Thrombectomy in Pulmonary Embolism

Official title

Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism

Overview

Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.

Detailed description

Acute intermediate-risk pulmonary embolism (PE) and high-risk PE can be life threatening. The incidence of PE is increasing , and patients who survive the acute presentation may experience significant morbidity including reduced exercise tolerance, and decreased quality of life (QoL). Often patients are treated with anticoagulation to stop the clot getting worse and encourage the body to slowly break up the clot. However in more severe cases thrombolysis medication can be given to actively break up the clot. Catheter directed thrombolysis can be used to target the lytic medication into the pulmonary arteries and reduced the systemic effects. Percutaneous thrombectomy is a newer treatment option that aspirates the clot, providing a faster and potentially lytic free solution to sick patients. Pulmonary artery thrombectomy (PAT) is a treatment option that is variably utilised and has unclear evidence base . The penumbra device uses a computer modulated vacuum aspiration system to both fatigue, breakup and aspirate the clot. This has been shown to be safe and effective in small cohorts. CAVT can prevent acute hemodynamic decompensation, alleviate acute PE-related symptoms, accelerate right ventricular recovery, and improve quality of life as measured by patient-reported outcomes (PROs). Despite existing literature addressing clinical outcomes with PE treatment, comprehensive data on PE-related morbidity, PROs and longer-term outcomes after mechanical thrombectomy are still lacking.

Primary outcome measures

• LV/RV ratio [Time frame: 48 (+ 48 /- 24) hours post procedure.]
• Morbidity and mortality [Time frame: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).]

Eligibility criteria

Inclusion criteria

• Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
• Patients who present with computed tomography confirmed pulmonary embolism
• Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
• Date of computed tomography imaging from within a two-year period
• Patient is greater than or equal to 18 years of age
• Informed consent obtained
• Evidence of cardiac dysfunction (either biochemical or imaging features of right heart strain)

Exclusion criteria

• Known serious, uncontrolled sensitivity to radiographic agents
• Computed tomography not available to evaluate pulmonary embolism
• Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
• Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
• Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Inclusion criteria

• Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
• Patients who present with CT confirmed PE
• Defined as intermediate or high-risk PE (according to ESC guidelines1)
• Date of CT imaging from within a two-year period
• Patient is ≥ 18 years of age
• Informed consent obtained
• Evidence of cardiac dysfunction (Either biochemical or imaging features of RHS)

Exclusion criteria

• 1\. Known serious, uncontrolled sensitivity to radiographic agents 2. CT not available to evaluate PE 3. Low Risk PE as defined by ESC guidelines1 4. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 5. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• University Hospital Plymouth NHS Trust — Plymouth

Publications

• 11. National institute of Clinical Excellence. Pulmonary embolism: what are the risk factors. NICE guidelines. https://cks.nice.org.uk/topics/pulmonary-embolism/background-information/risk-factors/
• Noble S, Lewis R, Whithers J, Lewis S, Bennett P. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study. BMJ Open. 2014 Apr 2;4(4):e004561. doi: 10.1136/bmjopen-2013-004561. PMID 24694625
• Danielsbacka JS, Rostberg L, Olsen MF, Mannerkorpi K. "Whole life changed" - Experiences of how symptoms derived from acute pulmonary embolism affects life. A qualitative interview study. Thromb Res. 2021 Sep;205:56-62. doi: 10.1016/j.thromres.2021.07.004. Epub 2021 Jul 5. PMID 34247098
• 8. Perkowski, Paul et al Computer-aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.Journal of Vascular Surgery, Volume 77, Issue 4, 52S - 53S
• Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter DJ 2nd, Shavelle DM, Leal SRN, Attallah AS, West FM, Keeling WB, Sharp ASP, Weinberg I. Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study. J Vasc Interv Radiol. 2024 Aug;35(8):1154-1165.e6. doi: 10.1016/j.jvir.202 PMID 38729421
• Mathews SJ. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration. Tex Heart Inst J. 2021 Nov 1;48(5):e217571. doi: 10.14503/THIJ-21-7571. No abstract available. PMID 34911082
• Gotzinger F, Lauder L, Sharp ASP, Lang IM, Rosenkranz S, Konstantinides S, Edelman ER, Bohm M, Jaber W, Mahfoud F. Interventional therapies for pulmonary embolism. Nat Rev Cardiol. 2023 Oct;20(10):670-684. doi: 10.1038/s41569-023-00876-0. Epub 2023 May 12. PMID 37173409
• Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. 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 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epu PMID 31585051

Identifiers

NCT: NCT07650435 · 24RAD100 · 362530

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗