Aortic Valve Stenosis
Conditions
Brief summary
Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months): Documentation of treatment pathways and endpoints of routine patients without educational program Dedicated reflection and training (1 day): One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements. Implementation of tailored changes (2 months): Implementation of the changes developed in the training. Determination of the effect (3 months): Coordinator measures optimization changes and determines effects.
Detailed description
Along the severe aortic stenosis (sAS) treatment pathway there are delays that may impact quality management and hospital efficiency. A dedicated valve coordinator, interfering with all stages of patient handling throughout the hospital may increase the efficiency of the sAS patient flow, accelerate decision making and clinical outcomes while at the same time decreasing resource consumption. The hypothesis is that the implementation of a dedicated valve coordinator will improve the patient flow of sAS patients scheduled to undergo TAVI, their outcome, patient and physician satisfaction and will optimize costs. In total, three centers across Germany (Munich, Düsseldorf, Bad Bevensen) will participate.
Interventions
OTHERCoordinator
A THV coordinator will be responsible for communication with the patients and the caregivers as well as for monitoring medical documentation and treatment pathways. The registry will consist of 3 phases: * Determination of the status quo * Dedicated reflection and training followed by implementation of tailored changes * Determination of the effect
Sponsors
Edwards Lifesciences
Institut für Pharmakologie und Präventive Medizin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI
Exclusion criteria
* patients not providing written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of differences in length of stay (LoS) | 12 months | LoS in days. |
| Adverse event rate | 30 days | According to VARC-2 criteria. |
| Patient satisfaction | 30 days | Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied). |
| Economic evaluation | 12 months | Proportion of early discharges in patients with sAS undergoing TAVI. |
Countries
Germany
Outcome results
None listed