Background:
The Percutaneous closure of patent foramen ovale (PFO) is usually performed under continuous TTE guidance. TEE-guided interventions have the impact of the necessity for continuous sedation and potential injury oft he esophagus. We assessed the safety and efficacy of PFO closure by flouroscopy guidance only.
Purpose:
The aim of our study was to compare PFO closure performed under continuous transesophageal echocardiography (TEE) guidance with only flouroscopy guided PFO closure in terms of interventional duration, peri- and post-interventional complications respectively reflection on the primary and secondary points.
Methods:
At our hospital, from April 2021 to July 2025, 115 pts after paradoxical embolism (post-PE) with a PFO underwent flouroscopy-guiden PFO-closure. Prior to April 2021 respectively between 2005 and 2021 PFO-closure was performed with continuous TEE guidance. We analyzed procedural aspects, as well as intermediate-,long- term clinical and echocadiographic outcomes.
Results:
The study included a in total of 182 pts, composed of 71 women (39,0%) and 111 (61,0%) men with a mean age of 56.0 years. The pts divided into two groups: 65 pts in the TEE-guided group and 117 pts in the flouroscopy-guided group.
The occluder was technically successful implanted in 63 out of 65 (96,9%) pts in the TEE-guided group. The mean intervention time was significantly longer in the TEE-guided group 43.5 (36.0 – 53.3) vs. 26 (18 – 39) min. (median/IQR) p<0.001; Mean Area dose product was 1354 (942 – 1931) vs. 746 (427 – 1480)
p<0.001 significantly higher in the flouroscopy group. Amount of contrast agent was also higher in the flouroscopy group 100 (82.5 – 120) vs. 20 (10.0 – 35.0) ml (median/IQR) p<0.001. The mean flouroscopy time was shorter 4 (3.1 -¬ 5.4) vs. 5.68 (4.4 – 7.6) p<0.005 in the fluoroscopy group.
After six months, complete PFO-occlusion without residual shunt by contrast-TEE was achieved 61/65 patients (93,8%) in the TEE-group, a small shunt grade I was detected in two pts (3.1%) whereas shunt grade 3 was detected in two of the patients (3.1%).A revision was carried out in both cases. The shunts were reduced to grade I respect. to no shunt evidence. 3 (4.6%) of the 65 patients have had another stroke. No patients experienced a recurrence of peripheral embolism. Two implantations were found to be unsuccessful both with device embolization (3.15%).
The occluder was technically successful implanted in 114 out of 115 (99.1%) pts. in the flouroscopy group. After six months, complete PFO-occlusion without residual shunt by contrast-TEE was achieved 96/101 patients (95%), a small shunt grade I/II was detected in three pts, whereas shunt grade 3 was detected in two of the patients
There was no difference in the composite endpoint of stroke-reccurence, residual shunt or death. None of the pts experienced thrombus formation on the device after 6 weeks or 6 months respectively in the both groups.
Conclusion:
Transcatheter PFO-closure using double-disc-occluder under floeroscopic guidance only is non-inferior to TEE-guided PFO-closure and extremely simplifies the procedure.
