BERLIN, Germany

Landmark Sex-Specific Study Confirms Women Respond Better to Cardiac Resynchronization Therapy

  • BIOTRONIK’s BIOWOMEN Study Enrolled 474 Patients Across Eight Countries in Europe and Israel
  • Addressing Critical Gaps as Women Often Remain Undiagnosed and Undertreated in Heart Failure

This International Women’s Day, BIOTRONIK highlights a critical advance in women’s heart health with the BIO|WOMEN trial, an international study evaluating sex-specific responses to cardiac resynchronization therapy (CRT) in heart failure patients. Published in the International Journal of Cardiology, the results confirm that women experience significantly greater clinical and echocardiographic benefits from CRT than men. With these findings, BIOTRONIK aims to close persistent gaps in cardiovascular diagnosis and treatment.

The BIOWOMEN trial is the largest prospective study of its kind to investigate sex‑specific CRT outcomes. A total of 474 patients (230 women and 244 men) were enrolled across 25 sites in eight countries in Europe and Israel. This level of female participation marks an important step in addressing the historical underrepresentation of women in CRT research. All enrolled patients received BIOTRONIK CRT devices, including Edora HF‑T and Iperia HF‑T systems, or their successors.

Key findings include:

  • Greater improvement in left ventricular ejection fraction (LVEF) in women after 12 months (+14.7% vs. +11.5%, p ≤ 0.01)
  • Female sex was an independent predictor of CRT response (+2.53% adjusted LVEF improvement, p = 0.023)
  • Higher responder rates in women (83.3% vs. 70.6%, p = 0.003), with better reverse remodeling and quality of life
  • Lower composite endpoint of death or heart failure hospitalization in women (HR 0.41, p = 0.045)

“Women with heart failure with reduced ejection fraction remain underrepresented in device trials and are less likely to receive cardiac resynchronization therapy in routine practice. The BIOWOMEN study is crucial because it provides the evidence needed to ensure women are recognized, referred, and treated equally when they meet guideline criteria,” said Dr. Lieselot van Erven, Coordinating Clinical Investigator of the BIOWOMEN trial. 

The study results confirm the importance of recognizing sex-specific differences when screening patients for CRT. The findings also align with the updated 2023 Heart Rhythm Society guidelines, which now recognize female sex as a factor associated with better CRT outcomes.

In the International Journal of Cardiology, Dr. Majid Haghjoo, Professor at the Rajaie Cardiovascular Medical and Research Center in Tehran, Iran praised the BIOWOMEN trial as a “clarion call to recognize sex as a critical factor in CRT decision-making.” He emphasized the study’s robust design, balanced enrollment, and clinical relevance, noting that equitable access to CRT for eligible women is not only fair—it is a clinical imperative. These observations appear in the journal’s accompanying editorial.

The BIOWOMEN trial exemplifies BIOTRONIK’s leadership in advancing patient care and demonstrates how scientific research can drive greater equity in treatment. By investing in sex-specific research, BIOTRONIK deepens scientific understanding of how women respond to CRT, empowering physicians to make more informed, personalized treatment decisions.

Find more information about how BIOTRONIK is advocating for female heart health in the current #GoRed Campaign.

 

About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.