Evaluation of a new paclitaxel-coated balloon catheter in an in vivo porcine peripheral venous model: Feasibility, safety, and drug deliverability

Purpose: To evaluate in vivo the feasibility, safety, and paclitaxel (PTX) deliverability of a newly developed non-commercially available Paclitaxel-Coated Balloon (PCB) catheter in the swine healthy peripheral vein model. Materials and methods: In total 12 PCBs were deployed in 12 venous segments. Primary feasibility endpoint was the successful application of the devices to the veins of the animals. Primary efficacy endpoint was the determination of the drug content in the venous tissue at 24 h and 7 days after balloon expansion, as assessed by analysis of the vein tissue with High Performance Liquid Chromatography (HPLC) coupled with tandem mass spectrometry. Primary safety endpoint was freedom from any major adverse event. Secondary endpoint was the investigation of any independent factor affecting the primary endpoints. Results: Paclitaxel was detected in five out of six tissue samples 24 h post-intervention and five out of six tissues at 7 days following the procedure (10 tissue samples out of 12). The mean weight of tissue that was examined was 0.20604 ± 0.29822 g (range: 1.02823–0.03377 g) and the mean PTX concentration detected was 8.4 ± 13.1 μg/g (range: 0–36.1 μg/g). The average drug content detected at 24 h (17.1 ± 17.1 μg/g) was numerically superior, but non-statistically significant, compared to 7 days (3.1 ± 3.6 μg/g). An average of 33.8% of the drug remained on the balloon after retrieval. According to the multiple linear regression analysis, there was no significant correlation between transition time, PTX remaining on the balloon, time of analysis (24 h/7 days) and PTX tissue concentration. No abnormalities were noted during autopsy. Conclusion: The newly developed PCB successfully delivered within the healthy venous wall a dose of Paclitaxel that inhibits neointimal hyperplasia. No safety issues were raised at short-term follow-up. © The Author(s) 2022

Multicenter retrospective study of transcatheter arterial embolisation for life-threatening haemorrhage in patients with uncorrected bleeding diathesis

Background: We retrospectively investigated outcomes of emergency TAE for the management of life-threatening haemorrhage in patients with uncorrected bleeding diathesis. Materials and methods: This multicenter, retrospective, study, was designed to investigate the safety and efficacy of percutaneous TAE for the management of life-threatening haemorrhage in patients with uncorrected bleeding disorder at the time of embolization. All consecutive patients with uncorrected coagulation who underwent TAE for the treatment of haemorrhage, between January 1st and December 31th 2019 in three European centers were included. Inclusion criteria were thrombocytopenia (platelet count < 50,000/mL) and/or International Normalized Ratio (INR) ≥2.0, and/or activated partial thromboplastin time (aPTT) > 45 s, and/or a pre-existing underlying blood-clotting disorder such as factor VIII, Von Willebrand disease, hepatic cirrhosis with abnormal liver function tests. Primary outcome measures were technical success, rebleeding rate and clinical success. Secondary outcome measures included patients’ 30-day survival rate, and procedure-related complications. Results: In total, 134 patients underwent TAE for bleeding control. A subgroup of 17 patients with 18 procedures [11 female, mean age 70.5 ± 15 years] which represent 12.7% of the total number of patients, presented with pathological coagulation parameters at the time of TAE (haemophilia n = 3, thrombocytopenia n = 1, cirrhosis n = 5, anticoagulants n = 7, secondary to bleeding n = 1) and were analyzed. Technical success was 100%, as in all procedures the bleeding site was detected and successfully embolised. Clinical success was 100%, as none of the patients died of bleeding during hospitalization, nor was surgically treated for bleeding relapse. Only one rebleeding case was noted (5.9%) that was successfully treated with a second TAE. No procedure-related complications were noted. According to Kaplan-Meier analysis the estimated 30-day survival rate was 84.2%. Conclusion: TAE in selected patients with uncorrected bleeding diathesis should be considered as a suitable individualized management approach. Emergency TAE for life threatening haemorrhage in patients with coagulation cascade disorders should be used as an aid in realistic clinical decision making. © 2020, The Author(s)

Ultrasound-guided femoral approach for coronary angiography and interventions in the porcine model

Coronary angiography and percutaneous coronary intervention (PCI) procedural details in swine are similar to those performed to humans, since their heart and coronary anatomy closely resembles. However, only a few detailed descriptions of the procedure are available, containing notable differences. We present a feasible and reproducible protocol for percutaneous coronary interventions in porcine experimental models, utilizing ultrasound-guided femoral approach. Nine female pigs were studied to explore the feasibility of superficial femoral arterial (SFA) access for coronary angiography and provisional PCI, as well as the most suitable guiding coronary catheters and angiographic projections for the above interventions. Experiments were performed under general anesthesia, using ultrasound-guided puncture of the SFA to gain arterial access. The Amplatzer AR1® catheter, and the Right Coronary Bypass® catheter were used for the selective engagement of the right and the left coronary artery, respectively. Successful arterial access and subsequent cardiac catheterization were performed in all pigs. Only one animal required a second puncture for femoral artery access. None of the 9 animals presented any significant tachycardia or hypotensive episode. One animal developed an access site-related complication following the first catheterization procedure. During follow-up, 100% success of SFA catheterization was achieved using the same ultrasound-guided technique. The ultrasound-guided superficial femoral artery access for coronary angiography and provisional interventions in porcine models is a quick and safe alternative to the carotid artery approach. The RCB and AR1 catheters may be the best choice for the quick and easy selective coronary engagement of the right and left ostia, respectively. © 2022, The Author(s)

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results

Purpose: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. Materials and Methods: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. Results: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for 65120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). Conclusions: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas