The efficacy and safety of a novel domestic pulmonary artery thromoectomy system in the treatment of acute pulmonary embolization / 中华放射学杂志

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.