View Recording of New Valve Designs Webinar

April 16th, 2024

Recording of  the New Valve Designs Webinar on April 10, is now available. The recording features Dr. Christopher Meduri, Dr. Scott Lim, and Dr. Srujana Joshi presenting:

“DurAVR: An Innovative Biomimetic Approach”
“The New Laguna Tech Valve: Initial Experience”
“Engineering a Novel Polymer Valve”

Highlights of New Valve Design webinar is moderated by Dr. Stephanie Sellers, University of British Columbia and Dr. David Meier, CHUV Lausanne, Vaud, Switzerland.

Attendees rated the webinar “9.6/10” in the webinar exit survey.

ViVitro Labs and The Cardiovascular Translational Lab at St. Paul’s bring the latest in translational cardiovascular research in a free, quarterly interactive webinar format.

 

 

Karim Mouneimne, President at ViVitro Labs Inc and General Manager at Vivitro Labs SASU, shares his highlights from the presentation: Highlights

Dr. Christopher Meduri, Structural and Interventional Cardiologist at Karolinska University Hospital and Chief Medical Officer at Anteris Technologies reminded us about the Anteris success story with ADAPT, an a-cellular tissue technology which allowed the company to enter the TAVR space with the DurAVR valve. This valve has a unique BX design made of a single bovine pericardium tissue treated with ADAPT and molded in the shape of the native valve. This first Biomimetic valve has perfect hemodynamic properties when compared in-vitro to Evolut and Sapien in 21 mm round fixture.

For me, the most interesting feature of this technology is the difference in the leaflet dynamics upon opening which exhibit a “puff & pop” open behavior instead of the more standard hinging effect seen with other valves. In-vitro, the valve has shown superior hemodynamic performance in EOA and MPG when compared to other TAVI and surgical valves and in Valve in Valve (VnV) against the Sapien.

The in-vitro performance of the valve was confirmed by 2 clinical studies; a FIH study on 28 patients with 22 mm annulus which showed consistent hemodynamic results at 30 days and 1 year follow-up, and a US feasibility study on 15 patients with no PVL, no stroke, no death at 30 days.

The unique coaptation behavior of the leaflets was observed clinically with a mean coaptation length of 5-6 mm. Most importantly this valve has been shown to restore the laminar flow seen in native valves when compared to other valves in the Euro registry.

Dr. Meduri believes that profile of the turbulent flow coming out of current valves may have a significant impact on the ventricle and the aorta thrombogenicity and washout, inflammation and calcification.

Dr. Scott Lim, Director – Advanced Heart Valve Center at University of Virginia Health System showed advances in TAVR for non-calcific AR and Calcific AR/AS lesions using the LagunaTech valve technology. AR is not benign and posed specific challenges such as the landing zone visibility and asymmetricity.

There are no valves approved in the US for AR. The Alpha design is a BX system and Zeta design is a SX system both equipped with leaflet retention arms to sandwich the native leaflet around the implemented valve. The SX system pinches the native leaflets whereas the BX system pivots to wrap the native leaflets around.

Dr. Lim further explained those deployment differences with fluoroscopic images and necropsy images taken during animal studies. In one clinical FIH case performed with the SX system, the valve conformed well to the calcified annulus.

Dr. Lim raised question about the impact on durability of the valve asymmetric shape still observed at 30 days. Follow up scans confirmed commissural and coronary alignment. In another clinical FIH case performed with the BX system, and in patient with both AR and AS, the valve was able to land nicely and shallowly despite the calcification. Commissural and coronary alignment were also confirmed with follow-up scans.

Early feasibility clinical studies was conducted on 12 patients with both SX and BX systems. Implantation was successful in 10 patients with no residual regurgitation in patients with non-Calcific AR, and in patients with a combination of moderate and severe Calcific AR/AS lesions. One patient experienced a pacemaker issue at the wrong time which resulted in valve migration in the ascending aorta and was addressed by converting electively to surgery. The other failure was due to a patient selection issue which had a bicuspid valve with a significant asymmetric ascending aorta. The patient had a type A dissection at 30 days and unfortunately did not survive.

The SX system had consistent landing height between 0-1 mm of annulus, which is a very short similar to the Sapien XT. In most of the cases, Dr. Lim was teaching the practicing physician how to perform the procedure and achieve results all by fluoroscopy without echo guidance.

Srujana Joshi, Bioengineering PhD Student at Georgia Institute of Technology, and Lead Valve Engineer at  YoungHeartValve was very interesting to hear present the bio-inspired polymeric valve from Young Heart Valve. This prosthetic valve is made of a composite material that combines a LLDPE polymer for its desired mechanical properties and a hydrophilic biomolecule (HA, Hyaluronan) for Anti-thrombotic and anti-calcific properties. The valve is mounted on a BX CrCo stent frame and exhibited perfect hemodynamic performance in-vitro compared to 26-Evolut and 26-Sapien. The 6-month chronic animal studies have shown no thrombosis or calcification on the leaflets. The valve has a Proprietary Dynamic Sealing Technology (DST) to reduce PVL and facilitate tissue ingrowth. The automated Vacuum thermoforming process allows precise leaflet shaping.

 

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