RU2796189C1 - Combined method of treatment of patients with critical ischemia of the lower extremities - Google Patents

Abstract

FIELD: medicine; cardiovascular surgery.

SUBSTANCE: invention is intended for the combined treatment of critical ischemia of the lower extremities with occlusion of the arteries of the lower leg. After conservative treatment, a femoral foot bypass operation is performed with a reversed autovein, while a distal anastomosis is applied and an arteriovenous anastomosis is formed with one of the lower leg arteries. Preliminarily, according to the results of arteriography and ultrasound dopplerography (USDG), the leg artery with the best outflow paths is determined — the posterior tibial artery (PTA) or the anterior tibial artery (APTA). The operation is supplemented with fasciotomy along the anterior and posterior surface of the lower leg. Intraoperatively, bone marrow sampling is performed by puncture of the anterior and posterior iliac spines. After treatment of the bone marrow, a preparation of progenitor cells of the bone marrow is obtained, which is injected twice — on the third and thirtieth days after the operation, while the drug is administered paravasally, fractionally, 1 ml into the leg muscles in the projection of PBBA and ZBBA, after five injections along the course of each of the arteries, at a distance of 4–5 cm from each other, 3 cm deep at an angle of 90° to the skin.

EFFECT: method makes it possible to increase the efficiency of reconstructive surgery to restore arterial blood flow in patients with critical ischemia of the lower extremities by stimulating angiogenesis while the shunt is in operation.

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Description

The invention relates to medicine, namely to cardiovascular surgery, and is intended for the combined treatment of critical ischemia of the lower extremities with occlusion of the arteries of the leg.

A known method of conservative treatment of chronic ischemia of the lower extremities (National recommendations for the management of patients with pathology of the arteries of the lower extremities // Angiology and vascular surgery. - 2013. - T. 19, No. 2 - S.1-67).

The disadvantage of this method is its low efficiency, which leads to further progression of the disease and limb amputation.

There is a method of open (standard) vascular reconstruction and endovascular intervention - operations aimed at restoring the main arterial blood flow in the affected limb (Vascular surgery. National guide. Moscow, GEOTAR-Media Publishing Group, 2014, pp. 139-140).

The disadvantage of this method is that surgical treatment does not stop the progression of the disease and over the next 5 years, obliteration of the arterial bed and thrombosis of the reconstruction zone occur again, which is accompanied by a high risk of gangrene and amputation (I.I. Zatevakhin, V.N. Shipovsky, V. N. Zolkin et al.// Angiology and vascular surgery.- 2011. - V. 17, No. 3. - P. 59-62), and in case of occlusion of the arteries of the lower leg, a standard (femoral-popliteal, femoral-tibial bypass) ) open vascular reconstruction is impossible.

A known method of using autologous hematopoietic stem cells in inoperable patients with chronic critical ischemia of the lower extremities ("Journal of Surgery" - 2021. - T.180, No. 5. - S.85-90).

The disadvantages of this method include a high risk of complications of critical ischemia in the first month, such as necrosis and gangrene of the limb, due to prolonged angiogenesis after the procedure without reconstruction of distal forms (femoral bypass grafting). Also, the disadvantages include the invasiveness of the method of obtaining hematopoietic stem cells, the time of manufacture of cells and its cost.

A known method of endovascular treatment of atherosclerotic lesions of the arteries of the lower extremities, which consists in installing a stent in the superficial femoral artery and balloon angioplasty of the tibial arteries (National recommendations for the management of patients with vascular arterial pathology. Part 1. Peripheral arteries. Moscow: publishing house of the A.N. Bakuleva, RAMS, 2010. - 109 p.).

The disadvantage of this method is that this method is inapplicable in the widespread atherosclerotic process, especially in arteries with severe calcification ("Clinical Angiology" edited by Academician of the Russian Academy of Medical Sciences A.V. Pokrovsky, Moscow, 2004, volume 2, p. 277).

A known method for the treatment of critical ischemia of the lower extremities, which destroy the valvular apparatus of the trunk of the small saphenous vein (SSV). Impose an anastomosis between the popliteal artery (PCA) and MPV vein in situ. Perforating veins flowing into the SSV do not require the destruction of the valvular apparatus and carry arterialized blood from the vein to the muscle tissue (Patent RU No. 2201145, A61B17/00, 27.03.2003). According to the same principle, methods of arterialization of the foot and lower leg with the help of the GSV and deep veins of the foot were constructed (“Clinical Angiology” edited by Academician of the Russian Academy of Medical Sciences A.V. Pokrovsky Moscow 2004. Volume 2 pp. 223-224).

The disadvantages of these methods are the inability to include all potentially passable tibial arteries into the bloodstream, and there is also no possibility to subsequently perform angioplasty on the tibial arteries anastomosed with a shunt.

A known method for the treatment of chronic arterial ischemia of the distal lower extremities while maintaining the patency of the vessels distal to the occlusion by revascularization of the greater omentum, moved and fixed on the ischemic limb. In this case, the vessels of the omentum are an autoshunt, which allows you to combine the effects of direct and indirect revascularization (AC N1353434, A61B17 / 56, 11/23/1987).

The disadvantages of this method are its invasiveness, insufficient diameter of the vessels of the omentum for adequate femoral-tibial bypass blood flow and the inability to place the omentum on the distal parts of the lower extremities, even with its maximum lengthening.

An analysis of existing sources of information has shown that none of them can be a prototype for the claimed invention.

The problem to which this invention is directed is to increase the effectiveness of the treatment of patients with critical ischemia of the lower extremities.

The technical result of the invention is to increase the efficiency of reconstructive surgery to restore arterial blood flow in patients with critical ischemia of the lower extremities by stimulating angiogenesis with a working shunt.

The specified technical result is achieved by the fact that after conservative treatment, a femoral foot bypass operation is performed with a reversed autovein, while a distal anastomosis is applied and an arteriovenous anastomosis is formed with one of the arteries of the leg. Preliminarily, according to the results of arteriography and ultrasound dopplerography (USDG), the leg artery with the best outflow paths is determined - the posterior tibial artery (PTA) or the anterior tibial artery (APTA). The operation is supplemented with fasciotomy along the anterior and posterior surface of the lower leg. Intraoperatively, bone marrow sampling is performed by puncture of the anterior and posterior iliac spines. After treatment of the bone marrow, a preparation of bone marrow progenitor cells is obtained, which is injected twice - on the third and thirtieth days after the operation, while the drug is administered paravasally, fractionally, 1 ml into the calf muscles in the projection of PBBA and ZBBA, after five injections along the course of each of the arteries, at a distance of 4-5 cm from each other, 3 cm deep at an angle of 90 ° to the skin.

The novelty of this method lies in the fact that it allows you to stimulate angiogenesis on a working shunt in case of occlusion of the arteries of the leg and avoid acute arterial insufficiency in the case of shunt occlusion in the future.

Comparison of the proposed method of combined treatment of patients with critical lower limb ischemia with existing ones showed its compliance with the criteria of the invention.

In practice, a combined method for the treatment of patients with critical ischemia of the lower extremities with occlusion of the arteries of the lower leg is carried out as follows. Standard conservative treatment of patients with critical ischemia of the lower extremities is carried out in accordance with the classification of A.V. Pokrovsky (“National guidelines for the management of patients with pathology of the arteries of the lower extremities” / / Angiology and vascular surgery. - 2013. - V. 19, No. 2 (Appendix. - P. 1-67). Next, the operation of femoral foot shunting is performed with a reversed autogenous vein or a combined conduit - a reversed autovein in combination with a reinforced conical synthetic prosthesis. A distal anastomosis is applied and an arteriovenous anastomosis is formed with one of the shin arteries, and preliminary, according to the results of arteriography and ultrasound, the shin artery with the best outflow tracts - ZBBA or PBBA is determined. Next, fasciotomy is performed along the anterior and posterior surfaces of the lower leg. Intraoperatively, bone marrow sampling is performed by puncture of the anterior and posterior iliac spines. After treatment of the bone marrow, a preparation of bone marrow progenitor cells is obtained, which is injected twice - on the third and thirtieth days after the operation, while the drug is administered paravasally, fractionally, 1 ml into the calf muscles in the projection of PBBA and ZBBA, after five injections along the course of each of the arteries, at a distance of 4-5 cm from each other, 3 cm deep at an angle of 90 ° to the skin.

This method will be widely used in angiosurgical departments of medical institutions.

The method proposed by the authors is illustrated by clinical examples.

Clinical example 1

Patient R., 61 years old, was admitted to the Department of Cardiovascular Surgery of the Regional Clinical Hospital named after A.I. V.D. Seredavina on May 15, 2022 with a diagnosis of Multifocal atherosclerosis. Obliterating atherosclerosis of the arteries of the lower extremities, peripheral type. Occlusion of the superficial femoral, tibial arteries of the left lower limb. Critical ischemia of the left lower limb. Stenosing atherosclerosis of the MA without hemodynamically significant stenosis. KhSMN 1 tbsp.

Upon receipt of a complaint of pain at rest in the left lower limb and when walking at a distance of 10 meters, coldness and numbness of the left lower limb. According to the anamnesis: smokes more than 40 years; had not previously been seen by a vascular surgeon. Ill for a long time; pain of the type of intermittent claudication during the last 4 years. He was not treated independently, he noted a gradual decrease in the distance of pain-free walking. Pain at rest for the last 3 weeks. Objective examination: the general condition is satisfactory. From the side of the internal organs, no pathology was detected. In the local status: the lower limbs are cool to the touch, hypotrophic; hairline is depleted. Arterial pulsation on the left lower limb only on the common femoral artery (BOTH), distally - not determined. Crimson-cyanotic coloration of the fingers of the left foot. There were no necrotic defects in the left lower limb. According to the USG data of the left lower limb: blood flow in BOTH - main; superficial femoral artery (SFA) - occluded from the mouth; deep femoral artery (GBA) - passable, main blood flow; PCA - stenosis of about 40%, collateral blood flow; PBBA is occluded throughout; ZBBA is visualized in the lower third of the leg, the blood flow is retrograde. The CT angiography data confirm the ultrasound data.

Conducted standard conservative therapy: pentoxifylline 10.0 1 time per day in-in drops; sulodexide 600 IU once a day i.m.; vazaprostan 60 mcg once a day i.v. cap. - no effect, resting ischemia persisted. After preoperative preparation, the patient on May 19, 2022. A general femoral-posterior-tibial autovenous shunting with an autovein was performed with the formation of an arteriovenous anastomosis on the left lower limb at the level of the STBA. The course of the operation: the position of the patient lying on his back with the left lower limb abducted to the side. Anesthesia - spinal. Treatment of the surgical field with 10% solution of iodonate and 70% solution of ethyl alcohol twice. Palpation determined the localization of the medial condyle of the left tibia in the distal part. Performed a typical approach to the STBA in the ankle. PTA, posterior tibial vein (PTIV) were isolated. During the revision, the STBA is soft to the touch, passable. Accessed BOTH in a typical location. During revision, BOTH, HBA are passable, RAA is occluded from the orifice. Systemic heparinization 5000 units per page. The trunk of the great saphenous vein (GSV) was isolated through separate incisions. Autovein dilatation was performed. The autovein has been reversed. A longitudinal arteriotomy of the STBA was performed, and a moderate retrograde blood flow was obtained. Longitudinal venotomy of the PBAV was performed in the area of the arteriotomy of the PBA. A single anastomosis was made between the ZBBA and ZBBV in a side-to-side manner. Imposed proximal anastomosis between the autologous with BOTH type "end to side". The autovein was conducted subfascially to the STBA. A distal anastomosis of the autovein with an arteriovenous anastomosis was imposed according to the "end to side" type. Removing clamps. On palpation, there is a good pulse on BOTH, shunt, ZBBA. On palpation, a clear systolic trembling is determined in the area of the distal anastomosis. The seams are sealed. Fasciotomy on the anterior and posterior surface of the leg. Hemostasis. Layered wound closure. Bone marrow sampling by puncture of the anterior and posterior iliac spines. After treatment of the bone marrow, a preparation of bone marrow progenitor cells was obtained. Activation of the patient, physiotherapy treatment. Daily dressings. The patient was transferred to the Department of Cardiovascular Surgery in a satisfactory condition. In the postoperative period, conservative treatment was carried out (anticoagulant therapy for 5 days with further transfer to double antiplatelet therapy; infusion therapy; anesthesia; antibiotic prophylaxis). The preparation of bone marrow progenitor cells was injected twice - on the third and thirtieth days (in a day hospital) after the operation, while the drug was administered paravasally, fractionally, 1 ml into the leg muscles in the projection of the PBBA and ZBBA, after five injections along the course each of the arteries, at a distance of 4-5 cm from each other, 3 cm deep at an angle of 90 ° to the skin.

The patient was discharged in a satisfactory condition on the 23rd day after the operation. The patient was examined after 4 months. The patient noted the relief of pain; painless walking distance increased to 200 m. Objectively: the feet are cool to the touch, symmetrical; pulsation is determined on BOTH, shunt, ZBBA. The appearance of hairline on the lower leg on the left. Performed instrumental research methods: Dopplerography: ankle-brachial index - 0.8 on the left. Arterial blood flow in a patient with critical lower limb ischemia was restored by stimulating angiogenesis with a working shunt.

Clinical example 2

Patient M., 64 years old, was admitted to the Department of Cardiovascular Surgery of the Regional Clinical Hospital named after I. V.D. Seredavina on August 21, 2022 with a diagnosis of widespread obliterating atherosclerosis of the arteries of the lower extremities with a multi-story lesion of the arteries of the left lower extremity. Occlusion of the superficial femoral, tibial arteries of the left lower limb. KHAN 2b Art. left lower limb. Stenosing atherosclerosis of the MA without hemodynamically significant stenosis. KhSMN 2 tbsp.

Upon receipt of a complaint of pain at rest in the left lower limb and when walking at a distance of 40 meters, coldness and numbness of the left lower limb. According to the anamnesis: smokes more than 35 years; previously observed by a general practitioner and surgeon at the place of residence; took courses of outpatient and inpatient treatment (antiplatelet agents, statins, pentoxifylline, cilostazol) - without a positive effect. During the last months, a decrease in the distance of pain-free walking. During a previous hospitalization, a lower extremity angiography was performed for diagnostic purposes (see results). On objective examination: the general condition is relatively satisfactory. The skin is dry and clean. Breathing in the lungs is vesicular, no wheezing. Heart sounds are clear, rhythmic. In the local status: the lower limbs are cool to the touch, hypotrophic; hairline is depleted; signs of onychogryphosis on the feet. Arterial pulsation on the left lower limb only on BOTH, distally - not detected; on the right lower limb on BOTH, RCA (weakened). There were no necrotic defects in the left and right lower extremities. According to the angiography of the left lower limb: BOTH passable; superficial femoral artery (SFA) - occluded from the mouth; deep femoral artery (GBA) - passable; PCA - stenosis of about 30%, passable; ZBBA is occluded throughout; PBA is visualized in the lower third of the leg, the blood flow is retrograde.

Conducted standard conservative therapy - no effect, rest ischemia persisted. 5 days after hospitalization, after preoperative preparation, an operation was performed: general femoral-anterotibial autovenous shunting with an autovein with the formation of an arteriovenous anastomosis on the left lower extremity at the level of PBBA. The course of the operation: the position of the patient lying on his back with the left lower limb abducted to the side. Anesthesia - total intravenous anesthesia. Treatment of the surgical field with 10% solution of iodonate and 70% solution of "Kutasept" twice. A typical access to the PBBA was made in the ankle area. Selected ATBA, anterior tibial vein (ATI). During the revision, the PBBA is soft to the touch, passable. Accessed BOTH in a typical location. During revision, BOTH, HBA are passable, RAA is occluded from the orifice. Systemic heparinization 5000 units per page. The trunk of the GSV was isolated through separate incisions. Autovein dilatation was performed. The autovein has been reversed. A longitudinal arteriotomy of the STBA was performed, and a moderate retrograde blood flow was obtained. A longitudinal venotomy of the PBBV was performed in the area of the arteriotomy of the PBBA. A single anastomosis was made between PBBA and PBBV in a side-to-side manner. Imposed proximal anastomosis between the autologous with BOTH type "end to side". The autovein was conducted subfascially to the PBBA. A distal anastomosis of the autovein with an arteriovenous anastomosis was imposed according to the "end to side" type. Removing clamps. On palpation, there is a good pulse on BOTH, shunt, PBBA. On palpation, a clear systolic trembling is determined in the area of the distal anastomosis. The seams are sealed. Fasciotomy on the anterior and posterior surface of the left leg. Hemostasis. Layered wound closure. aseptic bandages. Bone marrow sampling was performed by puncture of the anterior and posterior iliac spines. After treatment of the bone marrow, a preparation of bone marrow progenitor cells was obtained. Activation of the patient, physiotherapy treatment. Daily dressings. The patient was transferred to the Department of Cardiovascular Surgery in a satisfactory condition. In the postoperative period, conservative treatment was carried out (anticoagulant therapy for 5 days with further transfer to double antiplatelet therapy; infusion therapy; anesthesia; antibiotic prophylaxis). The preparation of bone marrow progenitor cells was injected twice - on the third and thirtieth days (in a day hospital) after the operation, while the drug was administered paravasally, fractionally, 1 ml into the leg muscles in the projection of the PBBA and ZBBA, after five injections along the course each of the arteries, at a distance of 4-5 cm from each other, 3 cm deep at an angle of 90 ° to the skin.

The patient was discharged in a satisfactory condition 18 days after the operation. The patient was examined after 3 months. The patient noted an improvement in his condition: the distance of pain-free walking increased to 200 m. Objectively: the feet are cool to the touch, symmetrical; pulsation is determined on BOTH, shunt, PBBA on the left lower limb. Arterial blood flow in a patient with ischemia of the lower extremities was restored by stimulating angiogenesis with a working shunt.

Claims (1)

A combined method for the treatment of patients with critical ischemia of the lower extremities, which consists in the fact that after conservative treatment, a femoral foot bypass operation is performed with a reversed autovein, while applying a distal anastomosis and forming an arteriovenous anastomosis with one of the arteries of the lower leg, and preliminary, according to the results of arteriography and ultrasonic dopplerography, determine the artery of the lower leg with the best ways of outflow - the posterior tibial artery or the anterior tibial artery; additionally, fasciotomy is performed along the anterior and posterior surfaces of the lower leg; intraoperatively, bone marrow is taken by puncture of the anterior and posterior iliac spines, after its processing, a preparation of bone marrow progenitor cells is obtained, which is administered twice as injections - on the third and thirtieth days after the operation, while the drug is administered paravasally, fractionally, 1 ml into the muscles of the leg in the projection of the anterior tibial artery and the posterior tibial artery, through five injections along the course of each of the arteries, at a distance of 4-5 cm from each other, 3 cm deep at an angle of 90 ° to the skin.