Otolaryngology

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

bjancin@frontlinemedcom.com

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

bjancin@frontlinemedcom.com

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

bjancin@frontlinemedcom.com

DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.

“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.

SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.

SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m². Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.

Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.

At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.

Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.

He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.

Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.

Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.

Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.

The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.

Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.

bjancin@frontlinemedcom.com

DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.

“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.

SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.

SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m². Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.

Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.

At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.

Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.

He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.

Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.

Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.

Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.

The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.

Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.

bjancin@frontlinemedcom.com

DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.

“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.

SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.

SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m². Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.

Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.

At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.

Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.

He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.

Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.

Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.

Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.

The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.

Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.

bjancin@frontlinemedcom.com

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Continuous positive airway pressure (CPAP) and mandibular advancement devices (MADs) both achieved similar reductions in blood pressure in individuals with obstructive sleep apnea, compared with inactive controls.

In a systematic review and meta-analysis of 51 studies involving 4,888 patients, researchers found that CPAP use was associated with a significant mean systolic blood pressure reduction of 2.5 mm Hg and mean diastolic reduction of 2 mm Hg, compared with inactive controls. Each 1-hour increase in mean CPAP use was associated with a significant additional 1.5 mm Hg systolic and 0.9 mm Hg diastolic blood pressure reduction.

©viola83181/iStockphoto.com

Similarly, MADs were associated with a significant 2.1 mm Hg reduction in systolic pressure and 1.9 mm Hg reduction in diastolic pressure, compared with inactive controls.

“This is partly in contrast to a previous meta-analysis, which did not find a beneficial association with MADs, perhaps due to including only two [randomized controlled trials] and thus having inadequate power to detect a difference,” wrote Daniel J. Bratton, Ph.D., of the department of pulmonology, University Hospital, Zurich, and coauthors (JAMA. 2015 Dec 1;314:2280-93).

Overall, the authors found no significant differences between CPAP and MADs in the associated changes in systolic or diastolic blood pressure, although they noted that CPAP showed the strongest association with systolic blood pressure reductions.

The Swiss National Science Foundation and the University of Zurich supported the study. The authors declared no conflicts of interest.

Continuous positive airway pressure (CPAP) and mandibular advancement devices (MADs) both achieved similar reductions in blood pressure in individuals with obstructive sleep apnea, compared with inactive controls.

In a systematic review and meta-analysis of 51 studies involving 4,888 patients, researchers found that CPAP use was associated with a significant mean systolic blood pressure reduction of 2.5 mm Hg and mean diastolic reduction of 2 mm Hg, compared with inactive controls. Each 1-hour increase in mean CPAP use was associated with a significant additional 1.5 mm Hg systolic and 0.9 mm Hg diastolic blood pressure reduction.

©viola83181/iStockphoto.com

Similarly, MADs were associated with a significant 2.1 mm Hg reduction in systolic pressure and 1.9 mm Hg reduction in diastolic pressure, compared with inactive controls.

“This is partly in contrast to a previous meta-analysis, which did not find a beneficial association with MADs, perhaps due to including only two [randomized controlled trials] and thus having inadequate power to detect a difference,” wrote Daniel J. Bratton, Ph.D., of the department of pulmonology, University Hospital, Zurich, and coauthors (JAMA. 2015 Dec 1;314:2280-93).

Overall, the authors found no significant differences between CPAP and MADs in the associated changes in systolic or diastolic blood pressure, although they noted that CPAP showed the strongest association with systolic blood pressure reductions.

The Swiss National Science Foundation and the University of Zurich supported the study. The authors declared no conflicts of interest.

Continuous positive airway pressure (CPAP) and mandibular advancement devices (MADs) both achieved similar reductions in blood pressure in individuals with obstructive sleep apnea, compared with inactive controls.

In a systematic review and meta-analysis of 51 studies involving 4,888 patients, researchers found that CPAP use was associated with a significant mean systolic blood pressure reduction of 2.5 mm Hg and mean diastolic reduction of 2 mm Hg, compared with inactive controls. Each 1-hour increase in mean CPAP use was associated with a significant additional 1.5 mm Hg systolic and 0.9 mm Hg diastolic blood pressure reduction.

©viola83181/iStockphoto.com

Similarly, MADs were associated with a significant 2.1 mm Hg reduction in systolic pressure and 1.9 mm Hg reduction in diastolic pressure, compared with inactive controls.

“This is partly in contrast to a previous meta-analysis, which did not find a beneficial association with MADs, perhaps due to including only two [randomized controlled trials] and thus having inadequate power to detect a difference,” wrote Daniel J. Bratton, Ph.D., of the department of pulmonology, University Hospital, Zurich, and coauthors (JAMA. 2015 Dec 1;314:2280-93).

Overall, the authors found no significant differences between CPAP and MADs in the associated changes in systolic or diastolic blood pressure, although they noted that CPAP showed the strongest association with systolic blood pressure reductions.

The Swiss National Science Foundation and the University of Zurich supported the study. The authors declared no conflicts of interest.

Respiratory compromise and secondary hemorrhage were the most common early side effects in children who had adenotonsillectomies; children with obstructive sleep apnea (OSA) have nearly five times more respiratory complications after surgery than children without OSA, a multistudy review concluded.

janulla/Thinkstock.com

Graziela De Luca Canto, Ph.D., of the Federal University of Santa Catarina, Brazil, and her associates performed a data review by identifying 1,254 different citations found via electronic database searches; after eliminations, only 23 studies were included in the final analysis. Although children with OSA have nearly five times more respiratory complications after adenotonsillectomy than their peers, (odds ratio, 4.90), they are less likely to have postoperative bleeding, compared with children without OSA (OR, 0.41). Among both groups, the most frequent complication was respiratory compromise (9.4%), followed by secondary hemorrhage (2.6%).

Because children with OSA are more likely to require supplemental oxygen, oral or nasal airway insertion, or assisted ventilation in the immediate postoperative period than their peers, the authors suggested that anesthesiologists would be wise to screen patients for snoring, airway dysfunction, and other airway anatomic disorders before performing surgery.

“Children with OSA are clearly at higher anesthetic risk than are patients with normal upper airway function. … Despite the pressure to reduce costs, both surgeons and anesthesiologists should improve screening procedures, perhaps develop alternate surgical approaches, to decrease the risks,” the investigators wrote.

Read the full article in Pediatrics 2015 (doi: 10.1542/peds.2015-1283).

mbock@frontlinemedcom.com

Respiratory compromise and secondary hemorrhage were the most common early side effects in children who had adenotonsillectomies; children with obstructive sleep apnea (OSA) have nearly five times more respiratory complications after surgery than children without OSA, a multistudy review concluded.

janulla/Thinkstock.com

Graziela De Luca Canto, Ph.D., of the Federal University of Santa Catarina, Brazil, and her associates performed a data review by identifying 1,254 different citations found via electronic database searches; after eliminations, only 23 studies were included in the final analysis. Although children with OSA have nearly five times more respiratory complications after adenotonsillectomy than their peers, (odds ratio, 4.90), they are less likely to have postoperative bleeding, compared with children without OSA (OR, 0.41). Among both groups, the most frequent complication was respiratory compromise (9.4%), followed by secondary hemorrhage (2.6%).

Because children with OSA are more likely to require supplemental oxygen, oral or nasal airway insertion, or assisted ventilation in the immediate postoperative period than their peers, the authors suggested that anesthesiologists would be wise to screen patients for snoring, airway dysfunction, and other airway anatomic disorders before performing surgery.

“Children with OSA are clearly at higher anesthetic risk than are patients with normal upper airway function. … Despite the pressure to reduce costs, both surgeons and anesthesiologists should improve screening procedures, perhaps develop alternate surgical approaches, to decrease the risks,” the investigators wrote.

Read the full article in Pediatrics 2015 (doi: 10.1542/peds.2015-1283).

mbock@frontlinemedcom.com

Respiratory compromise and secondary hemorrhage were the most common early side effects in children who had adenotonsillectomies; children with obstructive sleep apnea (OSA) have nearly five times more respiratory complications after surgery than children without OSA, a multistudy review concluded.

janulla/Thinkstock.com

Graziela De Luca Canto, Ph.D., of the Federal University of Santa Catarina, Brazil, and her associates performed a data review by identifying 1,254 different citations found via electronic database searches; after eliminations, only 23 studies were included in the final analysis. Although children with OSA have nearly five times more respiratory complications after adenotonsillectomy than their peers, (odds ratio, 4.90), they are less likely to have postoperative bleeding, compared with children without OSA (OR, 0.41). Among both groups, the most frequent complication was respiratory compromise (9.4%), followed by secondary hemorrhage (2.6%).

Because children with OSA are more likely to require supplemental oxygen, oral or nasal airway insertion, or assisted ventilation in the immediate postoperative period than their peers, the authors suggested that anesthesiologists would be wise to screen patients for snoring, airway dysfunction, and other airway anatomic disorders before performing surgery.

“Children with OSA are clearly at higher anesthetic risk than are patients with normal upper airway function. … Despite the pressure to reduce costs, both surgeons and anesthesiologists should improve screening procedures, perhaps develop alternate surgical approaches, to decrease the risks,” the investigators wrote.

Read the full article in Pediatrics 2015 (doi: 10.1542/peds.2015-1283).

mbock@frontlinemedcom.com

An oral appliance that advances a patient’s lower jaw reduced episodes of obstructive sleep apnea, snoring, and restless legs symptoms, according to a report published online June 1 in JAMA Internal Medicine.

The device, however, failed to improve daytime sleepiness or quality of life in a Swedish study of adults who had daytime sleepiness and either snoring or mild to moderate sleep apnea, said Marie Marklund, Ph.D., D.D.S., of the department of odontology at Umeå (Sweden) University and her associates (JAMA Intern. Med. 2015 June 1 [doi:10.1001/jamainternmed.2015.2051]).

Previous studies of oral appliances have focused on patients with more severe sleep apnea and have yielded conflicting results, particularly regarding daytime sleepiness.

A total of 91 patients who were randomly assigned to receive either a placebo device (46 patients) or an oral appliance individually made by a dental technician using separate plaster casts of the upper and lower teeth (45 participants) completed the study. The device’s elastomer pieces fitted over the teeth and were connected with a screw that allowed continuous gradual advancement of the lower jaw by 6-7 mm. Holding the lower mandible forward improves breathing during sleep.

After 4 months of follow-up, at-home overnight polysomnography showed “a clear, significant treatment effect”: the mean apnea-hypopnea index (AHI) was 6.7 in the active-treatment group, compared with 16.7 in the placebo group. A total of 49% of the patients receiving active treatment had an AHI lower than 5, compared with only 11% of those using the placebo device, for an odds ratio of 7.8 and a number needed to treat of 3.

Snoring and symptoms of restless legs also were significantly less frequent with the active treatment, Dr. Marklund and her associates said.

In addition, 73% of patients who used oral appliances said that their expectations of treatment were either “totally” or “sufficiently” fulfilled, compared with only 11% of those who used placebo devices. And 89% of patients who used oral appliances said they would continue the treatment after completing the study, compared with only 52% of those who used the sham device.

However, daytime sleepiness, measured subjectively using the Epworth Sleepiness Scale and the Karolinska Sleepiness Scale and measured objectively using the Oxford Sleep Resistance test, did not differ significantly between the two study groups. The number of days with headaches, the intensity of headaches, the presence of nasal congestion, difficulty falling asleep, nighttime awakenings, nightmares, and reaction times also were not significantly different, nor were scores on a quality of life measure.

The study was supported by grants from the Swedish Research Council, the Swedish Heart and Lung Foundation, and the County Council of Vasterbotten. Dr. Marklund and her associates reported no conflicts of interest.

An oral appliance that advances a patient’s lower jaw reduced episodes of obstructive sleep apnea, snoring, and restless legs symptoms, according to a report published online June 1 in JAMA Internal Medicine.

The device, however, failed to improve daytime sleepiness or quality of life in a Swedish study of adults who had daytime sleepiness and either snoring or mild to moderate sleep apnea, said Marie Marklund, Ph.D., D.D.S., of the department of odontology at Umeå (Sweden) University and her associates (JAMA Intern. Med. 2015 June 1 [doi:10.1001/jamainternmed.2015.2051]).

Previous studies of oral appliances have focused on patients with more severe sleep apnea and have yielded conflicting results, particularly regarding daytime sleepiness.

A total of 91 patients who were randomly assigned to receive either a placebo device (46 patients) or an oral appliance individually made by a dental technician using separate plaster casts of the upper and lower teeth (45 participants) completed the study. The device’s elastomer pieces fitted over the teeth and were connected with a screw that allowed continuous gradual advancement of the lower jaw by 6-7 mm. Holding the lower mandible forward improves breathing during sleep.

After 4 months of follow-up, at-home overnight polysomnography showed “a clear, significant treatment effect”: the mean apnea-hypopnea index (AHI) was 6.7 in the active-treatment group, compared with 16.7 in the placebo group. A total of 49% of the patients receiving active treatment had an AHI lower than 5, compared with only 11% of those using the placebo device, for an odds ratio of 7.8 and a number needed to treat of 3.

Snoring and symptoms of restless legs also were significantly less frequent with the active treatment, Dr. Marklund and her associates said.

In addition, 73% of patients who used oral appliances said that their expectations of treatment were either “totally” or “sufficiently” fulfilled, compared with only 11% of those who used placebo devices. And 89% of patients who used oral appliances said they would continue the treatment after completing the study, compared with only 52% of those who used the sham device.

However, daytime sleepiness, measured subjectively using the Epworth Sleepiness Scale and the Karolinska Sleepiness Scale and measured objectively using the Oxford Sleep Resistance test, did not differ significantly between the two study groups. The number of days with headaches, the intensity of headaches, the presence of nasal congestion, difficulty falling asleep, nighttime awakenings, nightmares, and reaction times also were not significantly different, nor were scores on a quality of life measure.

The study was supported by grants from the Swedish Research Council, the Swedish Heart and Lung Foundation, and the County Council of Vasterbotten. Dr. Marklund and her associates reported no conflicts of interest.

An oral appliance that advances a patient’s lower jaw reduced episodes of obstructive sleep apnea, snoring, and restless legs symptoms, according to a report published online June 1 in JAMA Internal Medicine.

The device, however, failed to improve daytime sleepiness or quality of life in a Swedish study of adults who had daytime sleepiness and either snoring or mild to moderate sleep apnea, said Marie Marklund, Ph.D., D.D.S., of the department of odontology at Umeå (Sweden) University and her associates (JAMA Intern. Med. 2015 June 1 [doi:10.1001/jamainternmed.2015.2051]).

Previous studies of oral appliances have focused on patients with more severe sleep apnea and have yielded conflicting results, particularly regarding daytime sleepiness.

A total of 91 patients who were randomly assigned to receive either a placebo device (46 patients) or an oral appliance individually made by a dental technician using separate plaster casts of the upper and lower teeth (45 participants) completed the study. The device’s elastomer pieces fitted over the teeth and were connected with a screw that allowed continuous gradual advancement of the lower jaw by 6-7 mm. Holding the lower mandible forward improves breathing during sleep.

After 4 months of follow-up, at-home overnight polysomnography showed “a clear, significant treatment effect”: the mean apnea-hypopnea index (AHI) was 6.7 in the active-treatment group, compared with 16.7 in the placebo group. A total of 49% of the patients receiving active treatment had an AHI lower than 5, compared with only 11% of those using the placebo device, for an odds ratio of 7.8 and a number needed to treat of 3.

Snoring and symptoms of restless legs also were significantly less frequent with the active treatment, Dr. Marklund and her associates said.

In addition, 73% of patients who used oral appliances said that their expectations of treatment were either “totally” or “sufficiently” fulfilled, compared with only 11% of those who used placebo devices. And 89% of patients who used oral appliances said they would continue the treatment after completing the study, compared with only 52% of those who used the sham device.

However, daytime sleepiness, measured subjectively using the Epworth Sleepiness Scale and the Karolinska Sleepiness Scale and measured objectively using the Oxford Sleep Resistance test, did not differ significantly between the two study groups. The number of days with headaches, the intensity of headaches, the presence of nasal congestion, difficulty falling asleep, nighttime awakenings, nightmares, and reaction times also were not significantly different, nor were scores on a quality of life measure.

The study was supported by grants from the Swedish Research Council, the Swedish Heart and Lung Foundation, and the County Council of Vasterbotten. Dr. Marklund and her associates reported no conflicts of interest.

In patients who underwent surgical treatment for stage I or II oral cavity squamous cell cancer, positive tumor margin, the use of radiation or chemotherapy, treatment in a nonacademic facility, and having public health insurance were significantly associated with lower 5-year survival rates, according to a retrospective analysis published online in the JAMA Otolaryngology–Head & Neck Surgery.

The findings suggest that some factors associated with lower 5-year survival rates “may be targets for quality improvement efforts,” wrote Alexander L. Luryi of Yale University, New Haven, Conn., and colleagues.

Seventy percent of 6,830 patients who underwent surgery for stage I or II oral cavity squamous cell cancer (OCSCC) from 2003 to 2006 survived 5 years, according to information from the National Cancer Data Base.

Multivariate analysis showed higher survival rates were significantly associated with neck dissection (hazard ratio, 0.85; P = .003). Lower survival rates were significantly associated with radiation therapy (HR, 1.31; P < .001), chemotherapy (HR, 1.34; P = .03), nonprivate insurance (HR Medicaid, 1.96; HR Medicare, 1.45; P < .001), and nonacademic treatment facility (HR, 1.13; P = .03).

Care at academic centers compared with nonacademic centers was associated with improved survival, possibly due to health care provider expertise, the study authors noted (JAMA Otolaryngol. Head Neck Surg. 2015 May 14 [doi:10.1001/jamaoto.2015.0719]).

Survival rates were lower in patients treated at nonacademic cancer centers, but multivariate analysis showed no association between facility-based case volume and survival. Patients insured through Medicaid and Medicare had significantly lower 5-year survival rates (P < .001 for both). That finding may be the result of inconsistent treatment and follow-up, the investigators said, or worse baseline health among that patient population.

Controversy exists over the relationship between positive margins and outcomes, and the implications for aggressiveness of surgery. The study found positive margins were significantly associated with poorer outcomes, the researchers noted, which supports the use of aggressive surgery in early OCSCC to achieve negative margins.

Radiation and chemotherapy were linked to worse outcomes, and those therapies were possibly indicators of less aggressive resection in localized disease. The analysis could not adjust for potential confounding effects of perineural and lymphovascular invasion, because the information was not recorded in the National Cancer Data Base.

The study indicated a positive impact by neck dissection on survival. Patients with occult neck disease who underwent neck dissection likely would have been restaged to stage III or higher and removed from the early stage sample, the authors explained, which would account for higher survival rates for those remaining. Prospective trials are needed to determine the role of elective neck dissection in early OCSCC, the researchers added.

The William U. Gardner Memorial Research Fund at Yale University supported the study. Dr. Luryi and coauthors reported having no disclosures.

In patients who underwent surgical treatment for stage I or II oral cavity squamous cell cancer, positive tumor margin, the use of radiation or chemotherapy, treatment in a nonacademic facility, and having public health insurance were significantly associated with lower 5-year survival rates, according to a retrospective analysis published online in the JAMA Otolaryngology–Head & Neck Surgery.

The findings suggest that some factors associated with lower 5-year survival rates “may be targets for quality improvement efforts,” wrote Alexander L. Luryi of Yale University, New Haven, Conn., and colleagues.

Seventy percent of 6,830 patients who underwent surgery for stage I or II oral cavity squamous cell cancer (OCSCC) from 2003 to 2006 survived 5 years, according to information from the National Cancer Data Base.

Multivariate analysis showed higher survival rates were significantly associated with neck dissection (hazard ratio, 0.85; P = .003). Lower survival rates were significantly associated with radiation therapy (HR, 1.31; P < .001), chemotherapy (HR, 1.34; P = .03), nonprivate insurance (HR Medicaid, 1.96; HR Medicare, 1.45; P < .001), and nonacademic treatment facility (HR, 1.13; P = .03).

Care at academic centers compared with nonacademic centers was associated with improved survival, possibly due to health care provider expertise, the study authors noted (JAMA Otolaryngol. Head Neck Surg. 2015 May 14 [doi:10.1001/jamaoto.2015.0719]).

Survival rates were lower in patients treated at nonacademic cancer centers, but multivariate analysis showed no association between facility-based case volume and survival. Patients insured through Medicaid and Medicare had significantly lower 5-year survival rates (P < .001 for both). That finding may be the result of inconsistent treatment and follow-up, the investigators said, or worse baseline health among that patient population.

Controversy exists over the relationship between positive margins and outcomes, and the implications for aggressiveness of surgery. The study found positive margins were significantly associated with poorer outcomes, the researchers noted, which supports the use of aggressive surgery in early OCSCC to achieve negative margins.

Radiation and chemotherapy were linked to worse outcomes, and those therapies were possibly indicators of less aggressive resection in localized disease. The analysis could not adjust for potential confounding effects of perineural and lymphovascular invasion, because the information was not recorded in the National Cancer Data Base.

The study indicated a positive impact by neck dissection on survival. Patients with occult neck disease who underwent neck dissection likely would have been restaged to stage III or higher and removed from the early stage sample, the authors explained, which would account for higher survival rates for those remaining. Prospective trials are needed to determine the role of elective neck dissection in early OCSCC, the researchers added.

The William U. Gardner Memorial Research Fund at Yale University supported the study. Dr. Luryi and coauthors reported having no disclosures.

In patients who underwent surgical treatment for stage I or II oral cavity squamous cell cancer, positive tumor margin, the use of radiation or chemotherapy, treatment in a nonacademic facility, and having public health insurance were significantly associated with lower 5-year survival rates, according to a retrospective analysis published online in the JAMA Otolaryngology–Head & Neck Surgery.

The findings suggest that some factors associated with lower 5-year survival rates “may be targets for quality improvement efforts,” wrote Alexander L. Luryi of Yale University, New Haven, Conn., and colleagues.

Seventy percent of 6,830 patients who underwent surgery for stage I or II oral cavity squamous cell cancer (OCSCC) from 2003 to 2006 survived 5 years, according to information from the National Cancer Data Base.

Multivariate analysis showed higher survival rates were significantly associated with neck dissection (hazard ratio, 0.85; P = .003). Lower survival rates were significantly associated with radiation therapy (HR, 1.31; P < .001), chemotherapy (HR, 1.34; P = .03), nonprivate insurance (HR Medicaid, 1.96; HR Medicare, 1.45; P < .001), and nonacademic treatment facility (HR, 1.13; P = .03).

Care at academic centers compared with nonacademic centers was associated with improved survival, possibly due to health care provider expertise, the study authors noted (JAMA Otolaryngol. Head Neck Surg. 2015 May 14 [doi:10.1001/jamaoto.2015.0719]).

Survival rates were lower in patients treated at nonacademic cancer centers, but multivariate analysis showed no association between facility-based case volume and survival. Patients insured through Medicaid and Medicare had significantly lower 5-year survival rates (P < .001 for both). That finding may be the result of inconsistent treatment and follow-up, the investigators said, or worse baseline health among that patient population.

Controversy exists over the relationship between positive margins and outcomes, and the implications for aggressiveness of surgery. The study found positive margins were significantly associated with poorer outcomes, the researchers noted, which supports the use of aggressive surgery in early OCSCC to achieve negative margins.

Radiation and chemotherapy were linked to worse outcomes, and those therapies were possibly indicators of less aggressive resection in localized disease. The analysis could not adjust for potential confounding effects of perineural and lymphovascular invasion, because the information was not recorded in the National Cancer Data Base.

The study indicated a positive impact by neck dissection on survival. Patients with occult neck disease who underwent neck dissection likely would have been restaged to stage III or higher and removed from the early stage sample, the authors explained, which would account for higher survival rates for those remaining. Prospective trials are needed to determine the role of elective neck dissection in early OCSCC, the researchers added.

The William U. Gardner Memorial Research Fund at Yale University supported the study. Dr. Luryi and coauthors reported having no disclosures.

More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.

The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.

Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).

The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.

The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.

“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.

No conflicts of interest were declared.

More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.

The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.

Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).

The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.

The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.

“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.

No conflicts of interest were declared.

More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.

The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.

Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).

The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.

The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.

“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.

No conflicts of interest were declared.

CHICAGO – Lateral neck dissection for thyroid cancer is associated with significant early postoperative morbidity of 20%, even in the hands of experienced endocrine surgeons at a high-volume medical center.

Among 99 procedures, 20 patients had 26 complications, including surgical site infection in 10, chyle leak in 7, spinal accessory nerve dysfunction in 7, and seroma in 2.

Patrice Wendling/Frontline Medical News

Long-term complications were rare, however, occurring in just one patient with a spinal accessory nerve injury, Dr. Jason A. Glenn said at the annual meeting of the Central Surgical Association.

Using a prospectively collected thyroid database, the investigators reviewed 96 patients who underwent lateral neck dissection (LND) for suspicion of initial or recurrent lateral neck metastases by one of four experienced endocrine surgeons at the Medical College of Wisconsin in Milwaukee.

Three patients had reoperations during the study period of February 2009 and June 2014, resulting in 99 procedures and 198 lateral necks evaluated preoperatively. Most patients were women (73%) and their median age was 45 years.

LND was performed on 127 necks and metastatic disease was confirmed in 111 (87%). This included all 82 patients who had positive preoperative fine needle aspiration (FNA), 25 of 37 patients operated on without FNA, and 4 of 8 patients with a negative or nondiagnostic FNA, Dr. Glenn said.

The median number of lymph nodes excised was 22 (range 1-122), with a median of 3 (range 0-39) malignant nodes per lateral neck.

“FNA is an important adjunct in the preoperative evaluation, especially when it returns a positive result,” he said. “However, when FNA is negative, not available, or not performed, you really must consider the entire clinical picture, as 64% of these patients were found to have lymph node metastases in our study.”

Surgical drains were placed in 94% of the 127 lateral neck dissections and remained in place for a median of 6 days. The median length of stay was 1 day.

There was no association between drain duration and surgical site infection, although chyle leak was associated with a significantly longer median drain duration (12 days vs. 6 days; P value < .01), Dr. Glenn said.

Two of the seven patients with chyle leak, defined by drain output that was milky white and/or exceeded 1,000 cc in 24 hours, underwent reoperation with ligation of the cervical thoracic duct and fibrin sealant application. Both leaks resolved and patients were discharge on postoperative day 2.

“Surgical drains allow for early leak recognition and monitoring of leak resolution,” he said. “Most of these complications were diagnosed and managed on an outpatient basis, highlighting the importance of continuity of care between the inpatient and outpatient setting for the treatment of thyroid cancer.”

Discussant Janice L. Pasieka, head of general surgery and a clinical professor of surgery and oncology at the University of Calgary (Alberta), said the retrospective review is a very valuable contribution to the literature because of its comprehensive follow-up.

“Today, most patients with this type of procedure are discharged within the 23 hours, and as such, complications such as nerve palsies, chyle leaks, and surgical site infections are not apparent for the majority of patients during their hospital stay,” Dr. Pasieka said. “Many times, the true incidences are lost unless the patient re-presents to the health care system, thus introducing your bias of only those significant enough to require intervention.”

Dr. Glenn and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Lateral neck dissection for thyroid cancer is associated with significant early postoperative morbidity of 20%, even in the hands of experienced endocrine surgeons at a high-volume medical center.

Among 99 procedures, 20 patients had 26 complications, including surgical site infection in 10, chyle leak in 7, spinal accessory nerve dysfunction in 7, and seroma in 2.

Patrice Wendling/Frontline Medical News

Long-term complications were rare, however, occurring in just one patient with a spinal accessory nerve injury, Dr. Jason A. Glenn said at the annual meeting of the Central Surgical Association.

Using a prospectively collected thyroid database, the investigators reviewed 96 patients who underwent lateral neck dissection (LND) for suspicion of initial or recurrent lateral neck metastases by one of four experienced endocrine surgeons at the Medical College of Wisconsin in Milwaukee.

Three patients had reoperations during the study period of February 2009 and June 2014, resulting in 99 procedures and 198 lateral necks evaluated preoperatively. Most patients were women (73%) and their median age was 45 years.

LND was performed on 127 necks and metastatic disease was confirmed in 111 (87%). This included all 82 patients who had positive preoperative fine needle aspiration (FNA), 25 of 37 patients operated on without FNA, and 4 of 8 patients with a negative or nondiagnostic FNA, Dr. Glenn said.

The median number of lymph nodes excised was 22 (range 1-122), with a median of 3 (range 0-39) malignant nodes per lateral neck.

“FNA is an important adjunct in the preoperative evaluation, especially when it returns a positive result,” he said. “However, when FNA is negative, not available, or not performed, you really must consider the entire clinical picture, as 64% of these patients were found to have lymph node metastases in our study.”

Surgical drains were placed in 94% of the 127 lateral neck dissections and remained in place for a median of 6 days. The median length of stay was 1 day.

There was no association between drain duration and surgical site infection, although chyle leak was associated with a significantly longer median drain duration (12 days vs. 6 days; P value < .01), Dr. Glenn said.

Two of the seven patients with chyle leak, defined by drain output that was milky white and/or exceeded 1,000 cc in 24 hours, underwent reoperation with ligation of the cervical thoracic duct and fibrin sealant application. Both leaks resolved and patients were discharge on postoperative day 2.

“Surgical drains allow for early leak recognition and monitoring of leak resolution,” he said. “Most of these complications were diagnosed and managed on an outpatient basis, highlighting the importance of continuity of care between the inpatient and outpatient setting for the treatment of thyroid cancer.”

Discussant Janice L. Pasieka, head of general surgery and a clinical professor of surgery and oncology at the University of Calgary (Alberta), said the retrospective review is a very valuable contribution to the literature because of its comprehensive follow-up.

“Today, most patients with this type of procedure are discharged within the 23 hours, and as such, complications such as nerve palsies, chyle leaks, and surgical site infections are not apparent for the majority of patients during their hospital stay,” Dr. Pasieka said. “Many times, the true incidences are lost unless the patient re-presents to the health care system, thus introducing your bias of only those significant enough to require intervention.”

Dr. Glenn and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Lateral neck dissection for thyroid cancer is associated with significant early postoperative morbidity of 20%, even in the hands of experienced endocrine surgeons at a high-volume medical center.

Among 99 procedures, 20 patients had 26 complications, including surgical site infection in 10, chyle leak in 7, spinal accessory nerve dysfunction in 7, and seroma in 2.

Patrice Wendling/Frontline Medical News

Long-term complications were rare, however, occurring in just one patient with a spinal accessory nerve injury, Dr. Jason A. Glenn said at the annual meeting of the Central Surgical Association.

Using a prospectively collected thyroid database, the investigators reviewed 96 patients who underwent lateral neck dissection (LND) for suspicion of initial or recurrent lateral neck metastases by one of four experienced endocrine surgeons at the Medical College of Wisconsin in Milwaukee.

Three patients had reoperations during the study period of February 2009 and June 2014, resulting in 99 procedures and 198 lateral necks evaluated preoperatively. Most patients were women (73%) and their median age was 45 years.

LND was performed on 127 necks and metastatic disease was confirmed in 111 (87%). This included all 82 patients who had positive preoperative fine needle aspiration (FNA), 25 of 37 patients operated on without FNA, and 4 of 8 patients with a negative or nondiagnostic FNA, Dr. Glenn said.

The median number of lymph nodes excised was 22 (range 1-122), with a median of 3 (range 0-39) malignant nodes per lateral neck.

“FNA is an important adjunct in the preoperative evaluation, especially when it returns a positive result,” he said. “However, when FNA is negative, not available, or not performed, you really must consider the entire clinical picture, as 64% of these patients were found to have lymph node metastases in our study.”

Surgical drains were placed in 94% of the 127 lateral neck dissections and remained in place for a median of 6 days. The median length of stay was 1 day.

There was no association between drain duration and surgical site infection, although chyle leak was associated with a significantly longer median drain duration (12 days vs. 6 days; P value < .01), Dr. Glenn said.

Two of the seven patients with chyle leak, defined by drain output that was milky white and/or exceeded 1,000 cc in 24 hours, underwent reoperation with ligation of the cervical thoracic duct and fibrin sealant application. Both leaks resolved and patients were discharge on postoperative day 2.

“Surgical drains allow for early leak recognition and monitoring of leak resolution,” he said. “Most of these complications were diagnosed and managed on an outpatient basis, highlighting the importance of continuity of care between the inpatient and outpatient setting for the treatment of thyroid cancer.”

Discussant Janice L. Pasieka, head of general surgery and a clinical professor of surgery and oncology at the University of Calgary (Alberta), said the retrospective review is a very valuable contribution to the literature because of its comprehensive follow-up.

“Today, most patients with this type of procedure are discharged within the 23 hours, and as such, complications such as nerve palsies, chyle leaks, and surgical site infections are not apparent for the majority of patients during their hospital stay,” Dr. Pasieka said. “Many times, the true incidences are lost unless the patient re-presents to the health care system, thus introducing your bias of only those significant enough to require intervention.”

Dr. Glenn and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com