What Every Cardiologist Should Know About Contraception and Reproductive Planning in 2025

Authors: Leslie Cho, Joan E. Briller, Haywood L. Brown, Daniela R. Crousillat, Deirdre J. Mattina, Amy A. Sarma, Nandita S. Scott, Jyoti Sharma, Rachel Sinkey, Stephanie Teal, Kathryn J. Lindley

Abstract

Recent studies have shown that maternal mortality continues to increase for all racial and ethnic groups in the United States. The recent changes in reproductive legal policies combined with unacceptably high morbidity and mortality rates have made it crucial for every cardiologist to understand and engage with reproductive planning. The risk of cardiovascular complications during pregnancy is prohibitively high for patients in the modified World Health Organization Risk Class IV with maternal cardiovascular event rates of >40%, and pregnancy is not recommended. It is critical that cardiologists partner with primary care providers, Obstetrics and Gynecology, Complex Family Planning subspecialist, Maternal‐Fetal Medicine specialists, Anesthesia, and Pharmacist and Nursing to implement available contraception strategies and understand termination options that can be offered to these high‐risk patients. The aim of this article is to review risks and advantages of available contraception and pregnancy termination options as it pertains to these high‐risk cardiac patients.

Recent studies have shown that maternal mortality has increased for all racial and ethnic groups in the United States. ^1^ Many pregnancy‐capable individuals with cardiovascular disease (CVD) desire pregnancy and most cardiovascular conditions can be managed safely through pregnancy and the postpartum period with coordinated efforts of a multidisciplinary team of Cardiology, Maternal‐Fetal Medicine, Obstetrics and Gynecology, anesthesiology, pharmacists, and nursing staff. However, some very high‐risk conditions confer unacceptable risk of maternal and/or fetal morbidity and mortality, and avoidance of pregnancy is recommended. Recent changes in US reproductive legal policies have made it crucial for every cardiologist to understand and engage in reproductive planning. It is critical that cardiologists, working together with Primary Care Providers, Obstetrics and Gynecology, Complex Family Planning Subspecialist, and Maternal‐Fetal Medicine understand the available contraception, emergency contraception (EC), and termination options that can be offered for these high‐risk women. This article, written by the American College of Cardiology Cardiovascular Disease in Women's committee in conjunction with leading Obstetrics and Maternal‐Fetal Medicine specialists, will review current reproductive planning strategies for modified World Health Organization (mWHO) Risk Class IV patients. The aim of this article is not to express any political views but to review scientific data to promote health and well‐being for vulnerable patients.

HIGH‐RISK PREGNANCY

Preconception counseling on pregnancy prevention is imperative when caring for patients of reproductive age with high‐risk CVD. Unfortunately, only about one‐half of pregnancy‐capable individuals with congenital heart disease (CHD) recall discussing contraception with their cardiologist, and less than half received this counseling before their first sexual encounter. ^2^ The median age of menarche in the United States is 11.9 and 68% of girls are sexually active at least once by age 17 years. ^2^ , ^3^ Pediatric cardiologists should begin discussions of contraception with young adult patients at high risk and adult cardiologists must continue to re‐evaluate efficacy, safety, and patient preference for the method of contraception throughout their reproductive years.

Pregnancy in patients with CVD can be associated with significant morbidity and mortality. Common maternal adverse outcomes include heart failure, arrhythmias and progression of disease, and common adverse perinatal outcomes include fetal growth restriction, preterm delivery, neonatal intensive care unit admission, congenital heart lesions, and fetal demise. ^4^ , ^5^ , ^6^ Appropriate assessment requires integration of the available clinical information, functional assessment, and knowledge of individual cardiac lesion prognosis.

Several tools exist to help risk stratify patients for whom pregnancy may be poorly tolerated and not recommended. The most common currently used schemes include the mWHO, the CARPREG II (Cardiac disease in pregnancy II), and the ZAHARA (Zwangerschap bij aangeboren hartafwijking/pregnancy in women with congenital heart disease) score. ^4^ , ^5^ , ^6^ The mWHO classification is lesion specific and originally based on expert consensus, but subsequently validated in the Registry of pregnancy and cardiac disease (ROPAC) registry. ^7^ Patients who are mWHO class IV have the highest pregnancy risk and are strongly advised to avoid pregnancy or terminate the pregnancy if they become pregnant (Table 1). Lesions that are classified as mWHO class IV have an anticipated risk of adverse event rates that can approach 40%. Examples include severe left‐sided obstructive lesions, pulmonary arterial hypertension regardless of cause, severe left ventricular ejection fraction (<30%), and certain aortopathies. ^4^ The CARPREG II trial updated an earlier predictive scheme addressing outcomes in almost 2000 pregnancies in women with known CVD. ^5^ Ten maternal risk predictors were identified, including 4 lesion‐specific factors (mechanical valves, high‐risk aortopathy, pulmonary hypertension, and coronary artery disease), 5 general predictors (prior cardiac event or arrhythmia, poor functional class or cyanosis, high‐risk valve disease or left ventricular outflow obstruction, no prior cardiac intervention), and 1 factor related to late presentation for prenatal care (defined as after 20 weeks gestation) ^5^ (Table 1). The ZAHARA risk score is a validated weighted risk score developed specifically for women with congenital heart disease. Highest risk factors include presence of a mechanical valve and left‐sided obstructive lesions ^6^ (Table 1). The sum of the risk corresponds to event risk.

These scoring systems serve as a starting point for assessing risk of pregnancy, but have limitations. First, they only include patients with known pre‐existing CVD. Further, the ZAHARA and CARPREG risk scores were based largely on patients with congenital heart disease who were cared for at tertiary care centers with cardio‐obstetric expertise and excluded patients who terminated pregnancies, including those who terminated for cardiovascular causes; as such, it is possible that these tools underestimate risk in a broader healthcare setting. Overall, scoring systems are not always able to distinguish between mild and more severe variations of disease and the effect of concomitant comorbidities. They also do not account for access to medical care and cannot predict risk of clinical deterioration if cardiac medications not compatible with pregnancy are withdrawn. Full risk assessment requires comprehensive and nuanced integration of the individual patient's condition and may require functional testing, advanced imaging, and hemodynamic assessment. The ability of the patient to access high‐level maternity care, follow complex treatment regimens, and undergo frequent medical assessments should also guide the pregnancy risk assessment.

CONTRACEPTION

Contraception is an essential component of reproductive planning among the growing number of young patients with cardiac disease. Unfortunately, patients with high‐risk cardiac conditions often report limited awareness and education by their cardiovascular clinicians regarding the most effective and safe contraceptive options, and a minority of patients with cardiac disease report planning to use a highly reliable method of contraception postpartum. ^8^ , ^9^ Access to contraceptive care is significantly limited for Black and Hispanic patients and those with lower financial and sociodemographic status. Additionally, those residing in “maternity care deserts” have no provider for obstetric care or delivery facility and are disproportionately affected by the crippling maternal health crisis affected by the lack of access to maternal care. ^10^

All potentially child‐bearing patients with cardiac disease should have an initial discussion with their cardiovascular clinician surrounding reproductive planning followed by annual reassessment of reproductive goals, potential teratogenicity of cardiac medications, and risk of future pregnancy based on the status of their cardiac condition. ^2^ Shared decision‐making should be guided by reproductive goals within the context of their cardiac disease, with respect for patient autonomy and consideration of personal values and preferences. ^2^ , ^11^ Importantly, all members of the healthcare team including primary care and obstetrics and gynecology should be engaged in multidisciplinary discussions surrounding the risk of an unplanned pregnancy versus the risks and benefits of available contraceptive options (Figure 1).

Multiple safe and effective contraceptive methods are available (Table 2) based on the framework provided by the US Medical Eligibility Criteria for Contraception Use from the US Centers for Disease Control and Prevention. ^12^ Contraceptive methods are also categorized by efficacy, with Tier I methods representing low 1‐year failure rates (<1%/y) and Tier III methods with prohibitively high 1‐year failure rates of >18%. ^13^ , ^14^ For patients with mWHO Class IV conditions, long‐acting reversible contraception (LARC) or permanent sterilization (both Tier I) are the preferred methods of contraception due to their low failure rates and safe cardiovascular side‐effect profile. ^2^ , ^15^ Approximately two‐thirds of patients from 1 cardio‐obstetrics program utilized LARCs, suggesting that when patients are counseled by a multidisciplinary team, most are open to this form of contraception. ^16^ LARC includes the levonorgestrel intrauterine device (IUD), the nonhormonal copper IUD, and the etonogestrel subdermal implant, which can all safely be used with any cardiac condition, including in adolescent and nulliparous patients. ^14^ Among patients with an indication for chronic anti‐coagulation or anti‐platelet therapy (mechanical valve, ischemic heart disease, and thromboembolic disease), the levonorgestrel IUD may be preferred to avoid the higher risk of heavy and/or irregular menstrual bleeding that can occur with the copper IUD and subdermal implant. ^2^ , ^12^ , ^15^ For patients with single ventricle physiology or severe pulmonary hypertension, IUD placement is generally well tolerated but should be preferentially performed at a facility with appropriate staffing and resources due to the 2% risk of vasovagal reaction from cervical manipulation, which can result in transient hemodynamic compromise, primarily driven by nulliparous status. ^2^ , ^15^ However, optimal care location for IUD insertion in these patients should be a shared decision between the patient and their care team and individualized based on availability of resources and maternal risks. Although there is a theoretical concern for an increased risk of bacteremia and endocarditis with IUD insertion, this risk has not been substantiated and the American College of Cardiology/American Heart Association do not recommend antibiotic prophylaxis for IUD insertion. ^17^

Tier II contraception includes different formulations of combined hormonal contraceptives, including the pill, patch, or ring, as well as the progestin‐only pill and depot medroxyprogesterone acetate injection. All estrogen‐containing contraceptive options are associated with risk of increase in blood pressure, fluid retention, cholesterol levels, and thrombogenic profile, making them less favorable options among patients with elevated thromboembolic risk, including severe left ventricular dysfunction (left ventricular ejection fraction <30%), pulmonary arterial hypertension, severe mitral stenosis, mechanical valves, and complex congenital heart disease including Fontan circulation. Combined hormonal contraceptives should also generally be avoided in patients with uncontrolled hypertension, ischemic disease, and thoracic aortic disease due to mild increases in blood pressure (6–8 mm Hg) associated with estrogen. ^2^ , ^15^ Expert consensus also recommends against the use of combined hormonal contraceptives in patients with a history of spontaneous coronary artery dissection. ^18^

In general, progestin‐only contraceptive methods have a significantly lower risk of thromboembolism as compared with estrogen‐containing contraceptives. Depot medroxyprogesterone acetate has been associated with a potential increased risk of thromboembolism in some studies. ^15^ , ^19^ Thus, for patients with ischemic heart disease or a history of stroke, the use of depot medroxyprogesterone acetate should be avoided if possible. ^12^ Other side effects to consider for appropriateness of use are the risks of weight gain, reversible bone loss, and delayed return to fertility. Although the progestin‐only pill is not associated with an increased cardiovascular risk profile, it requires strict daily adherence for optimal efficacy, although newer formulations may offer more convenience and flexibility. Of note, the recently US Food and Drug Administration–approved over‐the‐counter contraception pill norgestrel is a progestin‐only pill. Additionally, endothelial receptor antagonists commonly used to treat pulmonary hypertension may reduce the efficacy of both CHC as well as progestin‐only methods and should prompt consideration of multiple synergistic methods of contraception. ^2^ , ^12^ Given significantly high failure rates, fertility awareness and barrier methods alone (Tier III) are not recommended for use among patients with exceptionally high maternal and/or fetal risks of pregnancy. ^12^

Timing of LARC insertion and sterilization should also be addressed. We encourage Cardiologists to work jointly with their Obstetrics, Gynecology, and Maternal‐Fetal Medicine colleagues to prioritize postdelivery IUD and Nexplanon insertions and immediate postpartum tubal sterilization services. One study found that offering postplacental LARCs to patients with heart disease tripled the use in patients with cardiac disease likely attributed to barriers at the postpartum visit, distance needed to travel, and conflicts with childcare and working obligations. ^20^ Contraception should be discussed and implemented for patients who are hospitalized with newly diagnosed mWHO IV disease as well as during hospital admission of a nonpregnant but pregnancy‐capable individual with CVD, especially those with mWHO Class IV lesions without a contraceptive plan. We recommend consulting gynecologic colleagues for a contraception consultation before hospital discharge in these patients. Patients who do not desire future pregnancies should be counseled regarding permanent sterilization as one of the most effective long‐term contraceptive options.

Shared decision‐making surrounding contraception should be a salient feature of preconception counseling by all cardiovascular clinicians for women of childbearing age. Ultimately, the choice of contraceptive method should be individualized to each patient with recognition that for many patients with high‐risk cardiac disease, the maternal risks associated with some contraceptive methods may be less than the risks associated with an unplanned pregnancy. Shared decision‐making about contraception should begin preconception, continue during the pregnancy, and be finalized in the postpartum and the interconception period.

EMERGENCY CONTRACEPTION

Though available for decades, EC was not US Food and Drug Administration approved until 1998 in the form of a combination of oral ethinyl estradiol and levonorgestrel. A year later the levonorgestrel‐only pill (Plan B) was approved for EC use. EC effectively reduces the chance of pregnancy after intercourse when contraception was not used, used incorrectly, or failed. As such it is not medical abortion. EC is legal throughout the United States and per the US Medical Eligibility Criteria for Contraceptive Use, there is no situation where the risk outweighs its benefits. ^12^ , ^14^ As abortion access becomes more restrictive across the United States, timely use of EC to prevent unintended pregnancy is critically important to reduce unplanned pregnancy for all individuals. Therefore, it is essential for cardiologists to be aware of EC options. Since EC is unfamiliar for most cardiologists, we recommend that all cardiology practices maintain relationships with local gynecologic providers or cardio‐obstetric specialists who are willing to create a workflow for timely provision of EC.

EC is broadly classified into 2 IUDs and oral medication. Copper IUDs are the most effective form of EC and can be effective up to 5 days after unprotected intercourse (Figure 2, Table 3). Copper IUDs negatively impact sperm viability and function, as well as the oocyte and endometrial implantation. Insertions are performed by trained providers (typically gynecology, internal or family medicine). Approximately 12% of patients experience irregular and/or heavy vaginal bleeding or pain, and uterine perforations occur in 1/1000 insertions. ^14^ In addition to providing EC, copper IUDs provide excellent ongoing contraception for 10 years, though it may cause increased bleeding at the time of menses, which may be worsened in individuals on anticoagulation. Emerging evidence also suggests that levonorgestrel IUDs may provide effective EC (ideal for individuals on anticoagulation or for those who desire reduced menses), but additional studies are needed. ^21^ , ^22^ , ^23^ , ^24^ Strong relationships with local gynecologic providers are essential to allow for timely referrals for placement of copper IUDs for EC.

Though not as effective as the copper IUD, oral medications are often easier to access and are therefore more commonly used. They are most effective if taken within 3 days but can be used up to 5 days after unprotected intercourse. ^2^ They reduce the chance of pregnancy by delaying or preventing ovulation and are available without a clinical examination or pregnancy test. In order of decreasing efficacy, the 3 types of oral EC readily available in the United States include ulipristal acetate/ella (prescription required), levonorgestrel/Plan B One‐Step (over the counter), and combined oral contraceptive pills (in doses higher than used for birth control, prescription required). ^14^ , ^25^ Due to the delay in ovulation, barrier methods should be used immediately after EC use and a reliable birth control plan should be established. Oral contraception can be started a minimum of 5 days after the use of ulipristal and immediately after oral levonorgestrel (Table 3). Obesity is a special consideration in the use of oral forms of EC because pregnancy rates increase with increasing body mass index. ^26^ , ^27^ , ^28^ Ulipristal acetate is the most effective oral EC in patients with body mass index >25 kg/m^2^, and a copper IUD is more effective than oral methods. ^2^ If EC fails and a pregnancy develops, it is important to educate the patient that EC does not lead to birth defects in a developing fetus. ^29^ Oral forms of EC may be used multiple times in the same cycle, if indicated, though reliable contraception is preferred. If multiple doses of EC are needed, ulipristal or levonorgestrel are preferred due to increased efficacy and side effects associated with high‐dose combined oral contraceptives including nausea, vomiting, and potential risk of venous thromboembolism given their high estrogen concentration. ^26^ There are no restrictions for the use of oral EC in individuals with CVD, including those with mWHO IV lesions.

There are many barriers to the use of EC including inadequate patient education, cost, and pharmacy availability. ^30^ These barriers highlight the important role a cardiologist has in counseling their patients on EC options, recommending and/or prescribing as appropriate, and providing urgent referrals for counseling and/or IUD insertions and long‐term contraceptive management. There are 2 free patient‐facing tools that a cardiologist may offer to their patient weighing EC options (Table 4).

In summary, EC is safe and effective in the prevention of undesired pregnancy. The use of EC is unrestricted in individuals with CVD. Cardiologists should be aware of the options available for their patients and be empowered to provide counseling on available options before the need to use EC is realized. For those at highest risk of cardiovascular complications from pregnancy, and in addition to discussing reliable contraception, we recommend that EC options should be discussed at each clinical encounter, especially in individuals with mWHO Class III/IV lesions. A prescription for ulipristal acetate can be given to patients so that it is available to them should they need it. These strategies enhance awareness and help to ensure timely and effective use of EC.

OPTIONS FOR TERMINATION

Access to safe pregnancy termination care and family planning services is an essential component of health care. In the United States, about 1 in 4 pregnancy‐capable individuals will have a pregnancy termination. ^31^ , ^32^ The overall rate of pregnancy termination has decreased significantly over the last 2 decades, due to multiple contributors including greater access to highly effective contraception, increased use of any contraception, better knowledge of fertility, and termination outside the formal medical system. ^33^ People with complex medical conditions including CVD may be at higher risk of needing access to pregnancy termination care for several reasons. First, they are less likely to use contraception due to misperceptions of relative risks of contraception versus pregnancy by both patients and healthcare providers. ^34^ , ^35^ Further, they are more likely to experience medical decompensation during pregnancy requiring consideration of pregnancy termination for threat to maternal life or health. ^36^ After the right to access pregnancy termination care was overturned at the federal level in June 2022, an inconsistent spectrum of state laws now governs termination access. Physicians should be aware of the most up‐to‐date regulations in their states so they can provide appropriate guidance and treatment for their patients. A summary of state pregnancy termination laws is maintained by the Guttmacher Institute. ^37^ When counseling a patient who inquires about pregnancy termination, physicians need to be aware of gestational age, patient preference for type of pregnancy termination, medical comorbidities, availability of services in their area, and legislative barriers.

In either the first or second trimester, pregnancy termination can be achieved by medications that cause expulsion of the pregnancy, or by procedural removal of all pregnancy tissue. In 2020, 93.1% of terminations in the United States occurred in the first trimester, before 13 weeks of gestation. ^38^ The highest percentage of terminations were performed by early medication abortion at ≤9 weeks' gestation (51.0%), and 2.4% of terminations occurred by medication at >9 weeks gestation. Among patients who were ≤9 weeks' gestation, 63.9% opted for medication terminations. About 40% of terminations in 2020 were procedural at <13 weeks gestation. ^38^ Thus, it is important for clinicians to maintain familiarity with both approaches.

MEDICATION OPTIONS

The US Food and Drug Administration–approved regimen for medication termination includes the use of mifepristone followed by misoprostol, before 70 days (10 weeks) of gestation. ^39^ Mifepristone is a progesterone receptor antagonist that causes decidual necrosis, cervical softening, increased uterine contractility, and prostaglandin sensitivity. Misoprostol is an E1 prostaglandin analog that induces cervical softening and dilation in conjunction with uterine contractions. Use of this combination before 10 weeks gestation is successful in 95% to 98% of patients. ^40^ , ^41^ , ^42^ During the COVID‐19 pandemic, many clinicians initiated “no touch” regimens for medication termination, using a telephonic clinical checklist for suitability, mailing the medications and instructions, and using a clinical checklist to assess successful expulsion. ^43^ Pregnancy termination access restrictions are leading to increased interest in self‐managed termination, which may replicate the no‐touch regimens, relying on medications obtained through online sources. While mifepristone access is complicated by a US Food and Drug Administration risk evaluation and mitigation strategy (REMS), misoprostol is inexpensive and available by a simple prescription. Misoprostol‐only regimens are effective in 78% to 87% of first trimester terminations. ^44^

PROCEDURE‐BASED OPTIONS

Uterine aspiration for first trimester pregnancy termination is typically performed in an outpatient clinic setting with the use of local anesthesia and/or sedation and has an efficacy of >99%. ^45^ Potential benefits of uterine aspiration include immediate efficacy, brief duration of procedure time, and more predictable vaginal bleeding. Second trimester procedural termination is usually accomplished by dilation and evacuation, in which the fetus and products of conception are grasped with forceps and removed from the uterus, frequently under direct ultrasound guidance. In contrast to aspiration termination, dilation and evacuation requires preparation of the cervix before the procedure to avoid traumatic laceration. In 2019, second trimester termination comprised 6.7% of terminations; only 0.9% occurred after 20 weeks of gestation. ^38^ Increasing gestational age is associated with increased risk of complications. Multiple prior cesarean births is the most significant risk factor for hemorrhage with or without placenta accreta spectrum. ^46^ Dilation and evacuation may be performed with the patient under local anesthesia, moderate sedation, or general anesthesia, depending on patient preferences, service availability, and comorbidities. If the patient desires, a postprocedural IUD, Nexplanon placement, or tubal sterilization can be performed immediately following termination of pregnancy to provide reliable contraception going forward.

COMPLICATIONS

Both medication and procedure‐based pregnancy termination options are very safe procedures with low rates of major complications. ^47^ Physicians should be aware of the most common complications that occur from either procedure including hemorrhage (<1% of cases), uterine perforation (<0.3% of cases from the first and second trimester procedure‐based terminations), ongoing pregnancy (more common in patients undergoing medication termination), and infection/retained products of conception. ^47^ For a pregnant person, termination is safer than carrying the pregnancy to term and the postpartum in 2019, the maternal mortality rate was 20.1 per 100 000 live births and 0.43 per 100 000 pregnancy terminations. ^38^ For patients with high‐risk medical conditions, counseling regarding pregnancy options including termination should be performed expeditiously to optimize choices. Health status may decompensate rapidly during pregnancy and logistical and legal barriers may delay care. ^48^ As access to pregnancy termination becomes increasingly challenging, cardiologists should be aware of agencies, such as https://www.midwestaccesscoalition.org/, who provide resources to patients who need to travel for reproductive service access.

CONCLUSIONS

Recent changes in US reproductive legal policies have made it crucial for every cardiologist to understand and be engaged with reproductive planning. The risk of cardiovascular complications during pregnancy is prohibitively high for women in the mWHO Risk Class IV, and pregnancy is not recommended. It is critical that cardiologists together with Obstetrics, Gynecology, Primary Care, Complex Family Planning specialist, and Maternal‐Fetal Medicine physicians become familiar with different contraception, EC, and termination options that can be offered to these high‐risk patients.

Sources of Funding

Women's Cardiovascular Center Cleveland Clinic is a fund set up by donation from patients at Cleveland Clinic.

Disclosures

L. Cho, H.L. Brown, D.R. Crousillat, D.J.M, N.S. Scott, J. Sharma, R. Sinkey, S. Teal, K.J. Lindley—None. J.E. Briller—unpaid consultant for the Illinois Maternal Mortality Committee. A.A. Sarma—Consultant—Pfizer, Grant—AHA and CRICO.