Title:  Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability

Technology of Interest:  Mechanical Aortic Heart Valves

Disease Area:  Cardiology

Duration:  12 months

Network Collaborator(s): Vanderbilt; Weill-Cornell

Valvular heart disease affects tens of millions of patients worldwide and is associated with high morbidity and mortality. Symptoms such as fatigue, shortness of breath, and chest pain can also contribute to significant quality-of-life limitations. Treatment for severe aortic valve disease often includes surgical replacement with a prosthetic heart valve. Mechanical heart valves (MHV) are a type of prosthetic heart valve constructed of durable materials such as titanium or carbon that can potentially last a patient’s lifetime. Despite their high durability, MHV are associated with an increased risk of developing blood clots that may interrupt blood flow and travel to various organs (thromboembolism).
Oral anticoagulation therapy with a vitamin K antagonist (warfarin) is a class I recommendation for patients implanted with a MHV based on the 2014 AHA/ACC Guidelines. The potential protective benefit of anticoagulation therapy against blood clots must be weighed against an increased risk of bleeding in patients with an MHV and adjusting the warfarin dose is necessary to reduce the risk of these complications. The efficacy of warfarin is monitored by measuring how fast the blood clots using a standardized measure called the International Normalized Ratio (INR). Clinical guidelines currently recommend a target INR of 2.0 – 3.0 for patients implanted with a MHV in the aortic position. However, recent data suggest that a lower target INR maintains the anticoagulation benefit while decreasing the risk of bleeding in patients implanted with an MHV in the aortic position.
This test-case will explore the safety of a reduced target INR in patients implanted with the mechanical valve prosthesis of interest in the aortic position. Retrospective data will be drawn from the electronic health records (EHR) and other data sources of participating NESTcc Data Network Collaborators. Longitudinal outcomes such as hemorrhage, stroke, and mortality will be collected to understand the feasibility to determine the risks and benefits of various anticoagulation strategies for MHV patients. Insights drawn from this test-case have the potential to impact long-term clinical care and outcomes for patients implanted with an MHV. In addition, this test-case will assess the feasibility of linking various sources of existing Real-World Data (RWD) to study longitudinal patient outcomes.

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At @MDEpiNet_ppp's Annual Meeting on Weds., 10/23, Data Network Dir. @robbert_z will present "An Update on NEST: From Real-World Data to Real-World Evidence" in a panel of experts from @FDADeviceInfo, @WeillCornell, @DCRINews, @JNJNews, and @AbbottNews: bit.ly/33Ca5Z6 pic.twitter.com/UuEXXA1Ptt 1 day ago

A committee tasked with developing the electronic claims form used by insurers formally recommended that a field be added for unique device identifiers. @GeisingerHealth's Jove Graham, @pewtrusts's @benmoscovitch and @FollowMercy's @jpdrozda weighed in. bit.ly/35FrXUQ Retweeted by NESTcc 2 days ago

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