Edwards Cardioband · 2019-09-13 · with valve systolic pulmonary pressure (sPAP) ≤ 60mmHg New...

Edwards Cardioband Tricuspid Valve Reconstruction System

Introduction and overview


Disease state background

Functional tricuspid regurgitation

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Tricuspid regurgitation is frequent but rarely treated

<8kSurgical procedures annually

1.6MModerate to severe TR

prevalence

Numbers reflective of US data.

Fender EA, Zack CJ, Nishimura RA. Heart 2018;104:798–806.

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Tricuspid regurgitation is associated with increased mortality

5,223 patientsStudy shows that moderate to

severe TR increases mortality*

*Independent of PASP, LVEF

Topilsky Y et al. JACC Cardiovasc Imaging 2018 Aug 6. Epub 2018 Aug 6

Nath J et. al. Journal of the American College of Cardiology. 2004 Feb 4;43(3):405-9.

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Functional tricuspid regurgitation is predominantly a consequence of RV enlargement and annular dilatation


Dreyfus GD et .al. Annals of Thoracic Surgery. 2005 Jan;79(1):127-32.

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System description and functionality

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▪ A transcatheter device designed to reduce tricuspid regurgitation through annular

reduction via transfemoral access

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Implant

Delivery system


▪ First CE-mark approved transcatheter device for the treatment of tricuspid regurgitation

▪ A dedicated technology to treat TR through annular reduction

▪ Expected shortened learning curve for Cardioband mitral system users

Tricuspid repairMitral repair

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Azeem Latib, MD. Presented at PCR London Valves 2018.

Restores valve to a

more functional state –

facilitating leaflet

coaptation

Enables annular

reduction based on

each patient’s anatomy

Allows real-time

adjustment and

confirmation of

procedural results

Cardioband Tricuspid System addresses the main cause of tricuspid regurgitation – annular dilatation

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Georg Nickenig, MD. Presented at TCT 2017.

Baldus, S. Interventional Cardiology Review 2018;13(3 Suppl 1):3–6.

Cardioband Tricuspid System has a reproducible and standardised procedure

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Insert Cardioband

tricuspid delivery system

into the right atrium using

a transfemoral approach.

1. Access

Deploy implant via a

steerable catheter to

navigate around the

tricuspid annulus,

securing the implant with

stainless steel anchors.

2. Deploy

Introduce the size-

adjustment tool over a

wire and rotate the

adjustment knob

clockwise for implant

contraction.

3. Adjust and reduce

Cardioband Tricuspid System delivers a significant and consistent reduction in tricuspid regurgitation

Baseline

Post-

reduction

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Georg Nickenig, MD. Presented at PCR London Valves 2018.

Images courtesy of Georg Nickenig, MD, Robert Schueler, MD, Heart Center University of Bonn, Germany.


TRI-REPAIR study

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▪ Single arm, multi-center, prospective

study to evaluate the performance and

safety of the Cardioband tricuspid

system for reconstruction of

pathological tricuspid valves.


TRI-REPAIR study

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Key admission criteria

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▪ Chronic functional tricuspid regurgitation

(FTR) 2+ to 4+ on a scale of 4+ (moderate to severe) with annular diameter ≥ 40 mm with valve systolic pulmonary pressure

(sPAP) ≤ 60mmHg

▪ New York Heart Association (NYHA) Class

II-IVa

▪ Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen

▪ LVEF ≥ 30%

▪ The local site Heart Team agrees surgery will not be offered as a treatment option

Inclusion Exclusion

▪ Aortic, mitral and/or pulmonic valve stenosis

and/or regurgitation ≥ moderate

▪ Previous tricuspid valve repair or replacement

▪ Presence of trans-tricuspid pacemaker or defibrillator leads which cause impingement of

the tricuspid valve leaflet as evaluated by echocardiography

▪ MI or known unstable angina within the 30 days prior to the index procedure

▪ Any PCI or transcatheter valvular intervention within 30 days prior to the index procedure or

planned 3 months post-index procedure

▪ Subject is on chronic dialysis and/or has anemia (Hb < 9 g/L)

▪ Life expectancy of less than 12 months

▪ Patients with cardiac cachexia


TRI-REPAIR study

Endpoints

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Safety

▪ Overall rate of Major Serious

Adverse Events (MSAEs)* and

serious adverse device effects

(SADE) until hospital discharge and

at post-operative 30 days

Technical Success

▪ Successful access, deployment and

positioning of the Cardioband device

▪ Septolateral reduction at intra-

procedure and discharge

Primary endpoints Secondary endpoints

▪ TR grade, EROA and Regurgitant

Volume

(by echocardiography)

▪ Tricuspid annular plane systolic

excursion (TAPSE)

▪ NYHA classification

▪ 6MWD

▪ KCCQ

▪ LVEF

▪ LVEDVI

▪ LVESVI

▪ Diuretic therapy

▪ Activity by wearable device (selected

sites only)

TRI-REPAIR study

*Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke

NYHA – New York Heart Association; 6MWD – Six Minute Walk Distance; KCCQ – Kansas City Cardiomyopathy Questionnaire

LVEF – Left Ventricular Ejection Fraction; LVEDVI – Left Ventricular End-Diastolic Volume Index; LVESVI – Left Ventricular End-Systolic Volume Index


Participating sites

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Heart Center, University Hospital Bonn

LMU Klinikum der Universität München, Campus Großhadern

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Universitäres Herzzentrum Hamburg GmbH

(UHZ), Hamburg

Asklepios, St. Georg Hospital

Heart Center University of Cologne

* Site activation pending approval.


TRI-REPAIR study

Zurich University Hospital*

San Raffaele Institute

Bichat Hospital

Patient flow

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TRI-REPAIR study

Demographics

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TRI-REPAIR study

Successful access, deployment and

positioning of the Cardioband device100% (30/30)

100% technical success

Francesco Maisano, MD. Presented at EuroPCR 2018.

TRI-REPAIR study

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Safety profile

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CEC adjudicated

*Events defined according to VARC Guidelines (European Heart Journal, 2012, 33:2403-2414).


TRI-REPAIR study

16% average reduction in septolateral diameter by core lab1 (paired analysis)

1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation


TRI-REPAIR study

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Sustained annular reduction at 6 months by core lab1

(paired analysis)

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TRI-REPAIR study

TRI-REPAIR study

Significant reduction in TR severity at 30 days and sustained at 6 months1



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Improvements in key echo parameters at 30 days by core lab1 (paired analysis)

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PISA – Proximal Isovelocity Surface Area, EROA – Effective Regurgitant Orif ice Area. PISA EROA is the regurgitant velocity.


TRI-REPAIR study

Sustained echo improvement at 6 months by core lab1

(paired analysis)

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PISA – Proximal Isovelocity Surface Area, EROA – Effective Regurgitant Orif ice Area. PISA EROA is the regurgitant velocity.


TRI-REPAIR study

Functional improvement at 30 days (paired analysis)

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6MWT – Six Minute Walk Test; KCCQ – Kansas City Cardiomyopathy Questionnaire; NYHA – New York Heart Association

Edema – measured on a scale of 1 to 4 (1 = minor, 4 = severe)


TRI-REPAIR study

Sustained functional improvement at 6 months (paired analysis)

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6MWT – Six Minute Walk Test; KCCQ – Kansas City Cardiomyopathy Questionnaire; NYHA – New York Heart Association

Edema – measured on a scale of 1 to 4 (1 = minor, 4 = severe)


TRI-REPAIR study

Conclusions

▪ Use of the Cardioband tricuspid system for tricuspid regurgitation is safe and feasible

▪ Significant reduction in EROA through annular reduction that is sustained at 6 months

▪ Clinically significant improvements in functional status, quality of life and exercise

sustained at 6 months

▪ Successful access, deployment and positioning of the Cardioband tricuspid implant in

100% of patients

▪ Further studies are warranted to validate these initial promising results

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Patients with functional tricuspid regurgitation have a large unmet need

with limited treatment options. The TRI-REPAIR study demonstrated:

Robert Schueler, MD. Presented at DGK 2018.


Georg Nickenig, MD. Presented at TCT 2017.

TRI-REPAIR study

Edwards CardiobandTricuspid Valve Reconstruction System

Case presentation of torrential TR courtesy of:

Georg Nickenig, MD and Robert Schueler, MD

Heart Center University of Bonn, Germany

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Baseline patient characteristics

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▪ 72 years old female

▪ NYHA III

▪ EUROScore 4.06

▪ STS 1.6

▪ Baseline risk factors and

comorbidities

– Systemic hypertension

– Congestive Heart Failure

▪ Previous surgery: SAVR, mitral valve

reconstruction, LAA occlusion

Clinical Background Baseline

▪ Preserved left ventricular ejection

fraction (63.5%)

▪ LVOT – 75.03ml

▪ Postcapillary pulmonary hypertension

(sPAP mmHg)

▪ “Torrential” TR

– PISA: 1.1cm

– Vena contracta: 0.9cm

– EROA: 0.92cm2

– Regurgitant volume: 145ml/beat

▪ MR mild

Baseline echo: torrential tricuspid regurgitation

sPAP: 47mmHg

PISA: 1.1cm

Vena contracta: 0.9cm

EROA: 0.92cm2

Regurgitant volume: 145ml/beat

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Baseline echo: coaptation defect area

Coaptation defect area: 1.8cm2

A

S

P

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Cardioband Tricuspid System annular reduction by fluoroscopy

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Implant original size Implant final size

Cardioband Tricuspid System final result by echo: trace TR

Baseline

Trace TR with significant reduction of annular diameter

(AP: 3.9cm to 2.1cm; SL: 3.1cm to 2.5cm)

Post-procedure

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How to get started

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Patient screening process

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Baseline

screening assessments/

images

Submit

assessments/images via

cloud to

central screening

committee

Internal/core

lab review

Central

screening committee

review

Case

scheduling

▪ Edwards offers additional echo support for interested centers

▪ A center has the option to submit both echo and CT scans simultaneously

Opening a Cardioband Tricuspid System center

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▪ In general, training will be scheduled after at least 2–3 patients were screened and

found eligible for the procedure

▪ After full training at least 2–3 procedures should take place in the following three weeks in order to ensure best outcomes for the patient

Center introductionCommercial

approval

Start patient

screening

Initial

training

Cardioband Tricuspid System training occurs in the hospital and concludes with device implantation

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A total of two days to complete site training and first procedure

Theoretical training

Cath lab practice (Cardioband tricuspid system and echo simulators)

Cardioband tricuspid device implantation

Day 1

Half-day

Day 2

Full-day

Day 3

Half-day

▪ An additional echo simulator training will be available separately

Startup center training detailsMandatory training for new users

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▪ One and a half day training program:

– Half day theoretical training

– One full day cath lab simulator practice

▪ Immediately followed by Cardioband device

implantation

Schedule Requirements

▪ Attendees

– 1st and 2nd operator

– Echocardiographist

▪ Equipment

– Human grade structural heart cath lab

– 3D TEE machine

– Meeting room with projector

▪ Device introduction

▪ Device functionality

▪ Procedural steps

▪ Troubleshooting

▪ Clinical study results

▪ Echo navigation

▪ Camera simulator

deployment

▪ Guided echo simulator

deployment

(fluoroscopy and echo)

▪ Solo echo simulator

deployment

(fluoroscopy and echo)

Topics Certificates

▪ 1st operator

▪ 2nd operator

▪ Echocardiographist

▪ System preparation

Edwards Lifesciences • Route de l’Etraz 70, 1260 Ny on, Switzerland • edwards.com

For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings,

precautions, and adverse events.

Edw ards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical

Device Directive 93/42/EEC bear the CE marking of conformity. Cardioband Systems are manufactured by Valtech Cardio Ltd for Edw ards Lifesciences.

Edw ards, Edw ards Lifesciences, the stylized E logo, and Cardioband are trademarks of Edw ards Lifesciences Corporation or its aff iliates.

© 2018 Edw ards Lifesciences Corporation. All rights reserved. E8554/10-18/TMTT

Edwards Cardioband · 2019-09-13 · with valve systolic pulmonary pressure (sPAP) ≤ 60mmHg New...

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