Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— CCQ  

Official title:

Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852552
• Other study ID #: GR-2009-1578270
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: November 11, 2016
• Start date: December 2011
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Absence of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• transcatheter aortic valve implantation
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access

Procedure:
• Aortic Valve Replacement
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

Locations

Country	Name	City	State
Italy	Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Ministry of Health, Italy, Region Emilia-Romagna, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Mental State Examination (MMSE)	Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement	baseline, 3-month, 12-month	No
Primary	Hospital Anxiety and Depression Scale (HADS)	Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement	baseline, 3-month, 12-month	No
Primary	Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement	baseline, 3-month, 12-month	No
Primary	In-hospital costs	Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.	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	No
Secondary	Myocardial infarction	Incidence of myocardial infarction	30-day, 12-month and up to 2-year (longest available follow-up)	No
Secondary	Stroke	Incidence of stroke	30-day, 12-month and up to 2-year (longest available follow-up)	No
Secondary	Pace-maker implantation	Need for permanent pacing	30-day, 12-month	No
Secondary	Vascular complications	Incidence of vascular complications as defined by the VARC	30-day	No
Secondary	Bleedings	Incidence of bleedings as defined by the VARC	30-day	No
Secondary	Acute kidney injury	Incidence of AKI as defined by the VARC	30-day	No
Secondary	Follow-up costs	Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs	12-month	No