Around the worldthere have been many studies on the risk factors, from these studies,many systems risk score predicted complications and mortality, andhas been applied in many heart cent
Trang 1POSITION OF THE PROBLEM
1 Importance of the problem:
Despite many advances in diagnosis and treatment in the lastdecade, 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 performedAndreas Gruntzig the first time in 1977 in Zurich (Switzerland), sofar has made tremendous strides to bring highly effective in thetreatment of coronary artery disease
PCI began to be applied in Vietnam since 1996 with 2 procedure:coronary angioplasty balloon and stenting in the coronary According
to a report by Pham Gia Khai et al about 516 PCI cases at theVietnam National Heart Institute from 2003 to 2004 showed that thesuccess rate reach 92,4% The rate of complications related to theprocedure, such as mortality (5,1%), arrhythmias (1,2%), acutecoronary occlusion (3,6%)
Risk factors in PCI plays a very important role, it contributes to thesuccess and failure of the intervention procedure Around the worldthere have been many studies on the risk factors, from these studies,many systems risk score predicted complications and mortality, andhas been applied in many heart center interventions such as the MayoClinic Risk Score, Score Euro, New York Risk Score
Besides the perfection and technical advances remaincomplication rate and mortality Therefore, clinicians need to quicklygrasp the possibilities of complications can occur as well as acomplete evaluation of risk factors for the disease Complications inthe first 24 hours of percutaneous coronary intervention has not been
Trang 2studied 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:
1 To study the rate, characteristics common complications anddeaths during the first 24 hours of percutaneous coronary intervention
2 Identified several risk factors related complications andmortality in the first 24 hours of percutaneous coronary interventionthrough a scale of Mayo Clinic Risk Score and New York Risk Score
3 To initially assess the points of risk to predict aboutcomplications and deaths in PCI by applying the scale Mayo ClinicRisk Score and New York Risk Score
2 Contributions of this thesis:
- Shows some common complication rates in the first 24 hours ofPCI in Vietnam
- Identify risk factors predict complications or death can occur inPCI
- Initial application values the scale Mayo Clinic Risk Score andNew York Risk Score to develop forecasts the risk of complicationsand deaths in PCI
PRESENTATION OF THE THESIS
The thesis comprises 118 pages, repartitioned in 4 chapters,dealing with 2 pages for Position of the Problem, 30 pages for theOverview, 21 pages for the Subjects and Research Method, 30 pagesfor the Study Results, 30 pages for the Discussion, 2 page for theConclusions, and 1 page for the Recommendations There are 65tables, 7 charts, 10 images, 1 diagram of the study design There are
154 references, including 26 Vietnamese documents and 128 Englishdocuments
Trang 3
CHAPTER 1 OVERVIEW
1.1 Percutaneous coronary intervention (PCI)
A method of expanding coronary artery blockages or injured byballoon, 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 = 2 mm)
Balloon is pushed under the wire to the target lesion Coronaryangiography to determine the exact position of the balloon in injury,pump by pump the balloon up slowly until the pressure expanderballoon completely from 10-60 seconds Coronary angiography tocheck If patient stable condition, the level of residual stenosis <30%, achieved TIMI 3 flow and no complications, the instrument isdrawn 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 ofballoon in Stent /diameter of normal coronary artery segments = 1.1.Dilated coronary artery lesions with the balloon in front to reducethe risk of vascular dissection, and helps ease stent placed, then theballoon is determined Stent pump can be fully dilated, and theprocedure may look apparent location of the original lesion In thecase of multiple stent placed in one coronary artery stent should beplaced in the most remote locations injury front end damage togovernment
Trang 41.2 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 normalupper limit), the CK or CK-MB increase ≥ 3 times the upper limit ofnormal Most of the major mechanisms of myocardial damage duringthe procedure due to distal embolization and side-branch occlusion.Other causes can also cause damage to the heart muscle as coronarydissection, 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 sidebranch 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 ofprocedures for bridging veins are more fragile plaque Distalembolization 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 3 coronary artery perforation types Type I: the circuit has cracksbut not leach contrast out of circuit, type II absorbed less contrastinto the myocardial or pericardium, type III: contrast escaped throughholes with a diameter > 1 mm into the pericardial cavity orventricular chamber
The majority of coronary artery perforation during the proceduredue to mechanical mechanisms: sharp instruments like end of thewire into the circuit puncture The size of the balloon or stent is toolarge compared to the size lumen Cut out a lot of different plaque
Trang 5attached by drilling and cutting equipment, injure the endotheliumand 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 thecracks causing intravascular plaque and endothelium separated thusforming a local snake cup Mild dissection: the endothelium but nottorn medial Complex dissection: medial torn by the forces ofintervention 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 formedcapillary membrane separator, cyclone separator spread obstruct thelumen When the endothelium interrupted crack, revealing layers ofcollagen causes activation of coagulation factors and organizationalfactors, together with the accumulation of platelet deposition andthrombus formation results, eventually leading and to reduce the flow
of blood stasis In addition, a number of vasoactive mediators and inflammatory also liberated cause vasospasm in place to form clots
anti-* No reflow phenomenon: Eric R Bates et al 1986 study and
describe the no reflow phenomena not show a weakening downstreamflow in the coronary arteries The main culprit of the no reflowphenomenon is due to the behavior of thrombosis and plaque clog peeling
or spasm circuits, particularly circuits with a diameter < 200 m
1.2.2 The medical complications
* Reperfusion syndrome: reperfusion injury is related to the
heart muscle, blood vessels, and/or electrical dysfunction of the heartmuscle physiology, due to the recovery of coronary arterial flow tothe ischemic myocardial tissue was before The expression ofischemia and reperfusion injury include:
Trang 6- 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 mol(≥ 0,5 mg/dl) or ≥ 25% increase in the first 24 hours and reached peaklevels from 48-96 hours Renal function returned to normal or near normalwithin 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 urgentintervention and elective intervention that very different, thusaffecting the results of the procedure
* Patient factors: consists of 2 main factors: older patients and
women
* Element clinical and subclinical: including pathological
manifestations such as disorders of left ventricular systolic function,
Trang 7cardiogenic shock, heart failure NYHA In addition, the coexistingillnesses such as diabetes and kidney failure.
* Pathological factors: including the nature and location of
coronary artery lesions as general disease left main, disease 3 branchsand of chronic total obstruction coronary artery
CHAPTER 2 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 2 groups:
- The group of patients diagnosed acute coronary syndrome,indicated urgent percutaneous coronary intervention (urgent PCI)
- The group of patients diagnosed stable angina, indicatedpercutaneous 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 andunstable angina
* Elective PCI: including patients diagnosed stable angina
2.2 Method of study
Trang 82.2.1 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, heartfailure 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, bloodtests, stress tests, coronary CT 64 range
* Process monitoring changes in procedure:
- Clinical: shortness of breath, chest pain, sweating, cold skin andpurple, heart rate, pulmonary ran Expression allergies: hives,difficulty breathing, nausea
- The equipments for monitoring changes in procedure:monitoring system to measure arterial pressure continuously Systemcontinuous electrocardiography monitoring Two light up the screenwith a camera connected circuit
* Process monitoring of patients after the procedure:
- Clinical: chest pain, shortness of breath, cardiogenic shock, heartrate, blood pressure, urine for 24 hours, marks on arterial access
- Subclinical: blood tests: urea, creatinine, glucose, electrolytes,
CK, CK-MB, electrocardiography, echocardiography, heart-lung Xray, abdominal ultrasound
* Statistics complications and deaths in the first 24 hours of procedure:
* Statistical evaluation of the results and forecasts the risk ofcomplications and deaths:
Trang 9- Apply Mayo Clinic Risk Score for statistical risk factors relatedcomplications, and New York Risk Score for statistical risk factorsrelated 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 acutemyocardial 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 interventionprocedure: assessed by flow in the DMV according to the TIMI scale
* Criteria for evaluation of a number of complications:
- Myocardial infarction
- Coronary artery dissection
- Perforation of the coronary
arteries
- No reflow phenomenon
- Reperfusion syndrome
- Arrhythmia during the procedure
- Contrast induced nephropathy
* Criteria for evaluation of a number of risk factors:
- Cardiogenic shock
- Heart failure Killip
- Heart failure NYHA
- Left ventricular systolic function (EF) on echocardiography
- Hypertension
- Diabetes mellitus
* Criteria for evaluation of system risk factors: scale assessment
of risk factors for complications (Mayo Clinic Risk Score) Scaleassessment 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
Trang 10interval estimates of OR to calculate risk Data were analyzed usingSPSS 16.0 software P value < 0,05 was considered statisticallysignificant.
* The risk scores predict complications and mortality in PCI: byapplying ROC curve chart ROC curve represented the relationshipbetween sensitivity and specificity of the total score overall risk ofcomplications or mortality risk score Each point on the ROC curvecoordinates 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 thearea under the ROC curve If the area = 1, the test is very good, if thearea = 0,5, the test is not valid
CHAPTER 3 RESULTS
3.1 The rate and characteristics of complications and deaths
3.1.1 The rate of complications during coronary intervention
Monitored patients in 2 group PCI in the first 24 hours have116/511 patients with complications (22,7%) Urgent PCI group had 81patients with complications (30,2%), elective PCI group had 35 patientswith complications (14,4%) The rate of complications of urgent PCIgroup (30,2%) was higher than elective PCI group (14,4%) with p <0,001
Table 3.5 Distribution of complication rate in the PCI
PCI
p Patient
s Percentage Patients Percentage
Trang 113.1.2 The complications in coronary artery
* Coronary artery perforation and dissection:
Table 3.11 Characteristics of coronary artery perforation and dissection Process
and standards
Features Perforation Dissection
Patients, percentage 1 (0,2%) 1 (0,4%) 4 (1,6%)
Risk factors
High age (81 age), disease 3 branchs, left main disease , chronic total occlusion
Urgent PCI, chronic total occlusion
High age, disease 3 branchs, left main disease, chronic total occlusion
Trang 12* No reflow phenomenon and distal embolism:
Table 3.12 Characteristics of no reflow phenomena and distal embolism Process
and standards
Features
No reflow phenomenon Distal embolism
Patients, percentage 10 (3,7%) 4 (1,6%) 3 (0,6%) Circumstances Postballooning Stenting Postballooning Placement
procedure LAD, Lcx and RCA. LAD and RCA.
NYHA III-IV.
Disease 3 branchs.
Total occlusion.
High age (> 70 age).
Left main disease.
Disease 3 branchs.
Total occlusion.
Urgent PCI Total occlusion Thrombosis.
Trang 13Table 3.14 Features reperfusion syndrome in procedure
Symptoms, percentage Cardiac arrhythmias (13,8%), hypotension (11,6%),
chest pain (10,4%), shortness of breath (7,0%), Risk factors Thrombosis, myocardial infarction
* Rối loạn nhịp tim trong thủ thuật:
Table 3.15 Characteristics of arrhythmia in procedure
Circumstances Postballooning Postballooning and
pumped the contrast
The type of
arrhythmia
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%).
Sinus bradycardia (0,4%), atrial fibrillation (0,6%), atrial tachycardia (0,2%), extrasystole ventricular (0,6%), ventricular tachycardia (0,6%), ventricular fibrillation (0,4%)
Risk factors Total occlusion RCA
(thrombosis), procedure of RCA
Heart failure NYHA III-IV, procedure of RCA