Patrice Wendling

CHICAGO — The use of topical mafenide acetate on burn wounds was associated with a higher incidence of fungal infection than was silver sulfadiazine in a retrospective analysis of 111 patients.

The chart review was initiated after physicians at the regional burn center of Miami Valley Hospital, Dayton, Ohio, observed more fungal infections after replacing the application of saline soaks for 24 hours followed by silver sulfadiazine 1% cream (Silvadene) with only the application of mafenide acetate 5% solution (Sulfamylon) as the topical antibiotic of choice for initial antimicrobial therapy.

The change in protocol was made in 2002 in an effort to improve patient outcomes, and has since been reversed, said research coordinator Ryan Shapiro, on behalf of principal investigator Dr. R. Michael Johnson, at the annual meeting of the American Burn Association.

From 1998 to 2006, 42 patients were treated twice daily with silver sulfadiazine, and 69 with mafenide acetate solution. The silver sulfadiazine group was significantly younger than the mafenide acetate group (mean age, 38 vs. 48 years), less likely to have a central line (16 vs. 43 patients), and more likely to have shorter ICU stays (4 vs. 10 days) and shorter total hospital stays (23.5 vs. 34 days).

Nonsignificant differences between the silver sulfadiazine and mafenide acetate groups included mean total body surface area burned (27% vs. 29%), inhalation injury (14 vs. 25 patients), and mortality (6 vs. 13 patients).

Univariate analysis showed that patients receiving mafenide acetate solution had twice the rate of burn infection or systemic fungal infection (48%) than did patients receiving silver sulfadiazine (24%), reported the investigators, who disclosed no relevant conflicts of interest.

Patients receiving mafenide acetate also had four times the rate of systemic fungal infections (27.5%) than did patients receiving silver sulfadiazine (7%). Both outcomes were statistically significant.

Significant predictors of fungal infection on univariate analysis included age, length of ICU stay, total length of stay, presence of a central line, and use of mafenide acetate.

However, in multivariate logistic regression analysis, only length of ICU stay and total length of stay remained as independent predictors of fungal infection, according to Dr. Johnson, chief of plastic surgery at Miami Valley Hospital, and colleagues.

The overall higher fungal infection rate in the series was higher than expected, and could be the result of an increase in the age of patients being treated rather than the choice of topical antibiotic, the investigators noted.

Although the protocol was changed back to using silver sulfadiazine cream in 2006, mafenide acetate is still used in the burn unit at the physician's discretion, they indicated.

Audience member Dr. Debra A. Reilly, director of the burn center and a surgeon at the University of Nebraska Medical Center in Omaha, recounted similar problems with mafenide acetate and fungal infections, but cautioned the audience not to discard the drug, calling it a “very useful product” with a long track record. She suggested adding the antifungal nystatin, with the caveat that it must be combined with mafenide acetate suspension and not mafenide acetate solution.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — The use of topical mafenide acetate on burn wounds was associated with a higher incidence of fungal infection than was silver sulfadiazine in a retrospective analysis of 111 patients.

The chart review was initiated after physicians at the regional burn center of Miami Valley Hospital, Dayton, Ohio, observed more fungal infections after replacing the application of saline soaks for 24 hours followed by silver sulfadiazine 1% cream (Silvadene) with only the application of mafenide acetate 5% solution (Sulfamylon) as the topical antibiotic of choice for initial antimicrobial therapy.

The change in protocol was made in 2002 in an effort to improve patient outcomes, and has since been reversed, said research coordinator Ryan Shapiro, on behalf of principal investigator Dr. R. Michael Johnson, at the annual meeting of the American Burn Association.

From 1998 to 2006, 42 patients were treated twice daily with silver sulfadiazine, and 69 with mafenide acetate solution. The silver sulfadiazine group was significantly younger than the mafenide acetate group (mean age, 38 vs. 48 years), less likely to have a central line (16 vs. 43 patients), and more likely to have shorter ICU stays (4 vs. 10 days) and shorter total hospital stays (23.5 vs. 34 days).

Nonsignificant differences between the silver sulfadiazine and mafenide acetate groups included mean total body surface area burned (27% vs. 29%), inhalation injury (14 vs. 25 patients), and mortality (6 vs. 13 patients).

Univariate analysis showed that patients receiving mafenide acetate solution had twice the rate of burn infection or systemic fungal infection (48%) than did patients receiving silver sulfadiazine (24%), reported the investigators, who disclosed no relevant conflicts of interest.

Patients receiving mafenide acetate also had four times the rate of systemic fungal infections (27.5%) than did patients receiving silver sulfadiazine (7%). Both outcomes were statistically significant.

Significant predictors of fungal infection on univariate analysis included age, length of ICU stay, total length of stay, presence of a central line, and use of mafenide acetate.

However, in multivariate logistic regression analysis, only length of ICU stay and total length of stay remained as independent predictors of fungal infection, according to Dr. Johnson, chief of plastic surgery at Miami Valley Hospital, and colleagues.

The overall higher fungal infection rate in the series was higher than expected, and could be the result of an increase in the age of patients being treated rather than the choice of topical antibiotic, the investigators noted.

Although the protocol was changed back to using silver sulfadiazine cream in 2006, mafenide acetate is still used in the burn unit at the physician's discretion, they indicated.

Audience member Dr. Debra A. Reilly, director of the burn center and a surgeon at the University of Nebraska Medical Center in Omaha, recounted similar problems with mafenide acetate and fungal infections, but cautioned the audience not to discard the drug, calling it a “very useful product” with a long track record. She suggested adding the antifungal nystatin, with the caveat that it must be combined with mafenide acetate suspension and not mafenide acetate solution.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — The use of topical mafenide acetate on burn wounds was associated with a higher incidence of fungal infection than was silver sulfadiazine in a retrospective analysis of 111 patients.

The chart review was initiated after physicians at the regional burn center of Miami Valley Hospital, Dayton, Ohio, observed more fungal infections after replacing the application of saline soaks for 24 hours followed by silver sulfadiazine 1% cream (Silvadene) with only the application of mafenide acetate 5% solution (Sulfamylon) as the topical antibiotic of choice for initial antimicrobial therapy.

The change in protocol was made in 2002 in an effort to improve patient outcomes, and has since been reversed, said research coordinator Ryan Shapiro, on behalf of principal investigator Dr. R. Michael Johnson, at the annual meeting of the American Burn Association.

From 1998 to 2006, 42 patients were treated twice daily with silver sulfadiazine, and 69 with mafenide acetate solution. The silver sulfadiazine group was significantly younger than the mafenide acetate group (mean age, 38 vs. 48 years), less likely to have a central line (16 vs. 43 patients), and more likely to have shorter ICU stays (4 vs. 10 days) and shorter total hospital stays (23.5 vs. 34 days).

Nonsignificant differences between the silver sulfadiazine and mafenide acetate groups included mean total body surface area burned (27% vs. 29%), inhalation injury (14 vs. 25 patients), and mortality (6 vs. 13 patients).

Univariate analysis showed that patients receiving mafenide acetate solution had twice the rate of burn infection or systemic fungal infection (48%) than did patients receiving silver sulfadiazine (24%), reported the investigators, who disclosed no relevant conflicts of interest.

Patients receiving mafenide acetate also had four times the rate of systemic fungal infections (27.5%) than did patients receiving silver sulfadiazine (7%). Both outcomes were statistically significant.

Significant predictors of fungal infection on univariate analysis included age, length of ICU stay, total length of stay, presence of a central line, and use of mafenide acetate.

However, in multivariate logistic regression analysis, only length of ICU stay and total length of stay remained as independent predictors of fungal infection, according to Dr. Johnson, chief of plastic surgery at Miami Valley Hospital, and colleagues.

The overall higher fungal infection rate in the series was higher than expected, and could be the result of an increase in the age of patients being treated rather than the choice of topical antibiotic, the investigators noted.

Although the protocol was changed back to using silver sulfadiazine cream in 2006, mafenide acetate is still used in the burn unit at the physician's discretion, they indicated.

Audience member Dr. Debra A. Reilly, director of the burn center and a surgeon at the University of Nebraska Medical Center in Omaha, recounted similar problems with mafenide acetate and fungal infections, but cautioned the audience not to discard the drug, calling it a “very useful product” with a long track record. She suggested adding the antifungal nystatin, with the caveat that it must be combined with mafenide acetate suspension and not mafenide acetate solution.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%–35%) and nonsmokers (average 6%, range 0.3%–36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said.

Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum, Dr. Doran explained in an interview. Still, smokers were almost four times as likely to have graft failure, compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Dr. Doran said burn injuries provide clinicians with a teachable moment for their patients who smoke. Burn patients are three times more likely to smoke than is the general population.

“When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior,” he said.

During the question-and-answer session, an audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuries that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and his associates, Arpi Minassian, Ph.D., and Dr. Bruce Potenza, include the lack of information on the exact number of cigarettes smoked prior to burn injury and the patients' smoking status during hospitalization.

Postdischarge outcomes in both groups are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%–35%) and nonsmokers (average 6%, range 0.3%–36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said.

Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum, Dr. Doran explained in an interview. Still, smokers were almost four times as likely to have graft failure, compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Dr. Doran said burn injuries provide clinicians with a teachable moment for their patients who smoke. Burn patients are three times more likely to smoke than is the general population.

“When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior,” he said.

During the question-and-answer session, an audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuries that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and his associates, Arpi Minassian, Ph.D., and Dr. Bruce Potenza, include the lack of information on the exact number of cigarettes smoked prior to burn injury and the patients' smoking status during hospitalization.

Postdischarge outcomes in both groups are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%–35%) and nonsmokers (average 6%, range 0.3%–36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said.

Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum, Dr. Doran explained in an interview. Still, smokers were almost four times as likely to have graft failure, compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Dr. Doran said burn injuries provide clinicians with a teachable moment for their patients who smoke. Burn patients are three times more likely to smoke than is the general population.

“When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior,” he said.

During the question-and-answer session, an audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuries that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and his associates, Arpi Minassian, Ph.D., and Dr. Bruce Potenza, include the lack of information on the exact number of cigarettes smoked prior to burn injury and the patients' smoking status during hospitalization.

Postdischarge outcomes in both groups are currently being analyzed.

CHICAGO — A technique that combines occlusion coils and alcohol sclerosis is the latest addition to the array of catheter-based approaches available to treat varicose veins.

"We have yet another tool in an area where I don't think we needed another tool; it's coil occlusion and sclerosis," Dr. Thom W. Rooke, head of vascular medicine at the Mayo Clinic, Rochester, Minn., said at a symposium on vascular surgery sponsored by Northwestern University. "It's definitely a feasible alternative to stripping or other catheter ablation mechanisms."

Potential advantages include no tumescent anesthesia and no potential for thermal skin damage. Radiofrequency and laser technologies have the potential—despite the use of tumescent anesthesia—to cause thermal injury, particularly in patients with relatively thin skin or in whom the veins are very superficial; they also have the potential to produce clots in the saphenous vein that may propagate into the femoral vein with the attendant risks of pulmonary embolism.

The new procedure is relatively simple and easy to incorporate, if the practitioner is already using fluoroscopy and catheterization in the daily routine. "And the final punch line: This [procedure] may be very cost effective, although we haven't analyzed that yet," he said.

Dr. Rooke reported results from a retrospective study of 96 patients (mean age 53 years) with incompetent saphenous veins, in whom the use of coil occlusion and sclerosis resulted in complete occlusion of the target vein in 94% of 119 limbs, and partial occlusion in the remaining 6%.

Nearly all of the patients were being treated for significant symptoms, such as discomfort/pain, edema, stasis changes, and ulceration, rather than for cosmetic indications.

Venous refilling rates dropped from a preprocedural mean of 11.6 mL/minute per 100 g (which corresponds to "moderate" venous incompetence at the Mayo Clinic), to a "normal" value of 5.4 mL/min per 100 g after the outpatient procedure. At a mean follow-up of 14 weeks, symptoms were resolved or markedly improved in 94% of patients, were partially improved in 4%, and showed no change in 2%.

A small, asymptomatic arteriovenous fistula in the region of the saphenofemoral junction was observed on follow-up ultrasound in one patient; two patients developed symptomatic superficial phlebitis; and none developed deep venous thrombosis, said Dr. Rooke, professor of vascular medicine at the Mayo Medical College, also in Rochester. In three limbs, the coils were inappropriately placed and had to be repositioned.

Interventional radiologists have been using various occlusion coils and sclerosing agents (typically ethanol) for decades to successfully and safely obliterate arteriovenous malformations, varicoceles, and other unwanted veins, so their application to varicose veins seemed a logical extension to physicians at the Mayo Clinic, Dr. Rooke explained.

The technique begins with a local injection of lidocaine to anesthetize the skin just above or below the knee, followed by an ultrasound-guided puncture of the greater saphenous vein. Fluoroscopy is used to guide a 5 French end-hole catheter to the saphenofemoral junction, after which a 4- to 14-mm Nester coil (Cook Medical Inc.) is placed near the junction with one end anchored into an appropriately positioned tributary. Once this coil is secure, 2 to 10 additional coils (average, 3) are added as needed.

After radiographic confirmation of occlusion is obtained, lidocaine (3 cc of 1% solution) is injected into the lumen of the vein and allowed to sit for a few minutes. The catheter is then slowly withdrawn, and ethanol (1–6 mL) is infused throughout the length of the saphenous vein.

Finally, the catheter is withdrawn, and full-length, graduated compression stockings are applied to the leg. The stockings should be worn continuously for 3 days, followed by daytime-only usage for about 10 days. Patients can ambulate immediately after the procedure, with no limitations placed on their routine, Dr. Rooke said.

In some cases, sodium tetradecanal sulfate (3%) was used instead of absolute alcohol because there are anecdotal reports of toxicity, especially to the lungs, with ethanol, Dr. Rooke said in an interview. However, most of the clinic's radiologists, who are more familiar with the alcohol, have returned to using ethanol as their preferred agent.

Coil occlusion and sclerosis have also been used to treat perforator veins and the shorter saphenous vein, with good results, he added. Dr. Rooke reported that he has no conflict to disclose with regard to this research.

The coil occlusion and sclerosis technique is easy to incorporate and could prove to be cost effective. DR. ROOKE

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A technique that combines occlusion coils and alcohol sclerosis is the latest addition to the array of catheter-based approaches available to treat varicose veins.

"We have yet another tool in an area where I don't think we needed another tool; it's coil occlusion and sclerosis," Dr. Thom W. Rooke, head of vascular medicine at the Mayo Clinic, Rochester, Minn., said at a symposium on vascular surgery sponsored by Northwestern University. "It's definitely a feasible alternative to stripping or other catheter ablation mechanisms."

Potential advantages include no tumescent anesthesia and no potential for thermal skin damage. Radiofrequency and laser technologies have the potential—despite the use of tumescent anesthesia—to cause thermal injury, particularly in patients with relatively thin skin or in whom the veins are very superficial; they also have the potential to produce clots in the saphenous vein that may propagate into the femoral vein with the attendant risks of pulmonary embolism.

The new procedure is relatively simple and easy to incorporate, if the practitioner is already using fluoroscopy and catheterization in the daily routine. "And the final punch line: This [procedure] may be very cost effective, although we haven't analyzed that yet," he said.

Dr. Rooke reported results from a retrospective study of 96 patients (mean age 53 years) with incompetent saphenous veins, in whom the use of coil occlusion and sclerosis resulted in complete occlusion of the target vein in 94% of 119 limbs, and partial occlusion in the remaining 6%.

Nearly all of the patients were being treated for significant symptoms, such as discomfort/pain, edema, stasis changes, and ulceration, rather than for cosmetic indications.

Venous refilling rates dropped from a preprocedural mean of 11.6 mL/minute per 100 g (which corresponds to "moderate" venous incompetence at the Mayo Clinic), to a "normal" value of 5.4 mL/min per 100 g after the outpatient procedure. At a mean follow-up of 14 weeks, symptoms were resolved or markedly improved in 94% of patients, were partially improved in 4%, and showed no change in 2%.

A small, asymptomatic arteriovenous fistula in the region of the saphenofemoral junction was observed on follow-up ultrasound in one patient; two patients developed symptomatic superficial phlebitis; and none developed deep venous thrombosis, said Dr. Rooke, professor of vascular medicine at the Mayo Medical College, also in Rochester. In three limbs, the coils were inappropriately placed and had to be repositioned.

Interventional radiologists have been using various occlusion coils and sclerosing agents (typically ethanol) for decades to successfully and safely obliterate arteriovenous malformations, varicoceles, and other unwanted veins, so their application to varicose veins seemed a logical extension to physicians at the Mayo Clinic, Dr. Rooke explained.

The technique begins with a local injection of lidocaine to anesthetize the skin just above or below the knee, followed by an ultrasound-guided puncture of the greater saphenous vein. Fluoroscopy is used to guide a 5 French end-hole catheter to the saphenofemoral junction, after which a 4- to 14-mm Nester coil (Cook Medical Inc.) is placed near the junction with one end anchored into an appropriately positioned tributary. Once this coil is secure, 2 to 10 additional coils (average, 3) are added as needed.

After radiographic confirmation of occlusion is obtained, lidocaine (3 cc of 1% solution) is injected into the lumen of the vein and allowed to sit for a few minutes. The catheter is then slowly withdrawn, and ethanol (1–6 mL) is infused throughout the length of the saphenous vein.

Finally, the catheter is withdrawn, and full-length, graduated compression stockings are applied to the leg. The stockings should be worn continuously for 3 days, followed by daytime-only usage for about 10 days. Patients can ambulate immediately after the procedure, with no limitations placed on their routine, Dr. Rooke said.

In some cases, sodium tetradecanal sulfate (3%) was used instead of absolute alcohol because there are anecdotal reports of toxicity, especially to the lungs, with ethanol, Dr. Rooke said in an interview. However, most of the clinic's radiologists, who are more familiar with the alcohol, have returned to using ethanol as their preferred agent.

Coil occlusion and sclerosis have also been used to treat perforator veins and the shorter saphenous vein, with good results, he added. Dr. Rooke reported that he has no conflict to disclose with regard to this research.

The coil occlusion and sclerosis technique is easy to incorporate and could prove to be cost effective. DR. ROOKE

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A technique that combines occlusion coils and alcohol sclerosis is the latest addition to the array of catheter-based approaches available to treat varicose veins.

"We have yet another tool in an area where I don't think we needed another tool; it's coil occlusion and sclerosis," Dr. Thom W. Rooke, head of vascular medicine at the Mayo Clinic, Rochester, Minn., said at a symposium on vascular surgery sponsored by Northwestern University. "It's definitely a feasible alternative to stripping or other catheter ablation mechanisms."

Potential advantages include no tumescent anesthesia and no potential for thermal skin damage. Radiofrequency and laser technologies have the potential—despite the use of tumescent anesthesia—to cause thermal injury, particularly in patients with relatively thin skin or in whom the veins are very superficial; they also have the potential to produce clots in the saphenous vein that may propagate into the femoral vein with the attendant risks of pulmonary embolism.

The new procedure is relatively simple and easy to incorporate, if the practitioner is already using fluoroscopy and catheterization in the daily routine. "And the final punch line: This [procedure] may be very cost effective, although we haven't analyzed that yet," he said.

Dr. Rooke reported results from a retrospective study of 96 patients (mean age 53 years) with incompetent saphenous veins, in whom the use of coil occlusion and sclerosis resulted in complete occlusion of the target vein in 94% of 119 limbs, and partial occlusion in the remaining 6%.

Nearly all of the patients were being treated for significant symptoms, such as discomfort/pain, edema, stasis changes, and ulceration, rather than for cosmetic indications.

Venous refilling rates dropped from a preprocedural mean of 11.6 mL/minute per 100 g (which corresponds to "moderate" venous incompetence at the Mayo Clinic), to a "normal" value of 5.4 mL/min per 100 g after the outpatient procedure. At a mean follow-up of 14 weeks, symptoms were resolved or markedly improved in 94% of patients, were partially improved in 4%, and showed no change in 2%.

A small, asymptomatic arteriovenous fistula in the region of the saphenofemoral junction was observed on follow-up ultrasound in one patient; two patients developed symptomatic superficial phlebitis; and none developed deep venous thrombosis, said Dr. Rooke, professor of vascular medicine at the Mayo Medical College, also in Rochester. In three limbs, the coils were inappropriately placed and had to be repositioned.

Interventional radiologists have been using various occlusion coils and sclerosing agents (typically ethanol) for decades to successfully and safely obliterate arteriovenous malformations, varicoceles, and other unwanted veins, so their application to varicose veins seemed a logical extension to physicians at the Mayo Clinic, Dr. Rooke explained.

The technique begins with a local injection of lidocaine to anesthetize the skin just above or below the knee, followed by an ultrasound-guided puncture of the greater saphenous vein. Fluoroscopy is used to guide a 5 French end-hole catheter to the saphenofemoral junction, after which a 4- to 14-mm Nester coil (Cook Medical Inc.) is placed near the junction with one end anchored into an appropriately positioned tributary. Once this coil is secure, 2 to 10 additional coils (average, 3) are added as needed.

After radiographic confirmation of occlusion is obtained, lidocaine (3 cc of 1% solution) is injected into the lumen of the vein and allowed to sit for a few minutes. The catheter is then slowly withdrawn, and ethanol (1–6 mL) is infused throughout the length of the saphenous vein.

Finally, the catheter is withdrawn, and full-length, graduated compression stockings are applied to the leg. The stockings should be worn continuously for 3 days, followed by daytime-only usage for about 10 days. Patients can ambulate immediately after the procedure, with no limitations placed on their routine, Dr. Rooke said.

In some cases, sodium tetradecanal sulfate (3%) was used instead of absolute alcohol because there are anecdotal reports of toxicity, especially to the lungs, with ethanol, Dr. Rooke said in an interview. However, most of the clinic's radiologists, who are more familiar with the alcohol, have returned to using ethanol as their preferred agent.

Coil occlusion and sclerosis have also been used to treat perforator veins and the shorter saphenous vein, with good results, he added. Dr. Rooke reported that he has no conflict to disclose with regard to this research.

The coil occlusion and sclerosis technique is easy to incorporate and could prove to be cost effective. DR. ROOKE

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A topical ointment containing components derived from green tea leaves is the latest addition to the available therapies for genital warts, Dr. Thomas C. Wright Jr. said at a conference on vulvovaginal diseases.

The ointment was approved by the Food and Drug Administration based on pooled results of two randomized, double-blind phase III trials in patients who used the ointment three times daily for up to 16 weeks.

Complete clearance was reported in 213 of 397 patients (54%) treated with Veregen, compared with 73 of 207 (35%) patients on placebo. Higher clearance rates were reported in Veregen-treated women (60%) than in men (47%).

Veregen Ointment 15% is a botanical drug product that is specifically indicated for the topical treatment of external genital and perianal warts in immunocompetent patients aged 18 years and older, said Dr. Wright, professor of pathology and director of gynecologic and obstetric pathology, Columbia University, New York.

The drug substance in Veregen Ointment is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O. Kuntze, and is a mixture of catechins and other green tea components. Catechins are thought to enhance immune system function and are more abundant in green tea leaves than in black tea leaves.

However, 30% of the patients who were treated with Veregen reported a severe local reaction that probably was related to the drug, said Dr. Wright.

The incidence of local adverse events leading to discontinuation or dose reduction was 5% (19 patients). The most common adverse events were erythema, pruritus, burning, pain or discomfort, and erosion or ulceration.

Veregen Ointment 15% has not been tested in immunosuppressed patients or in nursing mothers and is an FDA pregnancy category C drug, Dr. Wright said at the conference, which was sponsored by the American Society for Colposcopy and Cervical Pathology. The ointment was developed by MediGene AG, a biotech company that is based in Martinsried, Germany, and it is distributed in the United States by Doak Dermatologics.

MediGene has agreed to a phase IV trial, comparing the pharmacokinetics of catechins following topical administration of Veregen ointment 15% with that after oral administration of a green tea solution. The trial started in January and is slated to include 40 patients with external genital and perianal warts.

Other new treatments for external genital warts include Histofreezer (OraSure Technologies Inc.), a prepackaged portable cryosurgery unit that consists of a handheld canister of cryogen and a variety of applicators. The product is indicated for use on nine different types of lesions, including external genital warts. Histofreezer costs about $4 per usage and is much easier to use than large cryosurgery tanks, Dr. Wright said, adding that he has not used the product.

It produces a level of freezing (−55° C) similar to that achieved with carbon dioxide or nitrous oxide cryotherapy and therefore should perform similarly, he said. Reported clearance rates are similar to those in the literature for other forms of cryotherapy.

Local ablative methods such as cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions, whereas if there are more lesions, it is better to treat them with self-applied modalities such as imiquimod, Dr. Wright said.

Lasers also are useful but should be reserved for patients who fail chemical or immune modulation therapy. Lasers often are required in immunocompromised patients and those with large amounts of disease, he said.

Dr. Wright stated that he has no financial or advisory relationships with MediGene AG, Doak Dermatologics, or OraSure Technologies to disclose.

Cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions. DR. WRIGHT

CHICAGO — A topical ointment containing components derived from green tea leaves is the latest addition to the available therapies for genital warts, Dr. Thomas C. Wright Jr. said at a conference on vulvovaginal diseases.

The ointment was approved by the Food and Drug Administration based on pooled results of two randomized, double-blind phase III trials in patients who used the ointment three times daily for up to 16 weeks.

Complete clearance was reported in 213 of 397 patients (54%) treated with Veregen, compared with 73 of 207 (35%) patients on placebo. Higher clearance rates were reported in Veregen-treated women (60%) than in men (47%).

Veregen Ointment 15% is a botanical drug product that is specifically indicated for the topical treatment of external genital and perianal warts in immunocompetent patients aged 18 years and older, said Dr. Wright, professor of pathology and director of gynecologic and obstetric pathology, Columbia University, New York.

The drug substance in Veregen Ointment is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O. Kuntze, and is a mixture of catechins and other green tea components. Catechins are thought to enhance immune system function and are more abundant in green tea leaves than in black tea leaves.

However, 30% of the patients who were treated with Veregen reported a severe local reaction that probably was related to the drug, said Dr. Wright.

The incidence of local adverse events leading to discontinuation or dose reduction was 5% (19 patients). The most common adverse events were erythema, pruritus, burning, pain or discomfort, and erosion or ulceration.

Veregen Ointment 15% has not been tested in immunosuppressed patients or in nursing mothers and is an FDA pregnancy category C drug, Dr. Wright said at the conference, which was sponsored by the American Society for Colposcopy and Cervical Pathology. The ointment was developed by MediGene AG, a biotech company that is based in Martinsried, Germany, and it is distributed in the United States by Doak Dermatologics.

MediGene has agreed to a phase IV trial, comparing the pharmacokinetics of catechins following topical administration of Veregen ointment 15% with that after oral administration of a green tea solution. The trial started in January and is slated to include 40 patients with external genital and perianal warts.

Other new treatments for external genital warts include Histofreezer (OraSure Technologies Inc.), a prepackaged portable cryosurgery unit that consists of a handheld canister of cryogen and a variety of applicators. The product is indicated for use on nine different types of lesions, including external genital warts. Histofreezer costs about $4 per usage and is much easier to use than large cryosurgery tanks, Dr. Wright said, adding that he has not used the product.

It produces a level of freezing (−55° C) similar to that achieved with carbon dioxide or nitrous oxide cryotherapy and therefore should perform similarly, he said. Reported clearance rates are similar to those in the literature for other forms of cryotherapy.

Local ablative methods such as cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions, whereas if there are more lesions, it is better to treat them with self-applied modalities such as imiquimod, Dr. Wright said.

Lasers also are useful but should be reserved for patients who fail chemical or immune modulation therapy. Lasers often are required in immunocompromised patients and those with large amounts of disease, he said.

Dr. Wright stated that he has no financial or advisory relationships with MediGene AG, Doak Dermatologics, or OraSure Technologies to disclose.

Cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions. DR. WRIGHT

CHICAGO — A topical ointment containing components derived from green tea leaves is the latest addition to the available therapies for genital warts, Dr. Thomas C. Wright Jr. said at a conference on vulvovaginal diseases.

The ointment was approved by the Food and Drug Administration based on pooled results of two randomized, double-blind phase III trials in patients who used the ointment three times daily for up to 16 weeks.

Complete clearance was reported in 213 of 397 patients (54%) treated with Veregen, compared with 73 of 207 (35%) patients on placebo. Higher clearance rates were reported in Veregen-treated women (60%) than in men (47%).

Veregen Ointment 15% is a botanical drug product that is specifically indicated for the topical treatment of external genital and perianal warts in immunocompetent patients aged 18 years and older, said Dr. Wright, professor of pathology and director of gynecologic and obstetric pathology, Columbia University, New York.

The drug substance in Veregen Ointment is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O. Kuntze, and is a mixture of catechins and other green tea components. Catechins are thought to enhance immune system function and are more abundant in green tea leaves than in black tea leaves.

However, 30% of the patients who were treated with Veregen reported a severe local reaction that probably was related to the drug, said Dr. Wright.

The incidence of local adverse events leading to discontinuation or dose reduction was 5% (19 patients). The most common adverse events were erythema, pruritus, burning, pain or discomfort, and erosion or ulceration.

Veregen Ointment 15% has not been tested in immunosuppressed patients or in nursing mothers and is an FDA pregnancy category C drug, Dr. Wright said at the conference, which was sponsored by the American Society for Colposcopy and Cervical Pathology. The ointment was developed by MediGene AG, a biotech company that is based in Martinsried, Germany, and it is distributed in the United States by Doak Dermatologics.

MediGene has agreed to a phase IV trial, comparing the pharmacokinetics of catechins following topical administration of Veregen ointment 15% with that after oral administration of a green tea solution. The trial started in January and is slated to include 40 patients with external genital and perianal warts.

Other new treatments for external genital warts include Histofreezer (OraSure Technologies Inc.), a prepackaged portable cryosurgery unit that consists of a handheld canister of cryogen and a variety of applicators. The product is indicated for use on nine different types of lesions, including external genital warts. Histofreezer costs about $4 per usage and is much easier to use than large cryosurgery tanks, Dr. Wright said, adding that he has not used the product.

It produces a level of freezing (−55° C) similar to that achieved with carbon dioxide or nitrous oxide cryotherapy and therefore should perform similarly, he said. Reported clearance rates are similar to those in the literature for other forms of cryotherapy.

Local ablative methods such as cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions, whereas if there are more lesions, it is better to treat them with self-applied modalities such as imiquimod, Dr. Wright said.

Lasers also are useful but should be reserved for patients who fail chemical or immune modulation therapy. Lasers often are required in immunocompromised patients and those with large amounts of disease, he said.

Dr. Wright stated that he has no financial or advisory relationships with MediGene AG, Doak Dermatologics, or OraSure Technologies to disclose.

Cryotherapy, fulguration, and trichloroacetic acid are best if there are just a few lesions. DR. WRIGHT

CHICAGO – Recent studies are starting to suggest that identifying chronic obstructive pulmonary disease by spirometry and telling patients of the diagnosis might increase the likelihood of smoking cessation, Dr. Sidney S. Braman said.

A prospective, randomized study of 410 Swedish smokers that combined annual spirometry, brief smoking cessation advice from a nurse, and a letter from the physician to those patients who had COPD showed that smokers given a diagnosis of COPD stopped smoking significantly more often than did those with normal lung function. The 6-month, 1-year, and 3-year cessation rates were 29%, 28%, and 25%, respectively, among patients who were told they had COPD, compared with 5%, 6%, and 9% in those patients without COPD (Scand. J. Prim. Health Care 2006;24:133-9).

The study was highlighted by Dr. Braman as one of the top recent COPD articles during the annual meeting of the American College of Chest Physicians.

The research adds fuel to the controversy over routine use of spirometry for case finding in adults with exposure to risk factors such as cigarette smoking, or for those with persistent respiratory symptoms. This controversy exists, in part, because no randomized clinical trial has previously demonstrated that early detection of COPD changes the course of disease or increases the rate of smoking cessation, said Dr. Braman, professor of medicine at Brown University, Providence, R.I.

In 2005, the task force of the Agency for Healthcare Research and Quality conducted a systematic review of the evidence and concluded that it did not justify recommending spirometry as a routine tool in the practice of primary care.

The Swedish study may be limited to patients with mild COPD, because 85% of participants with COPD had mild disease. But he also cited a Polish study of 4,494 current smokers with a history of at least 10 pack-years of smoking that showed an improvement in validated smoking cessation rates of 16.3% in patients who were told they had COPD compared with 12% in those with normal spirometry (Thorax 2006;61:869-73).

In a study of 123 consecutive patients admitted to the emergency department with a COPD exacerbation, the diagnosis of pulmonary embolism (PE) using a standardized diagnostic algorithm was 6% in the 48 patients who had a clinical suspicion of PE by the ED physician and only 1.3% in the remaining 75 patients not suspected (Thorax 2007;62:121-5).

“This study showed that the prevalence of suspected pulmonary embolism in patients presenting with a COPD exacerbation is very low, and that routine investigation for PE in this group is not warranted,” Dr. Braman said.

However, Dr. Braman cautioned that a high clinical suspicion for PE should be maintained when there is no suspicion of infection in patients with a COPD exacerbation, especially those who require hospitalization. In a French study, PE was reported in 49 of 197 patients (25%) admitted to the hospital for a severe COPD exacerbation of unknown origin (Ann. Intern. Med. 2006;144:390-6).

The widely reported Towards a Revolution in COPD Health (TORCH) trial made the list (N. Engl. J. Med. 2007;356: 775-89). In many people's minds, this randomized, double-blind trial of 6,112 patients with COPD was a negative study, because mortality rates for salmeterol or fluticasone propionate monotherapies did not differ significantly from placebo. However, a review of the secondary end points is encouraging.

Compared with placebo, combination therapy with salmeterol 50 mcg plus fluticasone 500 mcg twice daily significantly reduced the annual rate of exacerbations from 1.13 to 0.85 and significantly improved health status and spirometric values.

Rounding out the list was a large cohort study of 1,302 individuals with airway obstruction that indicates serum C-reactive protein is a strong and independent predictor of future COPD hospitalization and death (Am. J. Respir. Crit. Care Med. 2007;175:250-5), and a study of 176 consecutive patients with various pulmonary diseases that suggests circulating brain natriuretic peptide levels can be used as a prognostic marker and screening tool for significant pulmonary hypertension in chronic lung disease (Am. J. Respir. Crit. Care Med. 2006;173:744-50).

CHICAGO – Recent studies are starting to suggest that identifying chronic obstructive pulmonary disease by spirometry and telling patients of the diagnosis might increase the likelihood of smoking cessation, Dr. Sidney S. Braman said.

A prospective, randomized study of 410 Swedish smokers that combined annual spirometry, brief smoking cessation advice from a nurse, and a letter from the physician to those patients who had COPD showed that smokers given a diagnosis of COPD stopped smoking significantly more often than did those with normal lung function. The 6-month, 1-year, and 3-year cessation rates were 29%, 28%, and 25%, respectively, among patients who were told they had COPD, compared with 5%, 6%, and 9% in those patients without COPD (Scand. J. Prim. Health Care 2006;24:133-9).

The study was highlighted by Dr. Braman as one of the top recent COPD articles during the annual meeting of the American College of Chest Physicians.

The research adds fuel to the controversy over routine use of spirometry for case finding in adults with exposure to risk factors such as cigarette smoking, or for those with persistent respiratory symptoms. This controversy exists, in part, because no randomized clinical trial has previously demonstrated that early detection of COPD changes the course of disease or increases the rate of smoking cessation, said Dr. Braman, professor of medicine at Brown University, Providence, R.I.

In 2005, the task force of the Agency for Healthcare Research and Quality conducted a systematic review of the evidence and concluded that it did not justify recommending spirometry as a routine tool in the practice of primary care.

The Swedish study may be limited to patients with mild COPD, because 85% of participants with COPD had mild disease. But he also cited a Polish study of 4,494 current smokers with a history of at least 10 pack-years of smoking that showed an improvement in validated smoking cessation rates of 16.3% in patients who were told they had COPD compared with 12% in those with normal spirometry (Thorax 2006;61:869-73).

In a study of 123 consecutive patients admitted to the emergency department with a COPD exacerbation, the diagnosis of pulmonary embolism (PE) using a standardized diagnostic algorithm was 6% in the 48 patients who had a clinical suspicion of PE by the ED physician and only 1.3% in the remaining 75 patients not suspected (Thorax 2007;62:121-5).

“This study showed that the prevalence of suspected pulmonary embolism in patients presenting with a COPD exacerbation is very low, and that routine investigation for PE in this group is not warranted,” Dr. Braman said.

However, Dr. Braman cautioned that a high clinical suspicion for PE should be maintained when there is no suspicion of infection in patients with a COPD exacerbation, especially those who require hospitalization. In a French study, PE was reported in 49 of 197 patients (25%) admitted to the hospital for a severe COPD exacerbation of unknown origin (Ann. Intern. Med. 2006;144:390-6).

The widely reported Towards a Revolution in COPD Health (TORCH) trial made the list (N. Engl. J. Med. 2007;356: 775-89). In many people's minds, this randomized, double-blind trial of 6,112 patients with COPD was a negative study, because mortality rates for salmeterol or fluticasone propionate monotherapies did not differ significantly from placebo. However, a review of the secondary end points is encouraging.

Compared with placebo, combination therapy with salmeterol 50 mcg plus fluticasone 500 mcg twice daily significantly reduced the annual rate of exacerbations from 1.13 to 0.85 and significantly improved health status and spirometric values.

Rounding out the list was a large cohort study of 1,302 individuals with airway obstruction that indicates serum C-reactive protein is a strong and independent predictor of future COPD hospitalization and death (Am. J. Respir. Crit. Care Med. 2007;175:250-5), and a study of 176 consecutive patients with various pulmonary diseases that suggests circulating brain natriuretic peptide levels can be used as a prognostic marker and screening tool for significant pulmonary hypertension in chronic lung disease (Am. J. Respir. Crit. Care Med. 2006;173:744-50).

CHICAGO – Recent studies are starting to suggest that identifying chronic obstructive pulmonary disease by spirometry and telling patients of the diagnosis might increase the likelihood of smoking cessation, Dr. Sidney S. Braman said.

A prospective, randomized study of 410 Swedish smokers that combined annual spirometry, brief smoking cessation advice from a nurse, and a letter from the physician to those patients who had COPD showed that smokers given a diagnosis of COPD stopped smoking significantly more often than did those with normal lung function. The 6-month, 1-year, and 3-year cessation rates were 29%, 28%, and 25%, respectively, among patients who were told they had COPD, compared with 5%, 6%, and 9% in those patients without COPD (Scand. J. Prim. Health Care 2006;24:133-9).

The study was highlighted by Dr. Braman as one of the top recent COPD articles during the annual meeting of the American College of Chest Physicians.

The research adds fuel to the controversy over routine use of spirometry for case finding in adults with exposure to risk factors such as cigarette smoking, or for those with persistent respiratory symptoms. This controversy exists, in part, because no randomized clinical trial has previously demonstrated that early detection of COPD changes the course of disease or increases the rate of smoking cessation, said Dr. Braman, professor of medicine at Brown University, Providence, R.I.

In 2005, the task force of the Agency for Healthcare Research and Quality conducted a systematic review of the evidence and concluded that it did not justify recommending spirometry as a routine tool in the practice of primary care.

The Swedish study may be limited to patients with mild COPD, because 85% of participants with COPD had mild disease. But he also cited a Polish study of 4,494 current smokers with a history of at least 10 pack-years of smoking that showed an improvement in validated smoking cessation rates of 16.3% in patients who were told they had COPD compared with 12% in those with normal spirometry (Thorax 2006;61:869-73).

In a study of 123 consecutive patients admitted to the emergency department with a COPD exacerbation, the diagnosis of pulmonary embolism (PE) using a standardized diagnostic algorithm was 6% in the 48 patients who had a clinical suspicion of PE by the ED physician and only 1.3% in the remaining 75 patients not suspected (Thorax 2007;62:121-5).

“This study showed that the prevalence of suspected pulmonary embolism in patients presenting with a COPD exacerbation is very low, and that routine investigation for PE in this group is not warranted,” Dr. Braman said.

However, Dr. Braman cautioned that a high clinical suspicion for PE should be maintained when there is no suspicion of infection in patients with a COPD exacerbation, especially those who require hospitalization. In a French study, PE was reported in 49 of 197 patients (25%) admitted to the hospital for a severe COPD exacerbation of unknown origin (Ann. Intern. Med. 2006;144:390-6).

The widely reported Towards a Revolution in COPD Health (TORCH) trial made the list (N. Engl. J. Med. 2007;356: 775-89). In many people's minds, this randomized, double-blind trial of 6,112 patients with COPD was a negative study, because mortality rates for salmeterol or fluticasone propionate monotherapies did not differ significantly from placebo. However, a review of the secondary end points is encouraging.

Compared with placebo, combination therapy with salmeterol 50 mcg plus fluticasone 500 mcg twice daily significantly reduced the annual rate of exacerbations from 1.13 to 0.85 and significantly improved health status and spirometric values.

Rounding out the list was a large cohort study of 1,302 individuals with airway obstruction that indicates serum C-reactive protein is a strong and independent predictor of future COPD hospitalization and death (Am. J. Respir. Crit. Care Med. 2007;175:250-5), and a study of 176 consecutive patients with various pulmonary diseases that suggests circulating brain natriuretic peptide levels can be used as a prognostic marker and screening tool for significant pulmonary hypertension in chronic lung disease (Am. J. Respir. Crit. Care Med. 2006;173:744-50).

CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.

Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.

The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America.

As an additional benefit, the total radiation dose of 1.5 mGy is about half that of a single mammographic exposure, she said.

The technique is neither clinically available nor Food and Drug Administration approved, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the U.S. Food andDrug Administration for approval of the combined modality of tomosynthesis and digital mammography.

“Mammography is a proven winner, and this will only make mammography better,” Dr. Rafferty of the radiology department at Harvard University Medical School in Boston, said in an interview. “Tomosynthesis is really the first new thing in breast imaging in decades, and I believe it will impact mortality rates.”

The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of which 141 were recalled by the site radiologist for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 benign and 48 malignant lesions were identified.

Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases were asked to score the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For those cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1-5 indicating the likelihood of disease in that patient, and to assign a probability of malignancy score rating from 1 to 100.

The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologist's performance, as demonstrated by receiver-operator curve analyses, said Dr. Rafferty, who has received research support from Hologic, which sponsored the study. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries.

A receiver-operator analysis showed that for all 12 readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.

Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 representing a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.

The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.

In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy, Dr. Rafferty said.

When a forced BIRADS score of 4 or 5 was considered positive for breast cancer and a BIRADS of 1-3 was considered negative, sensitivity improved from 65.5% for FFDM alone to 76% for FFDM plus tomosynthesis, and specificity improved from 84% to 89%, she said.

The mean recall rate for all 12 radiologists was 51.5% for FFDM alone and 12.9% for FFDM plus tomosynthesis, resulting in a reduction of 38.6%. Dr. Rafferty observed that the recall rate for digital mammography alone was very high, but said the data set was highly selected for recall and biopsy patients.

Architectural distortion and microcalcifications are clearer in tomosynthesis slices (right) than on digital mammography (left).

A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).

A spiculated cancer with microcalcifications is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). Hologic, Inc.

CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.

Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.

The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America.

As an additional benefit, the total radiation dose of 1.5 mGy is about half that of a single mammographic exposure, she said.

The technique is neither clinically available nor Food and Drug Administration approved, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the U.S. Food andDrug Administration for approval of the combined modality of tomosynthesis and digital mammography.

“Mammography is a proven winner, and this will only make mammography better,” Dr. Rafferty of the radiology department at Harvard University Medical School in Boston, said in an interview. “Tomosynthesis is really the first new thing in breast imaging in decades, and I believe it will impact mortality rates.”

The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of which 141 were recalled by the site radiologist for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 benign and 48 malignant lesions were identified.

Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases were asked to score the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For those cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1-5 indicating the likelihood of disease in that patient, and to assign a probability of malignancy score rating from 1 to 100.

The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologist's performance, as demonstrated by receiver-operator curve analyses, said Dr. Rafferty, who has received research support from Hologic, which sponsored the study. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries.

A receiver-operator analysis showed that for all 12 readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.

Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 representing a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.

The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.

In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy, Dr. Rafferty said.

When a forced BIRADS score of 4 or 5 was considered positive for breast cancer and a BIRADS of 1-3 was considered negative, sensitivity improved from 65.5% for FFDM alone to 76% for FFDM plus tomosynthesis, and specificity improved from 84% to 89%, she said.

The mean recall rate for all 12 radiologists was 51.5% for FFDM alone and 12.9% for FFDM plus tomosynthesis, resulting in a reduction of 38.6%. Dr. Rafferty observed that the recall rate for digital mammography alone was very high, but said the data set was highly selected for recall and biopsy patients.

Architectural distortion and microcalcifications are clearer in tomosynthesis slices (right) than on digital mammography (left).

A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).

A spiculated cancer with microcalcifications is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). Hologic, Inc.

CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.

Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.

The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America.

As an additional benefit, the total radiation dose of 1.5 mGy is about half that of a single mammographic exposure, she said.

The technique is neither clinically available nor Food and Drug Administration approved, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the U.S. Food andDrug Administration for approval of the combined modality of tomosynthesis and digital mammography.

“Mammography is a proven winner, and this will only make mammography better,” Dr. Rafferty of the radiology department at Harvard University Medical School in Boston, said in an interview. “Tomosynthesis is really the first new thing in breast imaging in decades, and I believe it will impact mortality rates.”

The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of which 141 were recalled by the site radiologist for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 benign and 48 malignant lesions were identified.

Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases were asked to score the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For those cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1-5 indicating the likelihood of disease in that patient, and to assign a probability of malignancy score rating from 1 to 100.

The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologist's performance, as demonstrated by receiver-operator curve analyses, said Dr. Rafferty, who has received research support from Hologic, which sponsored the study. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries.

A receiver-operator analysis showed that for all 12 readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.

Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 representing a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.

The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.

In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy, Dr. Rafferty said.

When a forced BIRADS score of 4 or 5 was considered positive for breast cancer and a BIRADS of 1-3 was considered negative, sensitivity improved from 65.5% for FFDM alone to 76% for FFDM plus tomosynthesis, and specificity improved from 84% to 89%, she said.

The mean recall rate for all 12 radiologists was 51.5% for FFDM alone and 12.9% for FFDM plus tomosynthesis, resulting in a reduction of 38.6%. Dr. Rafferty observed that the recall rate for digital mammography alone was very high, but said the data set was highly selected for recall and biopsy patients.

Architectural distortion and microcalcifications are clearer in tomosynthesis slices (right) than on digital mammography (left).

A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).

A spiculated cancer with microcalcifications is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). Hologic, Inc.

CHICAGO – New data suggest the human bocavirus may be an enteric pathogen, and that infection with the parvovirus varies by season, Dr. Jeffrey S. Kahn said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Researchers are beginning to piece together some information about the human bocavirus since its discovery just 2 years ago (Proc. Natl. Acad. Sci. USA 2005;102:12891-6).

The virus, which closely resembles the genome of viruses in the Parvoviridae family, is common, with a positive infection rate in most studies of 1%–8%, although it exceeds 18% in others.

The majority of positive specimens are from children, said Dr. Kahn, director of the infectious diseases laboratory at Yale University, New Haven, Conn.

The bocavirus is also frequently detected in the presence of other viruses or pathogens.

Three studies published this year support the theory that the human bocavirus (HBoV) is an enteric pathogen, Dr. Kahn said.

In what is believed to be the first report to document HBoV in human feces, Spanish researchers identified HBoV in 48 of 527 (9%) fecal samples collected from children less than 3 years old with acute gastroenteritis without respiratory tract disease (Emerg. Infect. Dis. 2007;13:636-7).

In 28 of 48 (58%) specimens, another enteric pathogen was detected, including salmonella, campylobacter, norovirus, and rotavirus.

A prospective clinical and molecular study in Hong Kong detected HBoV in 30 of 1,435 (2%) fecal samples and in 83 of 1,200 (7%) nasopharyngeal aspirates collected from patients less than 18 years of age (J. Infect. Dis. 2007;196:986-93).

HBoV was codetected with other pathogens in 33% of aspirates and in 56% of fecal samples. There was little difference in genome sequence from isolates detected in each anatomic site, Dr. Kahn said at the meeting, which was sponsored by the American Society for Microbiology.

A third study from Seoul identified HBoV in 0.8% of 962 children hospitalized with gastroenteritis (J. Infect. Dis. 2007;196:994-7). In all, 44% of the study population had a viral agent including rotavirus (26%), norovirus (14%), adenovirus (3%), and astrovirus (1%).

“The spectrum of disease caused by this virus has not yet been defined, though the observation that this virus is frequently identified with other pathogens suggests that HBoV may not, for some populations, be a major pathogen,” Dr. Kahn said in an interview.

A seasonal variation to HBoV infection has also been observed by Yale investigators, which suggests that in the United States the infection starts in the fall and runs into early spring. The study, led by Dr. Deniz Kesebir, identified HBoV in 5% or 22 of 425 respiratory specimens from children less than 2 years of age. Cases began in October (8%), peaked in November (10%) and December (9%), and dropped off in March (3%) and April (6%). No cases were reported from May to September.

None of the 96 asymptomatic children screened for HBoV were positive. Among the 20 children who were positive for HBoV, fever, rhinorrhea, cough, and wheezing were observed in more than 50%, and diarrhea was observed in 25% (J. Infect. Dis. 2006;194:1276-82).

A recent population-based surveillance study conducted in rural Thailand reported its highest number of cases from January to March and none from August to December, (J. Infect. Dis. 2007;195:1038-45). In the same study, HBoV infection was detected in 5% of hospitalized patients with pneumonia, of which 83% were children younger than 5 years old.

Although the amount of information collected on HBoV is impressive, further studies are needed on the biology and pathogenesis of the human bocavirus, Dr. Kahn said.

The study of HBoV is limited to the detection of viral DNA because the virus has yet to be successfully propagated in cell culture or animal models.

Among 20 patients positive for HBoV, more than half had rhinorrhea, fever, cough, and wheezing. DR. KESEBIR

Bocavirus Seen in Acute Asthma Cases

The recently identified human bocavirus is present in children hospitalized with asthma, and infects children older than 2 years of age, Dr. Dominique Gendrel and colleagues reported in a poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Human bocavirus was detected by real-time polymerase chain reaction in nasopharyngeal aspirate samples from 16 of 136 children (12%), aged 2-16 years, who were hospitalized with severe acute asthma from November 2005 to May 2007 in the St. Vincent de Paul-Cochin Hospital in Paris. All the children had been hospitalized with acute asthma after evaluation in the emergency department.

The infected children had a mean age of 3.2 years; two children were older than 5 years, which suggests that the respiratory tract infection is not limited to young infants.

The bocavirus was associated with Mycoplasma pneumoniae in two cases, respiratory syncytial virus (RSV) in one case, and human metapneumovirus in one case.

In all, there were 16 cases of M. pneumoniae (12%), 12 cases of RSV (9%), 4 cases of influenza A (3%), 1 case of influenza B, and 1 case of parainfluenza III. Three of 90 children (3%) tested positive for human metapneumovirus, the investigators reported at the meeting, which was sponsored by the American Society for Microbiology.

As was observed in other studies, Dr. Gendrel said in an interview that there was a seasonal variation to the virus, with more cases identified in winter and spring. Dr. Gendrel is with the Pediatric Department, Paris 5 University and Medical School, Hospital St. Vincent de Paul-Cochin, Paris, according to the poster.

CHICAGO – New data suggest the human bocavirus may be an enteric pathogen, and that infection with the parvovirus varies by season, Dr. Jeffrey S. Kahn said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Researchers are beginning to piece together some information about the human bocavirus since its discovery just 2 years ago (Proc. Natl. Acad. Sci. USA 2005;102:12891-6).

The virus, which closely resembles the genome of viruses in the Parvoviridae family, is common, with a positive infection rate in most studies of 1%–8%, although it exceeds 18% in others.

The majority of positive specimens are from children, said Dr. Kahn, director of the infectious diseases laboratory at Yale University, New Haven, Conn.

The bocavirus is also frequently detected in the presence of other viruses or pathogens.

Three studies published this year support the theory that the human bocavirus (HBoV) is an enteric pathogen, Dr. Kahn said.

In what is believed to be the first report to document HBoV in human feces, Spanish researchers identified HBoV in 48 of 527 (9%) fecal samples collected from children less than 3 years old with acute gastroenteritis without respiratory tract disease (Emerg. Infect. Dis. 2007;13:636-7).

In 28 of 48 (58%) specimens, another enteric pathogen was detected, including salmonella, campylobacter, norovirus, and rotavirus.

A prospective clinical and molecular study in Hong Kong detected HBoV in 30 of 1,435 (2%) fecal samples and in 83 of 1,200 (7%) nasopharyngeal aspirates collected from patients less than 18 years of age (J. Infect. Dis. 2007;196:986-93).

HBoV was codetected with other pathogens in 33% of aspirates and in 56% of fecal samples. There was little difference in genome sequence from isolates detected in each anatomic site, Dr. Kahn said at the meeting, which was sponsored by the American Society for Microbiology.

A third study from Seoul identified HBoV in 0.8% of 962 children hospitalized with gastroenteritis (J. Infect. Dis. 2007;196:994-7). In all, 44% of the study population had a viral agent including rotavirus (26%), norovirus (14%), adenovirus (3%), and astrovirus (1%).

“The spectrum of disease caused by this virus has not yet been defined, though the observation that this virus is frequently identified with other pathogens suggests that HBoV may not, for some populations, be a major pathogen,” Dr. Kahn said in an interview.

A seasonal variation to HBoV infection has also been observed by Yale investigators, which suggests that in the United States the infection starts in the fall and runs into early spring. The study, led by Dr. Deniz Kesebir, identified HBoV in 5% or 22 of 425 respiratory specimens from children less than 2 years of age. Cases began in October (8%), peaked in November (10%) and December (9%), and dropped off in March (3%) and April (6%). No cases were reported from May to September.

None of the 96 asymptomatic children screened for HBoV were positive. Among the 20 children who were positive for HBoV, fever, rhinorrhea, cough, and wheezing were observed in more than 50%, and diarrhea was observed in 25% (J. Infect. Dis. 2006;194:1276-82).

A recent population-based surveillance study conducted in rural Thailand reported its highest number of cases from January to March and none from August to December, (J. Infect. Dis. 2007;195:1038-45). In the same study, HBoV infection was detected in 5% of hospitalized patients with pneumonia, of which 83% were children younger than 5 years old.

Although the amount of information collected on HBoV is impressive, further studies are needed on the biology and pathogenesis of the human bocavirus, Dr. Kahn said.

The study of HBoV is limited to the detection of viral DNA because the virus has yet to be successfully propagated in cell culture or animal models.

Among 20 patients positive for HBoV, more than half had rhinorrhea, fever, cough, and wheezing. DR. KESEBIR

Bocavirus Seen in Acute Asthma Cases

The recently identified human bocavirus is present in children hospitalized with asthma, and infects children older than 2 years of age, Dr. Dominique Gendrel and colleagues reported in a poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Human bocavirus was detected by real-time polymerase chain reaction in nasopharyngeal aspirate samples from 16 of 136 children (12%), aged 2-16 years, who were hospitalized with severe acute asthma from November 2005 to May 2007 in the St. Vincent de Paul-Cochin Hospital in Paris. All the children had been hospitalized with acute asthma after evaluation in the emergency department.

The infected children had a mean age of 3.2 years; two children were older than 5 years, which suggests that the respiratory tract infection is not limited to young infants.

The bocavirus was associated with Mycoplasma pneumoniae in two cases, respiratory syncytial virus (RSV) in one case, and human metapneumovirus in one case.

In all, there were 16 cases of M. pneumoniae (12%), 12 cases of RSV (9%), 4 cases of influenza A (3%), 1 case of influenza B, and 1 case of parainfluenza III. Three of 90 children (3%) tested positive for human metapneumovirus, the investigators reported at the meeting, which was sponsored by the American Society for Microbiology.

As was observed in other studies, Dr. Gendrel said in an interview that there was a seasonal variation to the virus, with more cases identified in winter and spring. Dr. Gendrel is with the Pediatric Department, Paris 5 University and Medical School, Hospital St. Vincent de Paul-Cochin, Paris, according to the poster.

CHICAGO – New data suggest the human bocavirus may be an enteric pathogen, and that infection with the parvovirus varies by season, Dr. Jeffrey S. Kahn said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Researchers are beginning to piece together some information about the human bocavirus since its discovery just 2 years ago (Proc. Natl. Acad. Sci. USA 2005;102:12891-6).

The virus, which closely resembles the genome of viruses in the Parvoviridae family, is common, with a positive infection rate in most studies of 1%–8%, although it exceeds 18% in others.

The majority of positive specimens are from children, said Dr. Kahn, director of the infectious diseases laboratory at Yale University, New Haven, Conn.

The bocavirus is also frequently detected in the presence of other viruses or pathogens.

Three studies published this year support the theory that the human bocavirus (HBoV) is an enteric pathogen, Dr. Kahn said.

In what is believed to be the first report to document HBoV in human feces, Spanish researchers identified HBoV in 48 of 527 (9%) fecal samples collected from children less than 3 years old with acute gastroenteritis without respiratory tract disease (Emerg. Infect. Dis. 2007;13:636-7).

In 28 of 48 (58%) specimens, another enteric pathogen was detected, including salmonella, campylobacter, norovirus, and rotavirus.

A prospective clinical and molecular study in Hong Kong detected HBoV in 30 of 1,435 (2%) fecal samples and in 83 of 1,200 (7%) nasopharyngeal aspirates collected from patients less than 18 years of age (J. Infect. Dis. 2007;196:986-93).

HBoV was codetected with other pathogens in 33% of aspirates and in 56% of fecal samples. There was little difference in genome sequence from isolates detected in each anatomic site, Dr. Kahn said at the meeting, which was sponsored by the American Society for Microbiology.

A third study from Seoul identified HBoV in 0.8% of 962 children hospitalized with gastroenteritis (J. Infect. Dis. 2007;196:994-7). In all, 44% of the study population had a viral agent including rotavirus (26%), norovirus (14%), adenovirus (3%), and astrovirus (1%).

“The spectrum of disease caused by this virus has not yet been defined, though the observation that this virus is frequently identified with other pathogens suggests that HBoV may not, for some populations, be a major pathogen,” Dr. Kahn said in an interview.

A seasonal variation to HBoV infection has also been observed by Yale investigators, which suggests that in the United States the infection starts in the fall and runs into early spring. The study, led by Dr. Deniz Kesebir, identified HBoV in 5% or 22 of 425 respiratory specimens from children less than 2 years of age. Cases began in October (8%), peaked in November (10%) and December (9%), and dropped off in March (3%) and April (6%). No cases were reported from May to September.

None of the 96 asymptomatic children screened for HBoV were positive. Among the 20 children who were positive for HBoV, fever, rhinorrhea, cough, and wheezing were observed in more than 50%, and diarrhea was observed in 25% (J. Infect. Dis. 2006;194:1276-82).

A recent population-based surveillance study conducted in rural Thailand reported its highest number of cases from January to March and none from August to December, (J. Infect. Dis. 2007;195:1038-45). In the same study, HBoV infection was detected in 5% of hospitalized patients with pneumonia, of which 83% were children younger than 5 years old.

Although the amount of information collected on HBoV is impressive, further studies are needed on the biology and pathogenesis of the human bocavirus, Dr. Kahn said.

The study of HBoV is limited to the detection of viral DNA because the virus has yet to be successfully propagated in cell culture or animal models.

Among 20 patients positive for HBoV, more than half had rhinorrhea, fever, cough, and wheezing. DR. KESEBIR

Bocavirus Seen in Acute Asthma Cases

The recently identified human bocavirus is present in children hospitalized with asthma, and infects children older than 2 years of age, Dr. Dominique Gendrel and colleagues reported in a poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Human bocavirus was detected by real-time polymerase chain reaction in nasopharyngeal aspirate samples from 16 of 136 children (12%), aged 2-16 years, who were hospitalized with severe acute asthma from November 2005 to May 2007 in the St. Vincent de Paul-Cochin Hospital in Paris. All the children had been hospitalized with acute asthma after evaluation in the emergency department.

The infected children had a mean age of 3.2 years; two children were older than 5 years, which suggests that the respiratory tract infection is not limited to young infants.

The bocavirus was associated with Mycoplasma pneumoniae in two cases, respiratory syncytial virus (RSV) in one case, and human metapneumovirus in one case.

In all, there were 16 cases of M. pneumoniae (12%), 12 cases of RSV (9%), 4 cases of influenza A (3%), 1 case of influenza B, and 1 case of parainfluenza III. Three of 90 children (3%) tested positive for human metapneumovirus, the investigators reported at the meeting, which was sponsored by the American Society for Microbiology.

As was observed in other studies, Dr. Gendrel said in an interview that there was a seasonal variation to the virus, with more cases identified in winter and spring. Dr. Gendrel is with the Pediatric Department, Paris 5 University and Medical School, Hospital St. Vincent de Paul-Cochin, Paris, according to the poster.

CHICAGO — A simple severity-assessment tool for community-acquired pneumonia accurately identified patients needing intensive respiratory or inotropic support in a multicenter validation study.

SMART-COP was developed as part of the Australian Community-Acquired Pneumonia (CAP) study and measures eight features readily available at the time of initial assessment: low systolic blood pressure (less than 90 mm Hg), multilobar chest x-ray involvement, low albumin level (less than 3.5 g/dL), high respiratory rate (age-adjusted cutoffs), tachycardia (at least 125 beats per minute), confusion (new onset), poor oxygenation (age-adjusted cutoffs), and low arterial pH (less than 7.35).

A modified version for primary care physicians, called SMRT-CO, does not require the results of investigations such as serum albumin, arterial pH, and arterial oxygen tension.

For SMART-COP and SMRT-CO, the cutoff scores for increased risk of needing intensive respiratory or inotropic support (IRIS) are at least three points and at least two points, respectively, Dr. Patrick G.P. Charles of the department of infectious diseases, Austin Health, Heidelberg, Australia, and his associates reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers calculated the area under the receiver operating characteristic (ROC) curve and the Hosemer-Lemeshow goodness-of-fit statistic to determine the ability of SMART-COP to predict the need for IRIS in 7,464 patients from five CAP databases, including 474 patients who needed IRIS. The patients' mean age was 65 years (range 18–100 years).

Sensitivity and specificity for SMART-COP in each of the five databases were 80% and 61%, 58% and 75.5%, 69% and 73%, 86% and 73%, and 89% and 46%, respectively. For SMRT-CO, the results were 86% and 51%, 71% and 59%, 81% and 58%, 85% and 55%, and 95% and 36%, respectively.

This high accuracy was found even though it wasn't possible in most cases to assess the lower cutoff values for respiratory rate and oxygenation in patients aged 50 years or younger, as proposed in the SMART-COP model, the researchers said at the meeting sponsored by the American Society for Microbiology.

These data weren't available because some databases didn't record actual values, but simply noted whether, for example, the respiratory rate was 30 breaths or more per minute. In the SMART-COP model, the cutoff is at least 25 breaths per minute for patients aged 50 years or less, and at least 30 breaths per minute for those older than 50 years.

Without the actual value for each test, the missing data were assumed to be normal, and no points could be assigned, Dr. Charles explained in an interview. He said it is difficult to know exactly how many data points were missing, but noted that albumin level was not recorded in about 4,500 patients and arterial blood gases were not recorded in about 4,500 patients.

“Based on this, it is likely that the SMART-COP scores given to many patients were inappropriately low, making the sensitivity figures look lower than they probably should be if complete data were available,” he said. “A prospective study is planned, which should answer this.”

CHICAGO — A simple severity-assessment tool for community-acquired pneumonia accurately identified patients needing intensive respiratory or inotropic support in a multicenter validation study.

SMART-COP was developed as part of the Australian Community-Acquired Pneumonia (CAP) study and measures eight features readily available at the time of initial assessment: low systolic blood pressure (less than 90 mm Hg), multilobar chest x-ray involvement, low albumin level (less than 3.5 g/dL), high respiratory rate (age-adjusted cutoffs), tachycardia (at least 125 beats per minute), confusion (new onset), poor oxygenation (age-adjusted cutoffs), and low arterial pH (less than 7.35).

A modified version for primary care physicians, called SMRT-CO, does not require the results of investigations such as serum albumin, arterial pH, and arterial oxygen tension.

For SMART-COP and SMRT-CO, the cutoff scores for increased risk of needing intensive respiratory or inotropic support (IRIS) are at least three points and at least two points, respectively, Dr. Patrick G.P. Charles of the department of infectious diseases, Austin Health, Heidelberg, Australia, and his associates reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers calculated the area under the receiver operating characteristic (ROC) curve and the Hosemer-Lemeshow goodness-of-fit statistic to determine the ability of SMART-COP to predict the need for IRIS in 7,464 patients from five CAP databases, including 474 patients who needed IRIS. The patients' mean age was 65 years (range 18–100 years).

Sensitivity and specificity for SMART-COP in each of the five databases were 80% and 61%, 58% and 75.5%, 69% and 73%, 86% and 73%, and 89% and 46%, respectively. For SMRT-CO, the results were 86% and 51%, 71% and 59%, 81% and 58%, 85% and 55%, and 95% and 36%, respectively.

This high accuracy was found even though it wasn't possible in most cases to assess the lower cutoff values for respiratory rate and oxygenation in patients aged 50 years or younger, as proposed in the SMART-COP model, the researchers said at the meeting sponsored by the American Society for Microbiology.

These data weren't available because some databases didn't record actual values, but simply noted whether, for example, the respiratory rate was 30 breaths or more per minute. In the SMART-COP model, the cutoff is at least 25 breaths per minute for patients aged 50 years or less, and at least 30 breaths per minute for those older than 50 years.

Without the actual value for each test, the missing data were assumed to be normal, and no points could be assigned, Dr. Charles explained in an interview. He said it is difficult to know exactly how many data points were missing, but noted that albumin level was not recorded in about 4,500 patients and arterial blood gases were not recorded in about 4,500 patients.

“Based on this, it is likely that the SMART-COP scores given to many patients were inappropriately low, making the sensitivity figures look lower than they probably should be if complete data were available,” he said. “A prospective study is planned, which should answer this.”

CHICAGO — A simple severity-assessment tool for community-acquired pneumonia accurately identified patients needing intensive respiratory or inotropic support in a multicenter validation study.

SMART-COP was developed as part of the Australian Community-Acquired Pneumonia (CAP) study and measures eight features readily available at the time of initial assessment: low systolic blood pressure (less than 90 mm Hg), multilobar chest x-ray involvement, low albumin level (less than 3.5 g/dL), high respiratory rate (age-adjusted cutoffs), tachycardia (at least 125 beats per minute), confusion (new onset), poor oxygenation (age-adjusted cutoffs), and low arterial pH (less than 7.35).

A modified version for primary care physicians, called SMRT-CO, does not require the results of investigations such as serum albumin, arterial pH, and arterial oxygen tension.

For SMART-COP and SMRT-CO, the cutoff scores for increased risk of needing intensive respiratory or inotropic support (IRIS) are at least three points and at least two points, respectively, Dr. Patrick G.P. Charles of the department of infectious diseases, Austin Health, Heidelberg, Australia, and his associates reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers calculated the area under the receiver operating characteristic (ROC) curve and the Hosemer-Lemeshow goodness-of-fit statistic to determine the ability of SMART-COP to predict the need for IRIS in 7,464 patients from five CAP databases, including 474 patients who needed IRIS. The patients' mean age was 65 years (range 18–100 years).

Sensitivity and specificity for SMART-COP in each of the five databases were 80% and 61%, 58% and 75.5%, 69% and 73%, 86% and 73%, and 89% and 46%, respectively. For SMRT-CO, the results were 86% and 51%, 71% and 59%, 81% and 58%, 85% and 55%, and 95% and 36%, respectively.

This high accuracy was found even though it wasn't possible in most cases to assess the lower cutoff values for respiratory rate and oxygenation in patients aged 50 years or younger, as proposed in the SMART-COP model, the researchers said at the meeting sponsored by the American Society for Microbiology.

These data weren't available because some databases didn't record actual values, but simply noted whether, for example, the respiratory rate was 30 breaths or more per minute. In the SMART-COP model, the cutoff is at least 25 breaths per minute for patients aged 50 years or less, and at least 30 breaths per minute for those older than 50 years.

Without the actual value for each test, the missing data were assumed to be normal, and no points could be assigned, Dr. Charles explained in an interview. He said it is difficult to know exactly how many data points were missing, but noted that albumin level was not recorded in about 4,500 patients and arterial blood gases were not recorded in about 4,500 patients.

“Based on this, it is likely that the SMART-COP scores given to many patients were inappropriately low, making the sensitivity figures look lower than they probably should be if complete data were available,” he said. “A prospective study is planned, which should answer this.”

CHICAGO – Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.

Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.

The older smokers were significantly more likely than were the younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).

Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported that they were smoking more than two packs per day (15% vs. 11%).

Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.

“If you're talking to an older person, you're not going to talk about weight gain and going out drinking in the clubs, you're going to go right into how this is impacting that person's health in particular,” Ms. Reichert said in an interview. “With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it.”

The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.

Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.

At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO – Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.

Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.

The older smokers were significantly more likely than were the younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).

Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported that they were smoking more than two packs per day (15% vs. 11%).

Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.

“If you're talking to an older person, you're not going to talk about weight gain and going out drinking in the clubs, you're going to go right into how this is impacting that person's health in particular,” Ms. Reichert said in an interview. “With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it.”

The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.

Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.

At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO – Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.

Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.

The older smokers were significantly more likely than were the younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).

Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported that they were smoking more than two packs per day (15% vs. 11%).

Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.

“If you're talking to an older person, you're not going to talk about weight gain and going out drinking in the clubs, you're going to go right into how this is impacting that person's health in particular,” Ms. Reichert said in an interview. “With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it.”

The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.

Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.

At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Monitoring platelet response using a novel measuring tool allowed for tailored clopidogrel dosing and was associated with reduced major adverse cardiovascular events after percutaneous coronary intervention in a small, prospective study of 162 patients.

After 30 days of follow-up, none of the 78 patients whose therapy was adjusted using the vasodilator-stimulated phosphoprotein (VASP) index assay experienced a major adverse cardiovascular event (MACE), compared with 8 (10%) of the 84 patients in the standard-dosing group, lead investigator Dr. Laurent Bonello reported in a late-breaking clinical trial session at the Innovation and Intervention (i2) Summit. The between-group difference in MACE, defined as cardiovascular death, acute or subacute stent thrombosis, or revascularization, was significant.

Overall rates of MACE were driven by acute and subacute thrombosis, which was reported in 4 (5%) of the controls.

Thrombolysis in myocardial infarction (TIMI) major bleeding was reported in one patient in each group, and TIMI minor bleeding occurred in three patients in the control group and two in the VASP-guided group.

The VASP index is an assay that measures the degree of phosphorylation of the vasodilator phosphoprotein, which is directly dependent on the P2Y12 and adenosine diphosphate (ADP) receptors. These receptors are targets for clopidogrel, making the assay highly specific to the response of clopidogrel, said Dr. Bonello, of the Hôpital Universitaire Nord, Marseilles, France.

The ability to tailor the loading dose of clopidogrel is valuable because there is a large interindividual variability in response to clopidogrel. Moreover, several studies have established a link between low response to clopidogrel and ischemic events, including stent thrombosis, he said at the meeting, cosponsored by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.

All patients in the study were undergoing elective PCI for unstable angina or non-ST-elevation acute coronary syndrome, and were defined as low responders to clopidogrel, based on a platelet reactivity of 50% or more using the VASP index after a standard loading dose of 600 mg clopidogrel and 250 mg aspirin.

Patients in the control group underwent PCI after the standard clopidogrel dose, whereas patients in the VASP tailored-therapy group could receive three additional 600 mg doses, up to a maximum of 2,400 mg, every 24 hours until platelet activity dropped below 50% before undergoing PCI.

The dose adjustment was effective in 67 (86%) patients. Despite having received 2,400 mg of clopidogrel, 11 (14%) patients remained low responders, he said. The average clopidogrel dose was 1,620 mg in the VASP tailored-therapy group.

Baseline characteristics were similar between the VASP and control groups. In both groups, the mean age was 66 years and the mean body mass index was mean 27 kg/m

The 50% cutoff value used in the study was based on previous work by the same group in which the negative predictive value of the VASP index to predict MACE after PCI was 100% using a cutoff value of 50% of platelet reactivity (J. Thromb. Haemost. 2007;5:1630–6).

The assay is commercially available, but its use is currently restricted to the research setting.

Dr. Bonello did not disclose any conflict of interest. The study was supported by a grant from the French Federation of Cardiology.

CHICAGO — Monitoring platelet response using a novel measuring tool allowed for tailored clopidogrel dosing and was associated with reduced major adverse cardiovascular events after percutaneous coronary intervention in a small, prospective study of 162 patients.

After 30 days of follow-up, none of the 78 patients whose therapy was adjusted using the vasodilator-stimulated phosphoprotein (VASP) index assay experienced a major adverse cardiovascular event (MACE), compared with 8 (10%) of the 84 patients in the standard-dosing group, lead investigator Dr. Laurent Bonello reported in a late-breaking clinical trial session at the Innovation and Intervention (i2) Summit. The between-group difference in MACE, defined as cardiovascular death, acute or subacute stent thrombosis, or revascularization, was significant.

Overall rates of MACE were driven by acute and subacute thrombosis, which was reported in 4 (5%) of the controls.

Thrombolysis in myocardial infarction (TIMI) major bleeding was reported in one patient in each group, and TIMI minor bleeding occurred in three patients in the control group and two in the VASP-guided group.

The VASP index is an assay that measures the degree of phosphorylation of the vasodilator phosphoprotein, which is directly dependent on the P2Y12 and adenosine diphosphate (ADP) receptors. These receptors are targets for clopidogrel, making the assay highly specific to the response of clopidogrel, said Dr. Bonello, of the Hôpital Universitaire Nord, Marseilles, France.

The ability to tailor the loading dose of clopidogrel is valuable because there is a large interindividual variability in response to clopidogrel. Moreover, several studies have established a link between low response to clopidogrel and ischemic events, including stent thrombosis, he said at the meeting, cosponsored by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.

All patients in the study were undergoing elective PCI for unstable angina or non-ST-elevation acute coronary syndrome, and were defined as low responders to clopidogrel, based on a platelet reactivity of 50% or more using the VASP index after a standard loading dose of 600 mg clopidogrel and 250 mg aspirin.

Patients in the control group underwent PCI after the standard clopidogrel dose, whereas patients in the VASP tailored-therapy group could receive three additional 600 mg doses, up to a maximum of 2,400 mg, every 24 hours until platelet activity dropped below 50% before undergoing PCI.

The dose adjustment was effective in 67 (86%) patients. Despite having received 2,400 mg of clopidogrel, 11 (14%) patients remained low responders, he said. The average clopidogrel dose was 1,620 mg in the VASP tailored-therapy group.

Baseline characteristics were similar between the VASP and control groups. In both groups, the mean age was 66 years and the mean body mass index was mean 27 kg/m

The 50% cutoff value used in the study was based on previous work by the same group in which the negative predictive value of the VASP index to predict MACE after PCI was 100% using a cutoff value of 50% of platelet reactivity (J. Thromb. Haemost. 2007;5:1630–6).

The assay is commercially available, but its use is currently restricted to the research setting.

Dr. Bonello did not disclose any conflict of interest. The study was supported by a grant from the French Federation of Cardiology.

CHICAGO — Monitoring platelet response using a novel measuring tool allowed for tailored clopidogrel dosing and was associated with reduced major adverse cardiovascular events after percutaneous coronary intervention in a small, prospective study of 162 patients.

After 30 days of follow-up, none of the 78 patients whose therapy was adjusted using the vasodilator-stimulated phosphoprotein (VASP) index assay experienced a major adverse cardiovascular event (MACE), compared with 8 (10%) of the 84 patients in the standard-dosing group, lead investigator Dr. Laurent Bonello reported in a late-breaking clinical trial session at the Innovation and Intervention (i2) Summit. The between-group difference in MACE, defined as cardiovascular death, acute or subacute stent thrombosis, or revascularization, was significant.

Overall rates of MACE were driven by acute and subacute thrombosis, which was reported in 4 (5%) of the controls.

Thrombolysis in myocardial infarction (TIMI) major bleeding was reported in one patient in each group, and TIMI minor bleeding occurred in three patients in the control group and two in the VASP-guided group.

The VASP index is an assay that measures the degree of phosphorylation of the vasodilator phosphoprotein, which is directly dependent on the P2Y12 and adenosine diphosphate (ADP) receptors. These receptors are targets for clopidogrel, making the assay highly specific to the response of clopidogrel, said Dr. Bonello, of the Hôpital Universitaire Nord, Marseilles, France.

The ability to tailor the loading dose of clopidogrel is valuable because there is a large interindividual variability in response to clopidogrel. Moreover, several studies have established a link between low response to clopidogrel and ischemic events, including stent thrombosis, he said at the meeting, cosponsored by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.

All patients in the study were undergoing elective PCI for unstable angina or non-ST-elevation acute coronary syndrome, and were defined as low responders to clopidogrel, based on a platelet reactivity of 50% or more using the VASP index after a standard loading dose of 600 mg clopidogrel and 250 mg aspirin.

Patients in the control group underwent PCI after the standard clopidogrel dose, whereas patients in the VASP tailored-therapy group could receive three additional 600 mg doses, up to a maximum of 2,400 mg, every 24 hours until platelet activity dropped below 50% before undergoing PCI.

The dose adjustment was effective in 67 (86%) patients. Despite having received 2,400 mg of clopidogrel, 11 (14%) patients remained low responders, he said. The average clopidogrel dose was 1,620 mg in the VASP tailored-therapy group.

Baseline characteristics were similar between the VASP and control groups. In both groups, the mean age was 66 years and the mean body mass index was mean 27 kg/m

The 50% cutoff value used in the study was based on previous work by the same group in which the negative predictive value of the VASP index to predict MACE after PCI was 100% using a cutoff value of 50% of platelet reactivity (J. Thromb. Haemost. 2007;5:1630–6).

The assay is commercially available, but its use is currently restricted to the research setting.

Dr. Bonello did not disclose any conflict of interest. The study was supported by a grant from the French Federation of Cardiology.