Valve Replacement Mechanical versus Biological Prof. Dr. T. Carrel Swiss Cardiovascular Center...

Valve ReplacementMechanical versus Biological

Prof. Dr. T. CarrelSwiss Cardiovascular Center

University Hospital BerneSwitzerlandNo Disclosure

AATS 2015 – Postgraduate Adults (Mechanical vs Tissue Valves)

Swiss Cardiovascular Center, University Hospital Berne - Switzerland

• The Institutional Experience

• The Market (Current Estimations)

• The ESC and ACC/AHA Guidelines

• The Decision-Making Process

• The Literature: Pro and Cons

• The Future

Agenda



2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 20140

100

200

300

400

500

600

700

800

900

AVR bio

AVR mech

TAVI

sAVR total

AVR total

The Institutional Experience

Swiss Cardiovascular Center University Hospital Berne, Switzerland

185

400

768

Ross ≈10/yrDavid ≈20-30/yr



(1) Increasing Number of Patients with AVR

(2) Absolute number of mechanical AVR remains stable

(3) Relative number of mechanical AVR decreased

New generation of tissue valves have a lower rate of SVD

Life-style changes (QoL without warfarin)

Changes in Guidelines and Literature regarding cut-off age

The Institutional Experience



The Current (surgical) Market

(≈ 200‘000 pts per year)

78-85% 15-22%(43% in 1997) (55% in 1997)



The Future (global) Market

(≈ 500‘000 - 1‘000‘000 pts per year)

> 50%



The ESC/EACTS Guidelines



The AHA/ACC Guidelines

Nishimura RA, AHA/ACC Guidelines Circulation 2015



The Decision-Making Process

Objective Criterias

• Durability of the Device

• Need for Anticoagulation

• Risk of Prosthetic Endocarditis

• Life expectancy of the Patient

• Quality of Life

Subjective Criterias

• Patient’s opinion

• Cardiologist’s Recommendation

• Institutional Strategy

• Recommendations through others

(online, relatives, patients)



Arguments that may influence valve selection

New anticoagulation strategies

New valve design

pro mechanical valve

Valve-in-valve concept with TAVI

pro tissue valve

The Decision-Making Process

Individual Confort vs Economic Burden



The Patient‘s Perspective

„Patients who need heart valve replacement come

with the anticipation of receiving, according to

their conditions, the most appropriate valve

substitute for the rest of their life. They hope to be

operated on only once and to be free of

complications

K. Arom, J Heart Valve Dis 1996;5:505-10




“Consensus guidelines have increasingly emphasized

patient preference in preoperative decision making.

Quality-of-life surveys indicate that many patients view the

distant possibility of reoperation as a reasonable trade-off

for freedom from lifelong anticoagulation, reduced quality

of life, and poorer perceived health status associated with

mechanical prosthetic valves“.

Chikwe J et al. JAMA, April 14,

2015




Mechanical Valves• Freedom from Reoperation but Anticoagulation

Tissue Valves • Freedom from Anticoagulation but Reoperation



The Literature: Historical

Suri R, Circulation 2013;128:1372










• Actuarial: freedom from SVD - assumes all patients are alive

• Actual: death competes to reduce the likelihood of reoperation




• Old type of tilting-disk prosthesis

• Biological design no more available

• Results not stratified by age groups

• Perioperative mortality was higher



The Literature: Pro and Cons

Circulation 2013;128:1365-1381



The Literature: Pro Mechanical

Suri R, Circulation 2013;128:1372



Brown M, J Thorac Cardiovasc Surg 2008;135:878-84

Freedom from bleeding Overall survival

The Literature: Pro mechanical

220 pts, matched for age, gender, CABG and valve size

SJM vs CE



Chan V et al. Circulation 2011;124 Suppl1:S75-80


Reoperation according to age at implantation

3975 pts (3152 AVR) with first time tissue valve

75% redos in pts 40-60 !



345 pts > 80 years 58% tissue vs 42% mechanical

Follow-up 40±33 months

Overall survival benefit in pts with mechanical valves

No influence on QoL

Ann Thorac Surg 2008;85:1296-302




The Future

Avoid Unpredictable SVD

- negative effects of adverse cumulative hemodynamics - ViV-TAVI is less than optimal and expensive

Mitral CE and Aortic Trifecta 3 yrs after AVR+MVR



The Future

Hope for a MEC valve w/o AC(Triflo Medical Switzerland)



Thrombogenicity of prosthetic heart valves is design-related

• Material factor is NOT a reason for the poorer performance of CARBON valve

The Future

• No inherent difference in material thrombogenicity between mechanical and tissue valves



• Projected Dynamic Valve Area (PDVA)

• Digital Particle Imaging Velocimetry (DPIV)

• Parallel Computational Platforms (CFD)

• Platelet-Shear Flow Interactions (PSFI)

a

New Methodologies to Test Mechanical Prostheses

The Future

Biomolecular Link between Fluid Forces

and Platelet Aggregation



abrupt closingclose earlier and more smoothly

Closure starts after Onset of Reversed Flow



Unadressed Extreme Closing Volume Velocity

- Cavitation

- Micro-bubbles formation (HITS)

- Vortex Formation



Physiologic hemodynamic profile

No “jet-like” flow regions

No “hot spots” in the pivoting spaces

Leakage flow velocity 1 m/s

• Warfarin-free

• Not prone to structural failure

The Future A mechanical valve w/o anticoagulation



Pts with Life Expectancy > 10-15 yrs

- MECHANICAL prosthesis w/o AC

All others Pts: TA - or TF-TAVI

The Future: „Predictions“

AVR Surgery must be „re-designed“

- Small incision

- Miniaturized CPB

- Single shot „low volume“ cardioplegia

- Valve device with unlimited durability

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Valve Replacement Mechanical versus Biological Prof. Dr. T. Carrel Swiss Cardiovascular Center...

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