Combined Epicardial and Endocardial Ablation for Treatment of Atrial Fibrillation. Ashkan Babaie MD Providence Portland Medical Center

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1 Combined Epicardial and Endocardial Ablation for Treatment of Atrial Fibrillation Ashkan Babaie MD Providence Portland Medical Center 1

2 Disclosures None 2

3 Cox-Maze III The Godfather Cure rates > 95% in patients with refractory AF All lesions were made by cut and sew incisions Required median sternotomy with cardiopulmonary bypass Includes left and right atrial appendage excision 3

incisions Required median sternotomy with

4 Cox-Maze IV All lesions were made by alternative energy source rather than incisions Requires sternotomy or lateral thoracotomy with cardiopulmonary bypass 4

5 Multiple Ablation Sources are Avaialble Damiano et al. MMCTS:2007 5

6 Single Center Outcomes of Stand-Alone Cox-Maze over 20 years % Sinus Rhythm % Sinus Rhythm No antiarrhythmics Weimar et al. Circ Arrhythm Electrophysiol. 2012;5(1):8-14 6

7 Single Center Outcomes of Stand-Alone Cox-Maze over 20 years: Complications Cox-Maze III Cox-Maze IV 30 day mortality: 2 pts (2%) Median LOS: 9 days 10% complication rate Reoperation 3 pts (3%) IABP 4 pts (4%) Renal Failure 2 pts (2%) Early Stroke 1 pt (1%) 30 day mortality: 1 pt (1%) Median LOS: 7 days 1% complication rate Early Stroke 1 pt (1%) Weimar et al. Circ Arrhythm Electrophysiol. 2012;5(1):8-14 7

pts (4%) Renal Failure 2 pts (2%) Early Stroke 1 pt (1%) 30 day mortality: 1 pt (1%) Median LOS: 7

8 Minimally Invasive PV Isolation Is performed on beating heart via bilateral minithoracotomies or thoracoscopic ports Lesions are made on PV antra via clamp device Ganglionic Plexi can be ablated LOM dissection can be performed Left atrial appendage can be excised 8 McClelland et al. J Cardiovasc Electrophysiol. 2007;18:

device Ganglionic Plexi can be ablated LOM dissection can be performed Left

9 Minimally InvasivePV isolation with GP Ablation Overall n=20 Paroxysmal n=11 Persistent n=5 Long-standing Persistent n=5 McClelland et al. J Cardiovasc Electrophysiol. 2007;18:

10 Minimally Invasive Atrial ablation with Linear Lesions for Treatment of Persistent Afib - Dallas Lesion Set Edgerton et al. Ann Thorac Surg 2009;88:

11 Minimally Invasive Atrial ablation with Linear Lesions for Treatment of Persistent Afib - Dallas Lesion Set Validation of linear lesions by pacing and looking for evidence of conduction delay Edgerton et al. Ann Thorac Surg 2009;88:

of linear lesions by pacing and looking for evidence of

12 Limitations of Minimally Invasive Epicardial Ablation Isthmus-dependent atrial flutter is not treated Non-PV triggers cannot be evaluated or treated Is there a role for waiting time/adenosine/isoproterenol in looking for PV reconnection CS isolation/ablation cannot be performed Mitral Isthmus ablation is often unsuccessful Assessment of block in linear lesions can be difficult 12

time/adenosine/isoproterenol in looking for PV reconnection CS isolation/ablation cannot be

13 Combined Procedures by Cardiothoracic Surgeon and Electrophysiologist Hybrid Ablation Convergent Ablation Minimally Invasive Atrial Ablation Pericardioscopic Atrial Ablation EPS Validation of PV isolation Validation/Completion of lines CAFE Right atrial lesions EPS Completion of PV isolation Validation of lines CAFE / Mitral Isthmus/ CS Right atrial lesions 13

EPS Validation of PV isolation Validation/Completion of lines CAFE Right atrial lesions

14 Epicardial ablation device operates via unipolar RF Catheter is irrigated with suction also applied through lumen to improve tissue contact 14

15 QuickTime and a decompressor are needed to see this picture. 15

16 QuickTime and a decompressor are needed to see this picture. 16

17 EU Convergent Outcomes Baseline Information

18 EU Convergent Outcomes Summary of 12 and 24 month follow-ups % Sinus Rhythm % SR, off AADs Redos 18

19 EU Convergent Outcomes 6 to 24 Month Reveal XT Monitoring

20 4-Site Convergent Data Baseline Information AF Type (HRS Definitions) Number % Paroxysmal % Persistent & Longstanding % TOTAL % Demographics Average (SD) Age (years) 60.9 (8.0) AF Duration (years) 5.0 (5.3) Left Atrial Size (cm) 4.5 (0.7) LVEF (%) 54.4 (8.4) Body Mass Index (kg/m 2 ) 34.1 (7.4)

5% TOTAL 115 100% Demographics Average (SD) Age (years) 60.9 (8.

21 4-Site Convergent Data Epicardial Lesions Created Locations of Epicardial Lesions Epicardial Lesion % Created Posterior RPV 100% Posterior LPV 100% Superior Posterior Roof 97% Inferior Posterior Roof 64% Anterior RPV 98% Anterior LPV 100% Ligament of Marshall 28% PV to IVC 46% PV to CS 38% Right Atrial 0% slpv slpv ilpv LAA LAA 100% ilpv 38% 28% LV LV AORTA CS AORTA 97% 100% 100% 64% CS srpv 98% irpv 46% RAA SVC IVC RAA SVC srpv irpv IVC Epicardial Lesions Pericardial Reflections

22 4-Site Convergent Data Endocardial Lesions Created Endocardial Lesion % Created RSPV 90% RIPV 84% LSPV 93% LIPV 64% LA Roof 23% Posterior Wall 14% LAA 6% Septal Wall 12% RAA 3% SVC 7% Cavotricuspid Annulus 25% CS 7% slpv slpv 7% ilpv LAA ilpv Locations of Endocardial Lesions LAA 6% 93% 64% LV LV CS AORTA CS AORTA 23% 90% 14% 84% srpv irpv RAA SVC IVC RAA SVC srpv irpv 25% IVC 3% 7% Epicardial Lesions Pericardial Reflections Endocardial Lesions

23 4-Site Epicardial Data All Patients MACE ( 30 Days Post-Procedure) Major Adverse Cardiac Events( 30 Days) Incidence < 30 day Mortality 0% (0/115) Myocardial Infarction 0% (0/115) Stroke 0% (0/115) Transient Ischemic Attack 0.9% (1/115) Pulmonary Embolus 0% (0/115) Esophageal Fistula 0% (0/115) Phrenic Nerve Injury 0% (0/115) Pulmonary Vein Stenosis 0% (0/115) Tamponade 0% (0/115) Pericardial Effusion 1.7% (2/115) Bleeding Requiring Transfusion 1.7% (2/115) TOTAL 4.3% (5/115)

24 4-Site Epicardial Data All Patients Other Adverse Events ( 30 Days Post-Procedure) Other Adverse Events ( 30 Days) Incidence Acute Blood Loss from Drain 0.9% (1/115) Ileus 1.7% (2/115) Liver Hematoma 2.6% (3/115) Pseudoaneurysm 0% (0/115) TOTAL 5.2% (6/115)

25 4-Site Epicardial Data All Patients Outcomes Average F/U 11.4 months, n=115 % Sinus Rhythm % SR, +/- AADs % SR, off AADs % Redos 25

26 Avoiding Esophageal Injury During early development of the procedure atrioesophageal fistulas were observed in 4 patients at three different facilities.

27 Avoiding Esophageal Injury Risk Mitigation Steps Addressed Early Observations Risk Mitigation Steps Irrigate pericardial space during epicardial ablation to allow cooling Avoid endocardial ablation along posterior left atrium Esophageal temperature monitoring Change ablation technique for posterior wall to avoid inadvertent pericardial ablation Testing of Risk Mitigation Steps Performed Esophagoscopies on 30 consecutive patients No esophageal damage (erythema or ulceration) visually detected 2 days PO Thermal esophageal damage reported 4-56% with catheter ablation No Fistulas observed after risk mitigation steps during over 400 ablations

28 Providence Portland Experience 28

29 Providence Portland Experience Baseline Information All cases performed in EP lab Lab was retrofitted to allow thoracotomy and emergent CPB if needed Epicardial ablation performed by Dr. Douville After epicardial ablation drain is placed. Transeptal Access is the obtained - Goal ACT PV isolation is completed and posterior line validated DC cardioversion Isoproterenol is administered at 20 mcg/min x 15 minutes looking for non- PV triggers Adenosine given looking for PV reconnection Cavotricuspid isthmus and SVC isolation performed Protamine given, sheaths removed in EP lab 29

30 Providence Portland Experience Baseline Information Short course of steroids for pericarditis Full anticoagulation next morning with lovenox/coumadin or pradaxa Antiarrhythmic for 6 weeks to 3 months Usual D/C hospital day 3 or 4 Close F/U over first 6 weeks, then at 3, 6 and 12 months 30

31 Providence Portland Experience Baseline Information - first 15 patients AF Type (HRS Definitions) Number % Paroxysmal % Persistent % Longstanding Persistent 6 40% TOTAL % Demographics Average (SD) Age (years) 60.6 AF Duration (years) 2.97 Left Atrial Size (cm) 4.7 (0.8) Left Atrial Size (ml/m 2 ) 44.7 (12.6)

32 Left Atrial Size of First 15 Ablation Patients Normal Mild Moderate Severe Left Atrial Size (ml/m 2 ) 32

33 Superior Pericardial Reflections Text Text Right Lower Pericardial Reflection Small Gap in Posterior Line 33

34 34

35 Progression of Epicardial Lesion Set 35

36 36

37 Providence Portland Experience First 15 patients Average F/U 11 months, n=15 % Sinus Rhythm % SR, off AADs % SR, off AADs % Redos After 1st Ablation 37

38 Providence Portland Experience First 15 patients % Sinus Rhythm % SR, off AADs % SR, off AADs % Redos After 1st Ablation 38

39 Providence Portland Experience Adverse Events (n=21) Adverse Events Adverse Events ( 30 Days) Incidence Intraoperative Arrest 1/15 Femoral Pseudoaneurysm 1/15 Adverse Events (> 30 Days) Incidence Incarcerated Hernia 1/15

40 Providence Portland Experience Lessons Learned There is a learning curve for the surgical procedure - probably around 10 cases All surgical lines need to be evaluated endocardially 2 recurrent tachycardias due to gaps in posterior line Empiric atrial flutter ablation added to lesion set 1 recurrent tachycardias due to atrial flutter There is a learning curve for the surgical procedure - probably around 10 cases Adenosine used to evaluate for latent conduction in PVs Avoid morbidly obese patients Approach cardiomyopathy patients with caution, especially when ablating near LAA 40

DISCLOSURE. Atrial Fibrillation Management An Evidence-based Approach OBJECTIVES BACKGROUND AFFIRM 9/16/2015

DISCLOSURE. Atrial Fibrillation Management An Evidence-based Approach OBJECTIVES BACKGROUND AFFIRM 9/16/2015 Death (%) Mortality (%) 9/16/2015 DISCLOSURE Atrial Fibrillation Management An Evidence-based Approach Jonathon Adams, MD, FHRS Relevant Financial Relationship(s) None Off Label Usage None OBJECTIVES What