Prevention of hemorrhagic complications after operations performed on the background of anticoagulant therapy

• Povarov V.O.
• Kalinin R.E.
• Mzhavanadze N.D.
• Zhurina O.N.
• Suchkov I.A.

Abstract

Background. According to the literature, the frequency of pacemaker (PM) pocket hematomas ranges from 0.2 to 16%. In patients on antiplatelet or anticoagulant therapy, the incidence of PM pocket hematomas increases to 2–20%. Hemorrhagic complications often prolong the length of hospital stay, may require repeated surgical interventions and, most importantly, significantly increase the risk of infection.

Objective. This study was undertaken to investigate the risk factors for hemorrhagic complications after permanent PM implantation, their relationship with the baseline parameters of the hemostasis system and the possibilities of prevention using an incomplete silver salt of polyacrylic acid.

Material and methods. The patients enrolled in our prospective, single-center study were assigned to the experimental and control groups by block randomization. In the experimental group, the hemostatic agent incomplete polyacrylic acid silver salt Hemoblock^® was used during PM placing. Before surgery, all patients underwent peripheral venous blood sampling to determine a series of parameters of the patient’s hemostasis system: levels of fibrinogen, P-selectin, soluble fibrin-monomer complexes, D-dimer, type 1 plasminogen activator inhibitor, activity of blood coagulation factors II (FII), V (FV), VII, VIII, IX, X (FX), XI (FXI), XII, von Willebrand factor, plasminogen, antithrombin III, protein C, additionally determining the parameters of total blood count: the level of platelets, thrombocrit, platelet distribution width, mean platelet volume. The postoperative wound was examined daily, with an ultrasound examination of the soft tissues of the PM pocket area performed on POD 3-5. After 1 month, the patients visited the research center for the final examination of the postoperative wound and testing of PM parameters.

Results and discussion. The follow-up period was completed by 91 patients (44 of the experimental group and 47 of the control group). In the experimental group, 9 (20.5%) patients were found to have soft tissue hematomas, whereas in the control group, 25 (53.2%) patients developed soft tissue hematomas and 6 (12.8%) PM pocket hematomas, with the differences being statistically significant (p=0.001 and p=0.027). Patients with hemorrhagic complications had lower activity of factors FII (p=0.007), FV (p=0.035), FX (p=0.012), FXI (p=0.048). According to multivariate analysis, the factors reducing hemorrhagic complications after PM implantation on the background of anticoagulant therapy turned out to be the use of apixaban as an anticoagulant drug (OR 0.25, 95% CI 0.07–0.889, р=0.032) and the use of incomplete silver salt of polyacrylic acid (OR 0.191, 95% CI 0.072–0.504, р=0.001). The chances of developing hemorrhagic complications increased against the background of reduced FXI activity (OR 0.975, 95% CI 0.951–0.999, р=0.044).

Conclusion. The use of incomplete polyacrylic acid silver salt proved to be an effective and safe method of preventing hematomas after PM placing in patients on anticoagulant therapy. It was found that patients with hemorrhagic complications initially had lower FII, FV, FX and FXI activity compared to other patients. In addition, the results of multivariate analysis proved that low FXI activity increased the chances of developing hemorrhagic complications.

Funding. The study was financed from the extra-budgetary funds of the Federal State Budgetary Educational Facility of Higher Education “Ryazan State Medical University” of the RF Ministry of Public Health. The hemostatic agent incomplete silver salt of polyacrylic acid (Hemoblock^®) was provided by the Autonomous Nonprofit Organization “Moscow Regional Blood Research Institute” free of charge.

Conflict of interest. The authors declare no conflicts of interest.

Authors’ contribution. Study conception and design – Kalinin R.E., Suchkov I.A., Zhurina O.N.; data collection and handling – Povarov V.O., Mzhavanadze N.D.; statistical processing – Povarov V.O., Mzhavanadze N.D.; draft manuscript preparation – Povarov V.O.; manuscript revision – Mzhavanadze N.D., Suchkov I.A.

For citation: Povarov V.O., Kalinin R.E., Mzhavanadze N.D., Zhurina O.N, Suchkov I.A. Prevention of hemorrhagic complications after operations performed on the background of anticoagulant therapy. Angiology and Vascular Surgery. Journal named after Academician A.V. Pokrovsky. 2023; 29 (4): 30–9. DOI: https://doi.org/10.33029/1027-6661-2023-29-4-30-39

Keywords:pacemaker; anticoagulant therapy; hematoma; hemostasis system; hemostatic therapy