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ObjectivePreclinical research suggests that the combined use of radiofrequency ablation and balloon dilation (CURB) could create stable interatrial communications without device implantation. This study examined the first in-human use of CURB for modified atrial septostomy in patients with severe pulmonary arterial hypertension (PAH).MethodsBetween July 2018 and October 2021, CURB was performed in 19 patients with severe PAH (age: 31.5±9.1 years; mean pulmonary artery pressure: 73 mm Hg (IQR: 66–92); pulmonary vascular resistance: 18.7 Wood units (IQR: 17.8–23.3)). Under guidance of intracardiac echocardiography and three-dimensional location system, (1) fossae ovalis was reconstructed and ablated point-by-point with radiofrequency; (2) then graded balloon dilation was performed after transseptal puncture and the optimal size was determined according to the level of arterial oxygen saturation (SatO2); (3) radiofrequency ablation was repeated around the rims of the created fenestration. The interatrial fenestrations were followed-up serially.ResultsAfter CURB, the immediate fenestration size was 4.4 mm (IQR: 4.1–5.1) with intracardiac echocardiography, systolic aortic pressure increased by 10.2±6.9 mm Hg, cardiac index increased by 0.7±0.3 L/min/m2and room-air resting SatO2 decreased by 6.2±1.9% (pConclusionThe interatrial communications created with CURB in patients with severe PAH were stable and the mid-term outcomes were satisfactory.Trial registration numberNCT03554330.

Background: High-resolution optical coherence tomography can detect in situ thrombi within patent foramen ovale (PFO), which can become a dangerous embolic source. This study aimed to investigate the frequency and size of in situ thrombus within PFO using optical coherence tomography. Methods: The cross-sectional study was conducted at Fuwai Hospital (Beijing, China) between 2020 and 2021. From 528 consecutive patients with PFO, 117 (age, 34.33 [SD, 11.30] years) without known vascular risk factors were included; according to PFO-related symptoms, they were divided into the stroke (n=43, including 5 patients with transient ischemic attack), migraine (n=49) and asymptomatic (n=25) groups. Optical coherence tomography was used to evaluate in situ thrombi and abnormal endocardium within PFO. Univariable analysis and a logistic model were used to evaluate the association between stroke and in situ thrombus; age, sex, body mass index, and antithrombotic therapy were included as covariates. Results: Antithrombotic therapy was used more frequently in the stroke group than in the migraine group (76.7% versus 12.2%; P P P =0.199), maximum thrombus diameter (0.35 [0.20–0.46] versus 0.21 [0–0.68] mm; P =0.597), or total thrombus volume (0.02 [0.01–0.05] versus 0.01 [0–0.05] mm 3 ; P =0.386). Additionally, in situ thrombus was significantly associated with stroke risk (odds ratio, 4.59 [95% CI, 1.26–16.69]). Abnormal endocardium within PFO occurred in patients with in situ thrombi (71.9%) but not in those without. During optical coherence tomography examination, migraine occurred in 2 patients with in situ thrombi. Conclusions: The frequency of in situ thrombus was extremely high in stroke and migraine groups, while none of the asymptomatic individuals presented with an in situ thrombus. In situ thrombus formation may play a role in patients with PFO-associated stroke or migraines and have therapeutic implications. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04686253.