February 5, 2021
Focusing on heart health with real-world evidence research
Heart disease continues to be the leading cause of death for men and women in the U.S., as well as a significant driver of health costs – over $200 billion each year from 2014 to 2015 – including the cost of health care services, medicine and lost productivity.
As American Heart Month gets underway this year, there is a renewed focus on encouraging measures that can be taken to prevent cardiovascular disease, such as regular physical activity and a healthy diet. It is also an important time to consider the therapies and devices that support people in the management of their heart health.
Together with the partners in our Research Network, NESTcc is undertaking multiple studies to leverage real-world data (RWD) generated in the routine course of clinical care – electronic health records (EHR), medical claims, patient-generated data, and others – to better understand the effectiveness of health technologies in cardiovascular care. Nearly one-third of NESTcc’s 21 real-world evidence (RWE) Test-Cases specifically explore device applications for the disease area, including studies in adult and pediatric populations.
Nearly one third of NESTcc’s 21 Test-Cases specifically explore device applications for the disease area, including studies in adult and pediatric populations.
NESTcc has also identified Demonstration Projects that contribute to the field of RWE within the medical device ecosystem. These projects, seven of which are cardiovascular in nature, provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle (TPLC).
It is vital to ensure that people facing heart health challenges have access to innovative technologies, and that their devices can be safely and effectively relied upon. Below are some of the studies NESTcc is leading to generate real-world evidence (RWE) to help inform decision-making for patients, clinicians and regulators in the evaluation of medical devices.
NESTcc Test-Cases (Cardiovascular)
The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters
This Test-Case assessed the ability of the NESTcc Research Network to reliably and validly capture data on class III surgical devices to study the safety and effectiveness outcomes for an indication expansion. Read more about this Test-Case here.
Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability
This Test-Case explores the safety of a reduced target International Normalized Ratio, a standardized measure of the speed at which blood clots, in patients implanted with the mechanical valve prosthesis of interest in the aortic position. Insights drawn from this Test-Case have the potential to impact long-term clinical care and outcomes for patients implanted with mechanical heart valves. Read more about this Test-Case here.
Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension
This Test-Case assesses the feasibility of NESTcc Network Collaborators using EHRs to gather relevant RWD to better characterize numbers of and outcomes experienced by patients with uncontrolled hypertension. The project seeks to leverage RWD to better characterize the population that may benefit most from identification and better management of poorly-controlled hypertension. Read more about this Test-Case here.
Effect of Wearable Devices on Patient-Reported Outcomes and Clinical Utilization: A Randomized, Controlled Trial
The objective of this Test-Case is to assess the effect of the Apple Watch’s ECG and irregular rhythm notification detection software features on both patient-reported outcomes and clinical utilization. Read more about this Test-Case here.
Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease
This Test-Case seeks to determine whether data capture of device utilization in a Pediatric Cardiac Catheterization Laboratory is possible across multiple different institutions. The study aims to allow for the collection of prevalence information across a consortium of multiple institutions; system protocols and conventions already established by NESTcc would serve as an ideal framework in the initial real-time phase of this project. Read more about this Test-Case here.
Assessment of the Value of Electronic Health Records Data for Identifying Implantable Cardiac Lead Failures
The primary objective of this study is to examine the feasibility of establishing a generalizable and efficient process for determining medical device reliability, specifically focusing on implantable leads (i.e., electrodes) for permanent cardiac pacemakers and defibrillators. Read more about this Test-Case here.