Research and development of an implantable, axial-flow left ventricular assist device: the Jarvik 2000 Heart (original) (raw)
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Journal of Artificial Organs, 2014
The aim of this study was to evaluate our clinical experience with the Jarvik 2000 axial flow pump (Jarvik Heart, Inc, New York, NY, USA), a miniature axial flow left ventricular assist device (LVAD). The clinical results of eight patients, who underwent LVAD implantation with the Jarvik 2000 (median age 55.0 years; six men) between 2005 and 2010, including two who participated in a multicenter clinical trial in Japan, were reviewed. Two patients underwent LVAD implantation as destination therapy. Four patients underwent Jarvik 2000 implantation via median sternotomy, while the other four underwent implantation via left thoracotomy. There were no major complications during surgery. Four patients were supported for more than 2 years. The longest support duration was 1,618 days. Six patients successfully bridged to heart transplantation after a median 725 days of support. One patient on destination therapy died of a cerebral infarction. The other patient on destination therapy had had the LVAD for 1,618 days. The overall survival rates at 1, 2, and 3 years were 100, 86, and 86 %, respectively. The median postoperative serum lactate dehydrogenase level was 860.
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2018
The Jarvik 2000 ventricular assist device features a miniaturized intraventricular pump and an intermittent low-speed function that facilitates aortic valve opening. Despite its long history, little is known about the Jarvik device with regard to post-implantation outcomes. Prospectively collected data from 13 participating hospitals were extracted from the Japanese Registry for Mechanically Assisted Circulatory Support database to analyze mortality, morbidity and de-novo aortic regurgitation. Data on 83 patients who underwent implantation of the Jarvik 2000 were reviewed. Median support duration was 191 (maximum 758) days. All recipients underwent implantation as a bridge to transplantation. Overall survival proportions at 1 and 2 years were 85.0% and 79.3%, respectively. Nine patients were in INTERMACS Level 1, and 28 patients were on mechanical circulatory support at the time of implantation. Causes of death included stroke, infection and device malfunction. Three patients had th...
Midterm experience with the Jarvik 2000 axial flow left ventricular assist device
The Journal of Thoracic and Cardiovascular Surgery, 2007
Rotary axial flow pumps have several potential advantages and disadvantages over pulsatile pumps. The Jarvik 2000 is distinctive in being intracardiac. We report our experience in 22 patients. The Jarvik 2000 was implanted in 15 men and 7 women. Mean age was 38.8 (range 23-59) years, preoperative diagnosis was dilated cardiomyopathy in 16, postpartum cardiomyopathy in 3, ischemic heart disease in 2, and chronic allograft failure in 1. Twenty-one patients were in New York Heart Association class IV, and 1 patient was in class III. Nineteen patients were on inotropic support, 6 were supported with an intra-aortic balloon pump, and 2 patients had been salvaged with a Centrimag (Levitronix) ventricular assist device. The median pulmonary vascular resistance was 3 Wood units; median pulmonary capillary wedge pressure was 26.6 mm Hg; and mean Cardiac Index was 1.5 L/min/m2. There were 2 early deaths and 6 late deaths. The average postoperative ventilation time and Intensive Treatment Unit stay was 2.2 and 10 days, respectively. One patient required a right ventricular assist device for short-term support and another for medium-term support. Seven patients were bridged to transplant, 3 had myocardial recovery, and 4 are ongoing. Mean and total duration of support was 280.5 and 6172 days, respectively. Driveline failures were noted in 3, but there were no pump infections or failure. The Jarvik 2000 provides satisfactory intermediate-term results as a bridge to transplant or recovery. It appears to be associated with a low rate of serious driveline or pump infections and technical failure. However, bleeding complications due to the required anticoagulation treatment frequently occurred.
European Journal of Cardio-Thoracic Surgery, 2003
Objective: The MicroMed DeBakey left ventricular assist device (LVAD) axial blood flow pump was used as bridge to heart transplantation (HTx) in patients with terminal heart failure. The aim was to evaluate this novel mechanical circulatory support system in regard to overall outcome. Methods: Prospective study in 15 HTx candidates (mean age 40^7 years) with terminal heart failure and maximal medical treatment due to ischemic cardiomyopathy (CMP, n ¼ 5), dilated CMP ðn ¼ 3Þ, restrictive CMP ðn ¼ 2Þ, unclassified CMP ðn ¼ 1Þ, metabolic CMP ðn ¼ 1Þ, valvular CMP ðn ¼ 1Þ and congenital CMP ðn ¼ 2Þ. All patients were implanted with a MicroMed DeBakey LVAD. A rescue procedure was necessary in eight critical patients, while seven underwent elective LVAD implantation. Procedures were performed via median sternotomy, in normotherm femoro-femoral CPB (mean duration 59^1 min). Oral Marcoumar q (INR 2.0-3.0) and Aspirin q (100 mg daily) were started as soon as possible. Patients were discharged into a specialized rehabilitation clinic from which it was possible to release them home after a few weeks. Results: Successful implantation and discharge from ICU (mean stay 10^7 days) was possible in 11 patients. Seven were transplanted (mean support 50.7 days) and one is awaiting HTx (support .310 days) in the comfort of his home (NYHA I). Survival was 100% among the transplanted patients. Of the seven elective implants, five, and of the eight rescue procedures three patients underwent successful HTx. Four patients died early, while three patients died late on pump support due to intracranial hemorrhage (n ¼ 2, 73 and 76 days) and chest infection (n ¼ 1, 124 days). All survivors were discharged from hospital, with significant decrease in NYHA class (mean 3.8-2.4 ðn ¼ 11Þ). Treadmill testing showed increased exercise tolerance, from 35 to 71 W ðn ¼ 4Þ. Plasma BNP values (mean 950-162 ng/l ðn ¼ 4Þ) and pulmonary resistance (mean 316 -194.5 dyne s/cm 5 ðn ¼ 3Þ) decreased significantly during LVAD support. Conclusions: The MicroMed DeBakey LVAD is simple to implant; outpatient treatment is safe and efficient. Patients' condition and pulmonary resistances normalize within 6 weeks, making previously considered inoperable patients amenable for HTx. HTx can be performed in low-risk situation, allowing better donor -recipient matching and improving overall outcome. q
A Short-Term In Vivo Evaluation of the Istanbul Heart Left Ventricular Assist Device in a Pig Model
Experimental and Clinical Transplantation, 2019
Objectives: A continuous-flow centrifugal blood pump system has been recently developed as an implantable left ventricular assist device for patients with endstage heart failure. The objective of this study was to evaluate the initial in vivo performance of a newly developed left ventricular assist device (iHeart or Istanbul heart; Manufacturing and Automation Research Center, Koc University, Istanbul, Turkey) in an acute setting using a pig model. Materials and Methods: Three pigs (77, 83, 92 kg) received implants via a median sternotomy, with animals supported for up to 6 hours. An outflow cannula was anastomosed to the ascending aorta. Anticoagulation was applied by intravenous heparin administration. During the support period, pump performance was evaluated under several flow and operating conditions. All pigs were humanely sacrificied after the experiments, and organs were examined macroscopically and histopathologically. Results: Flow rate ranged between 1.5 and 3.6 L/min with pump speeds of 1500 to 2800 revolutions/min and motor current of 0.6 to 1.3 A. Initial findings confirmed that the iHeart ventricular assist device had sufficient hydraulic performance to support the circulation. During the experimental period, plasma free hemoglobin levels were found to be within normal ranges. Thrombus formation was not observed inside the pump in all experiments. Conclusions: The iHeart ventricular assist device demonstrated encouraging hemodynamic performance and good biocompatibility in the pig model for use as an implantable left ventricular assist device. Further acute in vivo studies will evaluate the short-term pump performance prior to chronic studies for long-term evaluation.
HeartMate Left Ventricular Assist Devices: A Multigeneration of Implanted Blood Pumps
Artificial Organs, 2001
The HeartMate family of implanted left ventricular assist devices (LVADs) developed by Thermo Cardiosystems, Inc. (TCI) span a time frame that goes back to the beginning of clinical use of mechanical circulatory support and will stretch well into the foreseeable future. Associated blood pump technology employed in the HeartMates range from an original pusher plate concept to the most advanced rotary pump devices. Starting initially with a pneumatic actuated pusher plate pump, clinical use of the HeartMate I began in 1986. In 1990, electric motor-actuated versions of the HeartMate I began to be used clinically. Presently, the HeartMate I has been implanted in some 2,300 patients worldwide, and this LVAD is a standard by which all others are currently measured. Following the HeartMate I is TCI's next-genera-tion, the HeartMate II, a rotary-pump-based LVAD that uses an axial flow blood pump having blood immersed mechanical bearings. Clinical trials of the HeartMate II were initiated in 2000. The HeartMate III, representing TCI's next-generation LVAD, is structured around a centrifugal blood pump that uses a magnetically levitated rotating assembly. Compared to the HeartMate II, the HeartMate III has the potential for higher overall efficiency. The pump's operating life is not dependent on bearing wear. Given the significantly advanced LVAD technology represented by HeartMates II and III, coupled with the experience of HeartMate I, TCI is well-poised to keep its LVAD products as industry standards in the future.