CRT 2010
Washington DC, January 21, 2010
MITRALIGN: Direct Annuloplasty
Device Evolution, Technique and
Clinical Trial Update
Eberhard Grube, MD, FACC, FSCAI
St.Elisabeth Hospital, Heart Center Rhein-Ruhr, Essen, Germany
Instituto Cardiologico Dante Pazzanese, São Paulo, Brazil
DISCLOSURES
Eberhard Grube, MD
Consulting Fees
– Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson &
Johnson Company, Medtronic CardioVascular, Inc.
Honoraria
– Biosensors International , Boston Scientific Corporation, Medtronic
CardioVascular, Inc
Ownership Interest (Stocks, Stock Options or Other Ownership
Interest)
– Biosensors International , Medtronic CardioVascular, Inc.
I intend to reference unlabeled/ unapproved uses of drugs or
devices in my presentation.
I intend to reference off-label use of stents and valve prosthesis.
Disclosure
Within the past 12 months, the presenter or their spouse/partner
have had a financial interest/arrangement or affiliation with the
organization(s) listed below.
Physician Name
Company/Relationship
Eberhard Grube, MD Mitralign: C
Key
G – Grant and or Research Support E – Equity Interests
S - Salary
C – Consulting fees, Honoraria R – Royalty Income
I – Intellectual Property Rights
SB – Speaker’s Bureau
O – Ownership
OF – Other Financial
Benefits‘
MITRALIGN Concept
● Surgical approaches for treatment of FMR are focused on
size reduction of the mitral valve annulus.
● A relatively small (1 cm) plication of the posterior annulus
can normalize the septo-lateral dimension and reduce
MR.
● Mitralign concept emulates suture annuloplasty.
- Retrograde LV approach
- Surgical pledgets are delivered percutaneously through the
posterior annulus
- Plicate the annulus
Trident Design
● 12.5 Fr. Guide Catheter
-
●
provide ventricular access for all catheters
Steerable catheter
-
access mitral annulus at P2 center
deliver crossing wire (RF) to penetrate the annulus
● A triple lumen catheter (Trident)
-
advanced over the P2 crossing wire
provide positioning of P1 and P3 locations
deliver P1 and P2 crossing wires to penetrate the
annulus
● Pledget delivery catheter
-
tracked over a crossing wire through the annulus
deliver the pledget
● Plication catheter
-
●
plicate by exerting tension via the sutures
deploy a stainless steel lock to lock the three sutures
Suture cutter
-
cut the sutures following deployment of the lock
Mitralign Concept
- Interventional surrogate of
surgical suture annuloplasty
- Anchors are placed along
the posterior annulus
- Plication using these
anchores, herewith
reducing the circumference
which restores leaflet
coaptation
P3
P1
P2
Concept
Annular Plication
First in Man Experience
Paraguay
Pre-Plication
Final Implant
P1
P1
P2
P3
P2
P3
Baseline
12 months FU
MR
3+
2+
EDV (ml)
168
115
ESV (ml)
115
85
MVA (cm2)
4.0
2.83
NYHA
III
I
Trident Concept
First in Man Experience
● Four patients implanted in Paraguay by Dr. A.
Ebner
• 3 patients with all 3 pledgets
• 1 patient with 2 pledges only
● Surgical pledgets can be delivered through the
mitral annulus
- Mitralign approach can be developed further
● Difficult to manage 3 components (wires,
pledgets and sutures) at the same time:
- Simpler design is needed
New MITRALIGN Design
Bident Catheter
● A double lumen catheter (Bident) to be advanced over a crossing
wire and to provide positioning of a pair of wires
● Two pairs of pledgets to be delivered in
- P1-P2 location
- P2-P3 location
● Span of the bident catheter available:
- 1.4 cm or
- 1.7 cm.
MITRALIGN Bident Design
Permanent Implants
Atrial Side
Ventricle Side
● Two plications in two locations: P1-P2 and P2-P3
● Minimum permanent implants
- 4 surgical pledgets
- 2 locks to lock the sutures after plication
Mitralign System
Steerable Guide
Steerable Wire
Delivery Catheter
Crossing Wire
Translation
Catheter
Pledget Delivery
Catheter
Plication Lock
and Cut Catheter
Bench Test: Bident vs. Trident
Before Plication
20 mm
TRIDENT
16 mm
27mm
26 mm
12 mm
20 mm
BIDENT
After Plication
27 mm
22 mm
● Bident 2x2 plication outperforms Trident plication
Pre-Clinical Study: Bident
● MITRALIGN Bident Design simplifies the procedure.
Normal Healing Response
30 Days After Implantation
30-Day Histology
Finite Element Analysis:
Trident vs Bident
Model
Initial Position
Plication
TRIDENT
BIDENT
Model
SL distance (mm)
CC-distance (mm)
MVA (cm2)
Baseline
27.6
43.1
9.50
TRIDENT plication
26.6
44.4
8.30
BIDENT– 2x2 plication
23.5
39.9
7.43
Bident 2x2 plication outperforms Trident plication
Finite Element Analysis
Selecting Bident Location
Control
Placement
Plication
• MR due to annulus dilatation
• Intermediate placement of pledgets in P2/P1 and P2/P3 seems to be the
best
• Plication causes an anterior displacement of the posterior wall of 5-10
mm
Mitralign FIM Studies
South America and Europe
Phase I
(Trident)
• Device optimization
in Paraguay
• Limited number of implanted
patients (n=4)
• One patient with complete FU at
1 year
• Significant changes in the MPAS
Phase II
(Bident)
•
Feasibility and safety of Bident MPAS
(optimized design)
• 12 patients to be enrolled at 4 sites
• Echo Core Lab
• Primary objective:
- to assess the safety and feasibility
of MPAS for treatment of FMR
• Primary enpoint:
- Device related NACE (net adverse
clinical events) at 30 days. Devicerelated NACE include: Death, MI,
Cardiac tamponade, Cardiac
surgery, Stroke
Bident FIM Study
Clinical Sites
● Study PI:
-
Eberhard Grube, MD
● Study sites and Site PIs
- St.Elisabeth Krankenhaus,Heart Center Rhein-Ruhr
• Dr. E. Grube
- Helios Heart Center, Siegburg, Germany:
• Dr. L. Buellesfeld
- Asklepios Klinik St. Georg, Hamburg, Germany:
• Dr. K.H. Kuck
- Dante Pazzanesse Cardiology Center, Sao Paulo, Brazil:
• Drs. A. Abizaid, C. Esteves, E. Grube
- Klinikum-Oldenburg, Oldenburg, Germany:
• Dr. A. Elsaesser
●
Echo Core Lab
- MedStar, Washington , DC, USA
• Dr. Neil Weissman
Inclusion Criteria
● Patient is ≥18 years old
● Functional Mitral Regurgitation ≥ 2+
● NYHA Class: II-IV
● EF% ≥ 30%
● Mitral plane to apex dimension ≥ 5 cm
● Structurally normal mitral valve
● No significant calcification
● No thrombus in LV or LA
Conclusions
● Mitralign Percutaneous Annuloplasty System is
emerging technology for direct annuloplasty.
● First experience with the Trident System was promising
but change in design concept was needed.
- To simplify the procedure
- To possibly improve outcomes
● Safety and feasibility of the new Bident System will be
studied in the new FIM study in Germany and Brazil.
Thank you for your attention !