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A retrospective review of Paparella Type 1 tympanostomy tubes
International Journal of Pediatric Otorhinolaryngology 129 (2020) 109739
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
A retrospective review of Paparella Type 1 tympanostomy tubes a
b
c
T
c,∗
Devika D. Sparks , Danielle Blake , Bridgette Carter , Scott Schoem a b c
University of Connecticut School of Medicine, USA University of Connecticut Department of Otolaryngology, USA Connecticut Children's Medical Center, USA
A R T I C LE I N FO
A B S T R A C T
Keywords: Bilateral myringotomy Pressure equalizing tubes Pe tubes BMT PET Chronic otitis media Recurrent acute otitis media Mucoid otitis media Serous otitis media Grommets Ear tubes Tympanostomy tubes
Objective: This study aims to provide data on ear tube extrusion and complication rates for patients who have Paparella Type 1 tympanostomy tube (TT) placement. Methods: Retrospective chart review of patients 6 months to 12 years old who underwent insertion of Paparella Type 1 TT by a single surgeon. Results: Of 197 tubes evaluated, 3% were plugged between 1 and 3 months after surgery. Of the 144 tubes evaluated long-term, all tubes extruded within 4 years. There were no tympanic membrane perforations. Conclusions: This chart review showed expected rate of initial ear tube plugging. The rate of tympanic membrane perforation was lower than expected.
1. Introduction Myringotomy with tympanostomy tube (TT) insertion is the most common ambulatory procedure performed on children under the age of 15 in the United States, with over 600,000 procedures done annually [1]. Otitis media, more commonly known as an ear infection, is responsible for the vast majority of TT placements. It is an inflammatory condition of the middle ear that is second in frequency only to acute upper respiratory infection as the most common illness diagnosed in US children. Complications of untreated otitis media include tympanosclerosis, retraction pockets, adhesive otitis, cholesteatomas, tympanic membrane perforation, facial nerve paralysis, chronic suppurative otitis media, and mastoiditis [2]. Approximately 80% of children will have experienced one or more episodes of otitis media by the age of 3 years [3]. Current recommendations for pediatric TT placement in children 6 months to 12 years of age includes treatment for chronic symptomatic otitis media with effusion (OME) associated with balance problems, poor school performance, behavioral problems, or ear discomfort thought to be due to OME [4]. Other indications include bilateral OME for at least 3 months with simultaneous documented hearing impairment, or recurrent acute otitis media with effusions [4]. Such recommendations highlight the importance of TTs in preventing the long-
∗
Corresponding author. 282 Washington Street, 2L, Hartford, CT, 06106, USA. E-mail address: [email protected] (S. Schoem).
https://doi.org/10.1016/j.ijporl.2019.109739 Received 27 August 2019; Accepted 21 October 2019 Available online 02 November 2019 0165-5876/ © 2019 Elsevier B.V. All rights reserved.
term sequale of chronic otitis media. Tympanostomy tubes were first introduced in 1954 by Armstrong, with the purpose of aerating the middle ear space and preventing accumulation of middle ear inflammation and effusion [5]. Once inserted, TTs are typically displaced naturally, avoiding the need for surgery to remove the TT, however there is a risk of early tube extrusion or tube retention. Additionally, post-tympanostomy otorrhea, obstruction, granulation tissue formation, cholesteatoma development, or persistent perforation are associated complications with the procedure. Currently, there is no definite consensus on the complication rate of TT insertion or the timing of tube extrusion. Although we as providers are trained on evidence-based medicine, the wide variety of TT options can make it challenging for a clinical otolaryngologist to select an appropriate TT when there is limited statistical data. Otolaryngologists often counsel patients that the TTs have a less than 3% rate of tube plugging and tympanic membrane perforation, yet there is limited published research data to support these statistics. This study aims to quantify the complications following TT insertion to provide tangible data for otolaryngologists to accurately inform patients. Considering the plethora and variability of TT options, we have focused solely on Paparella Type 1 TT in order to provide meaningful data for providers. Our goal is to establish the complication rate for TT plugging and permanent perforation in using Paparella Type 1 TT in the pediatric
International Journal of Pediatric Otorhinolaryngology 129 (2020) 109739
D.D. Sparks, et al.
population over a 4-year time period.
Table 1 Breakdown of follow-up for each of the TT placements.
2. Methods
# of TT placements (% of TT) Seen in follow-up until non-operative tube extrusion Lost to follow-up and still had TT in place at last office visit No post-operative visit TOTAL
This retrospective chart review was conducted to analyze the rate of: ear tube extrusion, initial complications, ear drum perforation, and plugging of the ear tubes after Paparella Type 1 TT placement at the time of the first post-op visit and each follow up visit up until the ear tubes extrude or up until the subject has been followed for 4 years. We retrospectively analyzed 115 subjects (228 ears) who underwent Paparella Type 1 TT placement. All subjects were 6 months–12 years of age at the time of TT placement and underwent their surgical procedure at Connecticut Children's Medical Center, Hartford, Connecticut from January 2010 through December 2011. To reduce bias all subjects included in the study were from one surgical provider and were undergoing their first set of TT. All subjects excluded from this study were without birth defects such as cleft palate, chromosomal or neuromuscular disorders, or acute mastoiditis. All subjects must have received Paparella Type 1 TT. All patients received standard of care treatment during the surgical and post-op process. Follow up visits were recorded and varied from 1 to 3 months post op and each follow up visit varied from 6 to 12 months and continued until TT extruded or TT failure. Study data were collected and managed using REDCap electronic data capture tools hosted at UConn Health [13,14]. REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources.
144 (63.2) 78 (34.2) 6 (2.6) 228
Table 2 Demographic information of the 115 study patients. Gender Male Female Unknown Age (years) Average (range) Ethnicity Hispanic or Latino Non-Hispanic or Latino Unknown Tube laterality Bilateral Unilateral
56.5% 42.6% 0.9% 2.72 (0–9) 7.8% 90.5% 1.7% 98.3% 1.7%
whereas 7.8% of the subjects were categorized as Hispanic/Latino. 4. Discussion There are many types and designs of tympanostomy tubes for chronic ear disease. Most otolaryngologists use a few types based on their training, familiarity with a particular tube, availability of tube at their institution, and whether the aim is short-term v. long-term intubation of the eardrum. Unfortunately, there is relatively little guidance for clinicians based on longitudinal clinical studies of specific tube types. Quoted percentages of complication rates are often based on historical data and anecdotal information. Previous studies provide some general guidance on length of intubation time, non-extrusion rate, perforation rate post-extrusion and other complications. In 1980, Leopold and McCabe suggested that the epithelial layer of the tympanic membrane influences the longevity of tube function and that the tube tended to stay in place longer on “virgin” ears [6]. In 1991, Bulkley et al., reported a perforation rate of 18.7% of 182 intubated ears following removal or extrusion of Goode T tubes [7]. Cunningham et al., in 1993 conducted a study evaluating the necessity of tube removal when the retained tube caused complications. Of 2436 tubes, 131 were removed for otorrhea, granulation tissue, and for medialized tube. However, the study did not specify tube type [8]. Levine et al., in 1994 reported a 14% initial perforation rate in 149 children who had tube insertion for persistent middle ear fluid. Multiple tube types were studies and most perforations closed spontaneously [9]. And in 1998, Nichols et al., noted that there was an increased perforation rate when tubes remained in place longer than 36 months duration [10]. A more recent study in 2000 involving several tube types demonstrated persistent perforation of 11% if the tube was removed for a variety of reasons including tube retention, otorrhea, nonfunctional tube, and granulation [11]. Based in part on these studies, the prevailing assumption developed that retained ear tubes lead to permanent perforation. This led to the teaching that ear tubes needed to be removed if they remained in place for over 36–48 months to avoid permanent perforation. However, this clinical practice did not account for tube type, or whether the tube was a soft silastic v. hard plastic tube. The senior author (SS) noted this common practice among some clinicians, while other otolaryngologists did not remove functioning ear tubes based on time of eardrum
3. Results A total of 228 Paparella Type 1 TTs were placed and monitored in 115 subjects. Of the TT placement surgeries, 98.3% were bilateral insertions while 1.7% were unilateral insertions. Of this total, 197 tubes were evaluated within 1–3 months after surgery with 3% plugged at that time (6 of 197). Of the 144 spontaneously extruded tubes, a majority extruded within the first 18 months (98 of 144), over 90% within the first 2 years (130 of 144), and all tubes extruded within 4 years (Fig. 1). Of the same 144 extruded tubes, there were no perforations of the tympanic membrane after 4 years. Of the 228 Paparella Type 1 TT placements, 63.2% (144 of 228) were seen in follow-up and monitored until non-operative extrusion of the TT, 34.2% (78 of 228) were lost to follow-up and still had their TT in place at their last office visit, and 2.6% (6 of 228) were never seen post-operatively, as outlined in Table 1. Demographic information, as seen in Table 2, showed a nearly equal number of male and female subjects at 56.5% and 42.6% respectively. Average subject age was 2.72 years with a range of 0–9 years. A significant majority of the subjects were non-Hispanic/Latino at 90.5%,
Fig. 1. Percent of extruded tubes organized by post-operative months. 2
International Journal of Pediatric Otorhinolaryngology 129 (2020) 109739
D.D. Sparks, et al.
References
intubation. A provocative study published in 2013 by Moon et al., found that spontaneous extrusion seldom occurred after 18 months using Paparella type 1 tubes, and strongly advocated for tube removal at that time rather than continued observation [12]. Based on general lack of knowledge regarding Paparella type 1 ear tubes, and this one study that seemed to contradict the senior author's clinical practice of allowing Paparella type 1 ear tubes to remain in place for up to 4 year duration with minimal anecdotal complications, we decided to perform both a retrospective analysis followed by a prospective study comparing Paparella type 1 tubes with Armstrong grommets. Based on the results of this retrospective study, there appears to be little to no risk of permanent eardrum perforation by waiting for up to 4 years for spontaneous extrusion of Paparella type 1 tubes. All tubes in this report extruded naturally by 4 years. The average length of intubation time was 13–18 months. There were no cholesteatomas. Strengths of our study include only one physician performing procedure, one type of tube analyzed, and similar sample sizes to some of the other reported studies. The greatest weakness of our study is its retrospective nature that might skew data. However, the overwhelming evidence contradicts the practice of removing small soft silastic tubes such as Paparella type 1 ear tubes due to the concern over resulting permanent perforation requiring further surgery to close the eardrum. In the future, we hope to report our prospective data on this topic.
[1] K.A. Cullen, M.J. Hall, A. Golosinskiy, Ambulatory surgery in the United States, 2006, Natl. Health Stat. Rep. (11) (2009) 1–25. [2] P.J. Yoon, M.A. Scholes, N.R. Friedman, Ear, nose, & throat, in: William W. Hay, Jr.M.J. Levin, R.R. Deterding, M.J. Abzug (Eds.), Current Diagnosis & Treatment: Pediatrics, 24th ed., McGraw-Hill Education, New York, NY, 2018. [3] D.W. Teele, J.O. Klein, B. Rosner, Group GBOMS, Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study, J. Infect. Dis. 160 (1) (1989) 83–94. [4] Guidelines and Measures, Agency for Healthcare Research & Quality, July 2018. [5] S. Pai, S.R. Parikh, Chapter 49. Otitis media, in: A.K. Lalwani (Ed.), Current Diagnosis & Treatment in Otolaryngology—Head & Neck Surgery, third ed., The McGraw-Hill Companies, New York, NY, 2012. [6] D.A. Leopold, B.F. McCabe, Factors influencing tympanostomy tube function and extrusion: a study of 1,127 ears, Otolaryngol. Head Neck Surg. 88 (4) (1980) 447–454. [7] W.J. Bulkley, A.K. Bowes, J.F. Marlowe, Complications following ventilation of the middle ear using Goode T tubes, Arch. Otolaryngol. Head Neck Surg. 117 (8) (1991) 895–898. [8] M.J. Cunningham, R.D. Eavey, J.H. Krouse, R.M. Kiskaddon, Tympanostomy tubes: experience with removal, The Laryngoscope 103 (6) (1993) 659–662. [9] S. Levine, K. Daly, G.S. Giebink, Tympanic membrane perforations and tympanostomy tubes, Ann. Otol. Rhinol. Laryngol. 103 (5_suppl) (1994) 27–30. [10] P.T. Nichols, H.H. Ramadan, M.K. Wax, R.D. Santrock, Relationship between tympanic membrane perforations and retained ventilation tubes, Arch. Otolaryngol. Head Neck Surg. 124 (4) (1998) 417–419. [11] E.J. Lentsch, S. Goudy, T.M. Ganzel, J.L. Goldman, A.J. Nissen, Rate of persistent perforation after elective tympanostomy tube removal in pediatric patients, Int. J. Pediatr. Otorhinolaryngol. 54 (2) (2000) 143–148. [12] I.S. Moon, M.O. Kwon, C.Y. Park, et al., When should retained Paparella type I tympanostomy tubes be removed in asymptomatic children? Auris Nasus Larynx 40 (2) (2013) 150–153. [13] P.A. Harris, R. Taylor, R. Thielke, J. Payne, N. Gonzalez, J.G. Conde, Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support, J. Biomed. Inform. 42 (2) (2009 Apr) 377–381. [14] P.A. Harris, R. Taylor, B.L. Minor, V. Elliott, M. Fernandez, L. O'Neal, L. McLeod, G. Delacqua, F. Delacqua, J. Kirby, S.N. Duda, REDCap Consortium, The REDCap consortium: building an international community of software partners, J. Biomed. Inform. (2019 May 9), https://doi.org/10.1016/j.jbi.2019.103208.
5. Conclusion Otolaryngologists typically counsel approximately a 3% rate of tube plugging and tympanic membrane perforation. This retrospective chart review study of Paparella Type 1 TT showed supporting evidence for the rate of tube plugging, but the rate of tympanic membrane perforation was lower than expected.
3
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
A retrospective review of Paparella Type 1 tympanostomy tubes a
b
c
T
c,∗
Devika D. Sparks , Danielle Blake , Bridgette Carter , Scott Schoem a b c
University of Connecticut School of Medicine, USA University of Connecticut Department of Otolaryngology, USA Connecticut Children's Medical Center, USA
A R T I C LE I N FO
A B S T R A C T
Keywords: Bilateral myringotomy Pressure equalizing tubes Pe tubes BMT PET Chronic otitis media Recurrent acute otitis media Mucoid otitis media Serous otitis media Grommets Ear tubes Tympanostomy tubes
Objective: This study aims to provide data on ear tube extrusion and complication rates for patients who have Paparella Type 1 tympanostomy tube (TT) placement. Methods: Retrospective chart review of patients 6 months to 12 years old who underwent insertion of Paparella Type 1 TT by a single surgeon. Results: Of 197 tubes evaluated, 3% were plugged between 1 and 3 months after surgery. Of the 144 tubes evaluated long-term, all tubes extruded within 4 years. There were no tympanic membrane perforations. Conclusions: This chart review showed expected rate of initial ear tube plugging. The rate of tympanic membrane perforation was lower than expected.
1. Introduction Myringotomy with tympanostomy tube (TT) insertion is the most common ambulatory procedure performed on children under the age of 15 in the United States, with over 600,000 procedures done annually [1]. Otitis media, more commonly known as an ear infection, is responsible for the vast majority of TT placements. It is an inflammatory condition of the middle ear that is second in frequency only to acute upper respiratory infection as the most common illness diagnosed in US children. Complications of untreated otitis media include tympanosclerosis, retraction pockets, adhesive otitis, cholesteatomas, tympanic membrane perforation, facial nerve paralysis, chronic suppurative otitis media, and mastoiditis [2]. Approximately 80% of children will have experienced one or more episodes of otitis media by the age of 3 years [3]. Current recommendations for pediatric TT placement in children 6 months to 12 years of age includes treatment for chronic symptomatic otitis media with effusion (OME) associated with balance problems, poor school performance, behavioral problems, or ear discomfort thought to be due to OME [4]. Other indications include bilateral OME for at least 3 months with simultaneous documented hearing impairment, or recurrent acute otitis media with effusions [4]. Such recommendations highlight the importance of TTs in preventing the long-
∗
Corresponding author. 282 Washington Street, 2L, Hartford, CT, 06106, USA. E-mail address: [email protected] (S. Schoem).
https://doi.org/10.1016/j.ijporl.2019.109739 Received 27 August 2019; Accepted 21 October 2019 Available online 02 November 2019 0165-5876/ © 2019 Elsevier B.V. All rights reserved.
term sequale of chronic otitis media. Tympanostomy tubes were first introduced in 1954 by Armstrong, with the purpose of aerating the middle ear space and preventing accumulation of middle ear inflammation and effusion [5]. Once inserted, TTs are typically displaced naturally, avoiding the need for surgery to remove the TT, however there is a risk of early tube extrusion or tube retention. Additionally, post-tympanostomy otorrhea, obstruction, granulation tissue formation, cholesteatoma development, or persistent perforation are associated complications with the procedure. Currently, there is no definite consensus on the complication rate of TT insertion or the timing of tube extrusion. Although we as providers are trained on evidence-based medicine, the wide variety of TT options can make it challenging for a clinical otolaryngologist to select an appropriate TT when there is limited statistical data. Otolaryngologists often counsel patients that the TTs have a less than 3% rate of tube plugging and tympanic membrane perforation, yet there is limited published research data to support these statistics. This study aims to quantify the complications following TT insertion to provide tangible data for otolaryngologists to accurately inform patients. Considering the plethora and variability of TT options, we have focused solely on Paparella Type 1 TT in order to provide meaningful data for providers. Our goal is to establish the complication rate for TT plugging and permanent perforation in using Paparella Type 1 TT in the pediatric
International Journal of Pediatric Otorhinolaryngology 129 (2020) 109739
D.D. Sparks, et al.
population over a 4-year time period.
Table 1 Breakdown of follow-up for each of the TT placements.
2. Methods
# of TT placements (% of TT) Seen in follow-up until non-operative tube extrusion Lost to follow-up and still had TT in place at last office visit No post-operative visit TOTAL
This retrospective chart review was conducted to analyze the rate of: ear tube extrusion, initial complications, ear drum perforation, and plugging of the ear tubes after Paparella Type 1 TT placement at the time of the first post-op visit and each follow up visit up until the ear tubes extrude or up until the subject has been followed for 4 years. We retrospectively analyzed 115 subjects (228 ears) who underwent Paparella Type 1 TT placement. All subjects were 6 months–12 years of age at the time of TT placement and underwent their surgical procedure at Connecticut Children's Medical Center, Hartford, Connecticut from January 2010 through December 2011. To reduce bias all subjects included in the study were from one surgical provider and were undergoing their first set of TT. All subjects excluded from this study were without birth defects such as cleft palate, chromosomal or neuromuscular disorders, or acute mastoiditis. All subjects must have received Paparella Type 1 TT. All patients received standard of care treatment during the surgical and post-op process. Follow up visits were recorded and varied from 1 to 3 months post op and each follow up visit varied from 6 to 12 months and continued until TT extruded or TT failure. Study data were collected and managed using REDCap electronic data capture tools hosted at UConn Health [13,14]. REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources.
144 (63.2) 78 (34.2) 6 (2.6) 228
Table 2 Demographic information of the 115 study patients. Gender Male Female Unknown Age (years) Average (range) Ethnicity Hispanic or Latino Non-Hispanic or Latino Unknown Tube laterality Bilateral Unilateral
56.5% 42.6% 0.9% 2.72 (0–9) 7.8% 90.5% 1.7% 98.3% 1.7%
whereas 7.8% of the subjects were categorized as Hispanic/Latino. 4. Discussion There are many types and designs of tympanostomy tubes for chronic ear disease. Most otolaryngologists use a few types based on their training, familiarity with a particular tube, availability of tube at their institution, and whether the aim is short-term v. long-term intubation of the eardrum. Unfortunately, there is relatively little guidance for clinicians based on longitudinal clinical studies of specific tube types. Quoted percentages of complication rates are often based on historical data and anecdotal information. Previous studies provide some general guidance on length of intubation time, non-extrusion rate, perforation rate post-extrusion and other complications. In 1980, Leopold and McCabe suggested that the epithelial layer of the tympanic membrane influences the longevity of tube function and that the tube tended to stay in place longer on “virgin” ears [6]. In 1991, Bulkley et al., reported a perforation rate of 18.7% of 182 intubated ears following removal or extrusion of Goode T tubes [7]. Cunningham et al., in 1993 conducted a study evaluating the necessity of tube removal when the retained tube caused complications. Of 2436 tubes, 131 were removed for otorrhea, granulation tissue, and for medialized tube. However, the study did not specify tube type [8]. Levine et al., in 1994 reported a 14% initial perforation rate in 149 children who had tube insertion for persistent middle ear fluid. Multiple tube types were studies and most perforations closed spontaneously [9]. And in 1998, Nichols et al., noted that there was an increased perforation rate when tubes remained in place longer than 36 months duration [10]. A more recent study in 2000 involving several tube types demonstrated persistent perforation of 11% if the tube was removed for a variety of reasons including tube retention, otorrhea, nonfunctional tube, and granulation [11]. Based in part on these studies, the prevailing assumption developed that retained ear tubes lead to permanent perforation. This led to the teaching that ear tubes needed to be removed if they remained in place for over 36–48 months to avoid permanent perforation. However, this clinical practice did not account for tube type, or whether the tube was a soft silastic v. hard plastic tube. The senior author (SS) noted this common practice among some clinicians, while other otolaryngologists did not remove functioning ear tubes based on time of eardrum
3. Results A total of 228 Paparella Type 1 TTs were placed and monitored in 115 subjects. Of the TT placement surgeries, 98.3% were bilateral insertions while 1.7% were unilateral insertions. Of this total, 197 tubes were evaluated within 1–3 months after surgery with 3% plugged at that time (6 of 197). Of the 144 spontaneously extruded tubes, a majority extruded within the first 18 months (98 of 144), over 90% within the first 2 years (130 of 144), and all tubes extruded within 4 years (Fig. 1). Of the same 144 extruded tubes, there were no perforations of the tympanic membrane after 4 years. Of the 228 Paparella Type 1 TT placements, 63.2% (144 of 228) were seen in follow-up and monitored until non-operative extrusion of the TT, 34.2% (78 of 228) were lost to follow-up and still had their TT in place at their last office visit, and 2.6% (6 of 228) were never seen post-operatively, as outlined in Table 1. Demographic information, as seen in Table 2, showed a nearly equal number of male and female subjects at 56.5% and 42.6% respectively. Average subject age was 2.72 years with a range of 0–9 years. A significant majority of the subjects were non-Hispanic/Latino at 90.5%,
Fig. 1. Percent of extruded tubes organized by post-operative months. 2
International Journal of Pediatric Otorhinolaryngology 129 (2020) 109739
D.D. Sparks, et al.
References
intubation. A provocative study published in 2013 by Moon et al., found that spontaneous extrusion seldom occurred after 18 months using Paparella type 1 tubes, and strongly advocated for tube removal at that time rather than continued observation [12]. Based on general lack of knowledge regarding Paparella type 1 ear tubes, and this one study that seemed to contradict the senior author's clinical practice of allowing Paparella type 1 ear tubes to remain in place for up to 4 year duration with minimal anecdotal complications, we decided to perform both a retrospective analysis followed by a prospective study comparing Paparella type 1 tubes with Armstrong grommets. Based on the results of this retrospective study, there appears to be little to no risk of permanent eardrum perforation by waiting for up to 4 years for spontaneous extrusion of Paparella type 1 tubes. All tubes in this report extruded naturally by 4 years. The average length of intubation time was 13–18 months. There were no cholesteatomas. Strengths of our study include only one physician performing procedure, one type of tube analyzed, and similar sample sizes to some of the other reported studies. The greatest weakness of our study is its retrospective nature that might skew data. However, the overwhelming evidence contradicts the practice of removing small soft silastic tubes such as Paparella type 1 ear tubes due to the concern over resulting permanent perforation requiring further surgery to close the eardrum. In the future, we hope to report our prospective data on this topic.
[1] K.A. Cullen, M.J. Hall, A. Golosinskiy, Ambulatory surgery in the United States, 2006, Natl. Health Stat. Rep. (11) (2009) 1–25. [2] P.J. Yoon, M.A. Scholes, N.R. Friedman, Ear, nose, & throat, in: William W. Hay, Jr.M.J. Levin, R.R. Deterding, M.J. Abzug (Eds.), Current Diagnosis & Treatment: Pediatrics, 24th ed., McGraw-Hill Education, New York, NY, 2018. [3] D.W. Teele, J.O. Klein, B. Rosner, Group GBOMS, Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study, J. Infect. Dis. 160 (1) (1989) 83–94. [4] Guidelines and Measures, Agency for Healthcare Research & Quality, July 2018. [5] S. Pai, S.R. Parikh, Chapter 49. Otitis media, in: A.K. Lalwani (Ed.), Current Diagnosis & Treatment in Otolaryngology—Head & Neck Surgery, third ed., The McGraw-Hill Companies, New York, NY, 2012. [6] D.A. Leopold, B.F. McCabe, Factors influencing tympanostomy tube function and extrusion: a study of 1,127 ears, Otolaryngol. Head Neck Surg. 88 (4) (1980) 447–454. [7] W.J. Bulkley, A.K. Bowes, J.F. Marlowe, Complications following ventilation of the middle ear using Goode T tubes, Arch. Otolaryngol. Head Neck Surg. 117 (8) (1991) 895–898. [8] M.J. Cunningham, R.D. Eavey, J.H. Krouse, R.M. Kiskaddon, Tympanostomy tubes: experience with removal, The Laryngoscope 103 (6) (1993) 659–662. [9] S. Levine, K. Daly, G.S. Giebink, Tympanic membrane perforations and tympanostomy tubes, Ann. Otol. Rhinol. Laryngol. 103 (5_suppl) (1994) 27–30. [10] P.T. Nichols, H.H. Ramadan, M.K. Wax, R.D. Santrock, Relationship between tympanic membrane perforations and retained ventilation tubes, Arch. Otolaryngol. Head Neck Surg. 124 (4) (1998) 417–419. [11] E.J. Lentsch, S. Goudy, T.M. Ganzel, J.L. Goldman, A.J. Nissen, Rate of persistent perforation after elective tympanostomy tube removal in pediatric patients, Int. J. Pediatr. Otorhinolaryngol. 54 (2) (2000) 143–148. [12] I.S. Moon, M.O. Kwon, C.Y. Park, et al., When should retained Paparella type I tympanostomy tubes be removed in asymptomatic children? Auris Nasus Larynx 40 (2) (2013) 150–153. [13] P.A. Harris, R. Taylor, R. Thielke, J. Payne, N. Gonzalez, J.G. Conde, Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support, J. Biomed. Inform. 42 (2) (2009 Apr) 377–381. [14] P.A. Harris, R. Taylor, B.L. Minor, V. Elliott, M. Fernandez, L. O'Neal, L. McLeod, G. Delacqua, F. Delacqua, J. Kirby, S.N. Duda, REDCap Consortium, The REDCap consortium: building an international community of software partners, J. Biomed. Inform. (2019 May 9), https://doi.org/10.1016/j.jbi.2019.103208.
5. Conclusion Otolaryngologists typically counsel approximately a 3% rate of tube plugging and tympanic membrane perforation. This retrospective chart review study of Paparella Type 1 TT showed supporting evidence for the rate of tube plugging, but the rate of tympanic membrane perforation was lower than expected.
3