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

Brief Title

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

Official Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Mini Mental State Examination (MMSE)

Secondary Outcome

 Myocardial infarction

Condition

Aortic Valve Stenosis

Intervention

transcatheter aortic valve implantation

Study Arms / Comparison Groups

 Transcatheter aortic valve implantation

Description:  All consecutive patients undergoing TAVI at participating centres during study period

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

December 2011

Completion Date

January 2016

Primary Completion Date

January 2016

Eligibility Criteria

        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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT01852552

Organization ID

GR-2009-1578270

Responsible Party

Principal Investigator

Study Sponsor

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Collaborators

 Ministry of Health, Italy

Study Sponsor

, ,

Verification Date

November 2016