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INVENTION
Russian Federation Patent RU2288641

METHOD OF CLINICAL determine the probability of pulmonary embolism in patients with atrioventricular block, pacemaker to correct

Name of the inventor: Staff Igor (RU); Tyukalova Lyudmila (RU); Juraev Rustamovna Elena (RU); Popov Sergey V.
The name of the patentee: Staff Igor (RU); Tyukalova Lyudmila (RU); Juraev Rustamovna Elena (RU); Popov Sergey V.
Address for correspondence: 634050, Tomsk, Moscow highway, 2, Siberian State Medical University, Department of IS, pat.pov. NG Zubareva
Starting date of the patent: 2005.06.08

The invention relates to medicine, namely to cardiology. Patients determine the presence of clinical signs such as the presence probability of an alternative diagnosis, the presence of hemoptysis. Evaluation of the symptoms in each score 3 and score 1, followed by determination of the diagnosis by their sum. At the same time further comprises determining the presence of the following clinical signs: two or more typical PE respiratory and / or cardiac symptoms and evaluated in 3 points. The appearance of ECG signs of atrial fibrillation is estimated at 1.5 points. Pacemaker implantation fact in the previous 6 months is estimated at 1 point. The presence of thrombosis of the upper extremity veins after pacemaker implantation is estimated at 1.5 points. The presence of one or more risk factors evaluated in point 1. The absence of any of these clinical signs is estimated at 0 points. Then spend the amount of counting points and the total score of more than 6, respectively, define a high, with the total score of 2 to 6 - moderate and the total score of at least 2 - a low clinical probability of pulmonary embolism. The method improves the accuracy of the information content and method of determining the clinical probability of pulmonary embolism in patients with atrioventricular block, pacemaker corrected.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to cardiology, specifically to methods for determining the likelihood of clinical pulmonary embolism in patients with atrioveitrikulyarnoy blockade corrected pacemaker.

The closest to the proposed method is to determine the likelihood of clinical pulmonary embolism (PE), in which clinical signs were scored and then summed scores. The presence of clinical signs and symptoms of deep vein thrombosis, namely swelling of legs, pain on palpation of the deep veins is estimated at 3 points, less likely alternative diagnosis is estimated at 3 points, heart rate (HR), more than 100 per minute is estimated at 1.5 points, immobilization or surgery in the preceding 4 weeks is estimated at 1.5 points, deep vein thrombosis history estimate of 1.5 points, hemoptysis evaluated at 1 point, neoplasms evaluated at 1 point. When the amount of more than 6 points higher ascertain, from 2 to 6 - moderate and less than 2 - a low clinical probability of pulmonary embolism [1, 2]. According to the research tool that verifies the diagnosis of pulmonary embolism, with a high clinical probability of this pathology is present in 80-96%, with the average - at 32-40%, with the lowest - in 3-8% of patients [1, 2, 3].

However, this method has the following disadvantages: its scope is limited as there are no specific criteria for determining the clinical probability of pulmonary embolism in patients with atrioventricular (AV) blockade corrected pacemaker (pacemaker). The criteria of the known method is not fully manifested in patients with AV block and pacemaker, as the source of pulmonary embolism in these patients, as a rule, is in the subclavian vein or a cardiac origin, in this case there is no deep vein thrombosis. In addition, the heart rate during AV block, corrected pacemaker does not exceed the rate at which a stimulator is programmed (60-70 min).

Thus, the identification of a known method of clinical probability of pulmonary embolism in patients with AV block, corrected pacemaker, in some cases does not allow to reliably verify the diagnosis upon further examination, as the first stage of diagnostics - assessment of clinical probability of pulmonary embolism is difficult lack of specific criteria and their values, in connection thereby reducing the information content and accuracy of the diagnosis using a known method.

New technical problem - improving the accuracy and informative way to determine the clinical probability of pulmonary embolism in patients with atrioventricular block, pacemaker corrected.

The problem is solved in a new way the clinical definition of probability of pulmonary embolism in patients with AV block, corrected pacemaker, is to determine the clinical signs, such as the availability of lower probability of an alternative diagnosis, the presence of hemoptysis, followed by the evaluation of each of them in points 3 and 1 points, and determining the diagnosis their sum, and further determine the presence of the following signs: 2, and more typically estimated at 3 points, the appearance of ECG signs of atrial fibrillation is estimated at 1.5 points for PE respiratory or cardiac symptoms, the fact of pacemaker implantation in the previous 6 months is estimated at 1 point , the presence of thrombosis of the upper extremity veins after pacemaker implantation is estimated at 1.5 points, the presence of one or more risk factors is estimated at 1 point, followed by scoring the amount and the amount of more than 6 points respectively define high, while the total score of 2 to 6 - moderate and the total score of less than 2 define a low clinical probability of pulmonary embolism.

The process is carried out as follows: in patients with implanted pacemakers find out the history and complaints, examine ECG, comparing it with the previous ECG studies, carried out a thorough examination, including inspection and palpation of the upper limb veins, measuring its circumference, conduct routine clinical studies (general and biochemical tests blood). The observed signs are entered in a table that is being scoring. In the absence of reliable clinical and instrumental signs of the disease, non-PE, (alternative) in the column "points" record "3", if diagnosed with other pathology, and in which there are cardiac or respiratory complaints - write "0". In the presence of hemoptysis in the column "score" written to "1" if this condition is not available, write "0". In the presence of 2 or more typical PE respiratory or cardiac symptoms (the emergence or strengthening of a pre-existing shortness of breath, pleural chest pain, cough, chest pain, hypotension, the emergence or strengthening of right heart failure) in the column "score" written "3" if this condition is not, write a value "0". When the ECG signs of atrial fibrillation (f waves in the background stimulated or spontaneous ventricular complexes) in the column "score" written to "1.5" if this condition is not available, write "0". If after pacemaker implantation was less than 6 months, in the column "Score" recorded "1" if more - the "0" value is recorded. In the presence of upper extremity venous thrombosis symptoms (swelling, increasing from an implanted pacemaker upper limb circumference) in the column "Score" are recorded to "1.5" if this condition is not - record the value "0". If a patient has at least one of the risk factors (heart failure, obesity, stroke history, old age, nephrotic syndrome) in the column "score" written to "1" if this condition is not available, write "0". Then, count the amount of points. When the amount of more than 6 points define a high, from 2 to 6 - moderate and less than 2 - low probability of pulmonary embolism.

Determination of clinical probability of pulmonary embolism is the basis for further instrumental diagnosis of pulmonary embolism with a view to confirm or rule. In moderate and high probability of pulmonary embolism diagnosis tool may include research and ventilation perfusion lung perfusion method and ventilation scintigraphy, angiography, spiral computed angiography, rengenografii, transesophageal and transthoracic echocardiography, ultrasound veins. Selection of further diagnostic tests depends on the specific clinical conditions and clinical diagnostic capabilities of [3]. With a low clinical probability of PE waiver of further diagnostic tests and antithrombotic therapy is safe for the patient.

example 1

Patient M., born in 1941, in 1999 began to celebrate the attacks of vertigo, loss of consciousness. The ECG showed complete AV block, and therefore directed the Department of surgical treatment of cardiac arrhythmias. During the examination, the department in general, biochemical blood tests and coagulogram, chest radiograph and echocardiogram revealed no pathology. An operation of the primary pacemaker implantation, 530 and electrode Elodie. VVI mode, the stimulation threshold of 0.9 V, the pacing rate is 65 per minute. The postoperative period was uneventful. The wound healed by first intention. Sutures are removed on the 7th day.

2 months after implantation, the patient is admitted to the department with complaints of swelling of the left hand, her muscles sore. On examination, there was an increase of the left shoulder and arm circumference up to 3 cm in diameter. The diagnosis of thrombosis of the left subclavian vein system. A treatment including aspirin, 0.5 g of 3 times a day, 400 ml reopoliklyukin №10, subcutaneous heparin, 5000 units since 4 times a day, penicillin intramuscularly 1,000,000 IU 6 times per day. Against the background of the therapy within 5 days of swelling and soreness of the hands disappeared.

Subsequently, the above phenomenon hardly occurred, the patient is only rarely observed "swelling" of the left forearm and shoulder pain after exercise. At the same time, since 2001, began to complain of shortness of breath that occurs at rest, for no apparent reason, without regard to physical activity, and a dry cough. Given the history of smoking (1 pack of cigarettes per day), these complaints in the outpatient setting were regarded as manifestations of chronic obstructive pulmonary disease (COPD), and therefore were treated with ipratropium bromide, bromhexine, ambroxol, bronholitin, Mukaltin. The effectiveness of this therapy was low until 2003, shortness of breath and cough recurred.

In 2003, the patient again was observed by us in the clinical setting. When a pressing complained of chest pain, shortness of breath accompanied by a mixed character (alone, with little physical exertion), periodic disruptions of the heart. On examination, it drew the attention of the presence at the front of the chest to the left of the convoluted and dilated saphenous veins, auscultation breathing hard, with heart auscultation accent II tone of the pulmonary artery. The ECG - rate pacing in VVI mode, the background of atrial fibrillation.

The study according to the proposed method. At the same time there was a high clinical probability of pulmonary embolism - despite the high probability of an alternative diagnosis - COPD (Table 1), and therefore held pulmonary scintigraphy with ^99m Tc-labeled albumin macroaggregates. On scintigram performed in 4 projections, visualized both lungs. There was hypoperfusion 1, 2, 3 and 4 aperfuziya 5 bonholegochnyh segments of the left lung and hypo aperfuzii with elements of the upper sections of the right lung. An ultrasound cardiac study revealed enlargement of the right ventricular systolic pressure in the right ventricle to 38 mm Hg.

Spend and spiral computed tomography (CT), spiral CT venography upper left limb and SKT-angiography. On SKT venography diagnosis thrombophlebitis left upper limb was completely confirmed. When SKT-trunk angiography and segmental branches of pulmonary arteries were not expanded, filling defects are not detected. The reed segments of the left lung to trace subsegmentary branch failed, but Zones "infarction", hypoventilation not found that in the absence of pulmonary fibrosis and areas in comparison with the data of scintigraphy indicated thromboembolism of small branches of the pulmonary artery.

The treatment, including aspirin 0.5 g 3 times a day, fraxiparine 0.6 ml 2 times a day, warfarin (to achieve MHO 2,6), which came as a result of clinical improvement: the patient disappeared shortness of breath and pressing pain behind the breastbone. Further, the present, the patient is seen on an outpatient basis, takes the indirect anticoagulants (level MHO 2,5-3), complaints of shortness of breath, chest pain does not show.

example 2

Two patients, C, born in 1947, and A, born in 1951, with a diagnosis of "coronary heart disease, atherosclerotic cardio, complete AV blockade-corrected pacemaker", had been hospitalized (in 2002 and 2003) for planned change pacemaker due to battery discharge. The study according to the proposed method. Both patients had 2 or more typical PE respiratory or cardiac symptoms (3 points), and heart failure and II A degree (1 point), amounted to 4 points, indicating a high clinical probability of pulmonary embolism. However, during the perfusion lung scintigraphy in patients with perfusion defects were found that allowed us to exclude the diagnosis of pulmonary embolism, and the patient A on scintigrams series marked aperfuziya 4, 5, 9 bonholegochnyh left lung segments, in the absence of changes in the radiograph of the chest in the projection these segments, and in the absence of violations of ventilation, ventilation scintigraphy detected light that allowed the diagnosis of pulmonary embolism and assign adequate antithrombotic therapy.

example 3

Patient P, born in 1955, in 2005, a year after pacemaker implantation over the complete AV block, asked for the scheduled inspection EKS.Provedeno study parameters according to the proposed method. There were complaints of shortness of breath not related to physical activity, but the other symptoms characteristic of PE, there was no (0 points), overweight, circulatory insufficiency stage I (1 point). points amounted to 1 set at a low clinical probability of pulmonary embolism. Further research and antithrombotic therapy is required. After adjusting stimulation parameters (increase the frequency and pulse amplitude) shortness of breath decrease.

Proposed criteria for determining the clinical probability of pulmonary embolism in patients with atrioventricular block, corrected pacemaker, have been picked up with repeated hospitalizations field pacemaker implantation (1992) based on the interpretation of the data of a retrospective analysis of medical records of patients with AV block, but also the data of the clinical monitoring of patients having middle and high clinical probability of pulmonary embolism by the proposed method.

The case histories 274 patients, including 147 women, 127 men, average age 56,1 ± 1,4 years, the average life after pacemaker implantation was 3,17 ± 1,4 years. At the same time, we noted the time elapsed after implantation, complaints have arisen in this period, diagnosis and the extent of their validity, possible risk factors of pulmonary embolism. All figures are entered into the database. Then examined cardiovascular mortality in these patients. To assess the contribution of each of the factors and their interaction in the study of survival regression was used Cox proportional hazards model [4], which made it possible to allocate some workers algorithms determine the clinical probability of pulmonary embolism with different combinations of indicators and their scores. (Beta coefficients obtained by regression analysis, rounded and adapted so that the calculations in determining the clinical probability of pulmonary embolism were similar to the prior art [1, 2]). For each algorithm surveyed survival differences in two groups of patients - a) low clinical probability PE and b) a medium or high probability of PE on the subject algorithm. Groups were prepared by the method of "matching pairs" [4], that is, with each trial compared the same number of patients with similar demographic characteristics and differ only in the clinical probability of pulmonary embolism. Among the groups selected so the maximum difference in 5-year survival rate in the test there was proposed a method for determining the clinical probability of pulmonary embolism: a group with a low clinical probability of PE cumulative proportion of the Kaplan-Meier was 0.81, and in the group with moderate to high probability - 0 67, which was significantly (p <0.01) lower.

Clinical observation was performed for 54 patients (34 men, 20 women, mean age 59,3 ± 2,1 years), 40 of them - with moderate, and 14 - with a high clinical probability of pulmonary embolism with the parameters according to the assessment of the proposed method. All patients underwent pulmonary perfusion scintigraphy, radiography, and if necessary - SKT, ventilation scintigraphy. The evaluation of radiological studies used PIOPED criteria [5]. The data radionuclide studies were compared with lung x-ray picture of a spiral CT. The results of these studies have shown that a high probability (clinical symptoms) diagnosis of PE was confirmed in 13 patients, and a moderate - in 31.

Thus, the proposed method makes it possible most accurately diagnose the clinical probability of pulmonary embolism in patients with atrioventricular block, corrected pacemaker, which is important for improving the quality and length of life and of the most appropriate and timely diagnostic and therapeutic measures in these patients.

USED ​​BOOKS

1. Wells PS, Anderson DR, Rodger M, Ginsberg JS, Kearon C, Gent M, et al. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED Ddimer. 2000 // Thromb Haemost; 83: 416-20.

2. Kearon S.Diagnosis of pulmonary embolism. // CMAJ · JAN. 21, 2003; 168 (2) R.183-195.

3. Guidelines on diagnosis and management of acute pulmonary embolism. / Task Force on Pulmonary Embolism, European Society of Cardiology. // Eur. Heart J. - 2000. - Vol.21. - P.1301-1336

4. Fletcher, P. Clinical epidemiology. / R.Fletcher, S.Fletcher, E.Vagner; per. from English. S.E.Baschinskogo, S.Yu.Varshavskogo. - M .: Media Sphere, 1998. - 352 p.

5. Value of the ventilation / perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). The PIOPED Investigators. // JAMA - 1990. - Vol.263. - P.2753-2759.

CLAIM

Method Clinical determine the likelihood of pulmonary embolism in patients with atrioventricular block, corrected pacemaker, which consists in determining the clinical signs, such as the existence of the likelihood of an alternative diagnosis, the presence of hemoptysis, the evaluation of each of them in points 3 and 1 points, followed by determination of the diagnosis by their sum characterized in that it additionally determined for the following clinical signs: 2, and more typically for TEPA respiratory and / or cardiac symptoms and evaluated at 3 points, the appearance of ECG features of atrial fibrillation of 1.5 points evaluated, the fact of pacemaker implantation in the previous 6 months 1 was evaluated in point, the presence of the upper limb vein thrombosis after implantation of the pacemaker is estimated at 1.5 points, the presence of one or more risk factors evaluated in point 1, the absence of any of the following clinical signs was evaluated in points 0, followed by counting the total score and with the amount of more than 6 points, respectively, determined, high, while the total score of 2 to 6 - moderate and the total score of at least 2 - a low clinical probability of pulmonary embolism.

print version
Publication date 05.04.2007gg

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