Method for endovascular revascularization of chronic occlusions in tibial segment

Abstract

FIELD: endovascular surgery.SUBSTANCE: after treating the surgical field under local anesthesia, under X-ray and ultrasound control, a percutaneous puncture is performed using a puncture needle in the projection of the proximal part of the occlusion so that the cut of the puncture needle passes through the cap of the atherosclerotic plaque. The projection of the angiographic unit is changed to accurately position the needle inside the artery. Two milliliters of saline solution is injected through the puncture needle, creating a channel within the plaque that allows for successful recanalization through an introducer inserted into the common femoral artery. Then, recanalization of the occlusion of the crural artery is performed in the antegrade direction through a 6F introducer previously installed in the common femoral artery using a 0.014'' guidewire system - a 4F multifunctional catheter, previously brought to the site of the onset of occlusion with an exit into the true lumen of the artery. The puncture needle is removed. Manual hemostasis is performed. The 4F diagnostic catheter is removed, the guidewire remains in the lumen of the artery. A balloon catheter of the required diameter is inserted into the affected area through a guidewire and predilation is performed - the exposure time is at least 5 minutes, the pressure is at least 8 atmospheres. The balloon catheter is removed and repeat angiography is performed. Guidewire 0.014'' is removed from the vascular bed. A 70-cm pre-wired guidewire with a J-shaped and straight tip is inserted through a 6F introducer. The introducer is removed, the guidewire remains in the artery. A system is inserted through the guidewire to close the femoral artery puncture site. The puncture hole is sutured with a system to close the puncture site of the femoral artery. An aseptic dressing is applied.EFFECT: method allows to increase the effectiveness of surgical treatment for chronic occlusions in the tibial segment by reducing the trauma of operations, the time of intervention and decreasing the frequency of postoperative complications.1 cl, 2 ex

Description

[0001] The method relates to medicine, namely to endovascular surgery, and can be used in the recanalization of chronic occlusions of the arteries of the leg.

[0002] Surgical treatment of patients with obliterating atherosclerosis of the lower extremity arteries is actively used in clinical practice and includes open and endovascular surgical interventions. It is worth noting that the tibial segment is one of the most common locations of damage in patients with peripheral arterial disease, especially with chronic limb-threatening ischemia and diabetes mellitus [Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. Fowkes FG, Rudan D, Rudan I, et al., 2013]. Over the past decades, surgical tactics for lesions of the tibial arteries have evolved from the dominance of open bypass operations to the active implementation of endovascular technologies. However, despite the progress, none of the approaches is universal and devoid of significant limitations.Thus, a range of surgical approaches has now been developed for tibial segment revascularization, the main ones being open autovenous bypass and various endovascular techniques. Each of these methods, however, has its own advantages and disadvantages, which determines the indications for their use and necessitates further refinement.

[0003] Autovenous femorotibial bypass is known [Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vase Surg., 2019. Jul;58(1S):S1-S109.e33]. Limb revascularization using autovenous bypass surgery allows for the restoration of blood supply to the distal arteries of the leg and the lower limb as a whole.

[0004] Under endotracheal anesthesia, after preparing the surgical field, the following arteries are isolated in the upper third of the thigh / calf: the common and deep femoral arteries (depending on the proximal level of the lesion) in the upper third of the thigh; and the anterior tibial, posterior tibial, and peroneal arteries in the upper or lower third of the calf. All isolated arteries required for bypass are secured with slings. Simultaneously, the required length of the great or small saphenous vein is isolated through separate incisions. The vein is prepared for bypass grafting using hydropreparation and suturing of the defects. The calf artery is then prepared for distal anastomosis. After systemic intravenous heparin administration, the artery proximal and distal to the proposed anastomosis site is clamped using vascular clamps.An arteriotomy is performed on the target leg artery, and an end-to-side distal anastomosis is created between the artery and the reversed vein using a continuous, atraumatic, and embolic-prevention suture. The clamps are removed from the arteries, and a clamp is applied to the distal portion of the bypass graft. The vein is advanced subcutaneously or orthotopically to the site of the proximal anastomosis using a tunneler. Clamps are applied to the arteries, an arteriotomy is performed, and the proximal anastomosis is created using the aforementioned method. Blood flow is initiated by removing the clamps, with embolic prevention applied first. Once blood flow is initiated, pulsation is detected along the entire length of the autovenous bypass graft, as well as in the proximal and distal arteries. Hemostasis is achieved. The wounds are treated with an antiseptic solution. Layered wound suturing with drainage left in the anastomotic areas. The wounds are re-treated with an antiseptic solution.Aseptic adhesive tapes are applied to the areas of postoperative wounds.

[0005] The disadvantages of this method are:

[0006] 1. Inability to perform surgical intervention under local anesthesia;

[0007] 2. Increase in the duration of surgical intervention;

[0008] 3. Intraoperative risks associated with dissection of the arterial wall in the area of ​​anastomosis, as well as distal embolism of vascular wall fragments, intraoperatively formed thrombus;

[0009] 4. Thrombosis of the reconstruction zone with insufficient outflow, stenosis of the arteries of the leg distal to the bypass site, kinking or insufficient diameter of the bypass;

[0010] 5. Pronounced neoatherogenesis in the area of ​​anastomosis formation in the late postoperative period;

[0011] 6. Increasing the length of the patient's stay in hospital.

[0012] There is a method of combining non-directional rotational atherectomy and balloon angioplasty [Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009. Dec;16(6):653-62].

[0013] The method consists of: after preparing the surgical field under local anesthesia, the ipsilateral common femoral artery is punctured antegradely. A 6F (110 mm) introducer sheath is inserted over a 0.035" hydrophilic guidewire, and a diagnostic catheter is advanced to the occlusion site. Selective angiography is performed to assess the nature of the lesion and its distal course. The guidewire is replaced from 0.035" to 0.014". Then, with the help of a catheter, intraluminal recanalization of the affected artery is performed with the guidewire, exiting into the true lumen. Next, a catheter is advanced through the pre-installed guidewire to the occlusion site for atherectomy. Three passes are made through the occluded artery with the included catheter, during which the particles of atherosclerotic plaque, crushed by the catheter, are aspirated into a special collection bag, thereby reducing the risk of distal embolism.After the atherectomy, the catheter is removed from the vascular bed, and the reconstructed area is angioplastyed with a balloon catheter. A control angiogram is then performed. The instruments are removed from the vascular bed. The puncture site is sutured with a special suturing device. An aseptic seal is applied.

[0014] The disadvantages of this method are:

[0015] 1. High cost of the procedure;

[0016] 2. Risk of developing distal embolism during rotational atherectomy;

[0017] 3. Damage to the vessel wall during rotational atherectomy;

[0018] 4. High risk of bleeding from the puncture site of the common femoral artery.

[0019] The prototype of the proposed method is endovascular intervention: recanalization and balloon angioplasty of the occluded artery of the leg [Powell RJ, Farber A, Doros G, Chew D, Conte MS, Dake MD, Kiang S, Menard MT, Rosenfield K, Schneider PA, Siracuse JJ, Shaw P, Strong MB, Todoran T, White CJ, Kaufman JA. The Incidence and Consequences of Endovascular Technical Failure in Patients with Chronic Limb-Threatening Ischemia: Results from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) Trial. J Vase Interv Radiol. 2025 Jun;36(6):950-959], [Armstrong EJ, Bishu K, Waldo SW Endovascular Treatment of Infrapopliteal Peripheral Artery Disease. Curr Cardiol Rep. 2016. Apr;18(4):34].

[0020] After preparing the surgical field, under local anesthesia, the ipsilateral common femoral artery is punctured in the antegrade direction, a 6F (110 mm) introducer sheath is inserted over a 0.035" hydrophilic guidewire, and a diagnostic catheter is advanced to the occlusion site. Selective angiography is performed to assess the nature of the lesion and the distal artery. The guidewire is replaced from 0.035" to 0.014". Then, with the support of the catheter, the affected artery is recanalized with a guidewire, exiting into the true lumen. Next, a balloon catheter of a diameter compatible with the desired artery is advanced through a previously installed guidewire into the occlusion zone, and balloon angioplasty is performed. Control angiography is performed. The instruments are removed from the vascular bed. The puncture hole is sutured with a special suturing device. Aseptic sticker.

[0021] The disadvantages of this method are:

[0022] 1. Possibility of artery perforation during balloon angioplasty;

[0023] 2. High risk of arterial wall dissection in balloon angioplasty;

[0024] 3. High incidence of reocclusions in the late period;

[0025] 4. High recanalization failure rate.

[0026] The objective of the proposed invention is to create an effective method for endovascular revascularization of chronic occlusions in the tibial segment.

[0027] The technical result that ensures the solution of the set problem consists in improving the results of surgical treatment in patients with occlusions of the arteries of the lower leg: a reduction in the frequency of complications of surgical interventions, a decrease in the trauma and duration of surgical interventions; a decrease in the number of complications associated with access to the artery; a decrease in the number of recanalization failures.

[0028] The claimed technical result is achieved by performing, under ultrasound and X-ray control, a percutaneous puncture in the projection of the initial part of the occlusion using a puncture needle, the cut of which is passed through the plaque cover, then 2 milliliters of saline solution are injected directly into the plaque, the puncture needle is removed, manual hemostasis is performed, then recanalization of the occluded area is performed using a 0.014'' guidewire along a 4F multifunctional diagnostic catheter until it enters the true lumen of the artery, after which the 4F multifunctional diagnostic catheter is removed, while the guidewire is kept in the lumen of the artery, then a balloon catheter is inserted into the occluded area along the guidewire and balloon angioplasty is performed for 5 minutes and at a pressure of at least 8 atmospheres, then the balloon catheter and guidewire are removed, control angiography is performed,A 70-cm pre-wired guidewire with a J-shaped and straight tip is inserted through a 6F introducer, the introducer is removed while preserving the guidewire in the artery, a system for closing the femoral artery puncture site is inserted through the guidewire, the puncture hole is sutured with a system for closing the femoral artery puncture site.

[0029] The advantages of the claimed invention compared to the prototype are:

[0030] - Possibility of performing endovascular revascularization of an occluded artery after unsuccessful attempts at antegrade recanalization;

[0031] - Reducing the duration of the operation;

[0032] - Short rehabilitation periods for patients;

[0033] Reduced incidence of complications associated with the puncture site.

[0034] The method is as follows:

[0035] After preparing the surgical field, the first percutaneous puncture of the common femoral artery is performed in the antegrade direction under local anesthesia. A 6F / 110 mm introducer sheath is inserted over a 0.035" / 0.89 mm guidewire. Angiography is performed, and the proximal portion of the occlusion is visualized. A 0.0147 guidewire system and a 4F multifunctional catheter are inserted through the introducer sheath and advanced to the site of occlusion of the crural artery. After administering local anesthesia, under radiographic and ultrasound guidance, a second percutaneous puncture is performed using a puncture needle in the projection of the proximal portion of the occlusion (its beginning) so that the bevel of the puncture needle passes through the "cover" of the atherosclerotic plaque. The projection of the angiographic unit is changed to accurately position the needle within the artery.Two milliliters of saline solution are injected through the puncture needle, creating a channel within the plaque that allows for successful recanalization through an introducer installed in the common femoral artery. Then, recanalization of the crural artery occlusion is performed in the antegrade direction using a 0.014" guidewire-4F multifunctional catheter system, previously advanced to the site of occlusion and exiting into the true lumen of the artery. The puncture needle is removed. Manual hemostasis is performed. The 4F diagnostic catheter is removed, leaving the guidewire in the artery lumen. A balloon catheter of the required diameter is inserted into the affected area through the guidewire, and predilation is performed (exposure time of at least 5 minutes, pressure of at least 8 atmospheres). The balloon catheter is removed, and repeat angiography is performed. The 0.014" guidewire is removed from the vascular bed. A 70-cm pre-wired guidewire with a J-shaped and straight tip is inserted through a 6F introducer.The introducer sheath is removed, leaving the guidewire in the artery. A femoral artery puncture site closure system is inserted through the guidewire. The puncture site is sutured with a femoral artery puncture site closure system. An aseptic dressing is applied.

[0036] The proposed technical solution allows for endovascular revascularization of chronic occlusions of the arteries of the leg in the tibial segment without open surgery.

[0037] The proposed technical solution allows performing balloon angioplasty in case of chronic occlusions in the tibial segment without performing open surgery and in case of unsuccessful attempts at ante-retrograde recanalization.

[0038] The method is illustrated by the following clinical examples.

[0039] Example #1

[0040] Patient V., 72, with a clinical picture of chronic ischemia of the right lower limb, stage IV (according to the Fontaine-Pokrovsky classification). Long-term history of obliterating atherosclerosis of the arteries of the lower extremities, with a gradual decrease in pain-free walking distance to rest pain and trophic disorders of the 1st and 3rd toes of the right foot. The patient was urgently hospitalized in a surgical hospital. Multispiral computed tomography of the arteries of the lower extremities was performed, according to which occlusion of the right anterior tibial artery from the middle to the lower third of the leg, and a scattered posterior tibial artery. On examination, pulsation in the right common femoral and popliteal arteries is preserved, pulsation on the dorsum of the foot is not detected. Local status: trophic disorders of the 1st and 3rd toes, without discharge. After preparation, on the 2nd day of hospitalization, the patient underwent endovascular treatment:

[0041] After preparing the surgical field under local anesthesia with 10.0 ml of 0.25% lidocaine solution, a puncture of the right common femoral artery was performed. A 6F introducer sheath was inserted. Angiography was performed: occlusion of the anterior tibial artery from the middle to the lower third of the leg, collateral filling of the dorsalis pedis artery. Multiple attempts at antegrade recanalization with a 0.014'' guidewire supported by a 4F diagnostic catheter were unsuccessful. A decision was made to perform a distal puncture. After preparing the surgical field under local anesthesia with 5.0 ml of 0.25% lidocaine solution, as well as under X-ray and ultrasound guidance, a percutaneous puncture of the anterior tibial artery was performed at the level of the ankle joint in a retrograde direction. A thin-walled 4F introducer was inserted over a 0.018" guidewire. Numerous attempts at retrograde recanalization with a 0.014" guidewire supported by a 4F diagnostic catheter were unsuccessful.A decision was made to perform a puncture directly at the site of the onset of the arterial occlusion. After preparing the surgical field under local anesthesia with 5.0 ml of 0.25% lidocaine solution and under radiographic and ultrasound guidance, a percutaneous puncture was performed in the projection of the proximal portion of the occlusion, ensuring that the needle bevel passed through the atherosclerotic plaque cap. The angiographic positioning system was then changed to accurately position the needle within the artery. Next, 2 milliliters of saline were injected directly into the occlusion through the puncture needle. Subsequently, recanalization of the crural artery occlusion was performed in the antegrade direction using a 0.014" guidewire-4F multifunctional catheter system, previously advanced to the site of the onset of the occlusion. The puncture needle was removed from the puncture site of the anterior tibial artery, and manual hemostasis was performed.The 4F diagnostic catheter was removed, a 3.5*100 mm balloon catheter was inserted through the guidewire, and angioplasty was performed (exposure time 6 minutes, pressure of at least 8 atmospheres). Then, the balloon catheter was removed and control angiography was performed. The 0.014'' guidewire was removed from the vascular bed. A pre-assembled guidewire was inserted through the 6F introducer sheath. The introducer sheath was removed. A system for closure of the femoral artery puncture site was inserted through the guidewire. The puncture hole was sutured with a system for closure of the femoral artery puncture site. An aseptic dressing was applied. The early postoperative period was uneventful. On the first day after the intervention, ultrasound data showed main blood flow to the common arterial artery, subarterial coronary artery, and subarterial coronary artery. Against the background of antibacterial therapy and staged necrectomy, trophic defects completely epithelialized. The patient was discharged on the 20th day in satisfactory condition to his place of residence in a clinic under the supervision of a vascular surgeon.

[0042] Example #2

[0043] Patient V., 55 years old, with a clinical picture of chronic ischemia of the left lower limb, stage IV (according to the Fontaine-Pokrovsky classification).

[0044] A long-term history of obliterating atherosclerosis of the lower extremity arteries, with the dynamic development of trophic disorders of the calcaneal region of the left foot. The anamnesis includes ligation of the anterior tibial artery due to a wound. The patient was urgently hospitalized in a surgical hospital. Multispiral computed tomography of the lower extremity arteries was performed, according to which: occlusion of the left posterior tibial artery in the distal third with pronounced calcification, collateral filling of the lateral plantar arch. On examination, pulsation in the left common femoral and popliteal arteries is preserved, pulsation is not detected distally. Local status: trophic disorders of the calcaneal region of the left foot measuring 3 by 1 cm, without discharge. After preparation, on the third day of hospitalization, the patient underwent endovascular treatment:

[0045] After preparing the surgical field under local anesthesia with 10.0 ml of 0.25% lidocaine, a puncture of the left common femoral artery was performed. A 6F introducer sheath was inserted. Angiography was performed: occlusion of the left posterior tibial artery in the distal third with pronounced calcification, collateral filling of the lateral plantar arch. Multiple attempts at antegrade recanalization with a 0.014" guidewire supported by a 4F diagnostic catheter were unsuccessful. Given the absence of the posterior tibial artery in the lower third of the leg, distal puncture is technically impossible. A decision was made to perform a puncture directly at the site of the onset of arterial occlusion. After treating the surgical field under local anesthesia with 5.0 ml of 0.25% Lidocaine solution, as well as under X-ray and ultrasound control, a percutaneous puncture was performed in the projection of the proximal part of the occlusion so that the needle bevel passed through the cap of the atherosclerotic plaque.The angiographic setup projection was then changed to accurately position the needle inside the artery. Next, 2 milliliters of saline solution were injected directly into the occlusion through the puncture needle. Subsequently, recanalization of the crural artery occlusion was performed in the antegrade direction using a 0.014'' guidewire-4F multifunctional catheter system, previously advanced to the occlusion site. The puncture needle was removed from the posterior tibial artery puncture site, and manual hemostasis was performed. The 4F diagnostic catheter was removed, a 3.0*100 mm balloon catheter was inserted through the guidewire, and angioplasty was performed (exposure time 5 minutes, pressure of at least 8 atmospheres). Then, the balloon catheter was removed, and control angiography was performed. The 0.014'' guidewire was removed from the vascular bed. A pre-wired guidewire was inserted through a 6F introducer sheath. The introducer sheath was removed. A system was inserted through the guidewire to close the femoral artery puncture site.The puncture site was sutured with a femoral artery puncture site closure system. An aseptic dressing was applied. The early postoperative period was uneventful. On the first postoperative day, ultrasound data revealed major blood flow to the common arterial artery, the right coronary artery, and the periosteal artery. Following antibiotic therapy and staged necrotectomies, the trophic defect completely healed. The patient was discharged on the 15th day in satisfactory condition to his local outpatient clinic under the supervision of a vascular surgeon.

[0046] Thus, the method of endovascular revascularization of chronic occlusions of the arteries of the leg in the tibial segment helped to perform isolated endovascular revascularization.

Claims

A method for endovascular revascularization of chronic occlusions in the tibial segment, including a puncture in the antegrade direction of the common femoral artery, installation of an introducer along a 0.035" guidewire, performing angiography, characterized in that under ultrasound and X-ray control, a percutaneous puncture is performed in the projection of the initial part of the occlusion using a puncture needle, the cut of which is carried out through the plaque cover, then 2 milliliters of saline solution are introduced directly into the plaque, the puncture needle is removed, manual hemostasis is performed, then recanalization of the occluded area is performed using a 0.014" guidewire along a 4F multifunctional diagnostic catheter until it enters the true lumen of the artery, after which the 4F multifunctional diagnostic catheter is removed, while the guidewire is retained in the lumen of the artery,Next, a balloon catheter is inserted into the occluded area along the guidewire and balloon angioplasty is performed for 5 minutes under a pressure of at least 8 atmospheres. Then, the balloon catheter and guidewire are removed, control angiography is performed, a 70-cm pre-wire with a J-shaped and straight tip is inserted through the 6F introducer, the introducer is removed while preserving the guidewire in the artery, a system for closing the femoral artery puncture site is inserted along the guidewire, the puncture hole is sutured with a system for closing the femoral artery puncture site, and an aseptic dressing is applied to the puncture site.