背景: 经皮肺动脉瓣球囊扩张术(Percutaneous Balloon Pulmonary Valvuloplasty，PBPV)是目前治疗症状性或不伴有并发症的重性肺动脉瓣狭窄的推荐方法。与传统放射线引导的 PBPV相比，单纯超声引导的 PBPV可以完全避免辐射线和造影剂的使用，保护患者利益的同时，更可以保护术者免受辐射的损伤，具有长远的临床意义。我们已经证实单纯超声引导的 PBPV的疗效是肯定的，但由于传统扩张导管在超声下的显影性差，极大地限制了该技术的推广与应用。因此我们根据临床需要，自主研发了一款专用于超声引导的新型双球囊导管。

方法：新型双球囊导管是在传统导管的末端增设一个引导球囊，以便于超声探测。用新型导管或传统导管随机对三十只健康小型猪进行单纯超声引导的 PBPV，以评估新型导管的可行性及安全性。以球囊扩张肺动脉瓣的成功率和手术操作时间为指标评价新型导管的可行性，以扩张球囊滑脱频率和并发症的发生率为指标评价其安全性。

结果：两组动物的体重、扩张球囊直径与瓣环直径的比值均无显著性差异。实验组成功率为93.3%，对照组成功率为60%。实验组的平均手术时间(6.33 ± 6.86 min)明显低于对照组(24.8 ± 9.79 min)，且球囊滑脱频率(0.07 ± 0.26 vs 0.53 ± 0.52)，心律失常发生频率(0.07 ± 0.26 vs 0.47 ± 0.52)，三尖瓣反流发生频率(6.7% vs 40%)均明显低于对照组(P < 0.05)。实验组无心肌血肿或心包填塞发生。

结论：虽然尚需更进一步的研究，但动物实验结果表明，新型双球囊导管用于超声引导的PBPV是安全可行的。

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 haematoma 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.