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住院更短,花费更少!葛均波院士团队发布新研究

WeChat: 医学界 Medical Device Trials 2026-08-10
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TL;DR — PERSIST-III, a 19-center Chinese randomized non-inferiority trial (published 2026-07-29 in European Heart Journal, IF 45.3) from Zhongshan Hospital (Ge Junbo/Qian Juying/Zhao Gang) and PLA General Hospital (Chen Yundai), shows the domestic micro-axial flow pump SynFlow 3.0 is non-inferior to VA-ECMO for circulatory support in high-risk PCI, with better safety and lower resource use. Note: this is a medical-device trial, not an AI advance.

  • Design/population: prospective, multicenter, randomized, open-label, non-inferiority; 222 patients with LVEF ≤35% (median 32%), median SYNTAX 39, 68.9% NYHA III/IV, mean age 64.
  • Primary endpoint: 30-day major adverse events 7.3% (8/109) with SynFlow 3.0 vs 11.5% (13/113) with VA-ECMO; center-adjusted 95% CI upper bound below the non-inferiority margin (P<0.001). At 90 days: MAE 10.3% vs 15.2%, MACCE 4.7% vs 10.7% (not statistically significant).
  • Safety: device-related adverse events 3.7% vs 11.5% (P=0.041), anemia 9.2% vs 20.4% (P=0.023), intraoperative transfusion 2.8% vs 13.3% (P=0.004); no hemolysis, aortic injury, or ventricular perforation observed.
  • Resource use: post-procedure stay 4.1 vs 5.2 days (P=0.047) and lower hospitalization cost excluding device charges (P=0.027); the separated-motor design keeps the micromotor external (reusable, avoids blood heating/EMI).

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