ARITMOLOGIA INTERVENTISTICA

1. Progetto Formativo ANMCO - AIAC UNIVERSO TROMBOSI ROMPERE IL LEGAME TRA FIBRILLAZIONE ATRIALE & ICTUS CONSIGLI D’AUTORE ARITMOLOGIA INTERVENTISTICA 25 febbraio 2014 In collegamento con: Torino, Bergamo, Mestre, Bologna, Lucca, Roma, Napoli, Bari, Catania, Cagliari

2. Il Ruolo dell’Ablazione nel Trattamento della FA

3. Il Ruolo dell’Ablazione nel Trattamento della FA

4. Background • AF patients are at increased risk of thromboembolism during, immediately following, and for several weeks to months after an ablation procedure. • This prothrombotic period results in a higher but transient risk even in AF patients who were identified as low-risk before ablation. • Careful attention to anticoagulation of patients before, during, and after ablation for AF is critical to avoid the occurrence of a thromboembolic event. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF Heart Rhythm, Vol 9, No 4, April 2012

5. Systemic anticoagulation and AF ablation • There are two strategies that can be used for patients who are anticoagulatedwith warfarin. • Patients could have their warfarin discontinued, and they could be “bridged” with intravenous or LMW heparin prior to and following ablation. It is recognized that this approach may result in a high incidence of bleeding complications, especially at the site of vascular access. • Ablation can also be performed in patients who are continuously therapeutically anticoagulated with warfarin (INR 2.0-3.0). In the event of persistent bleeding or cardiac tamponadeprotamine is administered to reverse heparin. Fresh frozen plasma, prothrombin complex concentrates (PCC: Factors II, VII, IX, and X), or recombinant activated factor VII (rFVIIa) can be administered for reversal of warfarin. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF Heart Rhythm, Vol 9, No 4, April 2012

6. AF Ablation Under Therapeutic Warfarin Reduces Periprocedural Complications - Evidence From a Meta-Analysis A total of 27 402 patients were included in the analysis (6400 undergoing ablation with CW). CW was associated with a striking decrease of thromboembolic complications (OR, 0.10; 95% CI, 0.05– 0.23; P0.001) and minor bleeding complications (OR, 0.38; 95% CI, 0.21– 0.71; P0.002) compared with DW. CW also did not increase the risk of major bleeding (OR, 0.67; 95% CI, 0.31–1.43; P0.30), including cardiac tamponade (OR, 0.69; 95% CI, 0.19 –2.47; P0.57). Circ Arrhythm Electrophysiol. 2012;5:302-311

7. Anticoagulation strategies: Pre, during, and post- ablation 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF Heart Rhythm, Vol 9, No 4, April 2012

8. Safety and efficacy of dabigatran versus warfarinin patients undergoing AF ablation: a meta-analysis 14 studies were identified (total of 4782 patients - 1823 treated with DABI and 2959 with W). W was uninterrupted in 9 studies and used with heparin bridging in 5 studies. Different regimens were used in patients treated with DABI. The timing of the first withheld dose ranged from the morning of procedure (in 4 studies) to 48 h before; the time interval for restarting ranged from 3–4 h (in 6 studies) to 24 h after ablation. In one study, uninterrupted DABI was used. No deaths were reported. No significant differences were found between patients treated with DABI and W as regards thromboembolic events (0.55% DABI vs 0.17% W; RR=1.78, 95% CI 0.66 to 4.80; p=0.26) and major bleeding (1.48% DABI vs 1.35% W; RR=1.07, 95% CI 0.51 to 2.26; p=0.86). Heart 2014; 100: 324–335.

9. Outcomes Following Cardioversion and Atrial Fibrillation Ablation in Patients Treated with Rivaroxaban or Warfarin in the ROCKET AF Trial Jonathan P. Piccini, Susanna R. Stevens, Yuliya Lokhnygina, Manesh R. Patel, Jonathan L. Halperin, Daniel E. Singer, Graeme J. Hankey, Werner Hacke, Richard C. Becker, Christopher C. Nessel, Kenneth W. Mahaffey, Keith A. A. Fox, Robert M. Califf, Günter Breithardt for the ROCKET AF Steering Committee & Investigators Journal of the American College of Cardiology 2013;61:1998–2006

10. Results • Median follow-up of 2.1 (1.6 [25th], 2.4 [75th]) years • N= 321 patients had a total of 460 on-treatment cardioversion or AF ablation procedures. • 143 patients underwent 181 ECV procedures • 142 patients underwent 194 PCV procedures • 79 patients underwent 85 AF ablation procedures • Overall incidence of ECV, PCV, or AF ablation was 1.45 per 100 patient-years

11. Cumulative incidence of ECV, PCV, or AF ablation by randomized treatment

12. Cumulative incidence of ECV, PCV, or AF ablation by region

13. Overall outcomes following ECV, PCV, or AF ablation Values are events per 100 patient-years (total events), unless otherwise indicated. *Includes all patients, where cardioversion or ablation patients were censored at time of ECV/PCV/ablation if event-free at the time of ECV/PCV/ablation. †Includes cardioversion or ablation patients who were event-free at the time of ECV/PCV/ablation. ‡Includes all cardioversion or ablation patients. §Interaction between ECV/PCV/AF ablation and treatment p=0.8979 for hospitalization and p=0.2647 for major or non-major clinically relevant bleeding. CI=confidence interval; CV=cardiovascular; ECV=electrical cardioversion; HR=hazard ratio; PCV=pharmacologic cardioversion.

14. Outcomes after ECV, PCV, or catheter ablation according to randomized treatment (N=321) Values are events per 100 patient-years (total events). CV=cardiovascular; ECV=electrical cardioversion; PCV=pharmacologic cardioversion.

15. Conclusions • There is significant regional variation in the use of procedures for the restoration and maintenance of sinus rhythm. • In the overall trial population, despite an increase in hospitalization, there was no significant difference in long-term stroke rates or survival following cardioversion or AF ablation. • Outcomes following ECV, PCV, or AF ablation were similar in those patients treated with rivaroxaban or warfarin.