Department of Structural Heart Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital, Xicheng, Beijing, China
Department of Echocardiography, Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital, Xicheng, Beijing, China.
Heart. 2022 Oct 13;108(21):1690-1698. doi: 10.1136/heartjnl-2022-321212.
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).
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); (3) radiofrequency ablation was repeated around the rims of the created fenestration. The interatrial fenestrations were followed-up serially.
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 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).
The interatrial communications created with CURB in patients with severe PAH were stable and the mid-term outcomes were satisfactory.
NCT03554330.
临床前研究表明，射频消融联合球囊扩张（CURB）可在不植入器械的情况下形成稳定的房间隔交通。本研究探讨了 CURB 在伴有严重肺动脉高压（PAH）的患者中进行改良房间隔造口术的首次人体应用。
在 2018 年 7 月至 2021 年 10 月期间，对 19 例严重 PAH 患者（年龄：31.5±9.1 岁；平均肺动脉压：73mmHg（IQR：66-92）；肺血管阻力：18.7 Wood 单位（IQR：17.8-23.3））进行 CURB。在心脏内超声心动图和三维定位系统的引导下，（1）卵圆窝重建，采用射频进行点对点消融；（2）经房间隔穿刺后进行分级球囊扩张，并根据动脉血氧饱和度（SatO）水平确定最佳大小；（3）在创建的孔边缘重复射频消融。连续随访房间隔孔。
CURB 后，即刻房间隔孔大小为 4.4mm（IQR：4.1-5.1），心脏内超声心动图显示收缩期主动脉压升高 10.2±6.9mmHg，心指数增加 0.7±0.3L/min/m，休息时空气 SatO2 降低 6.2±1.9%（p<0.001）。1 例术后出现心包积液增多，其余患者无并发症。随访（中位数：15.5 个月），所有房间隔交通均保持开放且大小稳定（组内相关系数=0.96，95%CI：0.89 至 0.99）。WHO 功能分级增加 1 级（IQR：1-2）（p<0.001），运动能力改善（增加 159.5m，p<0.001）。
CURB 在伴有严重 PAH 的患者中形成的房间隔交通稳定，中期结果满意。
NCT03554330。
