Vascular Live

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Fri, 05/31/2019 - 14:54

Come see exhibitors present new ideas, showcase new technologies, and discuss the latest trends in vascular surgery. All Vascular Live events will take place at the Vascular Live stage in the Auditorium, on the lower level of the convention center.

 

Thursday, June 13

12:15 – 12:45 p.m.
Sponsored by Gore
Case Examples from the EU of the New GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL® System
Speaker: Prof. Dittmar Böckler

12:45 – 1:15 p.m.
Sponsored by Gore
Lower Limb Stent Grafting: Complex Cases and Techniques in SFA and Aortoiliac Disease
Speaker: Krishna Mannava, MD

3 – 3:30 p.m.
Sponsored by Silk Road Medical
Latest (Breaking) Clinical Evidence Strongly Supports Developing a TCAR Program – Why and How from a Vascular Surgery Perspective
Speakers: Sumaira Macdonald, MD; Jeffrey Jim, MD; Marc L. Schermerhorn, MD; and Michael C. Stoner, MD
 

5:30 – 6 p.m.
Sponsored by Thompson Surgical
Technological Advances and the Evolution of the ‘Mini-Open’ Anterior Spine Exposure Technique
Speaker: Jonathan E. Schoeff, MD

6 – 6:30 p.m.
Sponsored by Amgen
Criticality of LDC-C Lowering in Patients with PAD
Speaker: Marc P. Bonaca, MD
 

Friday, June 14

9:30 – 10 a.m.
Sponsored by Abbott
Access & Closure Techniques for Complex Aortic Cases
Speaker: Jason T. Lee, MD

12:30 – 1 p.m.
Sponsored by Abbott
A Clinical Review of the WavelineQ 4F EndoAVF System
Speakers: Todd Berland, MD; Paul B. Kreienberg, MD; and Eric K. Peden, MD

1 – 1:30 p.m.
Sponsored by Abbott
EPDs in the Lower Limb: Why and When to Use Them
Speaker: April Estelle Nedeau, MD

3 – 3:30 p.m.
Sponsored by Medtronic
Clinical Significance of Sac Regression with Case Examples
Speaker: TBD
 

Vascular Live presentations are not eligible for CME credit. 

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Come see exhibitors present new ideas, showcase new technologies, and discuss the latest trends in vascular surgery. All Vascular Live events will take place at the Vascular Live stage in the Auditorium, on the lower level of the convention center.

 

Thursday, June 13

12:15 – 12:45 p.m.
Sponsored by Gore
Case Examples from the EU of the New GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL® System
Speaker: Prof. Dittmar Böckler

12:45 – 1:15 p.m.
Sponsored by Gore
Lower Limb Stent Grafting: Complex Cases and Techniques in SFA and Aortoiliac Disease
Speaker: Krishna Mannava, MD

3 – 3:30 p.m.
Sponsored by Silk Road Medical
Latest (Breaking) Clinical Evidence Strongly Supports Developing a TCAR Program – Why and How from a Vascular Surgery Perspective
Speakers: Sumaira Macdonald, MD; Jeffrey Jim, MD; Marc L. Schermerhorn, MD; and Michael C. Stoner, MD
 

5:30 – 6 p.m.
Sponsored by Thompson Surgical
Technological Advances and the Evolution of the ‘Mini-Open’ Anterior Spine Exposure Technique
Speaker: Jonathan E. Schoeff, MD

6 – 6:30 p.m.
Sponsored by Amgen
Criticality of LDC-C Lowering in Patients with PAD
Speaker: Marc P. Bonaca, MD
 

Friday, June 14

9:30 – 10 a.m.
Sponsored by Abbott
Access & Closure Techniques for Complex Aortic Cases
Speaker: Jason T. Lee, MD

12:30 – 1 p.m.
Sponsored by Abbott
A Clinical Review of the WavelineQ 4F EndoAVF System
Speakers: Todd Berland, MD; Paul B. Kreienberg, MD; and Eric K. Peden, MD

1 – 1:30 p.m.
Sponsored by Abbott
EPDs in the Lower Limb: Why and When to Use Them
Speaker: April Estelle Nedeau, MD

3 – 3:30 p.m.
Sponsored by Medtronic
Clinical Significance of Sac Regression with Case Examples
Speaker: TBD
 

Vascular Live presentations are not eligible for CME credit. 

Come see exhibitors present new ideas, showcase new technologies, and discuss the latest trends in vascular surgery. All Vascular Live events will take place at the Vascular Live stage in the Auditorium, on the lower level of the convention center.

 

Thursday, June 13

12:15 – 12:45 p.m.
Sponsored by Gore
Case Examples from the EU of the New GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL® System
Speaker: Prof. Dittmar Böckler

12:45 – 1:15 p.m.
Sponsored by Gore
Lower Limb Stent Grafting: Complex Cases and Techniques in SFA and Aortoiliac Disease
Speaker: Krishna Mannava, MD

3 – 3:30 p.m.
Sponsored by Silk Road Medical
Latest (Breaking) Clinical Evidence Strongly Supports Developing a TCAR Program – Why and How from a Vascular Surgery Perspective
Speakers: Sumaira Macdonald, MD; Jeffrey Jim, MD; Marc L. Schermerhorn, MD; and Michael C. Stoner, MD
 

5:30 – 6 p.m.
Sponsored by Thompson Surgical
Technological Advances and the Evolution of the ‘Mini-Open’ Anterior Spine Exposure Technique
Speaker: Jonathan E. Schoeff, MD

6 – 6:30 p.m.
Sponsored by Amgen
Criticality of LDC-C Lowering in Patients with PAD
Speaker: Marc P. Bonaca, MD
 

Friday, June 14

9:30 – 10 a.m.
Sponsored by Abbott
Access & Closure Techniques for Complex Aortic Cases
Speaker: Jason T. Lee, MD

12:30 – 1 p.m.
Sponsored by Abbott
A Clinical Review of the WavelineQ 4F EndoAVF System
Speakers: Todd Berland, MD; Paul B. Kreienberg, MD; and Eric K. Peden, MD

1 – 1:30 p.m.
Sponsored by Abbott
EPDs in the Lower Limb: Why and When to Use Them
Speaker: April Estelle Nedeau, MD

3 – 3:30 p.m.
Sponsored by Medtronic
Clinical Significance of Sac Regression with Case Examples
Speaker: TBD
 

Vascular Live presentations are not eligible for CME credit. 

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Ketamine tied to remission from suicidal ideation

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Fri, 05/31/2019 - 15:33

Report of 235 cases deemed largest series to date on impact of infusions

 

– Serial ketamine infusions eliminated suicidal ideation in more than two-thirds of patients at a psychiatry office in Connecticut but at significantly higher doses than those recently approved for Janssen’s new esketamine nasal spray (Spravato).

Dr. Lori V. Calabrese, a psychiatrist in private practice in South Windsor, Conn.
M. Alexander Otto/MDedge News
Dr. Lori V. Calabrese

The patients were treated by Lori V. Calabrese, MD, at Innovative Psychiatry, her private outpatient practice in South Windsor. She presented her first 235 IV ketamine cases at the American Psychiatric Association annual meeting. It was likely the largest real-world series to date of ketamine infusions for treatment-resistant depression and suicidality.

The patients, 14-84 years old but mostly middle-aged, received six infusions over 2-3 weeks, starting at 0.5 mg/kg over 40-50 minutes, then titrated upward for dissociative effect to a maximum of 1.7 mg/kg. Subjects filled out the nine-item Patient Health Questionnaire (PHQ-9) at baseline and before each infusion. Item nine – “thoughts that you would be better off dead or of hurting yourself in some way” – was used to gauge suicidality. That item has been validated as a predictor of suicide risk.

Among 144 patients (62%) who were markedly suicidal, ketamine infusions were tied to diminished ideation in 118 (82%) and eliminated ideation in 98 (68%). They were severely depressed at baseline; PHQ-9 scores fell in 127 (89%), and depression went into remission in 89 (62%). There were no suicide attempts, ED visits, or hospitalizations during treatment and at 4-week follow-up.

“Even if they had been suicidal for a long time, been hospitalized, and made suicide attempts, 68% had full remission of suicidality. This is a life-saving treatment, a breakthrough option for psychiatrists,” Dr. Calabrese said.

The results are “fabulous,” said Jaskaran Singh, MD, who said he was clinical leader of the esketamine program at Janssen.

Dr. Jaskaran Singh, senior director, Janssen, San Diego
M. Alexander Otto/MDedge News
Dr. Jaskaran Singh


“You prevented hospitalizations and saved lives,” Dr. Singh said. “This is a marvelous study that we should have done.”

Dr. Calabrese’s report, however, raises the question of whether the nasal spray will be potent enough to achieve the same results. She found that cessation of suicidal thoughts required an average dose of 0.75 mg/kg IV ketamine, which is higher than the 0.5 mg/kg used by many ketamine infusion programs in the United States. It’s also significantly higher than Spravato dosing. The spray was cleared by the Food and Drug Administration in March for use with an oral antidepressant for treatment-resistant depression. It was the subject of much buzz at the APA meeting.

Esketamine is approved in doses of 56 mg, which works out to almost 0.2 mg/kg, and 84 mg, which works out to less than 4 mg/kg. Dosing is twice weekly at first, then weekly or biweekly for maintenance.

When asked whether he thought those doses would be enough to prevent suicide, Dr. Singh said his company has finished two trials in suicidal patients and would present results later in 2019.

Dr. Calabrese, meanwhile, plans to incorporate intranasal esketamine into her practice, but will continue to offer ketamine infusions. “How can I not? I’ve seen how effective they are,” she said.

She charges $500 per session, $2 for the ketamine plus nursing and other costs. Insurance companies have sometimes covered it for patients with a history of psychiatric ED visits and hospitalizations, on the grounds that infusions will prevent future admissions. But patients have to fight for coverage – and feel well enough to do so.

That’s the main reason Dr. Calabrese plans to start offering Spravato; coverage will likely be less of a hassle for patients once Janssen works out the insurance issues. Spravato has been reported to cost about $600-$900 per treatment session.

She noted that response among her infusion patients was bimodal, with suicidal ideation eliminated in some patients after one infusion, but most of the rest needed three or more. “Don’t give up,” she said.

Infusion response correlated with suicidality and depression severity, with the sickest patients having the most benefit. Among 91 moderately depressed, nonsuicidal patients, just over half responded to the infusions, and depression went into remission in about a third.

Side effects were minimal, transient, and easily handled in the office. A little bit of IV midazolam calmed patients who got too anxious, and IV ondansetron (Zofran) helped those who got nauseous. Blood pressure can bump up a bit with ketamine, so Dr. Calabrese follows it closely.

The report had no external funding and Dr. Calabrese had no disclosures.

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Report of 235 cases deemed largest series to date on impact of infusions

Report of 235 cases deemed largest series to date on impact of infusions

 

– Serial ketamine infusions eliminated suicidal ideation in more than two-thirds of patients at a psychiatry office in Connecticut but at significantly higher doses than those recently approved for Janssen’s new esketamine nasal spray (Spravato).

Dr. Lori V. Calabrese, a psychiatrist in private practice in South Windsor, Conn.
M. Alexander Otto/MDedge News
Dr. Lori V. Calabrese

The patients were treated by Lori V. Calabrese, MD, at Innovative Psychiatry, her private outpatient practice in South Windsor. She presented her first 235 IV ketamine cases at the American Psychiatric Association annual meeting. It was likely the largest real-world series to date of ketamine infusions for treatment-resistant depression and suicidality.

The patients, 14-84 years old but mostly middle-aged, received six infusions over 2-3 weeks, starting at 0.5 mg/kg over 40-50 minutes, then titrated upward for dissociative effect to a maximum of 1.7 mg/kg. Subjects filled out the nine-item Patient Health Questionnaire (PHQ-9) at baseline and before each infusion. Item nine – “thoughts that you would be better off dead or of hurting yourself in some way” – was used to gauge suicidality. That item has been validated as a predictor of suicide risk.

Among 144 patients (62%) who were markedly suicidal, ketamine infusions were tied to diminished ideation in 118 (82%) and eliminated ideation in 98 (68%). They were severely depressed at baseline; PHQ-9 scores fell in 127 (89%), and depression went into remission in 89 (62%). There were no suicide attempts, ED visits, or hospitalizations during treatment and at 4-week follow-up.

“Even if they had been suicidal for a long time, been hospitalized, and made suicide attempts, 68% had full remission of suicidality. This is a life-saving treatment, a breakthrough option for psychiatrists,” Dr. Calabrese said.

The results are “fabulous,” said Jaskaran Singh, MD, who said he was clinical leader of the esketamine program at Janssen.

Dr. Jaskaran Singh, senior director, Janssen, San Diego
M. Alexander Otto/MDedge News
Dr. Jaskaran Singh


“You prevented hospitalizations and saved lives,” Dr. Singh said. “This is a marvelous study that we should have done.”

Dr. Calabrese’s report, however, raises the question of whether the nasal spray will be potent enough to achieve the same results. She found that cessation of suicidal thoughts required an average dose of 0.75 mg/kg IV ketamine, which is higher than the 0.5 mg/kg used by many ketamine infusion programs in the United States. It’s also significantly higher than Spravato dosing. The spray was cleared by the Food and Drug Administration in March for use with an oral antidepressant for treatment-resistant depression. It was the subject of much buzz at the APA meeting.

Esketamine is approved in doses of 56 mg, which works out to almost 0.2 mg/kg, and 84 mg, which works out to less than 4 mg/kg. Dosing is twice weekly at first, then weekly or biweekly for maintenance.

When asked whether he thought those doses would be enough to prevent suicide, Dr. Singh said his company has finished two trials in suicidal patients and would present results later in 2019.

Dr. Calabrese, meanwhile, plans to incorporate intranasal esketamine into her practice, but will continue to offer ketamine infusions. “How can I not? I’ve seen how effective they are,” she said.

She charges $500 per session, $2 for the ketamine plus nursing and other costs. Insurance companies have sometimes covered it for patients with a history of psychiatric ED visits and hospitalizations, on the grounds that infusions will prevent future admissions. But patients have to fight for coverage – and feel well enough to do so.

That’s the main reason Dr. Calabrese plans to start offering Spravato; coverage will likely be less of a hassle for patients once Janssen works out the insurance issues. Spravato has been reported to cost about $600-$900 per treatment session.

She noted that response among her infusion patients was bimodal, with suicidal ideation eliminated in some patients after one infusion, but most of the rest needed three or more. “Don’t give up,” she said.

Infusion response correlated with suicidality and depression severity, with the sickest patients having the most benefit. Among 91 moderately depressed, nonsuicidal patients, just over half responded to the infusions, and depression went into remission in about a third.

Side effects were minimal, transient, and easily handled in the office. A little bit of IV midazolam calmed patients who got too anxious, and IV ondansetron (Zofran) helped those who got nauseous. Blood pressure can bump up a bit with ketamine, so Dr. Calabrese follows it closely.

The report had no external funding and Dr. Calabrese had no disclosures.

 

– Serial ketamine infusions eliminated suicidal ideation in more than two-thirds of patients at a psychiatry office in Connecticut but at significantly higher doses than those recently approved for Janssen’s new esketamine nasal spray (Spravato).

Dr. Lori V. Calabrese, a psychiatrist in private practice in South Windsor, Conn.
M. Alexander Otto/MDedge News
Dr. Lori V. Calabrese

The patients were treated by Lori V. Calabrese, MD, at Innovative Psychiatry, her private outpatient practice in South Windsor. She presented her first 235 IV ketamine cases at the American Psychiatric Association annual meeting. It was likely the largest real-world series to date of ketamine infusions for treatment-resistant depression and suicidality.

The patients, 14-84 years old but mostly middle-aged, received six infusions over 2-3 weeks, starting at 0.5 mg/kg over 40-50 minutes, then titrated upward for dissociative effect to a maximum of 1.7 mg/kg. Subjects filled out the nine-item Patient Health Questionnaire (PHQ-9) at baseline and before each infusion. Item nine – “thoughts that you would be better off dead or of hurting yourself in some way” – was used to gauge suicidality. That item has been validated as a predictor of suicide risk.

Among 144 patients (62%) who were markedly suicidal, ketamine infusions were tied to diminished ideation in 118 (82%) and eliminated ideation in 98 (68%). They were severely depressed at baseline; PHQ-9 scores fell in 127 (89%), and depression went into remission in 89 (62%). There were no suicide attempts, ED visits, or hospitalizations during treatment and at 4-week follow-up.

“Even if they had been suicidal for a long time, been hospitalized, and made suicide attempts, 68% had full remission of suicidality. This is a life-saving treatment, a breakthrough option for psychiatrists,” Dr. Calabrese said.

The results are “fabulous,” said Jaskaran Singh, MD, who said he was clinical leader of the esketamine program at Janssen.

Dr. Jaskaran Singh, senior director, Janssen, San Diego
M. Alexander Otto/MDedge News
Dr. Jaskaran Singh


“You prevented hospitalizations and saved lives,” Dr. Singh said. “This is a marvelous study that we should have done.”

Dr. Calabrese’s report, however, raises the question of whether the nasal spray will be potent enough to achieve the same results. She found that cessation of suicidal thoughts required an average dose of 0.75 mg/kg IV ketamine, which is higher than the 0.5 mg/kg used by many ketamine infusion programs in the United States. It’s also significantly higher than Spravato dosing. The spray was cleared by the Food and Drug Administration in March for use with an oral antidepressant for treatment-resistant depression. It was the subject of much buzz at the APA meeting.

Esketamine is approved in doses of 56 mg, which works out to almost 0.2 mg/kg, and 84 mg, which works out to less than 4 mg/kg. Dosing is twice weekly at first, then weekly or biweekly for maintenance.

When asked whether he thought those doses would be enough to prevent suicide, Dr. Singh said his company has finished two trials in suicidal patients and would present results later in 2019.

Dr. Calabrese, meanwhile, plans to incorporate intranasal esketamine into her practice, but will continue to offer ketamine infusions. “How can I not? I’ve seen how effective they are,” she said.

She charges $500 per session, $2 for the ketamine plus nursing and other costs. Insurance companies have sometimes covered it for patients with a history of psychiatric ED visits and hospitalizations, on the grounds that infusions will prevent future admissions. But patients have to fight for coverage – and feel well enough to do so.

That’s the main reason Dr. Calabrese plans to start offering Spravato; coverage will likely be less of a hassle for patients once Janssen works out the insurance issues. Spravato has been reported to cost about $600-$900 per treatment session.

She noted that response among her infusion patients was bimodal, with suicidal ideation eliminated in some patients after one infusion, but most of the rest needed three or more. “Don’t give up,” she said.

Infusion response correlated with suicidality and depression severity, with the sickest patients having the most benefit. Among 91 moderately depressed, nonsuicidal patients, just over half responded to the infusions, and depression went into remission in about a third.

Side effects were minimal, transient, and easily handled in the office. A little bit of IV midazolam calmed patients who got too anxious, and IV ondansetron (Zofran) helped those who got nauseous. Blood pressure can bump up a bit with ketamine, so Dr. Calabrese follows it closely.

The report had no external funding and Dr. Calabrese had no disclosures.

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Novel anti-PD-1 antibody can be given subcutaneously

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Mon, 06/03/2019 - 13:42

The novel anti–programmed cell death antibody PF-06801591 had tolerable safety and efficacy outcomes when given subcutaneously to patients with advanced solid tumors, based on results from an ongoing phase 1 trial.

“We assessed feasibility of monthly subcutaneous administration of PF-06801591, a humanized immunoglobulin G4 monoclonal antibody that binds to the programmed cell death [PD-1] receptor,” Melissa L. Johnson, MD, of the Sarah Cannon Research Institute, Nashville, Tenn., and colleagues wrote in JAMA Oncology. “Subcutaneous administration of an anti-PD-1 antibody in patients with advanced solid tumors appears to be feasible.”

The researchers evaluated the efficacy, safety, and pharmacokinetics of the novel anti-PD-1 therapy in a group of 40 patients with locally advanced or metastatic solid tumors. The antibody was administered in both subcutaneous and intravenous forms.

Study participants were administered the subcutaneous form of the antibody at 300 mg every 4 weeks or the intravenous form at 0.5, 1, 3, or 10 mg/kg every 3 weeks.

“Dose escalation occurred after two to four patients were enrolled per dose level, with additional patients enrolled in each cohort for further assessment,” the researchers wrote.

The primary endpoints were safety and dose-limiting adverse effects. Efficacy, immunogenicity, pharmacokinetics, and PD-1 receptor occupancy were secondary endpoints.

After analysis, Dr. Johnson and colleagues reported that the overall response rate was 18.4%. In addition, no dose-limiting toxicities were detected in both intravenous and subcutaneous groups, but grade 3 or greater adverse events were reported in 6.7% and 16% of patients treated with subcutaneous and intravenous dosage forms, respectively.

“No dose–adverse event associations were observed during intravenous dose escalation, and no serious skin toxic effects occurred with subcutaneous delivery,” they reported.

Based on the findings, the team selected the subcutaneous form (300 mg) of the therapy for additional assessment in the second half of this ongoing trial.

The study was funded by Pfizer. The authors reported financial affiliations with BerGenBio, EMD Serono, Janssen, Mirati Therapeutics, Pfizer, and several others.

SOURCE: Johnson ML et al. JAMA Oncol. 2019 May 30. doi: 10.1001/jamaoncol.2019.0836.

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The novel anti–programmed cell death antibody PF-06801591 had tolerable safety and efficacy outcomes when given subcutaneously to patients with advanced solid tumors, based on results from an ongoing phase 1 trial.

“We assessed feasibility of monthly subcutaneous administration of PF-06801591, a humanized immunoglobulin G4 monoclonal antibody that binds to the programmed cell death [PD-1] receptor,” Melissa L. Johnson, MD, of the Sarah Cannon Research Institute, Nashville, Tenn., and colleagues wrote in JAMA Oncology. “Subcutaneous administration of an anti-PD-1 antibody in patients with advanced solid tumors appears to be feasible.”

The researchers evaluated the efficacy, safety, and pharmacokinetics of the novel anti-PD-1 therapy in a group of 40 patients with locally advanced or metastatic solid tumors. The antibody was administered in both subcutaneous and intravenous forms.

Study participants were administered the subcutaneous form of the antibody at 300 mg every 4 weeks or the intravenous form at 0.5, 1, 3, or 10 mg/kg every 3 weeks.

“Dose escalation occurred after two to four patients were enrolled per dose level, with additional patients enrolled in each cohort for further assessment,” the researchers wrote.

The primary endpoints were safety and dose-limiting adverse effects. Efficacy, immunogenicity, pharmacokinetics, and PD-1 receptor occupancy were secondary endpoints.

After analysis, Dr. Johnson and colleagues reported that the overall response rate was 18.4%. In addition, no dose-limiting toxicities were detected in both intravenous and subcutaneous groups, but grade 3 or greater adverse events were reported in 6.7% and 16% of patients treated with subcutaneous and intravenous dosage forms, respectively.

“No dose–adverse event associations were observed during intravenous dose escalation, and no serious skin toxic effects occurred with subcutaneous delivery,” they reported.

Based on the findings, the team selected the subcutaneous form (300 mg) of the therapy for additional assessment in the second half of this ongoing trial.

The study was funded by Pfizer. The authors reported financial affiliations with BerGenBio, EMD Serono, Janssen, Mirati Therapeutics, Pfizer, and several others.

SOURCE: Johnson ML et al. JAMA Oncol. 2019 May 30. doi: 10.1001/jamaoncol.2019.0836.

The novel anti–programmed cell death antibody PF-06801591 had tolerable safety and efficacy outcomes when given subcutaneously to patients with advanced solid tumors, based on results from an ongoing phase 1 trial.

“We assessed feasibility of monthly subcutaneous administration of PF-06801591, a humanized immunoglobulin G4 monoclonal antibody that binds to the programmed cell death [PD-1] receptor,” Melissa L. Johnson, MD, of the Sarah Cannon Research Institute, Nashville, Tenn., and colleagues wrote in JAMA Oncology. “Subcutaneous administration of an anti-PD-1 antibody in patients with advanced solid tumors appears to be feasible.”

The researchers evaluated the efficacy, safety, and pharmacokinetics of the novel anti-PD-1 therapy in a group of 40 patients with locally advanced or metastatic solid tumors. The antibody was administered in both subcutaneous and intravenous forms.

Study participants were administered the subcutaneous form of the antibody at 300 mg every 4 weeks or the intravenous form at 0.5, 1, 3, or 10 mg/kg every 3 weeks.

“Dose escalation occurred after two to four patients were enrolled per dose level, with additional patients enrolled in each cohort for further assessment,” the researchers wrote.

The primary endpoints were safety and dose-limiting adverse effects. Efficacy, immunogenicity, pharmacokinetics, and PD-1 receptor occupancy were secondary endpoints.

After analysis, Dr. Johnson and colleagues reported that the overall response rate was 18.4%. In addition, no dose-limiting toxicities were detected in both intravenous and subcutaneous groups, but grade 3 or greater adverse events were reported in 6.7% and 16% of patients treated with subcutaneous and intravenous dosage forms, respectively.

“No dose–adverse event associations were observed during intravenous dose escalation, and no serious skin toxic effects occurred with subcutaneous delivery,” they reported.

Based on the findings, the team selected the subcutaneous form (300 mg) of the therapy for additional assessment in the second half of this ongoing trial.

The study was funded by Pfizer. The authors reported financial affiliations with BerGenBio, EMD Serono, Janssen, Mirati Therapeutics, Pfizer, and several others.

SOURCE: Johnson ML et al. JAMA Oncol. 2019 May 30. doi: 10.1001/jamaoncol.2019.0836.

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Exhibit Hall: The Place to Be for Food, Fun, Education

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Fri, 05/31/2019 - 14:25

The Exhibit Hall is an integral part of the Vascular Annual Meeting. All members of the vascular team, as well as other attendees, will be able to see a wide-ranging array of products of interest to vascular surgeons and their teams from dozens of vendors.

The VAM website (vsweb.org/VAM19) and mobile app offer a listing of exhibitors. A real-time floor plan (vsweb.org/FloorMap) helps attendees navigate the Exhibit Hall to find the products they most want to see.

Martin Allred
VAM attendees found much to entertain and educate them in last year's Exhibit Hall.

Input a keyword – such as “stents,” for example – and the website provides a listing of exhibitors who manufacture stents. Input “endovascular” and not only are companies listed but so are the Vascular and Endovascular Surgery Society and Vascular News/Charing Cross Symposium. Searches are possible for a specific vendor, as well, and can be refined.


This year’s Exhibit Hall also will include the Office Vascular Care Pavilion, of interest particularly for those clinicians who perform procedures in outpatient and office-based settings. Five vendors currently plan to exhibit at the pavilion, and four presentations for office-based providers are scheduled. 


The Exhibit Hall on the lower level also hosts fun and games – literally. It’s the site for the Opening and Closing receptions, on Thursday and Friday evenings, respectively and the Scavenger Hunt. And attendees can also take advantage of non-CME learning opportunities, giveaways, training opportunities and networking potential.

The Opening Reception takes place from 5 to 6:30 p.m., coinciding with the Interactive Poster Session. The Closing Reception is from 4:30 to 5:30 p.m. Friday. It’s a great time to browse the exhibits, talk with vendors, meet up with friends and colleagues, sip on a beverage, and enjoy the food.

Participate in Scavenger Hunt

Games? That would be the Vascular Annual Meeting Scavenger Hunt, sure to be a hit with those with even a bit of a competitive streak. It’s simple and it’s fun. Just download the Mobile App to scan the QR codes found in sponsors’ booths throughout the Exhibit Hall. When a multiple-choice question appears on the display, answer it. Correct answers earn 10 points. 

Vascular Live hosts innovative sessions about the latest products and development related to vascular surgery, in a theater-in-the-round setting during Thursday and Friday’s coffee breaks and lunch hours. These frequently are standing-room only, so be sure to arrive early for a good seat. (See the VAM Planner and the mobile app.)

The Exhibit Hall also is the place to be for coffee breaks, 10 a.m. and 3 p.m. Thursday and 9:30 a.m. and 3 p.m. Friday as well as lunch, at 12 p.m. Thursday and 12:15 p.m. Friday. Food stations offer box lunches – free to attendees, though tickets are required. And there are plenty of tables to permit sitting down and chatting with colleagues for a bit.

Industry participation in the VAM exhibits underwrites a significant portion of VAM, thereby allowing us to keep registration fees at a much lower rate than other industry meetings. Please support our industry partners. A complete list of exhibitors and their booth locations are found in the Connections on-site publication and in the Mobile App, VAM Planner and VAM website (vsweb.org/VAM19). 

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The Exhibit Hall is an integral part of the Vascular Annual Meeting. All members of the vascular team, as well as other attendees, will be able to see a wide-ranging array of products of interest to vascular surgeons and their teams from dozens of vendors.

The VAM website (vsweb.org/VAM19) and mobile app offer a listing of exhibitors. A real-time floor plan (vsweb.org/FloorMap) helps attendees navigate the Exhibit Hall to find the products they most want to see.

Martin Allred
VAM attendees found much to entertain and educate them in last year's Exhibit Hall.

Input a keyword – such as “stents,” for example – and the website provides a listing of exhibitors who manufacture stents. Input “endovascular” and not only are companies listed but so are the Vascular and Endovascular Surgery Society and Vascular News/Charing Cross Symposium. Searches are possible for a specific vendor, as well, and can be refined.


This year’s Exhibit Hall also will include the Office Vascular Care Pavilion, of interest particularly for those clinicians who perform procedures in outpatient and office-based settings. Five vendors currently plan to exhibit at the pavilion, and four presentations for office-based providers are scheduled. 


The Exhibit Hall on the lower level also hosts fun and games – literally. It’s the site for the Opening and Closing receptions, on Thursday and Friday evenings, respectively and the Scavenger Hunt. And attendees can also take advantage of non-CME learning opportunities, giveaways, training opportunities and networking potential.

The Opening Reception takes place from 5 to 6:30 p.m., coinciding with the Interactive Poster Session. The Closing Reception is from 4:30 to 5:30 p.m. Friday. It’s a great time to browse the exhibits, talk with vendors, meet up with friends and colleagues, sip on a beverage, and enjoy the food.

Participate in Scavenger Hunt

Games? That would be the Vascular Annual Meeting Scavenger Hunt, sure to be a hit with those with even a bit of a competitive streak. It’s simple and it’s fun. Just download the Mobile App to scan the QR codes found in sponsors’ booths throughout the Exhibit Hall. When a multiple-choice question appears on the display, answer it. Correct answers earn 10 points. 

Vascular Live hosts innovative sessions about the latest products and development related to vascular surgery, in a theater-in-the-round setting during Thursday and Friday’s coffee breaks and lunch hours. These frequently are standing-room only, so be sure to arrive early for a good seat. (See the VAM Planner and the mobile app.)

The Exhibit Hall also is the place to be for coffee breaks, 10 a.m. and 3 p.m. Thursday and 9:30 a.m. and 3 p.m. Friday as well as lunch, at 12 p.m. Thursday and 12:15 p.m. Friday. Food stations offer box lunches – free to attendees, though tickets are required. And there are plenty of tables to permit sitting down and chatting with colleagues for a bit.

Industry participation in the VAM exhibits underwrites a significant portion of VAM, thereby allowing us to keep registration fees at a much lower rate than other industry meetings. Please support our industry partners. A complete list of exhibitors and their booth locations are found in the Connections on-site publication and in the Mobile App, VAM Planner and VAM website (vsweb.org/VAM19). 

The Exhibit Hall is an integral part of the Vascular Annual Meeting. All members of the vascular team, as well as other attendees, will be able to see a wide-ranging array of products of interest to vascular surgeons and their teams from dozens of vendors.

The VAM website (vsweb.org/VAM19) and mobile app offer a listing of exhibitors. A real-time floor plan (vsweb.org/FloorMap) helps attendees navigate the Exhibit Hall to find the products they most want to see.

Martin Allred
VAM attendees found much to entertain and educate them in last year's Exhibit Hall.

Input a keyword – such as “stents,” for example – and the website provides a listing of exhibitors who manufacture stents. Input “endovascular” and not only are companies listed but so are the Vascular and Endovascular Surgery Society and Vascular News/Charing Cross Symposium. Searches are possible for a specific vendor, as well, and can be refined.


This year’s Exhibit Hall also will include the Office Vascular Care Pavilion, of interest particularly for those clinicians who perform procedures in outpatient and office-based settings. Five vendors currently plan to exhibit at the pavilion, and four presentations for office-based providers are scheduled. 


The Exhibit Hall on the lower level also hosts fun and games – literally. It’s the site for the Opening and Closing receptions, on Thursday and Friday evenings, respectively and the Scavenger Hunt. And attendees can also take advantage of non-CME learning opportunities, giveaways, training opportunities and networking potential.

The Opening Reception takes place from 5 to 6:30 p.m., coinciding with the Interactive Poster Session. The Closing Reception is from 4:30 to 5:30 p.m. Friday. It’s a great time to browse the exhibits, talk with vendors, meet up with friends and colleagues, sip on a beverage, and enjoy the food.

Participate in Scavenger Hunt

Games? That would be the Vascular Annual Meeting Scavenger Hunt, sure to be a hit with those with even a bit of a competitive streak. It’s simple and it’s fun. Just download the Mobile App to scan the QR codes found in sponsors’ booths throughout the Exhibit Hall. When a multiple-choice question appears on the display, answer it. Correct answers earn 10 points. 

Vascular Live hosts innovative sessions about the latest products and development related to vascular surgery, in a theater-in-the-round setting during Thursday and Friday’s coffee breaks and lunch hours. These frequently are standing-room only, so be sure to arrive early for a good seat. (See the VAM Planner and the mobile app.)

The Exhibit Hall also is the place to be for coffee breaks, 10 a.m. and 3 p.m. Thursday and 9:30 a.m. and 3 p.m. Friday as well as lunch, at 12 p.m. Thursday and 12:15 p.m. Friday. Food stations offer box lunches – free to attendees, though tickets are required. And there are plenty of tables to permit sitting down and chatting with colleagues for a bit.

Industry participation in the VAM exhibits underwrites a significant portion of VAM, thereby allowing us to keep registration fees at a much lower rate than other industry meetings. Please support our industry partners. A complete list of exhibitors and their booth locations are found in the Connections on-site publication and in the Mobile App, VAM Planner and VAM website (vsweb.org/VAM19). 

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Children’s anxiety during asthma exacerbations linked to better outcomes

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Changed
Fri, 05/31/2019 - 14:13

 

Experiencing panic-fear during asthma exacerbations predicted several beneficial outcomes in Mexican and Puerto Rican children with asthma, according to new research.

Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the Bronx, New York
Tara Haelle/MDedge News
Dr. Jonathan M. Feldman

“When kids are anxious specifically during their asthma attacks, that can be a good thing because it means that they’re more vigilant,” lead author Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the New York said in an interview. “They may be more likely to react during the early stages of an attack, and they may be more likely to be using self-management strategies at home and using their controller medications on a daily basis.”

He said pediatric providers can ask their patients with asthma how they feel during asthma attacks, such as whether they ever feel scared or worried.

“If a kid says no, not at all, then I would be concerned as a provider because they may not be paying attention to their asthma symptoms and they may not be taking it seriously,” Dr. Feldman said.

Past research has suggested that “illness-specific panic-fear” – the amount of anxiety someone experiences during asthma exacerbations – helps adults develop adaptive asthma management strategies, so Dr. Feldman and his colleagues examined the phenomenon as a potential protective factor in children. They shared their findings at the annual meeting of the Pediatric Academic Societies.

The research focused on Puerto Rican (n = 79) and Mexican (n = 188) children because of the substantial disparity in asthma prevalence and control between these two different Latino populations. Puerto Rican children have the highest asthma prevalence and morbidity among American children, whereas Mexican children have the lowest rates.

The 267 participants, aged 5-12 years, included 110 children from two inner-city hospitals in the New York and 157 children from two school-based health clinics and a Breathmobile in Phoenix. Nearly all the Arizona children were Mexican, and most (71%) of the Bronx children were Puerto Rican.

The authors collected the following measures at baseline and at 3, 6, 9, and 12 months follow-up: spirometry (forced expiratory volume in 1 second [FEV1]), Childhood Asthma Control Test (CACT) for children 5-11 years old, the Asthma Control Test (ACT) for 12-year-olds, adherence to inhaled corticosteroids (ICS), and acute health care utilizations (clinic sick visits, ED visits, and hospitalizations).

The authors also queried patients on four illness-specific panic-fear measures from the Childhood Asthma Symptoms Checklist: how often they felt frightened, panicky, afraid of being alone, and afraid of dying during an asthma attack (Likert 1-5 scale).

Mexican children reported higher levels of illness-specific panic-fear at the start of the study. They also tended to have lower severity of asthma, better asthma control, and better adherence to ICS, compared with Puerto Rican children.

Also at baseline, the Mexican children’s caregivers tended to be younger, poorer, and more likely to be married and to speak Spanish. The Puerto Rican caregivers, on the other hand, had a higher educational level, including 61% high school graduates, and had more depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D).

One-year data revealed several links between baseline reports of panic-fear and better outcomes. Mexican children who reported experiencing panic-fear at baseline were more likely to have higher FEV1 measures at 1 year of follow-up than were those who didn’t experience panic-fear (P = .02). Similarly, Puerto Rican children initially reporting panic-fear had better asthma control at 1 year, compared with those who didn’t report panic-fear (P = .007).

The researchers reported their effect sizes in terms of predicted variance in a model that accounted for the child’s age, sex, asthma duration, asthma severity, social support, acculturation, health care provider relationship, and number of family members with asthma. The model also factored in the caregiver’s age, sex, marital status, poverty level, education, and depressive symptoms.

For example, in their model, experiencing panic-fear accounted for 67% of the variance in FEV1 levels in Mexican children and 53% of the variance in asthma control in Puerto Rican children.

Less acute health care utilization also was associated with children’s baseline levels of illness-specific panic-fear. In the model, 12% of the variance in acute health care utilization among Mexican children (P = .03) and 41% of the variance among Puerto Rican children (P = .02) was explained by child-reported panic-fear. No association was seen with medication adherence.

Although caregivers’ reports of children feeling panic-fear were linked to better FEV1 outcomes in Mexican children (P = .02), the association was only slightly significant in Puerto Rican children (P = .05). Caregiver reports of children’s panic-fear were not associated with asthma control, acute health care utilization, or medication adherence.

“Providers should be aware that anxiety focused on asthma may be beneficial and facilitate adaptive asthma management strategies,” the authors concluded.

The research was funded by the National Institutes of Health. The authors reported no relevant financial disclosures.

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Experiencing panic-fear during asthma exacerbations predicted several beneficial outcomes in Mexican and Puerto Rican children with asthma, according to new research.

Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the Bronx, New York
Tara Haelle/MDedge News
Dr. Jonathan M. Feldman

“When kids are anxious specifically during their asthma attacks, that can be a good thing because it means that they’re more vigilant,” lead author Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the New York said in an interview. “They may be more likely to react during the early stages of an attack, and they may be more likely to be using self-management strategies at home and using their controller medications on a daily basis.”

He said pediatric providers can ask their patients with asthma how they feel during asthma attacks, such as whether they ever feel scared or worried.

“If a kid says no, not at all, then I would be concerned as a provider because they may not be paying attention to their asthma symptoms and they may not be taking it seriously,” Dr. Feldman said.

Past research has suggested that “illness-specific panic-fear” – the amount of anxiety someone experiences during asthma exacerbations – helps adults develop adaptive asthma management strategies, so Dr. Feldman and his colleagues examined the phenomenon as a potential protective factor in children. They shared their findings at the annual meeting of the Pediatric Academic Societies.

The research focused on Puerto Rican (n = 79) and Mexican (n = 188) children because of the substantial disparity in asthma prevalence and control between these two different Latino populations. Puerto Rican children have the highest asthma prevalence and morbidity among American children, whereas Mexican children have the lowest rates.

The 267 participants, aged 5-12 years, included 110 children from two inner-city hospitals in the New York and 157 children from two school-based health clinics and a Breathmobile in Phoenix. Nearly all the Arizona children were Mexican, and most (71%) of the Bronx children were Puerto Rican.

The authors collected the following measures at baseline and at 3, 6, 9, and 12 months follow-up: spirometry (forced expiratory volume in 1 second [FEV1]), Childhood Asthma Control Test (CACT) for children 5-11 years old, the Asthma Control Test (ACT) for 12-year-olds, adherence to inhaled corticosteroids (ICS), and acute health care utilizations (clinic sick visits, ED visits, and hospitalizations).

The authors also queried patients on four illness-specific panic-fear measures from the Childhood Asthma Symptoms Checklist: how often they felt frightened, panicky, afraid of being alone, and afraid of dying during an asthma attack (Likert 1-5 scale).

Mexican children reported higher levels of illness-specific panic-fear at the start of the study. They also tended to have lower severity of asthma, better asthma control, and better adherence to ICS, compared with Puerto Rican children.

Also at baseline, the Mexican children’s caregivers tended to be younger, poorer, and more likely to be married and to speak Spanish. The Puerto Rican caregivers, on the other hand, had a higher educational level, including 61% high school graduates, and had more depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D).

One-year data revealed several links between baseline reports of panic-fear and better outcomes. Mexican children who reported experiencing panic-fear at baseline were more likely to have higher FEV1 measures at 1 year of follow-up than were those who didn’t experience panic-fear (P = .02). Similarly, Puerto Rican children initially reporting panic-fear had better asthma control at 1 year, compared with those who didn’t report panic-fear (P = .007).

The researchers reported their effect sizes in terms of predicted variance in a model that accounted for the child’s age, sex, asthma duration, asthma severity, social support, acculturation, health care provider relationship, and number of family members with asthma. The model also factored in the caregiver’s age, sex, marital status, poverty level, education, and depressive symptoms.

For example, in their model, experiencing panic-fear accounted for 67% of the variance in FEV1 levels in Mexican children and 53% of the variance in asthma control in Puerto Rican children.

Less acute health care utilization also was associated with children’s baseline levels of illness-specific panic-fear. In the model, 12% of the variance in acute health care utilization among Mexican children (P = .03) and 41% of the variance among Puerto Rican children (P = .02) was explained by child-reported panic-fear. No association was seen with medication adherence.

Although caregivers’ reports of children feeling panic-fear were linked to better FEV1 outcomes in Mexican children (P = .02), the association was only slightly significant in Puerto Rican children (P = .05). Caregiver reports of children’s panic-fear were not associated with asthma control, acute health care utilization, or medication adherence.

“Providers should be aware that anxiety focused on asthma may be beneficial and facilitate adaptive asthma management strategies,” the authors concluded.

The research was funded by the National Institutes of Health. The authors reported no relevant financial disclosures.

 

Experiencing panic-fear during asthma exacerbations predicted several beneficial outcomes in Mexican and Puerto Rican children with asthma, according to new research.

Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the Bronx, New York
Tara Haelle/MDedge News
Dr. Jonathan M. Feldman

“When kids are anxious specifically during their asthma attacks, that can be a good thing because it means that they’re more vigilant,” lead author Jonathan M. Feldman, PhD, of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore and of Yeshiva University in the New York said in an interview. “They may be more likely to react during the early stages of an attack, and they may be more likely to be using self-management strategies at home and using their controller medications on a daily basis.”

He said pediatric providers can ask their patients with asthma how they feel during asthma attacks, such as whether they ever feel scared or worried.

“If a kid says no, not at all, then I would be concerned as a provider because they may not be paying attention to their asthma symptoms and they may not be taking it seriously,” Dr. Feldman said.

Past research has suggested that “illness-specific panic-fear” – the amount of anxiety someone experiences during asthma exacerbations – helps adults develop adaptive asthma management strategies, so Dr. Feldman and his colleagues examined the phenomenon as a potential protective factor in children. They shared their findings at the annual meeting of the Pediatric Academic Societies.

The research focused on Puerto Rican (n = 79) and Mexican (n = 188) children because of the substantial disparity in asthma prevalence and control between these two different Latino populations. Puerto Rican children have the highest asthma prevalence and morbidity among American children, whereas Mexican children have the lowest rates.

The 267 participants, aged 5-12 years, included 110 children from two inner-city hospitals in the New York and 157 children from two school-based health clinics and a Breathmobile in Phoenix. Nearly all the Arizona children were Mexican, and most (71%) of the Bronx children were Puerto Rican.

The authors collected the following measures at baseline and at 3, 6, 9, and 12 months follow-up: spirometry (forced expiratory volume in 1 second [FEV1]), Childhood Asthma Control Test (CACT) for children 5-11 years old, the Asthma Control Test (ACT) for 12-year-olds, adherence to inhaled corticosteroids (ICS), and acute health care utilizations (clinic sick visits, ED visits, and hospitalizations).

The authors also queried patients on four illness-specific panic-fear measures from the Childhood Asthma Symptoms Checklist: how often they felt frightened, panicky, afraid of being alone, and afraid of dying during an asthma attack (Likert 1-5 scale).

Mexican children reported higher levels of illness-specific panic-fear at the start of the study. They also tended to have lower severity of asthma, better asthma control, and better adherence to ICS, compared with Puerto Rican children.

Also at baseline, the Mexican children’s caregivers tended to be younger, poorer, and more likely to be married and to speak Spanish. The Puerto Rican caregivers, on the other hand, had a higher educational level, including 61% high school graduates, and had more depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D).

One-year data revealed several links between baseline reports of panic-fear and better outcomes. Mexican children who reported experiencing panic-fear at baseline were more likely to have higher FEV1 measures at 1 year of follow-up than were those who didn’t experience panic-fear (P = .02). Similarly, Puerto Rican children initially reporting panic-fear had better asthma control at 1 year, compared with those who didn’t report panic-fear (P = .007).

The researchers reported their effect sizes in terms of predicted variance in a model that accounted for the child’s age, sex, asthma duration, asthma severity, social support, acculturation, health care provider relationship, and number of family members with asthma. The model also factored in the caregiver’s age, sex, marital status, poverty level, education, and depressive symptoms.

For example, in their model, experiencing panic-fear accounted for 67% of the variance in FEV1 levels in Mexican children and 53% of the variance in asthma control in Puerto Rican children.

Less acute health care utilization also was associated with children’s baseline levels of illness-specific panic-fear. In the model, 12% of the variance in acute health care utilization among Mexican children (P = .03) and 41% of the variance among Puerto Rican children (P = .02) was explained by child-reported panic-fear. No association was seen with medication adherence.

Although caregivers’ reports of children feeling panic-fear were linked to better FEV1 outcomes in Mexican children (P = .02), the association was only slightly significant in Puerto Rican children (P = .05). Caregiver reports of children’s panic-fear were not associated with asthma control, acute health care utilization, or medication adherence.

“Providers should be aware that anxiety focused on asthma may be beneficial and facilitate adaptive asthma management strategies,” the authors concluded.

The research was funded by the National Institutes of Health. The authors reported no relevant financial disclosures.

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Can acid suppression prevent recurrent idiopathic gastroduodenal ulcer bleeding?

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Changed
Fri, 05/31/2019 - 15:32

 

Lansoprazole and famotidine are comparable for the prevention of recurrent ulcer bleeding in patients with a history of Helicobacter pylori–negative idiopathic bleeding ulcers, results from a double-blind, randomized trial showed. However, these patients face a considerable risk of overall mortality, despite a low incidence of recurrent GI bleeding.

Dr. Louis Lau
Doug Brunk/MDedge News
Dr. Louis Lau

“Peptic ulcer disease is a commonly encountered condition in our daily clinical practice,” one of the study authors, Louis Lau, MD, said at the annual Digestive Disease Week. “Most of the ulcers are due to H. pylori and NSAIDs or aspirin. However, idiopathic peptic ulcers remain an area to be investigated.”

According to Dr. Lau of the division of gastroenterology and hepatology at Prince of Wales Hospital, Hong Kong, H. pylori–negative idiopathic ulcers have increased in prevalence in the Asian Pacific region, from 1%-4% in 2000 to up to 20% in recent data. These ulcers have been shown to have a bleeding rate of up to 13% within 1 year (Gastroenterology. 2005;128:1845-50) and have been associated with a mortality rate of up to 88% in 7 years of follow-up (Gastroenterology. 2009;137:525-31).

“There is no consensus for the optimal management of this particular ulcer,” he continued. “One proposed management was maintenance PPI [proton pump inhibitors]. However, we would like to look for the best optimal prevention strategy.”



Dr. Lau and associates conducted a double-blind, randomized trial at Prince of Wales Hospital to determine if there were any differences between the PPI lansoprazole and the histamine2 receptor antagonist famotidine for the prevention of recurrent bleeding in patients with H. pylori–negative idiopathic peptic ulcers. It involved a 2-year follow-up period and included a screening and end-of-study esophagogastroduodenoscopy. The drugs were repackaged into identical green capsules.

The researchers limited the analysis to 228 patients over the age 18 with H. pylori–negative idiopathic ulcers, defined as having endoscopic biopsies negative for both rapid urease test and histology for H. pylori; no exposure to aspirin, NSAIDs, or drugs of unknown nature including traditional Chinese medicine within 4 weeks; and no other causes of ulceration identified. Exclusion criteria included patients with a strong indication for maintenance therapy with PPIs, those with prior gastric surgery, pregnant patients, and those with advanced malignancy or comorbidity.

The primary endpoint was clinical GI bleeding or reduction in hemoglobin level of 2 g/dL or more and confirmation of peptic ulcers by endoscopy. The secondary endpoint was recurrent ulcer detected by end-of-study endoscopy, with or without clinical symptoms.

Of the 228 patients, 114 received lansoprazole 30 mg daily and 114 received famotidine 40 mg daily. Recurrent upper GI bleeding was suspected in 10 patients in each of the treatment groups. Ulcer confirmation via endoscopy detected one ulcer in the lansoprazole group and three in the famotidine group (0.9% vs. 2.6%, respectively; P = .62). For the secondary endpoint, there were five recurrent ulcers in the lansoprazole group and nine in the famotidine group, (4.4% vs. 7.9%, respectively; P = .27).

Dr. Lau and colleagues observed eight deaths in the lansoprazole group (7%), compared with five (4.4%) in the famotidine group (P = .39), mainly caused by pneumonia, renal failure, and other chronic medical conditions. Intention-to-treat analysis at 2 years found that both groups were comparable in terms of time to analysis of recurrent upper GI bleeding, adjusted for death as a competing risk (Gray’s test, P = .313).

“In this randomized, controlled trial, we found that both a PPI and an H2 blocker are comparable in the prevention of idiopathic ulcer recurrent bleeding,” Dr. Lau concluded. “The rebleeding rate was five times lower than a previous cohort reported with no or irregular acid suppression therapy [Gastroenterology. 2005;128[7]:1845-50]. With all this, there is still a considerable risk of recurrent ulcers and death. We postulate that there is an underlying mechanism for this type of idiopathic ulcer.”

The study was funded in part by the General Research Fund–Research Grant Council. Dr. Lau reported having no financial disclosures. Many of his coauthors reported having numerous financial ties to the pharmaceutical industry.

SOURCE: Lau L et al. DDW 2019, Abstract 322.

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Lansoprazole and famotidine are comparable for the prevention of recurrent ulcer bleeding in patients with a history of Helicobacter pylori–negative idiopathic bleeding ulcers, results from a double-blind, randomized trial showed. However, these patients face a considerable risk of overall mortality, despite a low incidence of recurrent GI bleeding.

Dr. Louis Lau
Doug Brunk/MDedge News
Dr. Louis Lau

“Peptic ulcer disease is a commonly encountered condition in our daily clinical practice,” one of the study authors, Louis Lau, MD, said at the annual Digestive Disease Week. “Most of the ulcers are due to H. pylori and NSAIDs or aspirin. However, idiopathic peptic ulcers remain an area to be investigated.”

According to Dr. Lau of the division of gastroenterology and hepatology at Prince of Wales Hospital, Hong Kong, H. pylori–negative idiopathic ulcers have increased in prevalence in the Asian Pacific region, from 1%-4% in 2000 to up to 20% in recent data. These ulcers have been shown to have a bleeding rate of up to 13% within 1 year (Gastroenterology. 2005;128:1845-50) and have been associated with a mortality rate of up to 88% in 7 years of follow-up (Gastroenterology. 2009;137:525-31).

“There is no consensus for the optimal management of this particular ulcer,” he continued. “One proposed management was maintenance PPI [proton pump inhibitors]. However, we would like to look for the best optimal prevention strategy.”



Dr. Lau and associates conducted a double-blind, randomized trial at Prince of Wales Hospital to determine if there were any differences between the PPI lansoprazole and the histamine2 receptor antagonist famotidine for the prevention of recurrent bleeding in patients with H. pylori–negative idiopathic peptic ulcers. It involved a 2-year follow-up period and included a screening and end-of-study esophagogastroduodenoscopy. The drugs were repackaged into identical green capsules.

The researchers limited the analysis to 228 patients over the age 18 with H. pylori–negative idiopathic ulcers, defined as having endoscopic biopsies negative for both rapid urease test and histology for H. pylori; no exposure to aspirin, NSAIDs, or drugs of unknown nature including traditional Chinese medicine within 4 weeks; and no other causes of ulceration identified. Exclusion criteria included patients with a strong indication for maintenance therapy with PPIs, those with prior gastric surgery, pregnant patients, and those with advanced malignancy or comorbidity.

The primary endpoint was clinical GI bleeding or reduction in hemoglobin level of 2 g/dL or more and confirmation of peptic ulcers by endoscopy. The secondary endpoint was recurrent ulcer detected by end-of-study endoscopy, with or without clinical symptoms.

Of the 228 patients, 114 received lansoprazole 30 mg daily and 114 received famotidine 40 mg daily. Recurrent upper GI bleeding was suspected in 10 patients in each of the treatment groups. Ulcer confirmation via endoscopy detected one ulcer in the lansoprazole group and three in the famotidine group (0.9% vs. 2.6%, respectively; P = .62). For the secondary endpoint, there were five recurrent ulcers in the lansoprazole group and nine in the famotidine group, (4.4% vs. 7.9%, respectively; P = .27).

Dr. Lau and colleagues observed eight deaths in the lansoprazole group (7%), compared with five (4.4%) in the famotidine group (P = .39), mainly caused by pneumonia, renal failure, and other chronic medical conditions. Intention-to-treat analysis at 2 years found that both groups were comparable in terms of time to analysis of recurrent upper GI bleeding, adjusted for death as a competing risk (Gray’s test, P = .313).

“In this randomized, controlled trial, we found that both a PPI and an H2 blocker are comparable in the prevention of idiopathic ulcer recurrent bleeding,” Dr. Lau concluded. “The rebleeding rate was five times lower than a previous cohort reported with no or irregular acid suppression therapy [Gastroenterology. 2005;128[7]:1845-50]. With all this, there is still a considerable risk of recurrent ulcers and death. We postulate that there is an underlying mechanism for this type of idiopathic ulcer.”

The study was funded in part by the General Research Fund–Research Grant Council. Dr. Lau reported having no financial disclosures. Many of his coauthors reported having numerous financial ties to the pharmaceutical industry.

SOURCE: Lau L et al. DDW 2019, Abstract 322.

 

Lansoprazole and famotidine are comparable for the prevention of recurrent ulcer bleeding in patients with a history of Helicobacter pylori–negative idiopathic bleeding ulcers, results from a double-blind, randomized trial showed. However, these patients face a considerable risk of overall mortality, despite a low incidence of recurrent GI bleeding.

Dr. Louis Lau
Doug Brunk/MDedge News
Dr. Louis Lau

“Peptic ulcer disease is a commonly encountered condition in our daily clinical practice,” one of the study authors, Louis Lau, MD, said at the annual Digestive Disease Week. “Most of the ulcers are due to H. pylori and NSAIDs or aspirin. However, idiopathic peptic ulcers remain an area to be investigated.”

According to Dr. Lau of the division of gastroenterology and hepatology at Prince of Wales Hospital, Hong Kong, H. pylori–negative idiopathic ulcers have increased in prevalence in the Asian Pacific region, from 1%-4% in 2000 to up to 20% in recent data. These ulcers have been shown to have a bleeding rate of up to 13% within 1 year (Gastroenterology. 2005;128:1845-50) and have been associated with a mortality rate of up to 88% in 7 years of follow-up (Gastroenterology. 2009;137:525-31).

“There is no consensus for the optimal management of this particular ulcer,” he continued. “One proposed management was maintenance PPI [proton pump inhibitors]. However, we would like to look for the best optimal prevention strategy.”



Dr. Lau and associates conducted a double-blind, randomized trial at Prince of Wales Hospital to determine if there were any differences between the PPI lansoprazole and the histamine2 receptor antagonist famotidine for the prevention of recurrent bleeding in patients with H. pylori–negative idiopathic peptic ulcers. It involved a 2-year follow-up period and included a screening and end-of-study esophagogastroduodenoscopy. The drugs were repackaged into identical green capsules.

The researchers limited the analysis to 228 patients over the age 18 with H. pylori–negative idiopathic ulcers, defined as having endoscopic biopsies negative for both rapid urease test and histology for H. pylori; no exposure to aspirin, NSAIDs, or drugs of unknown nature including traditional Chinese medicine within 4 weeks; and no other causes of ulceration identified. Exclusion criteria included patients with a strong indication for maintenance therapy with PPIs, those with prior gastric surgery, pregnant patients, and those with advanced malignancy or comorbidity.

The primary endpoint was clinical GI bleeding or reduction in hemoglobin level of 2 g/dL or more and confirmation of peptic ulcers by endoscopy. The secondary endpoint was recurrent ulcer detected by end-of-study endoscopy, with or without clinical symptoms.

Of the 228 patients, 114 received lansoprazole 30 mg daily and 114 received famotidine 40 mg daily. Recurrent upper GI bleeding was suspected in 10 patients in each of the treatment groups. Ulcer confirmation via endoscopy detected one ulcer in the lansoprazole group and three in the famotidine group (0.9% vs. 2.6%, respectively; P = .62). For the secondary endpoint, there were five recurrent ulcers in the lansoprazole group and nine in the famotidine group, (4.4% vs. 7.9%, respectively; P = .27).

Dr. Lau and colleagues observed eight deaths in the lansoprazole group (7%), compared with five (4.4%) in the famotidine group (P = .39), mainly caused by pneumonia, renal failure, and other chronic medical conditions. Intention-to-treat analysis at 2 years found that both groups were comparable in terms of time to analysis of recurrent upper GI bleeding, adjusted for death as a competing risk (Gray’s test, P = .313).

“In this randomized, controlled trial, we found that both a PPI and an H2 blocker are comparable in the prevention of idiopathic ulcer recurrent bleeding,” Dr. Lau concluded. “The rebleeding rate was five times lower than a previous cohort reported with no or irregular acid suppression therapy [Gastroenterology. 2005;128[7]:1845-50]. With all this, there is still a considerable risk of recurrent ulcers and death. We postulate that there is an underlying mechanism for this type of idiopathic ulcer.”

The study was funded in part by the General Research Fund–Research Grant Council. Dr. Lau reported having no financial disclosures. Many of his coauthors reported having numerous financial ties to the pharmaceutical industry.

SOURCE: Lau L et al. DDW 2019, Abstract 322.

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REPORTING FROM DDW 2019

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Focus on Office-Based Care

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Fri, 05/31/2019 - 14:08

This year’s VAM features an exhibit pavilion, special Vascular Live presentations, and a breakfast session geared specifically to clinicians who work in office and outpatient settings.

The Office Vascular Care Pavilion is in Exhibit Hall B, on the lower level of the Gaylord National Resort & Convention Center, across from the SVS Booth. Office Vascular Care Live presentations (not eligible for CME credit) include:
 

Thursday, June 13

12:30 to 1 p.m. OBL 101; Krishna M. Jain, MD

3 to 3:30 p.m. OBL Chatter, industry presentations by Cordis®, A Cardinal Health company, Philips and Vein Care iGuide
Sessions include: Coming to a town near you! Life Cycle of an OBL, Factors Influencing Behavior of an OBL, and Industry Partnership, sponsored by Cordis®, A Cardinal Health company
Keys to Success and Methods of Failure in Today’s OBL, David Baker, sponsored by Philips
 

Friday, June 14

12:30 to 1 p.m. OBL Tips and Tools; R. Clement Darling III, MD

3 to 3:30 p.m. OBL Quality and Safety; Robert G. Molnar, MD 

8:30 to 9:30 a.m. Ticket Required - The SVS also has a new member section focused on the move to outpatient and office-based settings, the Section on Outpatient and Office Vascular Care (SOOVC), which will hold its first meeting Friday in National Harbor 3. Tickets are available at Registration. Prospective members are welcome.

Saturday, June 15

6:30 to 8 a.m. Breakfast Session 9 will cover “Complications in Office-Based Procedures: Their Prevention and Management.” It is being presented in collaboration with the Outpatient Endovascular and Interventional Society. 

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This year’s VAM features an exhibit pavilion, special Vascular Live presentations, and a breakfast session geared specifically to clinicians who work in office and outpatient settings.

The Office Vascular Care Pavilion is in Exhibit Hall B, on the lower level of the Gaylord National Resort & Convention Center, across from the SVS Booth. Office Vascular Care Live presentations (not eligible for CME credit) include:
 

Thursday, June 13

12:30 to 1 p.m. OBL 101; Krishna M. Jain, MD

3 to 3:30 p.m. OBL Chatter, industry presentations by Cordis®, A Cardinal Health company, Philips and Vein Care iGuide
Sessions include: Coming to a town near you! Life Cycle of an OBL, Factors Influencing Behavior of an OBL, and Industry Partnership, sponsored by Cordis®, A Cardinal Health company
Keys to Success and Methods of Failure in Today’s OBL, David Baker, sponsored by Philips
 

Friday, June 14

12:30 to 1 p.m. OBL Tips and Tools; R. Clement Darling III, MD

3 to 3:30 p.m. OBL Quality and Safety; Robert G. Molnar, MD 

8:30 to 9:30 a.m. Ticket Required - The SVS also has a new member section focused on the move to outpatient and office-based settings, the Section on Outpatient and Office Vascular Care (SOOVC), which will hold its first meeting Friday in National Harbor 3. Tickets are available at Registration. Prospective members are welcome.

Saturday, June 15

6:30 to 8 a.m. Breakfast Session 9 will cover “Complications in Office-Based Procedures: Their Prevention and Management.” It is being presented in collaboration with the Outpatient Endovascular and Interventional Society. 

This year’s VAM features an exhibit pavilion, special Vascular Live presentations, and a breakfast session geared specifically to clinicians who work in office and outpatient settings.

The Office Vascular Care Pavilion is in Exhibit Hall B, on the lower level of the Gaylord National Resort & Convention Center, across from the SVS Booth. Office Vascular Care Live presentations (not eligible for CME credit) include:
 

Thursday, June 13

12:30 to 1 p.m. OBL 101; Krishna M. Jain, MD

3 to 3:30 p.m. OBL Chatter, industry presentations by Cordis®, A Cardinal Health company, Philips and Vein Care iGuide
Sessions include: Coming to a town near you! Life Cycle of an OBL, Factors Influencing Behavior of an OBL, and Industry Partnership, sponsored by Cordis®, A Cardinal Health company
Keys to Success and Methods of Failure in Today’s OBL, David Baker, sponsored by Philips
 

Friday, June 14

12:30 to 1 p.m. OBL Tips and Tools; R. Clement Darling III, MD

3 to 3:30 p.m. OBL Quality and Safety; Robert G. Molnar, MD 

8:30 to 9:30 a.m. Ticket Required - The SVS also has a new member section focused on the move to outpatient and office-based settings, the Section on Outpatient and Office Vascular Care (SOOVC), which will hold its first meeting Friday in National Harbor 3. Tickets are available at Registration. Prospective members are welcome.

Saturday, June 15

6:30 to 8 a.m. Breakfast Session 9 will cover “Complications in Office-Based Procedures: Their Prevention and Management.” It is being presented in collaboration with the Outpatient Endovascular and Interventional Society. 

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Reappraisal in emotion regulation unrelated to working memory in bipolar disorder

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Fri, 05/31/2019 - 13:42

 

Working memory may not function properly during the reappraisal process of emotion regulation in patients with bipolar disorder, according to Dong Hun Oh of the department of psychiatry at Yonsei University, Seoul, South Korea, and associates.

For the study, published in the Journal of Affective Disorders, 43 patients with euthymic bipolar I disorder were recruited from a psychiatric outpatient clinic in Seoul and compared with 48 healthy controls. The Korean versions of the operation span task (OSPAN), emotion regulation questionnaire (K-ERQ), ruminative response scale (K-RRS), and Difficulties in Emotion Regulation Scale (K-DERS) were administered to all the patients.

In a between-group comparison of scores on the four scales measured, patients with bipolar disorder had significantly lower scores on OSPAN (P = .031), on the brooding section of the K-RRS (P =.016), and on the nonacceptance section of the K-DERS (P = .039). In a regression analysis of the interaction between working memory and the four components of emotion regulation (reappraisal, expressive suppression, brooding, and reflective pondering), a significant interaction was found in OSPAN scores for reappraisal between healthy controls and the BD group (P = .007). Brooding scores were significantly lower in the control group, but the interaction was not significant.

A simple slope analysis showed that, while working memory was worse in patients with bipolar disorder, a relationship between cognitive capacity and the efficacy of reappraisal was found only in healthy controls, the investigators noted.

“The absence of interaction between [working memory capacity] and reappraisal in euthymic [bipolar disorder] patients that we report may indicate that the positive effects of cognitive remediation or [working memory] training previously reported for healthy people, may not effectively improve [emotion regulation] for patients with [bipolar disorder],” they wrote.

This could mean that “top-down regulation of emotion is impaired” in patients with bipolar disorder. Furthermore, if this is the case, cognitive interventions aimed at improving emotion regulation in patients with bipolar disorder might not work.

The investigators cited several limitations. One limitation was the small sample size; another was the use of self-administered questionnaires.

The study was supported by a faculty research grant from Yonsei University. The authors did not report any conflicts of interest.

SOURCE: Oh DH et al. J Affect Disord. 2019 Apr 8. doi: 10.1016/j.jad.2019.04.042.

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Working memory may not function properly during the reappraisal process of emotion regulation in patients with bipolar disorder, according to Dong Hun Oh of the department of psychiatry at Yonsei University, Seoul, South Korea, and associates.

For the study, published in the Journal of Affective Disorders, 43 patients with euthymic bipolar I disorder were recruited from a psychiatric outpatient clinic in Seoul and compared with 48 healthy controls. The Korean versions of the operation span task (OSPAN), emotion regulation questionnaire (K-ERQ), ruminative response scale (K-RRS), and Difficulties in Emotion Regulation Scale (K-DERS) were administered to all the patients.

In a between-group comparison of scores on the four scales measured, patients with bipolar disorder had significantly lower scores on OSPAN (P = .031), on the brooding section of the K-RRS (P =.016), and on the nonacceptance section of the K-DERS (P = .039). In a regression analysis of the interaction between working memory and the four components of emotion regulation (reappraisal, expressive suppression, brooding, and reflective pondering), a significant interaction was found in OSPAN scores for reappraisal between healthy controls and the BD group (P = .007). Brooding scores were significantly lower in the control group, but the interaction was not significant.

A simple slope analysis showed that, while working memory was worse in patients with bipolar disorder, a relationship between cognitive capacity and the efficacy of reappraisal was found only in healthy controls, the investigators noted.

“The absence of interaction between [working memory capacity] and reappraisal in euthymic [bipolar disorder] patients that we report may indicate that the positive effects of cognitive remediation or [working memory] training previously reported for healthy people, may not effectively improve [emotion regulation] for patients with [bipolar disorder],” they wrote.

This could mean that “top-down regulation of emotion is impaired” in patients with bipolar disorder. Furthermore, if this is the case, cognitive interventions aimed at improving emotion regulation in patients with bipolar disorder might not work.

The investigators cited several limitations. One limitation was the small sample size; another was the use of self-administered questionnaires.

The study was supported by a faculty research grant from Yonsei University. The authors did not report any conflicts of interest.

SOURCE: Oh DH et al. J Affect Disord. 2019 Apr 8. doi: 10.1016/j.jad.2019.04.042.

 

Working memory may not function properly during the reappraisal process of emotion regulation in patients with bipolar disorder, according to Dong Hun Oh of the department of psychiatry at Yonsei University, Seoul, South Korea, and associates.

For the study, published in the Journal of Affective Disorders, 43 patients with euthymic bipolar I disorder were recruited from a psychiatric outpatient clinic in Seoul and compared with 48 healthy controls. The Korean versions of the operation span task (OSPAN), emotion regulation questionnaire (K-ERQ), ruminative response scale (K-RRS), and Difficulties in Emotion Regulation Scale (K-DERS) were administered to all the patients.

In a between-group comparison of scores on the four scales measured, patients with bipolar disorder had significantly lower scores on OSPAN (P = .031), on the brooding section of the K-RRS (P =.016), and on the nonacceptance section of the K-DERS (P = .039). In a regression analysis of the interaction between working memory and the four components of emotion regulation (reappraisal, expressive suppression, brooding, and reflective pondering), a significant interaction was found in OSPAN scores for reappraisal between healthy controls and the BD group (P = .007). Brooding scores were significantly lower in the control group, but the interaction was not significant.

A simple slope analysis showed that, while working memory was worse in patients with bipolar disorder, a relationship between cognitive capacity and the efficacy of reappraisal was found only in healthy controls, the investigators noted.

“The absence of interaction between [working memory capacity] and reappraisal in euthymic [bipolar disorder] patients that we report may indicate that the positive effects of cognitive remediation or [working memory] training previously reported for healthy people, may not effectively improve [emotion regulation] for patients with [bipolar disorder],” they wrote.

This could mean that “top-down regulation of emotion is impaired” in patients with bipolar disorder. Furthermore, if this is the case, cognitive interventions aimed at improving emotion regulation in patients with bipolar disorder might not work.

The investigators cited several limitations. One limitation was the small sample size; another was the use of self-administered questionnaires.

The study was supported by a faculty research grant from Yonsei University. The authors did not report any conflicts of interest.

SOURCE: Oh DH et al. J Affect Disord. 2019 Apr 8. doi: 10.1016/j.jad.2019.04.042.

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FROM THE JOURNAL OF AFFECTIVE DISORDERS

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Macrophages, Regulation, and Impaired Diabetic Wound Healing

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Fri, 05/31/2019 - 13:39
Resident Research Award Paper

Nonhealing wounds in patients with diabetes are a major cause of morbidity and mortality in the United States and are increasing at an alarming rate. Equally concerning, the current “standard of care” leaves 70% of diabetic wounds unhealed. Given this substantial impact on patient outcomes and health care expenditure, a critical unmet need exists for improved understanding of the pathophysiology of diabetic wounds to develop effective treatments.

Dr. Frank Davis of the University of Michigan
Dr. Frank Davis

This year’s SVS Foundation’s Resident Research Award is being presented to Frank M. Davis, MD, of the University of Michigan, Ann Arbor, for his research on the epigenetic regulation of the prostaglandin pathway in macrophages during type 2 diabetic wound healing. Dr. Davis, and his mentor Katherine Gallagher, MD, also from the University of Michigan, investigated how impairments in the innate immune system in patients with diabetes promote chronic inflammation and impair wound healing.

Dr. Davis will present his award-winning research in the von Liebig Forum, Thursday, June 13, discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing. “Our laboratory specifically looks at the role of monocytes/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – such as those seen in diabetes – affects monocyte/macrophage phenotype and ultimately wound healing” said Dr. Davis.

Dr. Katherine Gallagher of the University of Michigan
Dr. Katherine Gallagher

The talk will specifically cover the cyclo-oxygenase (COX)-2/prostaglandin E2 (PGE2) axis. Using both a murine model and human wound samples Dr. Davis demonstrates that PGE2 is substantially elevated in diabetic wound macrophages. Further, aberrant PGE2 production in diabetic macrophages depended on epigenetic alterations to key enzymes in the PGE2 pathway.

Specifically, MLL1, a histone methyltransferase, increased H3K4 trimethylation resulting in upregulation of PGE2 in diabetic wound macrophages. Additionally, the authors found that augmentation to miR-29b and DNA methyltransferases in diabetic macrophage result in increased COX-2 expression. Overall, the increased COX-2/PGE2 production in diabetic macrophages impairs bacterial killing, predisposing diabetic wounds to chronic infection.

“Our research provides insight into the prostaglandin E2 axis and its role in macrophage inflammation, which has previously been an unrecognized pathway leading to delayed diabetic wound healing” added Dr. Gallagher.

Finally, in his presentation, Dr. Davis will discuss translational therapies as inhibition of the PGE2 pathway through macrophage targeted nanoparticles decreased diabetic inflammation and improved healing. “Together, our results indicate the COX-2/PGE2 pathway is a critical regulator of macrophage phenotype and impaired diabetic wound healing. This work identifies therapeutic targets for negating dysregulated inflammation in diabetic wounds and identifies macrophage-targeted local therapy as an effective means of improving wound healing,” Dr. Davis concluded.

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Resident Research Award Paper
Resident Research Award Paper

Nonhealing wounds in patients with diabetes are a major cause of morbidity and mortality in the United States and are increasing at an alarming rate. Equally concerning, the current “standard of care” leaves 70% of diabetic wounds unhealed. Given this substantial impact on patient outcomes and health care expenditure, a critical unmet need exists for improved understanding of the pathophysiology of diabetic wounds to develop effective treatments.

Dr. Frank Davis of the University of Michigan
Dr. Frank Davis

This year’s SVS Foundation’s Resident Research Award is being presented to Frank M. Davis, MD, of the University of Michigan, Ann Arbor, for his research on the epigenetic regulation of the prostaglandin pathway in macrophages during type 2 diabetic wound healing. Dr. Davis, and his mentor Katherine Gallagher, MD, also from the University of Michigan, investigated how impairments in the innate immune system in patients with diabetes promote chronic inflammation and impair wound healing.

Dr. Davis will present his award-winning research in the von Liebig Forum, Thursday, June 13, discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing. “Our laboratory specifically looks at the role of monocytes/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – such as those seen in diabetes – affects monocyte/macrophage phenotype and ultimately wound healing” said Dr. Davis.

Dr. Katherine Gallagher of the University of Michigan
Dr. Katherine Gallagher

The talk will specifically cover the cyclo-oxygenase (COX)-2/prostaglandin E2 (PGE2) axis. Using both a murine model and human wound samples Dr. Davis demonstrates that PGE2 is substantially elevated in diabetic wound macrophages. Further, aberrant PGE2 production in diabetic macrophages depended on epigenetic alterations to key enzymes in the PGE2 pathway.

Specifically, MLL1, a histone methyltransferase, increased H3K4 trimethylation resulting in upregulation of PGE2 in diabetic wound macrophages. Additionally, the authors found that augmentation to miR-29b and DNA methyltransferases in diabetic macrophage result in increased COX-2 expression. Overall, the increased COX-2/PGE2 production in diabetic macrophages impairs bacterial killing, predisposing diabetic wounds to chronic infection.

“Our research provides insight into the prostaglandin E2 axis and its role in macrophage inflammation, which has previously been an unrecognized pathway leading to delayed diabetic wound healing” added Dr. Gallagher.

Finally, in his presentation, Dr. Davis will discuss translational therapies as inhibition of the PGE2 pathway through macrophage targeted nanoparticles decreased diabetic inflammation and improved healing. “Together, our results indicate the COX-2/PGE2 pathway is a critical regulator of macrophage phenotype and impaired diabetic wound healing. This work identifies therapeutic targets for negating dysregulated inflammation in diabetic wounds and identifies macrophage-targeted local therapy as an effective means of improving wound healing,” Dr. Davis concluded.

Nonhealing wounds in patients with diabetes are a major cause of morbidity and mortality in the United States and are increasing at an alarming rate. Equally concerning, the current “standard of care” leaves 70% of diabetic wounds unhealed. Given this substantial impact on patient outcomes and health care expenditure, a critical unmet need exists for improved understanding of the pathophysiology of diabetic wounds to develop effective treatments.

Dr. Frank Davis of the University of Michigan
Dr. Frank Davis

This year’s SVS Foundation’s Resident Research Award is being presented to Frank M. Davis, MD, of the University of Michigan, Ann Arbor, for his research on the epigenetic regulation of the prostaglandin pathway in macrophages during type 2 diabetic wound healing. Dr. Davis, and his mentor Katherine Gallagher, MD, also from the University of Michigan, investigated how impairments in the innate immune system in patients with diabetes promote chronic inflammation and impair wound healing.

Dr. Davis will present his award-winning research in the von Liebig Forum, Thursday, June 13, discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing. “Our laboratory specifically looks at the role of monocytes/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – such as those seen in diabetes – affects monocyte/macrophage phenotype and ultimately wound healing” said Dr. Davis.

Dr. Katherine Gallagher of the University of Michigan
Dr. Katherine Gallagher

The talk will specifically cover the cyclo-oxygenase (COX)-2/prostaglandin E2 (PGE2) axis. Using both a murine model and human wound samples Dr. Davis demonstrates that PGE2 is substantially elevated in diabetic wound macrophages. Further, aberrant PGE2 production in diabetic macrophages depended on epigenetic alterations to key enzymes in the PGE2 pathway.

Specifically, MLL1, a histone methyltransferase, increased H3K4 trimethylation resulting in upregulation of PGE2 in diabetic wound macrophages. Additionally, the authors found that augmentation to miR-29b and DNA methyltransferases in diabetic macrophage result in increased COX-2 expression. Overall, the increased COX-2/PGE2 production in diabetic macrophages impairs bacterial killing, predisposing diabetic wounds to chronic infection.

“Our research provides insight into the prostaglandin E2 axis and its role in macrophage inflammation, which has previously been an unrecognized pathway leading to delayed diabetic wound healing” added Dr. Gallagher.

Finally, in his presentation, Dr. Davis will discuss translational therapies as inhibition of the PGE2 pathway through macrophage targeted nanoparticles decreased diabetic inflammation and improved healing. “Together, our results indicate the COX-2/PGE2 pathway is a critical regulator of macrophage phenotype and impaired diabetic wound healing. This work identifies therapeutic targets for negating dysregulated inflammation in diabetic wounds and identifies macrophage-targeted local therapy as an effective means of improving wound healing,” Dr. Davis concluded.

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Some Brits snuff out TORCH screen to raise awareness of congenital syphilis

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Fri, 05/31/2019 - 13:19

 

LJUBLJANA, SLOVENIA– Pediatricians in the south of England are so concerned about the recent national increase in the diagnosis of syphilis in adults and its ramifications for neonates that they’ve ditched the traditional TORCH newborn screen because the acronym doesn’t specifically remind clinicians to think about congenital syphilis, Mildred A. Iro, MD, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Mildred A. Iro
Bruce Jancin/MDedge News
Dr. Mildred A. Iro

We recommend a relabeling of the TORCH screen to ‘the congenital infection screen’ in order to include syphilis, which is now our local practice,” explained Dr. Iro of the University of Southampton (England).

She highlighted salient features of three recent cases of congenital syphilis managed at Southampton Children’s Hospital.

“The key message that we’d like to share is that we just need to be more aware about congenital syphilis. Retest mothers if their risk factor status changes, and test suspected infants and children,” Dr. Iro said.

As a practical matter, however, even though current guidelines recommend retesting mothers whose risk factor status becomes heightened following an initial negative syphilis serology result early in pregnancy, clinicians often are unaware that a mother’s risk status has changed. And retesting all mothers during pregnancy isn’t attractive from a cost-benefit standpoint. This makes scrupulous screening of newborns all the more important. And yet TORCH, which stands for Toxoplasmosis, Other, Rubella, Cytomegalovirus, and Herpes infections, isn’t an acronym that promotes awareness of congenital syphilis, a disease which occupies an obscure position in TORCH under the “O” for “Other” heading. That’s why the term “congenital infection screen” has become the new norm in the south of England, she explained.

However, one pediatrician who didn’t consider congenital infection screen to be an improvement in terminology over TORCH had an alternative suggestion, which struck a favorable chord with his fellow audience members: Simply change the acronym to TORCHS, with the S standing for syphilis.



Dr. Iro noted that two of the three affected children were diagnosed at age 7-8 weeks. The third wasn’t diagnosed until age 15 months, when the mother tested positive for syphilis in a subsequent pregnancy. As is typical of the disease known as “the great masquerader,” while all three of the affected children were unwell early in infancy, they presented with a wide range of symptoms. Among the more prominent features were prolonged irritability, respiratory distress, odd rashes, anemia, hepatomegaly, and tachypnea. One infant had reduced movement and pain in one arm.

All three children underwent extensive testing. None had neurosyphilis. All achieved good outcomes on standard guideline-directed therapy.

As for the mothers, they were aged 19, 21, and 23 years when diagnosed with syphilis. All were Caucasian, and antenatal blood testing was negative in all three. None were retested during pregnancy, even though two of them had a male partner or former partner who was positive for syphilis, and the partner of the third disclosed to her that he had sex with men.

At diagnosis, all three women had a strongly positive Treponema pallidum particle agglutination assay, a high rapid plasma reagin, and a positive syphilis IgM assay.

Dr. Iro reported having no financial conflicts regarding her presentation.

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LJUBLJANA, SLOVENIA– Pediatricians in the south of England are so concerned about the recent national increase in the diagnosis of syphilis in adults and its ramifications for neonates that they’ve ditched the traditional TORCH newborn screen because the acronym doesn’t specifically remind clinicians to think about congenital syphilis, Mildred A. Iro, MD, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Mildred A. Iro
Bruce Jancin/MDedge News
Dr. Mildred A. Iro

We recommend a relabeling of the TORCH screen to ‘the congenital infection screen’ in order to include syphilis, which is now our local practice,” explained Dr. Iro of the University of Southampton (England).

She highlighted salient features of three recent cases of congenital syphilis managed at Southampton Children’s Hospital.

“The key message that we’d like to share is that we just need to be more aware about congenital syphilis. Retest mothers if their risk factor status changes, and test suspected infants and children,” Dr. Iro said.

As a practical matter, however, even though current guidelines recommend retesting mothers whose risk factor status becomes heightened following an initial negative syphilis serology result early in pregnancy, clinicians often are unaware that a mother’s risk status has changed. And retesting all mothers during pregnancy isn’t attractive from a cost-benefit standpoint. This makes scrupulous screening of newborns all the more important. And yet TORCH, which stands for Toxoplasmosis, Other, Rubella, Cytomegalovirus, and Herpes infections, isn’t an acronym that promotes awareness of congenital syphilis, a disease which occupies an obscure position in TORCH under the “O” for “Other” heading. That’s why the term “congenital infection screen” has become the new norm in the south of England, she explained.

However, one pediatrician who didn’t consider congenital infection screen to be an improvement in terminology over TORCH had an alternative suggestion, which struck a favorable chord with his fellow audience members: Simply change the acronym to TORCHS, with the S standing for syphilis.



Dr. Iro noted that two of the three affected children were diagnosed at age 7-8 weeks. The third wasn’t diagnosed until age 15 months, when the mother tested positive for syphilis in a subsequent pregnancy. As is typical of the disease known as “the great masquerader,” while all three of the affected children were unwell early in infancy, they presented with a wide range of symptoms. Among the more prominent features were prolonged irritability, respiratory distress, odd rashes, anemia, hepatomegaly, and tachypnea. One infant had reduced movement and pain in one arm.

All three children underwent extensive testing. None had neurosyphilis. All achieved good outcomes on standard guideline-directed therapy.

As for the mothers, they were aged 19, 21, and 23 years when diagnosed with syphilis. All were Caucasian, and antenatal blood testing was negative in all three. None were retested during pregnancy, even though two of them had a male partner or former partner who was positive for syphilis, and the partner of the third disclosed to her that he had sex with men.

At diagnosis, all three women had a strongly positive Treponema pallidum particle agglutination assay, a high rapid plasma reagin, and a positive syphilis IgM assay.

Dr. Iro reported having no financial conflicts regarding her presentation.

 

LJUBLJANA, SLOVENIA– Pediatricians in the south of England are so concerned about the recent national increase in the diagnosis of syphilis in adults and its ramifications for neonates that they’ve ditched the traditional TORCH newborn screen because the acronym doesn’t specifically remind clinicians to think about congenital syphilis, Mildred A. Iro, MD, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Mildred A. Iro
Bruce Jancin/MDedge News
Dr. Mildred A. Iro

We recommend a relabeling of the TORCH screen to ‘the congenital infection screen’ in order to include syphilis, which is now our local practice,” explained Dr. Iro of the University of Southampton (England).

She highlighted salient features of three recent cases of congenital syphilis managed at Southampton Children’s Hospital.

“The key message that we’d like to share is that we just need to be more aware about congenital syphilis. Retest mothers if their risk factor status changes, and test suspected infants and children,” Dr. Iro said.

As a practical matter, however, even though current guidelines recommend retesting mothers whose risk factor status becomes heightened following an initial negative syphilis serology result early in pregnancy, clinicians often are unaware that a mother’s risk status has changed. And retesting all mothers during pregnancy isn’t attractive from a cost-benefit standpoint. This makes scrupulous screening of newborns all the more important. And yet TORCH, which stands for Toxoplasmosis, Other, Rubella, Cytomegalovirus, and Herpes infections, isn’t an acronym that promotes awareness of congenital syphilis, a disease which occupies an obscure position in TORCH under the “O” for “Other” heading. That’s why the term “congenital infection screen” has become the new norm in the south of England, she explained.

However, one pediatrician who didn’t consider congenital infection screen to be an improvement in terminology over TORCH had an alternative suggestion, which struck a favorable chord with his fellow audience members: Simply change the acronym to TORCHS, with the S standing for syphilis.



Dr. Iro noted that two of the three affected children were diagnosed at age 7-8 weeks. The third wasn’t diagnosed until age 15 months, when the mother tested positive for syphilis in a subsequent pregnancy. As is typical of the disease known as “the great masquerader,” while all three of the affected children were unwell early in infancy, they presented with a wide range of symptoms. Among the more prominent features were prolonged irritability, respiratory distress, odd rashes, anemia, hepatomegaly, and tachypnea. One infant had reduced movement and pain in one arm.

All three children underwent extensive testing. None had neurosyphilis. All achieved good outcomes on standard guideline-directed therapy.

As for the mothers, they were aged 19, 21, and 23 years when diagnosed with syphilis. All were Caucasian, and antenatal blood testing was negative in all three. None were retested during pregnancy, even though two of them had a male partner or former partner who was positive for syphilis, and the partner of the third disclosed to her that he had sex with men.

At diagnosis, all three women had a strongly positive Treponema pallidum particle agglutination assay, a high rapid plasma reagin, and a positive syphilis IgM assay.

Dr. Iro reported having no financial conflicts regarding her presentation.

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