Single predictor of residual right-to-left shunt to optimally select patients for suture-mediated percutaneous patent fossa ovalis closure

Abstract

Abstract Background In patients with patent fossa ovalis (PFO) and paradoxical embolism, percutaneous closure of the interatrial communication has been proven more effective than medical treatment only to reduce recurrent thromboembolic events. Percutaneous suture-mediated PFO closure has been proved to be a safe and advantageous alternative to device-based PFO closure, yet its overall success rate is slightly lower in unselected patients. Hence, it is extremely important to define baseline features associated with unsatisfactory results to appropriately select patients suitable for this technique. Purpose Systematic assessment of PFO anatomy in the largest series of consecutive patients undergoing suture-mediated percutaneous PFO closure to identify a single baseline predictor of significant residual right-to-left shunt (procedural failure) for optimal selection of patient to be submitted to this procedure. Methods Pre-procedural transesophageal echocardiogram (TEE) of 302 consecutive patients (113 men, 45±12 years) who underwent percutaneous suture-mediated PFO closure at a single institution were accurately reviewed to assess a series of parameters: presence and grade of spontaneous right-to-left shunt (RLS), PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve). Results At echocardiographic follow-up (3–6 months from the closure procedure), a residual RLS ≥2 was found in 60 (19.9%) patients. At multivariable analysis, only two anatomical variables measured at pre-procedural TEE were found as independent predictors of residual RLS ≥2 at follow-up: PFO maximum width (OR 1.89, 95% CI 1.16–3.40, p=0.019) and PFO minimum length (OR 0.58, 95% CI 0.35–0.88, p=0.018). An index based on the ratio of PFO maximum width to PFO minimum septal overlapping (W/SO) was found to be the most powerful predictor of RLS ≥2 at follow-up (OR 48.1, 95% CI 9.3–352.2, p<0.001). The ROC curve for the W/SO ratio was found to have an AUC of 0.84 (95% CI 0.75–0.93) and a cut-off value of 0.61 yielding a sensitivity of 80% and specificity of 78% with a negative predictive value of 94%. Conclusions Baseline pre-procedural TEE assessment provides essential information for the selection of patients most suitable to undergo suture-mediated PFO closure. Our results indicate that the ratio between the maximum amplitude of the PFO and the minimum overlap of the septa is the optimal single baseline index to optimally select patient for an effective percutaneous PFO closure. Funding Acknowledgement Type of funding sources: None.