Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: transcatheter aortic valve implantationProcedure: Aortic Valve Replacement
- Registration Number
- NCT01852552
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
- All consecutive patients undergoing TAVI at participating centers during the period of enrollment
- All consecutive patients aged ≥80 years or with Logistic Euroscore ≥15% undergoing AVR at participating centers during the period of enrollment
- Absence of informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Transcatheter aortic valve implantation transcatheter aortic valve implantation All consecutive patients undergoing TAVI at participating centres during study period Aortic Valve Replacement Aortic Valve Replacement All consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment
- Primary Outcome Measures
Name Time Method Minnesota Living with Heart Failure Questionnaire (MLHFQ) baseline, 3-month, 12-month Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement
Mini Mental State Examination (MMSE) baseline, 3-month, 12-month Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement
Hospital Anxiety and Depression Scale (HADS) baseline, 3-month, 12-month Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement
In-hospital costs Participants will be followed for the duration of hospital stay, an expected average of 10 days for transcatheter aortic valve implantation and 2 weeks for surgical Aortic Valve Replacement Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.
- Secondary Outcome Measures
Name Time Method Stroke 30-day, 12-month and up to 2-year (longest available follow-up) Incidence of stroke
Vascular complications 30-day Incidence of vascular complications as defined by the VARC
Myocardial infarction 30-day, 12-month and up to 2-year (longest available follow-up) Incidence of myocardial infarction
Acute kidney injury 30-day Incidence of AKI as defined by the VARC
Pace-maker implantation 30-day, 12-month Need for permanent pacing
Bleedings 30-day Incidence of bleedings as defined by the VARC
Follow-up costs 12-month Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs
Trial Locations
- Locations (1)
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
🇮🇹Bologna, Italy