ACS Surgery News

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

[email protected]

On Twitter @maryjodales

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

[email protected]

On Twitter @maryjodales

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

[email protected]

On Twitter @maryjodales

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

Hospitals are doing a better job at avoiding preventable medical errors, injuries, accidents, and infections, according to a new report card from the Leapfrog Group.

Since 2012, average safety scores have improved by 6.3%. And nearly one-third of the more than 2,500 hospitals evaluated by the Leapfrog Group had a 10% or greater improvement in their overall safety performance since 2012.

"Hospitals are making incremental improvements indicating they are becoming safer," Leah Binder, president and CEO of the Leapfrog Group, said during a press conference.

Ms. Binder called the new data the "most important evidence to date of across-the-board improvement in patient safety."

The Leapfrog Group, a not-for-profit organization that conducts regular surveys of hospital quality, released its national report card on hospital safety on April 29.

The group calculated the grades according to performance on 28 process and outcomes measures of patient safety from the use of computerized physician order entry systems to death among surgical inpatients.

The composite safety scores are based on publicly available data from the Centers for Medicare & Medicaid Services, the Leapfrog Hospital Survey, and the American Hospital Association’s annual survey.

Hospitals were given a safety score based on those measures and the score was converted in a letter grade (A through F). Hospitals that scored 0.6 standard deviations or more above the mean earned an "A." To earn an "F," hospitals had to score more than 3.0 standard deviations below the mean.

Of the 2,523 hospitals issued a hospital safety score nationwide, 32% earned an "A," 26% earned a "B," 35% earned a "C," 6% earned a "D," and 1% earned an "F."

Maine has the highest percentage of top-rated hospitals, with 74% of its hospitals earning an "A" grade. Massachusetts was ranked second nationally, with 70% of its 64 graded hospitals earning the top grade. South Dakota, Illinois, and Hawaii rounded out the top five.

The poorest performers were in Connecticut, Idaho, Nebraska, Wyoming, and the District of Columbia. No hospital in those states or DC earned an "A" grade.

The current report reflects 2012 performance, with some data from early 2013. The report ranks general acute care hospitals that had enough publicly available data to allow for scoring.

The greatest improvements were seen among the 15 process measures evaluated, said Missy Danforth, Leapfrog Group’s senior director of hospital ratings. In particular, there were across-the-board improvements in the adoption of computerized provider order entry (CPOE).

There have been incremental improvements in the Surgical Care Improvement Project (SCIP), which measures adherence on starting and stopping antibiotics, removing urinary catheters, and the use of appropriate venous thromboembolism prophylaxis, Ms. Danforth said.

"It’s clear that we’re headed in the right direction," she said during the press conference.

But improvements have been slower on the 13 outcomes measures, she said. While there have been small improvements over time in reducing central line–associated bloodstream infection rates, other measures, such as catheter-associated urinary tract infection rates, still need improvement.

Dr. Alex Carbo, a hospitalist at Beth Israel Deaconess Medical Center in Boston, praised the Leapfrog Group for helping to draw attention to preventable infections.

"Any time we shine a light on something, that’s going to help drive behavior," said Dr. Carbo, who teaches quality improvement and safety to residents at Beth Israel, which received an "A" in the Leapfrog Group’s report.

Fifteen years ago, central line–associated bloodstream infections were largely considered a cost of doing business, he said, but today nearly all hospitals are focused on this problem. "Everyone is trying to reduce infections that are preventable," he said in an interview.

[email protected]

On Twitter @maryellenny

Hospitals are doing a better job at avoiding preventable medical errors, injuries, accidents, and infections, according to a new report card from the Leapfrog Group.

Since 2012, average safety scores have improved by 6.3%. And nearly one-third of the more than 2,500 hospitals evaluated by the Leapfrog Group had a 10% or greater improvement in their overall safety performance since 2012.

"Hospitals are making incremental improvements indicating they are becoming safer," Leah Binder, president and CEO of the Leapfrog Group, said during a press conference.

Ms. Binder called the new data the "most important evidence to date of across-the-board improvement in patient safety."

The Leapfrog Group, a not-for-profit organization that conducts regular surveys of hospital quality, released its national report card on hospital safety on April 29.

The group calculated the grades according to performance on 28 process and outcomes measures of patient safety from the use of computerized physician order entry systems to death among surgical inpatients.

The composite safety scores are based on publicly available data from the Centers for Medicare & Medicaid Services, the Leapfrog Hospital Survey, and the American Hospital Association’s annual survey.

Hospitals were given a safety score based on those measures and the score was converted in a letter grade (A through F). Hospitals that scored 0.6 standard deviations or more above the mean earned an "A." To earn an "F," hospitals had to score more than 3.0 standard deviations below the mean.

Of the 2,523 hospitals issued a hospital safety score nationwide, 32% earned an "A," 26% earned a "B," 35% earned a "C," 6% earned a "D," and 1% earned an "F."

Maine has the highest percentage of top-rated hospitals, with 74% of its hospitals earning an "A" grade. Massachusetts was ranked second nationally, with 70% of its 64 graded hospitals earning the top grade. South Dakota, Illinois, and Hawaii rounded out the top five.

The poorest performers were in Connecticut, Idaho, Nebraska, Wyoming, and the District of Columbia. No hospital in those states or DC earned an "A" grade.

The current report reflects 2012 performance, with some data from early 2013. The report ranks general acute care hospitals that had enough publicly available data to allow for scoring.

The greatest improvements were seen among the 15 process measures evaluated, said Missy Danforth, Leapfrog Group’s senior director of hospital ratings. In particular, there were across-the-board improvements in the adoption of computerized provider order entry (CPOE).

There have been incremental improvements in the Surgical Care Improvement Project (SCIP), which measures adherence on starting and stopping antibiotics, removing urinary catheters, and the use of appropriate venous thromboembolism prophylaxis, Ms. Danforth said.

"It’s clear that we’re headed in the right direction," she said during the press conference.

But improvements have been slower on the 13 outcomes measures, she said. While there have been small improvements over time in reducing central line–associated bloodstream infection rates, other measures, such as catheter-associated urinary tract infection rates, still need improvement.

Dr. Alex Carbo, a hospitalist at Beth Israel Deaconess Medical Center in Boston, praised the Leapfrog Group for helping to draw attention to preventable infections.

"Any time we shine a light on something, that’s going to help drive behavior," said Dr. Carbo, who teaches quality improvement and safety to residents at Beth Israel, which received an "A" in the Leapfrog Group’s report.

Fifteen years ago, central line–associated bloodstream infections were largely considered a cost of doing business, he said, but today nearly all hospitals are focused on this problem. "Everyone is trying to reduce infections that are preventable," he said in an interview.

[email protected]

On Twitter @maryellenny

Hospitals are doing a better job at avoiding preventable medical errors, injuries, accidents, and infections, according to a new report card from the Leapfrog Group.

Since 2012, average safety scores have improved by 6.3%. And nearly one-third of the more than 2,500 hospitals evaluated by the Leapfrog Group had a 10% or greater improvement in their overall safety performance since 2012.

"Hospitals are making incremental improvements indicating they are becoming safer," Leah Binder, president and CEO of the Leapfrog Group, said during a press conference.

Ms. Binder called the new data the "most important evidence to date of across-the-board improvement in patient safety."

The Leapfrog Group, a not-for-profit organization that conducts regular surveys of hospital quality, released its national report card on hospital safety on April 29.

The group calculated the grades according to performance on 28 process and outcomes measures of patient safety from the use of computerized physician order entry systems to death among surgical inpatients.

The composite safety scores are based on publicly available data from the Centers for Medicare & Medicaid Services, the Leapfrog Hospital Survey, and the American Hospital Association’s annual survey.

Hospitals were given a safety score based on those measures and the score was converted in a letter grade (A through F). Hospitals that scored 0.6 standard deviations or more above the mean earned an "A." To earn an "F," hospitals had to score more than 3.0 standard deviations below the mean.

Of the 2,523 hospitals issued a hospital safety score nationwide, 32% earned an "A," 26% earned a "B," 35% earned a "C," 6% earned a "D," and 1% earned an "F."

Maine has the highest percentage of top-rated hospitals, with 74% of its hospitals earning an "A" grade. Massachusetts was ranked second nationally, with 70% of its 64 graded hospitals earning the top grade. South Dakota, Illinois, and Hawaii rounded out the top five.

The poorest performers were in Connecticut, Idaho, Nebraska, Wyoming, and the District of Columbia. No hospital in those states or DC earned an "A" grade.

The current report reflects 2012 performance, with some data from early 2013. The report ranks general acute care hospitals that had enough publicly available data to allow for scoring.

The greatest improvements were seen among the 15 process measures evaluated, said Missy Danforth, Leapfrog Group’s senior director of hospital ratings. In particular, there were across-the-board improvements in the adoption of computerized provider order entry (CPOE).

There have been incremental improvements in the Surgical Care Improvement Project (SCIP), which measures adherence on starting and stopping antibiotics, removing urinary catheters, and the use of appropriate venous thromboembolism prophylaxis, Ms. Danforth said.

"It’s clear that we’re headed in the right direction," she said during the press conference.

But improvements have been slower on the 13 outcomes measures, she said. While there have been small improvements over time in reducing central line–associated bloodstream infection rates, other measures, such as catheter-associated urinary tract infection rates, still need improvement.

Dr. Alex Carbo, a hospitalist at Beth Israel Deaconess Medical Center in Boston, praised the Leapfrog Group for helping to draw attention to preventable infections.

"Any time we shine a light on something, that’s going to help drive behavior," said Dr. Carbo, who teaches quality improvement and safety to residents at Beth Israel, which received an "A" in the Leapfrog Group’s report.

Fifteen years ago, central line–associated bloodstream infections were largely considered a cost of doing business, he said, but today nearly all hospitals are focused on this problem. "Everyone is trying to reduce infections that are preventable," he said in an interview.

[email protected]

On Twitter @maryellenny

PARIS – Adding local anesthetic to the wound during total hip replacement surgery for osteoarthritis reduced chronic pain, according to a double-blind, randomized controlled trial.

At 12 months postoperative, the number of patients with severe pain was 8.6% with standard care, compared with 1.4% among those who also received 60 mL of 0.25% bupivacaine with lidocaine (Xylocaine) 1% with adrenaline 100 mcg/20 mL injected directly into the wound prior to closure.

Patrice Wendling/Frontline Medical News

The difference was statistically significant (P = .004; odds ratio, 10.19), but the confidence intervals were wide (95% C.I., 2.10-49.55) because of the small number of patients with severe pain, Vikki Wylde, Ph.D., said at the World Congress on Osteoarthritis.

She noted that 7%-23% of patients report moderate to severe chronic pain in the long term after total hip replacement, according to a recent systematic review (BMJ Open 2012:2:e000435), and that the severity of postoperative pain is a known risk factor for chronic postsurgical pain.

Local anesthetic wound infiltration has been shown to be effective at reducing the severity of acute postoperative pain after total hip replacement (J. Am Coll. Surg. 2006:203:914-32), but this is the first double-blind trial to assess its long-term effects.

Investigators at high-volume orthopedic centers in the United Kingdom randomly assigned 322 patients undergoing total hip replacement for osteoarthritis to standard care (spinal anesthesia with or without general anesthesia) alone or with local anesthetic infiltration. The primary outcome was WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale scores at 12 months postoperatively.

Use of in-patient analgesia or length of hospitalization did not differ between the groups, said Dr. Wylde, a research associate with the University of Bristol, England. Acute postoperative pain severity was also similar, except that patients in the intervention group reported less severe pain on postoperative night 2 (P = .008). This was unexpected, but the study was not powered to detect differences in these secondary measures, and no conclusions can be drawn from these data, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

There were no differences in other secondary measures including the WOMAC function or stiffness scales or in ICOAP (Intermittent and Constant Osteoarthritis Pain) scores.

Local anesthetic infiltration, however, significantly reduced neuropathic pain at 12 months, as assessed using the PainDETECT questionnaire, Dr. Wylde said.

"Our study suggests that local anesthetic infiltration is unlikely to change long-term pain outcomes for the majority of patients, but potentially can improve pain relief for a small number of patients who may otherwise go on to develop severe long-term pain after surgery," she concluded.

In a separate interview, Dr. Jeffrey Katz, codirector, Brigham Spine Center, Brigham & Women’s Hospital and professor at Harvard Medical School, both in Boston, said the study was very interesting mechanistically and potentially interesting from a public health standpoint because there are about 400,000 hips done a year in the United States and thus 4,000 or so of these patients are having chronic pain. Moreover, the problem of chronic pain after surgery is even more common in the knee than in the hip.

"The difference in severe pain of 8% vs. 1% or 2% is a striking difference, but it’s a small incidence, and so it does bear replication," he added. "I thought it was a very exciting study and think it’s important information for folks to begin to work with and might change practice."

Dr. Wylde reported funding from the National Institute for Health Research, London.

[email protected]

PARIS – Adding local anesthetic to the wound during total hip replacement surgery for osteoarthritis reduced chronic pain, according to a double-blind, randomized controlled trial.

At 12 months postoperative, the number of patients with severe pain was 8.6% with standard care, compared with 1.4% among those who also received 60 mL of 0.25% bupivacaine with lidocaine (Xylocaine) 1% with adrenaline 100 mcg/20 mL injected directly into the wound prior to closure.

Patrice Wendling/Frontline Medical News

The difference was statistically significant (P = .004; odds ratio, 10.19), but the confidence intervals were wide (95% C.I., 2.10-49.55) because of the small number of patients with severe pain, Vikki Wylde, Ph.D., said at the World Congress on Osteoarthritis.

She noted that 7%-23% of patients report moderate to severe chronic pain in the long term after total hip replacement, according to a recent systematic review (BMJ Open 2012:2:e000435), and that the severity of postoperative pain is a known risk factor for chronic postsurgical pain.

Local anesthetic wound infiltration has been shown to be effective at reducing the severity of acute postoperative pain after total hip replacement (J. Am Coll. Surg. 2006:203:914-32), but this is the first double-blind trial to assess its long-term effects.

Investigators at high-volume orthopedic centers in the United Kingdom randomly assigned 322 patients undergoing total hip replacement for osteoarthritis to standard care (spinal anesthesia with or without general anesthesia) alone or with local anesthetic infiltration. The primary outcome was WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale scores at 12 months postoperatively.

Use of in-patient analgesia or length of hospitalization did not differ between the groups, said Dr. Wylde, a research associate with the University of Bristol, England. Acute postoperative pain severity was also similar, except that patients in the intervention group reported less severe pain on postoperative night 2 (P = .008). This was unexpected, but the study was not powered to detect differences in these secondary measures, and no conclusions can be drawn from these data, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

There were no differences in other secondary measures including the WOMAC function or stiffness scales or in ICOAP (Intermittent and Constant Osteoarthritis Pain) scores.

Local anesthetic infiltration, however, significantly reduced neuropathic pain at 12 months, as assessed using the PainDETECT questionnaire, Dr. Wylde said.

"Our study suggests that local anesthetic infiltration is unlikely to change long-term pain outcomes for the majority of patients, but potentially can improve pain relief for a small number of patients who may otherwise go on to develop severe long-term pain after surgery," she concluded.

In a separate interview, Dr. Jeffrey Katz, codirector, Brigham Spine Center, Brigham & Women’s Hospital and professor at Harvard Medical School, both in Boston, said the study was very interesting mechanistically and potentially interesting from a public health standpoint because there are about 400,000 hips done a year in the United States and thus 4,000 or so of these patients are having chronic pain. Moreover, the problem of chronic pain after surgery is even more common in the knee than in the hip.

"The difference in severe pain of 8% vs. 1% or 2% is a striking difference, but it’s a small incidence, and so it does bear replication," he added. "I thought it was a very exciting study and think it’s important information for folks to begin to work with and might change practice."

Dr. Wylde reported funding from the National Institute for Health Research, London.

[email protected]

PARIS – Adding local anesthetic to the wound during total hip replacement surgery for osteoarthritis reduced chronic pain, according to a double-blind, randomized controlled trial.

At 12 months postoperative, the number of patients with severe pain was 8.6% with standard care, compared with 1.4% among those who also received 60 mL of 0.25% bupivacaine with lidocaine (Xylocaine) 1% with adrenaline 100 mcg/20 mL injected directly into the wound prior to closure.

Patrice Wendling/Frontline Medical News

The difference was statistically significant (P = .004; odds ratio, 10.19), but the confidence intervals were wide (95% C.I., 2.10-49.55) because of the small number of patients with severe pain, Vikki Wylde, Ph.D., said at the World Congress on Osteoarthritis.

She noted that 7%-23% of patients report moderate to severe chronic pain in the long term after total hip replacement, according to a recent systematic review (BMJ Open 2012:2:e000435), and that the severity of postoperative pain is a known risk factor for chronic postsurgical pain.

Local anesthetic wound infiltration has been shown to be effective at reducing the severity of acute postoperative pain after total hip replacement (J. Am Coll. Surg. 2006:203:914-32), but this is the first double-blind trial to assess its long-term effects.

Investigators at high-volume orthopedic centers in the United Kingdom randomly assigned 322 patients undergoing total hip replacement for osteoarthritis to standard care (spinal anesthesia with or without general anesthesia) alone or with local anesthetic infiltration. The primary outcome was WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale scores at 12 months postoperatively.

Use of in-patient analgesia or length of hospitalization did not differ between the groups, said Dr. Wylde, a research associate with the University of Bristol, England. Acute postoperative pain severity was also similar, except that patients in the intervention group reported less severe pain on postoperative night 2 (P = .008). This was unexpected, but the study was not powered to detect differences in these secondary measures, and no conclusions can be drawn from these data, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

There were no differences in other secondary measures including the WOMAC function or stiffness scales or in ICOAP (Intermittent and Constant Osteoarthritis Pain) scores.

Local anesthetic infiltration, however, significantly reduced neuropathic pain at 12 months, as assessed using the PainDETECT questionnaire, Dr. Wylde said.

"Our study suggests that local anesthetic infiltration is unlikely to change long-term pain outcomes for the majority of patients, but potentially can improve pain relief for a small number of patients who may otherwise go on to develop severe long-term pain after surgery," she concluded.

In a separate interview, Dr. Jeffrey Katz, codirector, Brigham Spine Center, Brigham & Women’s Hospital and professor at Harvard Medical School, both in Boston, said the study was very interesting mechanistically and potentially interesting from a public health standpoint because there are about 400,000 hips done a year in the United States and thus 4,000 or so of these patients are having chronic pain. Moreover, the problem of chronic pain after surgery is even more common in the knee than in the hip.

"The difference in severe pain of 8% vs. 1% or 2% is a striking difference, but it’s a small incidence, and so it does bear replication," he added. "I thought it was a very exciting study and think it’s important information for folks to begin to work with and might change practice."

Dr. Wylde reported funding from the National Institute for Health Research, London.

[email protected]

PARIS – Primary care physicians are only moderately confident about which patients to refer for total hip or knee replacement, according to cross-sectional survey of 218 physicians.

One-quarter (27.4%) were unsure about the risks of total joint arthroplasty (TJA), and 44.3% reported they were discouraged from referring patients for TJA because of a lack of clarity about surgical indications.

When asked how confident they were in deciding which patients should be referred to orthopedic surgery for consideration of hip or knee replacement, the average response was 6.9 on a 10-point scale from "not at all" to "highly confident," indicating a moderate level of confidence, Esther* Waugh, Ph.D., reported at the World Congress on Osteoarthritis.

"The results suggest the need for increased guidance for primary care physicians regarding which patient, and when, total joint arthroplasty should be considered," she concluded. "While lack of confidence does not necessarily equate with decreased competence, additional clarity may result in enhanced physician confidence, improved decision making, and ultimately better surgical outcomes through better patient selection of appropriate candidates."

A total of 376 primary care physicians (PCPs) were recruited from among those providing care to participants of an established community cohort with symptomatic hip or knee osteoarthritis (OA) in Ontario, Canada, with 218 (58%) completing the standardized questionnaire by mail or online.

One-third reported seeing more than 10 moderate to severe hip/knee OA patients in the previous 2 weeks.

Most had been in practice for more than 15 years (77%), were in group practice (63%), and were older than age 50 years (65%). One-third practiced in a rural location, and 31% had more than 10 TJA referrals per year.

Interestingly, total hip and total knee arthroplasty was perceived as "very effective" by 53% and 40% of physicians, respectively, according to Dr. Waugh of the physical therapy department at the University of Toronto.

Still, TJA was viewed as carrying high risks of death by 11.3%, of complications by 35%, and need for revision surgery by 12.3%.

Lower confidence in referring patients for TJA was independently associated with lack of clarity about surgical indications (P less than .0001; parameter estimate, –1.02) and female sex (P = .02; parameter estimate, –0.54), in multiple linear regression analysis.

Both factors were associated with fewer years of practice, she noted. Female physicians were significantly more likely to report fewer years of practice (P less than .0001), fewer OA patients (P = .0004), practicing in a group practice (P = .003), urban practice location (P = .003), and being unsure about risks (P = .02).

Confidence was not associated with uncertainty of TJA risks, volume of OA patients in the prior 2 weeks, group practice, years of practice, or rural practice setting, Dr. Waugh reported at the meeting, sponsored by the Osteoarthritis Research Society International.

Prior research by the University of Toronto team demonstrated underuse of total joint arthroplasty, but concerns have recently been raised regarding possible overuse, particularly in younger patients. In Canada, PCPs are responsible for referrals to orthopedic surgery for TJA. Thus, "inappropriate under- or overuse of TJA may be a consequence of uncertainty among PCPs about indications for TJA," the authors noted in the poster presentation

Conflict of interest disclosures were not available at press time.

[email protected]

*Correction, 5/8/2014: An earlier version of this story misspelled Dr. Esther Waugh's name.

PARIS – Primary care physicians are only moderately confident about which patients to refer for total hip or knee replacement, according to cross-sectional survey of 218 physicians.

One-quarter (27.4%) were unsure about the risks of total joint arthroplasty (TJA), and 44.3% reported they were discouraged from referring patients for TJA because of a lack of clarity about surgical indications.

When asked how confident they were in deciding which patients should be referred to orthopedic surgery for consideration of hip or knee replacement, the average response was 6.9 on a 10-point scale from "not at all" to "highly confident," indicating a moderate level of confidence, Esther* Waugh, Ph.D., reported at the World Congress on Osteoarthritis.

"The results suggest the need for increased guidance for primary care physicians regarding which patient, and when, total joint arthroplasty should be considered," she concluded. "While lack of confidence does not necessarily equate with decreased competence, additional clarity may result in enhanced physician confidence, improved decision making, and ultimately better surgical outcomes through better patient selection of appropriate candidates."

A total of 376 primary care physicians (PCPs) were recruited from among those providing care to participants of an established community cohort with symptomatic hip or knee osteoarthritis (OA) in Ontario, Canada, with 218 (58%) completing the standardized questionnaire by mail or online.

One-third reported seeing more than 10 moderate to severe hip/knee OA patients in the previous 2 weeks.

Most had been in practice for more than 15 years (77%), were in group practice (63%), and were older than age 50 years (65%). One-third practiced in a rural location, and 31% had more than 10 TJA referrals per year.

Interestingly, total hip and total knee arthroplasty was perceived as "very effective" by 53% and 40% of physicians, respectively, according to Dr. Waugh of the physical therapy department at the University of Toronto.

Still, TJA was viewed as carrying high risks of death by 11.3%, of complications by 35%, and need for revision surgery by 12.3%.

Lower confidence in referring patients for TJA was independently associated with lack of clarity about surgical indications (P less than .0001; parameter estimate, –1.02) and female sex (P = .02; parameter estimate, –0.54), in multiple linear regression analysis.

Both factors were associated with fewer years of practice, she noted. Female physicians were significantly more likely to report fewer years of practice (P less than .0001), fewer OA patients (P = .0004), practicing in a group practice (P = .003), urban practice location (P = .003), and being unsure about risks (P = .02).

Confidence was not associated with uncertainty of TJA risks, volume of OA patients in the prior 2 weeks, group practice, years of practice, or rural practice setting, Dr. Waugh reported at the meeting, sponsored by the Osteoarthritis Research Society International.

Prior research by the University of Toronto team demonstrated underuse of total joint arthroplasty, but concerns have recently been raised regarding possible overuse, particularly in younger patients. In Canada, PCPs are responsible for referrals to orthopedic surgery for TJA. Thus, "inappropriate under- or overuse of TJA may be a consequence of uncertainty among PCPs about indications for TJA," the authors noted in the poster presentation

Conflict of interest disclosures were not available at press time.

[email protected]

*Correction, 5/8/2014: An earlier version of this story misspelled Dr. Esther Waugh's name.

PARIS – Primary care physicians are only moderately confident about which patients to refer for total hip or knee replacement, according to cross-sectional survey of 218 physicians.

One-quarter (27.4%) were unsure about the risks of total joint arthroplasty (TJA), and 44.3% reported they were discouraged from referring patients for TJA because of a lack of clarity about surgical indications.

When asked how confident they were in deciding which patients should be referred to orthopedic surgery for consideration of hip or knee replacement, the average response was 6.9 on a 10-point scale from "not at all" to "highly confident," indicating a moderate level of confidence, Esther* Waugh, Ph.D., reported at the World Congress on Osteoarthritis.

"The results suggest the need for increased guidance for primary care physicians regarding which patient, and when, total joint arthroplasty should be considered," she concluded. "While lack of confidence does not necessarily equate with decreased competence, additional clarity may result in enhanced physician confidence, improved decision making, and ultimately better surgical outcomes through better patient selection of appropriate candidates."

A total of 376 primary care physicians (PCPs) were recruited from among those providing care to participants of an established community cohort with symptomatic hip or knee osteoarthritis (OA) in Ontario, Canada, with 218 (58%) completing the standardized questionnaire by mail or online.

One-third reported seeing more than 10 moderate to severe hip/knee OA patients in the previous 2 weeks.

Most had been in practice for more than 15 years (77%), were in group practice (63%), and were older than age 50 years (65%). One-third practiced in a rural location, and 31% had more than 10 TJA referrals per year.

Interestingly, total hip and total knee arthroplasty was perceived as "very effective" by 53% and 40% of physicians, respectively, according to Dr. Waugh of the physical therapy department at the University of Toronto.

Still, TJA was viewed as carrying high risks of death by 11.3%, of complications by 35%, and need for revision surgery by 12.3%.

Lower confidence in referring patients for TJA was independently associated with lack of clarity about surgical indications (P less than .0001; parameter estimate, –1.02) and female sex (P = .02; parameter estimate, –0.54), in multiple linear regression analysis.

Both factors were associated with fewer years of practice, she noted. Female physicians were significantly more likely to report fewer years of practice (P less than .0001), fewer OA patients (P = .0004), practicing in a group practice (P = .003), urban practice location (P = .003), and being unsure about risks (P = .02).

Confidence was not associated with uncertainty of TJA risks, volume of OA patients in the prior 2 weeks, group practice, years of practice, or rural practice setting, Dr. Waugh reported at the meeting, sponsored by the Osteoarthritis Research Society International.

Prior research by the University of Toronto team demonstrated underuse of total joint arthroplasty, but concerns have recently been raised regarding possible overuse, particularly in younger patients. In Canada, PCPs are responsible for referrals to orthopedic surgery for TJA. Thus, "inappropriate under- or overuse of TJA may be a consequence of uncertainty among PCPs about indications for TJA," the authors noted in the poster presentation

Conflict of interest disclosures were not available at press time.

[email protected]

*Correction, 5/8/2014: An earlier version of this story misspelled Dr. Esther Waugh's name.

PARIS – After total hip or knee replacement, men are at higher risk than women for heart attack, infection, and revision surgery, according to a large database analysis.

The elevated risk was particularly apparent following total knee arthroplasty (TKA), Dr. Gillian Hawker said at the World Congress on Osteoarthritis.

Prior research suggests that younger patients and males who have joint replacement are at higher risk of certain complications such as early revision, and that joint replacement is underutilized in women.

Based on the current study, underuse of total joint arthroplasty among women versus men does not appear to be explained by higher surgical risk, she said.

The investigators used administrative databases to analyze 97,445 patients who underwent primary, elective total joint arthroplasty in Ontario, Canada, between 2002 and 2009. In all, 59,564 patients (39% male) underwent TKA and 37,881 patients (46% male) had total hip arthroplasty.

Knee arthroplasty

Men had more acute myocardial infarctions within 90 days of undergoing TKA than did women (1.1% vs. 0.8%), more infection within 2 years of surgery (1.1% vs. 0.7%), and more revision TKA within 2 years (1.5% vs. 1%), said Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital, Toronto.

At baseline, the men were similar in age to women, but less likely to be frail (4% vs. 6.7%) and more likely to have a Charlson Comorbidity Index score of 2 or more (5.7% vs. 3.4%).

In Cox regression analysis, the risk for acute MI was significantly increased (hazard ratio, 1.79; P less than .0001) after adjustment for age, sex, income quartile, rurality, frailty, Charlson score, and hospital volume, she said.

Men were also at significantly increased risk for infection (HR, 1.67; P less than .0001) and revision TKA within 2 years (HR, 1.49; P less than .0001), after further adjustment for surgeon volume.

The investigators, led by colleague and orthopedic surgery resident Bheeshma Ravi, Ph.D., postulate that the increased risk of infection and revision among men is due to the high-impact activities that men may engage in after their prosthesis.

No sex differences were found for venous thromboembolism within 90 days or periprosthetic fracture within 2 years.

Hip arthroplasty

Men undergoing total hip replacement had higher rates of early acute MI than women (0.9% vs. 0.7%), but lower rates of periprosthetic fracture within 2 years (0.3% vs. 0.5%), Dr. Hawker said.

At baseline, male patients were younger than their female counterparts (65 years vs. 70 years) and less likely to be frail (3.5% vs. 6.6%), but more likely to have a Charlson score of 2 or more (5.3% vs. 3.7%).

After full adjustment, men were at significantly increased risk for acute MI (HR, 1.64; P less than .0001) and reduced risk for periprosthetic fracture (HR, 0.52; P = .0005), Dr. Hawker said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

"We think the potential explanations for acute MI after both hip and knee replacement may be additional cardiovascular risk factors," she said. "We did not control for preexisting cardiovascular risk; that is something we are doing now."

The study excluded patients who had a pre–joint replacement fragility fracture, but because of the quality of the data postoperatively and the availability of drug benefit data, "we don’t feel we have adequate control for the presence of osteoporosis," Dr. Hawker observed.

No differences were found between sexes in the hip replacement cohort for infection, death, venous thromboembolism, dislocation, or revision.

Session comoderator Dr. Martin Englund, of Lund (Sweden) University, commented that the study was well conducted and the findings very interesting, but he cautioned against generalizing the results too broadly.

"We have seen before, that results from Sweden are not necessarily the same as in North America," he said in an interview. "I’m sure these results are probably very generalizable in Canada and in that type of health care setting, but may not be the same elsewhere. ... These are also things that might change over time. So we just need to keep monitoring outcomes and repeating these studies and adjust our treatment to what we find."

Dr. Ravi reported fellowship support from the University of Toronto, Canadian Institutes of Health Research, and Women’s College Research Institute.

[email protected]

PARIS – After total hip or knee replacement, men are at higher risk than women for heart attack, infection, and revision surgery, according to a large database analysis.

The elevated risk was particularly apparent following total knee arthroplasty (TKA), Dr. Gillian Hawker said at the World Congress on Osteoarthritis.

Prior research suggests that younger patients and males who have joint replacement are at higher risk of certain complications such as early revision, and that joint replacement is underutilized in women.

Based on the current study, underuse of total joint arthroplasty among women versus men does not appear to be explained by higher surgical risk, she said.

The investigators used administrative databases to analyze 97,445 patients who underwent primary, elective total joint arthroplasty in Ontario, Canada, between 2002 and 2009. In all, 59,564 patients (39% male) underwent TKA and 37,881 patients (46% male) had total hip arthroplasty.

Knee arthroplasty

Men had more acute myocardial infarctions within 90 days of undergoing TKA than did women (1.1% vs. 0.8%), more infection within 2 years of surgery (1.1% vs. 0.7%), and more revision TKA within 2 years (1.5% vs. 1%), said Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital, Toronto.

At baseline, the men were similar in age to women, but less likely to be frail (4% vs. 6.7%) and more likely to have a Charlson Comorbidity Index score of 2 or more (5.7% vs. 3.4%).

In Cox regression analysis, the risk for acute MI was significantly increased (hazard ratio, 1.79; P less than .0001) after adjustment for age, sex, income quartile, rurality, frailty, Charlson score, and hospital volume, she said.

Men were also at significantly increased risk for infection (HR, 1.67; P less than .0001) and revision TKA within 2 years (HR, 1.49; P less than .0001), after further adjustment for surgeon volume.

The investigators, led by colleague and orthopedic surgery resident Bheeshma Ravi, Ph.D., postulate that the increased risk of infection and revision among men is due to the high-impact activities that men may engage in after their prosthesis.

No sex differences were found for venous thromboembolism within 90 days or periprosthetic fracture within 2 years.

Hip arthroplasty

Men undergoing total hip replacement had higher rates of early acute MI than women (0.9% vs. 0.7%), but lower rates of periprosthetic fracture within 2 years (0.3% vs. 0.5%), Dr. Hawker said.

At baseline, male patients were younger than their female counterparts (65 years vs. 70 years) and less likely to be frail (3.5% vs. 6.6%), but more likely to have a Charlson score of 2 or more (5.3% vs. 3.7%).

After full adjustment, men were at significantly increased risk for acute MI (HR, 1.64; P less than .0001) and reduced risk for periprosthetic fracture (HR, 0.52; P = .0005), Dr. Hawker said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

"We think the potential explanations for acute MI after both hip and knee replacement may be additional cardiovascular risk factors," she said. "We did not control for preexisting cardiovascular risk; that is something we are doing now."

The study excluded patients who had a pre–joint replacement fragility fracture, but because of the quality of the data postoperatively and the availability of drug benefit data, "we don’t feel we have adequate control for the presence of osteoporosis," Dr. Hawker observed.

No differences were found between sexes in the hip replacement cohort for infection, death, venous thromboembolism, dislocation, or revision.

Session comoderator Dr. Martin Englund, of Lund (Sweden) University, commented that the study was well conducted and the findings very interesting, but he cautioned against generalizing the results too broadly.

"We have seen before, that results from Sweden are not necessarily the same as in North America," he said in an interview. "I’m sure these results are probably very generalizable in Canada and in that type of health care setting, but may not be the same elsewhere. ... These are also things that might change over time. So we just need to keep monitoring outcomes and repeating these studies and adjust our treatment to what we find."

Dr. Ravi reported fellowship support from the University of Toronto, Canadian Institutes of Health Research, and Women’s College Research Institute.

[email protected]

PARIS – After total hip or knee replacement, men are at higher risk than women for heart attack, infection, and revision surgery, according to a large database analysis.

The elevated risk was particularly apparent following total knee arthroplasty (TKA), Dr. Gillian Hawker said at the World Congress on Osteoarthritis.

Prior research suggests that younger patients and males who have joint replacement are at higher risk of certain complications such as early revision, and that joint replacement is underutilized in women.

Based on the current study, underuse of total joint arthroplasty among women versus men does not appear to be explained by higher surgical risk, she said.

The investigators used administrative databases to analyze 97,445 patients who underwent primary, elective total joint arthroplasty in Ontario, Canada, between 2002 and 2009. In all, 59,564 patients (39% male) underwent TKA and 37,881 patients (46% male) had total hip arthroplasty.

Knee arthroplasty

Men had more acute myocardial infarctions within 90 days of undergoing TKA than did women (1.1% vs. 0.8%), more infection within 2 years of surgery (1.1% vs. 0.7%), and more revision TKA within 2 years (1.5% vs. 1%), said Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital, Toronto.

At baseline, the men were similar in age to women, but less likely to be frail (4% vs. 6.7%) and more likely to have a Charlson Comorbidity Index score of 2 or more (5.7% vs. 3.4%).

In Cox regression analysis, the risk for acute MI was significantly increased (hazard ratio, 1.79; P less than .0001) after adjustment for age, sex, income quartile, rurality, frailty, Charlson score, and hospital volume, she said.

Men were also at significantly increased risk for infection (HR, 1.67; P less than .0001) and revision TKA within 2 years (HR, 1.49; P less than .0001), after further adjustment for surgeon volume.

The investigators, led by colleague and orthopedic surgery resident Bheeshma Ravi, Ph.D., postulate that the increased risk of infection and revision among men is due to the high-impact activities that men may engage in after their prosthesis.

No sex differences were found for venous thromboembolism within 90 days or periprosthetic fracture within 2 years.

Hip arthroplasty

Men undergoing total hip replacement had higher rates of early acute MI than women (0.9% vs. 0.7%), but lower rates of periprosthetic fracture within 2 years (0.3% vs. 0.5%), Dr. Hawker said.

At baseline, male patients were younger than their female counterparts (65 years vs. 70 years) and less likely to be frail (3.5% vs. 6.6%), but more likely to have a Charlson score of 2 or more (5.3% vs. 3.7%).

After full adjustment, men were at significantly increased risk for acute MI (HR, 1.64; P less than .0001) and reduced risk for periprosthetic fracture (HR, 0.52; P = .0005), Dr. Hawker said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

"We think the potential explanations for acute MI after both hip and knee replacement may be additional cardiovascular risk factors," she said. "We did not control for preexisting cardiovascular risk; that is something we are doing now."

The study excluded patients who had a pre–joint replacement fragility fracture, but because of the quality of the data postoperatively and the availability of drug benefit data, "we don’t feel we have adequate control for the presence of osteoporosis," Dr. Hawker observed.

No differences were found between sexes in the hip replacement cohort for infection, death, venous thromboembolism, dislocation, or revision.

Session comoderator Dr. Martin Englund, of Lund (Sweden) University, commented that the study was well conducted and the findings very interesting, but he cautioned against generalizing the results too broadly.

"We have seen before, that results from Sweden are not necessarily the same as in North America," he said in an interview. "I’m sure these results are probably very generalizable in Canada and in that type of health care setting, but may not be the same elsewhere. ... These are also things that might change over time. So we just need to keep monitoring outcomes and repeating these studies and adjust our treatment to what we find."

Dr. Ravi reported fellowship support from the University of Toronto, Canadian Institutes of Health Research, and Women’s College Research Institute.

[email protected]

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

The Food and Drug Administration approval of Hemangeol, a pediatric formulation of propranolol, should reduce the potential for error in increment dosing conversions when treating proliferating infantile hemangiomas that require systemic therapy, according to Dr. Adelaide A. Hebert.

"This represents a real milestone in therapy for patients who have hemangiomas," Dr. Hebert, professor and director of pediatric dermatology at the University of Texas Health Science Center at Houston, said in an interview. "It’s a wonderful step forward for all of us who care for children in the earliest months of life."

Pediatric dermatologists have been using generic propranolol to treat infantile hemangioma for several years. In doing so, "I as well as other pediatric dermatologists have found occasionally that the pharmacist was not as mindful as I wished them to be," said Dr. Hebert, who said that to date she does not have clinical experience with Hemangeol. "There were conversions that were not accurate in the dosing, so the patient occasionally got too much medicine or too little medicine. It was a human error. We picked up on these. With this new medicine, we won’t have that problem. It’s my understanding that [Hemangeol] will go through a specialty pharmacy. It will come with a special syringe to measure how much [drug you’re using]. There’s only one concentration, so I believe that the risk of error will be reduced."

In pivotal, randomized, placebo-controlled multicenter trials, researchers compared four Hemangeol treatment protocols (1 or 3 mg/kg per day for 3 or 6 months) versus placebo in an effort to reach the primary endpoint: complete or nearly complete resolution of the target hemangioma.

In a cohort of 456 infants aged 5 weeks to 5 months with a proliferative infantile hemangioma that required systemic treatment, the investigators found that the treatment dose of 3 mg/kg per day for 6 months had a 60.4% success rate, compared with 3.6% in the placebo group (P less than .0001). They also found that 11.4% of patients required retreatment after initial Hemangeol treatment was stopped.

"It’s unique when we have a situation where we have a drug that was available off label but then gets approved as a new medication," said Dr. Lawrence F. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, which served as one of the Hemangeol study sites. "Propranolol for the treatment of hemangiomas is both a fascinating story and a tremendous breakthrough. The observation was that propranolol was incredibly effective at minimizing the growth and/or shrinking down the blood vessel tumors. This drug approval reflects a very large effort to study both the utility and safety of the drug."

In clinical trials, the most commonly reported adverse events among treated infants were sleep disorders; aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever; diarrhea; and vomiting. Adverse reactions resulted in treatment being stopped in less than 2% of treated patients.

"The FDA has been more conservative in recent years, so to get a drug that’s available and approved for small children is an enormous accomplishment," Dr. Hebert said. "It acknowledges that this is a significant part of health care in this pediatric population. I think each of us feels even more comfortable using a medicine specifically designed to meet this unmet need. The greatest challenge will be not the efficacy of the medicine, but difficulty getting it through [health] insurance [plans]."

Hemangeol is expected to be available in June 2014 and is marketed by Pierre Fabre Dermatologie in Castres, France. Dr. Eichenfield reported having served as a clinical investigator for, and/or consultant to, Pierre Fabre. Dr. Hebert disclosed that she has received one honorarium from Pierre Fabre for a single advisory board.

[email protected]

The Food and Drug Administration approval of Hemangeol, a pediatric formulation of propranolol, should reduce the potential for error in increment dosing conversions when treating proliferating infantile hemangiomas that require systemic therapy, according to Dr. Adelaide A. Hebert.

"This represents a real milestone in therapy for patients who have hemangiomas," Dr. Hebert, professor and director of pediatric dermatology at the University of Texas Health Science Center at Houston, said in an interview. "It’s a wonderful step forward for all of us who care for children in the earliest months of life."

Pediatric dermatologists have been using generic propranolol to treat infantile hemangioma for several years. In doing so, "I as well as other pediatric dermatologists have found occasionally that the pharmacist was not as mindful as I wished them to be," said Dr. Hebert, who said that to date she does not have clinical experience with Hemangeol. "There were conversions that were not accurate in the dosing, so the patient occasionally got too much medicine or too little medicine. It was a human error. We picked up on these. With this new medicine, we won’t have that problem. It’s my understanding that [Hemangeol] will go through a specialty pharmacy. It will come with a special syringe to measure how much [drug you’re using]. There’s only one concentration, so I believe that the risk of error will be reduced."

In pivotal, randomized, placebo-controlled multicenter trials, researchers compared four Hemangeol treatment protocols (1 or 3 mg/kg per day for 3 or 6 months) versus placebo in an effort to reach the primary endpoint: complete or nearly complete resolution of the target hemangioma.

In a cohort of 456 infants aged 5 weeks to 5 months with a proliferative infantile hemangioma that required systemic treatment, the investigators found that the treatment dose of 3 mg/kg per day for 6 months had a 60.4% success rate, compared with 3.6% in the placebo group (P less than .0001). They also found that 11.4% of patients required retreatment after initial Hemangeol treatment was stopped.

"It’s unique when we have a situation where we have a drug that was available off label but then gets approved as a new medication," said Dr. Lawrence F. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, which served as one of the Hemangeol study sites. "Propranolol for the treatment of hemangiomas is both a fascinating story and a tremendous breakthrough. The observation was that propranolol was incredibly effective at minimizing the growth and/or shrinking down the blood vessel tumors. This drug approval reflects a very large effort to study both the utility and safety of the drug."

In clinical trials, the most commonly reported adverse events among treated infants were sleep disorders; aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever; diarrhea; and vomiting. Adverse reactions resulted in treatment being stopped in less than 2% of treated patients.

"The FDA has been more conservative in recent years, so to get a drug that’s available and approved for small children is an enormous accomplishment," Dr. Hebert said. "It acknowledges that this is a significant part of health care in this pediatric population. I think each of us feels even more comfortable using a medicine specifically designed to meet this unmet need. The greatest challenge will be not the efficacy of the medicine, but difficulty getting it through [health] insurance [plans]."

Hemangeol is expected to be available in June 2014 and is marketed by Pierre Fabre Dermatologie in Castres, France. Dr. Eichenfield reported having served as a clinical investigator for, and/or consultant to, Pierre Fabre. Dr. Hebert disclosed that she has received one honorarium from Pierre Fabre for a single advisory board.

[email protected]

The Food and Drug Administration approval of Hemangeol, a pediatric formulation of propranolol, should reduce the potential for error in increment dosing conversions when treating proliferating infantile hemangiomas that require systemic therapy, according to Dr. Adelaide A. Hebert.

"This represents a real milestone in therapy for patients who have hemangiomas," Dr. Hebert, professor and director of pediatric dermatology at the University of Texas Health Science Center at Houston, said in an interview. "It’s a wonderful step forward for all of us who care for children in the earliest months of life."

Pediatric dermatologists have been using generic propranolol to treat infantile hemangioma for several years. In doing so, "I as well as other pediatric dermatologists have found occasionally that the pharmacist was not as mindful as I wished them to be," said Dr. Hebert, who said that to date she does not have clinical experience with Hemangeol. "There were conversions that were not accurate in the dosing, so the patient occasionally got too much medicine or too little medicine. It was a human error. We picked up on these. With this new medicine, we won’t have that problem. It’s my understanding that [Hemangeol] will go through a specialty pharmacy. It will come with a special syringe to measure how much [drug you’re using]. There’s only one concentration, so I believe that the risk of error will be reduced."

In pivotal, randomized, placebo-controlled multicenter trials, researchers compared four Hemangeol treatment protocols (1 or 3 mg/kg per day for 3 or 6 months) versus placebo in an effort to reach the primary endpoint: complete or nearly complete resolution of the target hemangioma.

In a cohort of 456 infants aged 5 weeks to 5 months with a proliferative infantile hemangioma that required systemic treatment, the investigators found that the treatment dose of 3 mg/kg per day for 6 months had a 60.4% success rate, compared with 3.6% in the placebo group (P less than .0001). They also found that 11.4% of patients required retreatment after initial Hemangeol treatment was stopped.

"It’s unique when we have a situation where we have a drug that was available off label but then gets approved as a new medication," said Dr. Lawrence F. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, which served as one of the Hemangeol study sites. "Propranolol for the treatment of hemangiomas is both a fascinating story and a tremendous breakthrough. The observation was that propranolol was incredibly effective at minimizing the growth and/or shrinking down the blood vessel tumors. This drug approval reflects a very large effort to study both the utility and safety of the drug."

In clinical trials, the most commonly reported adverse events among treated infants were sleep disorders; aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever; diarrhea; and vomiting. Adverse reactions resulted in treatment being stopped in less than 2% of treated patients.

"The FDA has been more conservative in recent years, so to get a drug that’s available and approved for small children is an enormous accomplishment," Dr. Hebert said. "It acknowledges that this is a significant part of health care in this pediatric population. I think each of us feels even more comfortable using a medicine specifically designed to meet this unmet need. The greatest challenge will be not the efficacy of the medicine, but difficulty getting it through [health] insurance [plans]."

Hemangeol is expected to be available in June 2014 and is marketed by Pierre Fabre Dermatologie in Castres, France. Dr. Eichenfield reported having served as a clinical investigator for, and/or consultant to, Pierre Fabre. Dr. Hebert disclosed that she has received one honorarium from Pierre Fabre for a single advisory board.

[email protected]