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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: transcatheter aortic valve implantation; Procedure: Aortic Valve Replacement

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.

• Study Type: Observational
• Enrollment (Actual): 518

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients undergoing TAVI or AVR for AS at participating centers during the period of enrollment

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transcatheter aortic valve implantation; All consecutive patients undergoing TAVI at participating centres during study period	Device: transcatheter aortic valve implantation; Patients undergoing TAVI with transfemoral, transapical, or any other vascular access; Other Names: Edwards Sapien XT; Corevalve; Acurate-TA
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	Procedure: Aortic Valve Replacement; Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental State Examination (MMSE)	Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement	baseline, 3-month, 12-month
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	Incidence of myocardial infarction	30-day, 12-month and up to 2-year (longest available follow-up)
Stroke	Incidence of stroke	30-day, 12-month and up to 2-year (longest available follow-up)
Pace-maker implantation	Need for permanent pacing	30-day, 12-month
Vascular complications	Incidence of vascular complications as defined by the VARC	30-day
Bleedings	Incidence of bleedings as defined by the VARC	30-day
Acute kidney injury	Incidence of AKI as defined by the VARC	30-day
Follow-up costs	Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs	12-month

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Ministry of Health, Italy; Region Emilia-Romagna, Italy

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Quality of life; Cognitive function; Aortic stenosis; Costs; Transcatheter aortic valve implantation; Aortic valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: GR-2009-1578270