Circ Arrhythm Electrophysiol. 2012 Oct 1;5(5):984-91. doi: 10.1161/CIRCEP.112.972620. Epub 2012 Sep 8.
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.
Sanatani S, Potts JE, Reed JH, Saul JP, Stephenson EA, Gibbs KA, Anderson CC, Mackie AS, Ro PS, Tisma-Dupanovic S, Kanter RJ, Batra AS, Fournier A, Blaufox AD, Singh HR, Ross BA, Wong KK, Bar-Cohen Y, McCrindle BW, Etheridge SP.
Background- Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.
Methods and Results- A randomized, double-blind, multicenter study of infants <4 atrioventricular="atrioventricular" comparing="comparing" digoxin="digoxin" excluding="excluding" months="months" nodal="nodal" or="or" propranolol.="propranolol." reciprocating="reciprocating" reentrant="reentrant" svt="svt" tachycardia="tachycardia" with="with" wolff-parkinson-white="wolff-parkinson-white">The primary end point was recurrence of SVT requiring medical intervention.
Time to recurrence and adverse events were secondary outcomes.
Sixty-one patients completed the study, 27 randomized to digoxin and 34 to propranolol.
SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25).
No first recurrence occurred after 110 days of treatment.
The 6-month recurrence-free status was 79% for patients on digoxin and 67% for patients on propranolol (P=0.34), and there were no first recurrences in either group between 6 and 12 months. There were no deaths and no serious adverse events related to study medication.
Conclusions- There was no difference in SVT recurrence in infants treated with digoxin versus propranolol. The current standard practice may be treating infants longer than required and indicates the need for a placebo-controlled trial.
Clinical Trial Registration Information- http://clinicaltrials.gov; NCT-00390546.
Saturday, October 20, 2012
Sunday, October 14, 2012
Balloon Pulmonary Valvuloplasty - Safety & Efficacy
Catheter Cardiovasc Interv. 2012 Oct 1;80(4):663-72.
Safety and efficacy of balloon pulmonary valvuloplasty: A Multicenter Experience.
Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L.
METHODS: Prospective data collection. C3PO Registry. Cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV.
RESULTS:
211 cases were included (45%, Less than 1 month old).
Procedural success was achieved in 91% procedures, being defined as one of the following:
(i) post-BPV peak systolic valvar gradient to < 25 mm Hg (88%),
(ii) decrease in gradient by 50% (79%), or
(iii) reduction of RV/systemic pressure ratio by 50% (45%).
Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03).
Procedure failure - Risk factors included (i) moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and (ii) presence of supravalve PS (OR 9.6, CI 2.7-33.8).
Adverse events:
Low severity AEs (levels 1-2) occurred in 9% of patients.
Higher severity AEs (levels 3-5) occurred in 3% of patient.
No deaths.
Risk factors for any AE (levels 1-5) were (i) age below 1 month (OR 3.5, CI 1.3-8.9) and (ii) operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).
CONCLUSIONS: Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.
© 2012 Wiley Periodicals Inc.
Safety and efficacy of balloon pulmonary valvuloplasty: A Multicenter Experience.
Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L.
METHODS: Prospective data collection. C3PO Registry. Cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV.
RESULTS:
211 cases were included (45%, Less than 1 month old).
Procedural success was achieved in 91% procedures, being defined as one of the following:
(i) post-BPV peak systolic valvar gradient to < 25 mm Hg (88%),
(ii) decrease in gradient by 50% (79%), or
(iii) reduction of RV/systemic pressure ratio by 50% (45%).
Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03).
Procedure failure - Risk factors included (i) moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and (ii) presence of supravalve PS (OR 9.6, CI 2.7-33.8).
Adverse events:
Low severity AEs (levels 1-2) occurred in 9% of patients.
Higher severity AEs (levels 3-5) occurred in 3% of patient.
No deaths.
Risk factors for any AE (levels 1-5) were (i) age below 1 month (OR 3.5, CI 1.3-8.9) and (ii) operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).
CONCLUSIONS: Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.
© 2012 Wiley Periodicals Inc.
