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Medical Devices

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Take the Lead on Safety With Temporary Cardiac Pacing

By Diane Dwyer, BSN, RN, and Kelly Bauer, BSN, RN

(Article reprinted from Nursing2010, March issue, p.63-64.)

TEMPORARY CARDIAC PACING is indicated for emergency treatment of some bradyarrhythmias and tachyarrhythmias, and prophylactically for patients at risk for brady - arrhythmias during cardiovascular surgery.1 A variety of temporary pacing leads are available, including transvenous and epicardial leads. A temporary transvenous pacing lead may be needed by some patients while they're waiting for permanent pacemaker implantation. A temporary epicardial pacing lead is placed on the pericardium at the end of cardiac surgery. Several epicardial and transvenous lead designs are available. Some balloon temporary pacing catheters have an extra lumen for infusion, hemodynamic monitoring, or blood sampling.2

The preferred routes for emergency transvenous pacing wire insertion are the right internal jugular vein and the right subclavian vein because these routes allow for ease of manipulation.1 Regardless of the placement route or type, once a pacing lead is connected to an external pulse generator or pacemaker, the heart's electrical activity can be sensed and the myocardium paced as needed. An extension cable between the pacing lead and pacemaker is frequently used. According to the medical literature, epicardial leads are typically removed 3 to 5 days after surgery; transvenous leads should be removed as soon as possible or electively changed after 7 days. They should be changed by a new puncture and wire to limit the risk of local
and systemic infection.1

Pacing lead wire disconnections, fractures, and misconnections are only some of the problems known to be associated with temporary transvenous pacing leads. The following case examples were reported to the FDA through the Medical Device Reporting Program.

Disconnection. Hospital staff reported many inadvertent disconnections associated with a new reusable extension cable. This problem hadn't occurred with the old model. Healthcare providers used surgical tape to maintain the extension between the pacing wire and extension cable, even though this practice wasn't included in the instructions for use. In this case, no adverse outcome was reported.

Fracture. A temporary epicardial lead was removed 13 days after cardiac surgery. The manufacturer's instructions for use recommend a 7-day lead implant duration.3 Inspection of the removed lead revealed a distal tip fracture. The lead tip reportedly remained in the patient. No patient consequences were reported and no effort to remove the fragment was reported.

Misconnection. A balloon temporary pacing catheter was inserted into a patient. In the ICU, a caregiver inadvertently connected I.V. tubing to the pacing catheter's balloon inflation port. The balloon burst in the patient and some injectate from the balloon was probably released in the patient. No injury was reported.

What went wrong?

In the disconnection we discussed, the caregiver reported that the new model of cable didn't maintain its connection with the temporary pacing lead. The extension cable with the connection problem was discarded. In some patients, disconnection of pacing systems may result in a complete loss of pacing and cardiac arrest.

The case of the unretrieved device lead fragment was related to a fractured lead tip, which might have been due to prolonged use of the epicardial lead beyond the manufacturer's recommended 7-day implant duration.3

The device misconnection occurred because the caregiver lacked knowledge and education about the proper use of the balloon pacing catheter. Care providers should never attempt to use any medical equipment without the proper education.

What precautions can you take?

Become familiar with the use and proper care of temporary pacemakers, pacemaker leads, and extension cables, by taking the following steps:

  • Make sure you're familiar with your hospital's policy and procedures for temporary cardiac pacing.
  • Attend staff-development sessions and read the labeling and instructions provided with the devices.
  • Contact the device manufacturer if you have any questions about the instructions for use.

Ensure the proper connections of the entire pacing system:

  • Verify that all connections within the pacing system are secure.
  • Report all pacing equipment problems to your manager promptly. Properly identify all equipment involved including the manufacturer's name, model, and serial number. Describe the clinical circumstances that led to discovery of the problem.

Know what to do with defective devices and lead fragments:

  • Ensure that your hospital policy and procedures include patient treatment guidelines for unretrieved device fragments.4 Refer to the FDA Public Health Notification for guidelines to address unretrieved device fragments.5
  • Temporary pacing systems, leads, and lead fragments explanted for performance issues should be returned to the manufacturer for device failure analysis even if they're damaged during removal.6 If leads or lead fragments and temporary pacing system components are returned, the manufacturer can perform an evaluation to track patterns of failures and take corrective actions to address the root cause of the reported device problem.

By taking these steps and remaining vigilant, you can protect your patient from problems with temporary invasive cardiac pacing leads.

REFERENCES

  1. Chow AWC, Buxton AE. Implantable Cardiac Pacemakers and Defibrillators. All You Wanted to Know. Malden, MA: Blackwell Publishing; 2006.
  2. Bard Electrophysiology Temporary Pacing Electrode Catheter Information for Use. Lowell, MA: Bard Electrophysiology Division; 2007.
  3. Medtronic Bipolar Coaxial Model 6945: Temporary Myocardial Pacing Lead.
  4. Fischer RA. Danger: beware of unretrieved device fragments. Nursing. 2007;37(11):17.
  5. FDA Public Health Notification: unretrieved device fragments.
  6. Maisel WH, Hauser RG, Hammill SC, et al. Recommendations From the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines: Developed in Collaboration With the American College of Cardiology (ACC) and the American Heart Association (AHA). Washington, DC: Heart Rhythm Society; 2009.

Although you need to support your healthcare facility's adverse event–reporting policy, you may voluntarily report a medical device that doesn't perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax 1-800-FDA-0178) or online. Diane Dwyer, BSN, RN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Silver Spring, Md. Kelly Bauer is a nurse consultant with the Medical Device Surveillance Network (MedSun) at the FDA.