Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†.

Details

Serval ID
serval:BIB_34D71C76DD0B
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†.
Journal
Interactive cardiovascular and thoracic surgery
Author(s)
Ferrari E., Demertzis S., Angelella J., Berdajs D., Tozzi P., Moccetti T., Maisano F., von Segesser L.K.
ISSN
1569-9285 (Electronic)
ISSN-L
1569-9285
Publication state
Published
Issued date
01/05/2017
Peer-reviewed
Oui
Volume
24
Number
5
Pages
721-726
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties.
Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEX TM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected.
Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage.
The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting.

Keywords
Apical closure device, Percutaneous heart valve procedures, Transapical valve implantation, Transcatheter valve implantation
Pubmed
Web of science
Open Access
Yes
Create date
28/03/2017 16:33
Last modification date
20/08/2019 13:21
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