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| Name | Class |
|---|---|
| Inari Medical | INDUSTRY |
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Clinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.
Acute pulmonary embolism (PE) is a common disease with variable presentation and clinical outcomes. Chronic sequelae including chronic thromboembolic pulmonary hypertension (CTEPH) and post-PE syndrome are common pathologies for patient who survive the already significant inpatient mortality, and have a significant impact on both quality of life and life expectancy. To date, the ELOPE trial is the only study to prospectively compare quality of life (QoL) and dyspnea measures and six-minute walk distance (6MWD) to cardiopulmonary exercise test, revealing worse post-PE syndrome in select populations, however this study is limited to a single arm that received anticoagulation alone. New catheter directed therapies, developed in response to such poor outcomes, provide treatment options for acute PE patients when first line therapies including anticoagulation are contraindicated or have failed.
Long term studies utilizing imaging have shown a majority of patients diagnosed with PE have residual pulmonary thrombi after 6 months, which is likely to be a large contributor to the development of CTEPH. Ventilation-perfusion (V/Q) scans remain the gold standard for detection of both acute and chronic pulmonary embolism and will serve as a primary outcome measure at 6 months post initial treatment. Clinical measures including 6MWD, QoL and dyspnea questionaries will be assessed prior to discharge, and at 1 and 6 months, in order to characterize the development of chronic symptomatology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter directed thrombectomy |
| ||
| Systemic anticoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter directed therapy | Device | Thrombectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation-perfusion mismatch | Mismatch on ventilation-perfusion scintigraphy per Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance | 30 days | |
| 6-minute walk distance | 6 months | |
| Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring treatment for acute pulmonary embolism.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol Stuehm | Contact | 520-626-8318 | carols@email.arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10227218 | Background | Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5. | |
| 22921592 | Background | Casazza F, Becattini C, Bongarzoni A, Cuccia C, Roncon L, Favretto G, Zonzin P, Pignataro L, Agnelli G. Clinical features and short term outcomes of patients with acute pulmonary embolism. The Italian Pulmonary Embolism Registry (IPER). Thromb Res. 2012 Dec;130(6):847-52. doi: 10.1016/j.thromres.2012.08.292. Epub 2012 Aug 24. |
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| Systemic anticoagulation |
| Drug |
Conservative therapy |
|
| Up to 30 days |
| Dyspnea questionnaire | up to 72 hours |
| Dyspnea questionnaire | 30 days |
| Dyspnea questionnaire | 6 months |
| Quality of life questionnaire | 30 days |
| Quality of life questionnaire | 6 months |
| 21268727 | Background | Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011 Jan 27;364(4):351-60. doi: 10.1056/NEJMra0910203. No abstract available. |
| 28400247 | Background | Kahn SR, Akaberi A, Granton JT, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Hernandez P, Aaron SD, Hirsch AM. Quality of Life, Dyspnea, and Functional Exercise Capacity Following a First Episode of Pulmonary Embolism: Results of the ELOPE Cohort Study. Am J Med. 2017 Aug;130(8):990.e9-990.e21. doi: 10.1016/j.amjmed.2017.03.033. Epub 2017 Apr 8. |
| 16424432 | Background | Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. doi: 10.1378/chest.129.1.192. |
| 27932051 | Background | Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6. |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
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