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    Design of an Experimental Test System to Investigate Parameters Affecting Distal Tip Loads of Pacemaker and Defibrillator Leads

    Source: Journal of Medical Devices:;2015:;volume( 009 ):;issue: 001::page 11001
    Author:
    Stephen, Elizabeth A.
    ,
    Walsh, Donna L.
    ,
    Duraiswamy, Nandini
    ,
    Vesnovsky, Oleg
    ,
    Timmie Topoleski, L. D.
    DOI: 10.1115/1.4028517
    Publisher: The American Society of Mechanical Engineers (ASME)
    Abstract: The purpose of this study was to design and evaluate a system to test the mechanical behavior of pacemaker and defibrillator leads. Over 300,000 pacemaker and implantable cardioverter defibrillator (ICD) procedures are performed every year in the U.S. for the treatment of cardiac arrhythmias, ventricular dysrhythmias, and congestive heart failure. These procedures require implanting transvenous leads into the interior wall of the heart. A serious and sometimes fatal complication that may occur during or after lead implantation is perforation of the lead tip through the heart wall. The factors that lead to perforation are not fully understood. This illustrates that the mechanical interactions between the lead tip and the cardiac tissue need to be further investigated to improve the outcome for pacemaker and ICD patients. To improve the performance of lead tips, the testing protocols must reproduce physiological and clinically relevant tiptissue interactions. As a first step toward this goal, testing parameters that influence those interactions must be identified. We investigated the effect of test system parameters, which reproduce potentially critical physiological constraints, on the load experienced at the distal tip of thirteen pacemaker and defibrillator activefixation leads. We evaluated the use of a constraint to simulate the effect of the right ventricle (RV constraint) in vivo, how and where the lead was fixed in the test configuration, location of the load cell in the test system, rotation and frequency of the test protocol, and the effect of stylets. Results showed the RV constraint and load cell placement had the largest impact on lead tip load, while rotation of the test setup and test frequency had a minimal impact. Recommendations are made for a test system and protocol for in vitro testing of leads that take into consideration in vivo conditions. Better approximations of the in vivo environment may lead to improved product development. The potential of this system to more effectively evaluate new pacemaker and defibrillator lead designs will require further study.
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      Design of an Experimental Test System to Investigate Parameters Affecting Distal Tip Loads of Pacemaker and Defibrillator Leads

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    http://yetl.yabesh.ir/yetl1/handle/yetl/159029
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    • Journal of Medical Devices

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    contributor authorStephen, Elizabeth A.
    contributor authorWalsh, Donna L.
    contributor authorDuraiswamy, Nandini
    contributor authorVesnovsky, Oleg
    contributor authorTimmie Topoleski, L. D.
    date accessioned2017-05-09T01:21:33Z
    date available2017-05-09T01:21:33Z
    date issued2015
    identifier issn1932-6181
    identifier othermed_009_01_011001.pdf
    identifier urihttp://yetl.yabesh.ir/yetl/handle/yetl/159029
    description abstractThe purpose of this study was to design and evaluate a system to test the mechanical behavior of pacemaker and defibrillator leads. Over 300,000 pacemaker and implantable cardioverter defibrillator (ICD) procedures are performed every year in the U.S. for the treatment of cardiac arrhythmias, ventricular dysrhythmias, and congestive heart failure. These procedures require implanting transvenous leads into the interior wall of the heart. A serious and sometimes fatal complication that may occur during or after lead implantation is perforation of the lead tip through the heart wall. The factors that lead to perforation are not fully understood. This illustrates that the mechanical interactions between the lead tip and the cardiac tissue need to be further investigated to improve the outcome for pacemaker and ICD patients. To improve the performance of lead tips, the testing protocols must reproduce physiological and clinically relevant tiptissue interactions. As a first step toward this goal, testing parameters that influence those interactions must be identified. We investigated the effect of test system parameters, which reproduce potentially critical physiological constraints, on the load experienced at the distal tip of thirteen pacemaker and defibrillator activefixation leads. We evaluated the use of a constraint to simulate the effect of the right ventricle (RV constraint) in vivo, how and where the lead was fixed in the test configuration, location of the load cell in the test system, rotation and frequency of the test protocol, and the effect of stylets. Results showed the RV constraint and load cell placement had the largest impact on lead tip load, while rotation of the test setup and test frequency had a minimal impact. Recommendations are made for a test system and protocol for in vitro testing of leads that take into consideration in vivo conditions. Better approximations of the in vivo environment may lead to improved product development. The potential of this system to more effectively evaluate new pacemaker and defibrillator lead designs will require further study.
    publisherThe American Society of Mechanical Engineers (ASME)
    titleDesign of an Experimental Test System to Investigate Parameters Affecting Distal Tip Loads of Pacemaker and Defibrillator Leads
    typeJournal Paper
    journal volume9
    journal issue1
    journal titleJournal of Medical Devices
    identifier doi10.1115/1.4028517
    journal fristpage11001
    journal lastpage11001
    identifier eissn1932-619X
    treeJournal of Medical Devices:;2015:;volume( 009 ):;issue: 001
    contenttypeFulltext
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    DSpace software copyright © 2002-2015  DuraSpace
    نرم افزار کتابخانه دیجیتال "دی اسپیس" فارسی شده توسط یابش برای کتابخانه های ایرانی | تماس با یابش
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