Miniaturized centrifugal ventricular assist device for bridge to decision: Preclinical chronic study in a bovine model.

Abstract:

:We developed a novel miniaturized extracorporeal centrifugal pump "BIOFLOAT NCVC (Nipro Corporation Osaka, Japan) as a ventricular assist device (VAD) and performed a preclinical study that is part of the process for its approval as a bridge to decision by the pharmaceutical and medical device agencies. The aim of this study was to assess the postoperative performance, hemocompatibility, and anticoagulative status during an extended period of its use. A VAD system, consisting of a hydrodynamically levitated pump, measuring 64 mm by 131 mm in size and weighing 635 g, was used. We installed this assist system in 9 adult calves (body weight, 90 ± 13 kg): as left ventricular assist device (LVAD) in 6 calves and right ventricular assist device (RVAD) in 3 calves, for over 30 days. Perioperative hemodynamic, hematologic, and blood chemistry measurements were obtained and end-organ effects on necropsy were investigated. All calves survived for over 30 days, with a good general condition. The blood pump was operated at a mean rotational speed and a mean pump flow of 3482 ± 192 rpm and 4.08 ± 0.15 L/min, respectively, for the LVAD and 3902 ± 210 rpm and 4.24 ± 0.3 L/min, respectively, for the RVAD. Major adverse events, including neurological or respiratory complications, bleeding events, and infection were not observed. This novel VAD enabled a long-term support with consistent and satisfactory hemodynamic performance and hemocompatibility in the calf model. The hemodynamic performance, hemocompatibility, and anticoagulative status of this VAD system were reviewed.

journal_name

Artif Organs

journal_title

Artificial organs

authors

Shimamura J,Mizuno T,Takewa Y,Tsukiya T,Naito N,Akiyama D,Iizuka K,Katagiri N,Nishimura T,Ono M,Tatsumi E

doi

10.1111/aor.13459

subject

Has Abstract

pub_date

2019-09-01 00:00:00

pages

821-827

issue

9

eissn

0160-564X

issn

1525-1594

journal_volume

43

pub_type

杂志文章
  • Bone marrow combined with dental bud cells promotes tooth regeneration in miniature pig model.

    abstract::Growth factors and morphogens secreted by bone marrow mesenchymal stem cells (BMSCs) of bone marrow fluid may promote tooth regeneration. Accordingly, a tissue engineering approach was utilized to develop an economical strategy for obtaining the growth factors and morphogens from BMSCs. Unerupted second molar tooth bu...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2010.01064.x

    authors: Kuo TF,Lin HC,Yang KC,Lin FH,Chen MH,Wu CC,Chang HH

    更新日期:2011-02-01 00:00:00

  • Coronary artery anatomy of the goat.

    abstract::The coronary arteries of the goat heart were studied using angiographic techniques and molds of the coronary vessel trees. Blood supplies to the left and right ventricles, interventricular septum, atrioventricular node, and apex of the caprine heart were studied. The goat possesses a left dominant pattern of coronary ...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1983.tb04192.x

    authors: Lipovetsky G,Fenoglio JJ,Gieger M,Srinivasan MR,Dobelle WH

    更新日期:1983-05-01 00:00:00

  • Artificial cells with emphasis on cell encapsulation of genetically engineered cells.

    abstract::Artificial cells are prepared in the laboratory for medical and biotechnological applications. Encapsulated cells are being studied for the treatment of diabetes, liver failure, and other conditions. More recently, there have been extensive studies into the use of encapsulated genetically engineered cells for gene the...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1046/j.1525-1594.1998.06243.x

    authors: Chang TM

    更新日期:1998-11-01 00:00:00

  • Electrical pulse train and single pulse stimulation of the small intestine: acute and chronic studies in the dog.

    abstract::In vitro tests have shown that electric currents may lead either to relaxation or contraction of the bowel wall. Because voluntary changes of the intestinal motility could be useful in the treatment of intestinal disorders, we investigated the reactions elicited by electrostimulation of the small intestine in the inta...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1989.tb02846.x

    authors: Moritz A,Grundfest-Broniatowski S,Ilyes L,Kasick J,Jacobs G,Olsen E,Nosé Y

    更新日期:1989-04-01 00:00:00

  • Differential functional coupling between human saphenous cryoallografts and arteries: importance of the arterial type and the biomechanical parameter evaluated.

    abstract::The aim of this study was to characterize and compare human great saphenous veins (HGSVs), HGSV cryoallografts, expanded polytetrafluoroethylene (ePTFE) segments, and elastic and muscular arteries' biomechanics, so as to identify if the biomechanical coupling and the HGSV advantages with respect to ePTFE depend on the...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2007.00467.x

    authors: Bia D,Zócalo Y,Pessana F,Armentano R,Pérez H,Saldías M,Alvarez I

    更新日期:2007-11-01 00:00:00

  • Changes in Total Cardiac Output and Oxygen Extraction During Exercise in Patients Supported With an HVAD Left Ventricular Assist Device.

    abstract::Following implantation of a left ventricular assist device (LVAD), acceptable functional performance is now being achieved; however, peak VO2 and peak work load (watts) remain considerably limited. Maximum physical capacity is essentially dependent on generated cardiac output (CO) and arteriovenous oxygen difference (...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/aor.13102

    authors: Schmidt T,Bjarnason-Wehrens B,Mommertz S,Hannig M,Schulte-Eistrup S,Willemsen D,Reiss N

    更新日期:2018-07-01 00:00:00

  • Evaluation of Combined Extracorporeal Life Support and Continuous Renal Replacement Therapy on Hemodynamic Performance and Gaseous Microemboli Handling Ability in a Simulated Neonatal ECLS System.

    abstract::The objective of this study was to evaluate the hemodynamic performance and gaseous microemboli (GME) handling ability of a simulated neonatal extracorporeal life support (ECLS) circuit with an in-line continuous renal replacement therapy (CRRT) device. The circuit consisted of a Maquet RotaFlow centrifugal pump or HL...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/aor.12987

    authors: Shank KR,Profeta E,Wang S,O'Connor C,Kunselman AR,Woitas K,Myers JL,Ündar A

    更新日期:2018-04-01 00:00:00

  • Flow through an outlet cannula of a rotary ventricular assist device.

    abstract::Rotary ventricular assist devices (VADs) are primarily used during surgery and short-term postoperative assistance. There are issues involving the use of rotary VADs including the behavior of flow emanating from the assist device which might induce flow irregularities that could potentially lead to stroke or cerebrova...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1046/j.1525-1594.2002.06931_4.x

    authors: Manning KB,Miller GE

    更新日期:2002-08-01 00:00:00

  • A clinical monitoring system for centrifugal blood pumps.

    abstract::In clinical application of rotary blood pumps, flow obstruction as a result of suction of the inflow cannula, kinking of tubing, or thrombus formation occurs quite frequently. Early detection of such problems is essential to avoid hemolysis, tissue degradation, or release of thrombi to the patient. A program was devel...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1995.tb02409.x

    authors: Holzer S,Scherer R,Schmidt C,Schwendenwein I,Wieselthaler G,Noisser R,Schima H

    更新日期:1995-07-01 00:00:00

  • Probing expert opinions on the future of kidney replacement therapies.

    abstract::Patients with kidney failure can only survive with some form of kidney replacement (transplant or dialysis). Unfortunately, innovations in kidney replacement therapy lag behind many other medical fields. This study compiles expert opinions on candidate technologies for future kidney replacement therapies. A worldwide ...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/aor.13784

    authors: Pereira Cabral B,Bonventre JV,Wieringa F,Mota FB

    更新日期:2020-07-22 00:00:00

  • Hemolysis Related to Turbulent Eddy Size Distributions Using Comparisons of Experiments to Computations.

    abstract::Turbulent blood flow in medical devices contributes to blood trauma, yet the exact mechanism(s) have not been fully elucidated. Local turbulent stresses, viscous stresses, and the rate of dissipation of the turbulent kinetic energy have been proffered as hypotheses to describe and predict blood damage. In this work, s...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/aor.12572

    authors: Ozturk M,O'Rear EA,Papavassiliou DV

    更新日期:2015-12-01 00:00:00

  • Prevention of renal disease progression and renal replacement therapy in emerging countries.

    abstract::Chronic kidney disease is increasing in both developed and emerging countries with progressive encroachment on health services budgets. In spite of the lack of accurate registries, we tried to focus on the magnitude of the problem on different continents. Prevention of progression has been a remote but reachable goal....

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2006.00251.x

    authors: Hafez MH,Abdellatif DA,Elkhatib MM

    更新日期:2006-07-01 00:00:00

  • New immunosuppressive proteins (KX-2, -4, and -5) induced by liver transplantation.

    abstract::The presence in rat serum of three novel immunosuppressive proteins is associated with induction of tolerance after liver grafting. One of these, KX-5 (40 kilodalton molecular weight) is present 40-100 days after grafting of DA liver into PVG, a combination in which liver grafts are not rejected; two others, KX-2 (87 ...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1996.tb00646.x

    authors: Kamada N

    更新日期:1996-10-01 00:00:00

  • A compact mock circulation loop for the in vitro testing of cardiovascular devices.

    abstract::In vitro cardiovascular device performance evaluation in a mock circulation loop (MCL) is a necessary step prior to in vivo testing. A MCL that accurately represents the physiology of the cardiovascular system accelerates the assessment of the device's ability to treat pathological conditions. To serve this purpose, a...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2010.01088.x

    authors: Timms DL,Gregory SD,Greatrex NA,Pearcy MJ,Fraser JF,Steinseifer U

    更新日期:2011-04-01 00:00:00

  • Characteristics of chronically paced cardiac functions in the congenital complete atrioventricular block.

    abstract::Characteristics of morphology, cardiac function, and cardiac reserve at late state were evaluated at rest, by changing the pacing rates, and after exercise in patients with ventricular pacemakers for isolated congenital complete atrioventricular block. Heart size was reduced statistically after pacemaker implantation,...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1987.tb02667.x

    authors: Nawa S,Kioka Y,Shimizu A,Tsuji H,Miyachi Y,Ebara K,Kino K,Shigenobu M,Murakami T,Senoo Y

    更新日期:1987-06-01 00:00:00

  • Clinical long-term results of vascular prosthesis sealed with fragmented autologous adipose tissue.

    abstract::Tissue engineering can improve the former limitations of artificial organs. This article reports the long-term clinical results of grafts constructed with fragmented autologous adipose tissue. We did a retrospective analysis of a series of 53 patients with lower leg ischemia that received 69 fragmented adipose tissue ...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1046/j.1525-1594.2001.025003218.x

    authors: Karube N,Soma T,Noishiki Y,Yamazaki I,Kosuge T,Ichikawa Y,Takanashi Y

    更新日期:2001-03-01 00:00:00

  • Assessment of skeletal muscle ventricle tissue blood flow using positron emission tomography.

    abstract::In this pilot study, we assessed the feasibility of using positron emission tomography (PET) imaging for in vivo measurement of skeletal muscle ventricle (SMV) tissue blood flow. In 4 dogs, with SMVs prepared from their latissimus dorsi muscle, we quantified SMV tissue blood flow by PET and related it to the tissue fl...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:

    authors: Singh TP,Greer K,Muzik O,Hammond RL,Stephenson LW,Di Carli MF

    更新日期:2001-04-01 00:00:00

  • A human lymph node in vitro--challenges and progress.

    abstract::Extracorporeal human lymphatic organs are expected to be excellent tools in the study of human molecular and cellular bases of the immunologic balance and tissue harmony. A rational approach and process to design a device and a procedure to recreate the human lymph node environment in vitro is described with emphasis ...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2006.00303.x

    authors: Giese C,Demmler CD,Ammer R,Hartmann S,Lubitz A,Miller L,Müller R,Marx U

    更新日期:2006-10-01 00:00:00

  • Rate of thrombus accumulation on intravenacaval IVOX devices explanted from human clinical trial patients with acute respiratory failure.

    abstract::The weight gain of IVOX devices removed from the first 49 human clinical trials patients after from 1 to 29 days of implantation into the venae caval blood stream has been assessed. Each patient had received sufficient systemic heparin to maintain activated clotting times between 150 and 200 s while the IVOX device wa...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1994.tb03329.x

    authors: Imai H,Schaap RN,Mortensen JD

    更新日期:1994-11-01 00:00:00

  • Impact of hemoglobin concentration and affinity for oxygen on tissue oxygenation: the case of hemoglobin-based oxygen carriers.

    abstract::In patients undergoing exchange-transfusion with hemoglobin (Hb)-based oxygen (O₂) carriers (HBOC), native Hb coexists with newly transfused Hb. The two Hb types share the same arterial and venous PO₂, but their affinities for O₂ vary. A simple spreadsheet model is described aiming at evaluating the contribution of ea...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2011.01296.x

    authors: Samaja M,Terraneo L

    更新日期:2012-02-01 00:00:00

  • Influence of hydration state on plasma volume changes during ultrafiltration.

    abstract::To assess the influence of hydration state on plasma volume (PV) changes during ultrafiltration, 11 clinically normhydrated patients on maintenance hemodialysis were studied intraindividually during 2 hydration states differing by 2-15% of lean body mass (LBM). Plasma volume was measured continually during a 15-min ul...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1995.tb02352.x

    authors: Wizemann V,Leibinger A,Mueller K,Nilson A

    更新日期:1995-05-01 00:00:00

  • Systemic consequences of ventricular assist devices: alterations of coagulation, immune function, inflammation, and the neuroendocrine system.

    abstract::Implantable ventricular assist devices have proven efficacious as a bridge to transplantation and as a bridge to recovery. Although current indications for use of assist devices are somewhat limited, they are likely to expand in the upcoming years, including their use as destination therapy for end-stage heart failure...

    journal_title:Artificial organs

    pub_type: 杂志文章,评审

    doi:10.1046/j.1525-1594.2002.07122.x

    authors: Hampton CR,Verrier ED

    更新日期:2002-11-01 00:00:00

  • Effects of pyridoxalated hemoglobin polyoxyethylene conjugate and other hemoglobin-related substances on arterial blood pressure in anesthetized and conscious rats.

    abstract::The effects of pyridoxalated hemoglobin polyoxyethylene conjugate (PHP) and other hemoglobin-related substances on arterial blood pressure (ABP) and heart rate (HR) were examined. Infusion of PHP and other hemoglobin-related substances elevated ABP and increased HR. The degree of the increase in ABP and HR did not dif...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1995.tb02300.x

    authors: Kida Y,Maeda M,Iwata S,Iwashita Y,Goto K,Nishi K

    更新日期:1995-02-01 00:00:00

  • Tissue-engineered skin containing mesenchymal stem cells improves burn wounds.

    abstract::There is increasing evidence showing that adult stem cells are useful for tissue regeneration. Bone marrow mesenchymal stem cells (MSCs) are self-renewing and are potent in differentiating into multiple cells and tissues. To investigate the practicability of repairing burn wounds with tissue-engineered (TE) skin combi...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2008.00654.x

    authors: Liu P,Deng Z,Han S,Liu T,Wen N,Lu W,Geng X,Huang S,Jin Y

    更新日期:2008-12-01 00:00:00

  • Pulsatile in vitro simulation of the pediatric univentricular circulation for evaluation of cardiopulmonary assist scenarios.

    abstract::The characteristic depressed hemodynamic state and gradually declining circulatory function in Fontan patients necessitates alternative postoperative management strategies incorporating a system level approach. In this study, the single-ventricle Fontan circulation is modeled by constructing a practical in vitro bench...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.2009.00951.x

    authors: Dur O,Lara M,Arnold D,Vandenberghe S,Keller BB,DeGroff C,Pekkan K

    更新日期:2009-11-01 00:00:00

  • Regenerative medicine for cardiovascular disorders-new milestones: adult stem cells.

    abstract::Cardiovascular disorders are the leading causes of mortality and morbidity in the developed world. Cell-based modalities have received considerable scientific attention over the last decade for their potential use in this clinical arena. This review was intended as a brief overview on the subject of therapeutic potent...

    journal_title:Artificial organs

    pub_type: 杂志文章,评审

    doi:10.1111/j.1525-1594.2006.00209.x

    authors: Akar AR,Durdu S,Corapcioglu T,Ozyurda U

    更新日期:2006-04-01 00:00:00

  • Hemolysis test of a centrifugal pump in a pulsatile mode: the effect of pulse rate and RPM variance.

    abstract::Centrifugal pumps are generally employed as nonpulsatile blood flow pumps; however, these pumps can produce pulsatile flow by periodically alternating the impeller rotation speed. This study investigates blood trauma due to the effect of pulse frequency and various ranges of pump speed. The hemolysis tests were conduc...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1997.tb00489.x

    authors: Tayama E,Niimi Y,Takami Y,Ohashi Y,Ohtsuka G,Glueck JA,Mueller J,Nosé Y

    更新日期:1997-12-01 00:00:00

  • Risk factor forlung infection in recipients after liver transplantation:a meta-analysis.

    abstract:OBJECTIVE:Lung infection (LI) often occurs in patients with liver transplantation (LT). This meta-analysis was conducted to determine the risk factors associated with LI after LT. METHODS:We retrieved relevant research published as of February 2020 from 8 electronic databases. The studieswere reviewed against the incl...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/aor.13826

    authors: Zhang J,He Q,Du L,Ji R,Yuan L,Zhang H,Yuan X,Shen L,Li Y

    更新日期:2020-09-26 00:00:00

  • Transcutaneous monitoring of blood gas tensions in patients on intermittent peritoneal dialysis.

    abstract::A relative contraindication to intermittent peritoneal dialysis (IPD) is chronic lung disease. To evaluate whether the instillation of 2 L of fluid into the peritoneal cavity affects respiratory function, five IPD patients were studied in the supine position during the first 4 h of a routine IPD session. Blood gas ten...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1988.tb02768.x

    authors: Korzets Z,Pomeranz A,Shachor Y,Bernheim J

    更新日期:1988-06-01 00:00:00

  • Effect of hemodialysis on T lymphocyte subsets, con-A-activated suppressor cell activity, and interleukin-2 receptor expression on lymphocytes in chronic uremic patients.

    abstract::Effect of hemodialysis (HD) on some indices of immune response was studied in nine chronic uremics. Total lymphocyte, OKT4+, and OKT8+ cell numbers significantly decreased during the first 20 min of HD, and they were decreased till the third hour of the procedure, whereas the OKT4+/OKT8+ cell number ratio did not chan...

    journal_title:Artificial organs

    pub_type: 杂志文章

    doi:10.1111/j.1525-1594.1989.tb02861.x

    authors: Tchórzewski H,Luciak M,Trznadel K,Majewska E,Pokoca L

    更新日期:1989-06-01 00:00:00