Adrian Ebner

First-in-Human Off-Pump Transcatheter Mitral Valve Replacement

Transcatheter mitral valve replacement (TMVR) faces significant challenges arising from the heterogeneous pathology of the mitral valve and the anatomic complexity of the mitral annulus, leaflets, and subvalvular apparatus [(1,2)][1]. The Tendyne mitral prosthesis (Tendyne Holdings, Roseville,

Arteriovenous Fistula Creation using the Optiflow Vascular Anastomosis Device: A First in Man Pilot Study

Although arteriovenous fistulae are the preferred form of dialysis vascular access they continue to have significant problems with maturation failure. The Optiflow device is a sutureless anastomotic conduit which could potentially reduce surgical time and also standardize the surgical procedure. We report herein on the “First in Man” experience with the Optiflow device.

Next generation renal denervation: chemical “perivascular” renal denervation with alcohol using a novel drug infusion catheter

BACKGROUND/PURPOSE We update the pre-clinical and early clinical results using a novel endovascular approach, to perform chemical renal denervation, via peri-adventitial injection of micro-doses of dehydrated alcohol (ethanol-EtOH). METHODS/MATERIALS A novel, three-needle delivery device (Peregrine™) was used to denervate the renal arteries of adult swine (n = 17) and in a first-in-man feasibility study (n = 18). In the pre-clinical testing EtOH was infused bilaterally with one infusion per renal artery into to the perivascular space, using EtOH doses of 0.3 ml/artery (n = 8), and 0.6 ml/artery (n = 9), and with saline sham control (0.4 ml/artery n = 3). Renal parenchymal norepinephrine (NE) concentration (performed blindly), and safety were the primary endpoints. Data from the first-in-man study (n = 18) to evaluate device performance, safety and peri-procedural pain are reported. RESULTS In the pre-clinical testing renal function was unchanged at 3-month follow-up. Angiography at 90 days (n = 34 arteries) demonstrated normal appearing renal arteries, unchanged from baseline, and without stenosis or other abnormalities. The reductions in mean renal parenchymal NE reductions at 3 months were 68% and 88% at doses of 0.3 and 0.6 ml, respectively (p < 0.001 vs. controls). In the first-in-man study, there was 100% device success, no complications, a mean treatment time of 4.3 ± 3 minutes/artery, and minimal or no patient discomfort during treatment. Angiography at 6-months showed no evidence of renal artery stenosis, and evidence of a reduction of blood pressure from baseline. CONCLUSION Perivascular RDN using micro-doses of alcohol is a promising alternative to energy-based systems to achieve dose-dependent, predictable, safe and essentially painless renal denervation. Further clinical evaluation is warranted. SUMMARY (For annotated table of contents) This paper describes the preclinical results, in a porcine model, and the early first-in-man results, using the Peregrine™ chemical renal denervation catheter to perform renal sympathetic denervation using micro-doses of alcohol.

Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection.

OBJECTIVES This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post-percutaneous transluminal balloon angioplasty (post-PTA) dissection. BACKGROUND Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device. METHODS A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries. RESULTS The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%. CONCLUSIONS Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement.

A lumen sizing workhorse guidewire for peripheral vasculature: Two functions in one device

Ideally, guidewires used during peripheral vasculature (PV) interventions could serve both as a therapy delivery platform and a diagnostic tool for real‐time vessel sizing (2‐in‐1 function).

Efficacy and safety of novel multi-lumen catheter for chronic total occlusions: From preclinical study to first-in-man experience

To report our initial animal and human experience with a new multi‐lumen catheter called MultiCross™ (Roxwood Medical, Inc.) in a porcine coronary model and patients with a chronic total occlusion (CTO).

First-in-human experience with Aortix intraaortic pump

There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high‐risk percutaneous coronary intervention.

Treatment of severe infrapopliteal vascular disease using a novel atherectomy device: A case report

We report two first in man cases of percutaneous revascularization for severe intrapopliteal arterial disease using the novel PV atherectomy device.