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Revista Brasileira de Cardiologia Invasiva

versão On-line ISSN 2179-8397

Rev. Bras. Cardiol. Invasiva vol.20 no.1 São Paulo jan./mar. 2012

http://dx.doi.org/10.1590/S2179-83972012000100015 

ORIGINAL ARTICLE

 

Percutaneous closure of a patent ductus arteriosus with the CeraTM PDA Occluder: another good option in the toolbox

 

 

Francisco ChamiéI,II; Luiz Carlos SimõesI,III; Daniel Silva Chamié de QueirozI,IV; Renata MattosI,III

IINTERCAT - Cardiologia Intervencionista - Rio de Janeiro, RJ, Brazil
IIHospital Federal dos Servidores do Estado - MS-RJ - Rio de Janeiro, RJ, Brazil
IIIInstituto Nacional de Cardiologia - Laranjeiras - Rio de Janeiro, RJ, Brazil
IVUniversity Hospitals at Case Medical Center - Cleveland, United States

Correspondence to

 

 


ABSTRACT

BACKGROUND: The percutaneous closure of a patent ductus arteriosus (PDA) has been considered the treatment of choice by most authors, and several devices with different structural characteristics have been used. The initial experience with the novel CeraTM PDA Occluder is reported.
METHODS: From March of 2010 through December of 2011, patients weighing over 5 kg with a PDA diagnosed by transthoracic echocardiogram (TTE) with colour Doppler flow mapping and no associated defects underwent the procedure. Follow-up was performed by TTE one, three, and six months after the procedure, and yearly thereafter.
RESULTS: Overall, 18 patients were referred for percutaneous occlusion; 61.2% were female. The mean age and weight were 13.7 ± 9.3 years and 42.9 ± 20.1 kg, respectively. Regarding morphology, 11 were type A, six were type E, and one had a residual postoperative defect. The mean diameter was 4.2 mm. Implantation was possible in all patients. Ten 6-4 mm, one 8-6 mm, three 10-8 mm, and four 12-10 mm devices were used. All defects were completely closed by the first follow-up TTE. Deaths or complications were not observed in this series.
CONCLUSIONS: The CeraTM prosthesis may be used for the occlusion of small or large defects, and delivers to excellent results in children and adults. The procedure is easy, safe, has a high efficacy and low morbidity, and may be an excellent option for the percutaneous closure of a PDA. Due to its flexibility, oversized devices greater than 2 mm should be used.

Descriptors: Ductus arteriosus, patent. Heart catheterization. Prostheses and implants. Heart defects, congenital.


 

 

The percutaneous closure of a patent ductus arteriosus (PDA) represents an established alternative to surgical ligation and has been defined as the treatment of choice by most authors. To this end, several devices have been used.1-15

At the end of the 1990s, the first metal mesh prosthesis, the Amplatzer® Duct Occluder I (ADO I), capable of occluding larger diameter channels was developed as an alternative to embolisation coils.16 Universally used, it has occlusion rates of nearly 100%, with very low short- and long-term complication rates.17-20 Despite the success, new devices with different structural characteristics have been produced.

The objective of the present study was to present an initial experience with a new prosthesis, the CeraTM PDA Occluder (Lifetech Scientific Co. Ltd., Shenzhen, China), and to examine its role as another option for the occlusion of medium and large calibre PDA.

 

METHODS

Study design

This was a prospective, single-arm study performed at two centres. All patients underwent closure of PDA with the CeraTM prosthesis between March 2010 and December 2011. Characteristics of the device and the immediate results are described.

Selection criteria

All consecutive patients weighing more than 5 kg with PDA, and without any other associated defects that required surgical correction, were included in this study. Cases were chosen by transthoracic echocardiograms (TTEs) with colour flow mapping. The dimensions and morphology of the defects did not constitute exclusion criteria.

The prosthesis

The CeraTM occluder is a self-expansible prosthesis with a nitinol fragmented cone and ceramic coating. The proximal (pulmonary) extremity has a female thread, measuring 2 mm less than the distal (aortic) extremity of the cone, and connects to the delivery system. There is a retention disc in the aortic extremity that measures 4 mm more than the distal extremity (Figure 1).

 

 

The device is available in 2-mm increments from 6 mm to 24 mm in diameter (distal extremity). The central portion measures 7 mm in 6- to 14-mm prostheses, 8 mm in 16- and 18-mm prostheses, 9 mm in 20- and 22-mm prostheses, and 10 mm in 24-mm prostheses.

The delivery system is composed of a 5 F to 12 F long and flexible sheath, a small loader of compatible size, a haemostatic valve, and a distal extremity with a metallic cable with threads.

Implant technique

The implant and follow-up protocols have been previously described and are the same protocols used for the ADO I prosthesis study.20

Statistical analysis

Continuous variables were expressed as mean and standard deviation, while categorical variables were expressed as numbers and percentages. The objective of this article was to present the initial experience with the new CeraTM prosthesis for the treatment of PDA in a single-arm registry; therefore, comparisons were not made.

 

RESULTS

Eighteen patients were referred for percutaneous closure with the CeraTM prosthesis; 61.2% were female. Their ages ranged from 1 to 33 years (13.7 ± 9.3 years), and their weights ranged from 10 kg to 72 kg (42.9 ± 20.1 kg).

Two patients had recent onset of exertional dyspnoea (cases 17 and 18). Regarding the morphology, 11 channels were type A, six were type E,21 and the other was a residual channel after surgical ligation.

The smaller channel diameters, measured at the pulmonary extremity, ranged from 1 mm to 8.6 mm (4.2 ± 2.4 mm) (Table).

The systolic pulmonary pressure was higher than 30 mmHg in 50% (9/18) of patients and ranged from 18 mmHg to 45 mmHg (31 ± 7.9 mmHg).

Implantation of the device was possible in all cases. Ten 6-4 mm, one 8-6 mm, three 10-8 mm, and four 12-10 mm prostheses were used.

At the end of the procedure, two patients had minimal leakage of contrast inside the device; however, all defects were completely closed on the first control TTE, which was performed within the first week after the procedure (Figure 2). A gradient in the descending aorta or in the left branch of the pulmonary artery was not observed. In this initial series, complications were not observed.

 

DISCUSSION

The percutaneous closure of a PDA has been successfully performed through the use of several devices. The introduction of the ADO I prosthesis brought safety and ease of use, with excellent occlusion rates (99% to 100%) and a low incidence of complications (0% to 7%). This constituted an excellent alternative to percutaneous coil closure, despite the higher cost. The reported complications, in general, are minor and are usually observed in more severe patients and in patients with less body weight.22,23 There are no reports of late complications with this device.24

The Nit-Occlud® (PFM, Cologne, Germany) device was introduced as an intermediate device between the ADO I and coils. It utilises a controlled-release pre-molded coil that is shaped as an inverted double cone. It is capable of occluding intermediate size channels (< 6 mm) and costs less. With an occlusion rate of 91% to 100% and few minor complications (0% to 9%), it has been used in some centres, including in Brazil.25-28

The Amplatzer® Duct Occluder II (ADO II) was developed to occlude channels in smaller children by reducing the introducer profile. It maintained the high occlusion rate of existing devices. With two articulated disks at the extremities and a central portion, it closes channels of less than 12 mm in length and less than 5.5 mm in diameter. Occlusion rates were maintained at nearly 100%, without reports of significant complications.29-33 The report of a case in which residual flow appeared 24 hours after the successful closure of a 3 mm channel due to kinking of the left disc in the ductal ampoule should be highlighted.34

The design of the CeraTM prosthesis is very similar to that of the ADO I, but it has a more flexible nitinol mesh and a ceramic coating. This characteristic gives the CeraTM prosthesis the theoretical advantage of less nickel release on the days after the implant, although this has not been a problem reported with the ADO I.

Its great flexibility allows for the supersizing of the prosthesis according to the channel diameter without damaging neighbouring structures. Hence, the prosthesis is more stable (greater constriction in its central portion), and, as a consequence, it has a lower embolisation risk.

The long introducer allows passage through accentuated curves without kinks or breaks. Another advantage is the presence of a radiopaque mark in the distal end, which allows the surgeon to safely know the position of the long sheath during all the steps of the procedure.

 

CONCLUSIONS

In this initial experience, the CeraTM prosthesis could be used in small or large calibre channels. This device was easy to use, was extremely safe, had a low risk of morbidity, and was highly effective. The implant procedure is very similar to that of other existing nitinol mesh prostheses.

The author believe that its greater flexibility allows its diameter to be supersized more than 2 mm above the smaller channel diameter.

 

CONFLICTS OF INTEREST

Francisco Chamié is a Boynton technical consultant. The other authors declare no conflicts of interest.

 

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Correspondence to:
Francisco Chamié
Av. Borges de Medeiros, 3.501/103 - Lagoa
Rio de Janeiro, RJ, Brazil - CEP 22470-001
E-mail: fchamie@pobox.com

Received: 1/9/2012
Accepted: 3/5/2012

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