Care Gaps for Women With Cardiogenic Shock Merit Action: SCAI

Numerous knowledge gaps exist regarding the care of female patients with cardiogenic shock, often because they have been consistently underrepresented in clinical trials, according to a new consensus statement from the Society for Cardiovascular Angiography and Interventions (SCAI).

Women made up just one in five patients enrolled in the recent DanGer Shock trial comparing Impella CP (Abiomed) with standard care, for example, which some say raises questions about whether there are sufficient data to support use of the microaxial flow pump in female patients. There is also a need to better understand local barriers and delays to care, the SCAI paper notes, as well as whether complete revascularization and its timing could alter outcomes in women.

Suzanne Baron, MD (Massachusetts General Hospital, Boston, MA), who co-led the writing group for the SCAI consensus statement, said that without a strong evidence base on sex differences it’s difficult “to definitively say whether entirely separate guideline documents are immediately warranted or even feasible across all aspects of cardiogenic shock care,” she noted in an email.

“That said, I do believe that we can and should enhance current guidelines to reflect what we do know about [shock] in women, while being transparent about what we don’t,” specified Baron.

The new document, published recently in the Journal of the Society for Cardiovascular Angiography & Interventions, is meant to complement existing clinical guidance that doesn’t specifically address women separately. Case in point: the latest US guidelines on acute coronary syndromes say selective Impella use for severe refractory shock in patients with acute MI and without coma—but don’t mention nuances related to patient sex. The need for additional randomized evidence on female patients who fit this description “is imperative,” the SCAI document urges, but for now clinicians can follow the broader recommendations with an eye toward potential complications.

Baron added that a more "gender-aware" approach within unified guidelines is crucial, and in the case of cardiogenic shock care for women, includes promoting standardized, team-based treatment protocols that incorporate mandatory hemodynamic assessment and timely diagnosis.

“Cardiovascular disease is the leading cause of death for women worldwide, yet mortality rates due to cardiogenic shock remain exceedingly high,” said Baron. “Women often face delays in treatment and are less likely to receive guideline-recommended interventions when compared to men, and this contributes to poor outcomes.”

More Awareness of Knowledge Gaps

An important aspect of the consensus document is its inclusion of a standardized approach to early diagnosis and treatment that incorporates etiology-specific management in relation to the five-stage SCAI SHOCK classification pyramid. The etiologies span conditions related to heart failure, acute MI complicated by cardiogenic shock (AMICS), valvular disease, Takotsubo syndrome, and peripartum cardiomyopathy.

In reviewing the evidence for temporary mechanical circulatory support (MCS), the writing committee notes that these devices should be used early for women in cardiogenic shock on inotropes/vasopressors, with persistent low cardiac output, rising lactate levels, or other signs of end-organ hypoperfusion, based on disease- and device-specific risk-benefit assessment.

However, the underrepresentation of women in MCS trials—coupled with the fact that most studies of shock focus on AMICS—raises questions about the benefits, optimal device selection, and timing of the therapies for women whose shock is due to another cause.

We can and should enhance current guidelines to reflect what we do know about [shock] in women, while being transparent about what we don’t. Suzanne Baron

A significant chunk of the SCAI document also covers what is known and unknown in pregnant and postpartum patients with shock. The committee stresses the importance of multidisciplinary cardio-obstetrics teams, early invasive assessment of hemodynamics and consideration for MCS, and reduction of fetal exposure to radiation and medications.

For those with cardiogenic shock related to peripartum cardiomyopathy, the committee says a bridge-to-recovery strategy is preferred because of high rates of at least partial LV recovery. However, the authors highlight the need to clarify the role of bromocriptine in LV recovery in this population, since it has appeared promising in some observational studies but not enough data on women exist to draw strong conclusions.

For women with cardiogenic shock related to heart failure, Baron and colleagues say work needs to be done to develop pathways of care to “ensure equal and timely access to durable LVAD and cardiac transplantation,” with the goal of addressing treatment disparities.

Additionally, for women with valvular cardiogenic shock, shortcomings in the evidence exist as well. Ensuring that adequate subsets of female participants are enrolled in percutaneous valve intervention trials, the committee concludes, “is paramount to understanding the sex-specific benefits and complications of these devices in the setting of CS.”

To TCTMD, Baron said all of this represents a significant challenge, but that awareness of sex-specific knowledge gaps in cardiology care is growing, which makes her hopeful for the future.

“That said, this optimism is contingent on the medical community committing to a dedicated and intentional shift in how we approach clinical research in this area, so that we can adequately generate the robust, sex-specific evidence we desperately need to optimize care for women with cardiogenic shock,” she added.