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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate \<100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).
Poznan University of Medical Sciences
Poznan, Greaterpoland, Poland
RECRUITINGReduction of pulmonary arterial pressures
Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.
Time frame: Immediately after catheter-directed thrombectomy procedure
Reduction of vascular obstruction
Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
Time frame: Immediately after catheter-directed thrombectomy procedure
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
Incidence of arterial blood saturation increase \>92%
Time frame: Immediately after catheter-directed thrombectomy procedure
Ventricular strain reduction
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
Time frame: 24 hours after catheter-directed thrombectomy
Early mortality rate from pulmonary embolism
Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
Time frame: 24 hours after catheter-directed thrombectomy
Total mortality rate from pulmonary embolism
1\. Number of patients who died from pulmonary embolism (right heart failure)
Time frame: 3 months after catheter-directed thrombectomy
Bleeding events incidence
Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria
Time frame: 3 months after catheter-directed thrombectomy
Adverse events incidence
Incidence of pulmonary vascular injury assessed on angiography
Time frame: 3 months after catheter-directed thrombectomy
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