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Table of Contents
ORIGINAL ARTICLE
Year : 2018  |  Volume : 19  |  Issue : 3  |  Page : 85-87  

Study of nickel levels in patients with atrial septal defect undergoing amplatzer device closure


1 Department of Cardiology, Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur, Tamil Nadu, India
2 Department of Pediatrics, Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur, Tamil Nadu, India
3 Department of Cardiology, Grant Medical College, Sir JJ Group of Hospitals, Mumbai, Maharashtra, India

Date of Web Publication18-Mar-2019

Correspondence Address:
Dr. Ganesh Narayana
Department of Cardiology, Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur - 621 212, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/HEARTVIEWS.HEARTVIEWS_76_17

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   Abstract 


Transcatheter closure of atrial septal defects (ASDs) using nickel titanium Naval Ordnance Laboratory (Nitinol)-containing devices (Amplatzer, AGA Medical, Golden Valley, Minnetosa) is being widely practiced. Controversies still exist regarding the release of nickel from these devices and the allergy and other ill effects of nickel and also the duration of antiplatelet therapy to aid endothelization of the device.
Objective: To study the nickel levels in patients who underwent ASD closure with platinum-coated Nitinol-containing Amplatzer septal occluder.
Methodology: A prospective study was conducted on 25 patients, between 6 years and 40 years of age who underwent ASD closure with Amplatzer septal occlude sizes ranging from 12 to 36 mm from January 2009 to January 2010. Blood nickel levels were estimated using atomic absorption photometry before and 24 h after the procedure and later at 1 month, 3 months, and 6 months postprocedure. A value of <2 mcg/dl was considered to be normal. Statistical analysis was performed by the use of the Wilcoxon test.
Results: The blood nickel levels at mean baseline, 24 h, 1 month, 3 months, and 6 months postprocedure were 1.05, 1.39, 0.98, 0.79, and 0.74 (mcg/dl), respectively.
Conclusions: Percutaneous ASD closure using Nitinol devices can be carried out safely without any significant ill effects related to nickel release.

Keywords: Defect, Device, nickel


How to cite this article:
Narayana G, Ramagopal G, Duggal B, Bansal NO. Study of nickel levels in patients with atrial septal defect undergoing amplatzer device closure. Heart Views 2018;19:85-7

How to cite this URL:
Narayana G, Ramagopal G, Duggal B, Bansal NO. Study of nickel levels in patients with atrial septal defect undergoing amplatzer device closure. Heart Views [serial online] 2018 [cited 2019 Nov 18];19:85-7. Available from: http://www.heartviews.org/text.asp?2018/19/3/85/254351




   Introduction Top


Transcatheter closure of atrial septal defects (ASDs) using nickel titanium Naval Ordnance Laboratory (Nitinol)-containing Amplatazer device is practiced worldwide. Nitinol was developed in the 1960s by the United States Navy and it is a metallic alloy that has 55% nickel and 45% titanium as its components, which contributes to its favorable physicochemical properties that include resistance to corrosion and material fatigue, thermal memory, and elasticity, allowing the passage of large devices through small catheters, in addition to its nonferrous properties, and allowing the performance of magnetic resonance imaging after device implantation.[1],[2],[3] A controversy still exists because of concerns about its biocompatibility.

Allergy after Nitinol prosthesis implantation has been rarely described. Skin rash may develop, sometimes followed by other symptoms such as dyspnea, pericarditis, chest discomfort, palpitations, and migraine with or without aura. These symptoms are seen more frequent in individuals that had a positive skin test reaction to nickel.[4],[5],[6],[7]

So, this study was undertaken to note the nickel levels, its adverse effects if any, and duration of antiplatelet therapy in patients with ASD who have undergone ASD closure with Amplatzer septal occlude sizes, before and after the procedure at different intervals.


   Methodology Top


A prospective study was conducted in the Department of Cardiology of Sir Jamsethji Jheejabhoy Hospital, from January 2009 to January 2010. All patients, aged between 6 years and 40 years of age who underwent ASD closure with Amplatzer septal occlude of sizes ranging from 12 to 36 mm from January 2009 to January 2010, were included in the study. After obtaining written informed consent from the patients, their blood nickel levels were estimated, using atomic absorption photometry before and 24 h after the procedure, and later at 1 month, 3 months and 6 months postprocedure when they came for follow-up. Antiplatelet therapy was instituted for 6 months postprocedure. A value of <2 mcg/dl was considered to be normal. Statistical analysis was performed by the use of the Wilcoxon test. The clearance of the Institutional Ethical Committee was obtained.


   Results Top


There were a total of 25 patients who were included in the study, and among them 12 were males and 13 were females. As summarized in [Table 1], the blood nickel levels at mean baseline, 24 h, 1 month, 3 months, and 6 months were 1.05, 1.39, 0.98, 0.79, and 0.74 (mcg/dl), respectively. A transient rise in nickel levels was noted in seven patients, which returned to normal levels in six patients at 3 months and in 1 patient at 6 months. No significant elevation in nickel levels was noted in the rest of the patients. None of the patients presented with nickel allergy or other complications in the 1 year follow-up. Antiplatelet therapy was administered 6 months postprocedure.
Table 1: Mean nickel levels

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   Discussion Top


In our study, a total of 25 patients were included in the study, and the blood nickel levels at mean baseline, 24 h, 1 month, 3 months, and 6, months were 1.05, 1.39, 0.98, 0.79, and 0.74 (mcg/dl), respectively. A transient rise in nickel levels was noted in seven patients, which returned to normal levels in six patients at 3 months and in one patient at 6 months. The transient rise was found mostly at 1 month postprocedure; thereafter, the values declined.

Nickel must have been released from the device, causing a systemic rise in the serum levels of nickel, during the formation of the calcium–phosphate layer on the passive oxide film of the device or until endothelialization is complete.

This was similar to a study by Ries et al. who conducted a prospective study in 67 patients with no history of nickel sensitivity, where blood samples were taken 24 h before, i.e., at baseline and 24 h, 1 month, 3 months, and 12 months after occluder implantation. Serum nickel levels were measured by atomic absorption spectrometry, and a value of <2 ng/mL of nickel was considered to be normal. A rise in mean serum levels of nickel was observed, from 0.47 ng/mL before implantation to 1.27 ng/mL (24 h after), to a maximum of 1.50 ng/mL 1 month after implantation, which was statistically significant, whereas in our study only a transient rise was found at 1 month postimplant which was statistically not significant. In this study, the nickel levels were not measured at 6 months but only at 12 months postprocedure. During follow-up, the values were found to decrease when compared to those measured before implantation, in contrast to our study where at 6 months itself we found that the values declined to the normal level.[8]

In another study conducted by Chaoren et al., the blood samples for serum nickel levels were taken from 31 patients, aged 4–59 years who underwent transcatheter closure, before and 1 day, 1 week, 1 month, and 3 months after implantation. There was no significant difference in serum nickel levels before and after implantation similar to our study where only a transient increase was found, which was not significant.[1]

Another prospective longitudinal observational study was conducted at a public hospital, and percutaneous ASD occlusion with the Cocoon device has shown that during the initial period of endothelization after the procedure there was no significant nickel release into the bloodstream in ten patients, with a mean age of 34.4 years (range 5–60 years). Serum nickel levels did not show any significant change and remained within the normal range for the population within 3 months of the procedure, which was again similar to the results of our study.[9]

In another study by Burian et al.,[10] blood and urine samples were obtained from 24 patients with ASD before occluder implantation (baseline) and during a 12-month postclosure period, with antiplatelet drugs being administered for the initial 6-month period postimplantation. The nickel content in the specimens was determined using electrothermal atomic absorption spectroscopy.

Mean baseline concentrations of nickel in serum and urine were found to be within the normal range, with values of 0.6 ± 0.2 mg/L and 3.1 ± 1.2 mg/L, respectively. During the 6-week postclosure period, the nickel levels in serum increased up to 5-fold (P < 0.01 vs. baseline), because that is the time needed for the formation of neointima on the surface of the graft. Mean concentrations in serum and urine returned to baseline levels within 4–6 months postimplantation.

This was in contrast to our study which did not show any significant difference before and after implantation, but we did not look for urinary nickel levels.

Limitations

The limitation of our study was the small sample size considered.


   Conclusions Top


Though there is a transient rise of serum nickel levels during the initial months of postimplantation, the values decline to normal by 6–12 months. Percutaneous ASD closure using Nitinol devices can be carried out safely without any significant ill effects related to nickel release, and antiplatelet therapy can be safely omitted after 6 months postprocedure.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Lertsapcharoen P, Khongphatthanayothin A, Srimahachota S, Leelanukrom R. Self-expanding platinum-coated nitinol devices for transcatheter closure of atrial septal defect: Prevention of nickel release. J Invasive Cardiol 2008;20:279-83.  Back to cited text no. 1
    
2.
Ansari HZ, Sadanandan H. Allergic reaction to percutaneously placed Amplatzer device for symptomatic patent foramen ovale. J Clin Case Rep 2013;3:324.  Back to cited text no. 2
    
3.
Kong H, Wilkinson JL, Coe JY, Gu X, Urness M, Kim TH, et al. Corrosive behaviour of Amplatzer devices in experimental and biological environments. Cardiol Young 2002;12:260-5.  Back to cited text no. 3
    
4.
Basko-Plluska JL, Thyssen JP, Schalock PC. Cutaneous and systemic hypersensitivity reactions to metallic implants. Dermatitis 2011;22:65-79.  Back to cited text no. 4
    
5.
Wertman B, Azarbal B, Riedl M, Tobis J. Adverse events associated with nickel allergy in patients undergoing percutaneous atrial septal defect or patent foramen ovale closure. J Am Coll Cardiol 2006;47:1226-7.  Back to cited text no. 5
    
6.
Belohlavek J, Belohlavkova S, Hlubocky J, Mrazek V, Linhart A, Podzimek S. Severe allergic dermatitis after closure of foramen ovale with Amplatzer occluder. Ann Thorac Surg 2013;96:e57-9.  Back to cited text no. 6
    
7.
Dasika UK, Kanter KR, Vincent R. Nickel allergy to the percutaneous patent foramen ovale occluder and subsequent systemic nickel allergy. J Thorac Cardiovasc Surg 2003;126:2112.  Back to cited text no. 7
    
8.
Ries MW, Kampmann C, Rupprecht HJ, Hintereder G, Hafner G, Meyer J. Nickel release after implantation of the Amplatzer occluder. Am Heart J 2003;145:737-41.  Back to cited text no. 8
    
9.
Badran AV, Haddad JL, Pavão RB, Novaes GC, Lago IM, Figueiredo GL, et al. Preliminary report of serum nickel concentration after atrial septal defect occlusion with the cocoon™ device. Rev Bras Cardiol Invasiva 2014;22:369-74.  Back to cited text no. 9
    
10.
Burian M, Neumann T, Weber M, Brandt R, Geisslinger G, Mitrovic V, et al. Nickel release, a possible indicator for the duration of antiplatelet treatment, from a nickel cardiac device in vivo: A study in patients with atrial septal defects implanted with an Amplatzer occluder. Int J Clin Pharmacol Ther 2006;44:107-12.  Back to cited text no. 10
    



 
 
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