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

Isabel Mattig; Kerstin Koehler; Gina Barzen; Meike Hiddemann; Elias Kugel; Constantin Roemmelt; Verena Mauckisch; Clarissa Vockeroth; Karl Stangl; Thomas Hoppe; Friedrich Koehler; Henryk Dreger

doi:10.3389/fcvm.2023.1352592

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

Front Cardiovasc Med. 2024 Jan 22:10:1352592. doi: 10.3389/fcvm.2023.1352592. eCollection 2023.

Authors

Isabel Mattig^{1

2

3

4}, Kerstin Koehler^{1

2

5}, Gina Barzen^{1

2}, Meike Hiddemann^{1

2

5}, Elias Kugel^{1

2}, Constantin Roemmelt^{1

2}, Verena Mauckisch^{1

2

5}, Clarissa Vockeroth^{1

2

5}, Karl Stangl^{1

2

3}, Thomas Hoppe⁶, Friedrich Koehler^{1

2

3

5}, Henryk Dreger^{2

3

7}

Affiliations

¹ Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine, Campus Charité Mitte, Berlin, Germany.
² Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
³ DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.
⁴ Berlin Institute of Health at Charité - Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, Berlin, Germany.
⁵ Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine, Berlin, Germany.
⁶ Fraunhofer FOKUS, Berlin, Germany.
⁷ Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine, Campus Virchow Klinikum, Berlin, Germany.

Abstract

Aims: The majority of patients with severe aortic stenosis (AS) planned for transcatheter aortic valve implantation (TAVI) are elective outpatients. During the COVID-19 pandemic, the time between the heart team's decision and TAVI increased due to limited healthcare resources. We therefore implemented telemedical approaches to identify AS patients at risk for clinical deterioration during the waiting time. The purpose of the prospective, randomized, controlled ResKriVer-TAVI study (DRKS00027842) is to investigate whether a digital concept of telemedical interventional management (TIM) in AS patients waiting for TAVI improves the clinical outcomes. In the present article, we report the study protocol of the ResKriVer-TAVI trial.

Methods: ResKriVer-TAVI will enroll AS patients planned for elective TAVI. Randomization to the TIM group or standard care will be made on the day of the heart team's decision. TIM will include a daily assessment of weight, blood pressure, a 2-channel electrocardiogram, peripheral capillary oxygen saturation, and a self-rated health status until admission for TAVI. TIM will allow optimization of medical therapy or an earlier admission for TAVI if needed. Standard care will not include any additional support for patients with AS. All patients of the TIM group will receive a rule-based TIM including standard operating procedures when a patient is crossing prespecified values of a vital sign.

Results: The primary endpoint consists of days lost due to cardiovascular hospitalization and death of any cause within 180 days after the heart team's decision. Major secondary endpoints include all-cause mortality within 365 days, the number of telemedical interventions, and adherence to TIM. Follow-up visits will be conducted at admission for TAVI as well as 6 and 12 months after the heart team's decision.

Conclusions: ResKriVer-TAVI will be the first randomized, controlled trial investigating a telemedical approach before TAVI in patients with AS. We hypothesize that primary and secondary endpoints of AS patients with TIM will be superior to standard care. The study will serve to establish TIM in the clinical routine and to increase the resilience of TAVI centers in situations with limited healthcare resources.

Keywords: COVID-19 pandemic; TAVI; aortic stenosis; telemedical interventional management; transcatheter aortic valve implantation.

Grants and funding

The authors declare financial support was received for the research, authorship, and/or publication of this article.