Mullins-Sheath Facilitated Delivery of Gore Cardioform ASD Occluder Devices for Closure of Large or Challenging Secundum Atrial Septal Defects.
Eilers LF, Gowda ST, Gowda S, Lahiri S, Aggarwal V, Stapleton GE, Gillespie MJ, Qureshi AM.J
Invasive Cardiol. 2021 Jun;33(6):E425-E430. Epub 2021 Apr 23.PMID: 33893794
Take Home Points:
- Gore Cardioform Atrial Septal Defect occluder is a new device which is approved by US FDA for closure of secundum atrial septal defect.
- The relatively stiff device delivery system can pose special challenges in complex anatomy (large atrial septal defect in small children especially with deficient rims).
- Use of Mullins sheath has been shown to be safe and help to favourably exaggerate the curve on the device delivery system and achieve successful device placement
Commentary from Dr. Varun Aggarwal (Minneapolis, MN, USA), editor-in-chief and section editor of Congenital Heart Disease Interventions Journal Watch:
One of the challenges in placement of any device to close the atrial septal defect is to align the device discs parallel to the plane of the atrial septum. This remains true for the most recent addition (the Gore Cardioform Atrial Septal Defect (ASD) occluder) to the tool kit on congenital and structural interventional cardiologists who perform transcatheter closure of ostium secundum ASD’s. Gore Cardioform ASD occluder was approved by US FDA in 2019 for closure of ASD varying in size from 8-35 mm in diameter. The device comes preloaded loaded on delivery cable and ready to be used after deairing and pulling inside the delivery cable (Figure 1). There is a small curve on the delivery catheter to assist with device positioning, however this may not be enough in challenging ASD’s (large defects with deficient rims). The MullinsTM sheath has a pre-shaped curve near the tip. With the advancement of catheters, wires, balloons and stents, this curve straightens out, especially if restricted within a vessel or on a reasonably straight route. According to the experience by Eilers LF et al (1), even with the introduction of the Gore Cardioform ASD Occluder delivery catheter to accentuate the curve of the Gore Cardioform ASD Occluder delivery catheter to align the device parallel to the atrial septum, the MullinsTM sheath maintains enough of a curve at its distal tip when positioned in a large chamber, such as the left atrium (Figure 1). This can be very useful to align the device discs parallel to the atrial septum to allow for capture of the rims of the ASD.
Authors describe the experience on 98 consecutive patients who underwent closure of ASD using the Gore Cardioform ASD device from June 2017 to December 2019 at Texas Children’s Hospital/Baylor College of Medicine (Houston, TX). The use of Mullins TM sheath was at the discretion of the implanting physician and not randomized in the study. Of the 98 patients, 52 patients underwent closure of the ASD using the Mullins TM sheath while the remaining 46 patients underwent attempted secundum ASD closure with the Gore Cardioform delivery catheter through a short sheath in standard fashion as described in the IFU.
Table 1 shows the baseline characteristics of the two groups and notably the group with MullinsTM sheath had larger ASD (inherent selection bias) and more patients with deficient rims. The success rate was 88% in the group with MullinsTM sheath. Three of the six patients who did not have a successful closure with the MullinsTM sheath assisted technique were referred for surgery, two had their ASD successfully closed with the Gore Cardioform ASD Occluder using a HausdorfTM sheath, and one had their ASD successfully closed with an Amplatzer Septal Occluder device (ASO) (Abbott, Abbott Park, IL). The two patients who had failed closure because to the lack of a Mullins sheath received effective surgical closure. There were 2 major adverse events (atrial fibrillation requiring cardioversion). At a median follow up of 43 (IQR 1, 374) days, no patient had more than a mild residual shunt.
We recently described the deployment procedure and techniques for challenging atrial septal defects using the new Gore Cardioform ASD occluder (2). We encourage the implanters of this device to consider use of these techniques while attempting closure of large secundum ASDs or secundum ASDs with challenging anatomy. This technique may be useful until a specific delivery sheath is designed and available for delivery of the Gore Cardioform ASD Occluder in such circumstances.
Figure 1: Device positioning and delivery using standard Gore delivery catheter and with use of Mullins
Sheath demonstrating the exaggeration of the delivery catheter angle(1).
Table I. Baseline demographics and procedural characteristics
1. Eilers LF, Gowda ST, Gowda S, Lahiri S, Aggarwal V, Stapleton GE, et al. Mullins TM sheath facilitated delivery of Gore Cardioform ASD Occluder Devices for closure of large or challenging secundum atrial septal defects. Journal of Invasive Cardiology 2021 (In Print).2021.
2. Aggarwal V, Mohan AK, Bass J, Steinberger J, Said SM, Qureshi AM. Gore Cardioform Atrial Septal Occluder: Deployment Procedure and Techniques for Closing Challenging Secundum Atrial Septal Defects. Cardiol Young. 2021:1-25.