RU2777182C2 - Method for hybrid surgical treatment with transcatheter implantation of pulmonary valve with transapical access - Google Patents

Abstract

FIELD: medicine; cardiac surgery.

SUBSTANCE: valve is implanted by means of transapical transcatheter delivery to the pulmonary artery. For this purpose, left side mini-thoracotomy is performed with the application of pouch sutures to the area of the top of the right ventricle and its subsequent punction.

EFFECT: method allows for minimally invasive hybrid implantation of a transcatheter valve of any available size to the lung position regardless a degree of expression of adhesive process behind the sternum and in the pericardium, as well as provision of highly accurate positioning of a valve-containing device during the implantation.

2 cl, 3 dwg, 1 ex

Description

SUBSTANCE: invention relates to medicine, namely to cardiac surgery, and can be used to correct pulmonary valve pathology of various etiologies and at any age when implantation of a transcatheter prosthesis is possible.

There are various surgical techniques aimed at reconstructing (commissurotomy, decalcification, planar resection), partial (application of a patch with a monocuspid valve) or complete replacement (prosthetics with a biological or synthetic prosthesis) of the affected pulmonary artery valve with a congenital or other nature of its pathology [Podzolkov V. P., 2008]. A variety of approaches in the replacement of the pulmonary valve or its reconstruction, usually are traumatic in volume, because. require an opening of the chest. The standard and most common approach to the heart is a median sternotomy performed by longitudinal sawing of the fudina, followed by intervention on the pulmonary valve under conditions of a connected heart-lung machine [Stulak J.M., 2006]. The method allows for a wide exposure, however, it is very invasive and has known disadvantages associated with this (after the operation, a long healing process, pain syndrome, the likelihood of sternum failure, and a number of others) [Danilov T.Yu.. 2010]. Besides. The vast majority of surgical interventions associated with pulmonary valve dysfunction after previously performed correction of congenital heart defects with obstruction of pulmonary blood flow are performed repeatedly. One of the reasons for this is. that in early childhood, according to indications, it is possible to eliminate obstruction without preserving the valve, usually in combination with transnanular expansion of the exit to the pulmonary artery [Bacha E.A., 2001]. At the time of radical correction of the underlying defect, this is a necessary measure to avoid residual obstruction on the paths of the flask to the pulmonary artery. However, in the future, severe dilatation of the right ventricle and pulmonary insufficiency in patients is statistically significantly more common after such interventions [De Ruijter F.T.H.. 2002]. The spectrum of these malformations is wide and includes tetralogy of Fallot, various types of pulmonary atresia, double origin of vessels from the right ventricle with pulmonary artery stenosis, agenesis of the pulmonary valve, and a number of others [Podzolkov V.P., 2008]. At the same time, the restenotomy approach (repeated sternotomy after a previous open heart surgery) is even more traumatic than with the primary intervention and, accordingly, all the negative aspects not only remain, but also the risk of damage to the structures of the heart and main vessels, nerves, bleeding, and, as a result, lengthening the terms of stay in the intensive care unit and hospitalization in general [Geva T. 2013]. Today, this problem is more and more relevant, because. the population of such patients is growing rapidly due to the increase in the number of interventions in childhood and the high survival rate that accompanies such operations in recent years [Balzer D., 2019]. Randomized trials have already begun, however, their results have not yet been presented [Heys R., 2019].

Minimally invasive operations using dosed mini-sternotomy, J-sternotomy, etc. are considered today as an alternative to standard accesses. on an open heart with the connection of a heart-lung machine [Gil-Jaurena J.M., 2019]. In addition, despite the fact that such operations are slightly traumatic, in comparison with classical abdominal ones, nevertheless, they are very resource-intensive, because. require complex special equipment, separately trained specialists and special tools, which limits their wide application. In any case, in the available literature, such interventions on the pulmonary artery are currently presented sporadically.

Another significant category of patients in whom reoperation is required over time is patients with an implanted, more often biological, artificial pulmonary artery trunk or conduit. It is well known that the operation to replace the conduit is a traumatic and complex intervention due to the tendency of the latter to calcification, the high risk of its increment to the posterior wall of the sternum, the severity of the adhesive process, the expansion of the chambers of the heart and, often, accompanied by symptoms of cardiac weakness due to hemodynamic disorders, caused by prosthesis dysfunction. These factors are responsible for the rather high mortality in such operations [Bielefeld M.R., 2001]. Ideal for such a patient is the ability to avoid the need for cardiolysis, cardiopulmonary bypass and heart traction, which are inevitable during open chest surgery [Geva T., 2013].

Potentially the least traumatic impact has transcatheter technologies. Endovascular methods in an isolated form, aimed only at balloon dilatation, are effective in such patients only in a limited number of cases. In these cases, the presence of valvular stenosis is assumed with preserved valve closing ability and the absence of gross changes in the leaflets themselves [Sherman W., 1990]. In other cases, the use of balloon dilatation is considered exclusively as a temporary palliative measure, the purpose of which is to eliminate a critical narrowing at the valve level. The valvular insufficiency resulting from such an intervention is almost inevitable and, over time, in the absence of the necessary surgical treatment, leads to the development of dilatation of the heart chambers and severe complications, primarily heart failure [Geva T., 2013]. In this regard, such a tactic is justified only in young children or newborns, when the possibilities of implanting valve-containing prostheses or devices in the lung position are limited [Berman D.P., 2014]. At an older age, the problem today can still be solved endovascularly and, importantly, without the use of artificial blood circulation. This became possible relatively recently, thanks to the emergence and implementation of the technology of transcatheter implantation of an artificial heart valve and with the development of such valves themselves both in Russia and abroad [Patent RU 125062 U1; Patent RU 2634418 C1; Patent US 10149757 B2; Patent AU 2011257298 B2; Patent 129387 U1; Patent US 20090192585 A1].

In the specific context of transcatheter pulmonary valve replacement, for example, the valvular element is presented in U.S. Patent Application Publication Nos. 2003/0199971 A1 and 2003/0199963 A1 in the form of a segment of the bull's jugular vein incorporated into an expandable metal stent [Patent US 20030199971 A1]. In the domestic modification, a similar valve obturator element is represented by leaflets made of polytetrafluoroethylene (PTFE) [Registration certificate "MedLab-KT" according to TU 9444-019-27771122-2014]. The principle of transcatheter replacement consists in the complex use of a transcatheter valve, previously attached to a balloon catheter, which serves to open the first in the target area of the affected native valve or valve-containing section of the artificial pulmonary artery trunk. In addition, a special delivery system is required, which initially provides percutaneous transluminal passage of the transcatheter valve to the implant site through the vessels of the limb, as described in articles by Bonhoeffer P. et al. dated 2000 and 2002 [Bonhoeffer R., 2000; 2002].

The studies reported in the literature have shown that the use of minimally invasive transcatheter implantation becomes important in reducing the risk of surgical intervention. There are a number of serious publications on this topic today: Louise Coats, et al., Institute of Child Health. London. Great Britain [Coats L., 2005]. Philipp Lurz et al., Great Ormond Street Hospital. London, UK [Lurz R., 2009]. Georg butter et al. Christian-Albrecht Institute, Kiel, Germany [Lutter G., 2004], Younes Boudjemline et al, Necker Hospital for Sick Children, Paris, France [Boudjemline Y. 2004] and others. the elimination of valvular pathology really significantly improves the hemodynamic status of the patient and. unlike open surgery, it does not involve sternotomy, connection of a heart-lung machine and artificial lung ventilation and pulmonotomy [McElhinney D.B., 2010]. There are also descriptions in the literature of successful procedures for repeated implantation of endovascularly delivered valves according to the “valve-to-valve” type [Chen Q., 2013]. Transcatheter and hybrid interventions that avoid cardiopulmonary bypass are also recommended for patients with a high risk of developing neurological complications, or who have already undergone them during previous open operations under perfusion [Travelli F.C., 2014]. However, despite the obvious advantages of this approach, domestic experience is limited either by single case reports or single clinics, where there are already whole series of such observations [Bazylev V.V. 2019; Alekyan B.G., 2010].

With the accumulation of world experience, ambiguity has emerged in the choice of access for transcatheter delivery of valve-containing devices. With regard to transcatheter valves, many currently prefer transfemoral access due to minimal invasiveness and ease, and this is true both for the arterial and venous vascular bed, respectively, depending on the damage to the aortic or pulmonary semilunar valves [Auffret V., 2017 McElhinney D.B. , 2010]. However, from a structural point of view, transcatheter delivery systems for prosthetic heart valves are complex products, the size of which creates certain restrictions on their use in terms of vascular access. It conditions that. that the initially described vascular femoral or other approach has both pluses and minuses.

On the example of the aortic femoral vascular access, as a target vessel for providing access to the aortic valve of the heart and located in the same anatomical zone as the femoral vein, it has been shown that in the presence of atherosclerotic lesions of the peripheral arteries or a small diameter of the vessels, they resort to transapical or transaortic [Nakatsuka D., 2017]. In a small proportion of patients with contraindications to all the previously mentioned approaches, when performing transcatheter aortic valve implantation (TAVI), a retroperitoneal mini-access to the iliac arteries was proposed [Patent RU 2581320]. The possibility of changing the vascular access from transfemoral to transapical was also previously reported in relation to transcatheter aortic valve replacement and in the technical characteristics of the devices being developed [Patent US 8366767 B2].

With regard to minimally invasive pulmonary valve replacement without the use of cardiopulmonary bypass, several methods of access are also known for transcatheter pulmonary valve implantation.

With regard to transfemoral venous vascular access, as a result of a search in the scientific and patent literature, the following data were found. Its application is based on the widespread and long-known Seldinger method, which involves the puncture of a large vessel, in this case the femoral vein [Seldinger S.l. 1953]. The vast majority of modern endovascular devices are initially adapted specifically for the possibility of delivery through a large vein, as can be seen in the examples of modern delivery systems and transcatheter valve implantation systems [Patent FR 9608334 A; Patent US 8721713 B2]. However, the conditions for the use of this access in the practice of specialists involved in the treatment of congenital heart disease are far from always ideal. The following aspects are listed below that make it difficult or impossible to use transfemoral venous access.

First, it is typical when, in the presence of complex cardiac pathology, patients undergo several invasive catheterization studies with probing of the chambers of the heart and blood vessels throughout their lives. Respectively. there is an increased likelihood of developing thrombosis and impaired vascular patency, as a result of damage to their intima as a result of numerous punctures [Alekyan B.G., 2017].

Secondly, the frequency of venous occlusion on the thigh in the long term can be 10-29% [Kveselis D.A., 1989; Syamasundar Rao P., 1989]. As a result, they have limited or no vascular access.

This access is limited by the small diameter of the vessels, which is a general contraindication for the use of any endovascular techniques when it is required to pass through the vascular lumen devices comparable to the diameter of the vessel itself or exceeding it. First of all, these are low-weight patients and children under 5 years of age [Zahn E.M., 2009].

Thirdly, even when a successful femoral vascular puncture is performed, one cannot ignore a certain aspect of the complexity of transcatheter manipulations within the heart and great vessels. Thus, in a series of patients who underwent grancatheter pulmonary valve replacement using transfemoral access, every fifth case of technical problems was described, the reasons were as follows:

1) go to the conduit;

2) position the catheter distally;

3) pass into the branches of the pulmonary artery;

4) the inability to complete the procedure from the ventral access, etc. [Zampi J.D., 2016].

In addition, when performing catheter manipulations with access through the venous access, perforations of the leaflets and even detachment of the structures of the tricuspid valve are described, which is fraught with severe complications requiring surgical treatment.

Strictly speaking, the very fact of passing the delivery systems through the tricuspid valve and the U-shaped cavity of the right ventricle, its complex geometric shape, carries a potential threat of damage to various anatomical structures. The mechanism of this complication is explained by the access technique itself, since the balloon device inserted into the right ventricle through the tricuspid valve, both at the time of conduction and during inflation, somehow interacts with the valve-subvalvular structures. At the same time, at the time of balloon expansion, its proximal third is defined as the largest problem area for the tricuspid valve [Attia 1., 1987]. Pronounced trabecularity inherent in the right ventricle by nature. especially in conditions of myocardial hypertrophy, it can create pronounced technical difficulties for the antegrade introduction of conductors and catheters into the pulmonary artery, up to their wedging between the trabeculae themselves, followed by open surgical extraction [Min Y.S., 1996]. At the same time, difficulties with passing catheters and conductors by standard transvenous access at the time of passage through the cavity of the right ventricle can be not only in small children. The well-known so-called “difficult” anatomy of the inflow and outflow parts of the right ventricle, which, together with the characteristic right ventricular trabecularity and various anomalies in the shape and size typical of congenital heart defects, significantly complicates in some cases even the most common endovascular interventions on the pulmonary valve and in adult patients (Deora S. 2014].

In addition, there are descriptions in the literature of a rupture of the outflow tract of the right ventricle at the time of transcatheter implantation by percutaneous gransfemoral access, which served as a refusal to complete the implantation procedure itself [Voe V.A., 2016].

The literature also came across a conclusion, the mechanism of which is not fully understood, that high pressure figures in the right chambers of the heart, combined with tricuspid valve insufficiency, determine a high risk of technical difficulties, up to the failure of the minimally invasive valve implantation procedure when using the femoral venous access in patients , which according to other criteria are candidates for transcatheter pulmonary valve replacement [Zampi J.D., 2016].

The absence of a segment of the inferior vena cava does not allow the use of a delusional venous access. Moreover, in such a situation, any minimally invasive endovascular diagnostic and therapeutic manipulations will require individual solutions [Conti S., 2018]. This is not a common situation, however, in the presence of concomitant congenital heart defects (including Fallot's tetralogy as one of the main defects that require reoperation on the pulmonary valve), up to 10% of the total number of these patients may have congenital anomalies of the systemic veins, including including the absence of the right superior vena cava or a segment of the inferior vena cava. [Irwin R.B., 2012].

The Applicant has described a venous jugular access for the delivery of transcatheter devices. The advantage of access in comparison with transfemoral access is the possible reduction of the threshold criterion for body weight for transcatheter delivery of the device [Berman D.P., 2010; Zampi J.D., 2016]. However, the authors of the papers describing the results of such a strategy indicate that the benefits of this approach are still not clear and which patients benefit from the transjugular approach is not entirely known. The known method is rarely used, no more than 17% of the total number of transcatheter pulmonary valve implantations requires preliminary preparation, since intraoperative access changes may lead to the risk of complications, for example, damage to the brachial plexus [Chen W., 2011; Zampi J.D., 2016]. In any case, no convincing technical advantages were shown with the femoral approach, moreover, the exposure time and the duration of the operation were significantly higher with the transjugular approach than with the transfemoral one. The disadvantage of the known method is also the exposure of the operator to large doses of radiation and the need to use additional protective screens for the patient. Difficulties also arise in placing anesthesia and other standard equipment at the head end of the patient in the operating room. Under these conditions, the use of access also creates objective difficulties in ensuring the sterility of the surgical field when manipulating long wires and catheters, especially in light of the risk of infectious complications [Armstrong A.K., 2014].

The use of transvenous access is described when performing bilateral implantation of a transcatheter valve in both branches of the pulmonary artery [Gillespie M.J., 2011]. The method is original, however, according to the description of the authors themselves, it was rather an individual, but forced decision due to the complex anatomy of the right ventricular outflow tract and a sharp dilatation of the pulmonary artery trunk in the absence of appropriate sizes of the transcatheter valve used by the manufacturer.

The disadvantages of the technique are the same as those of the others previously mentioned using an isolated endovascular device delivery method. The disadvantages of this technique:

1. limiting the size of implantable devices;

2. the impossibility of performing simultaneous narrowing, plication or reduction of the pulmonary artery trunk;

3. in addition, the complexity of the method due to the need to use two valve-containing devices, respectively, potentially, at least 2 times higher risk of specific complications (dislocation, not exactly positioning, etc.);

4. there is a possibility of technical difficulties in the subsequent replacement of both valves. Obviously, the extraction of two valve-containing devices from the branches of the pulmonary artery in the future will be associated with a certain risk, since such a reoperation is not well-established and is not described in modern literature;

5. The hemodynamic advantages or disadvantages of the functioning of valve-containing devices in the long-term period in the described heterotopic region are not clear.

Taking into account the fact that modern transcatheter valves are often already initially developed as universal in terms of delivery to the implantation site, since their design allows the use of various vascular access [Patent US 20190053901 A; 1 Patent US 5411552 A].

The objective of the claimed invention is to develop a highly effective method of minimally invasive surgical treatment using a hybrid transapical right ventricular access to the pulmonary artery valve, which makes it possible to implant a transcatheter valve-containing device without a high risk, providing the ability to significantly improve the quality of life of patients in the postoperative period.

From the available sources of methods close in technical essence in relation to the pathology of the pulmonary valve, a method of hybrid prosthetics of the pulmonary valve was identified, described in the work of Porras D., et al. (2015). In this case, a lateral horacotomy is performed in the 3rd intercostal space with separation of the pulmonary artery trunk from adhesions and adhesions for the purpose of plying with mattress sutures or, if plying is impossible. for bypassing and narrowing with braid. Then, a control inflation of the balloon is performed, which is brought in by a venous femoral access, and a transcatheter prosthesis of the pulmonary artery valve is delivered to the implantation site with the same access. The method makes it possible to simulate a sharply dilated trunk of the pulmonary artery to match the dimensions of the valve.

The method has the following disadvantages:

1. Described only for patients after transannular correction of conotruncus malformations. There is the possibility of using in relation to the artificial trunk of the pulmonary artery or homografts, and in the presence of their calcification is not possible or risky.

2. There is a possibility of damage to the trunk of the pulmonary artery during circular discharge from adhesions.

3. Manipulations but plicing or narrowing of the pulmonary artery to the required size seem unnecessary if there are valves of sufficiently large sizes. The technique is aimed at the possibility of using a valve with a maximum size of no more than 22 mm.

4. The main intracardiac stage associated with the implantation of a transcatheter valve is provided through the femoral venous access, which carries the corresponding disadvantages of this method described above.

From the studied prior art revealed a hybrid method proposed by Travelli F.C., et al. (2014), which involves a complete sternotomy with the isolation and wrapping of the dilated pulmonary artery trunk with a separate synthetic prosthesis, modeling it to the required reduced diameter (22 mm is described). The synthetic prosthesis is marked with metal clips that serve as guides during fluoroscopy for better positioning of the valve and determining the level of branching [Travelli F.C., 2014]. A purse-string suture is applied to the output tract of the right ventricle at some distance from the trunk of the pulmonary artery. Then, through the incision controlled by this suture, a transcatheter valve is inserted and implanted into the cone and then into the trunk of the pulmonary artery using a delivery system. The advantage is the absence of remote venous access with the corresponding disadvantages of the use described.

However, the method has disadvantages in parts 1, 2, 3 of the previous method.

4. The main access to the heart associated with the implantation of a transcatheter valve is provided through a median resternotomy, which carries the corresponding disadvantages of this method described above. In this sense, the repeated isolation of the heart from adhesions in terms of the volume of cardiolysis is comparable to that for connecting a heart-lung machine.

5. The proposed right ventricular puncture area is actively involved in the contraction, respectively, there is a certain myocardial injury.

Dittrich S., et al. (2008) proposed a hybrid transpulmonary pulmonary valve replacement with a left-sided thoracotomy in the 3rd intercostal space. The essence of the well-known method is that. that it includes a peripheral connection of a heart-lung machine with cannulation of the femoral vessels. The delivery system for a transcatheter self-expanding valve is inserted through a purse-string suture at the bifurcation of the pulmonary artery and then the device is fixed with three sutures through the vessel wall to prevent its migration [Dittrich S., 2008]. The method allows you to get the valve up to the size of 29 diameters without complete sternotomy and damage to the myocardium.

The method also has its drawbacks:

1. Performed under conditions of cardiopulmonary bypass.

2. Requires extensive mobilization of the pulmonary artery trunk area, which, under conditions of varying degrees of adhesion, carries a certain risk.

The known method of hybrid intervention Phillips AB, et al. (2016). After a thorough preoperative assessment based on MRI/CT data with the construction of a 3D model of the outflow tract of the right ventricle of a particular patient, the first stage is the creation of the so-called. "landing zone" with the help of pre-implantation of an uncovered metal stent with an expansion of the outflow tracts of less than 26 mm or a covered one with a more significant dilatation. Contact with the heart is carried out from a subxiphoidal approach with purse-string sutures on gaskets applied to the diaphragmatic surface. [Phillips A.V., 2016]. The method is indicated for complex anatomy and a significant expansion of the pancreatic outlet and does not require the use of cardiopulmonary bypass.

1. The created 3D model of the right ventricular outflow tract is “averaged”, i.e. is able to cover only a certain "middle" of the cardiac cycle between the phases of systole and diastole.

2. Puncture access to the cavity of the right ventricle is located close enough to the structures of the tricuspid valve and carries the risk of interaction with the delivery system, which explains the need for preliminary construction of a complex spatial 3D model.

3. The area of purse-string sutures on the diaphragmatic surface of the heart seems to be a rather problematic anatomical zone of an actively contracting myocardium and the passage of branches of the coronary arteries.

4. A subxiphoidal incision is made along the old scar, however, the area may be represented by adhesions that complicate local cardiolysis.

In general, the disadvantages of the methods described above is also their non-universality, since usually each of the available methods often depends on the profile and dimensions of the implanted devices used, does not cover a wide range of anatomical variants of the pulmonary valve pathology, in some cases requires cardiopulmonary bypass and, often, it is difficult to adapt to pronounced morpho-functional changes in the previously operated outflow department of the right ventricle and the pulmonary artery trunk.

The technical result of the claimed technical solution is the possibility of effective minimally invasive hybrid implantation of a transcatheter valve of any available size in the pulmonary position, regardless of the degree of severity of the adhesive adhesive process behind the sternum and in the pericardium, ensuring a high degree of positioning accuracy of the valve-containing device during implantation. As a result, restoration of normal blood flow through the outflow tract of the right ventricle to the pulmonary artery with prosthetics of the pulmonary valve function without the use of cardiopulmonary bypass is achieved, which is especially important for patients with expansion and hypertrophy of the right heart cavities, who have already undergone heart surgery to correct congenital heart failure. pathologies in the volume of transanular plasty of the pulmonary artery stem with various types of patches, elimination of valvular or combined valvular obstruction of the pulmonary artery without the possibility of preserving the valve, correction of the defect by implanting an artificial valveless trunk (conduit) of the pulmonary artery or valve-containing with the development of dysfunction in the late postoperative period.

The essence of the claimed method lies in the fact that the proposed hybrid technique for transcatheter pulmonary valve replacement is carried out by transapical puncture right ventricular access from the anterior-lateral thoracotomy on the left. The technique does not require the connection of cardiopulmonary bypass and resternotomy, an extensive process of isolating the heart and blood vessels from scarring, which is especially important in cases of severe adhesions (postponed mediastinitis, secondary wound healing, severe conduit calcification, several abdominal interventions in history, etc.) Also the technique provides an understandable and technically reproducible process of valve implantation in an orthotopic position without the need for intraluminal manipulations and intraventricular maneuvers using extended wires, catheters and support and delivery systems from a remote access point, at a considerable distance from the main valve implantation zone. In the claimed technical solution, the goal is realized in practice when the valve of interest to the surgeon and the area of access to it are on the same line, which is an advantage in determining the choice of an endovascular method [Alekyan B.G., 2017]. In this case, from the point of transapical puncture, i.e. from the apex of the right ventricle to the pulmonary valve, the distance is almost a straight line, on the path of which, in the absence of residual obstruction from abnormal muscle trabeculae. Normally, there are no anatomical formations. Thus, this fact itself significantly simplifies the procedure for installing a prosthetic valve and increases the accuracy of its positioning. This is a significant difference between this hybrid access technique and isolated endovascular ones. for which the main, fundamental and often irreparable drawback is expressed by the formula “too small device or too large delivery” [[Dittrich S., 2008; Morgan G.J., 2018].

The claimed combination of a new set of techniques used will reduce the number of early postoperative complications in the form of failure of sternotomy wounds. reduce the risk of bleeding, the need for severe re-interventions on the outflow tract of the right ventricle and the pulmonary valve in case of their dysfunction, the replacement of previously implanted conduits of various types, reduce the need for postoperative pain relief and shorten hospital stay, since the proposed access in the context of hybrid intervention is minimally invasive and less traumatic . The claimed method, in addition to the advantages described above, can be successfully used in patients who were denied endovascular treatment due to the lack of peripheral venous access or the small diameter of the vessels, the presence of anomalies in the confluence of the systemic veins, severe dilatation of the pulmonary artery trunk and / or the output section of the right ventricle, in which there are limitations in the availability of a large range of devices with the possibility of transcatheter venous implantation.

The main disadvantage of the claimed method is the complexity of its application in obesity.

The method is carried out as follows.

The patient is placed on his back, with a slight rotation of the table to the right, and the left half of the chest is raised. The operating field is marked for anterior-lateral minni-thoracotomy on the left at the level of the 5th intercostal space with marking under echocardiographic transthoracic control of the apex of the heart.

Under endotracheal anesthesia after heparinization, the common femoral artery is punctured on the right with the installation of a 6F introducer. Arterial access is further used to perform control coronary angiography. Perform a mini-thoracotomy. pericardiotomy with the imposition of traction sutures of holders on the edges of the pericardium. The region of the apex of the heart is mobilized, sufficient for the imposition of two rows of a purse-string suture, external myocardial electrodes are fixed and for subsequent hemostasis. Since there are either no adhesions in this zone, or there is a slight adhesion process, cardiolysis usually does not present difficulties even with the repeated nature of the intervention. The area of the apex is identified, represented by the right ventricle, on which two purse-string sutures are circularly applied on the pads, which are then taken into tourniquets. In the avascular zone, at some distance from the purse-string sutures, two myocardial electrodes are sutured for superfrequency ventricular stimulation. Under the control of fluoroscopy, the apex of the right ventricle is punctured in the area of purse-string sutures with the installation of a 6F introducer, then a diagnostic catheter is inserted transapically into the trunk of the pulmonary artery through it. After advancing the catheter to the level of the pulmonary artery valve, a diagnostic study is performed to clarify the anatomy of the trunk, branches of the pulmonary artery and the area of the proposed implantation of the transcatheter valve. The soft conductor is changed to a more rigid one capable of providing adequate support to the delivery system. Next, a balloon of the appropriate diameter is inserted into the trunk of the pulmonary artery and inflated, with the help of which the implantation area is measured and the tightness of the area covered by the balloon is assessed for paraprosthetic leaks of the contrast agent. Balloon inflation ^is performed against the background of superfrequency ventricular pacing. At the same time, at the moment of inflating the balloon in the pulmonary artery trunk, the patency of the left coronary artery is controlled, which is contrasted during coronary angiography with a catheter previously installed in the aorta. The obtained information about the position of the balloon later serves as a reference when displaying the image on the control monitor. After specifying the required size of the valve in case of its discrepancy along the length of the obstruction, usually in these cases we are talking about a stenotic conduit, stenting of the target implantation zone with a stent is preliminarily performed. Both bare metal and coated stents can be used. When deciding on the absence of preliminary stenting, the next stage is immediately performed, in which the introducer is changed to a delivery system. The latter includes a valve crimped onto a balloon catheter designed for transcatheter implantation. Under direct visual control, the delivery system is passed along a rigid guidewire transapically into the pulmonary artery trunk. When the image of the system is displayed on the monitor, the valve position is adjusted according to the available radiopaque balloon marks. Given that the delivery of the transcatheter valve is carried out over a short distance and in fact in a straight line from the apex of the right ventricle to the implantation zone in the pulmonary artery trunk, the process of precise positioning is greatly simplified. This does not require any additional maneuvers in the form of creating supporting and reinforcing the progression of conduction loops in the cavities of the heart and additional time for manipulations with various long catheters. After verifying the exact positioning of the valve-containing complex at the required level of implantation and the coincidence of landmarks with the reference image of the control monitor, the transcatheter valve is implanted and released against the background of high-frequency ventricular stimulation of the heart. After that, the delivery system is removed and a control angiographic and transesophageal assessment of the position and function of the implanted valve is performed. The guidewire is removed, the pouches are tied, hemostasis is controlled, and the mini-thoracotomy wound is sutured in layers, leaving cavity drainage for a day. The present invention is illustrated by drawings.

Fig. 1. Frontal image of the patient's chest area before the intervention with the projection of the heart and great vessels on the anterior chest wall (designations: Ao - aorta, LA - pulmonary artery, RA - right atrium). Hybrid thoracotomy mini-access is performed through a skin incision on the left (1), which starts 2-3 cm outward from the edge of the midclavicular line. Immediately before the intervention, according to transthoracic echocardiography, the area where the apex of the heart is projected onto the chest wall is marked (indicated by an asterisk *). Taking into account the increased size of the heart of these patients, the use of echocardiography is justified, since the standard anatomical orientation in conditions of cardiomegaly often changes. The direction of access corresponds to the 5th intercostal space, represented by a dotted line (2) (between the 4th and 5th ribs) along the edge of the costal arch, 1-2 cm short of the anterior axillary line posteriorly. The length of the incision is 6-9 cm. the incision of the skin itself may be moved downward for cosmetic purposes. The dilution of the intercostal muscles is performed along the upper edge of the underlying rib to prevent damage to the neurovascular bundle.

Fig. 2A. In this FIG. and all subsequent ones, a diagram-section of the heart is presented with the capture of the right and left sections. This demonstrates the performance of control balloon dilatation of the pulmonic valve before valve implantation. Through a previously applied circular double-row purse-string suture (the outer and inner rows are superimposed in opposite directions) on synthetic gaskets (3), controlled by tourniquets (5), a transapical (4) puncture of the cavity of the right ventricle (RV) was performed with introduction into the trunk of the pulmonary artery (LA) guide catheter (7). The catheter passes beyond the level of the diseased pulmonary valve (PAV) into one of the branches, usually the left one. Other designations: Ao - aorta, LV - left ventricle, 6 - subvalvular structures of the tricuspid valve.

Fig. 2 C. The continuation of the beginning of the previous procedure is shown, namely, the moment of inflating the transcatheterally (8) inserted balloon (9) for testing with simultaneous contrasting of the left coronary artery basin and the final determination of the dimensions of the pulmonary valve before valve implantation. Contrasting of the left coronary artery basin is performed from the aorta with another catheter inserted through a peripheral artery (not shown here). Given the typical dilation of the pulmonary artery and valvular insufficiency, a predilation procedure is not required. However, the latter is required in the presence of stenotic valve disease, usually after implantation of conduits at the first operation. Other designations as in Fig. 2A.

Fig. 3A. The first stage of the actual transapical implantation of the transcatheter valve is shown, when the introducer of the delivery system (10) with the guide catheter (11) is transapically inserted through the purse-string suture (3). The distal part of the introducer of the delivery system (12) is directed towards the intended entrance through the pulmonary valve (PA). It is important that the valve of interest to the surgeon and the area of access to it are on the same line, which facilitates all subsequent described manipulations. This stage, like all subsequent ones, requires displaying the image on monitors with the orientation of the delivery system according to radiopaque marks, and also, if necessary. visualization by other available methods (contrast ventriculography and pulmonography, transesophageal echocardiography, etc.)

Fig. 3B. The next stage of transapical implantation of a transcatheter valve is shown, when a balloon catheter (15) with a guide catheter (11) has already been inserted transapically through the introducer of the delivery system (10). The distal part of the sheath of the delivery system is still directed towards the intended entrance through the pulmonary valve, through which the catheter valve (13) is also already beginning to pass. which in turn is attached to the cylinder (14).

Fig. 3C. The stage of positioning of the transcatheter valve with the transapical delivery system (10) in the pulmonary artery trunk at the level of the native valve ring (KLA) is shown. The distal part of the sheath of the delivery system begins to pull back towards the operator, the transcatheter valve is released (13). however, it is still in the folded state on the as yet unopened balloon (14). This stage also marks the completion of all preparatory manipulations and the readiness of the valve for implantation.

Fig. 3D. The immediate stage of implantation of a transcatheter valve with a transapical delivery system (10) in the trunk of the pulmonary artery at the level of the native valve ring (KLA) is shown. At this moment, the balloon (14) is inflated, which is on the balloon catheter (15), wound through the guide catheter (11) of the delivery system, until the required degree of opening of the implantable valve (13) is reached and its outer surface optimally contacts the tissues and structures of the patient, forming a valve ring.

Fig. 3E. The view of the implanted transcatheter valve (13) is shown in an orthotopic position in the pulmonary artery trunk. This is preceded by deflation of the balloon from the transcatheter valve delivery system with the removal of the latter, including all other catheters and conductors, from the cavities of the heart and vessels. The site of transapical puncture of the right ventricle (16) is tightened with tourniquets (5) on purse-string sutures, which are then finally tied.

It should be noted that at the time of publication, our experience includes 5 successful cases of transcatheter pulmonary valve replacement using the proposed hybrid transapical approach. As an example, we present the case history of one of the patients.

Patient S., aged 25, was admitted to the Federal State Budgetary Institution "FTSSSH" of the Ministry of Health of Russia (Penza) for examination and surgical treatment in serious condition. From the anamnesis it is known that she was observed with a congenital heart disease - Fallot's tetralogy from birth, at the age of 8 years she underwent a radical correction of the defect in the volume of transanular plasty of the trunk and the right ventricular outflow tract with a patch with a monocuspid valve. After the correction of the defect, she felt satisfactorily, however, in the last 3 years she noted a progressive deterioration in the form of an increase in shortness of breath, the appearance of more frequent episodes of anxiety with panic attacks, accompanied by palpitations. Recently, she has been constantly taking medication (beta-blockers, ACE inhibitors, diuretics). Despite taking the drugs, there was a negative trend in the form of an increase in the chambers of the heart and an increase in insufficiency on the pulmonary artery valve. She was hospitalized in the Federal State Budgetary Institution "FTSSSH" of the Ministry of Health of Russia (Penza). Objectively, the patient has a slender physique, body weight 45 kg, body surface area was 1.44 m ² . Auscultatory: the heart rhythm is correct, the tones are muffled, diastolic murmur over the pulmonary artery in the 2nd intercostal space on the left 3/6 intensity. Percussion: the borders of the heart are expanded to the right. Blood pressure: A/D on the right upper limb = 90/60 mm Hg, A/D on the right lower limb = 100/65 mm Hg. Art. Pulse rate 80 beats / min. Blood oxygen saturation according to pulse oximetry was 100%. The functional test showed a decrease in exercise tolerance to functional class III. X-ray pulmonary pattern is not changed, the roots are structural, the heart is enlarged due to the right chambers. Echocardiography revealed a decrease in contractility with an ejection fraction of the left ventricle of 53%, for the right ventricle of 45%. expansion of the right chambers of the heart with end-diastolic and end-systolic sizes for the right ventricle, respectively, 217 ml and 119 ml, with corresponding indexed values of 151 ml/m ² and 82 ml/m ² . Pulmonary valve insufficiency was determined 3+ with a regurgitation fraction of 40%. The dimensions were 2.8 cm for the outlet section of the right ventricle in the subvalvular region, 2.0 cm at the level of the valve ring. At the level of the trunk, 1.9 cm. The data of magnetic resonance and computed tomography studies did not contradict the diagnosis and also coincided according to the latter, calcification of the excretory section and the trunk of the pulmonary artery was detected, corresponding to the transanular patch used for radical correction. Final diagnosis: condition after radical transanular correction of Fallot's tetrad. pulmonary valve insufficiency 3+, circulatory insufficiency stage 1, functional class III no NYHA. In accordance with the existing criteria, which take into account the high risk of deterioration due to planned pregnancy, the age at the time of radical correction of Fallot's tetrad is older than 3 years, and the presence of several additional criteria indicating the hemodynamic significance of the pathology of the pulmonary valve, indications for its transcatheter prosthetics using the hybrid method were determined. [Geva T., 2013].

The operation of transapical implantation of the mechanical flap valve "MedLab-KT" 23 with PTFE leaflets was performed in a hybrid X-ray without cardiopulmonary bypass. The operation was performed according to the described method. Transthoracic echocardiographic study established the position of the apex of the heart. After performing a lateral mini-thoracotomy in the 5th intercostal space, the pericardium was opened and taken on a holder. The presence of a moderate number of adhesions in the area of the apex was noted. Cardiolysis was performed without any features in this zone. Under endotracheal anesthesia, the common femoral artery on the right was punctured and a 6F introducer was placed. After heparinization, two rows of purse-string sutures were placed on the apex of the right ventricle, 2 myocardial electrodes were sutured, and its cavity was punctured under fluoroscopy control. Inserted transapically introducer 6F. A diagnostic catheter was passed along the conductor into the pulmonary artery system with the change of the soft conductor to a hard one. Next, the balloon catheter was installed in the LA swell and it was inflated with simultaneous coronary angiography of the basin of the left coronary artery, the patency of which was completely preserved at the time of balloon dilatation. Through the introducer, a delivery system with a 23 mm valve compressed on the balloon was inserted into the valve position of the pulmonary artery, and against the background of the initiated temporary high-frequency stimulation of 200 beats per minute, its orthotopic implantation was performed. After removal of the delivery system, control angiography and control transesophageal echocardiography were performed, according to which the position and function of the valve were unremarkable, the area of the effective orifice of the valve prosthesis was 1.31 cm/m ² . peak gradient (mean) 9 (3) mmHg Next, the conductor was removed, the purse-string suture at the top was tightened, and the standard completion of the operation. The postoperative period was uneventful, healing of the minithoracotomy wound by primary intention (the sutures were removed on the 8th day at the place of residence). The patient was discharged on the 3rd day after the operation. Re-examined after 6 months. At the time of examination, there were no complaints, normal physical activity is tolerated calmly, their tolerance has increased significantly, it corresponds to functional class 1 according to NYHA. Resting heart rate 75 beats per minute. auscultatory tones are rhythmic, in the projection of the pulmonary artery the usual 2nd tone is determined, there are no noises over the heart area. According to the echocardiographic examination, the same data were obtained from the side of the prosthesis as at discharge; from the side of the heart, the indicators also revealed a clear positive trend: the end-diastolic and end-systolic sizes for the right ventricle were 176 ml and 88 ml, with the corresponding indexed values of 122 ml/m ² and 61 ml/m ² . The contractility of both the left and right ventricles increased, respectively, amounting to 63% and 50%.

Thus, our proposed method of hybrid pulmonary valve replacement by transapical right ventricular access from the left lateral mini-thoracotomy allows avoiding the use of cardiopulmonary bypass and significantly reducing the trauma of surgical treatment in patients who are indicated for surgical treatment for valvular pulmonary pathology, as well as preventing or minimizing risks associated with the repeated nature of open surgery in such patients. This technique allows avoiding severe consequences that are possible when using another abdominal method of treatment (failure of a sternotomy wound, bleeding, the need to increase the volume of intervention in the form of conduit replacement, etc.) or isolated endovascular (characteristic difficulties in performing peripheral vascular access, performing intracardiac manipulations or other technical nature that makes it impossible to perform or complete the procedure). With the introduction of hybrid transcatheter pulmonary valve replacement into clinical practice, it can be considered as an alternative to surgical treatment in patients at high risk of cardiac surgery, as well as when it is impossible to perform an isolated endovascular intervention, which will improve the results of treatment of this severe category of patients.

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Claims (2)

1. The method of hybrid transcatheter implantation of the pulmonary valve by transapical access, which consists in the fact that the patient is laid on his back, with the table rotated to the right and the left half of the chest is raised, the operating field is marked for anterior-lateral mini-thoracotomy on the left at the level of the 5th intercostal space with marking under echocardiographic transthoracic control of the region of the apex of the heart, then, after endotracheal anesthesia, after heparinization, the common femoral artery is punctured on the right with the installation of a 6F introducer, then arterial access is used to perform control coronary angiography, mini-thoracotomy, pericardiotomy are performed with the imposition of traction sutures-holders on edges of the pericardium, after which the region of the apex of the heart is mobilized, sufficient for the imposition of two rows of a purse-string suture, external myocardial electrodes are fixed for subsequent hemostasis, then the region of the apex, represented by the right ventricle, is identified, on which the two purse-string sutures are placed on the pads, then taken into the tourniquets, while in the avascular zone, at a distance from the purse-string sutures, two myocardial electrodes are sutured to conduct microwave ventricular stimulation, then, under the control of fluoroscopy, the apex of the right ventricle is punctured in the area of the purse-string sutures with the installation of an introducer 6F, then a diagnostic catheter is inserted transapically into the pulmonary artery trunk through it, then after the catheter is advanced to the level of the pulmonary valve, a diagnostic study is performed to clarify the anatomy of the trunk, branches of the pulmonary artery and the area of the proposed implantation of the transcatheter valve, then the corresponding the diameter of the balloon, which is used to measure the implantation area and assess the tightness of the area covered by the balloon for paraprosthetic leaks of the contrast agent, the balloon is inflated against the background of microwave ventricular stimulation, at the same time With this, at the moment of inflation of the balloon in the pulmonary artery trunk, the patency of the left coronary artery is controlled, which is contrasted during coronary angiography with a catheter previously installed in the aorta, then information about the positioning of the balloon is obtained, and after receiving information about the correct positioning of the balloon, the specified size of the required valve is selected , then the introducer is changed to a delivery system, the latter includes a valve crimped on a balloon catheter, then, under direct visual control, the delivery system is passed along a rigid conductor transapically - the valve itself is inserted into the pulmonary artery trunk, while the image of the system is displayed on the monitor in real time , perform adjustment of the valve position according to the available radiopaque balloon marks, in case of visual confirmation that the delivery of the transcatheter valve was carried out correctly, i.e. with the exact positioning of the valve-containing complex at the required level of implantation and the coincidence of landmarks with the reference image of the control monitor, the transcatheter valve is implanted and released against the background of high-frequency ventricular stimulation of the heart, then the delivery system is removed and a control angiographic and transesophageal assessment of the position and function of the implanted valve is performed, then the guidewire is removed, the pouches are tied, hemostasis is controlled, and the mini-thoracotomy wound is sutured in layers, leaving cavity drainage for a day, thereby completing the surgical intervention. 2. The method according to claim 1, characterized in that in case of valve mismatch along the length of the obstruction, stenting of the target implantation zone with a stent is preliminarily performed, while using an uncoated or coated metal stent.

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