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Thrombectomy and distal protection devices
R Rajagopal1, C Musto, A La Manna
1Department of Cardiology, Royal Brompton Hospital, London, UK.
Insights
Distal embolization during angioplasty, especially in saphenous vein grafts and acute myocardial infarction, can be reduced by mechanical thrombectomy and distal protection devices. However, large trials are needed to confirm their clinical benefit and widespread use.
Area of Science:
- Interventional Cardiology
- Cardiovascular Devices
- Medical Technology
Background:
- Distal embolization is a complication of percutaneous coronary interventions (PCI), occurring in 15-20% of saphenous vein graft (SVG) angioplasties and in native artery thrombus, particularly during acute myocardial infarction (AMI).
- Mechanical thrombectomy and distal protection devices aim to mitigate this complication.
- Existing evidence for these devices in AMI is limited, with some showing promise in surrogate endpoints but lacking large randomized trials for hard clinical outcomes.
Purpose of the Study:
- To review the current status and clinical utility of mechanical thrombectomy and distal protection devices in reducing distal embolization during PCI.
- To evaluate the effectiveness of these devices in specific scenarios like SVG interventions and acute myocardial infarction.
- To discuss the potential future role of these devices in routine angioplasty procedures.
Main Methods:
- Review of existing literature on mechanical thrombectomy devices (e.g., Angiojet, X-Sizer, Excimer LASER, aspiration catheters) and distal protection devices.
- Analysis of outcomes from key randomized trials (e.g., SAFER, FIRE, EMERALD) and guidelines (e.g., ESC).
- Discussion of emerging technologies like proximal occlusion devices.
Main Results:
- Mechanical thrombectomy shows benefit in thrombus-containing lesions compared to thrombolysis, but not consistently in AMI.
- Distal protection devices are recommended for SVG treatment but showed no clinical benefit in AMI in the EMERALD trial.
- Proximal occlusion devices offer potential early protection, especially in totally occluded vessels.
Conclusions:
- While devices like distal protection are standard in SVG PCI, their benefit in AMI remains unproven by large trials.
- Miniaturized thrombectomy devices and filters show technical improvements, but their role in mainstream angioplasty is uncertain due to limited large-scale evidence.
- Further large, controlled studies are essential to determine if these devices will become standard adjuncts to PCI or remain niche applications.
Abstract:
Visible distal embolization is a relatively rare complication during percutaneous coronary interventions but it may occur in 15-20% of angioplasties in saphenous vein grafts (SVG) and in thrombus containing lesions of native coronary arteries, especially in the setting of acute myocardial infarction (AMI). Mechanical thrombectomy devices and distal protection devices have been introduced to reduce the incidence of distal embolisation. Angiojet thrombectomy has shown positive outcomes in thrombus containing lesions when compared with intracoronary thrombolysis but a randomised trial failed to show benefit in the context of AMI. The X-Sizer, Excimer LASER and various simple aspiration thrombectomy catheters show promise in treatment of AMI with improvement shown in surrogate end-points such as resolution of ST-elevation but there have been no randomised trials large enough to demonstrate changes in hard clinical end-points. Distal protection devices have come to be routinely used during SVG treatment and, after the results of the SAFER and FIRE trials; they became a treatment recommendation in the recently issued European Society of Cardiology (ESC) guidelines. For AMI, these devices showed great promise in early single-centre studies which have been offset by the lack of clinical benefit in the multi-centre EMERALD trial. Proximal occlusion devices may further decrease the incidence of distal embolisation, especially in the treatment of totally occluded SVGs or native arteries, by reversing the blood flow and offering protection at a very early stage of the procedure before wire passage. Despite continuous technical improvement and a growing number of miniaturised thrombectomy devices and filters, because of the paucity of controlled large studies, it remains unclear whether these devices will remain limited to niche' applications or will become a regular companion to balloons and stents in mainstream angioplasty procedures.
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