Mechanical or Bioprosthetic valve for middle-aged patient

Dr.Vijay Dikshit

Apollo Hospitals, Hyderabad

1963-1966

1967-1969

1969-1977

1977-1984

1985-1990

1990-1992

1993-1999

1999-2000

Valvular Heart Disease

• There are estimated 5 million patients in India suffering from Heart Valve Disease

• New patients added every year 50,000

• Total no. of Heart Valve Surgeriesperformed all over India in year

2007 12,234 2009 18,587

Choice for middle age patientsControversial

• USA : Life expectancy M 75 F 78 Middle age (55-65 yrs)

• India : Life expectancy M 63 F 64 Middle age ? ?

• Life expectancy with Valvular heart disease in IndiaClass III- IV Limited Life Span

Why Do I Prefer Tissue Valve ?

• Hemodynamics – Central flow without hindrance

• Freedom from disc Impingement or sudden mechanical Dysfunction

• Anti Coagulation- Less stringent

• Noise free

• Durability – A concern ?

% Prosthetic Valve Usage by Type

92% 89%83%

74%67%

8% 11%17%

26%33%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2005 2006 2007 2008 2009

MHV

THV

U.S. Aortic Valve Data : Tissue vs. Mechanical

Edwards Lifesciences Estimates

Myths about Mechanical Valves

• Mechanical valves last lifelong !Indeed they last beyond life but patient may not !!

• You’ll Not Need Another Operation !

• Risks of Thromboembolism is minimal on anti –coagulants !

• Coumadin therapy is simple

• Re-operation is very risky

• Mechanical valves are less expensive

Mechanical Prosthesis

Cost :AnticoagulantINR Test every 15-60 days

No. of visits to PhysiciansThrombolysisTreatment of HemorrhageRepeated Hospitalization Reoperation

Perils of Life Long Anticoagulation

• Patient compliance• Dose standardisation• PT & INR results variation• Hemorrhage /Valve Thrombosis• Cerebral / Visceral bleed with advancing age• Dose regulations in variety of clinical situation• Drug interaction with Anticoagulants

Life after a Bioprosthetic Valve

• Safer

• No sudden untoward events

• Less hassles of anticoagulation

• Elective “Re-do” surgery

• Better Quality of life, socially acceptable

Mechanical Valves

Hufnagel 1952

Ball & Cage 1960

Monoleaflet

1964Bileaflet

1977

Little progress in design of mechanical valves since 1977

Current bioprosthesis (2nd and 3rd generation )

• Low or Zero pressure fixation(Edward Perimount,Medtronic Mosaic Porcine Valve)

• Anti mineralization techniques( Mitigate calcification)

a. Polysorbate 80 (Tween 80) + Ethanol(XenoLogiX) (Carpentier-Edwards SAV& Perimount)b. Sodium dodecyl sulphate (Hancock II Porcine Bioprosthesis)

Durability has markedly Increased

Projected Future Risks After Aortic Valve Replacement - - - in a 5 0 Year Old Man, Assuming 3 0 Year Survival

Mechanical Valve Bioprosthetic % %

Operative mortality 1.5 15.

R isk of death at reoperation 21. 58 108( . for

2nd Reoperation)

- Valve related mortality (cumulative for 30 y) 27

29

- Valve related morbidity 30(cumulative for y) 78

12

Total risk of morbidity and 1086. 4 8 .3 30mortality over y 2 (5 9 .1 2 nd

re2222222ons)

Circulation .2008;117:253-256

Our Experience(July1991 – Oct 2010)

• Total No. of Cardiac Surgical procedures 14,256• No. of valve repair 184• No. of Heart Valve Replacements 2,230 (15.6%)

MVR 804 358 1162AVR 662 252 914DVR 89 63 152TVR 2 2

TOTAL(Pt.) 1555 675 2230

(Valves) (1644) (742) (2386)

Mechanical Tissue Total

Experience of valve surgery at Apollo Hospital Hyderabad

(No .of valves)

Experience Of Bioprosthetic Valve

BIOCOR 360EPIC 94PERIMOUNT 171 MAGNA 21FREESTYLE 76HANCOCK 06HP 08TRONTO SPV 02PRIMA PLUS 01 MOSAIC 03Total 742

Experience with Mechanical valves• Medtronic hall 458• St.Jude 392• TTK Chitra 408• On X 85• Starr Edward 188• ATS 5• Edward Meera 16 • St.Vincents 15• Omniscience 2• Carbomedics 16• Others 23

Surgical Results of Bioprosthetic ValveTotal number of Pts – 675

Mortality (30 days) – 16 (2.3%)

CauseLow cardiac output – 12

Infection – 3

CVA – 1

New atrial fibrillation – 8Complete heart block – 2Prolonged ventilation – 17

Biocor – Lowest Profile valve

• Low Stent Post Height

• Minimizes aortic wall protrusion

• Reduces LV outflow tract obstruction in the mitral position

• Eases implantability

Benefits

Carpentier-Edwards PERIMOUNT Magna

• Leaflets made of bovine pericardium

• Good hemodynamics

• Dependable durability

FreestyleFreestyle®® Stentless Valve Stentless Valve

Design Features

Minimal PolyesterCovering

Surgeon’s Flags & Suture

Demarcation Line

Leaflets Fixed atZero-Pressure

AOA® Tissue Treatment on Wall and

LeafletsRoot-PressureFixation

Full Root Configuration

RE-OPERATION

• Risk of re-operation 0.5 - 1.8% / patient - year

• Freedom from re-operation 88% - Mechanical valves at 10 years 76% - Bioprosthesis Mortality• 15.3% - Bioprosthesis• 28.6% - Mechanical valves

Reason • Bioprosthesis - elective operation• Mechanical – urgent- may be in catastrophic circumstances

Tyers, Ann Thorac Surg, 1995:60:s 464-9, Munro, Jamieson Ann Thorac Surg 1995:60:S459-63

Webb, J. G. et al. Circulation 2010;121:1848-1857

Transcatheter valve deployed within a surgical prosthesis (SAPIEN THV and Carpentier-Edwards)

Percutaneous trans catheter valve-in-valve implantation

New Technologies In Bioprosthetic Valves

3f Aortic 3f Aortic BioprosthesisBioprosthesis

Stent less Single Stent less Single suture line suture line

MedtronicsMedtronics

FUTURE OF TISSUE VALVESThe future for heart valve replacement lies in tissue engineering (TEHV)

Vesely I Circ.Res.2005;97;743-755

Conclusion Preferred valve in middle age—BIOPROSTHETIC

• Present generation Bioprosthetic valves are expected to do well for 15-20 yrs & possibly beyond

• Unpredictable long term outcomes of mechanical valve

makes it of inferior choice

• With better Quality of life & low risk of repeat surgery, Tissue-valves deserve a second look for younger patients

• Evolving percutaneous Valve-in-Valve tecchnology makes tissue valve even more attractive choice