Chronic Survival of Calves Implanted with the DeBakey Ventricular Assist Device

Fossum, Theresa W.; Morley, Deborah; Benkowski, Robert; Tayama, Eiki; Olsen, Don B.; Burns, Gregory L.; Miller, Matthew W.; Franks, Joanne N.; Martinez, Elizabeth A.; Carroll, Gwendolyn L.; Edwards, John F.; Vinnerqvist, Anders; Lynch, Bryan; Stein, Frank; Noon, George P.; DeBakey, Michael E.

doi:10.1046/j.1525-1594.1999.06423.x

Cited by 23 publications

(9 citation statements)

References 5 publications

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“…Methods of postoperative anticoagulation management differed among this sample of investigators. The majority of investigators combined heparin with warfarin, with or without thrombocyte aggregation inhibitors like aspirin and clopidogrel (9,14,27–31,61). Promising results in minimizing thromboembolic complications have been obtained in these experiments, without a significant increase in the risk of postoperative bleeding.…”

Section: Discussionmentioning

confidence: 99%

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In Vivo Preclinical Anticoagulation Regimens After Implantation of Ventricular Assist Devices

Saeed¹,

Fukamachi²

2009

Artificial Organs

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Ventricular assist devices (VADs) have demonstrated successfully their ability to treat failing circulation of patients with end-stage heart failure. Among the main obstacles with these VADs is thromboembolic events that increase device-related morbidity and mortality. Prior to the clinical application of any newly developed VAD, the feasibility of the device is tested on animal models. Animal species have different hemostatic properties than human patients, and this factor creates a margin of error when comparing the occurrence of VAD-induced thrombosis in an animal versus a human. This detailed literature review provides a thorough documentation of various preclinical anticoagulation protocols used to date, including their outcomes and recommendations for future anticoagulation management strategies. In summary, the outcomes favor a sheep or pig model over other animal models, and discourage the application of a single anticoagulative agent to improve outcomes with any of the currently available devices.

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Section: Discussionmentioning

confidence: 99%

“…Fossum et al. (26,61) reported the outcomes of implantation of the DeBakey VAD initially in 19 calves for 7–145 days and in another experiment in six calves for 90 days. Anticoagulation was achieved with 50 U/kg heparin at a target ACT range of 1.5–2 times baseline.…”

Section: Effect Of Device Typementioning

confidence: 99%

In Vivo Preclinical Anticoagulation Regimens After Implantation of Ventricular Assist Devices

Saeed¹,

Fukamachi²

2009

Artificial Organs

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“…The purpose is to assess hemodynamic performance and the ability of the pump to support life and maintain the integrity of the cardiovascular system. Researchers typically select sheep (ovine), cows (bovine), pig (porcine), and nonsurvival dog (canine) models for artificial blood pump testing (39–42). Research institutes choose a certain animal based on the belief that physiologic data obtained from the experiment will provide the most valuable insight into pump performance.…”

Section: Methods Of Failure Evaluationmentioning

confidence: 99%

Methods of Failure and Reliability Assessment for Mechanical Heart Pumps

et al. 2005

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Artificial blood pumps are today's most promising bridge-to-recovery (BTR), bridge-to-transplant (BTT), and destination therapy solutions for patients suffering from intractable congestive heart failure (CHF). Due to an increased need for effective, reliable, and safe long-term artificial blood pumps, each new design must undergo failure and reliability testing, an important step prior to approval from the United States Food and Drug Administration (FDA), for clinical testing and commercial use. The FDA has established no specific standards or protocols for these testing procedures and there are only limited recommendations provided by the scientific community when testing an overall blood pump system and individual system components. Product development of any medical device must follow a systematic and logical approach. As the most critical aspects of the design phase, failure and reliability assessments aid in the successful evaluation and preparation of medical devices prior to clinical application. The extent of testing, associated costs, and lengthy time durations to execute these experiments justify the need for an early evaluation of failure and reliability. During the design stages of blood pump development, a failure modes and effects analysis (FMEA) should be completed to provide a concise evaluation of the occurrence and frequency of failures and their effects on the overall support system. Following this analysis, testing of any pump typically involves four sequential processes: performance and reliability testing in simple hydraulic or mock circulatory loops, acute and chronic animal experiments, human error analysis, and ultimately, clinical testing. This article presents recommendations for failure and reliability testing based on the National Institutes of Health (NIH), Society for Thoracic Surgeons (STS) and American Society for Artificial Internal Organs (ASAIO), American National Standards Institute (ANSI), the Association for Advancement of Medical Instrumentation (AAMI), and the Bethesda Conference. It further discusses studies that evaluate the failure, reliability, and safety of artificial blood pumps including in vitro and in vivo testing. A descriptive summary of mechanical and human error studies and methods of artificial blood pumps is detailed.

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“…After 5 years, this axial flow blood pump proved to be ready for clinical application ( Fig. 13) (28). MicroMed Technology, Inc. (Houston, TX, U.S.A.) achieved conversion of a preproduction model to a mass-produced model in 1 year.…”

Section: Long-term Blood Pump For Bridge-to-transplantationmentioning

confidence: 99%

Development of Rotary Blood Pump Technology: Past, Present, and Future

et al. 2000

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Even though clinical acceptance of a nonpulsatile blood flow was demonstrated almost 45 years ago, the development of a nonpulsatile blood pump was completely ignored until 20 years ago. In 1979, the first author's group demonstrated that completely pulseless animals did not exhibit any abnormal physiology if 20% higher blood flows were provided to them. However, during the next 10 years (1979-1988), minimum efforts were provided for the development of a nonpulsatile, permanently implantable cardiac prosthesis. In 1989, the first author and his team at Baylor College of Medicine initiated a developmental strategy of various types of nonpulsatile rotary blood pumps, including a 2-day rotary blood pump for cardiopulmonary bypass application, a 2 week pump for ECMO and short-term circulatory assistance, a 2 year pump as a bridge to transplantation, and a permanently implantable cardiac prosthesis. Following the design and developmental strategy established in 1989, successful development of a 2-day pump (the Nikkiso-Fairway cardiopulmonary bypass pump) in 4 years (1989-1993), a 2 week pump (Kyocera gyro G1E3 pump) in 6 years (1992-1998), and a bridge to transplant pump (DeBakey LVAD-an axial flow blood pump) in 10 years (1988-1998) was made. Currently, a permanently implantable centrifugal blood pump development program is successfully completing its initial Phase 1 program of 5 years (1995-2000). Implantation exceeded 9 months without any negative findings. An additional 5 year Phase II program (2000-2005) is expected to complete such a device that will be clinically available.

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Chronic Survival of Calves Implanted with the DeBakey Ventricular Assist Device

Cited by 23 publications

References 5 publications

In Vivo Preclinical Anticoagulation Regimens After Implantation of Ventricular Assist Devices

In Vivo Preclinical Anticoagulation Regimens After Implantation of Ventricular Assist Devices

Methods of Failure and Reliability Assessment for Mechanical Heart Pumps

Development of Rotary Blood Pump Technology: Past, Present, and Future

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