The evolution of transcarotid artery stenting with flow reversal
Stroke remains an important economic and social burden in western societies. The most common cause of stroke is an embolic event, which can originate from several different sources (i.e. carotid atheroma, arch atheroma, valvular heart disease, or atrial fibrillation). The annual risk of developing any cerebrovascular event in patients with a carotid atheroma is 1-2%, based on the Asymptomatic Carotid Atherosclerosis Study (ACAS) and the Asymptomatic Carotid Surgery Trial (ACST).
Carotid revascularization can be performed by open, endovascular, or hybrid approaches. For decades, carotid endarterectomy (CEA), first performed by Dr. Michael DeBakey in 1953, was the only carotid revascularization procedure proven to prevent stroke. Almost 25 years later, the advent and refinements of endovascular therapy made it possible for the first percutaneous carotid artery angioplasty to be performed in 1977 by Dr. Mathias. However, the risk of distal embolization, and therefore stroke, during unprotected carotid angioplasty remained a problem until the development of neuro protection systems in the late 1990s. Knowing about the evolution of cerebral protection during carotid artery revascularization is paramount to understanding the current commercially available devices. Juan Parodi carried out the first study on neuroprotection during carotid artery endovascular revascularization in 1998.
The same concept of monitoring MES during CEA was then extrapolated to percutaneous carotid artery procedures. Occlusion of the distal internal carotid artery was the first method employed to prevent distal embolization during carotid artery angioplasty.
The first flow reversal system was designed by Dr. Parodi and tested by Dr. Bates. Initially, continuous passive aspiration through a side port was created and flow reversal was confirmed by a contralateral carotid artery angiography, which confirmed retrograde flow in the ipsilateral carotid artery. Due to difficulties with complex aortic arch configurations, arch atheroma, and the need for ECA balloon placement in addition to CCA access to achieve true flow reversal, the transfemoral approach was abandoned and focus was once more directed to the transcervical approach. A combination of flow reversal and filter protection was also utilized in the early 2000s,
Feasibility studies were then conducted in which flow reversal was achieved by connecting commercially available 8Fr sheaths placed in the carotid artery and the jugular vein.
After Criado’s report of his technique and results, Alexandrescu et al.
To date, two pivotal multicenter trials designed to investigate CAS under neuroprotection with flow reversal have been published.
The most recent neuroprotection device approved by the FDA is the ENROUTE™ system (Silk Road Medical, Sunnyvale, California). The common carotid artery (CCA) is dissected out and controlled with vessel loops followed by insertion of a special sheath in the CCA; the CCA is then clamped and flow reversal started through the ENROUTE™ system. (
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