obstructive and nonobstructive diseases (p-values of 0.025, 0.005, and 0.043). The MV in the EIV, EIV/FV, and GSV/PV had ability to discriminate between obstructive and nonobstructive venous diseases (p-values of 0.02, 0.005, and 0.048). Conclusions: The SD and MV were lower for obstructive than nonobstructive disease in the EIV.

scholarly journals Novel Compliant Stent with Specific Design for Truncular Venous Malformations: Results of a Porcine Model Study

2019 ◽  
Vol 58 (6) ◽  
pp. e514-e515
Author(s):  
Pierfrancesco Veroux ◽  
Alessia Giaquinta ◽  
Giulia Bernardini ◽  
Carla Virgilio ◽  
Massimiliano Veroux
Keyword(s):  
Porcine Model ◽  
Venous Malformations ◽  
Specific Design ◽  
Model Study

Hybrid angioplasty-catheter placement procedure performed in a hemodialysis patient with central venous obstruction disease. Presentation of a case

2020 ◽  
pp. 112972982098318
Author(s):  
Nikolaos Ptohis ◽  
Panagiotis G Theodoridis ◽  
Ioannis Raftopoulos
Keyword(s):  
Therapeutic Option ◽  
Central Venous Access ◽  
Major Complication ◽  
Venous Catheter ◽  
Venous Access ◽  
Transluminal Angioplasty ◽  
Catheter Placement ◽  
Venous Disease ◽  
Central Venous ◽  
Brachiocephalic Trunk

Obstruction or occlusion of the central veins (Central venous disease, CVD) represents a major complication in hemodialysis patients (HD) limiting central venous access available for a central venous catheter placement. Endovascular treatment with percutaneous transluminal angioplasty (PTA) is the first therapeutic option to restore patency and gain access. This case presents our initial experience of a HD patient with CVD treated with a combination therapy of a balloon PTA to the left brachiocephalic trunk, through the right hepatic vein and standard catheter placement technique to the previously occluded junction of the left internal jugular vein to the left subclavian vein.

Chronic Cannabis Users: A New Special Population to Consider for Drug Development

2021 ◽  
Vol 16 ◽  
Author(s):  
Gina Pastino ◽  
Diana Shuster
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Cannabis User ◽  
Special Population ◽  
Safety And Efficacy ◽  
New Drug ◽  
Metabolic Interactions ◽  
Widespread Availability ◽  
Baseline Characteristics ◽  
Efficacy Profile

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate its use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

A novel endovenous scaffold for the treatment of chronic venous obstruction in a porcine model: Histological and ultrastructural assessment

2018 ◽  
Vol 34 (5) ◽  
pp. 336-346
Author(s):  
Paolo Zamboni ◽  
Alessia Giaquinta ◽  
Erika Rimondi ◽  
Massimo Pedriali ◽  
Eugenio Scanziani ◽  
...  
Keyword(s):  
Marked Reduction ◽  
Porcine Model ◽  
Biological Effects ◽  
Venous Obstruction ◽  
Jugular Veins ◽  
Transmission Microscopy ◽  
Chronic Venous Obstruction ◽  
And Migration ◽  
Venous Wall ◽  
Proliferation And Migration

Objective To investigate the biological effects of a novel endovenous scaffold in a porcine model. Methods Petalo is a compliant venous scaffold implanted into the internal jugular veins of 12 healthy pigs. The pigs were sacrificed at one, two, three, and six months, respectively. Microscopic investigations were performed at two blinded laboratories. Results Neo-intima formation progressively covering up the stent metallic bars was observed. The inflammatory response of the venous wall showed a peak after three months by the implant, followed by marked reduction after six months. The device induced a significant ( p < 0.01) increase of the thickness respect to the control regions, but was comparable in sections obtained after three and six months. Conclusions The implant of Petalo compliant venous scaffold in the venous wall of this porcine model is characterized by neointima formation and by an inflammatory reaction which tends to decrease after six months. Our data point against the induction of smooth muscle cells proliferation and migration as confirmed by electronic transmission microscopy analyses.

scholarly journals Endoscopic spray cryotherapy for genitourinary malignancies: safety and efficacy in a porcine model

2012 ◽  
Vol 5 (3) ◽  
pp. 135-141 ◽  
Author(s):  
Nicholas E. Power ◽  
Jonathan L. Silberstein ◽  
Tatum Tarin ◽  
Joyce Au ◽  
Daniel Thorner ◽  
...  
Keyword(s):  
Porcine Model ◽  
Safety And Efficacy
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