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
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 • • Consulting Fees/Honoraria Claret Medical • • Scientific Advisory Board Thubrikar Aortic Valve Inc, Dura Biotech, VS Medtech • PARTNER Trial (Edwards • Steering Committee (unpaid) Lifescieces)
FORMA Early Feasibility Study 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.
FORMA Tricuspid Valve Therapy System (Edwards Lifesciences) • Spacer Positioned within regurgitant orifice Provides surface for native leaflets to coapt 12, 15 and 18mm sizes Advanced from left subclavian vein • Rail Tracks Spacer into position Anchored at RV apex and subclavian vein
FORMA Tricuspid Valve Therapy System (Edwards Lifesciences)
FORMA Early Feasibility Study 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
FORMA Early Feasibility Study 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
FORMA Early Feasibility Study Key Exclusion Criteria Anatomic • ≥ Moderate tricuspid valve stenosis • RV anatomy not suitable for placement of anchor • Occluded or severely narrowed left subclavian vein Clinical • 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
FORMA Early Feasibility Study Study Flow Intent to Treat n=30 Procedure aborted (n=1) - Venogram revealed occluded subclavian vein Enrolled n=29 RV perforation (n=2) - 1 patient death day 0 - 1 patient converted to surgery Implanted n=27 Device migration (n=1) - Device explanted day 2, death day 36 Device explant (n=1) - Device explanted day 21 due to 30 Day Echo infection Follow Up n=25* *2 anchor dislodgements, Spacer remained in the transvalvular position, patients stable at 30 day follow-up
FORMA Early Feasibility Study Baseline Characteristics (1) 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 (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%
FORMA Early Feasibility Study 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) 129.0 ± 65.8 TV mean gradient (mmHg) 1.9 ± 1.1
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 Massive Torrential Severe
FORMA Early Feasibility Study Baseline Echocardiography (2) 65% ≥ Torrential TR by PISA EROA; 80% by Quantitative 2D or 3D
FORMA Early Feasibility Study Procedural Factors Mean or % N=27 Left Subclavian Vein Access 100% Time from Skin Incision to Closure (min) 110.5 ± 35.4 Spacer Size 12 mm 3.7% (1) 15 mm 85.2% (23) 18 mm 11.1% (3)
FORMA Early Feasibility Study Clinical Outcomes at 30 Days Patients % N = 29 Death (All-Cause) 2 6.9 Stroke/TIA 0 0.0 Vascular Injury 1 3.4 Bleeding* Life Threatening or Disabling 2 6.9 Major 4 13.8 Device Related Cardiac Surgery 3 10.3 AKI ≥ Stage 2* 3 10.3 * VARC-2 Guidelines 20/29 patients (69%) had none of the above events
FORMA Early Feasibility Study Echocardiography Outcomes at 30 Days (echo core lab, paired analysis) Baseline 30 Days P Value LVEF (%) 55.9 ± 13.8 58.6 ± 12.9 0.074 RV TAPSE (cm) 1.4 ± 0.4 1.5 ± 0.4 0.592 LVOT Stroke Volume (mL) 58.0 ± 14.7 60.8 ± 16.1 0.331 TV Annular Diameter (cm) 4.4 ± 0.7 4.5 ± 0.9 0.577 RV Diameter Base (cm) 5.9 ± 0.9 5.5 ± 1.0 0.020 PISA EROA (cm 2 ) 1.1 ± 0.6 0.6 ± 0.4 0.001 2D or 3D Quantitative EROA (cm 2 ) 2.1 ± 1.8 1.1 ± 0.9 0.012 Mean Vena Contracta Width (cm) 1.6 ± 0.5 1.1 ± 0.4 <0.001
FORMA Early Feasibility Study Echocardiography Outcomes at 30 Days (echo core lab) 2.1 ± 1.8 1.1 ± 0.6 1.1 ± 0.9 0.6 ± 0.4
FORMA Early Feasibility Study NYHA Class at 30 Days
FORMA Early Feasibility Study 6MWT and KCCQ at 30 Days 6MWT – Six Minute Walk Test; KCCQ- Kansas City Cardiomyopathy Questionnaire Overall Summary Score
FORMA Early Feasibility Study 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 Severe TR – ERO 1.72 cm 2 • AST 29, ALT 16, Alk Phos 144, Alb 4.5 • Hb 10.8, Hct 35.6, Plt 98 • Pro BNP 2699
FORMA Early Feasibility Study Case Example Baseline 30 days Final ERO - .74 cm 2 (Pre – 1.72 cm 2 ) No Tricuspid Stenosis – (mean gradient 0.6 cm 2 )
FORMA Early Feasibility Study 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.
FORMA Early Feasibility Study 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.
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