RU2799257C1 - Method of the treatment of acute arterial thrombosis of the popliteal-ankle segment associated with covid-19 - Google Patents

Abstract

FIELD: medicine; vascular surgery.

SUBSTANCE: antegrade puncture of the common femoral artery is performed on the affected limb, a catheter is inserted into it with its intravascular end placed at the proximal border of the thrombotic masses. The outer end of the catheter is connected to the pump. A retrograde puncture of one of the following arteries is performed on the affected limb below the distal border of thrombotic masses: posterior tibial artery, anterior tibial artery, and dorsal foot artery. An introducer is installed in it and at the same time thromboaspiration is performed through the catheter and washing of the arterial bed from thrombotic masses in the retrograde direction by introducing fluid under pressure through the introducer. The catheter can be inserted through a guidewire passed through an 8 Fr sheath placed in the common femoral artery, thromboaspiration can be performed using a suction pump power of 60 L/min, an arterial lavage sheath can be connected to a 150 ml syringe, and saline solution with heparin can be used to wash the vascular bed. Washing of the arterial bed can be performed by injecting fluid at a rate of 5 ml/s for 10 s. Additionally, the arterial bed can be flushed by injecting fluid at a rate of 10 ml/s for 10 s.

EFFECT: method allows to preserve tissue viability, excluding damage to the proximal vascular bed by combined intravascular hydrodynamic effect on thrombotic masses inside the arterial bed.

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Description

The invention relates to medicine, namely to vascular surgery, endovascular treatment of patients with acute arterial thrombosis, and can be used in the treatment of acute arterial thrombosis of the popliteal-ankle segment associated with COVID-19 in a hospital.

According to the registries of several countries, the incidence of acute lower limb ischemia in the non-COVID time is 3–14 cases per 100,000 patient-years, and the increase in incidence correlates with the age of patients, and in recent years, as a result of the COVID-19 pandemic, the problem of arterial limb thrombosis has become acquire pandemic proportions [GripO., WanhainenA., MichaelssonK., et al. Open or endovascular revascularization in the treatment of acute lower limb ischemia. 2018;105:1598-606].

All existing methods of lower extremity revascularization can be divided into three groups: open, endovascular and hybrid.

The most widely used methods are open surgery, although recently endovascular interventions have become more common. So over the past decade, the number of such procedures has almost doubled from 15.0% to 33.1%.

Endovascular techniques include catheter, pharmacomechanical and ultrasonic thrombolysis, thromboaspiration. A feature of endovascular treatment methods is a relatively fast and less traumatic restoration of blood flow in the affected limb, which is especially important for patients who have acute limb ischemia due to a new coronavirus infection (COVID-19).

Endovascular interventions demonstrate high efficiency (class IIa clinical guidelines of the European Society of Vascular Surgeons for the treatment of acute limb ischemia), and the results obtained using these techniques are comparable to those observed when using open surgery methods. At the same time, endovascular methods can be more often used in acute thrombosis of the arteries of the ankle segment.

Among endovascular techniques, catheter selective thrombolysis plays an important role [Venermo M., Sprynger M., Desormais I., et al. Follow-up of patients after revascularization for peripheral arterial diseases. A consensus document from the European Society of Cardiology (ESC) working group on Aorta & Peripheral Vascular Diseases and the European Society of Vascular Surgery (ESVS). Eur. J. Vasc. Endovasc. Surg. 2019;58:641-53]. However, the use of thrombolysis is limited by a number of contraindications, which limits its widespread use.

Another endovascular treatment for acute lower limb ischemia is mechanical thrombectomy. There are a number of thrombectomy devices on the market today, classified according to their mechanism of action.

The AngioJet® rheolytic thrombectomy device (AngioJet Peripheral Thrombectomy System; Boston Scientific, MA, USA) achieves good results quickly, but its main limitation is its inability to use the catheter in small arteries.

An example of another system for mechanical rotational thrombectomy is the Rotarex® system (Straub Medical AG, Vilters-Wangs, Switzerland). Its use is also associated with a high technical success rate, even in the case of well-organized thrombi, but the Rotarex® system also cannot be used in arteries of small diameter, i.e., as a rule, below the level of the knee joint.

One of the methods for the treatment of acute ischemia of the lower extremities from the level of the knee joint and below is catheter thromboaspiration [JongkindV, EarnshawJJ, BastosGF, CochennecF, DebusES, HinchliffeR. etal. Update of the European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischaemia in light of the COVID-19 pandemic, based on a scoping review of the literature. EurJVascEndovascSurg. 2022;63:80–89].

Unfortunately, the discrepancy between the diameters of the catheter and the artery is the main reason for the incomplete removal of thrombotic masses, which is especially often observed with thromboaspiration from the superficial femoral artery.

In addition, suction techniques are most effective in acute thrombosis (<14 days), large diameter catheters, and ankle aspiration.

Thromboaspiration is less effective with a large thrombotic load, i.e. with a large volume of thrombotic masses, which is especially often observed in the conditions of COVID-19 [JongkindV, EarnshawJJ, BastosGF, CochennecF, DebusES, HinchliffeR. etal. Update of the European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischaemia in light of the COVID-19 pandemic, based on a scoping review of the literature. EurJVascEndovascSurg. 2022;63:80–89].

In addition, there is a hybrid approach that combines the principles of open surgery and endovascular techniques.

There is also known a method for the treatment of acute arterial thrombosis - a thrombectomy method based on distal vascular lavage [Saveliev V.S., Zatevakhin I.I., Stepanov N.V. Acute obstruction of the bifurcation of the aorta and the main arteries of the extremities. M.: Medicine, 1987; 301]. The principle of the latter is to wash the thrombosed fragment of the artery retrogradely through the distal access, when the thrombotic masses are washed out through the proximal arteriotomy opening.

This technique was used by Zatevakhin I.I. et al. with the ineffectiveness of open thrombectomy using Fogarty-type catheters. In this case, the artery was dissected distally in a typical location (for example, in case of thrombosis of the popliteal artery and/or posterior tibial artery in the region of the medial malleolus), its lumen was opened, and isotonic sodium chloride solution was injected through a syringe under pressure. At the same time, under the pressure of the fluid injected by the operator, the thrombotic masses were washed out.

However, often in order to evacuate thrombotic masses from the lumen of the femoral artery or arteries of the leg, it was necessary to develop a sufficiently large pressure, which led to damage to the proximal vascular bed, in particular small arteries and capillaries. Thus, damage to the microvasculature was aggravated and, as a result, impaired tissue perfusion, which negatively affected the results of surgical treatment.

As a prototype, we have chosen a method for the treatment of acute arterial thrombosis associated with COVID-19, involving the definition of indications for performing transarterial catheter-guided thrombolysis with the introduction of alteplase into the thrombus (RU 2773295C1, 06/01/2022).

However, the most significant drawback of this technique is the time period required for the dissolution of the thrombus and, consequently, the resumption of blood flow. Often, the time required for recanalization of the thrombosed section of the artery exceeds the "reserve" of the viability of the soft tissues of the affected limb.

Therefore, it remains relevant to search for other approaches to revascularization in acute ischemia of the popliteal-ankle segment associated with COVID-19.

We set the task of developing an affordable method for effective treatment of acute arterial thrombosis of the popliteal-ankle segment associated with COVID-19, which could be used in case of ineffectiveness of solo catheter thromboaspiration in acute arterial thrombosis from the level of the popliteal artery and distally, moreover, as during a pandemic COVID-19, and outside of covid times.

The technical result achieved in the implementation of the invention is

- increasing the effectiveness of the treatment of acute arterial thrombosis of the popliteal-ankle segment associated with COVID-19, maintaining the viability of the tissues of the mentioned segment by radical rapid sanitation of the arterial bed by potentiating a dosed manual intravascular hydrodynamic effect on thrombotic masses inside the arterial bed - simultaneous increase and decrease in pressure in arteries through retrograde and antegrade approaches, respectively,

- low invasiveness of the intervention by eliminating damage to the proximal vascular bed, in particular, arteries of the second and subsequent orders (arteries of small diameter) and the capillary network due to the use of the original gentle manual mode of washing the vascular bed against the background of simultaneous mechanical thromboaspiration.

The patented method of retrograde-assisted catheter thromboaspiration from the arteries of the leg in acute arterial obstruction achieves a high success rate due to the combination of thromboaspiration achieved as a result of the negative pressure created by the vacuum pump and the hydrodynamic pressure of the fluid injected retrogradely through the distal arterial access. As a result, unidirectional forces of influence are potentiated, as a result of which the effect of the therapeutic effect is increased.

The essence of the invention is as follows.

For the treatment of acute arterial thrombosis of the popliteal-ankle segment associated with COVID-19, an antegrade puncture of the common femoral artery is performed on the affected limb, a catheter is inserted into it, placing the intravascular end of the catheter at the proximal border of the thrombotic masses. Connect the outer end of the catheter to the pump. A retrograde puncture of one of the following arteries is performed on the affected limb below the distal border of thrombotic masses: posterior tibial artery, anterior tibial artery, dorsal foot artery. An introducer is installed in it and at the same time thromboaspiration is carried out through the catheter and washing of the arterial bed from thrombotic masses in the retrograde direction by introducing fluid under pressure through the introducer.

The catheter can be inserted through a guide wire passed through an 8 Fr sheath placed in the common femoral artery.

Thromboaspiration can be performed using a suction pump flow rate (power) of 60 l/min.

An arterial lavage sheath can be connected to a 150 ml syringe, and saline with heparin can be used to lavage the vascular bed.

Washing of the arterial bed can be carried out by injecting fluid at a rate of 5 ml/sec for 10 sec.

Additionally, the arterial bed can be flushed by injecting fluid at a rate of 10 ml/s for 10 s.

The invention is illustrated by the following figures.

In FIG. 1 shows a diagram showing the principle of the proposed technique for retrograde-assisted catheter thromboaspiration; thrombotic masses are aspirated in the proximal direction against the background of saline injection through the retrograde approach.

In FIG. 2 shows an angiogram of the left lower limb at the level of the knee joint; thrombotic masses occlude the arteries of the lower leg almost from the very mouth.

In FIG. 3 shows retrograde saline injection through a bougie placed in the distal posterior tibial artery.

In FIG. 4 shows the control angiogram: the lumen of the posterior tibial artery became free from thrombotic masses.

The method is carried out as follows.

Our proposed method (figure 1) can be used in patients with acute arterial thrombosis (less than 14 days) at the level of the popliteal artery and distally, when unsatisfactory results were obtained after solo catheter thromboaspiration.

In our proposed technique, two puncture accesses are used: one is antegrade: under X-ray control, the ispilateral common femoral artery (the common femoral artery of the affected limb) is punctured in a typical location.

According to the generally accepted Seldinger technique, an introducer (caliber 8 Fr) was installed, which was washed with 20 ml of saline containing 5000 IU of heparin. A radiopaque substance was introduced through the introducer. The level of thrombosis was determined, and an aspiration catheter was brought close to the thrombotic masses along the conductor, the diameter of which corresponded to the diameter of the artery directly above the occluded area.

The catheter was connected to a Penymbra or Medela vacuum pump using an adapter and a transparent connecting tube. The latter was turned on at the maximum level of aspiration (60 l/min) and the process of thromboaspiration was controlled under visual control of a transparent connecting line.

If solo mechanical thromboaspiration was ineffective (absence of thrombotic masses in the aspiration system within 5 minutes after repeated changes in the position of the aspiration catheter and the absence of distal blood flow on control angiography), a second, distal access was created.

The posterior or anterior tibial artery, or the artery of the dorsum of the foot, is punctured at a typical location (for example, between the Achilles tendon and medial malleolus in the case of a puncture of the posterior tibial artery, or between the tendons of the extensor hallucis longus and extensor toe longus in the case of a puncture of the anterior tibial artery or artery dorsum of the foot).

According to the Seldinger method, the said artery was punctured and a small-caliber introducer or bougie (5 Fr) was installed to a depth of 5-7 cm (which is necessary for safe and confident distal washing of the artery), to which a large-volume syringe (150 ml) with saline was attached, in which was previously added heparin (in the ratio of 2500 IU of heparin to 200 ml of saline).

The resulting solution was manually injected with a syringe at a rate of 5 ml/sec for 10 seconds against the background of simultaneous thromboaspiration through an antegradely placed aspiration catheter.

If, after the first session, thrombotic masses were visualized in the aspiration system and a satisfactory blood flow with restoration of the lumen of the vascular bed was noted on the control angiographic study, the result of the procedure was regarded as positive.

If, after the first session of evacuation of thrombotic masses, the patency of the arterial bed was not restored, then the remaining amount of heparinized saline was injected retrogradely through the distal access using a syringe of the same volume at a higher rate of 10 ml/sec for 10 seconds.

If thrombotic masses were visualized in the aspiration system and satisfactory blood flow with restoration of the lumen of the vascular bed was noted at the control angiographic study, the result of the procedure was regarded as positive.

In the absence of residual hemodynamically significant narrowing of the arterial bed, the procedure ended with the achievement of hemostasis (finger or balloon - for distal access and manual or using suturing devices - for antegrade access).

The use of this technique, in our opinion, is most justified in case of acute (in the first 14 days) thrombosis of arteries, the diameter of which exceeds the diameter of the suction catheter by no more than 2 times (for example, with an internal artery diameter of 4 mm, the lumen of the aspiration catheter should not be less than 2 mm).

Given that the internal diameter of the suction catheter is 8 Fr (2.6 mm), the most suitable arteries in diameter would be the distal popliteal artery, the tibioperoneal trunk, the tibial arteries, and the proximal sections of the arteries of the foot.

Clinical example.

Patient I., 74 years old, was admitted on an emergency basis with a diagnosis of Coronavirus infection caused by the COVID-19 virus (virus identified by laboratory testing)

Complications. Community-acquired viral bilateral pneumonia of moderate course. Thrombosis of the arteries of the lower leg on the left lower limb. Acute ischemia of the left lower limb, 2nd degree.

Complaints: acute pain in the left lower limb, general weakness, dry cough.

Upon admission, the patient's condition was regarded as moderate, the value on the scale of assessing the severity of the condition NEWS2 (National Early WarningScore) was equal to 3. The body temperature was 37.6°C. The respiratory rate is 21 per minute. Saturation (SPO ₂ ) - 90%. Blood pressure was within normal limits - 120 and 70 mm Hg, but the heart rate was increased (94 beats per minute). diuresis was preserved.

Local status: the left foot and lower leg were cold to the touch, pale in color, not edematous. Sensitivity in the foot and lower leg was reduced. Active movements in the knee and ankle joints were limited. Pulsation on the common femoral artery is distinct, on the popliteal artery and arteries of the lower leg and foot was not determined.

Duplex examination of the arteries of the lower extremities revealed thrombotic masses located in the deep femoral artery and arteries of the lower leg.

Of the laboratory parameters at admission, significantly increased levels of D-dimer (4372 ng / ml at a rate of 0-500 ng / ml), C-reactive protein (25.9 mg / l at a rate of 0-5 mg / l) attracted attention , interleukin-6 (44 pg / ml at a rate of 0-7 pg / ml), serum ferritin (1307 mg / mol at a rate of 30-400 mg / mol), an increased number of platelets (650x10 ⁹ / l at a rate of 150-450x10 ⁹ /l). In addition, on admission, the levels of urea (14.9 mmol/l at the norm: 2.6-7.2 mmol/l) and creatinine (133.0 μmol/l at the norm of 80-115 μmol/l) were increased,

Based on complaints of impaired sensitivity and increasing pain in the left lower limb, anamnesis of the disease and data from laboratory and instrumental methods of research, the diagnosis was made: "Atherosclerosis of the arteries of the extremities. Thrombosis of the arteries of the left lower limb. Acute ischemia of the left lower limb of degree 2A". After a collegial discussion with the participation of vascular and endovascular surgeons, a decision was made on the possibility of catheter thromboaspiration in this patient.

The patient was operated in accordance with the proposed method. At the same time, an 8 Fr introducer inserted into the common femoral artery was used to insert the catheter through the guidewire; for thromboaspiration, the power of the suction pump was 60 l/min; lavage of the arterial bed was performed first by injecting fluid at a rate of 5 ml/sec for 10 sec, and then by injecting fluid at a rate of 10 ml/sec for 10 sec.

Approximately 15 hours after the appearance of the first signs of thrombosis of the arteries of the left lower limb, the patient was taken to the operating room, where, under local anesthesia and fluoroscopic control, an antegrade puncture of the left common femoral artery was performed. Installed introducer. Angiography revealed defects in contrasting the middle third of the deep femoral artery, as well as the initial sections of the tibial arteries.

A Vista BriteTip 8 Fr guide catheter was inserted through the guidewire. Thromboaspiration was performed through it from the proximal third of the posterior tibial artery. Control angiography revealed thrombotic masses in the middle and distal thirds of the posterior tibial artery that completely occluded the lumen of the artery (Fig. 2). Attempts to bring the guide catheter to the zone of thrombotic occlusion in the middle third of the artery were unsuccessful. It was decided to puncture the posterior tibial artery in its distal part and retrogradely flush the artery against the background of simultaneous thromboaspiration. Using an antegrade marker guide wire (Samurai, Boston Scientific, MA, USA), the distal third of the posterior tibial artery was punctured and a 5 Fr introducer bougie was placed (Fig. 3).

Saline was injected with a 150 ml syringe in a retrograde direction through a distally placed bougie against the background of aspiration through a guide catheter placed in the proximal third of the posterior tibial artery and connected to a Medela vacuum pump (Medela AG, Baar, Switzerland). During thromboaspiration, a significant amount of thrombotic masses was obtained.

During control angiography, the lumen of the posterior tibial artery became free from thrombotic masses (Fig. 4). The bougie was removed and manual retrograde hemostasis was performed.

All instruments were removed and manual hemostasis was performed. An aseptic pressure bandage was applied to the puncture site of the left common femoral artery. The total operation time was 90 minutes, the volume of non-ionic contrast agent used did not exceed 100 ml.

Palpation pulsation of the tibial arteries of the leg in the distal sections was determined, on the artery of the dorsal foot was absent.

The patient's pain syndrome regressed, the limb became warm and of normal color.

In the control Doppler study of the arteries of the left lower limb, performed at the end of the procedure, the main blood flow with good speed characteristics was located in the anterior and posterior tibial arteries. The blood flow in the artery of the dorsal foot was not determined.

According to the protocol adopted in the hospital, the patient was transferred to the intensive care unit for a heparin protocol, which is mandatory after thromboaspiration, as well as further observation and treatment. In addition to other standard and anti-covid therapy, it was recommended to take acetylsalicylic acid 125 mg/day for a long time and clopidogrel 75 mg/day for 6 months.

In the postoperative period, there were no signs of ischemia in the operated left lower limb, and the blood flow in it remained, which, in addition to the subjective clinical assessment, was confirmed by ultrasound data (the ABI values for the anterior and posterior tibial arteries of the operated lower limb were within the normal range, in the peroneal artery, the main blood flow absent).

The method of retrograde-assisted catheter thromboaspiration has demonstrated its effectiveness in resolving thrombotic occlusion of the arteries of the leg, while there was no recurrence, and the patency of the arteries was maintained.

Claims (6)

1. A method for treating acute arterial thrombosis of the popliteal-ankle segment associated with COVID-19, characterized in that an antegrade puncture of the common femoral artery is performed on the affected limb, a catheter is inserted into it, the intravascular end of the catheter is located at the proximal border of the thrombotic masses, and the outer end is connected catheter to the pump, then a retrograde puncture of one of the following arteries is performed on the affected limb below the distal border of the thrombotic masses: the posterior tibial artery, the anterior tibial artery, the artery of the dorsal foot, into which the introducer is installed and at the same time thromboaspiration is performed through the catheter and the arterial bed is washed from thrombotic masses in a retrograde direction by introducing fluid under pressure through an introducer. 2. The method according to claim 1, characterized in that the catheter is inserted through a conductor passed through an 8 Fr introducer inserted into the common femoral artery. 3. The method according to claim 1, characterized in that thromboaspiration is carried out at an aspiration pump flow rate of 60 l/min. 4. The method according to claim 1, characterized in that the sheath for washing the arterial bed is connected to a 150 ml syringe and a saline solution with heparin is used for washing. 5. The method according to claim 1, characterized in that the washing of the arterial bed is carried out for 10 with the introduction of fluid at a rate of 5 ml/s. 6. The method according to claim 5, characterized in that the arterial bed is additionally washed for 10 with the introduction of fluid at a rate of 10 ml/s.

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