New ESC Guideline on Cardiovascular Disease in Pregnancy

Marlene Busko

September 05, 2018

MUNICH — New European Society of Cardiology (ESC) guidelines on cardiovascular disease (CVD) in pregnancy provide a thorough update to the 2011 version, covering everything from prepregnancy counseling to safety of cardiovascular drugs during breastfeeding.

The document, the "2018 ESC Guidelines for the Management of Cardiovascular Diseases During Pregnancy," was discussed here at the ESC Congress 2018 and published online August 25 in the European Heart Journal

Task force co-chairs were Jolien W. Roos-Hesselink, MD, PhD, from Erasmus University in Rotterdam, the Netherlands, and Vera Regitz-Zagrosek, MD, PhD, from CHARITÉ Universitätsmedizin Berlin, Germany.

Roos-Hesselink said three of the most important updates in these guidelines are introduction of the pregnancy heart team (which includes at least a cardiologist, an obstetrician, and an anesthetist with experience in caring for such patients), advice for women with heart disease to not deliver later than 40 weeks, and a very extensive table on cardiovascular drugs during pregnancy and breastfeeding.

"Counseling Is Crucial"

"Every woman with at least moderate-risk heart disease should have counseling after a discussion with such a pregnancy heart team," Roos-Hesselink told theheart.org | Medscape Cardiology.

"Counselling is crucial" for women with CVD who are contemplating pregnancy or already pregnant, she stressed.  

Similarly, Regitz-Zagrosek also zeroed in on the importance of counseling, including advising very high-risk women against pregnancy, in an email to theheart.org | Medscape Cardiology.

The guidelines recommend using the modified World Health Organization classification of maternal risk to classify women with cardiac disease who are of childbearing age, she noted.

Women with a very high risk for complications during pregnancy, she continued, should be counseled against pregnancy. This group includes "those with pulmonary hypertension, with complex operated lesions with complications, with severe left heart systolic dysfunction, with outflow tract obstruction, aortic dilatation or with peripartum cardiomyopathy in which systolic function did not completely normalize."

American College of Cardiology (ACC) spokesperson and editor-in-chief of CardioSmart.org, Martha Gulati, MD, from the University of Arizona College of Medicine-Phoenix, who was not involved in preparing these guidelines, also identified risk assessment as one of three key updates.

"One of the most important and new recommendations," she told theheart.org | Medscape Cardiology, is one advising use of risk assessment in all women with cardiac diseases of childbearing age and before conception.  

"This should help us identify women at risk earlier and hopefully help women have the best outcomes," she said.

A second important update is a new recommendation to induce labor at 40 weeks' gestation for all women with cardiac disease, Gulati noted.

A third change is that the guidelines move away from prior US Food and Drug Administration (FDA) drug safety classification and provide a table summarizing the safety of cardiovascular drugs during pregnancy and breastfeeding.  

The key message is that "pregnancy in women with heart disease is safe," Gulati said, but cardiologists need to partner with their patients and their obstetricians.

A partnership and shared decision making, she added, will help women understand risks and make informed decisions and will translate into improved outcomes.

Cardiovascular Drugs Rated for Safety  

Like Roos-Hesselink and Gulati, Regitz-Zagrosek also emphasized that the table of the safety of cardiovascular drugs is an important addition to these guidelines.  

"On 30 June 2015, the [FDA] changed the previously used classification system for the counselling of pregnant women and nursing mothers requiring drug therapy," the guidelines explain.

"The former A to X categories have been replaced by the Pregnancy and Lactation Labelling Rule (PLLR), which provides a descriptive risk summary and detailed information on animal and clinical data."

"We assembled in our guidelines preclinical and clinical safety data for the most important CV drugs and suggest that these are checked before using a specific drug in pregnancy," said Regitz-Zagrosek.

Presenting the guidelines during the congress, Regitz-Zagrosek noted that they are important because "pregnancy is complicated by maternal disease in 1% to 4% of cases, CVDs are still the most common causes of maternal death in Europe, and hypertension affects up to 5% to 10% of all pregnant women."

The number of cases of severe CVD in pregnancy is luckily too small to allow the single physician to rely on his or her own experiences. Dr Vera Regitz-Zagrosek

 

Clinicians need to be aware of risks associated with CVD during pregnancy and know how to manage these risks and counsel patients.  

"The number of cases of severe CVD in pregnancy is luckily too small to allow the single physician to rely on his or her own experiences," she said, and the number of prospective studies is very limited, so the guidelines mostly have class C (expert opinion) recommendations.

The document first covers prepregnancy counseling, genetic counseling, fetal assessment, invasive therapy in the mother, timing and mode of delivery, risk for mother and child, and termination of pregnancy and in vitro fertilization.

It goes on to provide detailed recommendations for managing pregnancy in patients with coronary artery disease, cardiomyopathy and heart failure, arrhythmia, hypertension, venous thromboembolism (VTE), congenital heart disease, valvular heart disease, or aortic diseases.

Last, it discusses drug therapy and evidence gaps.

Need for Similar US Guidelines

"The ESC guidelines are far more encompassing than what we have in the United States," Gulati said. "We have the AHA scientific statement, but it is just for women with congenital heart disease and pregnancy."

The new ESC guidelines discuss different cardiovascular diseases and pregnancy, including outcomes that can occur in pregnancy, such as hypertension, preeclampsia, and peripartum cardiomyopathy.

Since the previous guidelines, "we have a lot more data related to women and pregnancy, and that has allowed these guidelines to be more robust," she said.

Nonetheless, many recommendations are evidence base C, meaning reliance on expert opinion or small studies or retrospective studies. "Few if any RCTs [randomized controlled trials] will ever be done in pregnant women."

Notably, the guidelines also recommend low-molecular-weight heparin (LMWH) rather than unfractionated heparin in women who need anticoagulation for VTE (prevention or treatment) during pregnancy, Gulati pointed out. "This is a big change."

The guidelines state that "LMWH is the drug of choice for the prevention and treatment of VTE in all pregnant patients (IB). It is recommended that the therapeutic dose of LMWH is based on body weight (IC)."

The document also discusses risks to women with CVD who undergo fertility treatments, she noted, "which, given its prevalence, is an important addition."

"The biggest thing for me," Gulati said, "is that this is a great guideline of everything related to women and pregnancy, and I have been hoping for a similar document from the AHA/ACC and have been a huge advocate for this, because we need it and we need US guidelines to be all together and in one place."

In the United States, "we have such high maternal morbidity and mortality rates," she added. "We need this addressed specifically related to any cardiovascular disease, because at least there we can offer guideline recommended assistance."

Roos-Hesselink has no disclosures. Regitz-Zagrosek has received speaker, advisory board, and similar fees, as well as investigator funds, from Vincenz von Paul Kliniken, Novartis, Berlin Chemie AG, Pfizer, Verband Deutscher Unternehmerinnen, Zahnmedizinisches Fortbildungszentrum, Saarländischer Hausärzteverband, and Cognomed. Gulati has disclosed no relevant financial relationships.

European Society of Cardiology (ESC) Congress 2018. Presented August 27, 2018.

Eur Heart J.  Published online August 25, 2018. Full text

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