Telemedical management in patients waiting for transcatheter aortic valve implantation: the ResKriVer-TAVI study...

Area of Science:

• Cardiology
• Digital Health
• Clinical Trials

Background:

• Severe aortic stenosis (AS) patients awaiting transcatheter aortic valve implantation (TAVI) are often elective outpatients.
• The COVID-19 pandemic led to increased waiting times for TAVI due to healthcare resource limitations.
• Telemedical approaches were implemented to monitor AS patients at risk of clinical deterioration during extended waiting periods.

Purpose of the Study:

• To investigate if a digital telemedical interventional management (TIM) approach improves clinical outcomes in AS patients awaiting TAVI.
• To report the study protocol for the prospective, randomized, controlled ResKriVer-TAVI trial (DRKS00027842).

Main Methods:

• Enrollment of AS patients scheduled for elective TAVI.
• Randomization to either the TIM group or standard care on the day of heart team decision.
• Daily monitoring in the TIM group: weight, blood pressure, ECG, oxygen saturation, and self-rated health status.
• TIM allows for medical therapy optimization or earlier TAVI admission if needed, guided by a rule-based system for vital sign deviations.

Main Results:

• Primary endpoint: days lost due to cardiovascular hospitalization and all-cause death within 180 days post-decision.
• Secondary endpoints: 365-day all-cause mortality, number of telemedical interventions, and adherence to TIM.
• Follow-up at TAVI admission, and 6 and 12 months post-heart team decision.

Conclusions:

• ResKriVer-TAVI is the first randomized trial evaluating a pre-TAVI telemedical approach for AS patients.
• Hypothesis: TIM will lead to superior primary and secondary endpoints compared to standard care.
• The study aims to integrate TIM into clinical routine and enhance TAVI center resilience during resource limitations.