Fenestration closure with Amplatzer Duct Occluder II in patients after total cavo-pulmonary connection

Abstract

Introduction: Creation of a fenestration during completion of a total cavopulmonary connection (TCPC) has been associated with a reduction in early mortality and morbidity. However, the long-term benefits are negated by an associated limitation in exercise tolerance and the potential risks of thrombo-embolic complications. We sought to describe the safety and efficacy of an Amplatzer Duct Occluder II (ADO II) for transcatheter fenestration closure following TCPC.

Material and methods: Between January 2000 and July 2014, 102 patients underwent percutaneous closure of extra-cardiac TCPC fenestrations with a range of devices. Patients in whom fenestration closure was performed with an ADO II and who had at least 6 months of follow-up were included in this study.

Results: Forty-seven patients had successful fenestration occlusion with an ADO II. The mean oxygen saturation and mean systemic venous pressures increased from 84.8 ±6.1% before to 97.6 ±2.9% (p < 0.001) after and from 14.2 ±2.15 mm Hg before to 15.6 ±2.2 mm Hg after closure (p < 0.001). Eight patients developed heart failure symptoms, managed by optimization of medical therapy, with 1 patient requiring device removal to reopen the fenestration. Color Doppler transthoracic echocardiography demonstrated residual flow across the device in 18 (38%), 10 (22%), 5 (11%) and 4 (9%) patients before discharge, at 1 and 6 months, and at the latest outpatient visit, respectively.

Conclusions: The ADO II can be safely and effectively used to close fenestrations in extra-cardiac type Fontan completions. Many of the design features of this device confer potential benefit in this population.

Keywords: congenital heart disease; new devices; percutaneous intervention.

Figure 1

Fenestration closure with ADO II in a HLHS patient. A – Initial rotational angiogram with simultaneous contrast injection in the innominate vein (black arrow) and inferior vena cava (white arrow) shows the fenestration. B – Hand contrast injection prior to release of the ADO II device (empty black arrow) shows trivial residual flow at the bottom edge of the occluder. C – Final angiography through the delivery sheath shows complete occlusion of the fenestration with both discs of the device well aligned to the walls of the tunnel and the right atrium ADO II – Amplatzer Duct Occluder II, HLHS – hypoplastic left heart syndrome.

Figure 2

Relation between fingertip arterial oxygen saturations (Sat O₂) and time after fenestration closure

Figure 3

Relation between persistence of residual flow and time after fenestration closure

Figure 4

Diagram presenting a 1 : 1 comparison of the most commonly used device in this study, 5/4 mm Amplatzer Duct Occluder II, and corresponding 5 mm Amplatzer Septal Occluder

Figure 5

Volume-rendered 3D reconstruction of rotational angiography images in fenestrated TCPC patient. A – Multisite contrast injection including IVC, lSVC and rSVC was used to obtain complete visualization of the Fontan pathway in one RA run. B, C – Cutting out of the right and left pulmonary artery respectively. D – Measurement of the size of fenestration in sagittal plane corresponding to RAO projection. E – Cutting out of part of the extracardiac tunnel. F – Measurement of the fenestration in transverse plane, which is not achievable in standard angiography TCPC – total cavo-pulmonary connection, IVC – inferior vena cava, lSVC – left-sided superior vena cava, rSVC – right-sided superior vena cava, RAO – right anterior oblique.