The safety and efficacy of the microaxial SynFlow 3.0 flow pump system for patients undergoing high-risk percutaneous coronary intervention

Abstract

Listen

Translate article

Background and purpose: Percutaneous coronary intervention (PCI) in complex high-risk and indicated patients (CHIP-PCI) remains a challenging procedure. The objective of this study was to evaluate the safety and efficacy of the novel microaxial flow pump, SynFlow 3.0, in patients undergoing CHIP-PCI. Methods: Between August and November 2022, a prospective, single-center, single-arm feasibility study was conducted at Zhongshan Hospital, Fudan University in Shanghai, China, to evaluate the SynFlow 3.0, a novel microaxial flow pump. A total of 10 nonemergency CHIP-PCI patients were recruited for this study. The complex high-risk condition was determined based on both clinical characteristics and anatomic lesions. Specifically, eligibility was defined by a left ventricular ejection fraction (LVEF) of less than 40%, accompanied by significant clinical symptoms. To evaluate hemodynamic stability, continuous invasive arterial pressure monitoring (IAPM) of mean arterial pressure (MAP) was conducted intraoperatively, with freedom from compromise serving as the primary efficacy endpoint in CHIP-PCI. The primary safety endpoint was the occurrence of major adverse cardiovascular and cerebrovascular events (MACCEs), including death, myocardial infarction, emergency coronary artery bypass surgery, or stroke at 30 days. Results: Preoperative stenosis was 90.00% (range: 70.00%–100.00%), with postoperative residual stenosis reduced to 0.00% (range: 0.00%–30.00%). The Syntax Score II decreased from 39.66 ± 9.69 to 35.51 ± 11.20, and thrombolysis in myocardial infarction (TIMI) flow grading improved to 2.94 ± 0.25 postoperatively. Hemodynamic stability during PCI was achieved in 90% of patients, with intraoperative MAP significantly higher than preoperative levels (94.50 ± 12.32 mmHg vs. 90.96 ± 9.92 mmHg; P < 0.05). The SynFlow 3.0 system achieved 100% technical success and a 90% PCI angiographic success rate. LVEF improved from 35.40 ± 3.95% to 38.40 ± 5.85% at 30 days. No MACCEs or serious adverse events occurred during the 30-day follow-up. The mean delivery time of the SynFlow 3.0 was 1.40 ± 0.97 minutes, with mechanical support lasting 87.30 ± 42.76 minutes. Minor complications included transiently elevated plasma-free hemoglobin levels in two patients (which normalized post-procedure) and three cases of puncture-site hematoma, with no major complications reported. Conclusions: The SynFlow 3.0 system is user-friendly, and its preliminary safety and efficacy have been verified in CHIP-PCI patients.