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Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it

Published online by Cambridge University Press:  21 July 2011

Franz P. Freudenthal
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Alexandra Heath*
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Jorge Villanueva
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Janne Mendes
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Ximena Vicente
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Inge von Alvensleben
Affiliation:
Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia
Gabriel Echazú
Affiliation:
Department of Pediatric Cardiology, Centro Médico Quirúrgico Boliviano Belga, University of San Simon, Cochabamba, Bolivia
Joaquin Navarro
Affiliation:
Department of Pediatric Cardiology, Centro Médico Quirúrgico Boliviano Belga, University of San Simon, Cochabamba, Bolivia
Nora Lang
Affiliation:
Klinikum Grosshadern, Ludwig Maximilian University, Munich, Germany
Rainer Kozlik-Feldmann
Affiliation:
Klinikum Grosshadern, Ludwig Maximilian University, Munich, Germany
*
Correspondence to: Dr A. Heath, MD, PhD, Pediatric Cardiologist, Interventional cardiologist, Department of Pediatric Cardiology, Kardiozentrum, Obrajes, Calle 14, 669, La Paz, Bolivia. Tel: 005912 2785037; E-mail: [email protected]

Abstract

Background

Interventional closure of patent arterial duct has become an accepted alternative to surgical closure. Clinical trial with “Nit-Occlud® PDA-R”.

Methods and results

To assess the safety and efficacy of the device, we performed a prospective clinical study between June, 2009 and December, 2010 in La Paz, Bolivia. In all, 29 – 22 female patients and 7 male patients – out of 59 patients were selected on the basis of inclusion criteria. The procedures were performed under sedation at an age and weight of 5.7 years and 22.7 kilograms, respectively, with 4–6 French arterial sheaths and 5–7 French venous sheaths. The minimal diameter of the duct was 3.5 millimetres. The procedure, fluoroscopy, and hospitalisation times were 96.4 minutes (55 to 145), 13.1 minutes (3 to 25.2), and 24 hours, respectively. The “Nit-Occlud® PDA-R” was successfully deployed in all patients. Immediate, 24-hour, 1-, 3-, and 6-month closure rates were 65.5%, 79.3%, 96.5%, and 100%, respectively. The systolic pulmonary pressure diminished from 37 millimetres of mercury (21 to 57) before the intervention to 31 millimetres of mercury (21 to 45) after the intervention. No early or late embolisation, haemolysis, left pulmonary artery, or descending aorta obstruction occurred.

Conclusions

We conclude that the “Nit-Occlud® PDA-R” device is safe and effective in closing patent arterial duct up to a diameter of 8 millimetres.

Type
Original Articles
Copyright
Copyright © Cambridge University Press 2011

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