Are your patients who are undergoing coronary stent placement at risk for an unintended retained foreign object?
Situation: An attempt is made to deploy a stent in a coronary artery. However, after several unsuccessful attempts to cross a moderate distal lesion, the stent deployment catheter is withdrawn, and the physician decides to treat the patient medically rather than making another attempt to stent the lesion. Several days later, the patient returns to the hospital complaining of chest pain and is taken back to the cath lab. Under fluoroscopy, it appears that a stent is “free-floating” in one of the coronary arteries. The free-floating stent is successfully crushed against the wall of the artery by deployment of another stent. The patient’s recovery goes well.
Stent detachment is a rare occurrence, but it has a definite impact on patients, and the outcomes are not always as positive as described in the scenario above.
When stents were first introduced into the market, it was not uncommon for them to easily detach from the deployment catheter. Cath lab staff members were diligent in their efforts to make sure the stent was still attached to the deployment system when a stent was unable to be deployed. Over the past decade, improvements in the manufacturing of stent deployment systems have reduced the likelihood of stents coming off of the deployment catheter. As a result, cath lab staff members may no longer be as diligent in verifying that an unsuccessfully deployed stent is still attached to the deployment catheter.
And often, a decrease in diligence results in an increase in risk.
How can you prevent this risk to the patient?
- Actively evaluate your current practices by talking with staff, observing the process, and reviewing documentation. We recently conducted a telephone survey of several cath lab managers to discuss what processes were in place to prevent an unintended retained stent. Our study revealed that although a process “should be in place” and “this used to be a part of our practice,” none confirmed that a formal (structured, documented, and approved) process was currently in place. Only one manager acknowledged that he was grateful that the question had been asked, because his lab did not have a process in place. He acknowledged that “this situation could have very easily happened” in his lab.
- If no process is in place, develop and implement one. Provide information to your cath lab staff members and cardiologists, emphasizing patient safety. Develop a standardized process for each time a stent is unable to be deployed. This process should include a visual inspection of the unsuccessfully deployed stent system by the interventional cardiologist and/or CV scrub to make sure the stent was removed. The staff member recording the case should document verification that the stent deployment system was removed intact. Standard language such as “stent deployment system removed with catheter and stent intact” can easily be added as a choice to the drop-down menus of most cath lab documentation systems.
- Monitor the new process for compliance. Changing behaviors can be difficult, and early in the implementation of a new process, staff members may need reminders. Initially, frequent monitoring should occur. Once 100% compliance with the new process is achieved, random monitoring should be instituted. Without ongoing monitoring, old habits are likely to creep back in to practice.
- Provide periodic reminders during staff meetings for this and other low-frequency safety issues.
Most importantly, appreciate that you are preparing to prevent a rare occurrence. To be successful, you must develop a mindset among the staff to be ever vigilant and to prioritize safety over convenience. Risky practices come into use because they are convenient for the worker; however, the risk is borne by the patient. Staff members must develop a patient safety attitude built on placing a higher value on the patient’s safety than on their own preferences.
Low frequency occurrences can still happen. One of management’s most difficult tasks is to maintain readiness to prevent adverse occurrences that are allegedly “too rare to worry about.”
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