This presentation is about Biomaterials that are used in Cardiovascular and Thoracic surgery. This is one field where lot of technology has gone into developing the biomaterials. For the purpose of presentation, they have been divided into Synthetic, natural and composite. The presentation talks about Valves, Conduits, and patches. There is also a segment on Ventricular Assist Devices (VADs)

1. BIOMATERIALS FOR
CARDIOVASCULAR SURGERY
DR. RAJESHT R
CONSULTANT
CARDIOVASCULAR AND THORACIC SURGERY
drrajeshtr@gmail.com

2. DEFINITION
By American National Institute of Health
ANY SUBSTANCE OR COMBINATION OF SUBSTANCES, OTHER
THAN DRUGS, SYNTHETIC OR NATURAL IN ORIGIN:-
WHICH CAN BE USED FOR ANY PERIOD OF TIME,
WHICH AUGMENTS OR REPLACES PARTIALLY OR TOTALLY
ANY TISSUE, ORGAN OR FUNCTION OF THE BODY,
IN ORDER TO MAINTAIN OR IMPROVE THE QUALITY OF LIFE
OF THE INDIVIDUAL.
A BIOMATERIAL IS BROADLY DEFINED AS A MATERIAL THAT
INTERACTS WITH BIOLOGICAL SYSTEMS FOR MEDICAL
PURPOSES
MaiT Lam, Expert Rev Cardiovasc Ther., 2012 August

3. CARDIOVASCULAR DISEASE
LEADING CAUSE OF DEATH IN INDIA
INCLUDING POORER STATESAND RURAL AREAS
AGE STANDARDIZED CVD DEATH RATE
INDIA 272 / 100,000 POPULATION
GLOBAL AVERAGE 235 / 100,000 POPULATION
PRABHAKARAN D et al, CIRCULATION 2016 Apr 19.
TREATMENT INCLUDES MEDICAL AND SURGICALTHERAPIES
NOVEL SURGICAL STRATEGIES REQUIRED FORTHE
REPAIR / REPLACEMENT / REGENERATIONOF DAMAGEDTISSUES

4. VAIIETY OF BIOMATERIALS ARE USED IN
THESE SURGERIES
BIOMATERIALS
SYNTHETIC
NATURAL
COMPOSITE

5. BIOMATERIALS
 SYNTHETIC
 METALS – TITANIUM, STAINLESS STEEL, OTHER ALLOYS
 POLYMERS – ePTFE / DACRON
 NATURAL
 AUTOGRAFTS –
PULMONARY AUTOGRAFTS / PERICARDIUM /VASCULAR CONDUITS
 HOMOGRAFTS –
VALVES ANDVALVE CONDUITS / PERICARDIUM /VASCULAR CONDUITS
 XENOGRAFTS –
BOVINE PERICARDIUM / JUGULAR VEIN, / PORCINEVALVES
 COMPOSITE
COMPOSITEVALVES – BOVINE AND PORCINEVALVES
PATCHES OF AUTOLOGOUS PERICARDIUM & DACRON
REINFORCED UMBILICALVEIN CONDUIT

6. IDEAL BIOMATERIAL
STRENGTH – RESISTANCETO DILATATION
DURABILITY – HEART BEATS 40 MILLIONTIMES AYEAR
MAINTAIN GOOD HEMODYNAMICS
NON / LOWTHROMBOGENECITY
DOESN’T CAUSE DAMAGETO BLOOD ELEMENTS
CHEMICAL
INERT
NONTOXIC
RESISTANCETO ALLERGIC REACTION / INFLAMMATION /
INFECTION
EASILY AVAILABLE / EASILY PROCESSABLE
EASYTO HANDLE

7. BIOMATERIALS USED IN CVS
• HEARTVALVES
• GRAFTS / PATCHES
• MECHANICAL CARDIO-RESPIRATORY ASSIST DEVICES
• EXTRA CORPOREAL MEMBRANE OXYGENATOR
• VENTRICULAR ASSIST DEVICE
• ARTIFICIAL HEART

8. HEART VALVES
 4 VALVES
 ALLOW FREE PASSAGE
OF BLOOD
 PREVENT
REGURGITATION
 VARIETY OF DISEASES
AFFECT THESE
VALVES

9. DIASEASEDAORTICVALVE

10. REPLACEMENT VALVES
MECHANICAL VALVES
MONOLEAFLET VALVES
BILEAFLET VALVES
NATURAL VALVES
AUTOGRAFTS
HOMOGRAFTS
COMPOSITE VALVES
BIOPROSTHETIC VALVES
COMBINATION OF SYNTHETIC
MATERIAL & BOVINE / PORCINE
TISSUES

11. MECHANICAL HEART VALVES
VERY DURABLE
PRIMARY STRUCTURALABNORMALITIESARE
RARE
LOW PROFILE – CAN BE USED IN SMALL
HEARTS
SMALL SIZES FOR SMALL PATIENTS

12. MONOLEAFLET MECHANICAL VALVE
TTK CHITRA
ONLY INDIANVALVE
SINGLE DISC MOVING
WITHIN A FRAME

13. HAYNES 25 ALLOY – HIGHLY WEAR RESISTANT
COBALT-NICKEL- CHROMIUM-TUNGSTEN ALLOY

14. TTK CHITRA
FRAME AND DISC – HYDRODYNAMICALLY DESIGNED
REDUCE DRAG AND INERTIA
POLISHED
REDUCE THROMBOGENECITY
DISC – ULTRA HIGH MOLECULAR WT POLYETHYLENE
CLOSING SOUNDS ARE SOFT

17. DRAW BACKS
SINGLE DISCVALVE
HIGH PROFILE
LESS FAVOURABLE HEMODYNAMICS

18. BILEAFLET MECHANICAL VALVE
ST JUDE VALVE
TWO SEMI-CIRCULAR DISCS
FRAME
MADE UP OF PYROLYTIC CARBON
SEWING RING – POLYESTER
85-DEGREE OPENING ANGLE
BLOOD FLOW CLOSEST TO
NATURAL

19. PYROLYTIC CARBON(PYC)
HIGHLY BIOCOMPATIBLE
HIGH THROMBORESISTANCE
EXTREMELY DURABLE
SUFFICIENT STRENGTH
GOOD MANUFACTURABLILITY

21. DRAWBACKS
ANTICOAGULATION
LIFELONG
MONITORING TESTS REQUIRED
COMPLICATION OF ANTICOAGULATION
THROMBOEMBOLISM – 1% / PATIENTYEAR
HEMORRHAGE – 0.5% / PATIENTYEAR
“TRADING ONE DISEASEWITH ANOTHER”

22. INFECTIVE ENDOCARIDTIS
0.5 % / PATIENT YEAR

23. PANNUS FORMATION
VASCULAR FIBROUS TISSUE INGROWTH
OBSTRUCTS ORIFICE
INTERFERES WITH DISC MOVEMENTS

24. NATURAL VALVES – AUTOGRAFTS
ROSS OPERATION
PULMONARY VALVE USED TO REPLACE DISEASED
AORTIC VALVE
HOMOGRAFT / BIOPROSTHETICVALVETO REPLACE
PULMONARYVALVE

26. ADVANTAGES DRAWBACKS
EXCELLENT HEMODYNAMICS
LIVING AND GROWING
AORTIC VALVE
LOW RISK OF
THROMBOEMNBOLISM
INFECTIVE ENDOCARDITIS
PROGRESSION OF
PRIMARY DISEASE
ONEVALVE DISEASE
INTOTWOVALVE
DISEASE

27. AUTOLOGOUS PERICARDIAL VALVES
AUTOLOGOUS PERICARDIUM –
ABUNDANTLY AVAILABLE
TREATEDWITH GLUTARALDEHYDE
TO INCREASE STRENGTH
MODELS AVAILABLE FOR CONSTRUCTING TRILEAFLET VALVE
DURING OPERATION

28. DRAW BACKS
NOT DURABLE
PRONE FOR
FAILURES
DEGENERATIONS

29. HOMOGRAFTS
VALVES OBTAINED FROM ANOTHER HUMAN BEING
AFTER BRAIN DEATH / FROM CADAVERS
CRYO-PRESERVED
LOSS OF ANTIGENECITY
LONG TERM STORAGE

30. ADVANTAGES DRAWBACKS
EXCELLENT
HEMODYNAMICS
NO ANTICOAGULATION
LOWER INCIDENCE OF
THROMBOEMBOLISM
CAN BE USED IN SURGERY
FOR INFECTIVE
ENDOCARIDITS
SHORTAGE
CRYOPRESERVATION
EXPENSIVE
PRONETO DEGENERATION
– RE-OPERATION

31. COMPOSITE – BIOPROSTHETIC VALVES
STENTED BIOPROSTHETICVALVES
BOVINE PERICARDIAL VALVES
PORCINE VALVES
STENTLESS BIOPROSTHETIC VALVES
MEDTRONIC FREESTYLE
SJM TORONTO SPV

32. PORICNE BIOPROSTHETIC VALVES
STJUDE EPIC VALVE
PORCINE AORTICVALVE
POLYESTER-COVERED FLEXIBLE ACETAL
COPOLYMER STENT.
SPECIAL ANTICALCIFICATION TREATMENT
LOW PRESSURE FIXATION WITH GLUTARALDEHYDE

33. PERICARDIAL BIOPROSTHETIC VALVE
ST J UDE TRIFECTA
BOVINE PERICARDIUM
LOW PRESSURE FIXATIONWITH GLUTARALDEHYDE
TITAMIUM STENT
POLYESTER SEWING RING
SPECIALANTI CALCIFICATION TREATMENT
UNIQUE DESIGN – LEAFLETSAROUND STRUT

34. STENTLESS BIOPROSTHETIC VALVE
SJM TORONTO SPV VALVE
DACRON COVERED PORCINE AORTIC
BIOPROSTHESIS
USEFUL IN SMALL ANNULUS
GOOD HEMODYNAMICS
LESS STRESS DUE ABSENCE OF
STENT-LEAFLET JUNCTION

35. NOT DURABLE

36. ADVANTAGES DISADVANTAGES
 EXCELLENT
HEMODYNAMICS
 NO NEED FOR
LONGTERM
ANTICOAGULATION
 REDUCED INCIDENCE OF
THROMBOEMBOLISM &
INFECTIVE
ENDOCARDITIS
 LARGE SIZE
 PRONE FOR
DEGENERATION
 MORE EXPENSIVE

37. GRAFTS
SYNTHETIC – DACRON / PTFE
NATURAL
AUTOGRAFTS – ARTERIES – IMA
VEINS – SAPHENOUSVEINS
HOMOGRAFTS – SAPHENOUSVEINS
TREATED UMBILICALVEIN GRAFT
XENOGRAFTS – BOVINE JUGULARVEINS
COMPOSITE --

38. SYNTHETIC GRAFTS
DACRONTUBE GRAFTS
POLYETHYLENETEREPHTHALATE –
CHEMICALLY INERT  BIOCOMPATIBLE
WOVEN / KNITTEDCONFIGURATION.
WOVEN PREFERRED  LESS LEAKAGE
COATEDWITHALBUMIN / COLLAGEN
SURFACE IS CRIMPED  TISSUE INCORPORATION

39. DACRON TUBE GRAFTS
REPLACEMENTOF DISEASEDARTERIES
BYPASS GRAFTS
PREFERRED FOR LARGEVESSELS LIKE
AORTA
AVAILABLE INVARIOUSCONFIGURATIONS

40. ePTFE
 FLUOROCARBON POLYMER, FORMED INTO SHEETS BY EXTRUSION.
 BIOCHEMICALLY INERT  GOOD BIOCOMPATIBILITY
 HIGH STRENGTH-TO-WEIGHT RATIO  RESISTANCE TO DILATATION.
 LOWTHROMBOGENICITY, LOWER RATES OF RESTENOSIS AND LESS CALCIFICATION
 HIGH RESISTANCE TO
ALLERGIC REACTION &
INFLAMMATION
 REPLACEMENT / BYPASS OF ARTERIES
 SUITABLE FOR ALLVESSELS,
PREFERRED IN SMALLER VESSELS

41. DRAW BACKS
BOTH HAVE SIGNIFICANTLY IMPROVED
BOTH GOODTO USE AND PREFERRED
PATENCY RATES REDUCE WITHTHE SIZE OFTHE NATIVE
VESSEL
STILL NOT USED FOR FINE ARTERIAL ANASTAMOSIS
LIKE CABG
PTFE GRAFTS STILLWEEP

42. NATURAL GRAFTS
ARTERIES
INTERNAL MAMMARYARTERY
RADIALARTERY
VEINS
SAPHENOUSVEINS

43. INTERNAL MAMMRY ARTERY  PERFECT CONDUIT FOR CABG

44. DRAWBACKS
 ATHEROSCLEROSISCAN INVOLVE
ARTERIALCONDUITS
 VEINS ARE MANYTIMES DISEASED
ESPECIALLY IN BAREFOOTWALKERS
 SOMETIMES, ESPECIALLY IN REPEAT
PROCEDURES  SHORTAGEOF CONDUITS

45. CARDIOVASCULAR PATCHES
TO REPLACE DEFECTS
CONGENITAL – ASD &VSD
AQUIRED – POST MI SEPTAL RUPTURE
RECONSTRUCT DEFORMED STRUCTURES
LEFTVENTRICLE ANEURYSM REPAIR
ENLARGE NAROWED PASSAGES

46. CARDIOVASCULAR PATCHES
NATURAL
AUTOLOGOUS PERICARDIUM
TREATED / CRYOPRESERVED
PERICARDIAL HOMOGRAFT
TREATED BOVINE PERICARDIUM
SYNTHETIC
DACRON / PTFE
COMPOSITE
COMBINATION OF ABOVE

47. DRAWBACKS
AUTOLOGOUS PERICARDIUM
NOT FREELYAVAILABLE
DILATESOVERTIME
STRENGTHCAN BE INCREASED BY
TREATINGWITH GLUTARALDEHYDE
ATTHE COST OFVIABILITY
HOMOGRAFT – NOT EASILY AVAILABLE
NONVIABLE
BOVINE PERICARDIUM
EXPENSIVE
DEGENERATE / CALCIFYOVERTIME

48. SYNTHETIC PATCHES
EASILY AVAILABLE
NONVIABLE
NONFUNCTIONAL
THROMBOGENIC
LEAK / POROUS (SOMETIMES ADVANTAGEOUS)

49. VENTRICULAR
ASSIST
DEVICES

50. DRAWS BLOOD
FROM ONE
VENTRICLE
AND
PUMPS INTO GREAT
VESSEL
HOW DOES A VAD WORK?

51. PULSATILE LVADS

52. 2ND GENERATION LVAD
Outflow
Cannula
Bend
Relief
Blood
Pump
Inflow
Cannula
Flex
Section
Percutaneous
Cable
ConnectionRev. 12.0 (3/24/04)

53. AXIAL FLOW (NON-PULSATILE) LVADS

54. VENTRASSIST– 3rD GENERATION CENTRIFUGAL LVAD

55. VentrAssist – Components
Internal components
Pump
Inflow Canula
Outflow Canula
DRIVELINE–
TUNNELLEDTHROUGH ANT. ABDOMINAL WALL
CONNECTS BOTH COMPONENTS
External components
Controller
Batteries

56. PUMP
 CENTRIFUGAL PUMP
 Small --298g
 Titanium
construction
 Rotor suspended in
blood
 Less hemolysis /
thrombosis
 Long lasting

57.  EXTERNALCOMPONENTS IN A COMPACT PACK

58.  CONTROLLER –
• CONTROLSTHE
PUMP
• SUPPLIES POWER
• PROVIDES ALARM
• STORES DATA

59.  SLOT FOR
PRIMARY
BATTERY
 PUMP DRAWS
POWER FROM
PRIMARY

60.  SLOT FOR
RESERVE
BATTERY
 RESERVE
BATTERY STAND
BY IN CASE
POWER IN
PRIMARY IS LOW

61.  RECHARGEABLE BATTERIES

62. DEPICTION OF A PERSON WITH LVAD

63. WELL HEALED DRIVELINE EXIT WOUND

64. DRAWBACKS
DRIVE LINE EXITINGTHROUGH SKIN
THROMBOGENIC
LOSS OF PULSATILE FLOW
GI BLEEDS
HEMOLYSIS
RISK OF INFECTION
EXPENSIVE

65. FUTURE
TRILEAFLETVALVES
POLYMERIC HEARTVALVES
BIOENGINEEREDTISSUES
ECM SCAFFOLD
3D PRINTING
VALVES
ARTIFICIALVALVES

66. VAD
FULLY IMPLANTABLE
TRANSDERMAL RECHARGE
NONTHROMBOGENIC
PULSATILE HEMODYNAMICS
REPLACE HEART TRANSPLANT

67. THE FUTURE IS EXCITING !!

68. THANK YOU