Key result
Hemoblock completely prevents soft tissue blood imbibition during pacemaker implantation compared to ~56% with saline.
Why the study?
Prevention of pacemaker pocket hematoma is an urgent clinical problem, and partial silver salt of polyacrylic acid may serve as an effective local hemostatic agent.
Does local application of partial silver salt of polyacrylic acid reduce pacemaker pocket hematoma and bleeding complications in patients undergoing pacemaker implantation on uninterrupted anticoagulant therapy?
RCT (n=29)
Envelope method
Yes
Does local application of partial silver salt of polyacrylic acid reduce pacemaker pocket hematoma and bleeding complications in patients undergoing pacemaker implantation on uninterrupted anticoagulant therapy?
Effect estimate: RR 2.3 (95% CI 1.3-4)
Absolute Event Rate: 0% vs 56.3%
p-value: p=0.001
Local application of partial silver salt of polyacrylic acid during pacemaker implantation safely and significantly reduces the risk of soft tissue bleeding complications in patients on uninterrupted oral anticoagulation.
Supports Hemoblock to prevent pocket hematoma in anticoagulated pacemaker recipients; extends evidence for local hemostatics in device implantation.
BACKGROUND: Prevention of pacemaker pocket hematoma is an urgent problem of modern cardiovascular surgery. A method of prevention of hematomas may be application of local hemostatic agents. One of such means is incomplete silver salt of polyacrylic acid, registered in the Russian Federation as a medical product under the trade name “Hemoblock”. AIM: To evaluate the efficacy and safety of partial silver salt of polyacrylic acid (Hemoblock®) as a hemostatic drug for prophylaxis of pacemaker (PM) pocket hematoma. MATERIALS AND METHODS: The study included 29 patients (18 men) with average age of 72.8 ± 9.8 years and indications for PM implantation. The patients were divided into 2 groups, partial silver salt of polyacrylic acid was used during the PM implantation in group A, 0.9% NaCl solution was used in group B. Anticoagulant therapy was not cancelled. In the postoperative period, patients underwent a daily examination by a surgeon, on the 3th–5th day — an ultrasound of soft tissues in the area of the PM pocket to diagnose hemorrhagic complications. After 1 month, a control examination of the postoperative wound and an assessment of the PM function were performed. RESULTS: In 1 (6.3%) patient in group B, a PM pocket hematoma was found which required drainage in the dressing room and increased the period of hospitalization after surgery to 7 days. Soft tissue imbibition with blood was observed in 9 (56.3%) group B patients. No PM pocket hematomas and imbibition of soft tissues were observed in group A. PM implantation with uninterrupted anticoagulant therapy without the use of hemostatic agents increases the risk of soft tissue imbibition with blood by 2.3 times (p = 0.001, r = 0.605, RR 2.3, 95% CI 1.3–4). Age, gender, body mass index, body surface area, left ventricular ejection fraction, type of anticoagulation therapy, indication for PM implantation, type of PM, and the peculiarities of the operation did not influence the risk of development of PM pocket hematoma or soft tissue imbibition with blood (p > 0.05). CONCLUSION: The use of a partial silver salt of polyacrylic acid (Hemoblock®) can reduce the risk of development of hematomas and soft tissue imbibition with blood in the area of the pacemaker pocket and does not lead to the development of infectious complications and allergic reactions.
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Kalinin et al. (2021) conducted an RCT in Pacemaker implantation on uninterrupted anticoagulant therapy (n=29). Partial silver salt of polyacrylic acid (Hemoblock) vs. 0.9% NaCl solution was evaluated on Presence of free fluid in the pacemaker pocket (soft tissue imbibition with blood) (RR 2.3, 95% CI 1.3-4, p=0.001). Hemoblock application during pacemaker implantation completely prevented soft tissue imbibition with blood compared to a 56.3% rate in the saline control group.
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