Vascular Specialist

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

The Food and Drug Administration approved rituximab (Rituxan) by injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoid treatment, according to an FDA news release.

Olivier Le Moal/Getty Images

These rare forms of vasculitis damage small blood vessels through inflammation and can lead to serious organ failure, including lungs and kidneys.

The Genentech drug received priority review and an orphan drug designation based on the results of a pediatric clinical trial of 25 patients aged 6-17 years with active GPA or MPA who were treated with rituximab in an international multicenter, open-label, uncontrolled study. Patients in the trial were also given methylprednisolone prior to starting treatment.

The trial consisted of a 6-month remission induction phase where patients were treated only with rituximab and glucocorticoids. In addition, patients who had not achieved remission could receive additional treatment, including other therapies, at the discretion of the investigator, according to the FDA. By 6 months, 14 of the patients were in remission, and after 18 months, all 25 patients were in remission.

Rituximab contains a boxed warning regarding increased risks of fatal infusion reactions, potentially fatal severe skin and mouth reactions, hepatitis B virus reactivation that may cause serious or lethal liver problems, and progressive multifocal leukoencephalopathy, a rare, potentially lethal brain infection.

The trial was conducted and sponsored by F. Hoffmann-La Roche, which owns Genentech.

[email protected]

The Food and Drug Administration approved rituximab (Rituxan) by injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoid treatment, according to an FDA news release.

Olivier Le Moal/Getty Images

These rare forms of vasculitis damage small blood vessels through inflammation and can lead to serious organ failure, including lungs and kidneys.

The Genentech drug received priority review and an orphan drug designation based on the results of a pediatric clinical trial of 25 patients aged 6-17 years with active GPA or MPA who were treated with rituximab in an international multicenter, open-label, uncontrolled study. Patients in the trial were also given methylprednisolone prior to starting treatment.

The trial consisted of a 6-month remission induction phase where patients were treated only with rituximab and glucocorticoids. In addition, patients who had not achieved remission could receive additional treatment, including other therapies, at the discretion of the investigator, according to the FDA. By 6 months, 14 of the patients were in remission, and after 18 months, all 25 patients were in remission.

Rituximab contains a boxed warning regarding increased risks of fatal infusion reactions, potentially fatal severe skin and mouth reactions, hepatitis B virus reactivation that may cause serious or lethal liver problems, and progressive multifocal leukoencephalopathy, a rare, potentially lethal brain infection.

The trial was conducted and sponsored by F. Hoffmann-La Roche, which owns Genentech.

[email protected]

The Food and Drug Administration approved rituximab (Rituxan) by injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoid treatment, according to an FDA news release.

Olivier Le Moal/Getty Images

These rare forms of vasculitis damage small blood vessels through inflammation and can lead to serious organ failure, including lungs and kidneys.

The Genentech drug received priority review and an orphan drug designation based on the results of a pediatric clinical trial of 25 patients aged 6-17 years with active GPA or MPA who were treated with rituximab in an international multicenter, open-label, uncontrolled study. Patients in the trial were also given methylprednisolone prior to starting treatment.

The trial consisted of a 6-month remission induction phase where patients were treated only with rituximab and glucocorticoids. In addition, patients who had not achieved remission could receive additional treatment, including other therapies, at the discretion of the investigator, according to the FDA. By 6 months, 14 of the patients were in remission, and after 18 months, all 25 patients were in remission.

Rituximab contains a boxed warning regarding increased risks of fatal infusion reactions, potentially fatal severe skin and mouth reactions, hepatitis B virus reactivation that may cause serious or lethal liver problems, and progressive multifocal leukoencephalopathy, a rare, potentially lethal brain infection.

The trial was conducted and sponsored by F. Hoffmann-La Roche, which owns Genentech.

[email protected]

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Oct. 7 to be considered. Learn more here.

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Oct. 7 to be considered. Learn more here.

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Oct. 7 to be considered. Learn more here.

The Food and Drug Administration has approved canagliflozin (Invokana) for the treatment of diabetic kidney disease and for reduction of the risk of hospitalization for heart failure in patients with type 2 diabetes and diabetic kidney disease, which makes it the first drug indicated for diabetic kidney disease treatment in 20 years.

FDA approval, which was announced in a press release by Janssen, the drug’s manufacturer, is based on results from the phase 3 CREDENCE trial. In that study patients with type 2 diabetes and chronic diabetic kidney disease received either 100 mg canagliflozin or placebo. Patients who received canagliflozin experienced a 30% reduction in the risk of the primary composite endpoint, which included end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. The risk of secondary outcomes were also reduced in patients receiving canagliflozin, including a 39% reduction in the risk of hospitalization for heart failure.

The most common adverse events associated with canagliflozin, according to the label, are female genital mycotic infections, urinary tract infection, and increased urination. Serious adverse events associated with canagliflozin include ketoacidosis, kidney problems, serious urinary tract infections, hypoglycemia, necrotizing fasciitis, serious allergic reaction, and bone fractures.

“The real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure,” LaVerne A. Burton, president and CEO of the American Kidney Fund, said in the press release. “We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure.”

Find the full press release on the Janssen website.

[email protected]

The Food and Drug Administration has approved canagliflozin (Invokana) for the treatment of diabetic kidney disease and for reduction of the risk of hospitalization for heart failure in patients with type 2 diabetes and diabetic kidney disease, which makes it the first drug indicated for diabetic kidney disease treatment in 20 years.

FDA approval, which was announced in a press release by Janssen, the drug’s manufacturer, is based on results from the phase 3 CREDENCE trial. In that study patients with type 2 diabetes and chronic diabetic kidney disease received either 100 mg canagliflozin or placebo. Patients who received canagliflozin experienced a 30% reduction in the risk of the primary composite endpoint, which included end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. The risk of secondary outcomes were also reduced in patients receiving canagliflozin, including a 39% reduction in the risk of hospitalization for heart failure.

The most common adverse events associated with canagliflozin, according to the label, are female genital mycotic infections, urinary tract infection, and increased urination. Serious adverse events associated with canagliflozin include ketoacidosis, kidney problems, serious urinary tract infections, hypoglycemia, necrotizing fasciitis, serious allergic reaction, and bone fractures.

“The real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure,” LaVerne A. Burton, president and CEO of the American Kidney Fund, said in the press release. “We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure.”

Find the full press release on the Janssen website.

[email protected]

The Food and Drug Administration has approved canagliflozin (Invokana) for the treatment of diabetic kidney disease and for reduction of the risk of hospitalization for heart failure in patients with type 2 diabetes and diabetic kidney disease, which makes it the first drug indicated for diabetic kidney disease treatment in 20 years.

FDA approval, which was announced in a press release by Janssen, the drug’s manufacturer, is based on results from the phase 3 CREDENCE trial. In that study patients with type 2 diabetes and chronic diabetic kidney disease received either 100 mg canagliflozin or placebo. Patients who received canagliflozin experienced a 30% reduction in the risk of the primary composite endpoint, which included end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. The risk of secondary outcomes were also reduced in patients receiving canagliflozin, including a 39% reduction in the risk of hospitalization for heart failure.

The most common adverse events associated with canagliflozin, according to the label, are female genital mycotic infections, urinary tract infection, and increased urination. Serious adverse events associated with canagliflozin include ketoacidosis, kidney problems, serious urinary tract infections, hypoglycemia, necrotizing fasciitis, serious allergic reaction, and bone fractures.

“The real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure,” LaVerne A. Burton, president and CEO of the American Kidney Fund, said in the press release. “We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure.”

Find the full press release on the Janssen website.

[email protected]

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

More people remain insured when enrollment is automatically renewed year over year, compared with those who do not have the option of automatic reenrollment, according to research appearing in JAMA Internal Medicine

copyright teekid/iStockphoto

Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.

The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.

“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).

“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.

Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.

“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”

[email protected]

SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.

More people remain insured when enrollment is automatically renewed year over year, compared with those who do not have the option of automatic reenrollment, according to research appearing in JAMA Internal Medicine

copyright teekid/iStockphoto

Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.

The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.

“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).

“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.

Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.

“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”

[email protected]

SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.

More people remain insured when enrollment is automatically renewed year over year, compared with those who do not have the option of automatic reenrollment, according to research appearing in JAMA Internal Medicine

copyright teekid/iStockphoto

Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.

The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.

“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).

“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.

Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.

“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”

[email protected]

SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.

The Affinity Program of expanded benefits is available to SVS members and can connect them with individual disability plans. These plans – available through Principal Life Insurance Company, Securian and Lloyds of London – provide tax-free benefits and can protect hundreds of thousands of dollars.

If interested in learning more about your disability insurance options, contact Mark Blocker at [email protected] or at 949-554- 9936; he is available after-hours and on weekends. Learn more here.

The Affinity Program of expanded benefits is available to SVS members and can connect them with individual disability plans. These plans – available through Principal Life Insurance Company, Securian and Lloyds of London – provide tax-free benefits and can protect hundreds of thousands of dollars.

If interested in learning more about your disability insurance options, contact Mark Blocker at [email protected] or at 949-554- 9936; he is available after-hours and on weekends. Learn more here.

The Affinity Program of expanded benefits is available to SVS members and can connect them with individual disability plans. These plans – available through Principal Life Insurance Company, Securian and Lloyds of London – provide tax-free benefits and can protect hundreds of thousands of dollars.

If interested in learning more about your disability insurance options, contact Mark Blocker at [email protected] or at 949-554- 9936; he is available after-hours and on weekends. Learn more here.

If you participated in the Merit-based Incentive Payment System (MIPS) in 2018, your performance feedback is now available for review on the Quality Payment Program website. Through a process called targeted review, MIPS eligible clinicians or groups can request for CMS to review their performance feedback and final score calculation. The MIPS payment adjustment you receive in 2020 will be based on your final score. Please refer to the QPP Access User Guide for additional details. The deadline to submit your request is 7 PM (CT), September 30, 2019.

If you participated in the Merit-based Incentive Payment System (MIPS) in 2018, your performance feedback is now available for review on the Quality Payment Program website. Through a process called targeted review, MIPS eligible clinicians or groups can request for CMS to review their performance feedback and final score calculation. The MIPS payment adjustment you receive in 2020 will be based on your final score. Please refer to the QPP Access User Guide for additional details. The deadline to submit your request is 7 PM (CT), September 30, 2019.

If you participated in the Merit-based Incentive Payment System (MIPS) in 2018, your performance feedback is now available for review on the Quality Payment Program website. Through a process called targeted review, MIPS eligible clinicians or groups can request for CMS to review their performance feedback and final score calculation. The MIPS payment adjustment you receive in 2020 will be based on your final score. Please refer to the QPP Access User Guide for additional details. The deadline to submit your request is 7 PM (CT), September 30, 2019.

Senior leadership at medical practices are not fully committed to pushing interoperability despite continued efforts to drive that level of connectivity between electronic health records and other health information technology, as the financial justification remains a concern.

In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”

That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.

“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.

“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”

But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.

“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.

Rather, he sees two key components that will drive interoperability.

First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.

“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.

The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.

“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”

And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.

“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.

The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.

Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.

But overall, it would appear that getting to an interoperable point is going to be a challenge.

The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”

[email protected]

SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”

Senior leadership at medical practices are not fully committed to pushing interoperability despite continued efforts to drive that level of connectivity between electronic health records and other health information technology, as the financial justification remains a concern.

In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”

That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.

“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.

“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”

But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.

“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.

Rather, he sees two key components that will drive interoperability.

First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.

“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.

The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.

“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”

And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.

“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.

The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.

Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.

But overall, it would appear that getting to an interoperable point is going to be a challenge.

The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”

[email protected]

SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”

Senior leadership at medical practices are not fully committed to pushing interoperability despite continued efforts to drive that level of connectivity between electronic health records and other health information technology, as the financial justification remains a concern.

In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”

That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.

“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.

“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”

But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.

“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.

Rather, he sees two key components that will drive interoperability.

First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.

“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.

The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.

“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”

And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.

“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.

The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.

Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.

But overall, it would appear that getting to an interoperable point is going to be a challenge.

The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”

[email protected]

SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”