Heidi Splete

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.

In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.

The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.

The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years. However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis. The results were published online on March 1 in the Annals of the Rheumatic Diseases.

In this study, Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. "Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR," the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland.

The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted. "We are currently analyzing a number of ‘midlife’ biomarkers and inflammatory markers available from previous visits in the 40-year-long Reykjavik Study in an attempt to clarify this relationship," they said.

The Reykjavik study was funded by the National Institutes of Health, the National Institute on Aging Intramural Research Program, the Icelandic Heart Association, the Icelandic Parliament, the Icelandic Osteoarthritis Fund, and the University of Iceland Research Fund. The researchers had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Decompressive craniectomy significantly relieved intracranial pressure and shortened hospital stays, but the patients were more likely to have poor functional outcomes 6 months later, based on data from a randomized trial of 155 patients. The results were published online March 25 in the New England Journal of Medicine.

Relief of intracranial pressure is an important part of treating severe traumatic brain injury, but few studies have examined the effectiveness of surgical decompressive craniectomy, a technique that is becoming more common for patients who don’t respond to first-tier therapies, said Dr. D. James Cooper of Monash University in Melbourne, Australia, and colleagues.

In this study, 73 patients underwent early decompressive craniectomy and 82 received standard care (N. Engl. J. Med. 2011 Mar. 25 [doi: 10.1056/NEJMoa1102077]). Baseline injury and demographic characteristics were not significantly different between the two groups, with the exception of significantly fewer patients with reactive pupils in the craniectomy group. The initial primary outcome was the proportion of patients who died, entered a vegetative state, or became severely disabled. After an interim analysis, the primary outcome was revised to the patients’ functional outcome, based on the Extended Glasgow Outcome Scale.

Compared with the standard care group, the mean intracranial pressure after randomization was significantly lower in the craniectomy group (19 mmHg vs. 14 mmHg, respectively) and the number of hours when intracranial pressure was greater than 20 mmHg was significantly lower in the craniectomy group (30 hours vs. 9 hours, respectively). Measures on the intracranial hypoperfusion index and cerebral hypoperfusion index also were significantly lower in the craniectomy group.

In addition, patients in the craniectomy group needed significantly fewer interventions, including venting the cerebrospinal fluid through the ventricular drain and using mannitol, hypertonic saline, neuromuscular blocking drugs, and barbiturates.

However, the primary outcome of functional assessment 6 months after the injury was significantly worse in the craniectomy patients, the researchers noted. Based on the Extended Glasgow Outcome Scale, unfavorable outcomes occurred in 51 craniectomy patients (70%) vs. 42 standard care patients (51%). The results were similar after controlling for predetermined variables, but differences for the risk of an unfavorable outcome were no longer significant after controlling for the baseline difference in pupil reactivity in a post hoc analysis, the researchers noted.

"We had speculated that decompressive craniectomy would decrease intracranial pressure, improve functional outcomes, and decrease the proportion of survivors with severe disability," the researchers wrote. "Decompressive craniectomy instead shifted survivors from a favorable outcome to an unfavorable outcome," they said.

Possible reasons for the poor outcomes in the craniectomy group include expansion of the swollen brain outside the skull during the procedure, and characteristics of the procedure itself, the researchers said. In this study, a standardized surgical approach was used. The approach, modeled on the Polin technique, "included a large bifrontotemporoparietal craniectomy with bilateral dural opening." The researchers noted that some surgeons prefer a unilateral over a bilateral approach, which some nonrandomized studies suggest may have more complications. However, complications are possible with each approach, they said.

Overall, 37% of craniectomy patients and 17% of standard care patients had a least one medical or surgical complication. The most common adverse event was wound infection or breakdown, which occurred in 7% of the craniectomy patients and 9% of the standard care patients.

The researchers recruited adults with severe nonpenetrating brain injury from 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010. The patients in this group, known as the Depressive Craniectomy (DECRA) study, were aged 15-59 years.

The results were limited by the lack of blinding for those evaluating the results and by the difference in pupil reactivity between the groups. But the results suggest the need for more research, and "the critical importance of conducting such trials to test common therapies, particularly in patients with complex critical illnesses," the researchers wrote.

The study was funded by several health organizations, including the National Health and Medical Research Council of Australia and the New Zealand Intensive Care Society. Dr. Cooper had no financial conflicts to disclose.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Use of tumor necrosis factor antagonist agents significantly reduced the risk of cardiovascular events in rheumatoid arthritis patients, according to an analysis of data from more than 10,000 patients.

Although previous studies have not shown that anti-TNF therapy reduces the risk of cardiovascular events in RA patients, "promising results for improving cardiovascular outcomes with TNF antagonist use have been reported by two European studies," Dr. Jeffrey D. Greenberg of New York University and colleagues wrote in the April Annals of the Rheumatic Diseases.

In this North American study, patients who used TNF antagonists had a 61% lower risk of a primary end point of composite cardiovascular events (HR, 0.39), compared with reference patients who used nonbiologic disease-modifying antirheumatic drugs (DMARDs). The researchers analyzed data from 10,156 patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) RA registry between Oct. 1, 2001, and Dec. 31, 2006. The average age of the patients was 59 years and 75% were women (Ann. Rheum. Dis. 2011;70:576-82).

During the study period, the researchers identified 88 composite cardiovascular events including 26 myocardial infarctions, 45 strokes or transient ischemic attacks, and 17 cardiovascular-related deaths. The incidence rate for composite cardiovascular events in patients who used TNF antagonists was 2.93/1,000 patient-years of exposure, compared with 6.73/1,000 patient-years for methotrexate and 7.51 for the reference group of patients who used DMARDs.

Methotrexate use did not have a significant impact on reducing cardiovascular risk. However, prednisone use was significantly associated with an increasing risk for cardiovascular events, compared with nonuse, the researchers noted.

When the researchers examined specific cardiovascular events, TNF antagonist use was associated with a significantly lower risk of myocardial infarction and a trend toward a significantly lower risk of transient ischemic attack or stroke.

The mechanism by which TNF antagonists could reduce cardiovascular risk remains unclear. Data suggest that TNF antagonists might stabilize atheromatous plaques, while other results have shown improved flow-mediated vasodilation and endothelial function associated with TNF antagonists, the researchers said.

Additional studies are needed to assess the role of inflammation in populations at increased risk for cardiovascular events, the researchers wrote. But "TNF antagonist drugs may represent a promising therapeutic strategy to attenuate the heightened cardiovascular risk associated with RA," they wrote.

In an editorial accompanying the report, Dr. Johan Askling and Dr. Will Dixon said that one of the unanswered questions in studying the relationship between anti-TNF therapy and a reduced risk of cardiovascular events is whether the risk reduction is only a shift in the risk between different subsets of patients.

The dramatic reduction in cardiovascular risk in the anti-TNF group could be due to a higher incidence of cardiovascular events in patients who do not receive anti-TNF therapy for any reason, the investigators said. More studies in other RA populations are needed, and might explain the disparate results seen in previous studies of anti-TNF and cardiovascular risk, they noted (Ann. Rheum. Dis. 2011;70:561-2).

"As evidence accumulates in this important topic, we move closer towards a true understanding of the effect of drug therapies on cardiovascular outcomes," said Dr. Askling of Karolinska University, Stockholm, and Dr. Dixon of the University of Manchester (England).

Disclosures were not provided for Dr. Askling and Dr. Dixon. Dr. Greenberg said he has received research grants from the National Institutes of Health, the Arthritis Foundation, and Bristol-Myers Squibb. He has served on advisory boards from multiple pharmaceutical companies including Centocor, Genentech, and Roche.

Partially or fully ablative lasers are safe and effective tools to treat many types of scars and keloids, Dr. Suzanne L. Kilmer reported.

In treating scars, "the challenge is to normalize the color and the texture and to somehow repopulate that area with normal collagen and return it to normal skin color for that individual," she said in an interview.

Photo courtesy Dr. Suzanne L. Kilmer

A key challenge to treatment is managing patient expectations. She described three treatment techniques to improve the appearance of scars and keloids at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF): pulsed dye lasers, fractional lasers, and fully ablative erbium/CO2 laser resurfacing.

Each of these lasers has its pros and cons for scar treatment, Dr. Kilmer explained. "In most cases now I will go straight to a fractional device, and depending on location, patient's tolerance for downtime, pain, and budget constraints, I will proceed with the best choice."

Pulsed-dye lasers help improve erythema by targeting hemoglobin, and they can also aid in collagen remodeling, reported Dr. Kilmer of the Laser & Skin Surgery Center of Northern California, Sacramento.

Fractional lasers heat up or even ablate thousands of tiny 120-mcm columns of tissue, allowing tissue remodeling and the regeneration of more normal collagen. This normal collagen gradually takes over the area with scar tissue and helps to return the skin to its prescar appearance. This is also helpful for striae (stretch marks), she noted.

Fractional resurfacing is often effective for pigment, texture, or vascular changes. The fractional laser produces a microthermal zone up to 1,500 mcm deep that creates lateral reepithelialization and promotes skin healing. A Fraxel 1550-nm erbium laser (Solta) or a StarLux 1540-nm laser (Palomar) is a good choice for these procedures.

Most patients find the Fraxel 1550-nm laser more painful, and anesthesia is needed for the entire procedure, she reported. However, the Fraxel is faster, so it is a better choice for procedures involving the full face, and provides a more even treatment.

By contrast, the StarLux 1,540-nm laser often allows the clinician to treat small areas without the need for anesthesia, and these areas blend easily into nontreated skin, Dr. Kilmer pointed out. Small areas of the skin can be treated quickly, but the StarLux can be slow and uneven when used on larger areas.

Swelling is common – but not usually painful – after nonablative fractional resurfacing, she explained, and most patients need only minimal aftercare. Usually ice or hydration is sufficient.

Fractional ablative laser resurfacing carries more risk and requires more downtime than do other scar treatments, but it offers "the greatest efficacy for a single treatment," noted Dr. Kilmer. This treatment allows the clinician to sculpt more deeply with less thermal damage, and provides the most predictable results, including skin tightening and smoothing of acne scar ridges. The fractional ablative component allows for deeper scar remodeling and can be done at the same time, but with caution, she noted.

Dr. Kilmer emphasized that clinicians who are new to laser scar treatments should go slowly while they become familiar with the device. "And go lighter when you are off the face," she added.

Dr. Kilmer has received research support from Palomar and Solta. SDEF and this news organization are owned by Elsevier.

Partially or fully ablative lasers are safe and effective tools to treat many types of scars and keloids, Dr. Suzanne L. Kilmer reported.

In treating scars, "the challenge is to normalize the color and the texture and to somehow repopulate that area with normal collagen and return it to normal skin color for that individual," she said in an interview.

Photo courtesy Dr. Suzanne L. Kilmer

A key challenge to treatment is managing patient expectations. She described three treatment techniques to improve the appearance of scars and keloids at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF): pulsed dye lasers, fractional lasers, and fully ablative erbium/CO2 laser resurfacing.

Each of these lasers has its pros and cons for scar treatment, Dr. Kilmer explained. "In most cases now I will go straight to a fractional device, and depending on location, patient's tolerance for downtime, pain, and budget constraints, I will proceed with the best choice."

Pulsed-dye lasers help improve erythema by targeting hemoglobin, and they can also aid in collagen remodeling, reported Dr. Kilmer of the Laser & Skin Surgery Center of Northern California, Sacramento.

Fractional lasers heat up or even ablate thousands of tiny 120-mcm columns of tissue, allowing tissue remodeling and the regeneration of more normal collagen. This normal collagen gradually takes over the area with scar tissue and helps to return the skin to its prescar appearance. This is also helpful for striae (stretch marks), she noted.

Fractional resurfacing is often effective for pigment, texture, or vascular changes. The fractional laser produces a microthermal zone up to 1,500 mcm deep that creates lateral reepithelialization and promotes skin healing. A Fraxel 1550-nm erbium laser (Solta) or a StarLux 1540-nm laser (Palomar) is a good choice for these procedures.

Most patients find the Fraxel 1550-nm laser more painful, and anesthesia is needed for the entire procedure, she reported. However, the Fraxel is faster, so it is a better choice for procedures involving the full face, and provides a more even treatment.

By contrast, the StarLux 1,540-nm laser often allows the clinician to treat small areas without the need for anesthesia, and these areas blend easily into nontreated skin, Dr. Kilmer pointed out. Small areas of the skin can be treated quickly, but the StarLux can be slow and uneven when used on larger areas.

Swelling is common – but not usually painful – after nonablative fractional resurfacing, she explained, and most patients need only minimal aftercare. Usually ice or hydration is sufficient.

Fractional ablative laser resurfacing carries more risk and requires more downtime than do other scar treatments, but it offers "the greatest efficacy for a single treatment," noted Dr. Kilmer. This treatment allows the clinician to sculpt more deeply with less thermal damage, and provides the most predictable results, including skin tightening and smoothing of acne scar ridges. The fractional ablative component allows for deeper scar remodeling and can be done at the same time, but with caution, she noted.

Dr. Kilmer emphasized that clinicians who are new to laser scar treatments should go slowly while they become familiar with the device. "And go lighter when you are off the face," she added.

Dr. Kilmer has received research support from Palomar and Solta. SDEF and this news organization are owned by Elsevier.

Partially or fully ablative lasers are safe and effective tools to treat many types of scars and keloids, Dr. Suzanne L. Kilmer reported.

In treating scars, "the challenge is to normalize the color and the texture and to somehow repopulate that area with normal collagen and return it to normal skin color for that individual," she said in an interview.

Photo courtesy Dr. Suzanne L. Kilmer

A key challenge to treatment is managing patient expectations. She described three treatment techniques to improve the appearance of scars and keloids at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF): pulsed dye lasers, fractional lasers, and fully ablative erbium/CO2 laser resurfacing.

Each of these lasers has its pros and cons for scar treatment, Dr. Kilmer explained. "In most cases now I will go straight to a fractional device, and depending on location, patient's tolerance for downtime, pain, and budget constraints, I will proceed with the best choice."

Pulsed-dye lasers help improve erythema by targeting hemoglobin, and they can also aid in collagen remodeling, reported Dr. Kilmer of the Laser & Skin Surgery Center of Northern California, Sacramento.

Fractional lasers heat up or even ablate thousands of tiny 120-mcm columns of tissue, allowing tissue remodeling and the regeneration of more normal collagen. This normal collagen gradually takes over the area with scar tissue and helps to return the skin to its prescar appearance. This is also helpful for striae (stretch marks), she noted.

Fractional resurfacing is often effective for pigment, texture, or vascular changes. The fractional laser produces a microthermal zone up to 1,500 mcm deep that creates lateral reepithelialization and promotes skin healing. A Fraxel 1550-nm erbium laser (Solta) or a StarLux 1540-nm laser (Palomar) is a good choice for these procedures.

Most patients find the Fraxel 1550-nm laser more painful, and anesthesia is needed for the entire procedure, she reported. However, the Fraxel is faster, so it is a better choice for procedures involving the full face, and provides a more even treatment.

By contrast, the StarLux 1,540-nm laser often allows the clinician to treat small areas without the need for anesthesia, and these areas blend easily into nontreated skin, Dr. Kilmer pointed out. Small areas of the skin can be treated quickly, but the StarLux can be slow and uneven when used on larger areas.

Swelling is common – but not usually painful – after nonablative fractional resurfacing, she explained, and most patients need only minimal aftercare. Usually ice or hydration is sufficient.

Fractional ablative laser resurfacing carries more risk and requires more downtime than do other scar treatments, but it offers "the greatest efficacy for a single treatment," noted Dr. Kilmer. This treatment allows the clinician to sculpt more deeply with less thermal damage, and provides the most predictable results, including skin tightening and smoothing of acne scar ridges. The fractional ablative component allows for deeper scar remodeling and can be done at the same time, but with caution, she noted.

Dr. Kilmer emphasized that clinicians who are new to laser scar treatments should go slowly while they become familiar with the device. "And go lighter when you are off the face," she added.

Dr. Kilmer has received research support from Palomar and Solta. SDEF and this news organization are owned by Elsevier.