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8/29/2015 Effect of Empirical Left Atrial Appendage Isolation on Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients with Long term Procedure Outcome in Patients with Effect of Empirical Left Atrial

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Effect of Empirical Left Atrial Appendage Isolation on long-term procedure outcome in patients with Long-Standing Persistent AF undergoing Catheter Ablation: Results from the BELIEF Randomized Trial

Luigi Di Luigi Di Biase Biase, MD, PhD, FACC, FHRS , MD, PhD, FACC, FHRS

Section Head of Electrophysiology at Albert Einstein and Section Head of Electrophysiology at Albert Einstein and Montefiore Montefiore Hospital, New York, USA; Hospital, New York, USA; Associate Professor, Albert Einstein College of Medicine at Associate Professor, Albert Einstein College of Medicine at Montefiore Montefiore Hospital, New York, USA; Hospital, New York, USA; Adjunct Associate Professor Department of Biomedical Engineering, Adjunct Associate Professor Department of Biomedical Engineering, University of Texas, Austin, Texas, USA; University of Texas, Austin, Texas, USA; Senior Researcher Texas Cardiac Arrhythmia Institute at St. David’s Senior Researcher Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA; Medical Center, Austin, Texas, USA; Assistant Prof. Department of Cardiology, University of Foggia, Italy Assistant Prof. Department of Cardiology, University of Foggia, Italy

Email: dibbia@gmail.com Email: dibbia@gmail.com

Texas

Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA; Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA;

 California Pacific Medical Center, San Francisco, California, USA;

California Pacific Medical Center, San Francisco, California, USA;

 University of Kansas, Kansas City, USA;

University of Kansas, Kansas City, USA;

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy;

Effect of Empirical Left Atrial Appendage Isolation on Effect of Empirical Left Atrial Appendage Isolation on Long Long-term Procedure Outcome in Patients with term Procedure Outcome in Patients with Long Long-standing Persistent AF undergoing Ablation: standing Persistent AF undergoing Ablation: Results from the Results from the BELIEF BELIEF Randomized Trial Randomized Trial

ClinicalTrials.gov Identifier: ClinicalTrials.gov Identifier: NCT01362738

Luigi Di Biase, J. David Burkhardt, MD, Prasant Mohanty, Sanghamitra Mohanty, , Javier E. Sanchez, Chintan Trivedi, Mahmut Güneş, Yalçın Gökoğlan, Carola Gianni, Rodney P. Horton,

  • G. Joseph Gallinghouse, Shane Bailey, Jason D. Zagrodzky,

Steven C. Hao, Richard H. Hongo, Salwa Beheiry, Pasquale Santangeli, Michela Casella, Antonio Dello Russo, Amin Al-Ahmad, Patrick Hranitzky, Dhanujaya R. Lakkireddy, Claudio Tondo, Andrea Natale.

DISCLOSURES I am a consultant for

Biosense Webster Stereotaxis St Jude Medical I received speaker honoraria/travel from Atricure Biotronik Boston Scientific Medtronic

Long standing persistent (LSP) atrial fibrillation Long standing persistent (LSP) atrial fibrillation (AF) is the most challenging type of AF to treat (AF) is the most challenging type of AF to treat with catheter ablation. with catheter ablation.

BACKGROUND BACKGROUND BACKGROUND BACKGROUND

  • Several studies have shown that in addition

Several studies have shown that in addition to pulmonary vein (PVs) isolation other non to pulmonary vein (PVs) isolation other non PVs areas may be the source of initiation and PVs areas may be the source of initiation and maintenance of atrial fibrillation in patients. maintenance of atrial fibrillation in patients.

  • The most common sites are: the superior

vena cava, the ligament of Marshall, the coronary sinus, the crista terminalis, the left atrial posterior wall and the left atrial appendage.

Di Biase et al. Circulation. 2010;122:109-118.

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Total Population (n=3,966)

PAF 36%, Persistent 20%, LS Persistent 44%

Referred for Redo (n=987)

PAF 29%, Persistent 20%, LS Persistent 51%

No LAA Firing 721 (73%)

LAA Firing 266 (27%)

PAF 18%, PER 23%, LSP 58%

Group 1-LAA Not Ablated (n=43) Group 2-Focal Ablation (n=56) Group 3- LAA Isolation (n=167)

LAA Isolation 2nd Redo (n=88)

Di Biase et al. Circulation. 2010;122:109-118.

EVIDENCE of the LAA as a TRIGGER for AF/AT

AIM AIM

We We sought to assess whether sought to assess whether in patients with Long in patients with Long Standing Persistent AF the Standing Persistent AF the EMPIRICAL EMPIRICAL ELECTRICAL ISOLATION ELECTRICAL ISOLATION of the left atrial

  • f the left atrial

appendage ( appendage (LAA) LAA) in addition to in addition to extensive PV extensive PV antrum antrum and triggers ablation could improve freedom and triggers ablation could improve freedom from AF/AT from AF/AT at at follow up follow up in a in a in in a multicenter a multicenter randomized randomized trial. trial. Methods Methods

  • This

This was a randomized, was a randomized, parallel parallel-group study assessing whether group study assessing whether empirical empirical isolation of the isolation of the LAA in LAA in addition addition to an extensive standard to an extensive standard ablation, ablation, could improve the freedom from atrial could improve the freedom from atrial arrhythmia in LSP arrhythmia in LSP AF patients AF patients

  • Power

Power Calculation: The study Calculation: The study had 80% power to had 80% power to detect at least detect at least 20% difference in success rate (50% to 70%) at 12 month follow 20% difference in success rate (50% to 70%) at 12 month follow-

  • up

up (using log (using log-rank test), with rank test), with two two-sided sided Type I error of 0.05. Type I error of 0.05.

  • 173 patients were enrolled and randomly assigned (1:1 ratio) to:

173 patients were enrolled and randomly assigned (1:1 ratio) to:

  • Extensive ablation plus

Extensive ablation plus Empirical LAA isolation (group (group 1, 1, n=85) n=85)

  • Extended PV

Extended PV antrum antrum and non PV triggers ablation (group and non PV triggers ablation (group 2, 2, n=88) n=88)

  • Patients ≥18 years of

Patients ≥18 years of age, age, with LSP AF refractory to with LSP AF refractory to antiarrhythmic antiarrhythmic drugs were included in the study drugs were included in the study

Study Design Study Design

173 Patients Enrolled (≥18 years, long-standing persistent AF refractory to antiarrhythmic drugs) Standard Ablation + Empirical LAA isolation (Group 1): n= 85 Randomized 1:1 Standard Ablation alone (group 2): n= 88

Ablation Success Assessed at 12 month Follow-up After Index Procedure

62 Patients underwent a second procedure (27 group 1 and 35 group 2). LAA isolation was performed in all patients during repeat ablation

Follow-up after Redo Outcome Assessed at 24 month

Kaplan Kaplan–Meier Meier curves: single procedure success rate curves: single procedure success rate

At the 12 month follow-up, 48(56%) in group 1 and 25 (28%) in group 2 were recurrence-free off-AAD after a single procedure. (Log-rank p=0.001, unadjusted HR 1.92 [1.3 to 2.9]).

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Cumulative Overall Success Cumulative Overall Success After 1.3 Procedures fter 1.3 Procedures

The cumulative success after multiple procedures was 65 (76%) in group 1 and 49 (56%) in group 2 ALL THE PATIENTS UNDERWENT LAA ISOLATION (Log-rank p= 0.003, unadjusted HR 2.24 [95% CI 1.3-3.8])

Results: Results: Predictor of Recurrence

  • After adjusting for

After adjusting for age, gender, LA diameter age, gender, LA diameter in Cox in Cox multivariate model multivariate model

–Isolation of LAA in addition to standard

Isolation of LAA in addition to standard ablation, ablation, was associated with was associated with 55% 55% reduction in overall reduction in overall recurrence (HR 0.45 [0.26 recurrence (HR 0.45 [0.26-0.77], p=0.004) 0.77], p=0.004)

Results: Results: Trans

Trans-esophageal echocardiogram ( esophageal echocardiogram (TEE) after a TEE) after a single procedure in patients undergoing LAA isolation single procedure in patients undergoing LAA isolation

  • Patients

atients undergoing LAA isolation received undergoing LAA isolation received TEE at TEE at 6 6 month month follow up, irrespective of their underlying follow up, irrespective of their underlying rhythm rhythm

  • Low peak

Low peak flow flow velocity (< velocity (<0.4 m/s) 0.4 m/s) in the in the LA LA appendage appendage was was observed in 48 patients

  • bserved in 48 patients

Hospitalization Hospitalization

22 (25%) 2 (2.4%) 19 (22%) 0.0% 0% 5% 10% 15% 20% 25% 30%

AF Related Hospitalizations HF Related Hospitalizations

Incidence Rate

Empirical LAA isolation Standard ablation group

P= 0.72 P= 0.24

Results Results: Stroke/TIA and Mortality : Stroke/TIA and Mortality

  • Stroke/TIA:

Stroke/TIA:

–No

No stroke or TIA was reported in the empirical LAA stroke or TIA was reported in the empirical LAA isolation group, isolation group,

–Four

Four (4.5%) (4.5%) patients had stroke patients had stroke in the standard in the standard ablation group (p=0.12 ablation group (p=0.12). None of them in patients ). None of them in patients with LAA isolation with LAA isolation

  • No deaths occurred during the study

No deaths occurred during the study period period

Results: Results: Peri Peri-Procedural Complications Procedural Complications

  • Complications:

Complications:

–One pericardial effusion occurred in each group

One pericardial effusion occurred in each group (p= (p= 1.0) 1.0)

–One gastrointestinal bleeding was reported in

One gastrointestinal bleeding was reported in Standard Ablation group Standard Ablation group (p= 0.49) (p= 0.49)

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CONCLUSIONS CONCLUSIONS

  • The results of this randomized study show that

The results of this randomized study show that both after a single and redo procedures in both after a single and redo procedures in patients with atients with long standing persistent AF long standing persistent AF, the , the EMPIRICAL ISOLATION EMPIRICAL ISOLATION of

  • f the

the LAA LAA improve improve the the long long-term freedom from atrial arrhythmias term freedom from atrial arrhythmias without increasing complications. without increasing complications.

  • Future

Future studies examining the physiopathology studies examining the physiopathology

  • f these findings are necessary.
  • f these findings are necessary.

Effect of Empirical Left Atrial Appendage Isolation on long-term procedure outcome in patients with Long-Standing Persistent AF undergoing Catheter Ablation: Results from the BELIEF Randomized Trial

Luigi Di Luigi Di Biase Biase, MD, PhD, FACC, FHRS , MD, PhD, FACC, FHRS

Section Head of Electrophysiology at Albert Einstein and Section Head of Electrophysiology at Albert Einstein and Montefiore Montefiore Hospital, New York, USA; Hospital, New York, USA; Associate Professor, Albert Einstein College of Medicine at Associate Professor, Albert Einstein College of Medicine at Montefiore Montefiore Hospital, New York, USA; Hospital, New York, USA; Adjunct Associate Professor Department of Biomedical Engineering, Adjunct Associate Professor Department of Biomedical Engineering, University of Texas, Austin, Texas, USA; University of Texas, Austin, Texas, USA; Senior Researcher Texas Cardiac Arrhythmia Institute at St. David’s Senior Researcher Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA; Medical Center, Austin, Texas, USA; Assistant Prof. Department of Cardiology, University of Foggia, Italy Assistant Prof. Department of Cardiology, University of Foggia, Italy

Email: dibbia@gmail.com Email: dibbia@gmail.com

Texas

Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA; Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, USA;

California Pacific Medical Center, San Francisco, California, USA;

California Pacific Medical Center, San Francisco, California, USA;

University of Kansas, Kansas City, USA;

University of Kansas, Kansas City, USA;

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy;

Effect of Empirical Left Atrial Appendage Isolation on Effect of Empirical Left Atrial Appendage Isolation on Long Long-term Procedure Outcome in Patients with term Procedure Outcome in Patients with Long Long-standing Persistent AF undergoing Ablation: standing Persistent AF undergoing Ablation: Results from the Results from the BELIEF BELIEF Randomized Trial Randomized Trial

ClinicalTrials.gov Identifier: ClinicalTrials.gov Identifier: NCT01362738

Luigi Di Biase, J. David Burkhardt, MD, Prasant Mohanty, Sanghamitra Mohanty, , Javier E. Sanchez, Chintan Trivedi, Mahmut Güneş, Yalçın Gökoğlan, Carola Gianni, Rodney P. Horton,

  • G. Joseph Gallinghouse, Shane Bailey, Jason D. Zagrodzky,

Steven C. Hao, Richard H. Hongo, Salwa Beheiry, Pasquale Santangeli, Michela Casella, Antonio Dello Russo, Amin Al-Ahmad, Patrick Hranitzky, Dhanujaya R. Lakkireddy, Claudio Tondo, Andrea Natale.