Prevalence and predictors of haemostatic complications in 412 Fontan patients: their relation to anticoagulation and haemodynamics.
OBJECTIVE
Our aim in the present study was to determine the prevalence of haemostatic events in our Fontan patients, to identify predictive factors and to determine their association with haemodynamics and anticoagulant therapy.


METHODS
We retrospectively evaluated 424 Fontan patients and examined correlations between postoperative haemodynamics and anticoagulant regimens with haemostatic events.


RESULTS
After exclusion of 12 patients with a mechanical valve at the time of Fontan operation, our 412 patients were sub-divided into 21 groups based on the therapeutic duration of warfarin and antiplatelet agent therapy. During the early 5- to 10-year postoperative period, patients receiving warfarin showed higher central venous pressure and lower arterial oxygen saturation (Sat) (P < 0.05-0.001). During a mean follow-up of 11.2 years, 29 (7.0%) haemostatic events occurred. With regard to haemorrhagic events, haemoptysis was most common (n = 13, 45%), followed by cerebral bleeds in 3 (10%). Of thrombo-embolic events, thrombosis in the Fontan pathway was the most common (n = 7, 24%), followed by cerebral infarction in 3. Early haemorrhagic events were associated with late Fontan operation and use of preoperative renin-angiotensin system blockers, while late events were related to heterotaxy syndrome, male gender and low Sat (P < 0.05-0.01). A low Sat was the only predictor of early postoperative thrombo-embolic events (P = 0.0192). Among the three subgroup analyses of fixed anticoagulant regimens, the most frequent haemorrhagic events were associated with long-term use of warfarin (P = 0.0033). None of the anticoagulant regimens that included warfarin and/or antiplatelet agents were independently associated with haemostatic events throughout the follow-up.


CONCLUSIONS
Anticoagulant regimens in Fontan patients varied widely with a significant trend for warfarin use in patients with impaired haemodynamics. Low arterial oxygenation may predict haemostatic events. The relatively high prevalence of haemorrhagic complications indicates the need for individualized anticoagulant administration throughout the follow-up.
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan hohuchi@hsp.ncvc.go.jp.
Hideo
H
Ohuchi
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Kenji
K
Yasuda
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Aya
A
Miyazaki
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Shin
S
Ono
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Yosuke
Y
Hayama
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Jun
J
Negishi
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Kanae
K
Noritake
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Masanori
M
Mizuno
Department of Pediatric Cardiology and Adult Congenital Heart Disease, National Cerebral and Cardiovascular Center, Osaka, Japan.
Osamu
O
Yamada
D000704:Analysis of Variance; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D002675:Child, Preschool; D005260:Female; D018729:Fontan Procedure / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000097:blood / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000097:blood / Q000209:etiology*; D012189:Retrospective Studies; D013923:Thromboembolism / Q000097:blood* / Q000188:drug therapy / Q000209:etiology
D000925:Anticoagulants
Anticoagulants; Fontan procedure; Haemorrhage; Thrombo-embolism