Fast Track en Cierre de Orejuela. Herramientas para facilitar el procedimiento, por Ignacio Cruz González

1. Fast-Track en Cierre de Orejuela Herramientas para facilitar el procedimiento Ignacio Cruz González, MD, PhD Profesor Titular, Universidad de Salamanca Departamento de Medicina, Universidad de Salamanca Servicio de Cardiología, Hospital Universitario de Salamanca Presidente Electo ACI-SEC

2. COI Proctor y consultor para Cierre de Orejuela Proctor

4. 98,8% 98,3% 98,5% 94,3% 95,1% 94,3% 90,9% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0 % EWOLUTION CAP2 PREVAIL CAP PROTECT AF PINNACLE FLX NCDR LAAO Registry N=400 N= 38,158 *Implant success defined as deployment and release of the device into the LAA N=576 N=566 N=449 N= 1019 N=265 PINNACLE FLX IDE Study - Implant Success

5. All-Cause Death 0% (0/400) Ischemic Stroke 0.5% (2/400) Systemic Embolism 0% (0/400) Device or Procedure Related 0% (0/400) Events Requiring Surgery or Major Endovascular Intervention Event Rate Primary Safety Endpoint 0.5% (2/400) *Based on the combined rate observed in PREVAIL1 and CAP22, plus a clinically acceptable delta Event Rate Performance Goal = 4.21% 0.5% (P<0.0001 0,0 3,0 2,0 1,0 4,0 5,0 )* PINNACLE FLX IDE Study - Safety

6. LMR

7. LMR

8. Spanish Registry 1000 900 800 700 600 500 400 300 200 100 0 2012 2013 2014 2015 2016 2017 2018 2019

9. Auscultación cardiaca

10. TAVI 2008 2021 What´s past is prologue ( W. Shakespeare)

11. TAVI

12. Auscultación cardiaca LAAO

13. Sedación vs anestesia general Técnicas de imagen Alta temprana

14. GLOBAL STRATEGY

15. GLOBAL STRATEGY Pre-procedure Procedure Post-procedure

16. Pre-procedure

17. Imaging based planning What do we need? Morphology

20. Imaging based planning What do we need? Do we exclude any patients based on anatomy?

21. Imaging based planning What do we need? Dimensions • Ostium • Landing zone • Depth

22. Imaging based planning What do we need? Thrombus

25. CT vs Echo

26. Imaging based planning TEE - Mayor experiencia y disponibilidad - Evaluación completa (estructura y flujos) - Medición 2 y 3D - Posible monitorización intraprocedimiento tiempo real - Evaluación no invasiva - Medición 2 y 3D. -Mejor resolución espacial. -Mejor definición anatomía (cardiaca y extracardiaca). - Posible guiado anatómico intraprocedimiento (no tiempo real) - Precisa radiación y medio de contraste

27. 45 135 90 0 Imaging based planning TEE

28. Imaging based planning TEE

29. Imaging based planning CT

32. Imaging based planning CT - extra tools

35. Imaging based planning FEOPS

36. Confidential With courtesy of Dr. De Backer Simulations Watchman 24mm Watchman 27mm Watchman 30mm Ostium Transeptal puncture site estimation Imaging based planning FEOPS

37. Proximal Proximal Proximal Distal Distal Distal Results not availabe, device too large Watchman 24 mm Watchman 27mm Watchman 30 mm Imaging based planning FEOPS With courtesy of Dr. De Backer

38. Proximal Proximal Proximal Distal Distal Distal Results not availabe, device too large Watchman 24 mm Watchman 27mm Watchman 30 mm Imaging based planning FEOPS With courtesy of Dr. De Backer

39. Virtual implant Watchman 27mm Peri-procedural fluoroscopy Imaging based planning FEOPS With courtesy of Dr. De Backer

40. Virtual implant Watchman 27mm Post-procedural MSCT scan @3months Perfect match of position and frame deformation between predicted and observed device No peri-device leaks observed on post-op, as predicted by the virtually deployed device apposition Imaging based planning FEOPS With courtesy of Dr. De Backer

41. Imaging based planning CT – Heart Nav

45. Procedure

46. Procedure 3D TEE

47. Procedure ICE vs MicroTEE

48. Procedure ICE

49. Procedure Micro TEE

50. Procedure Micro TEE

51. TEE probe S8-3t: • Has a shaft width of 5.2 mm and length of 85 mm, a transducer tip width of 7.5 mm, height of 5.5 mm, and length of 18.5 mm. • The microTEE transducer is a 32-element phased array transducer that is equipped with 2D B-mode echocardiography, colour Doppler, pulse-wave and continuous- wave Doppler, M- mode, and colour flow M-mode features. • It has a centre frequency of 6 MHz on a bandwidth of 3.2 to 7.4 MHz. Procedure Micro TEE

52. TEE probe S8-3t: • No X-plane • No 3D Procedure Micro TEE

53. Procedure Micro TEE – 2D

54. Procedure Micro TEE -Doppler

55. Spontaneous echo contrast vs Thrombus Procedure Micro TEE - Thrombus

56. Procedure Micro TEE - LAAO

61. Procedure Sedation vs GA

62. Procedure Sedation vs GA ANESTESIA LOCAL

63. Procedure Fusion -CT

66. Procedure Fusion -Echo

67. Procedure Fusion -Echo

68. Post-Procedure

69. Alta precoz

70. Alta precoz HD

71. Alta precoz 4 8 12 27 31 55 60 64 60 79 20 10 0 40 30 90 80 70 60 50 45 201 0 201 1 201 2 201 3 201 4 201 5 201 6 201 7 201 8 201 9 2020 HD

72. Alta precoz 4 8 12 27 31 55 60 64 60 79 20 10 0 40 30 90 80 70 60 50 45 201 0 201 1 201 2 201 3 201 4 201 5 201 6 201 7 201 8 201 9 2020 HD

73. Case #1

74. CT Case #1

75. Micro TEE Case #1

76. Fusion TS Case #1

77. Case #1

78. Case #1

79. Case #1

80. Case #1

81. Case #1

82. Case #1

83. Case #2

84. Ostium 23.5 mm Depth 16 mm Case #2

85. Sizing Charts 8-20% Compression 10-30% Compression Case #2

88. Case #2

89. Case #2

90. Ostium 24 mm Depth 15 mm Case #2

91. RAO CAU Case #2

92. Ball (Flx 27) Case #2

95. Leak Case #2

96. Tug-Test Case #2

97. Recapture Case #2

98. 2nd Deployment Case #2

99. Leak Case #2

100. 2nd Recapture Case #2

101. Ball (31mm) Case #2

102. Deployment Case #2

103. Tug-test Case #2

104. Injection Case #2

105. Released Case #2

106. Case #2

107. Conclusiones

108. Conclusiones PRE PROCEDURE POST

109. @icruzgonzalez

Fast Track en Cierre de Orejuela. Herramientas para facilitar el procedimiento, por Ignacio Cruz González

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Fast Track en Cierre de Orejuela. Herramientas para facilitar el procedimiento, por Ignacio Cruz González