Transesophageal echocardiograpy in patients with persistent atrial fibrillation undergoing electrical cardioversion on new oral anticoagulants: A multi center registry

Transesophageal echocardiograpy in patients with persistent atrial fibrillation undergoing electrical cardioversion on new oral anticoagulants: A multi center registry

International Journal of Cardiology 184 (2015) 283–284 Contents lists available at ScienceDirect International Journal of Cardiology journal homepag...

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International Journal of Cardiology 184 (2015) 283–284

Contents lists available at ScienceDirect

International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard

Letter to the Editor

Transesophageal echocardiograpy in patients with persistent atrial fibrillation undergoing electrical cardioversion on new oral anticoagulants: A multi center registry☆ Giuseppe Stabile a,⁎, Vincenzo Russo b, Antonio Rapacciuolo c, Marcello De Divitiis d, Antonio De Simone e, Francesco Solimene f, Antonio D'Onofrio g, Assunta Iuliano a, Gennaro Maresca c, Francesca Esposito c, Vincenzo La Rocca e, Vincenzo Schillaci f, Ilaria De Crescenzo d, Maria Angela Losi c, Mariateresa Librera a a

Clinica Mediterranea, Napoli, Italy Seconda Università di Napoli, Napoli, Italy c Università Federico II di Napoli, Napoli, Italy d Ospedale Pellegrini, Napoli, Italy e Clinica San Michele, Maddaloni (CE), Italy f Clinica Montevergine, Mercogliano (AV), Italy g Ospedale Monaldi, Napoli, Italy b

a r t i c l e

i n f o

Article history: Received 10 January 2015 Accepted 21 February 2015 Available online 24 February 2015 Keywords: Atrial fibrillation Electrical cardioversion New oral anticoagulants

Increased risk of thrombo-embolism following cardioversion for atrial fibrillation (AF) is well recognized. Therefore, anticoagulation is considered mandatory before elective cardioversion for AF of N 48 h or AF of unknown duration. Vitamin K antagonists (VKAs) (INR 2.0 to 3.0) are recommended for at least 3 weeks prior to and 4 weeks after cardioversion, regardless of the CHA2DS2-VASc score and the method (electrical or pharmacological) used to restore sinus rhythm [1,2]. The risk of thromboembolic events is high (up to 7%) if anticoagulation is inadequate, and is reduced to less than 1% if adequate anticoagulation is achieved [3]. Recently, new oral anticoagulants (NOACs) have been introduced in the clinical practice and suggested also in patients undergoing electrical cardioversion for AF. In this context compliance and adherence to treatment are crucial, as these drugs have a relatively short half-life. In fact patients missing more than one drug assumption cannot be considered under an adequate therapeutic regimen. Moreover, ☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. ⁎ Corresponding author at: Laboratorio di Elettrofisiologia, Clinica Mediterranea, Via Orazio 2, 80100 Napoli, Italy. E-mail address: [email protected] (G. Stabile).

http://dx.doi.org/10.1016/j.ijcard.2015.02.075 0167-5273/© 2015 Published by Elsevier Ireland Ltd.

differently from VKA treatment, that can be followed through INR measurements, there are no effective hemoreological tests to assess therapeutic anticoagulation. One way to assess the efficacy of anticoagulation therapy is the direct search for left atrial thrombus by means of transesophageal echocardiography (TEE). The aim of our study was to evaluate the incidence of left atrial (LA) thrombus in patients referred for electrical cardioversion, while on treatment with NOACs, using a pre-procedural TEE. Between January 2014 and December 2014 we collected the TEE data of 219 consecutive patients with persistent AF referred to seven Italian centers for elective electrical cardioversion, while on NOACs for at least 3 weeks before electrical cardioversion. This study followed the principles outlined in the latest update of the Declaration of Helsinki and all patients signed informed consent. This study was approved by our Institutional Review Boards. Main exclusion criteria were a history of thromboembolic events, a history of LA thrombus diagnosed by TEE, a TEE procedure performed in the 21 days before starting NOAC therapy, and the need for anticoagulation other than AF. TEE was performed with a 5–7-MHz multiplane transducer connected to an ultrasound system. Multiple standard tomographic planes were imaged. The LA appendage peak flow velocity, presence of thrombi in the LA, and severity of spontaneous echo contrast in the LA were determined. Atrial cavity or appendage thrombi were considered to be present when wellcircumscribed, echodense, intracavitary masses that were acoustically distinct from the underlying endocardium and pectinate muscles were identified. The clinical characteristics of the study population are summarized in Table 1. The mean duration of AF was 6.2 ± 4.3 months, and the mean duration of NOAC therapy was 4.1 ± 3 months. NOACs used were dabigatran (86 patients, 39%), rivaroxaban (61 patients, 28%), and apixaban (73 patients, 33%). The daily dabigratan dose was 220 mg in 21 patients, and 300 mg in 65 patients; the daily rivaroxaban dose was 15 mg in 2 patients, and 20 mg in 59 patients; the daily apixaban dose was 5 mg in 1 patient, and 10 mg in 72 patients. The

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G. Stabile et al. / International Journal of Cardiology 184 (2015) 283–284 Table 1 Clinical characteristics of study population (n = 219 patients). Variable

Mean ± SD or %

Mean age (years) Sex (male/female) Heart disease (%) Hypertension (%) Coronary artery disease (%) Valvulopathy Dilated cardiomyopathy Diabetes (%) Previous stroke (%) Mean CHA2DS2-VASc score

67 ± 9.9 156/63 86 83 26 13 4 17 4 2.37 ± 1.44

scheduled transesophageal echocardiography was performed in all patients. The mean LA diameter was 46 ± 5 mm, and the mean LA volume was 77 ± 28 ml. In three (1.4%) patients a LA appendage thrombus was found and electrical cardioversion was delayed. All the remaining subjects underwent electrical cardioversion safely, in the absence of symptoms or clinical signs of stroke or peripheral embolism. The NOACs for stroke prevention in AF fall into two classes: oral direct thrombin inhibitors (e.g., dabigatran) and oral direct factor Xa inhibitors (e.g., rivaroxaban, apixaban). In contrast to VKAs, which block the formation of multiple active vitamin K-dependent coagulation factors (factors II, VII, IX, and X), these drugs inhibit the activity of one single step in coagulation. According to prospective clinical trials, NOACs represent a valid alternative to VKAs for long-term stroke prevention in patients with non-valvular AF. Furthmore, at post hoc analyses, dabigatran, rivaroxaban, and apixaban have found to be as safe and effective as VKA treatment in the setting of cardioversion [4–6]. Recently, X-VeRT trial [7], the first completed prospective trial of a NOAC in patients with AF undergoing elective cardioversion, demonstrated that rivaroxaban administered de novo, or as ongoing therapy, or as a replacement for VKAs or another anticoagulant agent, was associated with thromboembolic and bleeding risks that were low and similar to those observed with VKA treatment. Currently, few data [8] are available on the use of NOACs in routine clinical practice. The differences between clinical trial efficacy and real-world effectiveness are primarily due to patient selection and an increased potential for medication non-adherence. Since NOACs do not require routine laboratory monitoring, they may require closer clinical follow-up to ensure adequate adherence. In a national cohort of Veterans treated with dabigatran [9], it has been demonstrated that more than one-quarter of patients were non-adherent and lower adherence was associated with increased risk of stroke and death. This issue becomes crucial for AF cardioversion, as this must be performed after at least 3 weeks of effective anticoagulant therapy. Therefore, the European Heart Rhythm

Association recommends that a prior TEE should be considered if there is doubt about compliance [10]. In post hoc analysis of randomized trial only few data on TEE were available and the incidence of atrial thrombus on TEE ranged from 0 to 1.8% [8–10]. Our registry is the first to investigate the incidence of atrial thrombus in patients on NOACs with persistent AF undergoing electrical cardioversion, in routine clinical practice, regardless of patients' adherence to treatment. Our data show that the incidence of atrial thrombus in patients assuming NOACs before electrical cardioversion is reasonably low and similar to the incidence observed with VKA treatment [3]. This finding provides further support to the current guidelines [1,2,10], that recommend to manage patients undergoing cardioversion on NOACs in the same fashion of patients on VKAs. In this multicenter registry, in patients with persistent AF, while on NOACs, the incidence of LA thrombus was low and similar to the one already reported with VKA treatment. Conflict of interest No conflicts of interest exist. References [1] A.J. Camm, P. Kirchhof, G.Y. Lip, U. Schotten, et al., Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC), Eur. Heart J. 31 (2010) 2369–2429. [2] C.T. January, L.S. Wann, J.S. Alpert, et al., 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society, Circulation 130 (2014) 2071–2104. [3] A.L. Klein, R.D. Murray, R.A. Grimm, Role of transesophageal echocardiographyguided cardioversion of patients with atrial fibrillation, J. Am. Coll. Cardiol. 37 (2001) 691–704. [4] R. Nagarakanti, M.D. Ezekowitz, J. Oldgren, et al., Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion, Circulation 123 (2011) 131–136. [5] J.P. Piccini, S.R. Stevens, Y. Lokhnygina, et al., Outcomes following cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial, J. Am. Coll. Cardiol. 61 (2013) 1998–2006. [6] G. Flaker, R.D. Lopes, S.M. Al Khatib, et al., Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), J. Am. Coll. Cardiol. 63 (2014) 1082–1087. [7] R. Cappato, M.D. Ezekowitz, A.L. Klein, et al., on behalf of the X-VeRT Investigators, Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation, Eur. Heart J. 35 (2014) 3346–3355. [8] A. Yadlapati, C. Groh, R. Passman, Safety of short-term use of dabigatran or rivaroxaban for direct-current cardioversion in patients with atrial fibrillation and atrial flutter, Am. J. Cardiol. 113 (2014) 1362–1363. [9] S. Shore, E.P. Carey, M.P. Turakhia, et al., Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration, Am. Heart J. 167 (6) (2014 Jun) 810–817. [10] H. Heidbuchel, P. Verhamme, M. Alings, et al., European Heart Rhythm Association, European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation, Europace 15 (5) (May 2013) 625–651.