The efficacy and safety of a novel domestic pulmonary artery thromoectomy system in the treatment of acute pulmonary embolization
10.3760/cma.j.cn112149-20221111-00905
- VernacularTitle:国产新型肺动脉血栓取出装置治疗急性肺动脉栓塞的有效性与安全性
- Author:
Wenguang ZHANG
1
;
Pengfei CHEN
;
Mengfan ZHANG
;
Hong LIU
;
Shaoxia LIU
;
Haibo YANG
;
Yan SONG
;
Deguang FENG
;
Jianzhuang REN
;
Xinwei HAN
Author Information
1. 郑州大学第一附属医院介入科 郑州大学介入治疗研究所，郑州 450000
- Keywords:
Pulmonary embolization;
Percutaneous mechanical thromoboectomy;
RV/LV ratio
- From:
Chinese Journal of Radiology
2023;57(10):1100-1105
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of a novel domestic pulmonary thromoboectomy system Tendvia TM in the treatment for high-risk patients complicated with acute pulmonary embolization (APE). Methods:The study was designed as a prospective single-center clinical trial. Twenty-four high-risk patients with APE were recruited and underwent percutaneous mechanical thromoectomy (PMT) with the Tendvia TM pulmonary thromoboectomy system. The primary efficacy endpoint was the reduction of RV/LV ratio at the post-operative 48 h. The secondary efficacy endpoints included technical success rate, mean pulmonary arterial pressure (mPAP), arterial PaO 2 and the instant post-operative thrombus clearance rate. The evaluation of the safety included the intraoperative complications and related complications during the follow-up period associated with the PMT operation and the major adverse event (MAE) rate within the post-operative 48 h. The pre-and post-operative data were compared with paired sample t-test or Wilcoxon rank sum test to evaluate the efficacy and safety of Tendvia TM pulmonary thromoboectomy system. Results:The technical success rate of PMT with Tendvia TM pulmonary thromoboectomy system was 100% (24/24). The 48 h pre-operative RV/LV ratio was 1.19±0.25 and the post-operative RV/LV ratio was 0.82±0.16. The mean RV/LV ratio of the patients was decreased by 0.37±0.25 at post-operative 48 h with significant statistical difference ( t=7.03, P<0.001). The 48 h pre-operative mPAP was (31.09±6.09) mmHg and the post-operative mPAP was (25.91±4.36) mmHg. The mPAP of the patients was reduced by 5.18 mmHg at post-operative 48 h with significant statistical difference ( t=6.73, P<0.001). The pre-operative PaO 2 was (74.66±11.28) mmHg and the post-operative PaO 2 was (88.01±10.57) mmHg. The pressure of oxygen in artery was increased by 13.36 mmHg. The differences were statistically significant( t=-4.08, P<0.001). The rate of thrombus removal was 68.17%±22.66%. 87.5% (21 cases) of patients achieved a thrombus removal greater than grade Ⅱ. One patient underwent catheter directed thrombolysis (CDT) after PMT based on the evaluation of operator. The patient′s thrombus removal achieved grade Ⅲ after 48 h and the CDT was ceased. Hemoptysis occurred intra-operatively in one case underwent PMT and the symptom of the patient was alleviated with conservative medication. The MAE incidence within the post-operative 48 h was 4.17% (1/24). No device-related mortality or all-cause mortality occurred in the trial. Conclusions:The Tendvia TM pulmonary thromoboectomy system is a safe and effective device to remove the pulmonary arterial thrombus for the treatment of patients with APE. The Tendvia TM pulmonary thromoboectomy system can be a new choice in the treatment for the patients with APE.
