8/29/2015 Effect of Empirical Left Atrial Appendage Isolation on - PDF document

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 Appendage Isolation on long-term procedure outcome in Long Long-standing Persistent AF undergoing Ablation: standing Persistent AF undergoing Ablation: patients with Long-Standing Persistent AF Results from the Results from the BELIEF BELIEF Randomized Trial Randomized Trial undergoing Catheter Ablation: ClinicalTrials.gov Identifier: ClinicalTrials.gov Identifier: Results from the BELIEF Randomized Trial NCT01362738 Luigi Di Biase Luigi Di Biase, MD, PhD, FACC, FHRS , MD, PhD, FACC, FHRS Luigi Di Biase, J. David Burkhardt, MD, Prasant Mohanty, Sanghamitra Mohanty, , Javier E. Sanchez, Chintan Trivedi, Section Head of Electrophysiology at Albert Einstein and Section Head of Electrophysiology at Albert Einstein and Mahmut Güneş , Yalçın Gökoğlan , Carola Gianni, Rodney P. Horton, Montefiore Montefiore Hospital, New York, USA; Hospital, New York, USA; G. Joseph Gallinghouse, Shane Bailey, Jason D. Zagrodzky, Associate Professor, Albert Einstein College of Medicine at Associate Professor, Albert Einstein College of Medicine at Montefiore Montefiore Steven C. Hao, Richard H. Hongo, Salwa Beheiry, Pasquale Santangeli, Hospital, New York, USA; Hospital, New York, USA; Michela Casella, Antonio Dello Russo, Amin Al-Ahmad, Patrick Hranitzky, Adjunct Associate Professor Department of Biomedical Engineering, Adjunct Associate Professor Department of Biomedical Engineering, Dhanujaya R. Lakkireddy, Claudio Tondo, Andrea Natale. 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  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; Medical Center, Austin, Texas, USA; Medical Center, Austin, Texas, USA; California Pacific Medical Center, San Francisco, California, USA;   University of Kansas, Kansas City, USA; University of Kansas, Kansas City, USA; Assistant Prof. Department of Cardiology, University of Foggia, Italy Assistant Prof. Department of Cardiology, University of Foggia, Italy  Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy; Email: dibbia@gmail.com Email: dibbia@gmail.com BACKGROUND BACKGROUND DISCLOSURES I am a consultant for Long standing persistent (LSP) atrial fibrillation Long standing persistent (LSP) atrial fibrillation  Biosense Webster (AF) is the most challenging type of AF to treat (AF) is the most challenging type of AF to treat  Stereotaxis with catheter ablation. with catheter ablation.  St Jude Medical I received speaker honoraria/travel from  Atricure  Biotronik  Boston Scientific  Medtronic 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. 1

8/29/2015 EVIDENCE of the LAA as a TRIGGER for AF/AT 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 LAA Firing 266 (27%) 721 (73%) PAF 18%, PER 23%, LSP 58% Group 1-LAA Group 2 - Focal Group 3- Not Ablated (n=43) Ablation (n=56) LAA Isolation (n=167) LAA Isolation 2 nd Redo (n=88) Di Biase et al. Circulation. 2010;122:109-118. Methods Methods AIM AIM • 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 We We sought to assess whether sought to assess whether in patients with Long in patients with Long AF patients AF patients Standing Persistent AF the Standing Persistent AF the EMPIRICAL EMPIRICAL • Power Power Calculation: The study Calculation: The study had 80% power to had 80% power to detect at least detect at least ELECTRICAL ISOLATION of the left atrial ELECTRICAL ISOLATION of the left atrial 20% difference in success rate (50% to 70%) at 12 month follow- 20% difference in success rate (50% to 70%) at 12 month follow - appendage ( LAA) appendage ( LAA) in addition to in addition to extensive PV extensive PV 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. antrum antrum and triggers ablation could improve freedom and triggers ablation could improve freedom • 173 patients were enrolled and randomly assigned (1:1 ratio) to: 173 patients were enrolled and randomly assigned (1:1 ratio) to: from AF/AT from AF/AT at at follow up follow up in a in a in in a multicenter a multicenter • Extensive ablation plus Extensive ablation plus Empirical LAA isolation (group (group 1, 1, n=85) n=85) randomized trial. randomized trial. • 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 Kaplan – Meier Kaplan Meier curves: single procedure success rate curves: single procedure success rate Study Design Study Design 173 Patients Enrolled (≥18 years, long-standing persistent AF refractory to antiarrhythmic drugs) Randomized 1:1 Standard Ablation + Standard Ablation alone Empirical LAA isolation (group 2): n= 88 (Group 1): n= 85 Follow-up After Index Procedure Ablation Success Assessed at 12 month 62 Patients underwent a second procedure (27 group 1 and 35 group 2). LAA isolation was performed in all patients during repeat ablation At the 12 month follow-up, 48(56%) in group 1 and 25 (28%) in group 2 Follow-up after Redo were recurrence-free off-AAD after a single procedure. (Log-rank p=0.001, unadjusted HR 1.92 [1.3 to 2.9]). Outcome Assessed at 24 month 2

8/29/2015 Cumulative Overall Success Cumulative Overall Success After 1.3 Procedures fter 1.3 Procedures Results: Predictor of Recurrence Results: • 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) 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]) Hospitalization Hospitalization 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 30% P= 0.72 • Patients atients undergoing LAA isolation received undergoing LAA isolation received TEE at TEE at 6 6 22 (25%) 25% 19 (22%) month month follow up, irrespective of their underlying follow up, irrespective of their underlying Empirical LAA isolation 20% rhythm rhythm Incidence Rate Standard ablation group • Low peak 15% Low peak flow flow velocity (< velocity (<0.4 m/s) 0.4 m/s) in the in the LA LA appendage was appendage was observed in 48 patients observed in 48 patients 10% P= 0.24 5% 2 (2.4%) 0.0% 0% AF Related HF Related Hospitalizations Hospitalizations Results Results: Stroke/TIA and Mortality : Stroke/TIA and Mortality Results: Results: Peri Peri-Procedural Complications Procedural Complications • Stroke/TIA: • Complications: Stroke/TIA: Complications: – No – One pericardial effusion occurred in each group No stroke or TIA was reported in the empirical LAA stroke or TIA was reported in the empirical LAA One pericardial effusion occurred in each group (p= (p= isolation group, isolation group, 1.0) 1.0) – Four – One gastrointestinal bleeding was reported in Four (4.5%) (4.5%) patients had stroke patients had stroke in the standard in the standard One gastrointestinal bleeding was reported in ablation group (p=0.12). None of them in patients ablation group (p=0.12 ). None of them in patients Standard Ablation group (p= 0.49) Standard Ablation group (p= 0.49) with LAA isolation with LAA isolation • No deaths occurred during the study No deaths occurred during the study period period 3