The objective of the study is to report the contraceptive methods used by patients with congenital heart disease (CHD) before referral to a specific preconception clinic and evaluate safety and treatment adherence of the alternative contraception method, progesterone-only component (PC), offered. Contraceptive methods in the CHD population reported included estrogen-progesterone combined contraceptives (EPCC), despite the potential risk for thromboembolism. PC has been suggested as an alternative, but, no information on its use has been reported. Retrospective analysis was performed of all patients (n = 237) referred to the preconception clinic of an adult CHD center. Thirty-three percent of patients had used EPCC in the past; 3.8% had had thromboembolic events during its use. Current contraception consisted of barrier methods in 58% of patients, EPCC in 18%, and PC in 1.3%; 21.7% of patients were not using any contraception. PC was offered as an alternative in 146 patients; 73% of patients agreed to start the treatment. At a median follow-up of 1 year, 73% of patients who started PC maintained the treatment. Gynecologic side effects were reported in 25% of patients, with no cardiovascular effects. In conclusion, a significant proportion of patients with CHD were former users of EPCC, although some had formal contraindications, and the rate of PC use before referral to the preconception clinic was low. After being offered as an alternative treatment, the use of PC in its various forms was extensive, with no thrombogenic side effects and an acceptable rate of gynecologic side effects being reported.
Barrier methods, although safe, have an inadmissible failure rate (a Pearl index of 11) in patients with pregnancy considered to be at high risk. Guidelines consider the presence of Fontan circulation, cyanosis, and pulmonary arterial hypertension to be contraindications for the use of estrogen-progesterone combined contraceptives (EPCC), but no data on complications with their use and the influence of concomitant anticoagulation are available. Furthermore, although there is no formal contraindication for EPCC in other patients with congenital heart disease (CHD), data confirming safety are also lacking. Alternative hormonal contraception includes progesterone-only component (PC) forms, which are considered safer, but no information has been reported regarding their use in the CHD population. The aim of the present study was to assess the contraceptive methods used by patients with CHD and the cardiovascular side effects reported before referral to the preconception clinic. PCs were offered as alternatives. The second objective of the study was to evaluate safety and treatment adherence of the alternative contraception offered during follow-up.
Methods
In 2007, we created a specific gynecology-cardiology preconception clinic to address patients’ risk after careful cardiologic and gynecologic assessment. From January 2007 to December 2010, all women of childbearing age attending a single-center adult CHD unit, with World Health Organization (WHO) classifications of ≥2, were invited to attend the preconception clinic for preconception issues and contraception during their routine cardiologic follow-up appointments. All women assessed at the preconception clinic were studied. After institutional review board approval was obtained, data were retrospectively collected from medical records.
Variables collected were age, type of CHD, functional class, presence of chronic cyanosis, chronic anticoagulation, residual left-to-right shunting, presence of mechanical valve, pulmonary hypertension, and Thorne modified WHO classification for risk using combined contraception.
The attending physician classified patients according to 1 of 4 functional classes. Data regarding the presence of chronic cyanosis, chronic anticoagulation, mechanical valve, and pulmonary hypertension were collected directly from the medical records. Residual left-to-right shunting was judged from the most recent echocardiogram. During the first preconception clinic appointment, the modified WHO classification for risk using combined contraception proposed by Thorne et al was applied in each patient and consequently registered.
Contraceptive methods, including former use of EPCC and side effects reported during their use (including thromboembolic effects), were recorded. Current contraceptives method uses were also registered.
Among the patients started on PC, side effects were registered as reported spontaneously by the patients at successive outpatient clinic appointments. A clinical appointment was routinely scheduled for 6 months after starting desogestrel, unless the patient had any doubts. Patients were systematically questioned during follow-up for amenorrhea, spotting, and new cardiovascular events.
Data were analyzed using SPSS version 15 (SPSS, Inc., Chicago, Illinois). Appropriate statistical methods were applied to define the distributions of variables. Descriptive statistics for nominal data are expressed as absolute numbers and percentages. Mean values and range are presented for normally distributed continuous variables, as medians with ranges for skewed continuous variables, and as counts with percentages of the total for nominal variables.
Results
Two hundred thirty-seven women (median age 28 years, range 14 to 52) were included in the study. Mean follow-up was 609 days, with a minimum of 83 days and a maximum of 1,340. The main patient characteristics are list in Table 1 . The main diagnoses are listed in Table 2 . Cases were classified according to the main residual hemodynamic lesion or risk factor to be considered in cases of pregnancy or contraception (see Table 3 ).
| Variable | n (%) |
|---|---|
| New York Heart Association functional class | |
| I | 157 (66%) |
| II | 71 (30%) |
| III | 8 (3.4%) |
| IV | 4 (1.6%) |
| WHO modified classification | |
| 2 | 159 (67%) |
| 3 | 33 (14%) |
| 4 | 45 (19%) |
| Previous use of EPCC | 79 (33%) |
| Previous pregnancy | 49 (21%) |
| Type of CHD | n (%) |
|---|---|
| Tetralogy of Fallot | 37 (15%) |
| Atrioventricular septal defect | 31 (13%) |
| TGA | 26 (11%) |
| Aortic stenosis | 23 (10%) |
| Pulmonary stenosis | 20 (8.4%) |
| Ventricular septal defect | 19 (8%) |
| Aortic coarctation | 18 (7.6%) |
| Univentricular heart | 18 (7.6%) |
| Atrial septal defect | 9 (4%) |
| Unrepaired pulmonary atresia | 7 (3%) |
| Repaired pulmonary atresia | 5 (2%) |
| Ebstein’s anomaly | 4 (1.7%) |
| Complete atrioventricular block | 3 (1.3%) |
| Congenitally corrected TGA | 3 (1.3%) |
| Double-outlet right ventricle | 3 (1.3%) |
| Persistence of ductus arteriosus | 3 (1.3%) |
| Subaortic stenosis | 2 (0.8%) |
| Type of Residual Lesion | n (%) |
|---|---|
| RV volume overload due to pulmonary or tricuspid regurgitation | 59 (25%) |
| Residual RV outflow tract obstruction | 8 (3%) |
| Small left-to-right shunt | 27 (11%) |
| Residual LV outflow tract obstruction | 21 (9.5%) |
| LV volume overload due to mitral or aortic regurgitation | 22 (9.5%) |
| Mechanical prosthesis | 12 (5.5%) |
| Cyanotic complex congenital heart disease (without pulmonary arterial hypertension) | 15 (6%) |
| Fontan circulation | 8 (3%) |
| Eisenmenger syndrome and other forms of pulmonary arterial hypertension | 13 (5.5%) |
| Aortic coarctation | 18 (8%) |
| Systemic right ventricle | 27 (11%) |
| Other | 8 (3%) |
| Total | 237 (100%) |
Contraceptive methods used before referral to the preconception clinic were as follows: 58.4% of patients were using barrier methods, 17.6% of patients were current users of EPCC (13% oral and 4.6% transdermal patch), 1.9% of patients were using copper intrauterine devices, and very small proportion were using the PC pill (1.3%) and impregnated intrauterine device (0.8%); no patients were using implants. Twenty-one percent of patients were not using any type of contraception at the time of assessment.
All patients were asked about previous use of EPCC in its different presentations (oral, transdermal patch, or vaginal ring). Seventy-nine patients (33%) had previously used EPCC, with a median duration of 36 months (range 1 to 624). Five patients (11.5%) in Thorne modified WHO group 4, and thus with formal contraindications to EPCC, had previously used EPCC. Of the patients in modified WHO group 3, 33.3% had previously used EPCC. During treatment with EPCC, 3.8% of patients reported cardiovascular side events (neurologic events): 2 in modified WHO group 4 and 1 in modified WHO group 2.
For patients inquiring about contraceptive methods (n = 145), desogestrel 75 mg was proposed as an alternative. One hundred seven patients agreed to start with desogestrel and were followed up at the outpatient clinic. After the median follow-up period of 385 days, 73.1% of patients (n = 79) were taking PCs: 63 (60.6%) were taking desogestrel pills, 16 (14.8%) had upgraded to implants or impregnated intrauterine devices, and 14.8% had returned to barrier methods; 12% of patients were not using any contraception at the end of follow-up.
Gynecologic side effects were reported in 18% of patients at the time of first assessment and in 25% at the end of follow-up. Spotting was the main symptom at the first assessment and amenorrhea during the long term ( Table 4 ). At the end of follow-up, 25% of patients had abandoned the treatment because of side effects. No pregnancies occurred during follow-up. No cardiovascular side effects or thromboembolic events during follow-up were reported. The proportions of contraceptive methods used at the time of referral and at the end of follow-up in each Thorne modified WHO group are given in Figure 1 .
