Kurt Amplatz MD

1

• 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
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Nickel allergy

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

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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 MDClinica San Rocco Di
Franciacorta SpAOme, 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 (14931541) 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. 2 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. 3 Nitinol arch wire explanted at 1 month
shows no evidence of corrosion.
14
Implanted Amplatzer devices
Amin Z, et al. Circulation 1999100320-328
Fig. 4 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. 5 One week after implantation, there is
complete closure of the communication.
16
Follow-up at 1, 14, and 18 months
Fig. 6 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
Masura J, et al. Cathet Cardiovasc Diagn
199742388-393

• 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. 10 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. 11 Scanning electromicroscopy again
reveals no corrosion of the explanted devices.
24
Explanted devices at x3000 magnification
Control
Explanted wire
Fig. 12 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.

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Conclusion
Edie JW, et al. Angle Orthod 198151,4319-24

• 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)