In the realm of medtech innovation, the margin for error is slim. Upwards of 90% of funding for an early-stage company may be allocated to engineering and clinical costs, making it essential for leaders to de-risk their clinical programs. Having access to a real-world, contemporary dataset can mean the difference between success and failure, innovation and stagnation. However, it is very often challenging to study standard of care due to lack of data with required clinical context and depth, especially for complex interventions.
To illustrate this point, Truveta Co-founder and chief medical officer, Ryan Ahern, recently co-hosted a webinar in collaboration with Mark Pacyna, CEO of Reprieve Cardiovascular, Dr. Alex Sandhu, a cardiologist with Stanford Cardiovascular Medicine, and Dr. Drew Ambrosy, a cardiologist with The Kaiser Permanente Medical Group. The team shared their personal experience using Truveta Data to de-risk Reprieve’s clinical programs and advance therapeutic innovation for patients with acute decompensated heart failure (ADHF).
ADHF is the most common cause of hospital admission among Medicare patients
6.5 million people in the US have heart failure, and nearly 1 million of them are hospitalized each year for ADHF – an acute worsening of their disease. These patients are clinically complex and often present in the emergency room requiring hospitalization and decongestion management to manage swelling and fluid build-up.
Despite the prevalence and severity of this disease, clinical standards have not changed much in decades. This is due, at least in part, to how challenging and costly it is to study complex in-patient interventions in depth. The best source of real-world data on these patients, the ADHERE registry, is nearly 20 years old. It took 4 years and tens of millions of dollars to create, making regular updates or replication a major challenge.
Truveta and Reprieve partner to elevate standard of care for ADHF patients
Reprieve, an early stage medtech company, approached Truveta to explore Truveta Data, comprising full medical records from EHRs from more than 30 health systems, including labs, clinical notes and images; linked to claims and SDOH data. Reprieve was seeking to better characterize the current standard of care for ADHF patients and dynamically test inclusion/exclusion (I/E) criteria to de-risk their programs. As part of this process, they also compared ADHERE registry data to a contemporary cohort from Truveta Data and ran a Truveta control to compare to published studies and a Reprieve pilot trial.
Over the course of the discussion, the team of experts highlighted several critical features of Truveta Data and what those features enabled the research team to accomplish.
Representativeness and scale
Reprieve’s first goal was to understand the contemporary ADHF standard of care, which required access to a highly representative cohort of patients, diverse in both clinical and demographic characteristics. Truveta Data comprises patient journeys for nearly 100 million patients across all 50 states, from more than 30 member health systems. While many other EHR datasets exist, they often cannot deliver on the promise of representativeness since they may comprise data from just a single academic medical center or region of the country, which may not be indicative of the care being delivered nationally.
Additionally, having access to a large enough dataset was important for Reprieve to ensure large enough sample sizes for research – even once rigorous inclusion/exclusion (I/E) criteria were applied. Truveta is able to generate data at this scale due to its relationships with health systems enabling daily updates from EHRs meeting specific quality standards; as well as use of clinical expert-led AI (Truveta Language Model) to normalize billions of data points to make the data clean and research-ready.
Completeness and clinical depth
In addition to scale, the Reprieve team required deep clinical context at the patient level, including patient weights over time, creatinine levels, time on inpatient IV diuretics, time to discharge after ADHF admission, and more. All those patient-level data were available within Truveta Data, enabling the researchers to iteratively test different I/E criteria and see the resulting impact on the population and outcomes. This was essential for Reprieve, given that clinical trials for medical devices often fail due to the control performing better than expected.
This process also allowed them to examine how various clinical characteristics compared with previously developed registries and the clinicians’ own experience taking care of ADHF patients – helping them put the insights into context to ensure nothing will be overlooked as they design their clinical programs.
The team noted that Medicare and commercial claims would not have allowed for this type of analysis, as they would not have contained the level of clinical depth needed to study care patterns and related outcomes, or to compare to registry data.
Timeliness and efficiency
And lastly, startups like Reprieve typically do not have the luxury of years and tens of millions of dollars to create registries to meet their specific data needs. With Truveta Data, the team was able to access a cohort of patients 1.5x larger than the ADHERE registry cohort almost instantly, as compared to the 4 years it took to create the registry. In six months, the team conducted numerous analyses and submitted a manuscript with critical takeaways on current standards of care for publication.
Through this work, Reprieve and its physician partners hope to elevate standards of care for ADHF patients and drive innovation in a space that is ripe for change.