Download The Detrimental Impact of Chronic Renal Insufficiency

Transcatheter Treatment of
Tricuspid Regurgitation:
Experience With the FORMA
Device
Josep Rodés-Cabau, MD
Quebec Heart & Lung Institute, Laval
University Quebec City, QC, Canada
Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
• Grant/Research Support
Company
• Edwards Lifesciences
FORMA Repair System Overview
Spacer
• Positioned into the regurgitant
orifice
•
Creates a platform for native
leaflet coaptation
•
Preserves underlying structure
Rail
• Tracks Spacer into position
• Distally and proximally anchored
Spacer
FORMA Compassionate Clinical Use Experience
Quebec Heart & Lung Institute, Quebec City, Canada

Josep Rodés-Cabau, Francois Philippon, Elisabeth Bedard, Rishi
Puri, Francisco Campelo-Parada
St. Paul’s Hospital, Vancouver, Canada

John Webb, Jian Ye, Gidon Perlman, Danny Dvir, Chris Thompson,
Philipp Blanke, Jonathon Leipsic
Bern University Hospital, Bern, Switzerland

Stephan Windecker, Fabien Praz, Thierry Carrel, David Reineke,
Aris Moschovitis
FORMA Compassionate Use
Baseline
Characteristic
n=18
Age
76 ± 9.7
Female sex
13 (72)
NYHA Class III or IV
17 (94)
Exertional dyspnea
18 (100)
Pulmonary hypertension*
6 (33)
eGFR (ml/min)
45.4 ± 16.7
Atrial fibrillation
16 (89)
Coronary artery disease
10 (56)
Previous open heart surgery
13 (72)
COPD
5 (28)
Pacemaker/defibrillator
3 (17)
EuroScore II (%)
9 ± 5.7
Baseline Echocargiogram
LVEF (%)
56 ± 7.3
TR Grade Severe
17(94)
MR Grade ≥ 2
16 (89)
Values are mean ± SD or n (%)
*Mean pulmonary artery pressure > 40 mmHg or Peak systolic pressure > 60
mmHg, or specific medical treatment for pulmonary arterial hypertension
FORMA Compassionate Use
Procedural
n=18
Mortality
0 (0)
Successful device implantation*
16 (89)
FORMA Spacer Size Successfully Implanted
15mm
12mm
15 (83)
1 (6)
Conversion to open heart surgery due to cardiac tamponade
1 (6)
Device retrieval
1 (6)
Device dislocation
1 (6)
Ventricular arrhythmia
1 (6)
Procedure time (skin-to-skin, min)
129 ± 31
Fluroscopy time (min)
24.7 ± 7.3
Contrast media (ml)
65 ± 29
Intra-procedural TEE TR reduction ≥ 1 grade
16 (89)
Hospital stay (median, IQR)
4 (2-5)
Values are mean ± SD or n (%)
*A successful implantation of a FORMA Spacer resulting in an acute reduction of TR by at least 1
FORMA Compassionate Use
30-Day & 1-Year Follow Up
30 Day
1 Year
(n = 18)
(n=15)
Death
0 (0)
0 (0)
Rehospitalization for HF
0 (0)
1 (7)
Life threatening/Major bleeding
2 (11)
2 (13)
Major vascular complications
0 (0)
0 (0)
Acute kidney injury ≥ 2
0 (0)
1 (7)
Device thrombosis
0 (0)
1 (7)*
Pulmonary embolism
0 (0)
0 (0)
Stroke
0 (0)
0 (0)
New pacemaker
0 (0)
0 (0)
Clinical Outcomes
Values are mean ± SD or n (%)
*Occurred in a patient with non-therapeutic INR levels, resolved with resumption of adequate anticoagulation
FORMA Compassionate Use
Paired Functional Outcomes at 1 Year Follow Up
NYHA Grade
6MWT (m)
N=6
N = 14*
500
Average
improvement
of 57m from
baseline to 1Y
450
IV
3
0
1
400
350
300
III
250
10
1
2
200
150
Baseline
II
1
12
7
1-year
KCCQ Score
N=8
100
I
90
0
1
4
80
70
60
Baseline
30-day
1y
*2 patients have not reached 1Y; patients with device dislodgment
(1) or conversion to open heart surgery (1) not included
50
Baseline
1-year
Average
improvement
18 points
FORMA Compassionate Use
Paired Echo Data (Baseline, 6m)
TTE – TR Grade
4
13
5
4
1
1
Baseline
6 Month
N = 14
Trace - Mild
Mild - Mod
Mod - Sev
Severe
Edwards Forma Repair. Case Example
83 year-old patient, female sex
Medical history
Hypertension, dyslipidemia
COPD
Prior CABG and mitral valve surgery
Atrial fibrillation
LogEuroscore: 16.9
Severe TR, NYHA class III
6-Month Follow-Up
Pre
Baseline
30-day
6-month
NYHA class
III
II
II
Weight
70
70
72
6MWT (m)
334
415
380
KCCQ
56.3
87.8
92.9
60
60
40
NT-proBNP (pg/mL)
3234
4009
3151
Creatinine (mmol/L)
93
72
74
Furosemide dose (mg)
Conclusions and Next Steps
• Transcatheter treatment of functional TR appears feasible with
the FORMA Repair System
• A low rate of safety events was observed at 30-day and at 1year follow-up
• Some degree of TR reduction was observed in all patients
following the intervention, along with improvements in functional
status
• Studies with larger number of patients and longer follow-up are
warranted
• Both U.S. Early Feasibility Study (NCT02471807) & EU/Canada
CE SPACER Trial (NCT02787408) are enrolling
The FORMA Trial
Early Feasibility Study of the Edwards
FORMA Tricuspid Transcatheter Repair System
N= 30
Adult subjects with clinically significant, symptomatic, tricuspid
regurgitation who are at high surgical risk for standard tricuspid
repair or replacement as assessed by the Heart Team
Primary Endpoint 30 days
All-Cause Mortality
6 Month and 1, 2, 3, Year
Clinical and Imaging Echo FUP
The SPACER Trial
Repair of Tricuspid Valve Regurgitation using the Edwards TricuSPid
TrAnsCatheter REpaiR System
N= 78
Adult subjects with clinically significant, symptomatic, tricuspid
regurgitation who are at high surgical risk for standard tricuspid
repair or replacement as assessed by the Heart Team
Primary Endpoint 30 days
All-Cause Mortality
6 Month and 1, 2, 3, Year
Clinical and Imaging Echo FUP
Thank you