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Iatrogenic Atrial Septal Defect Closure With PASCAL Guide System Post-Mitral Valve Transcatheter Edge-to-Edge Repair

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J INVASIVE CARDIOL 2025. doi:10.25270/jic/25.00031. Epub February 21, 2025.


The PASCAL System (Edwards Lifesciences) was approved by the Food and Drug Administration in 2022 as a transcatheter edge-to-edge repair (TEER) device for treating degenerative mitral regurgitation (MR).1 After transeptal puncture, the PASCAL system includes a 22-French (Fr) guiding sheath that is introduced into the left atrium, which may result in a subsequent iatrogenic atrial septal defect (iASD). Most iASDs exhibit left-to-right shunting; however, right-to-left shunting or bidirectional shunting usually necessitates closure of the iASD. In this case, we demonstrate how to use the PASCAL guide to assist in iASD closure.

An 87-year-old woman, with a history of percutaneous endoscopic gastrostomy tube feeding, presented with severe MR. Her echocardiogram revealed a left ventricular ejection fraction of 55%, reduced right ventricular function, a pulmonary artery systolic pressure of 88 mm Hg, and Barlow features in the context of mitral annular calcification. She successfully underwent intracardiac echocardiography-guided mitral valve TEER using 1 PASCAL P10 and 2 PASCAL Ace devices.

Post-procedure, a 1.2-cm iASD with a bidirectional shunt and oxygen desaturation was identified. Urgent closure was performed using a 22-mm Amplatz ASD occluder (Abbott). The PASCAL guiding sheath was re-crossed to the left atrium using a dilator over an Amplatz Super Stiff wire (Boston Scientific). After removing the dilator and wire, a 9-Fr femoral sheath was advanced into the guiding sheath to pass its sealing valve. The 22-mm Amplatz ASD device was then loaded into the 9-Fr sheath and advanced; the loader was subsequently removed.

The left disc of the device was exposed in the left atrium. The entire system was retracted, and the PASCAL guide was maneuvered from the left to right atrium, followed by advancement of the ASD cable to “sandwich” the iASD. This technique minimizes sheath exchanges, reduces procedural time and bleeding, and is easily replicable.

In cases requiring emergent closure of an iASD, the PASCAL guide system can facilitate the procedure, offering a valuable alternative to conventional methods.

Figure
Figure. (A) Transesophageal echocardiogram image demonstrating the bi-directional shunt. (B) Step-by-step guide for the closure of an interatrial ASD using the PASCAL guide. The left atrial disc is exposed in the left atrium after unsheathing the PASCAL guide. The entire system is then slowly retracted. Upon contacting the septum, the 'left-to-right' technique is employed to bring the PASCAL guide back into the right atrium. Finally, the cable wire is pushed to deploy the right atrial disc of the ASD occluder device, effectively 'sandwiching' the septum. (C) The 9-Fr sheath is advanced inside the PASCAL guide, with the atrial septal defect device loaded inside the 9-Fr sheath. The loader can be removed afterward. ASD = atrial septal defect.

 

Affiliations and Disclosures

Leo Kar Lok Lai, MD; Hussayn Alrayes, DO; Georgi Fram, MD; James C. Lee, MD; Bryan Zweig, MD; Brian P. O’Neill, MD; Tiberio M. Frisoli, MD; Pedro Engel Gonzalez, MD; William W. O´Neill, MD; Pedro A. Villablanca, MD

From the Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan.

Disclosures: Dr Lee is a consultant for Edwards Lifesciences and a proctor for Abbott. Dr O’Neill is a consultant to and receives research support from Edwards Lifesciences. Dr Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Villablanca is a consultant for Edwards Lifesciences, Medtronic, Shockwave, Abiomed, and Angiodynamics. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Consent statement: The authors confirm that informed consent was obtained from the patient(s) for the intervention(s) described in the manuscript and for the publication thereof.

Address for correspondence: Leo Kar-lok Lai, MD, Center for Structural Heart Disease, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA. Email: l.k.l.lai816@outlook.com

 

Reference

1. PASCAL Precision Transcatheter Valve Repair System. US Food and Drug Administration; 2022. Accessed February 20, 2025. https://www.fda.gov/medical-devices/recently-approved-devices/pascal-precision-transcatheter-valve-repair-system