Caso Clínico
Endovascular treatment in an intermediate-high risk pulmonary embolism but high bleeding risk: A great aspiration time!
Camila Belén Gallardo (orcid 000900904159733), Carlos Fernández Pereira (orcid 0000000285061464), Lisandro Tesoro, Jorge Restaino, Matías Rodríguez Granillo, Juan Mieres, Augusto Lavalle Cobo, Alfredo Rodríguez
Revista Argentina de Cardioangiología Intervencionista 2024;(3): 0130-0133 | Doi: 10.30567/RACI/20243/0130-0133
Pulmonary embolism is the third leading cause of cardiovascular death after myocardial infarction and stroke. We present the case of an 80-year-old woman with hypertension, hypertriglyceridemia, and ventricular extrasystoles, who experienced a sudden onset of dyspnea, NYHA functional class III-IV, and palpitations. Oxygen saturation was 93%, with poor ventilatory mechanics and anemia. A CT scan revealed a right ventricle/left ventricle ratio of 1.3. Echocardiography showed a dilated right ventricle with severe dysfunction and deep vein thrombosis. Biomarkers (TnI, BNP) were elevated, indicating an intermediate-to-high risk with a high bleeding risk. The therapeutic alternative of choice was endovascular treatment consisting of pulmonary arteriography followed by successful thromboaspiration using the FlowTriever device. At three months, the patient experienced no further hospitalizations, exhibited good functional class, and had normal pulmonary pressure.
Palabras clave: FlowTriever, thrombectomy, pulmonary embolism, pulmonary artery thrombectomy.
La embolia pulmonar es la tercera causa principal de muerte cardiovascular después del infarto de miocardio y el accidente cerebrovascular. Presentamos un caso de una paciente de 80 años, hipertensión arterial, hipertrigliceridemia, extrasístoles ventriculares, con episodio de disnea súbita CF III-IV asociado a palpitaciones, SO2 93% con mala mecánica ventilatoria, anémica. En tomografía, índice ventrículo derecho/ventrículo izquierdo = 1,3. Por ecocardiograma, ventrículo derecho dilatado, deterioro severo de la función y trombosis venosa profunda. Elevación de biomarcadores (TnI, BNP). Configura riesgo intermedio-alto, con alto riesgo de sangrado. Se decide tratamiento endovascular con arteriografía pulmonar seguido de tromboaspiración exitosa con dispositivo FlowTriever. A 3 meses sigue sin nuevas internaciones, buena clase funcional, presiones pulmonares normales.
Keywords: FlowTriever, trombectomía, embolia pulmonar, trombectomía arteria pulmonar.
Los autores declaran no poseer conflictos de intereses.
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Recibido 2024-05-02 | Aceptado 2024-08-24 | Publicado
Esta obra está bajo una Licencia Creative Commons Atribución-NoComercial-SinDerivar 4.0 Internacional.
Introduction
Pulmonary embolism (PE) is the third leading cause of cardiovascular death after myocardial infarction and stroke, with an overall 30-day mortality rate of approximately 10%1.
Management strategies for PE vary depending on disease severity.
Patients with submassive or intermediate-risk PE who exhibit biochemical evidence of myocardial injury or findings of right ventricular (RV) dysfunction constitute a controversial treatment group. Mortality rates between 7 and 30 days for intermediate-risk PE treated with anticoagulation only range from 2-3% in controlled studies, although registries have reported mortality rates up to 15% over a follow-up period of 7-90 days, with approximately 10% of patients deteriorating into a high-risk category2.
Adverse outcomes in this population with anticoagulant treatment have prompted consideration of higher-scale therapeutic strategies, whether they be medical therapy, catheter-based treatment, or surgical embolectomy (which is rare).
In this study, we present our case of pulmonary artery thrombectomy with a catheter using an endovascular device in a patient with intermediate-to-high risk and a high bleeding risk.
Clinical case
Our patient is an 80-year-old female woman with a history of hypertension, hypertriglyceridemia, and ventricular extrasystoles. Her regular medication included losartan 50 mg every 12 hours, bisoprolol 2.5 mg daily, and fenofibric acid 135 mg daily. Regarding her current illness, she experienced a sudden onset of dyspnea (NYHA class III-IV) lasting 2 hours with palpitations, leading her to seek emergency care. Upon physical examination, her blood pressure (BP) was 125/83 mmHg; her heart rate (HR), 112 bpm; oxygen saturation (SO2): 93% (FiO2 36%); respiratory rate (RR), 38 breaths/min. The patient was lucid with poor ventilatory mechanics, no clinical signs of heart failure, and good peripheral perfusion. Her electrocardiogram showed sinus tachycardia, HR of 110 bpm, axis 45°, complete right bundle branch block, with S1Q3T3 pattern (Figure 1).
Her laboratory results indicated hemoglobin at 9.9 g/dL; hematocrit, 30.7% (indicative of iron deficiency); pre-renal kidney dysfunction with creatinine 1.76 mg/dL; BNP, 9000 pg/mL; Troponin I, 193 ng/L. A chest computerized tomography showed that her RV/LV ratio was 1.3 (Figures 2A and 2B). An echocardiography showed a dilated RV (basal diameter, 48 mm; mid-diameter, 51 mm; longitudinal diameter, 59 mm), severe functional impairment, free wall hypokinesia, and tricuspid annular plane systolic excursion (TAPSE): 9 mm. Her pulmonary artery systolic pressure (PASP) was 65 mmHg. A lower limb Doppler ultrasound confirmed deep vein thrombosis (DVT) in the left popliteal vein and the soleus venous plexus. Based on RV dysfunction findings and elevated biomarkers (TnI, BNP), intermediate-to-high risk pulmonary thromboembolism was diagnosed (PESI score IV). Anticoagulation with enoxaparin 1 mg/kg was started.
At 72 hours, the patient remained stable but exhibited increasing oxygen requirements and poor ventilatory mechanics.
A reperfusion strategy was agreed upon and endovascular treatment was chosen due to the high bleeding risk (RIETE3 score: 5 points, high). The selected alternative included pulmonary arteriography and thromboaspiration using the Inari FlowTriever device (Inari Medical Inc, Irvine, CA, USA). A 24-Fr introducer sheath and a 24-Fr aspiration catheter were used, advancing the device over an Amplatz guidewire. The system allowed thrombi to be filtered and blood reinfused to minimize blood loss (Figure 3). A right femoral venous access was obtained under ultrasound guidance, followed by percutaneous closure with a device included in the kit. Additionally, a Swan-Ganz catheter was used to measure hemodynamic parameters. Thrombolysis was not considered as an alternative due to high bleeding risk.
In total, 14 aspirations were performed (Figure 4) and significant thrombotic material was filtered and extracted (8 thrombi from the right lung, 6 from the left); filtered blood was reinfused (Figure 5). The patient required no supplemental oxygen 24 hours after the procedure, with stable hemoglobin and hematocrit levels.
Her post-procedure hemodynamic parameters were BP 120/80 mmHg, HR 85 bpm, and SO2 96% (0.21).
At the 2-month follow-up, the patient remained anticoagulated with acenocoumarol, with no new hospitalizations and good functional status. Control echocardiography showed a mildly dilated RV with preserved systolic function and TAPSE 16 mm. Her PASP was 20 mmHg.
Discussion
The Inari FlowTriever catheter system is a valuable tool in the treatment of pulmonary embolism (PE). It features a thrombectomy catheter with nitinol discs and an aspiration cannula4-6.
This system is designed for effective emboli aspiration and removal in the pulmonary arteries. Studies have demonstrated successful outcomes using the FlowTriever system in cases of submassive and massive PE7.
The device has also been used in more complex scenarios, such as clot-in-transit in the right ventricle and in the right atrium, which shows its versatility in managing different PE-related complications8.
The safety and efficacy of the Inari FlowTriever system have been highlighted in various reports and clinical studies. In a retrospective study by Wible et al.9, which included 46 patients, large-bore mechanical aspiration thrombectomy significantly reduced mean pulmonary artery pressure in massive or submassive PE. Only 2 patients experienced significant procedure-related adverse, and there was no 30-day mortality. The average blood loss associated with aspiration was 280 mL, and only one patient required a transfusion of red blood cell concentrates. All patients survived until hospital discharge; the 30-day mortality rate was 4.3%, and it was not attributed to the procedure or pulmonary embolism. This is a promising “real-world” single-center experience.
The device has been proven effective in reducing clot burden, improving pulmonary reperfusion, and facilitating hemodynamic recovery in patients with acute PE. Additionally, it has been successfully used in challenging scenarios such as cardiac tamponade after catheter manipulation while trying to reach the distal portion of the pulmonary arterial tree, followed by pulmonary embolectomy, further showing its usefulness in challenging situations10
Additionally, the FlowTriever system has been employed as rescue treatment for PE in a critical patient undergoing resuscitation with venoarterial extracorporeal membrane oxygenation (VA-ECMO) who suffered from severe acute right heart failure. In this particular high-risk population, where thrombolysis is largely inapplicable, this new technology could be a promising solution, since the combination of aspiration and extraction of large-bore thrombi successfully removes large emboli. In this case, right ventricular function improved rapidly after the procedure, ECMO was discontinued, and the patient was discharged two weeks later11.
The device can also reduce right ventricular strain in patients with acute submassive PE, which emphasizes its role in improving hemodynamic parameters in such cases. A study by Toma et al.12 included 34 patients: 18 with massive PE, four intubated, and 12 normotensive but with a cardiac index (CI) < 1.8. The mean age was 56 years. The patients were at high bleeding risk: 13 had recently undergone surgery (posing a high bleeding risk), six had experienced trauma, and four had recently suffered a stroke. Six patients underwent cardiopulmonary resuscitation, and two required additional mechanical circulatory support. All patients exhibited RV dilation and elevated biomarkers. Clot extraction was successful in 32 out of 34 patients. The CI improved from 2.0±0.1 L/min/m2 before thrombectomy to 2.4±0.1 L/min/m2 after the procedure (p=0.01). Mean pulmonary artery pressure decreased from 33.2±1.6 mmHg to 25.0±1.5 mmHg (p=0.01). Two patients—both with either no thrombus or minimal thrombus extracted—deteriorated during the procedure: one died and the other was successfully stabilized on ECMO. There were no other significant complications. All other patients were alive at the time of data collection (mean follow-up: 205 days). Establishing a registry of pulmonary thrombectomies performed in Argentina using the FlowTriever device, following the example of the rheolytic thrombectomy in pulmonary embolism registry13, is of the utmost importance.
Such a registry would allow for the systematic evaluation of the safety, efficacy, and long-term outcomes of the FlowTriever device in our population, facilitating comparisons with alternative techniques and devices, and promoting improved clinical decision-making.
Conclusions
The FlowTriever aspiration system was effective in this patient with intermediate-to-high-risk PE and high bleeding risk. The procedure, with no complications, was notably safe for this type of intervention.
Jolly M, Phillips J. Pulmonary embolism: current role of catheter treatment options and operative thrombectomy. Surg Clin North Am. 2018;98:279–292.
Giri J, Sista AK, Weinberg I, et al. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Circulation. 2019;140:774–801.
Nieto JA, Solano R, Ruiz-Ribó MD, et al (2010). Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry. J Thromb Haemost. 2010;8(6), 1216-12224.
Rousseau H, Del Giudice C, Sanchez O, et al. Endovascular therapies for pulmonary embolism. Heliyon. 2021 Apr 1;7(4):e06574.
Rivera-Lebron B, McDaniel M, Ahrar K, et al. PERT Consortium. Diagnosis, Treatment and Follow Up of Acute Pulmonary Embolism: Consensus Practice from the PERT Consortium. Clin Appl Thromb Hemost. 2019 Jan-Dec; 25:1076029619853037.
Haque MZ, Akbar T, Saleem A, Husain M. Becker muscular dystrophy and successful intervention with mechanical thrombectomy of right atrial clot-in-transit with pulmonary embolism. Clin Case Rep. 2023 May 22;11(5):e7390.
Elmoghrabi A, Shafi I, Abdelrahman A, et al. Outcomes of Catheter-Based Pulmonary Artery Embolectomy in Patients with Sub-Massive to Massive Pulmonary Embolism. Cureus. 2023 Feb 11;15(2):e34877.
Bayona Molano MDP, Salsamendi J, Mani N. Emergent mechanical thrombectomy for right atrial clot and massive pulmonary embolism using flowtriever. Clin Case Rep. 2021 Jan 21;9(3):1241-1246.
Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J VascInterv Radiol. 2019 Sep;30(9):1370-1375.
Tanveer Ud Din M, Ramanujam D, Nasrullah A, et al.Novel Case of Cardiac Tamponade after Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System. Eur J Case Rep Intern Med. 2022 Aug 26;9(8):003522.
Stadler S, Debl K, Ritzka M, Maier LS, Sossalla S. Bail-out treatment of pulmonary embolism using a large-bore aspiration mechanical thrombectomy device. ESC Heart Fail. 2021 Oct;8(5):4318-4321.
Toma C, Khandhar S, Zalewski AM, et al. Percutaneous thrombectomy in patients with massive and very high-risk submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2020 Dec;96(7):1465-1470.
Fernandez Pereira C, Rodríguez Granillo M, Cristodulo Cortes R, et al. Tratamiento de la embolia pulmonar masiva con trombectomía reolítica percutánea: resultado intrahospitalario y al seguimiento. Revista Argentina de Cardioangiología Intervencionista 2014;(02): 0130-0136 | Doi:10.30567/RACI/201402/0130-0136.
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Revista Argentina de Cardioangiología intervencionista
Issue # 3 | Volumen
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Etiquetas
FlowTriever, thrombectomy, pulmonary embolism, pulmonary artery thrombectomy
Tags
FlowTriever, trombectomía, embolia pulmonar, trombectomía arteria pulmonar
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