Apical closure device for transapical valve procedures?.

Détails

ID Serval
serval:BIB_A3CC35A9BF25
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Apical closure device for transapical valve procedures?.
Périodique
Interactive Cardiovascular and Thoracic Surgery
Auteur⸱e⸱s
Ferrari E., Berdajs D., Tozzi P., Siniscalchi G., von Segesser L.K.
ISSN
1569-9285 (Electronic)
ISSN-L
1569-9285
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
21
Numéro
5
Pages
561-564
Langue
anglais
Notes
Publication types: Journal ArticlePublication Status: ppublishDocument Type: Article; Proceedings Paper
Résumé
OBJECTIVES: Transapical transcatheter valve procedures are performed through a left minithoracotomy and require apical sutures to seal the apical access site. The use of large-calibre devices compromises any attempt to fully perform the procedure with a thoracoscopic approach or percutaneously. We report our preliminary experience in animals with a new sutureless self-expandable apical occluder, engineered to perform transapical access site closure in a minimally invasive setting with large-size introducer sheaths.
METHODS: The apical occluder with extendable waist was implanted in six young pigs during an acute animal study. Under general anaesthesia, animals (mean weight: 62 ± 8 kg) received full heparinization (heparin: 100 UI/kg; activated clotting time above 250 s). Through a median sternotomy, a 21-Fr Certitude? introducer sheath (outer diameter: 25 Fr) was placed over the wire into the cardiac apex. The delivery catheter carrying the constrained apical plug was inserted into the sheath and deployed under fluoroscopic control, whereas the Certitude? was retrieved. After protamine infusion, we observed and recorded the 1-h bleeding with standard haemodynamic parameters. Animals were sacrificed, and hearts analysed.
RESULTS: Six apical closure devices were successfully introduced and deployed in six pig hearts through large-size apical sheaths at first attempt. In all animals, the plugs guaranteed immediate apical sealing and traces of blood were collected in the pericardium during the 1-h observational period (mean of 16 ± 3.4 ml of blood loss per animal). Haemodynamic parameters remained stable during the entire study period and no plug dislodgement was detected with normal systemic blood pressure (mean arterial mean blood pressure: 65 ± 7 mmHg). Post-mortem analysis confirmed the full deployment and good fixation of all plugs, without macroscopic damages to the surrounding myocardium.
CONCLUSIONS: This sutureless self-expandable apical occluder is a simple device capable of sealing large-size apical access sites (20-35 Fr) in an acute animal study. This approach is a step further towards less invasive transapical valve procedures in the clinical setting, and further animal tests will be performed to confirm the long-term efficacy and safety of this device.
Mots-clé
Transcatheter aortic valve replacement, Transapical valve replacement, Closure device, Percutaneous heart procedures
Pubmed
Web of science
Open Access
Oui
Création de la notice
09/11/2015 14:06
Dernière modification de la notice
20/08/2019 15:09
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