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      Rotary mechanical circulatory support systems

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          Abstract

          A detailed survey of the current trends and recent advances in rotary mechanical circulatory support systems is presented in this paper. Rather than clinical reports, the focus is on technological aspects of these rehabilitating devices as a reference for engineers and biomedical researchers. Existing trends in flow regimes, flow control, and bearing mechanisms are summarized. System specifications and applications of the most prominent continuous-flow ventricular assistive devices are provided. Based on the flow regime, pumps are categorized as axial flow, centrifugal flow, and mixed flow. Unique characteristics of each system are unveiled through an examination of the structure, bearing mechanism, impeller design, flow rate, and biocompatibility. A discussion on the current limitations is provided to invite more studies and further improvements.

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          Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation.

          Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes. We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly. A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
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            A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience.

            We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI). The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation. In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction 10 min). The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI. The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859).
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              Gastrointestinal bleeding rates in recipients of nonpulsatile and pulsatile left ventricular assist devices.

              Pulsatile and nonpulsatile left ventricular assist devices are effective in managing congestive heart failure. Despite early evidence for clinical efficacy, the long-term impact of nonpulsatile flow on end-organ function remains to be determined. Our goal was to compare rates of gastrointestinal bleeding in nonpulsatile and pulsatile device recipients. In a retrospective review of 101 left ventricular assist device recipients (55 nonpulsatile, 46 pulsatile) from October 31, 2003, to June 1, 2007, at a single center, gastrointestinal bleeding was defined as guaiac-positive stool with hemoglobin drop requiring transfusion of at least 2 units of packed red blood cells. To assess bleeding risk outside the initial postoperative course, any patients with a device in place for 15 days or less was excluded. Twelve nonpulsatile and 3 pulsatile left ventricular assist device recipients had gastrointestinal bleeding 16 days or longer after device implantation. The event rates were 63 events/100 patient-years for nonpulsatile devices and 6.8 events/100 patient-years for pulsatile devices (P = .0004). This difference persisted for bleeding occurring 31 days or longer after device implantation, with 46.5 events/100 patient-years for nonpulsatile devices versus 4.7 events/100 patient-years for pulsatile devices (P = .0028). Mortalities were similar between groups (15% nonpulsatile vs 17% pulsatile, P = .6965). Patients with nonpulsatile left ventricular assist devices appear to have a higher rate of gastrointestinal bleeding events than do pulsatile left ventricular assist device recipients. Further prospective evaluation is needed to determine potential etiologies and strategies for reducing gastrointestinal bleeding in this population.
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                Author and article information

                Journal
                J Rehabil Assist Technol Eng
                J Rehabil Assist Technol Eng
                JRT
                spjrt
                Journal of Rehabilitation and Assistive Technologies Engineering
                SAGE Publications (Sage UK: London, England )
                2055-6683
                01 September 2017
                Jan-Dec 2017
                : 4
                : 2055668317725994
                Affiliations
                [1 ]Dynamic and Smart Systems Laboratory, The University of Toledo, Toledo, OH, USA
                [2 ]Department of Mechanical Engineering, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA
                [3 ]Cardiovascular Medicine Division, The University of Toledo Medical Center, Toledo, OH, USA
                [4 ]Cardiothoracic Surgery Division, The University of Toledo Medical Center, Toledo, OH, USA
                Author notes
                [*]Milad Hosseinipour, Department of Mechanical Engineering, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA. Email: mhp@ 123456vt.edu
                Author information
                http://orcid.org/0000-0002-7532-0282
                Article
                10.1177_2055668317725994
                10.1177/2055668317725994
                6453075
                4d090ec0-fa81-484e-8648-89d46bd51be6
                © The Author(s) 2017

                This article is distributed under the terms of the Creative Commons Attribution 4.0 License ( http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 27 May 2017
                : 20 July 2017
                Categories
                Special Collection: Advances in Rehabilitation Engineering with Robotics and Mechatronic Devices
                Custom metadata
                January-December 2017

                assistive technology,biomedical devices,life support systems,orthotics,rehabilitation devices,heart failure,mechanical circulatory support,ventricular assistive device

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