Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy
Copyright © 2023 Elsevier Inc. All rights reserved..
OBJECTIVE(S): Coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (PEAK) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat. This study aims to describe and compare adverse events related to these devices for tonsillectomy.
STUDY DESIGN: Retrospective cross-sectional study.
SETTING: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database.
METHODS: The MAUDE database was queried for reports involving coblation devices and the PEAK plasmablade from 2011 to 2021. Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy.
RESULTS: There were 331 reported adverse events for coblation and 207 for the plasmablade. For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions. Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions. The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs. 50.9 %, respectively, p = 0.042). For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs. 27.0 %, respectively, p = 0.010). The Plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury.
CONCLUSIONS: While coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, they are associated with adverse events. Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use. Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:44 |
|---|---|
| Enthalten in: |
American journal of otolaryngology - 44(2023), 4 vom: 01. Juli, Seite 103894 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Shah, Rema [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Coblation |
|---|
| Anmerkungen: |
Date Completed 12.06.2023 Date Revised 12.06.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.amjoto.2023.103894 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35681310X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35681310X | ||
| 003 | DE-627 | ||
| 005 | 20231226071248.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.amjoto.2023.103894 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1189.xml |
| 035 | |a (DE-627)NLM35681310X | ||
| 035 | |a (NLM)37178539 | ||
| 035 | |a (PII)S0196-0709(23)00108-4 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Shah, Rema |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.06.2023 | ||
| 500 | |a Date Revised 12.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE(S): Coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (PEAK) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat. This study aims to describe and compare adverse events related to these devices for tonsillectomy | ||
| 520 | |a STUDY DESIGN: Retrospective cross-sectional study | ||
| 520 | |a SETTING: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database | ||
| 520 | |a METHODS: The MAUDE database was queried for reports involving coblation devices and the PEAK plasmablade from 2011 to 2021. Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy | ||
| 520 | |a RESULTS: There were 331 reported adverse events for coblation and 207 for the plasmablade. For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions. Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions. The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs. 50.9 %, respectively, p = 0.042). For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs. 27.0 %, respectively, p = 0.010). The Plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury | ||
| 520 | |a CONCLUSIONS: While coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, they are associated with adverse events. Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use. Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Coblation | |
| 650 | 4 | |a FDA | |
| 650 | 4 | |a MAUDE | |
| 650 | 4 | |a Patient safety/quality improvement (PS/QI) | |
| 650 | 4 | |a Plasmablade | |
| 650 | 4 | |a Tonsillectomy | |
| 700 | 1 | |a Shah, Hemali P |e verfasserin |4 aut | |
| 700 | 1 | |a Rohrbaugh, Tagan |e verfasserin |4 aut | |
| 700 | 1 | |a Reeder, Allison |e verfasserin |4 aut | |
| 700 | 1 | |a Kohli, Nikita |e verfasserin |4 aut | |
| 700 | 1 | |a Maurrasse, Sarah E |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t American journal of otolaryngology |d 1993 |g 44(2023), 4 vom: 01. Juli, Seite 103894 |w (DE-627)NLM000961876 |x 1532-818X |7 nnns |
| 773 | 1 | 8 | |g volume:44 |g year:2023 |g number:4 |g day:01 |g month:07 |g pages:103894 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.amjoto.2023.103894 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 44 |j 2023 |e 4 |b 01 |c 07 |h 103894 | ||