Long-term Outcomes of Patients Undergoing ECMO-assisted PCI
NCT ID: NCT06713876
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
220 participants
OBSERVATIONAL
2016-08-01
2025-07-31
Brief Summary
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The purpose of this retrospective single-center, observational registry in China is to investigate the long-term outcomes of patients undergoing VA-ECMO-assisted PCI and the impact of the operator experience.
Detailed Description
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Mechanical circulatory support (MCS) devices for elective high-risk PCI can provide hemodynamic support preventing hemodynamic failure during PCI. Several studies have suggested that intra aortic balloon pump (IABP) showed no significant benefits. Impella with a larger hemodynamic support also failed to demonstrate benefits, despite a tendency favoring the device. Venoarterial extracorporeal membrane oxygenation (VA -ECMO) is an alternative option for mechanical support, providing more extensive hemodynamic support in patients with potential or ongoing circulation failure. Initial reports on the use of VA-ECMO showed controversial results in the treatment of cardiogenic shock due to myocardial infarction. However, available evidence for the use of VA-ECMO in high-risk PCI has been restricted to retrospective small sizes; large-volume studies about the long-term outcome in this patient are limited.
ECMO requires a complex multidisciplinary approach and advanced technology. The potential benefits of hemodynamic support may be outweighed by the risk of device-associated complications, particularly bleeding and peripheral vascular events. Two studies have demonstrated that ECMO center experience may be associated with lower mortality in patients with cardiorespiratory failure. However, the relationship between operator experience and long-term outcomes post-VA-ECMO-assisted PCI in high-risk patients, and the ideal threshold to classify an operator as "experienced" have not been previously studied. Therefore, the aim of the present study was also to analyze the association between operator experience and one-year mortality post-VA-ECMO-assisted PCI.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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VA-ECMO-assisted PCI
VA-ECMO-assisted PCI
A total of 220 consecutive patients with VA-ECMO-assisted PCI will be enrolled. Data related to medical history, procedural characteristics, and outcomes were collected. Clinical follow-up will be conducted in the periprocedural and postoperative at 1 month, 1 year, 2 years, 3 years, 4 years, and 5 years.
Interventions
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VA-ECMO-assisted PCI
A total of 220 consecutive patients with VA-ECMO-assisted PCI will be enrolled. Data related to medical history, procedural characteristics, and outcomes were collected. Clinical follow-up will be conducted in the periprocedural and postoperative at 1 month, 1 year, 2 years, 3 years, 4 years, and 5 years.
Eligibility Criteria
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Inclusion Criteria
2. Coronary artery disease of the left main and/or multivessel disease
3. Combined with severely impaired left ventricular ejection fraction (LVEF), defined as LVEF ≤ 35% or decompensated heart failure
4. The heart team and the patient rejected CABG or OMT
18 Years
ALL
No
Sponsors
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Ling Tao, MD, PhD
OTHER
Responsible Party
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Ling Tao, MD, PhD
Director of the Department of Cardiology
Principal Investigators
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Ling Tao, M.D., Ph.D
Role: STUDY_CHAIR
Xijing Hospital
Chao Gao, M.D., Ph.D.
Role: STUDY_CHAIR
Xijing Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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References
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Cheng A, Wang B, Fu G, Li C, Liu Y, Li F, Wang Q, Yin Z, Gao H, Gao C, Tao L. Long-Term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-Assisted High-Risk Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Aug 21. doi: 10.1002/ccd.70098. Online ahead of print.
Other Identifiers
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KY20242366-C-1
Identifier Type: -
Identifier Source: org_study_id