Factors associated with thrombotic complications after the Fontan procedure: a secondary analysis of a multicenter, randomized trial of primary thromboprophylaxis for 2 years after the Fontan procedure.
J Am Coll Cardiol
; 61(3): 346-53, 2013 Jan 22.
Article
em En
| MEDLINE
| ID: mdl-23246393
ABSTRACT
OBJECTIVES:
The study sought to identify factors associated with increased risk of thrombosis after Fontan.BACKGROUND:
The Fontan procedure is the culmination of staged palliation for patients with univentricular physiology. Thrombosis is an important complication after this procedure.METHODS:
An international multicenter randomized controlled trial of acetylsalicylic acid versus warfarin for thromboprophylaxis after the Fontan procedure was conducted in 111 patients, and did not show a significant difference regarding thrombotic complications. We performed a secondary analysis of this previously published manuscript to identify factors associated with thrombosis in this population. Standardized prospective data collection included independent adjudication of all events.RESULTS:
At 2.5 years after randomization, time-related freedom from thrombosis was 69% (all venous, no arterial events), with 28% of thrombosis presenting with clinical signs or events. Hazard of thrombosis was highest immediately after Fontan with a gradual increase in risk during late follow-up. In multivariable models, factors associated with higher risk of thrombosis were pulmonary atresia with intact ventricular septum (hazard ratio [HR] 3.64, 95% confidence interval [CI] 1.04 to 12.70, p = 0.04), pulmonary artery distortion (HR 2.35, 95% CI 0.96 to 5.73, p = 0.06), lower pre-operative unconjugated bilirubin (HR 0.84 µmol/l, 95% CI 0.72 to 0.99, p = 0.04), use of central venous lines for >10 days or until hospital discharge (HR 17.8, 95% CI 3.97 to 79.30, p < 0.001), and lower FiO(2) 24 h after the procedure (HR 0.67/10%, 95% CI 0.45 to 1.00, p = 0.06). Patients on warfarin who consistently achieved minimum target international normalized ratio levels or those on acetylsalicylic acid had a decrease in risk of thrombosis compared with patients who often failed to meet target international normalized ratio level (HR 3.53, 95% CI 1.35 to 9.20, p = 0.01).CONCLUSIONS:
More favorable thromboprophylaxis strategies are needed in light of the difficulties in controlling warfarin therapy and the high prevalence of thrombosis in this population.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Trombose
/
Técnica de Fontan
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Child
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Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article