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Published on: June 12, 2021
The role of distal myocardial protection devices during percutaneous coronary interventions
1Imperial College, London, and East and North Hertfordshire NHS Trust, Queen Elizabeth II Hospital, Howlands, Welwyn Garden City, Herts AL7 4HQ, UK. d.gorog@imperial.ac.uk
Insights
Distal embolization during percutaneous coronary intervention (PCI) reduces outcomes. While routine embolic protection isn't proven for ST-elevation myocardial infarction (STEMI), selective use and routine use in saphenous vein graft (SVG) interventions are recommended.
Area of Science:
- Cardiovascular Interventions
- Interventional Cardiology
- Medical Device Technology
Background:
- Distal embolization during percutaneous coronary intervention (PCI) significantly worsens clinical outcomes, particularly in acute myocardial infarction (AMI) patients.
- Saphenous vein graft (SVG) interventions carry a high risk of major adverse cardiac events (MACE) and no-reflow due to embolization.
- Existing embolic protection strategies include distal occlusion/aspiration, filters, proximal occlusion/aspiration, and thrombectomy catheters.
Purpose of the Study:
- To evaluate the efficacy of various embolic protection systems in reducing complications during PCI, especially in AMI and SVG interventions.
- To determine the optimal use cases for different embolic protection devices based on patient risk and intervention type.
- To assess the impact of embolic protection on clinical outcomes, perfusion, and MACE.
Main Methods:
- Review of clinical trial data (EMERALD, PROMISE) and observational evidence on embolic protection devices during PCI.
- Analysis of angiographic indicators of embolization and their correlation with clinical outcomes.
- Comparison of outcomes between standard PCI, PCI with thrombus aspiration, and PCI with various embolic protection systems.
Main Results:
- Routine embolic protection systems have not demonstrated benefit in ST-elevation myocardial infarction (STEMI) patients undergoing PCI.
- Pretreatment with thrombus aspiration improves angiographic reperfusion but not early clinical outcomes in AMI.
- Both balloon occlusion/aspiration and filter-based distal protection significantly reduced 30-day MACE in SVG interventions, driven by a reduction in AMI.
Conclusions:
- Selective use of embolic protection may be justified for patients with high thrombus burden or acute stent thrombosis.
- Routine use of embolic protection devices (balloon occlusion/aspiration or filters) is recommended for saphenous vein graft interventions due to reduced MACE.
- Ongoing device improvements enhance deliverability and profile, with demonstrated cost-effectiveness for selective use in high-risk graft cases.
Abstract:
The success of intervention and clinical outcome is markedly reduced in patients who sustain distal embolization during percutaneous coronary intervention (PCI). Such embolization occurs in up to 15% of patients with acute myocardial infarction (AMI) undergoing PCI, and angiographic indicators of embolization are highly predictive of clinical and functional outcome. Saphenous vein graft (SVG) interventions carry a 20% risk of major adverse cardiac events (MACE), predominantly AMI, and significant risk of no-reflow. There are four types of embolic protection: distal occlusion/aspiration systems, filters, proximal occlusion/aspiration devices, and thrombectomy catheters. There seem to be no data to suggest that routine use of any embolic protection system is beneficial in patients with ST-elevation myocardial infarction (STEMI) undergoing PCI. The message from both the EMERALD and PROMISE trials is that embolic protection does not improve perfusion in the setting of AMI. Although pretreatment with thrombus aspiration before PCI improves angiographic reperfusion rates compared with standard PCI, enzymatic release and early clinical outcomes are not improved. Although the clinical implications of routine thrombus aspiration have yet to be established, selective use may be justified in patients with the highest thrombus burden. In addition, it should be considered in those with acute stent thrombosis and elective use of filter-based protection considered in very high risk vessel PCI (eg, last remaining conduit). There is no easy way to anticipate which SVG intervention will result in embolization. In SVG intervention, both balloon occlusion/aspiration and filter-based distal protection devices have significantly reduced the incidence of 30-day MACE, driven by AMI and should, I believe, be used routinely. Risk of complications is low with all the established devices. The profile and deliverability are continuing to improve with newer devices. Cost-effectiveness of selective use in high-risk graft cases has only recently been demonstrated.
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