Georges Gabriel, Trudeau François, Doucet-Martineau Jade, Rochon Maxime, Potvin Jeannot, Ebner Adrian, Généreux Philippe
Quebec Heart and Lung Institute, Quebec, Quebec, Canada.
Puzzle Medical Devices Inc, Montreal, Quebec, Canada.
J Soc Cardiovasc Angiogr Interv. 2022 Sep 17;1(6):100449. doi: 10.1016/j.jscai.2022.100449. eCollection 2022 Nov-Dec.
ModulHeart (Puzzle Medical Devices Inc) is a modular device providing hemodynamic support through 3 endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. The current study evaluates the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk percutaneous coronary intervention (PCI).
This study was a prospective, single-center, first-in-human study. The primary end point was procedural success, defined as successful delivery, function, and removal of the ModulHeart device. Secondary end points included pump hemodynamics, cardiac hemodynamics, and urine output.
On June 28 and 29, 2022, 4 patients were enrolled and underwent high-risk PCI with ModulHeart implanted via transfemoral approach. All 4 patients achieved procedural success. The mean delivery time was 8 minutes, the mean support time was 49 minutes, and the mean pump removal time was 7 minutes. The mean pressure gradient across the pump was 5 ± 2 mm Hg. Under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and left ventricular end-diastolic pressure decreased by 78%. Urine output increased by ∼9-fold after 15 minutes of support. No device malfunction or procedural or device-related adverse events occurred. There was no evidence of pump thrombosis. All 4 patients were alive at 30 days.
This first-in-human study demonstrated the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk PCI. ModulHeart demonstrated significant improvement in cardiac output, left ventricular end-diastolic pressure, and urine output. Future studies are planned to assess outcomes associated with ModulHeart support in patients with heart failure.
ModulHeart（拼图医疗设备公司）是一种模块化设备，通过3个串联插入并并联组装成一个可自膨胀锚定器的血管内泵，该锚定器植入降主动脉，提供血流动力学支持。本研究评估了在接受高风险经皮冠状动脉介入治疗（PCI）的患者中，使用ModulHeart进行心肾支持的可行性和安全性。
本研究是一项前瞻性、单中心、首次人体研究。主要终点是手术成功，定义为ModulHeart设备成功输送、发挥功能并取出。次要终点包括泵的血流动力学、心脏血流动力学和尿量。
2022年6月28日和29日，4例患者入组并接受了经股动脉途径植入ModulHeart的高风险PCI。所有4例患者均手术成功。平均输送时间为8分钟，平均支持时间为49分钟，平均泵取出时间为7分钟。泵两端的平均压力梯度为5±2毫米汞柱。在ModulHeart支持下，心脏指数增加25%，中心静脉压降低37%，左心室舒张末期压力降低78%。支持15分钟后尿量增加约9倍。未发生设备故障或与手术或设备相关的不良事件。没有泵血栓形成的证据。所有4例患者在30天时均存活。
这项首次人体研究证明了在接受高风险PCI的患者中，使用ModulHeart进行心肾支持的可行性和安全性。ModulHeart在心输出量、左心室舒张末期压力和尿量方面有显著改善。计划开展未来研究以评估ModulHeart支持对心力衰竭患者结局的影响。
