Clinical Experience of a Novel Optical Coherence Tomography-Guided Coronary Chronic Total Occlusion Re-Entry Device.

We demonstrated a first-in-human case of successful antegrade dissection and re-entry using an image-guided re-entry catheter that enables real-time high-resolution visualization with graphical augmentation, and precision steering and advancement of a guidewire. The total time from over-the-wire deployment in the proximity of the distal cap to successful re-entry was <20 minutes. (Level of Difficulty: Advanced.).

The Surfacer® Inside-Out® Access System for right-sided catheter placement in dialysis patients with thoracic venous obstruction.

PURPOSE: Thoracic central venous obstruction is a common clinical complication in dialysis patients utilizing hemodialysis catheters. Thoracic central venous obstruction can lead to inability to utilize affected veins for catheter placement and sequential use of less preferred alternative venous access sites. The latter can affect the ability to create and/or mature permanent arteriovenous access and contribute to the future loss of thoracic veins for venous access. While alternative procedures exist for gaining venous access in patients who have exhausted routine venous access options, these procedures are complex, time-consuming, and associated with high patient risk. The Surfacer System provides a new approach in patients with right-sided thoracic central venous obstruction, enabling the ability to establish repeated access from the right side of the neck to the right atrium. METHODS: We describe the use of the Surfacer System to facilitate placement of hemodialysis catheters in a series of nine patients with thoracic central venous obstruction involving one or more central veins. Patient characteristics and procedure-related outcomes were recorded for all patients. RESULTS: Central venous access was successfully achieved in eight of nine patients using the Surfacer System. Significant venous tortuosity resulted in the inability to achieve venous access in one patient and prolonged procedural time to achieve access in another patient. The mean time required for Surfacer-related procedural steps and associated fluoroscopy time in the remaining seven patients was 13.3 and 3.7 min, respectively. CONCLUSION: The Surfacer System provides an efficient low-complexity alternative for gaining repeated right-sided central venous access in hemodialysis patients with obstructed thoracic veins.

Transcatheter Alcohol-Mediated Perivascular Renal Denervation With the Peregrine System: First-in-Human Experience.

OBJECTIVES: This study evaluated the first clinical use of a new endovascular approach to renal denervation, using chemical neurolysis, via periadventitial infusion of dehydrated alcohol (ethanol) to perform "perivascular" renal artery sympathetic denervation. BACKGROUND: Renal denervation remains a promising technology for the treatment of hypertension and other disorders. METHODS: A novel 3-needle delivery device (Peregrine System Infusion Catheter, Ablative Solutions, Inc., Kalamazoo, Michigan) was introduced into the renal arteries of 18 subjects with refractory hypertension. Microdoses of alcohol were infused bilaterally via the 3 needles into to the adventitial space (0.30 ml/artery, 37 arteries). Renal artery angiography was performed at the time of the procedure and at 6 months (n = 16). The primary safety endpoints were complications associated with the catheter insertion and delivery of the neurolytic agent or any major vascular access complications. The secondary performance endpoint was a reduction in office-based systolic blood pressure at 6 months compared with baseline. RESULTS: Procedural success was achieved in 100% of subjects (N = 18) and arteries (N = 37). There were no study-related adverse clinical events at follow-up. One death of a subject was recorded but determined by the investigator and an independent medical monitor to be non-study related. There were no angiographic observations of renal artery stenosis, aneurysms, or other renal artery abnormalities at 6 months (32 renal arteries). Sixteen of the 18 subjects had a 6-month follow-up. The mean office systolic blood pressure decreased from 175 ± 17 mm Hg to 151 ± 26 mm Hg (-24 mm Hg). There was an average reduction of antihypertensive medications from 3.4 (baseline) to 2.0 per subject at 6 months. CONCLUSIONS: Chemical renal denervation using the infusion of very low doses of alcohol directly into the adventitial space appears to be feasible and safe. This approach may be a promising alternative approach to perform catheter-based renal denervation. These results need to be confirmed in larger scale clinical studies.