Miguel Angel De Gregorio1, José A Guirola1, Wiliam T Kuo2, Carolina Serrano3, José Urbano4, Ana L Figueredo5, Sergio Sierre6, Carlos Andrés Quezada7, Esther Barbero7, David Jiménez8. 1. Interventional Radiology, Hospital Clinico Universitario Lozano Blesa, Gómez Laguna 18, 50009 Zaragoza, Spain; GITMI (Group of Research in Minimally Invasive Techniques), University of Zaragoza, Domingo Miral s/n, Zaragoza, Spain. 2. Division of Vascular and Interventional Radiology, Department of Radiology, Stanford University Medical Center, Stanford, CA, United States. 3. GITMI (Group of Research in Minimally Invasive Techniques), University of Zaragoza, Domingo Miral s/n, Zaragoza, Spain. 4. GITMI (Group of Research in Minimally Invasive Techniques), University of Zaragoza, Domingo Miral s/n, Zaragoza, Spain; Nisa Vithas Hospital, Pardo de Aravaca, La Salle 12, 28023 Madrid, Spain. 5. Respiratory Department, Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009 Zaragoza, Spain. 6. GITMI (Group of Research in Minimally Invasive Techniques), University of Zaragoza, Domingo Miral s/n, Zaragoza, Spain; Interventional Radiology, Pediatric Hospital Universitario Austral, Juan Domingo Peron 1500, Pilar Centro, Buenos Aires, Argentina. 7. Respiratory Department, Hospital Ramón y Cajal and Universidad de Alcalá (IRYCIS), Madrid, Spain. 8. Respiratory Department, Hospital Ramón y Cajal and Universidad de Alcalá (IRYCIS), Madrid, Spain. Electronic address: djimenez.hrc@gmail.com.
Abstract
OBJECTIVES: To evaluate the efficacy and safety of aspiration thrombectomy in combination with low-dose catheter-directed thrombolysis for acute unstable pulmonary embolism (PE). BACKGROUND: Acute unstable (PE) is a life-threatening condition requiring treatment escalation, but many patients cannot receive full-dose systemic thrombolysis due to contraindications. METHODS: Eligible patients had a PE with sustained hypotension. We used a 115-cm, 8-F continuous aspiration mechanical thrombectomy catheter to perform mechanical thrombectomy, followed by catheter-directed thrombolysis with low-dose urokinase. The primary efficacy outcome was the change in the pulmonary artery pressure after aspiration thrombectomy and catheter-directed thrombolysis. Secondary efficacy outcomes were stabilization of hemodynamics post-procedure and survival to hospital discharge. The primary safety outcome was major procedure-related complications and major bleeding events. RESULTS: We included 54 patients with acute unstable PE. After thrombectomy, mean systolic pulmonary artery pressure decreased from 60.2 mm Hg to 55.2 mm Hg (P < 0.01), and to 40.5 mm Hg after catheter thrombolysis (P < 0.0001). The in-hospital PE-related death occurred in six patients (11%; 95% confidence interval [CI], 4.2-23%) at a mean follow-up of 1.1 days, and hemodynamics stabilized in the remaining 48 patients. Minor complications after thrombectomy included arrhythmias (4 of 48 patients, 8.3%; 95% CI, 2.3-20%), and minor bleeding episodes (3 of 48 patients; 6.2%; 95% CI, 1.3-17%). Major complication occurred in one patient (2.1%; 95% CI, 0.1-11%) who developed hemorrhagic transformation of paradoxical embolic stroke following catheter-directed thrombolysis. CONCLUSIONS: Aspiration thrombectomy followed by catheter-directed thrombolysis was overall effective and safe in treating patients with acute unstable PE.
OBJECTIVES: To evaluate the efficacy and safety of aspiration thrombectomy in combination with low-dose catheter-directed thrombolysis for acute unstable pulmonary embolism (PE). BACKGROUND: Acute unstable (PE) is a life-threatening condition requiring treatment escalation, but many patients cannot receive full-dose systemic thrombolysis due to contraindications. METHODS: Eligible patients had a PE with sustained hypotension. We used a 115-cm, 8-F continuous aspiration mechanical thrombectomy catheter to perform mechanical thrombectomy, followed by catheter-directed thrombolysis with low-dose urokinase. The primary efficacy outcome was the change in the pulmonary artery pressure after aspiration thrombectomy and catheter-directed thrombolysis. Secondary efficacy outcomes were stabilization of hemodynamics post-procedure and survival to hospital discharge. The primary safety outcome was major procedure-related complications and major bleeding events. RESULTS: We included 54 patients with acute unstable PE. After thrombectomy, mean systolic pulmonary artery pressure decreased from 60.2 mm Hg to 55.2 mm Hg (P < 0.01), and to 40.5 mm Hg after catheter thrombolysis (P < 0.0001). The in-hospital PE-related death occurred in six patients (11%; 95% confidence interval [CI], 4.2-23%) at a mean follow-up of 1.1 days, and hemodynamics stabilized in the remaining 48 patients. Minor complications after thrombectomy included arrhythmias (4 of 48 patients, 8.3%; 95% CI, 2.3-20%), and minor bleeding episodes (3 of 48 patients; 6.2%; 95% CI, 1.3-17%). Major complication occurred in one patient (2.1%; 95% CI, 0.1-11%) who developed hemorrhagic transformation of paradoxical embolic stroke following catheter-directed thrombolysis. CONCLUSIONS: Aspiration thrombectomy followed by catheter-directed thrombolysis was overall effective and safe in treating patients with acute unstable PE.