First-in-human experience with Tulyp: a novel extracorporeal perfusion system for acute limb ischemia
C Said, P Natov, J McCarthy, T Lenihan, M Iyer, P Schneider, I Aslam, N Kapur, R KarasAbstract
Background/Introduction
Lower extremity ischemia remains a frequent and serious complication of percutaneous mechanical circulatory support. Despite current approaches that rely on antegrade perfusion driven by systemic blood pressure or a cardiopulmonary support (CPS) circuit, many patients suffer significant morbidity including limb amputation. We report the first-in-human experience with a novel extracorporeal limb perfusion system that sources arterial blood and autonomously regulates pressurized perfusion via a distal perfusion catheter to the ischemic limb.
Purpose
The primary endpoint was technical feasibility, defined as successful device deployment, ability to deliver therapy, and successful device removal. The secondary safety endpoint was freedom from device or procedure-related major adverse events through 24 hours of follow-up. The secondary efficacy endpoints included an increase in SFA-MAP and treatment-limb near infrared spectroscopy during active perfusion.
Methods
After informed consent, adult patients undergoing arterial cannulation for cardiopulmonary support (CPS) were enrolled. A sheath for the Tulyp pump was placed into a donor artery and the outlet connected to a distal perfusion catheter in the superficial femoral artery of the ischemic limb. The Tulyp device was programmed to deliver a fixed mean arterial pressure in the limb for the duration of CPS therapy and removed at decannulation. Results are reported as medians with interquartile ranges.
Results
The Tulyp extracorporeal system was successfully deployed in all 6 patients (100% technical success). After cannulation, the Tulyp system was programmed to achieve an SFA-MAP of 80mmHg. Within 10 minutes of activation, SFA mean arterial pressure increased significantly to 81.0 (80.0–85.8) from 62.5 (56.8–66.8) mmHg, p=0.04 in the target limb. SFA-MAP was maintained by Tulyp at 80mmHg for an average duration of 133.2±26.8 min across all 6 subjects. Near infrared spectroscopy correlated directly with SFA-MAP across all subjects (R=0.60; 95% CI, 0.41–0.74; p < 0.001). No device-related adverse events, vascular complications, or limb ischemia events were observed within 24 hours of Tulyp activation.
Conclusion
First in human experience with Tulyp demonstrated excellent technical feasibility and early safety data. The device autonomously delivered pressurized perfusion to the treatment limb and enhanced markers of tissue perfusion without adverse events. Prospective studies to evaluate the impact of this device on limb ischemia outcomes are in development.