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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