Inferior vena cava (IVC) filters have long been a thorn in the collective side of the United States (U.S.) medical sector. Statistics show U.S. medical practitioners insert over 65,000 of these medical devices into patients every year. The filters are a proven method of averting pulmonary embolism (PE) in patients with deep venous thrombosis or other risk factors who cannot be anticoagulated. However, despite having a good overall safety profile, the FDA has increased its scrutiny of IVC filters because of the high number of adverse reports received. Many of these are related to the length of time a filter is in place, leading to the FDA recommending they be removed after the dangers of venous thromboembolism have passed. This process requires tracking patients successfully to ensure follow-up.
Reasons for Filter Retrieval
Risks associated with these umbrella-like devices increase with the longevity of the device. When a filter remains implanted for long enough, it can cause scar tissue to form around it. Eventually, the device anchors can become ingrown and embedded in the blood vessel. Over time, filter components can also perforate through the vein wall, while other parts can fracture. These broken pieces are at risk of migrating to the heart, lungs, and other organs where they might cause damage. Such developments impact patient health and necessitate timely retrieval. However, many patients eligible for filter retrieval are currently lost to follow-up because of inadequate tracking methods.
Complications of Delayed IVC Filters Retrieval
While timely filter retrieval procedures are typically successful, delayed retrieval carries inherently higher risks, including vessel rupture and fractured pieces migrating through the body. Delayed retrieval has become such an issue that the Philips’ CavaClear filter removal laser sheath, a device specific to this purpose, recently received De Novo clearance from the FDA. Despite a high success rate of retrieval, one in every fifty patients still developed a major complication during this type of retrieval. This situation presents an extensive challenge for healthcare providers, affecting institutions’ reputations, financial success, and the value provided to patients.
Facilitating Retrieval of IVC Filters
As a result of these complications, the FDA recommends that implanting physicians take responsibility for the ongoing care of the recipients and the removal of IVC filters once they are no longer needed. To implement these requirements effectively, a hospital or clinic needs to be able to track the recipients of the filters. Once a patient’s chances of embolism have passed, risk/benefit data suggests removing the filter between 29 and 54 days after implantation. To achieve this, practitioners must be able to contact the recipients to arrange removal.
This requirement highlights the critical need to implement a reliable mechanism or process for tracking IVC filter recipients. However, creating a program that complies with the required standards of care presents a challenge.
Benefit of a Dedicated Tracking Program
A 2018 study conducted by the University of Alabama at Birmingham (UAB) demonstrated how implementing a dedicated retrieval program helped to reduce the number of patients who were lost to follow-up. Prior to implementation of the program, 55.3% of patients who received IVC filters were lost to follow-up. Once the program was in effect, this dropped to 9.4%.
These results provided real-world evidence that a committed effort to trace the recipients of medical devices has a high chance of success and can potentially save patients’ lives. However, the process was manual and prohibitively labor-intensive, making it impractical to implement on a large scale.
Compliance with Requirements
2015 Certified Electronic Health Record (EHR) Technology (CEHRT) requires all EHR vendors and hospitals to be able to document unique device identifiers (UDIs) in the EHR as individual data points. To implement an effective method of tracking IVC filter recipients, healthcare providers can deploy software that enables them to streamline the process and achieve optimal results. A data-driven communications platform that leverages automated workflows enables health systems and providers to reach patients and require acknowledgment-based responses.
Deploying a Unique, Data-Driven Solution
CAREier’s revolutionary approach to this challenge offers an innovative solution for maintaining accurate records and automating workflows. This market-leading platform saves providers extensive time with its multi-pronged approach to communication focused on engaging the patient through already-accepted mediums. These essential messages are sent based on rules the system establishes with customizable templates and macros. Automated, outbound reminders and messages can be tracked according to actions taken by the intended target, such as opens, answers, and acknowledgments of risk.
CAREier finally makes data actionable for hospitals and simultaneously smooths the way for providers to maintain accurate data and track implantations for the purpose of IVC filter follow-up and retrieval.
Discover how our software can protect your healthcare institution, reduce costs while improving standards of care, increase the retrieval IVC filters, and enable you to adopt the best practices driving quality outcomes for patients. For more information about our seamless workflow solution, please contact us at info@CAREier.com or call us at (202) 571-6157.