Combined catheter ablation and left atrial appendage closure as a hybrid procedure for the treatment of atrial fibrillation Giulio Molon, MD FACC, FESC, Fellow ANMCO Card Dept, S.Cuore hospital Negrar www.aritmologo.it
My Disclosures Medtronic and Boston: Consultant Fees/Honoraria Medtronic, Boston, St.Jude: Clinical Studies fees Medtronic, Boston, St. Jude, Bayer and Boehringer Ingelheim: Congress Reimbursements
LAAC and AF ablation
LAAC
PROTECT AF Death, Stroke, Embolism WATCHMAN superior over Warfarin during long-term FU Reddy VY et al., JAMA 2014; 312(19): 1988-98
Main studies/registries Pilot Early feasibility with >6 years of follow-up N=66 PROTECT-AF Primary efficacy, CV death, and all-cause mortality superior to warfarin at 4 years1 N=707 CAP Registry Significantly improved safety results2 N=460 ASAP Expected rate of stroke reduced by 77% in patients contraindicated to warfarin3 N=150 PREVAIL Improved implant success procedure safety confirmed with new and experienced operators4 N=407 CAP2 579 patients enrolled in 48 sites N= 579 Meta-Analysis Evaluation and analysis of the totality of WATCHMAN trial data N= >2,000 EWOLUTION Compilation of real-world clinical outcomes data for WATCHMAN N=1025 1 Reddy, VY et al. JAMA. 2014; 312(19):1988-1998 2 Reddy, VY et al. Circulation. 2011;123:417-424; 3 Reddy, et al. JACC. 2013; In Press. 4 Holmes, DR et al. JACC 2014; In Press
WATCHMAN Patient Meta-Analysis Left Atrial Appendage Closure as an alternative to Warfarin for stroke prevention in Atrial Fibrillation: A patient level Meta-Analysis of WATCHMAN Trials Purpose was to evaluate and analyze the totality of WATCHMAN trial data via a patient level meta-analysis: - all randomized patients from PROTECT AF and PREVAIL - All device patients from the two randomized trials and two non-randomized registries (PROTECT AF, PREVAIL, CAP and CAP2)
PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin HR p-value 0.79 0.22 1.02 0.94 Ischemic stroke or SE 1.95 0.05 Hemorrhagic stroke 0.22 0.004 Ischemic stroke or SE >7 days 1.56 0.21 0.48 0.006 All-cause death 0.73 0.07 Major bleed, all 1.00 0.98 Major bleeding, non procedure-related 0.51 0.002 Efficacy All stroke or SE CV/unexplained death Favors WATCHMAN Hazard Ratio (95% CI) Holmes, DR et al. JACC 2014 Favors warfarin
AF ablation
Meta-analysis of Catheter Ablation Patients Paroxysma l AF SHD Linear 443 75% 26% 33% 55% Focal 508 81% 35% 54% 71% 2,187 83% 36% 62% 75% Circumferential (all) 15,455 68% 37% 64% 74% Circumferential (LACA, WACA) 2,449 65% 37% 59% 72% Circumferential (PVAI) 11,132 68% 42% 67% 76% 559 51% 49% 75% 87% 23,626 61% 55% 63% 75% Ablation method Isolation Substrate ablation (CFAE) TOTAL Fisher JD, et al. PACE (2006) 29: 523 6-month cure 6-months OK
Randomized Controlled Trial of Amiodarone + Cardioversion + Catheter Ablation Amiodarone & cardioversion (n=69) vs. amiodarone & cardioversion plus PV ablation (n=77) 100 Circumferential pulmonary-vein ablation Control Sinus rhythm (%) 80 60 40 20 0 1 2 3 4 5 6 7 Months Oral H, et al. N Engl J Med (2006) 354: 9 8 9 10 11 12
Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation Karl-Heinz Kuck, MD, FACC Asklepios Klinik St. Georg, Hamburg, Germany RFC Ablation (䇾FIRE䇿) Power was not to exceed 40 W at A/I aspect 30 W at P/S aspect 3D electroanatomical mapping The FIRE AND ICE Trial Cryoballoon Ablation (䇾ICE䇿) Max. freeze duration of 240s recommended Bonus freeze after isolation recommended Phrenic nerve pacing required
Investigators must have documented experience 50 cases with either ablation technique; each center had to provide at least one investigator proficient in both techniques PVI-only approach (CTI flutter ablation allowed, but no additional lines or CFAE ablation) Must confirm PVI with a mapping catheter 30-minute waiting period after last application AADs discontinued after 90-day blanking period Amiodarone required to be discontinued at day of procedure
FIRE AND ICE AF Clinical Trial Primary Efficacy End Point Modified ITT analysis HR [95% CI] = 0.96 [0.76-1.22]; p = 0.0004 Non-inferiority hypothesis met Superiority test: p = 0.74
AF Catheter Ablation to Maintain Sinus Rhythm Recommendations AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication when a rhythm-control strategy is desired. Before consideration of AF catheter ablation, assessment of the procedural risks and outcomes relevant to the individual patient is recommended. AF catheter ablation is reasonable for some patients with symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. In patients with recurrent symptomatic paroxysmal AF, catheter ablation is a reasonable initial rhythm-control strategy before therapeutic trials of antiarrhythmic drug therapy, after weighing the risks and outcomes of drug and ablation therapy. COR LOE I A I C IIa A IIa B
AF Catheter Ablation to Maintain Sinus Rhythm (cont d) Recommendations COR AF catheter ablation may be considered for symptomatic long-standing (>12 months) persistent AF refractory or IIb intolerant to at least 1 class I or III antiarrhythmic medication when a rhythm-control strategy is desired. AF catheter ablation may be considered before initiation of antiarrhythmic drug therapy with a class I or III IIb antiarrhythmic medication for symptomatic persistent AF when a rhythm-control strategy is desired. AF catheter ablation should not be performed in patients III: who cannot be treated with anticoagulant therapy during Harm and after the procedure. AF catheter ablation to restore sinus rhythm should not be III: performed with the sole intent of obviating the need for Harm anticoagulation. LOE B C C C
There is a rational for combined LAA closure and AF ablation Can a combined procedure of PVI ablation and LAA closure as a hybrid procedure be used for the treatment of atrial fibrillation?
What do we know about? At the moment are not available data from trials, big studies or registries The only data are single centers experience based on few patients No guidelines mention
AF ablation and LAAC
Only 8 patients Long procedure time
Procedure time related?
In this proof-of-concept study in patients with nonvalvular AF with a moderate to severe risk of stroke or contraindication for VKA, we show for the first time that the combination of ablation and LAA occlusion with the Watchman device was performed successfully and safely and did not interfere with repeat PV isolation.
Europace 2015
Europace 2015
Total complications (procedural and FU) 14.3% Europace 2015
Why not in my centre?
Cryo Ablation vs LAAC- my cases Giugno 2012 - Dicembre 2015 Cryo LAAC N Patients 100 49 Age 63.5±7 74.4±5 Female 21% 33% Permanent AF 13% 87.5% Paroxysmal/persistent AF 87% 12.5% CHA2DS2-VASc 1.6±1.5 3.9±1 HAS-BLED 1.5±0.4 3.6±0.6 Watchman - 44 ACP/Amulet - 5
24 hours Adverse Events Cryo LAAC Death 0 0 Cardiac tamponade 0 1 Stroke 0 0 Thombosis 0 1 Device embolization - 1 Major bleeding 0 0 Vascular AE 5 2 Leaks < 3 mm - 5 Leaks > 3 mm - 0
Conclusions The combination of AF ablation and percutaneous LAA closure in the same procedure is technically feasible according to the single centers experiences available. Larger trials results are expected to assess the safety and efficacy of the combined approach:
Conclusions At the moment the hybrid procedure should be indicated to a very restricted number of selected patients Seems advisable to use Cryo Ballon AF ablation in combination with percutaneous LAA closure in order to cut down the total procedure time, and particularly the time to dwell in left atrium. Time Measurement (minutes) RFC (n=376) * Cryoballoon (n=374) * P-value** My Cases Procedure Time*** 140.9 ± 54.9 124.4 ± 39.0 <0.0001 78 LA Dwell Time*** 108.6 ± 44.9 92.3 ± 31.4 <0.0001 42 16.6 ± 17.8 21.7 ± 13.9 <0.0001 23 Fluoroscopy Time
Combined catheter ablation and left atrial appendage closure as a hybrid procedure for the treatment of atrial brillation Giulio Molon, MD FACC, FESC, Fellow ANMCO Card Dept, S.Cuore hospital Negrar www.aritmologo.it