Page 80 - BH-3-1

Brain & Heart Bovine pericardial patching in CEA

1. Introduction 2. Methods

Stroke is one of the most common causes of death and 8 – 2.1. Patient population
15% of ischemic strokes are due to atherosclerotic stenosis
of the carotid artery. Carotid endarterectomy (CEA) is This study protocol was approved by the ethics committees
1,2
the first-line treatment for carotid artery stenosis, effective of the five tertiary centers (including Xuanwu Hospital,
in considerably preventing the occurrence of stroke Capital Medical University [Department of Neurosurgery];
caused by carotid artery stenosis. According to the 2017 Zhongshan Hospital, Fudan University [Department of
3,4
European Society for Vascular Surgery (ESVS) Guidelines, Vascular Surgery]; the First Affiliated Hospital of Soochow
CEA remains the “gold standard for revascularization” University [Department of Neurosurgery]; Liaocheng
(class IIa; level of evidence: B). Possible closure techniques People’s hospital [Department of Neurosurgery]; and
5
after CEA include primary closure and patch angioplasty. the First Affiliated Hospital of Zhengzhou University
The comparison between these two types of closure after [Department of Vascular Surgery]), and informed consent
CEA remains rather controversial. The Society of Vascular was obtained from each patient. Indications for surgery
6
Surgery (SVS) stipulated in their guideline that routine included moderate or severe symptomatic carotid artery
carotid patching has a level of evidence at 1, especially stenosis and severe asymptomatic carotid artery stenosis.
in smaller diameter arteries (≤4 mm), in women, and in The degree of stenosis was calculated based on the North
12
7
the difficult distal portion of the internal carotid artery. American Symptomatic CEA Trial (NASCET) criteria.
Moreover, the flow characteristic of patch angioplasty may The pre-operative stenosis degree evaluation required
be superior to that of primary closure for minimizing early the use of computed tomography angiography (CTA).
perioperative adverse events and long-term restenosis. Symptomatic lesions were categorized as transient ischemic
6,8
A systematic review published in the Cochrane Library attack (TIA), amaurosis of the ipsilateral eye, or ischemic
included 11 articles involving 2100 patients and also stroke ipsilateral to the narrowed carotid artery within the
confirmed that patch closure can reduce the risk of previous 6 months. Our exclusion criteria are as follows:
short-term and long-term stroke after surgery compared (1) With an expected survival period <1 year; (2) unable to
tolerate general anesthesia; (3) unable to complete CTA of
with primary closure and may also be beneficial for blood vessels in the head and neck; (4) with a large-scale
restenosis. 9
stroke or myocardial infarction occurring within 30 days;
However, there are many types of patches. The patch (5) with coagulation dysfunction and contraindications to
material may be prepared from an autologous vein, heparin and antiplatelet drugs; (6) with a recent history of
bovine pericardium (BP), or synthetic materials such as gastrointestinal bleeding and difficulty in being treated with
Dacron, polytetrafluoroethylene (PTFE), polyester, and antiplatelet drugs; (7) with large intracranial aneurysms
polyurethane. The choice of a patch generally depends on that cannot be treated in advance or simultaneously;
the preference of the surgeon. Based on the summarization (8) with chronic complete occlusion without evident
of several randomized controlled clinical trials by Orrapin symptoms of cerebral ischemia; (9) with a history of
10
et al., the best type of patch cannot be determined because intracranial hemorrhage (intraparenchymal hemorrhage,
of the small number of outcome events. However, this subarachnoid hemorrhage, subdural, or epidural) within
review indicates that the BP patch may reduce the risk of 30 days before enrollment; (10) with severe diseases of
fatal perioperative stroke, death, and infection compared liver, kidney or circulatory systems, or other diseases; (11)
with other synthetic patches. with severe dementia or mental disorder that hampers
Our results from an animal study using the BP patch follows up in clinic; (12) participating in other clinical
showed that this type of patch could maintain stability trials within 3 months before enrollment; and (13) other
and provide early endothelialization. In clinical reasons that could preclude potential subjects for inclusion
11
applications, this property is beneficial to reduce the risk in the groups.
of post-operative thrombosis and may be beneficial to This prospective, randomized study was conducted
reduce restenosis. In the past few years, we conducted between September 2018 and September 2021. The
a multicenter, randomized controlled, non-inferiority patients were randomized in a 1:1 ratio using sealed opaque
trial comparing the BP patch with a polyurethane patch envelopes, each containing a slip of paper with two different
(Vascular-patch, B. Braun Medical AG, Germany, which is patches. Random numbers generated using a computer
widely used in China). Here, we compare the safety and were prepared in advance. Odd and even numbers
efficacy of these two patches in CEA to illustrate the broad represent BP patch and polyurethane patch, respectively.
prospects of BP patch. Patient demographics and clinical characteristics included

Volume 3 Issue 1 (2025) 2 doi: 10.36922/bh.4568