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Self-expanding apical closure device for full-percutaneous closed-chest transapical valve procedures with large-sized introducer sheaths: first study in an animal model
- Source :
- Interactive CardioVascular and Thoracic Surgery. 29:793-799
- Publication Year :
- 2019
- Publisher :
- Oxford University Press (OUP), 2019.
-
Abstract
- OBJECTIVES Available apical occluders do not fulfil requirements for full-percutaneous transapical valve procedures with large-sized introducer sheaths. A self-expanding closure device designed for closed-chest transapical valve procedures was tested in an animal model to verify safety, efficacy and thrombogenicity. METHODS Large-sized 21-Fr introducer sheaths (Certitudeā¢ system for Sapienā¢ valves) were percutaneously placed in the ventricles of nine 3-month old minipigs. To seal the apical access, delivery catheters carrying folded self-expanding plugs were inserted. Then, the plugs were deployed while sheaths were removed. Echocardiograms verified tamponade and cardiac function, drains were not placed and a 3-month long aspirin therapy was administered. After 6 and 9 months, animals were euthanized and organs were analysed for macroembolic lesions search. Histological analysis was also performed. RESULTS Nine minipigs (weight: 28±3 kg) were used for this study. Eight plugs were successfully deployed in 8 ventricles without cardiac tamponade or ventricular dysfunction (success rate: 88.9%). In a failed procedure (the animal died after 1 month of cardiac tamponade), the outer disc of the apical plug got stuck in the intercostal space and did not correctly deploy. Post-mortem analysis in 8 minipigs at 6 (n = 4) and 9 months (n = 4) confirmed full deployment and good fixation of all plugs with internal surfaces covered by new endocardium. Macroscopic analysis of myocardium and vital organs showed absence of embolic lesions. Histological analysis showed absence of significant inflammatory infiltration and thrombosis. CONCLUSIONS In this animal model, self-expanding closure devices sealed 21-Fr large percutaneous apical accesses without acute tamponade, thrombosis or embolization. Further tests to evaluate full-percutaneous closed-chest apical procedures are required.
- Subjects :
- Pulmonary and Respiratory Medicine
Cardiac Catheterization
medicine.medical_specialty
Percutaneous
Swine
Heart Ventricles
medicine.medical_treatment
Heart Valve Diseases
Thrombogenicity
610 Medicine & health
030204 cardiovascular system & hematology
11171 Cardiocentro Ticino
2705 Cardiology and Cardiovascular Medicine
03 medical and health sciences
0302 clinical medicine
Cardiac tamponade
medicine
Animals
030212 general & internal medicine
Embolization
Endocardium
Fixation (histology)
Heart Valve Prosthesis Implantation
business.industry
medicine.disease
2746 Surgery
Surgery
Disease Models, Animal
medicine.anatomical_structure
2740 Pulmonary and Respiratory Medicine
Heart Valve Prosthesis
Swine, Miniature
Tamponade
Intercostal space
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- ISSN :
- 15699285
- Volume :
- 29
- Database :
- OpenAIRE
- Journal :
- Interactive CardioVascular and Thoracic Surgery
- Accession number :
- edsair.doi.dedup.....26556e3bed645c0faba0d8516eb812c1