1. Beating-heart patch closure of muscular ventricular septal defects under real-time three-dimensional echocardiographic guidance: A preclinical study
- Author
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Nikolay V. Vasilyev, Franz Freudenthal, Ivan S. Salgo, Alistair Phillips, Pedro J. del Nido, Rainer Kozlik-Feldmann, Kazuo Kitahori, Ivan Melnychenko, and Emile A. Bacha
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Cardiac Catheterization ,Heart disease ,Swine ,medicine.medical_treatment ,Echocardiography, Three-Dimensional ,Sensitivity and Specificity ,Heart Septal Defects, Atrial ,Article ,law.invention ,Prosthesis Implantation ,Random Allocation ,law ,Internal medicine ,medicine ,Cardiopulmonary bypass ,Animals ,Minimally Invasive Surgical Procedures ,cardiovascular diseases ,Cardiac Surgical Procedures ,Ultrasonography, Interventional ,Cardiac catheterization ,Cardiopulmonary Bypass ,business.industry ,Prostheses and Implants ,medicine.disease ,Cardiac surgery ,Surgery ,Echocardiography, Doppler, Color ,Catheter ,Disease Models, Animal ,medicine.anatomical_structure ,Ventricle ,Circulatory system ,Cardiology ,cardiovascular system ,business ,Cardiology and Cardiovascular Medicine ,Shunt (electrical) - Abstract
Objectives Safe and effective device closure of ventricular septal defects remains a challenge. We have developed a transcardiac approach to close ventricular septal defects using a patch delivery and fixation system that can be secured under real-time three-dimensional echocardiographic guidance. Methods In Yorkshire pigs (n = 8) a coring device was introduced into the left ventricle through a purse-string suture placed on the left ventricular apex, and a muscular ventricular septal defect was created. The patch deployment device containing a 20-mm polyester patch was advanced toward the ventricular septal defect through another purse-string suture on the left ventricular apex, and the patch was deployed under real-time three-dimensional echocardiographic guidance. The anchor delivery device was then introduced into the left ventricle through the first purse-string suture. Nitinol anchors to attach the patch around the ventricular septal defect were deployed under real-time three-dimensional echocardiographic guidance. After patch attachment, residual shunts were sought by means of two-dimensional and three-dimensional color Doppler echocardiography. The heart was then excised, and the septum with the patch was inspected. Results A ventricular septal defect was created in the midventricular (n = 4), anterior (n = 2), and apical (n = 2) septum. The mean size was 9.8 mm (8.2โ12.0 mm), as determined by means of two-dimensional color Doppler scanning. The ventricular septal defects were completely closed in 7 animals. In one a 2.4-mm residual shunt was identified. No anatomic structures were compromised. Conclusions Beating-heart perventricular muscular ventricular septal defect closure without cardiopulmonary bypass can be successfully achieved by using a catheter-based patch delivery and fixation system under real-time three-dimensional echocardiographic guidance. This approach might be a better alternative to cardiac surgery or transcatheter device closure.
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