Patients with Advanced Fibrotic Myopathy Should be Surgically Ablated Ralph J. Damiano, Jr., MD Evarts A. Graham Professor of Surgery Chief, Division of Cardiothoracic Surgery Barnes-Jewish Hospital Washington University School of Medicine St. Louis, MO USA Western AF Meeting 2019 Park City, Utah February 22, 2019

Surgical Treatment of Atrial Fibrillation Washington University Experience: Patients have been followed prospectively with an extensive database since 1987 Dedicated AF clinical coordinator, clinical research team Careful evaluation of clinical results have allowed continuing evolution of techniques. We have had a common approach over the last 30 years, in that the majority of the patients have had a Cox-Maze lesion set.

Three Decades of Surgery for Atrial Fibrillation

The Cox Maze IV Procedure Introduced in 2002 Biatrial lesion set, performed with RF and cryoablation Left atrial appendage was amputated or oversewn

Patients with Advanced Fibrotic Myopathy Should be Surgically Ablated There are no studies to support this treatment strategy, since very few surgical patients have had preoperative imaging to determine the degree of fibrosis, and there have been no prospective studies.

Patients with Advanced Fibrotic Myopathy Should be Surgically Ablated However, we know that patients with advanced fibrosis do poorly following catheter ablation.

Copyright © 2014 American Medical Association. All rights reserved. From: Association of Atrial Tissue Fibrosis Identified by Delayed Enhancement MRI and Atrial Fibrillation Catheter Ablation: The DECAAF Study From: Association of Atrial Tissue Fibrosis Identified by Delayed Enhancement MRI and Atrial Fibrillation Catheter Ablation: The DECAAF Study JAMA. 2014;311(5):498-506. doi:10.1001/jama.2014.3 Figure Legend: Four Stages of Left Atrial Tissue Fibrosis Based on 3D Delayed Enhancement Magnetic Resonance Imaging ScansRepresentative example from 4 different patients of each stage of left atrial tissue fibrosis. Normal left atrial wall is displayed in blue; fibrotic changes are in green and white. Stages 1 through 4 show increasing amounts of fibrosis as a percentage of the total left atrial wall volume. The pulmonary veins and mitral valve are shown in gray. Date of download: 2/19/2019 Copyright © 2014 American Medical Association. All rights reserved.

Copyright © 2014 American Medical Association. All rights reserved. From: Association of Atrial Tissue Fibrosis Identified by Delayed Enhancement MRI and Atrial Fibrillation Catheter Ablation: The DECAAF Study JAMA. 2014;311(5):498-506. doi:10.1001/jama.2014.3 Figure Legend: Cumulative Incidence of Arrhythmia Recurrence Without Covariate Adjustment Through Day 475 After the Blanking PeriodSmall vertical ticks on curves indicate where a patient’s follow-up has completed without recurrent atrial fibrillation. Date of download: 2/19/2019 Copyright © 2014 American Medical Association. All rights reserved.

Patients with Advanced Fibrotic Myopathy Should be Surgically Ablated We do have three decades of clinical outcomes to support surgical ablation in patients who are poor candidates for catheter ablation.

Patients Who are Poor Candidates for Catheter Ablation Should be Surgically Ablated Long-standing persistent AF Valvular heart disease Left atrial enlargement Failed catheter ablation

45% 20%

Results: Paroxysmal vs. LS Persisitent AF Freedom from ATAs (n=576) p = 0.104 p = 0.052 p = 0.554 p = 0.414 p = 0.949 Next, we compared freedom from ATAs between the groups with paroxysmal AF (in blue) and non-paroxysmal AF (in red), and demonstrated no significant difference at any time point. Overall freedom from ATAs was 78% in both groups at 5 years, (NEXT)

Patients Who are Poor Candidates for Catheter Ablation Should be Surgically Ablated Long-standing persistent AF Valvular heart disease Left atrial enlargement Failed catheter ablation

Atrial Fibrillation in Patients with Mitral Valve Disease How effective is surgical ablation of AF in this subgroup of patients?

Randomized Trials of Surgical Ablation for Atrial Fibrillation in Patients Undergoing Mitral Surgery FREEDOM FROM AF AUTHOR n SURGERY CONTROL Schuetz 43 95% 31% Filho 70 79% 27% Doukas 101 44% 5% Lima 30 80% 40% Deneke Blomstrom-Lindquist 65 73% 43% Chevalier 33% Every randomized trial has shown a significantly better freedom from AF with surgical ablation!!

Gillinov AM, et al N Engl J Med e-pub March 16, 2015

AF in Patients Undergoing Mitral Surgery: Does surgical ablation add to morbidity/mortality? 260 patients were randomized to ablation or no ablation of AF There was no difference between groups in major cardiac or cerebrovascular adverse events, readmission or mortality rates.

Freedom from AF in Patients Undergoing Mitral Surgery and a Concomitant Cox-Maze IV Saint LL, et al. Ann Thorac Surg 2012:93-789-795

Risk Factors for ATA Recurrence and Antiarrhythmic Drug Dependence Univariate Predictors Lone AF LA size, LVEF, early ATAs Concomitant MV disease LA size Multivariate analysis Failure to isolate posterior left atrium, (OR 4.8, p=0.01) Saint LL, et al. Ann Thorac Surg 2012:93-789-795

Surgical Treatment of AF in Patients with Mitral Disease Can the same results be obtained using a minimally invasive approach with even lower morbidity?

Robertson JO, et al. Ann Cardiothorac Surg 2014;3:105-116

Freedom from ATAs Percent RMT Versus ST CMIV p = 0.83 p = 0.41 Our overall freedom from atrial tachyarrhythmias was not different between groups at any time point. Overall freedom from atrial tachyarrhythmias was 91% at 1 year and 83% at two years in the right mini-thoracotomy group compared to 86% at 1 and 2 year time points in the sternotomy group.

Patients Who are Poor Candidates for Catheter Ablation Should be Surgically Ablated Long-standing persistent AF Valvular heart disease Left atrial enlargement Failed catheter ablation

CM-IV: Predictors of Late Recurrence Multivariate Analysis (n=282) Variables OR, CI p- value Box lesion set 0.38 [0.167-0.871] 0.022 LA diameter 1.42 [1.04-1.94] 0.027 Early ATAs 3.05 [1.299-7.17] 0.010 Damiano et al. J Thorac Cardiovasc Surg 2011

CM-IV: Predictors of Late Recurrence Left Atrial Diameter Left Atrial Size (cm) 2 3 4 5 6 7 8 9 1 20 40 60 80 100 Pr [AF] % p=0.002 Damiano et al. J Thorac Cardiovasc Surg 2011

LA size was no longer a predictor of failure at 5 years in our multivariate analysis

Patients Who are Poor Candidates for Catheter Ablation Should be Surgically Ablated Long-standing persistent AF Valvular heart disease Left atrial enlargement Failed catheter ablation

Okada S, et al. Ann Thorac Surg 2013;96:786-791

A Final Reason to Perform Surgical Ablation : Survival Benefit

Methods: Propensity Score Matching Covariates = 22 variables, caliper width = 0.1, match ratio 1:1 No AF n = 8911 CMPIV n = 438 Match #2 Untreated AF n = 1510 Match #1 CMPIV No AF n = 402 CMPIV Untreated AF n = 342 To mitigate the effect of our selection bias and to find comparable cohorts, we performed propensity score matching. We used 22 covariates that were identified in different risk models as predictors of mortality, and we included the type of operation being performed. We matched the maze group to the No AF group and ended up with 402 pairs of patients. Our second match was between the maze group and the Untreated AF group and we ended up with 342 pairs of patients.

Survival Curve: Matched CMPIV and Untreated AF Adjusted hazard ratio: 0.58 (CI: 0.43-0.78), p <0.001 62% 42% When comparing the maze and the untreated AF patients. The untreated AF patients had a worse late survival. Survival at 10 years was (CLICK) 62% for CMPIV and (CLICK) 42% for Untreated AF. (CLICK) Adjusted hazard ratio was 0.58. Adjusted hazard ratio: 0.58 (CI: 0.43-0.78), p <0.001

Surgery For Lone Atrial Fibrillation: Current Indications: HRS/EHRA/ECAS Expert Consensus Statement Patients with symptomatic AF who have failed medical therapy and either: have failed one or more catheter ablations, are poor candidates for catheter ablation, or prefer a surgical approach. single procedure with high success rates and low morbidity, with most patients off anticoagulation

Patients Who are Poor Candidates for Catheter Ablation Should be Surgically Ablated Thirty years of experience have shown excellent and durable late results for the Cox-Maze procedure as both a stand-alone and concomitant procedure in patients who are poor candidates for surgical ablation. There is strong evidence to support the benefits of ablation to patients in terms of restoration of sinus rhythm and survival. Please consider surgical ablation before giving up on rhythm control, as results are excellent in most subgroups of patients. Follow the consensus statement recommendations!

Thank you for your attention.