RU2394522C2 - Method to ensure transmural auricle myocardial injury when treating supraventricular arrhythmias and related device for implementation thereof - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, namely to cardiosurgery, and can be used to ensure a transmural auricle myocardial injury when treating supraventricular arrhythmias. That is ensured by additional through punctures of the auricle myocardium along the radiofrequency destruction lines with using a monopolar electrode with its distal end designed as a needled spherical working part whereto radiofrequency energy is supplied.

EFFECT: group of inventions ensures better contractility and reduced area of a thermal and wave auricle myocardial injury with assured transmural radiofrequency auricle myocardial injury when treating various supraventricular arrhythmias, provides reduced risk of hemodinamically significant complications in the early postoperative period and releases the patients in the postoperative period from necessity to carry out pacing and antiarrhythmic therapy.

2 cl, 4 dwg

Description

The invention relates to medicine, namely to cardiac surgery.

Transmural atrial myocardial damage due to radio frequency exposure is the key to success in the treatment of arrhythmias. Guaranteed transmurality of myocardial damage allows you to form a scar on the path of propagation of re-entry circles and to avoid recurrence of arrhythmias by blocking the conduct of excitation in these circles. In particular, this concerns areas of the myocardium that are difficult to access for radio frequency exposure in the region of the mitral valve fibrous ring and areas of the myocardium covered with adipose tissue, since adipose tissue is an insulator for radio frequency energy.

There are several ways to achieve transmural atrial myocardial damage in the surgical treatment of supraventricular arrhythmias [Benussi S. Treatment of atrial fibrillation // European Journal of Cardio-thoracic Surgery. - 2004 .-- Vol.26. - P.39-41]:

1) surgical (technique "incision-suture" proposed by J.Cox),

2) hyperthermic

- resistive heating (radio frequency (RF) effect),

- dielectric heating (microwave), laser

- mechanical heating (ultrasonic effect),

3) hypothermic (cryoablation).

Classical surgical technique is the most effective way to achieve transmurality of myocardial damage. According to J.Cox, its effectiveness reaches 97%. However, it is not without a number of significant drawbacks, such as the duration and difficulty of execution, an increased risk of bleeding.

These shortcomings are deprived of radio frequency exposure, cryotherapy, microwave, laser exposure. However, one of the main problems is the achievement of transmural damage in all of these procedures.

Various endocardial catheter procedures for exposure of the atrial myocardium are also known [Egorov D.F., Leshchinsky L.A., Nedostup A.V., Tyulkina E.E. Atrial fibrillation. Treatment strategy and tactics on the threshold of the 21st century. St. Petersburg, 1998; 413 s .; Fieguth H.G., Wahlers T., Borst H.G. Inhibition of atrial fibrillation by pulmonary vein isolation and auricular resection - experimental study in a sheep model. // Eur.J. CardioThorac.Surg.-1997.-V.11.-P.714-721; Kawaguchi A. Kosakai Y. Isobe F. Factors affecting rhythm after the Maze procedure for alrial fibrillation. // Circulation. - II 1996. - v. 94. - P.139-142].

The disadvantages of these techniques are the difficulty of achieving transmurality of myocardial damage due to poor controllability of the position of the catheter in the atrial cavity and, as a result, recurrence of atrial fibrillation in the postoperative period.

Closest to the proposed method is the method proposed by MEDTRONIC, a system for radio frequency destruction CARDIOBLATE ™. Radio-frequency energy from the generator is supplied to mono-or bipolar electrodes, which effect the atrial myocardium. A sterile physiological solution is supplied to the working surface of the electrodes. Irrigation of electrodes helps prevent carbonization and heating of tissues, which allows RF energy to penetrate to a depth of 7 mm [Medtronic Introduces Innovative 'Ablation Pen' for Use by European Heart Surgeons // Business Wire, March 15, 2001; Khargi K. Surgical treatment of atrial fibrillation; a systematic review / K. Khargi, B.A. Hutten, B. Lemke, T. Danke / European Journal of Cardio-thoracic Surgery. - 2005. - Vol. 27. - P. 258-265].

The disadvantage of this method is the problem of achieving transmural damage to the myocardium of the atria in the areas of the left atrium in the left pulmonary vein and the fibrous ring of the mitral valve, as well as a sufficiently long time for the procedure due to the need for multiple oscillating movements on one application line. Another disadvantage is that when using the MEDTRONIC CARDIOBLATE ™ system, it is not possible to achieve transmural damage in places covered with adipose tissue, since it is not a conductor for radio frequency energy.

The purpose of the invention is to increase the contractility of the atria and reduce the area of thermal and wave damage to their myocardium due to the guaranteed achievement of transmurality of radio-frequency damage to the myocardium of the atria in the treatment of various types of supraventricular arrhythmias.

This goal is achieved by a technical solution, which consists in radiofrequency exposure of the atrial myocardium using a monopolar electrode by applying additional through piercing of the atrial myocardium along the lines of radio frequency destruction.

New in the proposed method is the application of end-to-end atrial myocardial punctures with the simultaneous supply of radiofrequency energy from the side of the epicardium, and then conduct radiofrequency exposure from the side of the endocardium, the lines of which will exactly coincide with the lines of the epicardial effect, which will achieve guaranteed transmurality of myocardial damage, while the main part exposure is carried out by the spherical part of the electrode, which provides a sufficient width of the destruction line, which allows to cause an effective the first block of the pulse, and the needle is playing a supporting role for radiofrequency exposure on the entire thickness of the myocardium, and only a combination of these parameters makes it possible to achieve this goal.

The proposed method allows, by applying multiple through piercing of the atrial myocardium from the side of the epicardium along the lines of radio frequency destruction, to conduct radiofrequency exposure to the entire thickness of the atrial myocardium, then supplemented by endocardial exposure, the lines of which exactly coincide with the epicardial, thus guaranteeing the achievement of transmural damage even in parts of the atrial myocardium covered with adipose tissue, which can significantly increase the effectiveness of this procedure and reduce the risk of eniya atrial fibrillation in cardiac patients in the postoperative period.

A device for radio-frequency destruction is known - a monopolar electrode for radio-frequency destruction to the CARDIOBLATE ™ system, proposed by MEDTRONIC, which is a pen that integrates a disposable electrode with a rounded working surface onto which sterile saline solution is supplied, which prevents carbonization and heating of tissues and helps to penetration of radio frequency energy to a depth of 7 mm [Medtronic Introduces Innovative 'Ablation Pen' for Use by European Heart Surgeons // Business Wire, March 15, 2001; Khargi K. Surgical treatment of atrial fibrillation; a systematic review. / K. Khargi, B.A. Hutten, B. Lemke, T. Deneke. / European Journal of Cardio-thoracic Surgery. - 2005. - Vol. 27. - P. 258-265].

The disadvantage of this device is the problem of achieving transmural atrial myocardial damage in the region of the left pulmonary veins and the mitral valve fibrous ring, as well as the rather long time of the procedure due to the need for multiple oscillating movements on one application line. Another disadvantage is that when using this device it is impossible to achieve transmural damage in places covered with adipose tissue, since it is not a conductor for radio frequency energy.

The objective of the proposed device is to achieve guaranteed transmurality of radio frequency destruction of the myocardium while reducing the area of thermal and wave damage.

The problem is solved in that the working end of the electrode is made in the form of a ball with a needle to which radio-frequency energy is supplied, while the main radio-frequency effect is performed by the ball, and the needle is a conductor of radio-frequency energy deep into the myocardium of the atria. This allows the use of an electrode with a small diameter of the ball, which reduces the area of thermal and wave damage to the myocardium of the atria and allows to increase its contractility (figure 4). The length of the needle should correspond to the thickness of the myocardium of the atrium in such a way as to produce a puncture of the myocardium over the entire thickness, and the diameter of the needle is selected in such a way as to avoid bleeding from the puncture site.

New in the proposed device is the implementation of the working end of the electrode in the form of a ball with a needle.

New significant features showed in the inventive combination of new properties that are not explicitly derived from the prior art in this field and are not obvious to a specialist.

An identical set of features was not found in the literature studied by the authors.

The proposed method can be used in medical practice, as it reduces the risk of developing atrial fibrillation in the postoperative period.

Based on the foregoing, the technical solution of the problem proposed as an invention should be considered as meeting the criteria of “Novelty”, “Inventive step” and “Industrial applicability”.

The invention will be clear from the following description and the accompanying drawings.

figure 1 - Scheme of a spherical-needle electrode

1 - the body of the electrode,

2 - spherical working element,

3 - needle on the working element of the electrode.

figure 2 - Scheme of effects on the myocardium of the atria with a spherical-needle electrode

1 - the body of the electrode,

2 - spherical working element of the electrode,

3 - needle on the working element of the electrode,

4 - myocardium,

5 - zone of radio frequency destruction.

figure 3 - Determination of the maximum depth of radio frequency destruction using a new device in the experiment

A) myocardium of the left ventricle,

B) the area of radio frequency destruction.

figure 4 - the amplitude of the waves And with an echoscopic examination of the heart more than 1.1 m / s (waves A are indicated by arrows).

A device for implementing the proposed method (figure 1) is a monopolar electrode (1), the distal end of which is made in the form of a ball (2) with a needle (3).

The proposed device acts on the atrial myocardium as follows: radio-frequency destruction is performed by applying radio-frequency energy to the electrode (Fig. 2), while the spherical working element (2) of the electrode (1) is located on the surface of the atrial myocardium (4), and the electrode needle (3 ) a puncture is performed on the entire thickness of the myocardium of the atria. Then the same radio frequency exposure is applied next to the previous one so that when merged, these exposure points form a continuous line.

The depth of damage when using the proposed device can reach 12 mm (figure 3)

In the postoperative period, when restoring sinus rhythm, all patients are evaluated for the contractility of the atria, for this an echo is performed with the determination of the amplitude of wave A, which should be at least 0.8 m / s (figure 4).

The study included 3 stages:

1) Experimental

2) Morphological,

3) Clinical.

At the first stage, the possibility of performing radio-frequency exposure in the atrial myocardium using a spherical-needle electrode was studied, the diameter and length of the needle and the working head of the electrode were selected. At the second stage, we developed the optimal parameters of the radiofrequency effect on the myocardium of the atria, which allows to achieve transmural damage, avoiding carbonization of tissues and at the same time to avoid bleeding from puncture sites.

The method is as follows:

The patient is taken to the operating room. They give introductory anesthesia, intubate, cannulate the central veins and the radial artery on the left. A passive electrode of the destructor is placed under the patient’s back. Under conditions of neuroleptanalgesia, the surgical field is treated with an antiseptic solution, and it is delimited with sterile linen. Cut the skin, subcutaneous tissue, perform median sternotomy, longitudinal T-shaped pericardiotomy. The heart-lung machine is connected according to the “hollow vein-aorta” scheme. Carry out heparinization. After the onset of cardiopulmonary bypass, the ascending aorta is pinched. Then the epicardial stage of radiofrequency fragmentation of the atria is performed to the lines coinciding with the Labyrinth III pattern, acting along these lines with a spherical monopolar electrode, causing through punctures with a needle attached to it. Radiofrequency destruction begins with a monopolar spherical electrode with a needle from the base of the superior vena cava along the lateral wall of the right atrium (PP) along the atrial valvus to the right atrioventricular groove in the area of the mouth of the inferior vena cava (IVC) with circular isolation of the latter. A destruction band is drawn from the border of the lower and middle third of this line to the right atrioventricular sulcus in such a way as to isolate the position of the IVC cannula from the rest of the atrial surface, then from the ear of the PP outward and downward, not reaching 1 cm to the previous line. And on the opposite side of the RF, destruction is carried out from the ear to the upper edge of the interatrial septum, with the transition to the upper wall of the left atrium (PL), further from the “roof” of the PL to the base of the ear and to the mouth of the left superior pulmonary vein (LV), around it to the mouth of the left inferior pulmonary vein (LV), then, also bending it to the mouth of the right lower LV, rounding its effect, draw along the posterior interatrial roller to the mouth of the right upper LV, rounding which again leads to the destruction line to the upper LP wall until it is connected to line de design and provides isolation performed as the mouth of the superior vena cava.

After that, in conditions of parallel cardiopulmonary bypass, the vena cava is clamped with turnstiles, the abalone is resected, and through this incision, the interatrial septum and right atrial portions adjacent to the fibrous ring of the tricuspid valve are exposed. In this case, the lines of radio frequency destruction are applied in accordance with the lines of epicardial exposure, which are clearly visible on the endocardium of the atria in the form of multiple through punctures.

The next step is to perform the left atrial endocardial stage of radiofrequency exposure of the atria, the purpose of which is to perform destruction of the myocardium of the left atrium from the left lower pulmonary vein to the ear of the left atrium and from the left atrium to the fibrous ring of the mitral valve, that is, those areas that are not accessible epicardially. For this, a left atriotomy is performed and radiofrequency applications are performed from the left lower pulmonary vein to the left atrial ear and from the left atrium ear to the fibrous ring of the mitral valve. In this case, the lines of radio frequency destruction are also applied in accordance with the lines of epicardial exposure, which are clearly visible on the endocardium of the atria in the form of traces of multiple through punctures.

The next step is the main stage of the planned operation, then atriotomy sections are sutured, cardiac activity is restored.

Drain the pericardial cavity and anterior mediastinum. Hemostasis. Osteosynthesis of the sternum by wire ligatures. Layer wound closure. Antiseptic solution. Aseptic dressing.

EXAMPLE: Patient K-va, 46 years old, was in the Department of Cardiovascular Surgery of the Research Institute of Cardiology, Scientific Center of the Siberian Branch of the Russian Academy of Medical Sciences from 1.08.2007 to 08.30.2007 with a diagnosis of

- mains-: Congenital heart disease. Atrial septal defect. Tricuspid valve insufficiency II tbsp. Pulmonary Hypertension II. Atrial fibrillation. H IIA. NYHA III.

- Sop.-: Chronic pyelonephritis with preserved renal function, moderate exacerbation.

Due to the patient’s underlying disease, she underwent surgery on 08.08.2007: repair of the atrial septal defect with a patch from the autopericardium, DeVega tricuspid valve plastic surgery, radiofrequency fragmentation of the atria according to the Labyrinth pattern, suturing of the left atrial ear in cardiopulmonary bypass and antegrade blood cold cardioplegia. To perform radiofrequency fragmentation of the atria according to the Labyrinth scheme, the proposed device was taken and the proposed method performed radio frequency exposure by applying a plurality of applications along the radio frequency destruction lines with the proposed device with through piercing of the atrial myocardium so that all applications merged into one solid line. The transmural nature of the lesion was confirmed morphologically (taking biopsy samples from the right atrial abalone), and also, upon stimulation of the pulmonary vein site, the absence of atrial stimuli was recorded. A visual assessment of the punctures caused revealed no signs of bleeding. Immediately at the end of the main stage of the operation and the restoration of cardiac activity, a sinus rhythm was obtained, which persisted both in the early and late postoperative period. The postoperative period was uneventful. Postoperative wound healing by primary intention. The patient was discharged on the 22nd day after surgery with a sinus rhythm. In the postoperative period, according to 24-hour ECG monitoring data, 192 isolated ventricular and 115 supraventricular extrasystoles were recorded in 24 hours.

The application of the proposed method and device for its implementation can provide:

- guaranteed achievement of transmural damage during radiofrequency exposure of the atrial myocardium,

- adequate correction of cardiac arrhythmias in the early postoperative period,

- reducing application time per point of radio frequency exposure, as well as reducing the risk of damage to surrounding structures through the use of a smaller working diameter electrode head,

- the release of patients in the postoperative period from the need for ECS and antiarrhythmic therapy,

- preservation of active systole of the left atrium (amplitude of wave A, an average of 1.1 m / s) by reducing the area of atrial myocardial damage.

The present invention was applied in 7 patients (of which 2 men and 5 women, age - from 45 to 62 years, the average prescription of chronic AF - 4.8 ± 3.1 years) and allows to reduce the risk of hemodynamically significant complications in the early postoperative period by adequate correction of cardiac arrhythmias, which becomes possible due to the guaranteed achievement of transmurality of atrial myocardial damage during various methods of radio frequency destruction and to free patients in postoperative during the period from the need for ECS and antiarrhythmic therapy, as well as to ensure good contractile activity of both atria by reducing the area of thermal and wave damage to the atrial myocardium.

Claims (2)

1. A method of achieving transmural atrial myocardial damage in the treatment of supraventricular arrhythmias by radiofrequency exposure of the atrial myocardium using a monopolar electrode, characterized in that through-hole atrial myocardial punctures are additionally applied along radio-frequency destruction lines. 2. The device for implementing the method according to claim 1, which is a monopolar electrode, characterized in that the distal end of the electrode is made in the form of a spherical working element with a needle to which radio frequency energy is supplied.

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