Upload
winifred-hall
View
215
Download
0
Tags:
Embed Size (px)
Citation preview
CARILLON™ Mitral Annuloplasty Device European Union Study
Cardiac Dimensions® CARILLON™ Mitral Contour System™
Disclosures
Nothing to Disclose
2
AMADEUS™ Investigators
Hamburg University Cardiovascular Center
Prof. Dr. med. Joachim Schofer (PI) - Dr. Thilo Tübler - Ms. Anya Hoffman (Study Coordinator)
Universität zu KölnProf. Dr. med. Uta Hoppe - Dr. Mathias Brandt - Ms. Iris Berg (Study Coordinator)
OLVG (Amsterdam)Dr. Jean Paul HerrmanDr. Ton Slagboom (IC) - Dr. Gijsbert de Ruiter (EP) - Dr. Edske ter Bals (Study Coordinator)
Cardiac & Rehabilitation Hospital – Kowanówku
Prof. Dr. med. Tomasz Siminiak - Dr. Olga Jerzykowska (Echo) - Dr. Piotr Kalmucki (Study Coordinator)
Stadtische Kliniken NeussProf. Dr. med. Michael Haude - Dr. Hubertus Degen (Study Coordinator)
- Dr. Mathias Breise (Echo)
AZM (Maastricht)Dr. Luz Maria RodriguezDr. J. Vainer (IC) - Dr. David van Kraaij (HF) - Ms. Suzanne Philippines (Study Coordinator)
3
• Coronary Sinus approach
• Results Immediately observable
• Tension / Plication is controlled by operator
• Recapture Feature allows for Management of Coronary Arteries
• Does not preclude other HF therapies such as Bi-V pacing or surgery
4
Percutaneous Annuloplasty for Functional MR
CARILLON™ Animation
5
The AMADEUS™ Trial Study Design:
• Prospective, single-arm, 30 patient, Six month, multi-center trial
Inclusion Criteria• Dilated Ischemic or Non-ischemic Cardiomyopathy (LVEDd > 55mm)• NYHA Class II – IV• FMR moderate to severe• EF < 40%• 6 MWT distance between 150m & 450m• Stable on heart failure meds
Primary Endpoint: • Thirty day rate of Major Adverse Events
Secondary Endpoints: Long-term safety; Hemodynamic and functional changes• NYHA Class• Exercise (6 minute walk test; Maximum Exercise Time)• QOL (KCCQ)• Change in MR
6
Baseline DemographicsIntent to Treat Population (n=48)
AMADEUS™ Trial
Age 64 (25-81 yrs)
Gender M = 83% (40)F = 17% (8)
History of CAD 73%
NYHA Class II - 9 III - 37IV - 2
EF 29% (10-39)
MR
(TEE Procedure Baseline)
2+ = 153+ = 184+ = 15
LVEDD 67 mm (50 – 92 mm)
AMADEUS™ Patients were at High Cardiovascular Risk
7
AMADEUS™ Enrollment Tree
Enrolled PatientsN=48
CARILLON™ “XE” Procedure Initated
N=39
ImplantedN=29
Procedure Not Initiated
N=5
“Original” CARILLON™ Procedure
N=4
ImplantedN=1
Not Implanted N=3
• Insufficient MR reduction (4)• Coronary Compromise (1)• Both (5)
• Dissection / Perforation (3)• Screen Failure (2)
• Slip
Not Implanted N=10
8
Major Adverse Event RatePrimary Safety Endpoint at 30 Days
Event Intention to Treat (n=48**)
Death 2.2% (1 / 46)
Myocardial Infarction Enzyme bump only. No Sx or EKG change (n=2)
Enzyme bump plus EKG change (n=1)
6.5% (3 / 46)
CS Perforation During venous access. Non device related
6.5% (3 / 46)
Device Embolization 0.0% (0 / 46)
Surgery or PCI related to device failure 0.0% (0 / 46)
**Two patients withdrew consent before 25 days F/U
Total Major Adverse Events13% (6/46)
(7 events in 6 patients)
9
Managing Coronary Arteries
• 11 cases of crossed arteries required device “Recapture”• In 5 cases, a 2nd device was successfully placed proximal
Arteries crossed in 84% of cases
10
Chronic MR Reduction AMADEUS™ Implanted Patients (n=30 at Baseline)
Quantitative MR Measures @Baseline, One, & Six Months
cm cm2
ml
% A
rea
P<0.001
1127% Reduction in FMR on average @ 6 months
Sustained Benefit through 6 Mo.MR Reduction / LV Wall Motion
Baseline 1 Mo 3 Mo 6 Mo
Core Lab MR 3+ 0 0 0
NYHA II I I
6 MWT (meters) 320 450 400
Max Exercise (sec) 540 900 1080
QOL (KCCQ) 31.00 91.00 98.96
49 yr old Male
Baseline 3 Months
6 Months
12
13
NYHA Classification
P < 0.001
n=30 n=27 n=25
At baseline, 80% of patients were NYHA Class III or IVAt 6 Months, 88% of patients were NYHA Class I or II
Six Minute Walk Test
P < 0.001
Me
ters
n=30 n=26 n=23
14
15
QOLKCCQ Overall Summary
P < 0.001
n=30 n=27 n=25
QOLPatient portion of Global Assessment
Assessment 1 month 6 months
Markedly improved 27% 36%
Moderately improved 31% 24%
Slightly improved 19% 24%
No change 11% 8%
Slightly worse 8% 8%
Moderately worse 0% 0%
Markedly worse 4% 0%
n=26 n=25
} 77% } 84%
16
AMADEUS™ Procedural Times
• Procedure Times steadily declined over the course of the study• Reduced Procedure time benefits sick HF Population
Min
utes
17
At Baseline After Deployment
CARILLON™: Poznan case
AMADEUS™ Study Conclusions
AMADEUS™ study achieved its safety endpoint with an acceptable MAE profile. 13% MAE rate @ 30 days was primarily non-device related.
At-risk coronary arteries were successfully managed in AMADEUS™ with the CARILLON™ “recapture” feature.
MR was reduced by 27% out to 6 months.
Statistically significant improvements in functional parameters out to 6 months (e.g., exercise, NYHA, QOL) .
Short, simple procedure is important for this unstable HF patient population.
19