Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review

Mordechai Goode Sadowsky; Won Sik Jang; Subin Lim; DongKyu Kim; Jason Robert Waggoner; Philippe Grange; Paula Priscilla Veldhuis; Giovanni Antonio Tommaselli

doi:doi:10.11648/j.js.20221005.15

Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, Philippe Grange, Paula Priscilla Veldhuis, Giovanni Antonio Tommaselli

Published in Journal of Surgery (Volume 10, Issue 5)

Received: 7 September 2022 Accepted: 21 September 2022 Published: 11 October 2022

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Abstract

Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods: The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results: One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion: Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.

Published in	Journal of Surgery (Volume 10, Issue 5)
DOI	10.11648/j.js.20221005.15
Page(s)	168-174
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2022. Published by Science Publishing Group

Keywords

Urologic Surgery, HD1000i Shears, Safety, Performance, Ultrasonic Shears

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APA Style

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, et al. (2022). Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. Journal of Surgery, 10(5), 168-174. https://doi.org/10.11648/j.js.20221005.15

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ACS Style

Mordechai Goode Sadowsky; Won Sik Jang; Subin Lim; DongKyu Kim; Jason Robert Waggoner, et al. Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. J. Surg. 2022, 10(5), 168-174. doi: 10.11648/j.js.20221005.15

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AMA Style

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, et al. Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. J Surg. 2022;10(5):168-174. doi: 10.11648/j.js.20221005.15

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@article{10.11648/j.js.20221005.15,
  author = {Mordechai Goode Sadowsky and Won Sik Jang and Subin Lim and DongKyu Kim and Jason Robert Waggoner and Philippe Grange and Paula Priscilla Veldhuis and Giovanni Antonio Tommaselli},
  title = {Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review},
  journal = {Journal of Surgery},
  volume = {10},
  number = {5},
  pages = {168-174},
  doi = {10.11648/j.js.20221005.15},
  url = {https://doi.org/10.11648/j.js.20221005.15},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20221005.15},
  abstract = {Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods: The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results: One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion: Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.},
 year = {2022}
}

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TY  - JOUR
T1  - Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review
AU  - Mordechai Goode Sadowsky
AU  - Won Sik Jang
AU  - Subin Lim
AU  - DongKyu Kim
AU  - Jason Robert Waggoner
AU  - Philippe Grange
AU  - Paula Priscilla Veldhuis
AU  - Giovanni Antonio Tommaselli
Y1  - 2022/10/11
PY  - 2022
N1  - https://doi.org/10.11648/j.js.20221005.15
DO  - 10.11648/j.js.20221005.15
T2  - Journal of Surgery
JF  - Journal of Surgery
JO  - Journal of Surgery
SP  - 168
EP  - 174
PB  - Science Publishing Group
SN  - 2330-0930
UR  - https://doi.org/10.11648/j.js.20221005.15
AB  - Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods: The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results: One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion: Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.
VL  - 10
IS  - 5
ER  -

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Author Information

Mordechai Goode Sadowsky

Ethicon, Inc. Cincinnati, United States of America
Won Sik Jang

Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Subin Lim

Real-World Evidence Team, Yonsei University Health System, Seoul, Republic of Korea
DongKyu Kim

Real-World Evidence Team, Yonsei University Health System, Seoul, Republic of Korea
Jason Robert Waggoner

Ethicon, Inc. Cincinnati, United States of America
Philippe Grange

Department of Family Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
Paula Priscilla Veldhuis

Ethicon, Inc. Cincinnati, United States of America
Giovanni Antonio Tommaselli

Ethicon, Inc. Cincinnati, United States of America

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APA Style

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, et al. (2022). Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. Journal of Surgery, 10(5), 168-174. https://doi.org/10.11648/j.js.20221005.15

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ACS Style

Mordechai Goode Sadowsky; Won Sik Jang; Subin Lim; DongKyu Kim; Jason Robert Waggoner, et al. Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. J. Surg. 2022, 10(5), 168-174. doi: 10.11648/j.js.20221005.15

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AMA Style

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, et al. Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review. J Surg. 2022;10(5):168-174. doi: 10.11648/j.js.20221005.15

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@article{10.11648/j.js.20221005.15,
  author = {Mordechai Goode Sadowsky and Won Sik Jang and Subin Lim and DongKyu Kim and Jason Robert Waggoner and Philippe Grange and Paula Priscilla Veldhuis and Giovanni Antonio Tommaselli},
  title = {Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review},
  journal = {Journal of Surgery},
  volume = {10},
  number = {5},
  pages = {168-174},
  doi = {10.11648/j.js.20221005.15},
  url = {https://doi.org/10.11648/j.js.20221005.15},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20221005.15},
  abstract = {Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods: The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results: One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion: Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.},
 year = {2022}
}

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TY  - JOUR
T1  - Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review
AU  - Mordechai Goode Sadowsky
AU  - Won Sik Jang
AU  - Subin Lim
AU  - DongKyu Kim
AU  - Jason Robert Waggoner
AU  - Philippe Grange
AU  - Paula Priscilla Veldhuis
AU  - Giovanni Antonio Tommaselli
Y1  - 2022/10/11
PY  - 2022
N1  - https://doi.org/10.11648/j.js.20221005.15
DO  - 10.11648/j.js.20221005.15
T2  - Journal of Surgery
JF  - Journal of Surgery
JO  - Journal of Surgery
SP  - 168
EP  - 174
PB  - Science Publishing Group
SN  - 2330-0930
UR  - https://doi.org/10.11648/j.js.20221005.15
AB  - Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods: The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results: One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion: Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.
VL  - 10
IS  - 5
ER  -

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