Does Dural Substitute Confetti Technique Optimize Implantation of SCS Systems?

In screening trials used to assess patients’ response to spinal cord stimulation (SCS), researchers found that use of the Dural Substitute Confetti technique, first introduced in 2017, may prevent scar adhesions from forming, thereby optimizing the transition to permanent implantation of the complete SCS system, according to study results published in Pain Practice.

Over the last 2 decades, SCS has become an established technique to control chronic neuropathic pain via neuromodulation. Before implantation of a complete SCS system, however, clinicians often conduct screening trials lasting days or weeks to determine individual patient response to, and candidacy for, this mode of pain control. Most SCS-related trials require placement of temporary connections from the internal leads to an external pulse generator through a percutaneous extensor.

Given the continued and growing use of SCS for management of neuropathic pain, it has become increasingly important to understand and avoid complications associated with both the temporary trial and permanent implantation phases of SCS that can affect the safety and success of SCS procedures. Such complications include infections and fibrosis or scarring that can displace and damage the device’s leads, electrodes, or extension cables.

Although considerable attention has been focused on understanding complications typically related to permanent implantation of SCS devices, there is a paucity of research focused on complications arising during the temporary trial implantation phase.

To evaluate SCS implantation complications arising from the technique, investigators conducted a retrospective analysis of results of SCS implantations that employed the Dural Substitute Confetti technique to prevent scar-induced lead migration or breakage and to reduce the length of the implantation procedure.

Included in the analysis were results of SCS in a total of 174 patients treated at the investigators’ center in Italy from 2017 to 2022. In their review, the investigators compared the rate and type of SCS complications and the duration of SCS surgery during the 3 years before introduction of Dural Substitute Confetti (ie, 2015 through 2017) vs results during the years after 2017.

In the evaluated cohort, mean patient age was 48 years and 52.9% of patients were women. Medical indications for a trial of SCS included persistent spinal pain syndrome type 2 in 69.1% of patients, complex regional pain syndrome in 14.4% of patients, and peripheral neuropathy in 16.5%. The SCS trial lasted 20 to 28 days (mean, 21.4 days) and was considered successful if the patient reported neuropathic pain reduction of 50% or greater.

After the temporary trial of SCS ended, 85.1% of all patients experienced a greater than 50% reduction in pain, which resulted in the permanent implantation of a complete SCS system. The mean follow-up period was 52 (range, 15 to 84) months.

During initial surgery to evaluate a patient’s response to SCS, implantation surgeons used synthetic dural substitutes to protect the leads, which remained attached to an external pulse generator for a mean of 21.4 (range, 20 to 28) days. During the second surgery for permanent implantation of the device, clinicians were able to easily dissect the leads from the dural substitute via the Dural Substitute Confetti technique, then connect them to an internal pulse generator.

After the introduction of Dural Substitute Confetti in 2017, no technique-related complications occurred during the temporary trial implantation period of SCS, and the average duration of trial surgery decreased by 40.7%, from 54 minutes to 32 minutes. Medical complications included infections in 2.1% of patients and wound dehiscence in 1.3%.

In contrast, before 2017 a 3.9% rate of lead migration was found in patients treated with SCS. The lead migration resulted from scarring and required reimplantation of the device.

Limitations of this retrospective analysis included the fact that the mean duration of SCS surgery is not often reported in the literature; thus, it is challenging to evaluate potential operating time reduction associated with the Dural Substitute Confetti technique in this study vs similar published studies. Additionally, comparison of data on complications was made difficult by the investigators’ short trial duration vs SCS trial period durations in European centers (ranging from 10 to 28 days) and the United States (typically less than 1 week). Notably, use of the Dural Substitute Confetti technique may be more appropriate for trial periods longer than 10 days, which allow sufficient time for scar tissue formation that would affect permanent surgical implantation of the complete SCS system.

Determination of whether the Dural Substitute Confetti technique has broader applicability will require studies conducted at multiple medical centers and in diverse patient populations, the researchers emphasized.

They concluded, “The implementation of the Dural Substitute Confetti technique offers significant advantages in mitigating complications and optimizing the implantation process for the definitive SCS system.” They added, “By preventing the formation of scar adhesions, this technique streamlines the transition to the complete system, enhancing efficiency and patient outcomes. Moreover, the reduced risk of lead migration and iatrogenic damage during SCS trials contributes to a substantial decrease in technique-related complications. While further clinical studies and validation are warranted to establish the efficacy and safety profile of this innovative technique, its introduction represents a step forward in addressing critical challenges associated with SCS.”

This article originally appeared on Clinical Pain Advisor