Biomedical Engineering Reference
In-Depth Information
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Implantation, Explantation,
and Replacement of Devices and Leads
If any patient meets the indication of treatment by some
implantable system, this treatment starts by implanting the
system. In the case of a secondary preventive indication,
patients who underwent an arrhythmic accident usually stay
at a hospital up to the implantation. In the case of a primary
preventive indication, patients present at a hospital on the
agreed-upon date, in accordance with a waiting list. This
chapter describes techniques for implanting leads into vari-
ous heart chambers and deals with the invasive interventions
that relate to the devices themselves.
Before implantation, all the medical devices intended for
use are packaged and ready for use in the original sterile con-
tainers. The implantation of re-sterilized medical devices is
prohibited. The sterile package consists of the external and
internal container. The outer package and sterile tray may be
opened by an authorized person only under clean conditions.
The sterile tray is opened by peeling the cover back; then
only a scrubbed, masked, and gowned person is allowed to
open the sealed inner sterile packaging using accepted asep-
tic technique to ensure sterility. The inner tray is also opened
by peeling the cover back.
During implantation, the instrumentation for heart moni-
toring, imaging (fluoroscopy), external defibrillation, and
measuring electrical parameters must be available. When
using electric instrumentation, always isolate the patient
from potentially hazardous leakage currents. Common prac-
tice indicates that sterile duplicates of all implantable items
should be available for use if accidental damage, failure, or
contamination occurs.
Furthermore, some possible reactions upon implantation
of the cardiac pacing systems are lister here (in alphabetical
order) [ 49 ] :
Air embolism
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Erosion/extrusion
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Excessive growth of fi brous tissue
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Formation of hematomas or cysts
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Chronic nerve damage
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Impossibility of therapy application
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Inappropriate or excessive sensing
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Inappropriate therapy
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Infection
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Keloid formation
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Lead abrasion
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Lead displacement or dislodgment
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Lead fracture or lead insulation break
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Deformation or breakage of the lead tip
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Local reaction of tissue
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Loose connection of the lead pin to the device
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Myocardial injury
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Myocardial irritability
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Myocardial perforation/tamponade
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Pacing threshold elevation
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Pneumothorax
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Thromboembolism
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Transvenous lead-related thrombosis
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Venous blockage
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Venous perforation/erosion
12.1
Implanting Endocardial Leads
Endocardial pacing leads might be implanted using one of
the following methods:
Via venous cutdown through the left or right cephalic vein,
•
•
Via subclavian venipuncture or via venous cutdown
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through the subclavian vein or internal jugular vein.
Only one incision is required to insert the lead through the
cephalic vein (under the clavicle). The endocardial lead is
inserted into the right or left cephalic vein in the deltopec-
toral groove. The vein pick packaged with the lead may be
used during the venous cutdown procedure to simplify the
implantation of the lead into the vein.
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Allergic reaction
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Bleeding
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Component failure
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Conducting of current or insulation of myocardium dur-
ing defibrillation by internal or external leads
Death
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