Successful FIRM Ablation

Transcription

1 Mapping Based Catheter Ablation of Rotors for AF Vumed AF Webinar Monday January 4 th, 2016 Sanjiv M. Narayan, MD, PHD Stanford University Disclosures: Funded by NIH (R01 HL83359, R01 HL122384, K24 HL103800), British Heart Foundation, Fulbright Foundation, Heart Rhythm Society. SMN is co-inventor of IP owned by the University of California, licensed to Topera. Equity in Topera. Honoraria: ACC, Abbott, Medtronic, St Jude Medical, Uptodate Successful FIRM Ablation Clinical Data Need to Define Substrate Fibrillation: Gold Standard is Optical Mapping Different Techniques Alter Mechanisms of Fibrillation FIRM Algorithm Optical Mapping Validation FIRM Ablation Results: Multicenter Series AF Mechanisms Must Explain Observations 1. How Can Any Localized Therapy Rx AF? (cannot cardiovert, 1 st lesion terminates AF) (Herweg/Steinberg 2003) Haystack Yet 2. Extensive ablation Not Helpful (BOCA), STAR-AF2 Lines, CFAE don t help Calkins et al., HRS/ESC position paper Heart Rhythm 2012; Rensma, Circ Res 1988: ; Narayan, Circ 2002; Forclaz, A., S. M. Narayan, et al. (2011). "Early temporal and spatial regularization of persistent AF predicts arrhythmia-free outcome." Heart Rhythm 8(9):

2 Optical Mapping of Human AF Stable Endocardial Sources, Variable on Epicardium Diseased human RA (1) and LA (2) Stable Endocardial ( 1.5 x 0.5 cm) related to anatomy, fibrosis Variable epicardially Endocardial Ablation terminates AF 1. Hansen, Fedorov et al. AF driven by micro-anatomic intramural re-entry revealed by simultaneous subepicardial and sub-endocardial optical mapping in explanted human hearts. Eur Heart J epub 2. Zhao, Fedorov et al. Two Localized AF Rotors in Human Left Atrium. Circulation A/E 2015; epub Mapping Approach: Disorder Versus Rotors Nonhierarchical Disorganization Rotors Sources Cause multiwavelet disorganization Goats Wijffels, Circulation 1995 Canine Bhimani, Heart Rhythm 2014 Human De Groot, Circulation 2010 No localized sources Mouse Vaidya, Circ Res. 1999;85: Sheep Gray, Nature 1998; Skanes Circ ,2 Canine Chou, J Am Coll Cardiol 2011 No Human Early AF: Human Optical AF Mapping Stable Rotors Hansen et al, Eur H J 2015 (1) Vaquero/Jalife Heart Rhythm 2008; ; (2) Skanes Circulation 1998; ; (3) Ryu, Stambler JCE 2005; 16: ; (4) Lin Circ 2005; 112: ; (5) Cuculich, Rudy. Circ 2010; ; (6) Allessie Circ EP 2010; ; (7) Narayan, Miller et al, J Am Coll Cardiol 2012; 60(7): Successful FIRM Ablation Clinical Data Need to Define Substrate Fibrillation: Gold Standard is Optical Mapping Different Techniques Alter Mechanisms of Fibrillation FIRM Algorithm Optical Mapping Validation FIRM Ablation Results: Multicenter Series

3 Optical Maps Reduce Far-field Noise in AF Do Electrogram Rules Show the Same? Rotor Noise will summate with rotor Small 0.3 mm electrode 3 Question: 1. What is a qs or rr complex (or CFAE..) in AF? 2. Do EGM rules in AF alter clinical maps? Complexity What is local? 1.Narayan SM, Santori E, Toga AW, Optical Mapping of Rat Somatosensory Cortex; Cerebral Cortex 1994; 4(2): Kalifa et al., Circulation 2003; 108: ; 3 de Groot, Allessie et al. Circulation 2010;122: C3 Classical EGM Rules Miss Phase-Mapped C Rotors Ablation At Each Source/Rotor Terminated Persistent AF, n=24 65 yo with 7yr Hx of AF Annotated electrograms I V C3 Classical No Source 1 Phase Source D3 D3 D1 D1 2 E3 E3 B5 B5? 3 D5 D5? 510ms 170ms 170ms 170ms Haws & Lux, Circ 1990; Anderson et al. Circ Res 1991; Konings et al. Circ 1994 Classical EGM Analysis Misses Phase Mapped Rotors 170ms 170ms Junaid Zaman (Stanford/Imperial/Fulbright): AHA YIA Finalist 2015 Successful FIRM Ablation Clinical Data Need to Define Substrate Fibrillation: Gold Standard is Optical Mapping Different Techniques Alter Mechanisms of Fibrillation FIRM Algorithm Optical Mapping Validation FIRM Ablation Results: Multicenter Series

4 FIRM Validated by Optical Mapping. Human AF In Human AF, Does FIRM Represent Optically Mapped Wavefronts? Hansen, Fedorov et al., Circulation 2015 (abstract) Baskets A Strength and Weakness: Technical Pitfalls Benharash, Shivkumar : question rotors Jalife 1 re: Benharash... committed an unsettling array of errors 278 ms (Narayan, JCE 2012) Incorrect MD Interpretation? (not identified by system) CL = 1000/3.8 =263 ms Check basket in 2 views RAO 30 Basket In LV CL = 1000/3.6 =278 ms CL 500 ms (2 Hz) to 250 ms (4 Hz) In Half of recordings not c/w AF Unrecognized Placement in LV for AF mapping Benharash, Shivkumar, Circ AE 2015 Basket mispositioning was recognized, and the basket was withdrawn to the left atrium Narayan et al., J Cardiovasc Electrophysiol 2012; 23: Jalife, Berenfeld, Circulation A/E 2015; Benharash, Shivkumar et al., Circulation A/E 2015; 8: Successful FIRM Ablation Clinical Data Need to Define Substrate Fibrillation: Gold Standard is Optical Mapping Different Techniques Alter Mechanisms of Fibrillation FIRM Algorithm Optical Mapping Validation FIRM Ablation Results: Multicenter Series

5 Sommer/Hindricks, JCE 2015, n=20 Tomassoni, JICRM 2015 (N = 80) Hummel, HRS 2015 (N=40) Tilz/Kuck, GCS 2015 (N=25) Prystowsky/Foreman HRS 2015 (N=150) Buch et al, H/Rhythm 2015 (N=43) Miller, AHA 2015 (N = 175) Wang/Stanford, Venice 2015 (N=120) Shukla, Orlando AF 2015 (N=50) Rashid, JICRM 2015 (N=50) FIRM+PVI, 1-Procedure Outcomes (N>500) 2/3 rd Persistent/LS AF CONFIRM 3 Year FIRM+PVI PVI Multicenter 1 Year 1 st Ablation Redos Expected PVI alone AT, No AF No AF Narayan, JACC 2014; 63: Miller et al. JCE 2014; 9: Summary Optical mapping in human atria and clinical trial data support local sources/rotors for human AF Multicenter FIRM-guided ablation (>500 patients) similar to CONFIRM must explain why some differ. One explanation is that conventional EGM rules (what is a qs, rr?) may not apply in fibrillation and need validation and revision Needs 1: Multicenter randomized trials Needs 2: Better Baskets, Best ablation approach? Stanford Complex Arrhythmia Program/Funding EP Clinical/ Physiology Narayan NIH HL83359 ( ) NIH HL ( ) Tina Baykaner HRS Fellowship (2015-6) Imaging Philip Yang, Mike McConnell NIH HL ( ) Several other grants Computer Modeling Wouter Rappel/Narayan NIH HL ( ) Junaid Zaman Fulbright Scholar British Heart Found AHA Young Invest Trials/Out comes Mintu Turakhia, Kenneth Mahaffey (Bob Harrington) Narayan: NIH HL ( ) AJ Rogers Resident George Leef Resident Ongoing Clinical Trials Europe US Narayan Complex Arrhythmia Program: NIH ( ), AHA, ACC, HRS, Fulbright, BHF)

6 Mapping Human AF: Removal of Non-physiological Noise Benharash: Only ventricular activation... Raw Signal. Our Series Raw Basket Data FIRM Map (same data) Atrial Signals Clearly Seen QRS Subtraction EGM outside ERP restitution Resolution analysis Phase mapping. Show distribution APD Restitution Narayan/Franz, Circ 2002; ; Narayan PACE 2006; Narayan JACC 2008; ; Narayan, Circ 2011; 123:2922; Lalani, JACC 2012; 595; Rappel, Chaos 2013; Narayan, JCE 2014; Schricker, Circ A/E 2014 FIRM Rotors: Areas, Stability, Similar to Optical Maps Lack of Electrogram Signatures May Reflect Limitations of EGM Rules for AF Stable rotors and focal sources for human AF were revealed by contact panoramic mapping (FIRM), but not by EGM footprints 1 Although rotors are not associated with abnormal EGMs, rotor-egms in PeAF were more fractionated with lower amplitudes compared with that in PAF 2 1 Narayan et al., Circulation A/E 2013; 6:58-67; 2 Lin, Tilz, Europace 2015; in press 3 Hansen et al. Eur Heart J. 2015; in press Diverse Methods Show AF Source Regions Epicardial/Endocardial Differences Explain Discrepancies? Non-Invasive AF Mapping Contact: Stable Shape Ng Heart rhythm 2014 Stable Entropy, Ganesan Circ AE 2013 Sources in same region for days. HaÏssaguerre, Circ 2014 Human Optical Maps: Endocardium stable Epicardium unstable Hansen, EHJ, 2015 ECGI: Projection, Meander Rodrigo, Berenfeld. Heart Rhythm 2014;11: Wave Similarity. Lin Circ AE 2013

7 FIRM Ablation 2 cm 2 Per Source 5 mins 5.5 mins 4 mins, 6 mins Narayan et al., PLoSOne, 2012; 7(9):e46034 Narayan et al., Circulation Arrhyth Electrophys. 2013; 6(1):58-67

8 Contact Force Sensing During AF Ablation Moussa Mansour, MD Disclosures: Consultant: Biosense-Webster, St. Jude Medical, Medtronic Research Grants: St Jude Medical, Biosense-Webster, Boston Scientific, Endosense, MC10, Securus January 4 th, Does force sensing improve efficacy? 2. How to achieve the optimal contact force necessary to maximize the benefit? 3. Can force sensing be used to assess ablation lesion formation? Does Force Sensing Improve Efficacy? Data from TOCCASTAR and SMART AF studies 3 1

9 Comparison of the 2 Studies TOCCASTAR Prospective, multicenter, randomized, non-inferiority study TactiCath contact force RF catheter (St. Jude Medical) Control device Navistar Thermocool (Biosense Webster) 300 subjects with PAF treated with PVI 17 sites in the US and Europe SMART AF Prospective, multicenter, nonrandomized study Test device THERMOCOOL SMARTTOUCH contact force RF catheter (Biosense Webster) Safety and efficacy of force sensing compared to predetermined performance goals 172 patients with PAF treated with PVI 21 centers in the US 4 Parameters of Contact Force in TOCCASTAR and SMART AF Per protocol, physicians were not required to target a specific amount of contact force in either study TOCCASTAR Some operators aimed to achieve contact force > 10 g Pre-specified analysis was performed to study the effect of optimal force ( 90% lesions at 10g or more) 1 SMART AF Operators selected their force working ranges Post-hoc analysis was performed to study the effect of percentage of time the operator stayed in the selected range 1. Definition derived from findings of TOCCATA and EFFICAS: Reddy V, Shah D, Kautzner J, et al. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the Toccata study. Heart Rhythm Nov; 9(11): ; and Neuzil P, Reddy V, Kautzner J, et al. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the Efficas I Study. Circ Arrhythm Electrophysiol Apr. 6: Optimal Force in TOCCASTAR and Percentage of Time in Range in SMART AF TOCCASTAR: Percentage of subjects treated with optimal CF ( 90% lesions at 10g or more) 60% 50% 40% 30% 20% 10% 0% 57% Optimal CF (N=83) 43% Non-optimal CF (N=62) SMART AF: Operators remained in their preselected force ranges 73% of the time during ablation 6 2

10 Primary Effectiveness Endpoint in TOCCASTAR Non-inferiority Design / Primary End Point was Met Protocol Defined Treatment Success Clinically Relevant Treatment Success TactiCath 67.8% Control 69.4% p = ns TactiCath 78.1% Control 80.6% p = ns Acute procedural success and freedom from recurrence of symptomatic AF lasting longer than 30 seconds Post blanking, repeat ablation and/or use of Class I or III antiarrhythmic drugs (AAD) constitute treatment failure Use of AAD in the absence of documented atrial arrhythmia or reablation is not a failure Up to 2 positive TTM/ECG with no intervention is not a failure Primary effectiveness based on per protocol cohort (280 patients; 93.3% of randomized subjects) 7 Impact of Optimal Contact Force on Success TOCCASTAR- TactiCath Group Pre-Specified Analysis Optimal CF vs. Non-optimal CF Protocol Defined Success at 12 months 75.9% 58.1% Optimal CF 2 vs. Non-optimal CF 3 Clinically Relevant Success at 12 months 85.5% 67.7% p = 0.02 p = Repeat ablation after the protocol defined 3 month blanking period; protocol defined success used for analysis 2. Optimal CF cohort defined as those patients where 90% lesions 10g 3. Non-optimal CF cohort defined as those patients where < 90% lesions 10g 8 Significant Positive Impact of Optimal Contact Force on Repeat Ablations intoccastar Rate of Repeat Ablation 1 1. Repeat ablation after the protocol defined 3 month blanking period; protocol defined success used for analysis 2. Optimal CF cohort defined as those patients where 90% lesions 10g 3. Non-optimal CF cohort defined as those patients where < 90% lesions 10g 9 3

11 Primary Effectiveness Endpoint in SMART AF Primary End Point was Met 9.2 % of patients were on Class I/III AAD includes 2 subjects who were on new AAD during follow-up and were deemed protocol failures 10 Impact of Staying in the Pre-selected Force Range SMART-AF Post-hoc analysis p= Effectiveness Cohort, n= How to Achieve the Optimal Contact Force Necessary to Maximize the Benefit? Deflectable sheath High frequency jet ventilation Pacing 12 4

12 grams Impact of Deflectable Sheath on Contact Force and Outcome/ Data from TOCCASTAR Post-hoc analysis Average CF by Sheath Usage Contact Force Group only Protocol Defined Treatment Success by Sheath Usage All Subjects 2 Deflectable 74.0% P< Fixed 62.7% 0 Deflectable Fixed CF subjects treated with deflectable sheath had higher average CF vs. those treated without a deflectable sheath 1. Per protocol contact force cohort; CF data unavailable on one patient 2. Per protocol cohort p = High Frequency Jet Ventilation and Pacing High frequency jet ventilation Pacing 14 Can Force Sensing be Used to Assess Ablation Lesion Formation? The formation of adequate ablation lesion depends on many factors: force, duration, power, catheter stability Assessment of lesion formation must include integration of data from all these different sources In TOCCASTAR and SMART AF force information was not integrated with other ablation parameters 15 5

13 New Generation System after TOCCASTAR Lesion size index Complex formula integrating data from force, duration, and power Helpful in assessing lesion formation 16 New Generation System after SMART AF Integrates force sensing, duration, and catheter stability Lesion tag acquisition is automated A lesion tag is displayed only if it meets pre-set criteria 17 Tested Retrospectively in a Subgroup in SMART AF Ablation tags: force minimum 5 g, location stability 2 mm, for a minimum 10 sec/site Gap > 10 mm Gap < 10 mm 18 6

14 Summary TOCCASTAR and SMART AF studies demonstrated that force sensing improves the efficacy of AF ablation when ablation is performed at optimal contact force The use of deflectable sheath improves the ability to achieve the desired contact force and the efficacy of ablation Integration of force sensing with other ablation markers such as catheter location, power, and duration is likely to allow the assessment of lesion formation during ablation 19 Conclusion The data support the conclusion that force sensing represents a major advance in the field of catheter ablation for atrial fibrillation 20 7

15 Novel Ablation Technologies Andrea Natale MD Executive Medical Director, Texas Cardiac Arrhythmia Institute, St. David s Medical Center, Austin, Texas Professor of Medicine, Dell Medical school, Austin, Texas Director of Interventional EP, Scripps Green, San Diego, CA Clinical Professor, Case Western Reserve University, Cleveland, Ohio Consulting Professor, Stanford University, Palo Alto, California Senior Medical Director, AF & Arrhythmia Center, CPMC, San Francisco Enabling Technologies Contact Force Sensing Ablation Catheters Force Magnetic signal emitter 3 Magnetic signal sensors Force Spring coil Contact force and angle Resolution of measurement of contact force: < 1 gram 1

16 Stability of CF Improves Success Rate Sensitivity analysis indicated that across all subjects and centers, the success rate was consistently >80% when investigators stayed within pre-selected CF range 80-90% of the time Natale et al JACC 2015 Pre-Specified Analysis: Optimal CF Impact on Success and Repeat Ablations Optimal CF vs. Non-optimal CF Protocol Defined Success at 12 months Contact Force and Control: Rate of Repeat Ablation % 58.1% p = Repeat ablation after the protocol defined 3 month blanking period 2. Optimal CF cohort defined as those patients where 90% lesions 10g 3. Non-optimal CF cohort defined as those patients where < 90% lesions 10g Reddy et al Circulation in press 8 Why Contact Force? The TactiCath Quartz comes with unique FTI (Force Time Integral) and LSI (Lesion Index) designed as indicators of lesion quality. 7 2

17 IMAGING GUIDED LESIONS 3-D Assessment of Myocardial Ablation Lesions using Ultrasound-guided Spectroscopic Photoacoustic Imaging Nicholas Dana 1,2, Luigi Di Biase 1,3, Andrea Natale 1,3, Richard Bouchard 1,2 and Stanislav Emelianov 1,2 1 Department of Biomedical Engineering, University of Texas at Austin, Austin, TX Department of Imaging Physics, MD Anderson Cancer Center, Houston, TX Texas Cardiac Arrhythmia Institute, St. David s Medical Center, Austin, TX May 10 th, 2013 IMAGE REGISTRATION AND METRICS Segmented sample (blue) Segmented sample (white) REGISTERED REGISTERED Segmented US (yellow) Segmented US (red) Registered image metrics: Centroid displacement Mask agreement 10 3

18 EXTEND TO REAL TIME AND TEMP MAPPING Refine characterization algorithm More averages Laser pulse-to-pulse normalization Non-correlation based method Translate to real-time studies visualize lesion formation live Develop algorithm to estimate tissue temperature changes during ablation 11 4

19 VYTRONUS CONFIDENTIAL 15 Computerassisted Tip 3D Map Porcine ICPV Catheter (12.8 F) Sheath video VYTRONUS CONFIDENTIAL 16 5

20 VYTRONUS CONFIDENTIAL 17 VYTRONUS CONFIDENTIAL 18 VYTRONUS CONFIDENTIAL 19 6

21 VYTRONUS CONFIDENTIAL 20 Lesion Monitoring Microwave Radiometry Technology 7

22 Radiometry Performance: Energy/ Lesion Formation Control Microwaves coming of the heat-source inside the tissue are measured at the tip of the catheter in a realtime manner independent of irrigation and catheter positioning Tissue Imbedded 2mm Luxtron Temp probe vs Radiometer vs Thermocouple in Irrigated Catheter during Ablation Tissue 2mm imbedded probe- actual lesion temp. Radiometer Chip catheter tip temp meas. Thermocouple catheter tip temp. meas. 1 st Flutter Patient Ablation 18,19,20 8

23 Optically Coherence Reflectometry Guided RF Catheter Ablation Full View of Local Environment Necrosis Detection Warning Slippage 4mm 3mm 2mm Local Navigation Contact No Contact Soft Contact Good Contact Lesion Formation Depth Realtime 3D catheter environment: walls, blood, thin regions Display of previous necroses Contact assessment Warning for pop & slippage Live estimation of ablation depth Targetted lesion size Quantitative Contact Information Clear contrast between blood and myocardium Quantifiable soft & hard tissue contact Determination of catheter-tissue distance better than 15µm Presence of birefringence band consistent in all atrial walls Robust with respect to wall angle up to ±30 9

24 Evolution of Balloon and Multielectrode Technologies Natale et al. Circulation

25 Novel Camera Based RF Ablation Balloon Cameras inside balloon enable visualization of tissue to help identify good contact and monitor ablation progress Articulated Electrodes on surface of balloon enable electrical recording and ablation Guidewire based Irrigation from each electrode Ex Vivo Un-interrupted Linear Lesions 8 watts 60 sec 40 ml/min 4 bi-polar electrodes in saline 8 watts 60 sec 30 ml/min 4 bi-polar electrodes in saline 5 watts 60 sec 20 ml/min 4 bi-polar electrodes in saline 34 11

26 Trabeculated Tissue Ablation 10W bi-polar 4 electrode ablation performed on trabeculated tissue in left atrial appendage LAA INSIDE LAA OUTSIDE 35 nmarq Catheters Loop size 8.4 Fr Shaft size 7.6 Fr nmarq Circular Catheter mm loop diameter range nmarq Crescent Catheter mm loop diameter range nmarq Catheter Uniform Irrigation Irrigation hole pattern based on simulated flow modeling and optimized for uniform flow from the proximal to the distal electrodes The pattern was determined based upon flow simulations Cross Section Proximal Distal IRRIGATION HOLE DIAMETERS INCREASE FROM PROXIMAL TO DISTAL END 12

27 Newer Targets Can We Find Localized AF Sources? Ablation at Inferior Left Atrial Rotor (Focal Impulse and Rotor Modulation, FIRM) 81 YO man, AF for 31 Years, Multiple Cardioversions; 1 st ablation 13

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29 Symptomatic AF undergoing RFA N = 107 (paroxysmal 29%) FIRM-guided ablation PVAI ± lines (LA roof) Freedom from AF FU = median 8 months 82.4 vs 44.9% (p < 0.001) CONFIRM We need RCTs 79.3 vs 35.6% (p < 0.001) off-aad Narayan et al. J Am Coll Cardiol. 2012;60: LONG-TERM CLINICAL OUTCOMES OF FOCAL IMPULSE AND ROTOR MODULATION FOR TREATMENT OF ATRIAL FIBRILLATION: A MULTI- CENTER EXPERIENCE Buch E, Share M, Turng R, Benharash P, Shivkumar K, Ellenbogen K & Mandapati R- Long-term Clinical Outcomes Of Focal Impulse And Rotor Modulation For Treatment Of Atrial Fibrillation: A Multi-center Experience -HR 2015 No Evidence From Randomized Studies 15

30 The Heart Hospital Vu Medi Webinar January 4, 2016 James R Edgerton, MD, FACS, FACC, FHRS The Heart Hospital Surgery for LSP AF Indications, Technique, Outcomes Disclosures Atricure: Consultant, Speakers Bureau Take Aways Cox Maze is extensively studied & has a long track record of success and is recommended by AHA, HRS, ACC, STS, ISMICS To realize success in LSP AF the full lesion set must be performed The performance of a Maze Concomitant to another cardiac procedure does not increase risk or morbidity In Fact, performance of Concomitant Maze DECREASES long term mortality Decreases morbidity (including stroke, Tricuspid insufficiency) Improves QOL Comorbid conditions must be managed: sleep apnea, Htn, DM Close post-op follow-up is essential 1

31 Assigned Topics What we have time to present: Indications Procedural Technique Outcomes Indications for Concomitant Surgical Ablation of AF Calkins H, Brugada J, Cappato R, et al HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow up, Definitions, Endpoints, and Research Trial Design. Indications for Concomitant Surgical Ablation of LSP Consensus Statement on CA and Surgical AF 2012 Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society, in collaboration with the American College of Cardiology, American Heart Association, and Society of Thoracic Surgeons. It is advisable that all patients with documented AF referred for other cardiac surgeries undergo a left or biatrial procedure for AF at an experienced center, unless it will add significant risk 2

32 Indications for Concomitant Surgical Ablation of LSP The ISMICS Consensus Recommendations Concomitant surgical ablation is recommended to increase the incidence of sinus rhythm both at short- and long-term follow-up (class 1, level A) to improve ejection fraction and exercise tolerance (class 2a, level A) and to reduce the risk of stroke and thromboembolic events, to improve long-term survival (class 2a, level A). Indications for Stand Alone Surgical Ablation of LSP AF Calkins H, Brugada J, Cappato R, et al HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow up, Definitions, Endpoints, and Research Trial Design. Technique Cox Maze IV 3

33 Cryoablation RF Ablation Surgical Incision Maze IV: Left Atrial Lesions Left Atrial Lesions of the Cox-Maze IV PVI 4

34 Right Atrial Lesions : Two Lesions, Simple Inverted T : SVC to IVC, then up to Tricuspid Lesion from vertical limb of inverted T to tip of LAA Tricuspid Valve Right Atrium SVC IVC Left Atrium Cryoablation RF Ablation Surgical Incision Maze Lesions Potential Macro-Reentrant Circuits in N-PAF Classic Atrial Flutter Wave Atypical Left Atrial Flutter (Iatrogenic) Coronary Sinus LA Myocardium 2 Possible Routes Across LA Isthmus 5

35 Potential Macro-Reentrant Circuits in N-PAF Objective of the Maze Lesions for LSP AF Objective of the Maze Lesions 6

36 A Closer Look at the Right Atrial Lesions Rationale for the RA Lesions Peri-Tricuspid Circuit Flutter Wave Anterior to SVC Flutter Wave Posterior to SVC Santuchi et al: Heart Rhythm, 2009 Rationale for the RA Lesions 7

37 Completed Right Atrial Lesions On-Pump during Reperfusion / Re-warming Completed Left Atrial Lesions Completed Maze-IV Procedure 8

38 Outcomes ABLATE: Enrolled Patient Disposition 55 Patients Enrolled n=2 Patients expired day follow up 50 6 Months 48 Patients Long-term Median= 21.6 Months n=2 Patients expired, n=1 withdrawal n=2 Patients expired Six Month Efficacy: Non-paroxysmal Population (Primary Endpoint) (Secondary Endpoint) Success Rate N= (34/46) N= (38/46) N= (9/11) N= (10/11) N= (43/57) N= (48/57) Data on File 9

39 Outcomes of Maze IV The Journal of Thoracic and Cardiovascular Surgery, 2015 Late outcomes following the Cox-Maze IV procedure for atrial fibrillation Matthew C. Henn MD, Timothy S. Lancaster MD, Jacob R. Miller MD, Laurie A. Sinn RN, BSN, Richard B. Schuessler PhD, Marc R. Moon MD, Spencer J. Melby MD, Hersh S. ManiarMD, Ralph J. Damiano, Jr., MD Division of Cardiothoracic Surgery, Washington University School of Medicine, Barnes- JewishHospital, St. Louis, MO Henn MC, Lancaster TS, Miller JR, Sinn LA, Schuessler RB, Moon MR, Melby SJ, Maniar HS, Damiano Jr RJ, Late outcomes following the Cox-Maze IV procedure for atrial fibrillation, The Journal of Thoracic and Cardiovascular Surgery (2015), doi: /j.jtcvs Late outcomes following the Cox-Maze IV procedure for atrial fibrillation The Journal of Thoracic and Cardiovascular Surgery, 2015 Jan 2002 to Sept 2014, 576 pts At 5 years: freedom from ATAs was 73% (102/139). freedom from ATAs off AADs was 61% (83/135) No difference in outcomes between: patients with paroxysmal AF(n=204) or persistent/long-standing persistent AF(n=305), stand-alone Maze or concomitant Maze A brief look at Totally Thorascopic Surgical Ablation of AF 10

40 Totally Thorascopic Minimal Access Ablation Usually limited to left atrial lesions Connection to Mitral Valve is possible but difficult Totally Thorascopic Minimal Access Ablation Usually limited to left atrial lesions Connection to Mitral Valve (in transverse sinus) is possible but difficult Dallas Lesion Set Totally Thorascopic Minimal Access Ablation Usually limited to left atrial lesions Connection to Mitral Valve is possible but difficult Current area of investigation is Hybrid surgical & catheter ablation Early Results are promising, but series are small and few A formal multicenter trial is underway 11

41 Take Aways Cox Maze is extensively studied & has a long track record of success and is recommended by AHA, HRS, ACC, STS, ISMICS To realize success in LSP AF the full lesion set must be performed The performance of a Maze Concomitant to another cardiac procedure does not increase risk or morbidity In Fact, performance of Concomitant Maze DECREASES long term mortality Decreases morbidity (including stroke, Tricuspid insufficiency) Improves QOL Comorbid conditions must be managed: sleep apnea, Htn, DM Close post-op follow-up is essential Thank You Dr. Jim Cox and Dr. Syd Gaynor contributed many slides to this presentation 12