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

Autor:	Ferrari E; Department of Cardiovascular Surgery, Cardiocentro Ticino, Lugano, Switzerland.; Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland.; Department of Cardiac Surgery University Hospital of Lausanne, Lausanne, Switzerland., Demertzis S; Department of Cardiovascular Surgery, Cardiocentro Ticino, Lugano, Switzerland., Angelella J; Department of Cardiac Surgery University Hospital of Lausanne, Lausanne, Switzerland., Berdajs D; Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland., Tozzi P; Department of Cardiac Surgery University Hospital of Lausanne, Lausanne, Switzerland., Moccetti T; Department of Cardiology, Cardiocentro Ticino Foundation, Lugano, Switzerland., Maisano F; Department of Cardiovascular Surgery, University Hospital of Zurich, Zurich, Switzerland., von Segesser LK; Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland.
Jazyk:	angličtina
Zdroj:	Interactive cardiovascular and thoracic surgery [Interact Cardiovasc Thorac Surg] 2017 May 01; Vol. 24 (5), pp. 721-726.
DOI:	10.1093/icvts/ivw433
Abstrakt:	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 (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. 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. (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
Databáze:	MEDLINE
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