Impact of party balloon inflation manoeuvre during saline contrast transthoracic echocardiography for patent foramen ovale detection: INFLATE-PFO registry
AimsParadoxical embolism from a patent foramen ovale (PFO) can cause cryptogenic stroke. Agitated saline contrast transthoracic echocardiography (ASC-TTE), with the Valsalva manoeuvre (VM), is crucial for diagnosing PFO. However, the VM is associated with false-negative outcomes. The party balloon inflation manoeuvre (PBIM) provides improved visualisation of provocation; however, its real-world efficacy remains uncertain. This study aimed to demonstrate the superiority of the PBIM over standard provocative methods (conventional or abdominal compression VM) during ASC-TTE.Methods and resultsThis multicentre retrospective observational registry study involved 117 consecutive patients (62.3% male; mean age, 56.2 ± 13.8 years) with PFO detected by transoesophageal echocardiography. During ASC-TTE, patients underwent PBIM and standard provocative methods. The primary endpoint was a five-point microbubble grading [representing a right-to-left (RL) shunt] change. Diagnostic performance of a significant RL shunt defined as Grade ≥2 in the five-point microbubble grading was assessed using McNemar’s test. Compared with standard provocative methods using Wilcoxon paired analysis, the PBIM resulted in microbubble upgrading in 51 patients, no change in 54, and downgrading in 12. The PBIM had a significantly higher microbubble grade than standard provocative methods [median, 3.0; interquartile range (IQR), 3.0–4.0 vs. 3.0; IQR, 1.7–4.0; P < 0.001]. For significant RL shunts, where transcatheter PFO closure would be clinically advised, PBIM improved diagnostic performance from 75.2% to 91.5% (P < 0.001).ConclusionPBIM indicated transcatheter PFO closure in patients with cryptogenic stroke and suspected PFOs, particularly those with false-negative diagnoses for shunts. PBIM demonstrates greater efficacy than standard provocative methods during ASC-TTE, providing clinical practicality.Clinical Trial RegistrationuMIN Clinical Trials Registry UMIN000051954 (https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058907).
Read more