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Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review
The Pillar Palatal Implant System is a minimally invasive procedure for the treatment of obstructive sleep apnea and snoring. Prior studies have examined the effectiveness of this procedure, however no prior study has thoroughly evaluated its complications. We anticipate that this analysis will prov...
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| Published in: | American journal of otolaryngology 2020-01, Vol.41 (1), p.102303-102303, Article 102303 |
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| container_end_page | 102303 |
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| container_title | American journal of otolaryngology |
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| creator | Povolotskiy, Roman Abraham, Mickey E. Leverant, Adam B. Bresler, Amishav Paskhover, Boris |
| description | The Pillar Palatal Implant System is a minimally invasive procedure for the treatment of obstructive sleep apnea and snoring. Prior studies have examined the effectiveness of this procedure, however no prior study has thoroughly evaluated its complications. We anticipate that this analysis will provide valuable insight into these procedures which can be used in patient education and post-operative follow-up.
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for cases reporting injury related to the pillar procedure. The case narratives were individually analyzed and categorized by type of complication. A comparison of extruding parts and select complications was also performed using chi-square analysis.
Of the 261 cases reported, 73.6% reporting extruding parts, 47.5% described patient pain, and 38.7% included patients describing a foreign body sensation. Infection was reported in 7.7% of the cases with cellulitis and abscess formation specifically mentioned in one case. Cases describing pain and difficulty swallowing were significantly more likely to have reported extruding parts (p |
| doi_str_mv | 10.1016/j.amjoto.2019.102303 |
| format | article |
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The Manufacturer and User Facility Device Experience (MAUDE) database was queried for cases reporting injury related to the pillar procedure. The case narratives were individually analyzed and categorized by type of complication. A comparison of extruding parts and select complications was also performed using chi-square analysis.
Of the 261 cases reported, 73.6% reporting extruding parts, 47.5% described patient pain, and 38.7% included patients describing a foreign body sensation. Infection was reported in 7.7% of the cases with cellulitis and abscess formation specifically mentioned in one case. Cases describing pain and difficulty swallowing were significantly more likely to have reported extruding parts (p < 0.05).
This study describes various complications associated with this procedure. The description of these complications and accompanying literature review may provide healthcare professionals and patients with an understanding of the scope of adverse events related to this procedure.</description><identifier>ISSN: 0196-0709</identifier><identifier>EISSN: 1532-818X</identifier><identifier>DOI: 10.1016/j.amjoto.2019.102303</identifier><identifier>PMID: 31732316</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Abscesses ; Apnea ; Cellulitis ; Chi-square test ; Complications ; Databases, Factual ; Dysphagia ; Extrusion ; Gastrointestinal surgery ; Humans ; Implants ; Infections ; Literature reviews ; Migration ; Mouth ; Pain ; Patient education ; Postoperative Complications - epidemiology ; Prostheses and Implants ; Sleep ; Sleep apnea ; Sleep Apnea, Obstructive - surgery ; Sleep disorders ; Snoring - surgery ; Transplants & implants</subject><ispartof>American journal of otolaryngology, 2020-01, Vol.41 (1), p.102303-102303, Article 102303</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><rights>2019. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-f2d4e390919ae4ae00d9b04837acaa9425c649870a3dbbdd2fd2f613b5898b823</citedby><cites>FETCH-LOGICAL-c390t-f2d4e390919ae4ae00d9b04837acaa9425c649870a3dbbdd2fd2f613b5898b823</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31732316$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Povolotskiy, Roman</creatorcontrib><creatorcontrib>Abraham, Mickey E.</creatorcontrib><creatorcontrib>Leverant, Adam B.</creatorcontrib><creatorcontrib>Bresler, Amishav</creatorcontrib><creatorcontrib>Paskhover, Boris</creatorcontrib><title>Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review</title><title>American journal of otolaryngology</title><addtitle>Am J Otolaryngol</addtitle><description>The Pillar Palatal Implant System is a minimally invasive procedure for the treatment of obstructive sleep apnea and snoring. Prior studies have examined the effectiveness of this procedure, however no prior study has thoroughly evaluated its complications. We anticipate that this analysis will provide valuable insight into these procedures which can be used in patient education and post-operative follow-up.
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for cases reporting injury related to the pillar procedure. The case narratives were individually analyzed and categorized by type of complication. A comparison of extruding parts and select complications was also performed using chi-square analysis.
Of the 261 cases reported, 73.6% reporting extruding parts, 47.5% described patient pain, and 38.7% included patients describing a foreign body sensation. Infection was reported in 7.7% of the cases with cellulitis and abscess formation specifically mentioned in one case. Cases describing pain and difficulty swallowing were significantly more likely to have reported extruding parts (p < 0.05).
This study describes various complications associated with this procedure. The description of these complications and accompanying literature review may provide healthcare professionals and patients with an understanding of the scope of adverse events related to this procedure.</description><subject>Abscesses</subject><subject>Apnea</subject><subject>Cellulitis</subject><subject>Chi-square test</subject><subject>Complications</subject><subject>Databases, Factual</subject><subject>Dysphagia</subject><subject>Extrusion</subject><subject>Gastrointestinal surgery</subject><subject>Humans</subject><subject>Implants</subject><subject>Infections</subject><subject>Literature reviews</subject><subject>Migration</subject><subject>Mouth</subject><subject>Pain</subject><subject>Patient education</subject><subject>Postoperative Complications - epidemiology</subject><subject>Prostheses and Implants</subject><subject>Sleep</subject><subject>Sleep apnea</subject><subject>Sleep Apnea, Obstructive - surgery</subject><subject>Sleep disorders</subject><subject>Snoring - surgery</subject><subject>Transplants & implants</subject><issn>0196-0709</issn><issn>1532-818X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kU9r3DAQxUVoSbZJv0Eogl568Vay_E85FJZt2gYSkkMCvYmxNCYytrWV5JR8-2rjNIccAgIJzW_e8OYRcsrZmjNefe3XMPYuunXOuExfuWDigKx4KfKs4c3vd2SVClXGaiaPyIcQesaYKER5SI4Er0UueLUisHXjbrAaonVToK6jNzBAhIHe2GEATy9SGaYYzuhmojDB8BjsExfvkV5t7r6fU5P4FgKmsqGDjeghzh6pxweLf0_I-w6GgB-f72Ny9-P8dvsru7z-ebHdXGZaSBazLjcFppfkErAAZMzIlhWNqEEDyCIvdVXIpmYgTNsak3fpVFy0ZSObtsnFMfmy6O68-zNjiGq0QWMyMaGbg0p-SybrUsqEfn6F9m72ydsTVdVVUxd7wWKhtHcheOzUztsR_KPiTO0jUL1aIlD7CNQSQWr79Cw-tyOal6b_O0_AtwXAtI20Ia-CtjhpNNajjso4-_aEf5m8mFE</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Povolotskiy, Roman</creator><creator>Abraham, Mickey E.</creator><creator>Leverant, Adam B.</creator><creator>Bresler, Amishav</creator><creator>Paskhover, Boris</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7QR</scope><scope>7TK</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>202001</creationdate><title>Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review</title><author>Povolotskiy, Roman ; 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Prior studies have examined the effectiveness of this procedure, however no prior study has thoroughly evaluated its complications. We anticipate that this analysis will provide valuable insight into these procedures which can be used in patient education and post-operative follow-up.
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for cases reporting injury related to the pillar procedure. The case narratives were individually analyzed and categorized by type of complication. A comparison of extruding parts and select complications was also performed using chi-square analysis.
Of the 261 cases reported, 73.6% reporting extruding parts, 47.5% described patient pain, and 38.7% included patients describing a foreign body sensation. Infection was reported in 7.7% of the cases with cellulitis and abscess formation specifically mentioned in one case. Cases describing pain and difficulty swallowing were significantly more likely to have reported extruding parts (p < 0.05).
This study describes various complications associated with this procedure. The description of these complications and accompanying literature review may provide healthcare professionals and patients with an understanding of the scope of adverse events related to this procedure.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31732316</pmid><doi>10.1016/j.amjoto.2019.102303</doi><tpages>1</tpages></addata></record> |
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| ispartof | American journal of otolaryngology, 2020-01, Vol.41 (1), p.102303-102303, Article 102303 |
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| source | ScienceDirect Journals |
| subjects | Abscesses Apnea Cellulitis Chi-square test Complications Databases, Factual Dysphagia Extrusion Gastrointestinal surgery Humans Implants Infections Literature reviews Migration Mouth Pain Patient education Postoperative Complications - epidemiology Prostheses and Implants Sleep Sleep apnea Sleep Apnea, Obstructive - surgery Sleep disorders Snoring - surgery Transplants & implants |
| title | Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review |
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