Method for prevention of postpericardiotomy syndrome in patients with ischemic heart disease after coronary bypass surgery

FIELD: medicine.

SUBSTANCE: early postoperative period involves administering low-molecular heparins and anti-inflammatory agents. Anti-inflammatory therapy requires administering cycloferon according to the schedule: 2 tablets of cycloferon 0.15 mg on the first preoperative day, 2 tablets on the first postoperative day, 2 tablets in the morning on the 2nd, 4th, 6th postoperative day, and further, every third day throughout 1 postoperative month (on the 9th, 12th, 15th, 18th, 21st, 24th, 27th, 30th day).

EFFECT: method provides the effective prevention of postpericardiotomy syndrome with a lower risk of side effects by administering cycloferon according to the developed schedule requiring non-steroidal anti-inflammatory agents and glucocorticosteroids.

2 ex, 3 tbl

 

The invention relates to the field of medicine, particularly to cardiology.

Postpericardiotomy syndrome (PCTs) is the most frequent complication of open-heart surgery and occurs according to foreign authors in 10-40% of cases (1), according to various Russian clinics - in 16-68% (2). Although the incidence of serious complications such as cardiac tamponade, constrictive pericarditis and early occlusion of shunts relatively low, even favorable for PCTs significantly increases the postoperative rehabilitation of the patient.

In Russia there are currently no recommendations, respectively, and a common tactic for the management of patients undergoing surgical revascularization.

A method of treating PCTs in accordance with the practical recommendations of the European society of cardiology with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticosteroid (GCS) and the combination of NSAIDs with colchicine in recurrent forms of the syndrome; for the prophylaxis of thromboembolic complications low molecular weight heparins are used in full therapeutic doses (3).

This method is the closest to the claimed technical essence and the achieved result and selected as a prototype.

The disadvantage of this method of treatment PCTs in line�AI with practical recommendations of the European society of cardiology is the large number of side effects. The use of non-selective inhibitors of cyclooxygenase accompanied by many undesirable effects; leads to increased risk for cardiovascular complications in patients undergoing coronary bypass surgery, increases the risk of shunt thrombosis. The SCS also quite unsafe and leads to such unpleasant consequences, such as poor healing of surgical wounds, the development and exacerbation of metabolic disorders, exacerbation of gastric ulcer and duodenal ulcer, decrease the body's resistance to infection, hypercoagulation risk of thrombosis.

The pharmacological strategies with proven efficacy for the prevention of the development of PCTs do not currently exist: there are contradictory and ambiguous data on preventive appointment of NSAIDs and corticosteroids (2, 4, 5), the use of NSAIDs in conjunction with colchicine did not lead to lowering the risk of complications. In the COPPS study, to evaluate the effect of therapy with colchicine without NSAIDs as a primary prevention PCTs (6), with encouraging results, however, require further confirmation.

The problem solved by this invention is the optimization of pre - and postoperative management of patients undergoing coronary artery bypass graft surgery.

Set�the first task is solved by the use in patients underwent surgery on the heart, in the early postoperative period of therapeutic doses of low molecular weight heparins and anti-inflammatory therapy, as an anti-inflammatory drug prescribed inductor of endogenous interferon - cycloferon in the scheme: the day before surgery 2 tablets of cycloferon 0.15 g, the next day after surgery, 2 tablets, the following methods of preparation - in the morning, 2 tablets at 2, 4, 6 day after the intervention, then after 2 days up to 1 month after surgery(9, 12, 15, 18, 21, 24, 27, 30 day).

Anti-inflammatory effects of interferon-based inducing production of anti-inflammatory cytokines (IL-10, transforming growth factor) in combination with inhibition of the synthesis of anti-inflammatory cytokines (IL-1, IL-8, TNF), on the activation of cellular and humoral immune response (Th1-type immune response associated with production of IFN-γ, Il-2 and TNF; Th2-type with increased production of IL-4, 5, 6, 10). (7, 8, 9, 10). At high immunomodulatory activity of the drug has almost no side effects, it is not described clinically significant interactions with other drugs (11). The use of cycloferon eliminates the routine use of NSAIDs in early paleoposition�m period.

New in the proposed method is the use as anti-inflammatories inductor of endogenous interferon - cycloferon.

Distinctive 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 for the expert. Identical set of properties not found in the patent and scientific and medical literature. Proposed as a method of the invention can be used in medical practice for optimization of pre - and postoperative management of patients with coronary heart disease.

Based on the foregoing should be considered a proposed credit Marsyas with its relevant conditions of patentability of "Novelty", "Inventive step", "Industrial applicability".

The method is as follows: the day before surgery 2 tablets of cycloferon 0.15 g, the next day after surgery - 2 tablets after the intervention (in the probe), the following methods of preparation - in the morning 2 tablets 2, 4, 6 days after intervention. Further, the drug is produced in 2 days - duration up to 1 month after surgery(9, 12, 15, 18, 21, 24, 27, 30 day).

Low molecular weight heparins used at 1-7 days post intervention, was used in therapeutic doses�x (Fraxiparine 86 anti-Xa IU/kg, Clexane-1 mg/kg).

For the task, we examined 48 patients with ischemic heart disease undergoing surgical treatment of ischemic heart disease - coronary bypass grafting under cardiopulmonary bypass and cardioplegia. Patients were matched for age and sex, severity of disease, indicators of intracardiac hemodynamics and volume of surgical intervention - all of them performed namakaranam bypass surgery with coronary artery bypass 1-3 arteries without aneurysmectomy and valve replacement. The analysis took into account the time of the IR and the fact that perioperative blood transfusion, as a factor significantly contributing to the development of PCTs.

In the postoperative period, all of them received the standard therapy (aspirin, beta-blockers, inhibitory ACE-I, statins), antibiotics for the prevention of mediastinitis/perioperative infections. Initially, patients were randomized into 2 groups depending on the use of NSAIDs: group 1 (n=21); or cycloferon - 2 group (n=27) as a drug treatment PCTs. In the case of treatment failure in patients of both groups were allowed the use of corticosteroids.

Were analyzed such factors as the frequency of postoperative pleuritis, pericarditis, the number of pleural punctures, including repeated, the frequency of the forced use of corticosteroids, number of check�fucking patient in clinic hospital days. Puncture was performed in the presence of 300 ml by ultrasound. The patient's discharge from the hospital occurred only in the case of a complete lack of need for inpatient supervision of a cardiologist.

Clinical characteristics of the patients and the results of the analysis are shown in table 1.

In group 1 standard treatment there was a greater number of complications in 47% required pleural puncture (10 patients, 4 patients puncture was performed 2 or more times), pericarditis developed in 23.8% of cases (5 patients).

In group 2 with the use of cycloferon frequency of pleural puncture was 18.5% (5 patients, 2 of which require repeated puncturing), the incidence of pericarditis was also below - 11,1% (3 patients). In this group were less likely to become necessary to use corticosteroids compared with group 1 (11,1% compared to 52.4%, respectively), was observed earlier for the removal of stitches and a significantly shorter duration of hospitalization.

In accordance with the recommendations of the European countries for the prevention of thromboembolic complications (12, 13) in group 2, we have identified 2 subgroups: one group (n=14) were used cycloferon without prescription NSAID, anticoagulant therapy was conducted maintenance dose LMWH; another group (n=13) also polychlorination without NSAIDs however, anticoagulant therapy was carried out a full therapeutic dose of LMWH.

In the group of patients receiving cycloferon and LMWH in prophylactic doses, pleural puncture was performed in 28.6% of cases (n=4), in one case it took another puncture, pericarditis occurred in 14.3% of patients (n=2).

In the group receiving cycloferon and LMWH in therapeutic dose, the holding of pleural puncture it took only 7.6% (1 patient), 7.6% (n=1) pericarditis noted.

As in the group receiving NSAIDs, the frequency of perioperative blood transfusion was higher than in the group receiving cycloferon, we conducted additional analyses in subgroups taking into account these factors (see table 3).

In this embodiment, the analysis of groups of patients with perioperative blood transfusion, and without it, receiving cycloferon, also showed significantly better results regarding relevant subgroups, taking in a routine of NSAIDs.

Example 1. Patient S., age 66 (No. 3382), entered 24.03.13 with complaints of shortness of breath mixed character when climbing to the 3rd floor, interruptions in heart work. Previously held stationary examination and treatment, during which the results of CVG revealed constrictive Atheros�Eros, recommended surgical treatment of ischemic heart disease - coronary artery bypass grafting. This hospitalization is planned for surgical intervention. Objective examination: the pulse of 60 beats/min, blood pressure of 120/80 mm Hg.CT., respiratory rate of 17 per minute, peripheral edema no. Main clinical and laboratory characteristics at admission: General blood test, General urine analysis, biochemical blood analysis, coagulogram - without features, heart ultrasound IVS=12.5 mm; ssli=10 mm; MM=205 g; KDR=53 mm; CEB=34 mm; BWW=128 ml; CSR=49 ml; PV(B)=62%; EE=79 ml; LP(4K)=50×56 mm; PP(4K)=52×56 mm.

Pharmacological anamnesis at the time of admission: Concor 10 mg, hydrochlorothiazide 25 g losap 25 mg, simvastatin 20 mg.

Clinical diagnosis: IHD: exertional angina FC III. Stenosing atherosclerosis of the coronary arteries (PNA 75%, the MSC 75%, VTK 75%, DA 40%). Paroxysmal form of atrial fibrillation. NC I. FC II (NYHA). Background.: GB article III, risk 4.

The patient made namakaranam bypass surgery anterior descending artery, coronary artery bypass grafting branches blunt edges and posterior interventricular by IR and cardioplegia 8.05.2013.

In the postoperative period the patient was treated: cardiomagnyl 75 mg/day, coronal 10 mg/day, amlodipine 5 mg/day, atorvastatin 20 mg/day, Cefazolin 3 g/day to 8 days, Fraxiparine 1, 2 ml/day to 7 days, cycloferon ,15 g: the day before surgery - 2 pills the next day after surgery - 2 tablets (in the probe), 2 tablets 2, 4, 6, 9, 12 days (on the 13th day the patient was discharged, the reception of cycloferon on 15, 18, 21, 24, 27, 30 a day recommended outpatient). The postoperative period proceeded safely: infectious complications, phenomena postpericardiotomy syndrome (pleurisy, pericarditis and objective ultrasound) are not mentioned, the sutures were removed on the 12th day, the patient was discharged after surgery on the 13th day.

Example 2. Patient I., aged 65 (No. 3510), was admitted with complaints of shortness of breath mixed character when walking 50 meters, discomfort in the chest, stopped by IGT. Objective examination: the pulse of 68 beats/min, the rhythm is atrial fibrillation. HELL 110/70 mm Hg. article, respiratory rate 18 per minute, peripheral edema no.

Main clinical and laboratory characteristics at admission: General blood test, General urine analysis, coagulation - without features, in the biochemical analysis of blood: total bilirubin 16.6 µmol/l, urea 7.8 mmol/l, AST 29 U/l, ALT 29 U/l, total protein 83 g/l; creatinine 122 µmol/l, total cholesterol 3.7 mmol/l, glucose of 13.6. Ultrasound examination of the heart: IVS=10 mm; ssli=10 mm; MM=252 g; KDR=72 mm; CEB=63.5 mm; BWW=240 ml; CSR=180 ml; PV(B)=25%; EE=60 ml; LP(4K)=55×66 mm; PP(4K)=51×53 mm Coronaroventriculography: PNA PR3t stenosis, 1 YES 75%, OA ol3 75%, of the RCA CP3 75%d3 PAC 30%.

Clinical diagnosis: coronary heart disease: the walls�RDIA voltage FC III. PIX 2005 Constant form of atrial fibrillation. Ventricular premature beats IV (Lown). NC I. FC II a-b NYHA. Background.: GB III, achieved target BP. Residual effects of stroke in ischemic type from 2012, diabetes type 2, target glycated hemoglobin < 6.5%. Obesity 1 tbsp. Risk 4.

Performed surgery: coronary artery bypass grafting 1 median artery, 2 median artery, diagonal artery and namakaranam bypass grafting CABG IMA, 2MA, YES, and ungraded schools of the PNA in the cardiopulmonary bypass and cardioplegia (06.05.2013). In the postoperative period on the 1st day were single-group transfusion of Packed red cells to compensate for the volume of circulating fluid. Prescribed treatment: diver 2.5 mg, enalapril 2.5 mg/day, verospiron 25 mg, cordarone 200 mg, gliclazide MB 60 mg/day, atorvastatin 20 mg/day, Cefazolin - 3 gr/day for 10 days, Fraxiparine - 1.2 ml/day for 7 days, cycloferon 0.15 g: the day before surgery 2 tablets the next day after surgery - 2 tablets (in the probe), 2 tablets 2, 4, 6, 9, 12 days (on the 14th day the patient was discharged, acceptance of cycloferon on 15, 18, 21, 24, 27, 30 a day recommended outpatient).

The postoperative period proceeded safely: infectious complications, pericarditis, for objective and ultrasound were noted on 6 days in the left pleural cavity was observed 100 m� fluid, on the 8th day of fluid is not detected. Sutures were removed on the 11th day, the patient was discharged on the 14th postoperative day.

Thus, in addition to standard baseline therapy of cycloferon and LMWH in therapeutic doses has contributed to more effective early postoperative rehabilitation of the patient without connecting NSAIDs and corticosteroids.

The proposed method is tested in the Department of heart failure research Institute of Cardiology SB RAMS in 48 patients and reduces the risk of postoperative pleurisy and pericarditis, improve postoperative period and reduce the time of postoperative hospitalization in patients with ischemic heart disease undergoing coronary artery bypass grafting.

The list of references

1. Snefjellå N, K. T. Lappegård Development of post-pericardiotomy syndrome is preceded by an increase in pro-inflammatory and a decrease in anti-inflammatory serological markers. Journal of Cardiothoracic Surgery, 2012.

2. Nakatseva E. V., Moiseeva O. M., Gordeev M. L. Risk factors for development of postpericardiotomy syndrome. The Journal of Coronary artery diseases, 2007; 7 (1):201.

3. Maisch B, Seferovic PM, Ristic AD, et al. Guidelines on the diagnosis and management of pericardial diseases executive summary; The Task force on the diagnosis and management of pericardial diseases of the European society of cardiology. Eur Heart J. 2004;25 (7):587-610.

4. Artom G, Koren-Morag N, Spodick DH et al. Pretreatment with corticosteroids attenuates the efficacy of colchicine in preventing recurrent pericarditis: a multi-centre all-case analysis. Eur Heart J. 2005; 26 (7):723-727.

5. Maisch B, Ristic AD, Seferovic PM. New directions in diagnosis and treatment of pericardial disease. A project of the Taskforce on Pericardial Disease of the World Federation Heat. Herz. 2000; 25 (8):769-780.

6. Imazio M. The COPPS a multicenter, randomized, double-blind, placebo-controlled trial. Eur Heart J 2010; 31(22): 2749-2754.

7. Kardash O. F., Samovar V. V., Moroz-Vodolaz'ke N. N. The use of cycloferon after open-heart surgery. Vestn. SPb. 2006. - p. 84-87.

8. Nakazawa E. V., Moiseeva O. M., Shlyakhto E. V. Postpericardiotomy syndrome: risk factors, diagnosis and principles of treatment. Clinical medicine, 2009, 7. - P. 29-32.

9. Ershov F. I. Status of interferon system in norm and at a pathology. - M. - 1996. - Pp. 196-238.

10. Immunomodulator cycloferon in the secondary prevention of purulent-septic complications / edited by Z. A. Suslina and A. I. Fedin. - Moscow. - 2005.

11. Meiburg E. V., Kosyakova N. And., Murashev, A. N. Pharmaceutical composition on the basis of cycloferon local and external use for the treatment of purulent-destructive lesions of the mucosa and skin, system-wide diseases in immunodeficient States (EN 2414221).

12. Weiss A, Brose S. Ploetze K, Matschke K. Half-dose like enoxaparin vs. full-like enoxaparin dose for postoperative bridging therapy in patients after cardiac surgery: which dose regimen should be preferred? Clin Hemorheol Microcirc. 2013; 54(3):249-58.

13. SMDC Disease Management Guidelines. Anticoagulation Bridging Guidelines for Patients on Long-Term Warfarin Anticoagulation by Michael P. Gulseth, Pharm. D., BCPS. Sarah M. Westberg, Pharm. D., BCPS, December 2010.

Method of preventing the development postpericardiotomy syndrome in patients with coronary heart disease undergoing coronary artery bypass grafting, which consists in assigning medical�training doses of low molecular weight heparin and anti-inflammatory therapy, characterized in that as an anti-inflammatory drug prescribed inductor of endogenous interferon-cycloferon in the scheme: the day before surgery 2 tablets of cycloferon 0.15 g, the next day after surgery, 2 tablets, the following methods of preparation - in the morning, 2 tablets at 2, 4, 6 day after the intervention, then after 2 days up to 1 month after surgery(9, 12, 15, 18, 21, 24, 27, 30 day).



 

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