Transseptal Transcatheter Mitral Valve

Replacement

Howard C. Herrmann, MD, FACC, MSCAI

John Bryfogle Professor of Cardiovascular Medicine and Surgery

Health System Director for Interventional Cardiology

Director, Cardiac Cath Labs, Hospital of the Univ of PA

Perelman School of Medicine

University of Pennsylvania

Philadelphia

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.

➢ Discussion may include unapproved and off-label devices, procedures, and indications

Equity

MicrointerventionalDevices

Consulting Fees/Honoraria

Edwards LifesciencesBayerWells FargoLeering

Grant/Research Support

Abbott Vascular

Edwards Lifesciences

St. Jude Medical

Medtronic

Gore

Siemens

Bayer

Boston Sci

Corvia

Cardiokinetx

Univ Laval

TMVR Devices in US EFS

CardiAQ-Edwards

Intrepid

(Medtronic)

Tendyne (Abbott)

Tiara

(Neovasc)Caisson

510/17/2017

Caisson transseptal TMVR system

The CardiAQ-EdwardsTM Transcatheter Mitral Valve

Bovine Pericardial Leaflets

Intra-annular Sealing Skirt

Left Atrial Anchors

Left Ventricular Anchors

Tapered Outflow

Open Frame Cells• ONE VALVE, MULTIPLE DELIVERY SYSTEMS• TS – Transseptal approach

• TA – Transapical approach

• ANCHORING MECHANISM• Preserves chords and utilizes native

leaflets

• Promotes load distribution among annulus, leaflets and chords

• DESIGNED TO PROMOTE PHYSIOLOGIC FLOW

• Eliminate mitral regurgitation

• Supra-annular position and tapered outflow to minimize risk of LVOT obstruction

• Intra-annular sealing skirt to minimize PV leak

• Open frame cells to promote atrial flow

• FIH Compassionate use experience– Early learning experience

• Two device iterations, mix of TA and TS access• Enrollment spanning several years across 6 sites in Europe and Canada

– Very sick compassionate use population with a high burden of comorbidities – 30 day mortality

• 2/14 procedure related• 4/14 non device or procedure related (3 multi-organ failure and 1

pneumonia)

• Patient screening for The RELIEF Trial is underway in Europe and Canada • US EFS trial enrolling: high risk patients• Future Pipeline

– Reduced delivery profile– Additional valve sizes – Proven valve tissue – the same bovine pericardial tissue and processes as

Edwards surgical valves– Delivery system improvements

• Technical improvements expected to make this procedure easier

The CardiAQ-EdwardsTM TMVRClinical Program Status

Controlled Articulation

HPI

89 yo with fatigue and DOE (NYHA class III)

PH: Chronic AF (on warfarin)

s/p PPM

DM

PE: 134/66, 76 irreg irreg, BMI 23 kg/M2

JVD to 10 cm H2O, III/VI HSM at apex

Echo: LV EF 55%

Mild AS (mean grad 6 mmHg, AVA 1.5 cm2)

Severe (4+) MR: EROA 0.48 cm2, RV 61 cc, VC 0.65 cm

Mild-mod RV dysfunction, PASP 36 mmHg

TEE: Failure of leaflet coaptation with mult jets of MR along the entire line of

coaptation, cleft between P2/P3, RV 85 cc, EROA 0.78 cm2

STS PROM for MV Replacement: 8.2%

Enrolled in the EFS of the CardiAQ TMVI System

Imaging

CTA Cardiac:

Annulus Diameter and LA Height

CTA Cardiac

LVOT Analysis

Procedure

• GA and TEE

• Transseptal with septal dilation to 12 mm

• Amplatz super stiff wire curled in the LV apex (A 12 F Reliant balloon was

passed over the wire to insure no evidence of chordal entrapment)

• A #40 CardiAQ-Edwards prosthesis was advanced over the wire and

deployed under TEE and fluoroscopic guidance

• A 20 mm AGA ASO was deployed to close the septostomy

Transseptal TMVR with CardiAQ-Edwards

Insertion Positioning

Transseptal TMVR with CardiAQ-Edwards

LV Anchor Release

Transseptal TMVR with CardiAQ-Edwards

LA Anchor Release Device Release

Transseptal TMVR with CardiAQ-Edwards