RU2791401C1 - Method of surgical treatment of atherosclerotic lesions of bifurcation of the carotid artery - Google Patents

Abstract

FIELD: medicine; cardiovascular surgery.

SUBSTANCE: common carotid artery is accessed, heparin is injected intravenously, the common carotid artery is mobilized and fixed with silicone tape. An artery is punctured, angiography is performed, and a conductor is inserted into it through a needle and an introducer is installed. The common carotid artery is clamped proximal to the insertion site. Then, the stent is implanted into the site of atherosclerotic lesion, after which, to ensure retrograde blood flow, transverse arteriotomy is performed no more than 1/3 of the circumference of the common carotid artery, 50 ml of blood is evacuated. Then, the common carotid artery is clamped distally to the arteriotomy site and angiography is performed, followed by suturing of the arteriotomy opening, restoration of blood flow, and wound closure.

EFFECT: method allows to adequately restore the patency of the carotid artery and reduce the risk of acute cerebrovascular accidents, prevent the risk of cranial nerve damage, postoperative hematoma, especially in patients with complex anatomy, high surgical and perioperative risk of complications.

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Description

The invention relates to medicine, more specifically to cardiovascular surgery, and can be used in the surgical treatment of stenosis of the carotid bifurcation with its significant atherosclerotic lesion.

Cerebrovascular diseases (CVD) are included in class IX (CVD) of ICD-10: I60-I69 and are one of the most common non-communicable diseases - in 2020, 6,408,009 cases were recorded in Russia, which is 4375.3 per 100 thousand population ( in 2019 - 7,301,850 and 4974.7, respectively). Mortality from CVD of the entire population in 2020 increased by 7.1% and amounted to 190.2 per 100 thousand people (in 2019 - 177.6, in 2018 - 179.5 per 100 thousand people). The death rate of the working-age population in 2020 was 32.9 per 100 thousand of the corresponding population, and for persons older than working age - 684.6 (in 2019 - 28.0 and 622.4, in 2018 - 29.2 and 636.8, respectively). The share of cerebrovascular disease in the Russian Federation in 2020 is 190.2 per 100 thousand people, which is 29.7% in the proportion of deaths from diseases of the circulatory system and does not tend to decrease compared to previous years.

The most common cause of the development of acute and chronic forms of cerebral circulation disorders is atherosclerotic lesions of the precerebral and cerebral arteries, which are localized, as a rule, in the bifurcation zone of the common carotid artery and at the mouth of the internal carotid artery [Maistrenko D.N. et al. Influence of the hemodynamic factor on the level of tangential stress of the artery wall in the area of the carotid bifurcation. Bulletin of the National Medical and Surgical Center. N.I. Pirogov. 2020].

Surgical and endovascular methods of treatment are the main ones in the prevention of certain forms of CVD, primarily cerebral infarction (in 2020, the frequency was 411,063 cases), obstruction and stenosis of the precerebral arteries. According to the Russian Ministry of Health, in 2020, the number of operations on the arteries supplying the brain in the entire population decreased by 21.0% and amounted to 29,481 (in 2019 - an increase of 4.6%, 37,333, in 2018 - an increase of 7.6%, 35686). The share of interventions using X-ray surgical methods in this group increased compared to the previous year and amounted to 26.9% (in 2019 - 22.2%, in 2018 - 20.8%) [. Bokeria L.A. et al. Cardiovascular surgery - 2020. Diseases and congenital anomalies of the circulatory system. NMIC SSH them. A.N. Bakuleva Moscow. 294 S.].

Indications for open and endovascular operations in the treatment of stenosing lesions of the extracranial carotid arteries are known and described [Occlusion and stenosis of the carotid artery. Clinical recommendations of the Ministry of Health of the Russian Federation. 2016]. In asymptomatic patients, surgery is performed with a stenosis of more than 70% (measurement is performed using the NASCET method), with symptomatic stenosis that led to the development of TIA or stroke, indications for surgery may be more than 60% stenosis, and in some cases, 50% using the NASCET method .

A known method of open surgical treatment of stenosing lesions of the bifurcation of the carotid artery [Gavrilenko A.V. et al. Classical and eversion carotid endarterectomy in patients with stenosis of the internal carotid artery. Surgery. Journal them. N.I. Pirogov. 2018]. Carotid endarterectomy (CEAE) is performed from a standard approach along the anterior inner surface of the sternocleidomastoid muscle. After mobilization of the common, external, internal carotid artery, clamping and dissection of the carotid artery is performed, followed by endarterectomy. The arteriotomy is sutured. The wound is drained and sutures are applied in layers. The main disadvantages of open surgery are surgical trauma and possible damage to a number of cranial nerves, increased frequency of heart attacks, respiratory failure, postoperative hematoma, anatomy variability, especially high location of the bifurcation, difficulty in repeated accesses [Occlusion and stenosis of the carotid artery. Clinical recommendations of the Ministry of Health of the Russian Federation. 2016].

An effective way to treat stenosing lesions of the extracranial carotid arteries and prevent stroke is X-ray endovascular prosthetics with a stent of the internal carotid artery. Endovascular intervention - opening a stent in the carotid artery - presses the atherosclerotic plaque against the vessel wall, restoring blood flow in it. An introducer is inserted into the femoral artery. An anti-embolic protection system is installed in the carotid artery. If necessary, predilatation with a balloon catheter is carried out. Next, the stent is installed in the stenosis zone and post-dilatation is performed using a balloon catheter of the required diameter. After the control angiography, the instrument is removed. The main disadvantages of endovascular operations (femoral access) are slightly worse perioperative and long-term results due to the more frequent development of acute cerebrovascular accident (ACV) compared to CEAE, the high cost of the operation, the difficulty of performing the procedure in atherosclerotic lesions of the aortofemoral segment, tortuosity of the carotid arteries, atypical anatomy of the aortic arch.

It should also be noted that such manipulation is often accompanied by detachment of plaque fragments and their migration into the distal bloodstream. Brain-protected stenting was shown to have fewer complications, 1.8% versus 5.2% without protection. Atheromas with intraplaque hemorrhages with disintegration are especially dangerous in terms of the development of embolism. The use of brain protection devices prevents embolism during balloon dilatation and subsequent stent placement. However, in the presence of large atheromas (stenoses 75-95%) with decay, with an uneven surface, with a tortuous residual lumen of the artery (with discrete color flow mapping), the procedure for installing a protective device is technically complicated (RF patent No. 2530724).

To mitigate many of the above risks and prevent acute cerebrovascular events, dynamic flow reversal methods have been developed that are designed to prevent distal embolizations beyond what is possible with distal filters.

Closest to the proposed is a method of stenting the transcarotid artery (TCAR) with flow reversal, published in the study ROADSTER, 2015, [Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015], which we took as a prototype.

Positive results of treatment with TCAR (prototype) are presented in a prospective multicenter study. The safety and effectiveness of the flow reversal system during carotid artery stenting were analyzed. The study included 141 patients, including 36 symptomatic patients with >50% stenosis. All asymptomatic patients had >70% stenosis. The patients included in the study were at high risk for endarterectomy based on anatomical and physiological criteria. The primary endpoint was serious adverse events in the form of death, stroke and myocardial infarction.

The prototype method is carried out as follows. The patient is placed on his back, as in carotid endarterectomy. The inguinal region is prepared for the installation of a venous introducer. The procedure can be performed under general or local anesthesia. The patient is undergoing systemic heparinization. The common carotid artery is isolated at the base of the neck through a longitudinal or transverse incision. A silicone band is placed around the artery. A specially designed introducer with a fixator is installed in the common carotid artery of the CCA. Clamp (OSA) proximal to the introducer entry site. The ENROUTE neuroprotection system is then used to ensure retrograde blood flow. Once the lesion is confirmed and identified, the stent is placed in the usual manner. If necessary, pre-dilate with a smaller balloon. A final cerebral angiography is performed with cranial imaging to assess cerebral emboli and the adequacy of stenting. Antegrade cerebral blood flow is restored by removing the clamp from the proximal common carotid artery. The tool is removed. The ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnydale, CA) is a flow reversal circuit that connects two 8-French sheaths via a flow modulator. One end of the modulator is attached to the introducer, previously installed in the common carotid artery, and the other end is connected through the introducer, located in the femoral vein. The two sheaths are connected via a flow modulator that can control the rate of flow reversal. The flow modulator can also temporarily stop the flow reversal. When the common carotid artery is occluded proximal to the sheath, the arterial-venous pressure gradient results in reversal of blood flow from the external and internal carotid arteries to the femoral vein.

Undoubtedly, the use of this method of protection during stenting of the internal carotid artery (ICA) has proven its effectiveness. However, this method is not without a number of disadvantages. As the authors themselves note, five serious adverse events were registered during the study (4 (2.8%) deaths, including 2 (1.4%) from stroke). There were also minor adverse events including eight arterial dissections, five hematomas, and one cranial nerve injury.

A significant disadvantage is the implementation of additional access to the femoral vein to install the introducer. This often leads to postoperative complications such as hematomas and infections. And the use of additional devices to prevent thromboembolism contributes to an uncontrolled effect on the walls of the artery, which increases the risk of such adverse events as delamination of its walls and inflammation.

It should also be noted that in the prototype method, the authors use the ENROUTE anti-embolic protection system (Silk Road Medical, Sunnydale, California) to provide retrograde blood flow and additional consumable instruments (puncture needle, introducer, conductor) to ensure venous access of the femoral vein and the functioning of the system . However, such a system is expensive and unregistered in the Russian Federation.

The technical result of the present invention is to eliminate these shortcomings, reduce the number of postoperative complications and prevent acute disorders of cerebral circulation while restoring normal blood flow in the common carotid artery.

This result is achieved by the fact that in the known method of surgical treatment of atherosclerotic lesions of the bifurcation of the carotid artery, including access to the common carotid artery, mobilization of the common carotid artery and its fixation with a silicone tape, intravenous administration of heparin, puncture of the artery, installation of an introducer and conductor into it , and its clamping, implantation of a stent at the site of an atherosclerotic lesion and provision of retrograde blood flow, according to the invention, after implantation of a stent to ensure retrograde blood flow, transverse arteriotomy is performed no more than 1/3 of the circumference of the common carotid artery, 50 ml of blood is evacuated, then the common carotid artery the arteriotomy site is clamped distally and angiography is performed, followed by drainage and suturing of the wound.

The method is carried out as follows.

In the position of the patient on the back in the conditions of an X-ray surgical operating room under local anesthesia performed under ultrasound control, an incision is made along the inner edge of the sternocleidomastoid muscle, starting 1 cm lateral to the upper edge of the sternum 3-4 cm long. The proximal common carotid artery is mobilized (WASP). Silicone tapes are wound up - coverings for convenient work with the carotid artery. Heparin is administered at the rate of 70 units per kilogram of body weight. Creation of moderate hypertension (20-30 mm Hg above baseline). The artery is punctured and angiography is performed through the needle in ROAD MAP mode to securely insert the sheath.

A 0.014-inch coronary guidewire is passed through the introducer into the internal carotid artery beyond the stenosis. The CCA is clamped proximal to the site of insertion of the introducer to stop the main blood flow.

The stent is positioned and deployed along the conductor into the stenosis zone. The balloon post-dilatation of the stent is performed. Next, a transverse arteriotomy is performed no more than 1/3 of the circumference of the CCA. The introducer and guidewire are removed. About 50 ml of blood is retrogradely evacuated to prevent embolism with possible clots or fragments of an atherosclerotic plaque. This is sufficient for the complete evacuation of blood in the precerebral sections of the left common, proximal sections of the external and internal carotid arteries at the time of clamping the common carotid artery, and thus, washing out all emboli [Efremushkin G.G., Filippova T.V., Denisova E. .A. Volumetric blood flow in the main arteries at various levels of arterial pressure in elderly patients with arterial hypertension. Russian journal of cardiology. 2010.]

The artery is clamped distal to the arteriotomy site. Control angiography is performed through the needle. With good positioning of the stent and the absence of emboli, a linear suture of the arteriotomy opening is applied. Starting blood flow (removing the clamp from the carotid artery). Control angiography of the carotid artery at the extra- and intracranial level, cerebral arteries. Hemostasis. Stitches on the wound with its drainage.

The essence of the method is illustrated by examples.

Example 1

Patient K., born in 1966, was admitted to the Department of Cardiovascular Surgery of the Kaliningrad Regional Hospital on April 4, 2022 with a diagnosis of I65.2. cerebrovascular disease. Stenosis (restenosis) of the left internal carotid artery 70%. Condition after carotid endarterectomy on the left from 09/03/2022. Concomitant diseases: arterial hypertension 3 tbsp.

From the anamnesis it is known that he considers himself ill for about a year. On 09/03/2022, a carotid EAE was performed on the left for asymptomatic stenosis in a medical facility in the Kaliningrad region - without any features. In March, the patient began to notice periodic weakness, impaired movements in the hand of the right upper limb. Consulted by a neurologist, cardiovascular surgeon. According to ultrasound of the precerebral arteries, stenosis in the proximal third of the left internal carotid artery (ICA) 70% according to NASCET cannot be ruled out, systolic LBF in the stenosis zone is 200 cm/sec. MSCT angiography of the brachiocephalic arteries confirmed stenosis of the left ICA, a pronounced bend at the mouth of the left common carotid artery. The patient was urgently admitted to the department.

Taking into account the postoperative scar on the neck after the previous carotid endarterectomy, anatomical features (bending at the mouth and proximal third), significant stenosis of the bifurcation of the left carotid artery and the proximal third of the left ICA, the indications for transcarotid stenting of the left carotid artery were predetermined.

The patient is examined, examined. Analyzes - a general clinical minimum, ECG - without features. ECHOCG showed no significant pathology. There are no zones of hypokinesia, akinesia. PV - 57%. Repeatedly consulted by a neurologist. There are no data for acute neurological symptoms. neurologically stable.

Indications for surgical treatment were determined - transcarotid stenting of the left internal carotid artery under regional anesthesia. On April 5, 2022, the patient was examined by an anesthesiologist. Before entering the operating room, standard premedication is indicated: promedol 2% -1 ml, atropine 0.1% -0.5 ml.

On April 6, 2022, the patient was taken to the X-ray surgical operating room.

The ultrasound examination of the precerebral sections of the left carotid artery was performed by the operating physicians. Marking with a marker of the left common carotid artery, the bifurcation of the left carotid artery, the site of stenosis of the internal carotid artery was carried out. The distance from the proposed carotid puncture site to the carotid bifurcation was 8 cm.

Under ultrasound guidance, the patient underwent regional anesthesia of the incision zone. The incision was made along the inner edge of the sternocleidomastoid muscle, starting 1 cm lateral to the upper edge of the sternum, 4 cm long.

The proximal common carotid artery (CCA) was mobilized with silicone tape. The patient received heparin at the rate of 70 units per kilogram of body weight. Creation of moderate hypertension (20-30 mm Hg above baseline).

An artery puncture was performed, angiography in the “ROAD MAP” mode, a 7 Fr introducer and a 0.014-inch coronary guidewire were placed in the CCA in the stenosis zone. The CCA was clamped proximal to the introducer insertion site

A stent was implanted along the conductor into the stenosis zone. Control angiography ruled out dislocation of the stent, dissection of the artery, and areas of restenosis.

Next, the patient underwent a transverse arteriotomy no more than 1/3 of the CCA circumference. The intraducer and conductor were removed. The artery was clamped distally to the arteriotomy site. Control angiography was performed through the needle. There were no signs of stent dislocation, residual stenosis, dissection, material emboli in the bloodstream. The arteriotomy was sutured with 6-0 suture.

Clamps have been removed from the carotid artery to start blood flow. The total time of CCA clamping was 7 minutes.

Performed control angiography of the carotid artery at the extra- and intracranial level, cerebral arteries. There were no signs of stent dislocation, residual stenosis, dissection, material emboli in the bloodstream. Hemostasis. Layer-by-layer wound suture (Vicryl 3-0 thread was used) with its drainage.

The postoperative period is smooth. Control of ultrasound after 24 hours and at discharge - the carotid arteries are passable, without signs of stenosis. The wound healed by first intention. On the 4th day, the patient in a satisfactory condition was released for outpatient treatment. Recommended: antihypertensive therapy with BP control 2 r per day, acetylsalicylic acid 100 mg * 1 r per day, clopidogrel 75 mn * 1 r per day for 12 months, atorvastatin 20 mg * 1 r per day; observation of a neurologist, cardiovascular surgeon at the place of residence.

To date, the proposed method has been used to treat 7 patients with atherosclerotic lesions of the bifurcation of the carotid artery. Surgical interventions were successful, without complications. All patients had no material embolism in the intracranial bed. The postoperative period was uneventful due to a small postoperative trauma and the use of regional anesthesia.

Thus, the proposed method is easily reproducible by a person skilled in the art. EFFECT: method allows to adequately restore the patency of the carotid artery and reduces the risk of acute cerebrovascular accidents. There is no need to use a wide skin incision to mobilize the common, external internal carotid artery, which reduces the risk of cranial nerve damage, postoperative hematoma, especially in patients with complex anatomy, and high surgical and perioperative risk of complications. Due to this, postoperative hospital stay is reduced, less surgical trauma allows the patient to quickly adapt after surgery and get involved in an active lifestyle. The absence of the need to use expensive protective equipment and consumables during the operation makes it possible to introduce this method in hospitals.

Claims (1)

A method for surgical treatment of atherosclerotic lesions of the bifurcation of the carotid artery, including access to the common carotid artery, intravenous administration of heparin, mobilization of the common carotid artery and its fixation with a silicone tape, puncture of the artery, angiography, introduction of a guidewire into it through a needle and installation of an introducer, clamping of the common carotid artery of the carotid artery proximal to the site of insertion of the introducer, implantation of a stent at the site of an atherosclerotic lesion and provision of retrograde blood flow, characterized in that after implantation of the stent to ensure retrograde blood flow, transverse arteriotomy is performed no more than 1/3 of the circumference of the common carotid artery, 50 ml of blood is evacuated, then the common carotid artery is clamped distally to the site of arteriotomy and angiography is performed, followed by closure of the arteriotomy opening, restoration of blood flow and closure of the wound.