Sharon Worcester

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

CHICAGO – Longer operative time is independently associated with perioperative morbidity after laparoscopic and robotic hysterectomy, according to a review of cases from the American College of Surgeons National Surgical Quality Improvement Program.

The overall complication rate in the 9,064 laparoscopic and robotic hysterectomies recorded in the database (ACS NSQIP) increased significantly and in tandem with increasing operative time, Dr. Tatiana L. Catanzarite reported in a blue ribbon poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

For example, the overall complication rate was 2.79% for operative time of 20-59 minutes and 18.75% for operative time greater than 360 minutes, according to Dr. Catanzarite of Northwestern University, Chicago.

Operative time of 240 minutes or longer was associated with increased overall complications, medical complications, surgical complications, reoperation, transfusion, urinary tract infection, and deep vein thrombosis/pulmonary embolism on both bivariate and multivariable regression analysis. Factors associated with operative time of 240 minutes or longer included age over 50 years, obesity, nonsmoking status, hypertension, history of stroke or transient ischemic attack, and American Anesthesiologists Society (ASA) class greater than 3, she noted.

Patients included in the database, which contains prospectively collected data for more than 240 variables from more than 460 participating institutions, underwent total or subtotal laparoscopic hysterectomy between 2006 and 2011. Patients with concomitant procedures, emergency surgery, gynecologic cancer, ASA class 5, or operative time less than 20 minutes were excluded from the analysis.

Similar findings have been reported for general surgery, but studies in gynecology have been conflicting, Dr. Catanzarite noted.

"Future research should aim to identify risk factors for excessive operative time in order to select appropriate candidates for minimally invasive approaches and maximize surgical efficiency," she wrote.

Dr. Catanzarite reported having no relevant financial disclosures.

CHICAGO – Longer operative time is independently associated with perioperative morbidity after laparoscopic and robotic hysterectomy, according to a review of cases from the American College of Surgeons National Surgical Quality Improvement Program.

The overall complication rate in the 9,064 laparoscopic and robotic hysterectomies recorded in the database (ACS NSQIP) increased significantly and in tandem with increasing operative time, Dr. Tatiana L. Catanzarite reported in a blue ribbon poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

For example, the overall complication rate was 2.79% for operative time of 20-59 minutes and 18.75% for operative time greater than 360 minutes, according to Dr. Catanzarite of Northwestern University, Chicago.

Operative time of 240 minutes or longer was associated with increased overall complications, medical complications, surgical complications, reoperation, transfusion, urinary tract infection, and deep vein thrombosis/pulmonary embolism on both bivariate and multivariable regression analysis. Factors associated with operative time of 240 minutes or longer included age over 50 years, obesity, nonsmoking status, hypertension, history of stroke or transient ischemic attack, and American Anesthesiologists Society (ASA) class greater than 3, she noted.

Patients included in the database, which contains prospectively collected data for more than 240 variables from more than 460 participating institutions, underwent total or subtotal laparoscopic hysterectomy between 2006 and 2011. Patients with concomitant procedures, emergency surgery, gynecologic cancer, ASA class 5, or operative time less than 20 minutes were excluded from the analysis.

Similar findings have been reported for general surgery, but studies in gynecology have been conflicting, Dr. Catanzarite noted.

"Future research should aim to identify risk factors for excessive operative time in order to select appropriate candidates for minimally invasive approaches and maximize surgical efficiency," she wrote.

Dr. Catanzarite reported having no relevant financial disclosures.

CHICAGO – Longer operative time is independently associated with perioperative morbidity after laparoscopic and robotic hysterectomy, according to a review of cases from the American College of Surgeons National Surgical Quality Improvement Program.

The overall complication rate in the 9,064 laparoscopic and robotic hysterectomies recorded in the database (ACS NSQIP) increased significantly and in tandem with increasing operative time, Dr. Tatiana L. Catanzarite reported in a blue ribbon poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

For example, the overall complication rate was 2.79% for operative time of 20-59 minutes and 18.75% for operative time greater than 360 minutes, according to Dr. Catanzarite of Northwestern University, Chicago.

Operative time of 240 minutes or longer was associated with increased overall complications, medical complications, surgical complications, reoperation, transfusion, urinary tract infection, and deep vein thrombosis/pulmonary embolism on both bivariate and multivariable regression analysis. Factors associated with operative time of 240 minutes or longer included age over 50 years, obesity, nonsmoking status, hypertension, history of stroke or transient ischemic attack, and American Anesthesiologists Society (ASA) class greater than 3, she noted.

Patients included in the database, which contains prospectively collected data for more than 240 variables from more than 460 participating institutions, underwent total or subtotal laparoscopic hysterectomy between 2006 and 2011. Patients with concomitant procedures, emergency surgery, gynecologic cancer, ASA class 5, or operative time less than 20 minutes were excluded from the analysis.

Similar findings have been reported for general surgery, but studies in gynecology have been conflicting, Dr. Catanzarite noted.

"Future research should aim to identify risk factors for excessive operative time in order to select appropriate candidates for minimally invasive approaches and maximize surgical efficiency," she wrote.

Dr. Catanzarite reported having no relevant financial disclosures.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.

CHICAGO – Obstetrician-gynecologists have a unique and largely unaddressed opportunity to improve cardiovascular disease prevention, clinical care, and outcomes in their patients, a survey suggests.

Of 641 patients aged 18-40 years who were surveyed, 65% said their ob.gyn. is the doctor with whom they feel most comfortable, 41% said their ob.gyn. is their "main doctor," and 50% said their ob.gyn. is the one doctor they prefer to see. Of 52 ob.gyns. surveyed, 60% said they consider themselves primary care physicians, yet only 35% of the patients said their ob.gyn. discusses heart health during annual visits, Dr. Mary L. Rosser of Montefiore Medical Center, New York, reported in a poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Less than half (47%) of the physician respondents said they discuss risk factors for cardiovascular disease, and 16% educate patients about signs and symptoms of heart attack and stroke, Dr. Rosser found.

The findings are of concern because only 28% of the patients overall correctly identified heart disease as the "No. 1 killer of women," and only 21% of minority women and 22% of 18- to 40-year-olds did so, she noted.

Survey respondents were patients aged 18-40 years, as well as 356 women aged 40 or older, from five ob.gyn. offices affiliated with an ethnically diverse urban hospital in New York, and faculty respondents were affiliated with the same institution. Patients completed a 33-question survey that included items about which physician they prefer to see, and physicians completed a 19-question survey that addressed their perceptions of their primary care practices – and in particular, their cardiovascular disease practices.

The findings showed that cardiovascular disease awareness was low in this patient population, especially among young, nonwhite women, and that ob.gyns. do not appear to be providing education aimed at the prevention of cardiovascular disease, according to Dr. Rosser.

"The unique relationship between a woman and her ob.gyn., especially among 18- to 40-year-olds, provides an opportunity to influence change and empower patients to lead more healthful lives," she wrote, adding that educational strategies targeted to both women and their providers would improve awareness of chronic disease processes such as cardiovascular disease.

The American Congress of Obstetricians and Gynecologists and the American Heart Association have some basic information about heart disease in women on their websites.

Dr. Rosser reported having no relevant financial disclosures.

CHICAGO – Obstetrician-gynecologists have a unique and largely unaddressed opportunity to improve cardiovascular disease prevention, clinical care, and outcomes in their patients, a survey suggests.

Of 641 patients aged 18-40 years who were surveyed, 65% said their ob.gyn. is the doctor with whom they feel most comfortable, 41% said their ob.gyn. is their "main doctor," and 50% said their ob.gyn. is the one doctor they prefer to see. Of 52 ob.gyns. surveyed, 60% said they consider themselves primary care physicians, yet only 35% of the patients said their ob.gyn. discusses heart health during annual visits, Dr. Mary L. Rosser of Montefiore Medical Center, New York, reported in a poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Less than half (47%) of the physician respondents said they discuss risk factors for cardiovascular disease, and 16% educate patients about signs and symptoms of heart attack and stroke, Dr. Rosser found.

The findings are of concern because only 28% of the patients overall correctly identified heart disease as the "No. 1 killer of women," and only 21% of minority women and 22% of 18- to 40-year-olds did so, she noted.

Survey respondents were patients aged 18-40 years, as well as 356 women aged 40 or older, from five ob.gyn. offices affiliated with an ethnically diverse urban hospital in New York, and faculty respondents were affiliated with the same institution. Patients completed a 33-question survey that included items about which physician they prefer to see, and physicians completed a 19-question survey that addressed their perceptions of their primary care practices – and in particular, their cardiovascular disease practices.

The findings showed that cardiovascular disease awareness was low in this patient population, especially among young, nonwhite women, and that ob.gyns. do not appear to be providing education aimed at the prevention of cardiovascular disease, according to Dr. Rosser.

"The unique relationship between a woman and her ob.gyn., especially among 18- to 40-year-olds, provides an opportunity to influence change and empower patients to lead more healthful lives," she wrote, adding that educational strategies targeted to both women and their providers would improve awareness of chronic disease processes such as cardiovascular disease.

The American Congress of Obstetricians and Gynecologists and the American Heart Association have some basic information about heart disease in women on their websites.

Dr. Rosser reported having no relevant financial disclosures.

CHICAGO – Obstetrician-gynecologists have a unique and largely unaddressed opportunity to improve cardiovascular disease prevention, clinical care, and outcomes in their patients, a survey suggests.

Of 641 patients aged 18-40 years who were surveyed, 65% said their ob.gyn. is the doctor with whom they feel most comfortable, 41% said their ob.gyn. is their "main doctor," and 50% said their ob.gyn. is the one doctor they prefer to see. Of 52 ob.gyns. surveyed, 60% said they consider themselves primary care physicians, yet only 35% of the patients said their ob.gyn. discusses heart health during annual visits, Dr. Mary L. Rosser of Montefiore Medical Center, New York, reported in a poster at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Less than half (47%) of the physician respondents said they discuss risk factors for cardiovascular disease, and 16% educate patients about signs and symptoms of heart attack and stroke, Dr. Rosser found.

The findings are of concern because only 28% of the patients overall correctly identified heart disease as the "No. 1 killer of women," and only 21% of minority women and 22% of 18- to 40-year-olds did so, she noted.

Survey respondents were patients aged 18-40 years, as well as 356 women aged 40 or older, from five ob.gyn. offices affiliated with an ethnically diverse urban hospital in New York, and faculty respondents were affiliated with the same institution. Patients completed a 33-question survey that included items about which physician they prefer to see, and physicians completed a 19-question survey that addressed their perceptions of their primary care practices – and in particular, their cardiovascular disease practices.

The findings showed that cardiovascular disease awareness was low in this patient population, especially among young, nonwhite women, and that ob.gyns. do not appear to be providing education aimed at the prevention of cardiovascular disease, according to Dr. Rosser.

"The unique relationship between a woman and her ob.gyn., especially among 18- to 40-year-olds, provides an opportunity to influence change and empower patients to lead more healthful lives," she wrote, adding that educational strategies targeted to both women and their providers would improve awareness of chronic disease processes such as cardiovascular disease.

The American Congress of Obstetricians and Gynecologists and the American Heart Association have some basic information about heart disease in women on their websites.

Dr. Rosser reported having no relevant financial disclosures.

DESTIN, FLA. – Revolutionary advances in the treatment of psoriatic arthritis in recent years – particularly the advent of highly effective biologic therapies like tumor necrosis factor inhibitors – are opening other doors in the management of the disease, as well, according to Dr. Arthur Kavanaugh.

"One of the tangible benefits that came from the increased research in psoriatic arthritis is that it got all of us thinking not just about new therapies, but also about the disease itself," Dr. Kavanaugh, professor of medicine at the University of California, San Diego, said at the annual Congress of Clinical Rheumatology.

The "tremendous uptick" in interest in psoriatic arthritis – as evidenced by a surge in the annual number of related articles available at PubMed over the past decade or so – has helped drive collaborative efforts to further improve the care of patients with this complex condition. Rheumatologists and dermatologists came together, for example, to form the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), which has developed treatment recommendations in light of the new therapies, he said.

"All the different domains of disease, which all of us really assess and take into account as we see patients in our clinic – we needed to consider these in ways separate [from the disease as a whole], and see what the data were for them," he said, adding that psoriatic arthritis doesn’t lend itself to a very strict algorithm.

"Psoriatic arthritis is still an art; you still have to talk to the patient. Some patients have horrible peripheral arthritis and have never had dactylitis; some people have really bad dactylitis, and that’s really their main complaint. It’s been really exciting to learn more about how to capture all of these elements," he said.

The success with new treatments has opened up more conversation about how to approach the disease. Dr. Kavanaugh reviewed a few of the changes in the approach to psoriatic arthritis that highlight recent advances.

"We’ve come pretty far, and now we’re talking about how to manage people in a more comprehensive way," he said, explaining that:

• More attention is being paid to other areas of disease involvement.

Management is no longer just about skin disease. Attention is being paid both in trials and in the clinic to other disease characteristics, such as nail involvement.

"It’s not life threatening, but it is life changing," he said, noting that nail involvement in psoriatic arthritis can be painful, may be associated with distal interphalangeal joint arthritis, and can cause patients to feel self-conscious.

"So this is an important area of involvement, and we’re starting to say that in clinical trials we really ought to capture this, we really ought to look at what effect a new drug has on the skin and nails," said.

Similarly, dactylitis, enthesitis, and structural damage are garnering more attention, he said.

"We’re using adjunctive measures better. We’re using disease-modifying antirheumatic drugs more. We’re seeing patients early. We’re treating patients a little earlier," he said.

• More information is emerging about factors that affect treatment response.

Currently there are five tumor necrosis factor (TNF) inhibitors available, all of which are approved for psoriatic arthritis. What has been unclear is whether switching TNF inhibitors is an effective treatment strategy.

"It looks as if it can work," he said referring to findings from the RAPID-PsA study, which showed that certolizumab pegol (Cimzia) was effective in psoriatic arthritis – including in patients with prior TNF inhibitor therapy (Ann. Rheum. Dis. 2014;73:48-55).

Information from the Scandinavian NOR-DMARD (Ann. Rheum. Dis. 2013;72:1840-4) and DANBIO (Arthritis Rheum. 2013;65:1213-23) registries also provide some guidance on switching TNF inhibitors. The data from the two registries were not so different, but the interpretation was different, Dr. Kavanaugh said, explaining that the former’s findings were interpreted to mean that another mechanism should be tried if an initial TNF inhibitor fails; the latter was interpreted to suggest that trying a second TNF inhibitor is reasonable.

"I think both are correct. ... A second TNF inhibitor certainly can work. Maybe it doesn’t work as well as the first, maybe the third doesn’t work as well as the second, but switching certainly does seem to be a viable idea," he said, adding that nonetheless, "additional mechanisms of action certainly give us something to look forward to."

Another issue is the effect of obesity on treatment outcomes. Multiple studies show that losing weight has beneficial effects not only on psoriatic arthritis, but on response to TNF inhibitors.

"Obesity is an incredibly important factor. ... Study after study shows that," he said, noting that in the CORRONA (Consortium of Rheumatology Researchers of North America Inc.) study of patients starting a TNF inhibitor, the only factor that predicted treatment duration and response was obesity.

This has been shown to be true for both weight-based and fix-dosed treatment.

"So it’s not just that fat people aren’t getting enough of the drug, compared to the skinny people. It’s that obesity – as we’ve learned from our dermatology colleagues – is inflammatory and it’s something to be reckoned with," he said.

Weight loss really needs to be stressed to overweight patients in the clinic, he said.

• Important questions are being asked.

"Unlike for rheumatoid arthritis, we still don’t know if methotrexate and TNF inhibitors are synergistic. ... That’s a gap I would love to see filled in our psoriatic arthritis understanding," he said.

Another important idea that is being addressed involves thinking of how different means of attacking the immune system have disparate results in various immune diseases, thus showing that the diseases may be similar but are not the same.

Dr. Kavanaugh called this a "bedside-to-bench" phenomenon, in which treatment outcomes provide improved understanding of the disease processes.

Targeting interleukin (IL)-6, for example, works very well in RA, juvenile idiopathic arthritis (JIA), and systemic JIA, but it doesn’t work so well in ankylosing spondylitis, and it doesn’t appear that it will work well in several other conditions, based on anecdotal reports.

Similarly, drugs that target IL-17 – a very exciting prospect in psoriasis – don’t seem to work so well in RA. IL-17 inhibition theoretically should work well in inflammatory bowel disease, but it actually appears to make Crohn’s disease worse, he noted.

"We now have newer therapeutic approaches, and it’s very exciting, because we’re going to think of these diseases a little bit differently and almost define the diseases by how they respond to different focal immunomodulatory interventions," he said.

• New treatment targets and approaches are emerging.

There has been some question as to whether IL-23, which is known to be an important driver of IL-17, will be the mechanism by which IL-17 works.

Three IL-17 inhibitors are currently in development. Results in skin psoriasis have been remarkable, and there is a great deal of excitement about them, but data are just beginning to emerge for psoriatic arthritis, Dr. Kavanaugh said.

In an extension study reported at the 2013 annual meeting of the American College of Rheumatology (ACR), for example, the anti-IL-17 receptor A monoclonal antibody brodalumab demonstrated possible increased efficacy through 24 weeks of treatment.

"It’s very exciting to see new data. These drugs will come almost certainly to the clinic first for psoriasis, but I think if they are shown to have good effects in psoriatic arthritis, they will be available to us as another option in our patients," he said.

As for new treatment strategies, psoriatic arthritis is catching up with rheumatoid arthritis with respect to attention to tight control.

"The idea is to evaluate patients, and if they are not reaching a goal, you change treatment. That is the basis for TICOPA – tight control of early psoriatic arthritis," he said.

Joint and skin outcomes were significantly improved in patients in the 48-week, open-label, randomized controlled trial who were treated using a treat-to-target approach, compared with those treated with usual care, according to findings presented at ACR 2013.

However, more serious adverse events occurred in the tight control group (14 vs. 6 in the usual care group), Dr. Kavanaugh noted.

"So I think it’s a thought exercise. I think it shows us that tight control works in psoriatic arthritis. If you follow people very regularly, if you demand that they achieve a good goal like minimal disease activity, they are going to do better," he said.

The downside of increased adverse events raises interesting issues of value and pharmacoeconomics, he noted.

Another "superhot issue in psoriatic arthritis" is whether therapy – and particularly biologic therapy – can be stopped or tapered in patients who are doing very well. A number of studies are looking at this, and it’s an important issue that payers are interested in considering, but data are currently limited.

Based on data that are available, it appears that discontinuing therapy abruptly is not a good idea. In one small study, 77% of patients who discontinued therapy had a disease flare, with greater risk among those with longer treatment duration. Restart of treatment was effective in all cases.

"Certainly there is going to be a lot more interest in this in rheumatoid arthritis, and I think it’s going to spill over and we’ll see more studies in this in psoriatic arthritis as well," he said.

Dr. Kavanaugh reported having no financial disclosures.

DESTIN, FLA. – Revolutionary advances in the treatment of psoriatic arthritis in recent years – particularly the advent of highly effective biologic therapies like tumor necrosis factor inhibitors – are opening other doors in the management of the disease, as well, according to Dr. Arthur Kavanaugh.

"One of the tangible benefits that came from the increased research in psoriatic arthritis is that it got all of us thinking not just about new therapies, but also about the disease itself," Dr. Kavanaugh, professor of medicine at the University of California, San Diego, said at the annual Congress of Clinical Rheumatology.

The "tremendous uptick" in interest in psoriatic arthritis – as evidenced by a surge in the annual number of related articles available at PubMed over the past decade or so – has helped drive collaborative efforts to further improve the care of patients with this complex condition. Rheumatologists and dermatologists came together, for example, to form the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), which has developed treatment recommendations in light of the new therapies, he said.

"All the different domains of disease, which all of us really assess and take into account as we see patients in our clinic – we needed to consider these in ways separate [from the disease as a whole], and see what the data were for them," he said, adding that psoriatic arthritis doesn’t lend itself to a very strict algorithm.

"Psoriatic arthritis is still an art; you still have to talk to the patient. Some patients have horrible peripheral arthritis and have never had dactylitis; some people have really bad dactylitis, and that’s really their main complaint. It’s been really exciting to learn more about how to capture all of these elements," he said.

The success with new treatments has opened up more conversation about how to approach the disease. Dr. Kavanaugh reviewed a few of the changes in the approach to psoriatic arthritis that highlight recent advances.

"We’ve come pretty far, and now we’re talking about how to manage people in a more comprehensive way," he said, explaining that:

• More attention is being paid to other areas of disease involvement.

Management is no longer just about skin disease. Attention is being paid both in trials and in the clinic to other disease characteristics, such as nail involvement.

"It’s not life threatening, but it is life changing," he said, noting that nail involvement in psoriatic arthritis can be painful, may be associated with distal interphalangeal joint arthritis, and can cause patients to feel self-conscious.

"So this is an important area of involvement, and we’re starting to say that in clinical trials we really ought to capture this, we really ought to look at what effect a new drug has on the skin and nails," said.

Similarly, dactylitis, enthesitis, and structural damage are garnering more attention, he said.

"We’re using adjunctive measures better. We’re using disease-modifying antirheumatic drugs more. We’re seeing patients early. We’re treating patients a little earlier," he said.

• More information is emerging about factors that affect treatment response.

Currently there are five tumor necrosis factor (TNF) inhibitors available, all of which are approved for psoriatic arthritis. What has been unclear is whether switching TNF inhibitors is an effective treatment strategy.

"It looks as if it can work," he said referring to findings from the RAPID-PsA study, which showed that certolizumab pegol (Cimzia) was effective in psoriatic arthritis – including in patients with prior TNF inhibitor therapy (Ann. Rheum. Dis. 2014;73:48-55).

Information from the Scandinavian NOR-DMARD (Ann. Rheum. Dis. 2013;72:1840-4) and DANBIO (Arthritis Rheum. 2013;65:1213-23) registries also provide some guidance on switching TNF inhibitors. The data from the two registries were not so different, but the interpretation was different, Dr. Kavanaugh said, explaining that the former’s findings were interpreted to mean that another mechanism should be tried if an initial TNF inhibitor fails; the latter was interpreted to suggest that trying a second TNF inhibitor is reasonable.

"I think both are correct. ... A second TNF inhibitor certainly can work. Maybe it doesn’t work as well as the first, maybe the third doesn’t work as well as the second, but switching certainly does seem to be a viable idea," he said, adding that nonetheless, "additional mechanisms of action certainly give us something to look forward to."

Another issue is the effect of obesity on treatment outcomes. Multiple studies show that losing weight has beneficial effects not only on psoriatic arthritis, but on response to TNF inhibitors.

"Obesity is an incredibly important factor. ... Study after study shows that," he said, noting that in the CORRONA (Consortium of Rheumatology Researchers of North America Inc.) study of patients starting a TNF inhibitor, the only factor that predicted treatment duration and response was obesity.

This has been shown to be true for both weight-based and fix-dosed treatment.

"So it’s not just that fat people aren’t getting enough of the drug, compared to the skinny people. It’s that obesity – as we’ve learned from our dermatology colleagues – is inflammatory and it’s something to be reckoned with," he said.

Weight loss really needs to be stressed to overweight patients in the clinic, he said.

• Important questions are being asked.

"Unlike for rheumatoid arthritis, we still don’t know if methotrexate and TNF inhibitors are synergistic. ... That’s a gap I would love to see filled in our psoriatic arthritis understanding," he said.

Another important idea that is being addressed involves thinking of how different means of attacking the immune system have disparate results in various immune diseases, thus showing that the diseases may be similar but are not the same.

Dr. Kavanaugh called this a "bedside-to-bench" phenomenon, in which treatment outcomes provide improved understanding of the disease processes.

Targeting interleukin (IL)-6, for example, works very well in RA, juvenile idiopathic arthritis (JIA), and systemic JIA, but it doesn’t work so well in ankylosing spondylitis, and it doesn’t appear that it will work well in several other conditions, based on anecdotal reports.

Similarly, drugs that target IL-17 – a very exciting prospect in psoriasis – don’t seem to work so well in RA. IL-17 inhibition theoretically should work well in inflammatory bowel disease, but it actually appears to make Crohn’s disease worse, he noted.

"We now have newer therapeutic approaches, and it’s very exciting, because we’re going to think of these diseases a little bit differently and almost define the diseases by how they respond to different focal immunomodulatory interventions," he said.

• New treatment targets and approaches are emerging.

There has been some question as to whether IL-23, which is known to be an important driver of IL-17, will be the mechanism by which IL-17 works.

Three IL-17 inhibitors are currently in development. Results in skin psoriasis have been remarkable, and there is a great deal of excitement about them, but data are just beginning to emerge for psoriatic arthritis, Dr. Kavanaugh said.

In an extension study reported at the 2013 annual meeting of the American College of Rheumatology (ACR), for example, the anti-IL-17 receptor A monoclonal antibody brodalumab demonstrated possible increased efficacy through 24 weeks of treatment.

"It’s very exciting to see new data. These drugs will come almost certainly to the clinic first for psoriasis, but I think if they are shown to have good effects in psoriatic arthritis, they will be available to us as another option in our patients," he said.

As for new treatment strategies, psoriatic arthritis is catching up with rheumatoid arthritis with respect to attention to tight control.

"The idea is to evaluate patients, and if they are not reaching a goal, you change treatment. That is the basis for TICOPA – tight control of early psoriatic arthritis," he said.

Joint and skin outcomes were significantly improved in patients in the 48-week, open-label, randomized controlled trial who were treated using a treat-to-target approach, compared with those treated with usual care, according to findings presented at ACR 2013.

However, more serious adverse events occurred in the tight control group (14 vs. 6 in the usual care group), Dr. Kavanaugh noted.

"So I think it’s a thought exercise. I think it shows us that tight control works in psoriatic arthritis. If you follow people very regularly, if you demand that they achieve a good goal like minimal disease activity, they are going to do better," he said.

The downside of increased adverse events raises interesting issues of value and pharmacoeconomics, he noted.

Another "superhot issue in psoriatic arthritis" is whether therapy – and particularly biologic therapy – can be stopped or tapered in patients who are doing very well. A number of studies are looking at this, and it’s an important issue that payers are interested in considering, but data are currently limited.

Based on data that are available, it appears that discontinuing therapy abruptly is not a good idea. In one small study, 77% of patients who discontinued therapy had a disease flare, with greater risk among those with longer treatment duration. Restart of treatment was effective in all cases.

"Certainly there is going to be a lot more interest in this in rheumatoid arthritis, and I think it’s going to spill over and we’ll see more studies in this in psoriatic arthritis as well," he said.

Dr. Kavanaugh reported having no financial disclosures.

DESTIN, FLA. – Revolutionary advances in the treatment of psoriatic arthritis in recent years – particularly the advent of highly effective biologic therapies like tumor necrosis factor inhibitors – are opening other doors in the management of the disease, as well, according to Dr. Arthur Kavanaugh.

"One of the tangible benefits that came from the increased research in psoriatic arthritis is that it got all of us thinking not just about new therapies, but also about the disease itself," Dr. Kavanaugh, professor of medicine at the University of California, San Diego, said at the annual Congress of Clinical Rheumatology.

The "tremendous uptick" in interest in psoriatic arthritis – as evidenced by a surge in the annual number of related articles available at PubMed over the past decade or so – has helped drive collaborative efforts to further improve the care of patients with this complex condition. Rheumatologists and dermatologists came together, for example, to form the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), which has developed treatment recommendations in light of the new therapies, he said.

"All the different domains of disease, which all of us really assess and take into account as we see patients in our clinic – we needed to consider these in ways separate [from the disease as a whole], and see what the data were for them," he said, adding that psoriatic arthritis doesn’t lend itself to a very strict algorithm.

"Psoriatic arthritis is still an art; you still have to talk to the patient. Some patients have horrible peripheral arthritis and have never had dactylitis; some people have really bad dactylitis, and that’s really their main complaint. It’s been really exciting to learn more about how to capture all of these elements," he said.

The success with new treatments has opened up more conversation about how to approach the disease. Dr. Kavanaugh reviewed a few of the changes in the approach to psoriatic arthritis that highlight recent advances.

"We’ve come pretty far, and now we’re talking about how to manage people in a more comprehensive way," he said, explaining that:

• More attention is being paid to other areas of disease involvement.

Management is no longer just about skin disease. Attention is being paid both in trials and in the clinic to other disease characteristics, such as nail involvement.

"It’s not life threatening, but it is life changing," he said, noting that nail involvement in psoriatic arthritis can be painful, may be associated with distal interphalangeal joint arthritis, and can cause patients to feel self-conscious.

"So this is an important area of involvement, and we’re starting to say that in clinical trials we really ought to capture this, we really ought to look at what effect a new drug has on the skin and nails," said.

Similarly, dactylitis, enthesitis, and structural damage are garnering more attention, he said.

"We’re using adjunctive measures better. We’re using disease-modifying antirheumatic drugs more. We’re seeing patients early. We’re treating patients a little earlier," he said.

• More information is emerging about factors that affect treatment response.

Currently there are five tumor necrosis factor (TNF) inhibitors available, all of which are approved for psoriatic arthritis. What has been unclear is whether switching TNF inhibitors is an effective treatment strategy.

"It looks as if it can work," he said referring to findings from the RAPID-PsA study, which showed that certolizumab pegol (Cimzia) was effective in psoriatic arthritis – including in patients with prior TNF inhibitor therapy (Ann. Rheum. Dis. 2014;73:48-55).

Information from the Scandinavian NOR-DMARD (Ann. Rheum. Dis. 2013;72:1840-4) and DANBIO (Arthritis Rheum. 2013;65:1213-23) registries also provide some guidance on switching TNF inhibitors. The data from the two registries were not so different, but the interpretation was different, Dr. Kavanaugh said, explaining that the former’s findings were interpreted to mean that another mechanism should be tried if an initial TNF inhibitor fails; the latter was interpreted to suggest that trying a second TNF inhibitor is reasonable.

"I think both are correct. ... A second TNF inhibitor certainly can work. Maybe it doesn’t work as well as the first, maybe the third doesn’t work as well as the second, but switching certainly does seem to be a viable idea," he said, adding that nonetheless, "additional mechanisms of action certainly give us something to look forward to."

Another issue is the effect of obesity on treatment outcomes. Multiple studies show that losing weight has beneficial effects not only on psoriatic arthritis, but on response to TNF inhibitors.

"Obesity is an incredibly important factor. ... Study after study shows that," he said, noting that in the CORRONA (Consortium of Rheumatology Researchers of North America Inc.) study of patients starting a TNF inhibitor, the only factor that predicted treatment duration and response was obesity.

This has been shown to be true for both weight-based and fix-dosed treatment.

"So it’s not just that fat people aren’t getting enough of the drug, compared to the skinny people. It’s that obesity – as we’ve learned from our dermatology colleagues – is inflammatory and it’s something to be reckoned with," he said.

Weight loss really needs to be stressed to overweight patients in the clinic, he said.

• Important questions are being asked.

"Unlike for rheumatoid arthritis, we still don’t know if methotrexate and TNF inhibitors are synergistic. ... That’s a gap I would love to see filled in our psoriatic arthritis understanding," he said.

Another important idea that is being addressed involves thinking of how different means of attacking the immune system have disparate results in various immune diseases, thus showing that the diseases may be similar but are not the same.

Dr. Kavanaugh called this a "bedside-to-bench" phenomenon, in which treatment outcomes provide improved understanding of the disease processes.

Targeting interleukin (IL)-6, for example, works very well in RA, juvenile idiopathic arthritis (JIA), and systemic JIA, but it doesn’t work so well in ankylosing spondylitis, and it doesn’t appear that it will work well in several other conditions, based on anecdotal reports.

Similarly, drugs that target IL-17 – a very exciting prospect in psoriasis – don’t seem to work so well in RA. IL-17 inhibition theoretically should work well in inflammatory bowel disease, but it actually appears to make Crohn’s disease worse, he noted.

"We now have newer therapeutic approaches, and it’s very exciting, because we’re going to think of these diseases a little bit differently and almost define the diseases by how they respond to different focal immunomodulatory interventions," he said.

• New treatment targets and approaches are emerging.

There has been some question as to whether IL-23, which is known to be an important driver of IL-17, will be the mechanism by which IL-17 works.

Three IL-17 inhibitors are currently in development. Results in skin psoriasis have been remarkable, and there is a great deal of excitement about them, but data are just beginning to emerge for psoriatic arthritis, Dr. Kavanaugh said.

In an extension study reported at the 2013 annual meeting of the American College of Rheumatology (ACR), for example, the anti-IL-17 receptor A monoclonal antibody brodalumab demonstrated possible increased efficacy through 24 weeks of treatment.

"It’s very exciting to see new data. These drugs will come almost certainly to the clinic first for psoriasis, but I think if they are shown to have good effects in psoriatic arthritis, they will be available to us as another option in our patients," he said.

As for new treatment strategies, psoriatic arthritis is catching up with rheumatoid arthritis with respect to attention to tight control.

"The idea is to evaluate patients, and if they are not reaching a goal, you change treatment. That is the basis for TICOPA – tight control of early psoriatic arthritis," he said.

Joint and skin outcomes were significantly improved in patients in the 48-week, open-label, randomized controlled trial who were treated using a treat-to-target approach, compared with those treated with usual care, according to findings presented at ACR 2013.

However, more serious adverse events occurred in the tight control group (14 vs. 6 in the usual care group), Dr. Kavanaugh noted.

"So I think it’s a thought exercise. I think it shows us that tight control works in psoriatic arthritis. If you follow people very regularly, if you demand that they achieve a good goal like minimal disease activity, they are going to do better," he said.

The downside of increased adverse events raises interesting issues of value and pharmacoeconomics, he noted.

Another "superhot issue in psoriatic arthritis" is whether therapy – and particularly biologic therapy – can be stopped or tapered in patients who are doing very well. A number of studies are looking at this, and it’s an important issue that payers are interested in considering, but data are currently limited.

Based on data that are available, it appears that discontinuing therapy abruptly is not a good idea. In one small study, 77% of patients who discontinued therapy had a disease flare, with greater risk among those with longer treatment duration. Restart of treatment was effective in all cases.

"Certainly there is going to be a lot more interest in this in rheumatoid arthritis, and I think it’s going to spill over and we’ll see more studies in this in psoriatic arthritis as well," he said.

Dr. Kavanaugh reported having no financial disclosures.

DESTIN, FLA. – Scleroderma is generally thought of as a fibrotic autoimmune disease, but a vascular process is also fundamental to its underlying pathogenesis, according to Dr. Fredrick M. Wigley.

In essence, it is believed that this process involves an immunologic insult to the blood vessels, which leads to intimal proliferation, which in turn leads to narrowing of the lumen. Occlusion occurs, the blood vessels leak, and activated vascular endothelial growth factor leaks out into tissues, causing the fibrosis that is seen clinically in this disease, Dr. Wigley, director of the Johns Hopkins Scleroderma Center at Johns Hopkins University, Baltimore, explained at the annual Congress of Clinical Rheumatology.

A number of strategies exist or are emerging to provide protection against vasculopathy in patients with scleroderma, he said.

Immunosuppressive therapy

Vasculopathy in systemic sclerosis "is an inflammatory process caused by T cells helping granzymes out, so why don’t we try to use immunosuppressive therapy more than we do for the vascular disease?" he said.

In fact, there have been numerous case reports supporting this idea, including several reports of patients who experienced improvement of their nailfold capillary bed after treatment with cyclophosphamide for another indication.

"There also are case reports of bleeding from GAVE [gastric antral vascular ectasia] responding to infusion of cyclophosphamide ... and then there was evidence of capillary regeneration after immunoablation stem cell rescue, reported by several investigators," said Dr. Wigley, who also is professor of medicine and associate director of the division of rheumatology at the university.

In the latter cases, capillary loops were present prior to therapy, and 5 months later, the capillary beds looked normal. This suggests that in patients who receive high-dose cyclophosphamide with stem cell rescue, there is "some fundamental effect on the vasculature and its ability to recover," Dr. Wigley said, adding: "I think this is way too premature for us to put in our back pocket, but I think the use of immunosuppression in active disease is something that we need to study and think carefully about."

In another study, cyclophosphamide was associated with improvement in the number of vascular injury markers after treatment, suggesting the treatment was improving the vascular insult.

"Unfortunately, we don’t have much more information than that, but there are investigators who are taking a giant leap, and saying, ‘Well, if this is a vascular insult, why not use rituximab?’ " he said, noting that preclinical data and anecdotal reports suggest that immunomodulation of B cells may play a role in the management of systemic sclerosis-associated pulmonary arterial hypertension. A randomized, double-blind, phase II trial is now underway to evaluate the effects of rituximab on disease progression in patients with this condition.

Statins

Statins are also important for vascular protection, as there is good rationale that they can improve and protect blood vessel integrity, Dr. Wigley said.

"As you know, [statins] can stimulate some of those progenitor cells that we know are defective. There is evidence that they can improve endothelial function, they have antifibrotic properties and antioxidant properties, and they can modulate the immune system," he explained.

Atorvastatin, for example, has been shown to induce a significant increase in progenitor cells in patients with scleroderma and deficiency of such cells.

"And we know from other diseases that statins will increase release of progenitor cells from bone marrow that could, theoretically, go and help repair [blood vessels]," he said.

In a 2008 study from Egypt, patients treated with 40 mg of atorvastatin had a decrease in the evolution of new digital ulcers, compared with those who received placebo. The patients also experienced clinically important improvements in quality of life and pain measures (J. Rheumatol. 2008;35:1801-8).

"Frankly, in a difficult situation where I have recurrent digital ulcers and I’m giving them vasodilation therapy and antiplatelet therapy, I have a low threshold for trying statins because it makes biological sense that it could be helpful," he said.

Prostaglandins

Prostaglandins are being used in Europe intermittently – not just for vasospasm, but also for the possible "fundamental benefit for blood vessels," Dr. Wigley said.

They can inhibit platelets, down-regulate proliferation of smooth muscle, protect endothelial cells, and they can also stimulate production of stem cells from the marrow, so their intermittent use may make sense, he added.

The only oral prostaglandin – Beraprost – is approved for use in Japan but not in the United States, and has been shown to be helpful for the treatment of pulmonary hypertension, but not for Raynaud’s phenomenon, he noted.

"I think oral prostaglandins are something you are going to hear more about as companies take time to develop these agents," he said.

Endothelin inhibitors

Endothelin inhibitors also may play a role in vascular protection. Endothelin is secreted in scleroderma and is a potent vasoconstrictor. Endothelin inhibition has been shown to have benefit for pulmonary hypertension, but unlike in primary pulmonary hypertension, it does not appear to affect long-term survival in patients with scleroderma. However, endothelin inhibitors have some transient benefit in scleroderma patients with respect to measures of walking and pulmonary vascular resistance.

"It makes sense, because endothelin is a stimulant, not only for the vasoconstrictive pathway (by blocking nitric oxide), but it also stimulates proliferation of smooth muscle," he said.

In a controlled trial, bosentan was associated with fewer digital ulcers when compared with placebo, and also was associated with improvement in subjective hand function (Arthritis Rheum. 2004;50:3985-93). There was no benefit for Raynaud’s attack rate or duration of attack, so based on this trial the treatment was approved in Europe only for scleroderma patients with recurrent digital ulcers.

A study of another endothelin inhibitor – macitentan – was terminated for lack of benefit for digital ulcers, but a subanalysis of the patients showed an evolution of new ulcers in those who had been receiving active treatment, compared with those who had been receiving placebo, so there may be some benefit that the study design did not quite show, he said.

Angiotensin II type 1 receptor blockers

Angiotensin receptor blockers (ARBs) that block angiotensin 1 – and thereby decrease the angiotensin hormone’s signal to increase levels of the fibrosis-promoting transforming growth factor beta – have been shown to have dramatic effect for the vascular disease in Marfan’s syndrome. Marfan’s syndrome involves a fibrotic reaction similar to that seen in scleroderma.

"So it’s possible that using an ARB would be helpful," Dr. Wigley said.

In an uncontrolled trial in the United Kingdom, losartan at 50 mg was comparable or better than was nifedipine at 40 mg for treating Raynaud’s phenomenon, so losartan may be an option for those who don’t respond to or can’t tolerate nifedipine, he said.

Tyrosine kinase and Rho-kinase inhibitors

Tyrosine kinase and Rho-kinase inhibitors have also been evaluated for the treatment of pulmonary hypertension. Tyrosine kinase inhibitors were associated with dramatic reversal of disease, but are limited by cardiac toxicity. Rho-kinase inhibitors "make sense biologically" because of the role of the RhoA/Rho kinase pathway in regulating numerous pathologic processes including vasoconstriction, vascular remodeling, and fibrosis, Dr. Wigley said.

One Rho-kinase inhibitor – fasudil – is approved for use in Japan, and an inhaled formulation is currently being studied for pulmonary hypertension.

Stem cells

Studies in Japan of human mesenchymal stem cells suggest that bone-marrow-derived stem cells injected directly into the skin of patients with digital ulcers leads to improvement in the ulcers over time.

"There was no control group, so it’s not clear that the treatment was the reason for the benefit, but it is an interesting concept. Instead of stimulating the bone marrow to get stem cells, why not just inject them into the skin," he said.

These are just some of the approaches being looked at to provide vascular protection in patients with scleroderma, said Dr. Wigley, who also reviewed approaches for managing vasospasm, hypoxia, and superoxide injury, and vascular occlusion.

"I hope [these approaches] will stimulate your interest in looking at what may happen in the future," he said.

Dr. Wigley disclosed that he lectures, conducts research, and/or serves as a consultant for Actelion, CSL Behring, Hoffman-La Roche, KineMed, MedImmune, Novartis, Sanofi-Aventis, and United Therapeutics.

DESTIN, FLA. – Scleroderma is generally thought of as a fibrotic autoimmune disease, but a vascular process is also fundamental to its underlying pathogenesis, according to Dr. Fredrick M. Wigley.

In essence, it is believed that this process involves an immunologic insult to the blood vessels, which leads to intimal proliferation, which in turn leads to narrowing of the lumen. Occlusion occurs, the blood vessels leak, and activated vascular endothelial growth factor leaks out into tissues, causing the fibrosis that is seen clinically in this disease, Dr. Wigley, director of the Johns Hopkins Scleroderma Center at Johns Hopkins University, Baltimore, explained at the annual Congress of Clinical Rheumatology.

A number of strategies exist or are emerging to provide protection against vasculopathy in patients with scleroderma, he said.

Immunosuppressive therapy

Vasculopathy in systemic sclerosis "is an inflammatory process caused by T cells helping granzymes out, so why don’t we try to use immunosuppressive therapy more than we do for the vascular disease?" he said.

In fact, there have been numerous case reports supporting this idea, including several reports of patients who experienced improvement of their nailfold capillary bed after treatment with cyclophosphamide for another indication.

"There also are case reports of bleeding from GAVE [gastric antral vascular ectasia] responding to infusion of cyclophosphamide ... and then there was evidence of capillary regeneration after immunoablation stem cell rescue, reported by several investigators," said Dr. Wigley, who also is professor of medicine and associate director of the division of rheumatology at the university.

In the latter cases, capillary loops were present prior to therapy, and 5 months later, the capillary beds looked normal. This suggests that in patients who receive high-dose cyclophosphamide with stem cell rescue, there is "some fundamental effect on the vasculature and its ability to recover," Dr. Wigley said, adding: "I think this is way too premature for us to put in our back pocket, but I think the use of immunosuppression in active disease is something that we need to study and think carefully about."

In another study, cyclophosphamide was associated with improvement in the number of vascular injury markers after treatment, suggesting the treatment was improving the vascular insult.

"Unfortunately, we don’t have much more information than that, but there are investigators who are taking a giant leap, and saying, ‘Well, if this is a vascular insult, why not use rituximab?’ " he said, noting that preclinical data and anecdotal reports suggest that immunomodulation of B cells may play a role in the management of systemic sclerosis-associated pulmonary arterial hypertension. A randomized, double-blind, phase II trial is now underway to evaluate the effects of rituximab on disease progression in patients with this condition.

Statins

Statins are also important for vascular protection, as there is good rationale that they can improve and protect blood vessel integrity, Dr. Wigley said.

"As you know, [statins] can stimulate some of those progenitor cells that we know are defective. There is evidence that they can improve endothelial function, they have antifibrotic properties and antioxidant properties, and they can modulate the immune system," he explained.

Atorvastatin, for example, has been shown to induce a significant increase in progenitor cells in patients with scleroderma and deficiency of such cells.

"And we know from other diseases that statins will increase release of progenitor cells from bone marrow that could, theoretically, go and help repair [blood vessels]," he said.

In a 2008 study from Egypt, patients treated with 40 mg of atorvastatin had a decrease in the evolution of new digital ulcers, compared with those who received placebo. The patients also experienced clinically important improvements in quality of life and pain measures (J. Rheumatol. 2008;35:1801-8).

"Frankly, in a difficult situation where I have recurrent digital ulcers and I’m giving them vasodilation therapy and antiplatelet therapy, I have a low threshold for trying statins because it makes biological sense that it could be helpful," he said.

Prostaglandins

Prostaglandins are being used in Europe intermittently – not just for vasospasm, but also for the possible "fundamental benefit for blood vessels," Dr. Wigley said.

They can inhibit platelets, down-regulate proliferation of smooth muscle, protect endothelial cells, and they can also stimulate production of stem cells from the marrow, so their intermittent use may make sense, he added.

The only oral prostaglandin – Beraprost – is approved for use in Japan but not in the United States, and has been shown to be helpful for the treatment of pulmonary hypertension, but not for Raynaud’s phenomenon, he noted.

"I think oral prostaglandins are something you are going to hear more about as companies take time to develop these agents," he said.

Endothelin inhibitors

Endothelin inhibitors also may play a role in vascular protection. Endothelin is secreted in scleroderma and is a potent vasoconstrictor. Endothelin inhibition has been shown to have benefit for pulmonary hypertension, but unlike in primary pulmonary hypertension, it does not appear to affect long-term survival in patients with scleroderma. However, endothelin inhibitors have some transient benefit in scleroderma patients with respect to measures of walking and pulmonary vascular resistance.

"It makes sense, because endothelin is a stimulant, not only for the vasoconstrictive pathway (by blocking nitric oxide), but it also stimulates proliferation of smooth muscle," he said.

In a controlled trial, bosentan was associated with fewer digital ulcers when compared with placebo, and also was associated with improvement in subjective hand function (Arthritis Rheum. 2004;50:3985-93). There was no benefit for Raynaud’s attack rate or duration of attack, so based on this trial the treatment was approved in Europe only for scleroderma patients with recurrent digital ulcers.

A study of another endothelin inhibitor – macitentan – was terminated for lack of benefit for digital ulcers, but a subanalysis of the patients showed an evolution of new ulcers in those who had been receiving active treatment, compared with those who had been receiving placebo, so there may be some benefit that the study design did not quite show, he said.

Angiotensin II type 1 receptor blockers

Angiotensin receptor blockers (ARBs) that block angiotensin 1 – and thereby decrease the angiotensin hormone’s signal to increase levels of the fibrosis-promoting transforming growth factor beta – have been shown to have dramatic effect for the vascular disease in Marfan’s syndrome. Marfan’s syndrome involves a fibrotic reaction similar to that seen in scleroderma.

"So it’s possible that using an ARB would be helpful," Dr. Wigley said.

In an uncontrolled trial in the United Kingdom, losartan at 50 mg was comparable or better than was nifedipine at 40 mg for treating Raynaud’s phenomenon, so losartan may be an option for those who don’t respond to or can’t tolerate nifedipine, he said.

Tyrosine kinase and Rho-kinase inhibitors

Tyrosine kinase and Rho-kinase inhibitors have also been evaluated for the treatment of pulmonary hypertension. Tyrosine kinase inhibitors were associated with dramatic reversal of disease, but are limited by cardiac toxicity. Rho-kinase inhibitors "make sense biologically" because of the role of the RhoA/Rho kinase pathway in regulating numerous pathologic processes including vasoconstriction, vascular remodeling, and fibrosis, Dr. Wigley said.

One Rho-kinase inhibitor – fasudil – is approved for use in Japan, and an inhaled formulation is currently being studied for pulmonary hypertension.

Stem cells

Studies in Japan of human mesenchymal stem cells suggest that bone-marrow-derived stem cells injected directly into the skin of patients with digital ulcers leads to improvement in the ulcers over time.

"There was no control group, so it’s not clear that the treatment was the reason for the benefit, but it is an interesting concept. Instead of stimulating the bone marrow to get stem cells, why not just inject them into the skin," he said.

These are just some of the approaches being looked at to provide vascular protection in patients with scleroderma, said Dr. Wigley, who also reviewed approaches for managing vasospasm, hypoxia, and superoxide injury, and vascular occlusion.

"I hope [these approaches] will stimulate your interest in looking at what may happen in the future," he said.

Dr. Wigley disclosed that he lectures, conducts research, and/or serves as a consultant for Actelion, CSL Behring, Hoffman-La Roche, KineMed, MedImmune, Novartis, Sanofi-Aventis, and United Therapeutics.

DESTIN, FLA. – Scleroderma is generally thought of as a fibrotic autoimmune disease, but a vascular process is also fundamental to its underlying pathogenesis, according to Dr. Fredrick M. Wigley.

In essence, it is believed that this process involves an immunologic insult to the blood vessels, which leads to intimal proliferation, which in turn leads to narrowing of the lumen. Occlusion occurs, the blood vessels leak, and activated vascular endothelial growth factor leaks out into tissues, causing the fibrosis that is seen clinically in this disease, Dr. Wigley, director of the Johns Hopkins Scleroderma Center at Johns Hopkins University, Baltimore, explained at the annual Congress of Clinical Rheumatology.

A number of strategies exist or are emerging to provide protection against vasculopathy in patients with scleroderma, he said.

Immunosuppressive therapy

Vasculopathy in systemic sclerosis "is an inflammatory process caused by T cells helping granzymes out, so why don’t we try to use immunosuppressive therapy more than we do for the vascular disease?" he said.

In fact, there have been numerous case reports supporting this idea, including several reports of patients who experienced improvement of their nailfold capillary bed after treatment with cyclophosphamide for another indication.

"There also are case reports of bleeding from GAVE [gastric antral vascular ectasia] responding to infusion of cyclophosphamide ... and then there was evidence of capillary regeneration after immunoablation stem cell rescue, reported by several investigators," said Dr. Wigley, who also is professor of medicine and associate director of the division of rheumatology at the university.

In the latter cases, capillary loops were present prior to therapy, and 5 months later, the capillary beds looked normal. This suggests that in patients who receive high-dose cyclophosphamide with stem cell rescue, there is "some fundamental effect on the vasculature and its ability to recover," Dr. Wigley said, adding: "I think this is way too premature for us to put in our back pocket, but I think the use of immunosuppression in active disease is something that we need to study and think carefully about."

In another study, cyclophosphamide was associated with improvement in the number of vascular injury markers after treatment, suggesting the treatment was improving the vascular insult.

"Unfortunately, we don’t have much more information than that, but there are investigators who are taking a giant leap, and saying, ‘Well, if this is a vascular insult, why not use rituximab?’ " he said, noting that preclinical data and anecdotal reports suggest that immunomodulation of B cells may play a role in the management of systemic sclerosis-associated pulmonary arterial hypertension. A randomized, double-blind, phase II trial is now underway to evaluate the effects of rituximab on disease progression in patients with this condition.

Statins

Statins are also important for vascular protection, as there is good rationale that they can improve and protect blood vessel integrity, Dr. Wigley said.

"As you know, [statins] can stimulate some of those progenitor cells that we know are defective. There is evidence that they can improve endothelial function, they have antifibrotic properties and antioxidant properties, and they can modulate the immune system," he explained.

Atorvastatin, for example, has been shown to induce a significant increase in progenitor cells in patients with scleroderma and deficiency of such cells.

"And we know from other diseases that statins will increase release of progenitor cells from bone marrow that could, theoretically, go and help repair [blood vessels]," he said.

In a 2008 study from Egypt, patients treated with 40 mg of atorvastatin had a decrease in the evolution of new digital ulcers, compared with those who received placebo. The patients also experienced clinically important improvements in quality of life and pain measures (J. Rheumatol. 2008;35:1801-8).

"Frankly, in a difficult situation where I have recurrent digital ulcers and I’m giving them vasodilation therapy and antiplatelet therapy, I have a low threshold for trying statins because it makes biological sense that it could be helpful," he said.

Prostaglandins

Prostaglandins are being used in Europe intermittently – not just for vasospasm, but also for the possible "fundamental benefit for blood vessels," Dr. Wigley said.

They can inhibit platelets, down-regulate proliferation of smooth muscle, protect endothelial cells, and they can also stimulate production of stem cells from the marrow, so their intermittent use may make sense, he added.

The only oral prostaglandin – Beraprost – is approved for use in Japan but not in the United States, and has been shown to be helpful for the treatment of pulmonary hypertension, but not for Raynaud’s phenomenon, he noted.

"I think oral prostaglandins are something you are going to hear more about as companies take time to develop these agents," he said.

Endothelin inhibitors

Endothelin inhibitors also may play a role in vascular protection. Endothelin is secreted in scleroderma and is a potent vasoconstrictor. Endothelin inhibition has been shown to have benefit for pulmonary hypertension, but unlike in primary pulmonary hypertension, it does not appear to affect long-term survival in patients with scleroderma. However, endothelin inhibitors have some transient benefit in scleroderma patients with respect to measures of walking and pulmonary vascular resistance.

"It makes sense, because endothelin is a stimulant, not only for the vasoconstrictive pathway (by blocking nitric oxide), but it also stimulates proliferation of smooth muscle," he said.

In a controlled trial, bosentan was associated with fewer digital ulcers when compared with placebo, and also was associated with improvement in subjective hand function (Arthritis Rheum. 2004;50:3985-93). There was no benefit for Raynaud’s attack rate or duration of attack, so based on this trial the treatment was approved in Europe only for scleroderma patients with recurrent digital ulcers.

A study of another endothelin inhibitor – macitentan – was terminated for lack of benefit for digital ulcers, but a subanalysis of the patients showed an evolution of new ulcers in those who had been receiving active treatment, compared with those who had been receiving placebo, so there may be some benefit that the study design did not quite show, he said.

Angiotensin II type 1 receptor blockers

Angiotensin receptor blockers (ARBs) that block angiotensin 1 – and thereby decrease the angiotensin hormone’s signal to increase levels of the fibrosis-promoting transforming growth factor beta – have been shown to have dramatic effect for the vascular disease in Marfan’s syndrome. Marfan’s syndrome involves a fibrotic reaction similar to that seen in scleroderma.

"So it’s possible that using an ARB would be helpful," Dr. Wigley said.

In an uncontrolled trial in the United Kingdom, losartan at 50 mg was comparable or better than was nifedipine at 40 mg for treating Raynaud’s phenomenon, so losartan may be an option for those who don’t respond to or can’t tolerate nifedipine, he said.

Tyrosine kinase and Rho-kinase inhibitors

Tyrosine kinase and Rho-kinase inhibitors have also been evaluated for the treatment of pulmonary hypertension. Tyrosine kinase inhibitors were associated with dramatic reversal of disease, but are limited by cardiac toxicity. Rho-kinase inhibitors "make sense biologically" because of the role of the RhoA/Rho kinase pathway in regulating numerous pathologic processes including vasoconstriction, vascular remodeling, and fibrosis, Dr. Wigley said.

One Rho-kinase inhibitor – fasudil – is approved for use in Japan, and an inhaled formulation is currently being studied for pulmonary hypertension.

Stem cells

Studies in Japan of human mesenchymal stem cells suggest that bone-marrow-derived stem cells injected directly into the skin of patients with digital ulcers leads to improvement in the ulcers over time.

"There was no control group, so it’s not clear that the treatment was the reason for the benefit, but it is an interesting concept. Instead of stimulating the bone marrow to get stem cells, why not just inject them into the skin," he said.

These are just some of the approaches being looked at to provide vascular protection in patients with scleroderma, said Dr. Wigley, who also reviewed approaches for managing vasospasm, hypoxia, and superoxide injury, and vascular occlusion.

"I hope [these approaches] will stimulate your interest in looking at what may happen in the future," he said.

Dr. Wigley disclosed that he lectures, conducts research, and/or serves as a consultant for Actelion, CSL Behring, Hoffman-La Roche, KineMed, MedImmune, Novartis, Sanofi-Aventis, and United Therapeutics.

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

DESTIN, FLA. – Various environmental factors are known to play a role in immune-mediated disease, and the extent to which certain adjuvants contribute to both defined and nondefined immune-mediated diseases warrants a new classification for such diseases, according to Dr. Yehuda Shoenfeld.

He proposes that these adjuvant-induced conditions be classified under a common syndrome entitled Autoimmune Syndrome Induced by Adjuvants (ASIA).

©luiscar/Thinkstockphotos.com

In a 2011 article in the Journal of Autoimmunity, he and coauthor, Dr. Nancy Agmon-Levin of B’Sheba Medical Center, Tel-Hashomer, Israel, reviewed the data demonstrating links between adjuvants and autoimmune disease (J. Autoimmun. 2011;36:4-8).

"ASIA is not necessarily a full-blown, fully characterized autoimmune disease that we are aware of like systemic lupus erythematosus, systemic sclerosis, or rheumatoid arthritis. However, it might be that this syndrome will evolve over the years into a full-blown autoimmune disease," Dr. Shoenfeld of Tel Aviv University, Israel, said at the annual Congress of Clinical Rheumatology.

ASIA is a "special complex of clinical manifestations," he said, noting that chronic fatigue is a particularly important manifestation, as are numerous nonspecific symptoms.

Incubation time after exposure to the offending adjuvant may range from 3 weeks to years and may be associated with chronic stimulation of the immune system by the adjuvants. Multiple vaccines or silicone leakage or rupture – from breast implants, for example – represent such chronic exposure.

As with all autoimmune diseases, there is likely a genetic component that factors into the development of ASIA, he said.

"One of the most important adjuvants is aluminum ... and there is no question that there is involvement of the central nervous system," he said, noting that many affected patients thus experience memory loss and cognitive impairment.

Adjuvants were formerly thought to pose little or no independent threat, but animal models, and some human studies, have suggested otherwise, he said.

In his article and during his presentation, Dr. Shoenfeld reviewed the data on the role of infections, silicone, and aluminum salts commonly found in vaccines as they relate to the development of autoimmunity.

Activation of the autoimmune mechanisms by infectious agents is common, he explained in the article.

"Yet the appearance of an autoimmune disease is not as widespread and apparently not always agent specific. The adjuvant effect of microbial particles, namely the nonantigenic activation of the innate and regulatory immunity as well as the expression of various regulatory cytokines, may determine if an autoimmune response remains limited and harmless or evolves into a full blown disease," he continued.

As for silicone, he discussed multiple studies demonstrating various links with autoimmune disease. In one study, 100 women with silicone breast implants all reported symptoms after about 6 years, including weakness, fatigability, myalgia, morning stiffness, arthralgia, memory loss, sensory loss, headache, and dry mouth.

Abnormal levels of serum immunoglobulin or complement were found in 57% of patients and antibodies were found in 78%.

Other studies have suggested a link between silicone breast implants and lymphoma, polyarthritis, and connective tissue disease. Furthermore, numerous reports have shown that explantation is associated with symptom improvement, he noted.

As for vaccines, Dr. Shoenfeld stressed that he is not "antivaccine," and in his article, he described vaccines as "one of the greatest achievements of modern medicine," but he is concerned about the links between certain vaccines and ASIA.

He recently published a report on three cases of primary ovarian failure in association with the quadrivalent human papillomavirus vaccine (Am. J. Reprod. Immunol. 2013 [doi:10.1111/aji.12151]), and he noted that other studies have suggested an association between the vaccine and SLE, various hypersensitivity reactions, and demyelination syndromes, for example.

"My aim is to draw your attention to the association," he explained.

Reports of "an avalanche" of cases of narcolepsy in Finland following vaccination with the adjuvanted AH1N1 vaccine have also raised concerns – and raised the possibility that narcolepsy is an autoimmune disease, he said, noting that multiple studies have explored and provided support for this possibility.

Dr. Shoenfeld proposes that a diagnosis of ASIA should be based on the presence of either two major criteria or one major and two minor criteria.

Major criteria as defined in his article are:

• Exposure to an external stimulus prior to clinical manifestations.

• The appearance of typical clinical manifestations, including myalgia, myositis, or muscle weakness; arthralgia and/or arthritis; chronic fatigue, unrefreshing sleep or sleep disturbance; neurologic manifestations, cognitive impairment/memory loss; pyrexia and dry mouth.

• Removal of inciting agent induces improvement.

• Typical biopsy of involved organs.

Minor criteria are:

• The appearance of autoantibodies or antibodies directed at the suspected adjuvants.

• Other clinical manifestations such as irritable bowel syndrome.

• Specific human leukocyte antigen (HLA).

• Evolvement of an autoimmune disease.

These criteria are highly specific and sensitive, but could change based on further analysis, he said, noting that the "amassed data" regarding conditions that can be considered part of ASIA "may enable us a spacious view of the immune responses to environmental adjuvants, as well as better definition and diagnosis of these conditions. Moreover, unraveling the pathogenesis of this newly defined syndrome may facilitate the search for preventive and therapeutic inventions," he wrote.

Dr. Shoenfeld reported having no disclosures.

DESTIN, FLA. – Various environmental factors are known to play a role in immune-mediated disease, and the extent to which certain adjuvants contribute to both defined and nondefined immune-mediated diseases warrants a new classification for such diseases, according to Dr. Yehuda Shoenfeld.

He proposes that these adjuvant-induced conditions be classified under a common syndrome entitled Autoimmune Syndrome Induced by Adjuvants (ASIA).

©luiscar/Thinkstockphotos.com

In a 2011 article in the Journal of Autoimmunity, he and coauthor, Dr. Nancy Agmon-Levin of B’Sheba Medical Center, Tel-Hashomer, Israel, reviewed the data demonstrating links between adjuvants and autoimmune disease (J. Autoimmun. 2011;36:4-8).

"ASIA is not necessarily a full-blown, fully characterized autoimmune disease that we are aware of like systemic lupus erythematosus, systemic sclerosis, or rheumatoid arthritis. However, it might be that this syndrome will evolve over the years into a full-blown autoimmune disease," Dr. Shoenfeld of Tel Aviv University, Israel, said at the annual Congress of Clinical Rheumatology.

ASIA is a "special complex of clinical manifestations," he said, noting that chronic fatigue is a particularly important manifestation, as are numerous nonspecific symptoms.

Incubation time after exposure to the offending adjuvant may range from 3 weeks to years and may be associated with chronic stimulation of the immune system by the adjuvants. Multiple vaccines or silicone leakage or rupture – from breast implants, for example – represent such chronic exposure.

As with all autoimmune diseases, there is likely a genetic component that factors into the development of ASIA, he said.

"One of the most important adjuvants is aluminum ... and there is no question that there is involvement of the central nervous system," he said, noting that many affected patients thus experience memory loss and cognitive impairment.

Adjuvants were formerly thought to pose little or no independent threat, but animal models, and some human studies, have suggested otherwise, he said.

In his article and during his presentation, Dr. Shoenfeld reviewed the data on the role of infections, silicone, and aluminum salts commonly found in vaccines as they relate to the development of autoimmunity.

Activation of the autoimmune mechanisms by infectious agents is common, he explained in the article.

"Yet the appearance of an autoimmune disease is not as widespread and apparently not always agent specific. The adjuvant effect of microbial particles, namely the nonantigenic activation of the innate and regulatory immunity as well as the expression of various regulatory cytokines, may determine if an autoimmune response remains limited and harmless or evolves into a full blown disease," he continued.

As for silicone, he discussed multiple studies demonstrating various links with autoimmune disease. In one study, 100 women with silicone breast implants all reported symptoms after about 6 years, including weakness, fatigability, myalgia, morning stiffness, arthralgia, memory loss, sensory loss, headache, and dry mouth.

Abnormal levels of serum immunoglobulin or complement were found in 57% of patients and antibodies were found in 78%.

Other studies have suggested a link between silicone breast implants and lymphoma, polyarthritis, and connective tissue disease. Furthermore, numerous reports have shown that explantation is associated with symptom improvement, he noted.

As for vaccines, Dr. Shoenfeld stressed that he is not "antivaccine," and in his article, he described vaccines as "one of the greatest achievements of modern medicine," but he is concerned about the links between certain vaccines and ASIA.

He recently published a report on three cases of primary ovarian failure in association with the quadrivalent human papillomavirus vaccine (Am. J. Reprod. Immunol. 2013 [doi:10.1111/aji.12151]), and he noted that other studies have suggested an association between the vaccine and SLE, various hypersensitivity reactions, and demyelination syndromes, for example.

"My aim is to draw your attention to the association," he explained.

Reports of "an avalanche" of cases of narcolepsy in Finland following vaccination with the adjuvanted AH1N1 vaccine have also raised concerns – and raised the possibility that narcolepsy is an autoimmune disease, he said, noting that multiple studies have explored and provided support for this possibility.

Dr. Shoenfeld proposes that a diagnosis of ASIA should be based on the presence of either two major criteria or one major and two minor criteria.

Major criteria as defined in his article are:

• Exposure to an external stimulus prior to clinical manifestations.

• The appearance of typical clinical manifestations, including myalgia, myositis, or muscle weakness; arthralgia and/or arthritis; chronic fatigue, unrefreshing sleep or sleep disturbance; neurologic manifestations, cognitive impairment/memory loss; pyrexia and dry mouth.

• Removal of inciting agent induces improvement.

• Typical biopsy of involved organs.

Minor criteria are:

• The appearance of autoantibodies or antibodies directed at the suspected adjuvants.

• Other clinical manifestations such as irritable bowel syndrome.

• Specific human leukocyte antigen (HLA).

• Evolvement of an autoimmune disease.

These criteria are highly specific and sensitive, but could change based on further analysis, he said, noting that the "amassed data" regarding conditions that can be considered part of ASIA "may enable us a spacious view of the immune responses to environmental adjuvants, as well as better definition and diagnosis of these conditions. Moreover, unraveling the pathogenesis of this newly defined syndrome may facilitate the search for preventive and therapeutic inventions," he wrote.

Dr. Shoenfeld reported having no disclosures.

DESTIN, FLA. – Various environmental factors are known to play a role in immune-mediated disease, and the extent to which certain adjuvants contribute to both defined and nondefined immune-mediated diseases warrants a new classification for such diseases, according to Dr. Yehuda Shoenfeld.

He proposes that these adjuvant-induced conditions be classified under a common syndrome entitled Autoimmune Syndrome Induced by Adjuvants (ASIA).

©luiscar/Thinkstockphotos.com

In a 2011 article in the Journal of Autoimmunity, he and coauthor, Dr. Nancy Agmon-Levin of B’Sheba Medical Center, Tel-Hashomer, Israel, reviewed the data demonstrating links between adjuvants and autoimmune disease (J. Autoimmun. 2011;36:4-8).

"ASIA is not necessarily a full-blown, fully characterized autoimmune disease that we are aware of like systemic lupus erythematosus, systemic sclerosis, or rheumatoid arthritis. However, it might be that this syndrome will evolve over the years into a full-blown autoimmune disease," Dr. Shoenfeld of Tel Aviv University, Israel, said at the annual Congress of Clinical Rheumatology.

ASIA is a "special complex of clinical manifestations," he said, noting that chronic fatigue is a particularly important manifestation, as are numerous nonspecific symptoms.

Incubation time after exposure to the offending adjuvant may range from 3 weeks to years and may be associated with chronic stimulation of the immune system by the adjuvants. Multiple vaccines or silicone leakage or rupture – from breast implants, for example – represent such chronic exposure.

As with all autoimmune diseases, there is likely a genetic component that factors into the development of ASIA, he said.

"One of the most important adjuvants is aluminum ... and there is no question that there is involvement of the central nervous system," he said, noting that many affected patients thus experience memory loss and cognitive impairment.

Adjuvants were formerly thought to pose little or no independent threat, but animal models, and some human studies, have suggested otherwise, he said.

In his article and during his presentation, Dr. Shoenfeld reviewed the data on the role of infections, silicone, and aluminum salts commonly found in vaccines as they relate to the development of autoimmunity.

Activation of the autoimmune mechanisms by infectious agents is common, he explained in the article.

"Yet the appearance of an autoimmune disease is not as widespread and apparently not always agent specific. The adjuvant effect of microbial particles, namely the nonantigenic activation of the innate and regulatory immunity as well as the expression of various regulatory cytokines, may determine if an autoimmune response remains limited and harmless or evolves into a full blown disease," he continued.

As for silicone, he discussed multiple studies demonstrating various links with autoimmune disease. In one study, 100 women with silicone breast implants all reported symptoms after about 6 years, including weakness, fatigability, myalgia, morning stiffness, arthralgia, memory loss, sensory loss, headache, and dry mouth.

Abnormal levels of serum immunoglobulin or complement were found in 57% of patients and antibodies were found in 78%.

Other studies have suggested a link between silicone breast implants and lymphoma, polyarthritis, and connective tissue disease. Furthermore, numerous reports have shown that explantation is associated with symptom improvement, he noted.

As for vaccines, Dr. Shoenfeld stressed that he is not "antivaccine," and in his article, he described vaccines as "one of the greatest achievements of modern medicine," but he is concerned about the links between certain vaccines and ASIA.

He recently published a report on three cases of primary ovarian failure in association with the quadrivalent human papillomavirus vaccine (Am. J. Reprod. Immunol. 2013 [doi:10.1111/aji.12151]), and he noted that other studies have suggested an association between the vaccine and SLE, various hypersensitivity reactions, and demyelination syndromes, for example.

"My aim is to draw your attention to the association," he explained.

Reports of "an avalanche" of cases of narcolepsy in Finland following vaccination with the adjuvanted AH1N1 vaccine have also raised concerns – and raised the possibility that narcolepsy is an autoimmune disease, he said, noting that multiple studies have explored and provided support for this possibility.

Dr. Shoenfeld proposes that a diagnosis of ASIA should be based on the presence of either two major criteria or one major and two minor criteria.

Major criteria as defined in his article are:

• Exposure to an external stimulus prior to clinical manifestations.

• The appearance of typical clinical manifestations, including myalgia, myositis, or muscle weakness; arthralgia and/or arthritis; chronic fatigue, unrefreshing sleep or sleep disturbance; neurologic manifestations, cognitive impairment/memory loss; pyrexia and dry mouth.

• Removal of inciting agent induces improvement.

• Typical biopsy of involved organs.

Minor criteria are:

• The appearance of autoantibodies or antibodies directed at the suspected adjuvants.

• Other clinical manifestations such as irritable bowel syndrome.

• Specific human leukocyte antigen (HLA).

• Evolvement of an autoimmune disease.

These criteria are highly specific and sensitive, but could change based on further analysis, he said, noting that the "amassed data" regarding conditions that can be considered part of ASIA "may enable us a spacious view of the immune responses to environmental adjuvants, as well as better definition and diagnosis of these conditions. Moreover, unraveling the pathogenesis of this newly defined syndrome may facilitate the search for preventive and therapeutic inventions," he wrote.

Dr. Shoenfeld reported having no disclosures.

DESTIN, FLA. – A number of conditions are often misdiagnosed as malar rash, but certain clues can help in making the correct diagnosis, according to Dr. Ruth Ann Vleugels.

"One of the most helpful [clues] is this really prominent nasolabial sparing," Dr. Vleugels, assistant professor of dermatology at Harvard Medical School, and director of the autoimmune skin disease program at Brigham and Women’s Hospital, both in Boston, said at the annual Congress of Clinical Rheumatology.

Prominent hemorrhagic crusting on the lips in conjunction with the rash is another telltale sign that the condition is a malar rash, she said.

Often, other skin conditions such as erythematotelangiectatic rosacea are diagnosed as malar rash. Erythematotelangiectatic rosacea is common, affecting about a third of all patients with light skin, and many patients with the condition report having a photosensitive rash on the cheeks.

"So, already you have two criteria for systemic lupus," she said, stressing that self-reported malar erythema is "honestly, not a great criteria" for a malar rash diagnosis.

These patients will have transient flushing on the face or may have papulopustular rosacea.

The nasolabial sparing is thus a "really critical clue to look for," she noted.

Also, a malar rash is not going to go away after a few hours like the flush of erythematotelangiectatic rosacea, but will last for several days, at least.

The presence of alopecia also can help distinguish malar rash from other conditions, as it is a common feature in SLE (systemic lupus erythematosus), Dr. Vleugels noted.

Perhaps the most important differential diagnosis in the dermatology-rheumatology clinic is chronic mid-facial erythema, she said.

When such erythema "hugs or involves the nasolabial fold," think dermatomyositis, Dr. Vleugels advised.

She presented a case in which a patient had a subtle heliotrope along with this type of chronic mid-facial erythema. The patient had been referred for lupus but had amyopathic dermatomyositis, and the subtle edema and erythema of the upper eyelids provided a clue that led to a diagnosis of gastric cancer in the patient.

"When it’s subtle, it’s often missed," she said of the heliotrope a violaceous to dusky erythematous rash, with or without edema, which occurs in a symmetric distribution involving periorbital skin.

Another clue that a rash may indeed be malar rash is the presence of nonblanching erythematous macules. Dr. Vleugels described a patient with this presentation on her chest, in addition to other signs of malar rash, including the nasolabial sparing and hemorrhagic crusting on the lips.

"This is essentially petechiae. This is a sign on her skin of active systemic involvement," she said of the rash on the patient’s chest.

Patients with true malar rash by definition have active SLE, she said.

"So we don’t let them leave even the dermatology clinic without checking their kidneys, blood pressure, renal function, etc.," she said.

Dr. Vleugels also noted that there is a generalized form of acute cutaneous lupus to keep in mind.

"Unfortunately, this is very difficult to distinguish clinically from the morbilliform drug eruption or a viral exanthema. It essentially blanches pink to red," she said, adding that macules and papules may be present.

A high level of suspicion for this condition is needed, even though it is quite rare. A biopsy can confirm the diagnosis, as classic changes associated with lupus will be present on biopsy, she said.

Dr. Vleugels reported having no disclosures.

DESTIN, FLA. – A number of conditions are often misdiagnosed as malar rash, but certain clues can help in making the correct diagnosis, according to Dr. Ruth Ann Vleugels.

"One of the most helpful [clues] is this really prominent nasolabial sparing," Dr. Vleugels, assistant professor of dermatology at Harvard Medical School, and director of the autoimmune skin disease program at Brigham and Women’s Hospital, both in Boston, said at the annual Congress of Clinical Rheumatology.

Prominent hemorrhagic crusting on the lips in conjunction with the rash is another telltale sign that the condition is a malar rash, she said.

Often, other skin conditions such as erythematotelangiectatic rosacea are diagnosed as malar rash. Erythematotelangiectatic rosacea is common, affecting about a third of all patients with light skin, and many patients with the condition report having a photosensitive rash on the cheeks.

"So, already you have two criteria for systemic lupus," she said, stressing that self-reported malar erythema is "honestly, not a great criteria" for a malar rash diagnosis.

These patients will have transient flushing on the face or may have papulopustular rosacea.

The nasolabial sparing is thus a "really critical clue to look for," she noted.

Also, a malar rash is not going to go away after a few hours like the flush of erythematotelangiectatic rosacea, but will last for several days, at least.

The presence of alopecia also can help distinguish malar rash from other conditions, as it is a common feature in SLE (systemic lupus erythematosus), Dr. Vleugels noted.

Perhaps the most important differential diagnosis in the dermatology-rheumatology clinic is chronic mid-facial erythema, she said.

When such erythema "hugs or involves the nasolabial fold," think dermatomyositis, Dr. Vleugels advised.

She presented a case in which a patient had a subtle heliotrope along with this type of chronic mid-facial erythema. The patient had been referred for lupus but had amyopathic dermatomyositis, and the subtle edema and erythema of the upper eyelids provided a clue that led to a diagnosis of gastric cancer in the patient.

"When it’s subtle, it’s often missed," she said of the heliotrope a violaceous to dusky erythematous rash, with or without edema, which occurs in a symmetric distribution involving periorbital skin.

Another clue that a rash may indeed be malar rash is the presence of nonblanching erythematous macules. Dr. Vleugels described a patient with this presentation on her chest, in addition to other signs of malar rash, including the nasolabial sparing and hemorrhagic crusting on the lips.

"This is essentially petechiae. This is a sign on her skin of active systemic involvement," she said of the rash on the patient’s chest.

Patients with true malar rash by definition have active SLE, she said.

"So we don’t let them leave even the dermatology clinic without checking their kidneys, blood pressure, renal function, etc.," she said.

Dr. Vleugels also noted that there is a generalized form of acute cutaneous lupus to keep in mind.

"Unfortunately, this is very difficult to distinguish clinically from the morbilliform drug eruption or a viral exanthema. It essentially blanches pink to red," she said, adding that macules and papules may be present.

A high level of suspicion for this condition is needed, even though it is quite rare. A biopsy can confirm the diagnosis, as classic changes associated with lupus will be present on biopsy, she said.

Dr. Vleugels reported having no disclosures.

DESTIN, FLA. – A number of conditions are often misdiagnosed as malar rash, but certain clues can help in making the correct diagnosis, according to Dr. Ruth Ann Vleugels.

"One of the most helpful [clues] is this really prominent nasolabial sparing," Dr. Vleugels, assistant professor of dermatology at Harvard Medical School, and director of the autoimmune skin disease program at Brigham and Women’s Hospital, both in Boston, said at the annual Congress of Clinical Rheumatology.

Prominent hemorrhagic crusting on the lips in conjunction with the rash is another telltale sign that the condition is a malar rash, she said.

Often, other skin conditions such as erythematotelangiectatic rosacea are diagnosed as malar rash. Erythematotelangiectatic rosacea is common, affecting about a third of all patients with light skin, and many patients with the condition report having a photosensitive rash on the cheeks.

"So, already you have two criteria for systemic lupus," she said, stressing that self-reported malar erythema is "honestly, not a great criteria" for a malar rash diagnosis.

These patients will have transient flushing on the face or may have papulopustular rosacea.

The nasolabial sparing is thus a "really critical clue to look for," she noted.

Also, a malar rash is not going to go away after a few hours like the flush of erythematotelangiectatic rosacea, but will last for several days, at least.

The presence of alopecia also can help distinguish malar rash from other conditions, as it is a common feature in SLE (systemic lupus erythematosus), Dr. Vleugels noted.

Perhaps the most important differential diagnosis in the dermatology-rheumatology clinic is chronic mid-facial erythema, she said.

When such erythema "hugs or involves the nasolabial fold," think dermatomyositis, Dr. Vleugels advised.

She presented a case in which a patient had a subtle heliotrope along with this type of chronic mid-facial erythema. The patient had been referred for lupus but had amyopathic dermatomyositis, and the subtle edema and erythema of the upper eyelids provided a clue that led to a diagnosis of gastric cancer in the patient.

"When it’s subtle, it’s often missed," she said of the heliotrope a violaceous to dusky erythematous rash, with or without edema, which occurs in a symmetric distribution involving periorbital skin.

Another clue that a rash may indeed be malar rash is the presence of nonblanching erythematous macules. Dr. Vleugels described a patient with this presentation on her chest, in addition to other signs of malar rash, including the nasolabial sparing and hemorrhagic crusting on the lips.

"This is essentially petechiae. This is a sign on her skin of active systemic involvement," she said of the rash on the patient’s chest.

Patients with true malar rash by definition have active SLE, she said.

"So we don’t let them leave even the dermatology clinic without checking their kidneys, blood pressure, renal function, etc.," she said.

Dr. Vleugels also noted that there is a generalized form of acute cutaneous lupus to keep in mind.

"Unfortunately, this is very difficult to distinguish clinically from the morbilliform drug eruption or a viral exanthema. It essentially blanches pink to red," she said, adding that macules and papules may be present.

A high level of suspicion for this condition is needed, even though it is quite rare. A biopsy can confirm the diagnosis, as classic changes associated with lupus will be present on biopsy, she said.

Dr. Vleugels reported having no disclosures.

DESTIN, FLA. – Dermatomyositis doesn’t always present with the violaceous upper eyelid erythema and associated edema seen in textbook cases.

Rather, it often presents without muscle disease and with pink eyelid erythema, mid-facial erythema that hugs the nasolabial folds and extends onto the forehead, and subtle scaly pink plaques on the knuckles, Dr. Ruth Ann Vleugels said at the annual Congress of Clinical Rheumatology.

Dr. Vleugels described an unfortunate case involving a patient with this type of amyopathic presentation who presented to the emergency department with shortness of breath and what was thought to be a pulmonary infection. The patient was admitted to the intensive care unit, and dermatology was not consulted until the third day.

Unfortunately, the patient died in the ICU, said Dr. Vleugels of the department of dermatology at Harvard Medical School and director of the Autoimmune Skin Diseases Program at Brigham & Women’s Hospital, Boston.

The patient had skin-limited dermatomyositis; his family reported that his rash had been present for more than a year, she said.

Even Gottron’s papules, which are pathognomonic for dermatomyositis, don’t always present as pink to violaceous papules on the knuckles as expected. In some cases they can be very subtle – especially in darker skin types – and sometimes there is involvement between the knuckles as well, Dr. Vleugels said.

She described another patient who had been misdiagnosed with flat warts on the back of her hands before being diagnosed with dermatomyositis. In some cases, the papules are very scaly and can be mistaken for psoriasis, she noted.

"We have to recognize these clinical features," she said.

One helpful tip: Examine the nail folds. Nearly all dermatomyositis patients with active disease "have nice-looking nail folds," explained Dr. Vleugels.

"So the feature we will be looking for is cuticular hypertrophy," she said, noting that women tend to be acutely aware of this symptom and may want to push their cuticles back.

Dilated capillary loops, dropout capillaries, and hemosiderin deposition of the nail fold are also common.

"Really look at those nail folds. Lupus patients do not have nail folds like this," Dr. Vleugels emphasized.

Another clue to diagnosing dermatomyositis is poikiloderma in sun-exposed areas, characterized by redness, dispigmentation, and atrophy or thinning of the skin.

Poikiloderma becomes permanent, which is one reason why photoprotection is critical in these patients, said Dr. Vleugels. It can also involve the scalp (sometimes in addition to scaling), and in fact is "probably an underrecognized feature in our dermatomyositis patients," she said.

The condition is very pruritic and detrimental to quality of life, and hair loss can occur in association with the disease activity on the scalp.

"We treat this as a component of the rash, so if we don’t get their scalp better we increase or change their immunosuppressive therapy," Dr. Vleugels noted.

Keep in mind that poikiloderma can also occur on the lateral thighs (the "holster sign"), even though this is not typically a sun-exposed area, she added.

A recent study found that the MDA5 autoantibody, in particular, is associated with certain cutaneous findings in dermatomyositis. The most common was ulcerations in Gottron’s papules, and this is representative of vasculopathy (J. Am. Acad. Dermatol. 2011; 25-34).

Such ulcerations are not a sign of infection, but a sign that the disease is active and required more aggressive treatment.

Calcinosis is another concern, and occurs more often in children than adults.

However, "good data from the pediatric literature say if we treat these patients early and aggressively, they get less calcinosis," Dr. Vleugels said.

In an adult who is developing calcinosis, consider changing their overall treatment regimen, as this is a sign of active disease, she added.

"Mechanic’s hands" can be another sign of dermatomyositis, particularly if there is scaling and fissures on the lateral and palmar aspects of the fingers (as opposed to scaly Gottron’s papules elsewhere on the hands); this cutaneous phenotype is associated with high risk of antisynthetase syndrome or lung involvement, she said.

Recognizing these signs and symptoms of dermatomyositis can help prevent outcomes such as the death of the patient in the ICU after presenting with unrecognized fulminant lung disease associated with dermatomyositis, Dr. Vleugels emphasized.

"Our skin-limited patients are the ones who are often missed, and these are the ones who have approximately equal risk of lung disease and malignancy," she said.

Data suggest these conditions occur in about 25% of patients with skin-limited dermatomyositis

"So even the patients with amyopathic disease need to have regular screening with pulmonary function tests with diffusion capacity," she said.

Data from the Mayo Clinic, Rochester, Minn., suggest that about 20% of dermatomyositis patients have clinically amyopathic disease, and most (76%) of these cases are in women (Arch. Dermatol. 2010;146:26-30).

"The take-home point here is that these skin-limited patients are much harder to diagnose than the ones who come in with the classic muscle weakness, because the rash can be subtle," Dr. Vleugels said, noting that the diagnosis must be made clinically, because there is no confirmatory test.

She described a dermatomyositis patient who had experienced a rash for more than 2 years, and who was referred for lupus – even a biopsy was read as lupus.

"We need to say, ‘Oh, that could also be dermatomyositis,’" she said, adding: "If you see a patient with skin-limited disease, you’re still going to screen them for pulmonary disease, and you’re still going to screen them for cancer."

DESTIN, FLA. – Dermatomyositis doesn’t always present with the violaceous upper eyelid erythema and associated edema seen in textbook cases.

Rather, it often presents without muscle disease and with pink eyelid erythema, mid-facial erythema that hugs the nasolabial folds and extends onto the forehead, and subtle scaly pink plaques on the knuckles, Dr. Ruth Ann Vleugels said at the annual Congress of Clinical Rheumatology.

Dr. Vleugels described an unfortunate case involving a patient with this type of amyopathic presentation who presented to the emergency department with shortness of breath and what was thought to be a pulmonary infection. The patient was admitted to the intensive care unit, and dermatology was not consulted until the third day.

Unfortunately, the patient died in the ICU, said Dr. Vleugels of the department of dermatology at Harvard Medical School and director of the Autoimmune Skin Diseases Program at Brigham & Women’s Hospital, Boston.

The patient had skin-limited dermatomyositis; his family reported that his rash had been present for more than a year, she said.

Even Gottron’s papules, which are pathognomonic for dermatomyositis, don’t always present as pink to violaceous papules on the knuckles as expected. In some cases they can be very subtle – especially in darker skin types – and sometimes there is involvement between the knuckles as well, Dr. Vleugels said.

She described another patient who had been misdiagnosed with flat warts on the back of her hands before being diagnosed with dermatomyositis. In some cases, the papules are very scaly and can be mistaken for psoriasis, she noted.

"We have to recognize these clinical features," she said.

One helpful tip: Examine the nail folds. Nearly all dermatomyositis patients with active disease "have nice-looking nail folds," explained Dr. Vleugels.

"So the feature we will be looking for is cuticular hypertrophy," she said, noting that women tend to be acutely aware of this symptom and may want to push their cuticles back.

Dilated capillary loops, dropout capillaries, and hemosiderin deposition of the nail fold are also common.

"Really look at those nail folds. Lupus patients do not have nail folds like this," Dr. Vleugels emphasized.

Another clue to diagnosing dermatomyositis is poikiloderma in sun-exposed areas, characterized by redness, dispigmentation, and atrophy or thinning of the skin.

Poikiloderma becomes permanent, which is one reason why photoprotection is critical in these patients, said Dr. Vleugels. It can also involve the scalp (sometimes in addition to scaling), and in fact is "probably an underrecognized feature in our dermatomyositis patients," she said.

The condition is very pruritic and detrimental to quality of life, and hair loss can occur in association with the disease activity on the scalp.

"We treat this as a component of the rash, so if we don’t get their scalp better we increase or change their immunosuppressive therapy," Dr. Vleugels noted.

Keep in mind that poikiloderma can also occur on the lateral thighs (the "holster sign"), even though this is not typically a sun-exposed area, she added.

A recent study found that the MDA5 autoantibody, in particular, is associated with certain cutaneous findings in dermatomyositis. The most common was ulcerations in Gottron’s papules, and this is representative of vasculopathy (J. Am. Acad. Dermatol. 2011; 25-34).

Such ulcerations are not a sign of infection, but a sign that the disease is active and required more aggressive treatment.

Calcinosis is another concern, and occurs more often in children than adults.

However, "good data from the pediatric literature say if we treat these patients early and aggressively, they get less calcinosis," Dr. Vleugels said.

In an adult who is developing calcinosis, consider changing their overall treatment regimen, as this is a sign of active disease, she added.

"Mechanic’s hands" can be another sign of dermatomyositis, particularly if there is scaling and fissures on the lateral and palmar aspects of the fingers (as opposed to scaly Gottron’s papules elsewhere on the hands); this cutaneous phenotype is associated with high risk of antisynthetase syndrome or lung involvement, she said.

Recognizing these signs and symptoms of dermatomyositis can help prevent outcomes such as the death of the patient in the ICU after presenting with unrecognized fulminant lung disease associated with dermatomyositis, Dr. Vleugels emphasized.

"Our skin-limited patients are the ones who are often missed, and these are the ones who have approximately equal risk of lung disease and malignancy," she said.

Data suggest these conditions occur in about 25% of patients with skin-limited dermatomyositis

"So even the patients with amyopathic disease need to have regular screening with pulmonary function tests with diffusion capacity," she said.

Data from the Mayo Clinic, Rochester, Minn., suggest that about 20% of dermatomyositis patients have clinically amyopathic disease, and most (76%) of these cases are in women (Arch. Dermatol. 2010;146:26-30).

"The take-home point here is that these skin-limited patients are much harder to diagnose than the ones who come in with the classic muscle weakness, because the rash can be subtle," Dr. Vleugels said, noting that the diagnosis must be made clinically, because there is no confirmatory test.

She described a dermatomyositis patient who had experienced a rash for more than 2 years, and who was referred for lupus – even a biopsy was read as lupus.

"We need to say, ‘Oh, that could also be dermatomyositis,’" she said, adding: "If you see a patient with skin-limited disease, you’re still going to screen them for pulmonary disease, and you’re still going to screen them for cancer."

DESTIN, FLA. – Dermatomyositis doesn’t always present with the violaceous upper eyelid erythema and associated edema seen in textbook cases.

Rather, it often presents without muscle disease and with pink eyelid erythema, mid-facial erythema that hugs the nasolabial folds and extends onto the forehead, and subtle scaly pink plaques on the knuckles, Dr. Ruth Ann Vleugels said at the annual Congress of Clinical Rheumatology.

Dr. Vleugels described an unfortunate case involving a patient with this type of amyopathic presentation who presented to the emergency department with shortness of breath and what was thought to be a pulmonary infection. The patient was admitted to the intensive care unit, and dermatology was not consulted until the third day.

Unfortunately, the patient died in the ICU, said Dr. Vleugels of the department of dermatology at Harvard Medical School and director of the Autoimmune Skin Diseases Program at Brigham & Women’s Hospital, Boston.

The patient had skin-limited dermatomyositis; his family reported that his rash had been present for more than a year, she said.

Even Gottron’s papules, which are pathognomonic for dermatomyositis, don’t always present as pink to violaceous papules on the knuckles as expected. In some cases they can be very subtle – especially in darker skin types – and sometimes there is involvement between the knuckles as well, Dr. Vleugels said.

She described another patient who had been misdiagnosed with flat warts on the back of her hands before being diagnosed with dermatomyositis. In some cases, the papules are very scaly and can be mistaken for psoriasis, she noted.

"We have to recognize these clinical features," she said.

One helpful tip: Examine the nail folds. Nearly all dermatomyositis patients with active disease "have nice-looking nail folds," explained Dr. Vleugels.

"So the feature we will be looking for is cuticular hypertrophy," she said, noting that women tend to be acutely aware of this symptom and may want to push their cuticles back.

Dilated capillary loops, dropout capillaries, and hemosiderin deposition of the nail fold are also common.

"Really look at those nail folds. Lupus patients do not have nail folds like this," Dr. Vleugels emphasized.

Another clue to diagnosing dermatomyositis is poikiloderma in sun-exposed areas, characterized by redness, dispigmentation, and atrophy or thinning of the skin.

Poikiloderma becomes permanent, which is one reason why photoprotection is critical in these patients, said Dr. Vleugels. It can also involve the scalp (sometimes in addition to scaling), and in fact is "probably an underrecognized feature in our dermatomyositis patients," she said.

The condition is very pruritic and detrimental to quality of life, and hair loss can occur in association with the disease activity on the scalp.

"We treat this as a component of the rash, so if we don’t get their scalp better we increase or change their immunosuppressive therapy," Dr. Vleugels noted.

Keep in mind that poikiloderma can also occur on the lateral thighs (the "holster sign"), even though this is not typically a sun-exposed area, she added.

A recent study found that the MDA5 autoantibody, in particular, is associated with certain cutaneous findings in dermatomyositis. The most common was ulcerations in Gottron’s papules, and this is representative of vasculopathy (J. Am. Acad. Dermatol. 2011; 25-34).

Such ulcerations are not a sign of infection, but a sign that the disease is active and required more aggressive treatment.

Calcinosis is another concern, and occurs more often in children than adults.

However, "good data from the pediatric literature say if we treat these patients early and aggressively, they get less calcinosis," Dr. Vleugels said.

In an adult who is developing calcinosis, consider changing their overall treatment regimen, as this is a sign of active disease, she added.

"Mechanic’s hands" can be another sign of dermatomyositis, particularly if there is scaling and fissures on the lateral and palmar aspects of the fingers (as opposed to scaly Gottron’s papules elsewhere on the hands); this cutaneous phenotype is associated with high risk of antisynthetase syndrome or lung involvement, she said.

Recognizing these signs and symptoms of dermatomyositis can help prevent outcomes such as the death of the patient in the ICU after presenting with unrecognized fulminant lung disease associated with dermatomyositis, Dr. Vleugels emphasized.

"Our skin-limited patients are the ones who are often missed, and these are the ones who have approximately equal risk of lung disease and malignancy," she said.

Data suggest these conditions occur in about 25% of patients with skin-limited dermatomyositis

"So even the patients with amyopathic disease need to have regular screening with pulmonary function tests with diffusion capacity," she said.

Data from the Mayo Clinic, Rochester, Minn., suggest that about 20% of dermatomyositis patients have clinically amyopathic disease, and most (76%) of these cases are in women (Arch. Dermatol. 2010;146:26-30).

"The take-home point here is that these skin-limited patients are much harder to diagnose than the ones who come in with the classic muscle weakness, because the rash can be subtle," Dr. Vleugels said, noting that the diagnosis must be made clinically, because there is no confirmatory test.

She described a dermatomyositis patient who had experienced a rash for more than 2 years, and who was referred for lupus – even a biopsy was read as lupus.

"We need to say, ‘Oh, that could also be dermatomyositis,’" she said, adding: "If you see a patient with skin-limited disease, you’re still going to screen them for pulmonary disease, and you’re still going to screen them for cancer."