Jeff Evans

In a public health advisory, the Food and Drug Administration urged health care professionals and their patients and caregivers to switch to hydrofluoroalkane-propelled albuterol inhalers before chlorofluorocarbon-propelled inhalers are taken off the market Jan. 1, 2009.

Chlorofluorocarbon (CFC)-propelled albuterol inhalers will not be produced or sold in the United States in 2009 and beyond in order to meet mandates authorized by the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances That Deplete the Ozone Layer. CFCs contribute to the depletion of the ozone layer.

Three hydrofluoroalkane (HFA)-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. An inhaler containing levalbuterol (similar to albuterol) is available as Xopenex HFA Inhalation Aerosol. HFA-propelled albuterol inhalers are not currently available in generic forms.

“Manufacturers of the HFA versions have created financial assistance programs and eased income restrictions for low-income patients. Physician, pharmacy, and manufacturer's Web sites are also offering coupons for those who face a higher copay for these products,” said Deborah Henderson, senior adviser in the Office of Executive Programs at the FDA's Center for Drug Evaluation and Research.

The spray from HFA-propelled inhalers may taste and feel different than CFC-propelled inhalers. The properties of HFA and the weaker force of its spray from the inhalers make it “important to clean and prime the inhalers in order for the right dose of medicine to be delivered. Patients should be reinforced with the knowledge that they need to follow the directions very carefully,” Ms. Henderson said in a press teleconference.

The changes do not affect the medication's safety or effectiveness, she noted.

In the beginning of 2008, HFA-propelled albuterol inhalers composed only 5%–10% of albuterol inhaler sales in the market—even though the FDA in 2005 had finalized the end date for the sale of CFC-propelled albuterol inhalers. HFA-propelled albuterol inhalers now account for about 65% of the market, according to Dr. Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.

About 52 million albuterol metered-dose inhalers are prescribed in the United States each year, making them among the top 10 prescribed medications in the country, Dr. Chowdhury said during the teleconference.

Over the years, many manufacturers have stopped producing CFC-propelled albuterol inhalers. Currently, only one company, Armstrong Pharmaceuticals Inc., manufactures generic CFC-propelled albuterol inhalers, he said.

In a public health advisory, the Food and Drug Administration urged health care professionals and their patients and caregivers to switch to hydrofluoroalkane-propelled albuterol inhalers before chlorofluorocarbon-propelled inhalers are taken off the market Jan. 1, 2009.

Chlorofluorocarbon (CFC)-propelled albuterol inhalers will not be produced or sold in the United States in 2009 and beyond in order to meet mandates authorized by the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances That Deplete the Ozone Layer. CFCs contribute to the depletion of the ozone layer.

Three hydrofluoroalkane (HFA)-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. An inhaler containing levalbuterol (similar to albuterol) is available as Xopenex HFA Inhalation Aerosol. HFA-propelled albuterol inhalers are not currently available in generic forms.

“Manufacturers of the HFA versions have created financial assistance programs and eased income restrictions for low-income patients. Physician, pharmacy, and manufacturer's Web sites are also offering coupons for those who face a higher copay for these products,” said Deborah Henderson, senior adviser in the Office of Executive Programs at the FDA's Center for Drug Evaluation and Research.

The spray from HFA-propelled inhalers may taste and feel different than CFC-propelled inhalers. The properties of HFA and the weaker force of its spray from the inhalers make it “important to clean and prime the inhalers in order for the right dose of medicine to be delivered. Patients should be reinforced with the knowledge that they need to follow the directions very carefully,” Ms. Henderson said in a press teleconference.

The changes do not affect the medication's safety or effectiveness, she noted.

In the beginning of 2008, HFA-propelled albuterol inhalers composed only 5%–10% of albuterol inhaler sales in the market—even though the FDA in 2005 had finalized the end date for the sale of CFC-propelled albuterol inhalers. HFA-propelled albuterol inhalers now account for about 65% of the market, according to Dr. Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.

About 52 million albuterol metered-dose inhalers are prescribed in the United States each year, making them among the top 10 prescribed medications in the country, Dr. Chowdhury said during the teleconference.

Over the years, many manufacturers have stopped producing CFC-propelled albuterol inhalers. Currently, only one company, Armstrong Pharmaceuticals Inc., manufactures generic CFC-propelled albuterol inhalers, he said.

In a public health advisory, the Food and Drug Administration urged health care professionals and their patients and caregivers to switch to hydrofluoroalkane-propelled albuterol inhalers before chlorofluorocarbon-propelled inhalers are taken off the market Jan. 1, 2009.

Chlorofluorocarbon (CFC)-propelled albuterol inhalers will not be produced or sold in the United States in 2009 and beyond in order to meet mandates authorized by the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances That Deplete the Ozone Layer. CFCs contribute to the depletion of the ozone layer.

Three hydrofluoroalkane (HFA)-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. An inhaler containing levalbuterol (similar to albuterol) is available as Xopenex HFA Inhalation Aerosol. HFA-propelled albuterol inhalers are not currently available in generic forms.

“Manufacturers of the HFA versions have created financial assistance programs and eased income restrictions for low-income patients. Physician, pharmacy, and manufacturer's Web sites are also offering coupons for those who face a higher copay for these products,” said Deborah Henderson, senior adviser in the Office of Executive Programs at the FDA's Center for Drug Evaluation and Research.

The spray from HFA-propelled inhalers may taste and feel different than CFC-propelled inhalers. The properties of HFA and the weaker force of its spray from the inhalers make it “important to clean and prime the inhalers in order for the right dose of medicine to be delivered. Patients should be reinforced with the knowledge that they need to follow the directions very carefully,” Ms. Henderson said in a press teleconference.

The changes do not affect the medication's safety or effectiveness, she noted.

In the beginning of 2008, HFA-propelled albuterol inhalers composed only 5%–10% of albuterol inhaler sales in the market—even though the FDA in 2005 had finalized the end date for the sale of CFC-propelled albuterol inhalers. HFA-propelled albuterol inhalers now account for about 65% of the market, according to Dr. Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.

About 52 million albuterol metered-dose inhalers are prescribed in the United States each year, making them among the top 10 prescribed medications in the country, Dr. Chowdhury said during the teleconference.

Over the years, many manufacturers have stopped producing CFC-propelled albuterol inhalers. Currently, only one company, Armstrong Pharmaceuticals Inc., manufactures generic CFC-propelled albuterol inhalers, he said.

PHILADELPHIA — Laparoscopic Nissen fundoplication appears to offer better overall control of gastroesophageal reflux disease symptoms than does optimized medical therapy for patients who are stable and symptomatically controlled on long-term medical therapy, according to a randomized study of 101 patients.

At 3 years after the start of the trial, surgical patients generally had more symptom-free days, greater satisfaction with their control of symptoms, less esophageal acid exposure, and better quality of life than did patients who received optimal proton pump inhibitor (PPI) therapy throughout the trial, Dr. Mehran Anvari reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a randomized, nonblinded study, Dr. Anvari, director of the centre for minimal access surgery at McMaster University, Hamilton, Ont., and his colleagues compared the 3-year results of 101 patients who underwent either laparoscopic Nissen fundoplication or optimized PPI therapy.

The patients had controlled their GERD symptoms with PPIs but still required long-term PPI therapy. All of them had been taking PPIs continuously for at least 1 year and had good symptom control—a GERD symptom scale (GSS) score of less than 18 on a range of 0–60 and a visual analog scale score of greater than 70 on a range of 1–100.

The operations were done by four surgeons who each had performed more than 50 laparoscopic Nissen fundoplication procedures. Surgical patients stopped using PPIs after their operation. Patients randomized to medical therapy received treatment using a standardized management protocol based on best evidence and published guidelines.

The average GSS scores were similar in both groups at 1 and 3 years. At 3 years, the 51 patients randomized to surgery had an average of nearly 7 symptom-free days a week, compared with about 6 a week in the 50 patients randomized to medical therapy. Unlike medical therapy, surgery was associated with normalization of lower esophageal sphincter pressure.

On 24-hour pH monitoring at 3 years, surgical patients spent a mean of 2% of the duration of monitoring with a distal esophageal pH less than 4, but patients on medical therapy spent more than 4% of the duration with a pH below 4 even though they remained on PPIs. However, each group had a similar drop in the percentage of time spent at a pH less than 4.

At 3 years, satisfaction with symptom control was 15% higher in surgical patients than it was in patients on medical therapy. Although both treatments helped patients maintain a high quality of life as measured on the Short Form-36 questionnaire, surgery was superior to medical therapy in improving quality of life, said Dr. Anvari, professor of general surgery at the university.

Treatment failures occurred in 18% of surgical patients (three required revisions because of persistent dysphagia, and six needed PPI therapy) and in 16% of patients on medical therapy (eight required surgery).

“Laparoscopic Nissen fundoplication should be offered to patients requiring more than 2 years of PPI therapy who are seeking alternatives. And it should be a standard for comparison [against] all endoscopic antireflux procedures that are being devised,” Dr. Anvari advised.

He reported no relevant conflicts of interest and said there was no industry involvement in the conduct of the study.

PHILADELPHIA — Laparoscopic Nissen fundoplication appears to offer better overall control of gastroesophageal reflux disease symptoms than does optimized medical therapy for patients who are stable and symptomatically controlled on long-term medical therapy, according to a randomized study of 101 patients.

At 3 years after the start of the trial, surgical patients generally had more symptom-free days, greater satisfaction with their control of symptoms, less esophageal acid exposure, and better quality of life than did patients who received optimal proton pump inhibitor (PPI) therapy throughout the trial, Dr. Mehran Anvari reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a randomized, nonblinded study, Dr. Anvari, director of the centre for minimal access surgery at McMaster University, Hamilton, Ont., and his colleagues compared the 3-year results of 101 patients who underwent either laparoscopic Nissen fundoplication or optimized PPI therapy.

The patients had controlled their GERD symptoms with PPIs but still required long-term PPI therapy. All of them had been taking PPIs continuously for at least 1 year and had good symptom control—a GERD symptom scale (GSS) score of less than 18 on a range of 0–60 and a visual analog scale score of greater than 70 on a range of 1–100.

The operations were done by four surgeons who each had performed more than 50 laparoscopic Nissen fundoplication procedures. Surgical patients stopped using PPIs after their operation. Patients randomized to medical therapy received treatment using a standardized management protocol based on best evidence and published guidelines.

The average GSS scores were similar in both groups at 1 and 3 years. At 3 years, the 51 patients randomized to surgery had an average of nearly 7 symptom-free days a week, compared with about 6 a week in the 50 patients randomized to medical therapy. Unlike medical therapy, surgery was associated with normalization of lower esophageal sphincter pressure.

On 24-hour pH monitoring at 3 years, surgical patients spent a mean of 2% of the duration of monitoring with a distal esophageal pH less than 4, but patients on medical therapy spent more than 4% of the duration with a pH below 4 even though they remained on PPIs. However, each group had a similar drop in the percentage of time spent at a pH less than 4.

At 3 years, satisfaction with symptom control was 15% higher in surgical patients than it was in patients on medical therapy. Although both treatments helped patients maintain a high quality of life as measured on the Short Form-36 questionnaire, surgery was superior to medical therapy in improving quality of life, said Dr. Anvari, professor of general surgery at the university.

Treatment failures occurred in 18% of surgical patients (three required revisions because of persistent dysphagia, and six needed PPI therapy) and in 16% of patients on medical therapy (eight required surgery).

“Laparoscopic Nissen fundoplication should be offered to patients requiring more than 2 years of PPI therapy who are seeking alternatives. And it should be a standard for comparison [against] all endoscopic antireflux procedures that are being devised,” Dr. Anvari advised.

He reported no relevant conflicts of interest and said there was no industry involvement in the conduct of the study.

PHILADELPHIA — Laparoscopic Nissen fundoplication appears to offer better overall control of gastroesophageal reflux disease symptoms than does optimized medical therapy for patients who are stable and symptomatically controlled on long-term medical therapy, according to a randomized study of 101 patients.

At 3 years after the start of the trial, surgical patients generally had more symptom-free days, greater satisfaction with their control of symptoms, less esophageal acid exposure, and better quality of life than did patients who received optimal proton pump inhibitor (PPI) therapy throughout the trial, Dr. Mehran Anvari reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a randomized, nonblinded study, Dr. Anvari, director of the centre for minimal access surgery at McMaster University, Hamilton, Ont., and his colleagues compared the 3-year results of 101 patients who underwent either laparoscopic Nissen fundoplication or optimized PPI therapy.

The patients had controlled their GERD symptoms with PPIs but still required long-term PPI therapy. All of them had been taking PPIs continuously for at least 1 year and had good symptom control—a GERD symptom scale (GSS) score of less than 18 on a range of 0–60 and a visual analog scale score of greater than 70 on a range of 1–100.

The operations were done by four surgeons who each had performed more than 50 laparoscopic Nissen fundoplication procedures. Surgical patients stopped using PPIs after their operation. Patients randomized to medical therapy received treatment using a standardized management protocol based on best evidence and published guidelines.

The average GSS scores were similar in both groups at 1 and 3 years. At 3 years, the 51 patients randomized to surgery had an average of nearly 7 symptom-free days a week, compared with about 6 a week in the 50 patients randomized to medical therapy. Unlike medical therapy, surgery was associated with normalization of lower esophageal sphincter pressure.

On 24-hour pH monitoring at 3 years, surgical patients spent a mean of 2% of the duration of monitoring with a distal esophageal pH less than 4, but patients on medical therapy spent more than 4% of the duration with a pH below 4 even though they remained on PPIs. However, each group had a similar drop in the percentage of time spent at a pH less than 4.

At 3 years, satisfaction with symptom control was 15% higher in surgical patients than it was in patients on medical therapy. Although both treatments helped patients maintain a high quality of life as measured on the Short Form-36 questionnaire, surgery was superior to medical therapy in improving quality of life, said Dr. Anvari, professor of general surgery at the university.

Treatment failures occurred in 18% of surgical patients (three required revisions because of persistent dysphagia, and six needed PPI therapy) and in 16% of patients on medical therapy (eight required surgery).

“Laparoscopic Nissen fundoplication should be offered to patients requiring more than 2 years of PPI therapy who are seeking alternatives. And it should be a standard for comparison [against] all endoscopic antireflux procedures that are being devised,” Dr. Anvari advised.

He reported no relevant conflicts of interest and said there was no industry involvement in the conduct of the study.

NEW ORLEANS — Treatment of dangerously high blood pressure in the period immediately following an acute stroke was associated with significantly reduced 3-month mortality in the randomized, placebo-controlled Control of Hypertension and Hypotension Immediately Post-Stroke trial.

Patients in the CHHIPS pilot trial did not immediately benefit from antihypertensive medications because the trial's primary end point—the rate of death and dependency at 2 weeks after the stroke—was no different between treated and placebo patients, even though the patients who received antihypertensive drugs had significantly greater decline in systolic blood pressure (SBP) within the first 24 hours than did those who received placebo, Dr. John Potter reported at International Stroke Conference 2008.

“We know that elevated blood pressure levels are important in predicting primary and secondary [stroke] prevention, but we don't know much about the relationship in the acute situation,” said Dr. Potter of the University of East Anglia, Norwich, England.

Current guidelines on the early management of adult acute ischemic stroke patients advise the use of antihypertensive medications in patients who are eligible for tissue plasminogen activator when their blood pressure is greater than 185 mm Hg/110 mm Hg and in other patients when their blood pressure is above 220 mm Hg/120 mm Hg (Stroke 2007;38:1655–711).

To determine if antihypertensive treatment would benefit acute stroke patients with an SBP greater than 160 mm Hg, Dr. Potter and his colleagues randomized 179 patients to receive the β-blocker labetalol, the ACE inhibitor lisinopril, or placebo.

The investigators enrolled patients older than 18 years with a stroke onset within 36 hours and stroke symptoms lasting more than 60 minutes. The patients had not previously been taking antihypertensive medications and had undergone neuroimaging within 72 hours of stroke onset.

CT scans revealed that about 60% of patients in all groups had an ischemic stroke and about 15% had a primary intracerebral hemorrhage. No relevant abnormality could be seen in the other 25%.

The patients in all groups had a mean National Institutes of Health Stroke Severity score of 11. More than 90% of the patients had no history of stroke or transient ischemic attack. Nearly half of the patients in all groups were dysphagic.

After randomization, patients who could swallow oral medications received 5 mg lisinopril, 50 mg labetalol, or oral placebo. If after 4 hours, their SBP had not dropped to a target range of 145–155 mm Hg or decreased by at least 15%, the investigators gave another round of the same doses. If necessary, this was repeated at 8 hours. During the next 13 days, patients received 5–15 mg lisinopril, 50–150 mg labetalol, or placebo.

For dysphagic patients, the investigators combined sublingual lisinopril with an intravenous placebo, oral labetalol with sublingual placebo, or sublingual and intravenous placebos. Between days 1 and 5, dysphagic patients were switched to oral medications or received their medications through a nasogastric or percutaneous endoscopic gastrostomy tube. Lisinopril is not approved for use as a sublingual preparation, Dr. Potter noted.

Although the active treatment groups had a significantly greater mean decline in SBP than did placebo-treated patients within the first 24 hours (21 mm Hg vs. 11 mm Hg) and at 2 weeks (31 mm Hg vs. 24 mm Hg), there was no difference between the treatment groups in the rate of death and dependency at 2 weeks (61% vs. 59%).

Patients who received labetalol or lisinopril reached the target SBP outcomes in significantly higher proportions than did placebo-treated patients at 4 and 8 hours after stroke, but not at 24 hours. There were no differences in neurologic status between the groups at 72 hours after stroke.

However, patients who received placebo had a 2.2 times higher risk of dying by 3 months than did actively treated patients, based on 12 deaths in the placebo group and 11 deaths in the active treatment groups, Dr. Potter said at the conference, which was sponsored by the American Stroke Association.

NEW ORLEANS — Treatment of dangerously high blood pressure in the period immediately following an acute stroke was associated with significantly reduced 3-month mortality in the randomized, placebo-controlled Control of Hypertension and Hypotension Immediately Post-Stroke trial.

Patients in the CHHIPS pilot trial did not immediately benefit from antihypertensive medications because the trial's primary end point—the rate of death and dependency at 2 weeks after the stroke—was no different between treated and placebo patients, even though the patients who received antihypertensive drugs had significantly greater decline in systolic blood pressure (SBP) within the first 24 hours than did those who received placebo, Dr. John Potter reported at International Stroke Conference 2008.

“We know that elevated blood pressure levels are important in predicting primary and secondary [stroke] prevention, but we don't know much about the relationship in the acute situation,” said Dr. Potter of the University of East Anglia, Norwich, England.

Current guidelines on the early management of adult acute ischemic stroke patients advise the use of antihypertensive medications in patients who are eligible for tissue plasminogen activator when their blood pressure is greater than 185 mm Hg/110 mm Hg and in other patients when their blood pressure is above 220 mm Hg/120 mm Hg (Stroke 2007;38:1655–711).

To determine if antihypertensive treatment would benefit acute stroke patients with an SBP greater than 160 mm Hg, Dr. Potter and his colleagues randomized 179 patients to receive the β-blocker labetalol, the ACE inhibitor lisinopril, or placebo.

The investigators enrolled patients older than 18 years with a stroke onset within 36 hours and stroke symptoms lasting more than 60 minutes. The patients had not previously been taking antihypertensive medications and had undergone neuroimaging within 72 hours of stroke onset.

CT scans revealed that about 60% of patients in all groups had an ischemic stroke and about 15% had a primary intracerebral hemorrhage. No relevant abnormality could be seen in the other 25%.

The patients in all groups had a mean National Institutes of Health Stroke Severity score of 11. More than 90% of the patients had no history of stroke or transient ischemic attack. Nearly half of the patients in all groups were dysphagic.

After randomization, patients who could swallow oral medications received 5 mg lisinopril, 50 mg labetalol, or oral placebo. If after 4 hours, their SBP had not dropped to a target range of 145–155 mm Hg or decreased by at least 15%, the investigators gave another round of the same doses. If necessary, this was repeated at 8 hours. During the next 13 days, patients received 5–15 mg lisinopril, 50–150 mg labetalol, or placebo.

For dysphagic patients, the investigators combined sublingual lisinopril with an intravenous placebo, oral labetalol with sublingual placebo, or sublingual and intravenous placebos. Between days 1 and 5, dysphagic patients were switched to oral medications or received their medications through a nasogastric or percutaneous endoscopic gastrostomy tube. Lisinopril is not approved for use as a sublingual preparation, Dr. Potter noted.

Although the active treatment groups had a significantly greater mean decline in SBP than did placebo-treated patients within the first 24 hours (21 mm Hg vs. 11 mm Hg) and at 2 weeks (31 mm Hg vs. 24 mm Hg), there was no difference between the treatment groups in the rate of death and dependency at 2 weeks (61% vs. 59%).

Patients who received labetalol or lisinopril reached the target SBP outcomes in significantly higher proportions than did placebo-treated patients at 4 and 8 hours after stroke, but not at 24 hours. There were no differences in neurologic status between the groups at 72 hours after stroke.

However, patients who received placebo had a 2.2 times higher risk of dying by 3 months than did actively treated patients, based on 12 deaths in the placebo group and 11 deaths in the active treatment groups, Dr. Potter said at the conference, which was sponsored by the American Stroke Association.

NEW ORLEANS — Treatment of dangerously high blood pressure in the period immediately following an acute stroke was associated with significantly reduced 3-month mortality in the randomized, placebo-controlled Control of Hypertension and Hypotension Immediately Post-Stroke trial.

Patients in the CHHIPS pilot trial did not immediately benefit from antihypertensive medications because the trial's primary end point—the rate of death and dependency at 2 weeks after the stroke—was no different between treated and placebo patients, even though the patients who received antihypertensive drugs had significantly greater decline in systolic blood pressure (SBP) within the first 24 hours than did those who received placebo, Dr. John Potter reported at International Stroke Conference 2008.

“We know that elevated blood pressure levels are important in predicting primary and secondary [stroke] prevention, but we don't know much about the relationship in the acute situation,” said Dr. Potter of the University of East Anglia, Norwich, England.

Current guidelines on the early management of adult acute ischemic stroke patients advise the use of antihypertensive medications in patients who are eligible for tissue plasminogen activator when their blood pressure is greater than 185 mm Hg/110 mm Hg and in other patients when their blood pressure is above 220 mm Hg/120 mm Hg (Stroke 2007;38:1655–711).

To determine if antihypertensive treatment would benefit acute stroke patients with an SBP greater than 160 mm Hg, Dr. Potter and his colleagues randomized 179 patients to receive the β-blocker labetalol, the ACE inhibitor lisinopril, or placebo.

The investigators enrolled patients older than 18 years with a stroke onset within 36 hours and stroke symptoms lasting more than 60 minutes. The patients had not previously been taking antihypertensive medications and had undergone neuroimaging within 72 hours of stroke onset.

CT scans revealed that about 60% of patients in all groups had an ischemic stroke and about 15% had a primary intracerebral hemorrhage. No relevant abnormality could be seen in the other 25%.

The patients in all groups had a mean National Institutes of Health Stroke Severity score of 11. More than 90% of the patients had no history of stroke or transient ischemic attack. Nearly half of the patients in all groups were dysphagic.

After randomization, patients who could swallow oral medications received 5 mg lisinopril, 50 mg labetalol, or oral placebo. If after 4 hours, their SBP had not dropped to a target range of 145–155 mm Hg or decreased by at least 15%, the investigators gave another round of the same doses. If necessary, this was repeated at 8 hours. During the next 13 days, patients received 5–15 mg lisinopril, 50–150 mg labetalol, or placebo.

For dysphagic patients, the investigators combined sublingual lisinopril with an intravenous placebo, oral labetalol with sublingual placebo, or sublingual and intravenous placebos. Between days 1 and 5, dysphagic patients were switched to oral medications or received their medications through a nasogastric or percutaneous endoscopic gastrostomy tube. Lisinopril is not approved for use as a sublingual preparation, Dr. Potter noted.

Although the active treatment groups had a significantly greater mean decline in SBP than did placebo-treated patients within the first 24 hours (21 mm Hg vs. 11 mm Hg) and at 2 weeks (31 mm Hg vs. 24 mm Hg), there was no difference between the treatment groups in the rate of death and dependency at 2 weeks (61% vs. 59%).

Patients who received labetalol or lisinopril reached the target SBP outcomes in significantly higher proportions than did placebo-treated patients at 4 and 8 hours after stroke, but not at 24 hours. There were no differences in neurologic status between the groups at 72 hours after stroke.

However, patients who received placebo had a 2.2 times higher risk of dying by 3 months than did actively treated patients, based on 12 deaths in the placebo group and 11 deaths in the active treatment groups, Dr. Potter said at the conference, which was sponsored by the American Stroke Association.

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

KISSIMMEE, FLA. — A new 2,790-nm yttrium-scandium-gallium-garnet laser provides an option for skin resurfacing that appears to require less downtime than does resurfacing with either CO2 or er:YAG lasers.

This was the finding in two studies presented at the annual meeting of the American Society for Laser Medicine and Surgery. The results suggest that each treatment session with Cutera Inc.'s Pearl system 2,790-nm YSGG laser typically requires a recovery period from erythema and swelling of 3–4 days, unlike the several weeks of healing usually necessary with CO2 laser resurfacing.

A study conducted by Dr. David M. Verebelyi used the 2,790-nm YSGG laser to treat facial rhytids, dyschromia, and texture abnormalities in 19 patients aged 18–63 years with Fitzpatrick Skin types I-IV. One side of the face of each patient was randomly selected for treatment while the other side was left untreated. Dr. Verebelyi used the laser at a fluence of 3–3.5 J/cm

In Dr. Verebelyi's study and the other study, investigators performed two treatments with the laser on each patient, separated by about 4 weeks. A physician who did not know which side received treatment graded photos on a 10-point scale on which 0 equaled no improvement and 10 equaled excellent improvement.

The physician gave the treated side much higher average ratings than the untreated side in 17 patients who completed two treatment sessions, as follows: for fine lines (6.5 vs. 0.2), erythema (3.5 vs. 0.4), skin texture (7.7 vs. 1.5), scar improvement (3.2 vs. 0.2), and overall appearance (6.9 vs. 0.7), reported Dr. Verebelyi, who is in private practice in Highlands Ranch, Colo.

Erythema and swelling lasted for a mean of 4 days (range of 3–7 days); no patients experienced any permanent side effects.

Dr. Kei Negishi of Tokyo Women's Medical University performed a separate study with the laser to treat 23 patients aged 30–74 years with Fitzpatrick skin types III or IV. Each procedure was performed at a fluence of 1.5–2 J/cm

Improvement was graded as excellent or moderate by 91% of patients for skin texture and elasticity, by 52% for fine lines and elasticity, by 86% for irregular or overall pigmentation, and by 18% for mottled solar lentigos.

A total of 78% of patients rated overall satisfaction as excellent or moderate.

The patients had a mean downtime of 3.4 days with erythema, followed by a mean of 6.7 days of crust formation. Patients who were young or had oilier skin had a shorter period of downtime, according to Dr. Negishi.

The presenters of each of the studies reported having no conflicts of interest with Cutera, although Dr. Negishi reported borrowing the device from the company to perform her study.

A patient is shown before treatment with a yttrium-scandium-gallium-garnet laser.

The patient is shown 28 days after her second treatment with the new laser. Photos courtesy Dr. David M. Verebelyi

KISSIMMEE, FLA. — A new 2,790-nm yttrium-scandium-gallium-garnet laser provides an option for skin resurfacing that appears to require less downtime than does resurfacing with either CO2 or er:YAG lasers.

This was the finding in two studies presented at the annual meeting of the American Society for Laser Medicine and Surgery. The results suggest that each treatment session with Cutera Inc.'s Pearl system 2,790-nm YSGG laser typically requires a recovery period from erythema and swelling of 3–4 days, unlike the several weeks of healing usually necessary with CO2 laser resurfacing.

A study conducted by Dr. David M. Verebelyi used the 2,790-nm YSGG laser to treat facial rhytids, dyschromia, and texture abnormalities in 19 patients aged 18–63 years with Fitzpatrick Skin types I-IV. One side of the face of each patient was randomly selected for treatment while the other side was left untreated. Dr. Verebelyi used the laser at a fluence of 3–3.5 J/cm

In Dr. Verebelyi's study and the other study, investigators performed two treatments with the laser on each patient, separated by about 4 weeks. A physician who did not know which side received treatment graded photos on a 10-point scale on which 0 equaled no improvement and 10 equaled excellent improvement.

The physician gave the treated side much higher average ratings than the untreated side in 17 patients who completed two treatment sessions, as follows: for fine lines (6.5 vs. 0.2), erythema (3.5 vs. 0.4), skin texture (7.7 vs. 1.5), scar improvement (3.2 vs. 0.2), and overall appearance (6.9 vs. 0.7), reported Dr. Verebelyi, who is in private practice in Highlands Ranch, Colo.

Erythema and swelling lasted for a mean of 4 days (range of 3–7 days); no patients experienced any permanent side effects.

Dr. Kei Negishi of Tokyo Women's Medical University performed a separate study with the laser to treat 23 patients aged 30–74 years with Fitzpatrick skin types III or IV. Each procedure was performed at a fluence of 1.5–2 J/cm

Improvement was graded as excellent or moderate by 91% of patients for skin texture and elasticity, by 52% for fine lines and elasticity, by 86% for irregular or overall pigmentation, and by 18% for mottled solar lentigos.

A total of 78% of patients rated overall satisfaction as excellent or moderate.

The patients had a mean downtime of 3.4 days with erythema, followed by a mean of 6.7 days of crust formation. Patients who were young or had oilier skin had a shorter period of downtime, according to Dr. Negishi.

The presenters of each of the studies reported having no conflicts of interest with Cutera, although Dr. Negishi reported borrowing the device from the company to perform her study.

A patient is shown before treatment with a yttrium-scandium-gallium-garnet laser.

The patient is shown 28 days after her second treatment with the new laser. Photos courtesy Dr. David M. Verebelyi

KISSIMMEE, FLA. — A new 2,790-nm yttrium-scandium-gallium-garnet laser provides an option for skin resurfacing that appears to require less downtime than does resurfacing with either CO2 or er:YAG lasers.

This was the finding in two studies presented at the annual meeting of the American Society for Laser Medicine and Surgery. The results suggest that each treatment session with Cutera Inc.'s Pearl system 2,790-nm YSGG laser typically requires a recovery period from erythema and swelling of 3–4 days, unlike the several weeks of healing usually necessary with CO2 laser resurfacing.

A study conducted by Dr. David M. Verebelyi used the 2,790-nm YSGG laser to treat facial rhytids, dyschromia, and texture abnormalities in 19 patients aged 18–63 years with Fitzpatrick Skin types I-IV. One side of the face of each patient was randomly selected for treatment while the other side was left untreated. Dr. Verebelyi used the laser at a fluence of 3–3.5 J/cm

In Dr. Verebelyi's study and the other study, investigators performed two treatments with the laser on each patient, separated by about 4 weeks. A physician who did not know which side received treatment graded photos on a 10-point scale on which 0 equaled no improvement and 10 equaled excellent improvement.

The physician gave the treated side much higher average ratings than the untreated side in 17 patients who completed two treatment sessions, as follows: for fine lines (6.5 vs. 0.2), erythema (3.5 vs. 0.4), skin texture (7.7 vs. 1.5), scar improvement (3.2 vs. 0.2), and overall appearance (6.9 vs. 0.7), reported Dr. Verebelyi, who is in private practice in Highlands Ranch, Colo.

Erythema and swelling lasted for a mean of 4 days (range of 3–7 days); no patients experienced any permanent side effects.

Dr. Kei Negishi of Tokyo Women's Medical University performed a separate study with the laser to treat 23 patients aged 30–74 years with Fitzpatrick skin types III or IV. Each procedure was performed at a fluence of 1.5–2 J/cm

Improvement was graded as excellent or moderate by 91% of patients for skin texture and elasticity, by 52% for fine lines and elasticity, by 86% for irregular or overall pigmentation, and by 18% for mottled solar lentigos.

A total of 78% of patients rated overall satisfaction as excellent or moderate.

The patients had a mean downtime of 3.4 days with erythema, followed by a mean of 6.7 days of crust formation. Patients who were young or had oilier skin had a shorter period of downtime, according to Dr. Negishi.

The presenters of each of the studies reported having no conflicts of interest with Cutera, although Dr. Negishi reported borrowing the device from the company to perform her study.

A patient is shown before treatment with a yttrium-scandium-gallium-garnet laser.

The patient is shown 28 days after her second treatment with the new laser. Photos courtesy Dr. David M. Verebelyi

KISSIMMEE, FLA. — The 1,064-nm neodymium:YAG laser is effective for treating and preventing the recurrence of hidradenitis suppurativa lesions, according to the results of a randomized, controlled study of 22 patients with the disease.

The 1,064-nm Nd:YAG laser is commonly used for laser hair removal but also seems well suited for treating hidradenitis suppurativa, which histologic studies suggest is a disease of follicular occlusion with apocrine gland involvement as a secondary event, according to Dr. Emily P. Tierney and her colleagues in the department of dermatology at Henry Ford Hospital, Detroit.

Despite the fact that medical treatments for hidradenitis suppurativa have had limited efficacy against the disease and surgical treatment is associated with high morbidity, an initial pilot study conducted by Dr. Tierney and her associates found the laser to be efficacious in treating the disease.

One of Dr. Tierney's coinvestigators in Henry Ford's dermatology department, Dr. Iltefat Hamzavi, previously conducted a study of the Nd:YAG laser in four patients with dissecting cellulitis, a disorder analogous to hidradenitis suppurativa. In that study, 1 year after the initiation of laser treatment, patients achieved decreased pus formation, a reduced reliance on systemic treatments, and a controlled or terminated disease process without dyspigmentation (Dermatol. Surg. 2006;32:1039–44).

In a poster presentation at the annual meeting of the American Society for Laser Medicine and Surgery, Dr. Tierney and her coinvestigators reported on the effect of the laser on 22 patients with bilateral and symmetrical disease who were randomized to receive laser treatment plus topical antibiotics at affected sites on one side of the body and only topical antibiotics on affected sites on the contralateral side.

The patients had a mean age of 41 years, and 15 of them had Hurley stage II hidradenitis suppurativa, which is characterized by recurrent abscesses with tract formation and cicatrization and single or multiple widely separated lesions. The other seven patients had stage III disease, which is exemplified by diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses across the entire area.

Half of the 22 patients had Fitzpatrick skin type III, followed by 4 patients with type V, 3 with type IV, 3 with type II, and 1 with type VI.

After a series of up to four laser treatment sessions conducted once per month, there was a significant improvement in clinical scoring criteria based on a modified Hidradenitis Suppurativa European Research Group (HISERG) scale at all three anatomical sites treated with the laser (groin, axilla, and inframammary sites).

Compared with control sites, laser treatment improved the modified HISERG scale by the greatest amount for inguinal lesions (68% vs. 2%). Laser treatment also significantly improved HISERG scale scores of lesions in the axilla (63% vs. −11%) and at inframammary sites (30% vs. −71%).

Dr. Tierney reported that their research was supported by a Cutting Edge Research Grant from the American Society for Dermatologic Surgery and the Shahani Fund, a private individual donor that supports research at Henry Ford Hospital. Neither Dr. Tierney nor Dr. Hamzavi had any conflicts of interest to disclose.

At 2 months after the end of treatment, the patients continued to have significantly better modified HISERG scale scores at all sites combined, compared with all control sites combined.

The differences in response to laser treatment among anatomical sites appeared to be driven by the properties and distribution of hair at the site (density, volume, thickness, and proportion of follicles in anagen phase), according to the investigators.

The inguinal lesions of a patient with a 15-year history of disease are shown.

Lesion improvement is seen 2 months after four monthly laser treatments. Photos courtesy Dr. Emily P. Tierney

KISSIMMEE, FLA. — The 1,064-nm neodymium:YAG laser is effective for treating and preventing the recurrence of hidradenitis suppurativa lesions, according to the results of a randomized, controlled study of 22 patients with the disease.

The 1,064-nm Nd:YAG laser is commonly used for laser hair removal but also seems well suited for treating hidradenitis suppurativa, which histologic studies suggest is a disease of follicular occlusion with apocrine gland involvement as a secondary event, according to Dr. Emily P. Tierney and her colleagues in the department of dermatology at Henry Ford Hospital, Detroit.

Despite the fact that medical treatments for hidradenitis suppurativa have had limited efficacy against the disease and surgical treatment is associated with high morbidity, an initial pilot study conducted by Dr. Tierney and her associates found the laser to be efficacious in treating the disease.

One of Dr. Tierney's coinvestigators in Henry Ford's dermatology department, Dr. Iltefat Hamzavi, previously conducted a study of the Nd:YAG laser in four patients with dissecting cellulitis, a disorder analogous to hidradenitis suppurativa. In that study, 1 year after the initiation of laser treatment, patients achieved decreased pus formation, a reduced reliance on systemic treatments, and a controlled or terminated disease process without dyspigmentation (Dermatol. Surg. 2006;32:1039–44).

In a poster presentation at the annual meeting of the American Society for Laser Medicine and Surgery, Dr. Tierney and her coinvestigators reported on the effect of the laser on 22 patients with bilateral and symmetrical disease who were randomized to receive laser treatment plus topical antibiotics at affected sites on one side of the body and only topical antibiotics on affected sites on the contralateral side.

The patients had a mean age of 41 years, and 15 of them had Hurley stage II hidradenitis suppurativa, which is characterized by recurrent abscesses with tract formation and cicatrization and single or multiple widely separated lesions. The other seven patients had stage III disease, which is exemplified by diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses across the entire area.

Half of the 22 patients had Fitzpatrick skin type III, followed by 4 patients with type V, 3 with type IV, 3 with type II, and 1 with type VI.

After a series of up to four laser treatment sessions conducted once per month, there was a significant improvement in clinical scoring criteria based on a modified Hidradenitis Suppurativa European Research Group (HISERG) scale at all three anatomical sites treated with the laser (groin, axilla, and inframammary sites).

Compared with control sites, laser treatment improved the modified HISERG scale by the greatest amount for inguinal lesions (68% vs. 2%). Laser treatment also significantly improved HISERG scale scores of lesions in the axilla (63% vs. −11%) and at inframammary sites (30% vs. −71%).

Dr. Tierney reported that their research was supported by a Cutting Edge Research Grant from the American Society for Dermatologic Surgery and the Shahani Fund, a private individual donor that supports research at Henry Ford Hospital. Neither Dr. Tierney nor Dr. Hamzavi had any conflicts of interest to disclose.

At 2 months after the end of treatment, the patients continued to have significantly better modified HISERG scale scores at all sites combined, compared with all control sites combined.

The differences in response to laser treatment among anatomical sites appeared to be driven by the properties and distribution of hair at the site (density, volume, thickness, and proportion of follicles in anagen phase), according to the investigators.

The inguinal lesions of a patient with a 15-year history of disease are shown.

Lesion improvement is seen 2 months after four monthly laser treatments. Photos courtesy Dr. Emily P. Tierney

KISSIMMEE, FLA. — The 1,064-nm neodymium:YAG laser is effective for treating and preventing the recurrence of hidradenitis suppurativa lesions, according to the results of a randomized, controlled study of 22 patients with the disease.

The 1,064-nm Nd:YAG laser is commonly used for laser hair removal but also seems well suited for treating hidradenitis suppurativa, which histologic studies suggest is a disease of follicular occlusion with apocrine gland involvement as a secondary event, according to Dr. Emily P. Tierney and her colleagues in the department of dermatology at Henry Ford Hospital, Detroit.

Despite the fact that medical treatments for hidradenitis suppurativa have had limited efficacy against the disease and surgical treatment is associated with high morbidity, an initial pilot study conducted by Dr. Tierney and her associates found the laser to be efficacious in treating the disease.

One of Dr. Tierney's coinvestigators in Henry Ford's dermatology department, Dr. Iltefat Hamzavi, previously conducted a study of the Nd:YAG laser in four patients with dissecting cellulitis, a disorder analogous to hidradenitis suppurativa. In that study, 1 year after the initiation of laser treatment, patients achieved decreased pus formation, a reduced reliance on systemic treatments, and a controlled or terminated disease process without dyspigmentation (Dermatol. Surg. 2006;32:1039–44).

In a poster presentation at the annual meeting of the American Society for Laser Medicine and Surgery, Dr. Tierney and her coinvestigators reported on the effect of the laser on 22 patients with bilateral and symmetrical disease who were randomized to receive laser treatment plus topical antibiotics at affected sites on one side of the body and only topical antibiotics on affected sites on the contralateral side.

The patients had a mean age of 41 years, and 15 of them had Hurley stage II hidradenitis suppurativa, which is characterized by recurrent abscesses with tract formation and cicatrization and single or multiple widely separated lesions. The other seven patients had stage III disease, which is exemplified by diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses across the entire area.

Half of the 22 patients had Fitzpatrick skin type III, followed by 4 patients with type V, 3 with type IV, 3 with type II, and 1 with type VI.

After a series of up to four laser treatment sessions conducted once per month, there was a significant improvement in clinical scoring criteria based on a modified Hidradenitis Suppurativa European Research Group (HISERG) scale at all three anatomical sites treated with the laser (groin, axilla, and inframammary sites).

Compared with control sites, laser treatment improved the modified HISERG scale by the greatest amount for inguinal lesions (68% vs. 2%). Laser treatment also significantly improved HISERG scale scores of lesions in the axilla (63% vs. −11%) and at inframammary sites (30% vs. −71%).

Dr. Tierney reported that their research was supported by a Cutting Edge Research Grant from the American Society for Dermatologic Surgery and the Shahani Fund, a private individual donor that supports research at Henry Ford Hospital. Neither Dr. Tierney nor Dr. Hamzavi had any conflicts of interest to disclose.

At 2 months after the end of treatment, the patients continued to have significantly better modified HISERG scale scores at all sites combined, compared with all control sites combined.

The differences in response to laser treatment among anatomical sites appeared to be driven by the properties and distribution of hair at the site (density, volume, thickness, and proportion of follicles in anagen phase), according to the investigators.

The inguinal lesions of a patient with a 15-year history of disease are shown.

Lesion improvement is seen 2 months after four monthly laser treatments. Photos courtesy Dr. Emily P. Tierney

KISSIMMEE, FLA. — Dark-skinned patients who undergo hair removal with a 1,064-nm Nd:YAG laser while taking isotretinoin do not appear to experience any long-term complications, according to a retrospective study of 11 patients.

The near-infrared wavelength of the Nd:YAG laser is absorbed less efficiently by epidermal melanin than with some other lasers, Dr. Khalil A. Khatri said in a poster presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The patients in the study underwent Nd:YAG laser (Cutera CoolGlide) treatments with a pulse duration of 10–30 milliseconds, a spot size of 10 mm, and a repetition rate of 2 Hz. Laser fluence ranged from 30 to 55 J/cm

The patients stopped taking isotretinoin for 3 days before and after each laser hair removal treatment to reduce the severity of retinoid dermatitis. After 131 laser hair removal treatments, the patients—all of whom were taking isotretinoin for severe acne—had moderate erythema and perifollicular edema. No patients experienced vesiculation, scarring, or permanent pigmentary changes during follow-up visits, which occurred at intervals of 4, 10, or 12 weeks, he reported.

Only one patient with Fitzpatrick type V skin developed discrete crusting, which resulted in a slight hyperpigmentation that spontaneously resolved in 3 months, after the last and most intense treatment with the highest fluence used, noted Dr. Khatri, who has no financial interest in the products used in the study.

KISSIMMEE, FLA. — Dark-skinned patients who undergo hair removal with a 1,064-nm Nd:YAG laser while taking isotretinoin do not appear to experience any long-term complications, according to a retrospective study of 11 patients.

The near-infrared wavelength of the Nd:YAG laser is absorbed less efficiently by epidermal melanin than with some other lasers, Dr. Khalil A. Khatri said in a poster presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The patients in the study underwent Nd:YAG laser (Cutera CoolGlide) treatments with a pulse duration of 10–30 milliseconds, a spot size of 10 mm, and a repetition rate of 2 Hz. Laser fluence ranged from 30 to 55 J/cm

The patients stopped taking isotretinoin for 3 days before and after each laser hair removal treatment to reduce the severity of retinoid dermatitis. After 131 laser hair removal treatments, the patients—all of whom were taking isotretinoin for severe acne—had moderate erythema and perifollicular edema. No patients experienced vesiculation, scarring, or permanent pigmentary changes during follow-up visits, which occurred at intervals of 4, 10, or 12 weeks, he reported.

Only one patient with Fitzpatrick type V skin developed discrete crusting, which resulted in a slight hyperpigmentation that spontaneously resolved in 3 months, after the last and most intense treatment with the highest fluence used, noted Dr. Khatri, who has no financial interest in the products used in the study.

KISSIMMEE, FLA. — Dark-skinned patients who undergo hair removal with a 1,064-nm Nd:YAG laser while taking isotretinoin do not appear to experience any long-term complications, according to a retrospective study of 11 patients.

The near-infrared wavelength of the Nd:YAG laser is absorbed less efficiently by epidermal melanin than with some other lasers, Dr. Khalil A. Khatri said in a poster presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The patients in the study underwent Nd:YAG laser (Cutera CoolGlide) treatments with a pulse duration of 10–30 milliseconds, a spot size of 10 mm, and a repetition rate of 2 Hz. Laser fluence ranged from 30 to 55 J/cm

The patients stopped taking isotretinoin for 3 days before and after each laser hair removal treatment to reduce the severity of retinoid dermatitis. After 131 laser hair removal treatments, the patients—all of whom were taking isotretinoin for severe acne—had moderate erythema and perifollicular edema. No patients experienced vesiculation, scarring, or permanent pigmentary changes during follow-up visits, which occurred at intervals of 4, 10, or 12 weeks, he reported.

Only one patient with Fitzpatrick type V skin developed discrete crusting, which resulted in a slight hyperpigmentation that spontaneously resolved in 3 months, after the last and most intense treatment with the highest fluence used, noted Dr. Khatri, who has no financial interest in the products used in the study.

NEW ORLEANS — Insulin resistance independently predicted the risk of ischemic stroke and vascular disease in nondiabetic participants in the Northern Manhattan Study, a community-based, prospective cohort of 3,298 people.

The results of the study, which had a mean follow-up of 7.6 years in 1,680 nondiabetic participants with a known homeostasis model assessment for insulin resistance (HOMA-IR) index, suggest a possible role for insulin resistance in the etiology of stroke among nondiabetic individuals, especially men, Dr. Tatjana Rundek reported at the International Stroke Conference 2008.

The results also underscore the need for better characterization of individuals when assessing their risk for stroke and the potential role for preventive therapies targeted at insulin resistance, said Dr. Rundek of the department of neurology at the University of Miami.

Studies have indicated that insulin resistance likely contributes to the atherosclerotic process by creating a proinflammatory state and promoting endothelial dysfunction, she said.

“There have been at least 10–15 case-control studies showing the association between insulin resistance in nondiabetic subjects and cardiovascular risk. One of the more recent prospective studies, the Framingham Offspring Study, showed that in individuals without diabetes, the risk of cardiovascular disease rose in relation to quartiles of the HOMA-IR index.

“However, data on the [relationship between] insulin resistance and risk of stroke [are] pretty controversial and quite limited,” Dr. Rundek said at the conference, which was sponsored by the American Stroke Association.

In the current study, Dr. Rundek and her coinvestigators used the HOMA-IR index to estimate insulin resistance because of the practicality and simplicity of using it in a large, epidemiological study rather than measuring insulin resistance directly via a hyperinsulinemic euglycemic clamp or a fast-sampling intravenous glucose tolerance test.

Of 3,297 individuals in the study who had at least 1 year of follow-up, 1,680 (51%) did not have a history of diabetes or a previous ischemic stroke and had their HOMA-IR index calculated. These 1,680 participants with a mean age of 68 years included 63% women and comprised mostly Hispanic patients (58%), followed by African American (21%) and white patients (21%). Overall, 54% had not graduated from high school and 16% currently smoked.

At baseline, participants with insulin resistance—defined as a HOMA-IR index greater than 3, the 75th percentile for the distribution of the index—were significantly more likely than non-insulin resistant individuals to be Hispanic (68% vs. 55%, respectively), but less likely to be white (15% vs. 23%) or have more than a high school education (39% vs. 48%). Compared with participants without insulin resistance, significantly fewer insulin-resistant individuals drank alcohol in moderate amounts (67% vs. 58%) or were physically active (10% vs. 5%). Insulin-resistant participants also had significantly worse measurements for waist circumference, body mass index, high-density lipoprotein, and fasting blood glucose.

After a mean follow-up period of 7.6 years, 44 patients suffered an ischemic stroke, for an incidence of 3.4/1,000 person-years. Another 61 patients had a myocardial infarction, yielding a rate of 4.7/ 1,000 person-years. A total of 216 patients experienced the combined vascular events outcome of stroke, MI, or vascular death (mostly deaths from stroke and MI), giving an incidence of 17/1,000 person-years.

Insulin resistance was a significant, independent predictor of stroke and a combined outcome of stroke, MI, or vascular death after adjustment for age alone or the full model of socioeconomic and clinical variables (age, sex, race/ethnicity, high school education, waist circumference, systolic and diastolic blood pressure, moderate alcohol consumption, low-density and high-density lipoprotein, and history of smoking and heart disease). Insulin resistance increased the risk of these outcomes by 43%–75%. In analyses stratified by gender or ethnicity, insulin resistance was associated with a significantly higher risk of stroke only among men, but the study had limited power to make comparisons among such subgroups, she said.

“The results support a role for subclinical insulin resistance in the etiology of stroke among nondiabetics,” Dr. Rundek concluded.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Insulin resistance independently predicted the risk of ischemic stroke and vascular disease in nondiabetic participants in the Northern Manhattan Study, a community-based, prospective cohort of 3,298 people.

The results of the study, which had a mean follow-up of 7.6 years in 1,680 nondiabetic participants with a known homeostasis model assessment for insulin resistance (HOMA-IR) index, suggest a possible role for insulin resistance in the etiology of stroke among nondiabetic individuals, especially men, Dr. Tatjana Rundek reported at the International Stroke Conference 2008.

The results also underscore the need for better characterization of individuals when assessing their risk for stroke and the potential role for preventive therapies targeted at insulin resistance, said Dr. Rundek of the department of neurology at the University of Miami.

Studies have indicated that insulin resistance likely contributes to the atherosclerotic process by creating a proinflammatory state and promoting endothelial dysfunction, she said.

“There have been at least 10–15 case-control studies showing the association between insulin resistance in nondiabetic subjects and cardiovascular risk. One of the more recent prospective studies, the Framingham Offspring Study, showed that in individuals without diabetes, the risk of cardiovascular disease rose in relation to quartiles of the HOMA-IR index.

“However, data on the [relationship between] insulin resistance and risk of stroke [are] pretty controversial and quite limited,” Dr. Rundek said at the conference, which was sponsored by the American Stroke Association.

In the current study, Dr. Rundek and her coinvestigators used the HOMA-IR index to estimate insulin resistance because of the practicality and simplicity of using it in a large, epidemiological study rather than measuring insulin resistance directly via a hyperinsulinemic euglycemic clamp or a fast-sampling intravenous glucose tolerance test.

Of 3,297 individuals in the study who had at least 1 year of follow-up, 1,680 (51%) did not have a history of diabetes or a previous ischemic stroke and had their HOMA-IR index calculated. These 1,680 participants with a mean age of 68 years included 63% women and comprised mostly Hispanic patients (58%), followed by African American (21%) and white patients (21%). Overall, 54% had not graduated from high school and 16% currently smoked.

At baseline, participants with insulin resistance—defined as a HOMA-IR index greater than 3, the 75th percentile for the distribution of the index—were significantly more likely than non-insulin resistant individuals to be Hispanic (68% vs. 55%, respectively), but less likely to be white (15% vs. 23%) or have more than a high school education (39% vs. 48%). Compared with participants without insulin resistance, significantly fewer insulin-resistant individuals drank alcohol in moderate amounts (67% vs. 58%) or were physically active (10% vs. 5%). Insulin-resistant participants also had significantly worse measurements for waist circumference, body mass index, high-density lipoprotein, and fasting blood glucose.

After a mean follow-up period of 7.6 years, 44 patients suffered an ischemic stroke, for an incidence of 3.4/1,000 person-years. Another 61 patients had a myocardial infarction, yielding a rate of 4.7/ 1,000 person-years. A total of 216 patients experienced the combined vascular events outcome of stroke, MI, or vascular death (mostly deaths from stroke and MI), giving an incidence of 17/1,000 person-years.

Insulin resistance was a significant, independent predictor of stroke and a combined outcome of stroke, MI, or vascular death after adjustment for age alone or the full model of socioeconomic and clinical variables (age, sex, race/ethnicity, high school education, waist circumference, systolic and diastolic blood pressure, moderate alcohol consumption, low-density and high-density lipoprotein, and history of smoking and heart disease). Insulin resistance increased the risk of these outcomes by 43%–75%. In analyses stratified by gender or ethnicity, insulin resistance was associated with a significantly higher risk of stroke only among men, but the study had limited power to make comparisons among such subgroups, she said.

“The results support a role for subclinical insulin resistance in the etiology of stroke among nondiabetics,” Dr. Rundek concluded.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Insulin resistance independently predicted the risk of ischemic stroke and vascular disease in nondiabetic participants in the Northern Manhattan Study, a community-based, prospective cohort of 3,298 people.

The results of the study, which had a mean follow-up of 7.6 years in 1,680 nondiabetic participants with a known homeostasis model assessment for insulin resistance (HOMA-IR) index, suggest a possible role for insulin resistance in the etiology of stroke among nondiabetic individuals, especially men, Dr. Tatjana Rundek reported at the International Stroke Conference 2008.

The results also underscore the need for better characterization of individuals when assessing their risk for stroke and the potential role for preventive therapies targeted at insulin resistance, said Dr. Rundek of the department of neurology at the University of Miami.

Studies have indicated that insulin resistance likely contributes to the atherosclerotic process by creating a proinflammatory state and promoting endothelial dysfunction, she said.

“There have been at least 10–15 case-control studies showing the association between insulin resistance in nondiabetic subjects and cardiovascular risk. One of the more recent prospective studies, the Framingham Offspring Study, showed that in individuals without diabetes, the risk of cardiovascular disease rose in relation to quartiles of the HOMA-IR index.

“However, data on the [relationship between] insulin resistance and risk of stroke [are] pretty controversial and quite limited,” Dr. Rundek said at the conference, which was sponsored by the American Stroke Association.

In the current study, Dr. Rundek and her coinvestigators used the HOMA-IR index to estimate insulin resistance because of the practicality and simplicity of using it in a large, epidemiological study rather than measuring insulin resistance directly via a hyperinsulinemic euglycemic clamp or a fast-sampling intravenous glucose tolerance test.

Of 3,297 individuals in the study who had at least 1 year of follow-up, 1,680 (51%) did not have a history of diabetes or a previous ischemic stroke and had their HOMA-IR index calculated. These 1,680 participants with a mean age of 68 years included 63% women and comprised mostly Hispanic patients (58%), followed by African American (21%) and white patients (21%). Overall, 54% had not graduated from high school and 16% currently smoked.

At baseline, participants with insulin resistance—defined as a HOMA-IR index greater than 3, the 75th percentile for the distribution of the index—were significantly more likely than non-insulin resistant individuals to be Hispanic (68% vs. 55%, respectively), but less likely to be white (15% vs. 23%) or have more than a high school education (39% vs. 48%). Compared with participants without insulin resistance, significantly fewer insulin-resistant individuals drank alcohol in moderate amounts (67% vs. 58%) or were physically active (10% vs. 5%). Insulin-resistant participants also had significantly worse measurements for waist circumference, body mass index, high-density lipoprotein, and fasting blood glucose.

After a mean follow-up period of 7.6 years, 44 patients suffered an ischemic stroke, for an incidence of 3.4/1,000 person-years. Another 61 patients had a myocardial infarction, yielding a rate of 4.7/ 1,000 person-years. A total of 216 patients experienced the combined vascular events outcome of stroke, MI, or vascular death (mostly deaths from stroke and MI), giving an incidence of 17/1,000 person-years.

Insulin resistance was a significant, independent predictor of stroke and a combined outcome of stroke, MI, or vascular death after adjustment for age alone or the full model of socioeconomic and clinical variables (age, sex, race/ethnicity, high school education, waist circumference, systolic and diastolic blood pressure, moderate alcohol consumption, low-density and high-density lipoprotein, and history of smoking and heart disease). Insulin resistance increased the risk of these outcomes by 43%–75%. In analyses stratified by gender or ethnicity, insulin resistance was associated with a significantly higher risk of stroke only among men, but the study had limited power to make comparisons among such subgroups, she said.

“The results support a role for subclinical insulin resistance in the etiology of stroke among nondiabetics,” Dr. Rundek concluded.

ELSEVIER GLOBAL MEDICAL NEWS

HOT SPRINGS, VA. — Routine use of bilateral breast MRI before surgery may change the management of nearly 20% of candidates for breast conservation, lowering reexcision rates to achieve clear surgical margins, according to a retrospective study.

The ability to perform MRI-directed biopsies is a “critical component” of a program that uses preoperative MRI to locate breast cancer lesions, said Dr. William G. Cance at the annual meeting of the Southern Surgical Association.

Dr. Cance and his coauthors evaluated the ability of preoperative MRI scans to improve the selection of candidates for breast-conserving therapy, plan multimodality treatments more precisely, and improve cancer-related outcomes by identifying occult sites of disease at an earlier stage.

They reviewed a series of 79 consecutive candidates for breast conservation who underwent preoperative MRI scanning. The median age of the women was 57 years. Each patient received a physical exam, mammogram, ultrasound, and MRI during an 18-month period in 2006–2007, said Dr. Cance, chairman of the surgery department at the University of Florida, Gainesville.

Patients who had lesions that were suspicious for cancer on an MRI and confirmed on an ultrasound had an ultrasound-guided core biopsy. The lesions that were detected by MRI but not by ultrasound were biopsied under MRI guidance.

The results obtained on the initial MRI scan prompted an additional 25 biopsies in 21 patients. Positive results for cancer or ductal carcinoma in situ were detected in 3 of 6 ultrasound-guided biopsies and in 8 of 19 MRI-guided biopsies. Changes in treatment plans were necessary for 15 (19%) of the 79 patients, because of multicentric disease (7 patients), greater extent of the primary tumor (6), or contralateral breast cancer (2).

Breast-conserving therapy was contraindicated in patients with multicentric tumors in multiple quadrants of the breast or solitary tumors that were large relative to breast size.

In all, breast-conserving therapy was possible for 60 of the 79 patients. Of 61 lumpectomies performed in those 60 patients, 6 patients (10%) required reexcision for close or positive margins. These results compare favorably with other series, Dr. Cance said.

Receipt of an MRI did not significantly delay treatment. A median of 2 days passed between the initial surgical consult and the receipt of a bilateral breast MRI, while a median of 8 days occurred between the initial surgical consult and an MRI-directed biopsy.

Dr. Cance speculated that MRI scanning may lower reexcision rates for close or positive margins by improving the selection of patients for neoadjuvant chemotherapy, the selection of patients for partial versus total mastectomy, and the planning of the extent of partial mastectomy.

Patient selection is crucial for the best oncologic outcomes and cosmesis with breast-conserving therapy, he said. But even after efforts are made to characterize the tumor, locate it radiographically, and then excise it with clear surgical margins, “reexcision rates to achieve clear margins still remain high,” he said.

“The only prognostic factor that we as surgeons can affect is margin status,” Dr. V. Suzanne Klimberg of the University of Arkansas, Little Rock, said in a scheduled discussion of the study. “This paper demonstrates that preoperative MRI may help us select out those patients in which we would be unlikely to obtain negative margins.”

Although the investigators did not evaluate the costs of MRI scanning, Dr. Stephen R. Grobmyer, Dr. Cance's colleague at the University of Florida, suggested that the scans may save money in the long term by decreasing reexcision rates and recurrent disease. MRI scans and MRI-guided biopsies cost about $1,500 at the University of Florida, according to Dr. Grobmyer.

The MRI-directed biopsy has been shown to improve the accuracy of preoperative staging. It may be used in conjunction with a second-look ultrasound to confirm the extent of the disease seen on MRI or prevent overtreatment in the event of an MRI scan that is negative for disease, said Dr. Cance.

Bilateral MRI in a patient with multicentric breast cancer detected a primary lesion (left, in white) that was also found by mammography; MRI detected another invasive lesion (right) that was not revealed by mammography. Photos courtesy Dr. Stephen R. Grobmyer

HOT SPRINGS, VA. — Routine use of bilateral breast MRI before surgery may change the management of nearly 20% of candidates for breast conservation, lowering reexcision rates to achieve clear surgical margins, according to a retrospective study.

The ability to perform MRI-directed biopsies is a “critical component” of a program that uses preoperative MRI to locate breast cancer lesions, said Dr. William G. Cance at the annual meeting of the Southern Surgical Association.

Dr. Cance and his coauthors evaluated the ability of preoperative MRI scans to improve the selection of candidates for breast-conserving therapy, plan multimodality treatments more precisely, and improve cancer-related outcomes by identifying occult sites of disease at an earlier stage.

They reviewed a series of 79 consecutive candidates for breast conservation who underwent preoperative MRI scanning. The median age of the women was 57 years. Each patient received a physical exam, mammogram, ultrasound, and MRI during an 18-month period in 2006–2007, said Dr. Cance, chairman of the surgery department at the University of Florida, Gainesville.

Patients who had lesions that were suspicious for cancer on an MRI and confirmed on an ultrasound had an ultrasound-guided core biopsy. The lesions that were detected by MRI but not by ultrasound were biopsied under MRI guidance.

The results obtained on the initial MRI scan prompted an additional 25 biopsies in 21 patients. Positive results for cancer or ductal carcinoma in situ were detected in 3 of 6 ultrasound-guided biopsies and in 8 of 19 MRI-guided biopsies. Changes in treatment plans were necessary for 15 (19%) of the 79 patients, because of multicentric disease (7 patients), greater extent of the primary tumor (6), or contralateral breast cancer (2).

Breast-conserving therapy was contraindicated in patients with multicentric tumors in multiple quadrants of the breast or solitary tumors that were large relative to breast size.

In all, breast-conserving therapy was possible for 60 of the 79 patients. Of 61 lumpectomies performed in those 60 patients, 6 patients (10%) required reexcision for close or positive margins. These results compare favorably with other series, Dr. Cance said.

Receipt of an MRI did not significantly delay treatment. A median of 2 days passed between the initial surgical consult and the receipt of a bilateral breast MRI, while a median of 8 days occurred between the initial surgical consult and an MRI-directed biopsy.

Dr. Cance speculated that MRI scanning may lower reexcision rates for close or positive margins by improving the selection of patients for neoadjuvant chemotherapy, the selection of patients for partial versus total mastectomy, and the planning of the extent of partial mastectomy.

Patient selection is crucial for the best oncologic outcomes and cosmesis with breast-conserving therapy, he said. But even after efforts are made to characterize the tumor, locate it radiographically, and then excise it with clear surgical margins, “reexcision rates to achieve clear margins still remain high,” he said.

“The only prognostic factor that we as surgeons can affect is margin status,” Dr. V. Suzanne Klimberg of the University of Arkansas, Little Rock, said in a scheduled discussion of the study. “This paper demonstrates that preoperative MRI may help us select out those patients in which we would be unlikely to obtain negative margins.”

Although the investigators did not evaluate the costs of MRI scanning, Dr. Stephen R. Grobmyer, Dr. Cance's colleague at the University of Florida, suggested that the scans may save money in the long term by decreasing reexcision rates and recurrent disease. MRI scans and MRI-guided biopsies cost about $1,500 at the University of Florida, according to Dr. Grobmyer.

The MRI-directed biopsy has been shown to improve the accuracy of preoperative staging. It may be used in conjunction with a second-look ultrasound to confirm the extent of the disease seen on MRI or prevent overtreatment in the event of an MRI scan that is negative for disease, said Dr. Cance.

Bilateral MRI in a patient with multicentric breast cancer detected a primary lesion (left, in white) that was also found by mammography; MRI detected another invasive lesion (right) that was not revealed by mammography. Photos courtesy Dr. Stephen R. Grobmyer

HOT SPRINGS, VA. — Routine use of bilateral breast MRI before surgery may change the management of nearly 20% of candidates for breast conservation, lowering reexcision rates to achieve clear surgical margins, according to a retrospective study.

The ability to perform MRI-directed biopsies is a “critical component” of a program that uses preoperative MRI to locate breast cancer lesions, said Dr. William G. Cance at the annual meeting of the Southern Surgical Association.

Dr. Cance and his coauthors evaluated the ability of preoperative MRI scans to improve the selection of candidates for breast-conserving therapy, plan multimodality treatments more precisely, and improve cancer-related outcomes by identifying occult sites of disease at an earlier stage.

They reviewed a series of 79 consecutive candidates for breast conservation who underwent preoperative MRI scanning. The median age of the women was 57 years. Each patient received a physical exam, mammogram, ultrasound, and MRI during an 18-month period in 2006–2007, said Dr. Cance, chairman of the surgery department at the University of Florida, Gainesville.

Patients who had lesions that were suspicious for cancer on an MRI and confirmed on an ultrasound had an ultrasound-guided core biopsy. The lesions that were detected by MRI but not by ultrasound were biopsied under MRI guidance.

The results obtained on the initial MRI scan prompted an additional 25 biopsies in 21 patients. Positive results for cancer or ductal carcinoma in situ were detected in 3 of 6 ultrasound-guided biopsies and in 8 of 19 MRI-guided biopsies. Changes in treatment plans were necessary for 15 (19%) of the 79 patients, because of multicentric disease (7 patients), greater extent of the primary tumor (6), or contralateral breast cancer (2).

Breast-conserving therapy was contraindicated in patients with multicentric tumors in multiple quadrants of the breast or solitary tumors that were large relative to breast size.

In all, breast-conserving therapy was possible for 60 of the 79 patients. Of 61 lumpectomies performed in those 60 patients, 6 patients (10%) required reexcision for close or positive margins. These results compare favorably with other series, Dr. Cance said.

Receipt of an MRI did not significantly delay treatment. A median of 2 days passed between the initial surgical consult and the receipt of a bilateral breast MRI, while a median of 8 days occurred between the initial surgical consult and an MRI-directed biopsy.

Dr. Cance speculated that MRI scanning may lower reexcision rates for close or positive margins by improving the selection of patients for neoadjuvant chemotherapy, the selection of patients for partial versus total mastectomy, and the planning of the extent of partial mastectomy.

Patient selection is crucial for the best oncologic outcomes and cosmesis with breast-conserving therapy, he said. But even after efforts are made to characterize the tumor, locate it radiographically, and then excise it with clear surgical margins, “reexcision rates to achieve clear margins still remain high,” he said.

“The only prognostic factor that we as surgeons can affect is margin status,” Dr. V. Suzanne Klimberg of the University of Arkansas, Little Rock, said in a scheduled discussion of the study. “This paper demonstrates that preoperative MRI may help us select out those patients in which we would be unlikely to obtain negative margins.”

Although the investigators did not evaluate the costs of MRI scanning, Dr. Stephen R. Grobmyer, Dr. Cance's colleague at the University of Florida, suggested that the scans may save money in the long term by decreasing reexcision rates and recurrent disease. MRI scans and MRI-guided biopsies cost about $1,500 at the University of Florida, according to Dr. Grobmyer.

The MRI-directed biopsy has been shown to improve the accuracy of preoperative staging. It may be used in conjunction with a second-look ultrasound to confirm the extent of the disease seen on MRI or prevent overtreatment in the event of an MRI scan that is negative for disease, said Dr. Cance.

Bilateral MRI in a patient with multicentric breast cancer detected a primary lesion (left, in white) that was also found by mammography; MRI detected another invasive lesion (right) that was not revealed by mammography. Photos courtesy Dr. Stephen R. Grobmyer

NEW ORLEANS — The administration of tissue plasminogen activator to acute ischemic stroke patients with blood pressure values above the cutoff recommended by current guidelines is associated with significantly higher odds of developing a symptomatic intracerebral hemorrhage, according to a retrospective study.

The study is one of the first to corroborate the recommended cutoff values of a systolic BP of less than 185 mm Hg and a diastolic BP of less than 110 mm for Hg for treatment with intravenous tissue plasminogen activator (TPA), Dr. Georgios K. Tsivgoulis reported at the International Stroke Conference 2008.

These thresholds, part of the American Heart Association/American Stroke Association guidelines on the early management of adults with ischemic stroke (Stroke 2007;38:1655–711), advise against use of TPA in patients with BP greater than those values, said Dr. Tsivgoulis of the University of Alabama at Birmingham Comprehensive Stroke Research Center at the conference, which was sponsored by the American Stroke Association.

In a review of 510 patients with acute ischemic stroke who received intravenous TPA at a single center during 1996–2005, Dr. Tsivgoulis and his colleagues found 63 (12%) patients received TPA when their blood pressure was above the cutoff. They used blood pressure measurements that were taken closest in time before the TPA bolus was administered. Overall, the patients had a median onset-to-treatment time of 125 minutes and a median baseline National Institutes of Health Stroke Scale score of 9.

Compared with patients who did not hemorrhage after receiving TPA, the 31 (6%) patients who developed a symptomatic intracerebral hemorrhage had significantly higher mean prebolus systolic BP (169 mm Hg in the bleeders vs. 156 mm Hg in the others) but similar prebolus diastolic BP (85 mm Hg vs. 82 mm Hg). The investigators defined a symptomatic intracerebral hemorrhage by brain-imaging evidence of the hemorrhage and neurological worsening of 4 or more points on the NIHSS within 36 hours of receiving the bolus.

Pretreatment BP protocol violations also were more common in patients who had a symptomatic intracerebral hemorrhage than in those who did not (26% vs. 12%). The absolute risk of developing a symptomatic intracerebral hemorrhage also was significantly greater in patients with a pretreatment BP protocol violation than in those without such a violation (12.7% vs. 5.1%). However, the patients with and without pretreatment BP protocol violations had similar mortality (7.9% vs. 5.8%, respectively).

The occurrence of a pretreatment blood pressure protocol violation was associated with about 2.5 times higher odds of developing a symptomatic intracerebral hemorrhage than in the absence of any blood pressure protocol violation, after adjustment for demographics, stroke risk factors, baseline stroke severity, and onset-to-treatment time.

NEW ORLEANS — The administration of tissue plasminogen activator to acute ischemic stroke patients with blood pressure values above the cutoff recommended by current guidelines is associated with significantly higher odds of developing a symptomatic intracerebral hemorrhage, according to a retrospective study.

The study is one of the first to corroborate the recommended cutoff values of a systolic BP of less than 185 mm Hg and a diastolic BP of less than 110 mm for Hg for treatment with intravenous tissue plasminogen activator (TPA), Dr. Georgios K. Tsivgoulis reported at the International Stroke Conference 2008.

These thresholds, part of the American Heart Association/American Stroke Association guidelines on the early management of adults with ischemic stroke (Stroke 2007;38:1655–711), advise against use of TPA in patients with BP greater than those values, said Dr. Tsivgoulis of the University of Alabama at Birmingham Comprehensive Stroke Research Center at the conference, which was sponsored by the American Stroke Association.

In a review of 510 patients with acute ischemic stroke who received intravenous TPA at a single center during 1996–2005, Dr. Tsivgoulis and his colleagues found 63 (12%) patients received TPA when their blood pressure was above the cutoff. They used blood pressure measurements that were taken closest in time before the TPA bolus was administered. Overall, the patients had a median onset-to-treatment time of 125 minutes and a median baseline National Institutes of Health Stroke Scale score of 9.

Compared with patients who did not hemorrhage after receiving TPA, the 31 (6%) patients who developed a symptomatic intracerebral hemorrhage had significantly higher mean prebolus systolic BP (169 mm Hg in the bleeders vs. 156 mm Hg in the others) but similar prebolus diastolic BP (85 mm Hg vs. 82 mm Hg). The investigators defined a symptomatic intracerebral hemorrhage by brain-imaging evidence of the hemorrhage and neurological worsening of 4 or more points on the NIHSS within 36 hours of receiving the bolus.

Pretreatment BP protocol violations also were more common in patients who had a symptomatic intracerebral hemorrhage than in those who did not (26% vs. 12%). The absolute risk of developing a symptomatic intracerebral hemorrhage also was significantly greater in patients with a pretreatment BP protocol violation than in those without such a violation (12.7% vs. 5.1%). However, the patients with and without pretreatment BP protocol violations had similar mortality (7.9% vs. 5.8%, respectively).

The occurrence of a pretreatment blood pressure protocol violation was associated with about 2.5 times higher odds of developing a symptomatic intracerebral hemorrhage than in the absence of any blood pressure protocol violation, after adjustment for demographics, stroke risk factors, baseline stroke severity, and onset-to-treatment time.

NEW ORLEANS — The administration of tissue plasminogen activator to acute ischemic stroke patients with blood pressure values above the cutoff recommended by current guidelines is associated with significantly higher odds of developing a symptomatic intracerebral hemorrhage, according to a retrospective study.

The study is one of the first to corroborate the recommended cutoff values of a systolic BP of less than 185 mm Hg and a diastolic BP of less than 110 mm for Hg for treatment with intravenous tissue plasminogen activator (TPA), Dr. Georgios K. Tsivgoulis reported at the International Stroke Conference 2008.

These thresholds, part of the American Heart Association/American Stroke Association guidelines on the early management of adults with ischemic stroke (Stroke 2007;38:1655–711), advise against use of TPA in patients with BP greater than those values, said Dr. Tsivgoulis of the University of Alabama at Birmingham Comprehensive Stroke Research Center at the conference, which was sponsored by the American Stroke Association.

In a review of 510 patients with acute ischemic stroke who received intravenous TPA at a single center during 1996–2005, Dr. Tsivgoulis and his colleagues found 63 (12%) patients received TPA when their blood pressure was above the cutoff. They used blood pressure measurements that were taken closest in time before the TPA bolus was administered. Overall, the patients had a median onset-to-treatment time of 125 minutes and a median baseline National Institutes of Health Stroke Scale score of 9.

Compared with patients who did not hemorrhage after receiving TPA, the 31 (6%) patients who developed a symptomatic intracerebral hemorrhage had significantly higher mean prebolus systolic BP (169 mm Hg in the bleeders vs. 156 mm Hg in the others) but similar prebolus diastolic BP (85 mm Hg vs. 82 mm Hg). The investigators defined a symptomatic intracerebral hemorrhage by brain-imaging evidence of the hemorrhage and neurological worsening of 4 or more points on the NIHSS within 36 hours of receiving the bolus.

Pretreatment BP protocol violations also were more common in patients who had a symptomatic intracerebral hemorrhage than in those who did not (26% vs. 12%). The absolute risk of developing a symptomatic intracerebral hemorrhage also was significantly greater in patients with a pretreatment BP protocol violation than in those without such a violation (12.7% vs. 5.1%). However, the patients with and without pretreatment BP protocol violations had similar mortality (7.9% vs. 5.8%, respectively).

The occurrence of a pretreatment blood pressure protocol violation was associated with about 2.5 times higher odds of developing a symptomatic intracerebral hemorrhage than in the absence of any blood pressure protocol violation, after adjustment for demographics, stroke risk factors, baseline stroke severity, and onset-to-treatment time.