Transcatheter Mitral Valve Replacementwith the Tendyne Valve.with the Tendyne Valve.

A Pichard,

L Satler, Ron Waksman, I Ben-Dor, P Corso,L Satler, Ron Waksman, I Ben-Dor, P Corso,

C Shults, N Bernardo, E Woo, G Weigold,

G Weissman, A Ertel, T. Weddington, S Boyce, A Bafi, PG Weissman, A Ertel, T. Weddington, S Boyce, A Bafi, POkubagzi.

Medstar Washington Hospital CenterMedstar Washington Hospital Center

Washington, DC

Professor of Medicine (Cardiology)Professor of Medicine (Cardiology)

Georgetown University

Tendyne Transcatheter Mitral ValveTendyne DeviceTendyne Device

• D-Shaped Self-Expanding Nitinol Outer Frame

• Conforms to Native MV Anatomy

• Circular Self-Expanding Nitinol Inner Frame• Circular Self-Expanding Nitinol Inner Frame

• Large Effective Orifice Area (>3.0cm2), larger thanany Surgical Valve

• Porcine Pericardial Tri-Leaflet Valve• Porcine Pericardial Tri-Leaflet Valve

• Large Valve Size Matrix to Treat Varying Anatomies

• Outer Frame Sizes: 30-43mm AP x 34-50mm CC

• Valve Tether to Apex• Valve Tether to Apex

• Provides Valve Stability - Designed to Reduce PVL

• Apical Pad Assists in Access Closure

Tendyne product is currently in development at Abbott. Neither approved or available for sale.

Tendyne Transcatheter Mitral Valve

Tendyne Procedure

Fully RepositionableFully Repositionable

Fully Retrievable

No Rapid Pacing or CPB

Procedural Steps

TA Approach TA Approach

Insert Catheter into LA

Intra-Annular Deployment

Ensure Valve Seating Ensure Valve Seating

Adjust Tether Tension

Secure Apical PadTendyne product is currently in development at Abbott. Neither approved or available for sale.

Tendyne Implant Experience

EFS/CE Mark StudySite Name (n=12 sites)

St. Vincent’s

Prince Charles Hospital

Abbott

Cleveland Clinic

• Compassionate cases

– Royal Brompton Hospital

Cleveland Clinic

Baylor

Northshore

MedStar – Royal Brompton Hospital

– University Hospital Zurich

– University of Bonn

– Abbott NW (MHI)

– Bad Nauheim

MedStar

Henry Ford Hospital

Pinnacle Health

West Virginia University – Bad NauheimWest Virginia University

Oslo University Hospital

Emory30Oct2016

Total experience to date: >70 casesLongest follow-up 2yrs

J Am Coll Cardiol. 2017 Jan 31; 69(4): 381-391

P rotocolP rotocolInclusion Criteria:Symptomatic severe MR (3-4+)

Exclusion Criteria:EF <30%EF <30%LV diastolic ID >70mmSevere MV annular calcificationSevere MV annular calcificationSevere RV dysfunction or severe TRPAP > 70 mm Hg

BaselineEchoP aram etersBaselineEchoP aram eters

30 day MV gradient: 3.4 mm Hg• 30 day MV gradient: 3.4 mm Hg• 30 day LVOT gradient: 1.9 mm Hg• KCCQ improved from 50 to 64 p=0.002

Complications

Trial CommentsTrial Comments

• Small initial series of very high risk patients.

• Experience for each Site: 50% of Sites did only 1-2 cases.

• Proved that MVR with dedicated valve and without

CP Bypass is possible.CP Bypass is possible.

• Procedure is safe with low risk of procedural death orcomplications.complications.

• Effectively treated severe MR, with significant clinicalimprovement and LV improvement.

STS score: 5.5%

83 y/o male

Severe MR – restricted posterior mitralleaflet. Mitral jet is eccentric

STS score: 5.5%

leaflet. Mitral jet is eccentric

Ht=175cm, Wt=72g, BMI=22, BSA=1.8, Cr=1.1

PMHx:

Scalp sarcoma

HTN, GERD, AF, seizures, Kidney mass

FEV1= 46% with Sev. Restriction

PMHx:

FrailtyFEV1= 46% with Sev. Restriction

FEV1 41%Frailty

Criteria Score Cutoff

ADL 4 ≤ 4/6

Grip Strength 20 < 30 kgGrip Strength 20 < 30 kg

15-Foot Walk 10.3 > 6 sec

Albumin 3.3 < 3.5g/dl

TOTAL 4/4

TEE (2/23/2016)

Echo Variable (TTE) Measure

Severity of AR Moderate

Severity of MR Severe

Ejection Fraction 30-35 %Ejection Fraction 30-35 %

Severe MR – restricted posteriormitral leaflet. Mitral jet is eccentric

M itralorificedim ensions.CT

13

End DiastoleEnd Systole

Evaluatingneo-LVO T (diastole)Evaluatingneo-LVO T (diastole)

14

TA AccessSwan from Apex to LA

S w anfrom ApextoL A

Confidaw ireinL A L argeS heathintoApex(34F)Confidaw ireinL A L argeS heathintoApex(34F)

ValveintroducedandDeploym entS tartValveintroducedandDeploym entS tart

FinalR esultFinalR esult

ApicalP lateforT etherApicalP lateforT ether

ConclusionsConclusions

• This is the first percutaneous MVR with a successful clinical start.

• The Trial is actively enrolling patients.

• Much to be learned yet about clinical and procedural aspects.

• It has initiated and exciting new era in Interventional Cardiology.• It has initiated and exciting new era in Interventional Cardiology.