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1 POSITION OF THE PROBLEM Importance of the problem: Despite many advances in diagnosis and treatment in the last decade, coronary artery disease especially myocardial infarction (MI) remains a matter of public health concern in the country development is becoming more and more important in the developing countries, including Vietnam Percutaneous coronary intervention (PCI) was performed Andreas Gruntzig the first time in 1977 in Zurich (Switzerland), so far has made tremendous strides to bring highly effective in the treatment of coronary artery disease PCI began to be applied in Vietnam since 1996 with procedure: coronary angioplasty balloon and stenting in the coronary According to a report by Pham Gia Khai et al about 516 PCI cases at the Vietnam National Heart Institute from 2003 to 2004 showed that the success rate reach 92,4% The rate of complications related to the procedure, such as mortality (5,1%), arrhythmias (1,2%), acute coronary occlusion (3,6%) Risk factors in PCI plays a very important role, it contributes to the success and failure of the intervention procedure Around the world there have been many studies on the risk factors, from these studies, many systems risk score predicted complications and mortality, and has been applied in many heart center interventions such as the Mayo Clinic Risk Score, Score Euro, New York Risk Score Besides the perfection and technical advances remain complication rate and mortality Therefore, clinicians need to quickly grasp the possibilities of complications can occur as well as a complete evaluation of risk factors for the disease Complications in the first 24 hours of percutaneous coronary intervention has not been studied systematically in Vietnam So we conducted a research topic “Study on the characteristics some complications of percutaneous coronary intervention during the first 24 hours at Vietnam Heart Institute” has been carried out with the following objectives: To study the rate, characteristics common complications and deaths during the first 24 hours of percutaneous coronary intervention Identified several risk factors related complications and mortality in the first 24 hours of percutaneous coronary intervention through a scale of Mayo Clinic Risk Score and New York Risk Score To initially assess the points of risk to predict about complications and deaths in PCI by applying the scale Mayo Clinic Risk Score and New York Risk Score Contributions of this thesis: - Shows some common complication rates in the first 24 hours of PCI in Vietnam - Identify risk factors predict complications or death can occur in PCI - Initial application values the scale Mayo Clinic Risk Score and New York Risk Score to develop forecasts the risk of complications and deaths in PCI PRESENTATION OF THE THESIS The thesis comprises 118 pages, repartitioned in chapters, dealing with pages for Position of the Problem, 30 pages for the Overview, 21 pages for the Subjects and Research Method, 30 pages for the Study Results, 30 pages for the Discussion, page for the Conclusions, and page for the Recommendations There are 65 tables, charts, 10 images, diagram of the study design There are 154 references, including 26 Vietnamese documents and 128 English documents CHAPTER OVERVIEW 1.1 Percutaneous coronary intervention (PCI) A method of expanding coronary artery blockages or injured by balloon, then put the stent in the location of lesion, with the purpose of restoration of coronary circulation 1.1.1 Technical summary coronary balloon angioplasty Balloon diameter ratio versus selected coronary artery diameter is 1:1 Coronary artery diameter was assessed by comparing the size of the target vessel catheter (6F = mm) Balloon is pushed under the wire to the target lesion Coronary angiography to determine the exact position of the balloon in injury, pump by pump the balloon up slowly until the pressure expander balloon completely from 10-60 seconds Coronary angiography to check If patient stable condition, the level of residual stenosis < 30%, achieved TIMI flow and no complications, the instrument is drawn out and coronary angiography for the last time at the end 1.1.2 Technical summary Stent placed in a coronary artery Size of balloon and Stent was selected in proportion: diameter of balloon in Stent /diameter of normal coronary artery segments = 1.1 Dilated coronary artery lesions with the balloon in front to reduce the risk of vascular dissection, and helps ease stent placed, then the balloon is determined Stent pump can be fully dilated, and the procedure may look apparent location of the original lesion In the case of multiple stent placed in one coronary artery stent should be placed in the most remote locations injury front end damage to government 1.2 The common complications in percutaneous coronary intervention 1.2.1 The complications in coronary artery * Peri-procedural myocardial infarction: defined as an increase in the biomarker (troponin above the 99% increase of the normal upper limit), the CK or CK-MB increase ≥ times the upper limit of normal Most of the major mechanisms of myocardial damage during the procedure due to distal embolization and side-branch occlusion Other causes can also cause damage to the heart muscle as coronary dissection, coronary perforation, thrombosis, no reflow or slow flow * Side-branch occlusion: study of Páez L et al with the ratio is 12% of direct stenting According Kralev S et al: intervention side branch lumen diameter ≤ 0,6 mm and small interfering narrow hole in the side branch elements threaten to side branches * Distal embolism: ballooning or stenting placed at the culprit lesion thrombus or plaque peeling distal embolization High risk of procedures for bridging veins are more fragile plaque Distal embolization leads to clogging of blood vessels, causing slow flow or no reflow thereby increasing myocardial necrosis * Coronary artery perforation: Stephen G Ellis et al divided into coronary artery perforation types Type I: the circuit has cracks but not leach contrast out of circuit, type II absorbed less contrast into the myocardial or pericardium, type III: contrast escaped through holes with a diameter > mm into the pericardial cavity or ventricular chamber The majority of coronary artery perforation during the procedure due to mechanical mechanisms: sharp instruments like end of the wire into the circuit puncture The size of the balloon or stent is too large compared to the size lumen Cut out a lot of different plaque attached by drilling and cutting equipment, injure the endothelium and vascular tear crack formation * Coronary artery dissection: classification system coronary artery dissection of National Heart Lung and Blood Institute (NHLBI) according to the level of A, B, C, D, E and F Procedure widening the cracks causing intravascular plaque and endothelium separated thus forming a local snake cup Mild dissection: the endothelium but not torn medial Complex dissection: medial torn by the forces of intervention devices, thus forming stretch or road split snake twisting, line integral intravascular contrast material or residual stenosis > 50% * Acute coronary artery obstruction: force stretches of balloon as filter for the endothelium, the endothelium and medial crack formed capillary membrane separator, cyclone separator spread obstruct the lumen When the endothelium interrupted crack, revealing layers of collagen causes activation of coagulation factors and organizational factors, together with the accumulation of platelet deposition and thrombus formation results, eventually leading and to reduce the flow of blood stasis In addition, a number of vasoactive mediators and antiinflammatory also liberated cause vasospasm in place to form clots * No reflow phenomenon: Eric R Bates et al 1986 study and describe the no reflow phenomena not show a weakening downstream flow in the coronary arteries The main culprit of the no reflow phenomenon is due to the behavior of thrombosis and plaque clog peeling or spasm circuits, particularly circuits with a diameter < 200 µm 1.2.2 The medical complications * Reperfusion syndrome: reperfusion injury is related to the heart muscle, blood vessels, and/or electrical dysfunction of the heart muscle physiology, due to the recovery of coronary arterial flow to the ischemic myocardial tissue was before The expression of ischemia and reperfusion injury include: - Arrhythmia - Dysfunction of microcirculation - Myocardial stunning * Arrhythmia cardiac in procedure: pathophysiological mechanisms causing cardiac arrhythmia due to the following factors: - Anemia and myocardial reperfusion - Intensity vagus - Contrast - The measure of coronary flow reserve * Contrast Induced Nephropathy (CIN): CIN is the deterioration of renal function occurred within 48 hours after the patient is using contrast After contrast in the body, increased serum creatinine levels ≥ 44,2 µ mol (≥ 0,5 mg/dl) or ≥ 25% increase in the first 24 hours and reached peak levels from 48-96 hours Renal function returned to normal or near normal within 1-3 weeks 1.2.3 Complications at the access arterial - Bleeding and hematoma at the access of radial artery - Obstruction of the radial artery and hand ischemia - Bleeding and hematoma at the access of femoral artery - Assume femoral artery aneurysm - Retroperitoneal bleeding 1.3 The risk factors in percutaneous coronary intervention * The nature of the urgent intervention and elective intervention: The nature and level of the disease coronary in urgent intervention and elective intervention that very different, thus affecting the results of the procedure * Patient factors: consists of main factors: older patients and women * Element clinical and subclinical: including pathological manifestations such as disorders of left ventricular systolic function, cardiogenic shock, heart failure NYHA In addition, the coexisting illnesses such as diabetes and kidney failure * Pathological factors: including the nature and location of coronary artery lesions as general disease left main, disease branchs and of chronic total obstruction coronary artery CHAPTER SUBJECTS AND RESEARCH METHODS 2.1 Subjects 2.1.1 Selection criteria of patients: included 511 male and female patients admitted to hospital emergency and inpatient hospitalization at the Vietnam Heart Institute is divided into groups: - The group of patients diagnosed acute coronary syndrome, indicated urgent percutaneous coronary intervention (urgent PCI) - The group of patients diagnosed stable angina, indicated percutaneous coronary intervention routine (elective PCI) 2.1.2 Exclusion criteria: those patients with the following characteristics: - Being hematopoietic organ disease or coagulopathy - Acute liver failure - Just coronary angiography without intervention procedure - Procedure intervention for abnormal anatomy - Complications and death beyond 24 hours after procedure 2.1.3 Indications for percutaneous coronary intervention * Urgent PCI: including patients diagnosed: - ST segment elevation acute myocardial infarction: - Acute myocardial infarction without ST segment elevation and unstable angina * Elective PCI: including patients diagnosed stable angina 2.2 Method of study 2.2.1 Study design: prospective studies, cross-sectional descriptive, longitudinal follow up within 24 hours from the start of procedure 2.2.2 Steps of the processing * The process of clinical examination, clinical testing preprocedure: - Patients admitted to hospital emergency: clinical examination, such as heart rate, blood pressure, pulmonary ran Cardiogenic shock, heart failure NYHA, heart failure Killip Electrocardiography, echocardiogram, blood tests CK, CK-MB, CBC, coagulation basic electrolytes - Hospitalized patients: clinical examination admitted to hospital as an emergency Making electrocardiography, echocardiogram, blood tests, stress tests, coronary CT 64 range * Process monitoring changes in procedure: - Clinical: shortness of breath, chest pain, sweating, cold skin and purple, heart rate, pulmonary ran Expression allergies: hives, difficulty breathing, nausea - The equipments for monitoring changes in procedure: monitoring system to measure arterial pressure continuously System continuous electrocardiography monitoring Two light up the screen with a camera connected circuit * Process monitoring of patients after the procedure: - Clinical: chest pain, shortness of breath, cardiogenic shock, heart rate, blood pressure, urine for 24 hours, marks on arterial access - Subclinical: blood tests: urea, creatinine, glucose, electrolytes, CK, CK-MB, electrocardiography, echocardiography, heart-lung X ray, abdominal ultrasound * Statistics complications and deaths in the first 24 hours of procedure: * Statistical evaluation of the results and forecasts the risk of complications and deaths: - Apply Mayo Clinic Risk Score for statistical risk factors related complications, and New York Risk Score for statistical risk factors related to mortality - Assessment scores predicted the risk of complications and death 2.2.3 The criteria used in the study * Diagnostic criteria for coronary artery disease: including acute myocardial infarction, unstable angina, stable angina * Diagnostic criteria for MI and MI area on the electrocardiographic: * Indications for percutaneous coronary intervention: including Urgent PCI and elective PCI * Criteria for evaluation of the results of the intervention procedure: assessed by flow in the DMV according to the TIMI scale * Criteria for evaluation of a number of complications: - Myocardial infarction - Reperfusion syndrome - Coronary artery dissection - Arrhythmia during the procedure - Perforation of the coronary - Contrast induced nephropathy arteries - No reflow phenomenon * Criteria for evaluation of a number of risk factors: - Cardiogenic shock - Left ventricular systolic function (EF) on - Heart failure Killip echocardiography - Heart failure NYHA - Hypertension - Diabetes mellitus * Criteria for evaluation of system risk factors: scale assessment of risk factors for complications (Mayo Clinic Risk Score) Scale assessment of risk factors for death (New York Risk Score) 2.3 Statistical analysis of data research * Statistical analysis of data: data collected by the study, the algorithm is treated by T-test to compare average, comparison of rate by algorithm χ2 (Chi-Square test), calculated OR and confidence 10 interval estimates of OR to calculate risk Data were analyzed using SPSS 16.0 software P value < 0,05 was considered statistically significant * The risk scores predict complications and mortality in PCI: by applying ROC curve chart ROC curve represented the relationship between sensitivity and specificity of the total score overall risk of complications or mortality risk score Each point on the ROC curve coordinates corresponding to the frequency of true-positive (sensitivity) on the vertical axis and the frequency of false positives (1-specificity) on the horizontal axis Accuracy is measured by the area under the ROC curve If the area = 1, the test is very good, if the area = 0,5, the test is not valid CHAPTER RESULTS 3.1 The rate and characteristics of complications and deaths 3.1.1 The rate of complications during coronary intervention Monitored patients in group PCI in the first 24 hours have 116/511 patients with complications (22,7%) Urgent PCI group had 81 patients with complications (30,2%), elective PCI group had 35 patients with complications (14,4%) The rate of complications of urgent PCI group (30,2%) was higher than elective PCI group (14,4%) with p < 0,001 Table 3.5 Distribution of complication rate in the PCI Complication Patient s Percentag e None Patient s Percentag e 12 * No reflow phenomenon and distal embolism: Table 3.12 Characteristics of no reflow phenomena and distal embolism Process and standards Nature of PCI Patients, percentage Circumstances Features No reflow phenomenon Distal embolism Urgent Elective Urgent 10 (3,7%) (1,6%) (0,6%) Postballooning Stenting Postballooning Placement procedure LAD, Lcx and RCA LAD and RCA Segment of LAD Image No flow No flow Image "amputation" Flow level TIMI 0, High age (> 70 age) Urgent intervention TIMI 0, High age (> 70 age) Level of risk (MCRS) Urgent PCI Total occlusion Thrombosis Disease branchs Total occlusion Risk score (MCRS) NYHA III-IV Disease branchs Risk factors Left main disease TIMI 0-1 Total occlusion - 10 Low - Medium 3.1.3 The medical complications * Reperfusion syndrome: - 11 5-6 Very low - Low Medium 13 Table 3.14 Features reperfusion syndrome in procedure Process and standards Features Nature of PCI Urgent Patients, percentage Procedure 37 (7,2%) Thrombosis Circumstances Symptoms, percentage Postballooning Cardiac arrhythmias (13,8%), hypotension (11,6%), chest pain (10,4%), shortness of breath (7,0%), Risk factors Thrombosis, myocardial infarction Risk score (MCRS) - 10 Level of risk (MCRS) Low - Medium * Rối loạn nhịp tim thủ thuật: Table 3.15 Characteristics of arrhythmia in procedure Process and Features standards Nature of PCI Patients, percentage Circumstances The type of arrhythmia Risk factors Risk score (MCRS) Urgent 37 (7,2 %) Postballooning Sinus bradycardia (1,6%), sinus tachycardia (1,2%), atrial fibrillation (0,4%), atrial tachycardia (0,4%), extrasystole ventricular (1,6%), ventricular tachycardia (1,8%), ventricular fibrillation (0,6%), atrial-ventricular block level III (1,0%) Total occlusion RCA (thrombosis), procedure of RCA - 10 Elective 13 (2,5%) Postballooning and pumped the contrast Sinus bradycardia (0,4%), atrial fibrillation (0,6%), atrial tachycardia (0,2%), extrasystole ventricular (0,6%), ventricular tachycardia (0,6%), ventricular fibrillation (0,4%) Heart failure NYHA III-IV, procedure of RCA 14 Level of risk (MCRS) Low - Medium Low * Contrast induced nephropathy (CIN): Table 3.18 Average serum creatinine levels at time points Circumstance s Creatinin (µmol/l) Preprocedure Postprocedure p General X 99,09 ± 29,25 110,18 ± 42,97 < 0,001 (n = 511) Lowest- 46 - 292 52 - 407 156,88 ± 58,43 226,38 ± 66,47 80 - 292 143 - 407 ± SD Highest X CIN (n = 40) ± SD Lowest- < 0,001 Highest 3.1.4 Complications bleeding - hematoma at the access arterial Table 3.21 The rate of bleeding - hematoma at the access arterial follow gender and age group Features Femal Genera e Bleeding Male l Patients Percentag 0,3 6,0 1,6 Patients 394 109 503 Percentag 99,7 94,0 98,4 e None e Age group < 70 age Patients 4 (n = 343) Percentag 5,8 1,2 Patients Percentag 0,8 6,4 2,4 e ≥ 70 age OR (95% CI) 25,3 p 15 (n = 168) e p > 0,05 > 0,05 > 0,05 16 3.1.5 The rate and characteristics of deaths Tabe 3.23 Distribution of mortality in coronary intervention Deaths No deaths OR Patient s Percentag e Patient s Percentag e Urgent (n = 268) 10 3,7 258 96,3 Elective (n = 243) 0,4 242 99,6 General (n = 511) 11 2,2 500 97,8 9,38 (1,19- 3.2 The risk factors related to complications 3.2.1 The system of risk factors related to complications Table 3.31 The rate of risk factors related to complications Complications Risk factors Patient Percentage s None Patient Percentage p s Cardiogenic shock 15 100 0 0,05 Disease branchs 73 37,8 120 62,2 0,05 17 3.2.2 The system of risk factors related to deaths Table 3.32 The rate of risk factors related to deaths Risk factors Deaths (n = 11) No deaths (n = 500) Patients Percentag e Patients Percentag e p Cardiogenic shock 60,0 40,0

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