Hemodynamic evaluation of a new pulsatile flow generation method in cardiopulmonary bypass system

This paper proposes a new method of generating pulsatile flow using non-pulsating pumps (NPP) without modulating the rotation speed of the pump rotor. At the initial stage, this method was proposed for NPP-based cardiopulmonary bypass (CPB) systems. The method is based on parallel connection to the NPP shunt (input-output) on which a controlled valve is installed. This valve ensures periodically clamps and opens the shunt partially. A comparative evaluation of the operation of pumps with and without a pulsator was done on a hydrodynamic bench with simulation of heart failure (HF) conditions. The pump-shunt system was connected according to the “veinartery” CPB scheme under copulsation mode. Rotaflow (Maquet Inc.) was used as the NPP. For a comparative assessment of the hemodynamic efficiency of the method, the following were used: aortic pulsatility index Ip, energy equivalent pressure (EEP) and surplus hemodynamic energy (SHE). The indices in the pulsating mode compared with the non-pulsating mode increased: Ip by 3 times, EEP index by 3.76% and SHE index increased by 4 times. Results show that the proposed method of generating a pulsating flow is effective.

cardiopulmonary bypass, continuous flow, pulsatile flow, hydrodynamic stand, shunt, controlled valve

1. Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson LW, Blume ED et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant. 2015; 34: 1495–1504.

2. Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D et al. Advanced heart failure treated with continuous – flow left ventricular assist device. N Engl J Med. 2009; 361: 2241–2251.

3. Miller L, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007; 357: 885–896.

4. Crow S, John R, Boyle A, Shumway S, Liao K, ColvinAdams M et al. Gastrointestinal bleeding rates in recipients of nonpulsatile and pulsatile left ventricular assist devices. J Thorac Cardiovasc Surg. 2009; 137: 208–215.

5. Demirozu ZT, Radovancevic R, Hochman LF, Gregoric ID, Letsou GV, Kar B et al. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2011; 30: 849–853.

6. Molina TL, Krisl JC, Donahue KR, Varnado S. Gastrointestinal Bleeding in Left Ventricular Assist Device: Octreotide and Other Treatment Modalities. ASAIO J. 2018; 64: 433–439.

7. Letsou GV, Shah N, Gregoric ID, Myers HJ, Delgado R, Frazier OH. Gastrointestinal bleeding from arteriovenous malformations in patients supported by the Jarvik 2000 axial-flow left ventricular assist device. J Heart Lung Transplant. 2005; 24: 105–109.

8. Muthiah K, Robson D, Macdonald PS, Keogh AM, Kotlyar E, Granger E et al. Increased incidence of angiodysplasia of the gastrointestinal tract and bleeding in patients with continuous flow left ventricular assist devices (LVADs). Int J Artif Organs. 2013; 36: 449–454.

9. Mudd JO, Cuda JD, Halushka M, Soderlund KA, Conte J, Russell SD. Fusion of aortic valve commissures in patients supported by a continuous axial flow left ventricular assist device. J Heart Lung Transplant. 2008; 27: 1269–1274.

10. Martina JR, Schipper ME, de Jonge N, Ramjankhan F, de Weger RA, Lahpor JR, Vink A. Analysis of aortic valve commissural fusion after support with continuousflow left ventricular assist device. Interact Cardiovasc Thorac Surg. 2013; 17: 616–624.

11. Morgan JA, Paone G, Nemeh HW, Henry SE, Patel R, Vavra J et al. Gastrointestinal bleeding with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2012; 31: 715–718.

12. Crow S, Milano C, Joyce L, Chen D, Arepally G, Bowles D et al. Comparative analysis of von Willebrand factor profiles in pulsatile and continuous left ventricular assist device recipients. ASAIO J. 2010; 56: 441–445.

13. Wang S, Rider AR, Kunselman AR et al. Effects of the pulsatile flow settings on pulsatile waveforms and hemodynamic energy in a PediVAS centrifugal pump. ASAIO J. 2009; 55: 271–276.

14. Guan Y, Karkhanis T, Wang S, Rider A, Koenig SC, Slaughter MS et al. Physiologic benefits of pulsatile perfusion during mechanical circulatory support for the treatment of acute and chronic heart failure in adults. Artif. Organs. 2010; 34: 529–536.

15. Wang S, Kunselman AR, Clark JB, Undar A. In vitro hemodynamic evaluation of a novel pulsatile extracorporeal life support system: impact of perfusion modes and circuit components on energy loss. Artif Organs. 2015; 39: 59–66.

16. Force M, Moroi M, Wang S., Kunselman AR, Undar A. In vitro Hemodynamic Evaluation of ECG-Synchronized Pulsatile Flow Using i-Cor Pump as Short-Term Cardiac Assist Device for Neonatal and Pediatric Population. Artif Organs. 2018; 1: 1–14.

17. Shepard RB, Simpson DC, Sharp JF. Energy equivalent pressure. Arch Surg. 1966; 93: 730–734.

18. Ising MS, Sobieski MA, Slaughter MS, Koenig SC, Giridharan GA. Feasibility of Pump Speed Modulation for Restoring Vascular Pulsatility with Rotary Blood Pumps. ASAIO J. 2015; 61: 526–532.

19. Vandenberghe S, Segers P, Antaki JF, Meyns B, Verdonck PR. Rapid Speed Modulation of a Rotary Total Artificial Heart Impeller. Artif Organs. 2016; 40: 824–833.

20. Ando M, Nishimura T, Takewa Y, Yamazaki K, Kyo S, Ono M et al. Electrocardiogram-synchronized rotational speed change mode in rotary pumps could improve pulsatility. Artificial Organs. 2011; 35: 941–947.

21. Soucy KG, Giridharan GA, Choi Y, Sobieski MA, Monreal G, Cheng A et al. Rotary pump speed modulation for generating pulsatile flow and phasic left ventricular volume unloading in a bovine model of chronic ischemic heart failure. J Heart Lung Transplant. 2015; 34: 122–131.

22. Bozkurt S, van de Vosse FN, Rutten MC. Enhancement of Arterial Pressure Pulsatility by Controlling ContinuousFlow Left Ventricular Assist Device Flow Rate in Mock Circulatory System. J Med Biol Eng. 2016; 36: 308–315.

23. Tayama E, Nakazawa T, Takami Y et al. The hemolysis test of Gyro C1E3 pump in pulsatile mode. Artif Organs. 1997; 21: 675–679.

24. Патент на изобретение № 2665180. Устройство и способ управления потоком крови в аппаратах сердечно-легочного обхода. Готье С.В., Иткин Г.П. Регистрация 28.08.2018.

25. Pantalos GM, Koenig SC, Gillars KJ, Giridharan GA, Dan L, Ewert DL. Characterization of an Adult Mock Circulation for Testing Cardiac Support Devices. ASAIO J. 2004; 50: 37–46.

26. Lim CH, Son HS, Fang YH et al. Hemodynamic energy generated by a combined centrifugal pump with an intraaortic balloon pump. ASAIO J. 2006; 52: 592–594.