Bruce K. Dixon

CHICAGO — The once-dismissed unicompartmental knee arthroplasty is regaining popularity due to its specific advantages in certain patients, compared with total knee arthroplasty, according to Dr. Bryan J. Nestor of the Hospital for Special Surgery in New York.

“It's an operation that's seen renewed interest over the last 10 years and I think for some good reasons,” Dr. Nestor said at a symposium sponsored by the American College of Rheumatology.

Indications for unicompartmental knee replacement (UKR), also called minimally invasive partial knee surgery, include:

▸ Isolated medial or lateral joint disease.

▸ Minimal and correctable deformity.

▸ Flexion contracture less than 5 degrees.

▸ Flexion greater than 115 degrees.

▸ Patient weight under 200 pounds.

“That leaves about 10% of the patients I see who have severe arthritis of the knee and are candidates for unicompartmental knee replacement,” said Dr. Nestor. He described the procedure as less invasive than total knee arthroplasty (TKA).

“If you're only bending to 110 degrees preoperatively, you're not going to gain that motion postoperatively and are better served with a TKA. However, if you're bending 130–135 degrees, which we sometimes see with isolated unicompartmental arthritis, doing a total knee [arthroplasty] may cause the patient to lose motion and I have to counsel him accordingly, as the average motion after total knee replacement is only about 115 degrees. With a unicompartmental knee I can feel pretty comfortable that I will preserve that 130-degree arc of motion,” he said.

In Dr. Nestor's experience, about half of UKR patients leave the hospital within 2–3 days, and many of these are bending beyond 90 degrees and can do outpatient rehabilitation. Further, many feel better by the 6th week, “whereas with total knee replacement we don't usually see that much self-reported improvement until 3 months,” he said. “More importantly, patients will tell you that the knee feels like a normal knee.”

“This technique is associated with a failure rate of 10%–15% at 10 years, compared with 2% or less for TKA. The unicompartmental procedure can now be revised. Today, a revision of a failed unicompartmental knee replacement approaches the results of a total knee arthroplasty, so we're not burning a bridge and that's why I think the renewed interest in UKR for selected patients is justified.”

CHICAGO — The once-dismissed unicompartmental knee arthroplasty is regaining popularity due to its specific advantages in certain patients, compared with total knee arthroplasty, according to Dr. Bryan J. Nestor of the Hospital for Special Surgery in New York.

“It's an operation that's seen renewed interest over the last 10 years and I think for some good reasons,” Dr. Nestor said at a symposium sponsored by the American College of Rheumatology.

Indications for unicompartmental knee replacement (UKR), also called minimally invasive partial knee surgery, include:

▸ Isolated medial or lateral joint disease.

▸ Minimal and correctable deformity.

▸ Flexion contracture less than 5 degrees.

▸ Flexion greater than 115 degrees.

▸ Patient weight under 200 pounds.

“That leaves about 10% of the patients I see who have severe arthritis of the knee and are candidates for unicompartmental knee replacement,” said Dr. Nestor. He described the procedure as less invasive than total knee arthroplasty (TKA).

“If you're only bending to 110 degrees preoperatively, you're not going to gain that motion postoperatively and are better served with a TKA. However, if you're bending 130–135 degrees, which we sometimes see with isolated unicompartmental arthritis, doing a total knee [arthroplasty] may cause the patient to lose motion and I have to counsel him accordingly, as the average motion after total knee replacement is only about 115 degrees. With a unicompartmental knee I can feel pretty comfortable that I will preserve that 130-degree arc of motion,” he said.

In Dr. Nestor's experience, about half of UKR patients leave the hospital within 2–3 days, and many of these are bending beyond 90 degrees and can do outpatient rehabilitation. Further, many feel better by the 6th week, “whereas with total knee replacement we don't usually see that much self-reported improvement until 3 months,” he said. “More importantly, patients will tell you that the knee feels like a normal knee.”

“This technique is associated with a failure rate of 10%–15% at 10 years, compared with 2% or less for TKA. The unicompartmental procedure can now be revised. Today, a revision of a failed unicompartmental knee replacement approaches the results of a total knee arthroplasty, so we're not burning a bridge and that's why I think the renewed interest in UKR for selected patients is justified.”

CHICAGO — The once-dismissed unicompartmental knee arthroplasty is regaining popularity due to its specific advantages in certain patients, compared with total knee arthroplasty, according to Dr. Bryan J. Nestor of the Hospital for Special Surgery in New York.

“It's an operation that's seen renewed interest over the last 10 years and I think for some good reasons,” Dr. Nestor said at a symposium sponsored by the American College of Rheumatology.

Indications for unicompartmental knee replacement (UKR), also called minimally invasive partial knee surgery, include:

▸ Isolated medial or lateral joint disease.

▸ Minimal and correctable deformity.

▸ Flexion contracture less than 5 degrees.

▸ Flexion greater than 115 degrees.

▸ Patient weight under 200 pounds.

“That leaves about 10% of the patients I see who have severe arthritis of the knee and are candidates for unicompartmental knee replacement,” said Dr. Nestor. He described the procedure as less invasive than total knee arthroplasty (TKA).

“If you're only bending to 110 degrees preoperatively, you're not going to gain that motion postoperatively and are better served with a TKA. However, if you're bending 130–135 degrees, which we sometimes see with isolated unicompartmental arthritis, doing a total knee [arthroplasty] may cause the patient to lose motion and I have to counsel him accordingly, as the average motion after total knee replacement is only about 115 degrees. With a unicompartmental knee I can feel pretty comfortable that I will preserve that 130-degree arc of motion,” he said.

In Dr. Nestor's experience, about half of UKR patients leave the hospital within 2–3 days, and many of these are bending beyond 90 degrees and can do outpatient rehabilitation. Further, many feel better by the 6th week, “whereas with total knee replacement we don't usually see that much self-reported improvement until 3 months,” he said. “More importantly, patients will tell you that the knee feels like a normal knee.”

“This technique is associated with a failure rate of 10%–15% at 10 years, compared with 2% or less for TKA. The unicompartmental procedure can now be revised. Today, a revision of a failed unicompartmental knee replacement approaches the results of a total knee arthroplasty, so we're not burning a bridge and that's why I think the renewed interest in UKR for selected patients is justified.”

CHICAGO — Less invasive hip and knee arthroplasty techniques continue to progress and bring new advantages for patients, said Dr. Bryan J. Nestor.

Anterior two-incision total hip arthroplasty (THA), only recently touted as being “revolutionary,” is falling into disfavor and many surgeons have abandoned this approach, said Dr. Nestor at a symposium sponsored by the American College of Rheumatology. “There are indications that the two-incision THA causes significant gluteus medius and minimus muscle destruction, so muscle sparing it's probably not,” he said. Furthermore, the piriformis and conjoint tendons, which are the external rotators of the hip, are ruptured or damaged in about 70% of patients, “and you can't repair them. But most humbling has been the high complication rate associated with this procedure in the hands of very experienced total hip surgeons: femoral fracture, neuropraxia, a 25% incidence of lateral femoral cutaneous nerve palsies, and a 5%–10% reoperation rate,” said Dr. Nestor of the Hospital for Special Surgery, New York.

The approach favored by Dr. Nestor is the posterior mini-incision THA. With this procedure, surgeons can gradually decrease the lengths of their incisions. It also affords good direct visualization and works well with cemented or uncemented components. The dislocation rate with posterior mini-incision THA is unchanged from that of the standard approach, recovery may be less painful, and it produces only one relatively small scar. Patient body mass index should ideally be under 30 kg/m

“It's important to avoid the mini incision in complicated THA; patients who require hardware removal, osteotomy correction, or bone grafting at the time of the procedure are not candidates for a limited exposure to the hip,” Dr. Nestor said, going on to describe the procedure: “The incision is placed along the posterior border of the greater trochanter, about 6–10 cm in length. It's slightly angulated anteriorly at the distal point, and it's centered on a point midway between the tip of the trochanter and the vastus ridge. Proximal extension of the incision facilitates femoral exposure, and distal extension facilitates acetabular exposure,” he said.

Dr. Nestor is heading an ongoing study comparing 55 patients (62 hips) who underwent the mini posterior approach with 38 patients (46 hips) who had the standard surgical approach. Most of the stems were cemented. From 6-week to 1-year follow-up, there was no difference in clinical performance as measured by the Harris Hip Score. In addition, there were no significant differences in cup positioning, femoral component positioning, blood loss, or complications between the two groups. “Interestingly, there were more superficial wound problems in the standard approach than in the mini approach, and that probably reflects the larger body mass index of patients in the standard incision group,” he said, concluding that the mini THA incision can be done safely.

CHICAGO — Less invasive hip and knee arthroplasty techniques continue to progress and bring new advantages for patients, said Dr. Bryan J. Nestor.

Anterior two-incision total hip arthroplasty (THA), only recently touted as being “revolutionary,” is falling into disfavor and many surgeons have abandoned this approach, said Dr. Nestor at a symposium sponsored by the American College of Rheumatology. “There are indications that the two-incision THA causes significant gluteus medius and minimus muscle destruction, so muscle sparing it's probably not,” he said. Furthermore, the piriformis and conjoint tendons, which are the external rotators of the hip, are ruptured or damaged in about 70% of patients, “and you can't repair them. But most humbling has been the high complication rate associated with this procedure in the hands of very experienced total hip surgeons: femoral fracture, neuropraxia, a 25% incidence of lateral femoral cutaneous nerve palsies, and a 5%–10% reoperation rate,” said Dr. Nestor of the Hospital for Special Surgery, New York.

The approach favored by Dr. Nestor is the posterior mini-incision THA. With this procedure, surgeons can gradually decrease the lengths of their incisions. It also affords good direct visualization and works well with cemented or uncemented components. The dislocation rate with posterior mini-incision THA is unchanged from that of the standard approach, recovery may be less painful, and it produces only one relatively small scar. Patient body mass index should ideally be under 30 kg/m

“It's important to avoid the mini incision in complicated THA; patients who require hardware removal, osteotomy correction, or bone grafting at the time of the procedure are not candidates for a limited exposure to the hip,” Dr. Nestor said, going on to describe the procedure: “The incision is placed along the posterior border of the greater trochanter, about 6–10 cm in length. It's slightly angulated anteriorly at the distal point, and it's centered on a point midway between the tip of the trochanter and the vastus ridge. Proximal extension of the incision facilitates femoral exposure, and distal extension facilitates acetabular exposure,” he said.

Dr. Nestor is heading an ongoing study comparing 55 patients (62 hips) who underwent the mini posterior approach with 38 patients (46 hips) who had the standard surgical approach. Most of the stems were cemented. From 6-week to 1-year follow-up, there was no difference in clinical performance as measured by the Harris Hip Score. In addition, there were no significant differences in cup positioning, femoral component positioning, blood loss, or complications between the two groups. “Interestingly, there were more superficial wound problems in the standard approach than in the mini approach, and that probably reflects the larger body mass index of patients in the standard incision group,” he said, concluding that the mini THA incision can be done safely.

CHICAGO — Less invasive hip and knee arthroplasty techniques continue to progress and bring new advantages for patients, said Dr. Bryan J. Nestor.

Anterior two-incision total hip arthroplasty (THA), only recently touted as being “revolutionary,” is falling into disfavor and many surgeons have abandoned this approach, said Dr. Nestor at a symposium sponsored by the American College of Rheumatology. “There are indications that the two-incision THA causes significant gluteus medius and minimus muscle destruction, so muscle sparing it's probably not,” he said. Furthermore, the piriformis and conjoint tendons, which are the external rotators of the hip, are ruptured or damaged in about 70% of patients, “and you can't repair them. But most humbling has been the high complication rate associated with this procedure in the hands of very experienced total hip surgeons: femoral fracture, neuropraxia, a 25% incidence of lateral femoral cutaneous nerve palsies, and a 5%–10% reoperation rate,” said Dr. Nestor of the Hospital for Special Surgery, New York.

The approach favored by Dr. Nestor is the posterior mini-incision THA. With this procedure, surgeons can gradually decrease the lengths of their incisions. It also affords good direct visualization and works well with cemented or uncemented components. The dislocation rate with posterior mini-incision THA is unchanged from that of the standard approach, recovery may be less painful, and it produces only one relatively small scar. Patient body mass index should ideally be under 30 kg/m

“It's important to avoid the mini incision in complicated THA; patients who require hardware removal, osteotomy correction, or bone grafting at the time of the procedure are not candidates for a limited exposure to the hip,” Dr. Nestor said, going on to describe the procedure: “The incision is placed along the posterior border of the greater trochanter, about 6–10 cm in length. It's slightly angulated anteriorly at the distal point, and it's centered on a point midway between the tip of the trochanter and the vastus ridge. Proximal extension of the incision facilitates femoral exposure, and distal extension facilitates acetabular exposure,” he said.

Dr. Nestor is heading an ongoing study comparing 55 patients (62 hips) who underwent the mini posterior approach with 38 patients (46 hips) who had the standard surgical approach. Most of the stems were cemented. From 6-week to 1-year follow-up, there was no difference in clinical performance as measured by the Harris Hip Score. In addition, there were no significant differences in cup positioning, femoral component positioning, blood loss, or complications between the two groups. “Interestingly, there were more superficial wound problems in the standard approach than in the mini approach, and that probably reflects the larger body mass index of patients in the standard incision group,” he said, concluding that the mini THA incision can be done safely.

CHICAGO — Family history plays a larger role in Barrett's esophagus and associated cancers than was previously recognized, according to Dr. Amitabh Chak.

“There's clearly an inheritance pattern that suggests an autosomal dominant disease,” said Dr. Chak at the annual Midwestern clinical research meeting.

Efforts to track down a genetic basis for Barrett's esophagus (BE) and related adenocarcinomas began with a cross-sectional pilot study in which Dr. Chak, a gastroenterologist at Case Western Reserve University, Cleveland, and his colleagues compared 56 patients with BE or adenocarcinoma of the esophagus or gastroesophageal junction with 106 controls who had gastroesophageal reflux.

“The Barrett's and esophageal cancer cases reported a positive family history for these diseases significantly more often than did the reflux controls,” Dr. Chak said at the meeting of the Central Society for Clinical Research and the Midwestern Section of the American Federation for Medical Research.

“That pilot study led us to formulate the more focused hypothesis that BE and associated cancers are complex genetic diseases with a combined underlying genetic and environmental cause. I think there's an inherited susceptibility to develop intestinal metaplasia, but that susceptibility may be present in only a subset of these patients who have this disease,” he said.

To test their hypothesis, the investigators went on a “gene hunt,” beginning with the endoscopic screening of relatives with BE or esophageal cancer. The breakthrough came with the identification of a large family with 13 affected members. The findings showed an inheritance pattern that suggested an autosomal dominant disease, Dr. Chak said.

With the help of investigators in the Familial Barrett's Esophagus Consortium, the Case Western team began to accumulate prospective data on affected families and published its first report on phenotype and demographics in 2004. They found endoscopy-identified esophageal cancer and BE in a substantial proportion of first-degree relatives of affected members of 69 families. In addition, a familial susceptibility to develop Barrett's epithelium appeared to be present in a subset of patients with BE and esophageal cancer (Am. J. Gastroenterol. 2004;99:2107–14).

The database, which has now grown to include 140 families, shows that 7.3% of 413 probands have a confirmed affected (with BE or esophageal cancer) first-degree or second-degree relative.

“We compared the risk factors for BE in familial and nonfamilial BE and esophageal cancer, and the main difference was that familial patients with cancer have a lower body mass index at diagnosis and at 1, 5, and 10 years before diagnosis,” he said, adding that familial Barrett's esophagus probands with cancer may be less obese and have shorter durations of obesity than those with apparently “sporadic” cancer.

The researchers currently are conducting linkage analysis to identify putative susceptibility genes and confirm their hypothesis. Meanwhile, Dr. Chak's recommendation is that all susceptible patients be screened endoscopically, which can be done relatively quickly and without sedation using an ultrathin endoscope.

Screening should include individuals with reflux who have two or more family members with Barrett's esophagus or esophageal cancer, one of whom is a first-degree relative (parent, sibling, or child), Dr. Chak said in an interview.

An unusual incidence of disease in second-degree relatives should raise suspicion, he added.

CHICAGO — Family history plays a larger role in Barrett's esophagus and associated cancers than was previously recognized, according to Dr. Amitabh Chak.

“There's clearly an inheritance pattern that suggests an autosomal dominant disease,” said Dr. Chak at the annual Midwestern clinical research meeting.

Efforts to track down a genetic basis for Barrett's esophagus (BE) and related adenocarcinomas began with a cross-sectional pilot study in which Dr. Chak, a gastroenterologist at Case Western Reserve University, Cleveland, and his colleagues compared 56 patients with BE or adenocarcinoma of the esophagus or gastroesophageal junction with 106 controls who had gastroesophageal reflux.

“The Barrett's and esophageal cancer cases reported a positive family history for these diseases significantly more often than did the reflux controls,” Dr. Chak said at the meeting of the Central Society for Clinical Research and the Midwestern Section of the American Federation for Medical Research.

“That pilot study led us to formulate the more focused hypothesis that BE and associated cancers are complex genetic diseases with a combined underlying genetic and environmental cause. I think there's an inherited susceptibility to develop intestinal metaplasia, but that susceptibility may be present in only a subset of these patients who have this disease,” he said.

To test their hypothesis, the investigators went on a “gene hunt,” beginning with the endoscopic screening of relatives with BE or esophageal cancer. The breakthrough came with the identification of a large family with 13 affected members. The findings showed an inheritance pattern that suggested an autosomal dominant disease, Dr. Chak said.

With the help of investigators in the Familial Barrett's Esophagus Consortium, the Case Western team began to accumulate prospective data on affected families and published its first report on phenotype and demographics in 2004. They found endoscopy-identified esophageal cancer and BE in a substantial proportion of first-degree relatives of affected members of 69 families. In addition, a familial susceptibility to develop Barrett's epithelium appeared to be present in a subset of patients with BE and esophageal cancer (Am. J. Gastroenterol. 2004;99:2107–14).

The database, which has now grown to include 140 families, shows that 7.3% of 413 probands have a confirmed affected (with BE or esophageal cancer) first-degree or second-degree relative.

“We compared the risk factors for BE in familial and nonfamilial BE and esophageal cancer, and the main difference was that familial patients with cancer have a lower body mass index at diagnosis and at 1, 5, and 10 years before diagnosis,” he said, adding that familial Barrett's esophagus probands with cancer may be less obese and have shorter durations of obesity than those with apparently “sporadic” cancer.

The researchers currently are conducting linkage analysis to identify putative susceptibility genes and confirm their hypothesis. Meanwhile, Dr. Chak's recommendation is that all susceptible patients be screened endoscopically, which can be done relatively quickly and without sedation using an ultrathin endoscope.

Screening should include individuals with reflux who have two or more family members with Barrett's esophagus or esophageal cancer, one of whom is a first-degree relative (parent, sibling, or child), Dr. Chak said in an interview.

An unusual incidence of disease in second-degree relatives should raise suspicion, he added.

CHICAGO — Family history plays a larger role in Barrett's esophagus and associated cancers than was previously recognized, according to Dr. Amitabh Chak.

“There's clearly an inheritance pattern that suggests an autosomal dominant disease,” said Dr. Chak at the annual Midwestern clinical research meeting.

Efforts to track down a genetic basis for Barrett's esophagus (BE) and related adenocarcinomas began with a cross-sectional pilot study in which Dr. Chak, a gastroenterologist at Case Western Reserve University, Cleveland, and his colleagues compared 56 patients with BE or adenocarcinoma of the esophagus or gastroesophageal junction with 106 controls who had gastroesophageal reflux.

“The Barrett's and esophageal cancer cases reported a positive family history for these diseases significantly more often than did the reflux controls,” Dr. Chak said at the meeting of the Central Society for Clinical Research and the Midwestern Section of the American Federation for Medical Research.

“That pilot study led us to formulate the more focused hypothesis that BE and associated cancers are complex genetic diseases with a combined underlying genetic and environmental cause. I think there's an inherited susceptibility to develop intestinal metaplasia, but that susceptibility may be present in only a subset of these patients who have this disease,” he said.

To test their hypothesis, the investigators went on a “gene hunt,” beginning with the endoscopic screening of relatives with BE or esophageal cancer. The breakthrough came with the identification of a large family with 13 affected members. The findings showed an inheritance pattern that suggested an autosomal dominant disease, Dr. Chak said.

With the help of investigators in the Familial Barrett's Esophagus Consortium, the Case Western team began to accumulate prospective data on affected families and published its first report on phenotype and demographics in 2004. They found endoscopy-identified esophageal cancer and BE in a substantial proportion of first-degree relatives of affected members of 69 families. In addition, a familial susceptibility to develop Barrett's epithelium appeared to be present in a subset of patients with BE and esophageal cancer (Am. J. Gastroenterol. 2004;99:2107–14).

The database, which has now grown to include 140 families, shows that 7.3% of 413 probands have a confirmed affected (with BE or esophageal cancer) first-degree or second-degree relative.

“We compared the risk factors for BE in familial and nonfamilial BE and esophageal cancer, and the main difference was that familial patients with cancer have a lower body mass index at diagnosis and at 1, 5, and 10 years before diagnosis,” he said, adding that familial Barrett's esophagus probands with cancer may be less obese and have shorter durations of obesity than those with apparently “sporadic” cancer.

The researchers currently are conducting linkage analysis to identify putative susceptibility genes and confirm their hypothesis. Meanwhile, Dr. Chak's recommendation is that all susceptible patients be screened endoscopically, which can be done relatively quickly and without sedation using an ultrathin endoscope.

Screening should include individuals with reflux who have two or more family members with Barrett's esophagus or esophageal cancer, one of whom is a first-degree relative (parent, sibling, or child), Dr. Chak said in an interview.

An unusual incidence of disease in second-degree relatives should raise suspicion, he added.

SCOTTSDALE, ARIZ. — When a complex lower-extremity wound is unresponsive to conventional treatments and amputation looms as the only option, an acellular regenerative tissue matrix can be effective, Brock A. Liden, D.P.M., said at the annual meeting of the Wound Healing Society.

"Bioengineered skin grafts have become a promising alternative for the treatment of chronic, nonhealing, full-thickness lower-extremity wounds," said Dr. Liden, whose retrospective study evaluated the Graftjacket (Wright Medical Technology Inc.) human acellular dermal matrix.

"The matrix maintains a moist wound environment during the incorporation phase of wound healing and provides a barrier to the outside to reduce the chance of infection, and granulation tissue forms within 5–7 days, reducing the depth of wounds," explained Dr. Liden, a podiatrist in Circleville, Ohio.

The double-layered membrane, which prompts revascularization of the reticular layer and wound closure, can be applied over tendon and bone.

The regenerative tissue matrix was applied to 23 wounds on 13 patients under a standard protocol, and wounds were assessed using the University of Texas diabetic wound classifications. Dr. Liden said that 12 of the wounds were classified as III-D (infected to the bone) and had poor blood supply.

The cohort's average age was 62 years, with women outnumbering men 3:2. Nearly all patients had cardiac disease, while 78% were diabetic, 69% had infection on initial presentation, 65% had osteomyelitis initially, and 91% had peripheral vascular disease. The average age of treated wounds was 17 weeks.

"This was not front-line defense," explained Dr. Liden. "Everything else had failed for these patients." The defense held, with all but two of the patients achieving complete healing.

One exception was a woman who had stepped on a nail, developed an abscess, and required amputation.

The other was a noncompliant man who was successfully treated on a second attempt.

"The average time to graft incorporation, which is what I consider to be the most important part of the treatment, was about 1 week, and we averaged about 12 weeks to complete healing. The quickest we healed was 3 weeks and the slowest was 30 weeks," Dr. Liden explained. "This acellular tissue matrix is safe and efficacious for complex lower-extremity wounds and is universally applicable."

Graftjacket has several advantages over conventional wound coverings. "It has extremely high tensile strength, retains its vascular channels, and incorporates and converts in the host tissue. The collagen in this product is utilized rather than replaced. Also, its acellular structure eliminates worry about inflammation and rejection," he said, adding that growth factors FGF2 and VEGF are present in the product upon application.

When the graft is used on a full-thickness wound, he explained, it's important to remove as much necrotic tissue as possible and try to get down to the bleeding wound bed.

"Make sure the graft doesn't 'tent,' which occurs when you don't make maximum contact with the wound. And watch for bleeding, which can lift the graft away from the wound bed," Dr. Liden said. He added that the matrix has to be anchored down like a skin graft to eliminate motion.

"The more motion that occurs, the higher the chance of failure," he said, advising against the use of Steri-Strips. "You can lay this over necrotic tissue, bone, or tendon—all of which I've done without problems."

Dr. Liden acknowledged receiving a retainer, contribution to research funds, and contribution to travel funds from Wright Medical.

SCOTTSDALE, ARIZ. — When a complex lower-extremity wound is unresponsive to conventional treatments and amputation looms as the only option, an acellular regenerative tissue matrix can be effective, Brock A. Liden, D.P.M., said at the annual meeting of the Wound Healing Society.

"Bioengineered skin grafts have become a promising alternative for the treatment of chronic, nonhealing, full-thickness lower-extremity wounds," said Dr. Liden, whose retrospective study evaluated the Graftjacket (Wright Medical Technology Inc.) human acellular dermal matrix.

"The matrix maintains a moist wound environment during the incorporation phase of wound healing and provides a barrier to the outside to reduce the chance of infection, and granulation tissue forms within 5–7 days, reducing the depth of wounds," explained Dr. Liden, a podiatrist in Circleville, Ohio.

The double-layered membrane, which prompts revascularization of the reticular layer and wound closure, can be applied over tendon and bone.

The regenerative tissue matrix was applied to 23 wounds on 13 patients under a standard protocol, and wounds were assessed using the University of Texas diabetic wound classifications. Dr. Liden said that 12 of the wounds were classified as III-D (infected to the bone) and had poor blood supply.

The cohort's average age was 62 years, with women outnumbering men 3:2. Nearly all patients had cardiac disease, while 78% were diabetic, 69% had infection on initial presentation, 65% had osteomyelitis initially, and 91% had peripheral vascular disease. The average age of treated wounds was 17 weeks.

"This was not front-line defense," explained Dr. Liden. "Everything else had failed for these patients." The defense held, with all but two of the patients achieving complete healing.

One exception was a woman who had stepped on a nail, developed an abscess, and required amputation.

The other was a noncompliant man who was successfully treated on a second attempt.

"The average time to graft incorporation, which is what I consider to be the most important part of the treatment, was about 1 week, and we averaged about 12 weeks to complete healing. The quickest we healed was 3 weeks and the slowest was 30 weeks," Dr. Liden explained. "This acellular tissue matrix is safe and efficacious for complex lower-extremity wounds and is universally applicable."

Graftjacket has several advantages over conventional wound coverings. "It has extremely high tensile strength, retains its vascular channels, and incorporates and converts in the host tissue. The collagen in this product is utilized rather than replaced. Also, its acellular structure eliminates worry about inflammation and rejection," he said, adding that growth factors FGF2 and VEGF are present in the product upon application.

When the graft is used on a full-thickness wound, he explained, it's important to remove as much necrotic tissue as possible and try to get down to the bleeding wound bed.

"Make sure the graft doesn't 'tent,' which occurs when you don't make maximum contact with the wound. And watch for bleeding, which can lift the graft away from the wound bed," Dr. Liden said. He added that the matrix has to be anchored down like a skin graft to eliminate motion.

"The more motion that occurs, the higher the chance of failure," he said, advising against the use of Steri-Strips. "You can lay this over necrotic tissue, bone, or tendon—all of which I've done without problems."

Dr. Liden acknowledged receiving a retainer, contribution to research funds, and contribution to travel funds from Wright Medical.

SCOTTSDALE, ARIZ. — When a complex lower-extremity wound is unresponsive to conventional treatments and amputation looms as the only option, an acellular regenerative tissue matrix can be effective, Brock A. Liden, D.P.M., said at the annual meeting of the Wound Healing Society.

"Bioengineered skin grafts have become a promising alternative for the treatment of chronic, nonhealing, full-thickness lower-extremity wounds," said Dr. Liden, whose retrospective study evaluated the Graftjacket (Wright Medical Technology Inc.) human acellular dermal matrix.

"The matrix maintains a moist wound environment during the incorporation phase of wound healing and provides a barrier to the outside to reduce the chance of infection, and granulation tissue forms within 5–7 days, reducing the depth of wounds," explained Dr. Liden, a podiatrist in Circleville, Ohio.

The double-layered membrane, which prompts revascularization of the reticular layer and wound closure, can be applied over tendon and bone.

The regenerative tissue matrix was applied to 23 wounds on 13 patients under a standard protocol, and wounds were assessed using the University of Texas diabetic wound classifications. Dr. Liden said that 12 of the wounds were classified as III-D (infected to the bone) and had poor blood supply.

The cohort's average age was 62 years, with women outnumbering men 3:2. Nearly all patients had cardiac disease, while 78% were diabetic, 69% had infection on initial presentation, 65% had osteomyelitis initially, and 91% had peripheral vascular disease. The average age of treated wounds was 17 weeks.

"This was not front-line defense," explained Dr. Liden. "Everything else had failed for these patients." The defense held, with all but two of the patients achieving complete healing.

One exception was a woman who had stepped on a nail, developed an abscess, and required amputation.

The other was a noncompliant man who was successfully treated on a second attempt.

"The average time to graft incorporation, which is what I consider to be the most important part of the treatment, was about 1 week, and we averaged about 12 weeks to complete healing. The quickest we healed was 3 weeks and the slowest was 30 weeks," Dr. Liden explained. "This acellular tissue matrix is safe and efficacious for complex lower-extremity wounds and is universally applicable."

Graftjacket has several advantages over conventional wound coverings. "It has extremely high tensile strength, retains its vascular channels, and incorporates and converts in the host tissue. The collagen in this product is utilized rather than replaced. Also, its acellular structure eliminates worry about inflammation and rejection," he said, adding that growth factors FGF2 and VEGF are present in the product upon application.

When the graft is used on a full-thickness wound, he explained, it's important to remove as much necrotic tissue as possible and try to get down to the bleeding wound bed.

"Make sure the graft doesn't 'tent,' which occurs when you don't make maximum contact with the wound. And watch for bleeding, which can lift the graft away from the wound bed," Dr. Liden said. He added that the matrix has to be anchored down like a skin graft to eliminate motion.

"The more motion that occurs, the higher the chance of failure," he said, advising against the use of Steri-Strips. "You can lay this over necrotic tissue, bone, or tendon—all of which I've done without problems."

Dr. Liden acknowledged receiving a retainer, contribution to research funds, and contribution to travel funds from Wright Medical.

SCOTTSDALE, ARIZ. — The use of topical autologous human platelets was safe and effective for treating dermal wounds in two preliminary studies presented at the annual meeting of the Wound Healing Society.

"Our pilot study provides preliminary evidence that topical autologous platelet gel may hasten wound closure in full-thickness dermal wounds in healthy individuals," said Dr. David B. Hom of the University of Minnesota Hospital and Clinic in Minneapolis.

Animal studies have shown autologous platelet gel's (APG's) ability to increase wound granulation and organize collagen bundles, but its performance in treating animal wounds has been mixed. Clinical studies, however, have been promising.

To compare APG with conventional wound treatment, Dr. Hom and his associates created 80 full-thickness skin-punch wounds, each 6 mm in diameter, on the thighs of four men and four women. With each person serving as his or her own control, APG was applied topically to five sites per leg, while the opposite thigh had an antibiotic ointment and/or a semiocclusive dressing applied as the control, also on five punch sites per leg.

Biopsies showed that wound closure occurred significantly faster in the APG-treated sites. On day 17, the APG sites were, on average, 81% closed, vs. 57% for controls.

The biopsy findings correlated with digital planimetry photographic measurements taken over a 42-day period, and the APG wounds closed significantly faster than the controls within 14 days of wounding. "At 28 and 31 days, half of APG-treated wounds reached full closure vs. 15% of controls, though the controls did catch up by day 42," Dr. Hom explained.

Experimental and control sites over time were histologically similar. "APG should not be used in its present state in patients allergic to bovine products," he cautioned.

In another presentation at the meeting, New Jersey researchers reported that a thrombin-free autologous platelet-rich fibrin matrix (PRFM) "appears to show significant potential for accelerating complete closure of chronic venous leg ulcers and maintains an extended-release source of growth factors, obviating the potential harmful potential of bovine thrombin," which is used in other dressings, including APG. Bovine thrombin can trigger a harmful immune response.

The ongoing prospective study, led by Sean M. O'Connell, Ph.D., involved 11 patients with venous leg ulcers and 6 with nonvenous leg ulcers, all of which had been unresponsive to a variety of standard treatments for at least 4 months. Each PRFM-treated patient received up to three applications of a 50-mm fenestrated membrane. PRFM was prepared at bedside from 36 mL of whole blood from which platelet-rich plasma was isolated and processed to produce a 100-μm-thick membrane with 50–100 times the platelet-fibrin concentration of whole blood.

By 8 weeks, closure was complete in 7 of the 11 patients with venous leg ulcers. In the nonvenous ulcer group, 50% closure was achieved, said Dr. O'Connell of Englewood (N.J.) Hospital and Medical Center and Mount Sinai School of Medicine in New York. "We see a sustained and consistent release of growth factors over the first 7 days," he said in an interview.

Dr. Hom acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Medtronic Inc. Dr. O'Connell acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Cascade Medical Enterprises LLC.

ELSEVIER GLOBAL MEDICAL NEWS

SCOTTSDALE, ARIZ. — The use of topical autologous human platelets was safe and effective for treating dermal wounds in two preliminary studies presented at the annual meeting of the Wound Healing Society.

"Our pilot study provides preliminary evidence that topical autologous platelet gel may hasten wound closure in full-thickness dermal wounds in healthy individuals," said Dr. David B. Hom of the University of Minnesota Hospital and Clinic in Minneapolis.

Animal studies have shown autologous platelet gel's (APG's) ability to increase wound granulation and organize collagen bundles, but its performance in treating animal wounds has been mixed. Clinical studies, however, have been promising.

To compare APG with conventional wound treatment, Dr. Hom and his associates created 80 full-thickness skin-punch wounds, each 6 mm in diameter, on the thighs of four men and four women. With each person serving as his or her own control, APG was applied topically to five sites per leg, while the opposite thigh had an antibiotic ointment and/or a semiocclusive dressing applied as the control, also on five punch sites per leg.

Biopsies showed that wound closure occurred significantly faster in the APG-treated sites. On day 17, the APG sites were, on average, 81% closed, vs. 57% for controls.

The biopsy findings correlated with digital planimetry photographic measurements taken over a 42-day period, and the APG wounds closed significantly faster than the controls within 14 days of wounding. "At 28 and 31 days, half of APG-treated wounds reached full closure vs. 15% of controls, though the controls did catch up by day 42," Dr. Hom explained.

Experimental and control sites over time were histologically similar. "APG should not be used in its present state in patients allergic to bovine products," he cautioned.

In another presentation at the meeting, New Jersey researchers reported that a thrombin-free autologous platelet-rich fibrin matrix (PRFM) "appears to show significant potential for accelerating complete closure of chronic venous leg ulcers and maintains an extended-release source of growth factors, obviating the potential harmful potential of bovine thrombin," which is used in other dressings, including APG. Bovine thrombin can trigger a harmful immune response.

The ongoing prospective study, led by Sean M. O'Connell, Ph.D., involved 11 patients with venous leg ulcers and 6 with nonvenous leg ulcers, all of which had been unresponsive to a variety of standard treatments for at least 4 months. Each PRFM-treated patient received up to three applications of a 50-mm fenestrated membrane. PRFM was prepared at bedside from 36 mL of whole blood from which platelet-rich plasma was isolated and processed to produce a 100-μm-thick membrane with 50–100 times the platelet-fibrin concentration of whole blood.

By 8 weeks, closure was complete in 7 of the 11 patients with venous leg ulcers. In the nonvenous ulcer group, 50% closure was achieved, said Dr. O'Connell of Englewood (N.J.) Hospital and Medical Center and Mount Sinai School of Medicine in New York. "We see a sustained and consistent release of growth factors over the first 7 days," he said in an interview.

Dr. Hom acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Medtronic Inc. Dr. O'Connell acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Cascade Medical Enterprises LLC.

ELSEVIER GLOBAL MEDICAL NEWS

SCOTTSDALE, ARIZ. — The use of topical autologous human platelets was safe and effective for treating dermal wounds in two preliminary studies presented at the annual meeting of the Wound Healing Society.

"Our pilot study provides preliminary evidence that topical autologous platelet gel may hasten wound closure in full-thickness dermal wounds in healthy individuals," said Dr. David B. Hom of the University of Minnesota Hospital and Clinic in Minneapolis.

Animal studies have shown autologous platelet gel's (APG's) ability to increase wound granulation and organize collagen bundles, but its performance in treating animal wounds has been mixed. Clinical studies, however, have been promising.

To compare APG with conventional wound treatment, Dr. Hom and his associates created 80 full-thickness skin-punch wounds, each 6 mm in diameter, on the thighs of four men and four women. With each person serving as his or her own control, APG was applied topically to five sites per leg, while the opposite thigh had an antibiotic ointment and/or a semiocclusive dressing applied as the control, also on five punch sites per leg.

Biopsies showed that wound closure occurred significantly faster in the APG-treated sites. On day 17, the APG sites were, on average, 81% closed, vs. 57% for controls.

The biopsy findings correlated with digital planimetry photographic measurements taken over a 42-day period, and the APG wounds closed significantly faster than the controls within 14 days of wounding. "At 28 and 31 days, half of APG-treated wounds reached full closure vs. 15% of controls, though the controls did catch up by day 42," Dr. Hom explained.

Experimental and control sites over time were histologically similar. "APG should not be used in its present state in patients allergic to bovine products," he cautioned.

In another presentation at the meeting, New Jersey researchers reported that a thrombin-free autologous platelet-rich fibrin matrix (PRFM) "appears to show significant potential for accelerating complete closure of chronic venous leg ulcers and maintains an extended-release source of growth factors, obviating the potential harmful potential of bovine thrombin," which is used in other dressings, including APG. Bovine thrombin can trigger a harmful immune response.

The ongoing prospective study, led by Sean M. O'Connell, Ph.D., involved 11 patients with venous leg ulcers and 6 with nonvenous leg ulcers, all of which had been unresponsive to a variety of standard treatments for at least 4 months. Each PRFM-treated patient received up to three applications of a 50-mm fenestrated membrane. PRFM was prepared at bedside from 36 mL of whole blood from which platelet-rich plasma was isolated and processed to produce a 100-μm-thick membrane with 50–100 times the platelet-fibrin concentration of whole blood.

By 8 weeks, closure was complete in 7 of the 11 patients with venous leg ulcers. In the nonvenous ulcer group, 50% closure was achieved, said Dr. O'Connell of Englewood (N.J.) Hospital and Medical Center and Mount Sinai School of Medicine in New York. "We see a sustained and consistent release of growth factors over the first 7 days," he said in an interview.

Dr. Hom acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Medtronic Inc. Dr. O'Connell acknowledges contract payments for research performed and ad hoc consulting fees. His study was funded by Cascade Medical Enterprises LLC.

ELSEVIER GLOBAL MEDICAL NEWS

SCOTTSDALE, ARIZ. — Amputation of the diabetic foot can be prevented by surgical reconstruction using an anterolateral thigh perforator flap, according to a 4-year retrospective study reported by Dr. Joon Pio Hong at the annual meeting of the Wound Healing Society.

“Despite the fact that there is still controversy over whether to amputate or salvage the diabetic foot, anterolateral thigh perforator flaps can be used to achieve independent ambulation, and free microsurgical tissue transfer can be an alternative to amputation if the vascular supply is reliable,” said Dr. Hong, a professor of plastic and reconstructive surgery at the University of Ulsan College of Medicine, Seoul, Korea.

Between 2000 and 2004, 71 diabetic patients with infected foot ulcers underwent reconstruction with an anterolateral thigh perforator flap at Ulsan Hospital. Osteomyelitis was diagnosed in 36 of the patients using clinical, radiologic, and histologic findings. Five patients had undergone peripheral vascular surgery or intervention before reconstruction, and 35 patients had confirmed peripheral neuropathy. The 50 men and 21 women ranged in age from 33 to 72 years, with an average age of 51.

Prerequisites for surgery included strict blood glucose control, close monitoring of the patients' general condition, and relative control of infection (level of bacteria <105 cells/g of tissue). All patients required lower-extremity angiography, and patients suspected of having osteomyelitis underwent bone scanning, Dr. Hong said.

Transcutaneous oxygen measurements were greater than 30 mm Hg in patients before reconstruction. Through a multidisciplinary approach, a diabetic foot management protocol was applied according to each patient's needs, he said. After evaluation, 216 patients' feet were deemed nonsalvageable.

The operation included aggressive debridement of foot ulcers and necrotic tissues—including removal of nonviable bone tissue. The flap was harvested either as a perforator flap or in combination with the vastus lateralis muscle as a musculocutaneous flap.

The average length of stay in the plastic surgery department was 3.5 weeks, and additional hospitalization of 1–2 weeks was required for rehabilitation. The follow-up period ranged from 2 to 52 months, with an average of 11 months.

“Complete flap survival was noted in 66 cases, partial loss in 4 cases, and total loss in 1 case,” Dr. Hong said.

Three patients had what Dr. Hong described as “minor complications.” Of those, two showed partial wound dehiscence of the flap margin, but healing occurred without surgical management. In one patient, dehiscence and infection of the donor site were noted. Debridement, irrigation, and repair were required to achieve wound healing.

Partial flap loss occurred in four cases; of those, three required secondary skin graft procedures and eventually healed, but the fourth required below-knee amputation because of exposure of vital structures of the distal foot, Dr. Hong said.

Partial weight bearing began an average of 3.5 weeks after the surgery and bipedal gait began at 6 weeks, Dr. Hong said.

Unassisted bipedal gait was noted in 68 cases. One patient with a previous below-knee amputation of the right leg achieved full weight bearing with the reconstructed left foot and prosthesis.

“In cases where sensation of the foot was normal, a sensate flap was used. In these patients, protective sensation was observed as early as 4 months, with a positive response to the 5.07 Semmes-Weinstein monofilament test,” Dr. Hong said. Among the 34 patients who were employed, 25 returned to the same job and 5 found new jobs.

“However, controversy remains regarding which flap—muscle flap with skin grafts or fasciocutaneous flap—offers the optimal solution for reconstructing the foot, especially the weight-bearing surface,” he explained.

A consensus has developed supporting the thin fasciocutaneous flap as being advantageous for reducing shearing, providing a better contour, and increasing the chance for reinnervation. “However, clinical experience with fasciocutaneous flaps for reconstructing the foot has shown that the layer between the skin and the fascia may not be anatomically sufficient to prevent gliding of the skin when pressure is applied,” he said.

“Although a longer follow-up period should [confirm] the efficacy of the microvascular salvage procedure, a high degree of success can be achieved with strict patient selection and guidelines,” Dr. Hong concluded.

The flap is obtained between the anterior superior iliac spine and the lateral margin of the patella.

Anterolateral thigh flaps are ideal for foot reconstruction because they are thin with sufficient vascularity to fight infection and have reliable pedicles. Photos courtesy Dr. Joon Pio Hong

SCOTTSDALE, ARIZ. — Amputation of the diabetic foot can be prevented by surgical reconstruction using an anterolateral thigh perforator flap, according to a 4-year retrospective study reported by Dr. Joon Pio Hong at the annual meeting of the Wound Healing Society.

“Despite the fact that there is still controversy over whether to amputate or salvage the diabetic foot, anterolateral thigh perforator flaps can be used to achieve independent ambulation, and free microsurgical tissue transfer can be an alternative to amputation if the vascular supply is reliable,” said Dr. Hong, a professor of plastic and reconstructive surgery at the University of Ulsan College of Medicine, Seoul, Korea.

Between 2000 and 2004, 71 diabetic patients with infected foot ulcers underwent reconstruction with an anterolateral thigh perforator flap at Ulsan Hospital. Osteomyelitis was diagnosed in 36 of the patients using clinical, radiologic, and histologic findings. Five patients had undergone peripheral vascular surgery or intervention before reconstruction, and 35 patients had confirmed peripheral neuropathy. The 50 men and 21 women ranged in age from 33 to 72 years, with an average age of 51.

Prerequisites for surgery included strict blood glucose control, close monitoring of the patients' general condition, and relative control of infection (level of bacteria <105 cells/g of tissue). All patients required lower-extremity angiography, and patients suspected of having osteomyelitis underwent bone scanning, Dr. Hong said.

Transcutaneous oxygen measurements were greater than 30 mm Hg in patients before reconstruction. Through a multidisciplinary approach, a diabetic foot management protocol was applied according to each patient's needs, he said. After evaluation, 216 patients' feet were deemed nonsalvageable.

The operation included aggressive debridement of foot ulcers and necrotic tissues—including removal of nonviable bone tissue. The flap was harvested either as a perforator flap or in combination with the vastus lateralis muscle as a musculocutaneous flap.

The average length of stay in the plastic surgery department was 3.5 weeks, and additional hospitalization of 1–2 weeks was required for rehabilitation. The follow-up period ranged from 2 to 52 months, with an average of 11 months.

“Complete flap survival was noted in 66 cases, partial loss in 4 cases, and total loss in 1 case,” Dr. Hong said.

Three patients had what Dr. Hong described as “minor complications.” Of those, two showed partial wound dehiscence of the flap margin, but healing occurred without surgical management. In one patient, dehiscence and infection of the donor site were noted. Debridement, irrigation, and repair were required to achieve wound healing.

Partial flap loss occurred in four cases; of those, three required secondary skin graft procedures and eventually healed, but the fourth required below-knee amputation because of exposure of vital structures of the distal foot, Dr. Hong said.

Partial weight bearing began an average of 3.5 weeks after the surgery and bipedal gait began at 6 weeks, Dr. Hong said.

Unassisted bipedal gait was noted in 68 cases. One patient with a previous below-knee amputation of the right leg achieved full weight bearing with the reconstructed left foot and prosthesis.

“In cases where sensation of the foot was normal, a sensate flap was used. In these patients, protective sensation was observed as early as 4 months, with a positive response to the 5.07 Semmes-Weinstein monofilament test,” Dr. Hong said. Among the 34 patients who were employed, 25 returned to the same job and 5 found new jobs.

“However, controversy remains regarding which flap—muscle flap with skin grafts or fasciocutaneous flap—offers the optimal solution for reconstructing the foot, especially the weight-bearing surface,” he explained.

A consensus has developed supporting the thin fasciocutaneous flap as being advantageous for reducing shearing, providing a better contour, and increasing the chance for reinnervation. “However, clinical experience with fasciocutaneous flaps for reconstructing the foot has shown that the layer between the skin and the fascia may not be anatomically sufficient to prevent gliding of the skin when pressure is applied,” he said.

“Although a longer follow-up period should [confirm] the efficacy of the microvascular salvage procedure, a high degree of success can be achieved with strict patient selection and guidelines,” Dr. Hong concluded.

The flap is obtained between the anterior superior iliac spine and the lateral margin of the patella.

Anterolateral thigh flaps are ideal for foot reconstruction because they are thin with sufficient vascularity to fight infection and have reliable pedicles. Photos courtesy Dr. Joon Pio Hong

SCOTTSDALE, ARIZ. — Amputation of the diabetic foot can be prevented by surgical reconstruction using an anterolateral thigh perforator flap, according to a 4-year retrospective study reported by Dr. Joon Pio Hong at the annual meeting of the Wound Healing Society.

“Despite the fact that there is still controversy over whether to amputate or salvage the diabetic foot, anterolateral thigh perforator flaps can be used to achieve independent ambulation, and free microsurgical tissue transfer can be an alternative to amputation if the vascular supply is reliable,” said Dr. Hong, a professor of plastic and reconstructive surgery at the University of Ulsan College of Medicine, Seoul, Korea.

Between 2000 and 2004, 71 diabetic patients with infected foot ulcers underwent reconstruction with an anterolateral thigh perforator flap at Ulsan Hospital. Osteomyelitis was diagnosed in 36 of the patients using clinical, radiologic, and histologic findings. Five patients had undergone peripheral vascular surgery or intervention before reconstruction, and 35 patients had confirmed peripheral neuropathy. The 50 men and 21 women ranged in age from 33 to 72 years, with an average age of 51.

Prerequisites for surgery included strict blood glucose control, close monitoring of the patients' general condition, and relative control of infection (level of bacteria <105 cells/g of tissue). All patients required lower-extremity angiography, and patients suspected of having osteomyelitis underwent bone scanning, Dr. Hong said.

Transcutaneous oxygen measurements were greater than 30 mm Hg in patients before reconstruction. Through a multidisciplinary approach, a diabetic foot management protocol was applied according to each patient's needs, he said. After evaluation, 216 patients' feet were deemed nonsalvageable.

The operation included aggressive debridement of foot ulcers and necrotic tissues—including removal of nonviable bone tissue. The flap was harvested either as a perforator flap or in combination with the vastus lateralis muscle as a musculocutaneous flap.

The average length of stay in the plastic surgery department was 3.5 weeks, and additional hospitalization of 1–2 weeks was required for rehabilitation. The follow-up period ranged from 2 to 52 months, with an average of 11 months.

“Complete flap survival was noted in 66 cases, partial loss in 4 cases, and total loss in 1 case,” Dr. Hong said.

Three patients had what Dr. Hong described as “minor complications.” Of those, two showed partial wound dehiscence of the flap margin, but healing occurred without surgical management. In one patient, dehiscence and infection of the donor site were noted. Debridement, irrigation, and repair were required to achieve wound healing.

Partial flap loss occurred in four cases; of those, three required secondary skin graft procedures and eventually healed, but the fourth required below-knee amputation because of exposure of vital structures of the distal foot, Dr. Hong said.

Partial weight bearing began an average of 3.5 weeks after the surgery and bipedal gait began at 6 weeks, Dr. Hong said.

Unassisted bipedal gait was noted in 68 cases. One patient with a previous below-knee amputation of the right leg achieved full weight bearing with the reconstructed left foot and prosthesis.

“In cases where sensation of the foot was normal, a sensate flap was used. In these patients, protective sensation was observed as early as 4 months, with a positive response to the 5.07 Semmes-Weinstein monofilament test,” Dr. Hong said. Among the 34 patients who were employed, 25 returned to the same job and 5 found new jobs.

“However, controversy remains regarding which flap—muscle flap with skin grafts or fasciocutaneous flap—offers the optimal solution for reconstructing the foot, especially the weight-bearing surface,” he explained.

A consensus has developed supporting the thin fasciocutaneous flap as being advantageous for reducing shearing, providing a better contour, and increasing the chance for reinnervation. “However, clinical experience with fasciocutaneous flaps for reconstructing the foot has shown that the layer between the skin and the fascia may not be anatomically sufficient to prevent gliding of the skin when pressure is applied,” he said.

“Although a longer follow-up period should [confirm] the efficacy of the microvascular salvage procedure, a high degree of success can be achieved with strict patient selection and guidelines,” Dr. Hong concluded.

The flap is obtained between the anterior superior iliac spine and the lateral margin of the patella.

Anterolateral thigh flaps are ideal for foot reconstruction because they are thin with sufficient vascularity to fight infection and have reliable pedicles. Photos courtesy Dr. Joon Pio Hong

CHICAGO — A substantial chasm exists between children and adults when it comes to the diagnosis, course, and treatment of lupus erythematosus, Dr. Kathleen M. O'Neil said at a symposium sponsored by the American College of Rheumatology.

“Kids with lupus are not adults with lupus,” she said, noting that children with prepubertal onset often do not have fatigue but they do have alopecia, whereas teens and adults are more likely to have fatigue. When asked, children will say they feel tired, but their fatigue levels still remain well below those of older kids, according to Dr. O'Neil, professor of pediatric rheumatology at the University of Oklahoma, Oklahoma City.

Children with vague and miscellaneous aches and pains often are evaluated for lupus, and there's a common misconception that a positive antinuclear antibody (ANA) test result is as reliable an indicator of lupus in children as it is in adults. While antinuclear antibody is positive in all children with systemic lupus erythematosus (SLE), an estimated “30%–35% of children who are healthy have a positive ANA, if we use the normal cutoff of 1:40 defined in adults,” she said in an interview.

In addition, the ANA does not discriminate healthy children from children with systemic lupus erythematosus (SLE) unless the titer used is 1:320 or greater. “A misdiagnosis puts parents through unnecessary stress and they get frightened, especially when they research lupus on the Internet,” she said.

Another lab finding that supports a diagnosis of SLE in children is positivity for anti-DNA antibodies, “which are present in 67% of our children with lupus onset over age 13 and 100% of those under age 13.” Evidence of complement consumption and low serum C3 and/or C4 concentrations are also supportive, Dr. O'Neil said.

Complement deficiency and early complement component deficiencies may account for 20% to 30% of prepubertal lupus onset, most easily identified with a CH50 screening test in all SLE children under the age of 10, she said. When a very young child develops SLE, environmental factors probably play less of a role than in the typical adult patient, suggesting a greater role for genetic factors.

In the absence of an approved drug regimen for children with lupus, treatment must be extrapolated from clinical experience and the results of clinical trials involving adult patients. “But we have to treat these children, because their disease is quite aggressive and they do die from renal failure,” said Dr. O'Neil.

The child's future fertility and bone and heart health can be adversely affected by such drugs as cyclophosphamide and steroids. Future fertility does concern adolescents, but they usually will not acknowledge that concern. “So it's important to do that for them.” Raise these issues with them, and realize that “if they say they're feeling fine, don't accept that. You still have to do a very careful and directed review of systems each time you see these young patients,” she said. “And when you're putting a 16- or 17-year-old boy on cyclophosphamide, don't forget to talk to him about sperm donation and storage.”

“Nonsteroidal anti-inflammatory drugs can be helpful in treating the arthritis, pericarditis, and pleuritis in lupus, but they have to be used with caution in case of underlying kidney disease,” she said. Exercise is important for maintaining bone density, especially in patients taking steroids.

Premature atherosclerosis can occur in the adolescent lupus patient, and treating procoagulant phenotype in children can be very tricky because the metabolism of young lupus patients is complex. Most pediatric hematologist-oncologists anticoagulate with low-molecular-weight heparin. “Children metabolize oral anticoagulants differently than adults do, and their diets are more varied, and that changes the absorption rate of the drug. Furthermore, they can get infections, which change drug metabolism, so their clotting times can vary widely,” Dr. O'Neil said.

Antiphospholipid antibodies in lupus increase coagulation, but the overall result of this can be variable. The pediatric SLE patient can be excessively anticoagulated one week and then be inadequately anticoagulated a week later. “By using low-molecular-weight heparin, it's easier to set the dosage, to predict what the drug is going to do, and to maintain a steady anticoagulation,” she said in an interview.

CHICAGO — A substantial chasm exists between children and adults when it comes to the diagnosis, course, and treatment of lupus erythematosus, Dr. Kathleen M. O'Neil said at a symposium sponsored by the American College of Rheumatology.

“Kids with lupus are not adults with lupus,” she said, noting that children with prepubertal onset often do not have fatigue but they do have alopecia, whereas teens and adults are more likely to have fatigue. When asked, children will say they feel tired, but their fatigue levels still remain well below those of older kids, according to Dr. O'Neil, professor of pediatric rheumatology at the University of Oklahoma, Oklahoma City.

Children with vague and miscellaneous aches and pains often are evaluated for lupus, and there's a common misconception that a positive antinuclear antibody (ANA) test result is as reliable an indicator of lupus in children as it is in adults. While antinuclear antibody is positive in all children with systemic lupus erythematosus (SLE), an estimated “30%–35% of children who are healthy have a positive ANA, if we use the normal cutoff of 1:40 defined in adults,” she said in an interview.

In addition, the ANA does not discriminate healthy children from children with systemic lupus erythematosus (SLE) unless the titer used is 1:320 or greater. “A misdiagnosis puts parents through unnecessary stress and they get frightened, especially when they research lupus on the Internet,” she said.

Another lab finding that supports a diagnosis of SLE in children is positivity for anti-DNA antibodies, “which are present in 67% of our children with lupus onset over age 13 and 100% of those under age 13.” Evidence of complement consumption and low serum C3 and/or C4 concentrations are also supportive, Dr. O'Neil said.

Complement deficiency and early complement component deficiencies may account for 20% to 30% of prepubertal lupus onset, most easily identified with a CH50 screening test in all SLE children under the age of 10, she said. When a very young child develops SLE, environmental factors probably play less of a role than in the typical adult patient, suggesting a greater role for genetic factors.

In the absence of an approved drug regimen for children with lupus, treatment must be extrapolated from clinical experience and the results of clinical trials involving adult patients. “But we have to treat these children, because their disease is quite aggressive and they do die from renal failure,” said Dr. O'Neil.

The child's future fertility and bone and heart health can be adversely affected by such drugs as cyclophosphamide and steroids. Future fertility does concern adolescents, but they usually will not acknowledge that concern. “So it's important to do that for them.” Raise these issues with them, and realize that “if they say they're feeling fine, don't accept that. You still have to do a very careful and directed review of systems each time you see these young patients,” she said. “And when you're putting a 16- or 17-year-old boy on cyclophosphamide, don't forget to talk to him about sperm donation and storage.”

“Nonsteroidal anti-inflammatory drugs can be helpful in treating the arthritis, pericarditis, and pleuritis in lupus, but they have to be used with caution in case of underlying kidney disease,” she said. Exercise is important for maintaining bone density, especially in patients taking steroids.

Premature atherosclerosis can occur in the adolescent lupus patient, and treating procoagulant phenotype in children can be very tricky because the metabolism of young lupus patients is complex. Most pediatric hematologist-oncologists anticoagulate with low-molecular-weight heparin. “Children metabolize oral anticoagulants differently than adults do, and their diets are more varied, and that changes the absorption rate of the drug. Furthermore, they can get infections, which change drug metabolism, so their clotting times can vary widely,” Dr. O'Neil said.

Antiphospholipid antibodies in lupus increase coagulation, but the overall result of this can be variable. The pediatric SLE patient can be excessively anticoagulated one week and then be inadequately anticoagulated a week later. “By using low-molecular-weight heparin, it's easier to set the dosage, to predict what the drug is going to do, and to maintain a steady anticoagulation,” she said in an interview.

CHICAGO — A substantial chasm exists between children and adults when it comes to the diagnosis, course, and treatment of lupus erythematosus, Dr. Kathleen M. O'Neil said at a symposium sponsored by the American College of Rheumatology.

“Kids with lupus are not adults with lupus,” she said, noting that children with prepubertal onset often do not have fatigue but they do have alopecia, whereas teens and adults are more likely to have fatigue. When asked, children will say they feel tired, but their fatigue levels still remain well below those of older kids, according to Dr. O'Neil, professor of pediatric rheumatology at the University of Oklahoma, Oklahoma City.

Children with vague and miscellaneous aches and pains often are evaluated for lupus, and there's a common misconception that a positive antinuclear antibody (ANA) test result is as reliable an indicator of lupus in children as it is in adults. While antinuclear antibody is positive in all children with systemic lupus erythematosus (SLE), an estimated “30%–35% of children who are healthy have a positive ANA, if we use the normal cutoff of 1:40 defined in adults,” she said in an interview.

In addition, the ANA does not discriminate healthy children from children with systemic lupus erythematosus (SLE) unless the titer used is 1:320 or greater. “A misdiagnosis puts parents through unnecessary stress and they get frightened, especially when they research lupus on the Internet,” she said.

Another lab finding that supports a diagnosis of SLE in children is positivity for anti-DNA antibodies, “which are present in 67% of our children with lupus onset over age 13 and 100% of those under age 13.” Evidence of complement consumption and low serum C3 and/or C4 concentrations are also supportive, Dr. O'Neil said.

Complement deficiency and early complement component deficiencies may account for 20% to 30% of prepubertal lupus onset, most easily identified with a CH50 screening test in all SLE children under the age of 10, she said. When a very young child develops SLE, environmental factors probably play less of a role than in the typical adult patient, suggesting a greater role for genetic factors.

In the absence of an approved drug regimen for children with lupus, treatment must be extrapolated from clinical experience and the results of clinical trials involving adult patients. “But we have to treat these children, because their disease is quite aggressive and they do die from renal failure,” said Dr. O'Neil.

The child's future fertility and bone and heart health can be adversely affected by such drugs as cyclophosphamide and steroids. Future fertility does concern adolescents, but they usually will not acknowledge that concern. “So it's important to do that for them.” Raise these issues with them, and realize that “if they say they're feeling fine, don't accept that. You still have to do a very careful and directed review of systems each time you see these young patients,” she said. “And when you're putting a 16- or 17-year-old boy on cyclophosphamide, don't forget to talk to him about sperm donation and storage.”

“Nonsteroidal anti-inflammatory drugs can be helpful in treating the arthritis, pericarditis, and pleuritis in lupus, but they have to be used with caution in case of underlying kidney disease,” she said. Exercise is important for maintaining bone density, especially in patients taking steroids.

Premature atherosclerosis can occur in the adolescent lupus patient, and treating procoagulant phenotype in children can be very tricky because the metabolism of young lupus patients is complex. Most pediatric hematologist-oncologists anticoagulate with low-molecular-weight heparin. “Children metabolize oral anticoagulants differently than adults do, and their diets are more varied, and that changes the absorption rate of the drug. Furthermore, they can get infections, which change drug metabolism, so their clotting times can vary widely,” Dr. O'Neil said.

Antiphospholipid antibodies in lupus increase coagulation, but the overall result of this can be variable. The pediatric SLE patient can be excessively anticoagulated one week and then be inadequately anticoagulated a week later. “By using low-molecular-weight heparin, it's easier to set the dosage, to predict what the drug is going to do, and to maintain a steady anticoagulation,” she said in an interview.

CHICAGO — In the era of biologically active agents for rheumatoid arthritis, it is worth remembering that early treatment with other disease-modifying antirheumatic drugs such as methotrexate, either alone or in combination, also can preserve joint architecture, usually with fewer complications and for significantly less money, Dr. James R. O'Dell said at a symposium sponsored by the American College of Rheumatology.

Evaluation of disease-modifying antirheumatic drug (DMARD) monotherapy shows that early treatment with methotrexate slows disease progression and improves survival, said Dr. O'Dell, who is professor of medicine at the University of Nebraska Medical Center in Omaha. “And the earlier the better; if we treat early, we can put a high percentage of patients in remission,” he said, stressing that directing therapy at a specific target may improve outcome, as shown by the TICORA trial (Lancet 2004;364:263–9).

“They did not use biologics in the TICORA trial, but rather they ramped patients up to triple therapy. But the important thing is that they had a target, which was to accomplish a disease activity score of under 2.4, which equates to one or two tender or swollen joints. What they found was that those who got treatment with that target in mind did better,” Dr. O'Dell explained.

If the patient wants to avoid side effects and lab tests, and payment is a problem, hydroxychloroquine is a good drug to consider. “It's the safest DMARD and the only test that's required is an annual eye exam,” he said.

Another option is minocycline, a small-molecule medication which, like doxycycline, upregulates interleukin-10 production, and which outperformed hydroxychloroquine in a head-to-head study, the goal of which was to get patients to American College of Rheumatology rating scale (ACR) 50 in 2 years (Arthritis Rheum. 2001;44:2235–41). Caveats include the fact that minocycline's effectiveness in RA has been primarily demonstrated in seropositive patients. And in about 40% of patients treated longer than 2 years, minocycline may cause hyperpigmentation that is slow to resolve after the drug is discontinued, Dr. O'Dell cautioned.

Another option is azathioprine, which Dr. O'Dell called “a sort of forgotten drug. We use this in combination with methotrexate because it's effective and affordable for people with high copays.”

Combinations of DMARDs also preserve joints in RA. Tested combinations include:

▸ Triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine.

▸ Sulfasalazine, methotrexate, and high-dose prednisone (COBRA combo).

▸ Methotrexate and the tumor necrosis factor-? (TNF-α) inhibitors.

Combination therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was pitted against monotherapy (any one of these drugs) in what Dr. O'Dell called a somewhat obscure Turkish study. “What they showed was that three drugs are better than two and two drugs are better than one. In the three-drug group, 69% of patients had no radiographic progression, compared with 64% in the two-drug group and 24.5% in the monotherapy cohort,” he said (Clin. Exp. Rheumatol. 1999;6:699–704).

More recently, the PREMIER study of adalimumab and methotrexate alone or in combination showed that combining drugs was the best thing to do (Arthritis Rheum. 2006;54:26–37). “More drugs are better than fewer drugs if what you're striving for is efficacy. When we look at ACR 50, the two drugs alone were similar. However, achievement of ACR 20 statistically favored methotrexate (over the TNF inhibitor) and that's interesting,” explained Dr. O'Dell, adding that those taking a combination of the two drugs had the best clinical responses and the least radiographic progression. Of those PREMIER patients on combination therapy, 61% had no radiographic progression. However, the benefits came at a cost: Those receiving the TNF inhibitor had a significant increase in serious infections.

The side effects of TNF inhibitors, underscore the importance of screening patients for tuberculosis and other infections before placing them on these biologics, Dr. O'Dell stressed. “Infections are a concern … and if we hide our heads in the sand, we're doing our patients a disservice. These are extremely effective drugs, but we just need to take appropriate precautions.”

CHICAGO — In the era of biologically active agents for rheumatoid arthritis, it is worth remembering that early treatment with other disease-modifying antirheumatic drugs such as methotrexate, either alone or in combination, also can preserve joint architecture, usually with fewer complications and for significantly less money, Dr. James R. O'Dell said at a symposium sponsored by the American College of Rheumatology.

Evaluation of disease-modifying antirheumatic drug (DMARD) monotherapy shows that early treatment with methotrexate slows disease progression and improves survival, said Dr. O'Dell, who is professor of medicine at the University of Nebraska Medical Center in Omaha. “And the earlier the better; if we treat early, we can put a high percentage of patients in remission,” he said, stressing that directing therapy at a specific target may improve outcome, as shown by the TICORA trial (Lancet 2004;364:263–9).

“They did not use biologics in the TICORA trial, but rather they ramped patients up to triple therapy. But the important thing is that they had a target, which was to accomplish a disease activity score of under 2.4, which equates to one or two tender or swollen joints. What they found was that those who got treatment with that target in mind did better,” Dr. O'Dell explained.

If the patient wants to avoid side effects and lab tests, and payment is a problem, hydroxychloroquine is a good drug to consider. “It's the safest DMARD and the only test that's required is an annual eye exam,” he said.

Another option is minocycline, a small-molecule medication which, like doxycycline, upregulates interleukin-10 production, and which outperformed hydroxychloroquine in a head-to-head study, the goal of which was to get patients to American College of Rheumatology rating scale (ACR) 50 in 2 years (Arthritis Rheum. 2001;44:2235–41). Caveats include the fact that minocycline's effectiveness in RA has been primarily demonstrated in seropositive patients. And in about 40% of patients treated longer than 2 years, minocycline may cause hyperpigmentation that is slow to resolve after the drug is discontinued, Dr. O'Dell cautioned.

Another option is azathioprine, which Dr. O'Dell called “a sort of forgotten drug. We use this in combination with methotrexate because it's effective and affordable for people with high copays.”

Combinations of DMARDs also preserve joints in RA. Tested combinations include:

▸ Triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine.

▸ Sulfasalazine, methotrexate, and high-dose prednisone (COBRA combo).

▸ Methotrexate and the tumor necrosis factor-? (TNF-α) inhibitors.

Combination therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was pitted against monotherapy (any one of these drugs) in what Dr. O'Dell called a somewhat obscure Turkish study. “What they showed was that three drugs are better than two and two drugs are better than one. In the three-drug group, 69% of patients had no radiographic progression, compared with 64% in the two-drug group and 24.5% in the monotherapy cohort,” he said (Clin. Exp. Rheumatol. 1999;6:699–704).

More recently, the PREMIER study of adalimumab and methotrexate alone or in combination showed that combining drugs was the best thing to do (Arthritis Rheum. 2006;54:26–37). “More drugs are better than fewer drugs if what you're striving for is efficacy. When we look at ACR 50, the two drugs alone were similar. However, achievement of ACR 20 statistically favored methotrexate (over the TNF inhibitor) and that's interesting,” explained Dr. O'Dell, adding that those taking a combination of the two drugs had the best clinical responses and the least radiographic progression. Of those PREMIER patients on combination therapy, 61% had no radiographic progression. However, the benefits came at a cost: Those receiving the TNF inhibitor had a significant increase in serious infections.

The side effects of TNF inhibitors, underscore the importance of screening patients for tuberculosis and other infections before placing them on these biologics, Dr. O'Dell stressed. “Infections are a concern … and if we hide our heads in the sand, we're doing our patients a disservice. These are extremely effective drugs, but we just need to take appropriate precautions.”

CHICAGO — In the era of biologically active agents for rheumatoid arthritis, it is worth remembering that early treatment with other disease-modifying antirheumatic drugs such as methotrexate, either alone or in combination, also can preserve joint architecture, usually with fewer complications and for significantly less money, Dr. James R. O'Dell said at a symposium sponsored by the American College of Rheumatology.

Evaluation of disease-modifying antirheumatic drug (DMARD) monotherapy shows that early treatment with methotrexate slows disease progression and improves survival, said Dr. O'Dell, who is professor of medicine at the University of Nebraska Medical Center in Omaha. “And the earlier the better; if we treat early, we can put a high percentage of patients in remission,” he said, stressing that directing therapy at a specific target may improve outcome, as shown by the TICORA trial (Lancet 2004;364:263–9).

“They did not use biologics in the TICORA trial, but rather they ramped patients up to triple therapy. But the important thing is that they had a target, which was to accomplish a disease activity score of under 2.4, which equates to one or two tender or swollen joints. What they found was that those who got treatment with that target in mind did better,” Dr. O'Dell explained.

If the patient wants to avoid side effects and lab tests, and payment is a problem, hydroxychloroquine is a good drug to consider. “It's the safest DMARD and the only test that's required is an annual eye exam,” he said.

Another option is minocycline, a small-molecule medication which, like doxycycline, upregulates interleukin-10 production, and which outperformed hydroxychloroquine in a head-to-head study, the goal of which was to get patients to American College of Rheumatology rating scale (ACR) 50 in 2 years (Arthritis Rheum. 2001;44:2235–41). Caveats include the fact that minocycline's effectiveness in RA has been primarily demonstrated in seropositive patients. And in about 40% of patients treated longer than 2 years, minocycline may cause hyperpigmentation that is slow to resolve after the drug is discontinued, Dr. O'Dell cautioned.

Another option is azathioprine, which Dr. O'Dell called “a sort of forgotten drug. We use this in combination with methotrexate because it's effective and affordable for people with high copays.”

Combinations of DMARDs also preserve joints in RA. Tested combinations include:

▸ Triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine.

▸ Sulfasalazine, methotrexate, and high-dose prednisone (COBRA combo).

▸ Methotrexate and the tumor necrosis factor-? (TNF-α) inhibitors.

Combination therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was pitted against monotherapy (any one of these drugs) in what Dr. O'Dell called a somewhat obscure Turkish study. “What they showed was that three drugs are better than two and two drugs are better than one. In the three-drug group, 69% of patients had no radiographic progression, compared with 64% in the two-drug group and 24.5% in the monotherapy cohort,” he said (Clin. Exp. Rheumatol. 1999;6:699–704).

More recently, the PREMIER study of adalimumab and methotrexate alone or in combination showed that combining drugs was the best thing to do (Arthritis Rheum. 2006;54:26–37). “More drugs are better than fewer drugs if what you're striving for is efficacy. When we look at ACR 50, the two drugs alone were similar. However, achievement of ACR 20 statistically favored methotrexate (over the TNF inhibitor) and that's interesting,” explained Dr. O'Dell, adding that those taking a combination of the two drugs had the best clinical responses and the least radiographic progression. Of those PREMIER patients on combination therapy, 61% had no radiographic progression. However, the benefits came at a cost: Those receiving the TNF inhibitor had a significant increase in serious infections.

The side effects of TNF inhibitors, underscore the importance of screening patients for tuberculosis and other infections before placing them on these biologics, Dr. O'Dell stressed. “Infections are a concern … and if we hide our heads in the sand, we're doing our patients a disservice. These are extremely effective drugs, but we just need to take appropriate precautions.”

SAN DIEGO – Challenges such as declining reimbursements and limitations on payor approval of prescribed therapies are creating fertile ground for conflict of interest and profiteering by physicians, Dr. Jerome Schofferman said at the annual meeting of the American Academy of Pain Medicine.

Those involved in interventional pain management are especially vulnerable. “Some physicians–particularly interventional pain specialists–limit their practices to the most profitable patients: those needing injections, neuromodulation, and other interventions,” he told the audience. “They may say, 'well, it's what I do best, it's what I was trained to do, and it's what I like, and I've got a lot of overhead and I have to make a living.' There are a lot of rationalizations for limiting our practices to the most financially [rewarding] patients.”

That often leaves patients who require chronic medical management and rehabilitation out in the cold, according to Dr. Schofferman, who is in private practice in Daly City, Calif. “We've developed a system where some interventionalists are just doing injections all day long and don't follow up on patients to see how they're doing, and they use new technologies before there's adequate validation of their efficacy,” he said.

“I see patients all the time who, instead of having a single, well-done fluoroscopic-guided epidural, get three epidurals 10 days apart. There is no medical evidence justifying the automatic use of three epidurals,” he said.

Dr. Schofferman noted that his remarks were not intended as an indictment of profit. There's fair profit and then there is profit that is unfair and unethical, he said, citing the example of physicians who increase the numbers of patients they see and give less attention and thought–but perhaps more drugs–to each. “And those doctors may lower their threshold for interventional procedures, particularly those reimbursed at a higher level.”

Poor clinical management decisions are the bedfellows of conflict of interest, which Dr. Schofferman said elicits righteous indignation when mentioned in the same breath with health care. Conflict of interest is not as simple as accepting a laser pointer from a particular drug company and as a result deciding to prescribe their drug instead of comparable agents made by other companies. Few physicians would do that.

“But it doesn't work that way. Conflict of interest is much more subtle and unconscious. Conflict of interest is sort of like pornography–everybody knows it when they see it, but it's hard to define. Let's call it a situation where your professional judgment regarding a patient is unduly influenced by secondary interests.” Those secondary interests, he explained, can include power, one's position in the community, career advancement, biases, and financial gain. “Conflict of interest leads to bias and bias influences clinical decision making.”

One part of the solution is to practice evidence-based medicine, which Dr. Schofferman said would automatically minimize the effects of these secondary influences and reduce clinical practice patterns that are not in the best interests of patients.

“Evidence-based medicine, according to Dr. David L. Sackett [of Oxford University in England], is the integration of the best research evidence, clinical expertise, and patient values. Dr. Bradley Weiner [an orthopedic surgeon from Akron, Ohio] said that when equal alternatives exist, you provide a treatment that affords the least risk. If the treatments and risks are equal, provide the treatment with the lowest cost; then your practice can be ethical without being an ethicist, and you don't even have to know anything about ethics,” Dr. Schofferman said. “We have to critically analyze our practice outcomes. This requires integrity … this requires acceptance of a reasonable profit, not a greedy profit.”

SAN DIEGO – Challenges such as declining reimbursements and limitations on payor approval of prescribed therapies are creating fertile ground for conflict of interest and profiteering by physicians, Dr. Jerome Schofferman said at the annual meeting of the American Academy of Pain Medicine.

Those involved in interventional pain management are especially vulnerable. “Some physicians–particularly interventional pain specialists–limit their practices to the most profitable patients: those needing injections, neuromodulation, and other interventions,” he told the audience. “They may say, 'well, it's what I do best, it's what I was trained to do, and it's what I like, and I've got a lot of overhead and I have to make a living.' There are a lot of rationalizations for limiting our practices to the most financially [rewarding] patients.”

That often leaves patients who require chronic medical management and rehabilitation out in the cold, according to Dr. Schofferman, who is in private practice in Daly City, Calif. “We've developed a system where some interventionalists are just doing injections all day long and don't follow up on patients to see how they're doing, and they use new technologies before there's adequate validation of their efficacy,” he said.

“I see patients all the time who, instead of having a single, well-done fluoroscopic-guided epidural, get three epidurals 10 days apart. There is no medical evidence justifying the automatic use of three epidurals,” he said.

Dr. Schofferman noted that his remarks were not intended as an indictment of profit. There's fair profit and then there is profit that is unfair and unethical, he said, citing the example of physicians who increase the numbers of patients they see and give less attention and thought–but perhaps more drugs–to each. “And those doctors may lower their threshold for interventional procedures, particularly those reimbursed at a higher level.”

Poor clinical management decisions are the bedfellows of conflict of interest, which Dr. Schofferman said elicits righteous indignation when mentioned in the same breath with health care. Conflict of interest is not as simple as accepting a laser pointer from a particular drug company and as a result deciding to prescribe their drug instead of comparable agents made by other companies. Few physicians would do that.

“But it doesn't work that way. Conflict of interest is much more subtle and unconscious. Conflict of interest is sort of like pornography–everybody knows it when they see it, but it's hard to define. Let's call it a situation where your professional judgment regarding a patient is unduly influenced by secondary interests.” Those secondary interests, he explained, can include power, one's position in the community, career advancement, biases, and financial gain. “Conflict of interest leads to bias and bias influences clinical decision making.”

One part of the solution is to practice evidence-based medicine, which Dr. Schofferman said would automatically minimize the effects of these secondary influences and reduce clinical practice patterns that are not in the best interests of patients.

“Evidence-based medicine, according to Dr. David L. Sackett [of Oxford University in England], is the integration of the best research evidence, clinical expertise, and patient values. Dr. Bradley Weiner [an orthopedic surgeon from Akron, Ohio] said that when equal alternatives exist, you provide a treatment that affords the least risk. If the treatments and risks are equal, provide the treatment with the lowest cost; then your practice can be ethical without being an ethicist, and you don't even have to know anything about ethics,” Dr. Schofferman said. “We have to critically analyze our practice outcomes. This requires integrity … this requires acceptance of a reasonable profit, not a greedy profit.”

SAN DIEGO – Challenges such as declining reimbursements and limitations on payor approval of prescribed therapies are creating fertile ground for conflict of interest and profiteering by physicians, Dr. Jerome Schofferman said at the annual meeting of the American Academy of Pain Medicine.

Those involved in interventional pain management are especially vulnerable. “Some physicians–particularly interventional pain specialists–limit their practices to the most profitable patients: those needing injections, neuromodulation, and other interventions,” he told the audience. “They may say, 'well, it's what I do best, it's what I was trained to do, and it's what I like, and I've got a lot of overhead and I have to make a living.' There are a lot of rationalizations for limiting our practices to the most financially [rewarding] patients.”

That often leaves patients who require chronic medical management and rehabilitation out in the cold, according to Dr. Schofferman, who is in private practice in Daly City, Calif. “We've developed a system where some interventionalists are just doing injections all day long and don't follow up on patients to see how they're doing, and they use new technologies before there's adequate validation of their efficacy,” he said.

“I see patients all the time who, instead of having a single, well-done fluoroscopic-guided epidural, get three epidurals 10 days apart. There is no medical evidence justifying the automatic use of three epidurals,” he said.

Dr. Schofferman noted that his remarks were not intended as an indictment of profit. There's fair profit and then there is profit that is unfair and unethical, he said, citing the example of physicians who increase the numbers of patients they see and give less attention and thought–but perhaps more drugs–to each. “And those doctors may lower their threshold for interventional procedures, particularly those reimbursed at a higher level.”

Poor clinical management decisions are the bedfellows of conflict of interest, which Dr. Schofferman said elicits righteous indignation when mentioned in the same breath with health care. Conflict of interest is not as simple as accepting a laser pointer from a particular drug company and as a result deciding to prescribe their drug instead of comparable agents made by other companies. Few physicians would do that.

“But it doesn't work that way. Conflict of interest is much more subtle and unconscious. Conflict of interest is sort of like pornography–everybody knows it when they see it, but it's hard to define. Let's call it a situation where your professional judgment regarding a patient is unduly influenced by secondary interests.” Those secondary interests, he explained, can include power, one's position in the community, career advancement, biases, and financial gain. “Conflict of interest leads to bias and bias influences clinical decision making.”

One part of the solution is to practice evidence-based medicine, which Dr. Schofferman said would automatically minimize the effects of these secondary influences and reduce clinical practice patterns that are not in the best interests of patients.

“Evidence-based medicine, according to Dr. David L. Sackett [of Oxford University in England], is the integration of the best research evidence, clinical expertise, and patient values. Dr. Bradley Weiner [an orthopedic surgeon from Akron, Ohio] said that when equal alternatives exist, you provide a treatment that affords the least risk. If the treatments and risks are equal, provide the treatment with the lowest cost; then your practice can be ethical without being an ethicist, and you don't even have to know anything about ethics,” Dr. Schofferman said. “We have to critically analyze our practice outcomes. This requires integrity … this requires acceptance of a reasonable profit, not a greedy profit.”

SAN DIEGO – Pain patients with a history of substance abuse who are otherwise appropriate candidates for opioid medications should receive the same consideration from their physicians as patients without the disease of addiction, Dr. Howard A. Heit said the annual meeting of the American Academy of Pain Medicine.

“Patients should have their pain appropriately treated. But there are barriers to pain management, including the fear of addiction or misuse of controlled substances–especially opioids–in the treatment of this population,” he said. “These patients should be treated with dignity using medications approved by the Food and Drug Administration consistent with state and federal regulations, and we should never withhold these valuable medicines for the fear of the disease of addiction.”

Stress is a major cause of substance abuse relapse, and pain is probably the most severe of all life stressors, he said. “Undertreatment or nontreatment of pain can predispose those in recovery to relapse, and it stands to reason that if a patient is in recovery and the pain is undertreated, that patient may turn to the street for diverted prescription medications or listed meds, or he'll use legal drugs such as alcohol to anesthetize himself against the pain,” said Dr. Heit, a pain specialist in Fairfax, Va.

The disease of addiction, he said, strikes between 8% and 10% of the general population, but there are no good data on the incidence of addiction in chronic pain patients, though he believes it exceeds 10%. In addition, the prevalence of chronic pain appears to be higher among those who are addicted to opiates and alcohol.

To minimize situations in which opioids become the problem rather than the solution, Dr. Heit uses a patient assessment model that includes a possible history of aberrant behavior and the application of careful and reasonable limits based on mutual trust and honesty in the doctor-patient relationship.

“When a new patient comes into my office, I say, 'Please tell me everything that has happened in your life that is pertinent in relation to sexual and physical abuse, depression, addiction. … It will not be held against you, but I need that information in order to formulate a valid treatment program.' Then, using universal precautions, it's possible to treat chronic pain patients with histories of substance abuse with opioid agonist therapy,” he said.

The pain therapy process involves 10 key steps:

1. Make a diagnosis with an appropriate differential that elicits any chronic condition that the patient is dealing with.

2. Make a psychological assessment.

3. Obtain informed consent.

4. Make a treatment agreement placing responsibility on both parties.

5. Have a pre- and postintervention assessment of pain level and functioning.

6. Have an appropriate trial of opioid therapy (opioids might not be needed, indicated, or efficacious in a given patient).

7. Periodically reassess pain score and level of function.

8. Regularly assess the “four A's” of pain medicine: analgesia, activity, adverse reactions, aberrant behavior.

9. Periodically review pain diagnosis and comorbid conditions, including addictive disorders.

10. Create and maintain documentation.

This last step is no less important than the first nine, Dr. Heit stressed. “If you don't put it in your chart, legally it's a figment of your imagination and you may be open to investigation. I'm sure a patient of mine has diverted a prescription without my knowledge, but the key is, Did I do my due diligence after getting the information by changing the treatment plan to prevent that from happening again?” he said, adding that firing the wayward patient would be the wrong thing to do because he or she would then circulate to another doctor or another community. Instead, urged Dr. Heit, increase communication with the patient to solve the problem.

'Undertreatmentor nontreatmentof pain can predispose those in recovery to relapse.' DR. HEIT

SAN DIEGO – Pain patients with a history of substance abuse who are otherwise appropriate candidates for opioid medications should receive the same consideration from their physicians as patients without the disease of addiction, Dr. Howard A. Heit said the annual meeting of the American Academy of Pain Medicine.

“Patients should have their pain appropriately treated. But there are barriers to pain management, including the fear of addiction or misuse of controlled substances–especially opioids–in the treatment of this population,” he said. “These patients should be treated with dignity using medications approved by the Food and Drug Administration consistent with state and federal regulations, and we should never withhold these valuable medicines for the fear of the disease of addiction.”

Stress is a major cause of substance abuse relapse, and pain is probably the most severe of all life stressors, he said. “Undertreatment or nontreatment of pain can predispose those in recovery to relapse, and it stands to reason that if a patient is in recovery and the pain is undertreated, that patient may turn to the street for diverted prescription medications or listed meds, or he'll use legal drugs such as alcohol to anesthetize himself against the pain,” said Dr. Heit, a pain specialist in Fairfax, Va.

The disease of addiction, he said, strikes between 8% and 10% of the general population, but there are no good data on the incidence of addiction in chronic pain patients, though he believes it exceeds 10%. In addition, the prevalence of chronic pain appears to be higher among those who are addicted to opiates and alcohol.

To minimize situations in which opioids become the problem rather than the solution, Dr. Heit uses a patient assessment model that includes a possible history of aberrant behavior and the application of careful and reasonable limits based on mutual trust and honesty in the doctor-patient relationship.

“When a new patient comes into my office, I say, 'Please tell me everything that has happened in your life that is pertinent in relation to sexual and physical abuse, depression, addiction. … It will not be held against you, but I need that information in order to formulate a valid treatment program.' Then, using universal precautions, it's possible to treat chronic pain patients with histories of substance abuse with opioid agonist therapy,” he said.

The pain therapy process involves 10 key steps:

1. Make a diagnosis with an appropriate differential that elicits any chronic condition that the patient is dealing with.

2. Make a psychological assessment.

3. Obtain informed consent.

4. Make a treatment agreement placing responsibility on both parties.

5. Have a pre- and postintervention assessment of pain level and functioning.

6. Have an appropriate trial of opioid therapy (opioids might not be needed, indicated, or efficacious in a given patient).

7. Periodically reassess pain score and level of function.

8. Regularly assess the “four A's” of pain medicine: analgesia, activity, adverse reactions, aberrant behavior.

9. Periodically review pain diagnosis and comorbid conditions, including addictive disorders.

10. Create and maintain documentation.

This last step is no less important than the first nine, Dr. Heit stressed. “If you don't put it in your chart, legally it's a figment of your imagination and you may be open to investigation. I'm sure a patient of mine has diverted a prescription without my knowledge, but the key is, Did I do my due diligence after getting the information by changing the treatment plan to prevent that from happening again?” he said, adding that firing the wayward patient would be the wrong thing to do because he or she would then circulate to another doctor or another community. Instead, urged Dr. Heit, increase communication with the patient to solve the problem.

'Undertreatmentor nontreatmentof pain can predispose those in recovery to relapse.' DR. HEIT

SAN DIEGO – Pain patients with a history of substance abuse who are otherwise appropriate candidates for opioid medications should receive the same consideration from their physicians as patients without the disease of addiction, Dr. Howard A. Heit said the annual meeting of the American Academy of Pain Medicine.

“Patients should have their pain appropriately treated. But there are barriers to pain management, including the fear of addiction or misuse of controlled substances–especially opioids–in the treatment of this population,” he said. “These patients should be treated with dignity using medications approved by the Food and Drug Administration consistent with state and federal regulations, and we should never withhold these valuable medicines for the fear of the disease of addiction.”

Stress is a major cause of substance abuse relapse, and pain is probably the most severe of all life stressors, he said. “Undertreatment or nontreatment of pain can predispose those in recovery to relapse, and it stands to reason that if a patient is in recovery and the pain is undertreated, that patient may turn to the street for diverted prescription medications or listed meds, or he'll use legal drugs such as alcohol to anesthetize himself against the pain,” said Dr. Heit, a pain specialist in Fairfax, Va.

The disease of addiction, he said, strikes between 8% and 10% of the general population, but there are no good data on the incidence of addiction in chronic pain patients, though he believes it exceeds 10%. In addition, the prevalence of chronic pain appears to be higher among those who are addicted to opiates and alcohol.

To minimize situations in which opioids become the problem rather than the solution, Dr. Heit uses a patient assessment model that includes a possible history of aberrant behavior and the application of careful and reasonable limits based on mutual trust and honesty in the doctor-patient relationship.

“When a new patient comes into my office, I say, 'Please tell me everything that has happened in your life that is pertinent in relation to sexual and physical abuse, depression, addiction. … It will not be held against you, but I need that information in order to formulate a valid treatment program.' Then, using universal precautions, it's possible to treat chronic pain patients with histories of substance abuse with opioid agonist therapy,” he said.

The pain therapy process involves 10 key steps:

1. Make a diagnosis with an appropriate differential that elicits any chronic condition that the patient is dealing with.

2. Make a psychological assessment.

3. Obtain informed consent.

4. Make a treatment agreement placing responsibility on both parties.

5. Have a pre- and postintervention assessment of pain level and functioning.

6. Have an appropriate trial of opioid therapy (opioids might not be needed, indicated, or efficacious in a given patient).

7. Periodically reassess pain score and level of function.

8. Regularly assess the “four A's” of pain medicine: analgesia, activity, adverse reactions, aberrant behavior.

9. Periodically review pain diagnosis and comorbid conditions, including addictive disorders.

10. Create and maintain documentation.

This last step is no less important than the first nine, Dr. Heit stressed. “If you don't put it in your chart, legally it's a figment of your imagination and you may be open to investigation. I'm sure a patient of mine has diverted a prescription without my knowledge, but the key is, Did I do my due diligence after getting the information by changing the treatment plan to prevent that from happening again?” he said, adding that firing the wayward patient would be the wrong thing to do because he or she would then circulate to another doctor or another community. Instead, urged Dr. Heit, increase communication with the patient to solve the problem.

'Undertreatmentor nontreatmentof pain can predispose those in recovery to relapse.' DR. HEIT