Cited by 479Atrial Fibrillation Management and OutcomesCardiac Arrhythmias and TreatmentsCardiac electrophysiology and arrhythmias

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Outpatient Treatment of Recent-Onset Atrial Fibrillation with the “Pill-in-the-Pocket” Approach

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Alboni, Paolo, Botto, Giovanni L., Baldi, Nicola, Luzi, Mario, Russo, Vitantonio, Gianfranchi, Lorella, Marchi, Paola, Calzolari, Massimo, Solano, Alberto, Baroffio, Raffaele, Gaggioli, Germano·2004·New England Journal of Medicine

DOI 10.1056/nejmoa041233

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Abstract

BACKGROUND: In-hospital administration of flecainide and propafenone in a single oral loading dose has been shown to be effective and superior to placebo in terminating atrial fibrillation. We evaluated the feasibility and the safety of self-administered oral loading of flecainide and propafenone in terminating atrial fibrillation of recent onset outside the hospital. METHODS: We administered either flecainide or propafenone orally to restore sinus rhythm in 268 patients with mild heart disease or none who came to the emergency room with atrial fibrillation of recent onset that was hemodynamically well tolerated. Of these patients, 58 (22 percent) were excluded from the study because of treatment failure or side effects. Out-of-hospital self-administration of flecainide or propafenone--the "pill-in-the-pocket" approach--after the onset of heart palpitations was evaluated in the remaining 210 patients (mean age [+/-SD], 59+/-11 years). RESULTS: During a mean follow-up of 15+/-5 months, 165 patients (79 percent) had a total of 618 episodes of arrhythmia; of those episodes, 569 (92 percent) were treated 36+/-93 minutes after the onset of symptoms. Treatment was successful in 534 episodes (94 percent); the time to resolution of symptoms was 113+/-84 minutes. Among the 165 patients with recurrences, the drug was effective during all the arrhythmic episodes in 139 patients (84 percent). Adverse effects were reported during one or more arrhythmic episodes by 12 patients (7 percent), including atrial flutter at a rapid ventricular rate in 1 patient and noncardiac side effects in 11 patients. The numbers of monthly visits to the emergency room and hospitalizations were significantly lower during follow-up than during the year before the target episode (P<0.001 for both comparisons). CONCLUSIONS: In a selected, risk-stratified population of patients with recurrent atrial fibrillation, pill-in-the-pocket treatment is feasible and safe, with a high rate of compliance by patients, a low rate of adverse events, and a marked reduction in emergency room visits and hospital admissions.

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2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation
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Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2008)
JCS Joint Working Group (2010) · Circulation Journal · doi:10.1253/circj.cj-88-0001 · Cited by 137
Recommendations for participation in leisure-time physical activity and competitive sports in patients with arrhythmias and potentially arrhythmogenic conditions Part I: Supraventricular arrhythmias and pacemakers
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Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2008) : Digest Version
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JCS/JHRS 2020 Guideline on Pharmacotherapy of Cardiac Arrhythmias
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Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department
Stiell, I. G., & Macle, L. (2011) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2010.11.014 · Cited by 128
Newly Diagnosed Atrial Fibrillation
Page, R. L. (2004) · New England Journal of Medicine · doi:10.1056/nejmcp041956 · Cited by 124
Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Rate and Rhythm Management
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“Oral antiarrhythmic agents such as flecainide and propafenone may be given as single doses (see discussion of “pill in the pocket,” above).(59) Ibutilide is an intravenous class IIImedication that is typically givenas a single dose of 1 mg, which may be repeated once.”
Background
Quality of life in patients with atrial fibrillation: how to assess it and how to improve it
Aliot, E., Botto, G. L., Crijns, H. J. G. M., & Kirchhof, P. F. (2014) · EP Europace · doi:10.1093/europace/eut369 · Cited by 133
“The administration of oral antiarrhythmic agents at the time of symptom onset has been shown to be safe and reduces the number of emergency room visits and hospital admissions.(82) Therefore, it seems obvious that the earlier the AF can be treated, the higher the impact of treatment on QoL.”
BackgroundSelf-citation
Cardioversion of atrial fibrillation and atrial flutter revisited: current evidence and practical guidance for a common procedure
Brandes, A., Crijns, H. J. G. M., Rienstra, M., Kirchhof, P. F., Grove, E. L., Pedersen, K. B., & Gelder, I. C. V. (2020) · EP Europace · doi:10.1093/europace/euaa057 · Cited by 139
“may also be given orally using specific dosing schemes, including pillin-the-pocket.(33,34) Atrial flutter responds to Class III AAD, while”
Method
Atrial Fibrillation Occurring During Acute Hospitalization: A Scientific Statement From the American Heart Association
Chyou, J. Y., Barkoudah, E., Dukes, J. W., Goldstein, L. B., Joglar, J. A., Lee, A. M., Lubitz, S. A., Marill, K. A., Sneed, K., Streur, M. M., et al. (2023) · Circulation · doi:10.1161/cir.0000000000001133 · Cited by 127
Treatment of Atrial Fibrillation
Prystowsky, E. N., Padanilam, B. J., & Fogel, R. I. (2015) · JAMA · doi:10.1001/jama.2015.7505 · Cited by 117
2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry
Steinberg, J. S., Varma, N., Cygankiewicz, I., Aziz, P. F., Balsam, P., Baranchuk, A. M., Cantillon, D. J., Dilaveris, P., Dubner, S., El‐Sherif, N., et al. (2017) · Annals of Noninvasive Electrocardiology · doi:10.1111/anec.12447 · Cited by 123
“An alternative to emergency department treatment for patients with infrequent but disabling AF is the “pill- inthe- pocket” strategy (Alboni et al., 2004).”
Background
Association of the Ottawa Aggressive Protocol with rapid discharge of emergency department patients with recent-onset atrial fibrillation or flutter
Stiell, I. G., Clement, C. M., Perry, J. J., Vaillancourt, C., Symington, C., Dickinson, G. E., Birnie, D. H., & Green, M. S. (2010) · Canadian Journal of Emergency Medicine · doi:10.1017/s1481803500012227 · Cited by 117
Variation in Management of Recent-Onset Atrial Fibrillation and Flutter Among Academic Hospital Emergency Departments
Stiell, I. G., Clement, C. M., Brison, R. J., Rowe, B. H., Borgundvaag, B., Langhan, T. S., Lang, E., Magee, K. D., Stenstrom, R., Perry, J. J., et al. (2010) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2010.07.005 · Cited by 116
Early and comprehensive management of atrial fibrillation: Proceedings from the 2nd AFNET/EHRA consensus conference on atrial fibrillation entitled 'research perspectives in atrial fibrillation'
Kirchhof, P. F., Bax, J. J., Blomstrom-Lundquist, C., Calkins, H., Camm, A. J., Cappato, R., Cosío, F. G., Crijns, H. J. G. M., Diener, H., Goette, A., et al. (2009) · EP Europace · doi:10.1093/europace/eup124 · Cited by 112
“after cardioversion or post-operatively.(91,92) Other existing concepts use drugs for immediate conversion of AF (e.”
Background
State of the Art Review: Atrial Fibrillation in Athletes
Flannery, D., Kalman, J. M., Sanders, P., & Gerche, A. L. (2017) · Heart Lung and Circulation · doi:10.1016/j.hlc.2017.05.132 · Cited by 114
Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study
Crijns, H. J. G. M., Weijs, B., Fairley, A.-M., Lewalter, T., Maggioni, A. P., Martı́n, A., Ponikowski, P. P., Rosenqvist, M., Sanders, P., Scanavacca, M., et al. (2014) · International Journal of Cardiology · doi:10.1016/j.ijcard.2014.01.099 · Cited by 111
Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation
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Management of atrial fibrillation: Figure 1
Lip, G. Y. H., & Tello-Montoliu, A. (2006) · Heart · doi:10.1136/hrt.2005.071555 · Cited by 99
“In patients with paroxysmal AF who have infrequent paroxysms or few symptoms, or where symptoms are induced by known precipitants (for example, alcohol, caffeine), a “no drug treatment” strategy or a “pill-in-the-pocket” strategy could be considered.”
Background
Practical compendium of antiarrhythmic drugs: a clinical consensus statement of the European Heart Rhythm Association of the European Society of Cardiology
Merino, J. L., Tamargo, J. L., Blomström‐Lundqvist, C., Boriani, G., Crijns, H. J. G. M., Dobrev, D., Goette, A., Hohnloser, S. H., Naccarelli, G. V., Reiffel, J. A., et al. (2025) · EP Europace · doi:10.1093/europace/euaf076 · Cited by 112
The use of oral ranolazine to convert new or paroxysmal atrial fibrillation: a review of experience with implications for possible "pill in the pocket" approach to atrial fibrillation.
Murdock, D. K., Kersten, M., Kaliebe, J., & Larrain, G. (2009) · PubMed Central · Cited by 89
Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation
Lafuente‐Lafuente, C., Longás-Tejero, M. A., Bergmann, J., & Belmin, J. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005049.pub3 · Cited by 90
Pharmacological cardioversion of atrial fibrillation with vernakalant: evidence in support of the ESC Guidelines
Savelieva, I., Graydon, R., & Camm, A. J. (2013) · EP Europace · doi:10.1093/europace/eut274 · Cited by 85
“The efficacy and safety of ‘pill-in-the-pocket’ therapy with flecainide and propafenone in an out-of-hospital setting was tested in 210 patients.(30) Of 618 total episodes of AF, treatment was successful in 534 (94%), and the mean time to resolution of symptoms was 2 h.”
Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation
Gelsomino, S., van Breugel, H. N. A. M., Pison, L., Parise, O., Crijns, H. J. G. M., Wellens, F., Maessen, J. G., & Meir, M. L. (2013) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezt385 · Cited by 78
“Despite being often inadequate, medical treatment is still considered the ‘first-step’ approach [2, 3].”
Background
Contemporary Management of Atrial Fibrillation: Update on Anticoagulation and Invasive Management Strategies
Crandall, M. A., Bradley, D. J., Packer, D. L., & Asirvatham, S. J. (2009) · Mayo Clinic Proceedings · doi:10.4065/84.7.643 · Cited by 79
Emergency Department Use of Intravenous Procainamide for Patients with Acute Atrial Fibrillation or Flutter
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Drug‐Induced QT‐Interval Prolongation: Considerations for Clinicians
Li, E. C., Esterly, J. S., Pohl, S., Scott, S. D., & McBride, B. F. (2010) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1592/phco.30.7.684 · Cited by 70
Use of Flecainide for the Treatment of Atrial Fibrillation
Echt, D. S., & Ruskin, J. N. (2020) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2019.12.041 · Cited by 71
The progressive nature of atrial fibrillation: a rationale for early restoration and maintenance of sinus rhythm
Gelder, I. C. V., & Hemels, M. E. W. (2006) · EP Europace · doi:10.1093/europace/eul107 · Cited by 65
New developments in atrial antiarrhythmic drug therapy
Burashnikov, A., & Antzelevitch, C. N. (2010) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2009.245 · Cited by 64
“Anti-AF drugs can be very effective in the short term, with up to 80–90% efficacy for the termination of paroxysmal AF and some forms of persistent AF”
Background
New-onset atrial fibrillation as first clinical manifestation of latent Brugada syndrome: prevalence and clinical significance
Pappone, C., Radinovic, A., Manguso, F., Vicedomini, G., Sala, S., Sacco, F. M., Ciconte, G., Saviano, M., Ferrari, M., Sommariva, E., et al. (2009) · European Heart Journal · doi:10.1093/eurheartj/ehp326 · Cited by 64
Atrial Fibrillation
Camm, A. J., Savelieva, I., Ho, S. Y., Lindsay, B. D., Nattel, S., & Shinagawa, K. (2009) · Elsevier eBooks · doi:10.1016/b978-1-4377-0285-9.00044-2 · Cited by 60
Drug therapy for atrial fibrillation: where do we go from here?
Page, R. L., & Roden, D. M. (2005) · Nature Reviews Drug Discovery · doi:10.1038/nrd1876 · Cited by 60
“Although chronic therapy is the rule, intermittent therapy when symptoms arise has been used successfully in selected patient”
Method
Suppression of Spontaneous Ca Elevations Prevents Atrial Fibrillation in Calsequestrin 2-Null Hearts
Faggioni, M., Galimberti, E. S., Venkataraman, R., Hwang, H. S., Kannankeril, P. J., Darbar, D., & Knollmann, B. C. (2014) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.113.000994 · Cited by 58
Pharmacologic Management of Atrial Fibrillation: Established and Emerging Options
Kalus, J. S. (2009) · Journal of Managed Care Pharmacy · doi:10.18553/jmcp.2009.15.s6-b.10 · Cited by 57
Intravenous administration of flecainide or propafenone in patients with recent-onset atrial fibrillation does not predict adverse effects during ‘pill-in-the-pocket’ treatment
Alboni, P., Botto, G. L., Boriani, G., Russo, G., Pacchioni, F., Iori, M., Pasanisi, G., Mancini, M., Mariconti, B., & Capucci, A. (2010) · Heart · doi:10.1136/hrt.2009.187963 · Cited by 53
Self-citation
2020 ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease
Pelliccia, A., Sharma, S., Gati, S., Bäck, M., Börjesson, M., Caselli, S., Collet, J., Corrado, D., Drezner, J. A., Halle, M., et al. (2021) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2021.05.003 · Cited by 54
Cardioversion for atrial fibrillation in current European practice: results of the European Heart Rhythm Association survey
Hernández‐Madrid, A., Svendsen, J. H., Lip, G. Y. H., Gelder, I. C. V., Dobreanu, D., & Blomström‐Lundqvist, C. (2013) · EP Europace · doi:10.1093/europace/eut143 · Cited by 51
“The ‘pill-in-the-pocket’ strategy is frequently used in Europe.(12) Perhaps not surprisingly, amiodarone is still used in a large proportion of centres, but it is usually selected for sick patients with significant structural heart disease, including coronary artery disease and heart failure, in whom immediate CV is n…”
MethodInfluential
Recommendations for participation in leisure-time physical activity and competitive sports in patients with arrhythmias and potentially arrhythmogenic conditions: Part 1: Supraventricular arrhythmias. A position statement of the Section of Sports Cardiology and Exercise from the European Association of Preventive Cardiology (EAPC) and the European Heart Rhythm Association (EHRA), both associations of the European Society of Cardiology
Heidbüchel, H., Adami, P. E., Antz, M., Braunschweig, F., Delise, P., Scherr, D., Solberg, E. E., Wilhelm, M., & Pelliccia, A. (2020) · European Journal of Preventive Cardiology · doi:10.1177/2047487320925635 · Cited by 55
Drug Interactions Affecting Antiarrhythmic Drug Use
Mar, P. L., Horbal, P. J., Chung, M. K., Dukes, J. W., Ezekowitz, M. D., Lakkireddy, D., Lip, G. Y. H., Miletello, M., Noseworthy, P. A., Reiffel, J. A., et al. (2022) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.121.007955 · Cited by 51
Potassium Channel Blockade Enhances Atrial Fibrillation–Selective Antiarrhythmic Effects of Optimized State-Dependent Sodium Channel Blockade
Aguilar, M., Xiong, F., Qi, X. Y., Comtois, P., & Nattel, S. (2015) · Circulation · doi:10.1161/circulationaha.115.018016 · Cited by 49
Antiarrhythmic therapy in atrial fibrillation
Ravens, U. (2010) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2010.06.004 · Cited by 48
When Do Patients Need Admission to a Telemetry Bed?
Chen, E. H., & Hollander, J. E. (2007) · Journal of Emergency Medicine · doi:10.1016/j.jemermed.2007.01.017 · Cited by 50
Safety of Flecainide
Tamargo, J. L., Capucci, A., & Mabo, P. (2012) · Drug Safety · doi:10.2165/11599950-000000000-00000 · Cited by 46
Chinese guidelines for the diagnosis and management of atrial fibrillation
Ma, C., Wu, S., Liu, S., & Han, Y. (2024) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.14920 · Cited by 48
JCS / JHRS 2020 Guideline on Pharmacotherapy of Cardiac Arrhythmias
Ono, K., Iwasaki, Y., Akao, M., Ikeda, T., Ishii, K., Inden, Y., Kusano, K., Kobayashi, Y., Koretsune, Y., Sasano, T., et al. (2022) · Journal of Arrhythmia · doi:10.1002/joa3.12714 · Cited by 41
Atrial-Selective Sodium Channel Block Strategy to Suppress Atrial Fibrillation: Ranolazine versus Propafenone
Burashnikov, A., Belardinelli, L., & Antzelevitch, C. N. (2011) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.111.186395 · Cited by 43

Authors: Alboni, P., Botto, G. L., Baldi, N., Luzi, M., Russo, V., Gianfranchi, L., Marchi, P., Calzolari, M., Solano, A., Baroffio, R., & Gaggioli, G.
Affiliations: Ospedale Sant'Anna (IT)
Ospedale SS. Annunziata (IT)
Santa Maria Nuova Hospital (IT)
ORCID: Botto, Giovanni L.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2004-12-02
Volume: 351
Issue: 23
Pages: 2384-2391
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa041233
OpenAlex: W2026137049
Cited by: 479
References: 28
Citations by year: 2026: 15 · 2025: 11 · 2024: 18 · 2023: 19 · 2022: 16 · 2021: 21 · 2020: 21 · 2019: 10 · 2018: 18 · 2017: 22 · 2016: 25 · 2015: 20 · 2014: 31 · 2013: 23 · 2012: 20
FWCI: 16.59
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Keywords: atrial fibrillation, flecainide, propafenone, oral loading dose, outpatient care, self-administration, sinus rhythm restoration, emergency department visits, hospitalization reduction, adverse drug reactions, atrial flutter
MeSH terms: Administration, Oral, Ambulatory Care, Anti-Arrhythmia Agents, Atrial Fibrillation, Feasibility Studies, Female, Flecainide, Follow-Up Studies, Heart Failure, Humans, Male, Middle Aged, Propafenone, Prospective Studies, Self Administration, Stroke Volume

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Outpatient Treatment of Recent-Onset Atrial Fibrillation with the “Pill-in-the-Pocket” Approach

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