The FORMA Early Feasibility Study: 30-Day Outcomes of Transcatheter - - PowerPoint PPT Presentation

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

• Consulting Fees/Honoraria
• Scientific Advisory Board
• Steering Committee (unpaid)
• Claret Medical
• Thubrikar Aortic Valve Inc, Dura

Biotech, VS Medtech

• PARTNER Trial (Edwards

Lifescieces)

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

• 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

• perative mortality.
• Less-invasive transcatheter therapies designed to

reduce TR offer the potential to improve clinical

• utcomes.

FORMA Early Feasibility Study Background

FORMA Tricuspid Valve Therapy System

(Edwards Lifesciences)

• Spacer



Positioned within regurgitant

• rifice



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)

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

• 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 Inclusion 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 Key Exclusion Criteria

Intent to Treat n=30 Enrolled n=29 Implanted n=27 30 Day Echo Follow Up n=25*

Procedure aborted (n=1)

• Venogram revealed
• ccluded 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

FORMA Early Feasibility Study Study Flow

* calculated for MVR

Mean or % N = 29

Age (years) 75.9 ± 8.2 Female Gender 65.5% Body Mass Index (kg/m2) 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%

FORMA Early Feasibility Study Baseline Characteristics (1)

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 Characteristics (2)

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 (cm2) 1.2 ± 0.6 Tricuspid Regurgitant EROA 2D or 3D (cm2) 2.2 ± 1.5 Tricuspid Regurgitant volume (mL) 129.0 ± 65.8 TV mean gradient (mmHg) 1.9 ± 1.1

FORMA Early Feasibility Study Baseline Echocardiography (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

Severe Massive Torrential

65% ≥ Torrential TR by PISA EROA; 80% by Quantitative 2D or 3D

FORMA Early Feasibility Study Baseline Echocardiography (2)

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 Procedural Factors

Patients N = 29 % Death (All-Cause)

2 6.9

Stroke/TIA

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

20/29 patients (69%) had none of the above events

* VARC-2 Guidelines

FORMA Early Feasibility Study Clinical Outcomes at 30 Days

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 (cm2) 1.1 ± 0.6 0.6 ± 0.4 0.001 2D or 3D Quantitative EROA (cm2) 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, paired analysis)

2.1 ± 1.8 1.1 ± 0.9 1.1 ± 0.6 0.6 ± 0.4

FORMA Early Feasibility Study Echocardiography Outcomes at 30 Days

(echo core lab)

FORMA Early Feasibility Study NYHA Class at 30 Days

6MWT – Six Minute Walk Test; KCCQ- Kansas City Cardiomyopathy Questionnaire Overall Summary Score

FORMA Early Feasibility Study 6MWT and KCCQ at 30 Days

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
• 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 cm2

Baseline 30 days

FORMA Early Feasibility Study Case Example

Final ERO - .74 cm2 (Pre – 1.72 cm2) No Tricuspid Stenosis – (mean gradient 0.6 cm2)

• 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 Conclusions

In a patient cohort with torrential TR, severe symptoms, and multiple co-morbidities…

• 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
• f TR, evidence of RV remodeling, and late clinical
• utcomes.

FORMA Early Feasibility Study Implications and Future