Prof Nicolas M Van Mieghem Professor & Director of Interventional Cardiology Thoraxcenter, Erasmus University Medical Center Rotterdam, The Netherlands A Peek into the Future Repair and Replacement of the Mitral & Tricuspid Valves with The Edwards Portfolio
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Prof Nicolas M Van MieghemProfessor & Director of Interventional CardiologyThoraxcenter, Erasmus University Medical Center
Rotterdam, The Netherlands
A Peek into the Future Repair and Replacementof the Mitral & Tricuspid Valves with
The Edwards Portfolio
• Research Grant Support: Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath, Daiichi Sankyo , Teleflex
Conflict of Interest
Impact of Atrio-Ventricular Valve Regurgitation
Genereux et al. EHJ 2017;38:3351-8
Cardiac Damage Stratification in AS
Limitations of Surgery in Functional/Secondary MR & TR
Michler et al. NEJM 2016;374:1932-41Zack et al. JACC 2017;70:2953-60
with valve repair in the aortic and mitral position, thevalve repair itself may result in better outcome thanreplacement due to better maintenance of RV functionwith preservation of tricuspid continuity and fewerprosthetic valve–related complications (18,22).Comprehensive repair techniques for the tricuspidvalve now exist, and further investigation will beneeded to determine if surgeons should strive toperform an increasing percentage of valve repair in thisgroup of patients with severe primary TR.
The 2014 American College of Cardiology/AmericanHeart Association valvular heart disease guidelinesprovide a Class Ic recommendation for isolated TVsurgery in severe symptomatic tricuspid stenosis, aClass IIa recommendation for isolated TV surgery inprimary severe TR patients who are unresponsive tomedical therapy, and a Class IIb recommendation for
CENTRAL ILLUSTRATION Temporal Trends in Surgical Volume and Mortality for IsolatedTricuspid Valve Surgery
Tricuspid Valve ReplacementTricuspid Valve Repair (N)In-Hospital Mortality After Tricuspid Valve Surgery
500
400
300
200
100
02004 2005 2006 2007 2008 2009
Year
Surg
ical V
olum
e (N
)
In-Hospital Mortality (%
)
2010 2011 2012 2013
100
80
60
40
20
0p = 0.51
p < 0.001
p < 0.001
8.8%
Zack, C.J. et al. J Am Coll Cardiol. 2017;70(24):2953–60.
From 2004 to 2013, there was a significant increase in the number of isolated tricuspid valve repair and replacement surgeries performedannually in the United States (p < 0.001 for trend). Isolated valve replacement was performed more frequently than valve repair. In-hospitalmortality was 8.8% and remained unchanged despite increasing surgical volumes (p ¼ 0.51 for trend).
TABLE 2 In-Hospital Clinical Outcomes of Patients UndergoingIsolated Tricuspid Valve Surgery From 2004 to 2013(Unweighted)
In-hospital mortality 92 (8.8)
Cardiogenic shock 65 (6.2)
Permanent pacemaker implantation 271 (26.0)
Cerebrovascular accident 27 (2.6)
Acute kidney injury 276 (26.5)
AKI requiring hemodialysis 43 (4.1)
Blood transfusion 383 (36.8)
Post-operative infection 22 (2.1)
Length of stay, days 11 (7–20)
Hospital charges, " $1,000 161.5 (105.7–261.3)
Discharged to home 718 (69.0)
Discharged to SNF 216 (20.7)
Values are n (%) or median (interquartile range). N ¼ 1,041 total patients.
AKI ¼ acute kidney injury; SNF ¼ skilled nursing facility.
J A C C V O L . 7 0 , N O . 2 4 , 2 0 1 7 Zack et al.D E C E M B E R 1 9 , 2 0 1 7 : 2 9 5 3 – 6 0 Outcomes in Isolated TV Surgery
2957
CTSN Trial – Moderate FMR & CABGN=301 – M-repair vs. control
5,005 isolated TV operations between 2004-2013 Repair in 40.8% - Replacement in 59.2%
Potential of Transcatheter Repair
Mack, M.J. et al. J Am Coll Cardiol. 2021;77(8):1029–40.Taramasso et al. JACC 2019;74:2998-3008
FTR – Propensity matched analysisFMR - COAPT
Edwards Lifesciences is Developing a Broad Portfolio of Therapies
Treating a large and complex patient population with mitral and tricuspid regurgitation
2015
Cardioband MitralSystem Annular Reduction
CardiobandTricuspid SystemAnnular Reduction
2018
2019
PASCAL Repair Systemfor Mitral ValveLeaflet Repair
2020
Valve Replacements &Future TMTT InnovationsOngoing dedication to thedevelopment oftranscatheter mitral andtricuspid therapyinnovations supported by abody of clinical evidence
PASCAL Ace Implant SystemLeaflet Repair
PASCAL Repair System for Tricuspid ValveLeaflet Repair
Repair
For professional use. See instructions for use for full prescribing information. CE Marked medical device
Recent Publications on PASCAL platform for MR & TR
JACC 2021;77:345-56
CCI 2021;1-9 Epub ahead of Print
JACC CVI 2020;13:2769-78
JACC CVI 2020;13:2344-57
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