Key result
Fluoroscopy-guided PFO closure shows similar safety and ~48% shorter procedure times vs continuous TEE.
Why the study?
Percutaneous PFO closure is conventionally performed under continuous TEE guidance, but whether a simplified fluoroscopy-guided approach with final TEE control and targeted next-day discharge offers comparable outcomes was unknown.
Does pure fluoroscopy-guided PFO closure with final TEE control reduce procedure time and hospital stay compared to continuous TEE-guided closure in patients undergoing PFO closure?
Cohort (n=291)
No
Does pure fluoroscopy-guided PFO closure with final TEE control reduce procedure time and hospital stay compared to continuous TEE-guided closure in patients undergoing PFO closure?
Absolute Event Rate: 0% vs 0.5%
p-value: p=0.99
A simplified fluoroscopy-guided PFO closure approach with a final TEE check significantly reduces procedure time and hospital stay without increasing procedural complications compared to continuous TEE guidance.
Fluoroscopy-guided PFO closure was associated with shorter times and similar safety in registry data; leaves open whether randomized trials will confirm noninferiority to TEE guidance.
BACKGROUND: Percutaneous closure of patent foramen ovale (PFO) is conventionally performed under continuous transesophageal echocardiographic (TEE) guidance. We aimed to evaluate whether a simplified procedural approach, including pure fluoroscopy-guidance and final TEE control, as well as an aimed 'next-day-discharge' is comparable with the conventional TEE-guided procedure in terms of periprocedural and intermediate-term outcomes. METHODS: All patients who underwent a PFO closure at our center between 2010 and 2022 were retrospectively included. Prior to June 2019 cases were performed with continuous TEE guidance (TEE-guided group). Since June 2019, only pure fluoroscopy-guided PFO closures have been performed with TEE insertion and control just prior to device release (fluoroscopy-guided group). We analyzed procedural aspects, as well as long term clinical and echocardiographic outcomes. RESULTS: In total 291 patients were included in the analysis: 197 in the TEE-guided group and 94 in the fluoroscopy-guided group. Fluoroscopy-guided procedures were markedly shorter (48 ± 20 min vs. 25 ± 9 min; p < .01). There was no difference in procedural complications, including death, major bleeding, device dislodgement, stroke or clinically relevant peripheral embolization between the two groups (.5% vs. 0%; p = .99). Hospital stay was also shorter with the simplified approach (2.5 ± 1.6 vs. 3.5 ± 1.2 days; p < .01), allowing 85% same-day discharges during the last 12 months of observation period. At 6 ± 3 months echocardiographic follow-up a residual leakage was described in 8% of the TEE-guided cases and 2% of the fluoroscopy-guided cases (p = .08). CONCLUSION: While a complete TEE-free PFO closure might have potential procedural risks, our approach of pure fluoroscopy-guided with a brisk final TEE check seems to be advantageous in terms of procedural aspects with no sign of any acute or intermediate-term hazard and it could offer an equitable compromise between the two worlds: a complete TEE procedure and a procedure without any TEE.
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Achim et al. (2023) conducted a cohort in Patent foramen ovale (n=291). Fluoroscopy-guided PFO closure with final TEE control vs. Continuous TEE-guided PFO closure was evaluated on Procedural complications (death, major bleeding, device dislodgement, stroke or peripheral embolization) (p=0.99). Fluoroscopy-guided PFO closure with final TEE control had similar procedural complications (0% vs 0.5%; p=0.99) and shorter procedural times (25 vs 48 min; p<0.01) compared to continuous TEE guidance.
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