SURGICAL ABLATION OF ATRIAL FIBRILLATION DURING MITRAL VALVE SURGERY - - PowerPoint PPT Presentation

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SURGICAL ABLATION OF ATRIAL FIBRILLATION DURING MITRAL VALVE SURGERY THE CARDIOTHORACIC SURGICAL TRIALS NETWORK Marc Gillinov, M.D. For the CTSN Investigators ACC Late Breaking Clinical Trials March 16, 2015 Disclosures Consultant/Speaker

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SURGICAL ABLATION OF ATRIAL FIBRILLATION DURING MITRAL VALVE SURGERY

THE CARDIOTHORACIC SURGICAL TRIALS NETWORK

Marc Gillinov, M.D. For the CTSN Investigators ACC Late Breaking Clinical Trials March 16, 2015

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SLIDE 2

Disclosures

  • Consultant/Speaker
  • AtriCure
  • Medtronic
  • On-X
  • Edwards
  • Tendyne
  • Research Funding
  • St. Jude Medical
  • Equity Interest
  • Clear Catheter
  • Cleveland Clinic
  • Right to receive royalties from AtriCure for a left atrial appendage occlusion device
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AF and Mitral Valve Surgery Patients

Case Study

  • 69 year old woman
  • 4+ MR (Degenerative Disease)
  • Long-standing persistent AF
  • NYHA Class 2

How should the surgeon treat the AF?

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SLIDE 4

Recommendation COR LOE

An AF surgical ablation procedure is reasonable for selected patients with AF undergoing cardiac surgery for

  • ther indications

IIa C

J Am Coll Cardiol. 2014;64(21):2246-80

2014 AHA/ACC/HRS Guidelines Surgical AF Ablation

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SLIDE 5

Clinical Trial

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SLIDE 6

Purpose

  • To assess the safety and effectiveness
  • f ablation in patients presenting for

mitral valve surgery who have persistent

  • r long-standing persistent AF
  • To compare two different lesion sets

Pulmonary vein isolation (PVI)

Biatrial Maze

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SLIDE 7

Persistent and Long-Standing Persistent AF

  • Persistent AF
  • Non-self-terminating AF lasting more than 7

days or less than 7 days if cardioverted

  • Long-Standing Persistent AF
  • Continuous AF of more than one year’s

duration

HRS/EHRA/ECAS Consensus Statement, 2012

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SLIDE 8

Surgical Ablation Options

No Ablation PVI Biatrial Maze LAA closure performed in all patients

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SLIDE 9

Primary Endpoint

  • Freedom from AF at both 6 and 12 months by 3-

day Holter monitor

  • Powered (90%) to detect an increase of 20% in

the proportion of patients free of AF with ablation therapy

  • Pts who died before 12 month assessment or had

subsequent ablation were considered treatment failures

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SLIDE 10
  • Mortality
  • MACCE
  • Quality of life
  • Serious adverse events

Secondary Endpoints

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SLIDE 11

CTSN Surgical AF Ablation Trial Design

Excluded (n=3242)

Enrollment

Allocated to MVS + Ablation (n=133)

  • Pulmonary Vein Isolation (PVI) (n=67)
  • Biatrial Maze (n=66)

Allocated to MVS Alone (n=127)

Allocation

  • Withdrawal or lost to follow-up (n=8)
  • Death before month 12 (n=9)
  • Withdrawal or lost to follow-up (n=10)
  • Death before month 12 (n=11)

Follow-Up

Primary Endpoint Analysis (n=133)

  • Primary Endpoint Data (n=106)
  • 6 & 12 Month Holter (n=96)
  • Died (n=9)
  • Underwent Ablation (n=1)
  • Imputed (n=27)

Primary Endpoint Analysis (n=127)

  • Primary Endpoint Data (n=102)
  • 6 & 12 Month Holter (n=88)
  • Died (n=11)
  • Underwent Ablation (n=3)
  • Imputed (n=25)

Analysis

Randomized (n=260) Assessed for Eligibility (n=3502)

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SLIDE 12

MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3)

Baseline Characteristics

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SLIDE 13

MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3)

Baseline Characteristics

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SLIDE 14

MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3)

Baseline Characteristics

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SLIDE 15

MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3)

Baseline Characteristics

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SLIDE 16

MVS Alone (N=127) MVS & Ablation (N=133) Mitral Valve Surgery Replacement 61 (48.4) 54 (40.6) Repair 65 (51.6) 79 (59.4) Concomitant Procedures Tricuspid Valve Surgery 48 (38.1) 50 (37.6) Aortic Valve Replacement 20 (15.9) 14 (10.5) CABG 25 (19.8) 27 (20.3) Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3 Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5

Operative Characteristics

*P-Value for Cardiopulmonary Bypass Time = 0.03

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SLIDE 17

MVS Alone (N=127) MVS & Ablation (N=133) Mitral Valve Surgery Replacement 61 (48.4) 54 (40.6) Repair 65 (51.6) 79 (59.4) Concomitant Procedures Tricuspid Valve Surgery 48 (38.1) 50 (37.6) Aortic Valve Replacement 20 (15.9) 14 (10.5) CABG 25 (19.8) 27 (20.3) Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3 Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5

Operative Characteristics

*P-Value for Cardiopulmonary Bypass Time = 0.03

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SLIDE 18

29.4 63.2

20 40 60 80 MVS Alone MVS + Ablation Freedom From AF (%)

Risk Difference of Success 0.34 (95% CI, 0.21 - 0.47), P<0.001

Randomization Group

Primary Endpoint

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SLIDE 19

66 61

20 40 60 80 100 Biatrial Lesions PVI Freedom From AF (%)

Risk Difference of Success 0.05 (95% CI, -0.13 - 0.23), P=0.60

Ablation Group

Biatrial Maze vs. PVI

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SLIDE 20

Mortality

Mortality (%) Months

MVS Alone 127 118 111 108 104 MVS + Ablation 133 127 120 119 116

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SLIDE 21

MACCE

Composite Cardiac End Point (%) Months

MVS Alone 127 110 101 96 90 MVS + Ablation 133 114 110 106 97

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SLIDE 22

Quality of Life

MVS Alone (N=127) MVS & Ablation (N=133) P-Value SF-12 Physical Function 45.3 ±7.9 44.3 ±9.0 0.38 Mental Function 48.5 ±6.5 48.0 ±6.3 0.56 AF Severity Scale Daily AF –no. (%) 42 (45.2) 20 (19.8) <0.001 Life Rating (1-10, median) 8.0 (7,9) 8.0 (7,9) 0.45 NYHA Class III + IV –no. (%) 3 (2.9) 8 (7.0) 0.17

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SLIDE 23

120 143

50 100 150 200 MVS Alone MVS + Ablation Serious Adverse Events (Rate/100 Pt-Yrs)

Incidence Rate Ratio 1.20 (95% CI, 0.95 - 1.51), P=0.12

Randomization Group

Serious Adverse Events

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SLIDE 24

Serious Adverse Events (Rate/100 Pt-Yrs) Randomization Group

Pacemaker Implantation

8.1 21.5

10 20 30 MVS Alone MVS + Ablation

Incidence Rate Ratio 2.64 (95% CI, 1.20 - 6.41), P<0.001

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SLIDE 25

66.7 88.5

33.3 11.5 20 40 60 80 100 MVS Alone MVS + Ablation Permanent Pacemaker Timing (%) Randomization Group

Pacemaker Timing

Index Hospitalization During After

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Unique Trial Features

  • Largest RCT of surgical ablation for AF
  • Mitral valve patients
  • Persistent and long-standing persistent AF
  • Stringent heart rhythm endpoint
  • 3-day Holter monitor
  • Both 6 and 12 months
  • Repeat ablation procedures and death

considered treatment failures

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SLIDE 27

Limitations

  • Primary endpoint not a clinical endpoint
  • Trial with mortality or stroke endpoint would

require more than one thousand patients and many years of follow up

  • Twenty percent of patients did not have

primary endpoint data (Holter recordings, death or subsequent ablation)

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SLIDE 28

Summary

  • Ablation significantly increased 1-year

freedom from AF (63% vs. 29%)

  • No difference between PVI and biatrial

maze lesion sets

  • Ablation did not increase mortality or

major adverse cardiac or cerebrovascular events

  • Ablation was associated with increased

risk of permanent pacemaker implantation

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SLIDE 29

Conclusion

  • Surgical ablation improves rhythm

control in mitral valve patients with persistent and long-standing persistent AF

  • Establishing the impact of ablation on

long-term survival, freedom from stroke and need for anticoagulation will require further investigation

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SLIDE 30

Investigators

  • Data Coordinating Center: InCHOIR
  • Montefiore – Einstein
  • Emory University
  • Duke University
  • Hôpital Laval
  • University of Virginia Health System
  • Montreal Heart Institute
  • University of Pennsylvania
  • Columbia University Medical Center
  • Cleveland Clinic Foundation
  • University of Maryland
  • Brigham and Women's Hospital
  • Sacré-Cœur de Montréal
  • Ohio State University Medical

Center

  • East Carolina Heart Institute
  • Wellstar / Kennestone
  • Baylor Research Institute
  • University of Southern California
  • St. Michael’s Hospital
  • Toronto General Hospital
  • Mission Hospital
  • NIH Heart Center at Suburban

Hospital

  • Inova Heart & Vascular Institute
  • University of Alberta Hospital
  • Centre Hospitalier de l'Université de

Montréal

  • Sunnybrook Health Sciences Centre
  • Aarhus University
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SLIDE 31

Acknowledgements

  • Supported by U01 HL088942

Cardiothoracic Surgical Trials Network (CTSN)

  • Funding Agencies:
  • National Heart, Lung, and Blood Institute
  • National Institute of Neurological Disorders and

Stroke

  • Canadian Institutes for Health Research
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SLIDE 32
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SLIDE 33

Parked Slides

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SLIDE 34
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AF and Mitral Valve Surgery Patients

  • Present in 30% to 50%
  • Associated with adverse outcomes
  • How should surgeons treat the AF?
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SLIDE 36

Surgical Treatment Options

No Ablation PVI Biatrial Maze

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SLIDE 37

35,000 30,000 25,000 20,000 15,000 10,000 5,000

2005 2006 2007 2008 2009 2010

Number of Patients 45 44 43 42 41 40 39 35 36 Percent of Patients 37 Ablation for AF Preop AF Percent with Ablation

Year of Surgery

Ad et al, J Thorac Cardiovasc Surg 2012;144:1051-60)

AF Ablation in Cardiac Surgery

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SLIDE 38

70,000 60,000 50,000 40,000 30,000 20,000 10,000 65 60 55 50 45 40 35 25 30 Ablation for AF Preop AF Percent with Ablation

CABG AVR MV Surgery CABG +AVR CABG +MV Other

Number of Patients Percent of Patients

Ad et al, J Thorac Cardiovasc Surg 2012;144:1051-60)

Concomitant Surgical Ablation

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Heart Rhythm Interventions

MVS Alone (N=127) MVS & Ablation (N=133) P-Value Cardioversion (3 mths post- randomization) –no. (%) 12 (9.5) 8 (6.0) 0.30 AADs (1 year) –no. (%) 15 (14.6) 15 (13.2) 0.76 Ablation –no. (%) 3 (2.4) 1 (0.8) 0.36 Pacemaker –no. (rate/100 Pt-yrs) 9 (8.1) 26 (21.5) 0.01

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SLIDE 40

Pacemaker Indications

MVS Alone (N=9 PPM) MVS & Ablation (N=26 PPM) Heart Block –no. (%) 4 (44.4) 14 (53.9) Sinus Node Dysfunction –no. (%) 3 (33.3) 9 (34.6) Control AF –no. (%) 2 (22.2) 0 (0.0) Unknown –no. (%) 0 (0.0) 3 (11.5)

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SLIDE 41

Primary Safety Endpoint (Composite)

  • Death
  • Stroke
  • Heart failure
  • MI
  • Cardiac Readmissions
  • Pulmonary embolism
  • Peripheral embolism
  • Excessive bleeding
  • DSWI/Mediastinitis
  • Permanent pacemaker
  • Damage to adjacent

structures

  • TIA

At 30 days post index surgery / hospital discharge (whichever is first)

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SLIDE 42

Primary Safety Endpoint

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SLIDE 43

CTSN Surgical AF Ablation Trial Design

Excluded (n=3242)

Enrollment

Allocated to MVS + Ablation (n=133)

  • Pulmonary Vein Isolation (PVI) (n=67)
  • Biatrial Maze (n=66)

Allocated to MVS Alone (n=127)

Allocation

  • Withdrawal before month 12 (n=6)
  • Lost to follow-up before month 12 (n=2)
  • Death before month 12 (n=9)
  • Withdrawal before month 12 (n=6)
  • Lost to follow-up before month 12 (n=4)
  • Death before month 12 (n=11)

Follow-Up

Primary Endpoint Analysis (n=133)

  • Primary Endpoint Data (n=106)
  • 6 & 12 Month Holter (n=96)
  • Died (n=9)
  • Underwent Ablation (n=1)
  • Imputed (n=27)

Primary Endpoint Analysis (n=127)

  • Primary Endpoint Data (n=102)
  • 6 & 12 Month Holter (n=88)
  • Died (n=11)
  • Underwent Ablation (n=3)
  • Imputed (n=25)

Analysis

Randomized (n=260) Assessed for Eligibility (n=3502)

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SLIDE 44

Explore Two Different Lesion Sets

  • Ablation arm further randomized to

pulmonary vein isolation vs. biatrial maze

  • Lesion set randomization for exploratory

analysis only