Tearaway Introducer Benefits for CRM and Pacing Lead Placement Applications
Tearaway introducers have been used over many years to enhance a wide range of minimally invasive medical procedures. Over this time, considerable advances have been made in the design of tearaway introducers to improve patient outcomes, make procedures easier and more effective, and reduce risks.
As a result, tearaway introducers offer a range of benefits in CRM and pacing lead placement applications.
A Brief History of Tearaway Introducers in Pacing Lead Applications
The Early Days
For pacing leads to be properly placed, physicians require access to the heart. When CRM and pacemaker solutions were first introduced, this meant opening up the patient, inserting the device, and closing the patient up again in what was a highly invasive and risky procedure.
Minimally invasive methods of pacing lead placement were then introduced, and they were transformational. In these procedures, a dilator is first inserted into the patient to enlarge the tissue opening. The dilator is then removed, and the pacing leads are inserted through the opening.
While better than opening a patient up, this method of pacing lead placement still causes trauma and bleeding. The opening made by the dilator can also close again, plus delicate pacing leads can be damaged during insertion.
The commonly applied solution to these problems was to surround the dilator with an introducer sheath as it is inserted into the body. The dilator is then removed, with the introducer sheath maintaining the tissue opening while also protecting the leads as the physician places them within the heart.
However, using introducer sheaths in this way presented additional problems. Specifically, the internal diameter of the sheath must be at least as large as the largest part of the device. This is because the introducer sheath must pass over the device to remove it from the body after the placement of the pacing leads. This reality meant introducer sheaths needed to have quite large diameters.
Tearaway introducers are a more effective solution. With a tearaway introducer, the dilator and guidewire can be removed with the introducer sheath remaining in the body, creating a conduit for pacing lead placement. Once the lead is in place, the introducer sheath is then removed by tearing it along its perforated longitudinal length.
As removal takes place by peeling the sheath away, the sheath can be as small as the part of the device that is inside the patient’s body. In pacing lead placement applications, this means the introducer sheath can be minimized to be as small as possible, improving procedural success, reducing risks, and minimizing trauma.
Benefits of Using Tearaway Introducers for Pacing Lead Placement
- During the lead placement procedure, the tearaway introducer sheath prevents the pacing lead from interacting with the heart until the lead has been placed
- The introducer sheath can be removed without displacing the pacing lead
- Tearaway introducer sheaths are easy to use as the sheath can be removed from the patient’s body by one person
- Tearaway introducer sheaths reduce the risks that surround dilator-only systems
- They help to minimize tissue damage and trauma
- They also reduce the risk of clotting, infection, and air embolisms
- Tearaway introducers are suitable for permanent and temporary pacemaker leads
Choosing the Right Tearaway Introducer for Your Pacing Lead Placement Requirements
While tearaway introducers are the most effective method of performing pacing lead placement procedures, not all devices are the same as there are challenges in achieving an optimal design. Those challenges include kinking and poor torque transfer, largely due to the perforations that enable the tearaway functionality.
Other challenges include the dilator loosening or slipping from the sheath while it is being advanced in the patient’s body, as well as ensuring a smooth transition between the sheath and the dilator.
At Galt, we have designed our tearaway introducers to not only be suitable for CRM and pacing lead placement applications, but to also overcome the above challenges. Contact us today to find out more about our industry-leading tearaway introducers.