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Tocilizumab effective in giant cell arteritis
SAN FRANCISCO – Mounting evidence supports the use of tocilizumab in giant cell arteritis (GCA), and a new study supports use of the drug for induction and maintenance therapy in patients with newly diagnosed or relapsed GCA in the context of rapidly tapered glucocorticoid therapy.
“This is the first randomized controlled trial to prove efficacy of tocilizumab in induction and maintenance of remission in GCA. Tocilizumab reached the primary and secondary endpoints in our trial compared with placebo. After 12 months of therapy, more serious adverse events were observed in the placebo group,” said lead author Dr. Sabine Adler, University Hospital, Bern, Switzerland. Dr. Adler presented results of this late-breaking abstract at a special session during the annual meeting of the American College of Rheumatology.
A recent small open-label trial showed that tocilizumab was effective in patients with refractory GCA and unacceptable side effects on glucocorticoid (GC) therapy (Sem Arthr Rheum. Dec. 26, 2014. DOI:10.1016/j.semarthrit.2014.12.005). The present study was of newly diagnosed patients or those who had relapsed.
GCA is characterized by destructive inflammation in the walls of medium and large arteries. GC treatment has been the mainstay of therapy, controlling symptoms and reducing the risk of dreaded complications such as blindness, stroke, and claudication. But many patients require prolonged treatment, and cumulative doses of GC lead to substantial toxicity and morbidity. Thus, a better treatment is needed.
IL-6, the target of tocilizumab, is one of the cytokines involved in the pathogenesis of GCA. It is elevated in the serum and tissue of affected patients, Dr. Adler explained.
Dr. Adler and colleagues conducted a single-center, randomized, placebo-controlled trial evaluating tocilizumab in 30 patients with newly diagnosed or recurrent GCA. Patients were randomized in a 2:1 ratio to receive tocilizumab 8 mg/kg IV plus oral GC or IV placebo and oral GC. Infusions were given every 4 weeks for 1 year, over which time GC dose was slowly tapered to 0 mg in all patients. Some patients underwent angiography to rule out or define aortic involvement. Most patients in the trial had new onset GCA, she said.
The primary endpoint was complete remission at week 12 with GC dose of 0.1 mg/kg/day. Complete remission was defined as the absence of clinical signs and symptoms of GCA plus negative values for C-reactive protein (CRP) and erythrocyte sedimentation rate. At 12 weeks, the complete response rate was 85% for tocilizumab versus 40% for placebo, a significant difference. At the end of the trial, 85% and 20%, respectively, had not had a relapse; this difference was significant.
Placebo patients received a higher cumulative dose of GC, she continued.
There were 7 serious adverse events reported in the tocilizumab arm and 5 in the placebo arm; 1 death occurred in the placebo arm due to myocardial infarction.
“A closer look at serious adverse events reveals few cardiovascular problems,” Dr. Adler continued. Back pain and psychosis were reported as reasons for hospitalization.
During the question and answer session, an audience member noted that it was difficult to understand how a short-term treatment is effective in a chronic disease. “Probably patients will relapse when they stop the medication, so we are not on the ‘green’ side yet,” she replied. Dr. Adler noted that it could be possible that a reduced dose of tocilizumab could be effective but have fewer side effects, but that has not been studied.
Tocilizumab was provided by Roche for this investigator-initiated trial. Dr. Adler reported no financial disclosures.
SAN FRANCISCO – Mounting evidence supports the use of tocilizumab in giant cell arteritis (GCA), and a new study supports use of the drug for induction and maintenance therapy in patients with newly diagnosed or relapsed GCA in the context of rapidly tapered glucocorticoid therapy.
“This is the first randomized controlled trial to prove efficacy of tocilizumab in induction and maintenance of remission in GCA. Tocilizumab reached the primary and secondary endpoints in our trial compared with placebo. After 12 months of therapy, more serious adverse events were observed in the placebo group,” said lead author Dr. Sabine Adler, University Hospital, Bern, Switzerland. Dr. Adler presented results of this late-breaking abstract at a special session during the annual meeting of the American College of Rheumatology.
A recent small open-label trial showed that tocilizumab was effective in patients with refractory GCA and unacceptable side effects on glucocorticoid (GC) therapy (Sem Arthr Rheum. Dec. 26, 2014. DOI:10.1016/j.semarthrit.2014.12.005). The present study was of newly diagnosed patients or those who had relapsed.
GCA is characterized by destructive inflammation in the walls of medium and large arteries. GC treatment has been the mainstay of therapy, controlling symptoms and reducing the risk of dreaded complications such as blindness, stroke, and claudication. But many patients require prolonged treatment, and cumulative doses of GC lead to substantial toxicity and morbidity. Thus, a better treatment is needed.
IL-6, the target of tocilizumab, is one of the cytokines involved in the pathogenesis of GCA. It is elevated in the serum and tissue of affected patients, Dr. Adler explained.
Dr. Adler and colleagues conducted a single-center, randomized, placebo-controlled trial evaluating tocilizumab in 30 patients with newly diagnosed or recurrent GCA. Patients were randomized in a 2:1 ratio to receive tocilizumab 8 mg/kg IV plus oral GC or IV placebo and oral GC. Infusions were given every 4 weeks for 1 year, over which time GC dose was slowly tapered to 0 mg in all patients. Some patients underwent angiography to rule out or define aortic involvement. Most patients in the trial had new onset GCA, she said.
The primary endpoint was complete remission at week 12 with GC dose of 0.1 mg/kg/day. Complete remission was defined as the absence of clinical signs and symptoms of GCA plus negative values for C-reactive protein (CRP) and erythrocyte sedimentation rate. At 12 weeks, the complete response rate was 85% for tocilizumab versus 40% for placebo, a significant difference. At the end of the trial, 85% and 20%, respectively, had not had a relapse; this difference was significant.
Placebo patients received a higher cumulative dose of GC, she continued.
There were 7 serious adverse events reported in the tocilizumab arm and 5 in the placebo arm; 1 death occurred in the placebo arm due to myocardial infarction.
“A closer look at serious adverse events reveals few cardiovascular problems,” Dr. Adler continued. Back pain and psychosis were reported as reasons for hospitalization.
During the question and answer session, an audience member noted that it was difficult to understand how a short-term treatment is effective in a chronic disease. “Probably patients will relapse when they stop the medication, so we are not on the ‘green’ side yet,” she replied. Dr. Adler noted that it could be possible that a reduced dose of tocilizumab could be effective but have fewer side effects, but that has not been studied.
Tocilizumab was provided by Roche for this investigator-initiated trial. Dr. Adler reported no financial disclosures.
SAN FRANCISCO – Mounting evidence supports the use of tocilizumab in giant cell arteritis (GCA), and a new study supports use of the drug for induction and maintenance therapy in patients with newly diagnosed or relapsed GCA in the context of rapidly tapered glucocorticoid therapy.
“This is the first randomized controlled trial to prove efficacy of tocilizumab in induction and maintenance of remission in GCA. Tocilizumab reached the primary and secondary endpoints in our trial compared with placebo. After 12 months of therapy, more serious adverse events were observed in the placebo group,” said lead author Dr. Sabine Adler, University Hospital, Bern, Switzerland. Dr. Adler presented results of this late-breaking abstract at a special session during the annual meeting of the American College of Rheumatology.
A recent small open-label trial showed that tocilizumab was effective in patients with refractory GCA and unacceptable side effects on glucocorticoid (GC) therapy (Sem Arthr Rheum. Dec. 26, 2014. DOI:10.1016/j.semarthrit.2014.12.005). The present study was of newly diagnosed patients or those who had relapsed.
GCA is characterized by destructive inflammation in the walls of medium and large arteries. GC treatment has been the mainstay of therapy, controlling symptoms and reducing the risk of dreaded complications such as blindness, stroke, and claudication. But many patients require prolonged treatment, and cumulative doses of GC lead to substantial toxicity and morbidity. Thus, a better treatment is needed.
IL-6, the target of tocilizumab, is one of the cytokines involved in the pathogenesis of GCA. It is elevated in the serum and tissue of affected patients, Dr. Adler explained.
Dr. Adler and colleagues conducted a single-center, randomized, placebo-controlled trial evaluating tocilizumab in 30 patients with newly diagnosed or recurrent GCA. Patients were randomized in a 2:1 ratio to receive tocilizumab 8 mg/kg IV plus oral GC or IV placebo and oral GC. Infusions were given every 4 weeks for 1 year, over which time GC dose was slowly tapered to 0 mg in all patients. Some patients underwent angiography to rule out or define aortic involvement. Most patients in the trial had new onset GCA, she said.
The primary endpoint was complete remission at week 12 with GC dose of 0.1 mg/kg/day. Complete remission was defined as the absence of clinical signs and symptoms of GCA plus negative values for C-reactive protein (CRP) and erythrocyte sedimentation rate. At 12 weeks, the complete response rate was 85% for tocilizumab versus 40% for placebo, a significant difference. At the end of the trial, 85% and 20%, respectively, had not had a relapse; this difference was significant.
Placebo patients received a higher cumulative dose of GC, she continued.
There were 7 serious adverse events reported in the tocilizumab arm and 5 in the placebo arm; 1 death occurred in the placebo arm due to myocardial infarction.
“A closer look at serious adverse events reveals few cardiovascular problems,” Dr. Adler continued. Back pain and psychosis were reported as reasons for hospitalization.
During the question and answer session, an audience member noted that it was difficult to understand how a short-term treatment is effective in a chronic disease. “Probably patients will relapse when they stop the medication, so we are not on the ‘green’ side yet,” she replied. Dr. Adler noted that it could be possible that a reduced dose of tocilizumab could be effective but have fewer side effects, but that has not been studied.
Tocilizumab was provided by Roche for this investigator-initiated trial. Dr. Adler reported no financial disclosures.
AT THE ACR ANNUAL MEETING
Key clinical point: Tocilizumab was effective in newly diagnosed and recurrent giant cell arteritis.
Major finding: At week 12, 85% of the tocilizumab-treated patients were in complete remission versus 40% of placebo patients.
Data source: Single-center, randomized, double-blind trial of 30 patients.
Disclosures: Tocilizumab was provided by Roche for this investigator-initiated trial. Dr. Adler reported no financial disclosures.
Denosumab better at building bone than zoledronic acid
SAN FRANCISCO – Denosumab was superior to zoledronic acid (ZA) in building bone at the lumber spine, total hip, and femoral neck in postmenopausal women with osteoporosis previously treated with oral bisphosphonate therapy in a randomized phase III trial. This study is one more piece of level I evidence to support the effectiveness of transitioning to denosumab in such patients.
“In postmenopausal women with osteoporosis on prior oral bisphosphonates for 2 or more years, transitioning to denosumab resulted in significantly greater increases in bone mineral density [BMD], compared with zoledronic acid at all measured skeletal sites,” said lead author Dr. Paul D. Miller of the Colorado Center for Bone Research, Lakewood, Colo.
Speaking at the annual meeting of the American College of Rheumatology, Dr. Miller said: “This study completes a suite of trials that show transitioning from oral bisphosphonates to denosumab provides greater increases in bone mineral density and reduction in bone turnover markers, compared to maintaining therapy with another bisphosphonate.”
“Adherence rates to oral bisphosphonates are low,” he continued. “Patients who are intolerant to or fail other bisphosphonates may cycle from one bisphosphonate to another, but clinical benefits are not shown. Previous trials have shown that denosumab increased bone mineral density in women previously treated with oral bisphosphonates, whereas zoledronic acid did not, in women previously treated with alendronate.”
A prospective, double-blind, double-dummy, randomized trial was mounted to compare denosumab given subcutaneously at 60 mg every 6 months (n = 321) vs. ZA 5 mg once a year (n = 322) in postmenopausal women with osteoporosis who were intolerant to or who failed oral bisphosphonate therapy after at least 2 years of treatment.
Baseline characteristics were similar between both treatment arms. Median age was 69 years. About 38% had previous osteoporotic fracture. Bone mineral density T scores were similar between groups. Prior oral bisphosphonate exposure was a median of 6.4 years. Bone turnover marker levels were similar between the two arms.
For the primary endpoint, at 12 months, denosumab achieved a greater increase in BMD at all sites, compared with ZA: a 2.1% difference was observed at the lumbar spine and a 1.4% difference at the total hip.
Changes in bone turnover markers over time were more favorable with denosumab, he continued. Serum C-terminal cross-linking telopeptide (CTX) level was maintained in the denosumab arm and increased with ZA over 12 months. A similar pattern was observed with procollagen type 1 N-terminal propeptide (P1NP).
Adverse events were comparable between both groups. Serious adverse events were reported in 7.8% in the denosumab arm versus 9.1% in the ZA arm, but this difference was not statistically significant. Slightly more hypersensitivity adverse events were reported in the denosumab group: 3.8% versus 1.9% for ZA. The number of osteoporotic-related fractures was doubled in the ZA arm: 7 for denosumab vs. 15 for ZA.
Dr. Miller told listeners that this is the fourth study to show that denosumab is effective in osteoporotic patients previously on oral bisphosphonates, including prior risedronate, ibandronate, and alendronate.
SAN FRANCISCO – Denosumab was superior to zoledronic acid (ZA) in building bone at the lumber spine, total hip, and femoral neck in postmenopausal women with osteoporosis previously treated with oral bisphosphonate therapy in a randomized phase III trial. This study is one more piece of level I evidence to support the effectiveness of transitioning to denosumab in such patients.
“In postmenopausal women with osteoporosis on prior oral bisphosphonates for 2 or more years, transitioning to denosumab resulted in significantly greater increases in bone mineral density [BMD], compared with zoledronic acid at all measured skeletal sites,” said lead author Dr. Paul D. Miller of the Colorado Center for Bone Research, Lakewood, Colo.
Speaking at the annual meeting of the American College of Rheumatology, Dr. Miller said: “This study completes a suite of trials that show transitioning from oral bisphosphonates to denosumab provides greater increases in bone mineral density and reduction in bone turnover markers, compared to maintaining therapy with another bisphosphonate.”
“Adherence rates to oral bisphosphonates are low,” he continued. “Patients who are intolerant to or fail other bisphosphonates may cycle from one bisphosphonate to another, but clinical benefits are not shown. Previous trials have shown that denosumab increased bone mineral density in women previously treated with oral bisphosphonates, whereas zoledronic acid did not, in women previously treated with alendronate.”
A prospective, double-blind, double-dummy, randomized trial was mounted to compare denosumab given subcutaneously at 60 mg every 6 months (n = 321) vs. ZA 5 mg once a year (n = 322) in postmenopausal women with osteoporosis who were intolerant to or who failed oral bisphosphonate therapy after at least 2 years of treatment.
Baseline characteristics were similar between both treatment arms. Median age was 69 years. About 38% had previous osteoporotic fracture. Bone mineral density T scores were similar between groups. Prior oral bisphosphonate exposure was a median of 6.4 years. Bone turnover marker levels were similar between the two arms.
For the primary endpoint, at 12 months, denosumab achieved a greater increase in BMD at all sites, compared with ZA: a 2.1% difference was observed at the lumbar spine and a 1.4% difference at the total hip.
Changes in bone turnover markers over time were more favorable with denosumab, he continued. Serum C-terminal cross-linking telopeptide (CTX) level was maintained in the denosumab arm and increased with ZA over 12 months. A similar pattern was observed with procollagen type 1 N-terminal propeptide (P1NP).
Adverse events were comparable between both groups. Serious adverse events were reported in 7.8% in the denosumab arm versus 9.1% in the ZA arm, but this difference was not statistically significant. Slightly more hypersensitivity adverse events were reported in the denosumab group: 3.8% versus 1.9% for ZA. The number of osteoporotic-related fractures was doubled in the ZA arm: 7 for denosumab vs. 15 for ZA.
Dr. Miller told listeners that this is the fourth study to show that denosumab is effective in osteoporotic patients previously on oral bisphosphonates, including prior risedronate, ibandronate, and alendronate.
SAN FRANCISCO – Denosumab was superior to zoledronic acid (ZA) in building bone at the lumber spine, total hip, and femoral neck in postmenopausal women with osteoporosis previously treated with oral bisphosphonate therapy in a randomized phase III trial. This study is one more piece of level I evidence to support the effectiveness of transitioning to denosumab in such patients.
“In postmenopausal women with osteoporosis on prior oral bisphosphonates for 2 or more years, transitioning to denosumab resulted in significantly greater increases in bone mineral density [BMD], compared with zoledronic acid at all measured skeletal sites,” said lead author Dr. Paul D. Miller of the Colorado Center for Bone Research, Lakewood, Colo.
Speaking at the annual meeting of the American College of Rheumatology, Dr. Miller said: “This study completes a suite of trials that show transitioning from oral bisphosphonates to denosumab provides greater increases in bone mineral density and reduction in bone turnover markers, compared to maintaining therapy with another bisphosphonate.”
“Adherence rates to oral bisphosphonates are low,” he continued. “Patients who are intolerant to or fail other bisphosphonates may cycle from one bisphosphonate to another, but clinical benefits are not shown. Previous trials have shown that denosumab increased bone mineral density in women previously treated with oral bisphosphonates, whereas zoledronic acid did not, in women previously treated with alendronate.”
A prospective, double-blind, double-dummy, randomized trial was mounted to compare denosumab given subcutaneously at 60 mg every 6 months (n = 321) vs. ZA 5 mg once a year (n = 322) in postmenopausal women with osteoporosis who were intolerant to or who failed oral bisphosphonate therapy after at least 2 years of treatment.
Baseline characteristics were similar between both treatment arms. Median age was 69 years. About 38% had previous osteoporotic fracture. Bone mineral density T scores were similar between groups. Prior oral bisphosphonate exposure was a median of 6.4 years. Bone turnover marker levels were similar between the two arms.
For the primary endpoint, at 12 months, denosumab achieved a greater increase in BMD at all sites, compared with ZA: a 2.1% difference was observed at the lumbar spine and a 1.4% difference at the total hip.
Changes in bone turnover markers over time were more favorable with denosumab, he continued. Serum C-terminal cross-linking telopeptide (CTX) level was maintained in the denosumab arm and increased with ZA over 12 months. A similar pattern was observed with procollagen type 1 N-terminal propeptide (P1NP).
Adverse events were comparable between both groups. Serious adverse events were reported in 7.8% in the denosumab arm versus 9.1% in the ZA arm, but this difference was not statistically significant. Slightly more hypersensitivity adverse events were reported in the denosumab group: 3.8% versus 1.9% for ZA. The number of osteoporotic-related fractures was doubled in the ZA arm: 7 for denosumab vs. 15 for ZA.
Dr. Miller told listeners that this is the fourth study to show that denosumab is effective in osteoporotic patients previously on oral bisphosphonates, including prior risedronate, ibandronate, and alendronate.
AT THE ACR ANNUAL MEETING
Key clinical point: Denosumab was superior to zoledronic acid in building bone mineral density in postmenopausal women with osteoporosis who had previously been treated with oral bisphosphonates.
Major finding: Denosumab achieved a 2.1% difference in BMD at the lumbar spine and a 1.4% difference at the hip, compared with zoledronic acid.
Data source: Prospective, randomized, double-blind, double-dummy trial that included 643 patients.
Disclosures: Dr. Miller’s financial disclosures include Alexion, Amgen, Merck, Merck Serono, Boehringer Ingelheim, Regeneron, National Bone Health Alliance, Eli Lilly, Pfizer, Radius, and he is owner and director of the Colorado Center for Bone Research. The study was supported by Amgen.
ACR: Video capsule endoscopy finds Crohn’s disease best in spondyloarthropathy patients
SAN FRANCISCO – Video capsule endoscopy proved superior to ileocolonoscopy in detecting lesions consistent with Crohn’s disease in patients with known spondyloarthropathies in a study presented at the annual meeting of the American College of Rheumatology.
“The incremental yield of CE [capsule endoscopy) was 31% over IC [ileocolonoscopy]. CE changed management in two-thirds of patients in this study. CE should be the first round of tests to detect CD [Crohn’s disease] in patients with SpA [spondyloarthropathies]. This is a ‘game-changer,’ ” stated senior author Dr. Ernest Seidman of McGill University, Montreal.
Although IC can show asymptomatic inflammation of the terminal ileum, it is “ignoring the rest of the small bowel,” he said.
About 5%-10% of patients with SpA manifest with inflammatory bowel disease, whereas 40%-60% of SpA patients have microscopic biological evidence of gut inflammation that typically occurs without symptoms. These patients don’t meet the criteria for inflammatory bowel disease, Dr. Seidman explained.
The study included 64 patients with SpA or ankylosing spondylitis with or without gastrointestinal symptoms; 58% had gastrointestinal symptoms. All patients were taken off NSAIDs for 1 month prior to the study because their use may be associated with inflammation that is indistinguishable from microscopic bowel inflammation. Treatment with anti–tumor necrosis factor biologics was not allowed, with the exception of etanercept. On the day before CE, patients had a liquid diet. CE was performed on all patients first, and then IC was performed.
“The sequence was important,” Dr. Seidman noted.
The investigators used a value of greater than 350 on the Lewis score, a validated measure of inflammatory activity on small-bowel CE, to identify moderate Crohn’s disease.
None of the patients with negative CE had Crohn’s disease; 45.3% had inflammation typical for Crohn’s disease on CE, compared with 14% on IC (P =.036). All positive ileal and colonoscopic biopsies were consistent with Crohn’s disease.
The study also showed that fecal calprotectin levels were significantly correlated with mucosal inflammation observed on CE. However, the presence of gastrointestinal symptoms, C-reactive protein level, and the results from a panel of serologic, inflammatory and genetic tests (a commercial test called IBD sgi Diagnostic) were not predictive of small bowel inflammation in these patients.
AbbVie funded the study. Dr. Seidman reported financial disclosures with Abbott Immunology Pharmaceuticals and Prometheus Laboratories, which he said supplied the video capsules.
SAN FRANCISCO – Video capsule endoscopy proved superior to ileocolonoscopy in detecting lesions consistent with Crohn’s disease in patients with known spondyloarthropathies in a study presented at the annual meeting of the American College of Rheumatology.
“The incremental yield of CE [capsule endoscopy) was 31% over IC [ileocolonoscopy]. CE changed management in two-thirds of patients in this study. CE should be the first round of tests to detect CD [Crohn’s disease] in patients with SpA [spondyloarthropathies]. This is a ‘game-changer,’ ” stated senior author Dr. Ernest Seidman of McGill University, Montreal.
Although IC can show asymptomatic inflammation of the terminal ileum, it is “ignoring the rest of the small bowel,” he said.
About 5%-10% of patients with SpA manifest with inflammatory bowel disease, whereas 40%-60% of SpA patients have microscopic biological evidence of gut inflammation that typically occurs without symptoms. These patients don’t meet the criteria for inflammatory bowel disease, Dr. Seidman explained.
The study included 64 patients with SpA or ankylosing spondylitis with or without gastrointestinal symptoms; 58% had gastrointestinal symptoms. All patients were taken off NSAIDs for 1 month prior to the study because their use may be associated with inflammation that is indistinguishable from microscopic bowel inflammation. Treatment with anti–tumor necrosis factor biologics was not allowed, with the exception of etanercept. On the day before CE, patients had a liquid diet. CE was performed on all patients first, and then IC was performed.
“The sequence was important,” Dr. Seidman noted.
The investigators used a value of greater than 350 on the Lewis score, a validated measure of inflammatory activity on small-bowel CE, to identify moderate Crohn’s disease.
None of the patients with negative CE had Crohn’s disease; 45.3% had inflammation typical for Crohn’s disease on CE, compared with 14% on IC (P =.036). All positive ileal and colonoscopic biopsies were consistent with Crohn’s disease.
The study also showed that fecal calprotectin levels were significantly correlated with mucosal inflammation observed on CE. However, the presence of gastrointestinal symptoms, C-reactive protein level, and the results from a panel of serologic, inflammatory and genetic tests (a commercial test called IBD sgi Diagnostic) were not predictive of small bowel inflammation in these patients.
AbbVie funded the study. Dr. Seidman reported financial disclosures with Abbott Immunology Pharmaceuticals and Prometheus Laboratories, which he said supplied the video capsules.
SAN FRANCISCO – Video capsule endoscopy proved superior to ileocolonoscopy in detecting lesions consistent with Crohn’s disease in patients with known spondyloarthropathies in a study presented at the annual meeting of the American College of Rheumatology.
“The incremental yield of CE [capsule endoscopy) was 31% over IC [ileocolonoscopy]. CE changed management in two-thirds of patients in this study. CE should be the first round of tests to detect CD [Crohn’s disease] in patients with SpA [spondyloarthropathies]. This is a ‘game-changer,’ ” stated senior author Dr. Ernest Seidman of McGill University, Montreal.
Although IC can show asymptomatic inflammation of the terminal ileum, it is “ignoring the rest of the small bowel,” he said.
About 5%-10% of patients with SpA manifest with inflammatory bowel disease, whereas 40%-60% of SpA patients have microscopic biological evidence of gut inflammation that typically occurs without symptoms. These patients don’t meet the criteria for inflammatory bowel disease, Dr. Seidman explained.
The study included 64 patients with SpA or ankylosing spondylitis with or without gastrointestinal symptoms; 58% had gastrointestinal symptoms. All patients were taken off NSAIDs for 1 month prior to the study because their use may be associated with inflammation that is indistinguishable from microscopic bowel inflammation. Treatment with anti–tumor necrosis factor biologics was not allowed, with the exception of etanercept. On the day before CE, patients had a liquid diet. CE was performed on all patients first, and then IC was performed.
“The sequence was important,” Dr. Seidman noted.
The investigators used a value of greater than 350 on the Lewis score, a validated measure of inflammatory activity on small-bowel CE, to identify moderate Crohn’s disease.
None of the patients with negative CE had Crohn’s disease; 45.3% had inflammation typical for Crohn’s disease on CE, compared with 14% on IC (P =.036). All positive ileal and colonoscopic biopsies were consistent with Crohn’s disease.
The study also showed that fecal calprotectin levels were significantly correlated with mucosal inflammation observed on CE. However, the presence of gastrointestinal symptoms, C-reactive protein level, and the results from a panel of serologic, inflammatory and genetic tests (a commercial test called IBD sgi Diagnostic) were not predictive of small bowel inflammation in these patients.
AbbVie funded the study. Dr. Seidman reported financial disclosures with Abbott Immunology Pharmaceuticals and Prometheus Laboratories, which he said supplied the video capsules.
AT THE ACR ANNUAL MEETING
Key clinical point:Video capsule endoscopy is better than ileocolonoscopy for detection of Crohn’s disease in patients with spondyloarthropathies.
Major finding: Video capsule endoscopy detected Crohn’s disease in 45% of patients, compared with 14% detected by ileocolonoscopy (P =.036).
Data source: Prospective study of 64 patients with SpA who underwent video capsule endoscopy followed by ileocolonoscopy.
Disclosures: AbbVie funded the study. Dr. Seidman reported financial disclosures with Abbott Immunology Pharmaceuticals and Prometheus Laboratories, which he said supplied the video capsules.
ACR: Ozone injections reduce pain and improve function in knee OA
SAN FRANCISCO – Intra-articular ozone injections were effective in reducing pain, improving function, and improving quality of life in patients with knee osteoarthritis in the first randomized study to evaluate this approach.
Patients treated with a series of ozone injections achieved significant improvements on all measures, except for the Timed Up and Go Test, compared with patients given placebo, according to study results presented at the annual meeting of the American College of Rheumatology.
“After 8 weeks of treatment, ozone can give patients with knee osteoarthritis [OA] better quality of life with less pain and more independence in performing daily activities. More studies are needed to validate this option in patients with OA. Intra-articular ozone injections are safe with similar complications to placebo. In elderly people with comorbidities requiring chronic medication, this approach is a good option because it doesn’t interact with medications. The only restriction is anticoagulant therapy, as there may be bleeding at the injection site,” said Dr. Virginia Trevisani, professor at the Federal University of São Paulo.
The next series of studies Dr. Trevisani and her coauthors are planning will incorporate MRI imaging to assess the effect of the ozone injections on structural progression in knee OA.
Ozone is thought to have anti-inflammatory effects by reducing oxidative stress. Ozone is being used for medical purposes in countries such as Russia, Germany, and Spain, but it is not currently used clinically in the United States. “You can’t perform these injections in patients without experience. The only requirement is a machine to make ozone that costs about $1,000 USD,” she said.
Before this study, evidence in support of ozone injections in knee OA was anecdotal and from observational studies. The present study is the first randomized trial to evaluate intra-articular ozone injections in patients with knee OA.
The study enrolled 98 patients with documented knee OA between the ages of 60 and 85 years; 63 patients were randomized to intra-articular injections of ozone in the knee with the most pain (one injection per week for 8 consecutive weeks), and 35 were randomized to placebo injections of a small amount of air.
Patients were evaluated at baseline, after 4 and 8 injections, and 8 weeks following the last injection. Two patients in the ozone group withdrew from the study. The only adverse events were three puncture-site wounds – two in the ozone group and one in the placebo group.
Significant improvement was observed on all measures, except for the Timed Up and Go Test (getting up from a chair), at every time point for the ozone injections. Dr. Trevisani said that the ability to get up from a chair without help depends on balance and muscle strength, which may explain why the results were not significant.
Measures of pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analog scale improved significantly with ozone, compared with placebo, and by week 16, the P value was .000 for both measures. WOMAC joint stiffness intensity was significantly improved by ozone (P = .075 at week 4; P = .002 at week 8). Quality of life on the Short Form–36 for pain and functional capacity were significantly improved by ozone, compared with placebo (P = .000 at week 16 for both measures).
Dr. Trevisani said ozone injections may be able to delay the need for total joint replacement surgery, and that they are cost effective, compared with surgery and other pharmacologic treatments.
Dr. Trevisani had no relevant financial disclosures.
SAN FRANCISCO – Intra-articular ozone injections were effective in reducing pain, improving function, and improving quality of life in patients with knee osteoarthritis in the first randomized study to evaluate this approach.
Patients treated with a series of ozone injections achieved significant improvements on all measures, except for the Timed Up and Go Test, compared with patients given placebo, according to study results presented at the annual meeting of the American College of Rheumatology.
“After 8 weeks of treatment, ozone can give patients with knee osteoarthritis [OA] better quality of life with less pain and more independence in performing daily activities. More studies are needed to validate this option in patients with OA. Intra-articular ozone injections are safe with similar complications to placebo. In elderly people with comorbidities requiring chronic medication, this approach is a good option because it doesn’t interact with medications. The only restriction is anticoagulant therapy, as there may be bleeding at the injection site,” said Dr. Virginia Trevisani, professor at the Federal University of São Paulo.
The next series of studies Dr. Trevisani and her coauthors are planning will incorporate MRI imaging to assess the effect of the ozone injections on structural progression in knee OA.
Ozone is thought to have anti-inflammatory effects by reducing oxidative stress. Ozone is being used for medical purposes in countries such as Russia, Germany, and Spain, but it is not currently used clinically in the United States. “You can’t perform these injections in patients without experience. The only requirement is a machine to make ozone that costs about $1,000 USD,” she said.
Before this study, evidence in support of ozone injections in knee OA was anecdotal and from observational studies. The present study is the first randomized trial to evaluate intra-articular ozone injections in patients with knee OA.
The study enrolled 98 patients with documented knee OA between the ages of 60 and 85 years; 63 patients were randomized to intra-articular injections of ozone in the knee with the most pain (one injection per week for 8 consecutive weeks), and 35 were randomized to placebo injections of a small amount of air.
Patients were evaluated at baseline, after 4 and 8 injections, and 8 weeks following the last injection. Two patients in the ozone group withdrew from the study. The only adverse events were three puncture-site wounds – two in the ozone group and one in the placebo group.
Significant improvement was observed on all measures, except for the Timed Up and Go Test (getting up from a chair), at every time point for the ozone injections. Dr. Trevisani said that the ability to get up from a chair without help depends on balance and muscle strength, which may explain why the results were not significant.
Measures of pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analog scale improved significantly with ozone, compared with placebo, and by week 16, the P value was .000 for both measures. WOMAC joint stiffness intensity was significantly improved by ozone (P = .075 at week 4; P = .002 at week 8). Quality of life on the Short Form–36 for pain and functional capacity were significantly improved by ozone, compared with placebo (P = .000 at week 16 for both measures).
Dr. Trevisani said ozone injections may be able to delay the need for total joint replacement surgery, and that they are cost effective, compared with surgery and other pharmacologic treatments.
Dr. Trevisani had no relevant financial disclosures.
SAN FRANCISCO – Intra-articular ozone injections were effective in reducing pain, improving function, and improving quality of life in patients with knee osteoarthritis in the first randomized study to evaluate this approach.
Patients treated with a series of ozone injections achieved significant improvements on all measures, except for the Timed Up and Go Test, compared with patients given placebo, according to study results presented at the annual meeting of the American College of Rheumatology.
“After 8 weeks of treatment, ozone can give patients with knee osteoarthritis [OA] better quality of life with less pain and more independence in performing daily activities. More studies are needed to validate this option in patients with OA. Intra-articular ozone injections are safe with similar complications to placebo. In elderly people with comorbidities requiring chronic medication, this approach is a good option because it doesn’t interact with medications. The only restriction is anticoagulant therapy, as there may be bleeding at the injection site,” said Dr. Virginia Trevisani, professor at the Federal University of São Paulo.
The next series of studies Dr. Trevisani and her coauthors are planning will incorporate MRI imaging to assess the effect of the ozone injections on structural progression in knee OA.
Ozone is thought to have anti-inflammatory effects by reducing oxidative stress. Ozone is being used for medical purposes in countries such as Russia, Germany, and Spain, but it is not currently used clinically in the United States. “You can’t perform these injections in patients without experience. The only requirement is a machine to make ozone that costs about $1,000 USD,” she said.
Before this study, evidence in support of ozone injections in knee OA was anecdotal and from observational studies. The present study is the first randomized trial to evaluate intra-articular ozone injections in patients with knee OA.
The study enrolled 98 patients with documented knee OA between the ages of 60 and 85 years; 63 patients were randomized to intra-articular injections of ozone in the knee with the most pain (one injection per week for 8 consecutive weeks), and 35 were randomized to placebo injections of a small amount of air.
Patients were evaluated at baseline, after 4 and 8 injections, and 8 weeks following the last injection. Two patients in the ozone group withdrew from the study. The only adverse events were three puncture-site wounds – two in the ozone group and one in the placebo group.
Significant improvement was observed on all measures, except for the Timed Up and Go Test (getting up from a chair), at every time point for the ozone injections. Dr. Trevisani said that the ability to get up from a chair without help depends on balance and muscle strength, which may explain why the results were not significant.
Measures of pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analog scale improved significantly with ozone, compared with placebo, and by week 16, the P value was .000 for both measures. WOMAC joint stiffness intensity was significantly improved by ozone (P = .075 at week 4; P = .002 at week 8). Quality of life on the Short Form–36 for pain and functional capacity were significantly improved by ozone, compared with placebo (P = .000 at week 16 for both measures).
Dr. Trevisani said ozone injections may be able to delay the need for total joint replacement surgery, and that they are cost effective, compared with surgery and other pharmacologic treatments.
Dr. Trevisani had no relevant financial disclosures.
AT THE ACR ANNUAL MEETING
Key clinical point:Intra-articular ozone injections reduce pain, improve function, and improve quality of life in patients with knee osteoarthritis.
Major finding: On all measures of pain, function, and quality of life, ozone injections were significantly superior to placebo.
Data source: A randomized, double-blind placebo-controlled trial of 98 patients with knee OA.
Disclosures: Dr. Trevisani had no relevant financial disclosures.
ACR: Mortality gap narrows between RA patients and general population
SAN FRANCISCO – Two population-based studies provide encouraging evidence that mortality, particularly cardiovascular mortality, is declining in people with rheumatoid arthritis.
The first study – conducted in British Columbia – showed that people diagnosed with rheumatoid arthritis (RA) during 2001-2006 had a lower risk of death, compared with the general population, than did those diagnosed during 1996-2000. The second study focused on cardiovascular death and also found declining death rates in people diagnosed with RA since 2000, compared with RA patients in previous decades.
Both studies suggest that improved detection and management of RA and improved vigilance in screening and managing cardiovascular disease risk factors have contributed to this decline. The studies were presented at the annual meeting of the American College of Rheumatology.
Canadian study
“The take-home message from our study is that with improved treatments and better ability to control inflammation in patients with RA, we are closing the mortality gap between RA patients and the general population. This is a reassuring message for patients and clinicians,” said lead investigator Dr. Diane Lacaille of the University of British Columbia, Vancouver.
It has been recognized for decades that risk of death is higher in people with RA than in the general population, mainly due to an increased risk of cardiovascular disease and cardiovascular death, she noted.
“We have improved RA therapies to attack inflammation, and cardiovascular disease is also linked to inflammation, so we would expect improved mortality along with better treatments,” she continued.
The study compared two cohorts of RA patients with age- and gender-matched controls from the general population: early, those diagnosed with RA during 1996-2000, and late, those diagnosed during 2001-2006. All study subjects were followed from the onset of RA until death or for 5 years.
The entire RA cohort included almost 25,000 people, two thirds of them women, with a mean age of onset of 57 years.
Over the entire 10 years, there was about a 30% increased risk of death from cardiovascular disease, cancer, and infections in people with RA. The mortality was 24.43 per 1,000 person-years in RA participants versus 18.77 deaths per 1,000 person-years in controls, respectively.
When the late cohort of RA patients and controls were compared, the risk of death improved over time, whereas this was not the case in the early cohort. In the early cohort, there was a 64% increase in all-cause mortality, compared with controls. In the late cohort, there was no significant increase in risk of death in RA patients, compared with controls.
RA patients had a 66% increase in cardiovascular disease deaths when compared against controls in the early cohort, but there was no statistically significant increase in the comparison for the late cohort.
Overall, comparisons against controls showed that mortality in the late cohort improved significantly for cardiovascular disease and cancer, but not for infection. Dr. Lacaille speculated that there were too few cases of death due to infection to achieve significance.
“I should caution you that follow-up of 5 years is too short to conclude that there is no increased risk, but we can say that the gap is narrowing,” Dr. Lacaille concluded.
Focus on cardiovascular death
A second study looked for trends among 315 people diagnosed with RA during 2000-2007, 498 people diagnosed with RA in earlier years, and 813 controls without the disease. Participants were followed until death, or until they moved out of the region, or Jan. 1, 2014. These investigators found a decline since 2000 in cardiovascular deaths in people with RA, compared with RA patients in earlier years and controls.
“The implications of our study appear to be broad, that is, there is a beneficial trend in cardiovascular death rates in recent years. We don’t know for sure what factors are causative, but we can assume that improved and more aggressive screening and treatment, as well as being more vigilant about the management of cardiovascular disease in our patients might play a role. This study represents an important step forward and potentially the dawn of a new era in cardiovascular disease management in patients with RA,” said lead investigator Dr. Elena Myasoedova of the Mayo Clinic in Rochester, Minn.
“Although the link between RA and cardiovascular disease is well established, the trends in recent years are not well characterized. We aimed to address this in our study,” she explained.
The database included adult patients older than 18 years diagnosed with incident RA during 2000-2007 and patients diagnosed with RA in the 1990s. RA diagnosis was based on 1997 ACR criteria.
They found a 57% decrease in the overall cardiovascular death rate in patients with RA onset in 2000-2007, compared with the earlier RA cohort. The improvement in deaths from myocardial infarction (coronary heart disease deaths) was particularly striking – an 80% decline in the most recent cohort versus the earlier cohort. Furthermore, the 10-year overall cardiovascular mortality and coronary heart disease mortality in those diagnosed during 2000-2007 did not differ from that of non-RA subjects, which was not observed in RA patients diagnosed in prior decades.
“We observed that cardiovascular disease deaths in patients with recent onset RA is now similar to that of the general population. This suggests that the gap in cardiovascular disease is closing, which has not been reported before,” she stated.
Both investigators emphasized the importance of screening RA patients for cardiovascular morbidity and for managing cardiovascular risk factors.
Dr. Lacaille and Dr. Myasoedova had no financial disclosures. Dr. Myasoedova’s study was supported by a grant from the National Institutes of Health.
SAN FRANCISCO – Two population-based studies provide encouraging evidence that mortality, particularly cardiovascular mortality, is declining in people with rheumatoid arthritis.
The first study – conducted in British Columbia – showed that people diagnosed with rheumatoid arthritis (RA) during 2001-2006 had a lower risk of death, compared with the general population, than did those diagnosed during 1996-2000. The second study focused on cardiovascular death and also found declining death rates in people diagnosed with RA since 2000, compared with RA patients in previous decades.
Both studies suggest that improved detection and management of RA and improved vigilance in screening and managing cardiovascular disease risk factors have contributed to this decline. The studies were presented at the annual meeting of the American College of Rheumatology.
Canadian study
“The take-home message from our study is that with improved treatments and better ability to control inflammation in patients with RA, we are closing the mortality gap between RA patients and the general population. This is a reassuring message for patients and clinicians,” said lead investigator Dr. Diane Lacaille of the University of British Columbia, Vancouver.
It has been recognized for decades that risk of death is higher in people with RA than in the general population, mainly due to an increased risk of cardiovascular disease and cardiovascular death, she noted.
“We have improved RA therapies to attack inflammation, and cardiovascular disease is also linked to inflammation, so we would expect improved mortality along with better treatments,” she continued.
The study compared two cohorts of RA patients with age- and gender-matched controls from the general population: early, those diagnosed with RA during 1996-2000, and late, those diagnosed during 2001-2006. All study subjects were followed from the onset of RA until death or for 5 years.
The entire RA cohort included almost 25,000 people, two thirds of them women, with a mean age of onset of 57 years.
Over the entire 10 years, there was about a 30% increased risk of death from cardiovascular disease, cancer, and infections in people with RA. The mortality was 24.43 per 1,000 person-years in RA participants versus 18.77 deaths per 1,000 person-years in controls, respectively.
When the late cohort of RA patients and controls were compared, the risk of death improved over time, whereas this was not the case in the early cohort. In the early cohort, there was a 64% increase in all-cause mortality, compared with controls. In the late cohort, there was no significant increase in risk of death in RA patients, compared with controls.
RA patients had a 66% increase in cardiovascular disease deaths when compared against controls in the early cohort, but there was no statistically significant increase in the comparison for the late cohort.
Overall, comparisons against controls showed that mortality in the late cohort improved significantly for cardiovascular disease and cancer, but not for infection. Dr. Lacaille speculated that there were too few cases of death due to infection to achieve significance.
“I should caution you that follow-up of 5 years is too short to conclude that there is no increased risk, but we can say that the gap is narrowing,” Dr. Lacaille concluded.
Focus on cardiovascular death
A second study looked for trends among 315 people diagnosed with RA during 2000-2007, 498 people diagnosed with RA in earlier years, and 813 controls without the disease. Participants were followed until death, or until they moved out of the region, or Jan. 1, 2014. These investigators found a decline since 2000 in cardiovascular deaths in people with RA, compared with RA patients in earlier years and controls.
“The implications of our study appear to be broad, that is, there is a beneficial trend in cardiovascular death rates in recent years. We don’t know for sure what factors are causative, but we can assume that improved and more aggressive screening and treatment, as well as being more vigilant about the management of cardiovascular disease in our patients might play a role. This study represents an important step forward and potentially the dawn of a new era in cardiovascular disease management in patients with RA,” said lead investigator Dr. Elena Myasoedova of the Mayo Clinic in Rochester, Minn.
“Although the link between RA and cardiovascular disease is well established, the trends in recent years are not well characterized. We aimed to address this in our study,” she explained.
The database included adult patients older than 18 years diagnosed with incident RA during 2000-2007 and patients diagnosed with RA in the 1990s. RA diagnosis was based on 1997 ACR criteria.
They found a 57% decrease in the overall cardiovascular death rate in patients with RA onset in 2000-2007, compared with the earlier RA cohort. The improvement in deaths from myocardial infarction (coronary heart disease deaths) was particularly striking – an 80% decline in the most recent cohort versus the earlier cohort. Furthermore, the 10-year overall cardiovascular mortality and coronary heart disease mortality in those diagnosed during 2000-2007 did not differ from that of non-RA subjects, which was not observed in RA patients diagnosed in prior decades.
“We observed that cardiovascular disease deaths in patients with recent onset RA is now similar to that of the general population. This suggests that the gap in cardiovascular disease is closing, which has not been reported before,” she stated.
Both investigators emphasized the importance of screening RA patients for cardiovascular morbidity and for managing cardiovascular risk factors.
Dr. Lacaille and Dr. Myasoedova had no financial disclosures. Dr. Myasoedova’s study was supported by a grant from the National Institutes of Health.
SAN FRANCISCO – Two population-based studies provide encouraging evidence that mortality, particularly cardiovascular mortality, is declining in people with rheumatoid arthritis.
The first study – conducted in British Columbia – showed that people diagnosed with rheumatoid arthritis (RA) during 2001-2006 had a lower risk of death, compared with the general population, than did those diagnosed during 1996-2000. The second study focused on cardiovascular death and also found declining death rates in people diagnosed with RA since 2000, compared with RA patients in previous decades.
Both studies suggest that improved detection and management of RA and improved vigilance in screening and managing cardiovascular disease risk factors have contributed to this decline. The studies were presented at the annual meeting of the American College of Rheumatology.
Canadian study
“The take-home message from our study is that with improved treatments and better ability to control inflammation in patients with RA, we are closing the mortality gap between RA patients and the general population. This is a reassuring message for patients and clinicians,” said lead investigator Dr. Diane Lacaille of the University of British Columbia, Vancouver.
It has been recognized for decades that risk of death is higher in people with RA than in the general population, mainly due to an increased risk of cardiovascular disease and cardiovascular death, she noted.
“We have improved RA therapies to attack inflammation, and cardiovascular disease is also linked to inflammation, so we would expect improved mortality along with better treatments,” she continued.
The study compared two cohorts of RA patients with age- and gender-matched controls from the general population: early, those diagnosed with RA during 1996-2000, and late, those diagnosed during 2001-2006. All study subjects were followed from the onset of RA until death or for 5 years.
The entire RA cohort included almost 25,000 people, two thirds of them women, with a mean age of onset of 57 years.
Over the entire 10 years, there was about a 30% increased risk of death from cardiovascular disease, cancer, and infections in people with RA. The mortality was 24.43 per 1,000 person-years in RA participants versus 18.77 deaths per 1,000 person-years in controls, respectively.
When the late cohort of RA patients and controls were compared, the risk of death improved over time, whereas this was not the case in the early cohort. In the early cohort, there was a 64% increase in all-cause mortality, compared with controls. In the late cohort, there was no significant increase in risk of death in RA patients, compared with controls.
RA patients had a 66% increase in cardiovascular disease deaths when compared against controls in the early cohort, but there was no statistically significant increase in the comparison for the late cohort.
Overall, comparisons against controls showed that mortality in the late cohort improved significantly for cardiovascular disease and cancer, but not for infection. Dr. Lacaille speculated that there were too few cases of death due to infection to achieve significance.
“I should caution you that follow-up of 5 years is too short to conclude that there is no increased risk, but we can say that the gap is narrowing,” Dr. Lacaille concluded.
Focus on cardiovascular death
A second study looked for trends among 315 people diagnosed with RA during 2000-2007, 498 people diagnosed with RA in earlier years, and 813 controls without the disease. Participants were followed until death, or until they moved out of the region, or Jan. 1, 2014. These investigators found a decline since 2000 in cardiovascular deaths in people with RA, compared with RA patients in earlier years and controls.
“The implications of our study appear to be broad, that is, there is a beneficial trend in cardiovascular death rates in recent years. We don’t know for sure what factors are causative, but we can assume that improved and more aggressive screening and treatment, as well as being more vigilant about the management of cardiovascular disease in our patients might play a role. This study represents an important step forward and potentially the dawn of a new era in cardiovascular disease management in patients with RA,” said lead investigator Dr. Elena Myasoedova of the Mayo Clinic in Rochester, Minn.
“Although the link between RA and cardiovascular disease is well established, the trends in recent years are not well characterized. We aimed to address this in our study,” she explained.
The database included adult patients older than 18 years diagnosed with incident RA during 2000-2007 and patients diagnosed with RA in the 1990s. RA diagnosis was based on 1997 ACR criteria.
They found a 57% decrease in the overall cardiovascular death rate in patients with RA onset in 2000-2007, compared with the earlier RA cohort. The improvement in deaths from myocardial infarction (coronary heart disease deaths) was particularly striking – an 80% decline in the most recent cohort versus the earlier cohort. Furthermore, the 10-year overall cardiovascular mortality and coronary heart disease mortality in those diagnosed during 2000-2007 did not differ from that of non-RA subjects, which was not observed in RA patients diagnosed in prior decades.
“We observed that cardiovascular disease deaths in patients with recent onset RA is now similar to that of the general population. This suggests that the gap in cardiovascular disease is closing, which has not been reported before,” she stated.
Both investigators emphasized the importance of screening RA patients for cardiovascular morbidity and for managing cardiovascular risk factors.
Dr. Lacaille and Dr. Myasoedova had no financial disclosures. Dr. Myasoedova’s study was supported by a grant from the National Institutes of Health.
AT THE ACR ANNUAL MEETING
Key clinical point: Mortality, particularly for cardiovascular disease, declined in patients with rheumatoid arthritis in the early to mid-2000s, compared with earlier periods.
Major finding: In patients diagnosed with RA during 2001-2006, there was no increased risk of all-cause mortality, compared with controls, and only a slightly increased risk in cardiovascular disease–related deaths. In a separate study, a 57% decline in the cardiovascular death rate and an 80% decline in deaths due to myocardial infarction were observed in 2000-2007, compared with previous decades.
Data source: Two separate population-based retrospective studies.
Disclosures: Dr. Lacaille and Dr. Myasoedova had no financial disclosures. Dr. Myasoedova’s study was supported by a grant from the National Institutes of Health.
VIDEO: Cardiovascular deaths declining in rheumatoid arthritis patients
SAN FRANCISCO – Deaths from cardiovascular disease are declining in rheumatoid arthritis patients diagnosed after the year 2000, compared with previous decades, according to a new study presented at the annual meeting of the American College of Rheumatology.
The study researchers found significant improvement in the relative 10-year cardiovascular mortality rate, including coronary heart disease mortality, in people with RA in the years 2000-2007, compared with previous decades, explained lead investigator Dr. Elena Myasoedova, assistant professor of medicine at the Mayo Clinic, Rochester, Minn.,
In a video interview, Dr. Myasoedova talked about the trends identified in the study, which included 315 people who developed RA between 2000 and 2007, 498 people who developed RA in earlier years, and 813 people without RA.
Dr. Myasoedova had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Deaths from cardiovascular disease are declining in rheumatoid arthritis patients diagnosed after the year 2000, compared with previous decades, according to a new study presented at the annual meeting of the American College of Rheumatology.
The study researchers found significant improvement in the relative 10-year cardiovascular mortality rate, including coronary heart disease mortality, in people with RA in the years 2000-2007, compared with previous decades, explained lead investigator Dr. Elena Myasoedova, assistant professor of medicine at the Mayo Clinic, Rochester, Minn.,
In a video interview, Dr. Myasoedova talked about the trends identified in the study, which included 315 people who developed RA between 2000 and 2007, 498 people who developed RA in earlier years, and 813 people without RA.
Dr. Myasoedova had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Deaths from cardiovascular disease are declining in rheumatoid arthritis patients diagnosed after the year 2000, compared with previous decades, according to a new study presented at the annual meeting of the American College of Rheumatology.
The study researchers found significant improvement in the relative 10-year cardiovascular mortality rate, including coronary heart disease mortality, in people with RA in the years 2000-2007, compared with previous decades, explained lead investigator Dr. Elena Myasoedova, assistant professor of medicine at the Mayo Clinic, Rochester, Minn.,
In a video interview, Dr. Myasoedova talked about the trends identified in the study, which included 315 people who developed RA between 2000 and 2007, 498 people who developed RA in earlier years, and 813 people without RA.
Dr. Myasoedova had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACR ANNUAL MEETING
VIDEO: Mortality gap is closing between rheumatoid arthritis patients, general population
SAN FRANCISCO – Mortality rates are declining in people with rheumatoid arthritis (RA) and more closely match those in the general population, according to a retrospective, population-based study reported at the annual meeting of the American College of Rheumatology.
The study did not identify why deaths from cardiovascular disease and cancer declined in people diagnosed with RA in the years 2001-2006, compared with those diagnosed between 1996 and 2000. But the findings suggest that the decline is related to earlier and more aggressive treatment of RA, as well as recognition of the importance of managing cardiovascular risk factors in patients with the disease.
In a video interview, the study’s lead investigator, Dr. Diane Lacaille, professor of rheumatology at the University of British Columbia, Vancouver, discussed the study findings and the implications for management of inflammation in both RA and cardiovascular disease.
Dr. Lacaille had no relevant financial disclosures to report.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Mortality rates are declining in people with rheumatoid arthritis (RA) and more closely match those in the general population, according to a retrospective, population-based study reported at the annual meeting of the American College of Rheumatology.
The study did not identify why deaths from cardiovascular disease and cancer declined in people diagnosed with RA in the years 2001-2006, compared with those diagnosed between 1996 and 2000. But the findings suggest that the decline is related to earlier and more aggressive treatment of RA, as well as recognition of the importance of managing cardiovascular risk factors in patients with the disease.
In a video interview, the study’s lead investigator, Dr. Diane Lacaille, professor of rheumatology at the University of British Columbia, Vancouver, discussed the study findings and the implications for management of inflammation in both RA and cardiovascular disease.
Dr. Lacaille had no relevant financial disclosures to report.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Mortality rates are declining in people with rheumatoid arthritis (RA) and more closely match those in the general population, according to a retrospective, population-based study reported at the annual meeting of the American College of Rheumatology.
The study did not identify why deaths from cardiovascular disease and cancer declined in people diagnosed with RA in the years 2001-2006, compared with those diagnosed between 1996 and 2000. But the findings suggest that the decline is related to earlier and more aggressive treatment of RA, as well as recognition of the importance of managing cardiovascular risk factors in patients with the disease.
In a video interview, the study’s lead investigator, Dr. Diane Lacaille, professor of rheumatology at the University of British Columbia, Vancouver, discussed the study findings and the implications for management of inflammation in both RA and cardiovascular disease.
Dr. Lacaille had no relevant financial disclosures to report.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACR ANNUAL MEETING
Developing alternatives to unprotected power morcellation
NEW YORK – Power morcellation has been highly controversial since the Food and Drug Administration warned against its use in the majority of women undergoing myomectomy or hysterectomy for fibroid treatment last year. So where does that leave ob.gyns. who perform minimally invasive surgery?
At the annual Minimally Invasive Surgery Week, experts from around the world discussed alternative methods for tumor or organ extraction that are safe and can be used with minimally invasive techniques.
Dr. Antonio Curyof Positivo University in Curitiba, Brazil, highlighted the importance of surgical techniques to prevent port site metastasis.
There are three theories about how these occur: tumor-related, wound-related, and surgical technique–related metastases, he said. Focusing on the surgical technique, he said that contamination is likely the cause.
“Tumor manipulation is the principal factor. Avoid violating the tumor boundary. Avoid gas leakage, as well. I use a single trocar tight to the skin to avoid gas leakage,” Dr. Cury said. “Do not touch the tumor. Use instruments to extract the tumor and avoid rupture.”
Morcellation can be considered cautiously, he said, but use a bag and protect the wound.
“Surgical techniques are related to port site metastasis. Surgical and laparoscopic principles need to be taught. The learning curve is important,” said Dr. Cury, who is on the speakers bureau for and a consultant to Medtronic and Covidien.
In-bag morcellation appears to be the evolving alternative to unprotected power morcellation by minimizing the risk of intraperitoneal tissue dissemination, said Dr. Ceana Nezhat, director of the Nezhat Medical Center in Atlanta.
Tissue extraction transvaginally or via laparoscopic-assisted minilaparotomy is one option. “Using this technique, the patient has the benefit of minimally access surgery without concern about unprotected power morcellation,” said Dr. Nezhat, who reported being a consultant for Karl Storz Endoscopy and a medical adviser to Plasma Surgery, and serving on the advisory board for SurgiQuest.
When performing morcellation with a containment bag, Dr. Jens Rassweiler said it’s important that the bag is stable. “We have to try to get the whole tumor specimen with morcellation. Then we put the pieces together for the pathologist. We have to beware of the risk of tumor spillage,” said Dr. Rassweiler of Klinikum Heilbronn, the academic hospital of the University of Heidelberg, Germany.
The type of extraction bag is important, he said. The bag should be self-opening, have enough working space, and should not be permeable. Several types of extraction bags are available but none is perfect, he told listeners. Newer bags are under development, according to Dr. Rassweiler, who reported having no relevant financial disclosures.
Dr. Nezhat emphasized that surgeons have an important role to play in the public debate on morcellation and its alternatives.
“The power of public opinion has put us where we are. There were reports of injuries, tissue disruption, and dispersion prior to the 2013 public campaign to ban power morcellation. In light of the FDA black box warning, we have to make decisions on how to improve morcellation, with new instrumentation and proper training. We also have to get our patients involved in the decision-making process. It is imperative to educate and inform the patient of the potential risks.”
NEW YORK – Power morcellation has been highly controversial since the Food and Drug Administration warned against its use in the majority of women undergoing myomectomy or hysterectomy for fibroid treatment last year. So where does that leave ob.gyns. who perform minimally invasive surgery?
At the annual Minimally Invasive Surgery Week, experts from around the world discussed alternative methods for tumor or organ extraction that are safe and can be used with minimally invasive techniques.
Dr. Antonio Curyof Positivo University in Curitiba, Brazil, highlighted the importance of surgical techniques to prevent port site metastasis.
There are three theories about how these occur: tumor-related, wound-related, and surgical technique–related metastases, he said. Focusing on the surgical technique, he said that contamination is likely the cause.
“Tumor manipulation is the principal factor. Avoid violating the tumor boundary. Avoid gas leakage, as well. I use a single trocar tight to the skin to avoid gas leakage,” Dr. Cury said. “Do not touch the tumor. Use instruments to extract the tumor and avoid rupture.”
Morcellation can be considered cautiously, he said, but use a bag and protect the wound.
“Surgical techniques are related to port site metastasis. Surgical and laparoscopic principles need to be taught. The learning curve is important,” said Dr. Cury, who is on the speakers bureau for and a consultant to Medtronic and Covidien.
In-bag morcellation appears to be the evolving alternative to unprotected power morcellation by minimizing the risk of intraperitoneal tissue dissemination, said Dr. Ceana Nezhat, director of the Nezhat Medical Center in Atlanta.
Tissue extraction transvaginally or via laparoscopic-assisted minilaparotomy is one option. “Using this technique, the patient has the benefit of minimally access surgery without concern about unprotected power morcellation,” said Dr. Nezhat, who reported being a consultant for Karl Storz Endoscopy and a medical adviser to Plasma Surgery, and serving on the advisory board for SurgiQuest.
When performing morcellation with a containment bag, Dr. Jens Rassweiler said it’s important that the bag is stable. “We have to try to get the whole tumor specimen with morcellation. Then we put the pieces together for the pathologist. We have to beware of the risk of tumor spillage,” said Dr. Rassweiler of Klinikum Heilbronn, the academic hospital of the University of Heidelberg, Germany.
The type of extraction bag is important, he said. The bag should be self-opening, have enough working space, and should not be permeable. Several types of extraction bags are available but none is perfect, he told listeners. Newer bags are under development, according to Dr. Rassweiler, who reported having no relevant financial disclosures.
Dr. Nezhat emphasized that surgeons have an important role to play in the public debate on morcellation and its alternatives.
“The power of public opinion has put us where we are. There were reports of injuries, tissue disruption, and dispersion prior to the 2013 public campaign to ban power morcellation. In light of the FDA black box warning, we have to make decisions on how to improve morcellation, with new instrumentation and proper training. We also have to get our patients involved in the decision-making process. It is imperative to educate and inform the patient of the potential risks.”
NEW YORK – Power morcellation has been highly controversial since the Food and Drug Administration warned against its use in the majority of women undergoing myomectomy or hysterectomy for fibroid treatment last year. So where does that leave ob.gyns. who perform minimally invasive surgery?
At the annual Minimally Invasive Surgery Week, experts from around the world discussed alternative methods for tumor or organ extraction that are safe and can be used with minimally invasive techniques.
Dr. Antonio Curyof Positivo University in Curitiba, Brazil, highlighted the importance of surgical techniques to prevent port site metastasis.
There are three theories about how these occur: tumor-related, wound-related, and surgical technique–related metastases, he said. Focusing on the surgical technique, he said that contamination is likely the cause.
“Tumor manipulation is the principal factor. Avoid violating the tumor boundary. Avoid gas leakage, as well. I use a single trocar tight to the skin to avoid gas leakage,” Dr. Cury said. “Do not touch the tumor. Use instruments to extract the tumor and avoid rupture.”
Morcellation can be considered cautiously, he said, but use a bag and protect the wound.
“Surgical techniques are related to port site metastasis. Surgical and laparoscopic principles need to be taught. The learning curve is important,” said Dr. Cury, who is on the speakers bureau for and a consultant to Medtronic and Covidien.
In-bag morcellation appears to be the evolving alternative to unprotected power morcellation by minimizing the risk of intraperitoneal tissue dissemination, said Dr. Ceana Nezhat, director of the Nezhat Medical Center in Atlanta.
Tissue extraction transvaginally or via laparoscopic-assisted minilaparotomy is one option. “Using this technique, the patient has the benefit of minimally access surgery without concern about unprotected power morcellation,” said Dr. Nezhat, who reported being a consultant for Karl Storz Endoscopy and a medical adviser to Plasma Surgery, and serving on the advisory board for SurgiQuest.
When performing morcellation with a containment bag, Dr. Jens Rassweiler said it’s important that the bag is stable. “We have to try to get the whole tumor specimen with morcellation. Then we put the pieces together for the pathologist. We have to beware of the risk of tumor spillage,” said Dr. Rassweiler of Klinikum Heilbronn, the academic hospital of the University of Heidelberg, Germany.
The type of extraction bag is important, he said. The bag should be self-opening, have enough working space, and should not be permeable. Several types of extraction bags are available but none is perfect, he told listeners. Newer bags are under development, according to Dr. Rassweiler, who reported having no relevant financial disclosures.
Dr. Nezhat emphasized that surgeons have an important role to play in the public debate on morcellation and its alternatives.
“The power of public opinion has put us where we are. There were reports of injuries, tissue disruption, and dispersion prior to the 2013 public campaign to ban power morcellation. In light of the FDA black box warning, we have to make decisions on how to improve morcellation, with new instrumentation and proper training. We also have to get our patients involved in the decision-making process. It is imperative to educate and inform the patient of the potential risks.”
EXPERT ANALYSIS FROM MINIMALLY INVASIVE SURGERY WEEK
Debunking five myths about minilaparoscopy
NEW YORK – The next big advance in gynecologic minimally invasive surgery could be the wider adoption of minilaparoscopy using newer, frictionless instruments.
Minilaparoscopy is commonly used in cholecystectomy, but is making inroads in gynecology. Minilaparoscopy performed with the newer, smaller instruments is especially well suited for fertility procedures and endometriosis surgery, according to Dr. Gustavo Carvalho, a pioneer in minilaparoscopy. Gynecologists are using minilaparoscopy successfully in hysterectomy as well, but the mini-instruments are not strong enough to survive many hysterectomies, he added.
“Traditional laparoscopy is suited for brutal procedures, such as hysterectomy, but minilap is better for delicate procedures requiring precise, tiny instruments,” Dr. Carvalho said at the meeting.
Despite the promise of utilizing the newer instruments, many surgeons have misconceptions about them.
“This is partly related to instruments used in older procedures called minilap. But after they try it with these newer instruments and learn how to do it, they actually prefer it for many procedures,” Dr. Carvalho, an associate professor of general surgery at Pernambuco University, Recife, Brazil, said in an interview.
Dr. Carvalho debunked the following “myths” about minilaparoscopy:
1. Single-port laparoscopy is cosmetically superior to minilaparoscopy. That’s not the case, Dr. Carvalho said. The few published papers on this subject compared single-port laparoscopy with older, high-friction instruments for minilaparoscopy, he said.
2. Minilaparoscopy should not be performed on obese patients. That’s false, Dr. Carvalho said. “Using newer instruments, we can move around better and see better for delicate operations in obese patients, but surgeons need special training,” he said.
3. Patients don’t want minilaparoscopy. The only published paper looking at patient preference did not offer patients minilaparoscopy with the newer instruments, Dr. Carvalho said. He and his colleagues plans to publish a paper based on research showing that 47% of patients prefer minilaparoscopy, compared with 27% who preferred single-port procedures. “There is a role for single-port procedures,” he added.
4. Minilaparoscopy hurts more than single-port laparoscopy. “No one can prove that minilap hurts less, but it is obvious and intuitive that smaller trocars and instruments cause less pain,” Dr. Carvalho said. “Surgeons want randomized trials, but they won’t be done because this is obvious.”
5. Surgeons lose dexterity and precision with minilaparoscopy. In new research that will be published in the Journal of the Society Laparoendoscopic Surgeons, Dr. Caravalho and his colleagues demonstrate that newer minilaparoscopy instruments are better than larger instruments for delicate tasks. In this study, 22 medical students and 22 surgical residents were given one gross task and three delicate tasks to perform randomly with a 3-mm frictionless trocar, a 3-mm high-friction trocar, and a 5-mm trocar. The larger instruments were significantly better for the gross task, while the smaller instruments were significantly better for the delicate tasks, Dr. Carvalho said. “This study shows the utility of precise, delicate instruments for delicate procedures,” he said.
Dr. Caravalho reported that he is an unpaid consultant for Karl Storz on the development of minilaparoscopic low-friction trocars.
NEW YORK – The next big advance in gynecologic minimally invasive surgery could be the wider adoption of minilaparoscopy using newer, frictionless instruments.
Minilaparoscopy is commonly used in cholecystectomy, but is making inroads in gynecology. Minilaparoscopy performed with the newer, smaller instruments is especially well suited for fertility procedures and endometriosis surgery, according to Dr. Gustavo Carvalho, a pioneer in minilaparoscopy. Gynecologists are using minilaparoscopy successfully in hysterectomy as well, but the mini-instruments are not strong enough to survive many hysterectomies, he added.
“Traditional laparoscopy is suited for brutal procedures, such as hysterectomy, but minilap is better for delicate procedures requiring precise, tiny instruments,” Dr. Carvalho said at the meeting.
Despite the promise of utilizing the newer instruments, many surgeons have misconceptions about them.
“This is partly related to instruments used in older procedures called minilap. But after they try it with these newer instruments and learn how to do it, they actually prefer it for many procedures,” Dr. Carvalho, an associate professor of general surgery at Pernambuco University, Recife, Brazil, said in an interview.
Dr. Carvalho debunked the following “myths” about minilaparoscopy:
1. Single-port laparoscopy is cosmetically superior to minilaparoscopy. That’s not the case, Dr. Carvalho said. The few published papers on this subject compared single-port laparoscopy with older, high-friction instruments for minilaparoscopy, he said.
2. Minilaparoscopy should not be performed on obese patients. That’s false, Dr. Carvalho said. “Using newer instruments, we can move around better and see better for delicate operations in obese patients, but surgeons need special training,” he said.
3. Patients don’t want minilaparoscopy. The only published paper looking at patient preference did not offer patients minilaparoscopy with the newer instruments, Dr. Carvalho said. He and his colleagues plans to publish a paper based on research showing that 47% of patients prefer minilaparoscopy, compared with 27% who preferred single-port procedures. “There is a role for single-port procedures,” he added.
4. Minilaparoscopy hurts more than single-port laparoscopy. “No one can prove that minilap hurts less, but it is obvious and intuitive that smaller trocars and instruments cause less pain,” Dr. Carvalho said. “Surgeons want randomized trials, but they won’t be done because this is obvious.”
5. Surgeons lose dexterity and precision with minilaparoscopy. In new research that will be published in the Journal of the Society Laparoendoscopic Surgeons, Dr. Caravalho and his colleagues demonstrate that newer minilaparoscopy instruments are better than larger instruments for delicate tasks. In this study, 22 medical students and 22 surgical residents were given one gross task and three delicate tasks to perform randomly with a 3-mm frictionless trocar, a 3-mm high-friction trocar, and a 5-mm trocar. The larger instruments were significantly better for the gross task, while the smaller instruments were significantly better for the delicate tasks, Dr. Carvalho said. “This study shows the utility of precise, delicate instruments for delicate procedures,” he said.
Dr. Caravalho reported that he is an unpaid consultant for Karl Storz on the development of minilaparoscopic low-friction trocars.
NEW YORK – The next big advance in gynecologic minimally invasive surgery could be the wider adoption of minilaparoscopy using newer, frictionless instruments.
Minilaparoscopy is commonly used in cholecystectomy, but is making inroads in gynecology. Minilaparoscopy performed with the newer, smaller instruments is especially well suited for fertility procedures and endometriosis surgery, according to Dr. Gustavo Carvalho, a pioneer in minilaparoscopy. Gynecologists are using minilaparoscopy successfully in hysterectomy as well, but the mini-instruments are not strong enough to survive many hysterectomies, he added.
“Traditional laparoscopy is suited for brutal procedures, such as hysterectomy, but minilap is better for delicate procedures requiring precise, tiny instruments,” Dr. Carvalho said at the meeting.
Despite the promise of utilizing the newer instruments, many surgeons have misconceptions about them.
“This is partly related to instruments used in older procedures called minilap. But after they try it with these newer instruments and learn how to do it, they actually prefer it for many procedures,” Dr. Carvalho, an associate professor of general surgery at Pernambuco University, Recife, Brazil, said in an interview.
Dr. Carvalho debunked the following “myths” about minilaparoscopy:
1. Single-port laparoscopy is cosmetically superior to minilaparoscopy. That’s not the case, Dr. Carvalho said. The few published papers on this subject compared single-port laparoscopy with older, high-friction instruments for minilaparoscopy, he said.
2. Minilaparoscopy should not be performed on obese patients. That’s false, Dr. Carvalho said. “Using newer instruments, we can move around better and see better for delicate operations in obese patients, but surgeons need special training,” he said.
3. Patients don’t want minilaparoscopy. The only published paper looking at patient preference did not offer patients minilaparoscopy with the newer instruments, Dr. Carvalho said. He and his colleagues plans to publish a paper based on research showing that 47% of patients prefer minilaparoscopy, compared with 27% who preferred single-port procedures. “There is a role for single-port procedures,” he added.
4. Minilaparoscopy hurts more than single-port laparoscopy. “No one can prove that minilap hurts less, but it is obvious and intuitive that smaller trocars and instruments cause less pain,” Dr. Carvalho said. “Surgeons want randomized trials, but they won’t be done because this is obvious.”
5. Surgeons lose dexterity and precision with minilaparoscopy. In new research that will be published in the Journal of the Society Laparoendoscopic Surgeons, Dr. Caravalho and his colleagues demonstrate that newer minilaparoscopy instruments are better than larger instruments for delicate tasks. In this study, 22 medical students and 22 surgical residents were given one gross task and three delicate tasks to perform randomly with a 3-mm frictionless trocar, a 3-mm high-friction trocar, and a 5-mm trocar. The larger instruments were significantly better for the gross task, while the smaller instruments were significantly better for the delicate tasks, Dr. Carvalho said. “This study shows the utility of precise, delicate instruments for delicate procedures,” he said.
Dr. Caravalho reported that he is an unpaid consultant for Karl Storz on the development of minilaparoscopic low-friction trocars.
EXPERT ANALYSIS FROM MINIMALLY INVASIVE SURGERY WEEK
Rigorous certification needed for minimally invasive surgery
NEW YORK – Certification programs for minimally invasive surgery should be more rigorous and continuous, relying on simulation and other hands-on tests of skills, according to Dr. Larry R. Glazerman.
Having rigorous certification could improve the uptake of minimally invasive techniques among patients and encourage insurers to pay for these procedures, he said at the annual Minimally Invasive Surgery Week.
“Right now there is no specific, universally accepted certification in gynecologic laparoscopy. We need certification to go beyond what is currently required. Our certification and recertification standards should confirm competence and confidence,” said Dr. Glazerman, medical director of Planned Parenthood of Delaware.
Several factors contribute to the lack of focus on certification, as well as low uptake of minimally invasive surgery (MIS) by gynecologists. The first is that gynecologists wear “many hats,” he said.
“They serve as primary care doctors, obstetricians, and gynecologists. Also a unique, and negative, feature is that gynecology is the only surgical specialty with a preexisting, ongoing, trusting relationship with the patient. Most gynecologists use traditional surgery, not MIS,” he said.
And gynecologists spend less than half of their training time on surgery, compared with other surgical specialties, he added.
Currently, the American Board of Obstetrics and Gynecology offers certification in obstetrics and gynecology, as well as in the subspecialities of gynecologic oncology, maternal-fetal medicine, reproductive endocrinology and infertility, and female pelvic medicine and reconstructive surgery.
But there’s no board certification specifically in MIS, and no requirement for simulation as part of the certification or maintenance of certification process.
And few organizations offer voluntary programs to recognize minimally invasive surgical skills.
The AAGL (formerly the American Association of Gynecologic Laparoscopists) is working on remedying the situation. The AAGL’s Centers of Excellence in Minimally Invasive Gynecologic Surgery is a voluntary designation developed for individuals and institutions.
“The program is still in its early stages, and there has been minimal interest in that kind of certification, but it’s starting to come,” Dr. Glazerman said.
“In an ideal world, certification would require an in-person evaluation at a simulation center,” he said. “At the very least, certification or recertification should entail a review of surgical videos performed by an examiner who reviews the gynecologic surgeon’s procedures.”
Different types of simulation include simple tasks, virtual reality, and team-based simulation.
“We should encourage teamwork among MIS doctors to make sure we are operating on the right patient, with the right equipment, at the right time,” Dr. Glazerman said. “In my opinion, we need to go further than multiple-choice tests. Pilots have to undergo measurement of confidence and competence. We need to minimize confusion and maximize collaboration.”
In recognition of the importance of simulation, the Society of Laparoendoscopic Surgeons is starting a fellowship to train physicians to set up simulation centers, said Dr. Paul Wetter, the Society’s chairman. The first center is under the direction of Dr. Robert Sweet at the University of Minnesota, Minneapolis.
At the Minimally Invasive Surgery Week meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies, physicians were trained via simulation on how not to nick the vena cava.
“Now we have the ability to train and check doctors on these simulators. This can be lifesaving,” Dr. Wetter said. “It will happen. We are headed in the right direction.”
NEW YORK – Certification programs for minimally invasive surgery should be more rigorous and continuous, relying on simulation and other hands-on tests of skills, according to Dr. Larry R. Glazerman.
Having rigorous certification could improve the uptake of minimally invasive techniques among patients and encourage insurers to pay for these procedures, he said at the annual Minimally Invasive Surgery Week.
“Right now there is no specific, universally accepted certification in gynecologic laparoscopy. We need certification to go beyond what is currently required. Our certification and recertification standards should confirm competence and confidence,” said Dr. Glazerman, medical director of Planned Parenthood of Delaware.
Several factors contribute to the lack of focus on certification, as well as low uptake of minimally invasive surgery (MIS) by gynecologists. The first is that gynecologists wear “many hats,” he said.
“They serve as primary care doctors, obstetricians, and gynecologists. Also a unique, and negative, feature is that gynecology is the only surgical specialty with a preexisting, ongoing, trusting relationship with the patient. Most gynecologists use traditional surgery, not MIS,” he said.
And gynecologists spend less than half of their training time on surgery, compared with other surgical specialties, he added.
Currently, the American Board of Obstetrics and Gynecology offers certification in obstetrics and gynecology, as well as in the subspecialities of gynecologic oncology, maternal-fetal medicine, reproductive endocrinology and infertility, and female pelvic medicine and reconstructive surgery.
But there’s no board certification specifically in MIS, and no requirement for simulation as part of the certification or maintenance of certification process.
And few organizations offer voluntary programs to recognize minimally invasive surgical skills.
The AAGL (formerly the American Association of Gynecologic Laparoscopists) is working on remedying the situation. The AAGL’s Centers of Excellence in Minimally Invasive Gynecologic Surgery is a voluntary designation developed for individuals and institutions.
“The program is still in its early stages, and there has been minimal interest in that kind of certification, but it’s starting to come,” Dr. Glazerman said.
“In an ideal world, certification would require an in-person evaluation at a simulation center,” he said. “At the very least, certification or recertification should entail a review of surgical videos performed by an examiner who reviews the gynecologic surgeon’s procedures.”
Different types of simulation include simple tasks, virtual reality, and team-based simulation.
“We should encourage teamwork among MIS doctors to make sure we are operating on the right patient, with the right equipment, at the right time,” Dr. Glazerman said. “In my opinion, we need to go further than multiple-choice tests. Pilots have to undergo measurement of confidence and competence. We need to minimize confusion and maximize collaboration.”
In recognition of the importance of simulation, the Society of Laparoendoscopic Surgeons is starting a fellowship to train physicians to set up simulation centers, said Dr. Paul Wetter, the Society’s chairman. The first center is under the direction of Dr. Robert Sweet at the University of Minnesota, Minneapolis.
At the Minimally Invasive Surgery Week meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies, physicians were trained via simulation on how not to nick the vena cava.
“Now we have the ability to train and check doctors on these simulators. This can be lifesaving,” Dr. Wetter said. “It will happen. We are headed in the right direction.”
NEW YORK – Certification programs for minimally invasive surgery should be more rigorous and continuous, relying on simulation and other hands-on tests of skills, according to Dr. Larry R. Glazerman.
Having rigorous certification could improve the uptake of minimally invasive techniques among patients and encourage insurers to pay for these procedures, he said at the annual Minimally Invasive Surgery Week.
“Right now there is no specific, universally accepted certification in gynecologic laparoscopy. We need certification to go beyond what is currently required. Our certification and recertification standards should confirm competence and confidence,” said Dr. Glazerman, medical director of Planned Parenthood of Delaware.
Several factors contribute to the lack of focus on certification, as well as low uptake of minimally invasive surgery (MIS) by gynecologists. The first is that gynecologists wear “many hats,” he said.
“They serve as primary care doctors, obstetricians, and gynecologists. Also a unique, and negative, feature is that gynecology is the only surgical specialty with a preexisting, ongoing, trusting relationship with the patient. Most gynecologists use traditional surgery, not MIS,” he said.
And gynecologists spend less than half of their training time on surgery, compared with other surgical specialties, he added.
Currently, the American Board of Obstetrics and Gynecology offers certification in obstetrics and gynecology, as well as in the subspecialities of gynecologic oncology, maternal-fetal medicine, reproductive endocrinology and infertility, and female pelvic medicine and reconstructive surgery.
But there’s no board certification specifically in MIS, and no requirement for simulation as part of the certification or maintenance of certification process.
And few organizations offer voluntary programs to recognize minimally invasive surgical skills.
The AAGL (formerly the American Association of Gynecologic Laparoscopists) is working on remedying the situation. The AAGL’s Centers of Excellence in Minimally Invasive Gynecologic Surgery is a voluntary designation developed for individuals and institutions.
“The program is still in its early stages, and there has been minimal interest in that kind of certification, but it’s starting to come,” Dr. Glazerman said.
“In an ideal world, certification would require an in-person evaluation at a simulation center,” he said. “At the very least, certification or recertification should entail a review of surgical videos performed by an examiner who reviews the gynecologic surgeon’s procedures.”
Different types of simulation include simple tasks, virtual reality, and team-based simulation.
“We should encourage teamwork among MIS doctors to make sure we are operating on the right patient, with the right equipment, at the right time,” Dr. Glazerman said. “In my opinion, we need to go further than multiple-choice tests. Pilots have to undergo measurement of confidence and competence. We need to minimize confusion and maximize collaboration.”
In recognition of the importance of simulation, the Society of Laparoendoscopic Surgeons is starting a fellowship to train physicians to set up simulation centers, said Dr. Paul Wetter, the Society’s chairman. The first center is under the direction of Dr. Robert Sweet at the University of Minnesota, Minneapolis.
At the Minimally Invasive Surgery Week meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies, physicians were trained via simulation on how not to nick the vena cava.
“Now we have the ability to train and check doctors on these simulators. This can be lifesaving,” Dr. Wetter said. “It will happen. We are headed in the right direction.”
EXPERT ANALYSIS FROM MINIMALLY INVASIVE SURGERY WEEK
