RU2698990C2 - Method for loop extraction of electrode of constant pacemaking from right heart through throat approach - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, particularly to cardiovascular surgery. Triple puncture approach is created. First goos-neck trap is inserted through the first puncture approach and positioned in an inferior vena cava. Two conductors are passed through the second and third puncture approaches, besides, they are carried out through the lumen of the first trap. Conductors are brought to a heart cavity. Then, two multi-purpose introducers are conducted along conductors. First multi-purpose introducer is used to conduct the first conductor behind the loop of the extracted electrode and to withdraw it into the upper hollow vein. Second introducer is followed by a second goos-neck trap ahead of the loop of the extracted electrode and trapped by a trap to form a grip loop. First multipurpose introducer is advanced above the point of contact of the grip loop with the loop of the extracted electrode. Grip loop is traversed with the first trap moving above the grip loop connection level with the electrode loop. First trap is tightened around the electrode. Whole system traction is performed before electrode separation from tissues.

EFFECT: method enables performing endocardial extraction of electrodes of constant pacemaking with electrodes increment to upper vena cava or atrium wall with complex arrangement of electrode loop in heart and if necessary selective extraction of one electrode from several to reduce operational and postoperative complications, reduce time and cost of operation.

1 cl, 9 dwg

Description

The method of extraction of the electrode loop of constant pacing from the right heart through the femoral access.

The invention relates to medicine, namely to cardiovascular surgery, and can be used for the extraction of endocardial electrodes for pacemaking in patients with broken electrodes when trying to extract the upper access, with a complex anatomical location of the electrode loop in the cavities of the right heart, including due to repeated increment of the electrode loop to several sections of the endocardium of the right heart, an excessively close arrangement of the electrode loop to the endocardium.

All over the world and in Russia there is an increase in the absolute number of implanted pacemakers (EX), cardioverter defibrillators (ICDs), and resynchronization therapy devices (CPT). In 2010, 168 ECS were implanted in the Russian Federation per million people. [Bokeria L.A., Revishvili A.Sh., Dubrovsky I.A. The state of pacing in Russia in 2011 // Bulletin of Arrhythmology 2013; 73: 75-79]. The website of the All-Russian Scientific Society of Arrhythmologists (vnoa.ru) has published reports of the All-Russian database of ECS. In accordance with the latest report published on this website for 2013 (https://vnoa.ru/upload/otchet_2013.pdf), 32643 ECS were implanted in Russia in 2013.

An increase in the number of implanted antiarrhythmic devices causes an increase in the complications associated with implantation. Some complications, including infection of the ECS system, fracture of the electrode, thrombosis and obliteration of the main venous vessels, electrical interference as a result of direct mechanical contact between the two electrodes, ventricular tachycardia starting from the fixation point of the electrode, insufficiency of the tricuspid valve may require the extraction of electrodes [Ardashev A.V. Clinical arrhythmology // Medpraktika-M, 2009, 1220 s, chapter 31, pages 706-725]. According to the 2013 report of the all-Russian EX-base (https://vnoa.ru/upload/otchet_2013.pdf), 1,198 electrodes were removed in Russia in 2013.

Current methods for removing electrodes are represented by methods using the upper access through the subclavian or jugular veins, using the lower access through the femoral vein and methods using limited thoracotomy [Drozdov IV, Amiraslanov A.Yu., Aleksandrov AN , Knigin A.V., Alimov D.G., Kokov L.S. Methods for removing endocardial electrodes. // Diagnostic and interventional radiology, volume 4, No. 1, 2010, pp. 35-51].

Upper access is represented by traction on a locking stylet, using telescopic plastic catheters, using an excimer laser, and electrosurgical extraction. Removal techniques from the upper access are feasible only with an accessible proximal end of the electrode. When the proximal end of the electrode is broken, there is a need for lower access through the femoral vein, or thoracotomy access.

Thoracotomy access is used when it is impossible to remove the electrodes by endovascular methods. This access includes introducing the patient into anesthesia, surgical access to the right atrium (median thoracotomy, extended thoracotomy or limited thoracotomy), a purse string suture on the atria, atriotomy, capture and removal of the electrode. With thoracotomy access, it is also possible to use closure stilettos and telescopic catheters [Drozdov I.V., Amiraslanov A.Yu., Aleksandrov AN, Knigin AV, Alimov DG, Kokov LS Methods for removing endocardial electrodes. // Diagnostic and interventional radiology, volume 4, No. 1, 2010, pp. 35-51]. Thoracotomy access is less desirable for the patient, since the time of the operation increases, the morbidity increases, the hospitalization and rehabilitation period after the operation lengthens, there is a need to use general anesthesia, the risk of complications increases, and the cost of intervention increases.

The closest prototypes of the proposed extraction method are a variety of options for extraction from the femoral access, which are used when it is impossible to remove the electrode by the upper access through the subclavian and jugular veins.

A known method of removing the electrode loop from the right sections through the femoral approach using a pig tail catheter and a Dotter basket is that the pig tail catheter is wrapped several times around the electrode and captured by the Dotter basket, after which traction is used to separate the electrode from the tissues [Drozdov I. V., Amiraslanov A.Yu., Aleksandrov A.N., Knigin A.V., Alimov D.G., Kokov L.S. Methods for removing endocardial electrodes. // Diagnostic and interventional radiology, volume 4, No. 1, 2010, pp. 35-51].

The disadvantages and limitations of this known method:

1. This method is irreversible: after the catheter is trapped in the basket, if the electrode cannot be removed, the catheter cannot be released.

2. The pig tail catheter is not actively fixed to the electrode. As a result, if one end of the electrode loop breaks away from the tissue, the entire system can simply slide off the electrode.

3. The pig tail catheter and the Dotter basket should be inserted through one introducer, which is dictated by the irreversibility of the connection of the catheter and the Dotter basket. This single introducer restricts the ability to capture the electrode in complex anatomical cases, such as the proximity of the electrode loop to the atrial wall, since the catheter and Dotter's basket cannot be controlled completely independently of each other.

A known method of removing the electrode from the right sections through the femoral approach using the Amplatz trap (goos neck snare) is to provide femoral access, the Amplatz trap (goos neck snare) is started. An electrode is captured by a trap and traction and release of the electrode from surrounding tissues are performed [Drozdov IV, Amiraslanov A.Yu., Aleksandrov AN, Knigin AV, Alimov DG, Kokov LS Methods of removal endocardial electrodes. // Diagnostic and interventional radiology, volume 4, No. 1, 2010, pp. 35-51].

The disadvantages and limitations of this known method:

1. The Amplatz trap (goos neck snare) can be isolated only if there is a free end of the electrode in the heart cavity. When the electrode is incremented with the distal end to the tissues of the heart and a loop to the wall of the atrium or superior vena cava, this method cannot be used.

A known method of removing the electrode loop from the right sections through the femoral access using the Birda workstation, which consists of an introjuser with a pre-installed curved conductor and a Dotter basket, consists in starting an intruder with a pre-installed curved conductor and a manual manipulator. The electrode is captured by the curved conductor, the distal end of the curved conductor is captured by the dotter basket, which is fed through the 6 F introjuser, which is placed in the main common introdusser with a pre-installed curved conductor. Traction separates the electrode from the tissues. [AVI FISCHER, MD, VICTOR PRETORIUS, MbchB, ULRIKA BIRGERSDOTTER-GREEN, MD, Femoral Lead Extraction: An Underappreciated and Underutilized Approach to Lead Removal, The Journal of Innovations in Cardiac Rhythm Management, 3 (2012), 682-687]

The disadvantages and limitations of this known method:

1. This method is irreversible: after the catheter is trapped in the basket, if the electrode cannot be removed, the catheter cannot be released.

2. The bent conductor and the Dotter basket are inserted through one introdusser, which prevents completely independent control of the bent conductor and the basket, which limits access applications for complex anatomy: the proximity of the electrode loop to the atrium wall, the need to remove one electrode from several located in the right heart .

3. A conductor with a bent end has a complex controllability, due to the radius of curvature of the bent end and is not always able to capture the electrode with a complex anatomical location of the electrode in the cavities of the heart.

4. The small thickness of the conductor with a dense increment of the electrode to the tissues and the need for traction with considerable force can lead to cutting of the removed electrode.

The closest prototype is a well-known method of removing the electrode loop from the right sections through the femoral access using the Byrd workstation and Amplatz trap, which is used instead of the Dotter basket. The method consists in starting up an intruder with a pre-installed curved conductor and a manual manipulator. An electrode is captured by a curved conductor, the distal end of a curved conductor is captured by an Amplatz trap (goose neck snare), which is placed in the main common introducer with a pre-installed curved conductor. Traction separates the electrode from the tissues.

This technique is similar to the use of the Beard workstation, but instead of the Dotter basket, an Amplatz trap is used to capture a conductor with a bent end, which ensures reversibility of capture [AVI FISCHER, MD, VICTOR PRETORIUS, MbchB, ULRIKA BIRGERSDOTTER-GREEN, MD, Femoral Lead Extraction: An Underappreciated and Underutilized Approach to Lead Removal, The Journal of Innovations in Cardiac Rhythm Management, 3 (2012), 682-687].

The disadvantages and limitations of this known method:

1. The bent conductor and Amplaci traps are introduced through a single introducer, which prevents completely independent control of the bent conductor and the basket, which limits access applications for complex anatomy: the closure of the electrode loop to the atrial wall, the need to remove one electrode from several located in the right heart .

2. A conductor with a curved end has complex controllability due to the radius of curvature of the curved end and is not always able to capture the electrode with a complex anatomical location of the electrode in the cavities of the heart, or penetrate into the narrow gap between the electrode and the heart wall.

3. The small thickness of the conductor with a dense increment of the electrode to the tissues and the need for traction with considerable force can lead to cutting the removed electrode.

The second closest prototype is the well-known technique of removing the electrode loop from the right through the femoral approach using a needle-eye trap (Needle eye snare), which consists of a catheter with a pre-installed wide curved loop for gripping the electrode and a narrow loop for fixing it. During traction of the loops, the electrode is fixed to the catheter and during further traction of the entire system, the electrode is separated from the tissues. [AVI FISCHER, MD, VICTOR PRETORIUS, MbchB, ULRIKA BIRGERSDOTTER-GREEN, MD, Femoral Lead Extraction: An Underappreciated and Underutilized Approach to Lead Removal, The Journal of Innovations in Cardiac Rhythm Management, 3 (2012), 682-687].

The disadvantages and limitations of this known method:

1. Both loops in the trap are preinstalled in one introducer, which prevents completely independent control of the large and small loops, which limits access applications for complex anatomy: the proximity of the electrode loop to the atrial wall, the need to remove one electrode from several located in the right heart.

2. Limitations in the controllability of a large loop are due to its radius of curvature. In this case, it is not always possible to capture the electrode with a complex anatomical location of the electrode in the cavities of the heart, or to draw a large loop between the electrode and the heart wall when it is close to the heart wall.

3. The thickness of the slice of the wire of a large loop, together with a dense increment of the electrode to tissues and the need for traction with considerable effort, can lead to cutting the removed electrode.

The technical result of the invention is to provide the possibility of extraction of the electrode loops through the lower femoral access with a complex anatomical location, including the proximity of the loop to the walls of the cavities of the heart, the electrode increment over a significant length with short sections of the free loop in the cavities, if necessary, the extraction of one electrode from several located in the cavities of the heart; conditions have been created that exclude the cutting of the electrode loop during traction, for reliable fixation of the electrode and the exclusion of its migration into the venous bed.

The technical result is achieved by the fact that in the present invention create a triple puncture access to the femoral vein, through the first puncture access conduct the first trap of the goos-neck type and position it in the inferior vena cava, through the second and third puncture access conduct two conductors, and they are conducted through the lumen of the first trap, the conductors are brought to the cavities of the heart, then two multipurpose introducers are passed along the conductors; by means of the first multipurpose introducer sheath, conduct the first conductor behind the loop of the extractable electrode and bring it into the superior vena cava, conduct the second goos-neck trap along the second introducer sheath anterior to the loop of the extractable electrode and trap the conductor with the formation of a capture loop, push the first multipurpose introducer sheath above the place the capture loop with the loop of the extracted electrode, traction of the capture loop with the advancement of the first trap above the level of connection of the capture loop with the loop electrode, tighten the first trap around the electrode, perform traction of the entire system until the electrode is separated from the tissues.

The present invention meets the criteria of "novelty" and "inventive step", since in the process of conducting patent information research there were no sources of scientific and technical information discrediting the novelty of the invention, nor technical solutions containing essential features of the invention.

The proposed method is as follows.

Under local anesthesia, triple puncture access to the right femoral vein is created, or one access to the left femoral vein and two to the right femoral vein.

The first goos-neck trap is passed into the first puncture access through a thick introdusser (from 8 to 16 F), for example 12 F, and is positioned in the inferior vena cava (Fig. 1).

Two conductors are guided through the second and third puncture accesses (for example, guides from the Preface multipurpose catheter set). These conductors are passed through the lumen of the first trap positioned in the inferior vena cava and brought to the cardiac cavities (Fig. 2).

Two multipurpose introducers Preface, 8 F, are guided along the conductors, which, with further actions, will make it possible to conveniently capture the electrodes and independently control the conductor and the second trap (Fig. 3).

By controlling the first multipurpose introducer sheath, the first conductor is drawn between the extracted electrode and the heart wall and discharged into the superior vena cava, if possible, or left in the cavity of the right atrium (Fig. 4). Trap-independent control of the conductor using a multi-purpose introducer sheath provides a great advantage in complex anatomical cases, in particular when the loop of the extracted electrode is close to the atrial wall. Using a straight conductor without a bent tip allows them to pass even with an extremely small portion of the free loop of the extracted electrode and an extremely narrow gap between the extracted electrode and the heart wall.

In the second introducer sheath, the conductor is replaced by a second goose neck trap, which grabs the conductor at the level of the superior vena cava, or atrial cavity, thereby forming a capture loop (Fig. 5). When capturing a conductor, an important role is played by the ability to independently manipulate the trap using a multi-purpose sheath.

The first multipurpose introducer moves above the point of contact of the capture loop with the loop of the extracted electrode (Fig. 6). This step is not necessary, but desirable, since in consequence it will reduce the likelihood of eruption of the extracted electrode and, thus, increase the chances of successful extraction.

Next, the prododus is fixed with a second trap and traction of the second multipurpose introducer and traps is carried out, pulling the capture loop. Moreover, if the distance to hold the first multipurpose introducer is higher than the place of contact with the extracted electrode, then it bends around the extracted electrode (Fig. 7). If not remoteness, then the extracted electrode will stretch due to the conductor, which together with the second trap forms a capture loop.

Next, the first trap from the inferior vena cava is advanced upward and positioned above the contact of the capture loop with the extracted electrode (Fig. 8).

After this, the extractable electrode is fixed by the first trap. Next, traction is performed by the first and second trap until the electrode is completely separated from the tissues. Next, the second trap relaxes and the conductor and the first multi-purpose sheath are released. In this case, the selected, extracted electrode remains trapped in the first trap. (pic 9)

Next, the first introducer with the conductor, the second introducer with the second trap, the third introducer with the first trap and the released electrode are removed.

The method has the following features. The method uses two goose neck traps. The use of the first goos-neck type trap provides at the end of the method reliable fixation of the electrode and eliminates the possibility of its migration to the venous bed. To capture the loop of the extracted electrode, a capture loop is formed using a second goos-neck trap and a long conductor, which are controlled by multipurpose introductors independently of each other, which makes them more maneuverable. A direct conductor is used, which allows you to capture the electrode with a minimum area of the free electrode in the cavity of the heart and its proximity to the heart wall. At the point of contact of the capture loop with the loop of the extracted electrode, a multipurpose introducer is positioned, which prevents the penetration of the electrode.

A clinical example of the implementation of the method:

Extract from the medical history.

Patient 3., 54 years old, was admitted to the cardiac surgery department No. 3 of the Federal Center for Veterinary Surgery in Chelyabinsk with a bed sore clinic CPT-D.

Diagnosis at admission: Dilated cardiomyopathy. Relative insufficiency of mitral and tricuspid valves of I-II degree. Moderate pulmonary hypertension. Paroxysmal unstable ventricular tachycardia. Implantation CRT-P (2008). Reimplantation of the Cognis 100 DR CRT-D device from 12/19/2014, without complications. Hypertension III stage, risk 4. CHF I, f. NYHA Class 2. Obesity of 1 degree. An emerging bedsore bed.

The patient complained of shortness of breath, weakness, fever, swelling and redness in the area of the CPT-D bed.

The patient was shown to remove the CPT-D system and the extraction of the electrodes.

According to x-ray in the cavities of the patient, the patient had 4 electrodes: atrial, right ventricular stimulation - remaining from CPT-R since 2008, right ventricular defibrillation, left ventricular.

The operation was performed under local anesthesia.

The SRT-D device with electrodes was isolated from the tissues, the electrodes were disconnected. The right ventricular defibrillation electrode is removed using simple traction on the stylet. The right ventricular stimulation and atrial electrodes were removed using locking stelae and Spectranetics polyurethane telescopic extractors. When trying to remove the left ventricular electrode using a locking stiletto and polyurethane telescopic extractors, the electrode broke.

The distal fragment of the left ventricular electrode was removed by the second stage the next day from the femoral access.

The second stage operation was performed under local anesthesia. During the operation, an electrode increment was detected over a considerable length in the cavity of the right atrium and the presence of a free section of the loop near the place where it entered the mouth of the coronary sinus. The capture of the electrode by a goos neck snare trap was not possible due to the absence of the free end of the electrode. Capture of the electrode by a needle eye snare trap was not possible due to the proximity of the electrode loop to the wall of the right atrium. It was decided to choose the developed method as the extraction method. Produced triple puncture access to the right femoral vein.

The first goos-neck trap was introduced into the first puncture access via the 12 F introducer and positioned in the inferior vena cava.

Through the second and third puncture accesses, two long conductors from the set of multi-purpose catheters Preface. These conductors are drawn through the lumen of the first trap positioned in the inferior vena cava and brought to the cavity of the right atrium.

Two multi-purpose introducers Preface, 8 F., were guided along the conductors.

By controlling the first multipurpose introducer sheath, the first conductor is drawn between the extracted electrode and the heart wall and led into the superior vena cava.

In the second introducer, the conductor was replaced with a second goose neck trap, which captured the conductor at the level of the superior vena cava, forming a capture loop.

The first multipurpose introducer is advanced above the point of contact of the capture loop with the loop of the extractable electrode.

Traction of the second multipurpose introducer and trap was carried out for tensioning the pickle and extractable electrode.

The first trap is advanced upward from the inferior vena cava and positioned above the contact of the capture loop with the extracted electrode.

After that, the extracted electrode was fixed by the first trap and traction was performed by the first and second trap until the electrode was completely separated from the tissues. Next, the second trap is relaxed and the guide and the first multi-purpose sheath are released. In this case, the selected, extracted electrode remained trapped in the first trap.

Next, sequential removal of instruments and introducers from the venous system through the femoral vein, including the introducer with a trap and trapped extracted electrode, was performed.

No intraoperative and postoperative complications were noted. The follow-up period was 6 months.

Using the claimed method allows the extraction of the electrode with a complex anatomical location, due to the increment of the electrode to the walls of the heart and the proximity of the electrode to the walls of the heart, to relieve the patient of the need to perform a more complex thoracotomy operation, and, as a result, reduce the number of complications, the cost of the operation, the operation time , postoperative hospital stay.

Explanations for graphic materials.

Figures 1 through 9 contain the following elements:

1. The plot of the extracted electrode, adhered to the superior vena cava.

2. The free area of the extracted electrode in the right atrium.

3. A portion of the extracted electrode sprouted to a vein in the coronary sinus.

4. Introducer 12 F.

5. First goose neck trap.

6. Two conductors drawn through the lumen of the first trap to the cavities of the heart.

7. Multipurpose introducers Preface, conducted on conductors.

8. A conductor drawn between the free portion of the electrode and the wall of the heart.

9. The second goose neck trap, introduced into the introducer Preface.

10. Capture of the second trap of the conductor held between the free portion of the electrode and the wall of the heart.

11. The multipurpose Introducer Preface, held along the conductor between the free portion of the electrode and the wall of the heart.

12. An electrode loop captured by a capture loop from a second trap and conductor.

13. A second goose neck trap that holds the conductor and forms a grip loop with it.

14. The first trap of the goose neck type, advanced above the point of contact of the electrode loop with the capture loop.

15. The first trap, fixing the electrode released from the tissues.

16. A relaxed second trap in the multipurpose introducer

17. Exempted capture loop conductor in a multipurpose introducer sheath.

Claims (1)

The method of extraction of the electrode pacing electrode loop from the right heart through the femoral approach, which includes creating a puncture access to the right femoral vein, conducting a goos-neck trap and introducing a conductor, characterized in that they create a triple puncture access, through the first puncture access a goos-neck type trap and position it in the inferior vena cava, two conductors pass through the second and third puncture accesses, and they are passed through the lumen of the first trap, the conductors are brought to cavities of the heart, then two multipurpose introducers are conducted along the conductors; by means of the first multipurpose introducer sheath, conduct the first conductor behind the loop of the extracted electrode and output it into the superior vena cava, conduct the second goos-neck trap along the second introducer sheath anterior to the loop of the extractable electrode and trap the conductor with the formation of a capture loop, move the first multipurpose contact sheath above the place the capture loop with the loop of the extracted electrode, traction of the capture loop with the advancement of the first trap above the level of connection of the capture loop with the loop electrode, tighten the first trap around the electrode, perform traction of the entire system until the electrode is separated from the tissues.

Images