Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: A Japanese multicenter study using J-MACS

Saito, Satoshi; Yamazaki, Kenji; Nishinaka, Tomohiro; Ichihara, Yuki; Ōno, Minoru; Kyo, Syunei; Nishimura, Takashi; Nakatani, Takeshi; Toda, Köichi; Sawa, Yoshiki; Tominaga, Ryuji; Tanoue, Tadahisa; Saiki, Yoshikatsu; Matsui, Yoshiro; Takemura, T; Niinami, Hiroshi; Matsumiya, Goro

doi:10.1016/j.healun.2014.02.015

Cited by 84 publications

(56 citation statements)

References 18 publications

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“…1) However, the relationship between AI and EVAHEART, which tends to preserve PP better than other devices, 2) remains uncertain. We here compared EVAHEART with other devices from the viewpoint of AI.…”

Section: Letter To Editor Centrifugal Pump Evaheart Prevents Developmmentioning

confidence: 99%

Centrifugal Pump EVAHEART Prevents Development of Aortic Insufficiency Preserving Pulse Pressure

Imamura

Kinugawa

2016

Int. Heart J.

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Aortic insufficiency (AI) during continuous flow (CF) left ventricular assist device (LVAD) treatment is one of the major complications that reduces patient exercise tolerability and increases the cardiovascular event rate. 1) We reported that preserved pulse pressure (PP) was associated with prevention of AI by repressing remodeling of the aortic root and degeneration of native aortic valve (AV).1) However, the relationship between AI and EVAHEART, which tends to preserve PP better than other devices, 2) remains uncertain. We here compared EVAHEART with other devices from the viewpoint of AI.We enrolled 45 patients who had undergone CF LVAD (EVAHEART, 14; DuraHeart, 9; HeartMate II, 14; Jarvik 2000, 7; HeartWare, 1) between 2006 and 2015. We excluded patients whose native aortic valve (AV) was open because no AI developed in such patients as we described previously.1) We defined < 30% of native AV opening per native heart rate as "remaining closed", and patients whose AV remained closed at 6 months after the operation were enrolled. The rotation speed was optimized considering patient hemodynamics and interventricular septum shift observed in regular echocardiography. Preoperative baseline characteristics were obtained < 24 hours before LVAD implantation. Transthoracic echocardiography was performed regularly, and we defined AI as aortic regurgitation ≥ mild at 6 months.There were no significant differences in preoperative background characteristics between the EVAHEART group and other devices group (Table I). Of 45 patients with a closed native AV, 14 (31%) avoided development of AI. Among preoperative data, EVAHEART usage was the only significant predictor of AI-free (P = 0.012, odds ratio 15.79). After the operation, most of the patients (93%) avoided AI during EVA-HEART treatment. PP was higher in the EVAHEART group, and the aortic root was less dilated in the EVAHEART group compared with the other devices group (Table II, P < 0.05 for all comparison).Some patients achieve improvement of LV ejection fraction through LV reverse remodeling under unloading by LVAD and opening of the native AV, and avoid AI. 3,4) Although the opening of the native AV is the first target to avoid AI, most patients have a closed native AV accompanied by a persistent low LV ejection fraction.1) Among such patients, the preservation of pulsatility is important. Preserved PP prevents remodeling of the aortic root and degeneration of the native AV, and then avoids AI. 1)We previously showed that pulsatile flow LVAD had an advantage over CF LVAD for preventing AI by preserving PP. 5)However, pulsatile flow devices are not recommended under most of the current situation, considering the established advantages of CF LVADs over pulsatile flow devices. 6) Among CF LVADs, we also showed that centrifugal devices had an advantage over axial ones for preventing AI, because centrifugal pumps tend to preserve PP. 1)One of the centrifugal pumps, EVAHEART, provides extraordinary augmentation capability of pulsatility by providing wide-ranging flo...

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Section: Letter To Editor Centrifugal Pump Evaheart Prevents Developmmentioning

confidence: 99%

Centrifugal Pump EVAHEART Prevents Development of Aortic Insufficiency Preserving Pulse Pressure

Imamura

Kinugawa

2016

Int. Heart J.

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“…To evaluate the frictional force generated at the sealing surface of a mechanical VAD seal, a test apparatus was designed based on the actual structure of the VAD [2]. A schematic of the designed test apparatus is shown in Fig.…”

Section: Test Apparatusmentioning

confidence: 99%

“…In particular, implantable VADs [2] are implanted into the patient's body, along with the controller, battery and water-circulation unit [3] used to drive the VAD, to make the system portable for patients [2]. Therefore, implantable VADs enable patients to rehabilitate into society [4].…”

Section: Introductionmentioning

confidence: 99%

Influence of Surface Texture on Friction Properties of Mechanical Seals for Blood -Design Concept of Sealing Surface of Mechanical Seal for Ventricular Assist Device-

Kanda

Sato

Kinoshita³

et al. 2016

Tribology Online

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Low, stable friction, a higher load-carrying capacity, and lower leakage of sealed blood are required for mechanical seals in implantable ventricular assist devices. One solution is to apply surface texture to the mechanical seal surface, consisting of self-mated silicon carbide. However, the effect of surface texture on the frictional properties of mechanical seals under blood sealing conditions has not yet been studied. Therefore, this study aimed to clarify the effect of surface texture on fundamental frictional properties of mechanical seals and to propose design concepts for mechanical seals in ventricular assist devices. The results show that surface texture increases the critical load of mechanical seals, although it also causes periodic peaks in friction. Further, it was found that surface texture induces the formation of denatured protein aggregates on the sealing surface, also inducing periodic surface friction peaks. The frictional properties of the mechanical seals were stabilized by creating small, dispersed concave features with wet blast fabrication, followed by coating with diamond-like carbon. Lower and more stable frictional properties were thus achieved, while simultaneously ensuring a higher critical load.

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“…In recent years, most of the researches on blood pump focused on the impeller structure, flow channel, drive system, hemolysis, suspension mechanism and so on [5][6][7][8][9]. But the research on the kinetic system of blood pump in implantation environment was few.…”

Section: Introductionmentioning

confidence: 99%

The research on the influence of kinetic parameters on the vibration of blood pump in viscoelastic implantation environment

2017

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Abstract. The implantable axial flow blood pump would be vibrated when in actual use because of the viscoelastic implantation environment, unbalanced driven force, high speed rotor and so on. The blood pump researched in the paper was designed to be implanted in ascending aortic and driven by external magnetic force. The kinetic equation of blood pump worked in viscoelastic implantation environment was built, and then the blood pump's vibration influenced by viscoelasticity of implantation environment, running speed of blood pump, weight of blood pump were studied. Appropriate damping coefficient of implantation environment, running speed of blood pump and weight of blood pump for blood pump's more stable working were found in the paper. The paper could provide theoretical basis and research method for blood pump's structure parameters and work performance improving.

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Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: A Japanese multicenter study using J-MACS

Cited by 84 publications

References 18 publications

Centrifugal Pump EVAHEART Prevents Development of Aortic Insufficiency Preserving Pulse Pressure

Centrifugal Pump EVAHEART Prevents Development of Aortic Insufficiency Preserving Pulse Pressure

Influence of Surface Texture on Friction Properties of Mechanical Seals for Blood -Design Concept of Sealing Surface of Mechanical Seal for Ventricular Assist Device-

The research on the influence of kinetic parameters on the vibration of blood pump in viscoelastic implantation environment

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