Doctor consults with a family

Photo by Rhoda Baer

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

Doctor consults with a family

Photo by Rhoda Baer

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

Doctor consults with a family

Photo by Rhoda Baer

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

Prescription drugs

Photo courtesy of CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

Prescription drugs

Photo courtesy of CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

Prescription drugs

Photo courtesy of CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).

KAUAI, HAWAII – Using photodynamic therapy in place of blue-light therapy to reverse sun damage such as actinic keratosis is less expensive and associated with fewer adverse events such as pain, according to Dr. Christopher Zachary.

Dr. Zachary, chair of dermatology at the University of California, Irvine, shared his perspectives in a video on the advantages of photodynamic therapy over other field treatments, particularly in an era of changing health care reimbursements.

He spoke at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.

[email protected]


On Twitter @whitneymcknight

KAUAI, HAWAII – Using photodynamic therapy in place of blue-light therapy to reverse sun damage such as actinic keratosis is less expensive and associated with fewer adverse events such as pain, according to Dr. Christopher Zachary.

Dr. Zachary, chair of dermatology at the University of California, Irvine, shared his perspectives in a video on the advantages of photodynamic therapy over other field treatments, particularly in an era of changing health care reimbursements.

He spoke at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.

[email protected]


On Twitter @whitneymcknight

KAUAI, HAWAII – Using photodynamic therapy in place of blue-light therapy to reverse sun damage such as actinic keratosis is less expensive and associated with fewer adverse events such as pain, according to Dr. Christopher Zachary.

Dr. Zachary, chair of dermatology at the University of California, Irvine, shared his perspectives in a video on the advantages of photodynamic therapy over other field treatments, particularly in an era of changing health care reimbursements.

He spoke at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.

[email protected]


On Twitter @whitneymcknight

PRACTICE CHANGER
Consider adding simvastatin (40 mg/d) to standard wound care and compression for patients with venous stasis ulcers.¹

STRENGTH OF RECOMMENDATION
B: Based on a high-quality randomized controlled trial (RCT).¹

ILLUSTRATIVE CASE
A 74-year-old woman with chronic lower extremity edema seeks treatment for a nonhealing venous stasis ulcer. For the past nine months, she’s been wearing compression stockings and receiving intermittent home-based wound care, but nothing seems to help. She asks if there’s anything else she can try.

Venous stasis ulcers affect 1% of US adults and lead to substantial morbidity and more than $2 billion in annual health care expenditures.^1,2 Edema management—generally limb elevation and compression therapy—has been the mainstay of therapy. Treatment can be lengthy, and ulcer recurrence is common.^2,3

Statins have been found to aid wound healing through their diverse physiologic (pleiotropic) effects. Evidence indicates they can be beneficial in treatment of diabetic foot ulcers,⁴ pressure ulcers,⁵ and ulcerations associated with systemic sclerosis and Raynaud phenomenon.⁶ Evangelista et al¹ investigated whether adding a statin to standard wound care and compression could improve venous stasis ulcer healing.

Continue for study summary >>

STUDY SUMMARY
Ulcers more likely to close when statin added
This randomized, double-blind, placebo-controlled trial was performed at a large medical center in the Philippines. It was designed to assess the efficacy and safety of simvastatin (40 mg/d) for venous ulcer healing when combined with standard treatment (compression therapy, limb elevation, and standard wound care).¹

Study subjects were 66 patients, ages 41 to 71, who’d had one or more venous ulcers for at least three months. They were randomly assigned to receive either simvastatin (40 mg/d; n = 32) or an identical-appearing placebo (n = 34). Patients were excluded if they were pregnant, had an ulcer that was infected or > 10 cm in diameter, or were taking any medication that could interact with a statin. Patients were stratified according to ulcer diameter (≤ 5 cm and > 5 cm). There was no statistically significant difference between the two groups in the duration of venous ulceration (3.80 y in the placebo group vs 3.93 y in the simvastatin group) or incidence of diabetes (5% vs 3%, respectively).

The primary outcome was the proportion of patients whose ulcers completely healed at 10 weeks. Secondary outcomes were measures of the total surface area healed, healing time, and Dermatology Life Quality Index (DLQI) scores. Baseline ulcer diameter and surface area and DLQI scores were obtained prior to therapy initiation. The same dermatologist, who was blinded to the patients’ group assignments, evaluated all patients every two weeks until wound closure or for a maximum of 10 weeks.

Overall, 90% of the patients who received simvastatin had complete ulcer closure at 10 weeks, compared with 34% of patients in the control group (relative risk [RR], 0.16; number needed to treat [NNT], 2).

Among patients with ulcers ≤ 5 cm, 100% of the ulcers healed in the simvastatin group, compared to 50% in the control group (RR, 0.10; NNT, 2). Perhaps more importantly, in patients with ulcers > 5 cm, 67% in the simvastatin group had closure with a mean healing time of nine weeks, whereas none of the ulcers of this size closed in the control group (RR, 0.33; NNT, 1.5), and the mean healed area was significantly larger in patients who received simvastatin (28.9 cm² vs 19.6 cm²).

In addition, in the simvastatin group, healing times were significantly reduced (7.53 ± 1.34 wk vs 8.55 ± 1.13 wk) and quality of life (as evaluated by DLQI scoring) significantly improved compared to the control group.

Study dropouts were minimal (8%; two in the placebo group and three in the intervention group). Using intention-to-treat analysis and worst-case scenarios for those who dropped out did not affect the primary outcome. There were no withdrawals due to adverse reactions.

WHAT’S NEW
Statins offer significant benefits for treating venous stasis ulcers
This is the first human study to investigate the use of a statin in venous stasis ulcer healing. This intervention demonstrated significant improvements in healing rate and time, a very small NNT for benefit, and improved patient quality of life compared to placebo.

Next page: Caveats >>

CAVEATS
Carefully selected patients
Many wounds will heal with compression therapy alone, as occurred in this study, in which 50% of ulcers ≤ 5 cm treated with standard therapy healed, albeit at a somewhat slower rate. Adding another medication to the regimen when target patients generally have multiple comorbidities should always prompt caution.

The study by Evangelista et al¹ was performed in a select population, and the exclusion criteria included the use of some commonly prescribed medications, such as ACE inhibitors. No data were collected on patient BMI, which is a risk factor for delayed healing.

The prevalence of obesity is lower in the Philippines than in the US. It is uncertain what role this difference would have in the statin’s effectiveness.

Further studies, especially those conducted with a less selective population, would better clarify the generalizability of this intervention.

Nontheless, we found the results of this study impressive. The methods reported are rigorous and consistent with standard RCT methodologies.

This is the only study of a statin in human venous stasis disease, but studies in animals—and studies of statins for other types of ulcers in humans—have consistently suggested benefit. It seems hard to argue against adding this low-cost, low-risk intervention.

CHALLENGES TO IMPLEMENTATION
There are no known barriers to implementation of this practice.

REFERENCES
1. Evangelista MT, Casintahan MF, Villafuerte LL. Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial. Br J Dermatol. 2014; 170:1151-1157.

2. Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010;81: 989-996.

3. The Australian Wound Management Association Inc, New Zealand Wound Care Society Inc. Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcers (2011). www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ext003_venous_leg_ulcers_aust_nz_0.pdf. Accessed March 21, 2015.

4. Johansen OE, Birkeland KI, Jørgensen AP, et al. Diabetic foot ulcer burden may be modified by high-dose atorvastatin: a 6-month randomized controlled pilot trial. J Diabetes. 2009; 1:182-187.

5. Farsaei S, Khalili H, Farboud ES, et al. Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial. Pharmacotherapy. 2014;34:19-27.

6. Abou-Raya A, Abou-Raya S, Helmii M. Statins: potentially useful in therapy of systemic sclerosis-related Raynaud’s phenomenon and digital ulcers. J Rheumatol. 2008;35:1801-1808.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2015. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2015;64(3):182-184.

PRACTICE CHANGER
Consider adding simvastatin (40 mg/d) to standard wound care and compression for patients with venous stasis ulcers.¹

STRENGTH OF RECOMMENDATION
B: Based on a high-quality randomized controlled trial (RCT).¹

ILLUSTRATIVE CASE
A 74-year-old woman with chronic lower extremity edema seeks treatment for a nonhealing venous stasis ulcer. For the past nine months, she’s been wearing compression stockings and receiving intermittent home-based wound care, but nothing seems to help. She asks if there’s anything else she can try.

Venous stasis ulcers affect 1% of US adults and lead to substantial morbidity and more than $2 billion in annual health care expenditures.^1,2 Edema management—generally limb elevation and compression therapy—has been the mainstay of therapy. Treatment can be lengthy, and ulcer recurrence is common.^2,3

Statins have been found to aid wound healing through their diverse physiologic (pleiotropic) effects. Evidence indicates they can be beneficial in treatment of diabetic foot ulcers,⁴ pressure ulcers,⁵ and ulcerations associated with systemic sclerosis and Raynaud phenomenon.⁶ Evangelista et al¹ investigated whether adding a statin to standard wound care and compression could improve venous stasis ulcer healing.

Continue for study summary >>

STUDY SUMMARY
Ulcers more likely to close when statin added
This randomized, double-blind, placebo-controlled trial was performed at a large medical center in the Philippines. It was designed to assess the efficacy and safety of simvastatin (40 mg/d) for venous ulcer healing when combined with standard treatment (compression therapy, limb elevation, and standard wound care).¹

Study subjects were 66 patients, ages 41 to 71, who’d had one or more venous ulcers for at least three months. They were randomly assigned to receive either simvastatin (40 mg/d; n = 32) or an identical-appearing placebo (n = 34). Patients were excluded if they were pregnant, had an ulcer that was infected or > 10 cm in diameter, or were taking any medication that could interact with a statin. Patients were stratified according to ulcer diameter (≤ 5 cm and > 5 cm). There was no statistically significant difference between the two groups in the duration of venous ulceration (3.80 y in the placebo group vs 3.93 y in the simvastatin group) or incidence of diabetes (5% vs 3%, respectively).

The primary outcome was the proportion of patients whose ulcers completely healed at 10 weeks. Secondary outcomes were measures of the total surface area healed, healing time, and Dermatology Life Quality Index (DLQI) scores. Baseline ulcer diameter and surface area and DLQI scores were obtained prior to therapy initiation. The same dermatologist, who was blinded to the patients’ group assignments, evaluated all patients every two weeks until wound closure or for a maximum of 10 weeks.

Overall, 90% of the patients who received simvastatin had complete ulcer closure at 10 weeks, compared with 34% of patients in the control group (relative risk [RR], 0.16; number needed to treat [NNT], 2).

Among patients with ulcers ≤ 5 cm, 100% of the ulcers healed in the simvastatin group, compared to 50% in the control group (RR, 0.10; NNT, 2). Perhaps more importantly, in patients with ulcers > 5 cm, 67% in the simvastatin group had closure with a mean healing time of nine weeks, whereas none of the ulcers of this size closed in the control group (RR, 0.33; NNT, 1.5), and the mean healed area was significantly larger in patients who received simvastatin (28.9 cm² vs 19.6 cm²).

In addition, in the simvastatin group, healing times were significantly reduced (7.53 ± 1.34 wk vs 8.55 ± 1.13 wk) and quality of life (as evaluated by DLQI scoring) significantly improved compared to the control group.

Study dropouts were minimal (8%; two in the placebo group and three in the intervention group). Using intention-to-treat analysis and worst-case scenarios for those who dropped out did not affect the primary outcome. There were no withdrawals due to adverse reactions.

WHAT’S NEW
Statins offer significant benefits for treating venous stasis ulcers
This is the first human study to investigate the use of a statin in venous stasis ulcer healing. This intervention demonstrated significant improvements in healing rate and time, a very small NNT for benefit, and improved patient quality of life compared to placebo.

Next page: Caveats >>

CAVEATS
Carefully selected patients
Many wounds will heal with compression therapy alone, as occurred in this study, in which 50% of ulcers ≤ 5 cm treated with standard therapy healed, albeit at a somewhat slower rate. Adding another medication to the regimen when target patients generally have multiple comorbidities should always prompt caution.

The study by Evangelista et al¹ was performed in a select population, and the exclusion criteria included the use of some commonly prescribed medications, such as ACE inhibitors. No data were collected on patient BMI, which is a risk factor for delayed healing.

The prevalence of obesity is lower in the Philippines than in the US. It is uncertain what role this difference would have in the statin’s effectiveness.

Further studies, especially those conducted with a less selective population, would better clarify the generalizability of this intervention.

Nontheless, we found the results of this study impressive. The methods reported are rigorous and consistent with standard RCT methodologies.

This is the only study of a statin in human venous stasis disease, but studies in animals—and studies of statins for other types of ulcers in humans—have consistently suggested benefit. It seems hard to argue against adding this low-cost, low-risk intervention.

CHALLENGES TO IMPLEMENTATION
There are no known barriers to implementation of this practice.

REFERENCES
1. Evangelista MT, Casintahan MF, Villafuerte LL. Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial. Br J Dermatol. 2014; 170:1151-1157.

2. Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010;81: 989-996.

3. The Australian Wound Management Association Inc, New Zealand Wound Care Society Inc. Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcers (2011). www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ext003_venous_leg_ulcers_aust_nz_0.pdf. Accessed March 21, 2015.

4. Johansen OE, Birkeland KI, Jørgensen AP, et al. Diabetic foot ulcer burden may be modified by high-dose atorvastatin: a 6-month randomized controlled pilot trial. J Diabetes. 2009; 1:182-187.

5. Farsaei S, Khalili H, Farboud ES, et al. Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial. Pharmacotherapy. 2014;34:19-27.

6. Abou-Raya A, Abou-Raya S, Helmii M. Statins: potentially useful in therapy of systemic sclerosis-related Raynaud’s phenomenon and digital ulcers. J Rheumatol. 2008;35:1801-1808.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2015. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2015;64(3):182-184.

PRACTICE CHANGER
Consider adding simvastatin (40 mg/d) to standard wound care and compression for patients with venous stasis ulcers.¹

STRENGTH OF RECOMMENDATION
B: Based on a high-quality randomized controlled trial (RCT).¹

ILLUSTRATIVE CASE
A 74-year-old woman with chronic lower extremity edema seeks treatment for a nonhealing venous stasis ulcer. For the past nine months, she’s been wearing compression stockings and receiving intermittent home-based wound care, but nothing seems to help. She asks if there’s anything else she can try.

Venous stasis ulcers affect 1% of US adults and lead to substantial morbidity and more than $2 billion in annual health care expenditures.^1,2 Edema management—generally limb elevation and compression therapy—has been the mainstay of therapy. Treatment can be lengthy, and ulcer recurrence is common.^2,3

Statins have been found to aid wound healing through their diverse physiologic (pleiotropic) effects. Evidence indicates they can be beneficial in treatment of diabetic foot ulcers,⁴ pressure ulcers,⁵ and ulcerations associated with systemic sclerosis and Raynaud phenomenon.⁶ Evangelista et al¹ investigated whether adding a statin to standard wound care and compression could improve venous stasis ulcer healing.

Continue for study summary >>

STUDY SUMMARY
Ulcers more likely to close when statin added
This randomized, double-blind, placebo-controlled trial was performed at a large medical center in the Philippines. It was designed to assess the efficacy and safety of simvastatin (40 mg/d) for venous ulcer healing when combined with standard treatment (compression therapy, limb elevation, and standard wound care).¹

Study subjects were 66 patients, ages 41 to 71, who’d had one or more venous ulcers for at least three months. They were randomly assigned to receive either simvastatin (40 mg/d; n = 32) or an identical-appearing placebo (n = 34). Patients were excluded if they were pregnant, had an ulcer that was infected or > 10 cm in diameter, or were taking any medication that could interact with a statin. Patients were stratified according to ulcer diameter (≤ 5 cm and > 5 cm). There was no statistically significant difference between the two groups in the duration of venous ulceration (3.80 y in the placebo group vs 3.93 y in the simvastatin group) or incidence of diabetes (5% vs 3%, respectively).

The primary outcome was the proportion of patients whose ulcers completely healed at 10 weeks. Secondary outcomes were measures of the total surface area healed, healing time, and Dermatology Life Quality Index (DLQI) scores. Baseline ulcer diameter and surface area and DLQI scores were obtained prior to therapy initiation. The same dermatologist, who was blinded to the patients’ group assignments, evaluated all patients every two weeks until wound closure or for a maximum of 10 weeks.

Overall, 90% of the patients who received simvastatin had complete ulcer closure at 10 weeks, compared with 34% of patients in the control group (relative risk [RR], 0.16; number needed to treat [NNT], 2).

Among patients with ulcers ≤ 5 cm, 100% of the ulcers healed in the simvastatin group, compared to 50% in the control group (RR, 0.10; NNT, 2). Perhaps more importantly, in patients with ulcers > 5 cm, 67% in the simvastatin group had closure with a mean healing time of nine weeks, whereas none of the ulcers of this size closed in the control group (RR, 0.33; NNT, 1.5), and the mean healed area was significantly larger in patients who received simvastatin (28.9 cm² vs 19.6 cm²).

In addition, in the simvastatin group, healing times were significantly reduced (7.53 ± 1.34 wk vs 8.55 ± 1.13 wk) and quality of life (as evaluated by DLQI scoring) significantly improved compared to the control group.

Study dropouts were minimal (8%; two in the placebo group and three in the intervention group). Using intention-to-treat analysis and worst-case scenarios for those who dropped out did not affect the primary outcome. There were no withdrawals due to adverse reactions.

WHAT’S NEW
Statins offer significant benefits for treating venous stasis ulcers
This is the first human study to investigate the use of a statin in venous stasis ulcer healing. This intervention demonstrated significant improvements in healing rate and time, a very small NNT for benefit, and improved patient quality of life compared to placebo.

Next page: Caveats >>

CAVEATS
Carefully selected patients
Many wounds will heal with compression therapy alone, as occurred in this study, in which 50% of ulcers ≤ 5 cm treated with standard therapy healed, albeit at a somewhat slower rate. Adding another medication to the regimen when target patients generally have multiple comorbidities should always prompt caution.

The study by Evangelista et al¹ was performed in a select population, and the exclusion criteria included the use of some commonly prescribed medications, such as ACE inhibitors. No data were collected on patient BMI, which is a risk factor for delayed healing.

The prevalence of obesity is lower in the Philippines than in the US. It is uncertain what role this difference would have in the statin’s effectiveness.

Further studies, especially those conducted with a less selective population, would better clarify the generalizability of this intervention.

Nontheless, we found the results of this study impressive. The methods reported are rigorous and consistent with standard RCT methodologies.

This is the only study of a statin in human venous stasis disease, but studies in animals—and studies of statins for other types of ulcers in humans—have consistently suggested benefit. It seems hard to argue against adding this low-cost, low-risk intervention.

CHALLENGES TO IMPLEMENTATION
There are no known barriers to implementation of this practice.

REFERENCES
1. Evangelista MT, Casintahan MF, Villafuerte LL. Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial. Br J Dermatol. 2014; 170:1151-1157.

2. Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010;81: 989-996.

3. The Australian Wound Management Association Inc, New Zealand Wound Care Society Inc. Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcers (2011). www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ext003_venous_leg_ulcers_aust_nz_0.pdf. Accessed March 21, 2015.

4. Johansen OE, Birkeland KI, Jørgensen AP, et al. Diabetic foot ulcer burden may be modified by high-dose atorvastatin: a 6-month randomized controlled pilot trial. J Diabetes. 2009; 1:182-187.

5. Farsaei S, Khalili H, Farboud ES, et al. Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial. Pharmacotherapy. 2014;34:19-27.

6. Abou-Raya A, Abou-Raya S, Helmii M. Statins: potentially useful in therapy of systemic sclerosis-related Raynaud’s phenomenon and digital ulcers. J Rheumatol. 2008;35:1801-1808.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2015. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2015;64(3):182-184.

Cerebral blood flow recovery could be a biomarker of outcomes in athletes following concussion, according to an imaging study published online ahead of print March 2 in JAMA Neurology. “To our knowledge, this study provides the first prospective evidence of reduced cerebral blood flow and subsequent recovery following concussion in a homogeneous sample of collegiate football athletes and also demonstrates the potential of quantified cerebral blood flow as an objective biomarker for concussion,” said lead author Timothy B. Meier, PhD, and his research colleagues. According to the investigators, the resolution of cerebral blood flow abnormalities closely mirrors that of previous reports from the animal literature and shows real-world validity for predicting outcome following concussion.

Dr. Meier, of the Mind Research Network/Lovelace Biomedical and Environmental Research Institute in Albuquerque, and colleagues enrolled 44 collegiate football athletes in a mixed longitudinal and cross-sectional study at a private research institute specializing in neuroimaging. The study was conducted from March 2012 to December 2013.

Of the 44 football players, 17 were concussed and had serial imaging performed approximately one day, one week, and one month postconcussion. The study also included 27 healthy football players who served as a control group. All athletes reported no premorbid mood disorders, anxiety disorders, substance abuse, or alcohol abuse.

Arterial spin labeling MRI was used to collect voxelwise relative cerebral blood flow data at each visit. Neuropsychiatric evaluations and a brief cognitive screen also were performed at all three time points (ie, one day, one week, and one month). Clinicians trained in sports medicine provided an independent measure of real-world concussion outcome (ie, number of days withheld from competition).

Cognitive (ie, simple reaction time) and neuropsychiatric symptoms at one day postconcussion resolved at either one week postinjury or one month postinjury. Imaging data suggested cross-sectional (ie, healthy vs concussed athletes) and longitudinal (ie, one day and one week vs one month postinjury) evidence of cerebral blood flow recovery in the right insular and superior temporal cortex. The researchers also found that cerebral blood flow in the dorsal midinsular cortex was decreased at one month postinjury in slower-to-recover athletes and was inversely related to the magnitude of initial psychiatric symptoms, as rated on the Hamilton Depression Scale and the Hamilton Anxiety Scale.

“The current results suggest that regional cerebral blood flow may provide an objective biomarker for tracking both normal and potentially pathologic recovery from concussion,” the researchers concluded.

Future studies identifying the time course of metabolic dysfunction following concussion and its relationship to cerebral blood flow are crucial to characterize the physiologic effect of concussion, according to the investigators. “Specifically, the cerebral metabolic rate of glucose, the cerebral metabolic rate of oxygen, and cerebral blood flow are tightly coupled in health, but become dysregulated following mild traumatic brain injury.”

—Glenn S. Williams

Cerebral blood flow recovery could be a biomarker of outcomes in athletes following concussion, according to an imaging study published online ahead of print March 2 in JAMA Neurology. “To our knowledge, this study provides the first prospective evidence of reduced cerebral blood flow and subsequent recovery following concussion in a homogeneous sample of collegiate football athletes and also demonstrates the potential of quantified cerebral blood flow as an objective biomarker for concussion,” said lead author Timothy B. Meier, PhD, and his research colleagues. According to the investigators, the resolution of cerebral blood flow abnormalities closely mirrors that of previous reports from the animal literature and shows real-world validity for predicting outcome following concussion.

Dr. Meier, of the Mind Research Network/Lovelace Biomedical and Environmental Research Institute in Albuquerque, and colleagues enrolled 44 collegiate football athletes in a mixed longitudinal and cross-sectional study at a private research institute specializing in neuroimaging. The study was conducted from March 2012 to December 2013.

Of the 44 football players, 17 were concussed and had serial imaging performed approximately one day, one week, and one month postconcussion. The study also included 27 healthy football players who served as a control group. All athletes reported no premorbid mood disorders, anxiety disorders, substance abuse, or alcohol abuse.

Arterial spin labeling MRI was used to collect voxelwise relative cerebral blood flow data at each visit. Neuropsychiatric evaluations and a brief cognitive screen also were performed at all three time points (ie, one day, one week, and one month). Clinicians trained in sports medicine provided an independent measure of real-world concussion outcome (ie, number of days withheld from competition).

Cognitive (ie, simple reaction time) and neuropsychiatric symptoms at one day postconcussion resolved at either one week postinjury or one month postinjury. Imaging data suggested cross-sectional (ie, healthy vs concussed athletes) and longitudinal (ie, one day and one week vs one month postinjury) evidence of cerebral blood flow recovery in the right insular and superior temporal cortex. The researchers also found that cerebral blood flow in the dorsal midinsular cortex was decreased at one month postinjury in slower-to-recover athletes and was inversely related to the magnitude of initial psychiatric symptoms, as rated on the Hamilton Depression Scale and the Hamilton Anxiety Scale.

“The current results suggest that regional cerebral blood flow may provide an objective biomarker for tracking both normal and potentially pathologic recovery from concussion,” the researchers concluded.

Future studies identifying the time course of metabolic dysfunction following concussion and its relationship to cerebral blood flow are crucial to characterize the physiologic effect of concussion, according to the investigators. “Specifically, the cerebral metabolic rate of glucose, the cerebral metabolic rate of oxygen, and cerebral blood flow are tightly coupled in health, but become dysregulated following mild traumatic brain injury.”

—Glenn S. Williams

Cerebral blood flow recovery could be a biomarker of outcomes in athletes following concussion, according to an imaging study published online ahead of print March 2 in JAMA Neurology. “To our knowledge, this study provides the first prospective evidence of reduced cerebral blood flow and subsequent recovery following concussion in a homogeneous sample of collegiate football athletes and also demonstrates the potential of quantified cerebral blood flow as an objective biomarker for concussion,” said lead author Timothy B. Meier, PhD, and his research colleagues. According to the investigators, the resolution of cerebral blood flow abnormalities closely mirrors that of previous reports from the animal literature and shows real-world validity for predicting outcome following concussion.

Dr. Meier, of the Mind Research Network/Lovelace Biomedical and Environmental Research Institute in Albuquerque, and colleagues enrolled 44 collegiate football athletes in a mixed longitudinal and cross-sectional study at a private research institute specializing in neuroimaging. The study was conducted from March 2012 to December 2013.

Of the 44 football players, 17 were concussed and had serial imaging performed approximately one day, one week, and one month postconcussion. The study also included 27 healthy football players who served as a control group. All athletes reported no premorbid mood disorders, anxiety disorders, substance abuse, or alcohol abuse.

Arterial spin labeling MRI was used to collect voxelwise relative cerebral blood flow data at each visit. Neuropsychiatric evaluations and a brief cognitive screen also were performed at all three time points (ie, one day, one week, and one month). Clinicians trained in sports medicine provided an independent measure of real-world concussion outcome (ie, number of days withheld from competition).

Cognitive (ie, simple reaction time) and neuropsychiatric symptoms at one day postconcussion resolved at either one week postinjury or one month postinjury. Imaging data suggested cross-sectional (ie, healthy vs concussed athletes) and longitudinal (ie, one day and one week vs one month postinjury) evidence of cerebral blood flow recovery in the right insular and superior temporal cortex. The researchers also found that cerebral blood flow in the dorsal midinsular cortex was decreased at one month postinjury in slower-to-recover athletes and was inversely related to the magnitude of initial psychiatric symptoms, as rated on the Hamilton Depression Scale and the Hamilton Anxiety Scale.

“The current results suggest that regional cerebral blood flow may provide an objective biomarker for tracking both normal and potentially pathologic recovery from concussion,” the researchers concluded.

Future studies identifying the time course of metabolic dysfunction following concussion and its relationship to cerebral blood flow are crucial to characterize the physiologic effect of concussion, according to the investigators. “Specifically, the cerebral metabolic rate of glucose, the cerebral metabolic rate of oxygen, and cerebral blood flow are tightly coupled in health, but become dysregulated following mild traumatic brain injury.”

—Glenn S. Williams

SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

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The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

[email protected]

The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

[email protected]

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”