Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

Infrastructural needs and expected benefits of telemonitoring in left ventricular assist device therapy: Results of a qualitative study using expert interviews and focus group discussions with patients.

BACKGROUND: Heart failure is one of the most expensive chronic diseases, as it leads to considerable expenses due to increasing hospitalisation rates. In addition to the implications of the demographic transition and the lack of available organs for transplantation, a major challenge in this context is that conservative treatment options are limited. This has led to the research and development of mechanical circulatory assist systems. Telemonitoring is anticipated to be an effective tool in outpatient management, which may be a key to improved outcomes of left ventricular assist devices therapy. In patients with chronic cardiac diseases, telemedicine is already used and has been shown to reduce premature mortality. This study aims to provide insights into the left ventricular assist device-specific requirements for telemonitoring and infrastructural translation from caregivers' and patients' points of view. METHOD: A qualitative investigation based on guided interview and focus group techniques was conducted at two German heart centres. The study included 15 patients and 7 caregivers (4 cardiac surgeons, 3 ventricular assist device coordinators). Qualitative content analysis was used for data analysis. The categories for analysis were (1) benefits for patients, (2) benefits for hospitals and the healthcare system, (3) acceptance and causative factors and (4) infrastructural implementation. RESULTS: Patients and experts expect the following benefits for telemonitored patients: added safety, early detection of complications, rapid intervention in case of emergency, regular inspection of pump parameters, fewer outpatient clinic visits and the ability to provide more informed feedback and instructions to the family members who take care of the patient. However, the expected acceptance of telemonitoring in left ventricular assist device therapy differed among the interviewed groups. Alongside the aforementioned expected benefits, patients and clinical experts criticised the reduced self-determination for the patient, probable large amounts of time/effort required of the patient and caregiver and data protection/integrity issues (data misuse, device manipulation and mistransfer). Interviewees expected easy handling, proper education and safe data transmission to be necessary factors leading to acceptance. Complication rate reduction, fewer hospitalisations and cost reductions were benefits recorded for the healthcare system and clinics. Clinical experts preferred a telemonitoring centre run by ventricular assist device coordinators. CONCLUSION: Although positive expectations are associated with the use of telemonitoring in left ventricular assist device therapy, further action is needed. For example, software and infrastructure developers will need to address issues such as variations among patients and may need to find a balance between designing individualised solutions for compliant patients and a safe and easy-to-handle set-up. In addition, proper elucidation of users will contribute to the successful implementation of a left ventricular assist device telemonitoring programme among patients and caregivers.

Telemonitoring and Medical Care of Heart Failure Patients Supported by Left Ventricular Assist Devices - The Medolution Project.

Long-term survival after left ventricular assist device (LVAD) implantation in heart failure patients is mainly determined by a sophisticated after-care. Ambulatory visits only take place every 12 weeks. In case of life-threatening complications (pump thrombosis, driveline infection) this might lead to delayed diagnosis and delayed intervention. It is the intention of the international project Medolution (Medical care evolution) to develop new approaches in order to create best structures for telemonitoring of LVAD patients. In the very early period of the project a questionnaire was sent to 180 LVAD patients to evaluate the need and acceptance of telemonitoring. Thereafter, a graphical user interface (GUI) mockup was developed as one of the first steps to improve the continuous contact between the LVAD patient and the physician. As a final goal the Medolution project aims to bundle all relevant informations from different data sources into one platform in order to provide the physician a comprehensive overview of a patient's situation. In the systems background a big data analysis should run permanently and should try to detect abnormalities and correlations as well. At crucial events, a notification system should inform the physician and should provide the causing data via a decision support system. With this new system we are expecting early detection and prevention of common and partially life-threatening complications, less readmissions to the hospital, an increase in quality of life for the patients and less costs for the health care system as well.