Concurrent AF Ablation with Mitral Valve Surgery

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1 Concurrent AF Ablation with Mitral Valve Surgery James L. Cox, MD Surgical Director, Center for Heart Rhythm Disorders Bluhm Cardiovascular Institute Professor of Surgery Feinberg School of Medicine Northwestern University Medical Center Chicago, Illinois, USA

2 Disclosures Adagio Medical, Inc Laguna Hills, CA - Co-Founder, Board of Directors, Stockholder, Stipend Atricure, Inc Mason, Ohio - Consultant, Stockholder, Stipend SentreHEART, Inc Redwood City, CA - Consultant, Stockholder, Stipend PAVmed, Inc New York City, NY - Board of Directors, Stockholder Lucid Diagnostics New York City, NY - Board of Directors PotentiaMED, Inc St. Louis, MO - Board of Directors, Stockholder

3 5-Year Survival Rates 1. PANCREAS 2. MESOTHELIOMA 3. BRAIN & CNS 4. LIVER & IBD 5. LUNG & BRONCHUS 6. ESOPHAGUS 7. STOMACH 8. OVARY 9. MYELOMA 10. CERVIX UTERI ATRIAL FIBRILLATION 11. HODGKIN LYMPHOMA 12. ORAL CAVITY & PHARYNX 13. RECTUM 14. NON-HODGKIN LYMPHOMA 15. COLON 16. KIDNEY&RENAL PELVIS 17. CHRONIC LYMPHOCYTIC LEUKEMIA 18. URINARY BLADDER 19. CORPUS UTERI 20. KAPOSI SARCOMA 21. MELANOMA 22. TESTIS 23. BREAST 24. THYROID 25. PROSTATE ATRIAL FIBRILLATION OVERALL Adapted from: Piccini, Eur Heart J 2014; 35, Howlader N Cancer Statistics Review, , National Cancer Institute. Bethesda, MD, based on April 2013.

4 Adapted from: Picini et al. Eur Heart J 2014;35: Mozaffarian et al. Circulation. 2015;131:e29-e322 Cumulative Incidence of Events in the 5 Years after Diagnosis of In-Hospital AF in Medicare Patients 49% Death 20% Heart Failure Stroke Acute MI

5 Impact of AF on Cardiovascular Event-Free Survival Adapted from: Stewart et al. Am J Med. 2002;113:

6 Incidence of AF in Patients Referred for Mitral Surgery Article n n with AF % with AF Ngaage, ,821 1,016 36% Wang, % Coutino, % Szymanski, % TOTALS 4,228 1,593 38%

7 Incidence of AF in Patients Referred for Mitral Surgery Gillinov AM: J Interv Card Electrophysiol, 2007

8 Preop AF in Mitral Valve Patients - Survival following MV Surgery - No Preop AF Preop AF Gillinov, Current Opinion in Cardiology, 2005

9 Paroxysmal Atrial Fibrillation (PAF) NSR Self-Limiting Episode of Atrial Fibrillation

10 Non-Paroxysmal Atrial Fibrillation (N-PAF) Once an episode of AF is established and is being sustained by the macro-reentrant drivers, the triggers NSRhave nothing to do with the AF. Therefore, any temporary or limited benefit of a PVI or a Box Lesion for N-PAF is not due to isolation of the triggers. Persistent, L-S Persistent, or Permanent Episode of Atrial Fibrillation

11 Clinical Presentation of Atrial Fibrillation Stand-Alone AF Concomitant AF PAF Stand-Alone PAF Concomitant PAF 60% N-PAF Stand-Alone N-PAF Concomitant N-PAF 40% 97% 3%

12 Differences in Stand-Alone PAF and Concomitant PAF Stand-Alone PAF - There is no associated surgical heart disease - The etiology of most stand-alone AF is a mystery - Both atria are usually grossly normal Concomitant PAF - Secondary to Left-Heart Disease - Mitral valve disease - Aortic valve disease - Ischemic heart disease - LV cardiomyopathies - Heart Failure - Systemic Hypertension - The LA is almost always grossly abnormal - The RA may or may not be grossly abnormal

13 Location of Triggers in Stand-Alone PAF 90%

14 Location of Triggers in Concomitant PAF 70%

15 Location of Triggers in Concomitant PAF 10% 25% 20% 25% 20%

16 The Objectives of AF Surgery PAF N-PAF Paroxysmal AF Persistent AF Long-Standing Persistent AF Permanent AF

17 The Objectives of AF Surgery PAF N-PAF Paroxysmal AF Isolate the Triggers Persistent AF Long-Standing Persistent AF Permanent AF

18 The Objectives of AF Surgery PAF N-PAF Paroxysmal AF Isolate the Triggers Persistent AF Long-Standing Persistent AF Permanent AF Interrupt the Drivers

19 Paroxysmal AF (PAF) in Patients having CABG, AVR, or MV Surgery

20 CABG and/or AVR Patients with PAF PAF Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 50% less PAF & Stroke Protection Box Lesion + LAAO - 70% less PAF & Stroke Protection Maze + LAAO - 90% less PAF & Stroke Protection

21 CABG and/or AVR Patients with PAF PAF Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 50% less PAF & Stroke Protection Box Lesion + LAAO - 70% less PAF & Stroke Protection Maze + LAAO - 90% less PAF & Stroke Protection

22 CABG and/or AVR Patients with PAF PAF Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 70% less PAF & Stroke Protection Maze + LAAO - 90% less PAF & Stroke Protection

23 CABG and/or AVR Patients with PAF PAF Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze + LAAO - 90% less PAF & Stroke Protection

24 CABG and/or AVR Patients with PAF PAF Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze Procedure - > 90% less PAF & Stroke Protection

25 CABG and/or AVR Patients with PAF Viable Options Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze Procedure - > 90% less PAF & Stroke Protection

26 CABG and/or AVR Patients with PAF Viable Options Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection - 10% PV less Isolation PAF & + Stroke LAAO Protection - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze Procedure - > 90% less PAF & Stroke Protection

27 Mitral Valve Patients with PAF Viable Options Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze Procedure - > 90% less PAF & Stroke Protection

28 Mitral Valve Patients with PAF Viable Options Surgical Options: Ignore the AF - Same PAF & No Stroke Protection LAAO - 10% less PAF & Stroke Protection PV Isolation + LAAO - 60% less PAF & Stroke Protection Box Lesion + LAAO - 80% less PAF & Stroke Protection Maze Procedure - > 90% less PAF & Stroke Protection

29 Non-PAF (N-PAF) (Persistent) in Patients with CABG, AVR, or MV Surgery

30 Surgery for Concomitant N-PAF

31 Surgery for Concomitant N-PAF

32 Surgery Maze for Concomitant Procedure N-PAF

33 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 10% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

34 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 10% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

35 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 10% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

36 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

37 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

38 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

39 CABG and/or AVR Patients with N-PAF N-PAF Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - > 90% less AF & Stroke Protection

40 CABG and/or AVR Patients with N-PAF Viable Options Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

41 CABG and/or AVR Patients with N-PAF Viable Options Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection - 40% LA less Maze N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

42 Mitral Valve Patients with N-PAF Viable Options Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection LA Maze - 70% less N-PAF & Stroke Protection Maze Procedure - 90% less AF & Stroke Protection

43 Mitral Valve Patients with N-PAF Viable Options Surgical Options: Ignore the AF - Same N-PAF & No Stroke Protection LAAO - 5% less N-PAF & Stroke Protection PV Isolation + LAAO - 5% less N-PAF & Stroke Protection Box Lesion + LAAO - 40% less N-PAF & Stroke Protection - 40% LA less Maze N-PAF & Stroke Protection Maze Procedure - >90% less AF & Stroke Protection

44 Summary PAF CABG, AVR Box Lesion + LAAO (80%) Mitral Valve Maze Procedure (>90%) Non-PAF CABG, AVR Maze Procedure (>90%) Mitral Valve Maze Procedure (>90%)

45 Treatment of Concomitant AF in USA Not Treated 85% Not Treated 70% Not Treated 50% 15% 30% 50%

46 Why do surgeons ignore AF when performing Mitral Valve surgery? Safety concerns Unsure of advantages Perceived lack of consensus Uncomfortable with AF surgery

47 Why do surgeons ignore AF when performing Mitral Valve surgery? Safety concerns Unsure of advantages Perceived lack of consensus Uncomfortable with AF surgery

48 The Safety of Concomitant AF Surgery Incremental risk of the Cox-maze IV procedure for patients with atrial fibrillation undergoing mitral valve surgery Saint LL, Damiano RJ Jr, Cuculich PS, Guthrie TJ, Moon MR, Munfakh NA, Maniar HS: Washington University in St. Louis, Barnes-Jewish Hospital, St. Louis, MO J Thor Cardiovas Surg, 2013 Aug 30. pii: S (13) doi: /j.jtcvs The addition of a Cox-maze IV procedure did not significantly affect the procedural mortality.

49 The Safety of Concomitant AF Surgery Surgical ablation of atrial fibrillation in the United States: Trends and Propensity Matched Outcomes Badhwar V, Rankin JS, Ad N, Grau-Sepulveda M, Damiano RJ, Gillinov AM, McCarthy PM, Thourani VH, Suri RM, Jacobs JP, Cox, JL Ann Thor Surg, 2017;104: STS National Database 86,941 Patients Performance of surgical ablation is accompanied by a 30-day reduction in mortality and stroke.

50 2017 Guidelines Safety 2017 STS Guidelines on Surgery for Atrial Fibrillation Adding AF surgery does not affect operative morbidity Class Ia, Level B Adding AF surgery does not affect operative mortality Class I, Level A 2017 AATS Guidelines on Surgery for Atrial Fibrillation Adding AF surgery does not affect operative morbidity Class IIa, Levels A, B-R, B-NR Adding AF surgery improves operative mortality Class I, Level A

51 Why do surgeons ignore AF when performing Mitral Valve surgery? Safety concerns Unsure of advantages Perceived lack of consensus Uncomfortable with AF surgery

52 Advantage # 1 Restoration of Normal Sinus Rhythm Treated AF Untreated AF Louagie, Ann Thorac Surg, 2009

53 Advantage # 2 An Improved Quality of Life Conversion to sinus rhythm by ablation improves quality of life in patients submitted to mitral valve surgery. Forlani S, De Paulis R, Guerrieri WL, Greco R, Polisca P, Moscarelli M, Chiariello L Ann Thor Surg, 2006;81(3): Variables Good QOL Poor QOL p Follow-up (mos) 20 ± ± 15 NS Normal Sinus Rhythm 59% 22% Atrial fibrillation 40% 78% NYHA III IV (%)

54 Advantage # 3 Halts Progression of Tricuspid Insufficiency Stulak, Ann Thorac Surg, 2008

55 Advantage # 4 Freedom from Long-Term Strokes % Percent Freedom from Stroke Years Damiano, JTCVS, 2003

56 Freedom from Stroke Advantage # 4 Freedom from Long-Term Strokes 100% Treated AF 80% Untreated AF 60% 40% 20% Years after surgery Itoh, Eur J Cardiothorac Surg, 2006

57 Advantage # 5 Improves Long-Term Survival No AF AF Lim, Circulation, 2001

58 Advantage # 5 Improves Long-Term Survival Surgery for atrial fibrillation in patients with mitral valve disease: Results at five years from the International Registry of Atrial Fibrillation Surgery Melo J, Santiago T, Aguiar C, Berglin E, Knaut M, Alfieri O, Benussi S, Sie H, Williams M, Hornero F, Marinelli G, Ridley P, Fulquet-Carreras E, Ferreira A J Thor Cardiovasc Surg, 2008;135(4):

59 Advantage # 5 Improves Long-Term Survival No AF Treated AF Untreated AF p = Lee, J Thor CardiovascSurg, 2012

60 Advantage # 5 Improves Long-Term Survival Musharabash FN, Damiano, RJ Jr, JTCVS, 2018

61 2017 AATS Guidelines Advantages 2017 AATS Guidelines on Surgery for Atrial Fibrillation Improves quality of life Class IIa, Levels B-R,C-LD Decreases perioperative stroke Class IIa, Level A Decreases long-term stroke/tia Class IIa, Levels A, B-NR Remained silent on survival Ad, et al: JTCVS, 2017;153(6):

62 Why do surgeons ignore AF when performing Mitral Valve surgery? Safety concerns Unsure of advantages Perceived lack of consensus Uncomfortable with AF surgery

63 Consensus 2012 Consensus Statement on Surgical AF: It is advisable that all patients with documented AF referred for other cardiac surgeries undergo a. procedure for AF. Heart Rhythm Society American College of Cardiology American Heart Association Society of Thoracic Surgeons European Heart Rhythm Association European Cardiac Arrhythmia Society

64 2017 STS Guidelines on AF Concomitant AF Surgery Recommended with Mitral Valve Surgery Class I, Level A Recommended with CABG, AVR, CABG+AVR Class I, Level B Does not affect operative mortality Class I, Level A Does not affect operative morbidity Class Ia, Level B Badhwar, et al: Ann Thor Surg, 2017;103(1):

65 2017 AATS Guidelines on AF Concomitant AF Surgery Recommended with Mitral Valve Surgery Class I, Level A Recommended with CABG, AVR, CABG+AVR Class I, Level B Improves operative mortality Class I, Level A Does not affect operative morbidity Class IIa, Levels A, B-R, B-NR Decreases perioperative stroke Class IIa, Level A Improves quality of life Class IIa, LeveLS B-R,C-LD Decreases long-term stroke/tia Class IIa, Levels A, B-NR Ad, et al: JTCVS, 2017;153(6):

66 Why do surgeons ignore AF when performing Mitral Valve surgery? Safety concerns Unsure of advantages Perceived lack of consensus Uncomfortable with AF Surgery

67 Successful and Unsuccessful AF Surgery Decrease in All Cardiac Complications AF Surgery Successful AF Surgery Failed Untreated AF Fukunaga, Ann Thorac Surg, 2008

68 Many Patterns but only one Principle A Maze-I Procedure B Maze-II Procedure C Maze-III Procedure D Maze-IV Procedure

69 CTSN Clinical Trials Paper (NEJM) This is NOT a Maze Procedure!

70 A Wolf Mini Maze B Left-Sided Maze This is NOT a Maze Procedure! This is NOT a Maze Procedure! C The Dallas Lesion Set D The 5-Box Maze This is NOT a Maze Procedure! This is NOT a Maze Procedure!

71 LEFT ATRIUM 1. Isolation of Left Pulmonary Veins Diagram of Isolation of Left Pulmonary Veins A B Operative Photo of Isolation of Left Pulmonary Veins Drivers Remaining After Isolation of Left Pulmonary Veins C D

72 LEFT ATRIUM 1. Isolation of Left Pulmonary Veins 2. LAA to LSPV Lesion Diagram of LSPV to LAA Lesion A B Operative Photo of LSPV to LAA Lesion Drivers Remaining After LSPV to LAA Lesion LAA C D

73 LEFT ATRIUM 1. Isolation of Left Pulmonary Veins 2. LAA to LSPV Lesion 3. Clip LAA Diagram of LAA Clip A B Operative Photo of LAA Clip Drivers Remaining After LAA Clip C D

74 LEFT ATRIUM 1. Isolation of Left Pulmonary Veins 2. LAA to LSPV Lesion 3. Clip LAA 4. Isolation of Right Pulmonary Veins Diagram of Isolation of Right Pulmonary Veins LA PA RSPV A B Operative Photo of Isolation of Right Pulmonary Veins Drivers Remaining After Isolation of Right Pulmonary Veins LA PA RSPV C D

75 LEFT ATRIUM 1. Isolation of Left Pulmonary Veins 2. LAA to LSPV Lesion 3. Clip LAA 4. Isolation of Right Pulmonary Veins 5. Creation of Box Lesion Diagram of Creation of Box Lesion LIPV Floor Lesion Roof Lesion LIPV A B Operative Photo of Creation of Box Lesion Drivers Remaining After Creation of Box Lesion LSPV LIPV Floor Lesion C Roof Lesion D

76 An Alternative

77 A B Operative Photo of CS Lesion C D

78 A B Operative Photos of Mitral Line C D

79 RA Drivers Remaining After LA Lesions RA Drivers After SVC-IVC Lesion A B RA Drivers After Completion of T Lesion No RA Drivers Remaining After RAA Lesion C D

80 RA Incision A B Diagram of SVC-IVC Lesion Operative Photo of SVC-IVC Lesion SVC Lesion IVC Lesion C D

81 Diagram of T Lesion Endocardial Cryolesion to Tricuspid Valve T Lesion (Partial) A B Operative Photo of Completion of T Lesion Operative Photo of Completion of T Lesion End of Atriotomy End of Atriotomy Tricuspid Annulus C D Tricuspid Annulus

82 Diagram of RAA Lesion A B Operative Photo of RAA Lesion Completed RA Lesions RAA Aorta C SVC D

83 Management of the LAA in patients with AF undergoing CABG, AVR, or Mitral surgery

84 Major LAA Types This is the same Left Atrial Appendage! Courtesy of Prof. Andrew Cook, U.K.

85 Comparative effectiveness of LAA occlusion among patients with atrial fibrillation undergoing concomitant cardiac surgery: A report from the STS Adult Cardiac Surgery Database Friedman DJ (DCRI) Presented at 2017 ACC Meeting, Washington, DC Thromboembolism 1,000 participating institutions 90% of all programs in country 10,524 patients 37% had LAA occlusion (3,892) All Cause Mortality TE, Hemorrhagic Stroke, or Death

86 The LAAOS-III Trial The only RCT to evaluate if LAA occlusion will reduce stroke in patients undergoing routine cardiac surgery CHA 2 DS 2 VASc Score >2 4,700 Patients 3,000 patients enrolled as of April ,700 patients enrolled as of September Year study, to be completed in summer 2018

87 23 years 21 years 26 years

88 Summary In 2018, we must have a valid reason for not performing a Maze procedure in patients with a history of AF who are undergoing Mitral Valve surgery. Otherwise, we are not providing an acceptable Standard of Care to our patients.

89 Thank You

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