Should Paroxysmal Atrial Fibrillation be Treated During Cardiac Surgery?

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Should Paroxysmal Atrial Fibrillation be Treated During Cardiac Surgery? Patrick M. McCarthy MD, Adarsh Manjunath, BA, Jane Kruse, RN, BSN, Adin-Cristian Andrei, PhD, Zhi Li, MS, Edwin C. McGee, MD, S. Chris Malaisrie, MD, Richard Lee, MD Monday, May 6, 2013 Adult Cardiac Surgery Scientific Session AATS 93 rd Annual Meeting Minneapolis, MN

Should Paroxysmal Atrial Fibrillation be Treated During Cardiac Surgery? Patrick M. McCarthy MD, Adarsh Manjunath, BA, Jane Kruse, RN, BSN, Adin-Cristian Andrei, PhD, Zhi Li, MS, Edwin C. McGee, MD, S. Chris Malaisrie, MD, Richard Lee, MD Monday, May 6, 2013 Adult Cardiac Surgery Scientific Session AATS 93 rd Annual Meeting Minneapolis, MN

Disclosures Adin-Cristian Andrei, PhD: Consultant, AtriCure S. Chris Malaisrie, MD: Research, Medtronic Speaker: Edwards Lifesciences and Abiomed None for other authors

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., 2002 30 Unipolar Cooled RF 26.7% 80% (p < 0.01) Schuetz et al., 2003 Akpinar et al., 2003 43 Microwave 33.3% 80% (p = 0.036) 67 Unipolar RF 9.4% 93.6% (p = 0.0001) Abreu Filho et al., 2005 70 Unipolar Cooled RF 26.9% 79.4% (p = 0.001) Doukas et al., 2005 Blomström- Lunqvist 2007 Chevalier 2009 101 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)

7 RCT Permanent AF/MVR All p< 0.001 in favor of NSR if AF treated No Peri-op AF Treatment Complications None powered or followed for late survival Heterogenous NSR rates (44-94%)

Little Known About PAF Risk CVA and thromboembolism Symptoms Medication effects

Survival Preop AF impacts other outcomes 100 80 60 40 20 0 0 5 10 15 20 Years Increased Mortality Increased incidence of stroke and heart failure Increased Pacemakers Ngaage, DL, et al. Thorac and Cardiovasc Surg 2007;133 (1):182-189 Ngaage, DL et al. Ann Thorac Surg. 2007;84 (2):434-42 Banach, M, et al. Thorac Cardiov Surg 2008; 56:20-23 Quader MA, et al. Does preoperative atrial fibrillation reduce survival after coronary artery bypass grafting? Ann Thorac Surg. May 2004;77(5):1514-1522

AF Treated vs. no AF Hx vs Untreated AF J Thorac Cardiovasc Surg 2012;143(6):1350-41

Investigate 1. Does AF Treatment Increase Risk? 2. Does AF Ablation Impact Survival? 3. FFAF outcomes?

Methods 4947 cardiac surgery pts (04/2004 06/2012) 1150 pre-op AF (23%) 3797 no history of AF 552 pre-op PAF (48%) 423 Treated PAF (77%) 129 Untreated PAF (23%)

Decision Making Treatment or No Treatment: Dependent on Surgeon and concomitant operation Lesion Set: Which Concomitant Operation

Types of Ablation Surgery PAF ablated (N = 423) n % Left atrial only 199 47 PVI 119 28 Biatrial 85 20 Classic Maze 20 5

Preoperative Unmatched p < 0.001 Untreated PAF (N = 129) Treated PAF (N = 423) No AF (n=3797) Characteristics n % n % n % Age 68.7 + 13.7 66.5 + 11.8 61.7 + 14.1 CHF 59 46 165 39 915 24 NYHA Class III-IV 64 50 153 36 1130 30 Previous MI 37 29 56 13 712 19 CAD 82 66 173 41 2117 58 Prior Pacemaker 21 16 46 11 103 3 Reoperation 62 48 69 16 454 12 Elective 89 69 364 86 2945 78 Ejection fraction 55 57 60 Left atrial size 4.2 4.3 3.8

Intra/Post-op Unmatched all p <0.001 Untreated PAF (n=129) Treated PAF (n=423) No AF (n=3797) Variable n % n % n % Mitral Valve 33 26 263 62 949 25 Aortic Valve 70 54 158 37 1517 40 CABG 54 42 144 34 185 5 Euroscore 26.5 + 21.8 12.7 + 13.2 11.2 + 13.2 CPB 117 [86, 160] 120 [94, 150] 106 [79, 142] XClamp 91 [73, 118] 89 [70, 115] 87 [66, 115] Complications 56 43 117 28 1506 40 PPM new 6 5 27 6 92 2 30 day Mortality 8 6 10 2 78 2

PS Matched: Preoperative No AF (n = 879) Treated PAF (n =343) Characteristics n % n % p value Age 65.5 + 12.9 66.3 + 11.9 0.35 CHF 309 53 133 39 0.24 NYHA Class III-IV 283 32 117 34 0.52 Previous MI 125 14 42 12 0.37 CAD 387 45 146 43 0.58 Prior Pacemaker 36 4 33 10 <.001 Reoperation 113 13 51 15 0.35 Elective 761 87 295 86 0.79 Ejection fraction 60 58 0.06 Left atrial size 4.0 4.3 <.001

PS Matched: Preoperative No AF (n = 314) Untreated PAF (n =114) Characteristics n % n % p value Age 67.8 + 12.5 68.1 + 13.9 0.85 CHF 127 40 48 42 0.76 NYHA Class III-IV 283 32 117 34 0.52 Previous MI 95 30 30 26 0.43 CAD 208 69 72 66 0.62 Prior Pacemaker 21 7 15 13 0.033 Reoperation 144 46 49 43 0.60 Elective 229 73 81 71 0.70 Ejection fraction 55 55 0.51 Left atrial size 4.0 4.2 0.24

PS Matched: Preoperative Untreated AF (n =80) Treated PAF (n =166) Characteristics n % n % p value Age 67.7 + 14.8 67.9 + 11.6 0.93 CHF 35 44 63 38 0.38 NYHA Class III-IV 35 44 71 43 0.88 Previous MI 20 25 32 19 0.30 CAD 47 60 98 60 0.98 Prior Pacemaker 9 11 22 13 0.66 Reoperation 23 29 42 25 0.57 Elective 59 74 131 79 0.37 Ejection fraction 55 55 0.87 Left atrial size 4.1 4.3 0.11

FFAF: Unmatched 75% 85% 96%

PS Matched FFAF off AADs at Last Follow-up P= 0.0013 92% 84% P=0.0041 91% 71% P=0.0539 81% 65%

Unmatched: Treated PAF, Untreated PAF and No history of AF P<.0001 3797 3263 2724 2208 1748 1303 423 365 313 250 206 131 129 99 73 62 47 28

PS Matched Survival

Findings No increase in Periop Risk - Perhaps some decreased complications with TrAF - No increased PPM Improved FFAF Tr PAF vs. UnTrPAF - Decreased FFAF vs. No history of AF (reduced follow-up No AF Group) Survival TrPAF better than UnTrPAF and equal to No AF

Does AF Treatment Change the Curve?

Limitations/Implications Not a RCT Follow-up more intense in Tr PAF group Various Lesions sets for various operations. Selective use of AF ablation for PAF pts is safe and effective

Conclusions Concomitant surgical ablation of PAF does not increase perioperative risk Treated PAF patients had higher late FFAF and survival compared to untreated PAF patients Consider AF ablation in select PAF patients at time of cardiac surgery

Does AF Treatment Change the Curve? 3797 3263 2724 2208 1748 1303 423 365 313 250 206 131 129 99 73 62 47 28

Prospective data collection Methods 1, 3, 6, 12 months after surgery, then annually Rhythm management Anti-arrhythmic (AA) drugs for 3 months Coumadin discontinued if SR regained at 3-6 months Cardioversion or ablation if AF persists Rhythm follow-up 12-lead EKG Mobile telemetry or Holter monitor at 3, 6 months Implanted device (ICD, Pacer, etc) interrogation Evaluation of success Freedom from AF, AA, and stroke

1 Percent of Patients with Diagnosis of AF treated at time of MV Surgery AF surgery was performed in 91% of isolated MV surgery patients with a previous history of AF compared to 53% nationally 100% Calendar Year 2009 80% 60% 40% Northwestern Memorial Hospital Society of Thoracic Surgeons 20% 0%

HRS / STS Guidelines It is appropriate to consider all patients with symptomatic AF undergoing other cardiac surgery for AF ablation. Calkins H, et al. HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF. Heart Rhythm 2012; 9 (4): 632-696.

PS Matched Survival

Original groups: LA only vs BA B Original groups: LA only vs BA

Percent of Patients Freedom from Atrial Fibrillation at Last Rhythm 100 N=58 90 80 70 N=77 N=15 N=22 N=39 60 50 40 30 20 10 0 Classic BiAtrial Left HIFU PVI Maze Type J Thorac Cardiovasc Surg 2010; 139(4):860-7

McCarthy et al. JTCVS 2010: 140(4):885-9