A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only

A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only
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一种新型双球囊导管,用于超声心动图引导下的经皮球囊肺动脉瓣成形术

DOI:
10.1016/j.jjcc.2020.03.014
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发表时间:
2020-09-01
影响因子:
2.5
通讯作者:
Pan, Xiang-Bin
Pan, Xiang-Bin
中科院分区:
医学3区
文献类型:
--
作者:
Deng, Run-Di;Zhang, Feng-Wen;Pan, Xiang-Bin

文献摘要

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背景:经皮球囊肺动脉瓣成形术(PBPV)是无并发症的重度或症状性肺动脉瓣狭窄的首选手术。与透视引导的PBPV相比,超声心动图(回声)引导的PBPV可以完全避免使用辐射和造影剂。虽然我们已经证实了超声引导PBPV在人体中是可行的,但传统导管在超声下的可见性差极大地限制了这项新技术的推广。在30只健康猪上使用新型导管或传统导管进行超声引导的PBPV,以评价新型双球囊导管的可行性和安全性。通过肺动脉瓣环球囊扩张成功率和手术时间评价其可行性。安全性进行了评估的球囊滑脱的频率和并发症的发生率。结果:有没有显着的组间差异,在重量和球囊直径肺动脉瓣环直径的比率。新型组和传统组的成功率分别为93.3%和60%。小说组有显著的(p < 0.05)平均手术时间较短(6.33 +/- 6.86 min vs 24.8 +/- 9.79 min)和球囊滑脱频率较低(0.07 +/- 0.26 vs 0.53 +/- 0.52)、心律失常(0.07 +/- 0.26 vs 0.47 +/- 0.52)和三尖瓣返流(6.7% vs 40%)。结论:尽管需要进一步的研究和改进,但研究结果表明,新型双球囊导管用于超声引导下PBPV是可行和安全的。(C)2020年由Elsevier Ltd代表日本心脏病学院出版。
Background: Percutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. Echocardiography (echo)-guided PBPV can completely avoid the use of radiation and contrast agents compared to fluoroscopy-guided PBPV. Although we have confirmed that echo-guided PBPV is feasible in humans, the poor visibility of the traditional catheter under echo greatly limits the promotion of this new technology.Methods: We produced a novel double-balloon catheter to make the catheter easy to be detected by echo through adding a guiding balloon at the distal end of the catheter. Echo-guided PBPV was performed on thirty healthy swine using either a novel catheter or a traditional catheter to evaluate the feasibility and safety of the novel double-balloon catheter. The feasibility was evaluated by the success rate of balloon inflation at the pulmonary valve annulus and the operating time. The safety was evaluated by the frequency of balloon slippage and the incidence of complications.Results: There were no significant between-group differences in terms of weight and the ratio of balloon diameter to pulmonary annulus diameter. The success rate was 93.3% and 60% in the novel and traditional groups, respectively. The novel group had significantly (p < 0.05) lower mean procedure time (6.33 +/- 6.86 min vs 24.8 +/- 9.79 min) and lower frequency of balloon slippage (0.07 +/- 0.26 vs 0.53 +/- 0.52), arrhythmia (0.07 +/- 0.26 vs 0.47 +/- 0.52), and tricuspid regurgitation (6.7% vs 40%) than the traditional group. No myocardial hematoma or pericardial tamponade occurred in the novel catheter group.Conclusion: Although further studies and improvements are required, the study results indicate that the novel double-balloon catheter for echo-guided PBPV is feasible and safe. (C) 2020 Published by Elsevier Ltd on behalf of Japanese College of Cardiology.