Procedures: Procedures 2 |

Performance of a Novel 19g EBUS-TBNA Needle in Patients FREE TO VIEW

Anna Sczaniecka, PhD; Xavier Gonzalez, MD; Alain Tremblay, MD; Kazuhiro Yasufuku, MD
Author and Funding Information

Spiration, Inc., dba Olympus Respiratory America, Redmond, WA

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;150(4_S):1015A. doi:10.1016/j.chest.2016.08.1121
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SESSION TITLE: Procedures 2

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM

PURPOSE: To evaluate the performance of a new flexible 19G EBUS-TBNA needle in patients.

METHODS: A new 19G EBUS-TBNA needle (Olympus Respiratory America, Redmond, WA, USA) with a larger diameter and improved flexibility was provided to 2 centers experienced with EBUS-TBNA (20 needles each). Physicians at both sites were asked to complete forms evaluating the performance of the needles in a case series 07/2015-09/2015. The stations sampled were recorded and needle performance was assessed at each target location. The questions included ratings of absolute (stand-alone) and relative (compared to physicians’ historical experience with other needles) performance in the areas of penetration, visibility, and ability to collect samples.

RESULTS: A total of 93 lymph node stations were sampled in 39 patients by 10 physicians with 40 needles. All 40 evaluation forms were returned and subsequently analyzed. The needles were used in the following locations: 72.5% were used to sample station 7, 57.5% in 4R, 30.0% in 11R, 25.0% in 4L, 17.5% in tumors, 15.0% in 11L, 5.0% in 2R, 2.5% in 2L, 2.5% in 10L, 2.5% in 10R, and 2.5% in 11Ri. There were no complications. For relative performance, when asked “Did the device collect adequate samples?,” physicians graded the sample collected by the Flex 19G needle as comparable or better on 80% of forms. In response to the question, “Did the device penetrate the targets?” 75% of the forms indicated comparable or better results. To the question, “Was the device visible during sampling?” 75% of the forms provided comparable or better results. For absolute performance, physicians rated the ability of the device to collect samples, its ability to penetrate, and its visibility as acceptable 95%, 90%, and 97% of the time respectively.

CONCLUSIONS: The Flex 19G needle can easily access common EBUS-TBNA sampling locations. This device has design features that improve flexibility, visibility and penetration to allow the collection of large volumetric samples. No complications were observed. Further clinical evaluations are warranted.

CLINICAL IMPLICATIONS: The flexible 19G EBUS-TBNA needle has the potential to provide larger volumetric samples that may be helpful for conditions such as sarcoidosis or lymphoma and to provide more material for molecular testing.

DISCLOSURE: Anna Sczaniecka: Employee: Olympus Respiratory America Xavier Gonzalez: Employee: Olympus Respiratory America Alain Tremblay: Consultant fee, speaker bureau, advisory committee, etc.: Olympus, Grant monies (from industry related sources): Olympus Kazuhiro Yasufuku: Consultant fee, speaker bureau, advisory committee, etc.: Olympus, Grant monies (from industry related sources): Olympus

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