1. University of Minnesota Hospital and Clinics Minneapolis, MN presents
Kurt Amplatz MD
University of Minnesota Hospital and Clinics Minneapolis, MN
presents
Recorded at the 3rd Pediatric Interventional Cardiac Symposium, September 1999, in Chicago, Illinois.

2. Nickel toxicity: what is the issue?

3. Société Française de Cardiologie Conclusions: CardioSEAL
1. no nickel
2. less bulky
3. better endothelialization

4. CardioSEAL metal
The metal of our competitor is MP35N with a 33% nickel content!

5. Amplatzer® devices from Felix Berger MD
Fig. 1 Implanted high-profile Amplatzer devices

6. Nickel allergy
Nine percent of the population is allergic to nickel. However implantation of nickel-containing prostheses and devices virtually never causes problems.

7. Allergy and nickel-containing implants
Dear Dr. Amplatz,
Many thanks for answering about percutaneous closure of ASD with the Amplatzer device in patients with allergy to nickel. As you know, I decided to perform the procedure in this young lady that presented with a cutaneous allergic reaction to nickel: The procedure was uneventful and at one month follow-up, no shunt was detected by Echo and she is doing fine…
Eustaquio Onorato MD Clinica San Rocco Di Franciacorta SpA Ome, Italy

8. An essential element
Nickel is an essential element for nutrition. Lack of nickel results in retarded body growth, anemia, and increased neonatal mortality in experimental animals.
Inorganic elements essential for life:
Cu, Zn, Se, Mg, Mn, Ca, Fe, Mo, Ni, etc

9. Toxicity
Paracelsus (1493–1541): The factor determining whether a compound is toxic or not depends on the dose

10. Intake of nickel
Daily intake of nickel in the United States ranges from 300 to 600 micrograms per day.
Most of the ingested nickel is excreted via feces, urine, bile, and sweat.

11. Exposure to nickel Nickel-containing alloys used in:
coins (quarters, nickels, euros)
knives, forks, spoons, etc
implants: wires, clips, coils, stents, nails, cava filters, prostheses, heart valves, pacemakers, etc

12. Anodic corrosion test
Fig Nitinol wire corroded by anodic dissolution for 2 minutes at 6 mA. Pits and corrosion products are obvious.

13. Explanted orthodontal arch wires
Control
Explanted wire
Fig Nitinol arch wire explanted at 1 month shows no evidence of corrosion.

14. Implanted Amplatzer devices
Amin Z, et al. Circulation 1999;100:
Fig Amplatzer devices implanted in a dog with 2 ventricular septal defects. The second device is a "dog-bone" design that was investigated in some animals.

15. Follow-up at 1 week
Fig One week after implantation, there is complete closure of the communication.

16. Follow-up at 1, 14, and 18 months
Fig At one-month follow-up, there is no change. Inspection at 14 and 18 months (not shown) confirms the same and demonstrates no aortic or tricuspid insufficiency.

17. Cardioscopy of right disks
First device
Second device
Fig. 7 Right side of the device is completely endothelialized.

18. Cardioscopy of the left disks and valves
Fig. 8 Left side of the device shows complete endothelialization, except of the post. Cardioscopy, in other views (not shown), confirms normal aortic, mitral, and tricuspid valves.

19. Explanted Amplatzer devices
First device
Second device
Fig. 9 Amplatzer devices, explanted at 18 months and polyester fabric removed, are indistinguishable from brand-new devices. There is not a single wire broken.

20. Human experience September 1995: first implant in a patient
Masura J, et al. Cathet Cardiovasc Diagn 1997;42:
September 1995: first implant in a patient
November 1998: device is intact and shows only total heart motion

21. Nickel toxicity
Nickel toxicity occurs exclusively in nickel refineries due to inhalation of nickel carbonyl, Ni(CO)4, being part of the Mond process.

22. Explanted devices under light microscopy
Fig The explanted Amplatzer devices under light microscopy reveal a perfectly shiny surface with no evidence of pitting.

23. Explanted devices under scanning electromicroscopy
End disk
Disk with female screw
Fig Scanning electromicroscopy again reveals no corrosion of the explanted devices.

24. Explanted devices at x3000 magnification
Control
Explanted wire
Fig At x3000 magnification, the explanted Amplatzer devices still show no corrosion. At this magnification, 1 mm would measure 3 m!

25. Nickel corrosion in a biologic environment
A corrosion of 10% would produce a huge crater at 3000 times magnification and the daily dose of nickel would have been 15.4 micrograms, 33 times less than the daily intake.

26. Conclusion
Edie JW, et al. Angle Orthod 1981;51,4:319-24
“In conclusion, the results reported here suggest that there is no reason to believe that Nitinol wires are any more subject to corrosion than stainless steel wires in an environment that is typical of clinical service.”
Edie JW, et al (1981)