RU2453278C2 - Method of implantation of mechanical prosthesis of heart - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to cardio-surgery. Implanted is prosthesis cup, which contains stop element, equipped with fixer. Revision of left ventricle cavity is performed. Fixing of ring-shaped body of prosthesis, which contains locking elements in form of two leafs in prosthesis cup, is realised. Frame of prosthesis is placed in cup and fixer of stop element is compressed. Eyes of stop element are fixed with thread.

EFFECT: method makes it possible to considerably reduce risk of development of post -operative valve-induced complications and post-operative lethality, associated with prosthesis replacement.

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Description

The invention relates to medicine, namely to cardiac surgery, and can be used in the treatment of aortic valve defects, as well as in the treatment of dysfunctions of artificial heart valves (IKS) in the aortic position.

Pathology of the aortic valve of congenital or acquired etiology occurs in 3-18% of all heart diseases and remains one of the most urgent problems today (1).

Among patients with acquired heart valve defects, aortic valve pathology occurs in 30-35% of cases; the aortic valve is in second place after mitral rheumatic lesions (2).

The number of patients with calcified aortic defect in developed countries reached the third most frequent position after arterial hypertension and coronary heart disease (3).

The aortic valve in adult patients is least suitable for plastic correction. An alternative to valve-saving surgery for aortic defects is the replacement of the affected aortic valve with various mechanical prostheses. Currently used mechanical prostheses of heart valves have good hemodynamic characteristics and a small percentage of the development of complications and dysfunctions of artificial valves (4).

Early dysfunctions include paraannular fistulas of the aortic prosthesis, prosthetic thrombosis, which are caused by active infectious endocarditis, widespread calcification of both the fibrous ring of the aortic valve and paraannular structures. A late cause of aortic prosthesis dysfunction is the development of pannus syndrome. Complications of mechanical prosthetics range from 0.1 to 2%, an average of 0.2% per year. The freedom from repeated surgical interventions associated with prosthetic dysfunction ranges from 99% to 94% over 10 years (5).

With the development of mechanical valve dysfunctions associated with thrombosis, the formation of paraannular fistulas or pannus syndrome, it is necessary to replace the mechanical prosthesis. Replacing a mechanical prosthesis is associated with a risk of a number of serious complications, such as damage to the fibrous ring, interventricular septum and the development of complete atrioventricular block. Postoperative mortality, according to different authors, varies from 5 to 35%.

However, with the development of ICS dysfunction, it is not always necessary to perform prosthetics. In the presence of a paravalvular fistula, in some cases it is possible to suture it. According to the NNIIKK, in case of a pannus of the aortic prosthesis, in 26.9% of cases it was possible to perform de-clotting of ICS, in which special attention was paid to removing the pannus from the ventricular surface of the prosthesis (6). It should be noted that due to the design features of ICS, declotting in most cases is easier to perform if the patient has a ball prosthesis in the aortic position.

In cardiac surgery, methods of implanting artificial heart valves into the fibrous ring using various types of sutures are used. Due to the impossibility of a complete revision of the left ventricular cavity after fixing the artificial heart valve in the fibrous ring in the early postoperative period, in some cases, an increased gradient at the level of the prosthesis may arise due to incorrect orientation of the locking element or partial or complete blocking of the locking element of the prosthesis due to interposition of subvalvular tissue. This greatly increases the risk of a fatal outcome, even with timely diagnosis of this complication and reoperation.

The purpose of the invention is to more effectively eliminate valve defects, to minimize prosthetic dysfunction in the postoperative period, to facilitate the reprosthesis and declotting of heart valves.

To achieve the goal, a method is proposed for implanting a low-profile mechanical prosthesis of the heart valve - heart valve “Meding” with a removable casing fixed in the cuff containing locking elements.

The method is as follows.

Perform operative access to the heart, the connection of cardiopulmonary bypass, cardioplegia, access to the affected aortic valve. The valves of the affected valve or a previously implanted prosthesis of the aortic valve are excised, myoectomy of the output section of the left ventricle is possible, as well as the expansion of the fibrous ring by various methods. Figure 1 shows a fibrous ring after resection of a previously implanted aortic valve prosthesis.

Then the implantation of the prosthesis is carried out in three stages.

The first stage is carried out by implanting the cuff of the prosthesis (Figure 2), containing a locking element provided with a latch. The hemming of the cuff to the fibrous ring is carried out using separate U-shaped seams on the gaskets, carried out supraannularly or intraannually depending on the anatomical conditions. The main point at this stage is the correct orientation of the retainer element of the prosthesis cuff, which should be located during implantation in the aortic position in the projection of the non-coronary sinus, which avoids obstruction of the coronary arteries (Figure 3). The prosthesis cuff is lowered into the fibrous ring and the sutures are tied in turn.

Then, with a special tool for unclenching, the clamp of the stopper element of the prosthesis cuff is pushed open and the polymer device is removed, which forms a hole for installing the ring-shaped prosthesis body and allows the cuff to be implanted into the fibrous ring of the prosthetic valve without the prosthesis itself (Figs. 4 and 5).

The second stage is the revision of the fibrous ring, the cavity of the left ventricle and subvalvular structures after fixation of the prosthesis. If necessary, carry out additional intervention on the fibrous ring of the valve, interventricular septum. Compliance with this stage allows, if necessary, to strengthen the prosthesis in the fibrous ring with additional sutures, perform a myoectomy of the exit tract of the left ventricle and, if necessary, resect the excess tissue protruding into the lumen of the cuff (Figure 6).

The third stage is the fixation of the ring-shaped body of the prosthesis containing locking elements in the form of two wings in the cuff of the prosthesis. To do this, the tool unclenches the retainer element of the prosthesis cuff, the prosthesis frame is placed in the cuff and compresses the retainer element (Fig. 7 and 8). After confirming the correct location of the locking element in the cuff of the prosthesis, fix the ears of the locking element with Etibond thread (Figure 9).

Check the functioning of the locking element of the prosthesis. Sutured accesses on the heart and aorta. Restore cardiac activity. Turn off cardiopulmonary bypass. Drain the pericardium and mediastinum. Sutured operational access.

Clinical examples of the method.

Patient D., 47 years old. IS No. 5558, was admitted to the NNIIPK on 06/15/09 with a diagnosis of HRBC. Aortic valve replacement surgery in 1987. Dysfunction (pannus) of the prosthesis. Ventricular extrasystole. CHF I Art. FC II.

Anamnes Morbi: The diagnosis of the defect was made in 1986. In 1987, aortic valve prosthetics were performed using a ball prosthesis. During the control examination, an increase in the systolic gradient to 80 mm Hg was noted. on the prosthesis due to the pannus.

Status Praesens Communis: Patient's condition of moderate severity. In the lungs, vesicular breathing is heard in all departments. The boundaries of cardiac dullness are not expanded percussion. Heart sounds are rhythmic, muffled. Heart rate: 80 beats. in minutes HELL - 140/90 mm Hg Rough systolic murmur with an epicenter above the aorta, is carried out under the scapula, on the vessels of the neck. The abdomen is soft, painless. Liver at the edge of the costal arch. No swelling. Pasternatsky’s symptom is negative.

Instrumental studies at admission

Coronarography 06/16/2009. Conclusion: the pathology of the coronary bed is not determined.

Ultrasound on 05/19/2009 PP 3.9 × 4.6 cm, PL 4.8 × 5.3 cm. PV - 69%, PV - 39%, CRLD - 4.9 cm, CRLD - 3.0 cm, CRDL - 110 ml, KsoLZH - 34 ml, UO - 76 ml, ZSLZH - 1.47 cm, MF - 1.72 cm. LV myocardial hypertrophy: LVJL = 1.4 cm; MZHP = 1,65 cm, its global contractile ability is good. Violations of segmental contractility have not been identified. AOK: shadow of a mechanical prosthesis, works without failures. In the projection of the braid of the prosthesis, additional echo signals are visualized: 0.7 × 0.9 cm; 0.5 × 0.6 cm; 0.5 × 0.8 cm, non-mobile and partially mobile - elements of the pannus. Closer to the zone of mitral-aortic contact, three anechogenic cavities are visualized: 0.3 × 0.4 cm; 0.3 × 0.6 cm; 0.4 × 0.5 cm, communicating with the cavity of the left ventricle - the “old” paraannular abscesses drained into the cavity of the left ventricle. LV / AO systolic gradient = 76-84 mmHg Mitral regurgitation of 1-11 Art. insignificant in volume. Tricuspid regurgitation 1-11 tbsp. insignificant in volume.

X-ray 06/15/2009: Pulmonary pattern changed as moderate fibrosis and mild stagnation in the ICC. The roots are fibrically densified; in the roots there are moderate signs of pulmonary hypertension. SLK = 52%, in the projection AoK shadow prosthesis. In the thoracic spine, bone-degenerative changes.

ECG 06/15/09: Sinus rhythm. Diffuse changes in the myocardium of the apex, lateral wall of the left ventricle.

Operation: 06/18/2009. Aortic valve reprosthesis with a mechanical prosthesis MedInzh No. 23 (modifications Su6).

Median sternotomy. Sternal and pericardial cavity pronounced adhesive process. Cardiolysis performed. Bicaval cannulation. Transverse aortotomy cardioplegia (Custodiol): in the aortic position, a ball prosthesis. The braid of the prosthesis is covered with a pannus from the ventricle. In the projection of the right coronary sinus is a fistula with a diameter of 5 mm. The prosthesis is removed, the fibrous ring passes the calibrator No. 25.

A cuff of a mechanical denture "MedInzh No. 23" (modifications Su 6) was implanted into the aortic position on 15 separate U-shaped sutures, 8 of which are on synthetic pads. The lock of the locking element is oriented in the projection of the non-coronary sinus.

The LV cavity was revised, a section of the pannus protruding into the lumen of the cuff of the prosthesis was resected.

A prosthesis frame with a locking element is installed in the prosthesis cuff, fixed by the locking element of the cuff. The ears of the locking element are ligated with Etibond thread.

Sealing of the aorta. IR off Wound closure. IR: 83 minutes Aortic clamping duration: 61 min.

The course of the postoperative period: in the postoperative period, rhythm disturbances were noted according to the type of paroxysm of atrial fibrillation. Healing by first intention.

Instrumental studies at discharge

ECG: Sinus rhythm with a heart rate of 78 beats. in min., ST-T dynamics were not detected.

Echo KG 06/24/2009: EF - 61%, FU - 34%, CRDL - 4.5 cm, CSLD - 2.3 cm, KDLD - 86 ml, CSLD - 32 ml, UO - 54 ml, VLDL - 1.8 cm, MF - 1.8 cm, PL - 4.4 × 5.2 cm, PP - 4.2 × 4.8 cm, cdrP - 2.4 cm. Aorta: FC - 2.5 cm, adm. department - 3.7 cm. Conclusion: The cavities of both atria are slightly expanded, myocardial contractility is normal, the aortic walls are dense. In the aortic position - the shadow of a mechanical prosthesis, there are no signs of dysfunction. PP = 15.6 mm Hg Valves of the mitral valve are sealed at the base. Mitral regurgitation of the 1st degree is insignificant in volume. Tricuspid valves are thin. Regurgitation 0-1 degrees. LV diastolic function is not impaired.

X-ray 06/26/2009. Description: The lungs are straightened. In the accessible sections of the pulmonary fields, pneumatization is not impaired. Stagnant changes in the pulmonary circulation are not pronounced. The diaphragm position is not changed. Free air and fluid in the pleural cavities are not detected. Mediastinum without features. SLK 52%. In the position of the aortic valve, the prosthesis.

The proposed method of implantation of the heart valve prosthesis "Minge" with a removable body, containing locking elements, can reduce the likelihood of serious complications, such as damage to the fibrous ring, interventricular septum. And with the development of dysfunctions of the prosthetic valve of the heart associated with thrombosis, the formation of paraannular fistulas or pannus syndrome, the valve body can be replaced with a new one without excision of the cuff. The method significantly reduces the risk of developing postoperative valve-related complications and postoperative mortality associated with replacement of the prosthesis.

The method allows to eliminate defects of the aortic valve in any anatomical conditions and to minimize the development of prosthetic dysfunctions in the postoperative period.

Literature

1. Prosthesis of the heart valve. Copyright certificate No. 1761132.

2. Burakovsky V.I., Bokeria L.A. Cardiovascular surgery. Moscow, 1989

3. Aortic valve disease. S.L.Dzemeshkevich, L.U. Stevenson, V.V. Aleksia-Meskhishvili. 2004 year

4. Prosthesis of the heart valve. U.S. Patent No. 5,137,532.

5. A method of manufacturing a heart valve prosthesis. Copyright certificate No. 1718900.

6. Karaskov A.M., Nazarov V.M., Zheleznev S.I. Dysfunctions of artificial heart valves. Novosibirsk, 2008

Claims (3)

1. A method of implanting a mechanical prosthesis of a heart valve, comprising implanting an artificial heart valve into the fibrous ring, characterized in that the implantation of the prosthesis is carried out in several stages, first, the valves of the affected valve are excised or the previously implanted aortic valve prosthesis is resected, if necessary, the fibrous ring is expanded, then the prosthesis is implanted in stages - first, the prosthesis cuff is implanted, containing the locking element provided with a retainer, the cuff they are wound to the fibrous ring with the help of separate U-shaped seams on gaskets performed supraannularly or intraannually depending on the anatomical conditions; the retainer element retainer is oriented in the projection of the non-coronary sinus, after which the prosthesis cuff is lowered into the fibrous ring and the sutures are tied one by one, then the prosthesis cuff retainer retainer is opened and the device forming the opening for installing the prosthesis body is removed and the fibrous ring, the left ventricular cavity is inspected and subvalvular structures after fixation of the cuff of the prosthesis; Then, in the prosthesis cuff, the ring-shaped prosthesis casing is fixed, which contains locking elements in the form of two wings, while the clamp of the locking element of the prosthesis cuff is pushed open, the prosthesis casing is placed in the cuff, then the clamp of the locking element is compressed and the ears of the locking element are fixed. 2. The method of implantation of a mechanical prosthesis of a heart valve according to claim 1, characterized in that during the revision of the fibrous ring, if necessary, additional intervention is performed on the fibrous ring and interventricular septum. 3. The method of implantation of a mechanical prosthesis of a heart valve according to claim 1, characterized in that the retainer of the retaining element is unclenched with a tool to unclench the retainer.

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