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

Ferrari, Enrico ; Demertzis, Stefanos ; Angelella, Jennifer ; Berdajs, Denis ; Tozzi, Piergiorgio ; Moccetti, Tiziano ; Maisano, Francesco ; von Segesser, Ludwig K.

In: Interactive CardioVascular and Thoracic Surgery, 2017, vol. 24, no. 5, p. 721-726

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    Titre
    • Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†
    Auteur
    • Ferrari, Enrico. Department of Cardiovascular Surgery, Cardiocentro Ticino, Lugano, Switzerland
    • Demertzis, Stefanos. Department of Cardiovascular Surgery, Cardiocentro Ticino, Lugano, Switzerland
    • Angelella, Jennifer. Department of Cardiac Surgery University Hospital of Lausanne, Lausanne, Switzerland
    • Berdajs, Denis. Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland
    • Tozzi, Piergiorgio. Department of Cardiac Surgery University Hospital of Lausanne, Lausanne, Switzerland
    • Moccetti, Tiziano. Department of Cardiology, Cardiocentro Ticino Foundation, Lugano, Switzerland
    • Maisano, Francesco. Department of Cardiovascular Surgery, University Hospital of Zurich, Zurich, Switzerland
    • von Segesser, Ludwig K.. Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Interactive CardioVascular and Thoracic Surgery, 2017, vol. 24, no. 5, p. 721-726. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:331846
    Summary
    OBJECTIVES: 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. METHODS: 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 (SAFEXTM 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. RESULTS: 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. CONCLUSIONS: 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.