Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man
1. MiCardia:
Dynamic Mitral Annuloplasty
Device Design Concepts,
Experimental Insights and
First-in-Man
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
La Jolla, CA
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
2. Why Degradable Stents?
Disclosure
M.Buchbinder – Scientific Advisory,
Board Member
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
3. Ischemic MR
• Ischemic Mitral Regurgitation (IMR) is seen
in up to 20% of patients following acute
myocardial infraction. (Hickey; Circulation 1988;78:151-
159, Lamas; Circulation 1997; 96:827-833)
• Treatment of IMR includes medical therapy
and in severe cases surgical repair with an
undersized annuloplasty ring to reduce the
size of the mitral annulus and improve
leaflet coaptation.
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
4. Ischemic MR
• Following isolated annuloplasty surgery
recurrent (>2+) MR is seen in 10-30% of
patients (McGee; J. Thorac Cardiovasc Surg 2004;128:916-24)
• Recurrent MR appears to be commonly seen
within the first year following surgery and
remains relatively stable thereafter (McGee; J. Thorac
Cardiovasc Surg 2004;128:916-24)
• Unlike in dilated cardiomyopathy IMR is
associated with asymmetric deformation of the
annulus (Kwan; Circulation. 2003;107:1135.)
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
5. Current technology does not cope with
dynamic ischemic disease
• MITRAL
•Residual post-op Edwards Physio
occurrence of 6-
10%
•6m recurrence of
15%-25% Medtronic Duran
•3 Yr, recurrence of
30% to 50%
• TRICUSPID
•“Upon Discharge”
recurrence of 25% SJM Tailor
to 30%
•Directly contributes
to the onset of HF ATS Simulus
when untreated
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
6. MiCardia Semi-Rigid Dynamic
Annuloplasty “C” Ring (Degenerative)
Baseline Shape (Implanted)
Transparent = Baseline
Red = Post Activation Shape
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
7. MiCardia Rigid Dynamic Annuloplasty
“D” Ring (Ischemic)
Baseline
MiCardia Dynamic Ring
Transparent = Baseline
Red = Activated Shape
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
8. The MiCardia Dynamic Ring
• “C” and “D” shapes available sizes 28mm through 36mm
• Without activation functions as a “standard” ring
• Pre-attached electrodes used for activation make the ring
Dynamic
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
9. Intra-Operative Re-shaping
• Each RF wire is connected
to the propriatary MiCardia
RF generator.
P1 P3
• Following implantation and
pending degree of residual
P2
MR ,Wires are activated as
to re-shape the ring in vivo
• Echocardiography confirms
effectiveness of activation
during and post re-shaping
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
10. Dynamic Ring - Features
• Implants identical to
existing technology
• Semi-rigid metal core
maintains its shape.
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
11. Intra-Operative Reshaping
Early “In-Vivo” experience
• A-P distance
shortening by
0.5-3.0mm
• Inter-Commissural
distance contracted
by 1.0-3.5mm
• No heat damage to
the surrounding Postero-Medial commissure
activation
tissue
Courtesy Dr. Alex Marmureanu
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
12. Degenerative Ring Activation
Pre-Activation Intra-Op Activation
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
13. Ultimate Valve
Repair Modality
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
14. Percutaneous Reshaping
• The implanted ring is
accessed via transeptal
approach.
• Thru a Deflectable guide
catheter system for optimal
positioning
• An Expandable basket with
built in RF electrodes is used
to activate the ring upon
contact in multiple zones.
• On line echocardiography
confirms effectiveness of
activation during and after re-
shaping
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
15. Percutaneous Animal Experience
• A-P distance
shortened by
0.3-2.9mm
• Inter-Commissural
Distance
contracted by
1.2- 3.6mm
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
16. TransQ Device Platform
• Single lead, atrial exit
• No flow interference
• Subcutaneous “pocket“
deployment of lead
• Simple outpatient activation
30 Minute Outpatient
Adjustment • Activate days, weeks or
By Interventional months after the initial
Cardiologist procedure to correct
recurrence
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
22. Transcutaneous Activation
• Lead Exits Left
Atrium
• Completely
encapsulated 40 days
• Connects to
MiCardia RF
Generator
• Allows for Delayed
Activation
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
23. Transcutaneous Activation
• Full activation takes
place within 60
seconds.
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
24. Transcutaneous Activation
• No infection
• No dehiscence
• Full activation 60+
days
• 100% in-growth
• 40 and 60 day testing
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
27. 26 Human Implants completed
(June 09)
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
28. First-in-Man Experience
February 2008
• 4+MR with P2 leaflet prolapse
• Leaflet resection with implantation of a
28mm D+ ring.
• Reduced to trace MR
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
29. First-in-Man Experience
P2 prolapse
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
30. First-in-Man Experience
4+MR with eccentric anterior jet
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
31. First-in-Man Experience
Post repair no MR acute and at discharge
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
32. First-in-Man Experience
Ring shape at discharge
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
33. Future Developments
2004-2008 2009-2010 2009-2011
Mitral
Mitral
Shape Magnetic
Memory
Tricuspid
Percutaneous External
Tricuspid
Intra-Operative Trans‐Q
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
34. Magnetic Ring
• Magnetic drive: no motor
• AP + or AP - models
• Infinitely adjustable
• Can be titrated
• Reversible
• Multiple activations
• Percutaneous activation via
R. Heart Access (16Fr)
• External via TEE access
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
35. Conclusion
• From this early clinical experience the MiCardia Dynamic
Annuloplasty Ring appears to be a promising device for
treatment of Mitral regurgitation.
• The In-Vivo adjustable feature may be an extremely
valuable tool for optimization of surgical results
• Further percutaneous adjustments in ring geometry in
the healing phase could be a compelling advantage for
its use .
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine