The First Enrollment of the HaloStitch® Transseptal Closure System Under Zero Radiation Pure Ultrasound Guidance in China

On June 18th, Professor Pan Xiangbin's team from Shenzhen Hospital, affiliated with Fuwai Hospital of the Chinese Academy of Sciences, successfully applied the HaloStitch® transseptal closure system under zero radiation pure ultrasound guidance to treat Patent Foramen Ovale (PFO). This milestone not only marks the first enrollment in clinical trials using the HaloStitch® system for PFO closure, but also signifies a significant advancement in the treatment of PFO-related conditions such as stroke or transient ischemic attacks (TIAs).

Compared to traditional surgical methods, the HaloStitch® transseptal closure system offers smaller surgical trauma and shorter recovery times, significantly reducing patient discomfort. Unlike existing occluders, the HaloStitch® system avoids nickel ion release, allergenic reactions, abrasion of cardiac tissues, postoperative atrial fibrillation, atrial perforation risks, MRI contraindications, and the need for long-term anticoagulation. Moreover, it preserves the possibility of future transseptal approaches for atrial septal interventions.

 

The 29-year-old male patient suffered from chronic headaches for over a decade due to PFO. He experienced dizziness, blurry vision, and occasional transient ischemic attacks during physical activity, which greatly impacted his quality of life despite temporary relief with rest. Recently, the patient exhibited signs of a transient ischemic attack, a warning sign of stroke, necessitating surgical intervention.

 

Professor Pan Xiangbin's team utilized the HaloStitch® system to perform PFO closure for the patient, reducing the potential risks associated with foreign body implants and providing a safer and more effective treatment option.

 

Preoperative Imaging

 

 

Postoperative Imaging