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Edwards Cardioband Tricuspid Valve Reconstruction System
Introduction and overview
Edwards Cardioband Tricuspid Valve Reconstruction System
Disease state background
Functional tricuspid regurgitation
2
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.
3
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.
4
Functional tricuspid regurgitation is predominantly a consequence of RV enlargement and annular dilatation
Fender EA, Zack CJ, Nishimura RA. Heart 2018;104:798–806.
Dreyfus GD et .al. Annals of Thoracic Surgery. 2005 Jan;79(1):127-32.
5
Edwards Cardioband Tricuspid Valve Reconstruction System
System description and functionality
6
Edwards Cardioband Tricuspid Valve Reconstruction System
▪ A transcatheter device designed to reduce tricuspid regurgitation through annular
reduction via transfemoral access
7
Implant
Delivery system
Edwards Cardioband Tricuspid Valve Reconstruction 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
8
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
9
Fender EA, Zack CJ, Nishimura RA. Heart 2018;104:798–806.
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
10
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
11
Georg Nickenig, MD. Presented at PCR London Valves 2018.
Images courtesy of Georg Nickenig, MD, Robert Schueler, MD, Heart Center University of Bonn, Germany.
Edwards Cardioband Tricuspid Valve Reconstruction System
TRI-REPAIR study
12
Edwards Cardioband Tricuspid Valve Reconstruction System
▪ Single arm, multi-center, prospective
study to evaluate the performance and
safety of the Cardioband tricuspid
system for reconstruction of
pathological tricuspid valves.
Georg Nickenig, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
13
Key admission criteria
14
▪ 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
Georg Nickenig, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
Endpoints
15
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
Georg Nickenig, MD. Presented at PCR London Valves 2018.
Participating sites
16
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.
Georg Nickenig, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
Zurich University Hospital*
San Raffaele Institute
Bichat Hospital
Patient flow
17
Georg Nickenig, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
Demographics
18
Azeem Latib, MD. Presented at PCR London Valves 2018.
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
19
Safety profile
20
CEC adjudicated
*Events defined according to VARC Guidelines (European Heart Journal, 2012, 33:2403-2414).
Francesco Maisano, MD. Presented at EuroPCR 2018.
TRI-REPAIR study
16% average reduction in septolateral diameter by core lab1 (paired analysis)
1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation
Georg Nickenig, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
21
Sustained annular reduction at 6 months by core lab1
(paired analysis)
22
1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation
Azeem Latib, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
TRI-REPAIR study
Significant reduction in TR severity at 30 days and sustained at 6 months1
1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation
Georg Nickenig, MD. Presented at PCR London Valves 2018.
23
Improvements in key echo parameters at 30 days by core lab1 (paired analysis)
24
1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation
PISA – Proximal Isovelocity Surface Area, EROA – Effective Regurgitant Orif ice Area. PISA EROA is the regurgitant velocity.
Francesco Maisano, MD. Presented at EuroPCR 2018.
TRI-REPAIR study
Sustained echo improvement at 6 months by core lab1
(paired analysis)
25
1 Rebecca T. Hahn, MD – Cardiovascular Research Foundation
PISA – Proximal Isovelocity Surface Area, EROA – Effective Regurgitant Orif ice Area. PISA EROA is the regurgitant velocity.
Azeem Latib, MD. Presented at PCR London Valves 2018.
TRI-REPAIR study
Functional improvement at 30 days (paired analysis)
26
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)
Francesco Maisano, MD. Presented at EuroPCR 2018.
TRI-REPAIR study
Sustained functional improvement at 6 months (paired analysis)
27
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)
Azeem Latib, MD. Presented at PCR London Valves 2018.
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
28
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.
Azeem Latib, MD. Presented at PCR London Valves 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
29
Baseline patient characteristics
30
▪ 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
31
Baseline echo: coaptation defect area
Coaptation defect area: 1.8cm2
A
S
P
32
Cardioband Tricuspid System annular reduction by fluoroscopy
33
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
34
Edwards Cardioband Tricuspid Valve Reconstruction System
How to get started
35
Patient screening process
36
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
37
▪ 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
38
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
39
▪ 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