RU2467705C1 - Method of treating obliterating arterial sclerosis of lower extremities - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to vascular surgery. Loop endarterectomy is performed. Arterial blood flow is recovered. It is followed by intraoperative direct angiography. Stent grafts are implanted at the entry and exit of Hunter's canal with complete desobliteration. The presence of incomplete desobliteration requires implanting stent grafts in areas with preserved floating intima.

EFFECT: method enables maximum isolation of an injured arterial wall from blood flow; provided prevention of cicatrical arterial deformation; reduced time of extremity ischemia during stenting.

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Description

The invention relates to medicine, more specifically to vascular surgery, and may find application in operations of direct revascularization of the limbs.

Widespread atherosclerosis according to the World Health Organization over the past 5 years continues to be the main cause of death among the adult population of the planet. One of the most frequent and dangerous manifestations of atherosclerosis is the obliterating atherosclerosis of the vessels of the lower extremities (OASNK), which occurs in 10% of the population aged 60 years or more. Against this background, the progression of limb ischemia without adequate treatment almost inevitably leads to amputation. Almost 40% of patients who underwent amputation about the terminal stages of the disease die in the first year of life after crippling surgery. Since conservative treatment of atherosclerosis obliterans of the lower extremities, as a rule, is ineffective, the problem of improving the quality of reconstructive operations on the main arteries of the limbs remains extremely urgent. With atherosclerotic lesions of the arteries of the lower extremities, various types of reconstructive operations are used.

A known method of loop endarterectomy (PTEAE). This type of operation was proposed in 1958 by Cannon. Subsequently, with the development of surgical instruments, it became widely used in practical public health. There are two main methods for performing PTEAE: semi-closed and closed. Semi-closed PTEAE consists in the removal of atherosclerotically altered intima from the artery with occlusive plaques between the two sections of the arteriotomy, followed by plastic surgery of the arteriotomy holes (autologous or synthetic patch). Closed PTEAA consists in removing atherosclerotically altered intima with occlusive plaques from the artery using a single arteriotomy hole, often in the antegrade direction, rarely in the retrograde direction, then arteriotomy opening is performed.

The result of a successful PTEAE operation is the restoration of blood flow through a topographically normal passing artery. The deobliterated vessel retains its own innervation, blood supply (“vasa vasorum” of the adventitia membrane), as well as physiological diameter and flexibility. The elasticity of the deobliterated arterial wall is preserved, comparable with the elasticity of the autovein and 3-7 times higher than the elasticity of synthetic prostheses.

Removal of the pathological substrate is carried out exclusively in the affected area of the artery; at the same time, blood flow can also be restored along collateral branches due to the release of their mouths, which is of particular importance when the femoral artery is occluded in the Hunter canal and popliteal artery. With almost the same regression of the stage of limb ischemia in the immediate postoperative period, both after femoral-popliteal bypass surgery and after PTEAA, a clear divergence of the results of these operations is observed in the case of reocclusion of the reconstruction zone. Artery thrombosis after PTEAE occurs mainly in local areas of the main artery, devoid of large collaterals, which is accompanied by the progression of limb ischemia compared with preoperative.

When using PTEAE, the risk of infectious complications is reduced due to the absence of heterologous material in the tissues.

The main advantage of PTEAE is the adequacy of the diameter of the reconstruction site. In addition, a positive aspect of this reconstruction method is less invasiveness of the intervention. The use of PTEAA allows to reduce the time of revascularization of the arterial segment by 1.5-2 times.

However, the long-term results of de-obliterating operations, according to many authors, are not satisfactory. Reocclusions after loop endarterectomies are apparently associated both with the development of the cicatricial process in the area of the deobliterated artery and with the fact that after endarterectomies fragments of the inner membrane remain in the artery, which can serve as a source of development of both thrombotic complications and embolism.

Currently, X-ray endovascular interventions (balloon angioplasty, stenting), which in many patients are an alternative to open surgeries, are becoming more widespread. However, with extensive occlusions of the superficial femoral artery, this method of treatment is often ineffective.

With the continuous improvement of surgical treatment techniques and especially endovascular interventions, the long-term results of treatment of patients with atherosclerosis obliterans of lower limb arteries remain unsatisfactory. The annual patency of the femoral-popliteal structures largely depends on the site of the formation of the distal anastomosis of the shunt and the choice of plastic material (synthetic prosthesis or autovein), but, according to some authors, it does not exceed 76%. The cumulative patency of the reconstruction after 5 years does not exceed 58%.

Closest to the proposed method is “Loop thrombendarterectomy in the surgical treatment of multilevel atherosclerotic lesions of the arteries of the lower extremities” (Methodological recommendations of the Federal Agency for Health and Social Development of the Russian Federation, GOU VPO, Saratov State Medical University, publishing house GOU VPO Saratov State Medical University, UDC 616.13- 004.6-007.072-031.58-089 (07) P 76).

With this method, under conditions of epidural anesthesia, the common femoral artery and its branches are exposed, as well as the superficial femoral artery at the exit of the Gunther canal. Within the Hunter Canal, a small number of branches oriented in three directions depart from the femoral artery for a short distance. In this zone, the presence of calcified plaques with spatial deformation of the artery is most often noted. Arteriotomy is performed 5-7 cm long and is performed in the area of bifurcation of the common femoral artery, with the transition to the superficial femoral artery (PBA). An open endarterectomy is performed from the common, deep, initial part of the superficial femoral artery. The distal plaque exfoliates as low as possible, right up to the clamp applied. The exfoliated complex is introduced into the lumen of the loop. Loops with a diameter of 6-8 mm are used for endarterectomy from PBA. The edge of the plaque is proximal. By trapping the artery wall with vascular forceps, a traction is provided. After this, translational-rotational movements of the loop continue detachment of the plaque in the antegrade direction until the sensation of failure, if necessary, plaque fragments are removed through arteriotomy of the distal PBA. By rotational movements of the loop around its own axis with simultaneous extraction of it from the vessel, the plaque is usually removed in one block.

Evaluation of the effectiveness of deobliteration is carried out during the first 15-20 minutes after turning on the blood flow in the revascularization zones. The presence of a mechanical obstacle in the lumen of the vessel (early thrombosis of the operated vessels, technical errors in performing PTEAE, etc.) is manifested in the first 3-5 minutes after the resumption of blood flow through the vessels, the volumetric blood flow velocity progressively decreases to zero despite the clearly preserved pulsation of the vessels in the studied area. Upon receipt of small values of ultrasonic Doppler flowmetry (less than 50 ml / min), with suspected residual hemodynamic stenosis, intraoperative angiography or an audit of the zone of vascular deobliteration is mandatory.

The disadvantages of the prototype method are:

1) intraoperative control of the reconstructed segment (angioscopy) is carried out only after performing a closed loop endarterthrombectomy;

2) angiographic control is carried out only according to clinical indications, i.e. in the presence of a large fragment of intima that occludes the lumen of a deobliterated vessel;

3) if there is an occluding fragment of intima in a place of the artery that is inaccessible for open surgery, a stent is installed in the lumen of the vessel, which allows restoration of its lumen. This is not done with hemodynamically insignificant narrowing of the lumen of the artery, which leads to the abandonment in most cases of floating fragments of intima, which subsequently play the role of a matrix for reocclusion sites;

4) the use of stents does not allow to delimit the blood flow and the injured (deobliterated) artery wall, which is a thrombogenic factor;

5) the stent is implanted only in the area of the artery with an occluding fragment of intima, which does not solve the issue of preventing reocclusions in areas most susceptible to the cicatricial process (entry and exit from the Gunther canal, the beginning of the deobliterated area of the external iliac artery).

Thus, when using the prototype method, it is practically impossible to prolong the obtained positive effect of loop endarterectomy in the long-term postoperative period, when stenoses in the flotation zones of intima fragments and cicatricial deformations of deobliterated arteries are remodeled over time, which reduces the patency of deobliterated arteries to 76% for 1 of the year.

The technical result of the present invention is to extend the functioning of arterial structures by installing stent grafts directly during surgery in a deobliterated vessel.

This result is achieved by the fact that in the known method for the treatment of atherosclerosis obliterans of the lower extremities, including loop endarterectomy with subsequent endovascular stenting, according to the invention, after loop endarterectomy in the limbs, arterial blood flow is restored and intraoperative direct angiography is performed, endovascular stenting is performed by stent insertion and stent placement by the installation of stent and exit from the Gunther Canal with complete deobliteration, and in the presence of incomplete deobliteration, up to complete stent grafts in areas with preserved floating intima.

The restoration of arterial blood flow allows to reduce the time of limb ischemia, to adequately evaluate the intravascular relief during subsequent direct intraoperative angiography.

The installation of stent grafts at the entrance and exit of the Gunther canal with complete deobliteration reinforces the lumen of the artery and does not allow it to deform the scar process.

In case of incomplete deobliteration, an additional installation of stent grafts in the artery with floating parts of the intima allows excluding sources of thrombosis and embolism from the bloodstream.

The measures taken during surgical intervention contribute to the prevention of reocclusions and, accordingly, extend the functioning of arterial structures.

In their work, for several years, the authors performed intraoperative angiographic monitoring of all patients after completion of loop endarterectomy. These data, according to generally accepted criteria, gave an idea of the degree of stenosis of the lumen of the artery at the site of deobliteration. In addition, the flowmetry recommended in these cases gave an indirect idea of the hemodynamic significance of blood flow obstruction. The accumulation of data, comparing them with clinical observations of patients convinced the subjectivity of the forecasts made on the basis of generally accepted studies after loop endarterectomy. Having extensive experience in the treatment of patients with OASNK on the basis of long-term observations, the authors were convinced that all areas of deobliterated vessels with irregularities in the contour should not only be stented, but isolated from blood flow by installing a graft. In addition, the mandatory use of stent grafts in the area of entry and exit of PBA from the Hunter Canal, according to the authors, has a positive effect of reinforcing the sections of the artery that are most susceptible to cicatricial deformities, and this solution turned out to be the most acceptable for the treatment process of patients with OASNA, since the specific component of the event used in this method of treatment, increases many times for practical significance. Thus, on the basis of long observation periods, a method for the complex treatment of patients with OASNA was created.

The essence of the method is that after performing a loop endarterthrombectomy, blood flow is restored directly in the deobliterated section of the artery, direct intraoperative angiography is performed and the intravascular relief is adequately assessed. After that, the localization of floating fragments of intima and zones of residual stenosis is determined. Then, in the areas most susceptible to cicatricial deformities (in the superficial femoral artery at the entrance and exit of the Hunter canal, into the external iliac artery, including the level of the beginning of the deobliterated area), stent grafts are implanted. The installation of stent grafts at the entrance and exit of the Hunter canal with complete deobliteration of the artery reinforces its lumen and does not allow the scar process to deform the artery. In addition, depending on the results of angiography, in the presence of flotation of intima in the lumen of the artery, stent grafts are also placed in these areas. Installation of stent grafts in areas with floating parts of the intima allows you to exclude the source of thrombosis and embolism from the bloodstream. The use of a stent graft makes it possible to distinguish between blood flow and an injured (deobliterated) artery wall, which is a thrombogenic factor.

The essence of the method is illustrated by examples.

Example 1

Patient Azarova Z.A., born in 1950 (58 years old), was examined and treated at the ARCHMDL RSCRHT from 03/02/2008 to 03/18/2008, medical history No. 804.

The patient was hospitalized in a planned manner with complaints of pain in the right lower limb when walking, occurring when walking at a distance of about 60 m, paresthesia, chilliness of the right foot.

I considered myself sick for 1 year, when pain began to appear in the right lower limb when walking. Treated conservatively, without much effect. Over time, the disease progressed, the distance of painless walking decreased, at the time of examination the dysbasia on the right was about 60 meters. She also noted paresthesia, chilliness of the right foot. Hospitalized in a planned manner.

The patient was examined: angiography of the aorta and lower extremities (n / a), echocardiography (ECHOCG), consultation with a cardiologist.

According to the data of ultrasonic duplex scanning (USDS) of the brachiocephalic arteries, hemodynamically significant stenoses of the internal carotid arteries (ICA) were not detected.

According to n / c angiography: aorta, common iliac arteries from 2 sides, external iliac artery on the right without hemodynamically significant stenosis. Right: occlusion of the common femoral artery throughout, the superficial femoral artery from the mouth throughout, multilevel local stenosis of the deep femoral artery. The popliteal and tibial arteries on both sides are passable, with numerous stenoses in the anterior tibial artery.

The diagnosis of Obliterating atherosclerosis of the vessels of the n / limbs. Occlusion of the common and superficial femoral arteries on the right. Chronic ischemia of the right n / limb II B Art. Coronary heart disease, atherosclerotic cardiosclerosis. Hypertension II Art. The risk of cardiovascular complications 4 tbsp.

After preoperative preparation, on March 11, 2008, the patient underwent surgery: a semi-closed loop endarterthrombectomy of the superficial femoral artery on the right, autovenous plastic of the common and superficial femoral arteries, popliteal artery. After restoration of blood flow through the arteries of the lower extremities, direct angiography was performed. Based on the data obtained: the absence of hemodynamically significant obstacles, preventive endoprosthesis replacement of the superficial femoral arteries was performed on the left (2 Fluensy plus stent grafts at the entrance and exit of the artery from the Hunter canal) with the aim of preventing cicatricial deformities of the deobliterated vessel.

In the postoperative period without features, a significant improvement in the form of the cessation of pain in the right n / limb when walking, it is warm, sensitivity, movement in full. Blood circulation in the limbs is restored, the pulse on the arteries of the foot is distinct. According to duplex angioscanning, all the main arteries of the operated limb are passable, the ankle-brachial index (LPI) is 0.9. Discharged March 18, 2008 for outpatient treatment at the clinic in the community in a satisfactory condition.

The patient monitoring period is more than 3 years, a control study was conducted on 04/24/2011, the design is passable.

Example 2

The patient Primak L.A., born in 1946 (63 years old), was examined and treated at the ORCHMDL RSCRHT from 06/01/2009 to 06/15/2009, medical history No. 2106.

The patient was hospitalized in a planned manner with complaints of pain in the left lower limb when walking, occurring when walking at a distance of about 100 m, paresthesia, chilliness of the left foot.

He considered himself sick for 1 year, when pain began to appear in the left lower limb when walking. Treated conservatively, without much effect. Over time, the disease progressed, the distance of painless walking decreased, at the time of examination, the left dysbasia was about 100 meters. He also noted paresthesia, chilliness of the left foot. Hospitalized in a planned manner.

The patient was examined: angiography of the aorta and lower extremities (n / a), echocardiography (ECHOCG), consultation with a cardiologist.

According to the data of ultrasound duplex scanning (USDS) of the brachiocephalic arteries, hemodynamically significant stenoses of the internal carotid arteries (ICA) were not detected (less than 30%).

According to angiography of n / extremities: aorta, common iliac arteries from 2 sides, external iliac artery on the right without hemodynamically significant stenosis, stenosis of the external iliac artery on the left in the proximal part up to 40%. Left: occlusion of the common femoral artery along the entire length, the superficial femoral artery from the mouth throughout the entire course, multilevel local stenoses of the deep femoral artery. The popliteal and tibial arteries on both sides are passable, with numerous stenoses.

The diagnosis was established: Obliterating atherosclerosis of the vessels of the lower extremities. Occlusion of the common and superficial femoral arteries on the left, hemodynamically significant stenosis of the deep femoral artery on the left. Chronic ischemia of the left n / limb II B st. Coronary heart disease, atherosclerotic and post-infarction cardiosclerosis (acute myocardial infarction 2005). Hypertension II Art.

After preoperative preparation, on June 08, 2009, the patient underwent surgery: closed loop endarterectomy from the external iliac artery, deep and superficial femoral arteries on the left, autovenous plastic of the common and superficial femoral arteries, popliteal artery. After restoration of blood flow in the arteries of the lower extremities, direct angiography was performed. The result was obtained: stenosis of the external iliac artery in the flotation zone of dangling intima and stenosis of the superficial femoral artery in the Hunter canal, in the flotation zone of the remaining sections of intima. According to the results of angiography, balloon angioplasty and external iliac arthroplasty were performed immediately (1 stent graft Fluensy plus), left femoral artery arthroplasty: 2 Fluensy plus stent grafts at the entrance and exit of the artery from the Gunther canal to prevent cicatricial deformity of the deobliterated vessel, 1 stent graft Fluensy plus in the middle third of the Gunther canal - in the flotation zone of the remaining intima.

In the postoperative period without features, a significant improvement in the form of the cessation of pain in the left n / limb when walking, it is warm, sensitivity, movement in full. Blood circulation in the limbs is restored, the pulse on the posterior tibial artery is distinct. According to duplex angioscanning, all the main arteries of the operated limb are passable, the ankle-brachial index (LPI) is 1.0. Discharged on June 15, 2009 for outpatient treatment at the clinic at the place of residence in satisfactory condition.

The patient observation period is more than 2 years, a control study was conducted on 06/10/2011, the design is passable.

To date, the proposed method has operated on 26 patients. The observation period ranged from 1 to 3 years.

The proposed method of treatment in comparison with the known, including the prototype, has advantages.

1) The passability of structures is lengthened in 95% of operated more than 3 years, while when using the prototype method does not exceed the generally accepted 76%.

2) The risk of thrombosis and reocclusion of the artery is reduced due to the installation of stent grafts, which allows to isolate the injured artery wall from the bloodstream as much as possible.

3) Prevention of cicatricial deformity of the artery, which is not allowed by other known methods.

4) Reducing the time of limb ischemia (using direct angiography, not angioscopy).

The method was developed in the group of transplantation and vascular surgery of the Russian Science Center RHT and underwent clinical testing in 26 patients with a positive result.

Claims (1)

A method for the treatment of atherosclerosis obliterans of the lower extremities, including loop endarterectomy followed by endovascular stenting, characterized in that after loop endaterectomy in the limbs arterial blood flow is restored and intraoperative direct angiography is performed, endovascular stenting is performed by installing stent grafts at the entrance and exit of the G channel at the entrance and exit disobliteration, and in the presence of incomplete disobliteration with additional stent grafts in areas with preserved shayya intimacy.