Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial.
BACKGROUND
The FinPAC trial showed that the strategy of uninterrupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm management device (CRMD) implantation.


METHODS
We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of significant (> 100 cm(2)) pocket hematoma after CRMD implantation among the study population (n = 447). A total of 213 patients were on OAC, 128 were on aspirin, and 106 on no antithrombotic therapy.


RESULTS
The incidence of significant pocket hematoma during hospital stay was significantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrombotic medications (0.9%), but only one patient (0.8%) in the aspirin group needed revision of hematoma. Two patients (0.9%) in the OAC group and one (0.8%) in the aspirin group needed blood products. In multivariable regression analysis, no pre- procedural features predicted the significant hematoma in any of the groups.


CONCLUSIONS
Clinically significant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of significant pocket hematoma formation is similar in patients using OAC and those using aspirin.
Heart Center, Turku University Hospital and University of Turku , Turku , Finland.
Wail
W
Nammas
M J Pekka
MJ
Raatikainen
Petri
P
Korkeila
Juha
J
Lund
Antti
A
Ylitalo
Pasi
P
Karjalainen
Vesa
V
Virtanen
Ulla-Maija
UM
Koivisto
Seppo
S
Utriainen
Tuija
T
Vasankari
Juhani
J
Koistinen
K E Juhani
KE
Airaksinen
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects; D005260:Female; D005387:Finland / Q000453:epidemiology; D006406:Hematoma / Q000209:etiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D011183:Postoperative Complications / Q000139:chemically induced* / Q000453:epidemiology; D019919:Prosthesis Implantation / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D001241:Aspirin