Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up

Karen P Phillips, Evgeny Pokushalov, Aleksandr Romanov, Sergey Artemenko, Richard J Folkeringa, Tamas Szili-Torok, Gaetano Senatore, Kenneth M Stein, Omar Razali, Nicole Gordon, Lucas V A Boersma, Karen P Phillips, Evgeny Pokushalov, Aleksandr Romanov, Sergey Artemenko, Richard J Folkeringa, Tamas Szili-Torok, Gaetano Senatore, Kenneth M Stein, Omar Razali, Nicole Gordon, Lucas V A Boersma

Abstract

Aims: Long-term results from catheter ablation therapy for atrial fibrillation (AF) remain uncertain and clinical practice guidelines recommend continuation of long-term oral anticoagulation in patients with a high stroke risk. Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the initial results of combining catheter ablation procedures for AF and LAAC in a multicentre registry.

Methods and results: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure.

Conclusion: The outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.

Figures

Figure 1
Figure 1
Kaplan–Meier curves and rates at zero (0), 1, 7, and 30 days post-implant for (A) all serious adverse events and (B) all bleeding serious adverse events.

References

    1. Steinberg JS, Palekar R, Sichrovsky T, Arshad A, Preminger M, Musat D. et al. Very long-term outcome after initially successful catheter ablation of atrial fibrillation. Heart Rhythm 2014;11:771–6.
    1. Jacobs V, May HT, Bair TL, Crandall BG, Cutler M, Day JD. et al. The impact of risk score (CHADS2 versus CHA2DS2-VASc) on long-term outcomes after atrial fibrillation ablation. Heart Rhythm 2015;12:681–6.
    1. Kornej J, Hindricks G, Kosiuk J, Arya A, Sommer P, Husser D. et al. Comparison of CHADS2, R2CHADS2, and CHA2DS2-VASc scores for the prediction of rhythm outcomes after catheter ablation of atrial fibrillation: the Leipzig Heart Center AF Ablation Registry. Circ Arrhythm Electrophysiol 2014;7:281–7.
    1. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace 2016;18:1609–78.
    1. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, PROTECT AF Investigators et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009;374:534–42.
    1. Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H. et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol 2015;65:2614–23.
    1. Meier B, Blaauw Y, Khattab A.. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. Europace 2015;10:1109–25.
    1. Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E. et al. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J 2016;37:2465.
    1. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J. et al. Standardized bleeding definition for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736–47.
    1. Sairaku A, Yoshida Y, Nakano Y, Maeda M, Hirayama H, Hashimoto H. et al. Who is the operator, that is the question: a multicenter study of catheter ablation of atrial fibrillation. Europace 2016;18:1352–6.
    1. Phillips KP, Walker DT, Humphries JA.. Combined catheter ablation for atrial fibrillation and Watchman® left atrial appendage occlusion procedures: Five-year experience. J Arrhythm 2016;32:119–26.
    1. Alipour A, Swaans MJ, van Dijk VF, Balt JC, Post MC, Bosschaert MAR. et al. Ablation for atrial fibrillation combined with left atrial appendage closure. JACC: Clin Electrophysiol 2015;1:486–95.
    1. Romanov A, Pokushalov E, Artemenko S, Yakubov A, Stenin I, Kretov E. et al. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. J Interv Card Electrophysiol 2015;44:9–16.
    1. Calvo N, Salterain N, Arguedas H, Macias A, Esteban A, García de Yébenes M. et al. Combined catheter ablation and left atrial appendage closure as a hybrid procedure for the treatment of atrial fibrillation. Europace 2015;17:1533–40.
    1. Holmes DR, Kar S, Price MJ, Whisenant B, Sievert H, Doshi S. et al. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL Trial. J Am Coll Cardiol 2014;64:1–12.
    1. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J. et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol 2010;3:32–8.
    1. Bai R, Horton RP, DI Biase L, Mohanty P, Pump A, Cardinal D. et al. Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience. J Cardiovasc Electrophysiol 2012;23:455–61.
    1. Viles-Gonzalez JF, Reddy VY, Petru J, Mraz T, Grossova Z, Kralovec S. et al. Incomplete occlusion of the left atrial appendage with the percutaneous left atrial appendage transcatheter occlusion device is not associated with increased risk of stroke. J Interv Card Electrophysiol 2012;33:69–75.
    1. Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA. et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace 2012;14:528–606.
    1. Vallakati A, Sharma A, Madmani M, Reddy M, Kanmanthareddy A, Gunda S. et al. Efficacy and safety of novel oral anticoagulants for atrial fibrillation ablation: an updated meta-analysis. Cardiol Ther 2016;5:85–100.

Source: PubMed

3
Suscribir