Sherry Boschert

Patients who don’t like the vertical lines that form above the lips when they pucker up may benefit from botulinum toxin injections.

"Many patients look at themselves in the morning and they’re not concerned about lip volume, but they’re concerned about these radiating lines that go around their mouth. We call this the ‘bar code,’ " Dr. Joel L. Cohen said.

These patients may complain of radiating lines when the mouth is animated, of lipstick bleeding out from the lips, or of a hollowed look around the mouth. The injection of botulinum toxin into the orbicularis oris muscles can "soften" the columns that appear when the mouth moves, he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery in Las Vegas.

He and his associates compared two doses of onabotulinumtoxinA (Botox) to treat the bar code in a recent study of 60 patients. To make the comparison, the investigators first developed three photographic scales for classifying aesthetic features of the perioral area; they presented the scales in a poster at the 2011 meeting of the American Society for Dermatologic Surgery. The scale used in this study assigns a severity grade of none, mild, moderate, or severe vertical lip-line attributes when the lips are at maximum contraction.

All patients had moderate or severe vertical perioral lines at maximum lip contraction before being randomized to receive either 7.5 U or 12 U of Botox in a blinded fashion. Results were assessed for 53 patients at 4 weeks and for 51 patients at 12 weeks. In the 7.5-U group, moderate or severe perioral lines were seen in 15 of 28 patients who had 4 weeks of follow-up (54%) and in 21 of 25 patients who had 12 weeks of follow-up (84%). In the 12-U group, 9 of 25 patients with 4 weeks of follow-up had moderate to severe perioral lines (36%), as did 11 of 26 patients with 12 weeks of follow-up (42%).

Results in either group tended to dissipate by 12-16 weeks of follow-up. As expected, the rate and duration of adverse events were higher in the group that got 12 U of Botox.

"It really convinced us that low-dose botulinum toxin – in this case, it was Botox at 7.5 U – can have a durable response for about 12-16 weeks," said Dr. Cohen, who practices dermatology and dermatologic surgery in Englewood and Lone Tree, Colo.

The safety assessment included 59 patients who had at least one follow-up visit or reported an adverse event. Treatment-related adverse events were seen in 13 of 30 patients in the 7.5-U group (43%) and 18 of 29 patients in the 12-U group (62%). The treatment-related adverse events tended to resolve faster in the 7.5-U group, he said. Five patients in the 12-U group who had mild or moderate adverse events required follow-up, compared with no patients in the 7.5-U group.

In regular daily clinical practice, Dr. Cohen tends to use a total of 6-10 U around the mouth, treating both the upper- and lower-lip regions because patients say they feel "a little bit funny" if only the upper lip area is treated. He injects using BD Medical’s 31-gauge, short-hub needle, inserting it about a third of the way into the skin to stay superficial, he said.

In addition to affecting perioral lines, the injections produce what appears to be a pseudoaugmentation of the upper lip in some patients, although he is unable to predict which patients will have that reaction. "I don’t think we have a great understanding of that," he said.

When they get informed consent for Botox injections to treat vertical lip lines, dermatologists should warn patients that the treatment may affect their ability to whistle, drink from a straw, purse their lips, or enunciate the letters "P" and "B," he said. Dr. Cohen avoids this treatment in patients for whom these effects may be important, such as singers, woodwind instrument players, broadcast journalists, and scuba divers.

Some dermatologists have shied away from using onabotulinumtoxinA in the lower face after having had unsatisfactory experiences in some cases. "Understanding the anatomy is absolutely critical to success," Dr. Cohen said. "I hope that with this type of precise [anatomical] knowledge, people will give lower-face [onabotulinumtoxinA] another try."

The use of onabotulinumtoxinA in the lower face, in combination with fillers or with laser- or light-based treatments, "may be very, very helpful," he added. Botox alone would not be the primary treatment, for example, in a patient who has significant vertical lines above the upper lip when the mouth is at rest.

A small trial by South American investigators evaluated 12 women and suggested that injecting the orbicularis oris muscle with onabotulinumtoxinA 1 week before treating upper-lip vertical rhytides with trichloroacetic acid and dermasanding improved results (Dermatol. Surg. 2007;33:1066-72).

Dr. Cohen has been a consultant or researcher for Allergan, Medicis, Johnson & Johnson/Mentor, and Merz.

Patients who don’t like the vertical lines that form above the lips when they pucker up may benefit from botulinum toxin injections.

"Many patients look at themselves in the morning and they’re not concerned about lip volume, but they’re concerned about these radiating lines that go around their mouth. We call this the ‘bar code,’ " Dr. Joel L. Cohen said.

These patients may complain of radiating lines when the mouth is animated, of lipstick bleeding out from the lips, or of a hollowed look around the mouth. The injection of botulinum toxin into the orbicularis oris muscles can "soften" the columns that appear when the mouth moves, he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery in Las Vegas.

He and his associates compared two doses of onabotulinumtoxinA (Botox) to treat the bar code in a recent study of 60 patients. To make the comparison, the investigators first developed three photographic scales for classifying aesthetic features of the perioral area; they presented the scales in a poster at the 2011 meeting of the American Society for Dermatologic Surgery. The scale used in this study assigns a severity grade of none, mild, moderate, or severe vertical lip-line attributes when the lips are at maximum contraction.

All patients had moderate or severe vertical perioral lines at maximum lip contraction before being randomized to receive either 7.5 U or 12 U of Botox in a blinded fashion. Results were assessed for 53 patients at 4 weeks and for 51 patients at 12 weeks. In the 7.5-U group, moderate or severe perioral lines were seen in 15 of 28 patients who had 4 weeks of follow-up (54%) and in 21 of 25 patients who had 12 weeks of follow-up (84%). In the 12-U group, 9 of 25 patients with 4 weeks of follow-up had moderate to severe perioral lines (36%), as did 11 of 26 patients with 12 weeks of follow-up (42%).

Results in either group tended to dissipate by 12-16 weeks of follow-up. As expected, the rate and duration of adverse events were higher in the group that got 12 U of Botox.

"It really convinced us that low-dose botulinum toxin – in this case, it was Botox at 7.5 U – can have a durable response for about 12-16 weeks," said Dr. Cohen, who practices dermatology and dermatologic surgery in Englewood and Lone Tree, Colo.

The safety assessment included 59 patients who had at least one follow-up visit or reported an adverse event. Treatment-related adverse events were seen in 13 of 30 patients in the 7.5-U group (43%) and 18 of 29 patients in the 12-U group (62%). The treatment-related adverse events tended to resolve faster in the 7.5-U group, he said. Five patients in the 12-U group who had mild or moderate adverse events required follow-up, compared with no patients in the 7.5-U group.

In regular daily clinical practice, Dr. Cohen tends to use a total of 6-10 U around the mouth, treating both the upper- and lower-lip regions because patients say they feel "a little bit funny" if only the upper lip area is treated. He injects using BD Medical’s 31-gauge, short-hub needle, inserting it about a third of the way into the skin to stay superficial, he said.

In addition to affecting perioral lines, the injections produce what appears to be a pseudoaugmentation of the upper lip in some patients, although he is unable to predict which patients will have that reaction. "I don’t think we have a great understanding of that," he said.

When they get informed consent for Botox injections to treat vertical lip lines, dermatologists should warn patients that the treatment may affect their ability to whistle, drink from a straw, purse their lips, or enunciate the letters "P" and "B," he said. Dr. Cohen avoids this treatment in patients for whom these effects may be important, such as singers, woodwind instrument players, broadcast journalists, and scuba divers.

Some dermatologists have shied away from using onabotulinumtoxinA in the lower face after having had unsatisfactory experiences in some cases. "Understanding the anatomy is absolutely critical to success," Dr. Cohen said. "I hope that with this type of precise [anatomical] knowledge, people will give lower-face [onabotulinumtoxinA] another try."

The use of onabotulinumtoxinA in the lower face, in combination with fillers or with laser- or light-based treatments, "may be very, very helpful," he added. Botox alone would not be the primary treatment, for example, in a patient who has significant vertical lines above the upper lip when the mouth is at rest.

A small trial by South American investigators evaluated 12 women and suggested that injecting the orbicularis oris muscle with onabotulinumtoxinA 1 week before treating upper-lip vertical rhytides with trichloroacetic acid and dermasanding improved results (Dermatol. Surg. 2007;33:1066-72).

Dr. Cohen has been a consultant or researcher for Allergan, Medicis, Johnson & Johnson/Mentor, and Merz.

Patients who don’t like the vertical lines that form above the lips when they pucker up may benefit from botulinum toxin injections.

"Many patients look at themselves in the morning and they’re not concerned about lip volume, but they’re concerned about these radiating lines that go around their mouth. We call this the ‘bar code,’ " Dr. Joel L. Cohen said.

These patients may complain of radiating lines when the mouth is animated, of lipstick bleeding out from the lips, or of a hollowed look around the mouth. The injection of botulinum toxin into the orbicularis oris muscles can "soften" the columns that appear when the mouth moves, he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery in Las Vegas.

He and his associates compared two doses of onabotulinumtoxinA (Botox) to treat the bar code in a recent study of 60 patients. To make the comparison, the investigators first developed three photographic scales for classifying aesthetic features of the perioral area; they presented the scales in a poster at the 2011 meeting of the American Society for Dermatologic Surgery. The scale used in this study assigns a severity grade of none, mild, moderate, or severe vertical lip-line attributes when the lips are at maximum contraction.

All patients had moderate or severe vertical perioral lines at maximum lip contraction before being randomized to receive either 7.5 U or 12 U of Botox in a blinded fashion. Results were assessed for 53 patients at 4 weeks and for 51 patients at 12 weeks. In the 7.5-U group, moderate or severe perioral lines were seen in 15 of 28 patients who had 4 weeks of follow-up (54%) and in 21 of 25 patients who had 12 weeks of follow-up (84%). In the 12-U group, 9 of 25 patients with 4 weeks of follow-up had moderate to severe perioral lines (36%), as did 11 of 26 patients with 12 weeks of follow-up (42%).

Results in either group tended to dissipate by 12-16 weeks of follow-up. As expected, the rate and duration of adverse events were higher in the group that got 12 U of Botox.

"It really convinced us that low-dose botulinum toxin – in this case, it was Botox at 7.5 U – can have a durable response for about 12-16 weeks," said Dr. Cohen, who practices dermatology and dermatologic surgery in Englewood and Lone Tree, Colo.

The safety assessment included 59 patients who had at least one follow-up visit or reported an adverse event. Treatment-related adverse events were seen in 13 of 30 patients in the 7.5-U group (43%) and 18 of 29 patients in the 12-U group (62%). The treatment-related adverse events tended to resolve faster in the 7.5-U group, he said. Five patients in the 12-U group who had mild or moderate adverse events required follow-up, compared with no patients in the 7.5-U group.

In regular daily clinical practice, Dr. Cohen tends to use a total of 6-10 U around the mouth, treating both the upper- and lower-lip regions because patients say they feel "a little bit funny" if only the upper lip area is treated. He injects using BD Medical’s 31-gauge, short-hub needle, inserting it about a third of the way into the skin to stay superficial, he said.

In addition to affecting perioral lines, the injections produce what appears to be a pseudoaugmentation of the upper lip in some patients, although he is unable to predict which patients will have that reaction. "I don’t think we have a great understanding of that," he said.

When they get informed consent for Botox injections to treat vertical lip lines, dermatologists should warn patients that the treatment may affect their ability to whistle, drink from a straw, purse their lips, or enunciate the letters "P" and "B," he said. Dr. Cohen avoids this treatment in patients for whom these effects may be important, such as singers, woodwind instrument players, broadcast journalists, and scuba divers.

Some dermatologists have shied away from using onabotulinumtoxinA in the lower face after having had unsatisfactory experiences in some cases. "Understanding the anatomy is absolutely critical to success," Dr. Cohen said. "I hope that with this type of precise [anatomical] knowledge, people will give lower-face [onabotulinumtoxinA] another try."

The use of onabotulinumtoxinA in the lower face, in combination with fillers or with laser- or light-based treatments, "may be very, very helpful," he added. Botox alone would not be the primary treatment, for example, in a patient who has significant vertical lines above the upper lip when the mouth is at rest.

A small trial by South American investigators evaluated 12 women and suggested that injecting the orbicularis oris muscle with onabotulinumtoxinA 1 week before treating upper-lip vertical rhytides with trichloroacetic acid and dermasanding improved results (Dermatol. Surg. 2007;33:1066-72).

Dr. Cohen has been a consultant or researcher for Allergan, Medicis, Johnson & Johnson/Mentor, and Merz.

LAS VEGAS – Manufacturers of the approved botulinum toxins may claim that their product is superior, but there is likely little difference between them for cosmetic dermatology purposes, according to Dr. Michael H. Gold.

"The reality is, they all work about the same," said Dr. Gold at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Unfortunately, there are hundreds of other botulinum toxin products available on the Internet that have not been tested or approved. "This is where it gets scary," added Dr. Gold, a dermatologist in private practice in Nashville, Tenn.

There is little difference between the three botulinum toxins approved by the Food and Drug Administration – Botox (onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Medicis/Ipsen), and Xeomin (incobotulinumtoxinA, Merz) – and a fourth that is likely to be approved, he said. Phase III clinical data for PurTox (Mentor), are being reviewed by the FDA.

"It’s going to get approved eventually, and will have the same approval as all the others," Dr. Gold predicted. He said that his office was the first in the United States to have done research on all four neurotoxins. All are approved in Europe, where they sell under different names.

There are well-known dosing differences between Botox and Dysport. Dosing charts are easily available on the Internet. "If you use both of these, you should have these charts in your office," he said.

Some company-sponsored studies claim differences in efficacy between the neurotoxins, but the industry-sponsored trials should be read skeptically, he said.

A 20-patient study, sponsored by Medicis, showed that Dysport reached full effect faster than Botox when injected into the frontalis muscle, which was already known from the pivotal clinical trials, Dr. Gold said (J. Drugs Dermatol. 2011;10:1148-57).

A separate Medicis-sponsored study of 90 patients treated for lateral orbital rhytids reported that Dysport worked better than Botox (Arch. Facial Plast. Surg. 2011;13:380-6[doi:10.1001/archfacial.2011.37]). On average, the full effect was achieved in 1-2 days with Dysport, compared with 3 days for Botox. "But again, this is a sponsored study," not an independent evaluation, he noted.

Noninferiority studies comparing Xeomin (approved by the FDA in August 2011) and Botox showed that "they work exactly the same," Dr. Gold said. Xeomin’s approval is nearly identical to the approvals of the other botulinum toxins, and its duration is equivalent – "about 3 months," he said.

Xeomin does not contain hemagglutinin and, therefore, should have a lower risk for an antigen effect than Botox and Dysport. Whether or not this is significant is unclear, because there have been no antigen effects reported from the use of Botox or Dysport, he said.

PurTox also is a pure neurotoxin, "which means no resistance," but again it’s not clear if containing hemagglutinin is a risk, he said.

Another difference between the approved toxins is that the FDA required a two-point satisfaction grading scale in the Xeomin clinical studies, compared with a one-point satisfaction grading scale in the studies of Botox and Dysport. To show an effect from Xeomin, the satisfaction rating had to change from 3 to 1 or from 2 to 0.

In comparing the products, "the numbers and how you put them together are hard," Dr. Gold said. "Both Allergan and Medicis are going to tell us how great their product is, and the poor folks from Merz are going to have to tell us the difference between a one-point and two-point satisfaction" rating change.

Data for botulinum toxins that have not been FDA approved, however, are even harder to find.

Makers of neurotoxins available in other parts of the world have their own sponsored studies claiming equivalence to Botox. In China, for example, the search engine Alibaba turns up hundreds of botulinum toxin products for sale from at least 24 suppliers, said Dr. Gold. Most of them have no data to back them up, are sold illegally, and put the buyer at risk of a jail sentence.

An Allergan researcher analyzed a product from Nanfeng, China, and found that it contained 240 times the dose of botulinum toxin available in a vial of Botox. It killed every animal on which it was tested until it was diluted in a 1:240 ratio (J. Am. Acad. Dermatol. 2009;61:149-50).

Several well-manufactured neurotoxins are available in China that have gone through extensive Chinese regulatory processes, but caution is needed even with these, Dr. Gold said. In one open-label study comparing ChinaTox with Botox for the treatment of spasms and dystonia, five patients developed rash, even though the neurotoxin is less powerful than Botox.

"You’ve got to be careful what you do," he said, and suggested that dermatologists stick with branded and approved neurotoxins.

Dr. Gold has been a consultant or researcher for Allergan, Galderma, Medicis, Mentor (Johnson & Johnson), and Merz Aesthetics.

LAS VEGAS – Manufacturers of the approved botulinum toxins may claim that their product is superior, but there is likely little difference between them for cosmetic dermatology purposes, according to Dr. Michael H. Gold.

"The reality is, they all work about the same," said Dr. Gold at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Unfortunately, there are hundreds of other botulinum toxin products available on the Internet that have not been tested or approved. "This is where it gets scary," added Dr. Gold, a dermatologist in private practice in Nashville, Tenn.

There is little difference between the three botulinum toxins approved by the Food and Drug Administration – Botox (onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Medicis/Ipsen), and Xeomin (incobotulinumtoxinA, Merz) – and a fourth that is likely to be approved, he said. Phase III clinical data for PurTox (Mentor), are being reviewed by the FDA.

"It’s going to get approved eventually, and will have the same approval as all the others," Dr. Gold predicted. He said that his office was the first in the United States to have done research on all four neurotoxins. All are approved in Europe, where they sell under different names.

There are well-known dosing differences between Botox and Dysport. Dosing charts are easily available on the Internet. "If you use both of these, you should have these charts in your office," he said.

Some company-sponsored studies claim differences in efficacy between the neurotoxins, but the industry-sponsored trials should be read skeptically, he said.

A 20-patient study, sponsored by Medicis, showed that Dysport reached full effect faster than Botox when injected into the frontalis muscle, which was already known from the pivotal clinical trials, Dr. Gold said (J. Drugs Dermatol. 2011;10:1148-57).

A separate Medicis-sponsored study of 90 patients treated for lateral orbital rhytids reported that Dysport worked better than Botox (Arch. Facial Plast. Surg. 2011;13:380-6[doi:10.1001/archfacial.2011.37]). On average, the full effect was achieved in 1-2 days with Dysport, compared with 3 days for Botox. "But again, this is a sponsored study," not an independent evaluation, he noted.

Noninferiority studies comparing Xeomin (approved by the FDA in August 2011) and Botox showed that "they work exactly the same," Dr. Gold said. Xeomin’s approval is nearly identical to the approvals of the other botulinum toxins, and its duration is equivalent – "about 3 months," he said.

Xeomin does not contain hemagglutinin and, therefore, should have a lower risk for an antigen effect than Botox and Dysport. Whether or not this is significant is unclear, because there have been no antigen effects reported from the use of Botox or Dysport, he said.

PurTox also is a pure neurotoxin, "which means no resistance," but again it’s not clear if containing hemagglutinin is a risk, he said.

Another difference between the approved toxins is that the FDA required a two-point satisfaction grading scale in the Xeomin clinical studies, compared with a one-point satisfaction grading scale in the studies of Botox and Dysport. To show an effect from Xeomin, the satisfaction rating had to change from 3 to 1 or from 2 to 0.

In comparing the products, "the numbers and how you put them together are hard," Dr. Gold said. "Both Allergan and Medicis are going to tell us how great their product is, and the poor folks from Merz are going to have to tell us the difference between a one-point and two-point satisfaction" rating change.

Data for botulinum toxins that have not been FDA approved, however, are even harder to find.

Makers of neurotoxins available in other parts of the world have their own sponsored studies claiming equivalence to Botox. In China, for example, the search engine Alibaba turns up hundreds of botulinum toxin products for sale from at least 24 suppliers, said Dr. Gold. Most of them have no data to back them up, are sold illegally, and put the buyer at risk of a jail sentence.

An Allergan researcher analyzed a product from Nanfeng, China, and found that it contained 240 times the dose of botulinum toxin available in a vial of Botox. It killed every animal on which it was tested until it was diluted in a 1:240 ratio (J. Am. Acad. Dermatol. 2009;61:149-50).

Several well-manufactured neurotoxins are available in China that have gone through extensive Chinese regulatory processes, but caution is needed even with these, Dr. Gold said. In one open-label study comparing ChinaTox with Botox for the treatment of spasms and dystonia, five patients developed rash, even though the neurotoxin is less powerful than Botox.

"You’ve got to be careful what you do," he said, and suggested that dermatologists stick with branded and approved neurotoxins.

Dr. Gold has been a consultant or researcher for Allergan, Galderma, Medicis, Mentor (Johnson & Johnson), and Merz Aesthetics.

LAS VEGAS – Manufacturers of the approved botulinum toxins may claim that their product is superior, but there is likely little difference between them for cosmetic dermatology purposes, according to Dr. Michael H. Gold.

"The reality is, they all work about the same," said Dr. Gold at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Unfortunately, there are hundreds of other botulinum toxin products available on the Internet that have not been tested or approved. "This is where it gets scary," added Dr. Gold, a dermatologist in private practice in Nashville, Tenn.

There is little difference between the three botulinum toxins approved by the Food and Drug Administration – Botox (onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Medicis/Ipsen), and Xeomin (incobotulinumtoxinA, Merz) – and a fourth that is likely to be approved, he said. Phase III clinical data for PurTox (Mentor), are being reviewed by the FDA.

"It’s going to get approved eventually, and will have the same approval as all the others," Dr. Gold predicted. He said that his office was the first in the United States to have done research on all four neurotoxins. All are approved in Europe, where they sell under different names.

There are well-known dosing differences between Botox and Dysport. Dosing charts are easily available on the Internet. "If you use both of these, you should have these charts in your office," he said.

Some company-sponsored studies claim differences in efficacy between the neurotoxins, but the industry-sponsored trials should be read skeptically, he said.

A 20-patient study, sponsored by Medicis, showed that Dysport reached full effect faster than Botox when injected into the frontalis muscle, which was already known from the pivotal clinical trials, Dr. Gold said (J. Drugs Dermatol. 2011;10:1148-57).

A separate Medicis-sponsored study of 90 patients treated for lateral orbital rhytids reported that Dysport worked better than Botox (Arch. Facial Plast. Surg. 2011;13:380-6[doi:10.1001/archfacial.2011.37]). On average, the full effect was achieved in 1-2 days with Dysport, compared with 3 days for Botox. "But again, this is a sponsored study," not an independent evaluation, he noted.

Noninferiority studies comparing Xeomin (approved by the FDA in August 2011) and Botox showed that "they work exactly the same," Dr. Gold said. Xeomin’s approval is nearly identical to the approvals of the other botulinum toxins, and its duration is equivalent – "about 3 months," he said.

Xeomin does not contain hemagglutinin and, therefore, should have a lower risk for an antigen effect than Botox and Dysport. Whether or not this is significant is unclear, because there have been no antigen effects reported from the use of Botox or Dysport, he said.

PurTox also is a pure neurotoxin, "which means no resistance," but again it’s not clear if containing hemagglutinin is a risk, he said.

Another difference between the approved toxins is that the FDA required a two-point satisfaction grading scale in the Xeomin clinical studies, compared with a one-point satisfaction grading scale in the studies of Botox and Dysport. To show an effect from Xeomin, the satisfaction rating had to change from 3 to 1 or from 2 to 0.

In comparing the products, "the numbers and how you put them together are hard," Dr. Gold said. "Both Allergan and Medicis are going to tell us how great their product is, and the poor folks from Merz are going to have to tell us the difference between a one-point and two-point satisfaction" rating change.

Data for botulinum toxins that have not been FDA approved, however, are even harder to find.

Makers of neurotoxins available in other parts of the world have their own sponsored studies claiming equivalence to Botox. In China, for example, the search engine Alibaba turns up hundreds of botulinum toxin products for sale from at least 24 suppliers, said Dr. Gold. Most of them have no data to back them up, are sold illegally, and put the buyer at risk of a jail sentence.

An Allergan researcher analyzed a product from Nanfeng, China, and found that it contained 240 times the dose of botulinum toxin available in a vial of Botox. It killed every animal on which it was tested until it was diluted in a 1:240 ratio (J. Am. Acad. Dermatol. 2009;61:149-50).

Several well-manufactured neurotoxins are available in China that have gone through extensive Chinese regulatory processes, but caution is needed even with these, Dr. Gold said. In one open-label study comparing ChinaTox with Botox for the treatment of spasms and dystonia, five patients developed rash, even though the neurotoxin is less powerful than Botox.

"You’ve got to be careful what you do," he said, and suggested that dermatologists stick with branded and approved neurotoxins.

Dr. Gold has been a consultant or researcher for Allergan, Galderma, Medicis, Mentor (Johnson & Johnson), and Merz Aesthetics.

SAN FRANCISCO – Societal trends will trump health reform in changing the health care system, and surgeons need to do their part to decrease costs, leaders in the American College of Surgeons said at their annual clinical congress.

"Change is happening in spite of, alongside, and with the Affordable Care Act [ACA]," said Thomas Ricketts, Ph.D., codirector of the American College of Surgeons Health Policy Research Institute. Change is being driven as much as or more by the economy along with institutional and professional decisions, he said.

Those forces are shifting the health care system from one that is dominated by independent physicians and surgeons to one in which physicians will be employees. Health insurers are linking up with clinician groups. Instead of community-based hospitals responsive to local needs, institutions are aggregating in large, geographically spread "empires" that are learning how to manage themselves, said Dr. Ricketts, professor of health policy and management at the University of North Carolina at Chapel Hill.

The pace of mergers accelerated after passage of the ACA in March 2010. In the first two quarters of 2011 there were 139 mergers or acquisitions involving hospitals, compared with 37-82 in each of the years from 2001 to 2010, he said.

The ACA will make health coverage accessible to an estimated 32 million currently uninsured Americans. Seven in 10 hospitals and health systems in the United States plan to hire more physicians in the next 1-3 years, but it’s unclear whether there will be enough physicians. "It’s a huge problem," Dr. Ricketts said.

Physicians and patients should brace themselves for what he called "simple complexity" in the evolving health system, which will define the individual roles of providers with specificity, yet add complexity as system structures evolve.

Major provisions of the ACA will roll out over time, but many of the provisions of particular concern to surgeons kick in by 2014, Dr. Don E. Detmer said in a separate presentation during the same session. Enactment began with 13 components in 2010 involving payment reform, workforce and quality-of-care improvements, access to care, and new insurance rules. Eight major provisions in 2011 affected physician quality reporting, new approaches to payment and delivery of care, and more, said Dr. Detmer, medical director of the ACS Division of Advocacy and Health Policy.

In 2012, four provisions kick in that involve reduced payments for preventable hospital readmissions, launch of Accountable Care Organizations, higher Medicare payments to hospitals with high-quality and outcomes data, and required reporting of data on health disparities.

Five major provisions starting in 2013 include bundled payments for episodes of postacute care, limits on flexible spending accounts, increased payroll taxes for Medicare, expansion of preventive services in Medicaid, and electronic simplification of some administrative functions.

The top four of nine provisions that start in 2014 include creation of an essential benefits package for insurers to offer, the start of insurance exchanges through employers or states to offer insurance to people who have no coverage, a requirement for uninsured individuals to buy coverage or pay a penalty, and creation of an independent payment advisory board to identify potentially wasteful spending in Medicare.

As enacted, the ACA is unlikely to produce sufficient reforms to significantly alter the curve of ever-increasing costs through overall system performance, "but the ACA plus physician payment reforms just might," predicted Dr. Detmer, professor emeritus at the University of Virginia, Charlottesville.

Another player besides the ACA could have had a drastic effect – the Congressional Joint Select Committee on Deficit Reduction (also called the Super Committee) was charged with decreasing federal budget deficits by $1.2 trillion between 2012 and 2021. They failed to agree on a plan, so, that will likely trigger massive, widespread cuts in federal spending starting in January 2013.

Policy-driven changes in health care make many physicians nervous, but any resulting changes are "probably not as scary as what we’ve got now," Dr. Detmer said.

A separate federal commission on government spending, known as the Debt Commission, has recommended a number of reductions in health care spending, including cutting $54 billion from graduate and indirect medical education between 2012 and 2020, Dr. George F. Sheldon said in a separate presentation during the session. Fifteen new U.S. medical schools currently are planned with no federal support, which may help supply the physicians and surgeons needed to meet growing demand for care, but the schools alone will not be sufficient, said Dr. Sheldon, codirector of the ACS Health Policy Research Institute.

Of the 26,769 active general surgeons in the United States, 42% are aged 55 years or older, 2008 data show. The number of active general surgeons decreased by 2% between 1996 and 2006, especially in rural areas, other studies report.

The regionalization of health systems offers an opportunity for different models of surgical care, he suggested. Surgeons and high-technology equipment may locate more in regional centers than individual practices.

Government programs could do more to increase the supply of surgeons, added Dr. Sheldon, professor of surgery at the University of North Carolina at Chapel Hill. The National Health Service Corps doesn’t include surgeons, "but it would be great if they did," he said.

Creating new medical schools – and somehow finding the residency programs to train the extra graduates – is a good long-term plan, but it doesn’t solve immediate workforce shortages, said Dr. Andrew L. Warshaw, chair of the ACS Health Policy Advisory Group. "If we have shortages now, it will be worse" as the ACA is implemented, he said in a presentation during the session. He noted that such shortages occurred in Massachusetts after the state adopted universal health care coverage.

Greater use of mid-level providers may help extend physicians’ reach, and regionalization models can either put more physicians where they’re needed or bring patients to physicians’ locations, he suggested.

But physicians need to tackle costs of health care, added Dr. Warshaw, of Harvard Medical School, Boston. If any solutions include a fix of the Sustainable Growth Rate (SGR) formula as requested by physicians, $1.6 trillion instead of $1.2 trillion would have to be cut from the federal deficit – cuts that could come from other parts of health care.

"What can surgeons do?" Dr. Warshaw said. "Every person in this room needs to do something, somewhere, somehow within your own practice to figure out what’s the right kind of care to give your patients. There’s good evidence that that can go a long way toward paying down the SGR."

If postoperative complications cost an average of $10,000, preventing just one postoperative complication per day at every U.S. hospital would reduce costs by $125-$250 billion over 10 years, he estimated.

Surgeons also need to figure out optimal care for patients and demand that other specialties do the same. One study at Massachusetts General Hospital found that physicians ordered between 1 and 30 CAT scans for patients seen in the emergency department for head trauma. Such a wide range in practices is "wrong," he said. "It’s our job to figure this out." Medical liability reform potentially could save another $62 billion in health care costs over 10 years, he added.

"I don’t think we can count on the ACA to reduce costs. We have to do a lot more," Dr. Warshaw said. "There’s a huge amount going on, and it’s way ahead of the Affordable Care Act in many ways."

Dr. Detmer has consulted for CS Placement. Dr. Ricketts, Dr. Sheldon, and Dr. Warshaw said that they had no financial conflicts. ☐

SAN FRANCISCO – Societal trends will trump health reform in changing the health care system, and surgeons need to do their part to decrease costs, leaders in the American College of Surgeons said at their annual clinical congress.

"Change is happening in spite of, alongside, and with the Affordable Care Act [ACA]," said Thomas Ricketts, Ph.D., codirector of the American College of Surgeons Health Policy Research Institute. Change is being driven as much as or more by the economy along with institutional and professional decisions, he said.

Those forces are shifting the health care system from one that is dominated by independent physicians and surgeons to one in which physicians will be employees. Health insurers are linking up with clinician groups. Instead of community-based hospitals responsive to local needs, institutions are aggregating in large, geographically spread "empires" that are learning how to manage themselves, said Dr. Ricketts, professor of health policy and management at the University of North Carolina at Chapel Hill.

The pace of mergers accelerated after passage of the ACA in March 2010. In the first two quarters of 2011 there were 139 mergers or acquisitions involving hospitals, compared with 37-82 in each of the years from 2001 to 2010, he said.

The ACA will make health coverage accessible to an estimated 32 million currently uninsured Americans. Seven in 10 hospitals and health systems in the United States plan to hire more physicians in the next 1-3 years, but it’s unclear whether there will be enough physicians. "It’s a huge problem," Dr. Ricketts said.

Physicians and patients should brace themselves for what he called "simple complexity" in the evolving health system, which will define the individual roles of providers with specificity, yet add complexity as system structures evolve.

Major provisions of the ACA will roll out over time, but many of the provisions of particular concern to surgeons kick in by 2014, Dr. Don E. Detmer said in a separate presentation during the same session. Enactment began with 13 components in 2010 involving payment reform, workforce and quality-of-care improvements, access to care, and new insurance rules. Eight major provisions in 2011 affected physician quality reporting, new approaches to payment and delivery of care, and more, said Dr. Detmer, medical director of the ACS Division of Advocacy and Health Policy.

In 2012, four provisions kick in that involve reduced payments for preventable hospital readmissions, launch of Accountable Care Organizations, higher Medicare payments to hospitals with high-quality and outcomes data, and required reporting of data on health disparities.

Five major provisions starting in 2013 include bundled payments for episodes of postacute care, limits on flexible spending accounts, increased payroll taxes for Medicare, expansion of preventive services in Medicaid, and electronic simplification of some administrative functions.

The top four of nine provisions that start in 2014 include creation of an essential benefits package for insurers to offer, the start of insurance exchanges through employers or states to offer insurance to people who have no coverage, a requirement for uninsured individuals to buy coverage or pay a penalty, and creation of an independent payment advisory board to identify potentially wasteful spending in Medicare.

As enacted, the ACA is unlikely to produce sufficient reforms to significantly alter the curve of ever-increasing costs through overall system performance, "but the ACA plus physician payment reforms just might," predicted Dr. Detmer, professor emeritus at the University of Virginia, Charlottesville.

Another player besides the ACA could have had a drastic effect – the Congressional Joint Select Committee on Deficit Reduction (also called the Super Committee) was charged with decreasing federal budget deficits by $1.2 trillion between 2012 and 2021. They failed to agree on a plan, so, that will likely trigger massive, widespread cuts in federal spending starting in January 2013.

Policy-driven changes in health care make many physicians nervous, but any resulting changes are "probably not as scary as what we’ve got now," Dr. Detmer said.

A separate federal commission on government spending, known as the Debt Commission, has recommended a number of reductions in health care spending, including cutting $54 billion from graduate and indirect medical education between 2012 and 2020, Dr. George F. Sheldon said in a separate presentation during the session. Fifteen new U.S. medical schools currently are planned with no federal support, which may help supply the physicians and surgeons needed to meet growing demand for care, but the schools alone will not be sufficient, said Dr. Sheldon, codirector of the ACS Health Policy Research Institute.

Of the 26,769 active general surgeons in the United States, 42% are aged 55 years or older, 2008 data show. The number of active general surgeons decreased by 2% between 1996 and 2006, especially in rural areas, other studies report.

The regionalization of health systems offers an opportunity for different models of surgical care, he suggested. Surgeons and high-technology equipment may locate more in regional centers than individual practices.

Government programs could do more to increase the supply of surgeons, added Dr. Sheldon, professor of surgery at the University of North Carolina at Chapel Hill. The National Health Service Corps doesn’t include surgeons, "but it would be great if they did," he said.

Creating new medical schools – and somehow finding the residency programs to train the extra graduates – is a good long-term plan, but it doesn’t solve immediate workforce shortages, said Dr. Andrew L. Warshaw, chair of the ACS Health Policy Advisory Group. "If we have shortages now, it will be worse" as the ACA is implemented, he said in a presentation during the session. He noted that such shortages occurred in Massachusetts after the state adopted universal health care coverage.

Greater use of mid-level providers may help extend physicians’ reach, and regionalization models can either put more physicians where they’re needed or bring patients to physicians’ locations, he suggested.

But physicians need to tackle costs of health care, added Dr. Warshaw, of Harvard Medical School, Boston. If any solutions include a fix of the Sustainable Growth Rate (SGR) formula as requested by physicians, $1.6 trillion instead of $1.2 trillion would have to be cut from the federal deficit – cuts that could come from other parts of health care.

"What can surgeons do?" Dr. Warshaw said. "Every person in this room needs to do something, somewhere, somehow within your own practice to figure out what’s the right kind of care to give your patients. There’s good evidence that that can go a long way toward paying down the SGR."

If postoperative complications cost an average of $10,000, preventing just one postoperative complication per day at every U.S. hospital would reduce costs by $125-$250 billion over 10 years, he estimated.

Surgeons also need to figure out optimal care for patients and demand that other specialties do the same. One study at Massachusetts General Hospital found that physicians ordered between 1 and 30 CAT scans for patients seen in the emergency department for head trauma. Such a wide range in practices is "wrong," he said. "It’s our job to figure this out." Medical liability reform potentially could save another $62 billion in health care costs over 10 years, he added.

"I don’t think we can count on the ACA to reduce costs. We have to do a lot more," Dr. Warshaw said. "There’s a huge amount going on, and it’s way ahead of the Affordable Care Act in many ways."

Dr. Detmer has consulted for CS Placement. Dr. Ricketts, Dr. Sheldon, and Dr. Warshaw said that they had no financial conflicts. ☐

SAN FRANCISCO – Societal trends will trump health reform in changing the health care system, and surgeons need to do their part to decrease costs, leaders in the American College of Surgeons said at their annual clinical congress.

"Change is happening in spite of, alongside, and with the Affordable Care Act [ACA]," said Thomas Ricketts, Ph.D., codirector of the American College of Surgeons Health Policy Research Institute. Change is being driven as much as or more by the economy along with institutional and professional decisions, he said.

Those forces are shifting the health care system from one that is dominated by independent physicians and surgeons to one in which physicians will be employees. Health insurers are linking up with clinician groups. Instead of community-based hospitals responsive to local needs, institutions are aggregating in large, geographically spread "empires" that are learning how to manage themselves, said Dr. Ricketts, professor of health policy and management at the University of North Carolina at Chapel Hill.

The pace of mergers accelerated after passage of the ACA in March 2010. In the first two quarters of 2011 there were 139 mergers or acquisitions involving hospitals, compared with 37-82 in each of the years from 2001 to 2010, he said.

The ACA will make health coverage accessible to an estimated 32 million currently uninsured Americans. Seven in 10 hospitals and health systems in the United States plan to hire more physicians in the next 1-3 years, but it’s unclear whether there will be enough physicians. "It’s a huge problem," Dr. Ricketts said.

Physicians and patients should brace themselves for what he called "simple complexity" in the evolving health system, which will define the individual roles of providers with specificity, yet add complexity as system structures evolve.

Major provisions of the ACA will roll out over time, but many of the provisions of particular concern to surgeons kick in by 2014, Dr. Don E. Detmer said in a separate presentation during the same session. Enactment began with 13 components in 2010 involving payment reform, workforce and quality-of-care improvements, access to care, and new insurance rules. Eight major provisions in 2011 affected physician quality reporting, new approaches to payment and delivery of care, and more, said Dr. Detmer, medical director of the ACS Division of Advocacy and Health Policy.

In 2012, four provisions kick in that involve reduced payments for preventable hospital readmissions, launch of Accountable Care Organizations, higher Medicare payments to hospitals with high-quality and outcomes data, and required reporting of data on health disparities.

Five major provisions starting in 2013 include bundled payments for episodes of postacute care, limits on flexible spending accounts, increased payroll taxes for Medicare, expansion of preventive services in Medicaid, and electronic simplification of some administrative functions.

The top four of nine provisions that start in 2014 include creation of an essential benefits package for insurers to offer, the start of insurance exchanges through employers or states to offer insurance to people who have no coverage, a requirement for uninsured individuals to buy coverage or pay a penalty, and creation of an independent payment advisory board to identify potentially wasteful spending in Medicare.

As enacted, the ACA is unlikely to produce sufficient reforms to significantly alter the curve of ever-increasing costs through overall system performance, "but the ACA plus physician payment reforms just might," predicted Dr. Detmer, professor emeritus at the University of Virginia, Charlottesville.

Another player besides the ACA could have had a drastic effect – the Congressional Joint Select Committee on Deficit Reduction (also called the Super Committee) was charged with decreasing federal budget deficits by $1.2 trillion between 2012 and 2021. They failed to agree on a plan, so, that will likely trigger massive, widespread cuts in federal spending starting in January 2013.

Policy-driven changes in health care make many physicians nervous, but any resulting changes are "probably not as scary as what we’ve got now," Dr. Detmer said.

A separate federal commission on government spending, known as the Debt Commission, has recommended a number of reductions in health care spending, including cutting $54 billion from graduate and indirect medical education between 2012 and 2020, Dr. George F. Sheldon said in a separate presentation during the session. Fifteen new U.S. medical schools currently are planned with no federal support, which may help supply the physicians and surgeons needed to meet growing demand for care, but the schools alone will not be sufficient, said Dr. Sheldon, codirector of the ACS Health Policy Research Institute.

Of the 26,769 active general surgeons in the United States, 42% are aged 55 years or older, 2008 data show. The number of active general surgeons decreased by 2% between 1996 and 2006, especially in rural areas, other studies report.

The regionalization of health systems offers an opportunity for different models of surgical care, he suggested. Surgeons and high-technology equipment may locate more in regional centers than individual practices.

Government programs could do more to increase the supply of surgeons, added Dr. Sheldon, professor of surgery at the University of North Carolina at Chapel Hill. The National Health Service Corps doesn’t include surgeons, "but it would be great if they did," he said.

Creating new medical schools – and somehow finding the residency programs to train the extra graduates – is a good long-term plan, but it doesn’t solve immediate workforce shortages, said Dr. Andrew L. Warshaw, chair of the ACS Health Policy Advisory Group. "If we have shortages now, it will be worse" as the ACA is implemented, he said in a presentation during the session. He noted that such shortages occurred in Massachusetts after the state adopted universal health care coverage.

Greater use of mid-level providers may help extend physicians’ reach, and regionalization models can either put more physicians where they’re needed or bring patients to physicians’ locations, he suggested.

But physicians need to tackle costs of health care, added Dr. Warshaw, of Harvard Medical School, Boston. If any solutions include a fix of the Sustainable Growth Rate (SGR) formula as requested by physicians, $1.6 trillion instead of $1.2 trillion would have to be cut from the federal deficit – cuts that could come from other parts of health care.

"What can surgeons do?" Dr. Warshaw said. "Every person in this room needs to do something, somewhere, somehow within your own practice to figure out what’s the right kind of care to give your patients. There’s good evidence that that can go a long way toward paying down the SGR."

If postoperative complications cost an average of $10,000, preventing just one postoperative complication per day at every U.S. hospital would reduce costs by $125-$250 billion over 10 years, he estimated.

Surgeons also need to figure out optimal care for patients and demand that other specialties do the same. One study at Massachusetts General Hospital found that physicians ordered between 1 and 30 CAT scans for patients seen in the emergency department for head trauma. Such a wide range in practices is "wrong," he said. "It’s our job to figure this out." Medical liability reform potentially could save another $62 billion in health care costs over 10 years, he added.

"I don’t think we can count on the ACA to reduce costs. We have to do a lot more," Dr. Warshaw said. "There’s a huge amount going on, and it’s way ahead of the Affordable Care Act in many ways."

Dr. Detmer has consulted for CS Placement. Dr. Ricketts, Dr. Sheldon, and Dr. Warshaw said that they had no financial conflicts. ☐

LAS VEGAS – Endovenous laser therapy is replacing ligation and vein stripping for many patients with superficial venous incompetence, especially in the legs.

"The endovenous laser has been a major revolutionary advance in the treatment of medical varicose veins of the lower extremities," Dr. Neil S. Sadick said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Endovenous laser fibers are inserted in the vessel under ultrasound guidance to eradicate truncal varicosities in the short and lower saphenous veins. The laser heat transfer causes shrinkage of the vein wall collagen and decreased lumen, with the shrinkage proportional to the delivered linear endovenous energy density.

Photos courtesy Dr. Neil S. Sadick

"This is an extremely easy procedure," that takes about 15 minutes, said Dr. Sadick, a dermatologist at Weill Cornell Medical Center in New York. "It’s almost bloodless. Patients can go back to work that day" wearing light compression hose, and "there’s very little discomfort after" the procedure.

Recurrence rates with endovenous laser therapy also are lower, compared with conventional invasive surgical ligation and stripping procedures, he added. Studies by Dr. Sadick and his associates showed that recurrence rates after treatment of superficial venous incompetence with a combination of endovascular laser and ambulatory phlebectomy were approximately 6% at 1 year, 4% at 2 years, 3% at 3 years, and 4% at 4 years.

Endovenous laser therapy "induces an endothelial type of thrombosis, and then the vein gets dissolved by the body," he said.

Treatment Algorithm

Dr. Sadick developed an algorithm for treatment based on the type of leg varicosity. He uses endovenous laser therapy or endovenous radiofrequency technology to treat large varicose veins of the axial junctions, such as in the long or short saphenous veins. Most intermediate-size varicose veins, such as truncal varicosities or perforations, can be treated by either ambulatory phlebectomy or foam sclerotherapy.

For reticular veins, he prefers to treat with an external 1064-nm Nd:YAG (neodymium YAG) laser or sclerotherapy with or without foam. Microtelangiectasia, or "very, very small vessels," can be treated with microsclerotherapy via very dilute concentrations of sclerosant, "but this is where an external 1064-nm Nd:YAG laser plays an important role" and may suffice without microsclerotherapy, he said.

"Not all leg veins are treated equally," he added. Red telangiectasias measuring less than 1 mm in tiny, oxygenated, red vessels usually are superficial and are "hit hard" with short pulse durations of high-fluence external laser energy in small spot sizes of 1-2 mm.

For more bluish veins that measure 1-2 mm (which he called blue venulectasia) and for larger reticular varicosities that are 2-4 mm, spot sizes and pulse durations increase but with more moderate fluences. External laser settings for blue venulectasia would be a spot size of 2-4 mm with a medium pulse width and moderately high fluence. For reticular veins, he uses an external spot size of 4-6 mm with a long pulse width and moderate fluence.

"You can see excellent results if you use this paradigm of variable pulse moding for treating telangiectasia without even injecting patients," he said.

Lasers are indicated for the cosmetic treatment of leg veins in patients whose veins are too small to cannulize for sclerotherapy, or for the small subset of patients who do not respond to sclerotherapy. Patients with needle phobia or those who have multiple sclerosant allergies also are candidates for cosmetic laser treatment of leg veins.

Leg veins require different treatment than do facial telangiectasias, Dr. Sadick added. Hydrostatic pressure is greater in the legs. Lower extremity vessels are larger, with increased basal lamina, compared with facial telangiectasias. The deeper location of many lower-extremity vessels makes access more difficult.

Caution Is Advised

The longer wavelengths and higher fluences of external laser treatment for leg veins cause a greater inflammatory reaction. "The worst thing you can do is treat patients on a weekly or biweekly basis" with external laser, he said. "You need to wait 6-8 weeks after each laser treatment so all the inflammation can resolve before the next treatment session" in order to avoid complications.

Dr. Sadick cautioned that the external 1064-nm Nd:YAG lasers are "sort of like weapons. They need to be handled very gently and understood, particularly when you’re treating the legs." Complications can include ulceration, purpura, blisters, and hyper- or hypopigmentation. These most commonly are caused by stacking pulses in a given area (especially with longer wavelengths), treating tanned skin, improperly matching wavelength to skin type, and failing to address hydrostatic pressure.

"If you use a short wavelength laser like a pulsed dye laser for a dark-skinned individual, for sure you’re going to get hypopigmentation and potential scarring," he said. Avoid laser treatment in patients who have larger vessels feeding the spider telangiectasia, because the hydrostatic pressure increases the risk for side effects.

The clinical goals of laser therapy for leg telangiectasia are to treat vasospasm, erythema, and urticaria. "It’s important to understand the end points of therapy. You don’t need to treat these veins until the vessels go away," he said.

Dr. Sadick has consulted for or received research grants from Cutera, Cynosure, Palomar, Solta Medical, and Syneron.

LAS VEGAS – Endovenous laser therapy is replacing ligation and vein stripping for many patients with superficial venous incompetence, especially in the legs.

"The endovenous laser has been a major revolutionary advance in the treatment of medical varicose veins of the lower extremities," Dr. Neil S. Sadick said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Endovenous laser fibers are inserted in the vessel under ultrasound guidance to eradicate truncal varicosities in the short and lower saphenous veins. The laser heat transfer causes shrinkage of the vein wall collagen and decreased lumen, with the shrinkage proportional to the delivered linear endovenous energy density.

Photos courtesy Dr. Neil S. Sadick

"This is an extremely easy procedure," that takes about 15 minutes, said Dr. Sadick, a dermatologist at Weill Cornell Medical Center in New York. "It’s almost bloodless. Patients can go back to work that day" wearing light compression hose, and "there’s very little discomfort after" the procedure.

Recurrence rates with endovenous laser therapy also are lower, compared with conventional invasive surgical ligation and stripping procedures, he added. Studies by Dr. Sadick and his associates showed that recurrence rates after treatment of superficial venous incompetence with a combination of endovascular laser and ambulatory phlebectomy were approximately 6% at 1 year, 4% at 2 years, 3% at 3 years, and 4% at 4 years.

Endovenous laser therapy "induces an endothelial type of thrombosis, and then the vein gets dissolved by the body," he said.

Treatment Algorithm

Dr. Sadick developed an algorithm for treatment based on the type of leg varicosity. He uses endovenous laser therapy or endovenous radiofrequency technology to treat large varicose veins of the axial junctions, such as in the long or short saphenous veins. Most intermediate-size varicose veins, such as truncal varicosities or perforations, can be treated by either ambulatory phlebectomy or foam sclerotherapy.

For reticular veins, he prefers to treat with an external 1064-nm Nd:YAG (neodymium YAG) laser or sclerotherapy with or without foam. Microtelangiectasia, or "very, very small vessels," can be treated with microsclerotherapy via very dilute concentrations of sclerosant, "but this is where an external 1064-nm Nd:YAG laser plays an important role" and may suffice without microsclerotherapy, he said.

"Not all leg veins are treated equally," he added. Red telangiectasias measuring less than 1 mm in tiny, oxygenated, red vessels usually are superficial and are "hit hard" with short pulse durations of high-fluence external laser energy in small spot sizes of 1-2 mm.

For more bluish veins that measure 1-2 mm (which he called blue venulectasia) and for larger reticular varicosities that are 2-4 mm, spot sizes and pulse durations increase but with more moderate fluences. External laser settings for blue venulectasia would be a spot size of 2-4 mm with a medium pulse width and moderately high fluence. For reticular veins, he uses an external spot size of 4-6 mm with a long pulse width and moderate fluence.

"You can see excellent results if you use this paradigm of variable pulse moding for treating telangiectasia without even injecting patients," he said.

Lasers are indicated for the cosmetic treatment of leg veins in patients whose veins are too small to cannulize for sclerotherapy, or for the small subset of patients who do not respond to sclerotherapy. Patients with needle phobia or those who have multiple sclerosant allergies also are candidates for cosmetic laser treatment of leg veins.

Leg veins require different treatment than do facial telangiectasias, Dr. Sadick added. Hydrostatic pressure is greater in the legs. Lower extremity vessels are larger, with increased basal lamina, compared with facial telangiectasias. The deeper location of many lower-extremity vessels makes access more difficult.

Caution Is Advised

The longer wavelengths and higher fluences of external laser treatment for leg veins cause a greater inflammatory reaction. "The worst thing you can do is treat patients on a weekly or biweekly basis" with external laser, he said. "You need to wait 6-8 weeks after each laser treatment so all the inflammation can resolve before the next treatment session" in order to avoid complications.

Dr. Sadick cautioned that the external 1064-nm Nd:YAG lasers are "sort of like weapons. They need to be handled very gently and understood, particularly when you’re treating the legs." Complications can include ulceration, purpura, blisters, and hyper- or hypopigmentation. These most commonly are caused by stacking pulses in a given area (especially with longer wavelengths), treating tanned skin, improperly matching wavelength to skin type, and failing to address hydrostatic pressure.

"If you use a short wavelength laser like a pulsed dye laser for a dark-skinned individual, for sure you’re going to get hypopigmentation and potential scarring," he said. Avoid laser treatment in patients who have larger vessels feeding the spider telangiectasia, because the hydrostatic pressure increases the risk for side effects.

The clinical goals of laser therapy for leg telangiectasia are to treat vasospasm, erythema, and urticaria. "It’s important to understand the end points of therapy. You don’t need to treat these veins until the vessels go away," he said.

Dr. Sadick has consulted for or received research grants from Cutera, Cynosure, Palomar, Solta Medical, and Syneron.

LAS VEGAS – Endovenous laser therapy is replacing ligation and vein stripping for many patients with superficial venous incompetence, especially in the legs.

"The endovenous laser has been a major revolutionary advance in the treatment of medical varicose veins of the lower extremities," Dr. Neil S. Sadick said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Endovenous laser fibers are inserted in the vessel under ultrasound guidance to eradicate truncal varicosities in the short and lower saphenous veins. The laser heat transfer causes shrinkage of the vein wall collagen and decreased lumen, with the shrinkage proportional to the delivered linear endovenous energy density.

Photos courtesy Dr. Neil S. Sadick

"This is an extremely easy procedure," that takes about 15 minutes, said Dr. Sadick, a dermatologist at Weill Cornell Medical Center in New York. "It’s almost bloodless. Patients can go back to work that day" wearing light compression hose, and "there’s very little discomfort after" the procedure.

Recurrence rates with endovenous laser therapy also are lower, compared with conventional invasive surgical ligation and stripping procedures, he added. Studies by Dr. Sadick and his associates showed that recurrence rates after treatment of superficial venous incompetence with a combination of endovascular laser and ambulatory phlebectomy were approximately 6% at 1 year, 4% at 2 years, 3% at 3 years, and 4% at 4 years.

Endovenous laser therapy "induces an endothelial type of thrombosis, and then the vein gets dissolved by the body," he said.

Treatment Algorithm

Dr. Sadick developed an algorithm for treatment based on the type of leg varicosity. He uses endovenous laser therapy or endovenous radiofrequency technology to treat large varicose veins of the axial junctions, such as in the long or short saphenous veins. Most intermediate-size varicose veins, such as truncal varicosities or perforations, can be treated by either ambulatory phlebectomy or foam sclerotherapy.

For reticular veins, he prefers to treat with an external 1064-nm Nd:YAG (neodymium YAG) laser or sclerotherapy with or without foam. Microtelangiectasia, or "very, very small vessels," can be treated with microsclerotherapy via very dilute concentrations of sclerosant, "but this is where an external 1064-nm Nd:YAG laser plays an important role" and may suffice without microsclerotherapy, he said.

"Not all leg veins are treated equally," he added. Red telangiectasias measuring less than 1 mm in tiny, oxygenated, red vessels usually are superficial and are "hit hard" with short pulse durations of high-fluence external laser energy in small spot sizes of 1-2 mm.

For more bluish veins that measure 1-2 mm (which he called blue venulectasia) and for larger reticular varicosities that are 2-4 mm, spot sizes and pulse durations increase but with more moderate fluences. External laser settings for blue venulectasia would be a spot size of 2-4 mm with a medium pulse width and moderately high fluence. For reticular veins, he uses an external spot size of 4-6 mm with a long pulse width and moderate fluence.

"You can see excellent results if you use this paradigm of variable pulse moding for treating telangiectasia without even injecting patients," he said.

Lasers are indicated for the cosmetic treatment of leg veins in patients whose veins are too small to cannulize for sclerotherapy, or for the small subset of patients who do not respond to sclerotherapy. Patients with needle phobia or those who have multiple sclerosant allergies also are candidates for cosmetic laser treatment of leg veins.

Leg veins require different treatment than do facial telangiectasias, Dr. Sadick added. Hydrostatic pressure is greater in the legs. Lower extremity vessels are larger, with increased basal lamina, compared with facial telangiectasias. The deeper location of many lower-extremity vessels makes access more difficult.

Caution Is Advised

The longer wavelengths and higher fluences of external laser treatment for leg veins cause a greater inflammatory reaction. "The worst thing you can do is treat patients on a weekly or biweekly basis" with external laser, he said. "You need to wait 6-8 weeks after each laser treatment so all the inflammation can resolve before the next treatment session" in order to avoid complications.

Dr. Sadick cautioned that the external 1064-nm Nd:YAG lasers are "sort of like weapons. They need to be handled very gently and understood, particularly when you’re treating the legs." Complications can include ulceration, purpura, blisters, and hyper- or hypopigmentation. These most commonly are caused by stacking pulses in a given area (especially with longer wavelengths), treating tanned skin, improperly matching wavelength to skin type, and failing to address hydrostatic pressure.

"If you use a short wavelength laser like a pulsed dye laser for a dark-skinned individual, for sure you’re going to get hypopigmentation and potential scarring," he said. Avoid laser treatment in patients who have larger vessels feeding the spider telangiectasia, because the hydrostatic pressure increases the risk for side effects.

The clinical goals of laser therapy for leg telangiectasia are to treat vasospasm, erythema, and urticaria. "It’s important to understand the end points of therapy. You don’t need to treat these veins until the vessels go away," he said.

Dr. Sadick has consulted for or received research grants from Cutera, Cynosure, Palomar, Solta Medical, and Syneron.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

SAN FRANCISCO -- The American College of Surgeons could consider taking over resident training from the Accreditation Council of Graduate Medical Education to avoid the council's latest duty-hour restrictions, which went into effect in July.

In considering strategies to address the unwelcome restrictions, "we haven't taken anything off the table," said Dr. L.D. Britt, immediate past president of the American College of Surgeons (ACS) and chair of the ACS Task Force on Resident Duty Hours. "We shouldn't allow any entity to destroy our training programs."

At least one College official later said the College has no plans to take over accreditation of residency programs, but the mere mention of this possibility as an option drew cheers at an emotional, standing-room-only session on resident duty hours during the annual Clinical Congress of the American College of Surgeons.

Dr. Britt and a panel of ACS leaders described their efforts thus far to modify the new duty-hour requirements before and after they went into effect. The session was the first time surgeons had gathered in large numbers since the new rules went into effect, and many of them vented their frustrations.

They objected most to the 16-hours/day limit on first-year residents. "The 16-hour day is an enemy to education," said Dr. Britt, an ACS Fellow and Brickhouse Professor of Surgery and Chairman at Eastern Virginia Medical School, Norfolk.

Limitations on the work hours of surgical trainees in England, Switzerland, and other European countries have been "devastating" to the quality of education there, he said. "Why aren't they looking at the international experience?" Dr. Britt asked in a lengthy discussion session after the formal presentations.

He and others emphasized that there are no data showing that reduced hours lead to better patient outcomes. On the contrary, the limits could hurt patients by increasing the risk for errors because the new schedule leads to an increased number of patient hand-offs and gives residents less experience, they suggested.

Dr. Ajit K. Sachdeva, an ACS Fellow, director of the ACS Division of Education, and moderator of the session, said in a phone interview afterward that there has been "a lot of chatter" on ACS listservs about the duty-hour restrictions, but the ACS "has no plans" to take over residency program accreditations.

"There's a prevailing sense in the surgical community that the 16 hours a day is not going to be good for surgical training and actually will do harm, because you will have less well-trained people in the future," said Dr. Sachdeva, adjunct professor of surgery at Northwestern University, Chicago. The ACS will continue to try to get the Accreditation Council of Graduate Medical Education (ACGME) to expand the daily 16-hour limit for first-year residents and to keep the 80-hour weekly limit from shrinking.

Under the 2011 regulations, residents must break the rules to get needed experience in continuity of care, said Dr. Thomas V. Whalen, an ACS Fellow and chief medical officer, department of surgery, Lehigh Valley Health Network, Allentown, Pa.

Dr. Whalen, who served on the ACGME task force that reviewed and revised the 2003 regulations, said that pressure for tighter limits on resident duty hours came largely from sleep scientists such as Dr. Charles A. Czeisler, professor and director of the division of sleep medicine, Harvard University, and chief of the division of sleep medicine at Brigham and Women's Hospital, Boston.

Dr. Czeisler said in an interview that he is an advocate of patient safety and evidence-based medicine. "In fact, this year is the 40th anniversary of the first study demonstrating that extended-duration shifts double the rate of errors that interns make when detecting cardiac arrhythmias," he said. Since then, his research has shown that work shifts longer than 24 hours lead to a 460% increase in serious diagnostic mistakes made by resident physicians caring for critically ill patients in the ICU, a 73% increase in the risk of percutaneous injuries, and a 168% increase in the odds of a resident being in a motor vehicle crash while driving home, among other adverse consequences.

An Institute of Medicine (IOM) consensus statement in December 2008 recommended, among other things, that 5 hours of sleep be allowed after any shift longer than 16 hours, and that this sleep time be counted toward the 80-hour/week limit, averaged over 4 weeks.

The ACS published a detailed response to the IOM report, arguing that the 16 hours/day limit "is entirely unworkable in the surgical environment" (Surgery 2009;146:398-409).

The ACGME rules don't go as far as the IOM recommendations because the ACGME applied the 16 hours/day limit only to interns and not to other residents, Dr. Czeisler has noted in previously published statements.

Limiting duty shifts for surgical residents will not necessarily hurt the quality of education or increase the number of years of training needed, according to Dr. Czeisler. He pointed out that "surgeons in New Zealand have been training with a 16-hour shift limit since 1985, without needing a longer training program."

Dr. Mark L. Friedell, an ACS Fellow and president of the Association of Program Directors in Surgery, suggested that the fourth year of medical school could be used to prepare students for surgical residency. Dr. Sachdeva said that the ACS is working with other organizations to develop a surgery "boot camp" for fourth-year medical students.

Another helpful alternative would be to develop a "milestone" for first-year residents that might make the ACGME feel comfortable in letting them work 24 consecutive hours, like other residents, said Dr. Friedell, who directs the residency program in general surgery at Orlando Health, a network of hospitals.

Reports from five residency programs on their experience thus far with duty-hour restrictions suggest that surgery interns now are working 6 days/week, and "golden weekends" have disappeared. Patient hand-offs have increased in many programs. Faculty and senior residents are under more stress as more of the workload shifts to them. Many programs have hired additional nurse practitioners and physician assistants to help handle the work residents no longer do.

First-year residents report that they do not feel blamed for the restrictions, but many feel they are being shortchanged by not having the same duty hours as other residents, Dr. Friedell said.

"Part of the reason we're in the mess we're in is because we didn't pay enough attention to what residents did in the pre-80-hour era," said Dr. Joshua M.V. Mammen, assistant professor at the University of Kansas, Kansas City, and past chair of the ACS Resident and Associate Society (RAS). He echoed a theme suggesting that enhanced supervision of residents -- rather than limiting duty hours -- is the key to safe practice.

In a 2006 Internet-based survey of RAS members, approximately 60% said that, ideally, residents should work less than 80 hours/week, and 40% favored more than 80 hours/week, said Dr. Mammen. In an ongoing survey of current RAS members with 841 respondents so far, it's more of a 50-50 split, he said. In all, 48% said that residents should work 60-80 hours/week, 47% believed 61-100 hours/week would be ideal, 2% favored fewer than 60 hours/week, and 3% wanted residents working more than 100 hours/week.

The speakers had no conflicts.

SAN FRANCISCO -- The American College of Surgeons could consider taking over resident training from the Accreditation Council of Graduate Medical Education to avoid the council's latest duty-hour restrictions, which went into effect in July.

In considering strategies to address the unwelcome restrictions, "we haven't taken anything off the table," said Dr. L.D. Britt, immediate past president of the American College of Surgeons (ACS) and chair of the ACS Task Force on Resident Duty Hours. "We shouldn't allow any entity to destroy our training programs."

At least one College official later said the College has no plans to take over accreditation of residency programs, but the mere mention of this possibility as an option drew cheers at an emotional, standing-room-only session on resident duty hours during the annual Clinical Congress of the American College of Surgeons.

Dr. Britt and a panel of ACS leaders described their efforts thus far to modify the new duty-hour requirements before and after they went into effect. The session was the first time surgeons had gathered in large numbers since the new rules went into effect, and many of them vented their frustrations.

They objected most to the 16-hours/day limit on first-year residents. "The 16-hour day is an enemy to education," said Dr. Britt, an ACS Fellow and Brickhouse Professor of Surgery and Chairman at Eastern Virginia Medical School, Norfolk.

Limitations on the work hours of surgical trainees in England, Switzerland, and other European countries have been "devastating" to the quality of education there, he said. "Why aren't they looking at the international experience?" Dr. Britt asked in a lengthy discussion session after the formal presentations.

He and others emphasized that there are no data showing that reduced hours lead to better patient outcomes. On the contrary, the limits could hurt patients by increasing the risk for errors because the new schedule leads to an increased number of patient hand-offs and gives residents less experience, they suggested.

Dr. Ajit K. Sachdeva, an ACS Fellow, director of the ACS Division of Education, and moderator of the session, said in a phone interview afterward that there has been "a lot of chatter" on ACS listservs about the duty-hour restrictions, but the ACS "has no plans" to take over residency program accreditations.

"There's a prevailing sense in the surgical community that the 16 hours a day is not going to be good for surgical training and actually will do harm, because you will have less well-trained people in the future," said Dr. Sachdeva, adjunct professor of surgery at Northwestern University, Chicago. The ACS will continue to try to get the Accreditation Council of Graduate Medical Education (ACGME) to expand the daily 16-hour limit for first-year residents and to keep the 80-hour weekly limit from shrinking.

Under the 2011 regulations, residents must break the rules to get needed experience in continuity of care, said Dr. Thomas V. Whalen, an ACS Fellow and chief medical officer, department of surgery, Lehigh Valley Health Network, Allentown, Pa.

Dr. Whalen, who served on the ACGME task force that reviewed and revised the 2003 regulations, said that pressure for tighter limits on resident duty hours came largely from sleep scientists such as Dr. Charles A. Czeisler, professor and director of the division of sleep medicine, Harvard University, and chief of the division of sleep medicine at Brigham and Women's Hospital, Boston.

Dr. Czeisler said in an interview that he is an advocate of patient safety and evidence-based medicine. "In fact, this year is the 40th anniversary of the first study demonstrating that extended-duration shifts double the rate of errors that interns make when detecting cardiac arrhythmias," he said. Since then, his research has shown that work shifts longer than 24 hours lead to a 460% increase in serious diagnostic mistakes made by resident physicians caring for critically ill patients in the ICU, a 73% increase in the risk of percutaneous injuries, and a 168% increase in the odds of a resident being in a motor vehicle crash while driving home, among other adverse consequences.

An Institute of Medicine (IOM) consensus statement in December 2008 recommended, among other things, that 5 hours of sleep be allowed after any shift longer than 16 hours, and that this sleep time be counted toward the 80-hour/week limit, averaged over 4 weeks.

The ACS published a detailed response to the IOM report, arguing that the 16 hours/day limit "is entirely unworkable in the surgical environment" (Surgery 2009;146:398-409).

The ACGME rules don't go as far as the IOM recommendations because the ACGME applied the 16 hours/day limit only to interns and not to other residents, Dr. Czeisler has noted in previously published statements.

Limiting duty shifts for surgical residents will not necessarily hurt the quality of education or increase the number of years of training needed, according to Dr. Czeisler. He pointed out that "surgeons in New Zealand have been training with a 16-hour shift limit since 1985, without needing a longer training program."

Dr. Mark L. Friedell, an ACS Fellow and president of the Association of Program Directors in Surgery, suggested that the fourth year of medical school could be used to prepare students for surgical residency. Dr. Sachdeva said that the ACS is working with other organizations to develop a surgery "boot camp" for fourth-year medical students.

Another helpful alternative would be to develop a "milestone" for first-year residents that might make the ACGME feel comfortable in letting them work 24 consecutive hours, like other residents, said Dr. Friedell, who directs the residency program in general surgery at Orlando Health, a network of hospitals.

Reports from five residency programs on their experience thus far with duty-hour restrictions suggest that surgery interns now are working 6 days/week, and "golden weekends" have disappeared. Patient hand-offs have increased in many programs. Faculty and senior residents are under more stress as more of the workload shifts to them. Many programs have hired additional nurse practitioners and physician assistants to help handle the work residents no longer do.

First-year residents report that they do not feel blamed for the restrictions, but many feel they are being shortchanged by not having the same duty hours as other residents, Dr. Friedell said.

"Part of the reason we're in the mess we're in is because we didn't pay enough attention to what residents did in the pre-80-hour era," said Dr. Joshua M.V. Mammen, assistant professor at the University of Kansas, Kansas City, and past chair of the ACS Resident and Associate Society (RAS). He echoed a theme suggesting that enhanced supervision of residents -- rather than limiting duty hours -- is the key to safe practice.

In a 2006 Internet-based survey of RAS members, approximately 60% said that, ideally, residents should work less than 80 hours/week, and 40% favored more than 80 hours/week, said Dr. Mammen. In an ongoing survey of current RAS members with 841 respondents so far, it's more of a 50-50 split, he said. In all, 48% said that residents should work 60-80 hours/week, 47% believed 61-100 hours/week would be ideal, 2% favored fewer than 60 hours/week, and 3% wanted residents working more than 100 hours/week.

The speakers had no conflicts.

SAN FRANCISCO -- The American College of Surgeons could consider taking over resident training from the Accreditation Council of Graduate Medical Education to avoid the council's latest duty-hour restrictions, which went into effect in July.

In considering strategies to address the unwelcome restrictions, "we haven't taken anything off the table," said Dr. L.D. Britt, immediate past president of the American College of Surgeons (ACS) and chair of the ACS Task Force on Resident Duty Hours. "We shouldn't allow any entity to destroy our training programs."

At least one College official later said the College has no plans to take over accreditation of residency programs, but the mere mention of this possibility as an option drew cheers at an emotional, standing-room-only session on resident duty hours during the annual Clinical Congress of the American College of Surgeons.

Dr. Britt and a panel of ACS leaders described their efforts thus far to modify the new duty-hour requirements before and after they went into effect. The session was the first time surgeons had gathered in large numbers since the new rules went into effect, and many of them vented their frustrations.

They objected most to the 16-hours/day limit on first-year residents. "The 16-hour day is an enemy to education," said Dr. Britt, an ACS Fellow and Brickhouse Professor of Surgery and Chairman at Eastern Virginia Medical School, Norfolk.

Limitations on the work hours of surgical trainees in England, Switzerland, and other European countries have been "devastating" to the quality of education there, he said. "Why aren't they looking at the international experience?" Dr. Britt asked in a lengthy discussion session after the formal presentations.

He and others emphasized that there are no data showing that reduced hours lead to better patient outcomes. On the contrary, the limits could hurt patients by increasing the risk for errors because the new schedule leads to an increased number of patient hand-offs and gives residents less experience, they suggested.

Dr. Ajit K. Sachdeva, an ACS Fellow, director of the ACS Division of Education, and moderator of the session, said in a phone interview afterward that there has been "a lot of chatter" on ACS listservs about the duty-hour restrictions, but the ACS "has no plans" to take over residency program accreditations.

"There's a prevailing sense in the surgical community that the 16 hours a day is not going to be good for surgical training and actually will do harm, because you will have less well-trained people in the future," said Dr. Sachdeva, adjunct professor of surgery at Northwestern University, Chicago. The ACS will continue to try to get the Accreditation Council of Graduate Medical Education (ACGME) to expand the daily 16-hour limit for first-year residents and to keep the 80-hour weekly limit from shrinking.

Under the 2011 regulations, residents must break the rules to get needed experience in continuity of care, said Dr. Thomas V. Whalen, an ACS Fellow and chief medical officer, department of surgery, Lehigh Valley Health Network, Allentown, Pa.

Dr. Whalen, who served on the ACGME task force that reviewed and revised the 2003 regulations, said that pressure for tighter limits on resident duty hours came largely from sleep scientists such as Dr. Charles A. Czeisler, professor and director of the division of sleep medicine, Harvard University, and chief of the division of sleep medicine at Brigham and Women's Hospital, Boston.

Dr. Czeisler said in an interview that he is an advocate of patient safety and evidence-based medicine. "In fact, this year is the 40th anniversary of the first study demonstrating that extended-duration shifts double the rate of errors that interns make when detecting cardiac arrhythmias," he said. Since then, his research has shown that work shifts longer than 24 hours lead to a 460% increase in serious diagnostic mistakes made by resident physicians caring for critically ill patients in the ICU, a 73% increase in the risk of percutaneous injuries, and a 168% increase in the odds of a resident being in a motor vehicle crash while driving home, among other adverse consequences.

An Institute of Medicine (IOM) consensus statement in December 2008 recommended, among other things, that 5 hours of sleep be allowed after any shift longer than 16 hours, and that this sleep time be counted toward the 80-hour/week limit, averaged over 4 weeks.

The ACS published a detailed response to the IOM report, arguing that the 16 hours/day limit "is entirely unworkable in the surgical environment" (Surgery 2009;146:398-409).

The ACGME rules don't go as far as the IOM recommendations because the ACGME applied the 16 hours/day limit only to interns and not to other residents, Dr. Czeisler has noted in previously published statements.

Limiting duty shifts for surgical residents will not necessarily hurt the quality of education or increase the number of years of training needed, according to Dr. Czeisler. He pointed out that "surgeons in New Zealand have been training with a 16-hour shift limit since 1985, without needing a longer training program."

Dr. Mark L. Friedell, an ACS Fellow and president of the Association of Program Directors in Surgery, suggested that the fourth year of medical school could be used to prepare students for surgical residency. Dr. Sachdeva said that the ACS is working with other organizations to develop a surgery "boot camp" for fourth-year medical students.

Another helpful alternative would be to develop a "milestone" for first-year residents that might make the ACGME feel comfortable in letting them work 24 consecutive hours, like other residents, said Dr. Friedell, who directs the residency program in general surgery at Orlando Health, a network of hospitals.

Reports from five residency programs on their experience thus far with duty-hour restrictions suggest that surgery interns now are working 6 days/week, and "golden weekends" have disappeared. Patient hand-offs have increased in many programs. Faculty and senior residents are under more stress as more of the workload shifts to them. Many programs have hired additional nurse practitioners and physician assistants to help handle the work residents no longer do.

First-year residents report that they do not feel blamed for the restrictions, but many feel they are being shortchanged by not having the same duty hours as other residents, Dr. Friedell said.

"Part of the reason we're in the mess we're in is because we didn't pay enough attention to what residents did in the pre-80-hour era," said Dr. Joshua M.V. Mammen, assistant professor at the University of Kansas, Kansas City, and past chair of the ACS Resident and Associate Society (RAS). He echoed a theme suggesting that enhanced supervision of residents -- rather than limiting duty hours -- is the key to safe practice.

In a 2006 Internet-based survey of RAS members, approximately 60% said that, ideally, residents should work less than 80 hours/week, and 40% favored more than 80 hours/week, said Dr. Mammen. In an ongoing survey of current RAS members with 841 respondents so far, it's more of a 50-50 split, he said. In all, 48% said that residents should work 60-80 hours/week, 47% believed 61-100 hours/week would be ideal, 2% favored fewer than 60 hours/week, and 3% wanted residents working more than 100 hours/week.

The speakers had no conflicts.

The 2011 "Resident Duty Hours in the Learning and Working Environment" replaced 2003 regulations from the ACGME. Here is a comparison of some of the 2003 and 2011 standards:

• Maximum Hours Per Week

2003: Duty hours limited to 80/week, averaged over a 4-week period, inclusive of in-house call activities.

2011: Also counts moonlighting hours in the 80-hour limit.

• Exceptions

2003: A review committee may grant exceptions for up to 10% or a maximum of 88 hours to individual programs.

2011: Same.

• Moonlighting

2003: Internal moonlighting must be counted toward the 80-hour limit.

2011: Also counts external moonlighting hours toward the limit.

• Maximum Duty Period

2003: Continuous on-site duty must not exceed 24 consecutive hours. Residents may remain on duty for up to 6 additional hours for didactic activities, transfer care of patients, outpatient clinics, or to maintain continuity of care. No new patients may be accepted after 24 hours of continuous duty.

2011: Maximum 16 consecutive hours for first-year residents. For second-year residents and above, in-hospital duty periods must not exceed 24 consecutive hours. Strategic napping is strongly suggested, especially after 16 hours of duty and between 10 p.m. and 8 a.m. Residents may remain on-site for up to 4 more hours for essential transitions of care but must not be assigned additional clinical responsibilities after 24 hours of continuous in-house duty. In unusual circumstances, residents may take the initiative to stay beyond the duty period to care for a single patient.

• Time Off

2003: One day in 7 free of responsibilities, averaged over 4 weeks, inclusive of call. Ten hours off between duty periods and after in-house call should be provided.

2011: Time off between duty periods must be at least 8 hours and should be 10 hours. Intermediate-level residents must have at least 14 hours free after 24 hours of in-house duty. No more than 6 consecutive nights of night float allowed.

The 2011 "Resident Duty Hours in the Learning and Working Environment" replaced 2003 regulations from the ACGME. Here is a comparison of some of the 2003 and 2011 standards:

• Maximum Hours Per Week

2003: Duty hours limited to 80/week, averaged over a 4-week period, inclusive of in-house call activities.

2011: Also counts moonlighting hours in the 80-hour limit.

• Exceptions

2003: A review committee may grant exceptions for up to 10% or a maximum of 88 hours to individual programs.

2011: Same.

• Moonlighting

2003: Internal moonlighting must be counted toward the 80-hour limit.

2011: Also counts external moonlighting hours toward the limit.

• Maximum Duty Period

2003: Continuous on-site duty must not exceed 24 consecutive hours. Residents may remain on duty for up to 6 additional hours for didactic activities, transfer care of patients, outpatient clinics, or to maintain continuity of care. No new patients may be accepted after 24 hours of continuous duty.

2011: Maximum 16 consecutive hours for first-year residents. For second-year residents and above, in-hospital duty periods must not exceed 24 consecutive hours. Strategic napping is strongly suggested, especially after 16 hours of duty and between 10 p.m. and 8 a.m. Residents may remain on-site for up to 4 more hours for essential transitions of care but must not be assigned additional clinical responsibilities after 24 hours of continuous in-house duty. In unusual circumstances, residents may take the initiative to stay beyond the duty period to care for a single patient.

• Time Off

2003: One day in 7 free of responsibilities, averaged over 4 weeks, inclusive of call. Ten hours off between duty periods and after in-house call should be provided.

2011: Time off between duty periods must be at least 8 hours and should be 10 hours. Intermediate-level residents must have at least 14 hours free after 24 hours of in-house duty. No more than 6 consecutive nights of night float allowed.

The 2011 "Resident Duty Hours in the Learning and Working Environment" replaced 2003 regulations from the ACGME. Here is a comparison of some of the 2003 and 2011 standards:

• Maximum Hours Per Week

2003: Duty hours limited to 80/week, averaged over a 4-week period, inclusive of in-house call activities.

2011: Also counts moonlighting hours in the 80-hour limit.

• Exceptions

2003: A review committee may grant exceptions for up to 10% or a maximum of 88 hours to individual programs.

2011: Same.

• Moonlighting

2003: Internal moonlighting must be counted toward the 80-hour limit.

2011: Also counts external moonlighting hours toward the limit.

• Maximum Duty Period

2003: Continuous on-site duty must not exceed 24 consecutive hours. Residents may remain on duty for up to 6 additional hours for didactic activities, transfer care of patients, outpatient clinics, or to maintain continuity of care. No new patients may be accepted after 24 hours of continuous duty.

2011: Maximum 16 consecutive hours for first-year residents. For second-year residents and above, in-hospital duty periods must not exceed 24 consecutive hours. Strategic napping is strongly suggested, especially after 16 hours of duty and between 10 p.m. and 8 a.m. Residents may remain on-site for up to 4 more hours for essential transitions of care but must not be assigned additional clinical responsibilities after 24 hours of continuous in-house duty. In unusual circumstances, residents may take the initiative to stay beyond the duty period to care for a single patient.

• Time Off

2003: One day in 7 free of responsibilities, averaged over 4 weeks, inclusive of call. Ten hours off between duty periods and after in-house call should be provided.

2011: Time off between duty periods must be at least 8 hours and should be 10 hours. Intermediate-level residents must have at least 14 hours free after 24 hours of in-house duty. No more than 6 consecutive nights of night float allowed.

SAN FRANCISCO – Awareness of four factors that predict increased risk for hospital readmission after coronary artery bypass grafting may improve physicians’ ability to reduce early readmission rates among patients undergoing the procedure.

The four factors that independently predicted increased risk for hospital readmission after CABG in a study of 818 patients were preoperative congestive heart failure, chronic lung disease, a body mass index of 40 kg/m² or greater, and longer time spent on cardiopulmonary bypass, Dr. Kelly B. Currie said at the annual clinical congress of the American College of Surgeons.

Medicare payments to hospitals with high readmission rates will be reduced starting in October 2012 under provisions of the Patient Protection and Affordable Care Act. Payments will change from a fee-for-service model to a value-based model.

Readmission rates within 30 days of CABG range from 6% to 21% in the medical literature. In the third quarter of 2010, 10% of patients in the Society of Thoracic Surgeons (STS) database who underwent CABG were readmitted within 30 days, said Dr. Currie, a surgery resident at Bassett Medical Center, Cooperstown, N.Y.

She and her associates analyzed data from 460 patients undergoing CABG at their center from 2003 to 2010 and from 358 patients in the STS Heartsource database. Once they identified independent predictors of readmission, they conducted a second logistic regression analysis on the 358 patients in the STS database and created a "probability calculator" of readmission risk.

Congestive heart failure was associated with a 77% increase in risk for early readmission after CABG, and chronic lung disease was associated with an 82% increase in risk. The risk of readmission increased significantly by 0.6% with longer perfusion time, and increased nearly fourfold in obese patients with a body mass index of 40 or greater compared with normal-weight patients.

The risk for readmission decreased significantly by 40% in patients who underwent endoscopic vein harvest, she added.

Physicians may want to focus resources on the high-risk patients to decrease readmissions, Dr. Curry said. Readmissions might be lessened by instituting follow-up calls within a day of discharge, and/or having patients see their primary care physicians within 7 days of discharge. Efforts to improve verbal handoffs of patient care between inpatient nurses and visiting nurses, as well as the use of telemedicine, might be other effective ways to help avoid readmissions, she suggested.

"These are things we are going to be implementing in the near future, hopefully," she said.

The readmission risk calculator developed in this study probably cannot be applied to a broad population of patients because some of the variables are specific to the cardiac surgery population, she noted. The study’s techniques could be applied, however, to develop risk calculators for other populations.

Dr. Currie is collaborating with researchers at Columbia University in New York to develop an improved calculator by studying data on an expected 1,400 adult cardiac surgery cases at nine hospitals in five states.

Dr. Currie said she has no relevant conflicts of interest.

SAN FRANCISCO – Awareness of four factors that predict increased risk for hospital readmission after coronary artery bypass grafting may improve physicians’ ability to reduce early readmission rates among patients undergoing the procedure.

The four factors that independently predicted increased risk for hospital readmission after CABG in a study of 818 patients were preoperative congestive heart failure, chronic lung disease, a body mass index of 40 kg/m² or greater, and longer time spent on cardiopulmonary bypass, Dr. Kelly B. Currie said at the annual clinical congress of the American College of Surgeons.

Medicare payments to hospitals with high readmission rates will be reduced starting in October 2012 under provisions of the Patient Protection and Affordable Care Act. Payments will change from a fee-for-service model to a value-based model.

Readmission rates within 30 days of CABG range from 6% to 21% in the medical literature. In the third quarter of 2010, 10% of patients in the Society of Thoracic Surgeons (STS) database who underwent CABG were readmitted within 30 days, said Dr. Currie, a surgery resident at Bassett Medical Center, Cooperstown, N.Y.

She and her associates analyzed data from 460 patients undergoing CABG at their center from 2003 to 2010 and from 358 patients in the STS Heartsource database. Once they identified independent predictors of readmission, they conducted a second logistic regression analysis on the 358 patients in the STS database and created a "probability calculator" of readmission risk.

Congestive heart failure was associated with a 77% increase in risk for early readmission after CABG, and chronic lung disease was associated with an 82% increase in risk. The risk of readmission increased significantly by 0.6% with longer perfusion time, and increased nearly fourfold in obese patients with a body mass index of 40 or greater compared with normal-weight patients.

The risk for readmission decreased significantly by 40% in patients who underwent endoscopic vein harvest, she added.

Physicians may want to focus resources on the high-risk patients to decrease readmissions, Dr. Curry said. Readmissions might be lessened by instituting follow-up calls within a day of discharge, and/or having patients see their primary care physicians within 7 days of discharge. Efforts to improve verbal handoffs of patient care between inpatient nurses and visiting nurses, as well as the use of telemedicine, might be other effective ways to help avoid readmissions, she suggested.

"These are things we are going to be implementing in the near future, hopefully," she said.

The readmission risk calculator developed in this study probably cannot be applied to a broad population of patients because some of the variables are specific to the cardiac surgery population, she noted. The study’s techniques could be applied, however, to develop risk calculators for other populations.

Dr. Currie is collaborating with researchers at Columbia University in New York to develop an improved calculator by studying data on an expected 1,400 adult cardiac surgery cases at nine hospitals in five states.

Dr. Currie said she has no relevant conflicts of interest.

SAN FRANCISCO – Awareness of four factors that predict increased risk for hospital readmission after coronary artery bypass grafting may improve physicians’ ability to reduce early readmission rates among patients undergoing the procedure.

The four factors that independently predicted increased risk for hospital readmission after CABG in a study of 818 patients were preoperative congestive heart failure, chronic lung disease, a body mass index of 40 kg/m² or greater, and longer time spent on cardiopulmonary bypass, Dr. Kelly B. Currie said at the annual clinical congress of the American College of Surgeons.

Medicare payments to hospitals with high readmission rates will be reduced starting in October 2012 under provisions of the Patient Protection and Affordable Care Act. Payments will change from a fee-for-service model to a value-based model.

Readmission rates within 30 days of CABG range from 6% to 21% in the medical literature. In the third quarter of 2010, 10% of patients in the Society of Thoracic Surgeons (STS) database who underwent CABG were readmitted within 30 days, said Dr. Currie, a surgery resident at Bassett Medical Center, Cooperstown, N.Y.

She and her associates analyzed data from 460 patients undergoing CABG at their center from 2003 to 2010 and from 358 patients in the STS Heartsource database. Once they identified independent predictors of readmission, they conducted a second logistic regression analysis on the 358 patients in the STS database and created a "probability calculator" of readmission risk.

Congestive heart failure was associated with a 77% increase in risk for early readmission after CABG, and chronic lung disease was associated with an 82% increase in risk. The risk of readmission increased significantly by 0.6% with longer perfusion time, and increased nearly fourfold in obese patients with a body mass index of 40 or greater compared with normal-weight patients.

The risk for readmission decreased significantly by 40% in patients who underwent endoscopic vein harvest, she added.

Physicians may want to focus resources on the high-risk patients to decrease readmissions, Dr. Curry said. Readmissions might be lessened by instituting follow-up calls within a day of discharge, and/or having patients see their primary care physicians within 7 days of discharge. Efforts to improve verbal handoffs of patient care between inpatient nurses and visiting nurses, as well as the use of telemedicine, might be other effective ways to help avoid readmissions, she suggested.

"These are things we are going to be implementing in the near future, hopefully," she said.

The readmission risk calculator developed in this study probably cannot be applied to a broad population of patients because some of the variables are specific to the cardiac surgery population, she noted. The study’s techniques could be applied, however, to develop risk calculators for other populations.

Dr. Currie is collaborating with researchers at Columbia University in New York to develop an improved calculator by studying data on an expected 1,400 adult cardiac surgery cases at nine hospitals in five states.

Dr. Currie said she has no relevant conflicts of interest.

SAN FRANCISCO – Training residents to notify attending surgeons of any significant change in a patient’s condition greatly reduced the proportion of critical events that were not communicated to attending surgeons, from 33% to 2%, in a prospective study of four hospitals.

The current study was undertaken in response to a previous study by the same research group showing that ambiguity about who is responsible for communications contributed to communication breakdowns between attending surgeons and other members of the team at any point in patient care, Dr. Caprice C. Greenberg said at the annual clinical congress of the American College of Surgeons.

In the previous study, 444 malpractice claims were reviewed, and this process identified 60 cases in which communication breakdown resulted in harm to a patient. Dr. Greenberg and colleagues found that communication breakdowns related to surgery are equally likely to happen during preoperative, intraoperative, and postoperative care, and most commonly involve communications attempted between an attending surgeon and another attending surgeon, a resident, or the patient or family.

Ambiguity about who is responsible for communicating played a role in 58% of communication breakdowns, said Dr. Greenberg, director of the Wisconsin Surgical Outcomes Research Program and associate professor of surgery at the University of Wisconsin, Madison.

Hand-offs of patient care from one provider to another contributed to 43% of communication breakdowns, and transferring a patient to a different location contributed to 39% of communication breakdowns. The data also showed that an asymmetry in status between the two communicating parties contributed to 74% of message breakdowns (J. Am. Coll. Surg. 2007;204:533-40).

Dr. Greenberg and her associates identified "triggers" that should prompt residents or nurses to contact attending surgeons, including a patient’s admission to a hospital, discharge, or a visit to an emergency department, transfer into or out of the ICU, unplanned intubation, or the development of cardiac arrest, new arrhythmia, or hemodynamic instability.

"Developing skills in communication are as important as the development and maintenance of technical skills."

Significant neurologic changes, major wound complications, unplanned blood transfusion, an invasive procedure or operation, or errors in medication or treatment necessitating an intervention also should trigger communication with the attending surgeon. Even simply concern by a surgical trainee or a request from a nurse or another physician to contact the attending surgeon were considered triggers for communication.

The triggers were included in guidelines created by representatives of the four hospitals in Harvard University’s system in a collaboration organized by the system’s malpractice insurers. Under the new guidelines, residents were to notify attending surgeons of any significant changes in a patient’s condition regardless of the day or time. The residents would be trained to understand what qualifies as "significant changes" based in part on specialty-specific definitions, she said.

"What a urologist cares about is probably a little bit different from what a neurosurgeon or cardiac surgeon cares about," she explained.

A study of practices before instituting these policies found that residents thought that 61 of 80 critical patient events (76%) did not need to be communicated to attending surgeons for safe patient care, and 26 events were not communicated (33%). Of the 54 events that were communicated, discussions with the attending surgeons changed management in 18 cases (33%). Attending surgeons responded to calls 100% of the time (Ann. Surg. 2009;250:861-5).

"It wasn’t that the attendings didn’t want to be called. It was that residents either felt unempowered to call or they felt that it wasn’t necessary," she said.

After adoption of the new guidelines, only 1 of 47 critical events (2%) was not communicated to an attending surgeon, the current study found (Ann. Surg. 2011;253:849-54).

"Developing skills in communication are as important as the development and maintenance of technical skills" to reduce the risk of errors, Dr. Greenberg said.

Breakdowns in communication are common and play a significant role in adverse events, prior data suggest. One study of 48 surgeries found that 31% of 421 attempted communications between surgical team members failed, and approximately a third of these communication failures potentially jeopardized patient safety (Qual. Saf. Health Care 2004;13:330-4).

Other strategies to reduce the risk of errors during surgery include "workload leveling," Dr. Greenberg added. This means the attending surgeon should communicate frequently to members of the interdisciplinary surgical team about the status of the case and expected progression of the case, so that team members can manage their time and plan to do auxiliary tasks at the appropriate times.

It’s probably impossible to avoid all errors, so surgeons need to find the right balance of error prevention and error mitigation through "resilience" – the ability to anticipate, cope with, recover from, and learn from unforeseen developments, she added. "To start to increase resilience, we really need to teach people adaptability and flexibility," she said.

Dr. Greenberg said she has no relevant conflicts of interest.

SAN FRANCISCO – Training residents to notify attending surgeons of any significant change in a patient’s condition greatly reduced the proportion of critical events that were not communicated to attending surgeons, from 33% to 2%, in a prospective study of four hospitals.

The current study was undertaken in response to a previous study by the same research group showing that ambiguity about who is responsible for communications contributed to communication breakdowns between attending surgeons and other members of the team at any point in patient care, Dr. Caprice C. Greenberg said at the annual clinical congress of the American College of Surgeons.

In the previous study, 444 malpractice claims were reviewed, and this process identified 60 cases in which communication breakdown resulted in harm to a patient. Dr. Greenberg and colleagues found that communication breakdowns related to surgery are equally likely to happen during preoperative, intraoperative, and postoperative care, and most commonly involve communications attempted between an attending surgeon and another attending surgeon, a resident, or the patient or family.

Ambiguity about who is responsible for communicating played a role in 58% of communication breakdowns, said Dr. Greenberg, director of the Wisconsin Surgical Outcomes Research Program and associate professor of surgery at the University of Wisconsin, Madison.

Hand-offs of patient care from one provider to another contributed to 43% of communication breakdowns, and transferring a patient to a different location contributed to 39% of communication breakdowns. The data also showed that an asymmetry in status between the two communicating parties contributed to 74% of message breakdowns (J. Am. Coll. Surg. 2007;204:533-40).

Dr. Greenberg and her associates identified "triggers" that should prompt residents or nurses to contact attending surgeons, including a patient’s admission to a hospital, discharge, or a visit to an emergency department, transfer into or out of the ICU, unplanned intubation, or the development of cardiac arrest, new arrhythmia, or hemodynamic instability.

"Developing skills in communication are as important as the development and maintenance of technical skills."

Significant neurologic changes, major wound complications, unplanned blood transfusion, an invasive procedure or operation, or errors in medication or treatment necessitating an intervention also should trigger communication with the attending surgeon. Even simply concern by a surgical trainee or a request from a nurse or another physician to contact the attending surgeon were considered triggers for communication.

The triggers were included in guidelines created by representatives of the four hospitals in Harvard University’s system in a collaboration organized by the system’s malpractice insurers. Under the new guidelines, residents were to notify attending surgeons of any significant changes in a patient’s condition regardless of the day or time. The residents would be trained to understand what qualifies as "significant changes" based in part on specialty-specific definitions, she said.

"What a urologist cares about is probably a little bit different from what a neurosurgeon or cardiac surgeon cares about," she explained.

A study of practices before instituting these policies found that residents thought that 61 of 80 critical patient events (76%) did not need to be communicated to attending surgeons for safe patient care, and 26 events were not communicated (33%). Of the 54 events that were communicated, discussions with the attending surgeons changed management in 18 cases (33%). Attending surgeons responded to calls 100% of the time (Ann. Surg. 2009;250:861-5).

"It wasn’t that the attendings didn’t want to be called. It was that residents either felt unempowered to call or they felt that it wasn’t necessary," she said.

After adoption of the new guidelines, only 1 of 47 critical events (2%) was not communicated to an attending surgeon, the current study found (Ann. Surg. 2011;253:849-54).

"Developing skills in communication are as important as the development and maintenance of technical skills" to reduce the risk of errors, Dr. Greenberg said.

Breakdowns in communication are common and play a significant role in adverse events, prior data suggest. One study of 48 surgeries found that 31% of 421 attempted communications between surgical team members failed, and approximately a third of these communication failures potentially jeopardized patient safety (Qual. Saf. Health Care 2004;13:330-4).

Other strategies to reduce the risk of errors during surgery include "workload leveling," Dr. Greenberg added. This means the attending surgeon should communicate frequently to members of the interdisciplinary surgical team about the status of the case and expected progression of the case, so that team members can manage their time and plan to do auxiliary tasks at the appropriate times.

It’s probably impossible to avoid all errors, so surgeons need to find the right balance of error prevention and error mitigation through "resilience" – the ability to anticipate, cope with, recover from, and learn from unforeseen developments, she added. "To start to increase resilience, we really need to teach people adaptability and flexibility," she said.

Dr. Greenberg said she has no relevant conflicts of interest.

SAN FRANCISCO – Training residents to notify attending surgeons of any significant change in a patient’s condition greatly reduced the proportion of critical events that were not communicated to attending surgeons, from 33% to 2%, in a prospective study of four hospitals.

The current study was undertaken in response to a previous study by the same research group showing that ambiguity about who is responsible for communications contributed to communication breakdowns between attending surgeons and other members of the team at any point in patient care, Dr. Caprice C. Greenberg said at the annual clinical congress of the American College of Surgeons.

In the previous study, 444 malpractice claims were reviewed, and this process identified 60 cases in which communication breakdown resulted in harm to a patient. Dr. Greenberg and colleagues found that communication breakdowns related to surgery are equally likely to happen during preoperative, intraoperative, and postoperative care, and most commonly involve communications attempted between an attending surgeon and another attending surgeon, a resident, or the patient or family.

Ambiguity about who is responsible for communicating played a role in 58% of communication breakdowns, said Dr. Greenberg, director of the Wisconsin Surgical Outcomes Research Program and associate professor of surgery at the University of Wisconsin, Madison.

Hand-offs of patient care from one provider to another contributed to 43% of communication breakdowns, and transferring a patient to a different location contributed to 39% of communication breakdowns. The data also showed that an asymmetry in status between the two communicating parties contributed to 74% of message breakdowns (J. Am. Coll. Surg. 2007;204:533-40).

Dr. Greenberg and her associates identified "triggers" that should prompt residents or nurses to contact attending surgeons, including a patient’s admission to a hospital, discharge, or a visit to an emergency department, transfer into or out of the ICU, unplanned intubation, or the development of cardiac arrest, new arrhythmia, or hemodynamic instability.

"Developing skills in communication are as important as the development and maintenance of technical skills."

Significant neurologic changes, major wound complications, unplanned blood transfusion, an invasive procedure or operation, or errors in medication or treatment necessitating an intervention also should trigger communication with the attending surgeon. Even simply concern by a surgical trainee or a request from a nurse or another physician to contact the attending surgeon were considered triggers for communication.

The triggers were included in guidelines created by representatives of the four hospitals in Harvard University’s system in a collaboration organized by the system’s malpractice insurers. Under the new guidelines, residents were to notify attending surgeons of any significant changes in a patient’s condition regardless of the day or time. The residents would be trained to understand what qualifies as "significant changes" based in part on specialty-specific definitions, she said.

"What a urologist cares about is probably a little bit different from what a neurosurgeon or cardiac surgeon cares about," she explained.

A study of practices before instituting these policies found that residents thought that 61 of 80 critical patient events (76%) did not need to be communicated to attending surgeons for safe patient care, and 26 events were not communicated (33%). Of the 54 events that were communicated, discussions with the attending surgeons changed management in 18 cases (33%). Attending surgeons responded to calls 100% of the time (Ann. Surg. 2009;250:861-5).

"It wasn’t that the attendings didn’t want to be called. It was that residents either felt unempowered to call or they felt that it wasn’t necessary," she said.

After adoption of the new guidelines, only 1 of 47 critical events (2%) was not communicated to an attending surgeon, the current study found (Ann. Surg. 2011;253:849-54).

"Developing skills in communication are as important as the development and maintenance of technical skills" to reduce the risk of errors, Dr. Greenberg said.

Breakdowns in communication are common and play a significant role in adverse events, prior data suggest. One study of 48 surgeries found that 31% of 421 attempted communications between surgical team members failed, and approximately a third of these communication failures potentially jeopardized patient safety (Qual. Saf. Health Care 2004;13:330-4).

Other strategies to reduce the risk of errors during surgery include "workload leveling," Dr. Greenberg added. This means the attending surgeon should communicate frequently to members of the interdisciplinary surgical team about the status of the case and expected progression of the case, so that team members can manage their time and plan to do auxiliary tasks at the appropriate times.

It’s probably impossible to avoid all errors, so surgeons need to find the right balance of error prevention and error mitigation through "resilience" – the ability to anticipate, cope with, recover from, and learn from unforeseen developments, she added. "To start to increase resilience, we really need to teach people adaptability and flexibility," she said.

Dr. Greenberg said she has no relevant conflicts of interest.

SAN FRANCISCO – Changing the clinical culture so that physicians were more willing to talk with patients about medical and surgical errors increased the number of errors reported, decreased lawsuits and legal costs, and improved safety at one institution.

"It used to be a ‘defend and deny’ culture," said Dr. Darrell A. Campbell Jr., professor of surgery and chief of clinical affairs at the University of Michigan, Ann Arbor. "Now it’s ‘disclose and discuss.’ "

The University of Michigan Health System’s "Disclosure of Unanticipated Outcomes" policy requires physicians to give patients "full disclosure of results, including results that differ significantly from what was anticipated" to allow patients to make informed decisions about future medical care, he said at the annual clinical congress of the American College of Surgeons.

The policy was inspired by a 1994 study showing that there are four main reasons patients sue medical caregivers: they need an explanation; they want to ensure the safety of others; they want a sense of accountability; and they seek compensation (Lancet 1994;343:1609-13).

Under the policy’s driving principles, the health system will defend medically appropriate care vigorously but will compensate quickly and fairly when inappropriate medical care causes injury and will learn from mistakes to improve patient safety and communication. The health system is able to compensate quickly and fairly because it is a closed-staff model covered by a captive insurance company, Dr. Campbell said.

Reports of errors and "risk management events" more than doubled since full implementation of the policy in February 2004, from 6,706 in 2004 to 15,650 in 2007, Dr. Campbell said. "I think people feel much more comfortable reporting errors" now.

A comparison of data from 2001 (before the policy) and 2005 (after the policy) found that the number of claims and lawsuits fell from 262 to 114, the average time to resolve claims and lawsuits decreased from 21 months to 10 months, and annual litigation costs declined from $3 million to $1 million, he said.

"It used to be a ‘defend and deny’ culture. Now it’s ‘disclose and discuss.’ "

A retrospective study by other investigators looked at the university’s experience from 1995 to 2007 and reported similar findings. The average monthly rate of new legal claims decreased from seven per 100,000 patient encounters to less than five per 100,000 patient encounters after adoption of the disclosure policy. The median time to resolve claims decreased from 1.36 to 0.95 years, and costs decreased for total liability, patient compensation, and legal costs not related to compensation (Ann. Intern. Med. 2010;153:213-21).

The money saved under the new policy has been redirected to patient safety programs, he said.

Dr. Campbell, a surgeon specializing in liver transplantation, described a case that went awry to illustrate possible responses to the situation. A 9-month-old girl undergoing a liver transplant had a small-diameter hepatic artery. Although the surgeon communicated to the anesthesiologist that the patient should not be overtransfused, the message may have been lost during a patient handoff when the anesthesia team changed. The first postoperative hematocrit was 50%, the hepatic artery thrombosed, and the patient required retransplantation.

Prior to the full-disclosure policy, it might have been tempting to tell the patient’s parents, "These things happen," he said. While this is true, and it may avoid litigation, it’s not the whole truth. Caregivers would feel bad about it, the clinical safety culture would suffer, nothing would be learned, and the same problem could happen again.

If the physician instead says to the parents, "I’m concerned about what just happened. Let’s talk," the conversation is more difficult and could lead to litigation, but it’s an honest approach that augments doctor-patient trust and the culture of safety, which should make caregivers feel better, he said.

"Let’s talk" does not mean the surgeon should make reckless comments, Dr. Campbell stressed. It would not be helpful to say, "Anesthesia is incompetent," or "The fellow dropped the ball," or "I should have been notified earlier," or "I did a perfect operation," or "Somebody’s head will roll," for example.

Disclosing an unanticipated outcome should sound something like the following, he suggested: "This was an unexpected result. I am going to investigate fully. You have the right to know the whole story – the facts. I will tell you what I learn, but not right now."

That provides a window for exploring other possible complications in the case he described, he said. There may have been a laboratory or transcription error. An artery may have been open at the time of reexploration and not seen on relatively insensitive ultrasound. A technical error could have been made, or the patient may have had a humorally mediated rejection of the organ.

The full-disclosure policy is "pretty dramatically different than what we’ve done before," he said.

Dr. Campbell said he has no relevant conflicts of interest.

SAN FRANCISCO – Changing the clinical culture so that physicians were more willing to talk with patients about medical and surgical errors increased the number of errors reported, decreased lawsuits and legal costs, and improved safety at one institution.

"It used to be a ‘defend and deny’ culture," said Dr. Darrell A. Campbell Jr., professor of surgery and chief of clinical affairs at the University of Michigan, Ann Arbor. "Now it’s ‘disclose and discuss.’ "

The University of Michigan Health System’s "Disclosure of Unanticipated Outcomes" policy requires physicians to give patients "full disclosure of results, including results that differ significantly from what was anticipated" to allow patients to make informed decisions about future medical care, he said at the annual clinical congress of the American College of Surgeons.

The policy was inspired by a 1994 study showing that there are four main reasons patients sue medical caregivers: they need an explanation; they want to ensure the safety of others; they want a sense of accountability; and they seek compensation (Lancet 1994;343:1609-13).

Under the policy’s driving principles, the health system will defend medically appropriate care vigorously but will compensate quickly and fairly when inappropriate medical care causes injury and will learn from mistakes to improve patient safety and communication. The health system is able to compensate quickly and fairly because it is a closed-staff model covered by a captive insurance company, Dr. Campbell said.

Reports of errors and "risk management events" more than doubled since full implementation of the policy in February 2004, from 6,706 in 2004 to 15,650 in 2007, Dr. Campbell said. "I think people feel much more comfortable reporting errors" now.

A comparison of data from 2001 (before the policy) and 2005 (after the policy) found that the number of claims and lawsuits fell from 262 to 114, the average time to resolve claims and lawsuits decreased from 21 months to 10 months, and annual litigation costs declined from $3 million to $1 million, he said.

"It used to be a ‘defend and deny’ culture. Now it’s ‘disclose and discuss.’ "

A retrospective study by other investigators looked at the university’s experience from 1995 to 2007 and reported similar findings. The average monthly rate of new legal claims decreased from seven per 100,000 patient encounters to less than five per 100,000 patient encounters after adoption of the disclosure policy. The median time to resolve claims decreased from 1.36 to 0.95 years, and costs decreased for total liability, patient compensation, and legal costs not related to compensation (Ann. Intern. Med. 2010;153:213-21).

The money saved under the new policy has been redirected to patient safety programs, he said.

Dr. Campbell, a surgeon specializing in liver transplantation, described a case that went awry to illustrate possible responses to the situation. A 9-month-old girl undergoing a liver transplant had a small-diameter hepatic artery. Although the surgeon communicated to the anesthesiologist that the patient should not be overtransfused, the message may have been lost during a patient handoff when the anesthesia team changed. The first postoperative hematocrit was 50%, the hepatic artery thrombosed, and the patient required retransplantation.

Prior to the full-disclosure policy, it might have been tempting to tell the patient’s parents, "These things happen," he said. While this is true, and it may avoid litigation, it’s not the whole truth. Caregivers would feel bad about it, the clinical safety culture would suffer, nothing would be learned, and the same problem could happen again.

If the physician instead says to the parents, "I’m concerned about what just happened. Let’s talk," the conversation is more difficult and could lead to litigation, but it’s an honest approach that augments doctor-patient trust and the culture of safety, which should make caregivers feel better, he said.

"Let’s talk" does not mean the surgeon should make reckless comments, Dr. Campbell stressed. It would not be helpful to say, "Anesthesia is incompetent," or "The fellow dropped the ball," or "I should have been notified earlier," or "I did a perfect operation," or "Somebody’s head will roll," for example.

Disclosing an unanticipated outcome should sound something like the following, he suggested: "This was an unexpected result. I am going to investigate fully. You have the right to know the whole story – the facts. I will tell you what I learn, but not right now."

That provides a window for exploring other possible complications in the case he described, he said. There may have been a laboratory or transcription error. An artery may have been open at the time of reexploration and not seen on relatively insensitive ultrasound. A technical error could have been made, or the patient may have had a humorally mediated rejection of the organ.

The full-disclosure policy is "pretty dramatically different than what we’ve done before," he said.

Dr. Campbell said he has no relevant conflicts of interest.

SAN FRANCISCO – Changing the clinical culture so that physicians were more willing to talk with patients about medical and surgical errors increased the number of errors reported, decreased lawsuits and legal costs, and improved safety at one institution.

"It used to be a ‘defend and deny’ culture," said Dr. Darrell A. Campbell Jr., professor of surgery and chief of clinical affairs at the University of Michigan, Ann Arbor. "Now it’s ‘disclose and discuss.’ "

The University of Michigan Health System’s "Disclosure of Unanticipated Outcomes" policy requires physicians to give patients "full disclosure of results, including results that differ significantly from what was anticipated" to allow patients to make informed decisions about future medical care, he said at the annual clinical congress of the American College of Surgeons.

The policy was inspired by a 1994 study showing that there are four main reasons patients sue medical caregivers: they need an explanation; they want to ensure the safety of others; they want a sense of accountability; and they seek compensation (Lancet 1994;343:1609-13).

Under the policy’s driving principles, the health system will defend medically appropriate care vigorously but will compensate quickly and fairly when inappropriate medical care causes injury and will learn from mistakes to improve patient safety and communication. The health system is able to compensate quickly and fairly because it is a closed-staff model covered by a captive insurance company, Dr. Campbell said.

Reports of errors and "risk management events" more than doubled since full implementation of the policy in February 2004, from 6,706 in 2004 to 15,650 in 2007, Dr. Campbell said. "I think people feel much more comfortable reporting errors" now.

A comparison of data from 2001 (before the policy) and 2005 (after the policy) found that the number of claims and lawsuits fell from 262 to 114, the average time to resolve claims and lawsuits decreased from 21 months to 10 months, and annual litigation costs declined from $3 million to $1 million, he said.

"It used to be a ‘defend and deny’ culture. Now it’s ‘disclose and discuss.’ "

A retrospective study by other investigators looked at the university’s experience from 1995 to 2007 and reported similar findings. The average monthly rate of new legal claims decreased from seven per 100,000 patient encounters to less than five per 100,000 patient encounters after adoption of the disclosure policy. The median time to resolve claims decreased from 1.36 to 0.95 years, and costs decreased for total liability, patient compensation, and legal costs not related to compensation (Ann. Intern. Med. 2010;153:213-21).

The money saved under the new policy has been redirected to patient safety programs, he said.

Dr. Campbell, a surgeon specializing in liver transplantation, described a case that went awry to illustrate possible responses to the situation. A 9-month-old girl undergoing a liver transplant had a small-diameter hepatic artery. Although the surgeon communicated to the anesthesiologist that the patient should not be overtransfused, the message may have been lost during a patient handoff when the anesthesia team changed. The first postoperative hematocrit was 50%, the hepatic artery thrombosed, and the patient required retransplantation.

Prior to the full-disclosure policy, it might have been tempting to tell the patient’s parents, "These things happen," he said. While this is true, and it may avoid litigation, it’s not the whole truth. Caregivers would feel bad about it, the clinical safety culture would suffer, nothing would be learned, and the same problem could happen again.

If the physician instead says to the parents, "I’m concerned about what just happened. Let’s talk," the conversation is more difficult and could lead to litigation, but it’s an honest approach that augments doctor-patient trust and the culture of safety, which should make caregivers feel better, he said.

"Let’s talk" does not mean the surgeon should make reckless comments, Dr. Campbell stressed. It would not be helpful to say, "Anesthesia is incompetent," or "The fellow dropped the ball," or "I should have been notified earlier," or "I did a perfect operation," or "Somebody’s head will roll," for example.

Disclosing an unanticipated outcome should sound something like the following, he suggested: "This was an unexpected result. I am going to investigate fully. You have the right to know the whole story – the facts. I will tell you what I learn, but not right now."

That provides a window for exploring other possible complications in the case he described, he said. There may have been a laboratory or transcription error. An artery may have been open at the time of reexploration and not seen on relatively insensitive ultrasound. A technical error could have been made, or the patient may have had a humorally mediated rejection of the organ.

The full-disclosure policy is "pretty dramatically different than what we’ve done before," he said.

Dr. Campbell said he has no relevant conflicts of interest.