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Research Papers

A Novel In Vitro Testing Approach for the Next Generation of Transvenous Cardiac Leads: Buckling Behavior

[+] Author and Article Information
Donna L. Walsh, Ashok Williams, Oleg Vesnovsky

Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993

L. D. Timmie Topoleski

Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland—Baltimore County,
Baltimore, MD 21250

Nandini Duraiswamy

Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903, New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: Nandini.duraiswamy@fda.hhs.gov

1Corresponding author.

Manuscript received September 15, 2017; final manuscript received February 8, 2018; published online April 2, 2018. Assoc. Editor: Xiaoming He.

J. Med. Devices 12(2), 021004 (Apr 02, 2018) (6 pages) Paper No: MED-17-1307; doi: 10.1115/1.4039593 History: Received September 15, 2017; Revised February 08, 2018

Manufacturers are constantly seeking to design new, better performing transvenous cardiac leads to prevent perforation of the heart by the lead tip. Currently, there is no standardized test method to measure the buckling load of leads, a major factor in the propensity of the lead to perforate the heart. This study further investigates the effect of boundary conditions on buckling loads at the lead tip of different transvenous cardiac leads achieved using different variations of our initial physiologically relevant test method. The goals of the test are to create the maximum buckling load with high repeatability and the simplest possible design. A buckling test was performed to capture maximum buckling load using three leads of each model (five currently available cardiac lead models) and were tested in each of six test setups. The buckling test methodology had a substantial effect on the load-displacement profiles, regardless of whether the lead was a pacemaker or defibrillator lead. By adding the right ventricular (RV) constraint, the buckling load more than doubled for most leads. The use of a lubricant reduced friction between the lead body and the RV surface, and thereby subsequently lowered the buckling load in those setups that used the RV constraint. In addition, the use of the lubricant reduced the variability in the results. The addition of both the RV constraint and the lubricant substantially influences the mechanical behavior of transvenous cardiac leads and is recommended for buckling testing of transvenous cardiac leads.

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References

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Figures

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Fig. 1

6 setups × 5 models × 3 leads × 3 sets = 270 total tests

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Fig. 2

The six different setups used in our tests. The setups with suffixes ending in “RV” have added the RV constraint and those ending in “L” added the silicone lubricant.

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Fig. 3

A representative lead reaching steady-state peak load

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Fig. 4

Average maximum load during 50th cycle in six different test setups with five transvenous cardiac lead models. Unless otherwise indicated, N = 3 leads per model, with each lead tested three times. *N = 1 lead (lead 4), tested three times; #N = 3 leads (lead 5), however, two out of the three leads could be tested only two times.

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Fig. 5

The normalized (unit-less) average maximum buckling loads (with respect to AV loads) for all transvenous cardiac leads in all setups

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Fig. 6

Fiftieth cycle load versus displacement profiles for a single lead model (N = 3, leads A, B, and C), showing each of the three tests for each lead

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Fig. 7

Types of interactions observed between the distal lead tip and the base plate: (a) tip of helix contacts base plate and the lead body touches inside of RV (rectangle shown here); (b) tip of the lead body touches base plate; (c) lead body is parallel and rests in contact with base plate; and (d) lead helix slides up the side of the base plate

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Fig. 8

Load versus displacement profiles of lead 2 showing differences in setups without (left) and with (right) RV constraint. Note different scales in the Y-axis.

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