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Studies of anesthesia’s effect on upper airway are limited

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Studies of anesthesia’s effect on upper airway are limited

CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.

Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”

Dr. Zarmina Ehsan

Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:

• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.

• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.

• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”

• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”

• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.

• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”

 

 

• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.

• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.

Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons

Dr. Ehsan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.

Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”

Dr. Zarmina Ehsan

Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:

• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.

• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.

• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”

• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”

• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.

• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”

 

 

• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.

• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.

Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons

Dr. Ehsan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.

Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”

Dr. Zarmina Ehsan

Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:

• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.

• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.

• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”

• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”

• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.

• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”

 

 

• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.

• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.

Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons

Dr. Ehsan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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Studies of anesthesia’s effect on upper airway are limited
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Inside the Article

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Key clinical point: Choice of an appropriate anesthetic protocol for drug-induced sleep endoscopy must be based on a limited number of comparative studies.

Major finding: Local anesthetics appear to affect upper airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse.

Data source: A qualitative systematic review of 56 studies related to common anesthetic agents and opioids published in the medical literature through September 2014.

Disclosures: Dr. Ehsan reported having no financial disclosures.

Upper airway stimulation an option in some patients

An option for some
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Upper airway stimulation an option in some patients

CORONADO, CALIF. – Some patients with treatment-refractory obstructive sleep apnea may be candidates for upper airway stimulation, though those with complete concentric palatal collapse may not respond, according to Dr. Marion Boyd Gillespie.

“There’s been sound research showing that patients with obstructive sleep apnea have reduced neural tone, so it may not be due to fat in the tongue; some of it may have to do with reduced neural tone,” Dr. Gillespie, who directs the snoring clinics at the Medical University of South Carolina, Charleston, said at the Triological Society’s Combined Sections Meeting. “During these apneic events, there’s a reduction in the neural tone of the genioglossus muscle, which is the main dilator of the upper airway. With upper airway stimulation, we’re trying to account for that loss of neural tone by providing more neural impulse to these muscle groups that perform the dilator functions.”

Dr. Marion Boyd Gillespie

In 2014 the Food and Drug Administration cleared an upper airway stimulation system manufactured by Inspire Medical Systems, a pacemakerlike device that’s implanted in the subclavicular space. The system features a stimulator lead that attaches to the right hypoglossal nerve and a sensing lead that goes between the external and internal intercostal muscles to detect breathing. “That allows the device to know when in the phase of respiration to fire,” said Dr. Gillespie, professor of otolaryngology–head and neck surgery at the university. “The sensing lead detects the respiratory wave, and the stimulatory lead starts stimulation at the end of expiration, because that’s when the airway is in its most collapsible state. It continues about two-thirds of the way through the inspiratory cycle to keep the airway open.”

Titration of the device is very similar to continuous positive airway pressure, he continued. Once implanted, the patient “will go back to the sleep lab where a tech who’s trained in the device will ramp up stimulation until observed apneas and hypopneas are adequately reduced. You would think that isolated stimulation of the hypoglossal nerve would only open up the airway at the level of the tongue. However, our initial investigation showed that there is dilation at the velopharynx as well,” Dr. Gillespie said. By moving the tongue out of the posterior airway, “you’re moving the dorsum of the tongue away from the velopharynx. You’re also getting active traction on the palatoglossal fold,” he added.

 

 

Results of the initial trial of the system in 126 patients with a mean body mass index of 28.4 kg/m2 were published last year (N. Engl. J. Med. 2014;370:139-49). At 12 months of follow-up, patients experienced a 68% overall reduction in their apnea-hypopnea index (AHI) score, from a preoperative mean of 29 to a postoperative mean of 9. In addition, patients had a 70% overall reduction in their oxygen desaturation index (ODI). The researchers also observed normalization of patient-based outcomes, with improvement in the Functional Outcomes of Sleep Questionnaire score and reduction of the Epworth Sleepiness Scale score to a level of 10 on average. “We also saw a reduction of snoring,” said Dr. Gillespie, who was a member of the research team. “Snoring went from 72% of patients having severe, annoying snoring to the point where a bed partner leaves the room, to 15% postoperatively.” Even so, 96% of patients who had a previous history of uvulopalatopharyngoplasty (UPPP) or laser-assisted uvulopalatoplasty (LAUP) still had tongue-based collapse after 12 months of follow-up. “But we found that their response to this therapy was just as good as people who had never had a UPPP or LAUP,” Dr. Gillespie said at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons. “So it seems like patients who have failed UPPP are still good candidates for upper airway stimulation therapy.”

Dr. Gillespie noted that selection criteria for the trial were limited to patients with a BMI of less than 32 kg/m2 and to those who did not have complete circumferential collapse at the level of the soft palate on preoperative drug-induced endoscopy. These criteria were based on an earlier pilot study that showed that patients with complete circumferential collapse at the level of the soft palate did not respond to upper airway stimulation (J. Clin. Sleep Med. 2013;9:433-8).

Dr. Gillespie disclosed that he has received research support from Inspire Medical Systems, Olympus, and Surgical Specialties. He is also a consultant for those companies as well as for Medtronic.

[email protected]

On Twitter @dougbrunk

References

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Dr. David Schulman, FCCP, comments: The data presented by Dr. Gillespie add to the growing body of literature showing the benefits of stimulation of the upper airway muscles during sleep in a selected subgroup of obstructive sleep apnea (OSA) patients, demonstrating improvements in both physiologic and functional parameters. Given the well-described issues with continuous positive airway pressure (CPAP) adherence and the lesser efficacy of currently available CPAP alternatives, patients with obstructive sleep apnea and their providers have long awaited access to hypoglossal nerve stimulators to add to the armamentarium of options for management of the disorder.

While early data continue to show promise for this treatment, a number of physiologic and anatomic characteristics serve as relative contraindications, limiting the generalizability of study results to some patient populations (such as those with body mass index greater than 32 kg/m2 or those with concentric collapse of the soft palate). While upper airway stimulation is not likely to be the first-line OSA treatment for the majority of patients, it is an important step forward for those unwilling or unable to use CPAP.

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Dr. David Schulman, FCCP, comments: The data presented by Dr. Gillespie add to the growing body of literature showing the benefits of stimulation of the upper airway muscles during sleep in a selected subgroup of obstructive sleep apnea (OSA) patients, demonstrating improvements in both physiologic and functional parameters. Given the well-described issues with continuous positive airway pressure (CPAP) adherence and the lesser efficacy of currently available CPAP alternatives, patients with obstructive sleep apnea and their providers have long awaited access to hypoglossal nerve stimulators to add to the armamentarium of options for management of the disorder.

While early data continue to show promise for this treatment, a number of physiologic and anatomic characteristics serve as relative contraindications, limiting the generalizability of study results to some patient populations (such as those with body mass index greater than 32 kg/m2 or those with concentric collapse of the soft palate). While upper airway stimulation is not likely to be the first-line OSA treatment for the majority of patients, it is an important step forward for those unwilling or unable to use CPAP.

Body

Dr. David Schulman, FCCP, comments: The data presented by Dr. Gillespie add to the growing body of literature showing the benefits of stimulation of the upper airway muscles during sleep in a selected subgroup of obstructive sleep apnea (OSA) patients, demonstrating improvements in both physiologic and functional parameters. Given the well-described issues with continuous positive airway pressure (CPAP) adherence and the lesser efficacy of currently available CPAP alternatives, patients with obstructive sleep apnea and their providers have long awaited access to hypoglossal nerve stimulators to add to the armamentarium of options for management of the disorder.

While early data continue to show promise for this treatment, a number of physiologic and anatomic characteristics serve as relative contraindications, limiting the generalizability of study results to some patient populations (such as those with body mass index greater than 32 kg/m2 or those with concentric collapse of the soft palate). While upper airway stimulation is not likely to be the first-line OSA treatment for the majority of patients, it is an important step forward for those unwilling or unable to use CPAP.

Title
An option for some
An option for some

CORONADO, CALIF. – Some patients with treatment-refractory obstructive sleep apnea may be candidates for upper airway stimulation, though those with complete concentric palatal collapse may not respond, according to Dr. Marion Boyd Gillespie.

“There’s been sound research showing that patients with obstructive sleep apnea have reduced neural tone, so it may not be due to fat in the tongue; some of it may have to do with reduced neural tone,” Dr. Gillespie, who directs the snoring clinics at the Medical University of South Carolina, Charleston, said at the Triological Society’s Combined Sections Meeting. “During these apneic events, there’s a reduction in the neural tone of the genioglossus muscle, which is the main dilator of the upper airway. With upper airway stimulation, we’re trying to account for that loss of neural tone by providing more neural impulse to these muscle groups that perform the dilator functions.”

Dr. Marion Boyd Gillespie

In 2014 the Food and Drug Administration cleared an upper airway stimulation system manufactured by Inspire Medical Systems, a pacemakerlike device that’s implanted in the subclavicular space. The system features a stimulator lead that attaches to the right hypoglossal nerve and a sensing lead that goes between the external and internal intercostal muscles to detect breathing. “That allows the device to know when in the phase of respiration to fire,” said Dr. Gillespie, professor of otolaryngology–head and neck surgery at the university. “The sensing lead detects the respiratory wave, and the stimulatory lead starts stimulation at the end of expiration, because that’s when the airway is in its most collapsible state. It continues about two-thirds of the way through the inspiratory cycle to keep the airway open.”

Titration of the device is very similar to continuous positive airway pressure, he continued. Once implanted, the patient “will go back to the sleep lab where a tech who’s trained in the device will ramp up stimulation until observed apneas and hypopneas are adequately reduced. You would think that isolated stimulation of the hypoglossal nerve would only open up the airway at the level of the tongue. However, our initial investigation showed that there is dilation at the velopharynx as well,” Dr. Gillespie said. By moving the tongue out of the posterior airway, “you’re moving the dorsum of the tongue away from the velopharynx. You’re also getting active traction on the palatoglossal fold,” he added.

 

 

Results of the initial trial of the system in 126 patients with a mean body mass index of 28.4 kg/m2 were published last year (N. Engl. J. Med. 2014;370:139-49). At 12 months of follow-up, patients experienced a 68% overall reduction in their apnea-hypopnea index (AHI) score, from a preoperative mean of 29 to a postoperative mean of 9. In addition, patients had a 70% overall reduction in their oxygen desaturation index (ODI). The researchers also observed normalization of patient-based outcomes, with improvement in the Functional Outcomes of Sleep Questionnaire score and reduction of the Epworth Sleepiness Scale score to a level of 10 on average. “We also saw a reduction of snoring,” said Dr. Gillespie, who was a member of the research team. “Snoring went from 72% of patients having severe, annoying snoring to the point where a bed partner leaves the room, to 15% postoperatively.” Even so, 96% of patients who had a previous history of uvulopalatopharyngoplasty (UPPP) or laser-assisted uvulopalatoplasty (LAUP) still had tongue-based collapse after 12 months of follow-up. “But we found that their response to this therapy was just as good as people who had never had a UPPP or LAUP,” Dr. Gillespie said at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons. “So it seems like patients who have failed UPPP are still good candidates for upper airway stimulation therapy.”

Dr. Gillespie noted that selection criteria for the trial were limited to patients with a BMI of less than 32 kg/m2 and to those who did not have complete circumferential collapse at the level of the soft palate on preoperative drug-induced endoscopy. These criteria were based on an earlier pilot study that showed that patients with complete circumferential collapse at the level of the soft palate did not respond to upper airway stimulation (J. Clin. Sleep Med. 2013;9:433-8).

Dr. Gillespie disclosed that he has received research support from Inspire Medical Systems, Olympus, and Surgical Specialties. He is also a consultant for those companies as well as for Medtronic.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Some patients with treatment-refractory obstructive sleep apnea may be candidates for upper airway stimulation, though those with complete concentric palatal collapse may not respond, according to Dr. Marion Boyd Gillespie.

“There’s been sound research showing that patients with obstructive sleep apnea have reduced neural tone, so it may not be due to fat in the tongue; some of it may have to do with reduced neural tone,” Dr. Gillespie, who directs the snoring clinics at the Medical University of South Carolina, Charleston, said at the Triological Society’s Combined Sections Meeting. “During these apneic events, there’s a reduction in the neural tone of the genioglossus muscle, which is the main dilator of the upper airway. With upper airway stimulation, we’re trying to account for that loss of neural tone by providing more neural impulse to these muscle groups that perform the dilator functions.”

Dr. Marion Boyd Gillespie

In 2014 the Food and Drug Administration cleared an upper airway stimulation system manufactured by Inspire Medical Systems, a pacemakerlike device that’s implanted in the subclavicular space. The system features a stimulator lead that attaches to the right hypoglossal nerve and a sensing lead that goes between the external and internal intercostal muscles to detect breathing. “That allows the device to know when in the phase of respiration to fire,” said Dr. Gillespie, professor of otolaryngology–head and neck surgery at the university. “The sensing lead detects the respiratory wave, and the stimulatory lead starts stimulation at the end of expiration, because that’s when the airway is in its most collapsible state. It continues about two-thirds of the way through the inspiratory cycle to keep the airway open.”

Titration of the device is very similar to continuous positive airway pressure, he continued. Once implanted, the patient “will go back to the sleep lab where a tech who’s trained in the device will ramp up stimulation until observed apneas and hypopneas are adequately reduced. You would think that isolated stimulation of the hypoglossal nerve would only open up the airway at the level of the tongue. However, our initial investigation showed that there is dilation at the velopharynx as well,” Dr. Gillespie said. By moving the tongue out of the posterior airway, “you’re moving the dorsum of the tongue away from the velopharynx. You’re also getting active traction on the palatoglossal fold,” he added.

 

 

Results of the initial trial of the system in 126 patients with a mean body mass index of 28.4 kg/m2 were published last year (N. Engl. J. Med. 2014;370:139-49). At 12 months of follow-up, patients experienced a 68% overall reduction in their apnea-hypopnea index (AHI) score, from a preoperative mean of 29 to a postoperative mean of 9. In addition, patients had a 70% overall reduction in their oxygen desaturation index (ODI). The researchers also observed normalization of patient-based outcomes, with improvement in the Functional Outcomes of Sleep Questionnaire score and reduction of the Epworth Sleepiness Scale score to a level of 10 on average. “We also saw a reduction of snoring,” said Dr. Gillespie, who was a member of the research team. “Snoring went from 72% of patients having severe, annoying snoring to the point where a bed partner leaves the room, to 15% postoperatively.” Even so, 96% of patients who had a previous history of uvulopalatopharyngoplasty (UPPP) or laser-assisted uvulopalatoplasty (LAUP) still had tongue-based collapse after 12 months of follow-up. “But we found that their response to this therapy was just as good as people who had never had a UPPP or LAUP,” Dr. Gillespie said at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons. “So it seems like patients who have failed UPPP are still good candidates for upper airway stimulation therapy.”

Dr. Gillespie noted that selection criteria for the trial were limited to patients with a BMI of less than 32 kg/m2 and to those who did not have complete circumferential collapse at the level of the soft palate on preoperative drug-induced endoscopy. These criteria were based on an earlier pilot study that showed that patients with complete circumferential collapse at the level of the soft palate did not respond to upper airway stimulation (J. Clin. Sleep Med. 2013;9:433-8).

Dr. Gillespie disclosed that he has received research support from Inspire Medical Systems, Olympus, and Surgical Specialties. He is also a consultant for those companies as well as for Medtronic.

[email protected]

On Twitter @dougbrunk

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Half of patients elect head and neck surgery before meeting surgeon

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CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

"If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether," said Dr. Maya Sardesai.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

 

 

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

"If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether," said Dr. Maya Sardesai.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

 

 

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

"If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether," said Dr. Maya Sardesai.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

 

 

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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Key clinical point: Otolaryngologists and head and neck surgeons should ensure that primary and referring providers are well educated about elective head and neck procedures.

Major finding: Nearly half of patients opted for elective head and neck surgery even before meeting their surgeon.

Data source: A survey of 48 consecutive adults who underwent elective head and neck surgery between March and September 2014.

Disclosures: Dr. Sardesai reported having no financial disclosures.

Ibuprofen superior to morphine following pediatric tonsillectomy

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Ibuprofen superior to morphine following pediatric tonsillectomy

Ibuprofen appears to be an effective and safer pain reliever than morphine in children undergoing tonsillectomies, according to a recent study.

Although the two medications, administered with acetaminophen, treated pain about equally, morphine showed a greater risk for oxygen desaturation the night after surgery.

“Given the unpredictable posttonsillectomy respiratory response to opioids (codeine, morphine, and hydrocodone) and the analgesic effectiveness of ibuprofen, perhaps the time has come to question the postoperative use of all opioids in this population,” wrote Lauren Kelly, Ph.D., of Western University in London, Ontario, and her associates. The study was published online Jan. 26 (Pediatrics 2014 Jan. 26 [doi: 10.1542/peds.2014-1906].

janulla/Thinkstock.com

The researchers randomized 91 children aged 1-10 years to acetaminophen (10-15 mg/kg per dose every 4 hours) with either an age appropriate dose of 0.2-0.5 mg/kg oral morphine every 4 hours or 10 mg/kg of oral ibuprofen every 6 hours after the children underwent a tonsillectomy with or without an adenoidectomy to treat sleep disordered breathing. The study ran from September 2012 to January 2014.

Parents put pulse oximeters on their children the nights before and after surgery to monitor oxygen saturation and apnea events.

The first evening after the surgery, 68% of children receiving ibuprofen showed improvement in oxygen desaturations, compared with 14% of children receiving morphine. The children receiving ibuprofen experienced an average 1.79 fewer desaturation events per hour, compared to an average 11.17 more desaturation events per hour in the morphine group.

No differences in average postsurgical oxygen saturation, pain relieving effectiveness, tonsillar bleeding or drug adverse events were identified.

“The results of this study support effective posttonsillectomy analgesia in children by using ibuprofen in combination with acetaminophen,” Dr. Kelly and her team wrote.

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Ibuprofen appears to be an effective and safer pain reliever than morphine in children undergoing tonsillectomies, according to a recent study.

Although the two medications, administered with acetaminophen, treated pain about equally, morphine showed a greater risk for oxygen desaturation the night after surgery.

“Given the unpredictable posttonsillectomy respiratory response to opioids (codeine, morphine, and hydrocodone) and the analgesic effectiveness of ibuprofen, perhaps the time has come to question the postoperative use of all opioids in this population,” wrote Lauren Kelly, Ph.D., of Western University in London, Ontario, and her associates. The study was published online Jan. 26 (Pediatrics 2014 Jan. 26 [doi: 10.1542/peds.2014-1906].

janulla/Thinkstock.com

The researchers randomized 91 children aged 1-10 years to acetaminophen (10-15 mg/kg per dose every 4 hours) with either an age appropriate dose of 0.2-0.5 mg/kg oral morphine every 4 hours or 10 mg/kg of oral ibuprofen every 6 hours after the children underwent a tonsillectomy with or without an adenoidectomy to treat sleep disordered breathing. The study ran from September 2012 to January 2014.

Parents put pulse oximeters on their children the nights before and after surgery to monitor oxygen saturation and apnea events.

The first evening after the surgery, 68% of children receiving ibuprofen showed improvement in oxygen desaturations, compared with 14% of children receiving morphine. The children receiving ibuprofen experienced an average 1.79 fewer desaturation events per hour, compared to an average 11.17 more desaturation events per hour in the morphine group.

No differences in average postsurgical oxygen saturation, pain relieving effectiveness, tonsillar bleeding or drug adverse events were identified.

“The results of this study support effective posttonsillectomy analgesia in children by using ibuprofen in combination with acetaminophen,” Dr. Kelly and her team wrote.

Ibuprofen appears to be an effective and safer pain reliever than morphine in children undergoing tonsillectomies, according to a recent study.

Although the two medications, administered with acetaminophen, treated pain about equally, morphine showed a greater risk for oxygen desaturation the night after surgery.

“Given the unpredictable posttonsillectomy respiratory response to opioids (codeine, morphine, and hydrocodone) and the analgesic effectiveness of ibuprofen, perhaps the time has come to question the postoperative use of all opioids in this population,” wrote Lauren Kelly, Ph.D., of Western University in London, Ontario, and her associates. The study was published online Jan. 26 (Pediatrics 2014 Jan. 26 [doi: 10.1542/peds.2014-1906].

janulla/Thinkstock.com

The researchers randomized 91 children aged 1-10 years to acetaminophen (10-15 mg/kg per dose every 4 hours) with either an age appropriate dose of 0.2-0.5 mg/kg oral morphine every 4 hours or 10 mg/kg of oral ibuprofen every 6 hours after the children underwent a tonsillectomy with or without an adenoidectomy to treat sleep disordered breathing. The study ran from September 2012 to January 2014.

Parents put pulse oximeters on their children the nights before and after surgery to monitor oxygen saturation and apnea events.

The first evening after the surgery, 68% of children receiving ibuprofen showed improvement in oxygen desaturations, compared with 14% of children receiving morphine. The children receiving ibuprofen experienced an average 1.79 fewer desaturation events per hour, compared to an average 11.17 more desaturation events per hour in the morphine group.

No differences in average postsurgical oxygen saturation, pain relieving effectiveness, tonsillar bleeding or drug adverse events were identified.

“The results of this study support effective posttonsillectomy analgesia in children by using ibuprofen in combination with acetaminophen,” Dr. Kelly and her team wrote.

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FROM PEDIATRICS

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Key clinical point: Ibuprofen safely and effectively replaces morphine for children’s pain relief following tonsillectomy.

Major finding: Among children receiving ibuprofen, 68% improved the first night post surgery, compared with 14% of children receiving morphine.

Data source: A prospective randomized clinical trial of 91 children, aged 1-10 years, assigned to receive 10-15 mg/kg acetaminophen with either 0.2-0.5 mg/kg oral morphine or 10 mg/kg of oral ibuprofen following a tonsillectomy with or without adenoidectomy.

Disclosures: The Canadian Institutes for Health Research Drug Safety and Effectiveness Network funded the study. The authors reported no relevant financial disclosures.

Analysis examines glossectomy as solo treatment for sleep apnea

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CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Dr. Alexander W. Murphey

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Dr. Alexander W. Murphey

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Dr. Alexander W. Murphey

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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Key clinical point: Among adults with obstructive sleep apnea, glossectomy significantly improved sleep outcomes when performed as part of a multi-level surgery, though evidence is sparse.

Major finding: There are no available data on the role of glossectomy as a stand-alone procedure for the treatment of OSA.

Data source: A meta-analysis of 15 articles concerning 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision.

Disclosures: The researchers reported having no financial disclosures.

Nerve monitoring linked to higher risk of vocal cord paralysis

Recurrent laryngeal nerve injury is a 'dreaded complication'
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Nerve monitoring linked to higher risk of vocal cord paralysis

SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.

“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.

Dr. Thomas Chung

He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.

The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).

There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.

Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).

The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.

“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”

Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.

The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.

Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”

Dr. Julie Ann Sosa

Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.

 

 

The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.

Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”

The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”

References

Body

Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.

Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.

The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.

Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.

Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.

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Body

Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.

Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.

The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.

Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.

Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.

Body

Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.

Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.

The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.

Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.

Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.

Title
Recurrent laryngeal nerve injury is a 'dreaded complication'
Recurrent laryngeal nerve injury is a 'dreaded complication'

SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.

“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.

Dr. Thomas Chung

He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.

The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).

There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.

Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).

The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.

“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”

Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.

The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.

Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”

Dr. Julie Ann Sosa

Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.

 

 

The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.

Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”

The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”

SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.

“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.

Dr. Thomas Chung

He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.

The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).

There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.

Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).

The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.

“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”

Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.

The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.

Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”

Dr. Julie Ann Sosa

Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.

 

 

The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.

Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”

The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”

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Nerve monitoring linked to higher risk of vocal cord paralysis
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Key clinical point: Patients who had intraoperative nerve monitoring were more likely to develop vocal cord paralysis.

Major finding: The propensity-adjusted rate of vocal cord paralysis was 1.3% without monitoring and 1.8% with monitoring.

Data source: A retrospective cohort study of 243,175 patients undergoing thyroidectomy.

Disclosures: Dr. Chung disclosed that he had no relevant conflicts of interest.

Expert: Choose your sinus surgeon carefully

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Expert: Choose your sinus surgeon carefully

KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

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KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

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Misery, thy name is chronic rhinosinusitis

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KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

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KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Dr. Todd Kingdom

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

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Sinus surgery: new rigor in research

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KEYSTONE, COLO. – Research-minded otolaryngologists have gotten serious about conducting high-quality, patient-centered outcomes studies of endoscopic sinus surgery for chronic rhinosinusitis, which more than 250,000 Americans undergo each year. And the results are eye opening.

Mounting evidence documents that endoscopic sinus surgery (ESS) in properly selected patients with chronic rhinosinusitis (CRS) results in markedly improved quality of life, functional status, and reduced use of medications, compared with medical management, Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

These studies utilize validated measures of patient-centered quality of life and symptoms. They are nothing like the lightweight, less-than-persuasive ESS research published in the 1990s, which reported glowing ‘success’ rates of 80%-97% in single-institution retrospective studies using variable inclusion criteria and often-sketchy definitions of success.

Dr. Todd Kingdom

"Those data are not acceptable, but that’s what we had. This was before evidence-based medicine with an emphasis on rigorously designed studies took hold," explained Dr. Kingdom, professor and vice chairman of the department of otolaryngology – head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Current research emphasizes the use of modern, validated patient-centered quality of life tools and symptom scores because CRS is a symptom-based diagnosis and it is symptom severity that drives patients to seek treatment. Also, objective measures, such as the Lund-Mackay CT staging system, fail to capture the full experience of disease burden. Nor do objective measures necessarily correlate with patient symptoms, according to the otolaryngologist.

A low point in the field of sinus surgery, in Dr. Kingdom’s view, was the 2006 Cochrane systematic review which concluded ESS "has not been demonstrated to confer additional benefit to that obtained by medical therapy" (Cochrane Database Syst. Rev. 2006:CD004458).

"This review was a disservice," he asserted.

The review was based entirely on three older randomized trials, which not only did not use current treatment paradigms but also did not study the key research question, which Dr. Kingdom believes is this: What’s the comparative effectiveness of ESS vs. continued medical therapy in patients who’ve failed initial medical therapy?

He offered as an example of the contemporary approach to comparative outcomes research in the field of ESS a recent multicenter prospective study led by otolaryngologists at Oregon Health and Science University, Portland. It involved 1 year of prospective follow-up of patients with CRS who had failed initial medical therapy, at which point they elected to undergo ESS or further medical management.

The 65 patients who opted for ESS and the 50 whose chose more medical management were comparable in terms of baseline CRS severity and comorbidities. Both groups showed durable improvement at 12 months, compared with baseline. But ESS was the clear winner, with a mean 71% improvement in the validated Chronic Sinusitis Survey total score, compared with a 46% improvement in the medically managed group. Moreover, during the year of follow-up 17 patients switched over from medical management to ESS and they, too, showed significantly greater improvement than those who remained on medical management (Int. Forum Allergy Rhinol. 2013;3:236-41).

An earlier interim report featuring 6 months of followup showed the surgical group experienced roughly twofold greater improvement, compared with the medical cohort in endpoints including number of days on oral antibiotics or oral corticosteroids and missed days of work or school (Int. Forum Allergy Rhinol. 2011;1:235-41).

Cost-effectiveness studies by various research groups are in the pipeline. The early indication is that the data will show an economic advantage for ESS over medical therapy in patients with recalcitrant disease, according to Dr. Kingdom.

The next research frontier in surgical outcomes in CRS is identification of cellular and molecular markers of disease activity and their genetic underpinnings, which it’s hoped can be used to select the best candidates for ESS, he added.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

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KEYSTONE, COLO. – Research-minded otolaryngologists have gotten serious about conducting high-quality, patient-centered outcomes studies of endoscopic sinus surgery for chronic rhinosinusitis, which more than 250,000 Americans undergo each year. And the results are eye opening.

Mounting evidence documents that endoscopic sinus surgery (ESS) in properly selected patients with chronic rhinosinusitis (CRS) results in markedly improved quality of life, functional status, and reduced use of medications, compared with medical management, Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

These studies utilize validated measures of patient-centered quality of life and symptoms. They are nothing like the lightweight, less-than-persuasive ESS research published in the 1990s, which reported glowing ‘success’ rates of 80%-97% in single-institution retrospective studies using variable inclusion criteria and often-sketchy definitions of success.

Dr. Todd Kingdom

"Those data are not acceptable, but that’s what we had. This was before evidence-based medicine with an emphasis on rigorously designed studies took hold," explained Dr. Kingdom, professor and vice chairman of the department of otolaryngology – head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Current research emphasizes the use of modern, validated patient-centered quality of life tools and symptom scores because CRS is a symptom-based diagnosis and it is symptom severity that drives patients to seek treatment. Also, objective measures, such as the Lund-Mackay CT staging system, fail to capture the full experience of disease burden. Nor do objective measures necessarily correlate with patient symptoms, according to the otolaryngologist.

A low point in the field of sinus surgery, in Dr. Kingdom’s view, was the 2006 Cochrane systematic review which concluded ESS "has not been demonstrated to confer additional benefit to that obtained by medical therapy" (Cochrane Database Syst. Rev. 2006:CD004458).

"This review was a disservice," he asserted.

The review was based entirely on three older randomized trials, which not only did not use current treatment paradigms but also did not study the key research question, which Dr. Kingdom believes is this: What’s the comparative effectiveness of ESS vs. continued medical therapy in patients who’ve failed initial medical therapy?

He offered as an example of the contemporary approach to comparative outcomes research in the field of ESS a recent multicenter prospective study led by otolaryngologists at Oregon Health and Science University, Portland. It involved 1 year of prospective follow-up of patients with CRS who had failed initial medical therapy, at which point they elected to undergo ESS or further medical management.

The 65 patients who opted for ESS and the 50 whose chose more medical management were comparable in terms of baseline CRS severity and comorbidities. Both groups showed durable improvement at 12 months, compared with baseline. But ESS was the clear winner, with a mean 71% improvement in the validated Chronic Sinusitis Survey total score, compared with a 46% improvement in the medically managed group. Moreover, during the year of follow-up 17 patients switched over from medical management to ESS and they, too, showed significantly greater improvement than those who remained on medical management (Int. Forum Allergy Rhinol. 2013;3:236-41).

An earlier interim report featuring 6 months of followup showed the surgical group experienced roughly twofold greater improvement, compared with the medical cohort in endpoints including number of days on oral antibiotics or oral corticosteroids and missed days of work or school (Int. Forum Allergy Rhinol. 2011;1:235-41).

Cost-effectiveness studies by various research groups are in the pipeline. The early indication is that the data will show an economic advantage for ESS over medical therapy in patients with recalcitrant disease, according to Dr. Kingdom.

The next research frontier in surgical outcomes in CRS is identification of cellular and molecular markers of disease activity and their genetic underpinnings, which it’s hoped can be used to select the best candidates for ESS, he added.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Research-minded otolaryngologists have gotten serious about conducting high-quality, patient-centered outcomes studies of endoscopic sinus surgery for chronic rhinosinusitis, which more than 250,000 Americans undergo each year. And the results are eye opening.

Mounting evidence documents that endoscopic sinus surgery (ESS) in properly selected patients with chronic rhinosinusitis (CRS) results in markedly improved quality of life, functional status, and reduced use of medications, compared with medical management, Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

These studies utilize validated measures of patient-centered quality of life and symptoms. They are nothing like the lightweight, less-than-persuasive ESS research published in the 1990s, which reported glowing ‘success’ rates of 80%-97% in single-institution retrospective studies using variable inclusion criteria and often-sketchy definitions of success.

Dr. Todd Kingdom

"Those data are not acceptable, but that’s what we had. This was before evidence-based medicine with an emphasis on rigorously designed studies took hold," explained Dr. Kingdom, professor and vice chairman of the department of otolaryngology – head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

Current research emphasizes the use of modern, validated patient-centered quality of life tools and symptom scores because CRS is a symptom-based diagnosis and it is symptom severity that drives patients to seek treatment. Also, objective measures, such as the Lund-Mackay CT staging system, fail to capture the full experience of disease burden. Nor do objective measures necessarily correlate with patient symptoms, according to the otolaryngologist.

A low point in the field of sinus surgery, in Dr. Kingdom’s view, was the 2006 Cochrane systematic review which concluded ESS "has not been demonstrated to confer additional benefit to that obtained by medical therapy" (Cochrane Database Syst. Rev. 2006:CD004458).

"This review was a disservice," he asserted.

The review was based entirely on three older randomized trials, which not only did not use current treatment paradigms but also did not study the key research question, which Dr. Kingdom believes is this: What’s the comparative effectiveness of ESS vs. continued medical therapy in patients who’ve failed initial medical therapy?

He offered as an example of the contemporary approach to comparative outcomes research in the field of ESS a recent multicenter prospective study led by otolaryngologists at Oregon Health and Science University, Portland. It involved 1 year of prospective follow-up of patients with CRS who had failed initial medical therapy, at which point they elected to undergo ESS or further medical management.

The 65 patients who opted for ESS and the 50 whose chose more medical management were comparable in terms of baseline CRS severity and comorbidities. Both groups showed durable improvement at 12 months, compared with baseline. But ESS was the clear winner, with a mean 71% improvement in the validated Chronic Sinusitis Survey total score, compared with a 46% improvement in the medically managed group. Moreover, during the year of follow-up 17 patients switched over from medical management to ESS and they, too, showed significantly greater improvement than those who remained on medical management (Int. Forum Allergy Rhinol. 2013;3:236-41).

An earlier interim report featuring 6 months of followup showed the surgical group experienced roughly twofold greater improvement, compared with the medical cohort in endpoints including number of days on oral antibiotics or oral corticosteroids and missed days of work or school (Int. Forum Allergy Rhinol. 2011;1:235-41).

Cost-effectiveness studies by various research groups are in the pipeline. The early indication is that the data will show an economic advantage for ESS over medical therapy in patients with recalcitrant disease, according to Dr. Kingdom.

The next research frontier in surgical outcomes in CRS is identification of cellular and molecular markers of disease activity and their genetic underpinnings, which it’s hoped can be used to select the best candidates for ESS, he added.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

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Thyroid cancer rise mostly overdiagnosis

What is needed are better tests
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The incidence of thyroid cancer has nearly tripled in the United States since the 1970s. However, this is mainly an epidemic of diagnosis, researchers reported.

Small papillary cancers are not likely to cause death or disease, and women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

For the research, published online Feb. 20 in JAMA Otolaryngology–Head & Neck Surgery, Dr. Louise Davies and Dr. H. Gilbert Welch reviewed diagnostic trends from the population-based Surveillance, Epidemiology, and End Results (SEER) 9 program, which covers four large U.S. metropolitan areas along with five states. They also reviewed mortality records from the National Vital Statistics System between 1975 and 2009 for the same areas, reported Dr. Davies of the Veterans Affairs Medical Center in White River Junction, Vt., and Dr. Welch of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, N.H.

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Women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

The researchers found that thyroid cancer incidence nearly tripled, from 4.9 to 14.3 per 100,000 individuals, in that time period (relative rate, 2.9) and that nearly all of the increase was attributable to diagnoses of small papillary cancers, the least aggressive form of thyroid cancer. The mortality rate from thyroid cancer remained stable – at 0.5 deaths per 100,000 – during the same time, Dr. Davies and Dr. Welch reported (JAMA Otolaryngol. Head Neck Surg. 2014 Feb. 20 [doi: 10.1001/jamaoto.2014.1]).

The investigators saw a much greater absolute increase in thyroid cancer in women, at 3.3-fold (from 6.5 to 21.4 cases per 100,000), than in men, at 2.2-fold (from 3.1 to 6.9), during the study period, which suggests that the burden of overdiagnosis fell heavily on women, they wrote.

Moreover, most thyroid cancers are treated "as though they are destined to cause real problems for the people who have them," Dr. Davies and Dr. Welch wrote, usually with total thyroidectomy, radiation, or both, putting patients at risk for complications and secondary cancers.

Patients – particularly women – might be better served with a less intensive diagnostic and treatment approach to these cancers, and even by relabeling them using a term other than cancer. Clinicians should take care to advise patients of the uncertainty surrounding the small papillary cancers and encourage them to consider the risks of treatment compared with active surveillance, the researchers said.

Dr. Davies and Dr. Welch received support from their institutions for their research; neither declared conflicts of interest.

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This is an interesting and important study, but one that is difficult to interpret. We don't yet know which of these cancers, no matter what size, will ultimately prove to be important. Once a diagnosis of cancer is made, it is difficult for patients and doctors to simply continue to observe the cancer. Most patients and doctors are uncomfortable with that.

In addition, the follow-up itself becomes burdensome, with annual ultrasounds and, possibly, multiple needle biopsies over time. Although much of this increased incidence seems related to increased use of imaging studies, several authors have also reported an absolute increase in the incidence of thyroid cancer.

Other issues related to this topic are the extent of surgery that is necessary for these small early cancers. The authors point out that many surgeons perform total thyroidectomy and postoperative radioactive iodine ablation, but there are some who advocate for lesser surgery. This becomes problematic when patients have other smaller nodules in the opposite lobe of the thyroid of uncertain significance. Some national guidelines recommend total or near-total thyroidectomy for T1 and T2 well-differentiated thyroid cancers, and it is difficult to go against these guidelines. What is really needed are better molecular and genetic tests to better define which well-differentiated thyroid cancers are likely to act in a more aggressive manner, and which are not.

Mark C. Weissler, M.D., FACS, is the J.P. Riddle Distinguished Professor of Otolaryngology-Head and Neck Surgery at the University of North Carolina, Chapel Hill. Dr. Weissler had no disclosures.

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This is an interesting and important study, but one that is difficult to interpret. We don't yet know which of these cancers, no matter what size, will ultimately prove to be important. Once a diagnosis of cancer is made, it is difficult for patients and doctors to simply continue to observe the cancer. Most patients and doctors are uncomfortable with that.

In addition, the follow-up itself becomes burdensome, with annual ultrasounds and, possibly, multiple needle biopsies over time. Although much of this increased incidence seems related to increased use of imaging studies, several authors have also reported an absolute increase in the incidence of thyroid cancer.

Other issues related to this topic are the extent of surgery that is necessary for these small early cancers. The authors point out that many surgeons perform total thyroidectomy and postoperative radioactive iodine ablation, but there are some who advocate for lesser surgery. This becomes problematic when patients have other smaller nodules in the opposite lobe of the thyroid of uncertain significance. Some national guidelines recommend total or near-total thyroidectomy for T1 and T2 well-differentiated thyroid cancers, and it is difficult to go against these guidelines. What is really needed are better molecular and genetic tests to better define which well-differentiated thyroid cancers are likely to act in a more aggressive manner, and which are not.

Mark C. Weissler, M.D., FACS, is the J.P. Riddle Distinguished Professor of Otolaryngology-Head and Neck Surgery at the University of North Carolina, Chapel Hill. Dr. Weissler had no disclosures.

Body

This is an interesting and important study, but one that is difficult to interpret. We don't yet know which of these cancers, no matter what size, will ultimately prove to be important. Once a diagnosis of cancer is made, it is difficult for patients and doctors to simply continue to observe the cancer. Most patients and doctors are uncomfortable with that.

In addition, the follow-up itself becomes burdensome, with annual ultrasounds and, possibly, multiple needle biopsies over time. Although much of this increased incidence seems related to increased use of imaging studies, several authors have also reported an absolute increase in the incidence of thyroid cancer.

Other issues related to this topic are the extent of surgery that is necessary for these small early cancers. The authors point out that many surgeons perform total thyroidectomy and postoperative radioactive iodine ablation, but there are some who advocate for lesser surgery. This becomes problematic when patients have other smaller nodules in the opposite lobe of the thyroid of uncertain significance. Some national guidelines recommend total or near-total thyroidectomy for T1 and T2 well-differentiated thyroid cancers, and it is difficult to go against these guidelines. What is really needed are better molecular and genetic tests to better define which well-differentiated thyroid cancers are likely to act in a more aggressive manner, and which are not.

Mark C. Weissler, M.D., FACS, is the J.P. Riddle Distinguished Professor of Otolaryngology-Head and Neck Surgery at the University of North Carolina, Chapel Hill. Dr. Weissler had no disclosures.

Title
What is needed are better tests
What is needed are better tests

The incidence of thyroid cancer has nearly tripled in the United States since the 1970s. However, this is mainly an epidemic of diagnosis, researchers reported.

Small papillary cancers are not likely to cause death or disease, and women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

For the research, published online Feb. 20 in JAMA Otolaryngology–Head & Neck Surgery, Dr. Louise Davies and Dr. H. Gilbert Welch reviewed diagnostic trends from the population-based Surveillance, Epidemiology, and End Results (SEER) 9 program, which covers four large U.S. metropolitan areas along with five states. They also reviewed mortality records from the National Vital Statistics System between 1975 and 2009 for the same areas, reported Dr. Davies of the Veterans Affairs Medical Center in White River Junction, Vt., and Dr. Welch of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, N.H.

©Sebastian Kaulitzki/Fotolia.com
Women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

The researchers found that thyroid cancer incidence nearly tripled, from 4.9 to 14.3 per 100,000 individuals, in that time period (relative rate, 2.9) and that nearly all of the increase was attributable to diagnoses of small papillary cancers, the least aggressive form of thyroid cancer. The mortality rate from thyroid cancer remained stable – at 0.5 deaths per 100,000 – during the same time, Dr. Davies and Dr. Welch reported (JAMA Otolaryngol. Head Neck Surg. 2014 Feb. 20 [doi: 10.1001/jamaoto.2014.1]).

The investigators saw a much greater absolute increase in thyroid cancer in women, at 3.3-fold (from 6.5 to 21.4 cases per 100,000), than in men, at 2.2-fold (from 3.1 to 6.9), during the study period, which suggests that the burden of overdiagnosis fell heavily on women, they wrote.

Moreover, most thyroid cancers are treated "as though they are destined to cause real problems for the people who have them," Dr. Davies and Dr. Welch wrote, usually with total thyroidectomy, radiation, or both, putting patients at risk for complications and secondary cancers.

Patients – particularly women – might be better served with a less intensive diagnostic and treatment approach to these cancers, and even by relabeling them using a term other than cancer. Clinicians should take care to advise patients of the uncertainty surrounding the small papillary cancers and encourage them to consider the risks of treatment compared with active surveillance, the researchers said.

Dr. Davies and Dr. Welch received support from their institutions for their research; neither declared conflicts of interest.

The incidence of thyroid cancer has nearly tripled in the United States since the 1970s. However, this is mainly an epidemic of diagnosis, researchers reported.

Small papillary cancers are not likely to cause death or disease, and women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

For the research, published online Feb. 20 in JAMA Otolaryngology–Head & Neck Surgery, Dr. Louise Davies and Dr. H. Gilbert Welch reviewed diagnostic trends from the population-based Surveillance, Epidemiology, and End Results (SEER) 9 program, which covers four large U.S. metropolitan areas along with five states. They also reviewed mortality records from the National Vital Statistics System between 1975 and 2009 for the same areas, reported Dr. Davies of the Veterans Affairs Medical Center in White River Junction, Vt., and Dr. Welch of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, N.H.

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Women are four times more likely to receive a diagnosis than men, even though autopsy findings show that these cancers occur more frequently in men.

The researchers found that thyroid cancer incidence nearly tripled, from 4.9 to 14.3 per 100,000 individuals, in that time period (relative rate, 2.9) and that nearly all of the increase was attributable to diagnoses of small papillary cancers, the least aggressive form of thyroid cancer. The mortality rate from thyroid cancer remained stable – at 0.5 deaths per 100,000 – during the same time, Dr. Davies and Dr. Welch reported (JAMA Otolaryngol. Head Neck Surg. 2014 Feb. 20 [doi: 10.1001/jamaoto.2014.1]).

The investigators saw a much greater absolute increase in thyroid cancer in women, at 3.3-fold (from 6.5 to 21.4 cases per 100,000), than in men, at 2.2-fold (from 3.1 to 6.9), during the study period, which suggests that the burden of overdiagnosis fell heavily on women, they wrote.

Moreover, most thyroid cancers are treated "as though they are destined to cause real problems for the people who have them," Dr. Davies and Dr. Welch wrote, usually with total thyroidectomy, radiation, or both, putting patients at risk for complications and secondary cancers.

Patients – particularly women – might be better served with a less intensive diagnostic and treatment approach to these cancers, and even by relabeling them using a term other than cancer. Clinicians should take care to advise patients of the uncertainty surrounding the small papillary cancers and encourage them to consider the risks of treatment compared with active surveillance, the researchers said.

Dr. Davies and Dr. Welch received support from their institutions for their research; neither declared conflicts of interest.

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Thyroid cancer rise mostly overdiagnosis
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incidence of thyroid cancer, diagnosis, Small papillary cancers, women, men. JAMA Otolaryngology–Head & Neck Surgery, Dr. Louise Davies, Dr. H. Gilbert Welch, Surveillance, Epidemiology, and End Results, (SEER) 9 program, National Vital Statistics System, Veterans Affairs Medical Center, Dartmouth Institute for Health Policy and Clinical Practice, thyroid cancer incidence,
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incidence of thyroid cancer, diagnosis, Small papillary cancers, women, men. JAMA Otolaryngology–Head & Neck Surgery, Dr. Louise Davies, Dr. H. Gilbert Welch, Surveillance, Epidemiology, and End Results, (SEER) 9 program, National Vital Statistics System, Veterans Affairs Medical Center, Dartmouth Institute for Health Policy and Clinical Practice, thyroid cancer incidence,
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