CRITICAL APPRAISAL I

Tuesday, August 14th

2018

Validation of modified World Health

Organization
classifiation for pregnant women with heart
disease in a tertiary care center in southern
Thailand

Presenter : Amarendra NW
Resource Person : dr. Dini HIdayat, SpOG (K),MKes
OVERVIEW
PURPOSE
 To validate the modifid World Health Organization (WHO) classifiation in pregnant
women with congenital and acquired heart diseases.
RESULT OF THIS STUDY
 The
overall maternal mortality rate was 3.6%, all of which were in the modifid WHO class IV.
Maternal cardiovascular events occurred in 24.2% of cases, increasing rates with higher modifid
WHO class: 4.2%, 15.0%, 25.0% and 56.4% in class I, II, III and IV, respectively (p,0.001).

CONCLUSION OF THIS STUDY

 The modifid WHO classifiation is useful not only for obtaining a cardiovascular
risk assessment in pregnant women with heart disease but also for predicting adverse fetal
outcomes. It must, therefore, be implemented into routine care service at all levels of health care
systems.
MATERIALS AND METHODS
DESIGN : Observational, retrospective cohort study
SETTING : Comparison of maternal and fetal outcomes among the modified WHO
classes were analyzed using the chi-square test or Fisher’s exact test and one-way
ANOVA
test. A p-value: of,0.05
POPULATION was considered
The database statistically
of pregnant women with signifiant.
heart disease, who delivered
at Songklanagarind Hospital between January 1995 and December 2016.

SAMPLE :
Each patient was retrospectively classifid according to the modifid WHO classifiation
of maternal cardiovascular risk
 Introduction
Heart disease is a leading cause of maternal
mortality in developed countries as well as
some developing countries, including Thailand,
with incidence varying from 1% to 4%

Pregnancy induces hemodynamic changes to meet the

demands of the mother along with the fetus, which include
increases in blood volume and cardiac output and
reduction in systemic vascular resistance coupled with
blood pressure. This can then lead to an increase in
maternal and perinatal morbidity and mortality

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 Introduction
The modified World Health Organization (WHO) classifiation in pregnant

•WHO class I consists of WHO class II (if otherwise well and

1) uncomplicated,small or mild pulmonary uncomplicated) includes
stenosis, patent ductus arteriosus and 1)unoperated atrial
mitral valve prolapse or ventricular septal defect;
2) successfully repaired simple
lesions (atrial or ventricular septal defect,
2)repaired tetralogy of Fallot;
patent ductus arteriosus, anomalous
pulmonary venous drainage); 3)most arrhythmias
3) atrial or ventricular ectopic beats,
isolated

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 Introduction
The modified World Health Organization (WHO) classifiation in pregnant

WHO class III includes WHO class IV (pregnancy contraindicated), there are seven
conditions including
1) mechanical valve;
1) pulmonary arterial hypertension of any cause;
2) systemic right ventricle;
2) severe systemic ventricular dysfunction (left ventricular ejection
3) Fontan circulation; fraction ,30%, New York Heart Association III–IV);
4) cyanotic heart disease (unrepaired); 3) previous peripartum cardiomyopathy with
any residual impairment of left ventricular function;
5) other complex
congenital heart disease; 4) Severe mitral stenosis and severe symptomatic aortic stenosis;

6) aortic dilatation 40–45 mm in 5) Marfan syndrome with aorta dilated .45 mm;
Marfan syndrome; and 6) Aortic dilatation 50 mm in aortic disease associated with
bicuspidaortic valve; and
7) 7) aortic dilatation 45–50 mm in aortic
disease associated with bicuspid aortic 7) native severe coarctation
valve 7
Outcomes
A total of 331 cases were studied, including 157 (47.4%) congenital heart
diseases and 174 (52.6%) acquired heart diseases (161 rheumatic heart
diseases, 8 arrhythmia and 5 cardiomyopathy). The most common type
of congenital heart disease was a ventricular septal defect (34.4%),
followed by an atrial septal defect (29.3%) and then patent ductus
arteriosus (13.4%). Congenital heart disease was corrected in 50 cases
(31.8%) before pregnancy. In acquired heart disease, rheumatic heart
disease was the most prevalent (92.5%), mainly involving the mitral
valve. Surgical correction was performed in 58 cases (33.3%) before
pregnancy. The percentage of referred cases was 47.4%.
• There were 48, 173, 32 and 78 cases in the modified WHO class I, II, III
and IV, respectively. Comparison of maternal characteristics in
addition to fetal outcomes among the four classes is shown in Table 1.
Age and parity were not statistically different among the four classes.
In the modified WHO class I, most cases were congenital heart
diseases, whereas in class II–IV, acquired heart disease was more
prevalent.
• Adverse events are shown in Table 2. Maternal cardiovascular events
occurred in 24.2% of cases, significantly increasing the rates with a
higher modified WHO class (p,0.001).
Discussion

• This study retrospectively simulated pregnant women with congenital

and acquired heart diseases for cardiovascular risk assessment
according to the modified WHO classification, so as to validate its
value in the context of a tertiary care center in a developing country.
The results confirmed that the modified WHO classification was
useful to predict not only maternal cardiovascular risk but also
offspring risk.
CRITICAL APPRAISAL OF THIS STUDY
CRITICAL APPRAISAL OF PROSPECTIVE
COHORT STUDY
• Validity Results
1. Was the cohort representative of the 7. How strong is the association between
population? Was everyone included who
should have been? exposure and outcome (relative risk)? What
2. Were the methods for determining exposure is the absolute risk reduction (risk
objective and consistent across the cohort? difference)?
Were the tools validated, where applicable? 8. How precise is the estimate of risk
3. Were the methods for determining outcome (confidence intervals)?
objective and consistent across the cohort?
Were the tools validated, where applicable?
4. Were the subjects and/or the outcome assessor Applicability
blinded to exposure? 9. Are there benefits that offset the risks of the
5. Have all important confounding factors been exposure?
identified and accounted for in the design
and/or analysis?
6. Was follow-up of subjects complete? and
sufficiently long?
1. Was the cohort representative of the
population? Was everyone included who should
have been?
• Yes, the cohort represent the population of pregnant women with
heart disease and all population should be included were included

331 pregnant women

157 (47,4%) 174 (52,6%)

congenital heart acquired heart
disease disease
2. Were the methods for determining exposure
objective and consistent across the cohort? Were
the tools validated, where applicable?
p-value of ,0.05 was considered statistically
significant.

The modified WHO Maternal cardiovascular

class IV had events occurred in
significantly lower 24.2% of cases,
birth weight than in significantly increasing
the class I (ß=- the rates with a higher
273.68 [71.34], (p < modified WHO class (p <
0.001). 0.001).
3. Were the methods for determining outcome
objective and consistent across the cohort? Were
the tools validated, where applicable?
The outcomes were determined according to study protocol, but may
be depending on the standard procedures in each center

In the modified WHO class I,

most cases were congenital
heart diseases, whereas in
class II–IV, acquired heart
disease was more
prevalent.
4. Were the subjects and/or the outcome
assessor blinded to exposure?
Yes, the exposure was blinded from the subjects and the assessor.
• Congestive heart failure = p value < 0,001
• arrhythmia = p value < 0,001
• Worsening of at least two NYHA functional classes = p value < 0,001
• Maternal death = p value < 0,001
• any cardiovascular event = p value < 0,001
• Small for gestational age = p value < 0,001
• Low birth weight = p value < 0,001
• neonatal intensive care unit admission = p value < 0,001
5. Have all important confounding factors been
identified and accounted for in the design and/or
analysis?
• Chi Square test
Age (years), nulliparity , Type of heart disease (Congenital, acquired),
Surgical correction before pregnancy, referred cases , Number of
antenatal care visits, Gestational age at first antenatal care (weeks),
Gestational age at delivery (weeks), Mode of delivery (Spontaneous
vaginal delivery, Vacuum extraction, cesarean section, Birth weight,
birth weight z-score, and apgar score at 5 minutes)

P value < 0,001

6. Was follow-up of subjects complete? and
sufficiently long?
Yes, subjects were observed to be grouped into classes, namely classes
I to IV according to WHO
7. How strong is the association between exposure
and outcome? What is the absolute risk reduction?
8. How precise is the estimate of risk
(confidence intervals)?
9. Are there benefits that offset the risks of the
exposure?
Yes there is, to classify pregnant women and also to anticipate
unwanted events so that they can be handled properly.
Thank you