Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Poznan University of Medical Sciences
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Updated on 5 August 2020
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Summary

Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.

The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.

Description

Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.

The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.

The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.

Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.

Details
Condition Pulmonary Embolism With Acute Cor Pulmonale
Age 18years - 100years
Treatment Catheter-directed thrombectomy
Clinical Study IdentifierNCT04473560
SponsorPoznan University of Medical Sciences
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Clinical symptoms and presentation consistent with pulmonary embolism (PE)
PE symptoms duration 14 days
High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy
Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours
Systolic blood pressure > 90 mmHg and 100 mmHg
Heart rate 110/min
Arterial blood saturation <90% during spontaneous breathing (atm)
Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed
factors
Systolic blood pressure > 90 mmHg and 100 mmHg
Heart rate 110/min
Arterial blood saturation <90% during spontaneous breathing (atm)

Exclusion Criteria

Pregnancy
Refusal to sign the informed consent form
Presence of intracardiac thrombus
Diagnosed thrombophilia
Severe thrombocytopenia (platelets count below 20 000 L)
History of severe or chronic pulmonary hypertension
Serum creatinine level higher than 1.8 mg/dl
Known serious and uncontrolled sensitivity to radiographic agents
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