1. Rush University Medical Center, Chicago, IL
First Prepackaged 26 mm Transcatheter Aortic Valve Premounted in a 14 Fr Delivery system: Miniswine implant in the Pulmonary Position of the Colibri Heart Valve
Ziyad M. Hijazi MD MPH, R. David Fish MD, David Paniagua MD, Carlos Mejia BA, Eduardo Induni MD, David E. Paniagua BS, Elizabeth Gonzalez BA and Damien Kenny, MB MRCPCH
Rush University Medical Center, Chicago, IL
St. Luke’s Episcopal Hospital / Texas Heart Institute, Houston, TX, Hospital México, Universidad de Costa Rica, San José Costa Rica, Michael E. DeBakey VA Medical Center, ColibriHeart Valve LLC, Houston, TX

2. I have no relevant disclosures to report
Damien Kenny, MB, MRCPCH
I have no relevant disclosures to report

3. Background: Current THV
Transcatheter heart valves (THV) are in rapid development, but currently have important deficiencies that complicate implantation and increase both technical and clinical risk.
Implanted bioprosthetic heart valves are stored, transported, and delivered for use in a jar of solution. Before implantation, they must be rinsed and are prepared for use in a "wet" state that imposes higher packing volume and delivery profile.
THV must be mounted and crimped upon the delivery catheter by the operators in the cath lab, which can be a source of delay, error and inconsistency.
Available THV require large diameter delivery catheters of 18 Fr or larger, which may complicate transfemoral delivery and cause vascular injury and bleeding.

4. PARTNER Cohort B: TAVI Complications
TAVI resulted in more frequent complications at 30 days
ENDPOINT
TAVI %
Standard % P
Major vascular complications
16.2
1.1
0.0001
Major bleeding episodes
16.8
3.9
Major strokes
5.0
0.06

5. Cause of Complications & Mortality?
Stroke =>
66.7 % Mortality
22 and 24 Fr
Sizes
Cause of Complications & Mortality?

6. Colibri Heart Valve
A new THV that addresses these shortcomings has been developed with core features:
Low profile
Folded, thin pericardium membrane
Dry valve, pre-mounted at manufacture
Fully integrated, pre-packaged delivery system
Storage and transport in dry state
Ready to use directly from package into the patient
Aortic and Pulmonary valve models
Though dry at insertion, the membrane leaflets function immediately on deployment in the body.

7. Colibri Heart Valve – Low Profile
Dry, Integrated, Pre-Packaged, Ready-to-use, Low-profile
Colibri Heart Valve – Low Profile
Special porcine pericardium tissue processing permits a dry membrane configuration that reduces THV profile:
22 – 26 mm : 14 Fr
27 – 30 mm : 16 Fr
Dry, Integrated, Pre-Packaged,
Ready-to-use, Low-profile

8. Thin-membrane, high tensile strength valve (>30 Mpa) :
3 x industry standard
Very low mass and packing volume ➠ Low profile
Aortic or pulmonary valve models: Balloon-expandable frame
THV Premounted in delivery system in a DRY state
DRY valve does not require rinsing, rehydration, or mounting in cath lab ➠ inserted directly from package into the body

9. Key to Low Profile and Dry Membrane: High Tensile Strength
Ultimate Tensile Strength
Tissue Strength
Superior to Industry Standard
Key to Low Profile and Dry Membrane: High Tensile Strength
50 MPa
Minimum
30 MPa
12 MPa
Aortic valve native operating load =13 KPa
Wet Tissue Stress-Strain Samples

10. Operation in Pulse Duplicator

11. 6 month sterility & accelerated aging confirmed
Very low mass and packing volume ➠ Successful implants of DRY, 1 - month AGED, PRE-PACKAGED valves in dogs:
Confirmed immediate hemodynamic competence in orthotopic implants in dogs: 5 Pulmonary + 3 Aortic
Confirmed 1 - month chronic performance: 4 Pulmonary
First – in – Man clinical pilot study scheduled for 2011
ICE: Dry PulmV 1 mo

12. ICE: Chronic Pulm - THV Long Axis from RVOT
THV stored DRY for 1 month
Dog Pulm Valve Implant
1 Month Chronic Explant

13. Mini-swine THV Implant in Pulmonary Position
Dr. ZiyadHijazi
Rush University Medical Center
Mini-swine THV Implant in Pulmonary Position
22-26 mm
TAVI valve
14 Fr Introducer

14. Mini-swine THV Implant in Pulmonary Position Dr. ZiyadHijazi
Rush University Medical Center

15. 22-26 mm
TAVI valve
Pulmonary
Implant
at 24 mm
14 Fr Introducer

16. Conclusions - 1
The folded, thin-membrane design of the Colibri valve achieves a very low-profile valve without a sacrifice in tensile strength, static loading or leakage.
In vitro testing shows that low leaflet mass achieves low opening gradients and high coaptation efficiency at maximum acceleration.
The Colibri dry-membrane valve functions immediately on deployment in both aortic and pulmonary positions in dog and sheep models.
Chronic function of pre-mounted, pre-packaged dry THV implants is confirmed at 1 month in the dog model in the pulmonary position.

17. Conclusions - 2
Transcatheter implantation of the Colibri dry-membrane THV that is pre-mounted and pre-packaged in an integrated 14 Fr (22-26 mm THV) delivery system is feasible.
A mini-swine pulmonary implant series is initiated in preparation for a first-in-human trial.
The Colibri valve and integrated delivery system may increase the success and efficiency of THV procedures by easing femoral access and reducing procedural time, complexityand complications.

18. Thank You