Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Percutaneous Pulmonary Thrombectomy (FlowTriever): Percutaneous pulmonary thrombectomy performed using the FlowTriever system as part of routine clinical care. Device selection is based on physician discretion and not assigned by the study protocol.

Percutaneous Pulmonary Thrombectomy (Indigo): Percutaneous pulmonary thrombectomy performed using the Indigo system as part of routine clinical care. Device selection is based on physician discretion and not assigned by the study protocol.

Study summary

Pulmonary embolism (PE) is a potentially life-threatening condition caused by the obstruction of pulmonary arteries by thrombi. Patients with high-risk or intermediate-high-risk PE may require immediate reperfusion therapies, including percutaneous pulmonary thrombectomy. However, this procedure can be associated with significant hemodynamic and respiratory instability, potentially leading to shock, cardiac arrest, or the need for advanced support such as mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

The mechanisms, timing, and causes of intraprocedural hemodynamic and respiratory deterioration during pulmonary thrombectomy are not well established. Factors such as catheter manipulation within the pulmonary arteries, increased pulmonary pressures, and the effects of anesthesia and mechanical ventilation may contribute to clinical instability. In addition, biomarkers such as NT-proBNP may reflect right ventricular strain and could help predict the risk of instability during the procedure.

The aim of this prospective observational study is to determine the incidence, causes, and timing of hemodynamic and/or respiratory instability during percutaneous pulmonary thrombectomy in patients with high-risk or intermediate-high-risk PE. The study will also compare the occurrence of instability between different thrombectomy devices (FlowTriever® and Indigo® systems) and evaluate the prognostic role of baseline NT-proBNP levels. Secondary objectives include the assessment of in-hospital and 30-day mortality and their underlying causes.

This study will include adult patients undergoing percutaneous pulmonary thrombectomy as part of routine clinical care. The results of this study may help improve risk stratification, guide procedural planning, and optimize the management of patients undergoing pulmonary thrombectomy, ultimately aiming to reduce morbidity and mortality.

Eligibility

Primary outcome measure(s)

• Intraprocedural Hemodynamic and/or Respiratory Instability — During the percutaneous pulmonary thrombectomy procedure
  Composite outcome defined as the occurrence of any of the following events during percutaneous pulmonary thrombectomy: sustained hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg for ≥15 minutes), initiation or escalation of vasopressor support, cardiopulmonary resuscitation, need for extracorporeal membrane oxygenation (ECMO), oxygen saturation \<90% sustained, escalation of ventilatory support, or need for endotracheal intubation. Events will also be analyzed according to procedural timing.

Trial sites (1)

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