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Dosing based on trough concentrations cut costs, flares in IBD patients
In adults with inflammatory bowel disease (IBD), basing maintenance infliximab dosing on serum trough concentrations instead of clinical response led to significantly fewer flares and cut costs by 28%, researchers reported in the June issue of Gastroenterology (2015 Feb. 24[doi:10.1053/j.gastro.2015.02.031]).
“Our results indicate that adaptive dosing of infliximab based on exposure results in better short-term clinical outcomes and that by maintaining this adequate exposure, the risk for loss of response can be reduced,” said Dr. Niels Vande Casteele at the University of Leuven, Belgium, and his associates. “A similar approach of dosing of tumor necrosis factor antagonists based on exposure could prove to be superior in other chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis.”
Infliximab is a tumor necrosis factor (TNF) antagonist with proven efficacy in Crohn’s disease (CD) and ulcerative colitis. But up to 60% of patients who initially respond to infliximab later stop responding and need either a dose increase or a switch to another TNF antagonist, the investigators noted. Loss of response has been tied to increased drug clearance, while serum trough concentrations have been found to help predict clinical response, remission, and mucosal healing, they added (Gastroenterology).
The study included 263 adults with moderate to severe CD or ulcerative colitis who had initially responded to infliximab therapy. The researchers first optimized maintenance infliximab dosing based on a target trough concentration of 3-7 mcL/mL, and then randomized patients to further dosing based on either clinical response or the same target concentration. The study’s primary endpoint was clinical and biological remission at 1 year. The investigators defined clinical remission as a Harvey-Bradshaw index of no more than 4 for CD, or a partial Mayo score no higher than 2 with no individual subscore above 1 for ulcerative colitis. They defined biological remission as a C-reactive protein concentration no higher than 5 mg/L.
One year after dose optimization, 69% of patients who were dosed based on trough concentrations had achieved clinical and biochemical remission, compared with 66% of the patients dosed based on clinical response (P =.686), the researchers reported. However, flares occurred in only 7% of the concentration-based dosing group, compared with 17% of the clinical dosing group (P =.018), they said. Furthermore, reducing the infliximab dose for patients whose trough concentrations were above 7 mcL/mL led to a cost savings of 28% and did not increase risk of flares. In patients with Crohn’s disease, upping the dose for underdosed patients improved remission rates from 65% to 88% (P =.02), and significantly lowered the median CRP level from 4.3 to 3.2 mg/L (P < .001), the investigators also reported. They did not observe these trends among patients with ulcerative colitis.
Based on the results, the researchers recommended longer-term randomized trials with early dose optimization and drug monitoring during induction or shortly afterward. “Because of the longer turnaround time of current assays for therapeutic drug monitoring, a change in treatment was only possible for the next administration of drug, thereby delaying the implementation of the algorithm,” they noted. The study also did not use other objective measures of disease activity, such as centrally read endoscopy or fecal calprotectin levels, they added.
The Research Foundation–Flanders in Belgium partially supported the research. Dr. Casteele reported consulting and speaker fees from MSD, Janssen Biologics, UCB, and AbbVie. Five coauthors reported relationships with numerous pharmaceutical companies, and the other four reported no relevant conflicts of interest.
In adults with inflammatory bowel disease (IBD), basing maintenance infliximab dosing on serum trough concentrations instead of clinical response led to significantly fewer flares and cut costs by 28%, researchers reported in the June issue of Gastroenterology (2015 Feb. 24[doi:10.1053/j.gastro.2015.02.031]).
“Our results indicate that adaptive dosing of infliximab based on exposure results in better short-term clinical outcomes and that by maintaining this adequate exposure, the risk for loss of response can be reduced,” said Dr. Niels Vande Casteele at the University of Leuven, Belgium, and his associates. “A similar approach of dosing of tumor necrosis factor antagonists based on exposure could prove to be superior in other chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis.”
Infliximab is a tumor necrosis factor (TNF) antagonist with proven efficacy in Crohn’s disease (CD) and ulcerative colitis. But up to 60% of patients who initially respond to infliximab later stop responding and need either a dose increase or a switch to another TNF antagonist, the investigators noted. Loss of response has been tied to increased drug clearance, while serum trough concentrations have been found to help predict clinical response, remission, and mucosal healing, they added (Gastroenterology).
The study included 263 adults with moderate to severe CD or ulcerative colitis who had initially responded to infliximab therapy. The researchers first optimized maintenance infliximab dosing based on a target trough concentration of 3-7 mcL/mL, and then randomized patients to further dosing based on either clinical response or the same target concentration. The study’s primary endpoint was clinical and biological remission at 1 year. The investigators defined clinical remission as a Harvey-Bradshaw index of no more than 4 for CD, or a partial Mayo score no higher than 2 with no individual subscore above 1 for ulcerative colitis. They defined biological remission as a C-reactive protein concentration no higher than 5 mg/L.
One year after dose optimization, 69% of patients who were dosed based on trough concentrations had achieved clinical and biochemical remission, compared with 66% of the patients dosed based on clinical response (P =.686), the researchers reported. However, flares occurred in only 7% of the concentration-based dosing group, compared with 17% of the clinical dosing group (P =.018), they said. Furthermore, reducing the infliximab dose for patients whose trough concentrations were above 7 mcL/mL led to a cost savings of 28% and did not increase risk of flares. In patients with Crohn’s disease, upping the dose for underdosed patients improved remission rates from 65% to 88% (P =.02), and significantly lowered the median CRP level from 4.3 to 3.2 mg/L (P < .001), the investigators also reported. They did not observe these trends among patients with ulcerative colitis.
Based on the results, the researchers recommended longer-term randomized trials with early dose optimization and drug monitoring during induction or shortly afterward. “Because of the longer turnaround time of current assays for therapeutic drug monitoring, a change in treatment was only possible for the next administration of drug, thereby delaying the implementation of the algorithm,” they noted. The study also did not use other objective measures of disease activity, such as centrally read endoscopy or fecal calprotectin levels, they added.
The Research Foundation–Flanders in Belgium partially supported the research. Dr. Casteele reported consulting and speaker fees from MSD, Janssen Biologics, UCB, and AbbVie. Five coauthors reported relationships with numerous pharmaceutical companies, and the other four reported no relevant conflicts of interest.
In adults with inflammatory bowel disease (IBD), basing maintenance infliximab dosing on serum trough concentrations instead of clinical response led to significantly fewer flares and cut costs by 28%, researchers reported in the June issue of Gastroenterology (2015 Feb. 24[doi:10.1053/j.gastro.2015.02.031]).
“Our results indicate that adaptive dosing of infliximab based on exposure results in better short-term clinical outcomes and that by maintaining this adequate exposure, the risk for loss of response can be reduced,” said Dr. Niels Vande Casteele at the University of Leuven, Belgium, and his associates. “A similar approach of dosing of tumor necrosis factor antagonists based on exposure could prove to be superior in other chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis.”
Infliximab is a tumor necrosis factor (TNF) antagonist with proven efficacy in Crohn’s disease (CD) and ulcerative colitis. But up to 60% of patients who initially respond to infliximab later stop responding and need either a dose increase or a switch to another TNF antagonist, the investigators noted. Loss of response has been tied to increased drug clearance, while serum trough concentrations have been found to help predict clinical response, remission, and mucosal healing, they added (Gastroenterology).
The study included 263 adults with moderate to severe CD or ulcerative colitis who had initially responded to infliximab therapy. The researchers first optimized maintenance infliximab dosing based on a target trough concentration of 3-7 mcL/mL, and then randomized patients to further dosing based on either clinical response or the same target concentration. The study’s primary endpoint was clinical and biological remission at 1 year. The investigators defined clinical remission as a Harvey-Bradshaw index of no more than 4 for CD, or a partial Mayo score no higher than 2 with no individual subscore above 1 for ulcerative colitis. They defined biological remission as a C-reactive protein concentration no higher than 5 mg/L.
One year after dose optimization, 69% of patients who were dosed based on trough concentrations had achieved clinical and biochemical remission, compared with 66% of the patients dosed based on clinical response (P =.686), the researchers reported. However, flares occurred in only 7% of the concentration-based dosing group, compared with 17% of the clinical dosing group (P =.018), they said. Furthermore, reducing the infliximab dose for patients whose trough concentrations were above 7 mcL/mL led to a cost savings of 28% and did not increase risk of flares. In patients with Crohn’s disease, upping the dose for underdosed patients improved remission rates from 65% to 88% (P =.02), and significantly lowered the median CRP level from 4.3 to 3.2 mg/L (P < .001), the investigators also reported. They did not observe these trends among patients with ulcerative colitis.
Based on the results, the researchers recommended longer-term randomized trials with early dose optimization and drug monitoring during induction or shortly afterward. “Because of the longer turnaround time of current assays for therapeutic drug monitoring, a change in treatment was only possible for the next administration of drug, thereby delaying the implementation of the algorithm,” they noted. The study also did not use other objective measures of disease activity, such as centrally read endoscopy or fecal calprotectin levels, they added.
The Research Foundation–Flanders in Belgium partially supported the research. Dr. Casteele reported consulting and speaker fees from MSD, Janssen Biologics, UCB, and AbbVie. Five coauthors reported relationships with numerous pharmaceutical companies, and the other four reported no relevant conflicts of interest.
Key clinical point: Basing infliximab dosing on serum trough concentrations cut disease flares and costs in patients with inflammatory bowel disease (IBD).
Major finding: Targeting infliximab doses to 3-7 mcL/mL significantly cut disease flares and cut treatment costs by 28%.
Data source: Randomized controlled trial of 263 adults with IBD who had stable responses to maintenance infliximab treatment.
Disclosures: The Research Foundation–Flanders in Belgium partially supported the research. Dr. Casteele reported consulting and speaker fees from MSD, Janssen Biologics, UCB, and AbbVie. Five coauthors reported relationships with numerous pharmaceutical companies, and the other four reported no relevant conflicts of interest.
Adding enhanced MR to CT might improve diagnosis, outcomes in hepatocellular carcinoma
Among patients with single-nodule hepatocellular carcinomas diagnosed by computed tomography, further imaging with gadoxetic acid–enhanced magnetic resonance (MR) revealed more tumors and was tied to a 28% drop in cancer recurrence and a 35% drop in mortality, a retrospective cohort study reported in the June issue of Gastroenterology (doi.org/10.1053/j.gastro.2015.02.051) found.
“To the best of our knowledge, this is the first study to demonstrate that evaluation of hepatocellular carcinoma [HCC] with gadoxetic acid–enhanced MR imaging is associated with an improvement in the clinical outcome of patients, compared with that of a standard evaluation with dynamic CT,” said Dr. Hyung-Don Kim at the University of Ulsan in Seoul, South Korea and his associates. “This is clinically meaningful, given that the prognosis of patients with early-stage HCC is poor even after a curative treatment, mainly because of the high rate of early intrahepatic recurrence, and because there is no form of adjuvant therapy with a proven clinical benefit.” At least a third of early HCC recurrences might result from dissemination of primary tumor that went undetected at initial treatment, the researchers noted. To investigate the effects of gadoxetic acid–enhanced magnetic resonance imaging on HCC detection and subsequent survival, they retrospectively studied 700 patients in Seoul, South Korea, who had single-nodule HCCs diagnosed by dynamic four-phase CT. A total of 323 patients underwent additional imaging with gadoxetic acid–enhanced MR. These patients resembled CT-only patients in terms of baseline demographic characteristics, except that they were an average of 3 years younger (P < .001), had significantly higher median ALT levels (66 vs. 57 IU/mL; P < .006) and significantly higher platelet counts and lower alpha-fetoprotein levels, the investigators said.Gadoxetic acid–enhanced MR detected additional small HCC nodules in 16% of patients, and was tied to a 28% drop in likelihood of recurrence (hazard ratio, 0.72; 95% confidence interval, 0.54-0.96) and a 35% drop in risk of mortality (HR, 0.65; 95% CI, 0.44-0.96), the investigators reported. Rates of both recurrence-free and overall survival also were significantly higher for patients who underwent contrast-enhanced MR in addition to CT, compared with patients who underwent CT alone, and the differences held true in univariate, multivariate, inverse probability weighting analyses, and propensity score-matched analyses, they added.
“The major limitation of this study is that it was based on observational data,” commented the researchers. “Further studies that evaluate the effectiveness of gadoxetic acid–enhanced MR imaging for the evaluation of HCC in patients in other clinical settings are warranted.” The findings also need cautious interpretation because of the chance that selection bias led to more curable cases among patients who underwent MR in addition to CT, they said. The Korean Ministry of Health & Welfare and the Korean Association for the Study of Liver helped fund the research. One coauthor reported serving on the advisory boards of Bayer Healthcare, Bristol-Myers Squibb, and Gilead Science, and receiving research funding from Bayer, Gilead, and Novartis. The other investigators reported no conflicts of interest.
Courtesy American Gastroenterological Association
Among patients with single-nodule hepatocellular carcinomas diagnosed by computed tomography, further imaging with gadoxetic acid–enhanced magnetic resonance (MR) revealed more tumors and was tied to a 28% drop in cancer recurrence and a 35% drop in mortality, a retrospective cohort study reported in the June issue of Gastroenterology (doi.org/10.1053/j.gastro.2015.02.051) found.
“To the best of our knowledge, this is the first study to demonstrate that evaluation of hepatocellular carcinoma [HCC] with gadoxetic acid–enhanced MR imaging is associated with an improvement in the clinical outcome of patients, compared with that of a standard evaluation with dynamic CT,” said Dr. Hyung-Don Kim at the University of Ulsan in Seoul, South Korea and his associates. “This is clinically meaningful, given that the prognosis of patients with early-stage HCC is poor even after a curative treatment, mainly because of the high rate of early intrahepatic recurrence, and because there is no form of adjuvant therapy with a proven clinical benefit.” At least a third of early HCC recurrences might result from dissemination of primary tumor that went undetected at initial treatment, the researchers noted. To investigate the effects of gadoxetic acid–enhanced magnetic resonance imaging on HCC detection and subsequent survival, they retrospectively studied 700 patients in Seoul, South Korea, who had single-nodule HCCs diagnosed by dynamic four-phase CT. A total of 323 patients underwent additional imaging with gadoxetic acid–enhanced MR. These patients resembled CT-only patients in terms of baseline demographic characteristics, except that they were an average of 3 years younger (P < .001), had significantly higher median ALT levels (66 vs. 57 IU/mL; P < .006) and significantly higher platelet counts and lower alpha-fetoprotein levels, the investigators said.Gadoxetic acid–enhanced MR detected additional small HCC nodules in 16% of patients, and was tied to a 28% drop in likelihood of recurrence (hazard ratio, 0.72; 95% confidence interval, 0.54-0.96) and a 35% drop in risk of mortality (HR, 0.65; 95% CI, 0.44-0.96), the investigators reported. Rates of both recurrence-free and overall survival also were significantly higher for patients who underwent contrast-enhanced MR in addition to CT, compared with patients who underwent CT alone, and the differences held true in univariate, multivariate, inverse probability weighting analyses, and propensity score-matched analyses, they added.
“The major limitation of this study is that it was based on observational data,” commented the researchers. “Further studies that evaluate the effectiveness of gadoxetic acid–enhanced MR imaging for the evaluation of HCC in patients in other clinical settings are warranted.” The findings also need cautious interpretation because of the chance that selection bias led to more curable cases among patients who underwent MR in addition to CT, they said. The Korean Ministry of Health & Welfare and the Korean Association for the Study of Liver helped fund the research. One coauthor reported serving on the advisory boards of Bayer Healthcare, Bristol-Myers Squibb, and Gilead Science, and receiving research funding from Bayer, Gilead, and Novartis. The other investigators reported no conflicts of interest.
Courtesy American Gastroenterological Association
Among patients with single-nodule hepatocellular carcinomas diagnosed by computed tomography, further imaging with gadoxetic acid–enhanced magnetic resonance (MR) revealed more tumors and was tied to a 28% drop in cancer recurrence and a 35% drop in mortality, a retrospective cohort study reported in the June issue of Gastroenterology (doi.org/10.1053/j.gastro.2015.02.051) found.
“To the best of our knowledge, this is the first study to demonstrate that evaluation of hepatocellular carcinoma [HCC] with gadoxetic acid–enhanced MR imaging is associated with an improvement in the clinical outcome of patients, compared with that of a standard evaluation with dynamic CT,” said Dr. Hyung-Don Kim at the University of Ulsan in Seoul, South Korea and his associates. “This is clinically meaningful, given that the prognosis of patients with early-stage HCC is poor even after a curative treatment, mainly because of the high rate of early intrahepatic recurrence, and because there is no form of adjuvant therapy with a proven clinical benefit.” At least a third of early HCC recurrences might result from dissemination of primary tumor that went undetected at initial treatment, the researchers noted. To investigate the effects of gadoxetic acid–enhanced magnetic resonance imaging on HCC detection and subsequent survival, they retrospectively studied 700 patients in Seoul, South Korea, who had single-nodule HCCs diagnosed by dynamic four-phase CT. A total of 323 patients underwent additional imaging with gadoxetic acid–enhanced MR. These patients resembled CT-only patients in terms of baseline demographic characteristics, except that they were an average of 3 years younger (P < .001), had significantly higher median ALT levels (66 vs. 57 IU/mL; P < .006) and significantly higher platelet counts and lower alpha-fetoprotein levels, the investigators said.Gadoxetic acid–enhanced MR detected additional small HCC nodules in 16% of patients, and was tied to a 28% drop in likelihood of recurrence (hazard ratio, 0.72; 95% confidence interval, 0.54-0.96) and a 35% drop in risk of mortality (HR, 0.65; 95% CI, 0.44-0.96), the investigators reported. Rates of both recurrence-free and overall survival also were significantly higher for patients who underwent contrast-enhanced MR in addition to CT, compared with patients who underwent CT alone, and the differences held true in univariate, multivariate, inverse probability weighting analyses, and propensity score-matched analyses, they added.
“The major limitation of this study is that it was based on observational data,” commented the researchers. “Further studies that evaluate the effectiveness of gadoxetic acid–enhanced MR imaging for the evaluation of HCC in patients in other clinical settings are warranted.” The findings also need cautious interpretation because of the chance that selection bias led to more curable cases among patients who underwent MR in addition to CT, they said. The Korean Ministry of Health & Welfare and the Korean Association for the Study of Liver helped fund the research. One coauthor reported serving on the advisory boards of Bayer Healthcare, Bristol-Myers Squibb, and Gilead Science, and receiving research funding from Bayer, Gilead, and Novartis. The other investigators reported no conflicts of interest.
Courtesy American Gastroenterological Association
Key clinical point: Gadoxetic acid–enhanced magnetic resonance (MR) imaging revealed smaller masses and was tied to better outcomes in patients with single-nodule hepatocellular carcinoma (HCC) diagnosed by computed tomography (CT).
Major finding: MR enhanced with gadoxetic acid detected additional HCC nodules in 16% of patients, and was tied to lower recurrence and mortality rates.
Data source: Retrospective study of 700 patients diagnosed with single-nodule HCC by dynamic four-phase CT.
Disclosures: The Korean Ministry of Health & Welfare and the Korean Association for the Study of Liver helped fund the research. One coauthor reported serving on the advisory boards of Bayer Healthcare, Bristol-Myers Squibb, and Gilead Science, and receiving research funding from Bayer, Gilead, and Novartis. The other investigators reported no conflicts of interest.
Referral centers varied significantly in IBD treatment approaches
Even high-volume referral centers varied significantly in their use of immunomodulators and some other therapies for patients with inflammatory bowel disease, particularly Crohn’s disease, a prospective cohort study found.
“The development and implementation of evidence-based standards of care may reduce variations and improve patient outcomes,” Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston and his associates wrote in the June issue of Clinical Gastroenterology and Hepatology (2014 Nov. 21 [doi: 10.1016/j.cgh.2014.11.020]). “Because adherence to guidelines frequently is inadequate, a reduction of practice variation also requires continual improvement, including setting goals and repeated measurement of processes to identify how standardizing care impacts outcomes.”
New biologics have created increasingly diverse treatment options for patients with inflammatory bowel disease (IBD), but few studies have looked at how clinicians and patients choose treatment regimens in daily practice, the researchers noted. To explore the issue, they prospectively studied 1,659 adults with Crohn’s disease (CD) and 946 patients with ulcerative colitis who were treated at one of seven academic medical centers, all of which see a high volume of IBD patients.
Referral centers varied about threefold in their use of immunomodulators for CD (odds ratio for between-center differences, 3.34; 95% confidence interval, 2.09-5.32) in a model that controlled for age at diagnosis, sex, race, smoking status, and duration and extent or behavior of disease, the researchers reported. Use of immunomodulators for ulcerative colitis varied by more than twofold, they found (OR, 2.32; 95% CI, 1.05 to 5.13). Furthermore, they uncovered significant differences in use of oral mesalamine in both forms of IBD, and in the use of corticosteroids and immunomodulator-tumor necrosis factor antagonist combinations for CD, they said.
Treatment practices tended to vary more for CD than for ulcerative colitis, perhaps because CD spans a broader spectrum of pathologies or because clinicians have not yet reached consensus on early aggressive therapy or treatment strategies for CD, the researchers said. “Variations in treatment generally occur when there is uncertainty about the best practice,” they commented. “It is possible that the variations will diminish as evidence on effective IBD therapy grows and evidence-based guidelines become available and are implemented. The continued variation suggests that there is significant potential for standardization of care across referral and community practices.”
The study did not pinpoint reasons for discrepancies in practice, which could have reflected differences related to referring physicians’ or patients’ behaviors or expectations, the researchers said. But the findings did not reflect a single outlier center, and the cohort was not chosen to study variations between centers, which should have helped eliminate selection bias, they added.
The Leona M. and Harry B. Helmsley Charitable Trust funded the study. Dr. Ananthakrishnan reported advisory board payments from Cubist Pharmaceuticals and AbbVe. One coauthor reported financial conflicts of interest with numerous pharmaceutical companies. The other authors reported no conflicts of interest.
Jack Wennberg, a pioneer in quality improvement, was the first to recognize the association between significant variation in health care utilization and poor quality of care. The problem is that Wennberg published this in Science in 1973 (182:1102-8), and now, over 40 years later, we are just making progress for patients with Crohn’s disease and ulcerative colitis.
As a field, we now need to catch up and learn how to address this variation. It won’t be by solely measuring the differences between practices. As a proverb that was taught to me by experts at the Institute for Healthcare Improvement says, “You can’t fatten a cow by weighing it.” We could measure our practice patterns, quality metrics, and report them every day to claim our appropriate reimbursement from the Centers for Medicare & Medicaid Services, but this won’t improve patient outcomes or our understanding of what drives a better quality of life for our patients.
We need to take what Dr. Ananthakrishnan and his team have taught us to the next level. We need to learn from the Model for Improvement (Langley G.J., The improvement guide: A practical approach to enhancing organizational performance. San Francisco: Jossey-Bass, 2009), which teaches us that, to improve, we need to answer three questions: What are we trying to accomplish? How will we know that a change is an improvement? and What changes can we make that will result in an improvement? If we can apply these questions to changes that we want to make in our practices and systematically pursue answers, we will start to improve the quality of care delivered to our patients, as opposed to simply reporting that it is poor.
Dr. Corey A. Siegel, M.S., is director of the Dartmouth-Hitchcock Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. He is supported by AHRQ grant 1R01HS021747-01 and serves as consultant or on an advisory board for Abbvie, Amgen, Lilly, Janssen, Salix, Pfizer, Prometheus, Takeda, Theradiag, and UCB. He serves as a speaker for CME activities for AbbVie, Janssen, and Takeda, and has received grant support from Abbvie, Janssen, Salix, Takeda, and UCB. He is cochair of the Crohn’s and Colitis Foundation of America’s Quality of Care Program.
Jack Wennberg, a pioneer in quality improvement, was the first to recognize the association between significant variation in health care utilization and poor quality of care. The problem is that Wennberg published this in Science in 1973 (182:1102-8), and now, over 40 years later, we are just making progress for patients with Crohn’s disease and ulcerative colitis.
As a field, we now need to catch up and learn how to address this variation. It won’t be by solely measuring the differences between practices. As a proverb that was taught to me by experts at the Institute for Healthcare Improvement says, “You can’t fatten a cow by weighing it.” We could measure our practice patterns, quality metrics, and report them every day to claim our appropriate reimbursement from the Centers for Medicare & Medicaid Services, but this won’t improve patient outcomes or our understanding of what drives a better quality of life for our patients.
We need to take what Dr. Ananthakrishnan and his team have taught us to the next level. We need to learn from the Model for Improvement (Langley G.J., The improvement guide: A practical approach to enhancing organizational performance. San Francisco: Jossey-Bass, 2009), which teaches us that, to improve, we need to answer three questions: What are we trying to accomplish? How will we know that a change is an improvement? and What changes can we make that will result in an improvement? If we can apply these questions to changes that we want to make in our practices and systematically pursue answers, we will start to improve the quality of care delivered to our patients, as opposed to simply reporting that it is poor.
Dr. Corey A. Siegel, M.S., is director of the Dartmouth-Hitchcock Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. He is supported by AHRQ grant 1R01HS021747-01 and serves as consultant or on an advisory board for Abbvie, Amgen, Lilly, Janssen, Salix, Pfizer, Prometheus, Takeda, Theradiag, and UCB. He serves as a speaker for CME activities for AbbVie, Janssen, and Takeda, and has received grant support from Abbvie, Janssen, Salix, Takeda, and UCB. He is cochair of the Crohn’s and Colitis Foundation of America’s Quality of Care Program.
Jack Wennberg, a pioneer in quality improvement, was the first to recognize the association between significant variation in health care utilization and poor quality of care. The problem is that Wennberg published this in Science in 1973 (182:1102-8), and now, over 40 years later, we are just making progress for patients with Crohn’s disease and ulcerative colitis.
As a field, we now need to catch up and learn how to address this variation. It won’t be by solely measuring the differences between practices. As a proverb that was taught to me by experts at the Institute for Healthcare Improvement says, “You can’t fatten a cow by weighing it.” We could measure our practice patterns, quality metrics, and report them every day to claim our appropriate reimbursement from the Centers for Medicare & Medicaid Services, but this won’t improve patient outcomes or our understanding of what drives a better quality of life for our patients.
We need to take what Dr. Ananthakrishnan and his team have taught us to the next level. We need to learn from the Model for Improvement (Langley G.J., The improvement guide: A practical approach to enhancing organizational performance. San Francisco: Jossey-Bass, 2009), which teaches us that, to improve, we need to answer three questions: What are we trying to accomplish? How will we know that a change is an improvement? and What changes can we make that will result in an improvement? If we can apply these questions to changes that we want to make in our practices and systematically pursue answers, we will start to improve the quality of care delivered to our patients, as opposed to simply reporting that it is poor.
Dr. Corey A. Siegel, M.S., is director of the Dartmouth-Hitchcock Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. He is supported by AHRQ grant 1R01HS021747-01 and serves as consultant or on an advisory board for Abbvie, Amgen, Lilly, Janssen, Salix, Pfizer, Prometheus, Takeda, Theradiag, and UCB. He serves as a speaker for CME activities for AbbVie, Janssen, and Takeda, and has received grant support from Abbvie, Janssen, Salix, Takeda, and UCB. He is cochair of the Crohn’s and Colitis Foundation of America’s Quality of Care Program.
Even high-volume referral centers varied significantly in their use of immunomodulators and some other therapies for patients with inflammatory bowel disease, particularly Crohn’s disease, a prospective cohort study found.
“The development and implementation of evidence-based standards of care may reduce variations and improve patient outcomes,” Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston and his associates wrote in the June issue of Clinical Gastroenterology and Hepatology (2014 Nov. 21 [doi: 10.1016/j.cgh.2014.11.020]). “Because adherence to guidelines frequently is inadequate, a reduction of practice variation also requires continual improvement, including setting goals and repeated measurement of processes to identify how standardizing care impacts outcomes.”
New biologics have created increasingly diverse treatment options for patients with inflammatory bowel disease (IBD), but few studies have looked at how clinicians and patients choose treatment regimens in daily practice, the researchers noted. To explore the issue, they prospectively studied 1,659 adults with Crohn’s disease (CD) and 946 patients with ulcerative colitis who were treated at one of seven academic medical centers, all of which see a high volume of IBD patients.
Referral centers varied about threefold in their use of immunomodulators for CD (odds ratio for between-center differences, 3.34; 95% confidence interval, 2.09-5.32) in a model that controlled for age at diagnosis, sex, race, smoking status, and duration and extent or behavior of disease, the researchers reported. Use of immunomodulators for ulcerative colitis varied by more than twofold, they found (OR, 2.32; 95% CI, 1.05 to 5.13). Furthermore, they uncovered significant differences in use of oral mesalamine in both forms of IBD, and in the use of corticosteroids and immunomodulator-tumor necrosis factor antagonist combinations for CD, they said.
Treatment practices tended to vary more for CD than for ulcerative colitis, perhaps because CD spans a broader spectrum of pathologies or because clinicians have not yet reached consensus on early aggressive therapy or treatment strategies for CD, the researchers said. “Variations in treatment generally occur when there is uncertainty about the best practice,” they commented. “It is possible that the variations will diminish as evidence on effective IBD therapy grows and evidence-based guidelines become available and are implemented. The continued variation suggests that there is significant potential for standardization of care across referral and community practices.”
The study did not pinpoint reasons for discrepancies in practice, which could have reflected differences related to referring physicians’ or patients’ behaviors or expectations, the researchers said. But the findings did not reflect a single outlier center, and the cohort was not chosen to study variations between centers, which should have helped eliminate selection bias, they added.
The Leona M. and Harry B. Helmsley Charitable Trust funded the study. Dr. Ananthakrishnan reported advisory board payments from Cubist Pharmaceuticals and AbbVe. One coauthor reported financial conflicts of interest with numerous pharmaceutical companies. The other authors reported no conflicts of interest.
Even high-volume referral centers varied significantly in their use of immunomodulators and some other therapies for patients with inflammatory bowel disease, particularly Crohn’s disease, a prospective cohort study found.
“The development and implementation of evidence-based standards of care may reduce variations and improve patient outcomes,” Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston and his associates wrote in the June issue of Clinical Gastroenterology and Hepatology (2014 Nov. 21 [doi: 10.1016/j.cgh.2014.11.020]). “Because adherence to guidelines frequently is inadequate, a reduction of practice variation also requires continual improvement, including setting goals and repeated measurement of processes to identify how standardizing care impacts outcomes.”
New biologics have created increasingly diverse treatment options for patients with inflammatory bowel disease (IBD), but few studies have looked at how clinicians and patients choose treatment regimens in daily practice, the researchers noted. To explore the issue, they prospectively studied 1,659 adults with Crohn’s disease (CD) and 946 patients with ulcerative colitis who were treated at one of seven academic medical centers, all of which see a high volume of IBD patients.
Referral centers varied about threefold in their use of immunomodulators for CD (odds ratio for between-center differences, 3.34; 95% confidence interval, 2.09-5.32) in a model that controlled for age at diagnosis, sex, race, smoking status, and duration and extent or behavior of disease, the researchers reported. Use of immunomodulators for ulcerative colitis varied by more than twofold, they found (OR, 2.32; 95% CI, 1.05 to 5.13). Furthermore, they uncovered significant differences in use of oral mesalamine in both forms of IBD, and in the use of corticosteroids and immunomodulator-tumor necrosis factor antagonist combinations for CD, they said.
Treatment practices tended to vary more for CD than for ulcerative colitis, perhaps because CD spans a broader spectrum of pathologies or because clinicians have not yet reached consensus on early aggressive therapy or treatment strategies for CD, the researchers said. “Variations in treatment generally occur when there is uncertainty about the best practice,” they commented. “It is possible that the variations will diminish as evidence on effective IBD therapy grows and evidence-based guidelines become available and are implemented. The continued variation suggests that there is significant potential for standardization of care across referral and community practices.”
The study did not pinpoint reasons for discrepancies in practice, which could have reflected differences related to referring physicians’ or patients’ behaviors or expectations, the researchers said. But the findings did not reflect a single outlier center, and the cohort was not chosen to study variations between centers, which should have helped eliminate selection bias, they added.
The Leona M. and Harry B. Helmsley Charitable Trust funded the study. Dr. Ananthakrishnan reported advisory board payments from Cubist Pharmaceuticals and AbbVe. One coauthor reported financial conflicts of interest with numerous pharmaceutical companies. The other authors reported no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: High-volume referral centers varied significantly in use of immunomodulators and other therapies for inflammatory bowel disease, especially Crohn’s disease.
Major finding: Centers varied as much as threefold in use of immunomodulators for CD (OR, 3.34; 95% CI, 2.09-4.32).
Data source: Prospective cohort study of 1,659 patients with Crohn’s disease and 946 patients with ulcerative colitis.
Disclosures: The Leona M. and Harry B. Helmsley Charitable Trust funded the study. Dr. Ananthakrishnan reported advisory board payments from Cubist Pharmaceuticals and AbbVie. One coauthor reported financial conflicts of interest with numerous pharmaceutical companies. The other authors reported no conflicts of interest.
Experts advocate ‘treat-to-target’ approach for Crohn’s disease
Patients with Crohn’s disease could benefit from a “treat-to-target” approach based on intervening early to reverse inflammation and gathering objective data to guide clinical decisions, according to a review article published in the June issue of Clinical Gastroenterology and Hepatology (2015 [doi:10.1016/j.cgh.2013.09.006]).
“In spite of available effective treatments, the development of complications such as stricture, fistula, and abscess that result in surgery and lead to a disabling course of Crohn’s disease remain common,” said Dr. Guillame Bouguen at the University of California, San Diego, and his associates. “This ‘natural history’ is not likely to improve unless the overall symptom-based therapeutic strategy for Crohn’s disease is changed,” they wrote.
Clinicians have historically managed Crohn’s disease (CD) by gradually intensifying treatments based on patients’ symptoms, but this approach has failed to achieve good long-term outcomes and puts patients at risk of bowel damage, the reviewers said. The advent of better drugs for other chronic inflammatory diseases, such as rheumatoid arthritis, “reinvigorated” treatment strategies to focus on intervening earlier and controlling inflammation as much as possible, including by augmenting the novel biologics with methotrexate or other older disease-modifying antirheumatic drugs, they said.A similar “treat-to-target” approach to CD would mean responding to objective evidence of inflammation before patients developed irreversible bowel damage, Dr. Bouguen and his associates said. The main treatment goal would be mucosal healing, but the target level would reflect individual comorbidities, demographic and behavioral factors, and risks of side effects. After refining the mucosal healing target, gastroenterologists would stick to it throughout treatment, and would adjust treatment based on imaging and other objective measures of bowel inflammation. Colonoscopies and related procedures would be performed every 6 months until ulcerations resolved, and every 1-2 years after that. To improve trust and adherence to treatment, gastroenterologists also would need to educate patients about the mucosal healing target and the plan for achieving that goal, the reviewers said.
Based on preliminary data, patients on azathioprine and tumor necrosis factor antagonists might be able to taper them after achieving sustained mucosal healing, although larger studies on the topic are lacking, said the reviewers. A treat-to-target approach also might help symptomatic CD patients who already have permanent bowel damage enhance their long-term quality of life and prevent worsening disability, the investigators said.The International Organization on Inflammatory Bowel Disease is leading a consensus effort to define the therapeutic target in the treatment of inflammatory bowel disease. “However, the principles of the treat-to-target strategy that uses both systematic follow-up of patients and therapy optimization focusing on inflammation and damage may persist,” they added. To better clarify whether a treat-to-target approach is useful in CD, researchers are enrolling patients in the REACT II trial, which will compare treatments that target mucosal healing with the conventional symptoms-based paradigm, they noted.The authors reported no funding sources. Dr. Bouguen reported receiving lecture fees from Abbott Laboratories, Ferring, and MSD Pharma. The other authors reported financial relationships with numerous pharmaceutical companies.
Patients with Crohn’s disease could benefit from a “treat-to-target” approach based on intervening early to reverse inflammation and gathering objective data to guide clinical decisions, according to a review article published in the June issue of Clinical Gastroenterology and Hepatology (2015 [doi:10.1016/j.cgh.2013.09.006]).
“In spite of available effective treatments, the development of complications such as stricture, fistula, and abscess that result in surgery and lead to a disabling course of Crohn’s disease remain common,” said Dr. Guillame Bouguen at the University of California, San Diego, and his associates. “This ‘natural history’ is not likely to improve unless the overall symptom-based therapeutic strategy for Crohn’s disease is changed,” they wrote.
Clinicians have historically managed Crohn’s disease (CD) by gradually intensifying treatments based on patients’ symptoms, but this approach has failed to achieve good long-term outcomes and puts patients at risk of bowel damage, the reviewers said. The advent of better drugs for other chronic inflammatory diseases, such as rheumatoid arthritis, “reinvigorated” treatment strategies to focus on intervening earlier and controlling inflammation as much as possible, including by augmenting the novel biologics with methotrexate or other older disease-modifying antirheumatic drugs, they said.A similar “treat-to-target” approach to CD would mean responding to objective evidence of inflammation before patients developed irreversible bowel damage, Dr. Bouguen and his associates said. The main treatment goal would be mucosal healing, but the target level would reflect individual comorbidities, demographic and behavioral factors, and risks of side effects. After refining the mucosal healing target, gastroenterologists would stick to it throughout treatment, and would adjust treatment based on imaging and other objective measures of bowel inflammation. Colonoscopies and related procedures would be performed every 6 months until ulcerations resolved, and every 1-2 years after that. To improve trust and adherence to treatment, gastroenterologists also would need to educate patients about the mucosal healing target and the plan for achieving that goal, the reviewers said.
Based on preliminary data, patients on azathioprine and tumor necrosis factor antagonists might be able to taper them after achieving sustained mucosal healing, although larger studies on the topic are lacking, said the reviewers. A treat-to-target approach also might help symptomatic CD patients who already have permanent bowel damage enhance their long-term quality of life and prevent worsening disability, the investigators said.The International Organization on Inflammatory Bowel Disease is leading a consensus effort to define the therapeutic target in the treatment of inflammatory bowel disease. “However, the principles of the treat-to-target strategy that uses both systematic follow-up of patients and therapy optimization focusing on inflammation and damage may persist,” they added. To better clarify whether a treat-to-target approach is useful in CD, researchers are enrolling patients in the REACT II trial, which will compare treatments that target mucosal healing with the conventional symptoms-based paradigm, they noted.The authors reported no funding sources. Dr. Bouguen reported receiving lecture fees from Abbott Laboratories, Ferring, and MSD Pharma. The other authors reported financial relationships with numerous pharmaceutical companies.
Patients with Crohn’s disease could benefit from a “treat-to-target” approach based on intervening early to reverse inflammation and gathering objective data to guide clinical decisions, according to a review article published in the June issue of Clinical Gastroenterology and Hepatology (2015 [doi:10.1016/j.cgh.2013.09.006]).
“In spite of available effective treatments, the development of complications such as stricture, fistula, and abscess that result in surgery and lead to a disabling course of Crohn’s disease remain common,” said Dr. Guillame Bouguen at the University of California, San Diego, and his associates. “This ‘natural history’ is not likely to improve unless the overall symptom-based therapeutic strategy for Crohn’s disease is changed,” they wrote.
Clinicians have historically managed Crohn’s disease (CD) by gradually intensifying treatments based on patients’ symptoms, but this approach has failed to achieve good long-term outcomes and puts patients at risk of bowel damage, the reviewers said. The advent of better drugs for other chronic inflammatory diseases, such as rheumatoid arthritis, “reinvigorated” treatment strategies to focus on intervening earlier and controlling inflammation as much as possible, including by augmenting the novel biologics with methotrexate or other older disease-modifying antirheumatic drugs, they said.A similar “treat-to-target” approach to CD would mean responding to objective evidence of inflammation before patients developed irreversible bowel damage, Dr. Bouguen and his associates said. The main treatment goal would be mucosal healing, but the target level would reflect individual comorbidities, demographic and behavioral factors, and risks of side effects. After refining the mucosal healing target, gastroenterologists would stick to it throughout treatment, and would adjust treatment based on imaging and other objective measures of bowel inflammation. Colonoscopies and related procedures would be performed every 6 months until ulcerations resolved, and every 1-2 years after that. To improve trust and adherence to treatment, gastroenterologists also would need to educate patients about the mucosal healing target and the plan for achieving that goal, the reviewers said.
Based on preliminary data, patients on azathioprine and tumor necrosis factor antagonists might be able to taper them after achieving sustained mucosal healing, although larger studies on the topic are lacking, said the reviewers. A treat-to-target approach also might help symptomatic CD patients who already have permanent bowel damage enhance their long-term quality of life and prevent worsening disability, the investigators said.The International Organization on Inflammatory Bowel Disease is leading a consensus effort to define the therapeutic target in the treatment of inflammatory bowel disease. “However, the principles of the treat-to-target strategy that uses both systematic follow-up of patients and therapy optimization focusing on inflammation and damage may persist,” they added. To better clarify whether a treat-to-target approach is useful in CD, researchers are enrolling patients in the REACT II trial, which will compare treatments that target mucosal healing with the conventional symptoms-based paradigm, they noted.The authors reported no funding sources. Dr. Bouguen reported receiving lecture fees from Abbott Laboratories, Ferring, and MSD Pharma. The other authors reported financial relationships with numerous pharmaceutical companies.
Key clinical point: A treat-to-target approach based on early control of inflammation and objective clinical data might benefit patients with Crohn’s disease.
Major finding: Using only symptoms to guide treatment decisions in Crohn’s disease has failed to achieve good long-term outcomes.
Data source: A review of 15 primary research and review articles.
Disclosures: The authors reported no funding sources. Dr. Bouguen reported receiving lecture fees from Abbott Laboratories, Ferring, and MSD Pharma. The other authors reported financial disclosures from numerous pharmaceutical companies.
Radiofrequency Device Significantly Cut Abdominal Fat
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
AT LASER 2015
Radiofrequency device significantly cut abdominal fat
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
KISSIMMEE, FLA. – Eight treatments with a noninvasive radiofrequency device reduced unwanted abdominal fat by an average of 428 cc in a prospective study.
“Can we consider this permanent fat loss? Yes, if a healthy lifestyle is maintained,” said Dr. Diane Duncan of Plastic Surgical Associates in Fort Collins, Colo. “I think the best candidates for these treatments are thin to modestly overweight patients, because while we did see significant fat reductions in obese patients, they want all their fat gone, and this won’t do that,” she said at the annual conference of the American Society for Laser Medicine and Surgery.
The study assessed the effects of the BodyFX device (Invasix, Yokneam, Israel) on 19 women aged 20-65 years who had localized abdominal adiposity, with body mass indices ranging from 18 to 30 kg/m2. Dr. Duncan used an energy setting of 42 watts until the target area reached 41° Celsius, which typically took 3-5 minutes, she said. Then she administered high-voltage pulses of oscillating radiofrequency waves in order to create holes in the cell walls of adipocytes, which triggered gradual cell death.
After adjusting for age and height, eight treatments with the device led to a 53% decrease in abdominal fat thickness at a 3-month follow-up visit, Dr. Duncan reported. “Visual results were similar to liposuction,” she added. “But generally, not much change was noted before the fourth treatment.”
The analysis included sequences of three-dimensional Vectra ultrasound measurements, which were taken at four sites around the abdomen at the moment when patients reached their maximum exhale, Dr. Duncan said. She excluded two patients from final analyses because they had gained or lost more than 5 pounds, compared with baseline.
“I think the mechanism of action of this device is what makes it so special,” said Dr. Duncan. Scanning electron microscope photographs showed that adipocytes treated with the radiofrequency device underwent pyroptosis, which combines programmed cell death with the proinflammatory features of necrosis. That process stimulates formation of new collagen, resulting in localized skin tightening, she noted. “These new SEM data show a different and more beneficial process is taking place,” she explained. “Apoptosis, by definition, would not stimulate neocollagenesis, so no tissue tightening would occur.”
Dr. Duncan reported no funding sources or relevant financial disclosures.
AT LASER 2015
Key clinical point: A noninvasive radiofrequency device significantly reduced abdominal fat in adults.
Major finding: Eight treatments with the device reduced abdominal fat by an average of 428 cc.
Data source: Prospective, 5-month study of 17 patients with localized abdominal adiposity.
Disclosures: Dr. Duncan reported no funding sources or relevant financial disclosures.
Early combination laser treatment boosts scar healing
KISSIMMEE, FLA. – Early treatment with fractional carbon dioxide ablative laser and light-emitting diode phototherapy sped healing and improved texture, discoloration, and range of motion in hypertrophic burn scars in a controlled, blinded study of 20 patients.
“I think as long as we have intact epithelium, we’re going to have improvements if we can laser these patients as early as possible,” Dr. Jill Waibel said at the annual conference of the American Society for Laser Medicine and Surgery.
Approximately 100 million new scars occur annually in developed countries, almost a third of which result from trauma or burns, noted Dr. Waibel, a dermatologist specializing in treating burn scars at the Miami Dermatology and Laser Institute. Scarred areas begin to hypertrophy about 3-7 months after injury, when they undergo increased collagen production and slowed collagen breakdown, said Dr. Waibel. “Traditionally, reconstructive efforts have been delayed until a year after injury,” she emphasized. “But by this time, many patients have formed hypertrophic scars and have significant decreases in range of motion.”
To determine how early treatment with a combination of laser/LED therapy might interrupt hypertrophy and improve outcomes, Dr. Waibel and coinvestigator Ashley Rudnick treated 20 patients aged 21-55 years with moderate to severe burns on at least 5% of the body surface area that had occurred in the past 1-3 months. For each patient, they divided similarly scarred areas into four 5- by 5-cm squares, one of which served as an untreated control. They treated the other three areas with 120-micron spot fractional ablative carbon dioxide laser only, continuous wave LED phototherapy only, or fractional ablative laser followed by LED. They spaced the three laser sessions 2 months apart, and used eight 20-minute LED treatments per laser session. The fractional laser wavelength was 10,600 nm, energy was 80-120 mJ per pixel, and the frequency was up to 200 Hz, Dr. Waibel said. The LED wavelength was 830 nm, and energy intensity was 40-100 mW per cm2.
All treated areas improved more than the untreated control areas of scarring, but combining the modalities was associated with the fastest healing, according to blinded photographic reviews by physicians based on the visual analog Manchester scar scale, Dr. Waibel reported.
Phototherapy with LED can penetrate up to an inch of tissue and promotes selective ATP production and DNA and RNA activity, she added. “The positive effects occur only in injured cells,” she said. “LED has wound healing and anti-inflammatory effects that might benefit acutely wounded skin.”
Based on her experience, patients usually need from three to five sessions of fractional laser/LED sessions to see clear results, Dr. Waibel said in response to a question from an audience member. “We know that every time we treat a hypertrophic scar, it will get better,” she added. “When patients stop coming for treatment, you know they’re happy. If you can combine modalities softly and safely, you’ll need fewer treatments.”
Dr. Waibel disclosed financial and advisory relationships with ALMA, Cutera, DUSA, Harvest Technologies, L’Oreal/SkinCeuticals, Lumenis, Lutronics, Sebacia, Syneron-Candela, Valeant, and Zeltiq.
KISSIMMEE, FLA. – Early treatment with fractional carbon dioxide ablative laser and light-emitting diode phototherapy sped healing and improved texture, discoloration, and range of motion in hypertrophic burn scars in a controlled, blinded study of 20 patients.
“I think as long as we have intact epithelium, we’re going to have improvements if we can laser these patients as early as possible,” Dr. Jill Waibel said at the annual conference of the American Society for Laser Medicine and Surgery.
Approximately 100 million new scars occur annually in developed countries, almost a third of which result from trauma or burns, noted Dr. Waibel, a dermatologist specializing in treating burn scars at the Miami Dermatology and Laser Institute. Scarred areas begin to hypertrophy about 3-7 months after injury, when they undergo increased collagen production and slowed collagen breakdown, said Dr. Waibel. “Traditionally, reconstructive efforts have been delayed until a year after injury,” she emphasized. “But by this time, many patients have formed hypertrophic scars and have significant decreases in range of motion.”
To determine how early treatment with a combination of laser/LED therapy might interrupt hypertrophy and improve outcomes, Dr. Waibel and coinvestigator Ashley Rudnick treated 20 patients aged 21-55 years with moderate to severe burns on at least 5% of the body surface area that had occurred in the past 1-3 months. For each patient, they divided similarly scarred areas into four 5- by 5-cm squares, one of which served as an untreated control. They treated the other three areas with 120-micron spot fractional ablative carbon dioxide laser only, continuous wave LED phototherapy only, or fractional ablative laser followed by LED. They spaced the three laser sessions 2 months apart, and used eight 20-minute LED treatments per laser session. The fractional laser wavelength was 10,600 nm, energy was 80-120 mJ per pixel, and the frequency was up to 200 Hz, Dr. Waibel said. The LED wavelength was 830 nm, and energy intensity was 40-100 mW per cm2.
All treated areas improved more than the untreated control areas of scarring, but combining the modalities was associated with the fastest healing, according to blinded photographic reviews by physicians based on the visual analog Manchester scar scale, Dr. Waibel reported.
Phototherapy with LED can penetrate up to an inch of tissue and promotes selective ATP production and DNA and RNA activity, she added. “The positive effects occur only in injured cells,” she said. “LED has wound healing and anti-inflammatory effects that might benefit acutely wounded skin.”
Based on her experience, patients usually need from three to five sessions of fractional laser/LED sessions to see clear results, Dr. Waibel said in response to a question from an audience member. “We know that every time we treat a hypertrophic scar, it will get better,” she added. “When patients stop coming for treatment, you know they’re happy. If you can combine modalities softly and safely, you’ll need fewer treatments.”
Dr. Waibel disclosed financial and advisory relationships with ALMA, Cutera, DUSA, Harvest Technologies, L’Oreal/SkinCeuticals, Lumenis, Lutronics, Sebacia, Syneron-Candela, Valeant, and Zeltiq.
KISSIMMEE, FLA. – Early treatment with fractional carbon dioxide ablative laser and light-emitting diode phototherapy sped healing and improved texture, discoloration, and range of motion in hypertrophic burn scars in a controlled, blinded study of 20 patients.
“I think as long as we have intact epithelium, we’re going to have improvements if we can laser these patients as early as possible,” Dr. Jill Waibel said at the annual conference of the American Society for Laser Medicine and Surgery.
Approximately 100 million new scars occur annually in developed countries, almost a third of which result from trauma or burns, noted Dr. Waibel, a dermatologist specializing in treating burn scars at the Miami Dermatology and Laser Institute. Scarred areas begin to hypertrophy about 3-7 months after injury, when they undergo increased collagen production and slowed collagen breakdown, said Dr. Waibel. “Traditionally, reconstructive efforts have been delayed until a year after injury,” she emphasized. “But by this time, many patients have formed hypertrophic scars and have significant decreases in range of motion.”
To determine how early treatment with a combination of laser/LED therapy might interrupt hypertrophy and improve outcomes, Dr. Waibel and coinvestigator Ashley Rudnick treated 20 patients aged 21-55 years with moderate to severe burns on at least 5% of the body surface area that had occurred in the past 1-3 months. For each patient, they divided similarly scarred areas into four 5- by 5-cm squares, one of which served as an untreated control. They treated the other three areas with 120-micron spot fractional ablative carbon dioxide laser only, continuous wave LED phototherapy only, or fractional ablative laser followed by LED. They spaced the three laser sessions 2 months apart, and used eight 20-minute LED treatments per laser session. The fractional laser wavelength was 10,600 nm, energy was 80-120 mJ per pixel, and the frequency was up to 200 Hz, Dr. Waibel said. The LED wavelength was 830 nm, and energy intensity was 40-100 mW per cm2.
All treated areas improved more than the untreated control areas of scarring, but combining the modalities was associated with the fastest healing, according to blinded photographic reviews by physicians based on the visual analog Manchester scar scale, Dr. Waibel reported.
Phototherapy with LED can penetrate up to an inch of tissue and promotes selective ATP production and DNA and RNA activity, she added. “The positive effects occur only in injured cells,” she said. “LED has wound healing and anti-inflammatory effects that might benefit acutely wounded skin.”
Based on her experience, patients usually need from three to five sessions of fractional laser/LED sessions to see clear results, Dr. Waibel said in response to a question from an audience member. “We know that every time we treat a hypertrophic scar, it will get better,” she added. “When patients stop coming for treatment, you know they’re happy. If you can combine modalities softly and safely, you’ll need fewer treatments.”
Dr. Waibel disclosed financial and advisory relationships with ALMA, Cutera, DUSA, Harvest Technologies, L’Oreal/SkinCeuticals, Lumenis, Lutronics, Sebacia, Syneron-Candela, Valeant, and Zeltiq.
AT LASER 2015
Key clinical point: Fractional carbon dioxide ablative laser with light-emitting diode (LED) phototherapy sped healing and improved the appearance and function of burn scars.
Major finding: Both laser and LED alone improved scar healing, compared with untreated control scars, but combining the modalities led to the best outcomes. The fractional laser wavelength was 10,600 nm, and the LED wavelength was 830 nm.
Data source: Prospective, blinded, controlled study of 20 adults with acute moderate to severe burns.
Disclosures: Dr. Waibel disclosed financial and advisory relationships with ALMA, Cutera, DUSA, Harvest Technologies, L’Oreal/Skinceuticals, Lumenis, Lutronic, Sebacia, Syneron-Candela, Valeant, and Zeltiq.
Microwave system cuts axillary hair by 70%
KISSIMMEE, FLA. – A noninvasive microwave system reduced light and dark axillary hair by approximately 70%, with durable results 1 year after treatment, according to data from a prospective multicenter study of 44 patients.
The device is Food and Drug Administration–approved for thermal treatment of axillary sweat glands, and has been used for about 35,000 such procedures, Dr. Jeremy Brauer said at the annual meeting of the American Society for Laser Medicine and Surgery.
The system targets microwave energy at the interface between the dermis and the hypodermis, “and we hypothesized that heat at this level in the skin may also have an important effect on the hair bulb,” he said.
Hair reduction is the third most common cosmetic procedure that U.S. dermatologists perform, said Dr. Brauer, a dermatologist with the Laser & Skin Surgery Center of New York. Laser is the primary modality, but is not always effective and can cause serious tissue damage if melanin concentrations in the hair and skin are too similar, he said.
For the study, Dr. Bauer and his associates used the microwave device to treat the axillae of 44 patients during either one or two treatment sessions. Average age of the patients was 33 years (range, 18-61 years), 80% were female, and 62% had dark axillary hair. Most had Fitzpatrick skin type II (33%), III (27%), or I (23%), but about 18% had type IV or V. During follow-up visits at 3, 6, 9, and 12 months, three blinded assessors counted hairs within a 2 cm x 2 cm area in the center of each axilla, and also qualitatively compared follow-up and baseline photos.
The blinded assessors correctly chose the baseline photos for all the photographic series, Dr. Brauer said. At 12 months, mean hair reduction was 75% for all patients, 72% for light-haired patients, and 76% for dark-haired patients, he reported. Ranges of response within these subgroups were relatively narrow, but patients who were treated at higher energy levels (settings of 3 or 4) achieved significantly more hair reduction (P < .0001) at 12 months than did patients who were treated at a setting of 1, he said. He recommended that future studies examine dose response and optimal number of treatment sessions.
Dr. Brauer reported consulting fees from Miramar, maker of the device.
KISSIMMEE, FLA. – A noninvasive microwave system reduced light and dark axillary hair by approximately 70%, with durable results 1 year after treatment, according to data from a prospective multicenter study of 44 patients.
The device is Food and Drug Administration–approved for thermal treatment of axillary sweat glands, and has been used for about 35,000 such procedures, Dr. Jeremy Brauer said at the annual meeting of the American Society for Laser Medicine and Surgery.
The system targets microwave energy at the interface between the dermis and the hypodermis, “and we hypothesized that heat at this level in the skin may also have an important effect on the hair bulb,” he said.
Hair reduction is the third most common cosmetic procedure that U.S. dermatologists perform, said Dr. Brauer, a dermatologist with the Laser & Skin Surgery Center of New York. Laser is the primary modality, but is not always effective and can cause serious tissue damage if melanin concentrations in the hair and skin are too similar, he said.
For the study, Dr. Bauer and his associates used the microwave device to treat the axillae of 44 patients during either one or two treatment sessions. Average age of the patients was 33 years (range, 18-61 years), 80% were female, and 62% had dark axillary hair. Most had Fitzpatrick skin type II (33%), III (27%), or I (23%), but about 18% had type IV or V. During follow-up visits at 3, 6, 9, and 12 months, three blinded assessors counted hairs within a 2 cm x 2 cm area in the center of each axilla, and also qualitatively compared follow-up and baseline photos.
The blinded assessors correctly chose the baseline photos for all the photographic series, Dr. Brauer said. At 12 months, mean hair reduction was 75% for all patients, 72% for light-haired patients, and 76% for dark-haired patients, he reported. Ranges of response within these subgroups were relatively narrow, but patients who were treated at higher energy levels (settings of 3 or 4) achieved significantly more hair reduction (P < .0001) at 12 months than did patients who were treated at a setting of 1, he said. He recommended that future studies examine dose response and optimal number of treatment sessions.
Dr. Brauer reported consulting fees from Miramar, maker of the device.
KISSIMMEE, FLA. – A noninvasive microwave system reduced light and dark axillary hair by approximately 70%, with durable results 1 year after treatment, according to data from a prospective multicenter study of 44 patients.
The device is Food and Drug Administration–approved for thermal treatment of axillary sweat glands, and has been used for about 35,000 such procedures, Dr. Jeremy Brauer said at the annual meeting of the American Society for Laser Medicine and Surgery.
The system targets microwave energy at the interface between the dermis and the hypodermis, “and we hypothesized that heat at this level in the skin may also have an important effect on the hair bulb,” he said.
Hair reduction is the third most common cosmetic procedure that U.S. dermatologists perform, said Dr. Brauer, a dermatologist with the Laser & Skin Surgery Center of New York. Laser is the primary modality, but is not always effective and can cause serious tissue damage if melanin concentrations in the hair and skin are too similar, he said.
For the study, Dr. Bauer and his associates used the microwave device to treat the axillae of 44 patients during either one or two treatment sessions. Average age of the patients was 33 years (range, 18-61 years), 80% were female, and 62% had dark axillary hair. Most had Fitzpatrick skin type II (33%), III (27%), or I (23%), but about 18% had type IV or V. During follow-up visits at 3, 6, 9, and 12 months, three blinded assessors counted hairs within a 2 cm x 2 cm area in the center of each axilla, and also qualitatively compared follow-up and baseline photos.
The blinded assessors correctly chose the baseline photos for all the photographic series, Dr. Brauer said. At 12 months, mean hair reduction was 75% for all patients, 72% for light-haired patients, and 76% for dark-haired patients, he reported. Ranges of response within these subgroups were relatively narrow, but patients who were treated at higher energy levels (settings of 3 or 4) achieved significantly more hair reduction (P < .0001) at 12 months than did patients who were treated at a setting of 1, he said. He recommended that future studies examine dose response and optimal number of treatment sessions.
Dr. Brauer reported consulting fees from Miramar, maker of the device.
AT LASER 2015
Key clinical point: A noninvasive microwave device reduced axillary hair by about 70%, with stable results 1 year later.
Major finding: Mean reduction in both light and dark axillary hair was about 70%, 12 months after one to two treatment sessions.
Data source: Prospective multicenter study of 44 patients with blinded assessments.
Disclosures: Dr. Brauer reported consulting fees from Miramar, maker of the device.
Up the anesthesia when treating axillary hyperhidrosis
KISSIMMEE, FLA. – Patients who received more local anesthesia before undergoing microwave-based treatment for axillary hyperhidrosis were happier with results and achieved the same objective improvements as patients who received less anesthesia, a follow-up study found.
“Patient satisfaction with the procedure was extremely high,” said Dr. Carolyn Jacob, a dermatologist and founding director of Chicago Cosmetic Surgery and Dermatology. “You can’t regenerate sweat glands – once they’re gone, they’re gone, and these patients have sustained results.”
The microwave system has been used commercially for more than 30,000 treatment sessions over 3 years and achieved high rates of efficacy and patient satisfaction in two pivotal trials, Dr. Jacob noted (Dermatol. Surg. 2012;38:185-91; Dermatol. Surg. 2012;38:728-35).
But clinicians often have kept to the relatively low volumes of local anesthesia used in the trials because they were concerned that higher volumes would interact with microwave energy and diminish efficacy, she said at the annual meeting of the American Society for Laser Medicine and Surgery.
To investigate that concern and assess overall longer-term treatment outcomes, Dr. Jacob and her associates compared 110 patients who received 10-25 cc of local lidocaine/epinephrine solution per axilla (the amount used in the clinical trials) with 30 patients who received 60-275 cc per axilla before undergoing microwave-based treatment of hyperhidrosis. At baseline, the two groups scored similarly on the 4-point measure of hyperhidrosis severity and on 10-point measures of sweat and odor severity (average scores of 3.4, 8.5, and 5.2, respectively, for the group that received less anesthesia and 3.3, 8.7, and 5.8, respectively, for the group that received more anesthesia), said Dr. Jacob. Patients were treated at energy levels of 3-5, and most were female. The researchers followed the lower anesthesia group and the higher anesthesia group for an average of 6 and 9 months, respectively.
At follow-up, 88% of patients in the lower-volume anesthesia group scored 1 or 2 on the 4-point measure of hyperhidrosis, as did 93% of patients in the higher-volume group, said Dr. Jacob. The groups also had very similar efficacy results on the 10-point measures of sweat and odor severity, she said (respective average scores, 3.0 and 3.2 on the sweat measure, and 1.9 and 2.0 on the odor measure). In all, 85% of patients who received less anesthesia said they were satisfied with results, as did 93% of patients in the higher-volume group.
Patients usually needed two treatment sessions that lasted 60-75 minutes each, depending on the size of the treatment area, Dr. Jacob noted. A few needed only one session. “There’s a high efficacy that’s consistent with the previous publications we have,” she concluded. “The high volumes of anesthesia seem to work just as well as the lower volumes.”
KISSIMMEE, FLA. – Patients who received more local anesthesia before undergoing microwave-based treatment for axillary hyperhidrosis were happier with results and achieved the same objective improvements as patients who received less anesthesia, a follow-up study found.
“Patient satisfaction with the procedure was extremely high,” said Dr. Carolyn Jacob, a dermatologist and founding director of Chicago Cosmetic Surgery and Dermatology. “You can’t regenerate sweat glands – once they’re gone, they’re gone, and these patients have sustained results.”
The microwave system has been used commercially for more than 30,000 treatment sessions over 3 years and achieved high rates of efficacy and patient satisfaction in two pivotal trials, Dr. Jacob noted (Dermatol. Surg. 2012;38:185-91; Dermatol. Surg. 2012;38:728-35).
But clinicians often have kept to the relatively low volumes of local anesthesia used in the trials because they were concerned that higher volumes would interact with microwave energy and diminish efficacy, she said at the annual meeting of the American Society for Laser Medicine and Surgery.
To investigate that concern and assess overall longer-term treatment outcomes, Dr. Jacob and her associates compared 110 patients who received 10-25 cc of local lidocaine/epinephrine solution per axilla (the amount used in the clinical trials) with 30 patients who received 60-275 cc per axilla before undergoing microwave-based treatment of hyperhidrosis. At baseline, the two groups scored similarly on the 4-point measure of hyperhidrosis severity and on 10-point measures of sweat and odor severity (average scores of 3.4, 8.5, and 5.2, respectively, for the group that received less anesthesia and 3.3, 8.7, and 5.8, respectively, for the group that received more anesthesia), said Dr. Jacob. Patients were treated at energy levels of 3-5, and most were female. The researchers followed the lower anesthesia group and the higher anesthesia group for an average of 6 and 9 months, respectively.
At follow-up, 88% of patients in the lower-volume anesthesia group scored 1 or 2 on the 4-point measure of hyperhidrosis, as did 93% of patients in the higher-volume group, said Dr. Jacob. The groups also had very similar efficacy results on the 10-point measures of sweat and odor severity, she said (respective average scores, 3.0 and 3.2 on the sweat measure, and 1.9 and 2.0 on the odor measure). In all, 85% of patients who received less anesthesia said they were satisfied with results, as did 93% of patients in the higher-volume group.
Patients usually needed two treatment sessions that lasted 60-75 minutes each, depending on the size of the treatment area, Dr. Jacob noted. A few needed only one session. “There’s a high efficacy that’s consistent with the previous publications we have,” she concluded. “The high volumes of anesthesia seem to work just as well as the lower volumes.”
KISSIMMEE, FLA. – Patients who received more local anesthesia before undergoing microwave-based treatment for axillary hyperhidrosis were happier with results and achieved the same objective improvements as patients who received less anesthesia, a follow-up study found.
“Patient satisfaction with the procedure was extremely high,” said Dr. Carolyn Jacob, a dermatologist and founding director of Chicago Cosmetic Surgery and Dermatology. “You can’t regenerate sweat glands – once they’re gone, they’re gone, and these patients have sustained results.”
The microwave system has been used commercially for more than 30,000 treatment sessions over 3 years and achieved high rates of efficacy and patient satisfaction in two pivotal trials, Dr. Jacob noted (Dermatol. Surg. 2012;38:185-91; Dermatol. Surg. 2012;38:728-35).
But clinicians often have kept to the relatively low volumes of local anesthesia used in the trials because they were concerned that higher volumes would interact with microwave energy and diminish efficacy, she said at the annual meeting of the American Society for Laser Medicine and Surgery.
To investigate that concern and assess overall longer-term treatment outcomes, Dr. Jacob and her associates compared 110 patients who received 10-25 cc of local lidocaine/epinephrine solution per axilla (the amount used in the clinical trials) with 30 patients who received 60-275 cc per axilla before undergoing microwave-based treatment of hyperhidrosis. At baseline, the two groups scored similarly on the 4-point measure of hyperhidrosis severity and on 10-point measures of sweat and odor severity (average scores of 3.4, 8.5, and 5.2, respectively, for the group that received less anesthesia and 3.3, 8.7, and 5.8, respectively, for the group that received more anesthesia), said Dr. Jacob. Patients were treated at energy levels of 3-5, and most were female. The researchers followed the lower anesthesia group and the higher anesthesia group for an average of 6 and 9 months, respectively.
At follow-up, 88% of patients in the lower-volume anesthesia group scored 1 or 2 on the 4-point measure of hyperhidrosis, as did 93% of patients in the higher-volume group, said Dr. Jacob. The groups also had very similar efficacy results on the 10-point measures of sweat and odor severity, she said (respective average scores, 3.0 and 3.2 on the sweat measure, and 1.9 and 2.0 on the odor measure). In all, 85% of patients who received less anesthesia said they were satisfied with results, as did 93% of patients in the higher-volume group.
Patients usually needed two treatment sessions that lasted 60-75 minutes each, depending on the size of the treatment area, Dr. Jacob noted. A few needed only one session. “There’s a high efficacy that’s consistent with the previous publications we have,” she concluded. “The high volumes of anesthesia seem to work just as well as the lower volumes.”
AT LASER 2015
Key clinical point: Higher volumes of local anesthesia did not adversely affect the efficacy of microwave-based treatment of axillary hyperhidrosis.
Major finding: At follow-up, 88% of the lower-volume group and 93% of the higher-volume group<b/>scored 1 or 2 on the 4-point measure of hyperhidrosis.
Data source: Multicenter follow-up study of 110 patients who received the standard low amount of local anesthesia and 30 who received higher volumes.
Disclosures: Dr. Jacob reported financial relationships with Miramar, Abbvie, Allergan, Galderma, and Medicis/Valeant.
LASER: How to succeed in perioperative ablative laser resurfacing
KISSIMMEE, FLA. – Ablative laser resurfacing may be the most effective cosmetic treatment for the periorbital area, excluding blepharoplasty, according to Dr. Suzanne L. Kilmer, a dermatologist specializing in laser and skin surgery in Sacramento, Calif.
“It gives you definite tightening and has the most predictable results,” Dr. Kilmer said at the annual meeting of the American Society for Laser Medicine and Surgery. “It also has the worst down time and side effects, but not for the upper lid – I’ve never had any scarring on the upper eyelid.”
In addition to its cosmetic potential, ablative laser resurfacing can remove epidermal lesions that might otherwise become actinic keratoses or basal cell carcinomas, and can smooth out syringomas, nevi, and seborrheic keratoses, Dr. Kilmer said. She shared some of her top tips for successful use of this technique.
Technique, safety, and analgesia
When treating patients with perioperative ablative laser resurfacing, Dr. Kilmer said she performs the first pass with a carbon dioxide laser at computerized pattern-generator (CPG) settings of pattern 3, size 9, density 6. She follows that with erbium laser resurfacing at a depth of 75-100 microns. “The first pass removes the epidermis,” she said. “Be sure to feather peripherally, and wipe everywhere you will do a second pass.”
The skin usually tightens visibly with the second pass, which can include the upper eyelids if patients have lax skin in this area, Dr. Kilmer noted. “You can be aggressive, like 3-9-5 [CPG settings],” she added. She then performs a “very light” second pass to the lower lids, with lower CPG settings of 3-7-3 or 3-6-2. She again follows with erbium ablation, including to the areas of the central face and midcheek.
The third pass includes the glabella and perioral area, as well as the upper eyelids if they are especially lax, Dr. Kilmer said. She ends with a sculpting pass with erbium laser.
Dr. Kilmer explained that she always treats the upper eyelids with ablative laser therapy in combination with fractional carbon dioxide laser treatment. “I also will include any area I think looks safe to do ablative on an individual patient,” she added. She noted that she sometimes combines ablative and fractional therapies with botulinum toxin treatment.
Patients should always wear eye shields during laser treatment sessions, Dr. Kilmer emphasized. Acceptable options include David-Baker lid clamps, Jaeger lid plates, and individual steel eye shields, but plastic corneal protectors should be avoided because they can sustain thermal damage with laser exposure, she said.
Options for analgesia during treatment include codeine, hydrocodone, hydromorphone, or nonsteroidal anti-inflammatory agents such as Toradol (ketorolac), which Dr. Kilmer gives intramuscularly at a dose of 30-60 mg. Furthermore, EMLA (lidocaine/prilocaine) cream enhances comfort, even if patients are also receiving conscious sedation or blocks, she said. The cream helps prevent several adverse effects, including superficial coagulative thermal damage, prolonged erythema, and delayed hypopigmentation, and does not seem to decrease efficacy, she added.
Before treatment
Clinicians should consider how a patient’s unique characteristics might affect treatment outcomes, Dr. Kilmer said. For example, ablation is more likely to cause hypopigmentation in patients with lighter skin types, and is unlikely to sufficiently resolve wrinkles that involve the facial muscles. “Always discuss Botox [botulinum toxin],” added Dr Kilmer. “If you’re tightening up the skin, and the area underneath is moving a lot, you’re not going to get as much tightening.” Clinicians also should discuss a face lift as an option for patients with substantial excess facial skin, she said.
The overall treatment plan should address existing skin lesions, too. Larger syringomas, trichoepitheliomas, and hyperplastic sebaceous glands should be “drilled out” with erbium ablation, but small tumors usually need only multiple or fractional laser treatment, said Dr. Kilmer.
For antimicrobial prophylaxis, patients should receive acyclovir, valcyclovir, or famvir starting 1 day before the procedure and continuing for 10-14 days, Dr. Kilmer said. “If I’m just treating around the eyes, I don’t worry as much about antivirals. I think about them more if I’m doing the full face,” she noted. Likewise, preoperative antibiotics such as doxycycline, cephalexin, azithromycin, or ciprofloxacin are especially important for full face or perioral ablative resurfacing, she said. To help prevent yeast infections, she gives patients a dose of fluconazole on day 3 after the procedure. “If they have a history of multiple yeast infections, I give it four times a day,” she said.
After the procedure
Postoperative diligence is key to good outcomes, Dr. Kilmer emphasized. During the first 10-14 days after the procedure, patients and clinicians should watch for signs of complications such as pain, purulence, itching, and worsening redness. If patients develop pain accompanied by purulence and redness, clinicians should perform bacterial cultures and switch patients to a quinolone, Dr. Kilmer said. Patients who develop pain consistent with herpes simplex virus infection should receive valcyclovir, she added. “If they’re itchy and red, think about yeast [infection] or contact dermatitis, and treat for both if you’re unsure,” she said.
Dr. Kilmer disclosed advisory relationships with Candela-Syneron, Living Proof, Lumeis, Miramar, Ulthera, and Zeltiq. She reported having received research funding from the same companies, and also from Allergan, CoolTouch, Cutera, Cynosure, Palomar, Sciton, and Solta.
KISSIMMEE, FLA. – Ablative laser resurfacing may be the most effective cosmetic treatment for the periorbital area, excluding blepharoplasty, according to Dr. Suzanne L. Kilmer, a dermatologist specializing in laser and skin surgery in Sacramento, Calif.
“It gives you definite tightening and has the most predictable results,” Dr. Kilmer said at the annual meeting of the American Society for Laser Medicine and Surgery. “It also has the worst down time and side effects, but not for the upper lid – I’ve never had any scarring on the upper eyelid.”
In addition to its cosmetic potential, ablative laser resurfacing can remove epidermal lesions that might otherwise become actinic keratoses or basal cell carcinomas, and can smooth out syringomas, nevi, and seborrheic keratoses, Dr. Kilmer said. She shared some of her top tips for successful use of this technique.
Technique, safety, and analgesia
When treating patients with perioperative ablative laser resurfacing, Dr. Kilmer said she performs the first pass with a carbon dioxide laser at computerized pattern-generator (CPG) settings of pattern 3, size 9, density 6. She follows that with erbium laser resurfacing at a depth of 75-100 microns. “The first pass removes the epidermis,” she said. “Be sure to feather peripherally, and wipe everywhere you will do a second pass.”
The skin usually tightens visibly with the second pass, which can include the upper eyelids if patients have lax skin in this area, Dr. Kilmer noted. “You can be aggressive, like 3-9-5 [CPG settings],” she added. She then performs a “very light” second pass to the lower lids, with lower CPG settings of 3-7-3 or 3-6-2. She again follows with erbium ablation, including to the areas of the central face and midcheek.
The third pass includes the glabella and perioral area, as well as the upper eyelids if they are especially lax, Dr. Kilmer said. She ends with a sculpting pass with erbium laser.
Dr. Kilmer explained that she always treats the upper eyelids with ablative laser therapy in combination with fractional carbon dioxide laser treatment. “I also will include any area I think looks safe to do ablative on an individual patient,” she added. She noted that she sometimes combines ablative and fractional therapies with botulinum toxin treatment.
Patients should always wear eye shields during laser treatment sessions, Dr. Kilmer emphasized. Acceptable options include David-Baker lid clamps, Jaeger lid plates, and individual steel eye shields, but plastic corneal protectors should be avoided because they can sustain thermal damage with laser exposure, she said.
Options for analgesia during treatment include codeine, hydrocodone, hydromorphone, or nonsteroidal anti-inflammatory agents such as Toradol (ketorolac), which Dr. Kilmer gives intramuscularly at a dose of 30-60 mg. Furthermore, EMLA (lidocaine/prilocaine) cream enhances comfort, even if patients are also receiving conscious sedation or blocks, she said. The cream helps prevent several adverse effects, including superficial coagulative thermal damage, prolonged erythema, and delayed hypopigmentation, and does not seem to decrease efficacy, she added.
Before treatment
Clinicians should consider how a patient’s unique characteristics might affect treatment outcomes, Dr. Kilmer said. For example, ablation is more likely to cause hypopigmentation in patients with lighter skin types, and is unlikely to sufficiently resolve wrinkles that involve the facial muscles. “Always discuss Botox [botulinum toxin],” added Dr Kilmer. “If you’re tightening up the skin, and the area underneath is moving a lot, you’re not going to get as much tightening.” Clinicians also should discuss a face lift as an option for patients with substantial excess facial skin, she said.
The overall treatment plan should address existing skin lesions, too. Larger syringomas, trichoepitheliomas, and hyperplastic sebaceous glands should be “drilled out” with erbium ablation, but small tumors usually need only multiple or fractional laser treatment, said Dr. Kilmer.
For antimicrobial prophylaxis, patients should receive acyclovir, valcyclovir, or famvir starting 1 day before the procedure and continuing for 10-14 days, Dr. Kilmer said. “If I’m just treating around the eyes, I don’t worry as much about antivirals. I think about them more if I’m doing the full face,” she noted. Likewise, preoperative antibiotics such as doxycycline, cephalexin, azithromycin, or ciprofloxacin are especially important for full face or perioral ablative resurfacing, she said. To help prevent yeast infections, she gives patients a dose of fluconazole on day 3 after the procedure. “If they have a history of multiple yeast infections, I give it four times a day,” she said.
After the procedure
Postoperative diligence is key to good outcomes, Dr. Kilmer emphasized. During the first 10-14 days after the procedure, patients and clinicians should watch for signs of complications such as pain, purulence, itching, and worsening redness. If patients develop pain accompanied by purulence and redness, clinicians should perform bacterial cultures and switch patients to a quinolone, Dr. Kilmer said. Patients who develop pain consistent with herpes simplex virus infection should receive valcyclovir, she added. “If they’re itchy and red, think about yeast [infection] or contact dermatitis, and treat for both if you’re unsure,” she said.
Dr. Kilmer disclosed advisory relationships with Candela-Syneron, Living Proof, Lumeis, Miramar, Ulthera, and Zeltiq. She reported having received research funding from the same companies, and also from Allergan, CoolTouch, Cutera, Cynosure, Palomar, Sciton, and Solta.
KISSIMMEE, FLA. – Ablative laser resurfacing may be the most effective cosmetic treatment for the periorbital area, excluding blepharoplasty, according to Dr. Suzanne L. Kilmer, a dermatologist specializing in laser and skin surgery in Sacramento, Calif.
“It gives you definite tightening and has the most predictable results,” Dr. Kilmer said at the annual meeting of the American Society for Laser Medicine and Surgery. “It also has the worst down time and side effects, but not for the upper lid – I’ve never had any scarring on the upper eyelid.”
In addition to its cosmetic potential, ablative laser resurfacing can remove epidermal lesions that might otherwise become actinic keratoses or basal cell carcinomas, and can smooth out syringomas, nevi, and seborrheic keratoses, Dr. Kilmer said. She shared some of her top tips for successful use of this technique.
Technique, safety, and analgesia
When treating patients with perioperative ablative laser resurfacing, Dr. Kilmer said she performs the first pass with a carbon dioxide laser at computerized pattern-generator (CPG) settings of pattern 3, size 9, density 6. She follows that with erbium laser resurfacing at a depth of 75-100 microns. “The first pass removes the epidermis,” she said. “Be sure to feather peripherally, and wipe everywhere you will do a second pass.”
The skin usually tightens visibly with the second pass, which can include the upper eyelids if patients have lax skin in this area, Dr. Kilmer noted. “You can be aggressive, like 3-9-5 [CPG settings],” she added. She then performs a “very light” second pass to the lower lids, with lower CPG settings of 3-7-3 or 3-6-2. She again follows with erbium ablation, including to the areas of the central face and midcheek.
The third pass includes the glabella and perioral area, as well as the upper eyelids if they are especially lax, Dr. Kilmer said. She ends with a sculpting pass with erbium laser.
Dr. Kilmer explained that she always treats the upper eyelids with ablative laser therapy in combination with fractional carbon dioxide laser treatment. “I also will include any area I think looks safe to do ablative on an individual patient,” she added. She noted that she sometimes combines ablative and fractional therapies with botulinum toxin treatment.
Patients should always wear eye shields during laser treatment sessions, Dr. Kilmer emphasized. Acceptable options include David-Baker lid clamps, Jaeger lid plates, and individual steel eye shields, but plastic corneal protectors should be avoided because they can sustain thermal damage with laser exposure, she said.
Options for analgesia during treatment include codeine, hydrocodone, hydromorphone, or nonsteroidal anti-inflammatory agents such as Toradol (ketorolac), which Dr. Kilmer gives intramuscularly at a dose of 30-60 mg. Furthermore, EMLA (lidocaine/prilocaine) cream enhances comfort, even if patients are also receiving conscious sedation or blocks, she said. The cream helps prevent several adverse effects, including superficial coagulative thermal damage, prolonged erythema, and delayed hypopigmentation, and does not seem to decrease efficacy, she added.
Before treatment
Clinicians should consider how a patient’s unique characteristics might affect treatment outcomes, Dr. Kilmer said. For example, ablation is more likely to cause hypopigmentation in patients with lighter skin types, and is unlikely to sufficiently resolve wrinkles that involve the facial muscles. “Always discuss Botox [botulinum toxin],” added Dr Kilmer. “If you’re tightening up the skin, and the area underneath is moving a lot, you’re not going to get as much tightening.” Clinicians also should discuss a face lift as an option for patients with substantial excess facial skin, she said.
The overall treatment plan should address existing skin lesions, too. Larger syringomas, trichoepitheliomas, and hyperplastic sebaceous glands should be “drilled out” with erbium ablation, but small tumors usually need only multiple or fractional laser treatment, said Dr. Kilmer.
For antimicrobial prophylaxis, patients should receive acyclovir, valcyclovir, or famvir starting 1 day before the procedure and continuing for 10-14 days, Dr. Kilmer said. “If I’m just treating around the eyes, I don’t worry as much about antivirals. I think about them more if I’m doing the full face,” she noted. Likewise, preoperative antibiotics such as doxycycline, cephalexin, azithromycin, or ciprofloxacin are especially important for full face or perioral ablative resurfacing, she said. To help prevent yeast infections, she gives patients a dose of fluconazole on day 3 after the procedure. “If they have a history of multiple yeast infections, I give it four times a day,” she said.
After the procedure
Postoperative diligence is key to good outcomes, Dr. Kilmer emphasized. During the first 10-14 days after the procedure, patients and clinicians should watch for signs of complications such as pain, purulence, itching, and worsening redness. If patients develop pain accompanied by purulence and redness, clinicians should perform bacterial cultures and switch patients to a quinolone, Dr. Kilmer said. Patients who develop pain consistent with herpes simplex virus infection should receive valcyclovir, she added. “If they’re itchy and red, think about yeast [infection] or contact dermatitis, and treat for both if you’re unsure,” she said.
Dr. Kilmer disclosed advisory relationships with Candela-Syneron, Living Proof, Lumeis, Miramar, Ulthera, and Zeltiq. She reported having received research funding from the same companies, and also from Allergan, CoolTouch, Cutera, Cynosure, Palomar, Sciton, and Solta.
EXPERT ANALYSIS FROM LASER 2015