OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

Study Overview
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Brief Summary
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In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. IRCCS (Scientific Research and Cure Institute) Policlinico San Donato is the responsible hospital for cardiac valve pathologies and has been appointed the leader for the present study. The non-calcific aortic valve stenosis in the elderly is one of the most frequent cardiovascular diseases. Different therapeutic options are available for treating this condition: medical therapy and follow-up, conventional surgery (including sternotomy and employment of mechanical, biological, or sutureless valves), and transcatheter valve implantation. The uncertainty about the advantages and limitations of the different approaches is still very high. In this panorama, the concept of mere survival should be replaced by a broader vision of the quality of life. The aim of the present study is to build an Italian registry of aortic valve stenosis in the elderly (age >= 65 years) who, following the current guidelines, would receive a biological aortic valve replacement. The following topics will be evaluated: (i) the results of the different therapeutical options; (ii) the determination of the choice criteria for the different therapeutical options and the verification of the appropriateness, economic and organizational impact for each of them; (iii) the evaluation of the quality of life modifications, periprocedural and at a long follow-up; (iv) the health technology assessment of the applied therapies.

Detailed Description
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In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. IRCCS (Scientific Research and Cure Institute) Policlinico San Donato is the responsible hospital for cardiac valve pathologies and has been appointed the leader for the present study. The proportion of the elderly in the general population is constantly increasing over the last few years and is destined to grow further in industrialized countries, representing a challenge for the sanitary authorities for a number of reasons. The non-calcific aortic valve stenosis in the elderly is one of the most frequent cardiovascular diseases. Different therapeutic options are available for treating this condition: medical therapy and follow-up, conventional surgery (including sternotomy and employment of mechanical, biological, or sutureless valves), and transcatheter valve implantation (TAVI). The uncertainty about the advantages and limitations of the different approaches is still very high. In this panorama, mere survival should be replaced by a broader vision of the quality of life. The aim of the present study is to build an Italian registry of aortic valve stenosis in the elderly (age >= 65 years) who, following the current guidelines, would receive a biological aortic valve replacement. The following topics will be evaluated: (i) the results of the different therapeutical options; (ii) the determination of the choice criteria for the different therapeutical options and the verification of the appropriateness, economic and organizational impact for each of them; (iii) the evaluation of the quality of life modifications, periprocedural and at an extended follow-up; (iv) the health technology assessment of the applied therapies.

Official Title
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OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: TAVR (Transcatheter Aortic Valve Replacement)
* Procedure: AVR (Aortic Valve Replacement)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age higher or equal to 65 years; aortic valve stenosis that, according to current guidelines, should be treated by a valve replacement; written consent to participate. Exclusion Criteria: aortic valve insufficiency not due to stenosis; refusal to participate.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR<br>Patients undergoing aortic valve replacement through the Transcatheter Aortic Valve Replacement procedure. For all the patients a set of clinical, anatomical, and procedural details will be obtained and registered. The outcome at the hospital discharge and at the 12-month follow-up will be collected, as well. The quality of life questionnaire will be administered to all the patients at the hospital discharge, at the 12-month follow-up (mandatory), and then at annual base (facultative). | Procedure: TAVR (Transcatheter Aortic Valve Replacement)<br>* Percutaneous aortic valve replacement, also known as percutaneous aortic valve implantation, transcatheter aortic valve implantation or transcatheter aortic valve replacement, is the replacement of the aortic valve of the heart through the blood vessels.<br>* Other names: TAVI (Transcatheter Aortic Valve Implantation);|
| AVR<br>Patients undergoing aortic valve replacement through conventional open-heart surgery (sternotomy and biological valve implantation). For all the patients a set of clinical, anatomical, and procedural details will be obtained and registered. The outcome at the hospital discharge and at the 12-month follow-up will be collected, as well. The quality of life questionnaire will be administered to all the patients at the hospital discharge, at the 12-month follow-up (mandatory), and then at annual base (facultative). | Procedure: AVR (Aortic Valve Replacement)<br>* Aortic valve replacement is a procedure whereby the failing aortic valve of a patient's heart is replaced with an artificial heart valve through an open-heart surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Percentage of patients died | 30 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life index | Index of well-being assessed through a questionnaire | Hospital discharge (average 2 to 7 days after procedure/surgery); 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve stenosis, aortic valve replacement, transcatheter aortic valve replacement, quality of life, patient registry