Definition of Success and Surgical Results That Shouldn t Be a Hard Talk, Right?

Transcription

1 Definition of Success and Surgical Results That Shouldn t Be a Hard Talk, Right? Patrick M. McCarthy MD, FACC Executive Director of the Bluhm Cardiovascular Institute Chief of Cardiac Surgery Division Heller-Sacks Professor of Surgery in the Feinberg School of Medicine November 17, 2017 Session IV: Concomitant Ablation How I Do it and Why Nobu Eden Roc Hotel Miami Beach, Florida

2 Disclosures None

3 What is Success? statement recommends a 3 month blanking period during which recurrences are not counted. reaffirms the use of freedom from any atrial arrhythmia (e.g., AF, AT, AFL) greater than 30 seconds to be the gold standard for reporting the efficacy of AF ablation strict cutoff might underestimate the true benefit of ablation Heart Rhythm, 2017:10, in press

4 Heart Rhythm 2017;14:e275 e444

5 Heart Rhythm 2017;14:e275 e444 The writing group also believes that all trials should report single procedure, off AAD therapy efficacy for ablation with a minimum of 12 months follow-up. Slight variations in this endpoint have been used in several clinical trials, but ideally, all categories of recurrence should be reported transparently, such as freedom from AF separately from other atrial arrhythmia, one- and multiple-procedure success rates, and success on and off antiarrhythmic therapy. By reporting all of these variations, the reader can determine the most relevant outcome for themselves and can also easily compare results between clinical trials.

6 Trial vs Real World Atricure Post Approval Study Example

7 Challenges in the Non-Trial World (and for those who review my papers) Surgeons Don t Manage Meds Late After Surgery Referring Docs Don t Do Holter, Zio, TEE Patients feel fine and don t come back at 6, 12, 24 month etc intervals Sometimes you don t need a holter, zio and an EKG is enough (ie failure) How do we report single center non trial studies?

8 Ann Thorac Surg 2017;103:329-41

9 How to Monitor Success ECG: That s Not Enough Holter: Most Common PPM and Implantables may be Best

10 PPM Most Accurate Cardioversion Surgery Procedure Failure: 35 seconds of AF after 90 days

11 The EP/AF World is Different It s all about perspective If 4+ MR became trace after repair would that be a failure? Not to the surgeon or patient If 4+ MR became moderate (2+) after MitraClip would that be a success? Yes to IC, no to surgeon/fda, maybe to patient Is >30 seconds of VT/VF a failure of aa? Yes! To EP, surgeon, and the patient! Is >30 sec of PAF the same? Does it cause a stroke? No one knows

12 Monitor Options Zio and Reveal LINQ Water resistant 14 days continuous recording Phone app to log symptoms Receive/return via mail Implanted by injection 3 year battery Remote download of data

13 Ann Thorac Surg 2016;101:42 8

14 Ann Thorac Surg 2016;101:42 8

15 Conclusions ILR was equivalent at detecting ATAs when compared with Holter monitoring or ECG. However, the high rate of false-positive readings and the limited number of events available for review present barriers to broad implementation of this form of monitoring. Very few symptomatic events were AF on review. Ann Thorac Surg 2016;101:42 8

16 Should we Focus on Clinical Measures of Success? Free From Stroke; Cardioversion; Catheter Ablation; Coumadin

17 CHA 2 DS 2 -VASc Am J Medicine 2012;125(6): 603

18 Heart Rhythm2015;12: )

19 Heart Rhythm2015;12: )

20 NMH: AF Ablation and Mitral Surgery June 06 to June MV patients 405 (71%) no intervention 169 (29%) intervention SR Fail CV CA Both 303 (53%) 102 (18%) % success 20% salvage SR 114 (67%)

21 Towards a Real World Approach to AF

22 What to Tell the Patient Before Surgery? Set Pre-op Expectations: Early AF recurrence is NOT a failure Meds; Monitoring (ppm, holter or zio); Frequency; Intervention (CV or CA) AF nurse ; printed materials for patient AND the referring cardiologist

23 Peri-op Meds Amiodarone 90% at DC Second Choice: The Prior AA Beta blocker: rate control 30% aren t on these due to bradycardia/heart block

24 Team Follow-up After Surgical Treatment of Atrial Fibrillation How do you make it happen? Develop care guidelines with all players - Cardiology, electrophysiology, cardiac surgery and patient - Based on the Expert Consensus Statement Communicate the plan Follow-up to keep the plan on track

25 Post AF Surgery Guidelines Phase I: DC to 3 months (Blanking Period) - Suppressive AAD and anticoagulation - Monitor for symptomatic arrhythmia and DCCV if needed - Phone follow-up with patient by AF nurse Phase II: 3-6 months (Cards?, EP?, You?) - H&P, ECG, extended cardiac monitoring - Consideration of discontinuing AAD at 3 months - Consideration of stopping anticoagulation (CHADS 2 or CHA 2 DS 2 VASc) - Phone follow-up by AF nurse

26 Post AF Surgery Guidelines Phase III: 1-2 years - At 6 months post-procedure and every 6 months for 2 years patients should have an ECG and a minimum of a Holter monitor - Phone follow-up with AF nurse Patients with Symptoms Suggestive of Arrhythmia - Patient activated cardiac event monitor - Referral for DCCV or catheter ablation if AF/AFL Patients with Implanted Cardiac Devices - Pacemaker, defibrillator, implanted cardiac monitor - Program to detect and store AHR to substitute external monitoring

27 Summary Failure is an OK term (still in AF and we all give up) Free from CV, CA Free from CVA, coumadin, aa Not AF at last follow-up (extended monitoring) Trials = strict timelines

28

29 Summary AF in the early post-operative period does not mean failure. Cardioversion or referral to EP for ablation can increase the success of procedure Monitoring is critical - Prior symptoms may no longer exist - Regular pulse may be controlled flutter

30 Summary Repeated CV after 6 months not usually useful. - Consider referral to EP for ablation - Consider re-initiation of suitable AAD Some patients who fail AF surgery are not appropriate to send for intervention - Stop the AAD they were discharged on - Evaluate appropriate anticoagulation

31

32 Peri-op Meds Amiodarone 90% at DC Second Choice: The Prior AA Beta blocker: rate control 30% aren t on these due to bradycardia/heart block

33 Team Follow-up After Surgical Treatment of Atrial Fibrillation How do you make it happen? Develop care guidelines with all players - Cardiology, electrophysiology, cardiac surgery and patient - Based on the Expert Consensus Statement Communicate the plan Follow-up to keep the plan on track

34 Summary AF in the early post-operative period does not mean failure. Cardioversion or referral to EP for ablation can increase the success of procedure Monitoring is critical - Prior symptoms may no longer exist - Regular pulse may be controlled flutter

35 Summary Repeated CV after 6 months not usually useful. - Consider referral to EP for ablation - Consider re-initiation of suitable AAD Some patients who fail AF surgery are not appropriate to send for intervention - Stop the AAD they were discharged on - Evaluate appropriate anticoagulation

36 CHA 2 DS 2 -VASc Am J Medicine 2012;125(6): 603

37 Ann Thorac Surg 2016;101:42 8

38 Ann Thorac Surg 2016;101:42 8

39 Conclusions ILR was equivalent at detecting ATAs when compared with Holter monitoring or ECG. However, the high rate of false-positive readings and the limited number of events available for review present barriers to broad implementation of this form of monitoring. Very few symptomatic events were AF on review. Ann Thorac Surg 2016;101:42 8

40 Monitor Options Zio and Reveal LINQ Water resistant 14 days continuous recording Phone app to log symptoms Receive/return via mail Implanted by injection 3 year battery Remote download of data

41 NMH: AF Ablation and Mitral Surgery June 06 to June MV patients 405 (71%) no intervention 169 (29%) intervention SR Fail CV CA Both 303 (53%) 102 (18%) % success 20% salvage SR 114 (67%)

42 Monitoring ECG: That s Not Enough Holter: Most Common

43 PPM Most Accurate Cardioversion Surgery Procedure Failure: 35 seconds of AF after 90 days

44 What is Success? Free From AF Off Antiarrthymics 3 month blanking period.freedom from any atrial arrhythmia (e.g., AF, AT, AFL) greater than 30 seconds to be the gold standard for reporting the efficacy of AF ablation Heart Rhythm, 2017:10, in press

45 Freedom from AF statement recommends a 3 month blanking period during which recurrences are not counted. reaffirms the use of freedom from any atrial arrhythmia (e.g., AF, AT, AFL) greater than 30 seconds to be the gold standard for reporting the efficacy of AF ablation strict cutoff might underestimate the true benefit of ablation Heart Rhythm, 2017:10, in press

46 Heart Rhythm 2017;14:e275 e444 The consensus statement reaffirms the use of freedom from any atrial arrhythmia (e.g., AF, AT, or AFL) greater than 30 seconds off antiarrhythmic therapy as the gold standard for reporting the efficacy of AF ablation.

47 Heart Rhythm 2017;14:e275 e444 The writing group also believes that all trials should report single procedure, off AAD therapy efficacy for ablation with a minimum of 12 months follow-up. Slight variations in this endpoint have been used in several clinical trials, but ideally, all categories of recurrence should be reported transparently, such as freedom from AF separately from other atrial arrhythmia, one- and multiple-procedure success rates, and success on and off antiarrhythmic therapy. By reporting all of these variations, the reader can determine the most relevant outcome for themselves and can also easily compare results between clinical trials.

48 Heart Rhythm 2017;14:e275 e444

49 AF Management with Valve Surgery in 17 Latest Guidelines Why? What s the Evidence? How? Lesion sets; Technologies; LAA Outcomes? How to Measure them

50 Surgical ablation for atrial fibrillation (AF) can be performed without additional risk of operative mortality or major morbidity, and is recommended at the time of concomitant mitral operations to restore sinus rhythm. (Class I, Level A) Ann Thorac Surg 2017;103:

51 Heart Rhythm, 2017:10, in press

52 Ann Thorac Surg 2017;103:329-41

53 Why Such Strong Guidelines?

54 Prospective Randomized Trials of Permanent AF Ablation with Mitral Valve Surgery Number Control Treated Trials, Year of Pts Technology 12 Month * NSR 12 Month NSR Deneke et al., Unipolar Cooled RF 26.7% 80% (p < 0.01) Schuetz et al., Microwave 33.3% 80% (p = 0.036) Akpinar et al., Unipolar RF 9.4% 93.6% (p =0.0001) Abreu Filho et al., Unipolar Cooled RF 26.9% 79.4% (p = 0.001) Doukas et al., 2005 Blomström- Lunqvist 2007 Chevalier Unipolar RF 4.5% 44.4% (p = 0.001) 69 Cryoablation 42.9% 73.3%(p=0.013) 43 Unipolar RF 4% 57% (p=0.004) Gillinov Radiofrequency and cryo 29.4% 63.2% (p<0.001)

55 Conclusions: Contemporary utilization of SA is increasing across all operative categories. Performance of SA is accompanied by a 30-day reduction in mortality and stroke. These findings further refine our understanding of the role of SA in the treatment of AF. Ann Thorac Surg 2017;104:

56 Unmatched: Treated PAF, Untreated PAF and No history of AF P<

57 PS Matched Survival

58 Does AF Treatment Change the Curve?

59 Maze Surgery is Complicated Can It Be Effective and Efficient?

60 Prospective Randomized Trials of Permanent AF Ablation with Mitral Valve Surgery Number Control Treated Trials, Year of Pts Technology 12 Month * NSR 12 Month NSR Deneke et al., Unipolar Cooled RF 26.7% 80% (p < 0.01) Schuetz et al., Microwave 33.3% 80% (p = 0.036) Akpinar et al., Unipolar RF 9.4% 93.6% (p = ) Abreu Filho et al., Unipolar Cooled RF 26.9% 79.4% (p = 0.001) Doukas et al., 2005 Blomström- Lunqvist 2007 Chevalier Unipolar RF 4.5% 44.4% (p = 0.001) 69 Cryoablation 42.9% 73.3%(p=0.013) 43 Unipolar RF 4% 57% (p=0.004) Gillinov Radiofrequency and cryo 29.4% 63.2% (p<0.001)

61 AF with MR is NOT The Same as Lone AF Volume Overload: Corrected by Surgery Pressure Overload: Corrected by Surgery Atrial Fibrosis/myopathy/hypertrophy: Anatomically Scattered, not at PV/LA junction Lessons from Basic Science and Lone AF Patients are of Limited Use, or Irrelevant

62 Cox Maze Procedure Pulmonary Vein Box Lesion MV Annulus to Box Lesion SVC-IVC TV Annulus flutter lines X2 Excision of LAA

63

64 MV Annulus Lesion

65

66 Ann Thorac Surg, 103(6):

67

68 Cryoablation: Not Just for Reops Anymore

69

70 Propensity matched groups FFAF at last FU, p=0.10 FFAF at last FU off AA, p=.09 80% 80% 60% 40% 20% 70% 89/127 79% 98/124 60% 40% 20% 69% 82/119 79% 86/109 0% LA BA 0% LA BA Pre-discharge PPM, p=0.57 Annualized Stroke rate per 10 person/year, p= % 10% 5% 0% 10% 14/147 LA 12% 17/147 BA LA 0.08 BA

71 What About the Appendage?

72 The atrial appendage is the source of stroke in 91% of non-rheumatic AF and 57% in rheumatic AF

73 J Thorac Cardiovasc Surg 2016;152:

74 European Journal of Cardio-Thoracic Surgery 45 (2014) patients, serial CT imaging over 3 year follow-up CONCLUSION: This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy for stroke prevention.

75 Conclusions Not Only Safe, it May Reduce Peri-op Risk Effective Surgery Can Be Efficient, even with LA Only Lesions (RA Ablation is Easy if Needed). 97% Use with MV. Close or Excise Appendage

76

77 What to Tell the Patient Before Surgery? Set Pre-op Expectations: Early AF recurrence is NOT a failure Meds; Monitoring (ppm, holter or zio); Frequency; Intervention (CV or CA) AF nurse ; printed materials for patient AND the referring cardiologist

78 Post AF Surgery Guidelines Phase I: DC to 3 months (Blanking Period) - Suppressive AAD and anticoagulation - Monitor for symptomatic arrhythmia and DCCV if needed - Phone follow-up with patient by AF nurse Phase II: 3-6 months (Cards?, EP?, You?) - H&P, ECG, extended cardiac monitoring - Consideration of discontinuing AAD at 3 months - Consideration of stopping anticoagulation (CHADS 2 or CHA 2 DS 2 VASc) - Phone follow-up by AF nurse

79 Peri-op Meds Amiodarone 90% at DC Second Choice: The Prior AA Beta blocker: rate control 30% aren t on these due to bradycardia/heart block

80 J Thorac Cardiovasc Surg 2016;151:

81 If You Don t Detect AF is it Safe to Stop A/C? What s the Stroke Risk?

82 CHA 2 DS 2 -VASc Am J Medicine 2012;125(6): 603

83 Ann Thorac Surg, 2017;104:

84 NM Freedom from Coumadin and Stroke At last follow-up, 496/935 patients (53%) off Coumadin Stroke rate 0.8%/year in AF Ablation MV surgery patients

85 Ann Thorac Surg 2017;103: After SA for AF, full anticoagulation therapy is common and reasonable until durable rhythm restoration is established, provided the patient otherwise meets criteria for the safe administration of systemic anticoagulant agents. Anticoagulation therapy is commonly continued until a stable sinus rhythm is documented by at least a 24-hour Holter monitor off all antiarrhythmic drugs, often between 2 and 6 months postoperatively. It is also common practice to obtain an echocardiogram before discontinuing anticoagulation to ensure adequate LA emptying by the absence of spontaneous LA echocardiography contrast.

86 Post AF Surgery Guidelines Phase III: 1-2 years - At 6 months post-procedure and every 6 months for 2 years patients should have an ECG and a minimum of a Holter monitor - Phone follow-up with AF nurse Patients with Symptoms Suggestive of Arrhythmia - Patient activated cardiac event monitor - Referral for DCCV or catheter ablation if AF/AFL Patients with Implanted Cardiac Devices - Pacemaker, defibrillator, implanted cardiac monitor - Program to detect and store AHR to substitute external monitoring

87 Post AF Surgery Guidelines 1 month 3 months 6 months 12 months 18 months 24 months H & P * * * * * * ECG * * * * * * Medication review Antiarrhythmic * STOP * * * * * Anticoagulation * * STOP Extended Monitoring Cardioversion Catheter Ablation * * * * * 6-8 weeks Consider

88 NMH AF Surgery (N=989) June 06 to June 16 60% 50% 40% 30% 20% 10% Left atrial Biatrial CM III PVI 0% Mitral Surgery All Other n=597 n=392

89 NMH AF Surgery (N=989) June 06 to June 16 60% 50% 40% 30% 20% 10% PAF Persistent LSP 0% Mitral Surgery All Others

90 Summary AF in the early post-operative period does not mean failure. Cardioversion or referral to EP for ablation can increase the success of procedure Monitoring is critical - Prior symptoms may no longer exist - Regular pulse may be controlled flutter

91 Summary Repeated CV after 6 months not usually useful. - Consider referral to EP for ablation - Consider re-initiation of suitable AAD Some patients who fail AF surgery are not appropriate to send for intervention - Stop the AAD they were discharged on - Evaluate appropriate anticoagulation

92

93 Team Follow-up After Surgical Treatment of Atrial Fibrillation How do you make it happen? Develop care guidelines with all players - Cardiology, electrophysiology, cardiac surgery and patient - Based on the Expert Consensus Statement Communicate the plan Follow-up to keep the plan on track

94 This important manuscript considers many of the factors that are important in the decision making process for the surgical treatment of atrial fibrillation. A clear treatment algorithm is offered which can help surgeons increase their success, to the obvious potential benefit for patients. Patrick M. McCarthy, et al. J. Thorac. Cardiovasc. Surg. Apr 01, 2010; 139:

95 Controversy About AF Ablation Lesion Set Strong proponents of Cox Maze IV Biatrial lesions 1, 2 Data Indicating Equal Efficacy of BA vs. LA lesions 3, 4 Increased Risk with Biatrial vs. Left Atrial Only 4,5 1 Henn MC, Lancaster TS, Miller JR, Sinn LA, Schuessler RB, Moon MR, et al. Late outcomes after the Cox maze IV procedure for atrial fibrillation. J Thorac Cardiovasc Surg. 2015;150(5): Ad N, Henry L, Massimiano P, Pritchard G, Holmes SD. The state of surgical ablation for atrial fibrillation in patients with mitral valve disease. Current opinion in cardiology. 2013;28(2): Gillinov AM, Gelijns AC, Parides MK, DeRose JJ, Jr., Moskowitz AJ, Voisine P, et al. Surgical ablation of atrial fibrillation during mitral-valve surgery. N Engl J Med. 2015;372(15): Phan K, Xie A, Tsai YC, Kumar N, La Meir M, Yan TD. Biatrial ablation vs. left atrial concomitant surgical ablation for treatment of atrial fibrillation: a meta-analysis. Europace: European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2015;17(1): Soni LK, Cedola SR, Cogan J, Jiang J, Yang J, Takayama H, et al. Right atrial lesions do not improve the efficacy of a complete left atrial lesion set in the surgical treatment of atrial fibrillation, but they do increase procedural morbidity. The Journal of thoracic and cardiovascular surgery. 2013;145(2):356-61

96 The Mechanism of AF in Our Surgical Patients is More Complicated than for Most Lone AF Patients and Experimental Studies And the Approach in Simple Patients Isn t All That Clear

97 J Am Coll Cardiol 2017;69:303-21

98 AF with MR is NOT The Same as Lone AF Volume Overload: Corrected by Surgery Pressure Overload: Corrected by Surgery Atrial Fibrosis/myopathy/hypertrophy: Anatomically Scattered, not at PV/LA junction Lessons from Basic Science and Lone AF Patients are of Limited Use, or Irrelevant

99 N Engl J Med 2015;372:

100 Treating The Mitral Treats the AF Adding Left Atrial Lesions (location of the Pathologic Change) Increases Success. For MR patients Do RA lesions Add Even More? Is There a Price for BA Lesions?

101 Ann Thorac Surg, in press 2017

102 Methods NMH 4-04 thru 6-14 Mitral surgery +/- other 2137 Mitral Surgery 838 (39%) AF pre-op 724 (86%) ablation 616 (79%) BA or LA lesion sets with cryo and/or bipolar RF available for analysis 359 (58%) LA lesion set 257 (42%) BA lesion set Lesion set was at discretion of surgeon based on patient characteristics

103 Characteristics of Original Groups Variable Left Only (N=359) Biatrial (N=257) P-value Age, years Ejection Fraction, Median (Q1, Q3) 55.0 (50.0, 61.0) 55.0 (45.0, 60.0) Cardiopulmonary Bypass time (min), median (Q1, Q3) (97.0, 154.0) (110.0, 156.0) 0.01 Repeat Sternotomy 86 (24%) 63 (25%) 0.87 Tricuspid Valve Surgery, No. (%) 92(26%) 158(61%) <.001 Mitral Valve repair 218 (61%) 145 (56%) 0.28 Mitral Valve Replacement 141 (39%) 112( 44%) 0.28 Mechanical valve 10 (7%) 4 (4% ) 0.28 AF duration, years 1.0 (0.5, 5.0) 4.0 (1.0, 10.5) <.001 Left Atrial Size, Median (Q1, Q3) 4.6 (4.1, 5.2) 4.8 (4.2, 5.3) Paroxysmal AF 223(62%) 86(33%) <.001 Post-Operative Length of Stay (Days), Median (Q1, Q3) 7.0 (6.0, 9.0) 8.0 (6.0, 10.0) Day Mortality, No. (%) 7 (2%) 7 (3%) 0.53

104 Characteristics of PS-Matched Groups Variable Left Only (N=147) Biatrial (N=147) P-value Age, years Ejection Fraction, Median (Q1, Q3) 55.0 (50.0, 60.0) 55.0 (45.0, 60.0) 0.75 Cardiopulmonary Bypass time (min), median (Q1, Q3) (110.0, 162.0) (110.0, 160.0) 0.83 Repeat Sternotomy 38 (26%) 36 (24%) 0.79 Tricuspid Valve Surgery, No. (%) 67(46%) 69(47%) 0.82 Mitral Valve repair 82 (56%) 82 (56%) 1.00 Mitral Valve Replacement 65 (44%) 65( 44%) 1.00 Mechanical valve 6 (9%) 4 (6% ) 0.74 AF duration, years 2.0 (0.5, 9.0) 3.0 (1.0, 8.0) 0.23 Left Atrial Size, Median (Q1, Q3) 4.9 (4.3, 5.4) 4.7 (4.2, 5.2) 0.12 Paroxysmal AF 62(42%) 63(43%) 0.78 Post-Operative Length of Stay (Days), Median (Q1, Q3) 7.0 (6.0, 10.0) 7.0 (5.0, 10.0) Day Mortality, No. (%) 4 (3%) 4 (3%) 1.00

105 Propensity matched groups FFAF at last FU, p=0.10 FFAF at last FU off AA, p=.09 80% 80% 60% 40% 20% 70% 89/127 79% 98/124 60% 40% 20% 69% 82/119 79% 86/109 0% LA BA 0% LA BA Pre-discharge PPM, p=0.57 Annualized Stroke rate per 10 person/year, p= % 10% 5% 0% 10% 14/147 LA 12% 17/147 BA LA 0.08 BA

106 Are There High Risk Subgroups Who May Benefit from BA, More Extensive Lesions?

107 No Difference in Matched High Risk Subgroups: FFAF off AA Last F/up LSP/Persistent: 71.4% BA vs. 66.2% LA; p=0.51 Increasing LA Size: OR=0.85; p=0.52 Increasing AF Duration: OR=0.96; p=0.13 Also No differences in CVA; Coumadin use; PPM

108 J Thorac Cardiovasc Surg 2010; 139:860-7 Failures Don t Often Come from the RA and, if so, are quick and easy to treat as an outpatient

109 What Have Others Found Recently?

110 Conclusions: PVI is associated with lower rhythm success than an extended left atrial lesion set. The addition of a right atrial lesion to an extended left atrial lesion set does not improve efficacy, but it does increase the rate of pacemaker placement for sinus dysfunction. Adding an LAA lesion may confer additional efficacy when added to a lesion set that includes PVI + MV. (J Thorac Cardiovasc Surg 2013;145:356-63)

111 .There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure (61.0% and 66.0%, respectively; P=0.60). N Eng J Med 2015;372(15):

112 532 patients with Maze IV 44 pts with left only lesions The success rates were reported for both the biatrial CMPIV and the left-sided CMPIV combined. The left sided CMPIV lesion set was included in the analysis because the success rates were observed to be similar to that of the biatrial CMPIV. However, this group of patients was highly selected. In our center, a left-sided CMPIV was chosen for patients with paroxysmal AF, left atrial size<5.0 cm, and no evidence of right atrial enlargement. In this selected group, late efficacy was good. J Thorac Cardiovasc Surg 2015;150(5):

113 800 patients in study 110 (14%) LA only and 682 Cox Maze LA-only ablation procedures included bilateral PVI (n = 82) with bipolar radiofrequency. A PVI-only procedure is referred to as bilateral PVI (or bilateral antral PVI), whereas a more extensive lesion set is referred to as a box lesion in combination with connecting lines to the LA appendage and the mitral valve isthmus endocardially and epicardially over the coronary sinus. PVI was accomplished with four to six repeated applications of bipolar radiofrequency. LA lesion set procedures (n = 28) were performed according to the Cox maze III/IV lesion scheme only on the left atrium by using either a combination of bipolar radiofrequency and cryothermal energy or cryothermal energy only. Ann Thorac Surg 2017;103:58-65

114 Ann Thorac Surg 2017;103:58-65 Propensity score matched outcomes LA-only (n= 93) Cox Maze (n=93) p value SR without AAD, 6M 80% 75% 0.41 SR without AAD, 12M 85% 83% 0.74 SR without AAD, 24M 75% 86% 0.13 Follow-up cardioversion 14% 17% 0.54 Folllow-up catheter ablation 7% 5% 0.76 Freedom from embolic stroke 95.1% 98.9% 0.21 Freedom from TIA 90.1% 93.0% 0.53

115 Europace (2015) 17, Biatrial and LA ablations produced comparable 30- day and late mortality but LA was associated with significantly reduced permanent pacemaker implantation rates. Biatrial ablation appeared to be more efficacious than LA ablation in achieving SR at 1 year, but this difference was not maintained beyond 1 year.

116 Permanent Pacemaker Implant 17.3% in ablation group vs. 5.5% in isolated Mitral Valve P= % in concomitant AVR vs. 5% in stand alone Cox Maze IV P=

117 Risk Factors for PPM Post-AF Ablation: Northwestern All Surgery

118 I d Rather Have a Pacemaker Than a Failed Ablation I d Rather Have a Late Right Side Ablation Than a Pacemaker the Rest of My Life!

119

120 Summary A Series Needs a Comparison: You Can t Say it only Works in Uncomplicated AF if you didn t use it in more Complex Patients

121 Why This Study? Northwestern Has Extensive Experience with Both Lesion Sets Hypothesis: - In mitral valve surgery patients, left atrial only (LA) and biatrial (BA) lesions result in similar outcomes Objectives: - Determine effectiveness of AF treatment with BA vs LA lesions - Determine postoperative complication rate in different lesion set groups - Determine possible subsets that may benefit

122 Ann Thorac Surg, in press 2016

123 Ann Thorac Surg 2017;103:58-65

124 Our study clearly demonstrates that early to intermediate success rates can be reasonably achieved with LA-only surgical ablation procedures in patients with no significant clinical predictors of failure. However, the results of the multivariate prediction models in this study should be evaluated with caution. Although these models provide initial evidence that ablation procedures confined to the LA may have reduced success in patients with traditional predictors of failure, the small sample size and event rate limit the generalizability and reliability of these results. Ann Thorac Surg 2017;103:58-65

125 Presented at The Society of Thoracic Surgeons 52 nd Annual Meeting, January 25, 2016, Phoenix, AZ Of 914 patients studied, 115 had LA only lesions

126 124 patients between undergoing AVR +/- CAB J Heart Valve Dis 2012;21:350-57

127 J Heart Valve Dis 2012;21:350-57

128

129 Unmatched groups FFAF at last FU, p=0.57 FFAF at last FU off AA, p= % 80% 60% 40% 20% 0% 75% 231/306 LA BA 73% 159/217 60% 40% 20% 0% 75% 210/280 LA 72% 143/198 BA Pre-discharge PMM, p=0.006 Stroke Rate per 10 person/year, p= % % 5% 0% 7% 24/359 LA 13% 34/257 BA LA BA

130 Long term survival of the original groups

131 Perioperative complications in propensity matched groups p=0.32 Left only Biatrial 44 30% 52 35% % 95 65% No complications Complications No complications Complications

132 Long term survival in propensity matched groups