September 16, 2020
VitalConnect Begins TELESTAR-TAVR Study of Remote Patient Monitoring System
September 16, 2020—VitalConnect, Inc. announced that it has begun the TELESTAR-TAVR clinical study that is evaluating the company’s VistaSolution Live technology to monitor patients after undergoing transcatheter aortic valve replacement (TAVR). The primary objective of this prospective trial is to measure the impact of remote patient monitoring (RPM) and telehealth on patient satisfaction, clinical outcomes, and readmission rates for patients.
TELESTAR-TAVR will enroll 100 patients, 50 each in the control and treatment groups, with initial study results available in 6 months and complete study results in 12 months. Patients will be discharged within 24 hours of their procedure, monitored for 7 days with the VitalPatch RTM biosensor, and then connect with their physician via secured video call using the VistaSolution Live at 7, 14, and 21 days. Patients will then return to the hospital for an in-person follow-up visit at 30 days.
According to the company, VistaSolution Live provides continuous, real-time monitoring and detection of cardiac arrhythmias. It can also monitor up to 11 unique patient vitals, such as heart rate, respiratory rate, body temperature, and activity. This information may aid providers to monitor early signs of deterioration, predict possible complications, and adjust treatment strategy to optimize clinical outcomes.
The system consists of three components: VitalPatch RTM, a wireless, wearable, and disposable biosensor to monitor ECG, vital signs, and 19 arrhythmias; VistaTablet, a mobile device to relay information from patch to cloud; and VistaCenter, a central monitoring interface accessible via the internet.
“The TELESTAR-TAVR study is a first-of-its-kind evaluation of the role remote patient monitoring may play in improving clinical outcomes and bringing new efficiencies to patient care,” commented Brijeshwar Maini, MD, in VitalConnect’s press release. “We’re looking forward to the results of this study and the impact that RPM may have on optimizing clinical outcomes and increasing patient satisfaction following TAVR.” Dr. Maini is National Medical Director of Cardiology at Tenet Healthcare and Professor of Medicine at Florida Atlantic University in Boca Raton, Florida.
The company noted that data from the Nationwide Readmissions Database indicated that all-cause 30-day readmission ranged from 14.6% to 20.9% for TAVR patients, with noncardiac causes accounting for 61.8% and cardiac causes account for 38.2% of readmissions. A retrospective analysis of 8,073 patients, who underwent TAVR, identified arrhythmia (tachyarrhythmias and atrial fibrillation), as one of the most prominent cardiac predictors for readmission.