SAN DIEGO – Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

SAN DIEGO – Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

SAN DIEGO – Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

NEW ORLEANS – A single 300-mg injection of inclisiran, a novel non–monoclonal antibody PCSK9 inhibitor, plus statin therapy, achieved a mean 51% reduction in LDL cholesterol, compared with placebo plus a statin, an effect sustained for 90 days.

Moreover, a second subcutaneous 300-mg dose given at day 90 resulted in a 57% reduction in LDL sustained at day 180 with a highly favorable safety profile in the phase II ORION-1 study, Kausik K. Ray, MD, reported at the American Heart Association scientific sessions.

“The efficacy, safety and dosing profile of inclisiran are likely to ensure significant and durable reductions in LDL-C and thus could potentially impact cardiovascular outcomes,” said Dr. Ray, professor of public health at Imperial College London.

Inclisiran is a synthetic RNA interference agent. After injection it selectively goes to the liver, bypassing other tissues and thereby limiting toxicity. Inclisiran halts PCSK9 protein synthesis in the liver, with a resultant sharp, steep, and sustained drop in LDL levels.

Inclisiran achieves LDL lowering of a magnitude similar to that of the PCSK9-inhibiting monoclonal antibodies alirocumab (Praluent) and evolocumab (Repatha), but it will be less expensive to produce and far less costly to administer than the monoclonal antibodies. Dosing is planned to be two or three injections per year, rather than every 2 or 4 weeks, as with the PCSK9 inhibitor monoclonal antibodies, which cost a hefty $14,000 per year. And the sustained efficacy of a dose of inclisiran should make patient adherence to LDL-lowering therapy less of an issue, Dr. Ray continued.

ORION-1 (Inhibition of PCSK9 Synthesis Via RNA Interference) was a double-blind, randomized, placebo-controlled trial comprising 501 patients already on maximally tolerated statin therapy for atherosclerotic cardiovascular disease or at high risk. Nevertheless, their baseline LDL was 125-135 mg/dL. Participants were randomized to one of six doses of inclisiran or placebo. At 90 days they received a second dose. Dr. Ray presented 90- and 180-day outcomes.

This was primarily a safety and dose-ranging study. Side effects at 90 days were no different from placebo regardless of whether patients received 100, 200, 300, or 500 mg of inclisiran. There was no signal of a problem with myalgia or elevated liver enzymes. Mild injection site reactions lasting for more than 4 hours occurred in 1.5%-3.3% of inclisiran-treated patients, but not in a dose-dependent fashion.

One 300-mg dose of inclisiran, in addition to achieving a mean 51% reduction in LDL from baseline at day 90, resulted in a mean 28% reduction in total cholesterol, a modest 10% drop in triglycerides, a 9% increase in HDL, a 37% drop in Apo-B, and a median 23% reduction in Lp(a). Plasma PCSK9 levels plunged in parallel with LDL.

The mean drop in LDL from baseline at day 180 after two 300-mg doses of inclisiran spaced 90 days apart was 65 mg/dL. The LDL reduction ranged from a minimum of 26.5 mg/dL to a maximum of 122 mg/dL.

Dr. Ray’s presentation of the ORION-1 findings followed on the heels of publication of a positive but much smaller phase I study of inclisiran (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1609243).

A large phase II clinical trial with cardiovascular outcomes is planned.

Discussant Borge G. Nordestgaard, MD, could find no fault with ORION-1 or inclisiran’s performance to date.

Bruce Jancin/Frontline Medical News

Dr. Ray discussed his findings in a video interview at the meeting.

[email protected]

NEW ORLEANS – A single 300-mg injection of inclisiran, a novel non–monoclonal antibody PCSK9 inhibitor, plus statin therapy, achieved a mean 51% reduction in LDL cholesterol, compared with placebo plus a statin, an effect sustained for 90 days.

Moreover, a second subcutaneous 300-mg dose given at day 90 resulted in a 57% reduction in LDL sustained at day 180 with a highly favorable safety profile in the phase II ORION-1 study, Kausik K. Ray, MD, reported at the American Heart Association scientific sessions.

“The efficacy, safety and dosing profile of inclisiran are likely to ensure significant and durable reductions in LDL-C and thus could potentially impact cardiovascular outcomes,” said Dr. Ray, professor of public health at Imperial College London.

Inclisiran is a synthetic RNA interference agent. After injection it selectively goes to the liver, bypassing other tissues and thereby limiting toxicity. Inclisiran halts PCSK9 protein synthesis in the liver, with a resultant sharp, steep, and sustained drop in LDL levels.

Inclisiran achieves LDL lowering of a magnitude similar to that of the PCSK9-inhibiting monoclonal antibodies alirocumab (Praluent) and evolocumab (Repatha), but it will be less expensive to produce and far less costly to administer than the monoclonal antibodies. Dosing is planned to be two or three injections per year, rather than every 2 or 4 weeks, as with the PCSK9 inhibitor monoclonal antibodies, which cost a hefty $14,000 per year. And the sustained efficacy of a dose of inclisiran should make patient adherence to LDL-lowering therapy less of an issue, Dr. Ray continued.

ORION-1 (Inhibition of PCSK9 Synthesis Via RNA Interference) was a double-blind, randomized, placebo-controlled trial comprising 501 patients already on maximally tolerated statin therapy for atherosclerotic cardiovascular disease or at high risk. Nevertheless, their baseline LDL was 125-135 mg/dL. Participants were randomized to one of six doses of inclisiran or placebo. At 90 days they received a second dose. Dr. Ray presented 90- and 180-day outcomes.

This was primarily a safety and dose-ranging study. Side effects at 90 days were no different from placebo regardless of whether patients received 100, 200, 300, or 500 mg of inclisiran. There was no signal of a problem with myalgia or elevated liver enzymes. Mild injection site reactions lasting for more than 4 hours occurred in 1.5%-3.3% of inclisiran-treated patients, but not in a dose-dependent fashion.

One 300-mg dose of inclisiran, in addition to achieving a mean 51% reduction in LDL from baseline at day 90, resulted in a mean 28% reduction in total cholesterol, a modest 10% drop in triglycerides, a 9% increase in HDL, a 37% drop in Apo-B, and a median 23% reduction in Lp(a). Plasma PCSK9 levels plunged in parallel with LDL.

The mean drop in LDL from baseline at day 180 after two 300-mg doses of inclisiran spaced 90 days apart was 65 mg/dL. The LDL reduction ranged from a minimum of 26.5 mg/dL to a maximum of 122 mg/dL.

Dr. Ray’s presentation of the ORION-1 findings followed on the heels of publication of a positive but much smaller phase I study of inclisiran (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1609243).

A large phase II clinical trial with cardiovascular outcomes is planned.

Discussant Borge G. Nordestgaard, MD, could find no fault with ORION-1 or inclisiran’s performance to date.

Bruce Jancin/Frontline Medical News

Dr. Ray discussed his findings in a video interview at the meeting.

[email protected]

NEW ORLEANS – A single 300-mg injection of inclisiran, a novel non–monoclonal antibody PCSK9 inhibitor, plus statin therapy, achieved a mean 51% reduction in LDL cholesterol, compared with placebo plus a statin, an effect sustained for 90 days.

Moreover, a second subcutaneous 300-mg dose given at day 90 resulted in a 57% reduction in LDL sustained at day 180 with a highly favorable safety profile in the phase II ORION-1 study, Kausik K. Ray, MD, reported at the American Heart Association scientific sessions.

“The efficacy, safety and dosing profile of inclisiran are likely to ensure significant and durable reductions in LDL-C and thus could potentially impact cardiovascular outcomes,” said Dr. Ray, professor of public health at Imperial College London.

Inclisiran is a synthetic RNA interference agent. After injection it selectively goes to the liver, bypassing other tissues and thereby limiting toxicity. Inclisiran halts PCSK9 protein synthesis in the liver, with a resultant sharp, steep, and sustained drop in LDL levels.

Inclisiran achieves LDL lowering of a magnitude similar to that of the PCSK9-inhibiting monoclonal antibodies alirocumab (Praluent) and evolocumab (Repatha), but it will be less expensive to produce and far less costly to administer than the monoclonal antibodies. Dosing is planned to be two or three injections per year, rather than every 2 or 4 weeks, as with the PCSK9 inhibitor monoclonal antibodies, which cost a hefty $14,000 per year. And the sustained efficacy of a dose of inclisiran should make patient adherence to LDL-lowering therapy less of an issue, Dr. Ray continued.

ORION-1 (Inhibition of PCSK9 Synthesis Via RNA Interference) was a double-blind, randomized, placebo-controlled trial comprising 501 patients already on maximally tolerated statin therapy for atherosclerotic cardiovascular disease or at high risk. Nevertheless, their baseline LDL was 125-135 mg/dL. Participants were randomized to one of six doses of inclisiran or placebo. At 90 days they received a second dose. Dr. Ray presented 90- and 180-day outcomes.

This was primarily a safety and dose-ranging study. Side effects at 90 days were no different from placebo regardless of whether patients received 100, 200, 300, or 500 mg of inclisiran. There was no signal of a problem with myalgia or elevated liver enzymes. Mild injection site reactions lasting for more than 4 hours occurred in 1.5%-3.3% of inclisiran-treated patients, but not in a dose-dependent fashion.

One 300-mg dose of inclisiran, in addition to achieving a mean 51% reduction in LDL from baseline at day 90, resulted in a mean 28% reduction in total cholesterol, a modest 10% drop in triglycerides, a 9% increase in HDL, a 37% drop in Apo-B, and a median 23% reduction in Lp(a). Plasma PCSK9 levels plunged in parallel with LDL.

The mean drop in LDL from baseline at day 180 after two 300-mg doses of inclisiran spaced 90 days apart was 65 mg/dL. The LDL reduction ranged from a minimum of 26.5 mg/dL to a maximum of 122 mg/dL.

Dr. Ray’s presentation of the ORION-1 findings followed on the heels of publication of a positive but much smaller phase I study of inclisiran (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1609243).

A large phase II clinical trial with cardiovascular outcomes is planned.

Discussant Borge G. Nordestgaard, MD, could find no fault with ORION-1 or inclisiran’s performance to date.

Bruce Jancin/Frontline Medical News

Dr. Ray discussed his findings in a video interview at the meeting.

[email protected]

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

A study in the American Journal of Pathology found that HIV impairs Mycobacterium tuberculosis antigen presentation in human dendritic cells, thereby suppressing an important cell-linking innate and adaptive immune response in TB.

alexskopje/ThinkStock.com

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

A study in the American Journal of Pathology found that HIV impairs Mycobacterium tuberculosis antigen presentation in human dendritic cells, thereby suppressing an important cell-linking innate and adaptive immune response in TB.

alexskopje/ThinkStock.com

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

A study in the American Journal of Pathology found that HIV impairs Mycobacterium tuberculosis antigen presentation in human dendritic cells, thereby suppressing an important cell-linking innate and adaptive immune response in TB.

alexskopje/ThinkStock.com

NEW ORLEANS – An interatrial septal shunt device continued to provide “sustained and meaningful clinical benefit” at 1-year follow-up for 64 patients who had heart failure with preserved ejection fraction (HFpEF), David M. Kaye, MD, PhD, reported at the American Heart Association scientific sessions.

The device is implanted via cardiac catheterization and is intended to reduce elevated left atrial pressure, particularly that associated with exertion, by allowing a small amount but not excessive left-to-right shunting. Patients showed improvements in 6-minute walk distance, New York Heart Association class, and HF-related quality of life scores at 6 months, and those effects persisted at the most recent (12-month) follow-up, he said in a presentation that was simultaneously published online in Circulation (2016 Nov 16).

American Heart Association

American Heart Association

NEW ORLEANS – An interatrial septal shunt device continued to provide “sustained and meaningful clinical benefit” at 1-year follow-up for 64 patients who had heart failure with preserved ejection fraction (HFpEF), David M. Kaye, MD, PhD, reported at the American Heart Association scientific sessions.

The device is implanted via cardiac catheterization and is intended to reduce elevated left atrial pressure, particularly that associated with exertion, by allowing a small amount but not excessive left-to-right shunting. Patients showed improvements in 6-minute walk distance, New York Heart Association class, and HF-related quality of life scores at 6 months, and those effects persisted at the most recent (12-month) follow-up, he said in a presentation that was simultaneously published online in Circulation (2016 Nov 16).

American Heart Association

American Heart Association

NEW ORLEANS – An interatrial septal shunt device continued to provide “sustained and meaningful clinical benefit” at 1-year follow-up for 64 patients who had heart failure with preserved ejection fraction (HFpEF), David M. Kaye, MD, PhD, reported at the American Heart Association scientific sessions.

The device is implanted via cardiac catheterization and is intended to reduce elevated left atrial pressure, particularly that associated with exertion, by allowing a small amount but not excessive left-to-right shunting. Patients showed improvements in 6-minute walk distance, New York Heart Association class, and HF-related quality of life scores at 6 months, and those effects persisted at the most recent (12-month) follow-up, he said in a presentation that was simultaneously published online in Circulation (2016 Nov 16).

American Heart Association

American Heart Association

BOSTON – State Medicaid programs have begun to loosen restrictions and improve transparency around access to direct-acting antiviral agents to treat hepatitis C virus infection, but inconsistencies are still the norm nationwide.

“Far too many states continue to restrict access in defiance to their obligations under the law,” said Robert Greenwald, clinical professor of law at Harvard University Center for Health Law and Policy Innovation (CHLPI), Boston.
 

Since 2014, the number of states that do not publish their access criteria for direct-acting antiviral agents (DAA) has dropped from 17 to 7, according to a report from CHLPI and the National Viral Hepatitis Roundtable (NVHR). Also during that period, 16 states relaxed or dropped fibrosis levels to qualify for access, and 7 decreased sobriety restrictions. The number of states that publish prescriber limitations has increased from 28 to 35. Because cost restrictions vary across insurance plans, some patients who need access get it, and others don’t, even if they have coverage, said Mr. Greenwald and Ryan Clary, NVHR executive director, who presented the report at the annual meeting of the American Association for the Study of Liver Diseases.

NVHR is a coalition of advocacy groups and local governmental agencies with interests in HCV, HIV, and infectious diseases. Its sponsors include AbbVie, Gilead Sciences, Merck, Bristol-Myers Squibb, Janssen, OraSure Technologies, Quest Diagnostics, and Walgreens. CHLPI is supported in part by Gilead, BMS, Johnson & Johnson, and ViiV Health Care.

In November 2015, the Centers for Medicaid & Medicare Services issued guidance to states, noting that while the cost of DAAs is prohibitive, states should use “sound clinical judgment” when determining access, and to “not unreasonably restrict coverage.” Varied interpretation of the guidance by state Medicaid directors means there is still a great deal of inconsistency in coverage.

Robert W. Zavoski, MD, Connecticut medical director of social services, noted that his state is making gains on balancing patient and taxpayer interests by emphasizing prevention, curbing reinfection rates, and using predictive modeling to determine the cost of HCV comorbidities.

Whitney McKnight/Frontline Medical News

[email protected]

On Twitter @whitneymcknight

BOSTON – State Medicaid programs have begun to loosen restrictions and improve transparency around access to direct-acting antiviral agents to treat hepatitis C virus infection, but inconsistencies are still the norm nationwide.

“Far too many states continue to restrict access in defiance to their obligations under the law,” said Robert Greenwald, clinical professor of law at Harvard University Center for Health Law and Policy Innovation (CHLPI), Boston.
 

Since 2014, the number of states that do not publish their access criteria for direct-acting antiviral agents (DAA) has dropped from 17 to 7, according to a report from CHLPI and the National Viral Hepatitis Roundtable (NVHR). Also during that period, 16 states relaxed or dropped fibrosis levels to qualify for access, and 7 decreased sobriety restrictions. The number of states that publish prescriber limitations has increased from 28 to 35. Because cost restrictions vary across insurance plans, some patients who need access get it, and others don’t, even if they have coverage, said Mr. Greenwald and Ryan Clary, NVHR executive director, who presented the report at the annual meeting of the American Association for the Study of Liver Diseases.

NVHR is a coalition of advocacy groups and local governmental agencies with interests in HCV, HIV, and infectious diseases. Its sponsors include AbbVie, Gilead Sciences, Merck, Bristol-Myers Squibb, Janssen, OraSure Technologies, Quest Diagnostics, and Walgreens. CHLPI is supported in part by Gilead, BMS, Johnson & Johnson, and ViiV Health Care.

In November 2015, the Centers for Medicaid & Medicare Services issued guidance to states, noting that while the cost of DAAs is prohibitive, states should use “sound clinical judgment” when determining access, and to “not unreasonably restrict coverage.” Varied interpretation of the guidance by state Medicaid directors means there is still a great deal of inconsistency in coverage.

Robert W. Zavoski, MD, Connecticut medical director of social services, noted that his state is making gains on balancing patient and taxpayer interests by emphasizing prevention, curbing reinfection rates, and using predictive modeling to determine the cost of HCV comorbidities.

Whitney McKnight/Frontline Medical News

[email protected]

On Twitter @whitneymcknight

BOSTON – State Medicaid programs have begun to loosen restrictions and improve transparency around access to direct-acting antiviral agents to treat hepatitis C virus infection, but inconsistencies are still the norm nationwide.

“Far too many states continue to restrict access in defiance to their obligations under the law,” said Robert Greenwald, clinical professor of law at Harvard University Center for Health Law and Policy Innovation (CHLPI), Boston.
 

Since 2014, the number of states that do not publish their access criteria for direct-acting antiviral agents (DAA) has dropped from 17 to 7, according to a report from CHLPI and the National Viral Hepatitis Roundtable (NVHR). Also during that period, 16 states relaxed or dropped fibrosis levels to qualify for access, and 7 decreased sobriety restrictions. The number of states that publish prescriber limitations has increased from 28 to 35. Because cost restrictions vary across insurance plans, some patients who need access get it, and others don’t, even if they have coverage, said Mr. Greenwald and Ryan Clary, NVHR executive director, who presented the report at the annual meeting of the American Association for the Study of Liver Diseases.

NVHR is a coalition of advocacy groups and local governmental agencies with interests in HCV, HIV, and infectious diseases. Its sponsors include AbbVie, Gilead Sciences, Merck, Bristol-Myers Squibb, Janssen, OraSure Technologies, Quest Diagnostics, and Walgreens. CHLPI is supported in part by Gilead, BMS, Johnson & Johnson, and ViiV Health Care.

In November 2015, the Centers for Medicaid & Medicare Services issued guidance to states, noting that while the cost of DAAs is prohibitive, states should use “sound clinical judgment” when determining access, and to “not unreasonably restrict coverage.” Varied interpretation of the guidance by state Medicaid directors means there is still a great deal of inconsistency in coverage.

Robert W. Zavoski, MD, Connecticut medical director of social services, noted that his state is making gains on balancing patient and taxpayer interests by emphasizing prevention, curbing reinfection rates, and using predictive modeling to determine the cost of HCV comorbidities.

Whitney McKnight/Frontline Medical News

[email protected]

On Twitter @whitneymcknight

Myth: Psoriasis treatments may cause depression

It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.

But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.

Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.

However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.

Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.

Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.

In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.

Expert Commentary

The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.

Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Psoriasis treatments may cause depression

It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.

But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.

Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.

However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.

Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.

Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.

In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.

Expert Commentary

The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.

Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Psoriasis treatments may cause depression

It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.

But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.

Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.

However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.

Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.

Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.

In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.

Expert Commentary

The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.

Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.

—Jashin J. Wu, MD (Los Angeles, California)

A biomarker may show whether acute respiratory distress syndrome (ARDS) is focal or nonfocal, a study showed.

This is an important distinction because some research suggests nonfocal ARDS, characterized by diffuse lung aeration loss, may have a worse prognosis and the two subtypes may respond differently to interventions such as positive end-expiratory pressure and recruitment maneuvers.

At present, the only way to identify focal versus nonfocal ARDS is a computed tomography scan, but that is often impractical because of the risks of moving the patient.

The current research, published in the November issue of CHEST (2016;150:998-1007), revealed that patients with nonfocal ARDS have higher plasma levels of the soluble form of the receptor for advanced glycation end product (sRAGE). At a cutoff of 1,188 pg/ml, the blood test differentiated between focal and nonfocal ARDS with a 94% sensitivity and an 84% specificity.

“Elevated baseline plasma sRAGE is a strong marker of nonfocal CT-based lung-imaging pattern in patients with early ARDS,” reported Jean-Michel Constantin of University Hospital of Clermont-Ferrand (France) and colleagues in the Azurea network.

The researchers recruited 119 consecutive ARDS patients from 10 intensive care units in France. They measured plasma levels of sRAGE, plasminogen activator inhibitor–1 (PAI-1), soluble intercellular adhesion molecule–1, and surfactant protein–D within 24 hours of ARDS onset. Each patient underwent a lung CT scan within 48 hours to assess focal versus nonfocal lung morphology.

Twenty-seven percent of patients had focal ARDS, while 73% were categorized as nonfocal. Mean plasma levels of sRAGE were much higher in nonfocal patients (3,074 pg/ml vs. 877 pg/ml, P less than .001). A cutoff value of 1,188 ng/ml distinguished focal and nonfocal ARDS with a sensitivity of 93% (95% confidence interval, 85%-97%) and a specificity of 84% (95% CI, 66%-95%). The test’s positive predictive value was 94% (95% CI, 87%-98%), and its negative predictive value was 81% (95% CI, 64%-93%).

The research is still in its early stage, but has a couple possible applications, according to Daniel R. Ouellette, MD, of Henry Ford Hospital, Detroit. “We might conceive of using this as a marker for nonfocal ARDS, and potentially use it to identify patients with worse outcomes. The other thing is, it may be a clue to help us learn about the underlying physiology of the disease,” he said in an interview.

If physicians can confidently categorize a patient, it could inform treatment. “We know that patients who have diffuse disease may be more likely to be treated successfully with advanced ventilator techniques. These techniques would be more useful and likely to lead to recovery in patients that don’t have focal disease,” said Dr. Ouellette.

However, he added that more research is needed. “These results are exciting, but they are very preliminary,” Dr Ouellette said.

The study was funded by the Auvergne Regional Council, the French Agence Nationale de la Recherche, and the Direction Generale de l’Offre de Soins, and the University Hospital of Clermont-Ferrand. The authors reported receiving funds from various pharmaceutical companies.

A biomarker may show whether acute respiratory distress syndrome (ARDS) is focal or nonfocal, a study showed.

This is an important distinction because some research suggests nonfocal ARDS, characterized by diffuse lung aeration loss, may have a worse prognosis and the two subtypes may respond differently to interventions such as positive end-expiratory pressure and recruitment maneuvers.

At present, the only way to identify focal versus nonfocal ARDS is a computed tomography scan, but that is often impractical because of the risks of moving the patient.

The current research, published in the November issue of CHEST (2016;150:998-1007), revealed that patients with nonfocal ARDS have higher plasma levels of the soluble form of the receptor for advanced glycation end product (sRAGE). At a cutoff of 1,188 pg/ml, the blood test differentiated between focal and nonfocal ARDS with a 94% sensitivity and an 84% specificity.

“Elevated baseline plasma sRAGE is a strong marker of nonfocal CT-based lung-imaging pattern in patients with early ARDS,” reported Jean-Michel Constantin of University Hospital of Clermont-Ferrand (France) and colleagues in the Azurea network.

The researchers recruited 119 consecutive ARDS patients from 10 intensive care units in France. They measured plasma levels of sRAGE, plasminogen activator inhibitor–1 (PAI-1), soluble intercellular adhesion molecule–1, and surfactant protein–D within 24 hours of ARDS onset. Each patient underwent a lung CT scan within 48 hours to assess focal versus nonfocal lung morphology.

Twenty-seven percent of patients had focal ARDS, while 73% were categorized as nonfocal. Mean plasma levels of sRAGE were much higher in nonfocal patients (3,074 pg/ml vs. 877 pg/ml, P less than .001). A cutoff value of 1,188 ng/ml distinguished focal and nonfocal ARDS with a sensitivity of 93% (95% confidence interval, 85%-97%) and a specificity of 84% (95% CI, 66%-95%). The test’s positive predictive value was 94% (95% CI, 87%-98%), and its negative predictive value was 81% (95% CI, 64%-93%).

The research is still in its early stage, but has a couple possible applications, according to Daniel R. Ouellette, MD, of Henry Ford Hospital, Detroit. “We might conceive of using this as a marker for nonfocal ARDS, and potentially use it to identify patients with worse outcomes. The other thing is, it may be a clue to help us learn about the underlying physiology of the disease,” he said in an interview.

If physicians can confidently categorize a patient, it could inform treatment. “We know that patients who have diffuse disease may be more likely to be treated successfully with advanced ventilator techniques. These techniques would be more useful and likely to lead to recovery in patients that don’t have focal disease,” said Dr. Ouellette.

However, he added that more research is needed. “These results are exciting, but they are very preliminary,” Dr Ouellette said.

The study was funded by the Auvergne Regional Council, the French Agence Nationale de la Recherche, and the Direction Generale de l’Offre de Soins, and the University Hospital of Clermont-Ferrand. The authors reported receiving funds from various pharmaceutical companies.

A biomarker may show whether acute respiratory distress syndrome (ARDS) is focal or nonfocal, a study showed.

This is an important distinction because some research suggests nonfocal ARDS, characterized by diffuse lung aeration loss, may have a worse prognosis and the two subtypes may respond differently to interventions such as positive end-expiratory pressure and recruitment maneuvers.

At present, the only way to identify focal versus nonfocal ARDS is a computed tomography scan, but that is often impractical because of the risks of moving the patient.

The current research, published in the November issue of CHEST (2016;150:998-1007), revealed that patients with nonfocal ARDS have higher plasma levels of the soluble form of the receptor for advanced glycation end product (sRAGE). At a cutoff of 1,188 pg/ml, the blood test differentiated between focal and nonfocal ARDS with a 94% sensitivity and an 84% specificity.

“Elevated baseline plasma sRAGE is a strong marker of nonfocal CT-based lung-imaging pattern in patients with early ARDS,” reported Jean-Michel Constantin of University Hospital of Clermont-Ferrand (France) and colleagues in the Azurea network.

The researchers recruited 119 consecutive ARDS patients from 10 intensive care units in France. They measured plasma levels of sRAGE, plasminogen activator inhibitor–1 (PAI-1), soluble intercellular adhesion molecule–1, and surfactant protein–D within 24 hours of ARDS onset. Each patient underwent a lung CT scan within 48 hours to assess focal versus nonfocal lung morphology.

Twenty-seven percent of patients had focal ARDS, while 73% were categorized as nonfocal. Mean plasma levels of sRAGE were much higher in nonfocal patients (3,074 pg/ml vs. 877 pg/ml, P less than .001). A cutoff value of 1,188 ng/ml distinguished focal and nonfocal ARDS with a sensitivity of 93% (95% confidence interval, 85%-97%) and a specificity of 84% (95% CI, 66%-95%). The test’s positive predictive value was 94% (95% CI, 87%-98%), and its negative predictive value was 81% (95% CI, 64%-93%).

The research is still in its early stage, but has a couple possible applications, according to Daniel R. Ouellette, MD, of Henry Ford Hospital, Detroit. “We might conceive of using this as a marker for nonfocal ARDS, and potentially use it to identify patients with worse outcomes. The other thing is, it may be a clue to help us learn about the underlying physiology of the disease,” he said in an interview.

If physicians can confidently categorize a patient, it could inform treatment. “We know that patients who have diffuse disease may be more likely to be treated successfully with advanced ventilator techniques. These techniques would be more useful and likely to lead to recovery in patients that don’t have focal disease,” said Dr. Ouellette.

However, he added that more research is needed. “These results are exciting, but they are very preliminary,” Dr Ouellette said.

The study was funded by the Auvergne Regional Council, the French Agence Nationale de la Recherche, and the Direction Generale de l’Offre de Soins, and the University Hospital of Clermont-Ferrand. The authors reported receiving funds from various pharmaceutical companies.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

A unifying genetic basis has been sought to explain the complex and heterogeneous nature of myeloid neoplasms since before Janet Rowley’s quinacrine banding discovered the Philadelphia chromosome (Nature. 1973;243[5405]:290-3). In the decades following that discovery, groundbreaking work has uncovered new chromosomal abnormalities, new gene fusions, new recurrent mutations – often with prognostic implications, but rarely with therapeutic ones.

The recent work by Elli Papaemmanuil, PhD, of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reaffirms the genetic heterogeneity of AML based on molecular profiling of patients from three large European trials. Yet the most insightful aspect of this reclassification is not just the detail of the genetic resolution but the realization that, even within a gene such as NRAS, the genetic background for acquisition of a codon 12/13 mutation is mutually exclusive with clones where NRAS codon 61 occurs.

[email protected]

On Twitter @thedoctorisvin

A unifying genetic basis has been sought to explain the complex and heterogeneous nature of myeloid neoplasms since before Janet Rowley’s quinacrine banding discovered the Philadelphia chromosome (Nature. 1973;243[5405]:290-3). In the decades following that discovery, groundbreaking work has uncovered new chromosomal abnormalities, new gene fusions, new recurrent mutations – often with prognostic implications, but rarely with therapeutic ones.

The recent work by Elli Papaemmanuil, PhD, of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reaffirms the genetic heterogeneity of AML based on molecular profiling of patients from three large European trials. Yet the most insightful aspect of this reclassification is not just the detail of the genetic resolution but the realization that, even within a gene such as NRAS, the genetic background for acquisition of a codon 12/13 mutation is mutually exclusive with clones where NRAS codon 61 occurs.

[email protected]

On Twitter @thedoctorisvin

A unifying genetic basis has been sought to explain the complex and heterogeneous nature of myeloid neoplasms since before Janet Rowley’s quinacrine banding discovered the Philadelphia chromosome (Nature. 1973;243[5405]:290-3). In the decades following that discovery, groundbreaking work has uncovered new chromosomal abnormalities, new gene fusions, new recurrent mutations – often with prognostic implications, but rarely with therapeutic ones.

The recent work by Elli Papaemmanuil, PhD, of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reaffirms the genetic heterogeneity of AML based on molecular profiling of patients from three large European trials. Yet the most insightful aspect of this reclassification is not just the detail of the genetic resolution but the realization that, even within a gene such as NRAS, the genetic background for acquisition of a codon 12/13 mutation is mutually exclusive with clones where NRAS codon 61 occurs.

[email protected]

On Twitter @thedoctorisvin

VANCOUVER—When children depict themselves having a headache, the presence of visual phenomena in their drawings predicts a diagnosis of migraine, according to a study described at the 45th Annual Meeting of the Child Neurology Society. In addition, although drawings by children with migraine and children with pseudotumor cerebri tend to have similar features, depictions of diplopia are much more common among children with pseudotumor cerebri, researchers said.

Migraine affects between 2% and 11% of children, and visual auras are the most prevalent symptom in patients with migraine with aura. Prior studies have found that children’s headache drawings can distinguish migraine from nonmigraine headaches based on the location and quality of pain, presence of nausea or vomiting, visual symptoms, and other features.

To determine whether children’s drawings of visual phenomena predict migraine diagnosis, Carl E. Stafstrom, MD, PhD, Professor of Neurology and Director of Pediatric Neurology, and Erica B. Lee, an undergraduate student, both at Johns Hopkins University School of Medicine in Baltimore, examined drawings by 675 patients from ages 6 to 18. The study included drawings by 498 children with migraine, 155 children with tension-type headache, and 22 children with pseudotumor cerebri.

Before providing a history, patients received a blank piece of paper and 12 colored pencils. Patients were asked to “Please draw a picture of yourself having headache,” without any leading questions. Examiners often asked patients to describe the pictorial features in their drawings and then conducted the usual history, examination, formulation, and management plan.

Visual symptoms included positive phenomena (eg, zigzags or spots), visual field defects, and blurring or tunnel vision. Of the children with migraine, 37.1% depicted visual symptoms in their drawings, compared with 4.5% of children with tension-type headache and 27.3% of children with pseudotumor cerebri. The positive predictive value of visual phenomena for a migraine diagnosis was 96.4%.

Among patients with pseudotumor cerebri, 18.2% depicted diplopia, compared with 0.9% of patients with migraine and 0.6% of patients with tension-type headache.

Dr. Stafstrom and Ms. Lee said that patient artwork is vastly underused in pediatric neurology, and they encouraged clinicians to adopt “this simple, enjoyable, inexpensive, noninvasive method” to support headache differential diagnosis in conjunction with diagnostic criteria and laboratory studies. “Drawings allow self-expression and afford insights into both medical and psychological aspects of a child’s illness experience that are often not expressed by the patient or parent or recognized by the clinician,” they concluded.

To see examples of the children’s drawings, click here.

—Jake Remaly

Suggested Reading

Schott GD. Exploring the visual hallucinations of migraine aura: the tacit contribution of illustration. Brain. 2007;130(Pt 6):1690-1703.

Stafstrom CE, Rostasy K, Minster A. The usefulness of children’s drawings in the diagnosis of headache. Pediatrics. 2002;109(3):460-472.

VANCOUVER—When children depict themselves having a headache, the presence of visual phenomena in their drawings predicts a diagnosis of migraine, according to a study described at the 45th Annual Meeting of the Child Neurology Society. In addition, although drawings by children with migraine and children with pseudotumor cerebri tend to have similar features, depictions of diplopia are much more common among children with pseudotumor cerebri, researchers said.

Migraine affects between 2% and 11% of children, and visual auras are the most prevalent symptom in patients with migraine with aura. Prior studies have found that children’s headache drawings can distinguish migraine from nonmigraine headaches based on the location and quality of pain, presence of nausea or vomiting, visual symptoms, and other features.

To determine whether children’s drawings of visual phenomena predict migraine diagnosis, Carl E. Stafstrom, MD, PhD, Professor of Neurology and Director of Pediatric Neurology, and Erica B. Lee, an undergraduate student, both at Johns Hopkins University School of Medicine in Baltimore, examined drawings by 675 patients from ages 6 to 18. The study included drawings by 498 children with migraine, 155 children with tension-type headache, and 22 children with pseudotumor cerebri.

Before providing a history, patients received a blank piece of paper and 12 colored pencils. Patients were asked to “Please draw a picture of yourself having headache,” without any leading questions. Examiners often asked patients to describe the pictorial features in their drawings and then conducted the usual history, examination, formulation, and management plan.

Visual symptoms included positive phenomena (eg, zigzags or spots), visual field defects, and blurring or tunnel vision. Of the children with migraine, 37.1% depicted visual symptoms in their drawings, compared with 4.5% of children with tension-type headache and 27.3% of children with pseudotumor cerebri. The positive predictive value of visual phenomena for a migraine diagnosis was 96.4%.

Among patients with pseudotumor cerebri, 18.2% depicted diplopia, compared with 0.9% of patients with migraine and 0.6% of patients with tension-type headache.

Dr. Stafstrom and Ms. Lee said that patient artwork is vastly underused in pediatric neurology, and they encouraged clinicians to adopt “this simple, enjoyable, inexpensive, noninvasive method” to support headache differential diagnosis in conjunction with diagnostic criteria and laboratory studies. “Drawings allow self-expression and afford insights into both medical and psychological aspects of a child’s illness experience that are often not expressed by the patient or parent or recognized by the clinician,” they concluded.

To see examples of the children’s drawings, click here.

—Jake Remaly

Suggested Reading

Schott GD. Exploring the visual hallucinations of migraine aura: the tacit contribution of illustration. Brain. 2007;130(Pt 6):1690-1703.

Stafstrom CE, Rostasy K, Minster A. The usefulness of children’s drawings in the diagnosis of headache. Pediatrics. 2002;109(3):460-472.

VANCOUVER—When children depict themselves having a headache, the presence of visual phenomena in their drawings predicts a diagnosis of migraine, according to a study described at the 45th Annual Meeting of the Child Neurology Society. In addition, although drawings by children with migraine and children with pseudotumor cerebri tend to have similar features, depictions of diplopia are much more common among children with pseudotumor cerebri, researchers said.

Migraine affects between 2% and 11% of children, and visual auras are the most prevalent symptom in patients with migraine with aura. Prior studies have found that children’s headache drawings can distinguish migraine from nonmigraine headaches based on the location and quality of pain, presence of nausea or vomiting, visual symptoms, and other features.

To determine whether children’s drawings of visual phenomena predict migraine diagnosis, Carl E. Stafstrom, MD, PhD, Professor of Neurology and Director of Pediatric Neurology, and Erica B. Lee, an undergraduate student, both at Johns Hopkins University School of Medicine in Baltimore, examined drawings by 675 patients from ages 6 to 18. The study included drawings by 498 children with migraine, 155 children with tension-type headache, and 22 children with pseudotumor cerebri.

Before providing a history, patients received a blank piece of paper and 12 colored pencils. Patients were asked to “Please draw a picture of yourself having headache,” without any leading questions. Examiners often asked patients to describe the pictorial features in their drawings and then conducted the usual history, examination, formulation, and management plan.

Visual symptoms included positive phenomena (eg, zigzags or spots), visual field defects, and blurring or tunnel vision. Of the children with migraine, 37.1% depicted visual symptoms in their drawings, compared with 4.5% of children with tension-type headache and 27.3% of children with pseudotumor cerebri. The positive predictive value of visual phenomena for a migraine diagnosis was 96.4%.

Among patients with pseudotumor cerebri, 18.2% depicted diplopia, compared with 0.9% of patients with migraine and 0.6% of patients with tension-type headache.

Dr. Stafstrom and Ms. Lee said that patient artwork is vastly underused in pediatric neurology, and they encouraged clinicians to adopt “this simple, enjoyable, inexpensive, noninvasive method” to support headache differential diagnosis in conjunction with diagnostic criteria and laboratory studies. “Drawings allow self-expression and afford insights into both medical and psychological aspects of a child’s illness experience that are often not expressed by the patient or parent or recognized by the clinician,” they concluded.

To see examples of the children’s drawings, click here.

—Jake Remaly

Suggested Reading

Schott GD. Exploring the visual hallucinations of migraine aura: the tacit contribution of illustration. Brain. 2007;130(Pt 6):1690-1703.

Stafstrom CE, Rostasy K, Minster A. The usefulness of children’s drawings in the diagnosis of headache. Pediatrics. 2002;109(3):460-472.