The FORMA Early Feasibility Study: 30-Day Outcomes of Transcatheter Tricuspid Valve Therapy in Patients with Severe Secondary Tricuspid Regurgitation

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1 The FORMA Early Feasibility Study: 30-Day Outcomes of Transcatheter Tricuspid Valve Therapy in Patients with Severe Secondary Tricuspid Regurgitation Susheel Kodali, MD Director, Structural Heart & Valve Center Columbia University Medical Center New York Presbyterian Hospital

2 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 Consulting Fees/Honoraria Scientific Advisory Board Steering Committee (unpaid) Company Claret Medical Thubrikar Aortic Valve Inc, Dura Biotech, VS Medtech PARTNER Trial (Edwards Lifescieces)

3 Background Severe secondary tricuspid regurgitation (TR) is increasingly prevalent with aging and is associated with a poor prognosis. Treatment alternatives for patients with severe symptomatic TR are limited; medical therapy is often ineffective and surgery is associated with high operative mortality. Less-invasive transcatheter therapies designed to reduce TR offer the potential to improve clinical outcomes.

4 FORMA Tricuspid Valve Therapy System (Edwards Lifesciences) Spacer Rail Positioned within regurgitant orifice Provides surface for native leaflets to coapt 12, 15 and 18mm sizes Advanced from left subclavian vein Tracks Spacer into position Anchored at RV apex and subclavian vein

5 FORMA Tricuspid Valve Therapy System (Edwards Lifesciences)

6 Purpose: To evaluate the safety, device performance, and clinical outcomes at 30 days in patients with severe symptomatic tricuspid regurgitation treated with the FORMA Tricuspid Transcatheter Therapy System Study Design: Single arm, multi-center, prospective study at 5 sites in the U.S. Clinical events committee Echocardiography core laboratory Sponsor: Edwards Lifesciences

7 Key Inclusion Criteria Severe secondary tricuspid regurgitation requiring treatment NYHA functional class II symptoms or persistent right heart failure despite optimal medical therapy High surgical risk for tricuspid valve repair or replacement as determined by the Heart Team

8 Anatomic Moderate tricuspid valve stenosis RV anatomy not suitable for placement of anchor Occluded or severely narrowed left subclavian vein Clinical FORMA Early Feasibility Study Key Exclusion Criteria Untreated clinically significant CAD requiring revascularization Renal insufficiency (Cr > 2.5) or ESRD on dialysis Severe left ventricular dysfunction (EF < 25%) Pulmonary hypertension (PA systolic 2/3 sys pressure or > 70 mmhg) Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (within 30 days) repair or replacement Life expectancy < 12 months

9 Study Flow Intent to Treat n=30 Enrolled n=29 Implanted n=27 30 Day Echo Follow Up n=25* Procedure aborted (n=1) - Venogram revealed occluded subclavian vein RV perforation (n=2) - 1 patient death day 0-1 patient converted to surgery Device migration (n=1) - Device explanted day 2, death day 36 Device explant (n=1) - Device explanted day 21 due to infection *2 anchor dislodgements, Spacer remained in the transvalvular position, patients stable at 30 day follow-up

10 Mean or % N = 29 Age (years) 75.9 ± 8.2 Female Gender 65.5% Body Mass Index (kg/m 2 ) 26.3 ± 4.4 NYHA Functional Class III or IV 86% STS Score* 9.1 ± 6.8 EuroSCORE II (%) 8.1 ± 5.3 Serum Creatinine (mg/dl) 1.3 ± 0.4 Atrial Fibrillation 82.8% Coronary Artery Disease 55.2% Right Heart Failure 75.9% Left Heart Failure 17.2% Diuretic Use 92.9% * calculated for MVR FORMA Early Feasibility Study Baseline Characteristics (1)

11 Baseline Characteristics (2) N = 29 Pulmonary Disease 24.1% Liver Disease 31.0% Prior Stroke or TIA 37.9% Pre-existing Pacemaker 24.1% Prior PCI 13.8% Prior CABG 31.0% Prior Valve Intervention 48.3% Aortic (AVR or TAVR) 34.5% Mitral (MVR, MV repair or MitraClip) 37.9% Tricuspid Valve Repair 6.9%

12 Baseline Echocardiography (1) Mean ± SD N = 29 LVEF (%) 56.9 ± 12.8 TAPSE (cm) 1.4 ± 0.4 TV Annular Diameter (cm) 4.5 ± 0.7 TR Vena Contracta mean (cm) 1.6 ± 0.5 PISA EROA (cm 2 ) 1.2 ± 0.6 Tricuspid Regurgitant EROA 2D or 3D (cm 2 ) 2.2 ± 1.5 Tricuspid Regurgitant volume (ml) ± 65.8 TV mean gradient (mmhg) 1.9 ± 1.1

13 Extended Grading Scheme Rebecca T. Hahn, and Jose L. Zamorano. The Need for a New Tricuspid Regurgitation Grading Scheme. European Heart Journal - Cardiovascular Imaging, 2017 Severe Massive Torrential

14 Baseline Echocardiography (2) 65% Torrential TR by PISA EROA; 80% by Quantitative 2D or 3D

15 Procedural Factors Mean or % N=27 Left Subclavian Vein Access 100% Time from Skin Incision to Closure (min) ± 35.4 Spacer Size 12 mm 3.7% (1) 15 mm 85.2% (23) 18 mm 11.1% (3)

16 Clinical Outcomes at 30 Days Patients N = 29 % Death (All-Cause) Stroke/TIA Vascular Injury Bleeding* Life Threatening or Disabling Major Device Related Cardiac Surgery AKI Stage 2* * VARC-2 Guidelines 20/29 patients (69%) had none of the above events

17 Echocardiography Outcomes at 30 Days (echo core lab, paired analysis) Baseline 30 Days P Value LVEF (%) 55.9 ± ± RV TAPSE (cm) 1.4 ± ± LVOT Stroke Volume (ml) 58.0 ± ± TV Annular Diameter (cm) 4.4 ± ± RV Diameter Base (cm) 5.9 ± ± PISA EROA (cm 2 ) 1.1 ± ± D or 3D Quantitative EROA (cm 2 ) 2.1 ± ± Mean Vena Contracta Width (cm) 1.6 ± ± 0.4 <0.001

18 Echocardiography Outcomes at 30 Days (echo core lab) 1.1 ± ± ± ± 0.9

19 NYHA Class at 30 Days

20 6MWT and KCCQ at 30 Days 6MWT Six Minute Walk Test; KCCQ- Kansas City Cardiomyopathy Questionnaire Overall Summary Score

21 Case Example clinical outcomes Clinical Presentation 82year old female with history Afib, CVA, CKD Stage IV and s/p AVR and MVR Presents with increasing SOB on exertion, orthopnea and severe edema. Recurrent hospital admissions with right-sided heart failure Labs BUN 73, Creatinine 2.0 AST 29, ALT 16, Alk Phos 144, Alb 4.5 Hb 10.8, Hct 35.6, Plt 98 Pro BNP 2699 Severe TR ERO 1.72 cm 2

22 Case Example Baseline 30 days Final ERO -.74 cm 2 (Pre 1.72 cm 2 ) No Tricuspid Stenosis (mean gradient 0.6 cm 2 )

23 Conclusions In a patient cohort with torrential TR, severe symptoms, and multiple co-morbidities The FORMA tricuspid valve therapy system proved feasible, but was associated with infrequent distal anchor dislodgements and RV perforations. Despite torrential TR in most patients, there was significant reduction of TR (EROA), especially in those patients with the worst baseline TR. At 30 days, there was significant improvement in NYHA functional class, 6 minute walk tests and KCCQ scores.

24 Implications and Future Next generation FORMA devices are being developed to ensure predictable anchor engagement without dislodgement or RV perforations. The magnitude of TR reduction was proportional to the severity of baseline TR; FORMA may be especially useful in patients with the most severe TR. Longer term follow-up is necessary to assess recurrence of TR, evidence of RV remodeling, and late clinical outcomes.