Abstract:
:The aim of this study was to evaluate the safety and performance of the Arrow CorAide left ventricular assist system (LVAS) (Arrow International, Reading, PA, USA), a continuous-flow left ventricular assist device, as bridge to transplantation or recovery as well as destination therapy in patients with New York Heart Association (NYHA) class IV heart failure. Twenty-one patients were implanted with the CorAide LVAS between February 2005 and February 2006 in a prospective, multicenter, nonrandomized trial. Seventeen patients (81%) survived to >180 days or to transplantation. The cumulative time on device was 16.58 patient years (range 23-796 days, median 192 days). No intraoperative technical issues were observed at the time of implantation. Of the 21 implants, nine patients died on device, two were converted to other devices, and 10 were transplanted. Three patient deaths were attributed to pump polymer coating delamination. Postmortem device inspection determined delamination of the polymer coating on the pump's internal surface to be the cause of the late hemolysis and sudden fatal pump stops. No embolic or driveline infection event was recorded. The automatic flow control algorithm functioned reliably throughout the trial. Primary performance trial endpoint was achieved with 81% survival to 180 days or transplantation. Delamination of the polymer coating on the internal surface of the pump with resultant hemolysis and pump stops was the sole major device event in this trial. Elimination of the polymer coating and replacement with an amorphous carbon coating has resolved this in preclinical testing, prior to initiation of further clinical testing of this device.
journal_name
Artif Organsjournal_title
Artificial organsauthors
Saeed D,Arusoglu L,Gazzoli F,Hetzer R,Morshius M,Alloni A,Viganò M,Koerfer R,Golding LA,El Banayosy Adoi
10.1111/j.1525-1594.2012.01539.xsubject
Has Abstractpub_date
2013-02-01 00:00:00pages
121-7issue
2eissn
0160-564Xissn
1525-1594journal_volume
37pub_type
杂志文章,多中心研究,随机对照试验abstract::In cardiac surgeries, it is frequently necessary to make the external blood circulation and oxygenation artificially. This procedure is called extracorporeal circulation (EC) or heart-lung bypass. During EC, one of the most important parameters, which demands continuous monitoring, is the blood flow. In many cases, th...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2000.06532.x
更新日期:2000-03-01 00:00:00
abstract::The heparin-conjugated fibrin (HCF) system has been developed to deliver bone morphogenetic proteins (BMPs) for a long-term period and thus enhance bone regeneration. In the present study, we tested the effectiveness of the delivery system for spinal fusion with a very low dose of BMP-2. A total of 15 rabbits underwen...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2012.01578.x
更新日期:2013-05-01 00:00:00
abstract::With the incidence of end-stage heart failure steadily increasing, the need for a practical total artificial heart (TAH) has never been greater. Continuous flow TAHs (CFTAH) are being developed using rotary blood pumps (RBPs), leveraging their small size, mechanical simplicity, and excellent durability. To completely ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13631
更新日期:2020-06-01 00:00:00
abstract::Plasma procoagulant activities of factors XII, XI, IX, and VIII and plasma concentrations of factor XII antigen and high molecular weight kininogen (HMK) were determined in nine men with chronic renal failure (CRF) associated with long-standing spinal cord injury (SCI) treated with hemodialysis. The results were compa...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1985.tb04366.x
更新日期:1985-05-01 00:00:00
abstract::The energy dissipated in blood or on a total artificial heart (TAH) chamber's elements directly or indirectly decreases the biological or technical safety of the TAH's work. The energetic analysis of the Polish total artificial heart (POLTAH) external work with the objective of estimating the valve and membrane roles ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.1998.05074.x
更新日期:1998-10-01 00:00:00
abstract::This study introduces a newly developed method for the formation of a stationary phase superficially embedded with immunoadsorbent, that is partially incomplete two-stage polymerization of acrylamide. Preliminary experimental studies show that binding activity of the immunoadsorbent was satisfactorily maintained after...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2005.29071.x
更新日期:2005-05-01 00:00:00
abstract::Sponge-type small-diameter vascular grafts were fabricated from a medical-grade polyurethane, Pellethane 2363-80A, by utilization of a salt casting technique. The grafts were compliance matched with a storage modulus of 0.53 +/- 0.08 MPa. The luminal surface of grafts was modified with a thin layer ( approximately 40 ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2003.07141.x
更新日期:2003-12-01 00:00:00
abstract::This article presents computational studies on the effects of inlet guide vanes (IGVs) on the flow pattern and shear stress in a centrifugal blood pump. The effect of IGVs is to introduce a pre-swirl to fluid particles entering the impeller with the intention that the fluid particles will travel along the blade profil...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2002.06917.x
更新日期:2002-06-01 00:00:00
abstract::To analyze the autonomic nervous system during left heart bypass with a vibrating flow pump (VFP), fluctuations in hemodynamic derivatives were evaluated by the spectral analysis method using fast fourier transform methodology. After the left pleural cavity was opened through the fourth intercostal space under general...
journal_title:Artificial organs
pub_type: 杂志文章
doi:
更新日期:1996-06-01 00:00:00
abstract::We have been developing a new type of centrifugal pump for long-term use. The magnetically suspended centrifugal pump (MSCP) contains no shaft and seal so that long life expectancy is predicted. Paracorporeal left ventricular (LV) assist circulation between the left atrium and the descending aorta was instituted using...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1997.tb03713.x
更新日期:1997-07-01 00:00:00
abstract::In 1976, the authors became the codevelopers of the first successful bileaflet heart valve which has become the standard in valvular surgery. However, there still remains a significant rate of thromboembolism and thrombosis which can be attributed to the inherent design of cavities in the pivot area. These cavities co...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2002.06999.x
更新日期:2002-05-01 00:00:00
abstract::Transcatheter aortic valve (TAV) replacement has become a viable alternative to surgery for high and intermediate risk patients with severe aortic stenosis. This technology may extend to the younger and lower risk patients. In this population, long-term durability of the TAV is key. Increased leaflet mechanical stress...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13654
更新日期:2020-07-01 00:00:00
abstract::Our study investigated the reliability of appearance of rapid atrial swirl flow (RASF) by ultrasonography (US) in the right atrium (RA), which occurred as a result of rapid isotonic saline infusion (RISI) into the central venous catheter (CVC), in predicting catheter tip position. This prospective observational study ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13281
更新日期:2018-12-01 00:00:00
abstract::Testing failed to detect free isocyanates in dialyzer rinses or significant levels of immunoglobulin E antibodies to isocyanate-protein conjugates in the serum of individuals reacting during hemodialysis with dialyzers containing Cuprophan membranes. Extended immunization of rabbits with Limulus lysate-reactive materi...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1984.tb04298.x
更新日期:1984-08-01 00:00:00
abstract::Aortic wall thinness was one of the most characteristic changes observed in experimental animals under prolonged continuous flow left heart bypass. The goal of this study was to determine the roles of smooth muscle cells in the vascular remodeling process in cases demonstrating aortic wall thinness under prolonged con...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2003.00022.x
更新日期:2003-10-01 00:00:00
abstract::In chronic cardiomyopathy, mechanical circulatory support (MCS) plays an increasingly important role for children as the shortage of suitable donor hearts increases waiting time on the transplant list. We report our experience with the paracorporal Berlin Heart EXCOR System (Berlin Heart AG, Berlin, Germany) used as a...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12062
更新日期:2013-08-01 00:00:00
abstract::Rheologic factors are likely to influence the balance between thrombotic and antithrombotic forces at the level of the vascular wall. In this study, the effects of flow-velocity/wall shear stress on the interaction of antithrombin (AT) with surface-immobilized heparin were investigated. The binding of AT to low-affini...
journal_title:Artificial organs
pub_type: 杂志文章
doi:
更新日期:1991-12-01 00:00:00
abstract::The major problems with existing centrifugal pumps are leakage, mechanical trauma, and thrombus formation. In consideration of these problems, a new compact centrifugal pump system was developed. The purpose of this study was to evaluate the new centrifugal pump system clinically. Ten patients underwent open heart sur...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1994.tb03403.x
更新日期:1994-09-01 00:00:00
abstract::We treated 12 patients with rheumatoid arthritis by filtration leukocytapheresis (FLCP) and evaluated its effect on leukocyte enzyme activities. We calculated the number of leukocytes removed and assessed the clinical response. We also evaluated the cellular enzyme activities of elastase and dipeptidylpeptidase IV (DP...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2002.06834.x
更新日期:2002-04-01 00:00:00
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
更新日期:2020-07-22 00:00:00
abstract::Therapeutic means to lower Lp(a) are limited. The most effective method to reduce plasma Lp(a) concentration significantly is therapeutic apheresis, namely, low-density lipoprotein (LDL) lipoprotein(a) (Lp(a)) apheresis. A novel technique based on reusable LDL adsorber called Lipocollect 200 (Medicollect, Rimbach, Ger...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2009.00959.x
更新日期:2009-12-01 00:00:00
abstract::Stents are small, usually metallic tubes that are intended to prop open arteries blocked with atherosclerotic plaques. While stents have been used successfully in recent years, they still suffer from failure due to development of new tissue in stented segment (restenosis). Variations in the failure rates associated wi...
journal_title:Artificial organs
pub_type: 杂志文章,评审
doi:10.1046/j.1525-1594.2002.07084.x
更新日期:2002-07-01 00:00:00
abstract::The kinetic features of ultrafiltration of cellulose dialysis membrane stored under various humidity and temperature conditions were studied to obtain basic information of shelf-life characteristics of dialyzers. The ultrafiltration rate (UFR) decreased with time and the UFR-time curve suggested that the UFR would app...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1981.tb04003.x
更新日期:1981-08-01 00:00:00
abstract::The products of complement activation, including C3a, C4a, C5a, and their des Arg derivatives, have been used by many investigators as indicators of blood or foreign surface bioincompatibility, e.g., during hemodialysis. One problem encountered is that after extracorporeal circulation over some dialysis membranes very...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1986.tb02518.x
更新日期:1986-02-01 00:00:00
abstract::For introduction of a left atrial (LA) cannula by the transseptal puncture technique, we examined the feasibility of using biplane transesophageal echocardiography (B-TEE). A transseptal puncture was performed on 15 patients (3 male; 12 female; mean age, 48.9 +/- 11.2 years) by B-TEE guide during percutaneous transven...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1992.tb00537.x
更新日期:1992-08-01 00:00:00
abstract::Current hemodialysis treatment is insufficient because of intermittent treatment and loss of tubular function. In order to overcome the loss of tubular function, a bioartificial kidney has been developed consisting of continuous hemofiltration (CHF) with 10 L/day of filtrate and a bioartificial tubule device using pro...
journal_title:Artificial organs
pub_type: 临床试验,杂志文章
doi:10.1111/j.1525-1594.2004.07323.x
更新日期:2004-01-01 00:00:00
abstract::The purpose of this paper is to review the pathways of hydrogen ion production and removal due to intermediary metabolism. The principal method of analysis employed was one based on a theoretical approach because it is the most accurate and has the broadest application. In the absence of hypoxia and insulin deficiency...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1982.tb04126.x
更新日期:1982-11-01 00:00:00
abstract::This article reports preliminary results of pilot studies of a new implantable two channel drop foot stimulator. The stimulator consists of an externally worn transmitter inductively coupled to an implanted receiver unit located in the lower leg, lateral and distal to the knee. The receiver is connected to electrodes ...
journal_title:Artificial organs
pub_type: 临床试验,杂志文章
doi:10.1046/j.1525-1594.2002.06949.x
更新日期:2002-03-01 00:00:00
abstract::The cochlea is an end organ, which is metabolically dependent on a nutrient and oxygen supply to maintain its normal physiological function. Cochlear ischemia and reperfusion (IR) injury is considered one of the most important causes of human idiopathic sudden sensorineural hearing loss. The aim of the present study w...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12863
更新日期:2017-08-01 00:00:00
abstract::Although extracorporeal membrane oxygenation (ECMO) improves oxygenation, pulmonary vascular resistance may be increased due to endothelial function impairment. Inhaled nitric oxide (iNO) is increasingly used for treatment of pulmonary hypertension after surgical repair of congenital heart defects, with or without ECM...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.1999.06448.x
更新日期:1999-11-01 00:00:00