POSITION OF THE PROBLEM
1. 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 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 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
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studied systematically in Vietnam. So we conducted a research topic
CHAPTER 1
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 = 2 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 3 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.
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1.2. The common complications in percutaneous coronary
intervention
* 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 anti-
inflammatory 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:
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- Arrhythmia.
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 3 branchs
and 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, 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
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2.2.1. Study design: prospective studies, cross-sectional descriptive,
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.
- 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). Scale
assessment of risk factors for death (New York Risk Score).
s
Percentag
e
Patient
s
Percentag
e
10
Urgent
(n = 268)
81 30,2 187 69,8
Elective
(n = 243)
35 14,4 208 85,6
General
(n = 511)
116 22,7 395 77,3
3.1.2. 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
Nature of PCI Elective Urgent Elective
Patients, percentage 1 (0,2%) 1 (0,4%) 4 (1,6%)
Lesions (ACC/AHA B A A and B
Type (Ellis) II - -
Type (NHLBI) A A and B
Circumstances
Postballooning Stenting
Postballooning
Placement
procedure
LAD, Lcx and
RCA.
LAD and RCA.
Segment 1 of LAD
Image No flow No flow Image
"amputation"
Flow level
TIMI 0, 1 TIMI 0, 1
TIMI 0-1
Risk factors
High age (> 70
age). Urgent
intervention.
NYHA III-IV.
Disease 3
branchs.
Total occlusion.
High age (> 70
age).
Left main
disease.
Disease 3
branchs.
Total
occlusion.
Patients, percentage 37 (7,2 %) 13 (2,5%)
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
l
OR (95% CI) p
Bleeding Patients 1 7 8
25,3
Percentag
e
0,3 6,0 1,6
None Patients 394 109 503
Percentag
e
99,7 94,0 98,4
Age group
< 70 age
(n = 343)
Patients 0 4 4
Percentag
e
0 5,8 1,2
≥ 70 age Patients 1 3 4
Percentag 0,8 6,4 2,4
14
(n = 168) e
p > 0,05 > 0,05 > 0,05
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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
Renal failure 8 100 0 0 <0,001
Diabetes 16 24,2 50 75,8 >0,05
Hypertension 72 22,8 244 77,2 >0,05
Left main disease 10 30,3 23 69,7 >0,05
Disease 3 branchs 73 37,8 120 62,2 <0,001
Total occlusion 50 26,6 138 73,4 > 0,05
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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 9 60,0 6 40,0 <0,001
Killip III 2 11,1 16 88,9 <0,05
NYHA III-IV 7 13,2 46 86,8 <0,001
EF < 29% 8 20,5 31 79,5 <0,001
Renal failure 2 25,0 6 75,0 <0,05
Left main disease 4 12,1 29 87,9 <0,01
Disease 3 branchs 10 5,2 183 94,8 <0,001
Total occlusion 6 3,2 182 96,8 >0,05
3.3. Risk score predicted complications and deaths in coronary
intervention
3.3.1. Scores predicted the risk of complications according to Mayo
Clinic Risk Score
ROC curve with a cut point of the total risk score = 6,5
corresponding to sensitivity = 0,63 and specificity = 0,67. The risk of
be the cause, such as advanced age (81 years old), disease 3 branchs,
narrow left main, complete obstruction of coronary, injury type B
(ACC/AHA). According to some authors about the causes of
coronary artery perforation in procedure may be due to the use of
balloon size ratio/lumen diameter. According Ajluni SC et al: balloon
ratio size/lumen diameter was 1,3 ± 0,3 coronary perforation rate
higher than the rate of balloon ratio size/lumen diameter was 1,0 ±
0,3 with p<0,001. According to Z. Rahman et al: use balloon size
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ratio/ lumen diameter > 1,1 is coronary artery 2-3 times higher than
the rate used balloon size/lumen diameter <1,1 .
* Coronary arterial dissection: coronary arterial dissection
accounted for 0.9%, 2 patients had dissection type A and 3 patients
had dissection type B (NHLBI), 5 patients occurred in stenting after
balloon dilatation. The principal risk factors that may cause
dissection: 5 patients were aged > 70, 1 BN in urgent PCI. These
patients generally had disease left main, disease 3 branchs, complete
obstruction of coronary, this could be a major risk factor for
dissection. All 5 patients were dissected level A and B. Coronary
arterial dissection is a common complication in PCI, which kind of
dissection for C, D, E and F indicated surgery.
* No reflow phenomenon: 14 patients reveal no reflow
phenomenon (2,7%) during the procedure. This is a common
complication was transient. There are several risk factors that could cause
such advanced age (>70 years), have 10/14 patients with urgent PCI,
NYHA III-IV, disease left main, disease 3 branchs, complete obstruction
of coronary.
No reflow phenomenon sometimes occurs in the procedure, many
authors suggest that the behavior of thrombus and plaque clog peeling
or spasm of microvascular (microvascular with diameter < 200 µm).
pump contrast as cardiac electrophysiological changes.
* Contrast Induced Nephropathy (CIN):
- The incidence of CIN: currently, according X Ray Society
Canada 2011 recommended: CIN is diagnosed when increasing
creatinine levels ≥ 44,2 µ mol/l compared with the preprocedure, the
diagnosis of CIN has high accuracy, such valuable monitoring and
prognosis of patients with short and long term. We apply the standard
serum creatinine levels ≥ 44,2 µmol/l at the postprocedure increase
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compared with serum creatinine levels at the preprocedure. Under
this standard had 40/511 patients with CIN (7,8%).
- The volume and chemical characteristics of contrast: Roxana
Mehran et al have used 80,4% of patients were > 150 ml (average
volume of 260,9 ± 12,2 ml) and showed correlation between the
volume with CIN (p = 0,045, OR = 1,24). Volume in our study was
very small (at most 300 ml, at least 100 ml). Thus, the results showed
no correlation between the volume with CIN. In our study, there are 3
types of contrast is used in procedures and low osmotic pressure. In
particular, the ionization was hexabrix, xenetic and ultravis were non
ionization. Results: The incidence of CIN in ionization used higher
incidence of CIN in nonionization (p < 0,001).
- Some risk factors related to CIN (results in table 3.20)
4.1.4. Bleeding and hematoma at the arterial access postprocedural
Incidence: 8 patients had bleeding and hematoma at arterial
access after procedures (1,6%).
* Gender: research results showed that the rate of bleeding-
hematoma artery road into higher among women than men with p
<0,01. Jose A. Silva and J. Christopher White said that women are
risk factors for bleeding in the street-artery hematoma after PCI.
* Age group: research findings have yet to see a high age is a
95% CI 1,40 to 9,31; p <0,01, EF <29% (OR = 3,27; 95% CI 1,68 to
6,38; <0.01), renal insufficiency grade I and II, p <0,001, disease 3
branchs DMV (OR = 3,9; 95% CI 2,5 to 6,0; p <0,001.
4.2.2. The system of risk factors related to deaths
We have identified a number of risk factors related to death, such
as cardiac shock (OR = 370,5; 95% CI 65.6 to 2091,5; p<0.001).
Killip III heart failure (OR = 6,7; 95% CI 1,3 to 33,7; p<0.05).
NYHA III-IV heart failure (OR = 17,3; 95% CI 4,9 to 61,2; p
<0,001). EF <29% (OR = 40,3; 95% CI 10,2 to 159,7 p <0,001). In
summary, for patients with cardiogenic shock, heart failure NYHA
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III, IV, left ventricular systolic function severely reduced (EF <29%),
all these factors make cardiac output is insufficient to meet the basic
needs be patient while undergoing intervention procedure, as
contributing to increased mortality risk.
Disease left main (OR = 9,28; 95% CI from 2,57 to 35,53; p
<0,01). Disease 3 branchs (OR = 17,32, 95% from 2,20 to 136,41 p
<0,001).
4.3. Risk score predicted complications and death in coronary
intervention
4.5.1. Risk score predicted complications and deaths
Mandeep Singh, Charanjit et al retrospectively studied 3,264
patients over PCI from NHLBI registry data to determine mortality
and complications (Q-wave myocardial infarction, all-bridging
surgical emergency coronary and accident cerebro-vascular). The
comparison showed that the complication rate of 29,4% occupied
compared complication rates by applying a scale MCRS is 28,6%.
Study of Brenner SJ et al applied a scale NYRS of 3,165 cases
with PCI shows the precision and accuracy of the risk factors related
to mortality in PCI.
- The rate of medical complications: reperfusion syndrome (7,2%);
Cardiac arrhythmias in the procedure (9,8%), including sinus bradycardia,
sinus tachycardia, atrial fibrillation, atrial tachycardia, ventricular
extrasystoles, ventricular tachycardia, ventricular fibrillation, atrial-
ventricular block grade III; Contrast induced nephropathy (7,8%) with some
risk factors: cardiogenic shock (p <0,001), NYHA III-IV heart failure (p
<0,05), EF <29% (p <0,01), hypertension (p <0,05), contrast ionization (p
<0,001).
- Bleeding-hematoma at the arterial access: the rate of 1,6%,
women have a higher rate of bleeding-hematoma (0,6%) than men
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(0,3%) with p <0,01, the risk bleeding-hematoma in women higher
than 25.3 times the risk bleeding-hematoma in men (OR = 25,3; 95%
CI 3,1 to 553,1; p <0,01).
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