Ian H Law1, Osman Alam1, Edward L Bove1, Richard G Ohye1, David J Bradley1, Sunkyung Yu1, Macdonald Dick2. 1. From the Division of Pediatric Cardiology, Department of Pediatrics, Carver College of Medicine, University of Iowa, Iowa City (I.H.L.); and Division of Pediatric Cardiology, Department of Pediatrics and Communicable Diseases (O.A., D.J.B., S.Y., M.D.) and Department of Cardiac Surgery (E.L.B., R.G.O.), University of Michigan Medical School, Ann Arbor. 2. From the Division of Pediatric Cardiology, Department of Pediatrics, Carver College of Medicine, University of Iowa, Iowa City (I.H.L.); and Division of Pediatric Cardiology, Department of Pediatrics and Communicable Diseases (O.A., D.J.B., S.Y., M.D.) and Department of Cardiac Surgery (E.L.B., R.G.O.), University of Michigan Medical School, Ann Arbor. mdick@umich.edu.
Abstract
BACKGROUND:Intra-atrial reentrant tachycardia (IART) after the Fontan operation had an early reported incidence of 10% to 35% during early and intermediate follow-up and posed substantial management challenges. METHODS AND RESULTS: To reduce the incidence of IART after the Fontan procedure, we performed a randomized, double-blind study to evaluate the impact of an incision in the right atrium joining the lateral tunnel suture line and the tricuspid valve annulus. Between March 1998 and September 2003, 134 subjects (median age: 1.8 years; range: 1.3-5.2 years; 91 men) were randomly assigned to receive the incision. All 134 patients had a form of single ventricle pathological anatomy. The clinical course, electrocardiograms, and Holter monitoring were available for review in 114 subjects at a median of 8.2-year follow-up (range: 0.9-11.9 years). There were 2 late deaths, neither subject had IART. The combined incidence of sustained IART was 3.5% (4/114). There was no difference in the occurrence of sustained IART between those subjects receiving the incision and those who did not (2 in each group) during follow-up. No patients of either group experienced short-term complications. CONCLUSIONS: Despite the fact that the primary outcome of this trial was not reached, the most significant finding was that with current management, the incidence of IART is considerably lower than the early retrospective, observational studies suggested.
RCT Entities:
BACKGROUND:Intra-atrial reentrant tachycardia (IART) after the Fontan operation had an early reported incidence of 10% to 35% during early and intermediate follow-up and posed substantial management challenges. METHODS AND RESULTS: To reduce the incidence of IART after the Fontan procedure, we performed a randomized, double-blind study to evaluate the impact of an incision in the right atrium joining the lateral tunnel suture line and the tricuspid valve annulus. Between March 1998 and September 2003, 134 subjects (median age: 1.8 years; range: 1.3-5.2 years; 91 men) were randomly assigned to receive the incision. All 134 patients had a form of single ventricle pathological anatomy. The clinical course, electrocardiograms, and Holter monitoring were available for review in 114 subjects at a median of 8.2-year follow-up (range: 0.9-11.9 years). There were 2 late deaths, neither subject had IART. The combined incidence of sustained IART was 3.5% (4/114). There was no difference in the occurrence of sustained IART between those subjects receiving the incision and those who did not (2 in each group) during follow-up. No patients of either group experienced short-term complications. CONCLUSIONS: Despite the fact that the primary outcome of this trial was not reached, the most significant finding was that with current management, the incidence of IART is considerably lower than the early retrospective, observational studies suggested.
Authors: I H Law; P S Fischbach; C Goldberg; R S Mosca; E L Bove; T R Lloyd; A P Rocchini; M Dick Journal: J Am Coll Cardiol Date: 2001-01 Impact factor: 24.094
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