BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).

Doctor examines SCD patient

Photo courtesy of St. Jude

Children’s Research Hospital

SAN FRANCISCO—A new study has shown that hydroxyurea (HU) can improve lung function in young patients with sickle cell disease (SCD).

“Persons with sickle cell disease experience an annual decline in lung function that starts in childhood,” said study investigator Anya McLaren, MD, of The Hospital for Sick Children in Toronto, Ontario, Canada.

“This study is the first of its kind to look at the effect of hydroxyurea on lung function. We found that hydroxyurea improves annual pulmonary function decline in children with sickle cell disease by more than one-third.”

The study was presented at the ATS 2016 International Conference as abstract 7225.

For this study, Dr McLaren and her colleagues evaluated the effects of HU in 94 SCD patients. The patients’ average age at baseline was 11 (range, 6 to 20), 96% of patients had HbSS genotype, and 47% were male.

The patients were followed for 4 years after HU initiation. The investigators assessed lung function before and after HU initiation in a few ways.

They used the forced expiratory volume (FEV) test, which measures how much air a person can exhale during a forced breath. The amount of air can be measured during the first second of the forced breath (FEV1) and at later time points.

Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. If the FEV1/FVC ratio is less than 80%, it indicates that an obstructive defect is present.

The investigators also assessed FEF25-75, or the forced expiratory flow at 25%–75% of FVC. This measurement helps determine if there is an obstruction in the airway.

In addition, the team measured total lung capacity.

Results

The investigators found no significant change in total lung capacity, FVC, or FEV1/FVC predicted measurements after patients began receiving HU.

However, there were significant improvements in both FEV1 and FEF25-75 after treatment.

The annual rate of decline in predicted FEV1 and FEF25-75 before patients started HU was -1.98%/year (95% CI -2.57 to -1.39) and -3.59%/year (95% CI -4.43 to -2.75), respectively.

After HU treatment began, there was a significant (P<0.05) improvement in the annual decline, to -1.28%/year (95% CI -1.79 to -0.76) and -2.88%/year (95% CI -3.49 to -2.28), respectively.

The investigators noted that changes in FEV1 and FEF25-75 were independent of a patient’s age at baseline and the time from HU therapy initiation.

Dr McLaren pointed out that HU is underused in SCD patients, likely because clinicians are concerned about patient non-compliance and afraid of potential side effects, particularly carcinogenesis. But some of those fears may be unfounded, she said.

“Long-term observational studies suggest beneficial effects [of HU] without excessive damage to bone marrow, deleterious effects on growth and development, altered fertility, accumulation of mutations, or increased carcinogenicity,” Dr McLaren said.

“Evidence that lung function may be better preserved while on hydroxyurea may encourage compliance and adherence to this medication for patients with sickle cell disease. In combination with the established safety data, it hopefully will promote physician recommendations for hydroxyurea initiation and encouragement of compliance.”

Doctor examines SCD patient

Photo courtesy of St. Jude

Children’s Research Hospital

SAN FRANCISCO—A new study has shown that hydroxyurea (HU) can improve lung function in young patients with sickle cell disease (SCD).

“Persons with sickle cell disease experience an annual decline in lung function that starts in childhood,” said study investigator Anya McLaren, MD, of The Hospital for Sick Children in Toronto, Ontario, Canada.

“This study is the first of its kind to look at the effect of hydroxyurea on lung function. We found that hydroxyurea improves annual pulmonary function decline in children with sickle cell disease by more than one-third.”

The study was presented at the ATS 2016 International Conference as abstract 7225.

For this study, Dr McLaren and her colleagues evaluated the effects of HU in 94 SCD patients. The patients’ average age at baseline was 11 (range, 6 to 20), 96% of patients had HbSS genotype, and 47% were male.

The patients were followed for 4 years after HU initiation. The investigators assessed lung function before and after HU initiation in a few ways.

They used the forced expiratory volume (FEV) test, which measures how much air a person can exhale during a forced breath. The amount of air can be measured during the first second of the forced breath (FEV1) and at later time points.

Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. If the FEV1/FVC ratio is less than 80%, it indicates that an obstructive defect is present.

The investigators also assessed FEF25-75, or the forced expiratory flow at 25%–75% of FVC. This measurement helps determine if there is an obstruction in the airway.

In addition, the team measured total lung capacity.

Results

The investigators found no significant change in total lung capacity, FVC, or FEV1/FVC predicted measurements after patients began receiving HU.

However, there were significant improvements in both FEV1 and FEF25-75 after treatment.

The annual rate of decline in predicted FEV1 and FEF25-75 before patients started HU was -1.98%/year (95% CI -2.57 to -1.39) and -3.59%/year (95% CI -4.43 to -2.75), respectively.

After HU treatment began, there was a significant (P<0.05) improvement in the annual decline, to -1.28%/year (95% CI -1.79 to -0.76) and -2.88%/year (95% CI -3.49 to -2.28), respectively.

The investigators noted that changes in FEV1 and FEF25-75 were independent of a patient’s age at baseline and the time from HU therapy initiation.

Dr McLaren pointed out that HU is underused in SCD patients, likely because clinicians are concerned about patient non-compliance and afraid of potential side effects, particularly carcinogenesis. But some of those fears may be unfounded, she said.

“Long-term observational studies suggest beneficial effects [of HU] without excessive damage to bone marrow, deleterious effects on growth and development, altered fertility, accumulation of mutations, or increased carcinogenicity,” Dr McLaren said.

“Evidence that lung function may be better preserved while on hydroxyurea may encourage compliance and adherence to this medication for patients with sickle cell disease. In combination with the established safety data, it hopefully will promote physician recommendations for hydroxyurea initiation and encouragement of compliance.”

Doctor examines SCD patient

Photo courtesy of St. Jude

Children’s Research Hospital

SAN FRANCISCO—A new study has shown that hydroxyurea (HU) can improve lung function in young patients with sickle cell disease (SCD).

“Persons with sickle cell disease experience an annual decline in lung function that starts in childhood,” said study investigator Anya McLaren, MD, of The Hospital for Sick Children in Toronto, Ontario, Canada.

“This study is the first of its kind to look at the effect of hydroxyurea on lung function. We found that hydroxyurea improves annual pulmonary function decline in children with sickle cell disease by more than one-third.”

The study was presented at the ATS 2016 International Conference as abstract 7225.

For this study, Dr McLaren and her colleagues evaluated the effects of HU in 94 SCD patients. The patients’ average age at baseline was 11 (range, 6 to 20), 96% of patients had HbSS genotype, and 47% were male.

The patients were followed for 4 years after HU initiation. The investigators assessed lung function before and after HU initiation in a few ways.

They used the forced expiratory volume (FEV) test, which measures how much air a person can exhale during a forced breath. The amount of air can be measured during the first second of the forced breath (FEV1) and at later time points.

Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. If the FEV1/FVC ratio is less than 80%, it indicates that an obstructive defect is present.

The investigators also assessed FEF25-75, or the forced expiratory flow at 25%–75% of FVC. This measurement helps determine if there is an obstruction in the airway.

In addition, the team measured total lung capacity.

Results

The investigators found no significant change in total lung capacity, FVC, or FEV1/FVC predicted measurements after patients began receiving HU.

However, there were significant improvements in both FEV1 and FEF25-75 after treatment.

The annual rate of decline in predicted FEV1 and FEF25-75 before patients started HU was -1.98%/year (95% CI -2.57 to -1.39) and -3.59%/year (95% CI -4.43 to -2.75), respectively.

After HU treatment began, there was a significant (P<0.05) improvement in the annual decline, to -1.28%/year (95% CI -1.79 to -0.76) and -2.88%/year (95% CI -3.49 to -2.28), respectively.

The investigators noted that changes in FEV1 and FEF25-75 were independent of a patient’s age at baseline and the time from HU therapy initiation.

Dr McLaren pointed out that HU is underused in SCD patients, likely because clinicians are concerned about patient non-compliance and afraid of potential side effects, particularly carcinogenesis. But some of those fears may be unfounded, she said.

“Long-term observational studies suggest beneficial effects [of HU] without excessive damage to bone marrow, deleterious effects on growth and development, altered fertility, accumulation of mutations, or increased carcinogenicity,” Dr McLaren said.

“Evidence that lung function may be better preserved while on hydroxyurea may encourage compliance and adherence to this medication for patients with sickle cell disease. In combination with the established safety data, it hopefully will promote physician recommendations for hydroxyurea initiation and encouragement of compliance.”

Hematopoietic stem cells

in the bone marrow

Scientists believe they have come one step closer to creating hematopoietic stem cells (HSCs) that are just like the real thing.

“Our work focuses on finding a way to generate a supply of these life-saving hematopoietic stem cells in the lab so that they are a perfect match to the patient in need of a transplant,” said Hanna Mikkola, MD, PhD, of the University of California, Los Angeles.

“One big challenge is that when we try to create hematopoietic stem cells from pluripotent stem cells in the lab, they don’t acquire the same abilities of the real hematopoietic stem cells found in the body.”

Dr Mikkola and her colleagues described their attempts to overcome this challenge in Nature Cell Biology.

The researchers tried to create HSCs from pluripotent stem cells, but when they compared the lab-created cells to HSCs found in the body, they found that HOXA genes weren’t activated in the lab-created cells.

The team also discovered that HOXA genes help HSCs maintain their stem-cell attributes, such as the ability to self-renew.

“Without the ability to self-renew, hematopoietic stem cells cannot be used for transplantation therapies,” said Vincenzo Calvanese, PhD, an assistant project scientist in Dr Mikkola’s lab.

“Our findings show that the activation of HOXA genes can be used as a marker for hematopoietic stem cells that have acquired the capacity to renew themselves.”

The researchers’ next challenge was to pinpoint the naturally occurring process that activates HOXA genes so they could try to replicate the process in the lab.

They found that mimicking the effects of retinoic acid acts like a switch that turns on the HOXA genes during HSC development.

“Inducing retinoic acid activity at a very specific time in cell development makes our lab-created cells more similar to the real hematopoietic stem cells found in the body,” said Diana Dou, a graduate student in Dr Mikkola’s lab.

“This is an important step forward as we work to develop hematopoietic stem cells for transplantation therapies for life-threatening blood diseases.”

The researchers’ next step will be to refine the process they’ve developed in order to produce lab-created HSCs that have—and maintain—all the functions of human HSCs.

Hematopoietic stem cells

in the bone marrow

Scientists believe they have come one step closer to creating hematopoietic stem cells (HSCs) that are just like the real thing.

“Our work focuses on finding a way to generate a supply of these life-saving hematopoietic stem cells in the lab so that they are a perfect match to the patient in need of a transplant,” said Hanna Mikkola, MD, PhD, of the University of California, Los Angeles.

“One big challenge is that when we try to create hematopoietic stem cells from pluripotent stem cells in the lab, they don’t acquire the same abilities of the real hematopoietic stem cells found in the body.”

Dr Mikkola and her colleagues described their attempts to overcome this challenge in Nature Cell Biology.

The researchers tried to create HSCs from pluripotent stem cells, but when they compared the lab-created cells to HSCs found in the body, they found that HOXA genes weren’t activated in the lab-created cells.

The team also discovered that HOXA genes help HSCs maintain their stem-cell attributes, such as the ability to self-renew.

“Without the ability to self-renew, hematopoietic stem cells cannot be used for transplantation therapies,” said Vincenzo Calvanese, PhD, an assistant project scientist in Dr Mikkola’s lab.

“Our findings show that the activation of HOXA genes can be used as a marker for hematopoietic stem cells that have acquired the capacity to renew themselves.”

The researchers’ next challenge was to pinpoint the naturally occurring process that activates HOXA genes so they could try to replicate the process in the lab.

They found that mimicking the effects of retinoic acid acts like a switch that turns on the HOXA genes during HSC development.

“Inducing retinoic acid activity at a very specific time in cell development makes our lab-created cells more similar to the real hematopoietic stem cells found in the body,” said Diana Dou, a graduate student in Dr Mikkola’s lab.

“This is an important step forward as we work to develop hematopoietic stem cells for transplantation therapies for life-threatening blood diseases.”

The researchers’ next step will be to refine the process they’ve developed in order to produce lab-created HSCs that have—and maintain—all the functions of human HSCs.

Hematopoietic stem cells

in the bone marrow

Scientists believe they have come one step closer to creating hematopoietic stem cells (HSCs) that are just like the real thing.

“Our work focuses on finding a way to generate a supply of these life-saving hematopoietic stem cells in the lab so that they are a perfect match to the patient in need of a transplant,” said Hanna Mikkola, MD, PhD, of the University of California, Los Angeles.

“One big challenge is that when we try to create hematopoietic stem cells from pluripotent stem cells in the lab, they don’t acquire the same abilities of the real hematopoietic stem cells found in the body.”

Dr Mikkola and her colleagues described their attempts to overcome this challenge in Nature Cell Biology.

The researchers tried to create HSCs from pluripotent stem cells, but when they compared the lab-created cells to HSCs found in the body, they found that HOXA genes weren’t activated in the lab-created cells.

The team also discovered that HOXA genes help HSCs maintain their stem-cell attributes, such as the ability to self-renew.

“Without the ability to self-renew, hematopoietic stem cells cannot be used for transplantation therapies,” said Vincenzo Calvanese, PhD, an assistant project scientist in Dr Mikkola’s lab.

“Our findings show that the activation of HOXA genes can be used as a marker for hematopoietic stem cells that have acquired the capacity to renew themselves.”

The researchers’ next challenge was to pinpoint the naturally occurring process that activates HOXA genes so they could try to replicate the process in the lab.

They found that mimicking the effects of retinoic acid acts like a switch that turns on the HOXA genes during HSC development.

“Inducing retinoic acid activity at a very specific time in cell development makes our lab-created cells more similar to the real hematopoietic stem cells found in the body,” said Diana Dou, a graduate student in Dr Mikkola’s lab.

“This is an important step forward as we work to develop hematopoietic stem cells for transplantation therapies for life-threatening blood diseases.”

The researchers’ next step will be to refine the process they’ve developed in order to produce lab-created HSCs that have—and maintain—all the functions of human HSCs.

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]

Introducing palliative care in combination with standard oncology care immediately following a cancer diagnosis results in improved quality of life and lower incidence of depression for caregivers of cancer patients.

“The integration of palliative care can improve patient care but the evidence is lacking about whether or not there are benefits [for] caregivers,” Dr. Areej El-Jawahri of Massachusetts General Hospital, Boston, said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“This study suggests that early palliative care creates a powerful positive feedback loop in families facing cancer. While patients receive a direct benefit from early palliative care, their caregivers experience a positive downstream effect, which may make it easier for them to care for their loved ones,” she said.

Investigators enrolled 275 family caregivers of patients newly diagnosed with incurable lung or gastrointestinal cancers. Patients were randomly assigned to receive early palliative care in addition to standard oncology care or to receive standard oncology care alone.

Palliative care involved a multifaceted team including nurses, social workers, and psychologists. The palliative care intervention was patient focused, and caregivers, who were defined as a relative or friend identified by the patient as the primary caregiver, were not required to attend palliative care appointments. However, about 50% of caregivers did attend, according to Dr. El-Jawahri.

At time of enrollment and then at time points 12 and 14 weeks post enrollment, caregivers completed standard questionnaires, the 36-Item Short Form Health Survey and the Hospital Anxiety and Depression Scale, that assessed quality of life and mood.

Twelve weeks after the cancer diagnosis, caregivers who received early palliative care reported significantly lower depression symptoms while vitality and social functioning improved. For patients who did not receive early palliative care, their caregivers’ vitality and social functioning decreased.

“This is the first study showing a positive impact of a patient-focused palliative care intervention on family caregivers,” said Dr. El-Jawahri.

“This study really points out that we have so many ways to help our patients and their families,” Dr. Julie Vose, president of ASCO, said during the presscast.

[email protected]

On Twitter @JessCraig_OP

Introducing palliative care in combination with standard oncology care immediately following a cancer diagnosis results in improved quality of life and lower incidence of depression for caregivers of cancer patients.

“The integration of palliative care can improve patient care but the evidence is lacking about whether or not there are benefits [for] caregivers,” Dr. Areej El-Jawahri of Massachusetts General Hospital, Boston, said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“This study suggests that early palliative care creates a powerful positive feedback loop in families facing cancer. While patients receive a direct benefit from early palliative care, their caregivers experience a positive downstream effect, which may make it easier for them to care for their loved ones,” she said.

Investigators enrolled 275 family caregivers of patients newly diagnosed with incurable lung or gastrointestinal cancers. Patients were randomly assigned to receive early palliative care in addition to standard oncology care or to receive standard oncology care alone.

Palliative care involved a multifaceted team including nurses, social workers, and psychologists. The palliative care intervention was patient focused, and caregivers, who were defined as a relative or friend identified by the patient as the primary caregiver, were not required to attend palliative care appointments. However, about 50% of caregivers did attend, according to Dr. El-Jawahri.

At time of enrollment and then at time points 12 and 14 weeks post enrollment, caregivers completed standard questionnaires, the 36-Item Short Form Health Survey and the Hospital Anxiety and Depression Scale, that assessed quality of life and mood.

Twelve weeks after the cancer diagnosis, caregivers who received early palliative care reported significantly lower depression symptoms while vitality and social functioning improved. For patients who did not receive early palliative care, their caregivers’ vitality and social functioning decreased.

“This is the first study showing a positive impact of a patient-focused palliative care intervention on family caregivers,” said Dr. El-Jawahri.

“This study really points out that we have so many ways to help our patients and their families,” Dr. Julie Vose, president of ASCO, said during the presscast.

[email protected]

On Twitter @JessCraig_OP

Introducing palliative care in combination with standard oncology care immediately following a cancer diagnosis results in improved quality of life and lower incidence of depression for caregivers of cancer patients.

“The integration of palliative care can improve patient care but the evidence is lacking about whether or not there are benefits [for] caregivers,” Dr. Areej El-Jawahri of Massachusetts General Hospital, Boston, said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“This study suggests that early palliative care creates a powerful positive feedback loop in families facing cancer. While patients receive a direct benefit from early palliative care, their caregivers experience a positive downstream effect, which may make it easier for them to care for their loved ones,” she said.

Investigators enrolled 275 family caregivers of patients newly diagnosed with incurable lung or gastrointestinal cancers. Patients were randomly assigned to receive early palliative care in addition to standard oncology care or to receive standard oncology care alone.

Palliative care involved a multifaceted team including nurses, social workers, and psychologists. The palliative care intervention was patient focused, and caregivers, who were defined as a relative or friend identified by the patient as the primary caregiver, were not required to attend palliative care appointments. However, about 50% of caregivers did attend, according to Dr. El-Jawahri.

At time of enrollment and then at time points 12 and 14 weeks post enrollment, caregivers completed standard questionnaires, the 36-Item Short Form Health Survey and the Hospital Anxiety and Depression Scale, that assessed quality of life and mood.

Twelve weeks after the cancer diagnosis, caregivers who received early palliative care reported significantly lower depression symptoms while vitality and social functioning improved. For patients who did not receive early palliative care, their caregivers’ vitality and social functioning decreased.

“This is the first study showing a positive impact of a patient-focused palliative care intervention on family caregivers,” said Dr. El-Jawahri.

“This study really points out that we have so many ways to help our patients and their families,” Dr. Julie Vose, president of ASCO, said during the presscast.

[email protected]

On Twitter @JessCraig_OP

YES: The importance of the concept is established.

An angiosome is a three-dimensional anatomic unit of tissue fed by a single-source artery. The angiosome theory was first investigated in the plastic surgical literature by Taylor in the British Journal of Plastic Surgery in 1987,¹ describing 40 angiosomes throughout the body. In the lower extremity, six distinct angiosomes have been defined; one arising from the anterior tibial artery (dorsalis pedis), two from the peroneal artery (the lateral calcaneal branch and the anterior perforating branch), and three from the posterior tibial artery (the calcaneal branch, the medial plantar branch, and the lateral plantar branch).² Indirect connections known as choke vessels exist to enhance perfusion between angiosomes.

The question arises as to whether angiosome-specific revascularization enhances the healing of ischemic tissue loss of the lower extremity. Is direct revascularization of the appropriate angiosome an important part of the planning process for such revascularization efforts? Personal experience with 60 consecutive bypasses for ischemic lower extremity wounds left little doubt that angiosome-specific revascularization enhanced healing. Direct revascularization obtained 91% healing, compared with 62% when revascularization was performed to an artery which indirectly perfused the angiosome where the wound was located.³ There was also a trend for faster healing with direct angiosome revascularization. Other investigators have reported similar findings. Kret and colleagues found similar results for bypass, reporting complete healing in 78% of 106 limbs with direct revascularization with only 46% healing after bypass resulting in indirect angiosome revascularization. These authors noted that a “significant predictor for wound healing and reduced healing time was angiosome revascularization.”⁴

Consideration of the appropriate angiosome may be even more important for endovascular techniques in determining the target artery for revascularization. Iida et al investigated 200 ischemic ulcers, showing that healing was greatly enhanced by direct revascularization of the angiosome in which the wound was located.⁵ Kabra examined a mixed cohort of bypass and endovascular procedures and documented increased healing with angiosome revascularization for both modalities in treating critical limb ischemia, therefore, advising that angiosomes should be considered whenever possible.⁶ This is also an important concept for those diabetic ulcers in need of robust perfusion for healing. Alexandrescu demonstrated improved healing for diabetic ischemic ulcers after endovascular therapy with direct angiosome revascularization, concluding, “an angiosome model of perfusion helps the treatment of diabetic foot ulcers.”⁷ The group in Helsinki documented statistically significant better healing with endovascular revascularization of the appropriate angiosome in more than 250 patients with ischemic diabetic ulcers, surmising that the angiosome model is important for ulcer healing in diabetic patients.⁸

Given the many series, from around the world, confirming the impact of direct revascularization of the appropriate angiosome for a wound or non-healing ulcer to enhance healing, the importance of this concept in planning lower extremity revascularization has been established. There are certainly many considerations in planning revascularization such as patient presentation, arterial anatomy, and conduit or device selection. However, as revascularization of the appropriate wound angiosome results in more complete and rapid healing, it is irrefutable that the angiosome concept should be a consideration in planning revascularization for healing and limb preservation.

Dr. Neville is the Sara and Arnold P. Friedman and Carol and Eugene A. Ludwig Chief of Vascular Surgery Professor, Department of Surgery, and the Director, Limb Preservation Center, George Washington University, Washington.

References

1. Br J Plast Surg. 1987 Mar;40:113-41.

2. Plast Reconstr Surg. 2006 Jun;117;261S-293S.

3. Ann Vasc Surg. 2009;23:367-73.

4. J Vasc Surg. 2014 Jan;59:121-8.

5. Endovascular Today. 2010;9;96-100.

6. J Vasc Surg. 2013 Jan;57:44-49.

7. J Endovasc Ther. 2008 Oct;15:580-83.

8. J Vasc Surg. 2013 Feb;57:427-35.

NO: Only a guide, not an absolute.

Despite an aggressive approach to revascularization, amputation rates of up to 20% can occur despite a patent bypass.¹ This has led to enthusiasm for an angiosome-based revascularization strategy for the management of ischemic foot lesions.^2-4 There is no question that clinicians would opt to revascularize a blood vessel that directly feeds an involved angiosome if the vessel is easily accessible, is of good quality, and has good run-off. The issue arises if the target vessel does not meet that criteria and the surgeon is forced to intervene on an alternative feeding vessel (indirect revascularization).

There have been several studies which compare outcomes after direct and indirect revascularization strategies and they conclude that direct revascularization has better limb salvage rates.² However, most of the studies were retrospective and details on the status and quality of the pedal arch were not consistently evaluated. Rashid et al studied the impact of direct angiosome revascularization on the healing of the foot and reported that healing and time to healing of foot tissue loss were significantly influenced by the quality of the pedal arch rather than the angiosome revascularized.³

Because of variations in the arterial anatomy of the foot,⁵ inconsistencies in the extent of an angiosome and the collateral connections between angiosomes are frequent, suggesting that the angiosome that needs to be revascularized may not be perfused by the predicted artery. This helps explain why technical success may not always equate directly with clinical success, as corroborated by indocyanine green (ICG) imaging and white-light tissue spectrophotometry.⁶ It is also important to emphasize that in their initial publication, Taylor and Palmer emphasized that the basis of their proposed angiosome concept was on the structural anatomy of the feeder vessel territory. They did not and could not assess the perfusion levels and extent of the feeder vessel with their corresponding choke vessels.

Forefoot procedures, such as trans-metatarsal amputations, frequently interrupt this foot arch. Likewise, a large proportion of patients with renal insufficiency and/or diabetes mellitus present with extensive foot wounds with deep infection that may result in compartmentalization within the foot. In one series, only one third of patients had a single angiosome involved in the tissue loss, 45% of patients had two angiosomes involved and more than 20% of patients had three angiosomes involved.⁷ Patients with more than one angiosome affected by extensive tissue loss are not easily analyzed using the angiosome-oriented concept and so attempts at classifying the intervention as being direct or indirect is problematic.

Studies analyzing the utility of the angiosome concept need to be careful in analyzing the extent of the territories encompassed by the wounds. More importantly, many interventionalists equate tibial or peroneal revascularization with angiosomal revascularization. This may not be the case if the terminal branches are diseased and pedal loop interventions may still be necessary.

In summary, the angiosome model should not be used as an absolute strategy for interventions on critical limb ischemia patients but should be a guide to assist with a patient-specific strategy for revascularization. Further well-structured prospective studies are needed to assess the value of integrating the interangiosome concept, the status of the pedal arch, and the anatomic-physiologic perfusion angiosome model.

Dr. Sumpio is a professor of surgery and radiology, Yale University, New Haven, Conn.

References

1. J Vasc Surg. 2010 Jun;51:1419-24.

2. J Vasc Surg. 2013 Sep;58:814-26.

3. J Vasc Surg. 2013 May;57:1219-26.

4. J Vasc Surg. 2013 Jan;57:44-9.

5. Am J Surg. 1993 Aug;166:130-5.

6. Microcirculation. 2015 Nov; 22:737-43.

7. Rev Mex Angiol. 2012;40:123-34.

YES: The importance of the concept is established.

An angiosome is a three-dimensional anatomic unit of tissue fed by a single-source artery. The angiosome theory was first investigated in the plastic surgical literature by Taylor in the British Journal of Plastic Surgery in 1987,¹ describing 40 angiosomes throughout the body. In the lower extremity, six distinct angiosomes have been defined; one arising from the anterior tibial artery (dorsalis pedis), two from the peroneal artery (the lateral calcaneal branch and the anterior perforating branch), and three from the posterior tibial artery (the calcaneal branch, the medial plantar branch, and the lateral plantar branch).² Indirect connections known as choke vessels exist to enhance perfusion between angiosomes.

The question arises as to whether angiosome-specific revascularization enhances the healing of ischemic tissue loss of the lower extremity. Is direct revascularization of the appropriate angiosome an important part of the planning process for such revascularization efforts? Personal experience with 60 consecutive bypasses for ischemic lower extremity wounds left little doubt that angiosome-specific revascularization enhanced healing. Direct revascularization obtained 91% healing, compared with 62% when revascularization was performed to an artery which indirectly perfused the angiosome where the wound was located.³ There was also a trend for faster healing with direct angiosome revascularization. Other investigators have reported similar findings. Kret and colleagues found similar results for bypass, reporting complete healing in 78% of 106 limbs with direct revascularization with only 46% healing after bypass resulting in indirect angiosome revascularization. These authors noted that a “significant predictor for wound healing and reduced healing time was angiosome revascularization.”⁴

Consideration of the appropriate angiosome may be even more important for endovascular techniques in determining the target artery for revascularization. Iida et al investigated 200 ischemic ulcers, showing that healing was greatly enhanced by direct revascularization of the angiosome in which the wound was located.⁵ Kabra examined a mixed cohort of bypass and endovascular procedures and documented increased healing with angiosome revascularization for both modalities in treating critical limb ischemia, therefore, advising that angiosomes should be considered whenever possible.⁶ This is also an important concept for those diabetic ulcers in need of robust perfusion for healing. Alexandrescu demonstrated improved healing for diabetic ischemic ulcers after endovascular therapy with direct angiosome revascularization, concluding, “an angiosome model of perfusion helps the treatment of diabetic foot ulcers.”⁷ The group in Helsinki documented statistically significant better healing with endovascular revascularization of the appropriate angiosome in more than 250 patients with ischemic diabetic ulcers, surmising that the angiosome model is important for ulcer healing in diabetic patients.⁸

Given the many series, from around the world, confirming the impact of direct revascularization of the appropriate angiosome for a wound or non-healing ulcer to enhance healing, the importance of this concept in planning lower extremity revascularization has been established. There are certainly many considerations in planning revascularization such as patient presentation, arterial anatomy, and conduit or device selection. However, as revascularization of the appropriate wound angiosome results in more complete and rapid healing, it is irrefutable that the angiosome concept should be a consideration in planning revascularization for healing and limb preservation.

Dr. Neville is the Sara and Arnold P. Friedman and Carol and Eugene A. Ludwig Chief of Vascular Surgery Professor, Department of Surgery, and the Director, Limb Preservation Center, George Washington University, Washington.

References

1. Br J Plast Surg. 1987 Mar;40:113-41.

2. Plast Reconstr Surg. 2006 Jun;117;261S-293S.

3. Ann Vasc Surg. 2009;23:367-73.

4. J Vasc Surg. 2014 Jan;59:121-8.

5. Endovascular Today. 2010;9;96-100.

6. J Vasc Surg. 2013 Jan;57:44-49.

7. J Endovasc Ther. 2008 Oct;15:580-83.

8. J Vasc Surg. 2013 Feb;57:427-35.

NO: Only a guide, not an absolute.

Despite an aggressive approach to revascularization, amputation rates of up to 20% can occur despite a patent bypass.¹ This has led to enthusiasm for an angiosome-based revascularization strategy for the management of ischemic foot lesions.^2-4 There is no question that clinicians would opt to revascularize a blood vessel that directly feeds an involved angiosome if the vessel is easily accessible, is of good quality, and has good run-off. The issue arises if the target vessel does not meet that criteria and the surgeon is forced to intervene on an alternative feeding vessel (indirect revascularization).

There have been several studies which compare outcomes after direct and indirect revascularization strategies and they conclude that direct revascularization has better limb salvage rates.² However, most of the studies were retrospective and details on the status and quality of the pedal arch were not consistently evaluated. Rashid et al studied the impact of direct angiosome revascularization on the healing of the foot and reported that healing and time to healing of foot tissue loss were significantly influenced by the quality of the pedal arch rather than the angiosome revascularized.³

Because of variations in the arterial anatomy of the foot,⁵ inconsistencies in the extent of an angiosome and the collateral connections between angiosomes are frequent, suggesting that the angiosome that needs to be revascularized may not be perfused by the predicted artery. This helps explain why technical success may not always equate directly with clinical success, as corroborated by indocyanine green (ICG) imaging and white-light tissue spectrophotometry.⁶ It is also important to emphasize that in their initial publication, Taylor and Palmer emphasized that the basis of their proposed angiosome concept was on the structural anatomy of the feeder vessel territory. They did not and could not assess the perfusion levels and extent of the feeder vessel with their corresponding choke vessels.

Forefoot procedures, such as trans-metatarsal amputations, frequently interrupt this foot arch. Likewise, a large proportion of patients with renal insufficiency and/or diabetes mellitus present with extensive foot wounds with deep infection that may result in compartmentalization within the foot. In one series, only one third of patients had a single angiosome involved in the tissue loss, 45% of patients had two angiosomes involved and more than 20% of patients had three angiosomes involved.⁷ Patients with more than one angiosome affected by extensive tissue loss are not easily analyzed using the angiosome-oriented concept and so attempts at classifying the intervention as being direct or indirect is problematic.

Studies analyzing the utility of the angiosome concept need to be careful in analyzing the extent of the territories encompassed by the wounds. More importantly, many interventionalists equate tibial or peroneal revascularization with angiosomal revascularization. This may not be the case if the terminal branches are diseased and pedal loop interventions may still be necessary.

In summary, the angiosome model should not be used as an absolute strategy for interventions on critical limb ischemia patients but should be a guide to assist with a patient-specific strategy for revascularization. Further well-structured prospective studies are needed to assess the value of integrating the interangiosome concept, the status of the pedal arch, and the anatomic-physiologic perfusion angiosome model.

Dr. Sumpio is a professor of surgery and radiology, Yale University, New Haven, Conn.

References

1. J Vasc Surg. 2010 Jun;51:1419-24.

2. J Vasc Surg. 2013 Sep;58:814-26.

3. J Vasc Surg. 2013 May;57:1219-26.

4. J Vasc Surg. 2013 Jan;57:44-9.

5. Am J Surg. 1993 Aug;166:130-5.

6. Microcirculation. 2015 Nov; 22:737-43.

7. Rev Mex Angiol. 2012;40:123-34.

YES: The importance of the concept is established.

An angiosome is a three-dimensional anatomic unit of tissue fed by a single-source artery. The angiosome theory was first investigated in the plastic surgical literature by Taylor in the British Journal of Plastic Surgery in 1987,¹ describing 40 angiosomes throughout the body. In the lower extremity, six distinct angiosomes have been defined; one arising from the anterior tibial artery (dorsalis pedis), two from the peroneal artery (the lateral calcaneal branch and the anterior perforating branch), and three from the posterior tibial artery (the calcaneal branch, the medial plantar branch, and the lateral plantar branch).² Indirect connections known as choke vessels exist to enhance perfusion between angiosomes.

The question arises as to whether angiosome-specific revascularization enhances the healing of ischemic tissue loss of the lower extremity. Is direct revascularization of the appropriate angiosome an important part of the planning process for such revascularization efforts? Personal experience with 60 consecutive bypasses for ischemic lower extremity wounds left little doubt that angiosome-specific revascularization enhanced healing. Direct revascularization obtained 91% healing, compared with 62% when revascularization was performed to an artery which indirectly perfused the angiosome where the wound was located.³ There was also a trend for faster healing with direct angiosome revascularization. Other investigators have reported similar findings. Kret and colleagues found similar results for bypass, reporting complete healing in 78% of 106 limbs with direct revascularization with only 46% healing after bypass resulting in indirect angiosome revascularization. These authors noted that a “significant predictor for wound healing and reduced healing time was angiosome revascularization.”⁴

Consideration of the appropriate angiosome may be even more important for endovascular techniques in determining the target artery for revascularization. Iida et al investigated 200 ischemic ulcers, showing that healing was greatly enhanced by direct revascularization of the angiosome in which the wound was located.⁵ Kabra examined a mixed cohort of bypass and endovascular procedures and documented increased healing with angiosome revascularization for both modalities in treating critical limb ischemia, therefore, advising that angiosomes should be considered whenever possible.⁶ This is also an important concept for those diabetic ulcers in need of robust perfusion for healing. Alexandrescu demonstrated improved healing for diabetic ischemic ulcers after endovascular therapy with direct angiosome revascularization, concluding, “an angiosome model of perfusion helps the treatment of diabetic foot ulcers.”⁷ The group in Helsinki documented statistically significant better healing with endovascular revascularization of the appropriate angiosome in more than 250 patients with ischemic diabetic ulcers, surmising that the angiosome model is important for ulcer healing in diabetic patients.⁸

Given the many series, from around the world, confirming the impact of direct revascularization of the appropriate angiosome for a wound or non-healing ulcer to enhance healing, the importance of this concept in planning lower extremity revascularization has been established. There are certainly many considerations in planning revascularization such as patient presentation, arterial anatomy, and conduit or device selection. However, as revascularization of the appropriate wound angiosome results in more complete and rapid healing, it is irrefutable that the angiosome concept should be a consideration in planning revascularization for healing and limb preservation.

Dr. Neville is the Sara and Arnold P. Friedman and Carol and Eugene A. Ludwig Chief of Vascular Surgery Professor, Department of Surgery, and the Director, Limb Preservation Center, George Washington University, Washington.

References

1. Br J Plast Surg. 1987 Mar;40:113-41.

2. Plast Reconstr Surg. 2006 Jun;117;261S-293S.

3. Ann Vasc Surg. 2009;23:367-73.

4. J Vasc Surg. 2014 Jan;59:121-8.

5. Endovascular Today. 2010;9;96-100.

6. J Vasc Surg. 2013 Jan;57:44-49.

7. J Endovasc Ther. 2008 Oct;15:580-83.

8. J Vasc Surg. 2013 Feb;57:427-35.

NO: Only a guide, not an absolute.

Despite an aggressive approach to revascularization, amputation rates of up to 20% can occur despite a patent bypass.¹ This has led to enthusiasm for an angiosome-based revascularization strategy for the management of ischemic foot lesions.^2-4 There is no question that clinicians would opt to revascularize a blood vessel that directly feeds an involved angiosome if the vessel is easily accessible, is of good quality, and has good run-off. The issue arises if the target vessel does not meet that criteria and the surgeon is forced to intervene on an alternative feeding vessel (indirect revascularization).

There have been several studies which compare outcomes after direct and indirect revascularization strategies and they conclude that direct revascularization has better limb salvage rates.² However, most of the studies were retrospective and details on the status and quality of the pedal arch were not consistently evaluated. Rashid et al studied the impact of direct angiosome revascularization on the healing of the foot and reported that healing and time to healing of foot tissue loss were significantly influenced by the quality of the pedal arch rather than the angiosome revascularized.³

Because of variations in the arterial anatomy of the foot,⁵ inconsistencies in the extent of an angiosome and the collateral connections between angiosomes are frequent, suggesting that the angiosome that needs to be revascularized may not be perfused by the predicted artery. This helps explain why technical success may not always equate directly with clinical success, as corroborated by indocyanine green (ICG) imaging and white-light tissue spectrophotometry.⁶ It is also important to emphasize that in their initial publication, Taylor and Palmer emphasized that the basis of their proposed angiosome concept was on the structural anatomy of the feeder vessel territory. They did not and could not assess the perfusion levels and extent of the feeder vessel with their corresponding choke vessels.

Forefoot procedures, such as trans-metatarsal amputations, frequently interrupt this foot arch. Likewise, a large proportion of patients with renal insufficiency and/or diabetes mellitus present with extensive foot wounds with deep infection that may result in compartmentalization within the foot. In one series, only one third of patients had a single angiosome involved in the tissue loss, 45% of patients had two angiosomes involved and more than 20% of patients had three angiosomes involved.⁷ Patients with more than one angiosome affected by extensive tissue loss are not easily analyzed using the angiosome-oriented concept and so attempts at classifying the intervention as being direct or indirect is problematic.

Studies analyzing the utility of the angiosome concept need to be careful in analyzing the extent of the territories encompassed by the wounds. More importantly, many interventionalists equate tibial or peroneal revascularization with angiosomal revascularization. This may not be the case if the terminal branches are diseased and pedal loop interventions may still be necessary.

In summary, the angiosome model should not be used as an absolute strategy for interventions on critical limb ischemia patients but should be a guide to assist with a patient-specific strategy for revascularization. Further well-structured prospective studies are needed to assess the value of integrating the interangiosome concept, the status of the pedal arch, and the anatomic-physiologic perfusion angiosome model.

Dr. Sumpio is a professor of surgery and radiology, Yale University, New Haven, Conn.

References

1. J Vasc Surg. 2010 Jun;51:1419-24.

2. J Vasc Surg. 2013 Sep;58:814-26.

3. J Vasc Surg. 2013 May;57:1219-26.

4. J Vasc Surg. 2013 Jan;57:44-9.

5. Am J Surg. 1993 Aug;166:130-5.

6. Microcirculation. 2015 Nov; 22:737-43.

7. Rev Mex Angiol. 2012;40:123-34.

A hepatitis C awareness initiative dramatically raised the rate of HCV screening and treatment in a large American Indian population – the ethnic group with the highest rate of HCV infection and HCV-related mortality in the United States, according to a report published May 13 in Morbidity and Mortality Weekly Report.

Cherokee Nation Health Services undertook the effort in 2012 to improve detection and management of HCV. It included a reminder in eligible patients’ electronic health records (EHRs) to offer screening; HCV education for primary care physicians and other health care providers; establishment of an HCV registry to monitor the clinical care of patients who initiated antiviral treatment; and outreach efforts by public health nurses to HCV patients, including home visits.

©Jezperklauzen/ThinkStock

In 2014, an additional initiative was implemented to expand services for the rapidly increasing number of patients diagnosed as having HCV. This allowed a transition from having a single clinic staffed by only one caregiver with expertise in HCV management to five clinics staffed by three physicians, two nurse practitioners, and two pharmacists with HCV expertise, said Dr. Jorge Mera, director of infectious diseases, Cherokee Nation Health Services, Tulsa, Okla., and his associates.

An analysis of deidentified data in the HCV registry and EHRs showed that 92,012 patients aged 20 years and older had at least one visit with Cherokee Nation Health Services after the program was implemented, between October 2012 and July 2015. The proportion of this patient population that was tested for HCV antibodies rose fivefold, from 3.6% to 18.2% during the study period. A total of 715 patients were antibody positive, and 388 of them were found to have chronic HCV infection. Approximately 60% of these patients initiated antiviral treatment, and approximately 90% of them achieved a sustained virologic response and were essentially cured, Dr. Mera and his associates said (MMWR. 2016 May 13;65[18]:461-6).

The program included a component that particularly targeted baby boomers – patients born between 1945 and 1965 – for HCV screening. Across the Indian Health Service clinics in 34 states that adopted this component of the program, such screening increased fourfold in this high-risk population during the study period (MMWR. 2016 May 13;65[18]:467-9).

These efforts, the first of their kind in the United States, may help eliminate hepatitis C as a health disparity for American Indian/Alaska Native populations and also may serve as a model for other health care settings, the investigators added.

A hepatitis C awareness initiative dramatically raised the rate of HCV screening and treatment in a large American Indian population – the ethnic group with the highest rate of HCV infection and HCV-related mortality in the United States, according to a report published May 13 in Morbidity and Mortality Weekly Report.

Cherokee Nation Health Services undertook the effort in 2012 to improve detection and management of HCV. It included a reminder in eligible patients’ electronic health records (EHRs) to offer screening; HCV education for primary care physicians and other health care providers; establishment of an HCV registry to monitor the clinical care of patients who initiated antiviral treatment; and outreach efforts by public health nurses to HCV patients, including home visits.

©Jezperklauzen/ThinkStock

In 2014, an additional initiative was implemented to expand services for the rapidly increasing number of patients diagnosed as having HCV. This allowed a transition from having a single clinic staffed by only one caregiver with expertise in HCV management to five clinics staffed by three physicians, two nurse practitioners, and two pharmacists with HCV expertise, said Dr. Jorge Mera, director of infectious diseases, Cherokee Nation Health Services, Tulsa, Okla., and his associates.

An analysis of deidentified data in the HCV registry and EHRs showed that 92,012 patients aged 20 years and older had at least one visit with Cherokee Nation Health Services after the program was implemented, between October 2012 and July 2015. The proportion of this patient population that was tested for HCV antibodies rose fivefold, from 3.6% to 18.2% during the study period. A total of 715 patients were antibody positive, and 388 of them were found to have chronic HCV infection. Approximately 60% of these patients initiated antiviral treatment, and approximately 90% of them achieved a sustained virologic response and were essentially cured, Dr. Mera and his associates said (MMWR. 2016 May 13;65[18]:461-6).

The program included a component that particularly targeted baby boomers – patients born between 1945 and 1965 – for HCV screening. Across the Indian Health Service clinics in 34 states that adopted this component of the program, such screening increased fourfold in this high-risk population during the study period (MMWR. 2016 May 13;65[18]:467-9).

These efforts, the first of their kind in the United States, may help eliminate hepatitis C as a health disparity for American Indian/Alaska Native populations and also may serve as a model for other health care settings, the investigators added.

A hepatitis C awareness initiative dramatically raised the rate of HCV screening and treatment in a large American Indian population – the ethnic group with the highest rate of HCV infection and HCV-related mortality in the United States, according to a report published May 13 in Morbidity and Mortality Weekly Report.

Cherokee Nation Health Services undertook the effort in 2012 to improve detection and management of HCV. It included a reminder in eligible patients’ electronic health records (EHRs) to offer screening; HCV education for primary care physicians and other health care providers; establishment of an HCV registry to monitor the clinical care of patients who initiated antiviral treatment; and outreach efforts by public health nurses to HCV patients, including home visits.

©Jezperklauzen/ThinkStock

In 2014, an additional initiative was implemented to expand services for the rapidly increasing number of patients diagnosed as having HCV. This allowed a transition from having a single clinic staffed by only one caregiver with expertise in HCV management to five clinics staffed by three physicians, two nurse practitioners, and two pharmacists with HCV expertise, said Dr. Jorge Mera, director of infectious diseases, Cherokee Nation Health Services, Tulsa, Okla., and his associates.

An analysis of deidentified data in the HCV registry and EHRs showed that 92,012 patients aged 20 years and older had at least one visit with Cherokee Nation Health Services after the program was implemented, between October 2012 and July 2015. The proportion of this patient population that was tested for HCV antibodies rose fivefold, from 3.6% to 18.2% during the study period. A total of 715 patients were antibody positive, and 388 of them were found to have chronic HCV infection. Approximately 60% of these patients initiated antiviral treatment, and approximately 90% of them achieved a sustained virologic response and were essentially cured, Dr. Mera and his associates said (MMWR. 2016 May 13;65[18]:461-6).

The program included a component that particularly targeted baby boomers – patients born between 1945 and 1965 – for HCV screening. Across the Indian Health Service clinics in 34 states that adopted this component of the program, such screening increased fourfold in this high-risk population during the study period (MMWR. 2016 May 13;65[18]:467-9).

These efforts, the first of their kind in the United States, may help eliminate hepatitis C as a health disparity for American Indian/Alaska Native populations and also may serve as a model for other health care settings, the investigators added.

In a House Veterans’ Affairs Committee hearing on efforts to prevent veteran suicide, the VA confirmed that it is focused on ensuring it has enough mental health care providers. The VA currently employs 5,500 psychologists and 3,203 psychiatrists. According to Maureen F. McCarthy, MD, deputy chief, VHA Office of Patient Care Services, the VA currently has 236 psychiatrist vacancies.

Veteran service organizations, House members, and the VA all agreed that hiring and retaining qualified mental health care providers is an essential component in reducing suicides. “We are aware that access to mental health care is one significant part of preventing suicide,” McCarthy said in prepared testimony. “VA is determined to address systemic problems with access to care in general and to mental health care, including substance use disorders in particular. VA has recommitted to a culture that puts the veteran first.”

As House members, veteran service organizations, and the VA have all admitted, the frequently quoted 22 veterans suicides each day statistic is based on dated and limited data. To better understand the scope of the problem, the VA is working with the CDC to obtain a more current and accurate count of veteran suicides—a move that many veterans advocacy groups have called for.

“Vietnam Veterans of America calls for an updated veteran suicide report that includes data from all 50 states and U.S. territories, and also strongly suggests that VA mental health services develop a nationwide strategy to address the problem of suicides among our older veterans—particularly Vietnam-era veterans,” Thomas J. Berger, PhD, executive director of the Veterans Health Council of the Vietnam Veterans of America (VVA) told the committee in his prepared remarks.

 According to Dr. McCarthy, the data will be available later this summer and will accessible to researchers. “We so wanted to have this information to you by this hearing. We don’t,” she said.

Challenges Remain

Ensuring access to care is one of the VA’s chief challenges. “We have to change our messaging to be more welcoming to all veterans,” Dr. McCarthy told the committee. “There are still veterans out there that do not know that they are eligible for benefits.”

Another one of the challenges is streamlining the transition from the military to the VA. “VA research has indicated that rates of suicide among those who use VA services have not shown increases similar to those observed in all veterans and the general U.S. population,” McCarthy explained. “This research suggests that an improved health care transition between DoD and VA could help mitigate suicide risk as well as other increased risks of morbidity.” According to McCarthy, the VA and DoD are working to create a seamless transition for mental health medications from the DoD to the VA, following a safety review

Following up on the Preventing Veterans Suicide – A Call to Action summit, in March, VA announced 8 steps it planned to take to improve its suicide prevention programs. They are:

1. Elevating VA’s suicide-prevention program with additional resources to help manage and strengthen current programs and initiatives;

2. Meeting urgent mental health needs by providing veterans with same-day evaluations and access by the end of calendar year 2016;

3. Establishing a new standard of care by using measures of veteran-reported symptoms to tailor mental health treatments to individual needs;

4. Launching a new study, “Coming Home from Afghanistan and Iraq,” that will look at the impact of deployment and combat as it relates to suicide, mental health, and well-being;

5. Using predictive modeling to guide early interventions for suicide prevention;

6. Using data on suicide attempts and overdoses to guide strategies to prevent suicide;

7. Increasing the availability of naloxone rescue kits throughout VA to prevent deaths from opioid overdoses;

8. Enhancing veteran mental health access by establishing 3 regional telemental health hubs; and

9. Continuing to partner with the DoD on suicide prevention and other efforts for a seamless transition from military service to civilian life.

“While these initiatives are laudable, VVA also believes strongly that they cannot fully succeed without a significant  increase in the recruitment, hiring, and retention of VA mental health staff, as well as timely access to VA mental health clinical facilities and programs, especially for our rural veterans,” Berger told the committee.

In a House Veterans’ Affairs Committee hearing on efforts to prevent veteran suicide, the VA confirmed that it is focused on ensuring it has enough mental health care providers. The VA currently employs 5,500 psychologists and 3,203 psychiatrists. According to Maureen F. McCarthy, MD, deputy chief, VHA Office of Patient Care Services, the VA currently has 236 psychiatrist vacancies.

Veteran service organizations, House members, and the VA all agreed that hiring and retaining qualified mental health care providers is an essential component in reducing suicides. “We are aware that access to mental health care is one significant part of preventing suicide,” McCarthy said in prepared testimony. “VA is determined to address systemic problems with access to care in general and to mental health care, including substance use disorders in particular. VA has recommitted to a culture that puts the veteran first.”

As House members, veteran service organizations, and the VA have all admitted, the frequently quoted 22 veterans suicides each day statistic is based on dated and limited data. To better understand the scope of the problem, the VA is working with the CDC to obtain a more current and accurate count of veteran suicides—a move that many veterans advocacy groups have called for.

“Vietnam Veterans of America calls for an updated veteran suicide report that includes data from all 50 states and U.S. territories, and also strongly suggests that VA mental health services develop a nationwide strategy to address the problem of suicides among our older veterans—particularly Vietnam-era veterans,” Thomas J. Berger, PhD, executive director of the Veterans Health Council of the Vietnam Veterans of America (VVA) told the committee in his prepared remarks.

 According to Dr. McCarthy, the data will be available later this summer and will accessible to researchers. “We so wanted to have this information to you by this hearing. We don’t,” she said.

Challenges Remain

Ensuring access to care is one of the VA’s chief challenges. “We have to change our messaging to be more welcoming to all veterans,” Dr. McCarthy told the committee. “There are still veterans out there that do not know that they are eligible for benefits.”

Another one of the challenges is streamlining the transition from the military to the VA. “VA research has indicated that rates of suicide among those who use VA services have not shown increases similar to those observed in all veterans and the general U.S. population,” McCarthy explained. “This research suggests that an improved health care transition between DoD and VA could help mitigate suicide risk as well as other increased risks of morbidity.” According to McCarthy, the VA and DoD are working to create a seamless transition for mental health medications from the DoD to the VA, following a safety review

Following up on the Preventing Veterans Suicide – A Call to Action summit, in March, VA announced 8 steps it planned to take to improve its suicide prevention programs. They are:

1. Elevating VA’s suicide-prevention program with additional resources to help manage and strengthen current programs and initiatives;

2. Meeting urgent mental health needs by providing veterans with same-day evaluations and access by the end of calendar year 2016;

3. Establishing a new standard of care by using measures of veteran-reported symptoms to tailor mental health treatments to individual needs;

4. Launching a new study, “Coming Home from Afghanistan and Iraq,” that will look at the impact of deployment and combat as it relates to suicide, mental health, and well-being;

5. Using predictive modeling to guide early interventions for suicide prevention;

6. Using data on suicide attempts and overdoses to guide strategies to prevent suicide;

7. Increasing the availability of naloxone rescue kits throughout VA to prevent deaths from opioid overdoses;

8. Enhancing veteran mental health access by establishing 3 regional telemental health hubs; and

9. Continuing to partner with the DoD on suicide prevention and other efforts for a seamless transition from military service to civilian life.

“While these initiatives are laudable, VVA also believes strongly that they cannot fully succeed without a significant  increase in the recruitment, hiring, and retention of VA mental health staff, as well as timely access to VA mental health clinical facilities and programs, especially for our rural veterans,” Berger told the committee.

In a House Veterans’ Affairs Committee hearing on efforts to prevent veteran suicide, the VA confirmed that it is focused on ensuring it has enough mental health care providers. The VA currently employs 5,500 psychologists and 3,203 psychiatrists. According to Maureen F. McCarthy, MD, deputy chief, VHA Office of Patient Care Services, the VA currently has 236 psychiatrist vacancies.

Veteran service organizations, House members, and the VA all agreed that hiring and retaining qualified mental health care providers is an essential component in reducing suicides. “We are aware that access to mental health care is one significant part of preventing suicide,” McCarthy said in prepared testimony. “VA is determined to address systemic problems with access to care in general and to mental health care, including substance use disorders in particular. VA has recommitted to a culture that puts the veteran first.”

As House members, veteran service organizations, and the VA have all admitted, the frequently quoted 22 veterans suicides each day statistic is based on dated and limited data. To better understand the scope of the problem, the VA is working with the CDC to obtain a more current and accurate count of veteran suicides—a move that many veterans advocacy groups have called for.

“Vietnam Veterans of America calls for an updated veteran suicide report that includes data from all 50 states and U.S. territories, and also strongly suggests that VA mental health services develop a nationwide strategy to address the problem of suicides among our older veterans—particularly Vietnam-era veterans,” Thomas J. Berger, PhD, executive director of the Veterans Health Council of the Vietnam Veterans of America (VVA) told the committee in his prepared remarks.

 According to Dr. McCarthy, the data will be available later this summer and will accessible to researchers. “We so wanted to have this information to you by this hearing. We don’t,” she said.

Challenges Remain

Ensuring access to care is one of the VA’s chief challenges. “We have to change our messaging to be more welcoming to all veterans,” Dr. McCarthy told the committee. “There are still veterans out there that do not know that they are eligible for benefits.”

Another one of the challenges is streamlining the transition from the military to the VA. “VA research has indicated that rates of suicide among those who use VA services have not shown increases similar to those observed in all veterans and the general U.S. population,” McCarthy explained. “This research suggests that an improved health care transition between DoD and VA could help mitigate suicide risk as well as other increased risks of morbidity.” According to McCarthy, the VA and DoD are working to create a seamless transition for mental health medications from the DoD to the VA, following a safety review

Following up on the Preventing Veterans Suicide – A Call to Action summit, in March, VA announced 8 steps it planned to take to improve its suicide prevention programs. They are:

1. Elevating VA’s suicide-prevention program with additional resources to help manage and strengthen current programs and initiatives;

2. Meeting urgent mental health needs by providing veterans with same-day evaluations and access by the end of calendar year 2016;

3. Establishing a new standard of care by using measures of veteran-reported symptoms to tailor mental health treatments to individual needs;

4. Launching a new study, “Coming Home from Afghanistan and Iraq,” that will look at the impact of deployment and combat as it relates to suicide, mental health, and well-being;

5. Using predictive modeling to guide early interventions for suicide prevention;

6. Using data on suicide attempts and overdoses to guide strategies to prevent suicide;

7. Increasing the availability of naloxone rescue kits throughout VA to prevent deaths from opioid overdoses;

8. Enhancing veteran mental health access by establishing 3 regional telemental health hubs; and

9. Continuing to partner with the DoD on suicide prevention and other efforts for a seamless transition from military service to civilian life.

“While these initiatives are laudable, VVA also believes strongly that they cannot fully succeed without a significant  increase in the recruitment, hiring, and retention of VA mental health staff, as well as timely access to VA mental health clinical facilities and programs, especially for our rural veterans,” Berger told the committee.