OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAVR (Transcatheter Aortic Valve Replacement), AVR (Aortic Valve Replacement).
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Procedure TAVR (Transcatheter Aortic Valve Replacement)
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. - Procedure AVR (Aortic Valve Replacement)
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.
Primary outcome measures
- Mortality [Time frame: 30 days after procedure]
Secondary outcome measures (1)
- Quality of life index [Time frame: Hospital discharge (average 2 to 7 days after procedure/surgery); 12-month follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Policlinico San Donato — San Donato Milanese
Publications
- Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8. PMID 16980116
- Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 2014 Sep;30(9):962-70. doi: 10.1016/j.cjca.2014.03.022. Epub 2014 Mar 21. PMID 24986049
- D'Agostino RS, Jacobs JP, Badhwar V, Fernandez FG, Paone G, Wormuth DW, Shahian DM. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2019 Update on Outcomes and Quality. Ann Thorac Surg. 2019 Jan;107(1):24-32. doi: 10.1016/j.athoracsur.2018.10.004. Epub 2018 Nov 10. PMID 30423335
- Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Sondergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013 Jul 16;62(3):210-219. doi: 1 PMID 23684674
- Cosgrove DM 3rd, Sabik JF. Minimally invasive approach for aortic valve operations. Ann Thorac Surg. 1996 Aug;62(2):596-7. No abstract available. PMID 8694642
- Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8. PMID 12473543
- Lababidi Z. Aortic balloon valvuloplasty. Am Heart J. 1983 Oct;106(4 Pt 1):751-2. doi: 10.1016/0002-8703(83)90097-2. No abstract available. PMID 6225323
- Lababidi Z, Wu JR, Walls JT. Percutaneous balloon aortic valvuloplasty: results in 23 patients. Am J Cardiol. 1984 Jan 1;53(1):194-7. doi: 10.1016/0002-9149(84)90709-4. PMID 6691261
Identifiers
NCT: NCT05778773 · OUSTANDING ITALY