Impact of patent foramen ovale on transvenous lead extraction characteristics and outcomes.

BACKGROUND

Transvenous lead extraction (TLE) may be indicated for cardiac implantable electronic device infection, malfunction, or upgrade. TLE can increase right heart pressures and mobilize debris, resulting in a right-to-left embolism and stroke via a patent foramen ovale (PFO).

OBJECTIVE

This study aimed to identify the prevalence of PFO in patients undergoing TLE and compare the incidence of adverse events.

METHODS

Intraoperative transesophageal echocardiogram is routinely performed during TLE at the University of California, San Diego, to identify PFO. Between June 2020 and October 2025, 283 patients underwent 289 lead extraction procedures and had intraoperative transesophageal echocardiogram reports available. Patients were compared by PFO status.

RESULTS

Of 283 patients, the mean age was 64.98 years (standard deviation ± 15.17); 65.74% were male. PFO was detected in 37 patients (12.80%) but was not associated with different baseline characteristics. Overall, the mean lead count was 2.14 ± 0.51, dwell time was 4.91 ± 4.25 years, and procedural success was 90.66% (odds ratio [OR] 0.43; 95% confidence interval 0.16-1.19; P = .106). The most common extraction indications were malfunction (45.67%) and infection (30.45%). Primary endpoints were in-hospital stroke (1 of 37 [2.7%] in PFO cohort vs 1 of 252 [0.40%]; OR 3.81; 95% confidence interval 0.18-79.38; P = .388), myocardial infarction (none in either cohort), and all-cause mortality (2 of 37 [5.41%] in PFO cohort vs 0 of 252 [0%] in no PFO cohort; Fisher's exact test P = .016; unable to calculate OR with multivariate regression). Of these 2 deaths in the PFO cohort, 1 was caused by stroke-related complications and the other by sepsis.

CONCLUSION

Stroke incidence was not significantly different by PFO status, but mortality was significantly higher in those with PFO.