{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Yan C"],"funding":["Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences","National Natural Science Foundation of China"],"pagination":["1690-1698"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9606506"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["108(21)"],"pubmed_abstract":["<h4>Objective</h4>Preclinical 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).<h4>Methods</h4>Between 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 (SatO<sub>2</sub>); (3) radiofrequency ablation was repeated around the rims of the created fenestration. The interatrial fenestrations were followed-up serially.<h4>Results</h4>After 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/m<sup>2</sup> and room-air resting SatO2 decreased by 6.2±1.9% (p<0.001). One patient experienced increased pericardiac effusion postoperatively; the others had no complications. On follow-up (median: 15.5 months), all interatrial communications were patent with stable size (intraclass correlation coefficient=0.96, 95%CI:0.89 to 0.99). The WHO functional class increased by 1 (IQR: 1-2) (p<0.001) with improvement of exercise capacity (+159.5 m, P<0.001).<h4>Conclusion</h4>The interatrial communications created with CURB in patients with severe PAH were stable and the mid-term outcomes were satisfactory.<h4>Trial registration number</h4>NCT03554330."],"journal":["Heart (British Cardiac Society)"],"pubmed_title":["First in-human modified atrial septostomy combining radiofrequency ablation and balloon dilation."],"pmcid":["PMC9606506"],"funding_grant_id":["2020-I2M-C&amp;T-B-065","61975240"],"pubmed_authors":["Li H","Li S","Wang C","Fang W","Wan L","Yan C","Guo T","Yundan P","Niu H","Wang L"],"additional_accession":[]},"is_claimable":false,"name":"First in-human modified atrial septostomy combining radiofrequency ablation and balloon dilation.","description":"<h4>Objective</h4>Preclinical 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).<h4>Methods</h4>Between 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 (SatO<sub>2</sub>); (3) radiofrequency ablation was repeated around the rims of the created fenestration. The interatrial fenestrations were followed-up serially.<h4>Results</h4>After 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/m<sup>2</sup> and room-air resting SatO2 decreased by 6.2±1.9% (p<0.001). One patient experienced increased pericardiac effusion postoperatively; the others had no complications. On follow-up (median: 15.5 months), all interatrial communications were patent with stable size (intraclass correlation coefficient=0.96, 95%CI:0.89 to 0.99). The WHO functional class increased by 1 (IQR: 1-2) (p<0.001) with improvement of exercise capacity (+159.5 m, P<0.001).<h4>Conclusion</h4>The interatrial communications created with CURB in patients with severe PAH were stable and the mid-term outcomes were satisfactory.<h4>Trial registration number</h4>NCT03554330.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Oct","modification":"2024-10-18T20:32:34.441Z","creation":"2024-10-18T20:32:34.441Z"},"accession":"S-EPMC9606506","cross_references":{"pubmed":["35676068"],"doi":["10.1136/heartjnl-2022-321212"]}}