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The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .
Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.
Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental.
The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge | The primary endpoint is to evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge in terms of:
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for aortic valve replacement with a Perceval valve
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Mikus, MD | Maria Cecilia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | Ravenna | 48033 | Italy |
All information related to the participation of a subject in this study will be treated with the utmost confidentiality, in accordance with good clinical practice (Decree of the Ministry of Health of 15 July 1997, and subsequent amendments and additions) and regulations on the protection of personal data: Information and Consent pursuant to Legislative Decree no. 196 of 30/06/2003 and the European General Data Protection Regulation (GDPR - General Data Protection Regulation), which came into force on 25 May 2018.
All patient names will be kept confidential. Patients will be identified throughout documentation and evaluation by the number allotted to them by the study. The patients will be assured that all findings will be stored on computer and handled in the strictest confidence. The Investigator agrees to maintain the confidentiality of the study protocol.
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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