The study of antiarrhythmic medications in infancy (SAMIS): A multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants

Circulation: Arrhythmia and Electrophysiology

Volumn 5, Issue 5, 2012, Pages 984-991

  Sanatani, Shubhayan ^a,b   Potts, James E ^a,b   Reed, John H ^c   Saul, J Philip ^c   Stephenson, Elizabeth A ^d,e   Gibbs, Karen A ^a,b   Anderson, Charles C ^f   MacKie, Andrew S ^g,h   Ro, Pamela S ^i,j   Tisma Dupanovic, Svjetlana ^k   Kanter, Ronald J ^l,m   Batra, Anjan S ^n,o   Fournier, Anne ^p,q   Blaufox, Andrew D ^r   Singh, Harinder R ^s,t   Ross, Bertrand A ^u,v   Wong, Kenny K ^w,x   Bar Cohen, Yaniv ^y,z   McCrindle, Brian W ^d,e   Etheridge, Susan P ^aa,ab  

^a BC CHILDREN S HOSPITAL   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d HOSPITAL FOR SICK CHILDREN   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f Sacred Heart Children's Hospital   (United States)

^g STOLLERY CHILDREN S HOSPITAL   (Canada)

^h UNIVERSITY OF ALBERTA   (Canada)

ⁱ NATIONWIDE CHILDREN S HOSPITAL   (United States)

^j OHIO STATE UNIVERSITY   (United States)

^k CHILDREN S MERCY HOSPITAL   (United States)

^l DUKE UNIVERSITY MEDICAL CENTER   (United States)

^m DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁿ CHILDREN S HOSPITAL OF ORANGE COUNTY   (United States)

^o UNIVERSITY OF CALIFORNIA   (United States)

^p UNIVERSITY OF MONTREAL   (Canada)

^q UNIVERSITÉ DE MONTRÉAL   (Canada)

^r SCHNEIDER CHILDREN'S HOSPITAL   (United States)

^s CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^t WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^u CHILDREN S HOSPITAL OF THE KING S DAUGHTERS   (United States)

^v EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^w IWK HEALTH CENTRE   (Canada)

^x DALHOUSIE UNIVERSITY   (Canada)

^y CHILDREN S HOSPITAL LOS ANGELES   (United States)

^z UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^aa PRIMARY CHILDREN'S MEDICAL CENTER   (United States)

^ab UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

more..

Author keywords

Clinical trials; Drugs; Patients; Pediatrics; Supraventricular tachycardia

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIGOXIN; FLECAINIDE; PROPAFENONE; PROPRANOLOL; SOTALOL; ANTIARRHYTHMIC AGENT;

ARTICLE; BRONCHIOLITIS; COMPARATIVE EFFECTIVENESS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; ENCEPHALOCELE; FEMALE; FOLLOW UP; GASTROENTERITIS; HERNIOPLASTY; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; RECURRENT DISEASE; REENTRY TACHYCARDIA; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; SEPSIS; SUPRAVENTRICULAR TACHYCARDIA; TREATMENT DURATION; VOMITING; WHEEZING; CANADA; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; COMPARATIVE STUDY; NEWBORN; PROPORTIONAL HAZARDS MODEL; TREATMENT OUTCOME; UNITED STATES;

ANTI-ARRHYTHMIA AGENTS; CANADA; CHI-SQUARE DISTRIBUTION; DIGOXIN; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; PROPORTIONAL HAZARDS MODELS; PROPRANOLOL; RECURRENCE; TACHYCARDIA, SUPRAVENTRICULAR; TREATMENT OUTCOME; UNITED STATES;

EID: 84872051659     PISSN: 19413149     EISSN: 19413084     Source Type: Journal    
DOI: 10.1161/CIRCEP.112.972620     Document Type: Article

References (44)

1. Geggel RL. Conditions leading to pediatric cardiology consultation in a tertiary academic hospital. Pediatrics. 2004;114:e409-e417.
2. Garson A Jr, Gillette PC, McNamara DG. Supraventricular tachycardia in children: clinical features, response to treatment, and long-term follow-up in 217 patients. J Pediatr. 1981;98:875-882.
3. Lundberg A. Paroxysmal tachycardia in infancy. A clinical and experimental study. Acta Paediatr. 1963;52:192-195.
4. Nadas AS, Daeschner CW, Roth A, Blumenthal SL. Paroxysmal tachycardia in infants and children; study of 41 cases. Pediatrics. 1952;9:167-181.
5. Weindling SN, Saul JP, Walsh EP. Efficacy and risks of medical therapy for supraventricular tachycardia in neonates and infants. Am Heart J. 1996;131:66-72.
6. Anand RG, Rosenthal GL, Van Hare GF, Snyder CS. Is the mechanism of supraventricular tachycardia in pediatrics influenced by age, gender or ethnicity? Congenit Heart Dis. 2009;4:464-468.
7. Ko JK, Deal BJ, Strasburger JF, Benson DW Jr. Supraventricular tachycardia mechanisms and their age distribution in pediatric patients. Am J Cardiol. 1992;69:1028-1032.
8. Pfammatter JP, Stocker FP. Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment. Eur J Pediatr. 1998;157:101-106.
9. Bauersfeld U, Pfammatter JP, Jaeggi E. Treatment of supraventricular tachycardias in the new millennium-drugs or radiofrequency catheter ablation? Eur J Pediatr. 2001;160:1-9.
10. Till JA, Shinebourne EA. Supraventricular tachycardia: diagnosis and current acute management. Arch Dis Child. 1991;66:647-652.
11. Sreeram N, Wren C. Supraventricular tachycardia in infants: response to initial treatment. Arch Dis Child. 1990;65:127-129.
12. Deal BJ, Keane JF, Gillette PC, Garson A Jr. Wolff-Parkinson-White syndrome and supraventricular tachycardia during infancy: management and follow-up. J Am Coll Cardiol. 1985;5:130-135.
13. Salerno JC, Garrison MM, Larison C, Seslar SP. Case fatality in children with supraventricular tachycardia in the United States. Pacing Clin Electrophysiol. 2011;34:832-836.
14. Sanatani S, Hamilton RM, Gross GJ. Predictors of refractory tachycardia in infants with supraventricular tachycardia. Pediatr Cardiol. 2002;23:508-512.
15. Salerno JC, Seslar SP. Supraventricular tachycardia. Arch Pediatr Adolesc Med. 2009;163:268-274.
16. Wong KK, Potts JE, Etheridge SP, Sanatani S. Medications used to manage supraventricular tachycardia in the infant: a north american survey. Pediatr Cardiol. 2006;27:199-203.
17. O'Sullivan JJ, Gardiner HM, Wren C. Digoxin or flecainide for prophylaxis of supraventricular tachycardia in infants? J Am Coll Cardiol. 1995;26:991-994.
18. Luedtke SA, Kuhn RJ, McCaffrey FM. Pharmacologic management of supraventricular tachycardias in children. Part 2: Atrial flutter, atrial fibrillation, and junctional and atrial ectopic tachycardia. Ann Pharmacother. 1997;31:1347-1359.
19. Kaemmerer WF, Rose MS, Mehra R. Distribution of patients' paroxysmal atrial tachyarrhythmia episodes: implications for detection of treatment efficacy. J Cardiovasc Electrophysiol. 2001;12:121-130.
20. Benson DW Jr, Dunnigan A, Benditt DG, Thompson TR, Narayan A, Boros S. Prediction of digoxin treatment failure in infants with supraventricular tachycardia: role of transesophageal pacing. Pediatrics. 1985;75:288-293.
21. Van Hare G. Supraventricular tachycardia. In: Gillette PC, Garson A, Jr., eds. Clinical Pediatric Arrhythmias. Philadelphia, PA: W.B. Saunders; 1999:97-120.
22. Perry JC, Garson A Jr. Supraventricular tachycardia due to Wolff-Parkinson- White syndrome in children: early disappearance and late recurrence. J Am Coll Cardiol. 1990;16:1215-1220.
23. Riggs TW, Byrd JA, Weinhouse E. Recurrence risk of supraventricular tachycardia in pediatric patients. Cardiology. 1999;91:25-30.
24. Lemler MS, Schaffer MS. Neonatal supraventricular tachycardia: predictors of successful treatment withdrawal. Am Heart J. 1997;133:130-131.
25. Etheridge SP, Judd VE. Supraventricular tachycardia in infancy: evaluation, management, and follow-up. Arch Pediatr Adolesc Med. 1999;153:267-271.
26. Tortoriello TA, Snyder CS, Smith EO, Fenrich AL Jr, Friedman RA, Kertesz NJ. Frequency of recurrence among infants with supraventricular tachycardia and comparison of recurrence rates among those with and without preexcitation and among those with and without response to digoxin and/or propranolol therapy. Am J Cardiol. 2003;92:1045-1049.
27. Benson DW Jr, Dunnigan A, Benditt DG. Follow-up evaluation of infant paroxysmal atrial tachycardia: transesophageal study. Circulation. 1987;75:542-549.
28. Lundberg A. Paroxysmal atrial tachycardia in infancy: long-term follow-up study of 49 subjects. Pediatrics. 1982;70:638-642.
29. Blaufox AD, Warsy I, D'Souza M, Kanter R. Transesophageal electrophysiological evaluation of children with a history of supraventricular tachycardia in infancy. Pediatr Cardiol. 2011;32:1110-1114.
30. Gillette PC, Garson A Jr, Kugler JD. Wolff-Parkinson-White syndrome in children: electrophysiologic and pharmacologic characteristics. Circulation. 1979;60:1487-1495.
31. Ratnasamy C, Rossique-Gonzalez M, Young ML. Pharmacological therapy in children with atrioventricular reentry: which drug? Curr Pharm Des. 2008;14:753-761.
32. Gross GJ, Epstein MR, Walsh EP, Saul JP. Characteristics, management, and midterm outcome in infants with atrioventricular nodal reentry tachycardia. Am J Cardiol. 1998;82:956-960.
33. Jaeggi ET, Gilljam T, Bauersfeld U, Chiu C, Gow R. Electrocardiographic differentiation of typical atrioventricular node reentrant tachycardia from atrioventricular reciprocating tachycardia mediated by concealed accessory pathway in children. Am J Cardiol. 2003;91:1084-1089.
34. Southall DP, Richards J, Mitchell P, Brown DJ, Johnston PG, Shinebourne EA. Study of cardiac rhythm in healthy newborn infants. Br Heart J. 1980;43:14-20.
35. Nagashima M, Matsushima M, Ogawa A, Ohsuga A, Kaneko T, Yazaki T, Okajima M. Cardiac arrhythmias in healthy children revealed by 24-hour ambulatory ECG monitoring. Pediatr Cardiol. 1987;8:103-108.
36. Kolditz DP, Wijffels MC, Blom NA, van der Laarse A, Markwald RR, Schalij MJ, Gittenberger-de Groot AC. Persistence of functional atrioventricular accessory pathways in postseptated embryonic avian hearts: implications for morphogenesis and functional maturation of the cardiac conduction system. Circulation. 2007;115:17-26.
37. Li JS, Colan SD, Sleeper LA, Newburger JW, Pemberton VL, Atz AM, Cohen MS, Golding F, Klein GL, Lacro RV, Radojewski E, Richmond ME, Minich LL. Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study. Am Heart J. 2011;161:233-240.
38. Monagle P, Cochrane A, Roberts R, Manlhiot C, Weintraub R, Szechtman B, Hughes M, Andrew M, McCrindle BW; Fontan Anticoagulation Study Group. A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. J Am Coll Cardiol. 2011;58:645-651.
39. Fish FA, Gillette PC, Benson DW Jr. Proarrhythmia, cardiac arrest and death in young patients receiving encainide and flecainide. The Pediatric Electrophysiology Group. J Am Coll Cardiol. 1991;18:356-365.
40. Janousek J, Paul T, Reimer A, Kallfelz HC. Usefulness of propafenone for supraventricular arrhythmias in infants and children. Am J Cardiol. 1993;72:294-300.
41. Maragnès P, Tipple M, Fournier A. Effectiveness of oral sotalol for treatment of pediatric arrhythmias. Am J Cardiol. 1992;69:751-754.
42. Pfammatter JP, Paul T, Lehmann C, Kallfelz HC. Efficacy and proarrhythmia of oral sotalol in pediatric patients. J Am Coll Cardiol. 1995;26:1002-1007.
43. Reimer A, Paul T, Kallfelz HC. Efficacy and safety of intravenous and oral propafenone in pediatric cardiac dysrhythmias. Am J Cardiol. 1991;68:741-744.
44. Vignati G, Mauri L, Figini A. The use of propafenone in the treatment of tachyarrhythmias in children. Eur Heart J. 1993;14:546-550.