Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

Summary

The hemostasis system is one of the many biological systems of the human body, designed to preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal balance between its coagulant and anticoagulant components never occurs. In various diseases and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts towards hypercoagulability lead to the development of hemorrhagic complications, opposite shifts lead to the development of thrombotic complications.

Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today doctors meet with them every day. Its more than 1.5 million CIED's implanted every year.

Before surgery these patients are standard cardiology department patients with chronic heart failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease, hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases and conditions. CHF is the most common, severe and unfavorable prognostic complication of these diseases. With CHF, the balance of the hemostasis system shifts towards hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis, pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and other complications.

After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition in the early postoperative period. In the long-term period, pacing, on the contrary, may contribute to the progression of CHF. The wrong choice of pacing mode or the place of electrode implantation can lead to desynchronization of the heart chambers, myocardial remodeling and left ventricular dysfunction.

Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the vessel wall during surgery, further placement of the CIED leads in the vessels, and perioperative stress can lead to even greater shifts towards hypercoagulation.

Conditions

• Thromboembolism
• Cardiac Event
• Hemostatic Disorder

Interventions

PROCEDURE

Cardiac implantable electronic device implantation.

Patients who have indications will receive cardiac implantable electronic device implantation.

PROCEDURE

Cardiac implantable electronic device replace.

Patients who have indications will receive cardiac implantable electronic device replace.

DIAGNOSTIC_TEST

Duplex ultrasound.

Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.

DIAGNOSTIC_TEST

Echocardiography.

Patients will undergo an ultrasound examination of the heart.

DIAGNOSTIC_TEST

Blood sampling.

Patients will be taken venous blood to determine the studied markers of hemostasis system.

Sponsors & Collaborators

• Ryazan State Medical University

  lead OTHER

Principal Investigators

• Igor A. Suchkov, MD, DSc · Ryazan State Medical University

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2023-11-01

Completion

2023-11-01

Countries

• Russia

Study Locations