A new peer-reviewed study from researchers at Saint Luke’s Mid America Heart Institute, Impulse Dynamics, and the Cardiovascular Research Foundation demonstrates the power of real-world data to evaluate device therapies. By evaluating survival outcomes of cardiac resynchronization therapy (CRT) and cardiac contractility modulation (CCM) patients in Truveta Data, the study validates real-world evidence as a reliable method to emulate and extend findings from landmark trials.
Published in Journal of Cardiac Failure, the study — Real-World Survival Outcomes With Cardiac Contractility Modulation: Methodological Validation Using Cardiac Resynchronization Therapy Data — uses Truveta Data to present the results characterizing the use and clinical outcomes of these device-based therapies in a real-world setting. It underscores the growing opportunity to evaluate safety, effectiveness, and clinical outcomes in real-world settings, particularly for therapies with limited long-term trial data.
Validating real-world survival data for device-based therapies
To evaluate survival outcomes for CCM, the authors first benchmarked CRT survival rates in Truveta Data against the landmark CARE-HF trial. Of the 52,500 CRT patients identified, a subset of 13,222 patients with LVEF ≤35% had an estimated 1000-day survival of 74.3% — similar to the 77% reported in CARE-HF. Stratification by NYHA class and ejection fraction showed expected survival gradients, reinforcing the validity of Truveta’s real-world dataset as a reliable source for evaluating clinical outcomes.
Using this validated approach, the authors then assessed long term survival outcomes for patients treated with CCM, demonstrating a 1000-day survival of 77.5% in patients with LVEF 25-45%.
Key findings
- CRT survival outcomes from Truveta Data closely aligned with the landmark CARE-HF trial, validating the use of real-world data to benchmark against clinical trials.
- 1000-day mortality rates varied appropriately by disease severity (e.g., NYHA class and LVEF), consistent with expected clinical patterns.
- CCM survival outcomes were consistent with previously published registry data, supporting the therapy’s favorable performance in routine clinical practice.
Real-world survival outcomes for CRT and CCM therapies, stratified by NYHA class and LVEF. CRT outcomes aligned with the CARE-HF trial, validating the real-world data approach. Source
Why it matters
Evaluating medical devices in the real world has long been challenging due to fragmented data, short follow-up windows, and patient heterogeneity. This study illustrates how high-quality, linked EHR data — including clinical notes, vital signs, and longitudinal outcomes — can enable real-world evidence studies that complement data from randomized trials.
The research highlights the potential of real-world data to accelerate evidence generation for device safety and efficacy, especially when randomized trials are limited or infeasible.
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