To evaluate the efficacy, safety, and prognostic regression of occlusion therapy for patent foramen ovale (PFO).

PFO patients who underwent interventional closure treatment in the Department of Cardiology, Xiangyang Central Hospital from July 2018 to September 2022 were included. Preoperative evaluations included transthoracic echocardiography (TTE), contrast transthoracic echocaidiography of right heart (cTTErr), transesophageal echocardiography (TEE), and transcranial Doppler ultrasound bubble test (c-TCD). Follow-up evaluations were conducted at 1, 3, 6, and 12 months postoperatively using TTE, with additional c-TCD if necessary. Migraine patients recorded headache symptoms and the Headache Impact Test-6 scores before surgery and at 1, 3, 6, and 12 months after surgery.

A total of 783 PFO patients with age of (55.5±21.3) years, and 30.0% (235/783) male were involved. Seven hundred and twenty patients were successfully occluded with a success rate of 92.0% (720/783). Of these, 608 (77.7%, 608/783) patients were passed through the PFO using the conventional approach, and 112 (14.3%, 112/783) using the SWARTZ sheath. Intraoperative cardiac perforation occurred in 8 (1.0%, 8/783) patients, acute pericardiocentesis in 2 patients, and a small amount of pericardial effusion was left untreated in 6 patients. Postoperatively, 3 patients coughed up blood, including 1 case with a large amount of blood and the other 2 patients with a small amount of blood, all of which improved after 2 days. Postoperative follow-up was (33.8±3.6) months. During the follow-up, 633 (77.7%, 633/783) patients were found to have reached the cure standard, 14 (1.8%, 14/783) significantly relieved, and 32 (4.1%, 32/783) ineffective, with an overall effective rate of 89.9% (647/783). Among them, 18 (4.1%, 18/439) patients with migraine were ineffective, 4 (4.8%, 4/83) with syncope were ineffective, and 10 (9.4%, 10/106) with nonspecific symptoms were ineffective. There were no complications such as blocker dislodgement, severe arrhythmia, femoral arteriovenous fistula, etc. during the perioperative period and up to 5-year follow-up. Forty eight patients had no relief or partial relief of their original symptoms after 6 months of follow-up. Their cTTErr was reviewed, and they still had residual right to left shunt. Tracing the patients' preoperative TTE or TEE suggested that the patients had thin peripheral margins of the foramen ovale (peripheral periphery of the foramen ovale was not visualized in the subxiphoid biatrial view) or combined with atrial septal aneurysm.

Patients with PFO undergoing occlusion therapy have fewer serious complications and a high rate of surgical success. Standardized preoperative evaluation is of utmost importance to improve the degree of symptomatic improvement and reduce complications in patients. There is a need to develop new types of patent foramen ovale occluders to improve the effectiveness of occlusion.