High levels of disability and low quality of life (QOL) were reported among children and adolescents with migraine utilizing infusion treatment, a new study found. Patients aged 6-19 years treated in an outpatient headache infusion center were included. A subset of these patients completed a behavioral health evaluation (treatment group) and were compared with a control group of similar age and gender to patients not seeking infusion treatment. Among the findings:

• 284 patients were included in the study (n=227 treatment group; n=57 controls).
• There was a promising difference in the Pediatric Pain Coping Inventory (PPCI) Distraction subscale, with a mean rank score of 61.90 for the treatment group vs 50.21 for the control group.
• There was a statistically significant difference on the Social Support subscale, with a mean rank score of 65.92 for the treatment group vs 46.26 for the control group.
• Patient-reported data also revealed a significantly higher level of disability among those seeking infusion treatment compared to the non-infusion group.

Woods K, et al. Psychosocial and demographic characteristics of children and adolescents with headache presenting for treatment in a headache infusion center. Headache. 2019;59(6):858-868. doi: 10.1111/head.13537.

High levels of disability and low quality of life (QOL) were reported among children and adolescents with migraine utilizing infusion treatment, a new study found. Patients aged 6-19 years treated in an outpatient headache infusion center were included. A subset of these patients completed a behavioral health evaluation (treatment group) and were compared with a control group of similar age and gender to patients not seeking infusion treatment. Among the findings:

• 284 patients were included in the study (n=227 treatment group; n=57 controls).
• There was a promising difference in the Pediatric Pain Coping Inventory (PPCI) Distraction subscale, with a mean rank score of 61.90 for the treatment group vs 50.21 for the control group.
• There was a statistically significant difference on the Social Support subscale, with a mean rank score of 65.92 for the treatment group vs 46.26 for the control group.
• Patient-reported data also revealed a significantly higher level of disability among those seeking infusion treatment compared to the non-infusion group.

Woods K, et al. Psychosocial and demographic characteristics of children and adolescents with headache presenting for treatment in a headache infusion center. Headache. 2019;59(6):858-868. doi: 10.1111/head.13537.

High levels of disability and low quality of life (QOL) were reported among children and adolescents with migraine utilizing infusion treatment, a new study found. Patients aged 6-19 years treated in an outpatient headache infusion center were included. A subset of these patients completed a behavioral health evaluation (treatment group) and were compared with a control group of similar age and gender to patients not seeking infusion treatment. Among the findings:

• 284 patients were included in the study (n=227 treatment group; n=57 controls).
• There was a promising difference in the Pediatric Pain Coping Inventory (PPCI) Distraction subscale, with a mean rank score of 61.90 for the treatment group vs 50.21 for the control group.
• There was a statistically significant difference on the Social Support subscale, with a mean rank score of 65.92 for the treatment group vs 46.26 for the control group.
• Patient-reported data also revealed a significantly higher level of disability among those seeking infusion treatment compared to the non-infusion group.

Woods K, et al. Psychosocial and demographic characteristics of children and adolescents with headache presenting for treatment in a headache infusion center. Headache. 2019;59(6):858-868. doi: 10.1111/head.13537.

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

SAN FRANCISCO – Patients with diabetes might soon be able to wear a necklace that warns of impending hypoglycemia 15 minutes or more before continuous glucose monitors notice a problem, according to investigators from Indiana University-Purdue University, Indianapolis.

M. Alexander Otto/MDedge News

The device would detect changes in the volatile organic compounds (VOCs) that patients exhale as their plasma glucose level drops. In an insulin clamp study in 11 people with type 1 diabetes, the Indianapolis team found a marked shift in VOCs at a plasma glucose level of 90 mg/dL that persisted all the way down to a level of 50 mg/dL.

The team is now working on a sensor to detect that shift and alert patients. It’s the same trick that diabetes alert dogs do – minus the pup.

The device would be worn like a necklace, and “sense the air around your breath every 15 minutes or so,” said lead investigator Amanda P. Siegel, PhD, an analytical chemist and assistant research professor at the university.

Some continuous glucose monitors already warn of impending hypoglycemia, but the interstitial glucose levels on which they rely lag behind plasma glucose level by about 15 minutes or so. A VOC sniffer offers the hope of a real-time warning, Dr. Siegel said at the annual scientific sessions of the American Diabetes Association.

The team used gas chromatography–mass spectrometry to analyze 94 breath samples from the 11 participants, starting at a median fasting plasma glucose level of 150 mg/dL all the way down to 50 mg/dL, and back up to recovery. Samples collected at the 90-mg/dL and 80-mg/dL levels demonstrated VOC concentrations very similar to those at and below the hypoglycemia threshold of 70 mg/dL.

Even at 90 mg/dL, the VOC profile “looked like patients were already low. These volatile compounds change early” and stay on the breath as plasma glucose drops. “They are different from normal levels for the entire time, and separate out nicely,” Dr. Siegel said.

The team is not saying which volatile compounds are involved while the sensor is under development. They are looking for funding, and if all goes well, they hope to submit a device application to the Food and Drug Administration in 2020.

Other teams are also looking to VOCs to replace poor Fido, but he can alert to hyperglycemia and other problems as well, so his job is safe for now.

The work has been supported by the National Science Foundation. Dr. Siegel did not have any disclosures.

[email protected]

SOURCE: Siegel AP et al. ADA 2019, Abstract 968-P.

SAN FRANCISCO – Patients with diabetes might soon be able to wear a necklace that warns of impending hypoglycemia 15 minutes or more before continuous glucose monitors notice a problem, according to investigators from Indiana University-Purdue University, Indianapolis.

M. Alexander Otto/MDedge News

The device would detect changes in the volatile organic compounds (VOCs) that patients exhale as their plasma glucose level drops. In an insulin clamp study in 11 people with type 1 diabetes, the Indianapolis team found a marked shift in VOCs at a plasma glucose level of 90 mg/dL that persisted all the way down to a level of 50 mg/dL.

The team is now working on a sensor to detect that shift and alert patients. It’s the same trick that diabetes alert dogs do – minus the pup.

The device would be worn like a necklace, and “sense the air around your breath every 15 minutes or so,” said lead investigator Amanda P. Siegel, PhD, an analytical chemist and assistant research professor at the university.

Some continuous glucose monitors already warn of impending hypoglycemia, but the interstitial glucose levels on which they rely lag behind plasma glucose level by about 15 minutes or so. A VOC sniffer offers the hope of a real-time warning, Dr. Siegel said at the annual scientific sessions of the American Diabetes Association.

The team used gas chromatography–mass spectrometry to analyze 94 breath samples from the 11 participants, starting at a median fasting plasma glucose level of 150 mg/dL all the way down to 50 mg/dL, and back up to recovery. Samples collected at the 90-mg/dL and 80-mg/dL levels demonstrated VOC concentrations very similar to those at and below the hypoglycemia threshold of 70 mg/dL.

Even at 90 mg/dL, the VOC profile “looked like patients were already low. These volatile compounds change early” and stay on the breath as plasma glucose drops. “They are different from normal levels for the entire time, and separate out nicely,” Dr. Siegel said.

The team is not saying which volatile compounds are involved while the sensor is under development. They are looking for funding, and if all goes well, they hope to submit a device application to the Food and Drug Administration in 2020.

Other teams are also looking to VOCs to replace poor Fido, but he can alert to hyperglycemia and other problems as well, so his job is safe for now.

The work has been supported by the National Science Foundation. Dr. Siegel did not have any disclosures.

[email protected]

SOURCE: Siegel AP et al. ADA 2019, Abstract 968-P.

SAN FRANCISCO – Patients with diabetes might soon be able to wear a necklace that warns of impending hypoglycemia 15 minutes or more before continuous glucose monitors notice a problem, according to investigators from Indiana University-Purdue University, Indianapolis.

M. Alexander Otto/MDedge News

The device would detect changes in the volatile organic compounds (VOCs) that patients exhale as their plasma glucose level drops. In an insulin clamp study in 11 people with type 1 diabetes, the Indianapolis team found a marked shift in VOCs at a plasma glucose level of 90 mg/dL that persisted all the way down to a level of 50 mg/dL.

The team is now working on a sensor to detect that shift and alert patients. It’s the same trick that diabetes alert dogs do – minus the pup.

The device would be worn like a necklace, and “sense the air around your breath every 15 minutes or so,” said lead investigator Amanda P. Siegel, PhD, an analytical chemist and assistant research professor at the university.

Some continuous glucose monitors already warn of impending hypoglycemia, but the interstitial glucose levels on which they rely lag behind plasma glucose level by about 15 minutes or so. A VOC sniffer offers the hope of a real-time warning, Dr. Siegel said at the annual scientific sessions of the American Diabetes Association.

The team used gas chromatography–mass spectrometry to analyze 94 breath samples from the 11 participants, starting at a median fasting plasma glucose level of 150 mg/dL all the way down to 50 mg/dL, and back up to recovery. Samples collected at the 90-mg/dL and 80-mg/dL levels demonstrated VOC concentrations very similar to those at and below the hypoglycemia threshold of 70 mg/dL.

Even at 90 mg/dL, the VOC profile “looked like patients were already low. These volatile compounds change early” and stay on the breath as plasma glucose drops. “They are different from normal levels for the entire time, and separate out nicely,” Dr. Siegel said.

The team is not saying which volatile compounds are involved while the sensor is under development. They are looking for funding, and if all goes well, they hope to submit a device application to the Food and Drug Administration in 2020.

Other teams are also looking to VOCs to replace poor Fido, but he can alert to hyperglycemia and other problems as well, so his job is safe for now.

The work has been supported by the National Science Foundation. Dr. Siegel did not have any disclosures.

[email protected]

SOURCE: Siegel AP et al. ADA 2019, Abstract 968-P.

Let’s begin with a brief case. A 25-year-old patient with a history of injection heroin use is in your care. He is admitted for treatment of endocarditis and will remain in the hospital for intravenous antibiotics for several weeks. Over the first few days of hospitalization, he frequently asks for pain medicine, stating that he is in severe pain, withdrawal, and having opioid cravings. On day 3, he leaves the hospital against medical advice. After 2 weeks, he presents to the ED in septic shock and spends several weeks in the ICU. Or, alternatively, he is found down in the community and pronounced dead from a heroin overdose.

These cases occur all too often, and hospitalists across the nation are actively building knowledge and programs to improve care for patients with opioid use disorder (OUD). It is evident that opioid misuse is the public health crisis of our time. In 2017, over 70,000 patients died from an overdose, and over 2 million patients in the United States have a diagnosis of OUD.^1,2 Many of these patients interact with the hospital at some point during the course of their illness for management of overdose, withdrawal, and other complications of OUD, including endocarditis, osteomyelitis, and skin and soft tissue infections. Moreover, just 20% of the 580,000 patients hospitalized with OUD in 2015 presented as a direct sequelae of the disease.³ Patients with OUD are often admitted for unrelated reasons, but their addiction goes unaddressed.

Opioid use disorder, like many of the other conditions we see, is a chronic relapsing remitting medical disease and a risk factor for premature mortality. When a patient with diabetes is admitted with cellulitis, we might check an A_1C, provide diabetic counseling, and offer evidence-based diabetes treatment, including medications like insulin. We rarely build similar systems of care within the walls of our hospitals to treat OUD like we do for diabetes or other commonly encountered diseases like heart failure and chronic obstructive pulmonary disease.

We should be intentional about separating prevention from treatment. Significant work has gone into reducing the availability of prescription opioids and increasing utilization of prescription drug monitoring programs. As a result, the average morphine milligram equivalent per opioid prescription has decreased since 2010.⁴ An unintended consequence of restricting legal opioids is potentially pushing patients with opioid addiction towards heroin and fentanyl. Limiting opioid prescriptions alone will only decrease opioid overdose mortality by 5% through 2025.⁵ Thus, treatment of OUD is critical and something that hospitalists should be trained and engaged in.

Food and Drug Administration–approved OUD treatment includes buprenorphine, methadone, and extended-release naltrexone. Buprenorphine is a partial opioid agonist that treats withdrawal and cravings. Buprenorphine started in the hospital reduces mortality, increases time spent in outpatient treatment after discharge, and reduces opioid-related 30-day readmissions by over 50%.^6-8 The number needed to treat with buprenorphine to prevent return to illicit opioid use is two.⁹ While physicians require an 8-hour “x-waiver” training (physician assistants and nurse practitioners require a 24-hour training) to prescribe buprenorphine for the outpatient treatment of OUD, such certification is not required to order the medication as part of an acute hospitalization.

Hospitalization represents a reachable moment and unique opportunity to start treatment for OUD. Patients are away from triggering environments and surrounded by supportive staff. Unfortunately, up to 30% of these patients leave the hospital against medical advice because of inadequately treated withdrawal, unaddressed cravings, and fear of mistreatment.¹⁰ Buprenorphine therapy may help tackle the physiological piece of hospital-based treatment, but we also must work on shifting the culture of our institutions. Importantly, OUD is a medical diagnosis. These patients must receive the same dignity, autonomy, and meaningful care afforded to patients with other medical diagnoses. Patients with OUD are not “addicts,” “abusers,” or “frequent fliers.”

Hospitalists have a clear and compelling role in treating OUD. The National Academy of Medicine recently held a workshop where they compared similarities of the HIV crisis with today’s opioid epidemic. The Academy advocated for the development of hospital-based protocols that empower physicians, physician assistants, and nurse practitioners to integrate the treatment of OUD into their practice.¹¹ Some in our field may feel that treating underlying addiction is a role for behavioral health practitioners. This is akin to having said that HIV specialists should be the only providers to treat patients with HIV during its peak. There are simply not enough psychiatrists or addiction medicine specialists to treat all of the patients who need us during this time of national urgency.

Mr. Bottner is a hospitalist at Dell Seton Medical Center, Austin, Texas, and clinical assistant professor at the University of Texas at Austin.

References

1. Katz J. You draw it: Just how bad is the drug overdose epidemic? New York Times. https://www.nytimes.com/interactive/2017/04/14/upshot/drug-overdose-epidemic-you-draw-it.html. Published Oct 26, 2017.

2. National Institute on Drug Abuse. Ohio – Opioid summaries by state. 2018. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/ohio_2018.pdf.

3. Peterson C et al. U.S. hospital discharges documenting patient opioid use disorder without opioid overdose or treatment services, 2011-2015. J Subst Abuse Treat. 2018;92:35-39. doi: 10.1016/j.jsat.2018.06.008.

4. Guy GP. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. Morb Mortal Wkly Rep. 2017;66. doi: 10.15585/mmwr.mm6626a4.

5. Chen Q et al. Prevention of prescription opioid misuse and projected overdose deaths in the United States. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.7621.

6. Liebschutz J et al. Buprenorphine treatment for hospitalized, opioid-dependent patients: A randomized clinical trial. JAMA Intern Med. 2014;174(8):1369-76.

7. Moreno JL et al. Predictors for 30-day and 90-day hospital readmission among patients with opioid use disorder. J Addict Med. 2019. doi: 10.1097/ADM.0000000000000499.

8. Larochelle MR et al. Medication for opioid use disorder after nonfatal opioid overdose and association with mortality: A cohort study. Ann Intern Med. June 2018. doi: 10.7326/M17-3107.

9. Raleigh MF. Buprenorphine maintenance vs. placebo for opioid dependence. Am Fam Physician. 2017;95(5). https://www.aafp.org/afp/2017/0301/od1.html. Accessed May 12, 2019.

10. Ti L et al. Leaving the hospital against medical advice among people who use illicit drugs: A systematic review. Am J Public Health. 2015;105(12):2587. doi: 10.2105/AJPH.2015.302885a.

11. Springer SAM et al. Integrating treatment at the intersection of opioid use disorder and infectious disease epidemics in medical settings: A call for action after a National Academies of Sciences, Engineering, and Medicine workshop. Ann Intern Med. 2018;169(5):335-6. doi: 10.7326/M18-1203.

Let’s begin with a brief case. A 25-year-old patient with a history of injection heroin use is in your care. He is admitted for treatment of endocarditis and will remain in the hospital for intravenous antibiotics for several weeks. Over the first few days of hospitalization, he frequently asks for pain medicine, stating that he is in severe pain, withdrawal, and having opioid cravings. On day 3, he leaves the hospital against medical advice. After 2 weeks, he presents to the ED in septic shock and spends several weeks in the ICU. Or, alternatively, he is found down in the community and pronounced dead from a heroin overdose.

These cases occur all too often, and hospitalists across the nation are actively building knowledge and programs to improve care for patients with opioid use disorder (OUD). It is evident that opioid misuse is the public health crisis of our time. In 2017, over 70,000 patients died from an overdose, and over 2 million patients in the United States have a diagnosis of OUD.^1,2 Many of these patients interact with the hospital at some point during the course of their illness for management of overdose, withdrawal, and other complications of OUD, including endocarditis, osteomyelitis, and skin and soft tissue infections. Moreover, just 20% of the 580,000 patients hospitalized with OUD in 2015 presented as a direct sequelae of the disease.³ Patients with OUD are often admitted for unrelated reasons, but their addiction goes unaddressed.

Opioid use disorder, like many of the other conditions we see, is a chronic relapsing remitting medical disease and a risk factor for premature mortality. When a patient with diabetes is admitted with cellulitis, we might check an A_1C, provide diabetic counseling, and offer evidence-based diabetes treatment, including medications like insulin. We rarely build similar systems of care within the walls of our hospitals to treat OUD like we do for diabetes or other commonly encountered diseases like heart failure and chronic obstructive pulmonary disease.

We should be intentional about separating prevention from treatment. Significant work has gone into reducing the availability of prescription opioids and increasing utilization of prescription drug monitoring programs. As a result, the average morphine milligram equivalent per opioid prescription has decreased since 2010.⁴ An unintended consequence of restricting legal opioids is potentially pushing patients with opioid addiction towards heroin and fentanyl. Limiting opioid prescriptions alone will only decrease opioid overdose mortality by 5% through 2025.⁵ Thus, treatment of OUD is critical and something that hospitalists should be trained and engaged in.

Food and Drug Administration–approved OUD treatment includes buprenorphine, methadone, and extended-release naltrexone. Buprenorphine is a partial opioid agonist that treats withdrawal and cravings. Buprenorphine started in the hospital reduces mortality, increases time spent in outpatient treatment after discharge, and reduces opioid-related 30-day readmissions by over 50%.^6-8 The number needed to treat with buprenorphine to prevent return to illicit opioid use is two.⁹ While physicians require an 8-hour “x-waiver” training (physician assistants and nurse practitioners require a 24-hour training) to prescribe buprenorphine for the outpatient treatment of OUD, such certification is not required to order the medication as part of an acute hospitalization.

Hospitalization represents a reachable moment and unique opportunity to start treatment for OUD. Patients are away from triggering environments and surrounded by supportive staff. Unfortunately, up to 30% of these patients leave the hospital against medical advice because of inadequately treated withdrawal, unaddressed cravings, and fear of mistreatment.¹⁰ Buprenorphine therapy may help tackle the physiological piece of hospital-based treatment, but we also must work on shifting the culture of our institutions. Importantly, OUD is a medical diagnosis. These patients must receive the same dignity, autonomy, and meaningful care afforded to patients with other medical diagnoses. Patients with OUD are not “addicts,” “abusers,” or “frequent fliers.”

Hospitalists have a clear and compelling role in treating OUD. The National Academy of Medicine recently held a workshop where they compared similarities of the HIV crisis with today’s opioid epidemic. The Academy advocated for the development of hospital-based protocols that empower physicians, physician assistants, and nurse practitioners to integrate the treatment of OUD into their practice.¹¹ Some in our field may feel that treating underlying addiction is a role for behavioral health practitioners. This is akin to having said that HIV specialists should be the only providers to treat patients with HIV during its peak. There are simply not enough psychiatrists or addiction medicine specialists to treat all of the patients who need us during this time of national urgency.

Mr. Bottner is a hospitalist at Dell Seton Medical Center, Austin, Texas, and clinical assistant professor at the University of Texas at Austin.

References

1. Katz J. You draw it: Just how bad is the drug overdose epidemic? New York Times. https://www.nytimes.com/interactive/2017/04/14/upshot/drug-overdose-epidemic-you-draw-it.html. Published Oct 26, 2017.

2. National Institute on Drug Abuse. Ohio – Opioid summaries by state. 2018. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/ohio_2018.pdf.

3. Peterson C et al. U.S. hospital discharges documenting patient opioid use disorder without opioid overdose or treatment services, 2011-2015. J Subst Abuse Treat. 2018;92:35-39. doi: 10.1016/j.jsat.2018.06.008.

4. Guy GP. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. Morb Mortal Wkly Rep. 2017;66. doi: 10.15585/mmwr.mm6626a4.

5. Chen Q et al. Prevention of prescription opioid misuse and projected overdose deaths in the United States. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.7621.

6. Liebschutz J et al. Buprenorphine treatment for hospitalized, opioid-dependent patients: A randomized clinical trial. JAMA Intern Med. 2014;174(8):1369-76.

7. Moreno JL et al. Predictors for 30-day and 90-day hospital readmission among patients with opioid use disorder. J Addict Med. 2019. doi: 10.1097/ADM.0000000000000499.

8. Larochelle MR et al. Medication for opioid use disorder after nonfatal opioid overdose and association with mortality: A cohort study. Ann Intern Med. June 2018. doi: 10.7326/M17-3107.

9. Raleigh MF. Buprenorphine maintenance vs. placebo for opioid dependence. Am Fam Physician. 2017;95(5). https://www.aafp.org/afp/2017/0301/od1.html. Accessed May 12, 2019.

10. Ti L et al. Leaving the hospital against medical advice among people who use illicit drugs: A systematic review. Am J Public Health. 2015;105(12):2587. doi: 10.2105/AJPH.2015.302885a.

11. Springer SAM et al. Integrating treatment at the intersection of opioid use disorder and infectious disease epidemics in medical settings: A call for action after a National Academies of Sciences, Engineering, and Medicine workshop. Ann Intern Med. 2018;169(5):335-6. doi: 10.7326/M18-1203.

Let’s begin with a brief case. A 25-year-old patient with a history of injection heroin use is in your care. He is admitted for treatment of endocarditis and will remain in the hospital for intravenous antibiotics for several weeks. Over the first few days of hospitalization, he frequently asks for pain medicine, stating that he is in severe pain, withdrawal, and having opioid cravings. On day 3, he leaves the hospital against medical advice. After 2 weeks, he presents to the ED in septic shock and spends several weeks in the ICU. Or, alternatively, he is found down in the community and pronounced dead from a heroin overdose.

These cases occur all too often, and hospitalists across the nation are actively building knowledge and programs to improve care for patients with opioid use disorder (OUD). It is evident that opioid misuse is the public health crisis of our time. In 2017, over 70,000 patients died from an overdose, and over 2 million patients in the United States have a diagnosis of OUD.^1,2 Many of these patients interact with the hospital at some point during the course of their illness for management of overdose, withdrawal, and other complications of OUD, including endocarditis, osteomyelitis, and skin and soft tissue infections. Moreover, just 20% of the 580,000 patients hospitalized with OUD in 2015 presented as a direct sequelae of the disease.³ Patients with OUD are often admitted for unrelated reasons, but their addiction goes unaddressed.

Opioid use disorder, like many of the other conditions we see, is a chronic relapsing remitting medical disease and a risk factor for premature mortality. When a patient with diabetes is admitted with cellulitis, we might check an A_1C, provide diabetic counseling, and offer evidence-based diabetes treatment, including medications like insulin. We rarely build similar systems of care within the walls of our hospitals to treat OUD like we do for diabetes or other commonly encountered diseases like heart failure and chronic obstructive pulmonary disease.

We should be intentional about separating prevention from treatment. Significant work has gone into reducing the availability of prescription opioids and increasing utilization of prescription drug monitoring programs. As a result, the average morphine milligram equivalent per opioid prescription has decreased since 2010.⁴ An unintended consequence of restricting legal opioids is potentially pushing patients with opioid addiction towards heroin and fentanyl. Limiting opioid prescriptions alone will only decrease opioid overdose mortality by 5% through 2025.⁵ Thus, treatment of OUD is critical and something that hospitalists should be trained and engaged in.

Food and Drug Administration–approved OUD treatment includes buprenorphine, methadone, and extended-release naltrexone. Buprenorphine is a partial opioid agonist that treats withdrawal and cravings. Buprenorphine started in the hospital reduces mortality, increases time spent in outpatient treatment after discharge, and reduces opioid-related 30-day readmissions by over 50%.^6-8 The number needed to treat with buprenorphine to prevent return to illicit opioid use is two.⁹ While physicians require an 8-hour “x-waiver” training (physician assistants and nurse practitioners require a 24-hour training) to prescribe buprenorphine for the outpatient treatment of OUD, such certification is not required to order the medication as part of an acute hospitalization.

Hospitalization represents a reachable moment and unique opportunity to start treatment for OUD. Patients are away from triggering environments and surrounded by supportive staff. Unfortunately, up to 30% of these patients leave the hospital against medical advice because of inadequately treated withdrawal, unaddressed cravings, and fear of mistreatment.¹⁰ Buprenorphine therapy may help tackle the physiological piece of hospital-based treatment, but we also must work on shifting the culture of our institutions. Importantly, OUD is a medical diagnosis. These patients must receive the same dignity, autonomy, and meaningful care afforded to patients with other medical diagnoses. Patients with OUD are not “addicts,” “abusers,” or “frequent fliers.”

Hospitalists have a clear and compelling role in treating OUD. The National Academy of Medicine recently held a workshop where they compared similarities of the HIV crisis with today’s opioid epidemic. The Academy advocated for the development of hospital-based protocols that empower physicians, physician assistants, and nurse practitioners to integrate the treatment of OUD into their practice.¹¹ Some in our field may feel that treating underlying addiction is a role for behavioral health practitioners. This is akin to having said that HIV specialists should be the only providers to treat patients with HIV during its peak. There are simply not enough psychiatrists or addiction medicine specialists to treat all of the patients who need us during this time of national urgency.

Mr. Bottner is a hospitalist at Dell Seton Medical Center, Austin, Texas, and clinical assistant professor at the University of Texas at Austin.

References

1. Katz J. You draw it: Just how bad is the drug overdose epidemic? New York Times. https://www.nytimes.com/interactive/2017/04/14/upshot/drug-overdose-epidemic-you-draw-it.html. Published Oct 26, 2017.

2. National Institute on Drug Abuse. Ohio – Opioid summaries by state. 2018. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/ohio_2018.pdf.

3. Peterson C et al. U.S. hospital discharges documenting patient opioid use disorder without opioid overdose or treatment services, 2011-2015. J Subst Abuse Treat. 2018;92:35-39. doi: 10.1016/j.jsat.2018.06.008.

4. Guy GP. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. Morb Mortal Wkly Rep. 2017;66. doi: 10.15585/mmwr.mm6626a4.

5. Chen Q et al. Prevention of prescription opioid misuse and projected overdose deaths in the United States. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.7621.

6. Liebschutz J et al. Buprenorphine treatment for hospitalized, opioid-dependent patients: A randomized clinical trial. JAMA Intern Med. 2014;174(8):1369-76.

7. Moreno JL et al. Predictors for 30-day and 90-day hospital readmission among patients with opioid use disorder. J Addict Med. 2019. doi: 10.1097/ADM.0000000000000499.

8. Larochelle MR et al. Medication for opioid use disorder after nonfatal opioid overdose and association with mortality: A cohort study. Ann Intern Med. June 2018. doi: 10.7326/M17-3107.

9. Raleigh MF. Buprenorphine maintenance vs. placebo for opioid dependence. Am Fam Physician. 2017;95(5). https://www.aafp.org/afp/2017/0301/od1.html. Accessed May 12, 2019.

10. Ti L et al. Leaving the hospital against medical advice among people who use illicit drugs: A systematic review. Am J Public Health. 2015;105(12):2587. doi: 10.2105/AJPH.2015.302885a.

11. Springer SAM et al. Integrating treatment at the intersection of opioid use disorder and infectious disease epidemics in medical settings: A call for action after a National Academies of Sciences, Engineering, and Medicine workshop. Ann Intern Med. 2018;169(5):335-6. doi: 10.7326/M18-1203.

Background: SDDs are as safe as non-SDDs (NSDDs) in patients after elective PCI, yet there has been only a modest increase in SDD.

Limitations include that 2015 data may not reflect current practices. ICD 9 codes used for obtaining complications data can be misclassified. Cost savings are variable. Patients with periprocedural complications were not candidates for SDD but were included in the data. The study does not account for variation in technique, PCI characteristics, or SDD criteria of hospitals.

Bottom line: Prevalence of SDDs for elective PCI patients varies by institution and is an underutilized opportunity to significantly reduce hospital costs and increase patient satisfaction while maintaining the safety of patients.

Citation: Amin AP et al. Association of same-day discharge after elective percutaneous coronary intervention in the United States with costs and outcomes. JAMA Cardiol. Published online 2018 Sep 26. doi: 10.1001/jamacardio.2018.3029.

Dr. Kochar is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

Background: SDDs are as safe as non-SDDs (NSDDs) in patients after elective PCI, yet there has been only a modest increase in SDD.

Limitations include that 2015 data may not reflect current practices. ICD 9 codes used for obtaining complications data can be misclassified. Cost savings are variable. Patients with periprocedural complications were not candidates for SDD but were included in the data. The study does not account for variation in technique, PCI characteristics, or SDD criteria of hospitals.

Bottom line: Prevalence of SDDs for elective PCI patients varies by institution and is an underutilized opportunity to significantly reduce hospital costs and increase patient satisfaction while maintaining the safety of patients.

Citation: Amin AP et al. Association of same-day discharge after elective percutaneous coronary intervention in the United States with costs and outcomes. JAMA Cardiol. Published online 2018 Sep 26. doi: 10.1001/jamacardio.2018.3029.

Dr. Kochar is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

Background: SDDs are as safe as non-SDDs (NSDDs) in patients after elective PCI, yet there has been only a modest increase in SDD.

Limitations include that 2015 data may not reflect current practices. ICD 9 codes used for obtaining complications data can be misclassified. Cost savings are variable. Patients with periprocedural complications were not candidates for SDD but were included in the data. The study does not account for variation in technique, PCI characteristics, or SDD criteria of hospitals.

Bottom line: Prevalence of SDDs for elective PCI patients varies by institution and is an underutilized opportunity to significantly reduce hospital costs and increase patient satisfaction while maintaining the safety of patients.

Citation: Amin AP et al. Association of same-day discharge after elective percutaneous coronary intervention in the United States with costs and outcomes. JAMA Cardiol. Published online 2018 Sep 26. doi: 10.1001/jamacardio.2018.3029.

Dr. Kochar is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

[email protected]

In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

[email protected]

In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

[email protected]

Urinary melatonin metabolites do not predict migraine attacks in children and adolescents, however, they may be predictive in those who experience premonitory phase symptoms as part of their migraine attacks. This according to a study that examined whether evening urinary melatonin metabolite levels could predict migraine the next day in children and adolescents with migraine. Among the details:

• Twenty-one children and adolescents with migraine were recruited to provide urine samples for 10 days and maintain a prospective headache diary during the same period.
• Mean aMT6s levels the night prior to a migraine attack were 56.2 ±39.0 vs 55.4 ±46.6 ng/mL.
• Mean melatonin metabolite levels the night following migraine were 55.5 ±46.9 vs 57.0 ±37.7 ng/mL.
• However, in post hoc exploratory analyses, aMT6s levels were lower the night before a migraine in those who experienced aura or premonitory symptoms.

Berger A, et al. Preliminary evidence that melatonin is not a biomarker in children and adolescents with episodic migraine. [Published online ahead of print May 3, 2019]. Headache. doi: 10.1111/head.13547.

Urinary melatonin metabolites do not predict migraine attacks in children and adolescents, however, they may be predictive in those who experience premonitory phase symptoms as part of their migraine attacks. This according to a study that examined whether evening urinary melatonin metabolite levels could predict migraine the next day in children and adolescents with migraine. Among the details:

• Twenty-one children and adolescents with migraine were recruited to provide urine samples for 10 days and maintain a prospective headache diary during the same period.
• Mean aMT6s levels the night prior to a migraine attack were 56.2 ±39.0 vs 55.4 ±46.6 ng/mL.
• Mean melatonin metabolite levels the night following migraine were 55.5 ±46.9 vs 57.0 ±37.7 ng/mL.
• However, in post hoc exploratory analyses, aMT6s levels were lower the night before a migraine in those who experienced aura or premonitory symptoms.

Berger A, et al. Preliminary evidence that melatonin is not a biomarker in children and adolescents with episodic migraine. [Published online ahead of print May 3, 2019]. Headache. doi: 10.1111/head.13547.

Urinary melatonin metabolites do not predict migraine attacks in children and adolescents, however, they may be predictive in those who experience premonitory phase symptoms as part of their migraine attacks. This according to a study that examined whether evening urinary melatonin metabolite levels could predict migraine the next day in children and adolescents with migraine. Among the details:

• Twenty-one children and adolescents with migraine were recruited to provide urine samples for 10 days and maintain a prospective headache diary during the same period.
• Mean aMT6s levels the night prior to a migraine attack were 56.2 ±39.0 vs 55.4 ±46.6 ng/mL.
• Mean melatonin metabolite levels the night following migraine were 55.5 ±46.9 vs 57.0 ±37.7 ng/mL.
• However, in post hoc exploratory analyses, aMT6s levels were lower the night before a migraine in those who experienced aura or premonitory symptoms.

Berger A, et al. Preliminary evidence that melatonin is not a biomarker in children and adolescents with episodic migraine. [Published online ahead of print May 3, 2019]. Headache. doi: 10.1111/head.13547.

Acute exacerbations in chronic obstructive pulmonary disease could also trigger a cardiac event such as MI or stroke, particularly in older individuals, new research has found.

In Respirology, researchers report the outcomes of a nationwide, register-based study involving 118,807 patients with chronic obstructive pulmonary disease (COPD) who experienced a major adverse cardiac event after an exacerbation.

They found that the risk of any major cardiac adverse event increased 270% in the 4 weeks after the onset of an exacerbation (95% confidence interval, 3.60-3.80). The strongest association was seen for cardiovascular death, for which there was a 333% increase in risk, but there was also a 257% increase in the risk of acute MI and 178% increase in the risk of stroke.

The risk of major adverse cardiac events was even higher among individuals who were hospitalized because of their COPD exacerbation (odds ratio, 5.92), compared with a 150% increase in risk among those who weren’t hospitalized but were treated with oral corticosteroids and 108% increase among those treated with amoxicillin with enzyme inhibitors.

The risk of a major cardiac event after a COPD exacerbation also increased with age. Among individuals younger than 55 years, there was a 131% increase in risk, but among those aged 55-69 years there was a 234% increase, among those aged 70-79 years the risk increased 282%, and among those aged 80 years and older it increased 318%.

Mette Reilev, from the department of public health at the University of Southern Denmark, Odense, and coauthors suggested that acute exacerbations were associated with elevated levels of systemic inflammatory markers such as fibrinogen and interleukin-6, which were potently prothrombotic and could potentially trigger cardiovascular events.

“Additionally, exacerbations may trigger type II myocardial infarctions secondary to an imbalance in oxygen supply and demand,” they wrote.

The authors raised the question of whether cardiovascular prevention strategies should be part of treatment recommendations for people with COPD, and suggested that prevention of COPD exacerbations could be justified even on cardiovascular grounds alone.

“Studies investigating the effect of cardiovascular treatment on the course of disease among COPD exacerbators are extremely scarce,” they wrote. “Thus, it is currently unknown how to optimize treatment and mitigate the increased risk of [major adverse cardiovascular events] following the onset of exacerbations.”

However, they noted that prednisolone treatment for more severe exacerbations may have a confounding effect, as oral corticosteroids could induce dyslipidemia, hypertension, and hyperglycemia, and increase long-term cardiovascular risk.

Six authors declared funding from the pharmaceutical industry – three of which were institutional support – unrelated to the study.

SOURCE: Reilev M et al. Respirology. 2019 Jun 21. doi: 10.1111/resp.13620.

Acute exacerbations in chronic obstructive pulmonary disease could also trigger a cardiac event such as MI or stroke, particularly in older individuals, new research has found.

In Respirology, researchers report the outcomes of a nationwide, register-based study involving 118,807 patients with chronic obstructive pulmonary disease (COPD) who experienced a major adverse cardiac event after an exacerbation.

They found that the risk of any major cardiac adverse event increased 270% in the 4 weeks after the onset of an exacerbation (95% confidence interval, 3.60-3.80). The strongest association was seen for cardiovascular death, for which there was a 333% increase in risk, but there was also a 257% increase in the risk of acute MI and 178% increase in the risk of stroke.

The risk of major adverse cardiac events was even higher among individuals who were hospitalized because of their COPD exacerbation (odds ratio, 5.92), compared with a 150% increase in risk among those who weren’t hospitalized but were treated with oral corticosteroids and 108% increase among those treated with amoxicillin with enzyme inhibitors.

The risk of a major cardiac event after a COPD exacerbation also increased with age. Among individuals younger than 55 years, there was a 131% increase in risk, but among those aged 55-69 years there was a 234% increase, among those aged 70-79 years the risk increased 282%, and among those aged 80 years and older it increased 318%.

Mette Reilev, from the department of public health at the University of Southern Denmark, Odense, and coauthors suggested that acute exacerbations were associated with elevated levels of systemic inflammatory markers such as fibrinogen and interleukin-6, which were potently prothrombotic and could potentially trigger cardiovascular events.

“Additionally, exacerbations may trigger type II myocardial infarctions secondary to an imbalance in oxygen supply and demand,” they wrote.

The authors raised the question of whether cardiovascular prevention strategies should be part of treatment recommendations for people with COPD, and suggested that prevention of COPD exacerbations could be justified even on cardiovascular grounds alone.

“Studies investigating the effect of cardiovascular treatment on the course of disease among COPD exacerbators are extremely scarce,” they wrote. “Thus, it is currently unknown how to optimize treatment and mitigate the increased risk of [major adverse cardiovascular events] following the onset of exacerbations.”

However, they noted that prednisolone treatment for more severe exacerbations may have a confounding effect, as oral corticosteroids could induce dyslipidemia, hypertension, and hyperglycemia, and increase long-term cardiovascular risk.

Six authors declared funding from the pharmaceutical industry – three of which were institutional support – unrelated to the study.

SOURCE: Reilev M et al. Respirology. 2019 Jun 21. doi: 10.1111/resp.13620.

Acute exacerbations in chronic obstructive pulmonary disease could also trigger a cardiac event such as MI or stroke, particularly in older individuals, new research has found.

In Respirology, researchers report the outcomes of a nationwide, register-based study involving 118,807 patients with chronic obstructive pulmonary disease (COPD) who experienced a major adverse cardiac event after an exacerbation.

They found that the risk of any major cardiac adverse event increased 270% in the 4 weeks after the onset of an exacerbation (95% confidence interval, 3.60-3.80). The strongest association was seen for cardiovascular death, for which there was a 333% increase in risk, but there was also a 257% increase in the risk of acute MI and 178% increase in the risk of stroke.

The risk of major adverse cardiac events was even higher among individuals who were hospitalized because of their COPD exacerbation (odds ratio, 5.92), compared with a 150% increase in risk among those who weren’t hospitalized but were treated with oral corticosteroids and 108% increase among those treated with amoxicillin with enzyme inhibitors.

The risk of a major cardiac event after a COPD exacerbation also increased with age. Among individuals younger than 55 years, there was a 131% increase in risk, but among those aged 55-69 years there was a 234% increase, among those aged 70-79 years the risk increased 282%, and among those aged 80 years and older it increased 318%.

Mette Reilev, from the department of public health at the University of Southern Denmark, Odense, and coauthors suggested that acute exacerbations were associated with elevated levels of systemic inflammatory markers such as fibrinogen and interleukin-6, which were potently prothrombotic and could potentially trigger cardiovascular events.

“Additionally, exacerbations may trigger type II myocardial infarctions secondary to an imbalance in oxygen supply and demand,” they wrote.

The authors raised the question of whether cardiovascular prevention strategies should be part of treatment recommendations for people with COPD, and suggested that prevention of COPD exacerbations could be justified even on cardiovascular grounds alone.

“Studies investigating the effect of cardiovascular treatment on the course of disease among COPD exacerbators are extremely scarce,” they wrote. “Thus, it is currently unknown how to optimize treatment and mitigate the increased risk of [major adverse cardiovascular events] following the onset of exacerbations.”

However, they noted that prednisolone treatment for more severe exacerbations may have a confounding effect, as oral corticosteroids could induce dyslipidemia, hypertension, and hyperglycemia, and increase long-term cardiovascular risk.

Six authors declared funding from the pharmaceutical industry – three of which were institutional support – unrelated to the study.

SOURCE: Reilev M et al. Respirology. 2019 Jun 21. doi: 10.1111/resp.13620.

The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.

The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.

The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.