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

Tricuspid Valve Therapy in Patients with Severe Secondary

Tricuspid Regurgitation

Susheel Kodali, MDDirector, 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

operative mortality.

• Less-invasive transcatheter therapies designed to

reduce TR offer the potential to improve clinical

outcomes.

FORMA Early Feasibility StudyBackground

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)

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 StudyKey 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 StudyKey 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

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

FORMA Early Feasibility StudyStudy 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 StudyBaseline 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 StudyBaseline 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 StudyBaseline 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 StudyBaseline 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 StudyProcedural Factors

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

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

* VARC-2 Guidelines

FORMA Early Feasibility StudyClinical 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 StudyEchocardiography 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 StudyEchocardiography Outcomes at 30 Days

(echo core lab)

FORMA Early Feasibility StudyNYHA Class at 30 Days

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

FORMA Early Feasibility Study6MWT and KCCQ at 30 Days

FORMA Early Feasibility StudyCase 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 StudyCase 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 StudyConclusions

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

of TR, evidence of RV remodeling, and late clinical

outcomes.

FORMA Early Feasibility StudyImplications and Future