European Commission approves rituximab biosimilar

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European Commission approves rituximab biosimilar

 

Follicular lymphoma

 

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

 

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

 

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

 

The approval is based on data submitted to the European Medicines Agency.

 

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

 

Therefore, the European Commission approved Truxima for the following indications.

 

Non-Hodgkin lymphoma 

 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

 

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

 

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

 

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

 

Chronic lymphocytic leukemia

 

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

 

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

 

RA, GPA, and MPA 

 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

 

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

 

Truxima studies

 

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

 

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

 

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

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Topics

 

Follicular lymphoma

 

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

 

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

 

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

 

The approval is based on data submitted to the European Medicines Agency.

 

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

 

Therefore, the European Commission approved Truxima for the following indications.

 

Non-Hodgkin lymphoma 

 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

 

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

 

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

 

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

 

Chronic lymphocytic leukemia

 

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

 

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

 

RA, GPA, and MPA 

 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

 

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

 

Truxima studies

 

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

 

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

 

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

 

Follicular lymphoma

 

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

 

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

 

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

 

The approval is based on data submitted to the European Medicines Agency.

 

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

 

Therefore, the European Commission approved Truxima for the following indications.

 

Non-Hodgkin lymphoma 

 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

 

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

 

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

 

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

 

Chronic lymphocytic leukemia

 

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

 

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

 

RA, GPA, and MPA 

 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

 

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

 

Truxima studies

 

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

 

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

 

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

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Tips for taming atopic dermatitis and managing expectations

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MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Dr. Adam Friedman


Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

 

 

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

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MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Dr. Adam Friedman


Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

 

 

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

 

MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Dr. Adam Friedman


Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

 

 

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

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Antibiotic prophylaxis for artificial joints

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A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.1

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

Dr. Douglas S. Paauw
The majority of prosthetic joint infections are due to Staphylococcus aureus, whereas the majority of bacteremias from dental procedures are due to streptococcus.1,2 Bacteremias following simple everyday activities such as tooth brushing and chewing occur.3

This information has called into question the wisdom of giving antibiotic prophylaxis for dental procedures when the same patients have transient bacteremias as a regular part of day-to-day life, and mouth organisms were infrequent causes of prosthetic joint infections.

The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) released an advisory statement 20 years ago on antibiotic prophylaxis for patients with dental replacements, which concluded: “Antibiotic prophylaxis is not indicated for dental patients with pins, plates, and screws, nor is it routinely indicated for most dental patients with total joint replacements.”4

In 2003, the AAOS and the ADA released updated guidelines that stated: “Presently, no scientific evidence supports the position that antibiotic prophylaxis to prevent hematogenous infections is required prior to dental treatment in patients with total joint prostheses. The risk/benefit and cost/effectiveness ratios fail to justify the administration of routine antibiotics.”5

Great confusion arose in 2009 when the AAOS published a position paper on its website that reversed this position.6 Interestingly, the statement was done by the AAOS alone, and not done in conjunction with the ADA.

In this position paper, the AAOS recommended that health care providers consider antibiotic prophylaxis prior to invasive procedures on all patients who had prosthetic joints, regardless of how long those joints have been in place. This major change in recommendations was not based on any new evidence that had been reviewed since the 2003 guidelines.

There are two studies that address outcome of patients with prosthetic joints who have and have not received prophylactic antibiotics.

Elie Berbari, MD, and colleagues reported on the results of a prospective case-control study comparing patients with prosthetic joints hospitalized with hip or knee infections with patients who had prosthetic joints hospitalized at the same time who did not have hip or knee infections.7

There was no increased risk of prosthetic hip or knee infection for patients undergoing a dental procedure who were not receiving antibiotic prophylaxis (odds ratio, 0.8; 95% confidence interval, 0.4-1.6), compared with the risk for patients not undergoing a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Antibiotic prophylaxis in patients undergoing high and low risk dental procedures did not decrease the risk of prosthetic joint infections.

In 2012, the AAOS and the ADA published updated guidelines with the following summary recommendation: “The practitioner might consider discontinuing the practice of routinely prescribing prophylactic antibiotics for patients with hip and knee prosthetic joint implants undergoing dental procedures.”8 They referenced the Berbari study as the best available evidence.

Feng-Chen Kao, MD, and colleagues published a study this year with a design very similar to the Berbari study, with similar results.9 All Taiwanese residents who had received hip or knee replacements over a 12-year period were screened. Those who had received dental procedures were matched with individuals who had not had dental procedures. The dental procedure group was subdivided into a group that received antibiotics and one that didn’t.

There was no difference in infection rates between the group that had received dental procedures and the group that did not, and no difference in infection rates between those who received prophylactic antibiotics and those who didn’t.

I think this myth can be put to rest. There is no evidence to give patients with joint prostheses prophylactic antibiotics before dental procedures.


 

 

 

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

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A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.1

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

Dr. Douglas S. Paauw
The majority of prosthetic joint infections are due to Staphylococcus aureus, whereas the majority of bacteremias from dental procedures are due to streptococcus.1,2 Bacteremias following simple everyday activities such as tooth brushing and chewing occur.3

This information has called into question the wisdom of giving antibiotic prophylaxis for dental procedures when the same patients have transient bacteremias as a regular part of day-to-day life, and mouth organisms were infrequent causes of prosthetic joint infections.

The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) released an advisory statement 20 years ago on antibiotic prophylaxis for patients with dental replacements, which concluded: “Antibiotic prophylaxis is not indicated for dental patients with pins, plates, and screws, nor is it routinely indicated for most dental patients with total joint replacements.”4

In 2003, the AAOS and the ADA released updated guidelines that stated: “Presently, no scientific evidence supports the position that antibiotic prophylaxis to prevent hematogenous infections is required prior to dental treatment in patients with total joint prostheses. The risk/benefit and cost/effectiveness ratios fail to justify the administration of routine antibiotics.”5

Great confusion arose in 2009 when the AAOS published a position paper on its website that reversed this position.6 Interestingly, the statement was done by the AAOS alone, and not done in conjunction with the ADA.

In this position paper, the AAOS recommended that health care providers consider antibiotic prophylaxis prior to invasive procedures on all patients who had prosthetic joints, regardless of how long those joints have been in place. This major change in recommendations was not based on any new evidence that had been reviewed since the 2003 guidelines.

There are two studies that address outcome of patients with prosthetic joints who have and have not received prophylactic antibiotics.

Elie Berbari, MD, and colleagues reported on the results of a prospective case-control study comparing patients with prosthetic joints hospitalized with hip or knee infections with patients who had prosthetic joints hospitalized at the same time who did not have hip or knee infections.7

There was no increased risk of prosthetic hip or knee infection for patients undergoing a dental procedure who were not receiving antibiotic prophylaxis (odds ratio, 0.8; 95% confidence interval, 0.4-1.6), compared with the risk for patients not undergoing a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Antibiotic prophylaxis in patients undergoing high and low risk dental procedures did not decrease the risk of prosthetic joint infections.

In 2012, the AAOS and the ADA published updated guidelines with the following summary recommendation: “The practitioner might consider discontinuing the practice of routinely prescribing prophylactic antibiotics for patients with hip and knee prosthetic joint implants undergoing dental procedures.”8 They referenced the Berbari study as the best available evidence.

Feng-Chen Kao, MD, and colleagues published a study this year with a design very similar to the Berbari study, with similar results.9 All Taiwanese residents who had received hip or knee replacements over a 12-year period were screened. Those who had received dental procedures were matched with individuals who had not had dental procedures. The dental procedure group was subdivided into a group that received antibiotics and one that didn’t.

There was no difference in infection rates between the group that had received dental procedures and the group that did not, and no difference in infection rates between those who received prophylactic antibiotics and those who didn’t.

I think this myth can be put to rest. There is no evidence to give patients with joint prostheses prophylactic antibiotics before dental procedures.


 

 

 

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].


A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.1

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

Dr. Douglas S. Paauw
The majority of prosthetic joint infections are due to Staphylococcus aureus, whereas the majority of bacteremias from dental procedures are due to streptococcus.1,2 Bacteremias following simple everyday activities such as tooth brushing and chewing occur.3

This information has called into question the wisdom of giving antibiotic prophylaxis for dental procedures when the same patients have transient bacteremias as a regular part of day-to-day life, and mouth organisms were infrequent causes of prosthetic joint infections.

The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) released an advisory statement 20 years ago on antibiotic prophylaxis for patients with dental replacements, which concluded: “Antibiotic prophylaxis is not indicated for dental patients with pins, plates, and screws, nor is it routinely indicated for most dental patients with total joint replacements.”4

In 2003, the AAOS and the ADA released updated guidelines that stated: “Presently, no scientific evidence supports the position that antibiotic prophylaxis to prevent hematogenous infections is required prior to dental treatment in patients with total joint prostheses. The risk/benefit and cost/effectiveness ratios fail to justify the administration of routine antibiotics.”5

Great confusion arose in 2009 when the AAOS published a position paper on its website that reversed this position.6 Interestingly, the statement was done by the AAOS alone, and not done in conjunction with the ADA.

In this position paper, the AAOS recommended that health care providers consider antibiotic prophylaxis prior to invasive procedures on all patients who had prosthetic joints, regardless of how long those joints have been in place. This major change in recommendations was not based on any new evidence that had been reviewed since the 2003 guidelines.

There are two studies that address outcome of patients with prosthetic joints who have and have not received prophylactic antibiotics.

Elie Berbari, MD, and colleagues reported on the results of a prospective case-control study comparing patients with prosthetic joints hospitalized with hip or knee infections with patients who had prosthetic joints hospitalized at the same time who did not have hip or knee infections.7

There was no increased risk of prosthetic hip or knee infection for patients undergoing a dental procedure who were not receiving antibiotic prophylaxis (odds ratio, 0.8; 95% confidence interval, 0.4-1.6), compared with the risk for patients not undergoing a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Antibiotic prophylaxis in patients undergoing high and low risk dental procedures did not decrease the risk of prosthetic joint infections.

In 2012, the AAOS and the ADA published updated guidelines with the following summary recommendation: “The practitioner might consider discontinuing the practice of routinely prescribing prophylactic antibiotics for patients with hip and knee prosthetic joint implants undergoing dental procedures.”8 They referenced the Berbari study as the best available evidence.

Feng-Chen Kao, MD, and colleagues published a study this year with a design very similar to the Berbari study, with similar results.9 All Taiwanese residents who had received hip or knee replacements over a 12-year period were screened. Those who had received dental procedures were matched with individuals who had not had dental procedures. The dental procedure group was subdivided into a group that received antibiotics and one that didn’t.

There was no difference in infection rates between the group that had received dental procedures and the group that did not, and no difference in infection rates between those who received prophylactic antibiotics and those who didn’t.

I think this myth can be put to rest. There is no evidence to give patients with joint prostheses prophylactic antibiotics before dental procedures.


 

 

 

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

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STEMI team repurposed for rapid treatment of pulmonary emboli

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– The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

 

 

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– The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

 

 

 

– The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

 

 

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Key clinical point: The same team assembled for rapid response to STEMI can also treat PE, according to a pilot study.

Major finding: In the initial series of patients, of whom 57% had massive PE, in-hospital mortality was 11%.

Data source: A nonrandomized prospective analysis.

Disclosures: Dr. Kendall reported no financial relationships.

Increased schizophrenia, affective disorder risks associated with infections

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Fri, 01/18/2019 - 16:33

 

Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

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Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

 

Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

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Robotic PCI success rates higher with radial access

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WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Dr. Ali Pourdjabbar
In this registry, called PRECISION, 11 centers are providing postmarketing procedural and outcome data with CorPath robotic assisted PCI systems. All the data in this analysis were drawn from procedures performed with the CorPath 200 system, which has been approved for coronary and peripheral interventions. For coronary procedures, the indication includes both femoral and radial access.

Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).

There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).

However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.

“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.

However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.

Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.

Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.

“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.

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WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Dr. Ali Pourdjabbar
In this registry, called PRECISION, 11 centers are providing postmarketing procedural and outcome data with CorPath robotic assisted PCI systems. All the data in this analysis were drawn from procedures performed with the CorPath 200 system, which has been approved for coronary and peripheral interventions. For coronary procedures, the indication includes both femoral and radial access.

Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).

There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).

However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.

“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.

However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.

Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.

Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.

“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.

 

WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Dr. Ali Pourdjabbar
In this registry, called PRECISION, 11 centers are providing postmarketing procedural and outcome data with CorPath robotic assisted PCI systems. All the data in this analysis were drawn from procedures performed with the CorPath 200 system, which has been approved for coronary and peripheral interventions. For coronary procedures, the indication includes both femoral and radial access.

Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).

There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).

However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.

“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.

However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.

Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.

Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.

“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.

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Key clinical point: Registry data shows higher success rate for radial versus femoral access in robotic percutaneous coronary interventions.

Major finding: In robotic PCI, the clinical success rate was 99.4% with radial access and 94.7% (P = .002) with femoral access.

Data source: A nonrandomized, retrospective analysis.

Disclosures: Dr. Pourdjabbar reported no financial relationships to disclose.

Preterm infants at higher risk of pertussis

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Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

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Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

 

Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

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FROM PEDIATRIC INFECTIOUS DISEASE JOURNAL

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Key clinical point: Lower gestational age was related to higher risk of pertussis in infants.

Major finding: The risk of pertussis infection was 4.49-fold higher in infants with a gestational age of 23-27 weeks.

Data source: A cohort study of 713,166 children from the Medical Birth Registry of Norway with a gestation period of 23-37 weeks during 1998-2010.

Disclosures: No funding was secured for this study. The authors had no relevant financial disclosures.

32-year-old woman with pelvic pain and irregular menstrual periods

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32-year-old woman with pelvic pain and irregular menstrual periods
What’s the diagnosis?

(A) Paratubal cyst CORRECT

Paratubal, or paraovarian, cysts typically are round or oval avascular hypoechoic cysts (long arrow) separate from the adjacent ovary (short arrow). Since they are congenital remnants of the Wolffian duct, they arise from the mesosalpinx, specifically the broad ligament or fallopian tube.1,2 They usually are seen in close proximity to but separate from the ovary without distorting the ovary’s architecture.1,2

Paratubal cyst. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an oval hypoechoic cyst (long arrow) separate from the adjacent ovary (short arrow). (B) The paratubal cyst is avascular on color Doppler.



B) Hydrosalpinx INCORRECT

A hydrosalpinx appears as an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion separate from the ovary. It often has incomplete septations that are infolding of the tube on itself (long arrow).3 Other findings include diametrically opposed indentations (short arrows) of the wall (Waist sign) and short linear mucosal or submucosal folds (arrowhead) that when viewed in cross section appear similar to the spokes of a cogwheel (Cogwheel sign).1–3 Prior tubal infection or gynecologic surgery represent risk factors for hydrosalpinx.

Hydrosalpinx. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion with incomplete septations (long arrow). (B) Longitudinal image of the right adnexa shows the dilated fallopian tube with diametrically opposed indentations of the wall consistent with the Waist sign (short arrows). (C) Transverse image of the dilated fallopian tube viewed in cross section has the appearance of several short mural nodules similar to the spokes of a cogwheel (arrowheads).



C) Peritoneal inclusion cyst INCORRECT

A peritoneal inclusion cyst appears as an anechoic cystic mass that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) and may contain entrapped ovaries (short arrow)  within or along the periphery of the fluid collection.1,2 Septations within it are likely from peritoneal adhesions (arrowhead) and may show vascularity.2 Prior (often multiple) gynecologic surgeries represent a risk factor for peritoneal inclusion cysts.

Peritoneal inclusion cyst. (A) Longitudinal transvaginal pelvic ultrasound of the left adnexa demonstrating an anechoic cystic lesion that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) with a thick septation (arrowhead). (B) Transverse image demonstrates the left ovary entrapped within the fluid collection (short arrow).



D) Dilated pelvic veins INCORRECT

Dilated pelvic veins appear on sonography as a cluster of elongated and tubular cystic lesions in the adnexa along the broad ligament and demonstrate low level echoes due to sluggish flow (long arrow) and visible red blood cell rouleaux formation. This can be confirmed on color Doppler images (short arrow) and help differentiate it from hydrosalpinx.

Dilated pelvic veins. (A) Transvaginal pelvic ultrasound of the left adnexa reveals a cluster of elongated and tubular cystic lesions that demonstrate low level echoes due to sluggish flow (long arrow). (B) Color Doppler ultrasound confirms vascularity within these dilated pelvic veins (short arrow).

References
  1. Laing FC, Allison SF. US of the ovary and adnexa: to worry or not to worry? Radiographics. 2012:32(6):1621−1639.
  2. Moyle PL, Kataoka MY, Nakai A, Takahata A, Reinhold C, Sala E. Nonovarian cystic lesions of the pelvis. Radiographics. 2010;30(4):921−938.
  3. Rezvani M, Shaaban AM. Fallopian tube disease in the nonpregnant patient. Radiographics. 2011;31(2):527−548.
Author and Disclosure Information

Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

The authors report no financial relationships relevant to this quiz.

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Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

The authors report no financial relationships relevant to this quiz.

Author and Disclosure Information

Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

The authors report no financial relationships relevant to this quiz.

What’s the diagnosis?
What’s the diagnosis?

(A) Paratubal cyst CORRECT

Paratubal, or paraovarian, cysts typically are round or oval avascular hypoechoic cysts (long arrow) separate from the adjacent ovary (short arrow). Since they are congenital remnants of the Wolffian duct, they arise from the mesosalpinx, specifically the broad ligament or fallopian tube.1,2 They usually are seen in close proximity to but separate from the ovary without distorting the ovary’s architecture.1,2

Paratubal cyst. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an oval hypoechoic cyst (long arrow) separate from the adjacent ovary (short arrow). (B) The paratubal cyst is avascular on color Doppler.



B) Hydrosalpinx INCORRECT

A hydrosalpinx appears as an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion separate from the ovary. It often has incomplete septations that are infolding of the tube on itself (long arrow).3 Other findings include diametrically opposed indentations (short arrows) of the wall (Waist sign) and short linear mucosal or submucosal folds (arrowhead) that when viewed in cross section appear similar to the spokes of a cogwheel (Cogwheel sign).1–3 Prior tubal infection or gynecologic surgery represent risk factors for hydrosalpinx.

Hydrosalpinx. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion with incomplete septations (long arrow). (B) Longitudinal image of the right adnexa shows the dilated fallopian tube with diametrically opposed indentations of the wall consistent with the Waist sign (short arrows). (C) Transverse image of the dilated fallopian tube viewed in cross section has the appearance of several short mural nodules similar to the spokes of a cogwheel (arrowheads).



C) Peritoneal inclusion cyst INCORRECT

A peritoneal inclusion cyst appears as an anechoic cystic mass that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) and may contain entrapped ovaries (short arrow)  within or along the periphery of the fluid collection.1,2 Septations within it are likely from peritoneal adhesions (arrowhead) and may show vascularity.2 Prior (often multiple) gynecologic surgeries represent a risk factor for peritoneal inclusion cysts.

Peritoneal inclusion cyst. (A) Longitudinal transvaginal pelvic ultrasound of the left adnexa demonstrating an anechoic cystic lesion that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) with a thick septation (arrowhead). (B) Transverse image demonstrates the left ovary entrapped within the fluid collection (short arrow).



D) Dilated pelvic veins INCORRECT

Dilated pelvic veins appear on sonography as a cluster of elongated and tubular cystic lesions in the adnexa along the broad ligament and demonstrate low level echoes due to sluggish flow (long arrow) and visible red blood cell rouleaux formation. This can be confirmed on color Doppler images (short arrow) and help differentiate it from hydrosalpinx.

Dilated pelvic veins. (A) Transvaginal pelvic ultrasound of the left adnexa reveals a cluster of elongated and tubular cystic lesions that demonstrate low level echoes due to sluggish flow (long arrow). (B) Color Doppler ultrasound confirms vascularity within these dilated pelvic veins (short arrow).

(A) Paratubal cyst CORRECT

Paratubal, or paraovarian, cysts typically are round or oval avascular hypoechoic cysts (long arrow) separate from the adjacent ovary (short arrow). Since they are congenital remnants of the Wolffian duct, they arise from the mesosalpinx, specifically the broad ligament or fallopian tube.1,2 They usually are seen in close proximity to but separate from the ovary without distorting the ovary’s architecture.1,2

Paratubal cyst. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an oval hypoechoic cyst (long arrow) separate from the adjacent ovary (short arrow). (B) The paratubal cyst is avascular on color Doppler.



B) Hydrosalpinx INCORRECT

A hydrosalpinx appears as an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion separate from the ovary. It often has incomplete septations that are infolding of the tube on itself (long arrow).3 Other findings include diametrically opposed indentations (short arrows) of the wall (Waist sign) and short linear mucosal or submucosal folds (arrowhead) that when viewed in cross section appear similar to the spokes of a cogwheel (Cogwheel sign).1–3 Prior tubal infection or gynecologic surgery represent risk factors for hydrosalpinx.

Hydrosalpinx. (A) Transvaginal pelvic ultrasound of the left adnexa demonstrates an elongated C- or S-shaped, thin-walled tubular serpiginous cystic lesion with incomplete septations (long arrow). (B) Longitudinal image of the right adnexa shows the dilated fallopian tube with diametrically opposed indentations of the wall consistent with the Waist sign (short arrows). (C) Transverse image of the dilated fallopian tube viewed in cross section has the appearance of several short mural nodules similar to the spokes of a cogwheel (arrowheads).



C) Peritoneal inclusion cyst INCORRECT

A peritoneal inclusion cyst appears as an anechoic cystic mass that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) and may contain entrapped ovaries (short arrow)  within or along the periphery of the fluid collection.1,2 Septations within it are likely from peritoneal adhesions (arrowhead) and may show vascularity.2 Prior (often multiple) gynecologic surgeries represent a risk factor for peritoneal inclusion cysts.

Peritoneal inclusion cyst. (A) Longitudinal transvaginal pelvic ultrasound of the left adnexa demonstrating an anechoic cystic lesion that conforms passively to the shape of the peritoneal cavity/pelvic sidewall (long arrow) with a thick septation (arrowhead). (B) Transverse image demonstrates the left ovary entrapped within the fluid collection (short arrow).



D) Dilated pelvic veins INCORRECT

Dilated pelvic veins appear on sonography as a cluster of elongated and tubular cystic lesions in the adnexa along the broad ligament and demonstrate low level echoes due to sluggish flow (long arrow) and visible red blood cell rouleaux formation. This can be confirmed on color Doppler images (short arrow) and help differentiate it from hydrosalpinx.

Dilated pelvic veins. (A) Transvaginal pelvic ultrasound of the left adnexa reveals a cluster of elongated and tubular cystic lesions that demonstrate low level echoes due to sluggish flow (long arrow). (B) Color Doppler ultrasound confirms vascularity within these dilated pelvic veins (short arrow).

References
  1. Laing FC, Allison SF. US of the ovary and adnexa: to worry or not to worry? Radiographics. 2012:32(6):1621−1639.
  2. Moyle PL, Kataoka MY, Nakai A, Takahata A, Reinhold C, Sala E. Nonovarian cystic lesions of the pelvis. Radiographics. 2010;30(4):921−938.
  3. Rezvani M, Shaaban AM. Fallopian tube disease in the nonpregnant patient. Radiographics. 2011;31(2):527−548.
References
  1. Laing FC, Allison SF. US of the ovary and adnexa: to worry or not to worry? Radiographics. 2012:32(6):1621−1639.
  2. Moyle PL, Kataoka MY, Nakai A, Takahata A, Reinhold C, Sala E. Nonovarian cystic lesions of the pelvis. Radiographics. 2010;30(4):921−938.
  3. Rezvani M, Shaaban AM. Fallopian tube disease in the nonpregnant patient. Radiographics. 2011;31(2):527−548.
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A 32-year-old women presents to her gynecologist’s office reporting pelvic pain and irregular menstrual periods. Results of a urine pregnancy test are negative. Pelvic ultrasonography is performed, with gray scale ( A ) and color Doppler ( B ) images of the left adnexa obtained. Figures shown above.

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VIDEO: Clot aspiration equals retrieval for ischemic stroke

Aspiration remains unproven in U.S. patients
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Changed
Tue, 07/21/2020 - 14:18

 

– Intracerebral clot aspiration was as safe and effective as stent retriever thrombectomy for restoring cerebral blood flow in a French multicenter, randomized trial with 381 acute ischemic stroke patients.

This study is the “first direct comparison of aspiration versus stent retrieval” as the initial strategy for clot removal in acute ischemic stroke, and it “opens the door to add a new tool” for clot removal, Bertrand Lapergue, MD, said at the International Stroke Conference sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News
Dr. Bertrand Lapergue
Although the results are a significant step forward for establishing “A Direct Aspiration, First Pass Technique (ADAPT)” as the equal of the now-standard approach of stent-retriever thrombectomy for clot removal, it is not completely definitive for U.S. practice, experts cautioned.

The new results “are the first to show that aspiration first is as good as a stent retriever, but we need to also see the results from COMPASS,” a U.S. multicenter trial that is in the process of making the same comparison, commented Ricardo A. Hanel, MD, a vascular neurosurgeon at Baptist Health in Jacksonville, Fla. The COMPASS Trial: a Direct Aspiration First Pass Technique has now enrolled about two-thirds of its target patient number, and until the study is complete the role of direct aspiration for clot removal in stroke remains investigational for U.S. practice, said Dr. Hanel, a COMPASS investigator.

The aspiration catheter tested in ASTER is marketed by Penumbra and has already received Food and Drug Administration approval for revascularization of ischemic stroke patients. U.S. use of aspiration for treating acute ischemic stroke, however, has remained limited because there is no clear evidence of the method’s efficacy. Dr. Hanel said that he occasionally uses aspiration as an adjunct to clot removal with a stent retriever.

Mitchel L. Zoler/Frontline Medical News
Dr. Ricardo A. Hanel
The Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke (ASTER) trial enrolled 381 patients with an anterior, large-vessel intracerebral occlusion at any of eight French centers. The study compared two different approaches to clot removal: using clot aspiration first or a stent retriever first. Participating interventionalists were encouraged to try the alternative technique if the initial strategy dictated by randomization proved ineffective after three attempts, explained Dr. Lapergue, a vascular neurologist at Foch Hospital in Suresnes, France.

ASTER’s primary endpoint was the percentage of patients who achieved thrombolysis in cerebral infarction (TICI) 2b or 3 flow at the end of treatment, which occurred in 85% of patients treated with aspiration first and in 83% of those treated by clot removal first, a difference that was not statistically significant, Dr. Lapergue reported. The rate of patients who achieved either TICI 2b or 3 flow after the initial strategy only was 63% with aspiration and 68% with clot removal, also a nonsignificant difference. The two strategies also showed no significant difference for any measured safety parameter. The results showed a trend toward more vasospasm with clot removal – a 6% rate, versus 3% with clot aspiration – but this did not reach statistical significance.

Results from additional analyses of the clinical outcomes of patients in the trial and of cost efficacy will be reported later in 2017, Dr. Lapergue said.

ASTER received an unrestricted research grant from Penumbra, a company that markets clot removal aspiration catheters. Dr. Lapergue had no personal disclosures. Dr. Hanel has been a consultant to and received grant support from Medtronic. He has received research grants from MicroVention and has an ownership interest in InNeuroCo.

Body

 

ASTER is an important trial. It shows for the first time that an aspiration device is probably as safe and reasonable for opening an acute occlusion in a large cerebral artery as is a stent retriever.

ASTER, however, was done entirely in a French population, making it uncertain whether the results are applicable to other populations. For example, U.S. acute ischemic stroke patients, especially African Americans and Hispanics, generally have more intracerebral atherostenotic disease than do patients from European countries, while French patients tend to have more embolic disease. Will aspiration be as effective in U.S. patients with atherostenotic blockages? I would love to see this study repeated in a U.S. population of ischemic stroke patients, and that is now happening in the COMPASS trial. It would be helpful to know if there are selected U.S. patients who might be better treated using either aspiration or a stent retriever first.

Although aspiration catheters have already received Food and Drug Administration approval for clot removal in acute ischemic stroke patients, many U.S. interventionalists have moved to deploying stent retrievers based on the very positive results reported with these devices about 2 years ago. For the moment, stent retrievers remain the most prominent devices to open large vessel occlusions.

Ralph L. Sacco, MD, is professor and chairman of neurology at the University of Miami. He had no relevant disclosures. He made these comments in a video interview and during a press conference.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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ASTER is an important trial. It shows for the first time that an aspiration device is probably as safe and reasonable for opening an acute occlusion in a large cerebral artery as is a stent retriever.

ASTER, however, was done entirely in a French population, making it uncertain whether the results are applicable to other populations. For example, U.S. acute ischemic stroke patients, especially African Americans and Hispanics, generally have more intracerebral atherostenotic disease than do patients from European countries, while French patients tend to have more embolic disease. Will aspiration be as effective in U.S. patients with atherostenotic blockages? I would love to see this study repeated in a U.S. population of ischemic stroke patients, and that is now happening in the COMPASS trial. It would be helpful to know if there are selected U.S. patients who might be better treated using either aspiration or a stent retriever first.

Although aspiration catheters have already received Food and Drug Administration approval for clot removal in acute ischemic stroke patients, many U.S. interventionalists have moved to deploying stent retrievers based on the very positive results reported with these devices about 2 years ago. For the moment, stent retrievers remain the most prominent devices to open large vessel occlusions.

Ralph L. Sacco, MD, is professor and chairman of neurology at the University of Miami. He had no relevant disclosures. He made these comments in a video interview and during a press conference.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Body

 

ASTER is an important trial. It shows for the first time that an aspiration device is probably as safe and reasonable for opening an acute occlusion in a large cerebral artery as is a stent retriever.

ASTER, however, was done entirely in a French population, making it uncertain whether the results are applicable to other populations. For example, U.S. acute ischemic stroke patients, especially African Americans and Hispanics, generally have more intracerebral atherostenotic disease than do patients from European countries, while French patients tend to have more embolic disease. Will aspiration be as effective in U.S. patients with atherostenotic blockages? I would love to see this study repeated in a U.S. population of ischemic stroke patients, and that is now happening in the COMPASS trial. It would be helpful to know if there are selected U.S. patients who might be better treated using either aspiration or a stent retriever first.

Although aspiration catheters have already received Food and Drug Administration approval for clot removal in acute ischemic stroke patients, many U.S. interventionalists have moved to deploying stent retrievers based on the very positive results reported with these devices about 2 years ago. For the moment, stent retrievers remain the most prominent devices to open large vessel occlusions.

Ralph L. Sacco, MD, is professor and chairman of neurology at the University of Miami. He had no relevant disclosures. He made these comments in a video interview and during a press conference.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Title
Aspiration remains unproven in U.S. patients
Aspiration remains unproven in U.S. patients

 

– Intracerebral clot aspiration was as safe and effective as stent retriever thrombectomy for restoring cerebral blood flow in a French multicenter, randomized trial with 381 acute ischemic stroke patients.

This study is the “first direct comparison of aspiration versus stent retrieval” as the initial strategy for clot removal in acute ischemic stroke, and it “opens the door to add a new tool” for clot removal, Bertrand Lapergue, MD, said at the International Stroke Conference sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News
Dr. Bertrand Lapergue
Although the results are a significant step forward for establishing “A Direct Aspiration, First Pass Technique (ADAPT)” as the equal of the now-standard approach of stent-retriever thrombectomy for clot removal, it is not completely definitive for U.S. practice, experts cautioned.

The new results “are the first to show that aspiration first is as good as a stent retriever, but we need to also see the results from COMPASS,” a U.S. multicenter trial that is in the process of making the same comparison, commented Ricardo A. Hanel, MD, a vascular neurosurgeon at Baptist Health in Jacksonville, Fla. The COMPASS Trial: a Direct Aspiration First Pass Technique has now enrolled about two-thirds of its target patient number, and until the study is complete the role of direct aspiration for clot removal in stroke remains investigational for U.S. practice, said Dr. Hanel, a COMPASS investigator.

The aspiration catheter tested in ASTER is marketed by Penumbra and has already received Food and Drug Administration approval for revascularization of ischemic stroke patients. U.S. use of aspiration for treating acute ischemic stroke, however, has remained limited because there is no clear evidence of the method’s efficacy. Dr. Hanel said that he occasionally uses aspiration as an adjunct to clot removal with a stent retriever.

Mitchel L. Zoler/Frontline Medical News
Dr. Ricardo A. Hanel
The Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke (ASTER) trial enrolled 381 patients with an anterior, large-vessel intracerebral occlusion at any of eight French centers. The study compared two different approaches to clot removal: using clot aspiration first or a stent retriever first. Participating interventionalists were encouraged to try the alternative technique if the initial strategy dictated by randomization proved ineffective after three attempts, explained Dr. Lapergue, a vascular neurologist at Foch Hospital in Suresnes, France.

ASTER’s primary endpoint was the percentage of patients who achieved thrombolysis in cerebral infarction (TICI) 2b or 3 flow at the end of treatment, which occurred in 85% of patients treated with aspiration first and in 83% of those treated by clot removal first, a difference that was not statistically significant, Dr. Lapergue reported. The rate of patients who achieved either TICI 2b or 3 flow after the initial strategy only was 63% with aspiration and 68% with clot removal, also a nonsignificant difference. The two strategies also showed no significant difference for any measured safety parameter. The results showed a trend toward more vasospasm with clot removal – a 6% rate, versus 3% with clot aspiration – but this did not reach statistical significance.

Results from additional analyses of the clinical outcomes of patients in the trial and of cost efficacy will be reported later in 2017, Dr. Lapergue said.

ASTER received an unrestricted research grant from Penumbra, a company that markets clot removal aspiration catheters. Dr. Lapergue had no personal disclosures. Dr. Hanel has been a consultant to and received grant support from Medtronic. He has received research grants from MicroVention and has an ownership interest in InNeuroCo.

 

– Intracerebral clot aspiration was as safe and effective as stent retriever thrombectomy for restoring cerebral blood flow in a French multicenter, randomized trial with 381 acute ischemic stroke patients.

This study is the “first direct comparison of aspiration versus stent retrieval” as the initial strategy for clot removal in acute ischemic stroke, and it “opens the door to add a new tool” for clot removal, Bertrand Lapergue, MD, said at the International Stroke Conference sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News
Dr. Bertrand Lapergue
Although the results are a significant step forward for establishing “A Direct Aspiration, First Pass Technique (ADAPT)” as the equal of the now-standard approach of stent-retriever thrombectomy for clot removal, it is not completely definitive for U.S. practice, experts cautioned.

The new results “are the first to show that aspiration first is as good as a stent retriever, but we need to also see the results from COMPASS,” a U.S. multicenter trial that is in the process of making the same comparison, commented Ricardo A. Hanel, MD, a vascular neurosurgeon at Baptist Health in Jacksonville, Fla. The COMPASS Trial: a Direct Aspiration First Pass Technique has now enrolled about two-thirds of its target patient number, and until the study is complete the role of direct aspiration for clot removal in stroke remains investigational for U.S. practice, said Dr. Hanel, a COMPASS investigator.

The aspiration catheter tested in ASTER is marketed by Penumbra and has already received Food and Drug Administration approval for revascularization of ischemic stroke patients. U.S. use of aspiration for treating acute ischemic stroke, however, has remained limited because there is no clear evidence of the method’s efficacy. Dr. Hanel said that he occasionally uses aspiration as an adjunct to clot removal with a stent retriever.

Mitchel L. Zoler/Frontline Medical News
Dr. Ricardo A. Hanel
The Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke (ASTER) trial enrolled 381 patients with an anterior, large-vessel intracerebral occlusion at any of eight French centers. The study compared two different approaches to clot removal: using clot aspiration first or a stent retriever first. Participating interventionalists were encouraged to try the alternative technique if the initial strategy dictated by randomization proved ineffective after three attempts, explained Dr. Lapergue, a vascular neurologist at Foch Hospital in Suresnes, France.

ASTER’s primary endpoint was the percentage of patients who achieved thrombolysis in cerebral infarction (TICI) 2b or 3 flow at the end of treatment, which occurred in 85% of patients treated with aspiration first and in 83% of those treated by clot removal first, a difference that was not statistically significant, Dr. Lapergue reported. The rate of patients who achieved either TICI 2b or 3 flow after the initial strategy only was 63% with aspiration and 68% with clot removal, also a nonsignificant difference. The two strategies also showed no significant difference for any measured safety parameter. The results showed a trend toward more vasospasm with clot removal – a 6% rate, versus 3% with clot aspiration – but this did not reach statistical significance.

Results from additional analyses of the clinical outcomes of patients in the trial and of cost efficacy will be reported later in 2017, Dr. Lapergue said.

ASTER received an unrestricted research grant from Penumbra, a company that markets clot removal aspiration catheters. Dr. Lapergue had no personal disclosures. Dr. Hanel has been a consultant to and received grant support from Medtronic. He has received research grants from MicroVention and has an ownership interest in InNeuroCo.

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Key clinical point: The first head-to-head comparison of clot aspiration and removal with a stent retriever showed similar safety and efficacy of the two methods for treating acute ischemic stroke.

Major finding: Recanalization occurred in 85% of patients treated with aspiration first and 83% treated with clot removal first.

Data source: ASTER, a multicenter, randomized French trial with 381 patients.

Disclosures: ASTER received an unrestricted research grant from Penumbra, a company that markets clot removal aspiration catheters. Dr. Lapergue had no personal disclosures. Dr. Hanel has been a consultant to and received grant support from Medtronic. He has received research grants from MicroVention and has an ownership interest in InNeuroCo.

Low-volume PEG linked to hypokalemia in at-risk patients

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Sat, 12/08/2018 - 03:20

 

FROM GASTROINTESTINAL ENDOSCOPY

Bowel preparation with low-volume polyethylene glycol led to hypokalemia in nearly 25% of high-risk patients who were normokalemic at baseline, according to a first-in-kind large single-center prospective study.

“Hypokalemia is frequently encountered after low-volume PEG bowel cleansing in high-risk patients,” wrote Ankie Reumkens, MD, and her associates at Maastricht University Medical Center, Maastricht, the Netherlands. The report was published online in Gastrointestinal Endoscopy. “Additional large-scale studies are needed on the prevalence of hypokalemia in nonselected populations undergoing bowel cleansing and on the occurrence of potentially very serious side effects in order to decide on screening of high-risk groups in daily clinical practice.”

Good bowel preparation is crucial to colonoscopy. Bowel preparation with both sodium phosphate and high-volume polyethylene glycol (PEG) has caused hypokalemia, but whether this is true of low-volume PEG is unclear, the investigators said. Recently, at their institution, two colonoscopy patients developed severe hypokalemia and died of ventricular arrhythmias after receiving low-volume PEG. These deaths spurred the researchers to prospectively study 1,822 colonoscopy patients who underwent bowel preparation with low-volume PEG in 2014 and who were considered at high risk of hypokalemia by their gastroenterologists or because of hospitalization or diuretic use.

The researchers measured serum potassium levels of all patients before bowel cleansing. After bowel testing, they retested a subgroup of 301 patients who were normokalemic (3.5-5 mmol/L) at baseline (Gastrointest Endosc. 2017 Feb 7. doi: 10.1016/j.gie.2017.01.040).

In all, 77 patients (4%) were hypokalemic before bowel cleansing, the researchers said. Fully one-third were hospitalized, and hospitalization remained a significant risk factor for baseline hypokalemia even after the researchers controlled for diuretic use, age, sex, and reason for colonoscopy (odds ratio, 2.5; 95% confidence interval, 1.5 to 4.2; P less than .001).

Follow-up testing showed that 71 patients (24%) who were normokalemic at baseline became hypokalemic (serum potassium less than 3.5 mmol/L) after bowel preparation with low-volume PEG. Only diuretic use remained significantly associated with this outcome after researchers accounted for age, sex, reason for colonoscopy, and hospitalization status (odds ratio, 2.3; 95% confidence interval, 1.3 to 4.0; P = .004).

This study included preselected groups of diuretic users and hospitalized patients, making it difficult to assess specific and detailed risk factors for hypokalemia, the researchers said. “Despite this limitation, our study clearly shows that hypokalemia may develop in a substantial percentage of patients after the ingestion of low-volume PEG,” they emphasized. But they recommended population-based studies to determine the true prevalence of hypokalemia after colonoscopy, examine risk factors for this outcome, and consider whether it makes sense to screen subgroups at risk.

The protocol at their hospital is to measure serum potassium before bowel cleansing in hospitalized patients and those on diuretics, they noted. Hypokalemic patients then receive oral potassium if their potassium level was 2.5-3.0 mmol/L, and intravenous potassium if their level was below 2.5 mmol/L.

The investigators reported having no funding sources and no competing interests.

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FROM GASTROINTESTINAL ENDOSCOPY

Bowel preparation with low-volume polyethylene glycol led to hypokalemia in nearly 25% of high-risk patients who were normokalemic at baseline, according to a first-in-kind large single-center prospective study.

“Hypokalemia is frequently encountered after low-volume PEG bowel cleansing in high-risk patients,” wrote Ankie Reumkens, MD, and her associates at Maastricht University Medical Center, Maastricht, the Netherlands. The report was published online in Gastrointestinal Endoscopy. “Additional large-scale studies are needed on the prevalence of hypokalemia in nonselected populations undergoing bowel cleansing and on the occurrence of potentially very serious side effects in order to decide on screening of high-risk groups in daily clinical practice.”

Good bowel preparation is crucial to colonoscopy. Bowel preparation with both sodium phosphate and high-volume polyethylene glycol (PEG) has caused hypokalemia, but whether this is true of low-volume PEG is unclear, the investigators said. Recently, at their institution, two colonoscopy patients developed severe hypokalemia and died of ventricular arrhythmias after receiving low-volume PEG. These deaths spurred the researchers to prospectively study 1,822 colonoscopy patients who underwent bowel preparation with low-volume PEG in 2014 and who were considered at high risk of hypokalemia by their gastroenterologists or because of hospitalization or diuretic use.

The researchers measured serum potassium levels of all patients before bowel cleansing. After bowel testing, they retested a subgroup of 301 patients who were normokalemic (3.5-5 mmol/L) at baseline (Gastrointest Endosc. 2017 Feb 7. doi: 10.1016/j.gie.2017.01.040).

In all, 77 patients (4%) were hypokalemic before bowel cleansing, the researchers said. Fully one-third were hospitalized, and hospitalization remained a significant risk factor for baseline hypokalemia even after the researchers controlled for diuretic use, age, sex, and reason for colonoscopy (odds ratio, 2.5; 95% confidence interval, 1.5 to 4.2; P less than .001).

Follow-up testing showed that 71 patients (24%) who were normokalemic at baseline became hypokalemic (serum potassium less than 3.5 mmol/L) after bowel preparation with low-volume PEG. Only diuretic use remained significantly associated with this outcome after researchers accounted for age, sex, reason for colonoscopy, and hospitalization status (odds ratio, 2.3; 95% confidence interval, 1.3 to 4.0; P = .004).

This study included preselected groups of diuretic users and hospitalized patients, making it difficult to assess specific and detailed risk factors for hypokalemia, the researchers said. “Despite this limitation, our study clearly shows that hypokalemia may develop in a substantial percentage of patients after the ingestion of low-volume PEG,” they emphasized. But they recommended population-based studies to determine the true prevalence of hypokalemia after colonoscopy, examine risk factors for this outcome, and consider whether it makes sense to screen subgroups at risk.

The protocol at their hospital is to measure serum potassium before bowel cleansing in hospitalized patients and those on diuretics, they noted. Hypokalemic patients then receive oral potassium if their potassium level was 2.5-3.0 mmol/L, and intravenous potassium if their level was below 2.5 mmol/L.

The investigators reported having no funding sources and no competing interests.

 

FROM GASTROINTESTINAL ENDOSCOPY

Bowel preparation with low-volume polyethylene glycol led to hypokalemia in nearly 25% of high-risk patients who were normokalemic at baseline, according to a first-in-kind large single-center prospective study.

“Hypokalemia is frequently encountered after low-volume PEG bowel cleansing in high-risk patients,” wrote Ankie Reumkens, MD, and her associates at Maastricht University Medical Center, Maastricht, the Netherlands. The report was published online in Gastrointestinal Endoscopy. “Additional large-scale studies are needed on the prevalence of hypokalemia in nonselected populations undergoing bowel cleansing and on the occurrence of potentially very serious side effects in order to decide on screening of high-risk groups in daily clinical practice.”

Good bowel preparation is crucial to colonoscopy. Bowel preparation with both sodium phosphate and high-volume polyethylene glycol (PEG) has caused hypokalemia, but whether this is true of low-volume PEG is unclear, the investigators said. Recently, at their institution, two colonoscopy patients developed severe hypokalemia and died of ventricular arrhythmias after receiving low-volume PEG. These deaths spurred the researchers to prospectively study 1,822 colonoscopy patients who underwent bowel preparation with low-volume PEG in 2014 and who were considered at high risk of hypokalemia by their gastroenterologists or because of hospitalization or diuretic use.

The researchers measured serum potassium levels of all patients before bowel cleansing. After bowel testing, they retested a subgroup of 301 patients who were normokalemic (3.5-5 mmol/L) at baseline (Gastrointest Endosc. 2017 Feb 7. doi: 10.1016/j.gie.2017.01.040).

In all, 77 patients (4%) were hypokalemic before bowel cleansing, the researchers said. Fully one-third were hospitalized, and hospitalization remained a significant risk factor for baseline hypokalemia even after the researchers controlled for diuretic use, age, sex, and reason for colonoscopy (odds ratio, 2.5; 95% confidence interval, 1.5 to 4.2; P less than .001).

Follow-up testing showed that 71 patients (24%) who were normokalemic at baseline became hypokalemic (serum potassium less than 3.5 mmol/L) after bowel preparation with low-volume PEG. Only diuretic use remained significantly associated with this outcome after researchers accounted for age, sex, reason for colonoscopy, and hospitalization status (odds ratio, 2.3; 95% confidence interval, 1.3 to 4.0; P = .004).

This study included preselected groups of diuretic users and hospitalized patients, making it difficult to assess specific and detailed risk factors for hypokalemia, the researchers said. “Despite this limitation, our study clearly shows that hypokalemia may develop in a substantial percentage of patients after the ingestion of low-volume PEG,” they emphasized. But they recommended population-based studies to determine the true prevalence of hypokalemia after colonoscopy, examine risk factors for this outcome, and consider whether it makes sense to screen subgroups at risk.

The protocol at their hospital is to measure serum potassium before bowel cleansing in hospitalized patients and those on diuretics, they noted. Hypokalemic patients then receive oral potassium if their potassium level was 2.5-3.0 mmol/L, and intravenous potassium if their level was below 2.5 mmol/L.

The investigators reported having no funding sources and no competing interests.

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Key clinical point. Bowel preparation with low-volume polyethylene glycol (PEG) led to hypokalemia in at-risk patients.

Major finding: In all, 24% of patients who were normokalemic before bowel cleansing developed hypokalemia afterward. Diuretic use was a significant risk factor for hypokalemia (odds ratio, 2.3; P = .004).

Data source: A prospective study of 1,822 colonoscopy patients considered at high risk of hypokalemia.

Disclosures: The investigators reported having no funding sources and no competing interests.