Aortic Valve Stenosis Clinical Trial
Official title:
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing
transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve
replacement (AVR).
The objectives of the study are:
1. Description of neurocognitive status before and after transcatheter aortic valve
implantation and aortic valve replacement procedures
2. Description of Quality of Life (QoL) after these procedures
3. Defining the relevance of baseline psychological, emotional and cognitive factors on
the outcomes associated to the different treatment modalities
4. Assessment of costs associated to each of the above mentioned strategies of treatment,
including costs of the index hospitalization and costs of follow-up.
In Italy, a nation-wide observational study endorsed by the Superior Institute of Health has
been previously launched in order to evaluate appropriateness and effectiveness of aortic
valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) procedures: the
OBservational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis
Treatment (OBSERVANT). The present study was designed to complement the national survey on
TAVI and AVR procedures including data about costs, cognitive functions and quality of life
after these procedures. This integrated framework may help defining the relevance of
baseline psychological, emotional and cognitive factors on the outcomes associated to the
different treatment modalities and, on the other hand, should enable accurate evaluation of
the impact of each kind of treatment on quality of life and neuropsychological functions.
These elements could also represent relevant keys to decision-making to the different
therapeutic strategies. In addition, we aim to ascertain costs associated to each of the
above mentioned strategies of treatment, including costs of the index hospitalization and
follow-up costs. Costs estimate, combined to the integrated physical and mental health
status outcome for each treatment modality, may represent the background for subsequent
cost-effectiveness analyses.
All consecutive patients undergoing transcatheter aortic valve implantation or aortic valve
replacement (if age ≥ 80 years or Logistic Euroscore ≥ 15%) for aortic stenosis at
participating centers during the period of enrollment will be included in the registry,
after release of written informed consent. Allocation of patients to different treatment
groups will be performed jointly by a cardiologist and a cardiac surgeon on the basis of a
complete clinical framework, independently from the present study and in accordance with
available guidelines. Type of treatment (for example, access site for TAVI, type of
prosthesis…) will be decided by the physicians based on local clinical practice and general
principles of good clinical practice.
The administration of neurocognitive and quality of life questionnaires will be performed
before the procedure and after 3 months and 1 year by trained personnel following standard
operation procedures defined by a coordinating unit. A telephone and web-based support for
operators will be available throughout the entire duration of the study. A common
methodology for data collection and analysis is defined to guarantee data reliability and
homogeneity of assessments among the participating units. The cost analysis will be
coordinated by the Regional Healthcare and Social Agency of the Emilia Romagna Region.
Data will be collected in a web-based database (OBSERVANT) through dedicated Case Records
Forms and a final database will be built by merging this database with a separate database
for costs and Hospital Discharge Records and Mortality Registry databases.
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Observational Model: Cohort, Time Perspective: Prospective
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