Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study
Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and...
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| Veröffentlicht in: | American journal of otolaryngology 2020-11, Vol.41 (6), p.102652-102652, Article 102652 |
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| creator | Tong, Jane Y. Pasick, Luke J. Benito, Daniel A. Sataloff, Robert T. |
| description | Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement.
The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses.
Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]).
While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.
•Tracheoesophageal puncture with voice prosthesis placement may cause complications.•Improper use was the most common root cause of patient-related adverse events.•Improved physician and patient education may help reduce associated adverse events.•Further research is needed to clarify optimal approaches to education. |
| doi_str_mv | 10.1016/j.amjoto.2020.102652 |
| format | Article |
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The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses.
Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]).
While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.
•Tracheoesophageal puncture with voice prosthesis placement may cause complications.•Improper use was the most common root cause of patient-related adverse events.•Improved physician and patient education may help reduce associated adverse events.•Further research is needed to clarify optimal approaches to education.</description><identifier>ISSN: 0196-0709</identifier><identifier>EISSN: 1532-818X</identifier><identifier>DOI: 10.1016/j.amjoto.2020.102652</identifier><identifier>PMID: 32711236</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adverse events ; Antibiotics ; Bronchoscopy ; Complications ; Data Analysis ; Databases, Factual ; Education ; Esophagus ; Esophagus - surgery ; Fistula ; Foreign Bodies - epidemiology ; Foreign Bodies - etiology ; Foreign Bodies - prevention & control ; Humans ; Laryngectomy - adverse effects ; Larynx, Artificial - adverse effects ; MAUDE ; Medical equipment ; Otolaryngology ; Patient Education as Topic ; Patient safety ; Patients ; Placement ; Pneumonia ; Pneumonia, Aspiration - epidemiology ; Pneumonia, Aspiration - etiology ; Pneumonia, Aspiration - prevention & control ; Prostheses ; Prosthesis Failure - etiology ; Prosthetics ; Punctures - methods ; Quality ; Rehabilitation ; Surveillance ; Trachea - surgery ; Tracheoesophageal puncture ; Voice Disorders - etiology ; Voice Disorders - rehabilitation ; Voice prostheses ; Voice prosthesis</subject><ispartof>American journal of otolaryngology, 2020-11, Vol.41 (6), p.102652-102652, Article 102652</ispartof><rights>2020</rights><rights>Copyright © 2020. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Nov 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-6b9296eb11617f05df03f164c8f344f9347c1f74ccca457221fb73cb4c4a0e393</citedby><cites>FETCH-LOGICAL-c390t-6b9296eb11617f05df03f164c8f344f9347c1f74ccca457221fb73cb4c4a0e393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S019607092030346X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32711236$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tong, Jane Y.</creatorcontrib><creatorcontrib>Pasick, Luke J.</creatorcontrib><creatorcontrib>Benito, Daniel A.</creatorcontrib><creatorcontrib>Sataloff, Robert T.</creatorcontrib><title>Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study</title><title>American journal of otolaryngology</title><addtitle>Am J Otolaryngol</addtitle><description>Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement.
The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses.
Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]).
While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.
•Tracheoesophageal puncture with voice prosthesis placement may cause complications.•Improper use was the most common root cause of patient-related adverse events.•Improved physician and patient education may help reduce associated adverse events.•Further research is needed to clarify optimal approaches to education.</description><subject>Adverse events</subject><subject>Antibiotics</subject><subject>Bronchoscopy</subject><subject>Complications</subject><subject>Data Analysis</subject><subject>Databases, Factual</subject><subject>Education</subject><subject>Esophagus</subject><subject>Esophagus - surgery</subject><subject>Fistula</subject><subject>Foreign Bodies - epidemiology</subject><subject>Foreign Bodies - etiology</subject><subject>Foreign Bodies - prevention & control</subject><subject>Humans</subject><subject>Laryngectomy - adverse effects</subject><subject>Larynx, Artificial - adverse effects</subject><subject>MAUDE</subject><subject>Medical equipment</subject><subject>Otolaryngology</subject><subject>Patient Education as Topic</subject><subject>Patient safety</subject><subject>Patients</subject><subject>Placement</subject><subject>Pneumonia</subject><subject>Pneumonia, Aspiration - epidemiology</subject><subject>Pneumonia, Aspiration - etiology</subject><subject>Pneumonia, Aspiration - prevention & control</subject><subject>Prostheses</subject><subject>Prosthesis Failure - etiology</subject><subject>Prosthetics</subject><subject>Punctures - methods</subject><subject>Quality</subject><subject>Rehabilitation</subject><subject>Surveillance</subject><subject>Trachea - surgery</subject><subject>Tracheoesophageal puncture</subject><subject>Voice Disorders - etiology</subject><subject>Voice Disorders - rehabilitation</subject><subject>Voice prostheses</subject><subject>Voice prosthesis</subject><issn>0196-0709</issn><issn>1532-818X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU9r3DAQxUVpabZJv0Eogl5y8Vb_LK17KCybtCkk5JJAb0KWR1kZe7WR5JR8-2hxmkMPOQ0Mv5l58x5Cp5QsKaHyW780Yx9yWDLCDi0ma_YOLWjNWbWiqz_v0YLQRlZEkeYIfUqpJ4RwweuP6IgzRSnjcoHMJoz7wVuTfdglbFIK1psMHf7r8xbnaOwWAqSw35p7MAN-DN4C3seQ8hYSJOxiGDEjlOAc8EHLd7zG1-u78wuc8tQ9naAPzgwJPr_UY3T38-J2c1ld3fz6vVlfVZY3JFeybVgjoaVUUuVI3TnCHZXCrhwXwjVcKEudEtZaI2rFGHWt4rYVVhgCvOHH6GzeW7Q9TJCyHn2yMAxmB2FKmgmmyoVayYJ-_Q_twxR3RV2h6pViqjhVKDFTtjybIji9j3408UlTog8R6F7PEejD23qOoIx9eVk-tSN0r0P_PC_AjxmA4sajh6iT9bCz0PkINusu-LcvPAMsnpb2</recordid><startdate>202011</startdate><enddate>202011</enddate><creator>Tong, Jane Y.</creator><creator>Pasick, Luke J.</creator><creator>Benito, Daniel A.</creator><creator>Sataloff, Robert T.</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>202011</creationdate><title>Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study</title><author>Tong, Jane Y. ; Pasick, Luke J. ; Benito, Daniel A. ; Sataloff, Robert T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-6b9296eb11617f05df03f164c8f344f9347c1f74ccca457221fb73cb4c4a0e393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adverse events</topic><topic>Antibiotics</topic><topic>Bronchoscopy</topic><topic>Complications</topic><topic>Data Analysis</topic><topic>Databases, Factual</topic><topic>Education</topic><topic>Esophagus</topic><topic>Esophagus - surgery</topic><topic>Fistula</topic><topic>Foreign Bodies - epidemiology</topic><topic>Foreign Bodies - etiology</topic><topic>Foreign Bodies - prevention & control</topic><topic>Humans</topic><topic>Laryngectomy - adverse effects</topic><topic>Larynx, Artificial - adverse effects</topic><topic>MAUDE</topic><topic>Medical equipment</topic><topic>Otolaryngology</topic><topic>Patient Education as Topic</topic><topic>Patient safety</topic><topic>Patients</topic><topic>Placement</topic><topic>Pneumonia</topic><topic>Pneumonia, Aspiration - epidemiology</topic><topic>Pneumonia, Aspiration - etiology</topic><topic>Pneumonia, Aspiration - prevention & control</topic><topic>Prostheses</topic><topic>Prosthesis Failure - etiology</topic><topic>Prosthetics</topic><topic>Punctures - methods</topic><topic>Quality</topic><topic>Rehabilitation</topic><topic>Surveillance</topic><topic>Trachea - surgery</topic><topic>Tracheoesophageal puncture</topic><topic>Voice Disorders - etiology</topic><topic>Voice Disorders - rehabilitation</topic><topic>Voice prostheses</topic><topic>Voice prosthesis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tong, Jane Y.</creatorcontrib><creatorcontrib>Pasick, Luke J.</creatorcontrib><creatorcontrib>Benito, Daniel A.</creatorcontrib><creatorcontrib>Sataloff, Robert T.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of otolaryngology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tong, Jane Y.</au><au>Pasick, Luke J.</au><au>Benito, Daniel A.</au><au>Sataloff, Robert T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study</atitle><jtitle>American journal of otolaryngology</jtitle><addtitle>Am J Otolaryngol</addtitle><date>2020-11</date><risdate>2020</risdate><volume>41</volume><issue>6</issue><spage>102652</spage><epage>102652</epage><pages>102652-102652</pages><artnum>102652</artnum><issn>0196-0709</issn><eissn>1532-818X</eissn><abstract>Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement.
The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses.
Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]).
While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.
•Tracheoesophageal puncture with voice prosthesis placement may cause complications.•Improper use was the most common root cause of patient-related adverse events.•Improved physician and patient education may help reduce associated adverse events.•Further research is needed to clarify optimal approaches to education.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32711236</pmid><doi>10.1016/j.amjoto.2020.102652</doi><tpages>1</tpages></addata></record> |
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| subjects | Adverse events Antibiotics Bronchoscopy Complications Data Analysis Databases, Factual Education Esophagus Esophagus - surgery Fistula Foreign Bodies - epidemiology Foreign Bodies - etiology Foreign Bodies - prevention & control Humans Laryngectomy - adverse effects Larynx, Artificial - adverse effects MAUDE Medical equipment Otolaryngology Patient Education as Topic Patient safety Patients Placement Pneumonia Pneumonia, Aspiration - epidemiology Pneumonia, Aspiration - etiology Pneumonia, Aspiration - prevention & control Prostheses Prosthesis Failure - etiology Prosthetics Punctures - methods Quality Rehabilitation Surveillance Trachea - surgery Tracheoesophageal puncture Voice Disorders - etiology Voice Disorders - rehabilitation Voice prostheses Voice prosthesis |
| title | Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study |
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