SHA24/034002

Saudi Heart Association. Riyadh, KSA, 2013

Mechanical vs Tissue Heart Valves Same indications world wide?

JosĂŠ L. Pomar, MD, PhD Professor of Surgery The Thorax Clinic Institiute Barcelona, Spain

Mechanical vs Tissue Heart Valves MECHANICAL Heart Valves

ANTICOAGULATION

TISSUE Heart Valves

DURABILITY - LIFE EXPECTANCY - REOPERATION

QUALITY OF LIFE

Mechanical vs Tissue Heart Valves MECHANICAL HV

TISSUE HV BEST QUALITY OF LIFE

ANTICOAGULATION Status Quo since the 70’ies

DURABILITY

LIFE EXPECTANCY = AGE THV last longer than the patients: patients are older Anti-calcification treats REOPERATION is not much of an issue: mortality rate has improved compared to 10 years ago

Objective of the lecture: MECHANICAL HV

TISSUE HV

ANTICOAGULATION

DURABILITY - LIFE EXPECTANCY - REOPERATION

QUALITY OF LIFE

Mechanical vs Tissue Heart Valves

MECHANICAL HV

TISSUE HV

BEST QUALITY OF LIFE ANTICOAGULATION

DURABILITY - LIFE EXPECTANCY - REOPERATION

1. Durability

Charles Hufnagel

(first prosthetic valve 1952)

1. Durability and type

Carlos M.G. Durรกn

Donald N. Ross

Brian Barratt-Boyes

1. Durability and design

Albert Starr

1. Durability and materials

1. Durability and techniques Stent mounted at 7 years

Freehand sewn at 13 years

1. Durability and same supposed THV

Results from Stanford University Results from Madrid, Spain

1. Durability and same supposed THV Were the valves from same animals?

Was the pre-fixation time similar?

Was the porcine tissue treated the same?

Were the patient cohorts comparable?

Was the analysis done under same definitions?

1. Durability and hemodynamics "Hemodynamics is concerned with the forces generated by the heart and the motion of blood through the cardiovascular system."

WR Milnor, Preface of Hemodynamics 1982

1. Durability and hemodynamics

1. Durability and management

Cusp Fixed at High Pressure

Cusp Fixed at Low Pressure

Cusp Fixed at Zero Pressure

1. Durability and management

Mechanical vs Tissue Heart Valves Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier-Edwards pericardial valve with the Toronto Stentless Porcine Valve.

Cohen G, Zagorski B, Christakis GT, Joyner CD, Vincent J, Sever J, Harbi S, Feder-Elituv R, Moussa F, Goldman BS, Fremes SE. Division of Cardiovascular Surgery at Sunnybrook Health Sciences Centre and the University of Toronto, H-429, 2075 Bayview Ave, Toronto, Ontario M4 N 3M5, Canada.

Although offering improved hemodynamic outcomes, the SPV did not afford superior mass regression or improved clinical outcomes up to 12 years after implantation.

J Thorac Cardiovasc Surg. 2010 Apr;139(4):848-59.

1. Durability and animal origin

Marian I. Ionescu

PERICARDIAL VS PORCINE THV

Porcine vs pericardial after Ionescu 100 Percentage of valves

90 80 70 60 50 40 30 20 10 0

1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001

Year of operation

Pericardial Porcine

1. Durability, materials and design

Alain Carpentier

1. Durability, materials and design

Alain Carpentier

Calcification Tears Thrombosis Pannus

1. Durability, materials and design

% freedom from valve dysfunction

Durability Perimount vs SJM MHV 100 SJM

90 AVR

80 70 60 50

Perimount 1

2 3 4 5 6

7 8 9 10 11 12 13 14 15 16 17

Durability: General concepts 

Durability of THV is overestimated due to misinformation – ‘Explant’ due to valve dysfunction is subset of valve dysfunction, should consider all valve dysfunction – Dysfunctional valves, if not explanted, impact valve performance and therefore patient outcome – Actual curves should not be mixed up with actuarial curves



Mechanical Heart Valves last more than a lifetime – In particular last generations of MH valves

Evolution of mechanical vs bioprostheses Mechanical

Bioprosthetic

Homograft

100

Percentage of valves

90 80 70 60 50 40 30 20 10 0 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 Year of operation

TODAY ?

Evolution of mechanical vs bioprostheses

Mechanical vs Tissue Heart Valves

IT IS MUCH MORE IMPORTANT THE “DURABILITY” OF THE PATIENT THAN THAT OF THE SUBSTITUTE And we know since years that for most authors SURVIVAL IS THE SAME, including some special cohorts with higher risk or children

2. Anticoagulation

Anticoagulation & Atrial fibrillation ATRIAL FIBRILLATION MITRAL AORTIC 15%

60%-80%

Anticoagulation & TE hazard

TE THV = TE MHV TE elderly = strongly associated with

non-valvular risk factors (age, presence of coronary disease)

Anticoagulation & Management

SHOULDN’T BE A PROBLEM ? 

AC can be perfectly managed at all ages (Baudet, Thulin, Logeais, Arom, Antunes, Masters, Davis)



AC can even be better managed with self management (Koertke, Preiss)



AC related risks are even lower with most recent MHV (Wang, Horstkotte, Arom)



Temporary interruption is manageable (JACC, Circulation)

Anticoagulation: Important points 

Not only a problem for MHV, also for many THV pts (a lot of THV patients end up with warfarin as well due to AF)



TE and BL should not be compared to 0 % for THV

– TE MHV = TE THV (Petersheim, Hammermeister, Holper, Khan) – BL MHV > BL THV, but only a little (Khan) 

AC can be perfectly managed at all ages (Baudet, Thilin, Logeais, Arom, Antunes, Masters, Davis)



AC can even be better managed with self management (Koertke, Preiss)



AC related risks are even lower with SJM MHV (Wang, Horstkotte, Arom)

3. Life expectancy 

LIFE EXPECTANCY is not the same as AGE

– The average age of patients increases but also their life expectancy (National Statistics) – 10 year survival of 70+ valve recipients is 50% and not different from the background population (Logeais, Galloway, Arom, McGrath)

– Therefore, life expectancy is a better criterion for valve selection (Thulin)

Life-expectancy of elderly valve recipients “In patients over 70 years of age and patients submitted to aortic or mitral valve replacement with mild or no symptoms, the survival rate was similar for many years to that in the Swedish population at large.�, Stahle E, et al., Long-term relative survival after primary heart valve replacement, Eur J Cardiothorac Surg 1997 Jan;11(1):81-91

N= 2365

Mechanical vs Tissue Heart Valves Biological or mechanical prostheses in tricuspid position? A meta-analysis of intrainstitutional results.

Rizzoli G, Vendramin I, Nesseris G, Bottio T, Guglielmi C, Schiavon L. Istituto di Chirurgia Cardiovascolare, UniversitĂ di Padova, Padua, Italy. giulio.rizzoli@unipd.it

There is not a gold standard in tricuspid prostheses replacement. Prosthetic choice is left to the surgeon's clinical judgment, taking into consideration each patient's characteristics and needs.

Ann Thorac Surg. 2004 May;77(5):1607-14.

3. Life expectancy

So much said, so little known‌..

Mechanical vs Tissue Heart Valves Impact of patient-prosthesis mismatch and aortic valve design on coronary flow reserve after aortic valve replacement.

Bakhtiary F, Schiemann M, Dzemali O, Dogan S, Sch채chinger V, Ackermann H, Moritz A, Kleine P. Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University Hospital, Frankfurt/Main, Germany.

Normalization of CFR after AVR in patients with AS was observed only for stentless valves. Coronary flow reserve might explain the excellent long-term results for stentless valves.

J Am Coll Cardiol. 2007 Feb 20;49(7):790-6.

4. Re-operation

12-16% Paul S. NY City Kevin A. Florida

Exponential increase as of 6-8 yrs MHV

THV

AVR patients

Khan et al, 2001

4. Re-operation Re-operative hazard outweighs AC-related hemorrhage with MHV 6-8 years post implant (Khan, Hammermeister) Beyond mortality, there are considerable neurologic and cognitive complications (Selnes, Newman) Mortality rates increase w/ age (STS database, Masters, Piehler) Mortality rates increase w/ number of valve operations database, UK valve registry)

(STS

MORTALITY > AGE

MORTALITY > REOP

STROKE > REOP

5. Quality of life

Mechanical vs Tissue Heart Valves Tissue Versus Mechanical Prostheses: Quality of Life in Octogenarians Mariano Vicchio, MD, Alessandro Della Corte, MD, Luca Salvatore De Santo, MD, Marisa De Feo, MD, PhD, Giuseppe Caianiello, MD, Michelangelo Scardone, MD, and Maurizio Cotrufo, MD

Department of Cardiothoracic and Respiratory Sciences, Second University of Naples, and Department of Cardiovascular Surgery

Conclusions: Long-term survival after AVR in selected octogenarians was similar to that of the general elderly population. The device type exerted no influence on QOL.

and Transplants, V. Monaldi Hospital, Naples, Italy

Ann Thorac Surg 2008;85:1290–5 Š 2008 by The Society of Thoracic Surgeons

Quality of life - patients’ perception SF-36 Questionnaire

QOL MHV = QOL THV QOL MHV = QOL POPULATION

Quality of life MINIMIZE SHORT TERM AND LONG TERM RISKS

MORTALITY

UK REGISTRY DATA 2001

Survival < 70 yrs

MHV: better survival in 70group

Survival > 70 yrs

MHV: similar survival in 70+ group

Quality of life - patientsâ&#x20AC;&#x2122; perception SF-36 questionnaires show same QOL for THV and MHV (Koertke, Perchinsky, Myken, Goldsmith)

QOL for MHV is same as background population

(Arom)

MHV have excellent hemodynamics, resulting in better patient outcome SJM MHV have better hemodynamics than stented THV (SJM Regent, Pelletier)

Survival between MHV and THV is similar, therefore minimizing valve related morbidity improves QOL In the longer run (6-8 years post-op), MHV have lower morbidity

(Peterseim,

Khan)

MHV patients can be as active as background population

(sjm.com)

Conclusion Some real facts and arguments There are enough scientific arguments to say that : THV and MHV differ considerably in durability Anticoagulation can be successfully managed at all ages, especially since self-regulation Risk associated with reoperations, both morbidity and mortality, increases with age and number of operations Life expectancy, not age should be a criterion for valve selection Patientsâ&#x20AC;&#x2122; perceived quality of life is the same between THV and MHV

Recommendation Recommendation (60+ age group): MHV for patients w/ life expectancy >8-10 yr (if not contra-indicated to warfarin) THV for patients w/ life expectancy < 8-10 yr

Mechanical vs Tissue Heart Valves Quality of life after mechanical vs. biological aortic valve replacement.

Aboud A, Breuer M, Bossert T, Gummert JF. Depatment of Cardiothoracic Surgery, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany .

Younger patients with mechanical valves and older patients with biological valves had significantly better item scores. In all age groups, men tended to have better scores than women, but a significant difference was noted only in the physical functioning index. The quality of life in patients with mechanical and biological valves was similar at 2 years postoperatively.

Asian Cardiovasc Thorac Ann. 2009 Jan;17(1):35-8.

Mechanical vs Tissue Heart Valves Are bioprostheses associated with better outcome than mechanical valves in patients with chronic kidney disease requiring dialysis who undergo valve surgery?

Bianchi G, Solinas M, Bevilacqua S, Glauber M. Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.

Therefore, survivals have been biased in favour of mechanical valves.

Taking together these data, biological valves are a suitable treatment for dialysis-dependent patients and, while not superior to mechanical valves in survival due to the aforementioned study biases, exhibit lower valve-related and anti-coagulation related events.

Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):473-83.

Mechanical vs Tissue Heart Valves Long-term results of mechanical and biological heart valves in dialysis and nondialysis patients.

BĂśning A, Boedeker RH, Rosendahl UP, Niemann B, Haberer S, Roth P, Ennker JA. Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany .

The long-term survival of dialysis-dependent patients after AVR is low (5-year survival: 29.5â&#x20AC;&#x160; %) irrespective of the type of heart valve prosthesis. Therefore, the use of biological AVR is not contraindicated in this group of patients.

Thorac Cardiovasc Surg. 2011 Dec;59(8):454-9.

Any device for everybody?

Mechanical vs Tissue Heart Valves Aortic valve replacement: choice between mechanical valves and bioprostheses.

Silberman S, Oren A, Dotan M, Merin O, Fink D, Deeb M, Bitran D. Department of Cardiothoracic Surgery, Shaare Zedek Medical Center, Jerusalem, Israel.

Survival and event-free survival are similar for patients receiving a mechanical or biological aortic valve substitute. Selection of a valve replacement device should be based on life expectancy, patient preference, ability to take anticoagulants, lifestyle, risk of bleeding, and risk of reoperation. Patient age alone should not be the determining factor.

J Card Surg. 2008 Jul-Aug;23(4):299-306.

Mechanical vs Tissue Heart Valves

Mechanical vs Tissue Heart Valves

Mechanical vs Tissue Heart Valves

Mechanical vs Tissue Heart Valves Ten-year comparison of pericardial tissue valves versus mechanical prostheses for aortic valve replacement in patients younger than 60 years of age.

Weber A, Noureddine H, Englberger L, Dick F, Gahl B, Aymard T, Czerny M, Tevaearai H, Stalder M, Carrel TP. Department of Cardiovascular Surgery, Inselspital, Bern University Hospital and University of Berne, Berne, Switzerland.

In the present limited cohort of patients younger than 60 years old, biologic aortic valve replacement was associated with reduced mid-term survival compared with survival after mechanical aortic valve replacement. Despite similar valve-related event rates in both groups, the better hemodynamic performance of the mechanical valves and/or protective effect of oral anticoagulation seemed to improve the outcome. The transcatheter valve-in-valve intervention as potential treatment of tissue valve degeneration should not be considered the sole bailout strategy for younger patients because no evidence is available that this would improve the outcome.

J Thorac Cardiovasc Surg. 2012 Nov;144(5):1075-83.

Mechanical vs Tissue Heart Valves

Transient ischemic attack (TIA) and thrombosis rates were low. Valve thrombosis was not reported in AVR in this or other series of On-X valves.

Reported thromboembolism is uncommon even in a population in whom 40% have no or inadequate anticoagulation.

Mechanical vs Tissue Heart Valves Reduced Anticoagulation After Mechanical Aortic Valve Replacement: Interim Results From the PROACT Randomized FDA IDE Trial Puskas, John D. , Nichols, Dennis , Gerdisch, Marc , Quinn, Reed , Rhenman, Birger , Fermin, Lilibeth , McGrath, Michael , Kong, Bobby , Hughes, Chad , Sethi, Gulshan , Wait, Michael , Martin, Thomas ,Graeve, Allen

AATS MONDAY, MAY 6, 2013 7:45 PLENARY SCIENTIFIC SESSION a.m. (8 minute presentation, 12 minute discussion) Moderators:Hartzell V. Schaff, MD Thoralf M. Sundt, III, MD

Conclusions: INR may be maintained safely between 1.5-2.0 in AVR patients after implantation of this approved bileaflet mechanical prosthesis. In combination with low-dose aspirin, this therapy resulted in significantly lower risk of bleeding than customary INR 2.0-3.0, without significant increase in TE.

Mechanical vs Tissue Heart Valves ASPIRIN, AS THE ONLY TREATMENT ?

A one year study

ESC-EACTS Guidelines

Mechanical vs Tissue Heart Valves

In favor of mechanical prosthesis

In favor of bioprosthesis

Mechanical vs Tissue Heart Valves Guidelines and registries are intended to help healthcare professionals in their work, but they should not replace their knowledge and skills.

Mechanical vs Tissue Heart Valves

.

Mechanical vs Tissue Heart Valves .

NGO approached FC NYHA III-IV One chance and no more Severe polivalvular disease LA thrombosis Permanent Afib Organic TR

Analphabetic, but the brother teacher