0. Transcatheter Treatment of Tricuspid Regurgitation: Experience With the FORMA Device
Josep Rodés-Cabau, MD
Quebec Heart & Lung Institute, Laval University Quebec City, QC, Canada

1. 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
Company
Grant/Research Support
Edwards Lifesciences

2. 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

4. 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

5. 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
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
*Mean pulmonary artery pressure > 40 mmHg or Peak systolic pressure > 60 mmHg, or specific medical treatment for pulmonary arterial hypertension
Values are mean ± SD or n (%)

6. 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
Device retrieval
Device dislocation
Ventricular arrhythmia
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
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

7. FORMA Compassionate Use
30-Day & 1-Year Follow Up
Clinical Outcomes
30 Day
(n = 18)
1 Year
(n=15)
Death
0 (0)
Rehospitalization for HF
1 (7)
Life threatening/Major bleeding
2 (11)
2 (13)
Major vascular complications
Acute kidney injury ≥ 2
Device thrombosis
1 (7)*
Pulmonary embolism
Stroke
New pacemaker
Values are mean ± SD or n (%)
*Occurred in a patient with non-therapeutic INR levels, resolved with resumption of adequate anticoagulation

8. FORMA Compassionate Use Paired Functional Outcomes at 1 Year Follow Up
NYHA Grade
6MWT (m)
N = 6
N = 14*
Average improvement of 57m from baseline to 1Y IV 3 1
III 10 1 2 II 1 12 7
KCCQ Score
N = 8
Average improvement 18 points I 1 4
Baseline
30-day 1y
*2 patients have not reached 1Y; patients with device dislodgment (1) or conversion to open heart surgery (1) not included

9. FORMA Compassionate Use Paired Echo Data (Baseline, 6m)

10. 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

11. 6-Month Follow-Up
Pre

12. Baseline
30-day
6-month
NYHA class
III II
Weight 70 72
6MWT (m)
334
415
380
KCCQ
56.3
87.8
92.9
Furosemide dose (mg) 60 40
NT-proBNP (pg/mL)
3234
4009
3151
Creatinine (mmol/L) 93 74

13. 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 1- year 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 (NCT ) & EU/Canada CE SPACER Trial (NCT ) are enrolling

14. FORMA Tricuspid Transcatheter Repair System
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

15. 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

16. Thank you