Mode of Contraception in Saudi Females with Prosthetic heart
valves at childbearing age
*Haitham M. Al Bar, MD **Mohammad Al Ghamdi, MD
Introduction:
Valvular Heart Disease is a common health problem in clinical cardiology
that particularly represents a major concern for females at childbearing age.
Heart valve replacement is a standard procedure for hemodynamically
significant valvular pathologies. Among the valve replacement options,
mechanical valves are commonly used in this young population for their
efficiency and durability. Mechanical valves however, carry the risk of valve
thrombosis and systemic embolization, which is significantly increased
during pregnancy. Optimal mode of contraception in this population is an
unresolved issue with pros and cons for each method. Based on previously
published studies, guidelines and recommendations the contraception
methods of choice in mechanical valves population include IUS (IUCD) and
implanon. Our study was conducted to evaluate the frequency, pattern,
efficacy and safety of the use of different contraceptive methods in the study
population.
Methods:
This is a retrospective analysis of prospectively collected clinical data for
124 female patients at childbearing age in Prosthetic Valve Clinic at KACCKAMC, Riyadh. Relevant clinical variables were directly entered into SPSS,
which was used for analysis. Only females who underwent valve
replacement at childbearing age (15 – 49 years) were included. Complete
data set was a prerequisite for inclusion and analysis.
Results:
Out of 480 patients followed up in prosthetic valve clinic, 124 patients
fulfilled the inclusion criteria. Mean age of the study population at the time
of valve replacement was (34.3 y). Seventy-five (60.5%) of study population
received mechanical valves. Underlying valvular pathologies included;
rheumatic heart disease (69,4%), congenital heart disease (12%) and mitral
valve prolapse (4%). Thirty two out of 124 patients (25%) admitted to have
used any of the different contraception methods after the index valve
replacement surgery as follows: DepoProvera (37.5%), tubal ligation
(28.1%), interutrine contraceptive device (15.6%), combined oral
contraception (12.5%) and condom (6.2%). Fifty-one (68%) of the
mechanical valve population (n=75) did not use any method of contraception
after valve replacement. Only twenty-four patients (32%) of the mechanical
valve population have used some sort of contraception. Twenty-four
pregnancies (19%) occurred in the study population.
Discussion & Conclusion:
Different methods of contraception seem to be underutilized in the study
population, particularly in the mechanical valve subgroup. This result
indicates that these patients are subject to get pregnant which make them at a
high risk for thrombosis or bleeding complications. Some of the reasons
behind the apparent underutilization of contraception in this high risk
population could be related to the maternal emotion of getting children, local
culture of having more children or due to lack of proper counseling and
patient education. Due to relatively small sample size and smaller outcome
end points in addition to the lack of adequate data about contraception
duration, efficacy and safety of different contraception methods in this
population cannot be reliably obtained. More research in the psychosocial
aspects of this population and finding simple and safe contraception methods
are needed. Increasing the couple awareness of health related issues in this
population are recommended to avoid undesirable pregnancy-related or
contraception related outcomes.
* Cardiac Surgery Demonstrator at Majmaah University, Cardiac Surgery
Resident at King Abdullaziz Medical City, National Guard, Majmaah,
Riyadh
** Consultant Adult Cardiology King Abdullziz Cardiac Center, King
Abdullaziz Medical City, National Guard, Riyadh
Introduction:
Valvular heart disease might be a result of a congenital defect or may
develop over the course of a lifetime. Acquired valve disease is most
frequently the result of rheumatic fever, which is the most common cause of
valvular heart disease in developing countries (1,2).
The prevalence of rheumatic heart disease in Saudi Arabia is higher in
the rural area and among female. The prevalence is 24 per 10,000
schoolchildren (6-15 years old)(2). Other causes of valvular heart disease
are Mitral valve prolapse, senile degeneration, Marfan syndrome, prosthetic
valve degeneration, ischemic heart disease, aortic dissection, endocarditis
and trauma (5).
Prosthetic heart valves are classified as either mechanical or
biological. Mechanical valves offer excellent durability, low risk of
reoperation and are superior hemodynamically. Patients with mechanical
valves must take anticoagulants that increase bleeding risk (3,4,5).
Biological valves including autograft, autologous pericardial, homograft,
porcine heterograft or (xenograft), and bovine pericardial valves frequently
have an inferior hemodynamic profile as compared to similar size
mechanical valves (4,5). This difference is most significant in small valves
in the aortic position size (4). Small biological valves in the aortic position
are associated with a high incidence of deterioration in young patients (4,5).
Deterioration of tissue valve may be accelerated during pregnancy (5).
Contraceptive methods differ in their efficacy and safety. Methods of
contraception include condoms, diaphragm, progesterone, combined
progesterone-estrogen, copper intrauterine devices (IUD), levonorgestrel
intrauterine system, DepoProvera (Depot Medroxyprogesterone Acetate),
rhythm method, vasectomy and tubal ligation. (6,7,8)
Women at childbearing age with heart disease should have counseling
about contraceptive methods if clinically indicated. There is little evidence
in the literature regarding the best method(s) of contraception in women with
valvular heart disease. Most of the guideline recommendation regarding the
use of contraception are based on expert opinion or indirectly extrapolated
form other studies. Up to date there is no clinical trial demonstrate the best
methods for this population (6,7).
This study was conducted to identify the frequency of women at
childbearing age using contraception methods and to evaluate the trend,
efficacy and safety of contraceptive methods used in women with prosthetic
heart valves.
Methodology:
The research committee of the King Saud bin Abdulaziz University
for Health Sciences, College of Medicine approved this project on 11th of
November 2009.
Retrospective data was collected from 462 patients,
which were cared for in the King AbdulazizCardic Center, prosthetic valve
clinic over the period from November 2009 to April 2010. One hundred
twenty four of the 462 patients were female at childbearing age. Thirty-two
of these patients were found to be using contraception.
Data collected from the file-included demographics (Age, gender,
marital status), date of the surgery, prosthetic valve type, valve position, the
underling pathology, contraception use, and pregnancy after surgery. The
clinic files contain prosthetic valve clinic data sheet, questioner, echo report
and surgical report. (See Appendix)
Our inclusion criteria:
1. Females at childbearing age, defined as 15 – 55 years of age at any time
during their care in the clinic.
2. Complete data essential for analysis of endpoints.
Clinical and laboratory details of missing data were collected
fromQuadramed System and Apollo Systems.
Statistical analyses of the collected data were carried out using SPSS
software. We used the crosstabulation and frequencies to analyze the data.
The patients grouped according to their childbearing age to know about the
type of valve, which they were on. Moreover, we attend to subgroup the
patients according to the use of contraceptive methods and the age as well
types of valve used either mechanical or biological. Other subgroups aimed
to show the underlying pathological causes for women at childbearing age.
Results:
Total patients were 462 patients. Two hundred thirty three were
female patients. A total of 124 patients were found to be of childbearing age.
In this population a total of 24 out of the 124 (19,4%) got pregnant. The
mean ages for these patients were 42.2 years as a current age and 34.3 as
surgical age. The minimum current age was 18 year and maximum 64 years.
The minimum surgical age was 12 years and maximum was 51 years. (Chart
1) The underlying pathology for them were following: 86 patients (69.4%)
had rheumatic heart disease, 15 patients (12.1%) had congenital heart
disease, 5 patients (4.03%) had mitral valve prolapsed, 3 patients (2.4%) had
endocarditis, 3 patients (2.4%) had ischemic heart disease, and 2 patients
(1.6%) had Marfansyndrome. However, 10 patients (8.1%) had unknown
underlying pathology.(Table 1)
A total of 75 female patients (60.5%) out of 124 at childbearing age
had mechanical valve. Thirty-six patients (48%)had isolated mitral
mechanical valve. Sixteen patients (21.3%) had isolated aortic mechanical
valve. One patients (1.3%) had isolated tricuspid mechanical valve. Twentytwo patients (29,3%) were had a combined mitral and aortic mechanical
valve. One patient (1.3%) was had combined mitral, aortic and tricuspid
mechanicalvalve. Fifty-one patients (68%) out of 75 patients were not using
any contraceptive methods. (Chart 2)
Ninety-two of the 124 (74,2%)patients of childbearing age did not use
contraception. Fourteen of these 92 patients (15,2%) got pregnant.
Thirty-two patients(25,8%) out of 124 patients at childbearing age
were on contraception. The mean ages for them were 43,7 years as current
age and 36.3 years as surgical age. The minimum current age was 31 years
and maximum was 61 years. The minimum surgical ages was 21 years and
maximum was 51 years old. The underlying pathological causes were as
follows: 28 patients (87,5%) had rheumatic heart disease, 3 patients (9,4%)
had congenital heart disease and one patient (3.1%) had an unknown
underlying pathology. Four patients (12.5%) were using the combined oral
contraceptive pill (estrogen and progesterone) and all them got pregnant
during follow up. twelve patients (37.5%) were using progesterone only
injection (Depo-Provera) and 3 of them (25%) got pregnant during follow up.
Five patients (15.6%) were using intrauterine contraceptive device (IUCD)
of which 2 them got pregnant during follow up. Nine (28.1%) patients had
tubal ligation and 2 (22.2%) of them got pregnant during the follow up. two
patients (6.25%) were there husbands using condom as contraceptive
methods non of which got pregnant. Overall 11 of these 32 of the patients
(34.4%) on contraception got pregnant. (Table 2)
Twenty-four patients (75%) of 32 patients taking contraception had
mechanical valves. Six of these patients had both mechanical mitral and
aortic valves. There were 2 patients (8.3%) who used oral combined
contraceptive methods (estrogen and progesterone) and all got pregnant
during follow up. Nine (37.5%) patients were using progesterone only
injection (Depo-Provera) two of them got pregnant during follow up. Four
(16.7%) patients were using IUCD and one of which got pregnant during
follow up. Eight (33.3%) patients underwent tubal ligation, 2 of which got
pregnant during follow up. One patient (4.2%) was here husband used
condom as a contraceptive methods and none of them got pregnant. Overall
7 of these 24 (29.2%) got pregnant during the course of follow up. (Table 3)
Six patients (25%) of 32 patients taking contraception had bioprsthetic
valves. Two patients (25%) were on oral combined contraceptive pill and all
of them got pregnant. three patients (37.5%) were on progesterone only
injection (Depo-Provera) and one of them (33.3%) got pregnant during
follow up. One patient (12.5%) had IUCD and she got pregnant during the
follow up. One patient (12.5%) had tubal ligation and she didn’t get
pregnant. One patient (16.6%) her husband was using condom and she didn’t
get pregnant. Overall 4 of these 6 (66.7%) got pregnant during the follow up
period. (Table 4)
Discussion:
Our study shows that 124 patients found to be at childbearing age
according to our criteria. Out of them a 24 patients (19,4%) got pregnant.
Moreover, 92 patients (74,2%) didn’t use any contraceptive methods at all.
Fifty-one (41.2%) were married and not using contraception. Out of them
14 women (15,2%) got pregnant. Due to this high percentage we should
know the reason not using any contraception methods, which could be either
defect in pre-counseling or lack of prober education of the patients. We are
lacking the pregnancies outcome in relation to the type of valve used
according to our population. In addition, our study shows that a total of 75
female patients (60.5%) out of 124 at childbearing age had mechanical valve.
Out of these patients 51 patients (68%) were not using any contraception
methods. Pregnancy in women with cardiac disease can challenge the health
care providers and carry a risk for the mother and the fetus (8). Precounseling is an essential part for all the women with heart disease
especially with valvular heart disease and congenital heart disease (6,7,8).
Women with mechanical valve during pregnancy can experience a
thromboembolic event or fatal complication as spontaneous abortion,
warfarinembryopathy, ventricular septal defect (VSD) and growth
retardation (9,10,11). Our study shows that a high percentage of the patients
(68%) had mechanical valve. Due to the risk of the pregnancy they need
further evaluation and pre counseling.
Our study show that 86 patients (69.4%) had rheumatic heart disease,
15 patients (12.1%) had congenital heart disease, 5 patients (4.03%) had
mitral valve prolapsed, 3 patients (2.4%) had endocarditis, 3 patients (2.4%)
had ischemic heart disease, and 2 patients (1.6%) had Marfansyndrome. We
found 10 patients (8.1%) had unknown underlying pathology. One of studies
has showed that the commonest form of heart disease in developing
countries is rheumatic heart disease (12,13). The prevalence of rheumatic
heart disease in Saudi Arabia is 24 per 10,000 among schoolchildren (6-15
years old)(2). Due to this high prevalence the need of prevention program is
an important factor to decrease the number of rheumatic heart disease among
children for healthy future (13).
In our study, patients who were on different contraception methods
were 32 patients (25,8%) out of 124 at childbearing age. The pregnancy
occurrence of the all was 34,4% (11 patients got pregnant) during there
follow up visit. Four women were using combined oral contraceptive. The
failure rates for combined oral contraceptive is 3-8 % with a typical use and
0.1% with a perfect use within the first year of use (6). Twelve patients were
using progesterone only injection (Depo-Provera). However, the failure rates
for this method is 3% with typical use and 0.3% with a perfect use within the
first year of use (6). Five patients were found to have intrauterine device
(IUD). However, the failure rate for IUD with typical use is 0.8% and 0.6
with perfect use within the first year of use (6). The IUD is the effective
method with high efficacy last for many years after insertion (7). It is
considered safe and effective for women with congenital heart disease (7).
No data available about the safety and efficacy for women with prosthetic
valve. Nine patients underwent tubal ligation method. However, the failure
rate with tubal ligation is 0.13-1.3% with typical and perfect use within the
first year (14). The risk of ectopic pregnancies is not rare especially for
women underwent the procedure before the age of 30 (15). The failure of the
tubal ligation can be due to inappropriate technique from the procedure done
by the surgeon (14). Two patients’ there husbands were using condom as
contraceptive method. However, the failure rates for these methods found to
be 15-32% with typical use and 2-26% with perfect use (6,7). Due to high
failure rate, women at risk to become pregnant should not use this form of
contraception (7). In our study we cannot estimate the failure rate of the
different contraceptive methods due to lack of data about contraception
duration and its relationship with pregnancy.
There were 24 patients out of 32 patients using contraception had
mechanical valve. Seven of them (29,2%) got pregnant during. Pregnancy in
women who had mechanical valve carries a risk of thrombotic complication
and fetal complication (16). We found in our study that two patients were
using combined oral contraceptive pill.
According to world health
organization (WHO) recommendation women with mechanical valve should
not be used COCs due to thrombotic risk even if they are at warfarin (6).
However, some specialists are comfortable recommending COCs in women
appropriately anticoagulated with warfrain (7). We found that nine patients
were on progesterone only injection (Depo-Provera). According to WHO
recommendation women with mechanical valve should use Depo-Provera
with caution WHO 3,risk usually outweigh advantages of the methods and
other methods preferable, (6). It is important to close monitoring the
international normalized ratio (INR) with any women start to use hormonal
contraception because estrogen and progesterone has an affect the
metabolism of warfarin (6). Our study showed that four patients were using
intrauterine contraceptive devices (IUCD). According to the data form our
study, we don’t know exactly the type of IUCD and that need further
evaluation. However, IUCD found to be safe and effective to be used in
women with mechanical heart valve (6). The levonogerstrel releasing
intrauterine device (LNG-IUDs) considered effective and superior to the
sterilization methods (6,17). Our study showed that eight patients who
underwent tubal ligation as contraceptive methods. There is no
contraindication with this method for women with mechanical valve (6). The
sterilization method is less effective than implanon, single rod long acting
reversible hormonal contraceptive sub dermal implant that is inserted just
under skin of the upper arm, and the intrauterine contraceptive device with
levonorogesterl (IUS) (6). It is consider WHO 2 (broadly useable), small
increased risk; advantages of the method generally outweigh the risk, (6).
Our study showed that one patient's husband used condom as contraceptive
method. The barrier methods are a user dependent and there is a high failure
rate (6). For women with mechanical valve the barrier methods are not
contraindicated (6). However, because of high risk of unplanned pregnancies
and pregnancy in this population this method should be avoided (6).
Our study shows that 8 patients were on different type of
contraception methods. Three patients were on COCs method, which
consider being WHO 2 classification of risk (6). Three patients were using
Depo-Provera as contraception method and there is no contraindication to
use this method (6).Three patients were found to use IUCD, tubal ligation or
male condom and all of these methods not contraindicated to use for this
group (6). Women with prosthetic tissue heart valve have a risk of structural
valve deterioration and risk of bleeding (9).
Conclusion:
The most common contraceptive methods uses in our population are
Depo-Provera (37.5%), tubal ligation (28.1%), intrauterine contraceptive
device (15.6%), combined oral contraceptive pill (12.5%) and condom
(6.2%).
Contraception of any type seems to be underutilized in prosthetic
mechanical valve population.
We concluded from the literature review of the previous studies,
guidelines and recommendations the best methods of contraception for
female with mechanical valve are the IUS and implanon for our population.
Implanon may produce oligomenorrhea and we need to conduct a study
regarding the use of this method according to mechanical valve.
Due to lack of data about contraception duration and its relationship to
pregnancy and small sample size we cannot rely on the efficacy of different
contraception methods. However, the adverse effect of planned and
unplanned pregnancy for our population is clinically significant in women
with prothstatic valve.
Our recommendations to establish a pre-counseling clinic for these
patients as well education for them about the risk of pregnancies and the use
of the best updated contraceptive method available. Establishing preventive
program to decrease the incidence of rheumatic heart disease.
Tables:
Table 1: summary of the underlying pathology among female at childbearing
age.
Underlying Pathology
Number of Patients
Percentage of Patients
Rheumatic heart
disease
86
69.4%
Congenital heart
disease
15
12.1%
Unknown
10
8.1%
Mitral valve prolapse
5
4.03%
Endocarditis
3
2.4%
Ischemic heart disease
3
2.4%
Marfan Syndrome
2
1.6%
Total
124
100%
Table 2: Contraception Methods and pregnancy occurrence:
Type of Contraception
Number
of
Patients
Percentage
Of Patients
Number of
Pregnancies
OCC
4
12.5%
4
Provera
12
37.5%
3
IUCD
5
15.6%
2
Ligation
9
28.1%
2
Condom
2
6.2%
0
Total
32
100%
11
Table 3: Contraception Methods and pregnancy occurrence with
Mechanical Valves:
Type of
Contraception
Number
of
Patients
% Of
Patients
Number of Pregnancies
OCC
2
8.3%
2
Provera
9
37.5%
2
IUCD
4
16.7%
1
Ligation
8
33.3%
2
Condom
1
4.2%
0
Total
24
100%
7
Table 4: Contraception Methods and pregnancy occurrence with
Bioprosthetic Valves:
Type of
Contraception
Number
of
Patients
% of
Patients
Number of
Pregnancies
OCC
2
25%
2
Provera
3
37.5%
1
IUCD
1
12.5%
1
Ligation
1
12.5%
0
Condom
1
12.5%
0
Total
8
100%
4
Charts:
Chart 1: summary of prosthetic valve population:
Chart 2: Summary of mechanical valve population at childbearing.
Appendix:
References:
1. Rheumatic heart disease in the developing world: prevalence,
prevention, and control. Eur Heart J. 1993 Jan; 14(1): 122-8.
2. Rheumatic heart disease in schoolchildren in western district, Saudi
Arabia. Al-Sekait MA, al-Sweliem AA, Tahir M.
3. Anticoagulation of pregnant women with mechanical heart valves: a
systematic review of the literature. Chan WS, Anand S, Ginsberg JS.
Arch Intern Med. 2000 Jan 24; 160(2): 191-6.
4. Outcomes 15 years after valve replacement with a mechanical versus
a bioprosthetic valve: final report of the Veterans Affairs randomized
trial
5. Karl Hammermeister, MD, FACC*, Gulshan K. Sethi, MD, FACC,
William G. Henderson, PhD, Frederick L. Grover, MD, FACC*,
Charles Oprian, PhD and Shahbudin H. Rahimtoola, MB, FRCP,
MACP, MACC
6. ACC/AHA Guidelines for the management of patients with valvular
heart disease .1998.
7. Risk of contraception and pregnancy in heart disease, sara thorn, anne
Macgregor, Cathrein Nelson-piercy, heart 2006.
8. Choosing the best contraceptive methods for the adult with congenital
heart disease, Candice K. Silverside, Mathew Sermer and Samuel C.
Siu, Current Cardiology Reports 2009.
9. Assessment and management of cardiac disease in pregnancy,
Georgory A. L. Davies, William N. P. Herbert, April JOGC AVRIL
2007.
10.Valvular Heart Disease and PregnancyPart II: Prosthetic Valves, Uri
Elkayam, MD, FACC, FahedBitar, MD.J Am CollCardiol
2005;46:403–10
11.Low molecular weight heparin for the prophylaxis of
thromboembolism in women with prosthetic mechanical heart valves
during pregnancy. Oran B, Lee-Parritz A, Ansell J. 2004 Oct; 92(4):
747-51.
12.Dose-dependent fetal complications of warfarin in pregnant women
with mechanical heart valves*1Nicola Vitale MD, ,*, Marisa De Feo
MD*, Luca Salvatore De Santo MD*, AlessioPollice PhD†, Nicola
Tedesco PhD† and Maurizio Cotrufo MD*, 1999 April.
13.Rheumatic fever and rheumatic heart disease. Report on a WHO study
group. Geneva, World Health Organization, 1988 (WHO Technical
Report Series, No.764).
14.Rheumatic heart disease among Omani schoolchildren, Eastern
Mediterranean Health Journal , Volume 3, Issue 1, 1997, Page 17-23 ,
Aly A. Hasab,Ali Jaffer and Abdulla M. Riyami
15.Failed female sterilization: a review of pathogenesis and subsequent
contraceptive options. Awonuga AO, Imudia AN, Shavell VI, Berman
J, Diamond MP, Puscheck EE. J Reprod Med. 2009 Sep; 54(9):541-7.
16.The Risk of Ectopic Pregnancy after Tubal SterilizationHerbert B.
Peterson, M.DZhisen Xia, Ph.D., Joyce M. Hughes, Lynne S. Wilcox,
M.D Lisa Ratliff Tylor, B.S James Trussell, Ph.D., for The U.S.
Collaborative Review of Sterilization Working GroupVolume
336:762-767 content/vol336/issue11/index.dtl, march 1997, BMJ
journal
17.Anticoagulation of Pregnant Women With Mechanical Heart Valves,
A Systematic Review of the Literature17, Wee Shian Chan, MD,
FRCPC; Sonia Anand, MD, FRCPC; Jeffrey S. Ginsberg, MD,
FRCPC ,Arch Intern Med. 2000; 160:191-196
18.The effect of levonogestrel – releasing intrauterine device on
menorrhagia in women taking anticoagulant medication after cardiac
valve replacement,SevtapKilic, BerilYuksel, MelikeDoganay,
HasmetBardakci, FilizAkinsu, Ozlem U zunlar and
LeylaMollamahutoglu , contraception DOI 2009.