Why electrophysiology trials need to include more women
There is a movement across cardiology to include more women in clinical trials. Most trials in the past were composed of white men and few minorities or women, leading to skewed data, and including a wider variety of patients in these trials can potentially make a significant impact on patient care.
For example, electrophysiology (EP) is now seeing vendors require additional numbers of women in their clinical studies for that very reason.
"We've known that there are sex-specific differences between men and women in the presentations for cardiology in different cardiac diseases," explained Anne Kroman, DO, PhD, director of lead management and the device clinic, and assistant professor at the Medical University of South Carolina (MUSC). "However, from the EP side, the research has historically focused predominantly on male populations. Women are significantly underrepresented in device trials, especially in ICD trials."
She spoke about this topic at length with Cardiovascular Business at the Heart Rhythm Society (HRS) 2024 meeting.
Kroman highlighted the efforts of her mentors, including Jeanne Poole, MD, to increase female representation in clinical trials.
"Device companies are starting to incorporate requirements for the number of female patients in their trials, but we still need to advocate for more women in our study populations," she said.
Delayed diagnoses and bias due to the underrepresentation of women in cardiac trials
The underrepresentation of women in clinical trials has led to delayed diagnoses and persistent biases in medical practice. Kroman pointed out that it took decades to understand that women presenting with symptoms resembling STEMI or myocardial infarction cases might actually have conditions like ischemia with no obstructive coronary arteries (INOCA) or myocardial infarction with non-obstructive coronary arteries (MINOCA). These conditions are more common in women, which were dismissed from emergency rooms in decades past because there was no clear blockages seen in imaging.
Subtle symptoms often overlooked in women
Kroman noted that many female patients with arrhythmia problems such as supraventricular tachycardia (SVT) or atrial fibrillation (AFib) often exhibit subtle symptoms like palpitations. These symptoms are frequently dismissed as anxiety, stress or lifestyle issues, leading to inadequate diagnoses and referrals.
"I can't tell you how many female patients I see in the clinic who have been told to drink less coffee or lose weight instead of being referred to an electrophysiologist for a thorough evaluation," Kromane said.
Advocacy for change in female EP patient referrals
Kroman emphasized the importance of continuing to advocate for more comprehensive and inclusive research.
"Once female patients are referred to an electrophysiologist, the discrepancies in care tend to even out. However, we must address the biases and delayed care that occur before these patients reach specialized care," she concluded.
She said this starts with inclusion of more women in clinical trials is crucial to developing a deeper understanding of sex differences in electrophysiology presentations, ultimately leading to better diagnosis and treatment for all patients.
Watch this related video interview with Kroman — Efforts to get more women involved in electrophysiology and why it is important.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com