Patrice Wendling

TORONTO — A retrospective analysis has shown no adverse effects of thiazolidinediones on diabetic heart failure patients.

Thiazolidinedione (TZD) use was associated with reductions in all-cause hospitalizations, heart failure hospitalizations, and total hospital days. The reduction in hospital days also was noted with TZD plus insulin.

The findings challenge recommendations against using TZDs in heart failure based on concerns about fluid retention, particularly when used in combination with insulin. No trials have assessed the impact of TZD therapy on heart failure.

“Perhaps the nonhypoglycemic cardiovascular effects of TZDs may have favorable clinical impact in heart failure patients,” John S. Golden, M.D., said during a poster presentation at the annual meeting of the Heart Failure Society of America.

“I can't tell you on the basis of this study that it is something we ought to be doing as a therapeutic intervention at this point,” said Dr. Golden of Mid-Atlantic Permanente Medical Group, Fairfax, Va. But the study “lends some clinical support to the biochemical mechanisms supporting not only the safety, but efficacy, of TZDs in this population.”

Consecutively, 97 diabetic patients were referred with left ventricular ejection fractions of 35% or less and New York Heart Association (NYHA) class II-IV. A total of 37% were treated with a TZD and 15% with a TZD plus insulin. All received ACE inhibitors or angiotensin receptor blockers; 97% got ?-blockers.

At 1 year, improvements in ejection fractions did not differ significantly between patients treated with TZDs and those who were not. TZD therapy led to reduced all-cause hospitalizations per patient (0.19 vs. 0.71), heart failure hospitalizations per patient (0.03 vs. 0.16), and total hospital days (0.67 vs. 2.72).

Patients on TZD plus insulin had a reduction in total hospital days per patient (0.07 vs. 2.30), compared with those not on the combination therapy.

TORONTO — A retrospective analysis has shown no adverse effects of thiazolidinediones on diabetic heart failure patients.

Thiazolidinedione (TZD) use was associated with reductions in all-cause hospitalizations, heart failure hospitalizations, and total hospital days. The reduction in hospital days also was noted with TZD plus insulin.

The findings challenge recommendations against using TZDs in heart failure based on concerns about fluid retention, particularly when used in combination with insulin. No trials have assessed the impact of TZD therapy on heart failure.

“Perhaps the nonhypoglycemic cardiovascular effects of TZDs may have favorable clinical impact in heart failure patients,” John S. Golden, M.D., said during a poster presentation at the annual meeting of the Heart Failure Society of America.

“I can't tell you on the basis of this study that it is something we ought to be doing as a therapeutic intervention at this point,” said Dr. Golden of Mid-Atlantic Permanente Medical Group, Fairfax, Va. But the study “lends some clinical support to the biochemical mechanisms supporting not only the safety, but efficacy, of TZDs in this population.”

Consecutively, 97 diabetic patients were referred with left ventricular ejection fractions of 35% or less and New York Heart Association (NYHA) class II-IV. A total of 37% were treated with a TZD and 15% with a TZD plus insulin. All received ACE inhibitors or angiotensin receptor blockers; 97% got ?-blockers.

At 1 year, improvements in ejection fractions did not differ significantly between patients treated with TZDs and those who were not. TZD therapy led to reduced all-cause hospitalizations per patient (0.19 vs. 0.71), heart failure hospitalizations per patient (0.03 vs. 0.16), and total hospital days (0.67 vs. 2.72).

Patients on TZD plus insulin had a reduction in total hospital days per patient (0.07 vs. 2.30), compared with those not on the combination therapy.

TORONTO — A retrospective analysis has shown no adverse effects of thiazolidinediones on diabetic heart failure patients.

Thiazolidinedione (TZD) use was associated with reductions in all-cause hospitalizations, heart failure hospitalizations, and total hospital days. The reduction in hospital days also was noted with TZD plus insulin.

The findings challenge recommendations against using TZDs in heart failure based on concerns about fluid retention, particularly when used in combination with insulin. No trials have assessed the impact of TZD therapy on heart failure.

“Perhaps the nonhypoglycemic cardiovascular effects of TZDs may have favorable clinical impact in heart failure patients,” John S. Golden, M.D., said during a poster presentation at the annual meeting of the Heart Failure Society of America.

“I can't tell you on the basis of this study that it is something we ought to be doing as a therapeutic intervention at this point,” said Dr. Golden of Mid-Atlantic Permanente Medical Group, Fairfax, Va. But the study “lends some clinical support to the biochemical mechanisms supporting not only the safety, but efficacy, of TZDs in this population.”

Consecutively, 97 diabetic patients were referred with left ventricular ejection fractions of 35% or less and New York Heart Association (NYHA) class II-IV. A total of 37% were treated with a TZD and 15% with a TZD plus insulin. All received ACE inhibitors or angiotensin receptor blockers; 97% got ?-blockers.

At 1 year, improvements in ejection fractions did not differ significantly between patients treated with TZDs and those who were not. TZD therapy led to reduced all-cause hospitalizations per patient (0.19 vs. 0.71), heart failure hospitalizations per patient (0.03 vs. 0.16), and total hospital days (0.67 vs. 2.72).

Patients on TZD plus insulin had a reduction in total hospital days per patient (0.07 vs. 2.30), compared with those not on the combination therapy.

As the technology of weight-bearing MRI has developed, so too have new applications—from gynecologic to cardiovascular evaluations—and new challenges in interpreting the complex images now available.

Upright MRI, introduced in fall 2000 by Fonar Corp., can scan a patient in virtually any position that reproduces pain or other symptoms. This allows the detection of pathologies visible only in a variety of weight-bearing positions, including standing, sitting, flexion, and extension, Raymond V. Damadian, M.D., president and founder of the Melville, N.Y.-based company, told FAMILY PRACTICE NEWS.

As a result, “we see things that are not there in patients lying down,” said Dr. Damadian. “The pathology just isn't there [in the recumbent position].”

In one case, anterolisthesis at the L4/5 level was noted in a recumbent view, whereas a standing flexion scan showed an interspinal ligamentous rupture at the same level.

In another patient, a recumbent scan demonstrated no evidence of bladder or uterine prolapse and showed the levator sling parallel to and partially obscured by the pubococcygeal line. However, with the patient standing, the descent of the bladder relative to the pubococcygeal line was accentuated, and the levator sling was oblique and nonparallel to the pubococcygeal line.

Yet as revealing as such weight-bearing images might be, some radiologists may lack the experience or training to correctly interpret what they see.

“The body has moving parts, and once you start scanning in different positions, … the anatomical relativity of the body parts shifts. That's something that we have never viewed before. You have to be careful as to what you are calling normal or abnormal,” said Sana Khan, M.D., chair and founder of TrueMRI, an Anaheim, Calif.-based medical imaging group.

“One of the reasons their [Fonar's] machines are having a harder time being sold is that radiologists look at it and say, 'Why am I going to put all the extra effort in to learn all of this again?'” Dr. Khan said.

TrueMRI, which operates four upright scanners in California and one in Houston and expects one soon in Las Vegas, claims its radiologists have performed and interpreted more kinetic scans than any other company in the world. The company and its radiologists have developed proprietary software that interprets and quantifies the pathologies detected by an upright scan and is negotiating with Fonar to provide such interpretation for all Fonar users.

Dr. Damadian admits the images are complex and require experience to interpret. Images taken in the upright position must be systematically compared with those taken in a recumbent position to determine with confidence what changes are real and evince disease pathology.

On the other hand, it's not as though radiologists are operating in the dark, he said. With each use of the technology, radiologists are building a frame of reference. They're “learning all the time.”

From the patient's perspective, the scanner's open configuration may make MRI imaging more tolerable for those who are claustrophobic, and it makes MRI available to patients who simply couldn't fit into other scanners. It also allows young children to sit comfortably watching TV in the scanner without the use of routine anesthesia and lets infants be scanned while sleeping in their parents' laps.

About 50% of all MRIs in the United States involve the spine, so the lion's share of Upright MRI is being used for such musculoskeletal evaluations. But other applications are underway.

Upright MRI scanning, for example, is being used to obtain images of the beating heart and the blood-vascular system while the patient is vertical. Fonar introduced the first-ever magnetic resonance angiography and cines of the beating heart in the standing, sitting, obliquely oriented, and reverse Trendelenburg positions at the recent annual meeting of the Radiological Society of North America.

The company also unveiled a prototype of a new MRI-compatible treadmill for use inside its Upright MRI. Both of these technologies will possibly be available later this year, according to a Fonar spokesperson.

“We think one of the major applications of upright imaging is cardiovascular, because the heart is pumping against gravity, and the impact of gravity on blood flow is significant,” Dr. Damadian said.

In the vertical position, multiple factors may lead to decreased arterial or venous circulation, such as decreased cardiac output or loss of autoregulation.

“If you're a cardiovascular surgeon trying to evaluate the impact of a coronary attack on the heart or trying to evaluate stenosis in a blood vessel, you're going to want to know how that patient's physiology is tolerating that pathology,” Dr. Damadian said.

Competing MRI manufacturers contend that unique diagnostic information is rarely captured in an upright scan. However, Dr. Damadian said about a dozen studies seem to suggest otherwise.

In a yet-to-be-published study by researchers at the University of Aberdeen (Scotland), roughly one in five patients with low back pain and sciatica had evidence of slippages of the spine that were only visible when the patient was imaged standing up, Dr. Damadian said.

Dr. Khan, who is working in association with researchers at the University of California, Los Angeles, will release information later this year from a series of studies in approximately 800 asymptomatic patients whose spines were assessed in a variety of positions with upright MR imaging.

Still, Dr. Damadian admits a more comprehensive study is needed before physicians would accept upright imaging as the new standard.

There are now more than 70 Upright MRI machines installed worldwide, up from just 18 scanners in mid-2003. Sales revenues are up 190%, from $6.1 million in the first quarter of last year to $17.7 million in the quarter just ended.

One indication of the inroads the technology has made is an agreement with GE Healthcare that allows its salespeople to sell Fonar's Upright MRI scanner.

Although only a few have been sold this way, the agreement enables GE to offer a “total breadth” of products and services to its customers, said Ron Petcheny, GE product sales manager for open-segment MRI scanners.

The conventional recumbent scan shows no evidence of bladder or uterine prolapse.

In a vertical scan, bladder or uterine prolapse is seen as these organs descend relative to the pubococcygeal line. Photos Courtesy Melville MRI, P.C./Fonar

In a patient with central spinal stenosis, a scan made in a recumbent position shows spondylolisthesis at L4 and L5.

This upright flexion scan shows a further anterior shift of L4 and L5 and more severe spinal canal stenosis.

This upright extension scan shows a comparative posterior shift of L4 and L5. Photos Courtesy Melville MRI, P.C./Fonar

As the technology of weight-bearing MRI has developed, so too have new applications—from gynecologic to cardiovascular evaluations—and new challenges in interpreting the complex images now available.

Upright MRI, introduced in fall 2000 by Fonar Corp., can scan a patient in virtually any position that reproduces pain or other symptoms. This allows the detection of pathologies visible only in a variety of weight-bearing positions, including standing, sitting, flexion, and extension, Raymond V. Damadian, M.D., president and founder of the Melville, N.Y.-based company, told FAMILY PRACTICE NEWS.

As a result, “we see things that are not there in patients lying down,” said Dr. Damadian. “The pathology just isn't there [in the recumbent position].”

In one case, anterolisthesis at the L4/5 level was noted in a recumbent view, whereas a standing flexion scan showed an interspinal ligamentous rupture at the same level.

In another patient, a recumbent scan demonstrated no evidence of bladder or uterine prolapse and showed the levator sling parallel to and partially obscured by the pubococcygeal line. However, with the patient standing, the descent of the bladder relative to the pubococcygeal line was accentuated, and the levator sling was oblique and nonparallel to the pubococcygeal line.

Yet as revealing as such weight-bearing images might be, some radiologists may lack the experience or training to correctly interpret what they see.

“The body has moving parts, and once you start scanning in different positions, … the anatomical relativity of the body parts shifts. That's something that we have never viewed before. You have to be careful as to what you are calling normal or abnormal,” said Sana Khan, M.D., chair and founder of TrueMRI, an Anaheim, Calif.-based medical imaging group.

“One of the reasons their [Fonar's] machines are having a harder time being sold is that radiologists look at it and say, 'Why am I going to put all the extra effort in to learn all of this again?'” Dr. Khan said.

TrueMRI, which operates four upright scanners in California and one in Houston and expects one soon in Las Vegas, claims its radiologists have performed and interpreted more kinetic scans than any other company in the world. The company and its radiologists have developed proprietary software that interprets and quantifies the pathologies detected by an upright scan and is negotiating with Fonar to provide such interpretation for all Fonar users.

Dr. Damadian admits the images are complex and require experience to interpret. Images taken in the upright position must be systematically compared with those taken in a recumbent position to determine with confidence what changes are real and evince disease pathology.

On the other hand, it's not as though radiologists are operating in the dark, he said. With each use of the technology, radiologists are building a frame of reference. They're “learning all the time.”

From the patient's perspective, the scanner's open configuration may make MRI imaging more tolerable for those who are claustrophobic, and it makes MRI available to patients who simply couldn't fit into other scanners. It also allows young children to sit comfortably watching TV in the scanner without the use of routine anesthesia and lets infants be scanned while sleeping in their parents' laps.

About 50% of all MRIs in the United States involve the spine, so the lion's share of Upright MRI is being used for such musculoskeletal evaluations. But other applications are underway.

Upright MRI scanning, for example, is being used to obtain images of the beating heart and the blood-vascular system while the patient is vertical. Fonar introduced the first-ever magnetic resonance angiography and cines of the beating heart in the standing, sitting, obliquely oriented, and reverse Trendelenburg positions at the recent annual meeting of the Radiological Society of North America.

The company also unveiled a prototype of a new MRI-compatible treadmill for use inside its Upright MRI. Both of these technologies will possibly be available later this year, according to a Fonar spokesperson.

“We think one of the major applications of upright imaging is cardiovascular, because the heart is pumping against gravity, and the impact of gravity on blood flow is significant,” Dr. Damadian said.

In the vertical position, multiple factors may lead to decreased arterial or venous circulation, such as decreased cardiac output or loss of autoregulation.

“If you're a cardiovascular surgeon trying to evaluate the impact of a coronary attack on the heart or trying to evaluate stenosis in a blood vessel, you're going to want to know how that patient's physiology is tolerating that pathology,” Dr. Damadian said.

Competing MRI manufacturers contend that unique diagnostic information is rarely captured in an upright scan. However, Dr. Damadian said about a dozen studies seem to suggest otherwise.

In a yet-to-be-published study by researchers at the University of Aberdeen (Scotland), roughly one in five patients with low back pain and sciatica had evidence of slippages of the spine that were only visible when the patient was imaged standing up, Dr. Damadian said.

Dr. Khan, who is working in association with researchers at the University of California, Los Angeles, will release information later this year from a series of studies in approximately 800 asymptomatic patients whose spines were assessed in a variety of positions with upright MR imaging.

Still, Dr. Damadian admits a more comprehensive study is needed before physicians would accept upright imaging as the new standard.

There are now more than 70 Upright MRI machines installed worldwide, up from just 18 scanners in mid-2003. Sales revenues are up 190%, from $6.1 million in the first quarter of last year to $17.7 million in the quarter just ended.

One indication of the inroads the technology has made is an agreement with GE Healthcare that allows its salespeople to sell Fonar's Upright MRI scanner.

Although only a few have been sold this way, the agreement enables GE to offer a “total breadth” of products and services to its customers, said Ron Petcheny, GE product sales manager for open-segment MRI scanners.

The conventional recumbent scan shows no evidence of bladder or uterine prolapse.

In a vertical scan, bladder or uterine prolapse is seen as these organs descend relative to the pubococcygeal line. Photos Courtesy Melville MRI, P.C./Fonar

In a patient with central spinal stenosis, a scan made in a recumbent position shows spondylolisthesis at L4 and L5.

This upright flexion scan shows a further anterior shift of L4 and L5 and more severe spinal canal stenosis.

This upright extension scan shows a comparative posterior shift of L4 and L5. Photos Courtesy Melville MRI, P.C./Fonar

As the technology of weight-bearing MRI has developed, so too have new applications—from gynecologic to cardiovascular evaluations—and new challenges in interpreting the complex images now available.

Upright MRI, introduced in fall 2000 by Fonar Corp., can scan a patient in virtually any position that reproduces pain or other symptoms. This allows the detection of pathologies visible only in a variety of weight-bearing positions, including standing, sitting, flexion, and extension, Raymond V. Damadian, M.D., president and founder of the Melville, N.Y.-based company, told FAMILY PRACTICE NEWS.

As a result, “we see things that are not there in patients lying down,” said Dr. Damadian. “The pathology just isn't there [in the recumbent position].”

In one case, anterolisthesis at the L4/5 level was noted in a recumbent view, whereas a standing flexion scan showed an interspinal ligamentous rupture at the same level.

In another patient, a recumbent scan demonstrated no evidence of bladder or uterine prolapse and showed the levator sling parallel to and partially obscured by the pubococcygeal line. However, with the patient standing, the descent of the bladder relative to the pubococcygeal line was accentuated, and the levator sling was oblique and nonparallel to the pubococcygeal line.

Yet as revealing as such weight-bearing images might be, some radiologists may lack the experience or training to correctly interpret what they see.

“The body has moving parts, and once you start scanning in different positions, … the anatomical relativity of the body parts shifts. That's something that we have never viewed before. You have to be careful as to what you are calling normal or abnormal,” said Sana Khan, M.D., chair and founder of TrueMRI, an Anaheim, Calif.-based medical imaging group.

“One of the reasons their [Fonar's] machines are having a harder time being sold is that radiologists look at it and say, 'Why am I going to put all the extra effort in to learn all of this again?'” Dr. Khan said.

TrueMRI, which operates four upright scanners in California and one in Houston and expects one soon in Las Vegas, claims its radiologists have performed and interpreted more kinetic scans than any other company in the world. The company and its radiologists have developed proprietary software that interprets and quantifies the pathologies detected by an upright scan and is negotiating with Fonar to provide such interpretation for all Fonar users.

Dr. Damadian admits the images are complex and require experience to interpret. Images taken in the upright position must be systematically compared with those taken in a recumbent position to determine with confidence what changes are real and evince disease pathology.

On the other hand, it's not as though radiologists are operating in the dark, he said. With each use of the technology, radiologists are building a frame of reference. They're “learning all the time.”

From the patient's perspective, the scanner's open configuration may make MRI imaging more tolerable for those who are claustrophobic, and it makes MRI available to patients who simply couldn't fit into other scanners. It also allows young children to sit comfortably watching TV in the scanner without the use of routine anesthesia and lets infants be scanned while sleeping in their parents' laps.

About 50% of all MRIs in the United States involve the spine, so the lion's share of Upright MRI is being used for such musculoskeletal evaluations. But other applications are underway.

Upright MRI scanning, for example, is being used to obtain images of the beating heart and the blood-vascular system while the patient is vertical. Fonar introduced the first-ever magnetic resonance angiography and cines of the beating heart in the standing, sitting, obliquely oriented, and reverse Trendelenburg positions at the recent annual meeting of the Radiological Society of North America.

The company also unveiled a prototype of a new MRI-compatible treadmill for use inside its Upright MRI. Both of these technologies will possibly be available later this year, according to a Fonar spokesperson.

“We think one of the major applications of upright imaging is cardiovascular, because the heart is pumping against gravity, and the impact of gravity on blood flow is significant,” Dr. Damadian said.

In the vertical position, multiple factors may lead to decreased arterial or venous circulation, such as decreased cardiac output or loss of autoregulation.

“If you're a cardiovascular surgeon trying to evaluate the impact of a coronary attack on the heart or trying to evaluate stenosis in a blood vessel, you're going to want to know how that patient's physiology is tolerating that pathology,” Dr. Damadian said.

Competing MRI manufacturers contend that unique diagnostic information is rarely captured in an upright scan. However, Dr. Damadian said about a dozen studies seem to suggest otherwise.

In a yet-to-be-published study by researchers at the University of Aberdeen (Scotland), roughly one in five patients with low back pain and sciatica had evidence of slippages of the spine that were only visible when the patient was imaged standing up, Dr. Damadian said.

Dr. Khan, who is working in association with researchers at the University of California, Los Angeles, will release information later this year from a series of studies in approximately 800 asymptomatic patients whose spines were assessed in a variety of positions with upright MR imaging.

Still, Dr. Damadian admits a more comprehensive study is needed before physicians would accept upright imaging as the new standard.

There are now more than 70 Upright MRI machines installed worldwide, up from just 18 scanners in mid-2003. Sales revenues are up 190%, from $6.1 million in the first quarter of last year to $17.7 million in the quarter just ended.

One indication of the inroads the technology has made is an agreement with GE Healthcare that allows its salespeople to sell Fonar's Upright MRI scanner.

Although only a few have been sold this way, the agreement enables GE to offer a “total breadth” of products and services to its customers, said Ron Petcheny, GE product sales manager for open-segment MRI scanners.

The conventional recumbent scan shows no evidence of bladder or uterine prolapse.

In a vertical scan, bladder or uterine prolapse is seen as these organs descend relative to the pubococcygeal line. Photos Courtesy Melville MRI, P.C./Fonar

In a patient with central spinal stenosis, a scan made in a recumbent position shows spondylolisthesis at L4 and L5.

This upright flexion scan shows a further anterior shift of L4 and L5 and more severe spinal canal stenosis.

This upright extension scan shows a comparative posterior shift of L4 and L5. Photos Courtesy Melville MRI, P.C./Fonar

CHICAGO — The first artificial disk approved for use in the United States offers patients with chronic degenerative disk disease an alternative to spinal fusion surgery, but beware: Surgeons have a steep learning curve for placing the device correctly.

The primary advantage of the Charite Artificial Disc system by DePuy Spine Inc., a subsidiary of Johnson & Johnson, is that it offers pain relief, motion retention, and earlier return to normal function, Charite clinical trial investigator Scott Blumenthal, M.D., said in an interview.

The Charite disk, which was approved by the Food and Drug Administration in October, is indicated for patients with single-level degenerative disk disease. The device consists of two cobalt chromium end plates and a polyethylene core. There's no secondary bone graft harvesting or fixation of the spine with screws and rods to stabilize, as in spinal fusion surgery. When implanted, the device restores the natural distance between two vertebrae and allows movement at the level of implantation. And unlike the strict limitation imposed on patients who have undergone fusion surgery, when the disk is implanted successfully, there are no movement restrictions, said Dr. Blumenthal of the Texas Back Institute, Plano.

The European experience with the Charite, which dates back 2 decades, suggests it also may reduce adjacent degenerative disease better than fusion surgery, although this hasn't been specifically evaluated in clinical trials.

The FDA is requiring DePuy to conduct a long-term effectiveness and safety study of patients who have the device implanted, which will include assessing its impact on adjacent vertebrae, and on other bony structures in the back of the spine.

The artificial disk is currently being used at a handful of spine centers in the United States, and as more surgeons become trained in the procedure, it should become more widely available. Surgeon training is mandatory, and the learning curve is steep.

“This procedure is intended for experienced surgeons who already are familiar with the anterior approach to the spine,” William Christianson, DePuy vice president of clinical and regulatory affairs, said in an interview. “These are for fellowship-trained surgeons who have a practice focused exclusively on the spine. We don't want knee arthroplasty guys coming to our course. They won't be able to get in.”

There are about 2,000–2,500 surgeons in the United States who have the training and the experience to qualify for the course, he estimated.

A new study, evaluating the learning curve associated with Charite implantation in patients with symptomatic degenerative disk disease at L4-L5 or L5-S1, has shown that surgeons at high-volume investigational trial sites had shorter operative times (85 minutes versus 127 minutes), compared with surgeons at low-volume sites, John Regan, M.D., reported at the annual meeting of the North American Spine Society.

Patients at the high-volume sites also left the hospital 1 day earlier than patients in the low-volume group (3.5 days vs. 4.5 days). Major complications of neurologic deterioration (14.1% vs. 4.5%, respectively) and device failure (4 cases vs. 1 case, respectively) occurred significantly more often in the 85-patient low-volume group, compared with the 120-patient high-volume group.

Absolute change in visual analog scale (VAS) and Oswestry Disability Index scores was similar in both groups.

“Implant positioning is very important, and in our particular series at Cedars [Sinai Medical Center in Los Angeles] we noticed we improved from the first 10 to the last 10 cases,” said Dr. Regan, who is a consultant for DePuy.

Surgeons new to the procedure should limit themselves to single-level replacement. However, two-level replacements have been implanted outside the United States, demonstrating that the technique is “very viable,” said Dr. Blumenthal, who is also a consultant for DePuy and receives funds to lecture on the device.

Approval of the device was based on a 15-center study involving 304 patients who underwent back surgery for symptomatic disk degeneration that was unresponsive to 6 months of nonoperative treatment. Of the total, 205 were randomly assigned to receive a single-level Charite disk, and 99 received anterior lumbar interbody fusion using Bagby and Kuslich cages.

At 2 years of follow-up, those patients who had the artificial disk “did no worse” than those who had intervertebral body fusion with similar rates of adverse events in both groups, according to an FDA statement issued at the time of approval. There was no significant “relationship between motion at the level where the disk was implanted and the patient's relief from pain.”

Mean operative time and estimated blood loss were similar in the two groups. Hospital stays were significantly shorter among Charite patients, compared with fusion patients (3.7 days vs. 4.3 days), Dr. Blumenthal reported at the meeting.

VAS scores improved significantly in both groups, although improvement was significantly greater among Charite patients at all but the 24-month follow-up. Oswestry scores, which measure disability and function, followed a similar pattern.

Among Charite patients, 73% were satisfied with their treatment at 24 months, compared with 55% in the fusion group. When asked if they would choose the same treatment again, 69% of patients in the Charite group responded “definitely yes” and an additional 13% responded “probably yes,” compared with 52% and 13%, respectively, in the fusion group.

The device will be sold only to surgeons who have been trained by DePuy, and its Web site clearly states that patients should discuss with their surgeon whether they are candidates for the device, Mr. Christianson said.

Senior Writer Elizabeth Mechatie contributed to this report.

Other Cervical Arthroplasty Options

The Charité Disc System might have made it to the market first, but several other cervical arthroplasty options are in the developmental pipeline. Here's a look at some of those devices under investigation in the United States and elsewhere:

▸ Bryan Cervical Disc System (Medtronic Sofamor Danek) was approved for use outside the United States in 2002, and is now being investigated in the United States.

Results from a multicenter prospective study of the Bryan disk showed positive clinical outcomes in both single-level and bilevel treated patients with disk herniation or spondylotic changes at the C3-C7 levels with radiculopathy and/or myelopathy.

At 2 years, 62% of 98 single-level patients and 59% of 41 bilevel patients were “excellent” according to modified Odom's criteria, Jan Goffin, M.D., reported at the meeting. At 2 years, 86% of single-level patients and 96% of bilevel patients had preserved motion of more than 2 degrees.

However, paravertebral ossification was observed on x-ray in 4 of the original 25 study patients at 4 years. The use of NSAIDs postoperatively seems to reduce this phenomenon, said Dr. Goffin, of University Hospital Gasthuisberg, Leuven, Belgium.

There was no evidence of adjacent-level degeneration in 15 of the 25 patients, although long-term follow-up of more than 5 years will be necessary to address this issue, Dr. Goffin noted.

In a separate yearlong study of 90 patients with radiculopathy and/or myelopathy, 16 patients or 18% had signs of heterotopic ossification following implantation of the Bryan disk, reported Clarence Leung, M.B., London.

“In 10 patients, the artificial disk actually stopped moving at 1 year,” Dr. Leung said.

Based on the McAfee classification, six patients had grade III and IV heterotopic ossification, which was strongly associated with loss of movement. Older males were more likely to develop heterotopic ossification, he said.

▸ PCM cervical artificial disk (Cervitech) is not yet in U.S. clinical trials.

In a study comparing the Bryan system with PCM or porous coated motion disk, the Bryan group had longer incisions and operative times, compared with the PCM group, reported lead investigator Luiz Pimenta, M.D., of the University of Sao Paulo (Brazil).

Both groups had minimal blood loss of less than 50 cc.

Range of motion averaged about 8.3 degrees for flexion and extension in the PCM group vs. 4.5 degrees in the Bryan group.

Heterotopic ossification, which is strongly correlated with loss of movement, was present in 19% of Bryan patients, and in none of the PCM group.

In the Bryan group, there were no cerebral spinal fluid leaks, one anterior device migration, two postoperative cases of kyphosis, and three cases of fusion. By comparison, in the PCM group there were two intraoperative leaks, two device migrations, no kyphosis, and no cases of fusion.

▸ Prestige Artificial Cervical Disc (Medtronic Sofamor Danek) has been studied in clinical trials outside the United States and is currently in trials in the United States. In a small, prospective study, there was no statistical difference in any clinical outcomes at 1 year among 22 patients randomized to receive the Prestige disk and 48 patients who received anterior cervical diskectomy and fusion using cortical allograft and a cervical plate.

Patients treated with the Prestige disk showed improvement in all outcomes and maintenance of motion on x-ray, reported J. Kenneth Burkus, M.D., of the Hughston Clinic in Columbus, Ga.

The Bryan cervical disk was approved for use outside the United States in 2002.

The Prestige cervical disk is now being tested in U.S. clinical trials. Medtrinic Sofamor Danek

CHICAGO — The first artificial disk approved for use in the United States offers patients with chronic degenerative disk disease an alternative to spinal fusion surgery, but beware: Surgeons have a steep learning curve for placing the device correctly.

The primary advantage of the Charite Artificial Disc system by DePuy Spine Inc., a subsidiary of Johnson & Johnson, is that it offers pain relief, motion retention, and earlier return to normal function, Charite clinical trial investigator Scott Blumenthal, M.D., said in an interview.

The Charite disk, which was approved by the Food and Drug Administration in October, is indicated for patients with single-level degenerative disk disease. The device consists of two cobalt chromium end plates and a polyethylene core. There's no secondary bone graft harvesting or fixation of the spine with screws and rods to stabilize, as in spinal fusion surgery. When implanted, the device restores the natural distance between two vertebrae and allows movement at the level of implantation. And unlike the strict limitation imposed on patients who have undergone fusion surgery, when the disk is implanted successfully, there are no movement restrictions, said Dr. Blumenthal of the Texas Back Institute, Plano.

The European experience with the Charite, which dates back 2 decades, suggests it also may reduce adjacent degenerative disease better than fusion surgery, although this hasn't been specifically evaluated in clinical trials.

The FDA is requiring DePuy to conduct a long-term effectiveness and safety study of patients who have the device implanted, which will include assessing its impact on adjacent vertebrae, and on other bony structures in the back of the spine.

The artificial disk is currently being used at a handful of spine centers in the United States, and as more surgeons become trained in the procedure, it should become more widely available. Surgeon training is mandatory, and the learning curve is steep.

“This procedure is intended for experienced surgeons who already are familiar with the anterior approach to the spine,” William Christianson, DePuy vice president of clinical and regulatory affairs, said in an interview. “These are for fellowship-trained surgeons who have a practice focused exclusively on the spine. We don't want knee arthroplasty guys coming to our course. They won't be able to get in.”

There are about 2,000–2,500 surgeons in the United States who have the training and the experience to qualify for the course, he estimated.

A new study, evaluating the learning curve associated with Charite implantation in patients with symptomatic degenerative disk disease at L4-L5 or L5-S1, has shown that surgeons at high-volume investigational trial sites had shorter operative times (85 minutes versus 127 minutes), compared with surgeons at low-volume sites, John Regan, M.D., reported at the annual meeting of the North American Spine Society.

Patients at the high-volume sites also left the hospital 1 day earlier than patients in the low-volume group (3.5 days vs. 4.5 days). Major complications of neurologic deterioration (14.1% vs. 4.5%, respectively) and device failure (4 cases vs. 1 case, respectively) occurred significantly more often in the 85-patient low-volume group, compared with the 120-patient high-volume group.

Absolute change in visual analog scale (VAS) and Oswestry Disability Index scores was similar in both groups.

“Implant positioning is very important, and in our particular series at Cedars [Sinai Medical Center in Los Angeles] we noticed we improved from the first 10 to the last 10 cases,” said Dr. Regan, who is a consultant for DePuy.

Surgeons new to the procedure should limit themselves to single-level replacement. However, two-level replacements have been implanted outside the United States, demonstrating that the technique is “very viable,” said Dr. Blumenthal, who is also a consultant for DePuy and receives funds to lecture on the device.

Approval of the device was based on a 15-center study involving 304 patients who underwent back surgery for symptomatic disk degeneration that was unresponsive to 6 months of nonoperative treatment. Of the total, 205 were randomly assigned to receive a single-level Charite disk, and 99 received anterior lumbar interbody fusion using Bagby and Kuslich cages.

At 2 years of follow-up, those patients who had the artificial disk “did no worse” than those who had intervertebral body fusion with similar rates of adverse events in both groups, according to an FDA statement issued at the time of approval. There was no significant “relationship between motion at the level where the disk was implanted and the patient's relief from pain.”

Mean operative time and estimated blood loss were similar in the two groups. Hospital stays were significantly shorter among Charite patients, compared with fusion patients (3.7 days vs. 4.3 days), Dr. Blumenthal reported at the meeting.

VAS scores improved significantly in both groups, although improvement was significantly greater among Charite patients at all but the 24-month follow-up. Oswestry scores, which measure disability and function, followed a similar pattern.

Among Charite patients, 73% were satisfied with their treatment at 24 months, compared with 55% in the fusion group. When asked if they would choose the same treatment again, 69% of patients in the Charite group responded “definitely yes” and an additional 13% responded “probably yes,” compared with 52% and 13%, respectively, in the fusion group.

The device will be sold only to surgeons who have been trained by DePuy, and its Web site clearly states that patients should discuss with their surgeon whether they are candidates for the device, Mr. Christianson said.

Senior Writer Elizabeth Mechatie contributed to this report.

Other Cervical Arthroplasty Options

The Charité Disc System might have made it to the market first, but several other cervical arthroplasty options are in the developmental pipeline. Here's a look at some of those devices under investigation in the United States and elsewhere:

▸ Bryan Cervical Disc System (Medtronic Sofamor Danek) was approved for use outside the United States in 2002, and is now being investigated in the United States.

Results from a multicenter prospective study of the Bryan disk showed positive clinical outcomes in both single-level and bilevel treated patients with disk herniation or spondylotic changes at the C3-C7 levels with radiculopathy and/or myelopathy.

At 2 years, 62% of 98 single-level patients and 59% of 41 bilevel patients were “excellent” according to modified Odom's criteria, Jan Goffin, M.D., reported at the meeting. At 2 years, 86% of single-level patients and 96% of bilevel patients had preserved motion of more than 2 degrees.

However, paravertebral ossification was observed on x-ray in 4 of the original 25 study patients at 4 years. The use of NSAIDs postoperatively seems to reduce this phenomenon, said Dr. Goffin, of University Hospital Gasthuisberg, Leuven, Belgium.

There was no evidence of adjacent-level degeneration in 15 of the 25 patients, although long-term follow-up of more than 5 years will be necessary to address this issue, Dr. Goffin noted.

In a separate yearlong study of 90 patients with radiculopathy and/or myelopathy, 16 patients or 18% had signs of heterotopic ossification following implantation of the Bryan disk, reported Clarence Leung, M.B., London.

“In 10 patients, the artificial disk actually stopped moving at 1 year,” Dr. Leung said.

Based on the McAfee classification, six patients had grade III and IV heterotopic ossification, which was strongly associated with loss of movement. Older males were more likely to develop heterotopic ossification, he said.

▸ PCM cervical artificial disk (Cervitech) is not yet in U.S. clinical trials.

In a study comparing the Bryan system with PCM or porous coated motion disk, the Bryan group had longer incisions and operative times, compared with the PCM group, reported lead investigator Luiz Pimenta, M.D., of the University of Sao Paulo (Brazil).

Both groups had minimal blood loss of less than 50 cc.

Range of motion averaged about 8.3 degrees for flexion and extension in the PCM group vs. 4.5 degrees in the Bryan group.

Heterotopic ossification, which is strongly correlated with loss of movement, was present in 19% of Bryan patients, and in none of the PCM group.

In the Bryan group, there were no cerebral spinal fluid leaks, one anterior device migration, two postoperative cases of kyphosis, and three cases of fusion. By comparison, in the PCM group there were two intraoperative leaks, two device migrations, no kyphosis, and no cases of fusion.

▸ Prestige Artificial Cervical Disc (Medtronic Sofamor Danek) has been studied in clinical trials outside the United States and is currently in trials in the United States. In a small, prospective study, there was no statistical difference in any clinical outcomes at 1 year among 22 patients randomized to receive the Prestige disk and 48 patients who received anterior cervical diskectomy and fusion using cortical allograft and a cervical plate.

Patients treated with the Prestige disk showed improvement in all outcomes and maintenance of motion on x-ray, reported J. Kenneth Burkus, M.D., of the Hughston Clinic in Columbus, Ga.

The Bryan cervical disk was approved for use outside the United States in 2002.

The Prestige cervical disk is now being tested in U.S. clinical trials. Medtrinic Sofamor Danek

CHICAGO — The first artificial disk approved for use in the United States offers patients with chronic degenerative disk disease an alternative to spinal fusion surgery, but beware: Surgeons have a steep learning curve for placing the device correctly.

The primary advantage of the Charite Artificial Disc system by DePuy Spine Inc., a subsidiary of Johnson & Johnson, is that it offers pain relief, motion retention, and earlier return to normal function, Charite clinical trial investigator Scott Blumenthal, M.D., said in an interview.

The Charite disk, which was approved by the Food and Drug Administration in October, is indicated for patients with single-level degenerative disk disease. The device consists of two cobalt chromium end plates and a polyethylene core. There's no secondary bone graft harvesting or fixation of the spine with screws and rods to stabilize, as in spinal fusion surgery. When implanted, the device restores the natural distance between two vertebrae and allows movement at the level of implantation. And unlike the strict limitation imposed on patients who have undergone fusion surgery, when the disk is implanted successfully, there are no movement restrictions, said Dr. Blumenthal of the Texas Back Institute, Plano.

The European experience with the Charite, which dates back 2 decades, suggests it also may reduce adjacent degenerative disease better than fusion surgery, although this hasn't been specifically evaluated in clinical trials.

The FDA is requiring DePuy to conduct a long-term effectiveness and safety study of patients who have the device implanted, which will include assessing its impact on adjacent vertebrae, and on other bony structures in the back of the spine.

The artificial disk is currently being used at a handful of spine centers in the United States, and as more surgeons become trained in the procedure, it should become more widely available. Surgeon training is mandatory, and the learning curve is steep.

“This procedure is intended for experienced surgeons who already are familiar with the anterior approach to the spine,” William Christianson, DePuy vice president of clinical and regulatory affairs, said in an interview. “These are for fellowship-trained surgeons who have a practice focused exclusively on the spine. We don't want knee arthroplasty guys coming to our course. They won't be able to get in.”

There are about 2,000–2,500 surgeons in the United States who have the training and the experience to qualify for the course, he estimated.

A new study, evaluating the learning curve associated with Charite implantation in patients with symptomatic degenerative disk disease at L4-L5 or L5-S1, has shown that surgeons at high-volume investigational trial sites had shorter operative times (85 minutes versus 127 minutes), compared with surgeons at low-volume sites, John Regan, M.D., reported at the annual meeting of the North American Spine Society.

Patients at the high-volume sites also left the hospital 1 day earlier than patients in the low-volume group (3.5 days vs. 4.5 days). Major complications of neurologic deterioration (14.1% vs. 4.5%, respectively) and device failure (4 cases vs. 1 case, respectively) occurred significantly more often in the 85-patient low-volume group, compared with the 120-patient high-volume group.

Absolute change in visual analog scale (VAS) and Oswestry Disability Index scores was similar in both groups.

“Implant positioning is very important, and in our particular series at Cedars [Sinai Medical Center in Los Angeles] we noticed we improved from the first 10 to the last 10 cases,” said Dr. Regan, who is a consultant for DePuy.

Surgeons new to the procedure should limit themselves to single-level replacement. However, two-level replacements have been implanted outside the United States, demonstrating that the technique is “very viable,” said Dr. Blumenthal, who is also a consultant for DePuy and receives funds to lecture on the device.

Approval of the device was based on a 15-center study involving 304 patients who underwent back surgery for symptomatic disk degeneration that was unresponsive to 6 months of nonoperative treatment. Of the total, 205 were randomly assigned to receive a single-level Charite disk, and 99 received anterior lumbar interbody fusion using Bagby and Kuslich cages.

At 2 years of follow-up, those patients who had the artificial disk “did no worse” than those who had intervertebral body fusion with similar rates of adverse events in both groups, according to an FDA statement issued at the time of approval. There was no significant “relationship between motion at the level where the disk was implanted and the patient's relief from pain.”

Mean operative time and estimated blood loss were similar in the two groups. Hospital stays were significantly shorter among Charite patients, compared with fusion patients (3.7 days vs. 4.3 days), Dr. Blumenthal reported at the meeting.

VAS scores improved significantly in both groups, although improvement was significantly greater among Charite patients at all but the 24-month follow-up. Oswestry scores, which measure disability and function, followed a similar pattern.

Among Charite patients, 73% were satisfied with their treatment at 24 months, compared with 55% in the fusion group. When asked if they would choose the same treatment again, 69% of patients in the Charite group responded “definitely yes” and an additional 13% responded “probably yes,” compared with 52% and 13%, respectively, in the fusion group.

The device will be sold only to surgeons who have been trained by DePuy, and its Web site clearly states that patients should discuss with their surgeon whether they are candidates for the device, Mr. Christianson said.

Senior Writer Elizabeth Mechatie contributed to this report.

Other Cervical Arthroplasty Options

The Charité Disc System might have made it to the market first, but several other cervical arthroplasty options are in the developmental pipeline. Here's a look at some of those devices under investigation in the United States and elsewhere:

▸ Bryan Cervical Disc System (Medtronic Sofamor Danek) was approved for use outside the United States in 2002, and is now being investigated in the United States.

Results from a multicenter prospective study of the Bryan disk showed positive clinical outcomes in both single-level and bilevel treated patients with disk herniation or spondylotic changes at the C3-C7 levels with radiculopathy and/or myelopathy.

At 2 years, 62% of 98 single-level patients and 59% of 41 bilevel patients were “excellent” according to modified Odom's criteria, Jan Goffin, M.D., reported at the meeting. At 2 years, 86% of single-level patients and 96% of bilevel patients had preserved motion of more than 2 degrees.

However, paravertebral ossification was observed on x-ray in 4 of the original 25 study patients at 4 years. The use of NSAIDs postoperatively seems to reduce this phenomenon, said Dr. Goffin, of University Hospital Gasthuisberg, Leuven, Belgium.

There was no evidence of adjacent-level degeneration in 15 of the 25 patients, although long-term follow-up of more than 5 years will be necessary to address this issue, Dr. Goffin noted.

In a separate yearlong study of 90 patients with radiculopathy and/or myelopathy, 16 patients or 18% had signs of heterotopic ossification following implantation of the Bryan disk, reported Clarence Leung, M.B., London.

“In 10 patients, the artificial disk actually stopped moving at 1 year,” Dr. Leung said.

Based on the McAfee classification, six patients had grade III and IV heterotopic ossification, which was strongly associated with loss of movement. Older males were more likely to develop heterotopic ossification, he said.

▸ PCM cervical artificial disk (Cervitech) is not yet in U.S. clinical trials.

In a study comparing the Bryan system with PCM or porous coated motion disk, the Bryan group had longer incisions and operative times, compared with the PCM group, reported lead investigator Luiz Pimenta, M.D., of the University of Sao Paulo (Brazil).

Both groups had minimal blood loss of less than 50 cc.

Range of motion averaged about 8.3 degrees for flexion and extension in the PCM group vs. 4.5 degrees in the Bryan group.

Heterotopic ossification, which is strongly correlated with loss of movement, was present in 19% of Bryan patients, and in none of the PCM group.

In the Bryan group, there were no cerebral spinal fluid leaks, one anterior device migration, two postoperative cases of kyphosis, and three cases of fusion. By comparison, in the PCM group there were two intraoperative leaks, two device migrations, no kyphosis, and no cases of fusion.

▸ Prestige Artificial Cervical Disc (Medtronic Sofamor Danek) has been studied in clinical trials outside the United States and is currently in trials in the United States. In a small, prospective study, there was no statistical difference in any clinical outcomes at 1 year among 22 patients randomized to receive the Prestige disk and 48 patients who received anterior cervical diskectomy and fusion using cortical allograft and a cervical plate.

Patients treated with the Prestige disk showed improvement in all outcomes and maintenance of motion on x-ray, reported J. Kenneth Burkus, M.D., of the Hughston Clinic in Columbus, Ga.

The Bryan cervical disk was approved for use outside the United States in 2002.

The Prestige cervical disk is now being tested in U.S. clinical trials. Medtrinic Sofamor Danek

CHICAGO — Psychostimulants are commonly prescribed for children with autism, and that treatment is often continued for several years, according to results of a large new study, Katherine Nickels, M.D., reported at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Nearly two-thirds of children with autism in a population-based cohort received psychopharmacologic treatment, with more than half having been treated with psychostimulants.

Previous studies have shown that 6.7%–20% of children with autism are treated with psychostimulants. But these studies were small or had biased subject populations, said Dr. Nickels, a pediatric resident at the Mayo Clinic, Rochester, Minn.

“What makes our research unique is that it is a large, population-based cohort of research-identified autism spectrum disorders,” Dr. Nickels said.

“The patients were nonreferred and represent every case of autism spectrum disorders in a population at risk,” she said.

Using data from the Rochester Epidemiology Project, Dr. Nickels and colleagues identified 124 patients that fulfilled the DSM-IV research criteria for autism. Ninety-five were male and 29 female, and the majority were cognitively impaired, as defined by an IQ of 70 or less.

The children were drawn from all 0- to 21-year-old residents of Olmsted County, Minn., who received either inpatient or outpatient care at all sites providing medical care from 1976 to 1997.

Information on all psychopharmacologic medications ever used was abstracted, including name, dose, and dates at which treatment was started and stopped. Duration of follow-up was defined as the time between the first and last documented medical visits. Treatment outcomes were not assessed.

Psychopharmacologic treatment of any kind was used for 82 cases (66%). Among these, 65 patients (79%) were treated with psychostimulants. Overall, 53% of the 124 patients with research-identified autism were treated with stimulants.

There was no difference in stimulant use by gender (53% male vs. 52% female). The median age at which treatment began was 8 years.

The most commonly prescribed stimulant was methylphenidate (80%), followed by dextroamphetamine (54%), and mixed amphetamine salts (20%).

The median time between the first and last documented psychostimulant treatment was 4.3 years. Median duration of follow-up was 12.5 years overall for autism cases and 13.9 years for cases treated with stimulants.

The study did not look at the difference in treatment preference by decade. But, some children were diagnosed after treatment began.

“Some of these children were treated at a time when autism and autism spectrum disorders were not a very popular diagnosis,” Dr. Nickels said. “I remember reading through charts of children, who very obviously fit all DSM-IV criteria, and yet their symptoms were still blamed on their mothers.”

The study was limited in that it was retrospective, although the investigators were able to apply the DSM-IV criteria to all patients given the detailed records available on this medically well-served population.

Additionally, the racial demographics of the study (96% white) suggest caution in generalizing the findings to the U.S. population, Dr. Nickels said. However, a recent population-based study demonstrated that the rate of autism spectrum disorders is comparable between African American and white children.

CHICAGO — Psychostimulants are commonly prescribed for children with autism, and that treatment is often continued for several years, according to results of a large new study, Katherine Nickels, M.D., reported at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Nearly two-thirds of children with autism in a population-based cohort received psychopharmacologic treatment, with more than half having been treated with psychostimulants.

Previous studies have shown that 6.7%–20% of children with autism are treated with psychostimulants. But these studies were small or had biased subject populations, said Dr. Nickels, a pediatric resident at the Mayo Clinic, Rochester, Minn.

“What makes our research unique is that it is a large, population-based cohort of research-identified autism spectrum disorders,” Dr. Nickels said.

“The patients were nonreferred and represent every case of autism spectrum disorders in a population at risk,” she said.

Using data from the Rochester Epidemiology Project, Dr. Nickels and colleagues identified 124 patients that fulfilled the DSM-IV research criteria for autism. Ninety-five were male and 29 female, and the majority were cognitively impaired, as defined by an IQ of 70 or less.

The children were drawn from all 0- to 21-year-old residents of Olmsted County, Minn., who received either inpatient or outpatient care at all sites providing medical care from 1976 to 1997.

Information on all psychopharmacologic medications ever used was abstracted, including name, dose, and dates at which treatment was started and stopped. Duration of follow-up was defined as the time between the first and last documented medical visits. Treatment outcomes were not assessed.

Psychopharmacologic treatment of any kind was used for 82 cases (66%). Among these, 65 patients (79%) were treated with psychostimulants. Overall, 53% of the 124 patients with research-identified autism were treated with stimulants.

There was no difference in stimulant use by gender (53% male vs. 52% female). The median age at which treatment began was 8 years.

The most commonly prescribed stimulant was methylphenidate (80%), followed by dextroamphetamine (54%), and mixed amphetamine salts (20%).

The median time between the first and last documented psychostimulant treatment was 4.3 years. Median duration of follow-up was 12.5 years overall for autism cases and 13.9 years for cases treated with stimulants.

The study did not look at the difference in treatment preference by decade. But, some children were diagnosed after treatment began.

“Some of these children were treated at a time when autism and autism spectrum disorders were not a very popular diagnosis,” Dr. Nickels said. “I remember reading through charts of children, who very obviously fit all DSM-IV criteria, and yet their symptoms were still blamed on their mothers.”

The study was limited in that it was retrospective, although the investigators were able to apply the DSM-IV criteria to all patients given the detailed records available on this medically well-served population.

Additionally, the racial demographics of the study (96% white) suggest caution in generalizing the findings to the U.S. population, Dr. Nickels said. However, a recent population-based study demonstrated that the rate of autism spectrum disorders is comparable between African American and white children.

CHICAGO — Psychostimulants are commonly prescribed for children with autism, and that treatment is often continued for several years, according to results of a large new study, Katherine Nickels, M.D., reported at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Nearly two-thirds of children with autism in a population-based cohort received psychopharmacologic treatment, with more than half having been treated with psychostimulants.

Previous studies have shown that 6.7%–20% of children with autism are treated with psychostimulants. But these studies were small or had biased subject populations, said Dr. Nickels, a pediatric resident at the Mayo Clinic, Rochester, Minn.

“What makes our research unique is that it is a large, population-based cohort of research-identified autism spectrum disorders,” Dr. Nickels said.

“The patients were nonreferred and represent every case of autism spectrum disorders in a population at risk,” she said.

Using data from the Rochester Epidemiology Project, Dr. Nickels and colleagues identified 124 patients that fulfilled the DSM-IV research criteria for autism. Ninety-five were male and 29 female, and the majority were cognitively impaired, as defined by an IQ of 70 or less.

The children were drawn from all 0- to 21-year-old residents of Olmsted County, Minn., who received either inpatient or outpatient care at all sites providing medical care from 1976 to 1997.

Information on all psychopharmacologic medications ever used was abstracted, including name, dose, and dates at which treatment was started and stopped. Duration of follow-up was defined as the time between the first and last documented medical visits. Treatment outcomes were not assessed.

Psychopharmacologic treatment of any kind was used for 82 cases (66%). Among these, 65 patients (79%) were treated with psychostimulants. Overall, 53% of the 124 patients with research-identified autism were treated with stimulants.

There was no difference in stimulant use by gender (53% male vs. 52% female). The median age at which treatment began was 8 years.

The most commonly prescribed stimulant was methylphenidate (80%), followed by dextroamphetamine (54%), and mixed amphetamine salts (20%).

The median time between the first and last documented psychostimulant treatment was 4.3 years. Median duration of follow-up was 12.5 years overall for autism cases and 13.9 years for cases treated with stimulants.

The study did not look at the difference in treatment preference by decade. But, some children were diagnosed after treatment began.

“Some of these children were treated at a time when autism and autism spectrum disorders were not a very popular diagnosis,” Dr. Nickels said. “I remember reading through charts of children, who very obviously fit all DSM-IV criteria, and yet their symptoms were still blamed on their mothers.”

The study was limited in that it was retrospective, although the investigators were able to apply the DSM-IV criteria to all patients given the detailed records available on this medically well-served population.

Additionally, the racial demographics of the study (96% white) suggest caution in generalizing the findings to the U.S. population, Dr. Nickels said. However, a recent population-based study demonstrated that the rate of autism spectrum disorders is comparable between African American and white children.

CHICAGO — The use of complementary and alternative medicine is very common among children with autistic spectrum disorders, according to two poster presentations at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Seventy-four percent of the 112 families of children with autistic spectrum disorders (ASDs) from Children's Hospital in Boston reported having used some type of complementary and alternative medicine (CAM). A Canadian study showed 91% of 183 families surveyed had used a CAM of any type.

“People are doing a lot of things that they aren't telling their doctor about, unless they ask,” Leonard Rappaport, M.D., director of the developmental medicine center at Children's Hospital, Boston, said. “This is something that needs to be reinforced continually.”

The most common CAM therapies were modified diet (38%), vitamins/minerals (30%), food supplements (23%), and prayer/shaman (16%), according to the Boston study, led by Ellen Hanson, Ph.D.

The most frequently used interventions were conventional therapies such as educational techniques (89%), sensory therapies (71%), and prescription drugs (50%).

CAM use was associated with having a more severe form of ASD. There was some suggestion that CAM use was associated with longer time since diagnosis, and with higher education level in mothers.

Very few families reported that any of the interventions were harmful. Most families reported that their chief motivations for choosing CAM were unacceptable side effects, concern about the side effects, and safety of prescription medications.

In a separate presentation, a cross-sectional survey of a study population of children aged 3–18 years (mean 8.9 years) diagnosed with any ASD in southern Alberta showed that the most common types of CAM used were vitamins and minerals (63%), mind-body therapies (51%), dietary-nutritional therapies (48%), natural therapies such as St. John's wort, Kava, and homeopathy (39%), and anti-yeast therapies (31%).

The most common reasons for CAM use were: to improve symptoms of autism (43%), to improve mental and emotional well being (39%), to improve health (36%), a belief it could not hurt (28%), a belief that conventional medicine did not have any answers (22%), and a belief in holistic health (20%).

“Only 10% of families used CAM because they wanted to heal their child of ASD, so this is a pretty aware population,” said lead investigator W. Ben Gibbard, M.D., of the University of Calgary (Alt.). “If you go online you'll find 20–30 sites that say there is a potential cure,” Dr. Rappaport said.

The mean number of therapies used was 10, but “some patients are up to 80 therapies that they've tried,” Dr. Gibbard said.

CHICAGO — The use of complementary and alternative medicine is very common among children with autistic spectrum disorders, according to two poster presentations at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Seventy-four percent of the 112 families of children with autistic spectrum disorders (ASDs) from Children's Hospital in Boston reported having used some type of complementary and alternative medicine (CAM). A Canadian study showed 91% of 183 families surveyed had used a CAM of any type.

“People are doing a lot of things that they aren't telling their doctor about, unless they ask,” Leonard Rappaport, M.D., director of the developmental medicine center at Children's Hospital, Boston, said. “This is something that needs to be reinforced continually.”

The most common CAM therapies were modified diet (38%), vitamins/minerals (30%), food supplements (23%), and prayer/shaman (16%), according to the Boston study, led by Ellen Hanson, Ph.D.

The most frequently used interventions were conventional therapies such as educational techniques (89%), sensory therapies (71%), and prescription drugs (50%).

CAM use was associated with having a more severe form of ASD. There was some suggestion that CAM use was associated with longer time since diagnosis, and with higher education level in mothers.

Very few families reported that any of the interventions were harmful. Most families reported that their chief motivations for choosing CAM were unacceptable side effects, concern about the side effects, and safety of prescription medications.

In a separate presentation, a cross-sectional survey of a study population of children aged 3–18 years (mean 8.9 years) diagnosed with any ASD in southern Alberta showed that the most common types of CAM used were vitamins and minerals (63%), mind-body therapies (51%), dietary-nutritional therapies (48%), natural therapies such as St. John's wort, Kava, and homeopathy (39%), and anti-yeast therapies (31%).

The most common reasons for CAM use were: to improve symptoms of autism (43%), to improve mental and emotional well being (39%), to improve health (36%), a belief it could not hurt (28%), a belief that conventional medicine did not have any answers (22%), and a belief in holistic health (20%).

“Only 10% of families used CAM because they wanted to heal their child of ASD, so this is a pretty aware population,” said lead investigator W. Ben Gibbard, M.D., of the University of Calgary (Alt.). “If you go online you'll find 20–30 sites that say there is a potential cure,” Dr. Rappaport said.

The mean number of therapies used was 10, but “some patients are up to 80 therapies that they've tried,” Dr. Gibbard said.

CHICAGO — The use of complementary and alternative medicine is very common among children with autistic spectrum disorders, according to two poster presentations at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Seventy-four percent of the 112 families of children with autistic spectrum disorders (ASDs) from Children's Hospital in Boston reported having used some type of complementary and alternative medicine (CAM). A Canadian study showed 91% of 183 families surveyed had used a CAM of any type.

“People are doing a lot of things that they aren't telling their doctor about, unless they ask,” Leonard Rappaport, M.D., director of the developmental medicine center at Children's Hospital, Boston, said. “This is something that needs to be reinforced continually.”

The most common CAM therapies were modified diet (38%), vitamins/minerals (30%), food supplements (23%), and prayer/shaman (16%), according to the Boston study, led by Ellen Hanson, Ph.D.

The most frequently used interventions were conventional therapies such as educational techniques (89%), sensory therapies (71%), and prescription drugs (50%).

CAM use was associated with having a more severe form of ASD. There was some suggestion that CAM use was associated with longer time since diagnosis, and with higher education level in mothers.

Very few families reported that any of the interventions were harmful. Most families reported that their chief motivations for choosing CAM were unacceptable side effects, concern about the side effects, and safety of prescription medications.

In a separate presentation, a cross-sectional survey of a study population of children aged 3–18 years (mean 8.9 years) diagnosed with any ASD in southern Alberta showed that the most common types of CAM used were vitamins and minerals (63%), mind-body therapies (51%), dietary-nutritional therapies (48%), natural therapies such as St. John's wort, Kava, and homeopathy (39%), and anti-yeast therapies (31%).

The most common reasons for CAM use were: to improve symptoms of autism (43%), to improve mental and emotional well being (39%), to improve health (36%), a belief it could not hurt (28%), a belief that conventional medicine did not have any answers (22%), and a belief in holistic health (20%).

“Only 10% of families used CAM because they wanted to heal their child of ASD, so this is a pretty aware population,” said lead investigator W. Ben Gibbard, M.D., of the University of Calgary (Alt.). “If you go online you'll find 20–30 sites that say there is a potential cure,” Dr. Rappaport said.

The mean number of therapies used was 10, but “some patients are up to 80 therapies that they've tried,” Dr. Gibbard said.

Long abandoned as ineffective at secondary stroke prevention, carotid artery bypass surgery for complete atherosclerotic occlusion is getting a second look.

Known as extracranial/intracranial (EC/IC) bypass, the procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA). It is getting its second chance to prove its effectiveness in selected patients for complete carotid occlusion because technologic advances, such as refinement of PET, have made it possible to identify which patients are the best candidates for the procedure.

EC/IC bypass surgery has been shown in a series of small studies to normalize the oxygen extraction fraction (OEF), a marker of impaired cerebral blood flow in patients with carotid occlusion.

Whether that translates into a decreased stroke risk is the subject of the Carotid Occlusion Surgery Study (COSS), a $21 million, 7-year trial funded by the National Institutes of Health that is now underway in 28 U.S. centers.

Candidates for the trial must be patients with symptomatic carotid occlusion and increased OEF on PET. To date, 169 patients have enrolled, and 38 patients have been randomized to treatment.

Enrollment in the nonblinded, controlled clinical trial has been slow, in part because few neurologists knew the option of bypass surgery existed, said Colin Derdeyn, M.D., principal investigator for the Washington University site in St. Louis.

The First EC/IC Bypass Study

STA-MCA surgical anastomosis was developed in 1967 and routinely performed on patients with carotid occlusion throughout the 1970s and mid-1980s.

However, data from the EC/IC Bypass Study showed no benefit for the prevention of subsequent stroke among 808 patients with symptomatic carotid occlusion, despite restoring blood flow to the carotid artery in 96% of cases (N. Engl. J Med. 1985;313:1191–200).

The researchers were unable to assess whether the procedure was more appropriate for one or another group of patients based on their cerebral hemodynamics because at the time the technology necessary to understand and measure cerebral blood flow had not been developed, according to M. Gazi Yasargil, M.D., professor of neurosurgery at the University of Arkansas, Little Rock, the Swiss neurosurgeon who pioneered the surgical procedure. “The time is ripe to work out a perfect indication for bypass surgery,” he said.

Identifying Hemodynamics

PET has made it possible to measure OEF, a proven predictor of which patients have significantly decreased cerebral blood flow and are at increased stroke risk.

When there is unrestricted cerebral blood flow, the brain extracts about 40% of the oxygen delivered to it in the blood. Blood vessels dilate and constrict to maintain an equal OEF across the brain. When cerebral blood flow falls because of reduced perfusion pressure, the brain increases the fraction of oxygen extracted from the blood to 70% or 80% to support normal oxygen metabolism. This elevated OEF allows the brain to maintain normal function, but it puts patients at increased risk for stroke in the future.

Two prospective natural history studies, one conducted in the United States (JAMA 1998;280:1055–69) and the other in Japan (J. Nucl. Med. 1999;40:1992–8), have shown that having an increased OEF as measured by PET is an independent predictor of future stroke in medically treated patients with symptomatic carotid artery occlusion.

Depending on the precise clinical and PET criteria used, the 2-year ipsilateral stroke rates ranged from 26% to 57% in patients with an elevated OEF, compared with stroke rates of 5%–15% in patients with normal OEF, according to Dr. Derdeyn, coauthor of the U.S. study.

“The best information we have right now, as far as connecting an abnormality by physiologic imaging with a risk factor, is for increased oxygen extraction,” Dr. Derdeyn told INTERNAL MEDICINE NEWS. OEF is a powerful and independent predictor of stroke. “It identifies a high-risk subgroup, without question,” he said.

William J. Powers, M.D., principal investigator of COSS, agreed on the importance of identifying subsets of patients most likely to benefit from EC/IC. “It's absolutely clear that if [EC/IC bypass] is ever going to work, there has to be some more refined selection criteria to pick out the people, number one, who would be at particularly high risk if treated with medical therapy, and number two, in whom the subsequent risk of stroke seems to be related to a problem that the bypass would fix,” he told this newspaper.

COSS is based on the hypothesis that surgical anastomosis of the superficial temporal artery to the middle cerebral artery, when added to the best medical therapy, can reduce subsequent ipsilateral ischemic stroke by 40% at 2 years' follow-up in this highly select patient population, despite perioperative stroke and death.

Investigators anticipate that the stroke rate in COSS will turn out to be 40% in the medically treated group and 24% in the surgically treated group, even taking into account a 12% perioperative stroke and mortality rate, as reported in the original EC/IC trial, said Dr. Powers, codirector of the Stroke Center at Barnes-Jewish Hospital and the Washington University School of Medicine.

Even if these reduced stroke rates are borne out by the study, EC/IC bypass surgery is unlikely to become as common as coronary artery bypass; elevated OEF occurs in only 30% of patients with carotid occlusion. The study's $21-million price tag over the next 5–7 years may prove to be money well spent if it settles the question of patient selection once and for all. A similar trial, the Japanese EC/IC Trial (JET), is also working on the question of patient selection. A third trial, the Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON) study, was recently funded by NIH to examine the hotly debated question of whether carotid bypass surgery affects cognitive function.

EC/IC Bypass In a Nutshell

The 4-hour EC/IC procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery.

While the patient is under general anesthesia, an incision of several centimeters is made in the scalp on the side of the head where the diseased artery is located. A branch of the superficial temporal artery, generally the anterior division, is then identified and dissected using a surgical microscope.

A small craniotomy is then made beneath the temporalis muscle. A frontal branch of the middle cerebral artery is identified and isolated.

Once a suitable location for the anastomosis is determined, temporary clips are placed above and below the site. A slit is cut into this branch, and the previously dissected and prepared superficial temporal artery is sewn directly onto this middle cerebral artery branch for an end-to-side anastomosis.

The clips are then removed and blood flow restored.

Risks of the surgery include subsequent stroke as a result of temporary occlusion of the middle cerebral artery branch, thrombosis of the bypass graft, myocardial infarction during surgery, bleeding, and infection.

A retrospective analysis of EC/IC bypass surgery performed on 67 patients from 1986 to 2000 reported a perioperative morbidity rate of 3%, with no mortality (Acta Neurochir. [Wien] 2004;146:95–101).

Long abandoned as ineffective at secondary stroke prevention, carotid artery bypass surgery for complete atherosclerotic occlusion is getting a second look.

Known as extracranial/intracranial (EC/IC) bypass, the procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA). It is getting its second chance to prove its effectiveness in selected patients for complete carotid occlusion because technologic advances, such as refinement of PET, have made it possible to identify which patients are the best candidates for the procedure.

EC/IC bypass surgery has been shown in a series of small studies to normalize the oxygen extraction fraction (OEF), a marker of impaired cerebral blood flow in patients with carotid occlusion.

Whether that translates into a decreased stroke risk is the subject of the Carotid Occlusion Surgery Study (COSS), a $21 million, 7-year trial funded by the National Institutes of Health that is now underway in 28 U.S. centers.

Candidates for the trial must be patients with symptomatic carotid occlusion and increased OEF on PET. To date, 169 patients have enrolled, and 38 patients have been randomized to treatment.

Enrollment in the nonblinded, controlled clinical trial has been slow, in part because few neurologists knew the option of bypass surgery existed, said Colin Derdeyn, M.D., principal investigator for the Washington University site in St. Louis.

The First EC/IC Bypass Study

STA-MCA surgical anastomosis was developed in 1967 and routinely performed on patients with carotid occlusion throughout the 1970s and mid-1980s.

However, data from the EC/IC Bypass Study showed no benefit for the prevention of subsequent stroke among 808 patients with symptomatic carotid occlusion, despite restoring blood flow to the carotid artery in 96% of cases (N. Engl. J Med. 1985;313:1191–200).

The researchers were unable to assess whether the procedure was more appropriate for one or another group of patients based on their cerebral hemodynamics because at the time the technology necessary to understand and measure cerebral blood flow had not been developed, according to M. Gazi Yasargil, M.D., professor of neurosurgery at the University of Arkansas, Little Rock, the Swiss neurosurgeon who pioneered the surgical procedure. “The time is ripe to work out a perfect indication for bypass surgery,” he said.

Identifying Hemodynamics

PET has made it possible to measure OEF, a proven predictor of which patients have significantly decreased cerebral blood flow and are at increased stroke risk.

When there is unrestricted cerebral blood flow, the brain extracts about 40% of the oxygen delivered to it in the blood. Blood vessels dilate and constrict to maintain an equal OEF across the brain. When cerebral blood flow falls because of reduced perfusion pressure, the brain increases the fraction of oxygen extracted from the blood to 70% or 80% to support normal oxygen metabolism. This elevated OEF allows the brain to maintain normal function, but it puts patients at increased risk for stroke in the future.

Two prospective natural history studies, one conducted in the United States (JAMA 1998;280:1055–69) and the other in Japan (J. Nucl. Med. 1999;40:1992–8), have shown that having an increased OEF as measured by PET is an independent predictor of future stroke in medically treated patients with symptomatic carotid artery occlusion.

Depending on the precise clinical and PET criteria used, the 2-year ipsilateral stroke rates ranged from 26% to 57% in patients with an elevated OEF, compared with stroke rates of 5%–15% in patients with normal OEF, according to Dr. Derdeyn, coauthor of the U.S. study.

“The best information we have right now, as far as connecting an abnormality by physiologic imaging with a risk factor, is for increased oxygen extraction,” Dr. Derdeyn told INTERNAL MEDICINE NEWS. OEF is a powerful and independent predictor of stroke. “It identifies a high-risk subgroup, without question,” he said.

William J. Powers, M.D., principal investigator of COSS, agreed on the importance of identifying subsets of patients most likely to benefit from EC/IC. “It's absolutely clear that if [EC/IC bypass] is ever going to work, there has to be some more refined selection criteria to pick out the people, number one, who would be at particularly high risk if treated with medical therapy, and number two, in whom the subsequent risk of stroke seems to be related to a problem that the bypass would fix,” he told this newspaper.

COSS is based on the hypothesis that surgical anastomosis of the superficial temporal artery to the middle cerebral artery, when added to the best medical therapy, can reduce subsequent ipsilateral ischemic stroke by 40% at 2 years' follow-up in this highly select patient population, despite perioperative stroke and death.

Investigators anticipate that the stroke rate in COSS will turn out to be 40% in the medically treated group and 24% in the surgically treated group, even taking into account a 12% perioperative stroke and mortality rate, as reported in the original EC/IC trial, said Dr. Powers, codirector of the Stroke Center at Barnes-Jewish Hospital and the Washington University School of Medicine.

Even if these reduced stroke rates are borne out by the study, EC/IC bypass surgery is unlikely to become as common as coronary artery bypass; elevated OEF occurs in only 30% of patients with carotid occlusion. The study's $21-million price tag over the next 5–7 years may prove to be money well spent if it settles the question of patient selection once and for all. A similar trial, the Japanese EC/IC Trial (JET), is also working on the question of patient selection. A third trial, the Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON) study, was recently funded by NIH to examine the hotly debated question of whether carotid bypass surgery affects cognitive function.

EC/IC Bypass In a Nutshell

The 4-hour EC/IC procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery.

While the patient is under general anesthesia, an incision of several centimeters is made in the scalp on the side of the head where the diseased artery is located. A branch of the superficial temporal artery, generally the anterior division, is then identified and dissected using a surgical microscope.

A small craniotomy is then made beneath the temporalis muscle. A frontal branch of the middle cerebral artery is identified and isolated.

Once a suitable location for the anastomosis is determined, temporary clips are placed above and below the site. A slit is cut into this branch, and the previously dissected and prepared superficial temporal artery is sewn directly onto this middle cerebral artery branch for an end-to-side anastomosis.

The clips are then removed and blood flow restored.

Risks of the surgery include subsequent stroke as a result of temporary occlusion of the middle cerebral artery branch, thrombosis of the bypass graft, myocardial infarction during surgery, bleeding, and infection.

A retrospective analysis of EC/IC bypass surgery performed on 67 patients from 1986 to 2000 reported a perioperative morbidity rate of 3%, with no mortality (Acta Neurochir. [Wien] 2004;146:95–101).

Long abandoned as ineffective at secondary stroke prevention, carotid artery bypass surgery for complete atherosclerotic occlusion is getting a second look.

Known as extracranial/intracranial (EC/IC) bypass, the procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA). It is getting its second chance to prove its effectiveness in selected patients for complete carotid occlusion because technologic advances, such as refinement of PET, have made it possible to identify which patients are the best candidates for the procedure.

EC/IC bypass surgery has been shown in a series of small studies to normalize the oxygen extraction fraction (OEF), a marker of impaired cerebral blood flow in patients with carotid occlusion.

Whether that translates into a decreased stroke risk is the subject of the Carotid Occlusion Surgery Study (COSS), a $21 million, 7-year trial funded by the National Institutes of Health that is now underway in 28 U.S. centers.

Candidates for the trial must be patients with symptomatic carotid occlusion and increased OEF on PET. To date, 169 patients have enrolled, and 38 patients have been randomized to treatment.

Enrollment in the nonblinded, controlled clinical trial has been slow, in part because few neurologists knew the option of bypass surgery existed, said Colin Derdeyn, M.D., principal investigator for the Washington University site in St. Louis.

The First EC/IC Bypass Study

STA-MCA surgical anastomosis was developed in 1967 and routinely performed on patients with carotid occlusion throughout the 1970s and mid-1980s.

However, data from the EC/IC Bypass Study showed no benefit for the prevention of subsequent stroke among 808 patients with symptomatic carotid occlusion, despite restoring blood flow to the carotid artery in 96% of cases (N. Engl. J Med. 1985;313:1191–200).

The researchers were unable to assess whether the procedure was more appropriate for one or another group of patients based on their cerebral hemodynamics because at the time the technology necessary to understand and measure cerebral blood flow had not been developed, according to M. Gazi Yasargil, M.D., professor of neurosurgery at the University of Arkansas, Little Rock, the Swiss neurosurgeon who pioneered the surgical procedure. “The time is ripe to work out a perfect indication for bypass surgery,” he said.

Identifying Hemodynamics

PET has made it possible to measure OEF, a proven predictor of which patients have significantly decreased cerebral blood flow and are at increased stroke risk.

When there is unrestricted cerebral blood flow, the brain extracts about 40% of the oxygen delivered to it in the blood. Blood vessels dilate and constrict to maintain an equal OEF across the brain. When cerebral blood flow falls because of reduced perfusion pressure, the brain increases the fraction of oxygen extracted from the blood to 70% or 80% to support normal oxygen metabolism. This elevated OEF allows the brain to maintain normal function, but it puts patients at increased risk for stroke in the future.

Two prospective natural history studies, one conducted in the United States (JAMA 1998;280:1055–69) and the other in Japan (J. Nucl. Med. 1999;40:1992–8), have shown that having an increased OEF as measured by PET is an independent predictor of future stroke in medically treated patients with symptomatic carotid artery occlusion.

Depending on the precise clinical and PET criteria used, the 2-year ipsilateral stroke rates ranged from 26% to 57% in patients with an elevated OEF, compared with stroke rates of 5%–15% in patients with normal OEF, according to Dr. Derdeyn, coauthor of the U.S. study.

“The best information we have right now, as far as connecting an abnormality by physiologic imaging with a risk factor, is for increased oxygen extraction,” Dr. Derdeyn told INTERNAL MEDICINE NEWS. OEF is a powerful and independent predictor of stroke. “It identifies a high-risk subgroup, without question,” he said.

William J. Powers, M.D., principal investigator of COSS, agreed on the importance of identifying subsets of patients most likely to benefit from EC/IC. “It's absolutely clear that if [EC/IC bypass] is ever going to work, there has to be some more refined selection criteria to pick out the people, number one, who would be at particularly high risk if treated with medical therapy, and number two, in whom the subsequent risk of stroke seems to be related to a problem that the bypass would fix,” he told this newspaper.

COSS is based on the hypothesis that surgical anastomosis of the superficial temporal artery to the middle cerebral artery, when added to the best medical therapy, can reduce subsequent ipsilateral ischemic stroke by 40% at 2 years' follow-up in this highly select patient population, despite perioperative stroke and death.

Investigators anticipate that the stroke rate in COSS will turn out to be 40% in the medically treated group and 24% in the surgically treated group, even taking into account a 12% perioperative stroke and mortality rate, as reported in the original EC/IC trial, said Dr. Powers, codirector of the Stroke Center at Barnes-Jewish Hospital and the Washington University School of Medicine.

Even if these reduced stroke rates are borne out by the study, EC/IC bypass surgery is unlikely to become as common as coronary artery bypass; elevated OEF occurs in only 30% of patients with carotid occlusion. The study's $21-million price tag over the next 5–7 years may prove to be money well spent if it settles the question of patient selection once and for all. A similar trial, the Japanese EC/IC Trial (JET), is also working on the question of patient selection. A third trial, the Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON) study, was recently funded by NIH to examine the hotly debated question of whether carotid bypass surgery affects cognitive function.

EC/IC Bypass In a Nutshell

The 4-hour EC/IC procedure involves surgical anastomosis of the superficial temporal artery to the middle cerebral artery.

While the patient is under general anesthesia, an incision of several centimeters is made in the scalp on the side of the head where the diseased artery is located. A branch of the superficial temporal artery, generally the anterior division, is then identified and dissected using a surgical microscope.

A small craniotomy is then made beneath the temporalis muscle. A frontal branch of the middle cerebral artery is identified and isolated.

Once a suitable location for the anastomosis is determined, temporary clips are placed above and below the site. A slit is cut into this branch, and the previously dissected and prepared superficial temporal artery is sewn directly onto this middle cerebral artery branch for an end-to-side anastomosis.

The clips are then removed and blood flow restored.

Risks of the surgery include subsequent stroke as a result of temporary occlusion of the middle cerebral artery branch, thrombosis of the bypass graft, myocardial infarction during surgery, bleeding, and infection.

A retrospective analysis of EC/IC bypass surgery performed on 67 patients from 1986 to 2000 reported a perioperative morbidity rate of 3%, with no mortality (Acta Neurochir. [Wien] 2004;146:95–101).

CHICAGO — Spine specialists have traditionally focused on specific degenerative pathology in the spine as the main determinant of back pain, but science now suggests that the central nervous system ultimately modulates chronic low back pain.

Acceptance of the new evidence will require a fundamental shift in thinking and could lessen the role of surgery and increase the role of exercise in the management of low back pain at a time when critics are assailing the overuse of spinal fusion surgery in the United States.

The central nervous system may be the site of both pain processing and augmentation, James Rainville, M.D., said at the annual meeting of the North American Spine Society.

Wide dynamic range neurons have been identified in the spine as responsible for “windup,” or the accentuation of painful stimuli, said Dr. Rainville, chief of rehabilitation at New England Baptist Hospital, Boston.

These neurons, when overly excited, also respond to inappropriate stimulation, such as on the contralateral limb from the primary site of nociception, said Dr. Rainville, who is also on the faculty at Harvard Medical School.

A recent study found evidence of central nervous system augmentation of pain processing in patients with chronic low back pain (Arthritis Rheum. 2004;50:613-23).

Experimental pain testing at the thumb revealed hyperalgesia in patients with idiopathic chronic low back pain as well as in patients with fibromyalgia, when compared with controls.

Moreover, functional magnetic resonance imaging detected five common regions of neuronal activation in pain-related cortical areas in the low back pain and fibromyalgia groups. The areas are responsible for the transmission of neurologic information into the conscious experience of pain and included the contralateral primary and secondary somatosensory cortices, inferior parietal lobule, cerebellum, and ipsilateral secondary somatosensory cortex. The same stimulus resulted in only a single activation in controls in the contralateral secondary somatosensory cortex.

Finally, these studies' findings are strengthened by research that suggests that thoughts can change brain activity induced by peripheral stimulation (J. Neurosci. 2004;24:7199-203).

“Could our thoughts, ideas, and feelings that we have all be acting through central mechanisms to change our central sensitization to pain? If that's the case, then we're in trouble if we're trying to treat it in the periphery always,” observed Dr. Rainville.

This has important implications for understanding the successes and failures of spinal surgery. Spine surgeons came under fire recently in an editorial (N. Engl. J. Med. 2004;350:722-6) that charged fusion surgery was being overused in the United States. NASS fired back with an editorial of its own (Spine J. 2004;4[suppl. 5]:S129-38) and a high-profile panel discussion at the annual meeting.

Still, several studies presented at the same meeting validated a different approach. The rehabilitation model suggests that pain can be stopped by desensitizing the pain-producing tissue and improving central processing

Exercise can improve muscle strength and flexibility, reduce disability, and even reduce pain intensity by 10%-50%. Exercise also can alter a patient's pain attitudes and beliefs.

A recent study by Dr. Rainville and colleagues showed that exercise reduced both the pain anticipated before and the pain induced with exercise.

Significant improvements were observed for global back pain, leg pain, disability, and performance on each physical testing in 70 patients with chronic low back pain who completed an intensive 2-hour exercise program delivered up to three times per week for 6 weeks.

Performances on all physical testing correlated with anticipated and induced pain for all tests at baseline, but only for measures of flexibility at discharge. The correlation between disability and pain attitudes and beliefs was extremely high, at 0.79.

“Something about the pain process has been changed,” Dr. Rainville said. “What, I don't know. Where, I don't know. But it's a fascinating observation. In addition, people improved their strength. They have less pain with lifting a lot more.

“Something has been learned differently within the central nervous system, because we didn't change their anatomy in any positive way.”

Finally, exercise may help wean patients with chronic low back pain from narcotics. After 6 weeks of exercise therapy, one-half of patients in the study who regularly used narcotics were able to stop taking them.

CHICAGO — Spine specialists have traditionally focused on specific degenerative pathology in the spine as the main determinant of back pain, but science now suggests that the central nervous system ultimately modulates chronic low back pain.

Acceptance of the new evidence will require a fundamental shift in thinking and could lessen the role of surgery and increase the role of exercise in the management of low back pain at a time when critics are assailing the overuse of spinal fusion surgery in the United States.

The central nervous system may be the site of both pain processing and augmentation, James Rainville, M.D., said at the annual meeting of the North American Spine Society.

Wide dynamic range neurons have been identified in the spine as responsible for “windup,” or the accentuation of painful stimuli, said Dr. Rainville, chief of rehabilitation at New England Baptist Hospital, Boston.

These neurons, when overly excited, also respond to inappropriate stimulation, such as on the contralateral limb from the primary site of nociception, said Dr. Rainville, who is also on the faculty at Harvard Medical School.

A recent study found evidence of central nervous system augmentation of pain processing in patients with chronic low back pain (Arthritis Rheum. 2004;50:613-23).

Experimental pain testing at the thumb revealed hyperalgesia in patients with idiopathic chronic low back pain as well as in patients with fibromyalgia, when compared with controls.

Moreover, functional magnetic resonance imaging detected five common regions of neuronal activation in pain-related cortical areas in the low back pain and fibromyalgia groups. The areas are responsible for the transmission of neurologic information into the conscious experience of pain and included the contralateral primary and secondary somatosensory cortices, inferior parietal lobule, cerebellum, and ipsilateral secondary somatosensory cortex. The same stimulus resulted in only a single activation in controls in the contralateral secondary somatosensory cortex.

Finally, these studies' findings are strengthened by research that suggests that thoughts can change brain activity induced by peripheral stimulation (J. Neurosci. 2004;24:7199-203).

“Could our thoughts, ideas, and feelings that we have all be acting through central mechanisms to change our central sensitization to pain? If that's the case, then we're in trouble if we're trying to treat it in the periphery always,” observed Dr. Rainville.

This has important implications for understanding the successes and failures of spinal surgery. Spine surgeons came under fire recently in an editorial (N. Engl. J. Med. 2004;350:722-6) that charged fusion surgery was being overused in the United States. NASS fired back with an editorial of its own (Spine J. 2004;4[suppl. 5]:S129-38) and a high-profile panel discussion at the annual meeting.

Still, several studies presented at the same meeting validated a different approach. The rehabilitation model suggests that pain can be stopped by desensitizing the pain-producing tissue and improving central processing

Exercise can improve muscle strength and flexibility, reduce disability, and even reduce pain intensity by 10%-50%. Exercise also can alter a patient's pain attitudes and beliefs.

A recent study by Dr. Rainville and colleagues showed that exercise reduced both the pain anticipated before and the pain induced with exercise.

Significant improvements were observed for global back pain, leg pain, disability, and performance on each physical testing in 70 patients with chronic low back pain who completed an intensive 2-hour exercise program delivered up to three times per week for 6 weeks.

Performances on all physical testing correlated with anticipated and induced pain for all tests at baseline, but only for measures of flexibility at discharge. The correlation between disability and pain attitudes and beliefs was extremely high, at 0.79.

“Something about the pain process has been changed,” Dr. Rainville said. “What, I don't know. Where, I don't know. But it's a fascinating observation. In addition, people improved their strength. They have less pain with lifting a lot more.

“Something has been learned differently within the central nervous system, because we didn't change their anatomy in any positive way.”

Finally, exercise may help wean patients with chronic low back pain from narcotics. After 6 weeks of exercise therapy, one-half of patients in the study who regularly used narcotics were able to stop taking them.

CHICAGO — Spine specialists have traditionally focused on specific degenerative pathology in the spine as the main determinant of back pain, but science now suggests that the central nervous system ultimately modulates chronic low back pain.

Acceptance of the new evidence will require a fundamental shift in thinking and could lessen the role of surgery and increase the role of exercise in the management of low back pain at a time when critics are assailing the overuse of spinal fusion surgery in the United States.

The central nervous system may be the site of both pain processing and augmentation, James Rainville, M.D., said at the annual meeting of the North American Spine Society.

Wide dynamic range neurons have been identified in the spine as responsible for “windup,” or the accentuation of painful stimuli, said Dr. Rainville, chief of rehabilitation at New England Baptist Hospital, Boston.

These neurons, when overly excited, also respond to inappropriate stimulation, such as on the contralateral limb from the primary site of nociception, said Dr. Rainville, who is also on the faculty at Harvard Medical School.

A recent study found evidence of central nervous system augmentation of pain processing in patients with chronic low back pain (Arthritis Rheum. 2004;50:613-23).

Experimental pain testing at the thumb revealed hyperalgesia in patients with idiopathic chronic low back pain as well as in patients with fibromyalgia, when compared with controls.

Moreover, functional magnetic resonance imaging detected five common regions of neuronal activation in pain-related cortical areas in the low back pain and fibromyalgia groups. The areas are responsible for the transmission of neurologic information into the conscious experience of pain and included the contralateral primary and secondary somatosensory cortices, inferior parietal lobule, cerebellum, and ipsilateral secondary somatosensory cortex. The same stimulus resulted in only a single activation in controls in the contralateral secondary somatosensory cortex.

Finally, these studies' findings are strengthened by research that suggests that thoughts can change brain activity induced by peripheral stimulation (J. Neurosci. 2004;24:7199-203).

“Could our thoughts, ideas, and feelings that we have all be acting through central mechanisms to change our central sensitization to pain? If that's the case, then we're in trouble if we're trying to treat it in the periphery always,” observed Dr. Rainville.

This has important implications for understanding the successes and failures of spinal surgery. Spine surgeons came under fire recently in an editorial (N. Engl. J. Med. 2004;350:722-6) that charged fusion surgery was being overused in the United States. NASS fired back with an editorial of its own (Spine J. 2004;4[suppl. 5]:S129-38) and a high-profile panel discussion at the annual meeting.

Still, several studies presented at the same meeting validated a different approach. The rehabilitation model suggests that pain can be stopped by desensitizing the pain-producing tissue and improving central processing

Exercise can improve muscle strength and flexibility, reduce disability, and even reduce pain intensity by 10%-50%. Exercise also can alter a patient's pain attitudes and beliefs.

A recent study by Dr. Rainville and colleagues showed that exercise reduced both the pain anticipated before and the pain induced with exercise.

Significant improvements were observed for global back pain, leg pain, disability, and performance on each physical testing in 70 patients with chronic low back pain who completed an intensive 2-hour exercise program delivered up to three times per week for 6 weeks.

Performances on all physical testing correlated with anticipated and induced pain for all tests at baseline, but only for measures of flexibility at discharge. The correlation between disability and pain attitudes and beliefs was extremely high, at 0.79.

“Something about the pain process has been changed,” Dr. Rainville said. “What, I don't know. Where, I don't know. But it's a fascinating observation. In addition, people improved their strength. They have less pain with lifting a lot more.

“Something has been learned differently within the central nervous system, because we didn't change their anatomy in any positive way.”

Finally, exercise may help wean patients with chronic low back pain from narcotics. After 6 weeks of exercise therapy, one-half of patients in the study who regularly used narcotics were able to stop taking them.

CHICAGO — A new triage system that puts critical information about patients with spinal symptoms before the eyes of a neurosurgeon early in the triage process dramatically improved patient access to neurosurgeons and spine specialists, William D. Tobler, M.D., reported in a poster presentation at the annual meeting of the North American Spine Society.

“It's helped us sift out the patients who really don't need to be seen by a surgeon,” Dr. Tobler, a neurosurgeon at the Mayfield Clinic in Cincinnati, told CLINICAL NEUROLOGY NEWS. “There are patients who have a whiplash injury that are told by their chiropractor to see a neurosurgeon. But when we review the x-rays, it's obvious [these patients] need to be seen by a rehabilitation therapist. It takes 45 minutes to see a patient and if you see six or eight [patients] a week who are clearly nonsurgical, you've occupied a significant part of that surgeon's time.”

The overall surgery rate for all new patients seen by a neurosurgeon has doubled from 22% to 44% since the Mayfield Clinic implemented the new triage system.

Under the “Priority Consult” triage system, intake specialists take scripted medical histories from new patients with spinal symptoms over the telephone and enter the information in a secure database. The patients are told to take any relevant imaging studies to the clinic in advance of any appointment.

Among clinic patients, 90% already have MRI or CT scans available and frequently use couriers, although electronic transmission is gaining ground.

A neurosurgeon then reviews the patient's history and imaging studies, if available, and determines whether the patient should undergo additional tests, receive treatment from a nonsurgical spine physician, or have an in-office consultation with a surgeon. Once the neurosurgeon has noted electronically which step should be taken next, the staff makes the appropriate arrangements for the patient, whether it be tests, treatment, or surgical consultation.

From January 2002 to July 2003, 8,783 new patient histories were entered into the database at the Mayfield Clinic. After the triage system was implemented, 3,213 patients (37%) were seen initially by a spine surgeon, of whom 1,354 (42%) required surgery.

Of 5,570 patients (63%) referred for treatment or nonsurgical evaluation, 4,233 (76%) were discharged without needing a surgical consultation.

Surgeons reviewed medical histories and imaging studies within 72 hours of an appointment request or of receiving the studies, compared with 30 days previously.

The average wait time for an initial appointment with a neurosurgeon decreased from about 6-8 weeks to 20 days, Dr. Tobler said. Because of the streamlined process, the average time it took to review a new spine patient's information also dropped from the previous average of 30-45 minutes to just about 5 minutes.

Of the 5,570 patients initially referred for nonsurgical consultation, 1,337 (24%) were eventually referred back to the surgeon for a surgical consult. Of these, 638 (47%) had surgery.

Not only does the system free up neurosurgeons, but it also takes pressure off primary care physicians, said Dr. Tobler, who is a shareholder in the Mayfield Clinic.

“The process begins to bottleneck for everyone. The primary care physicians start having to deal with patients who are unhappy because they can't be seen for weeks by the doctor they were referred to. This [triage system] gives the referring physicians some satisfaction because the problems are being taken care of,” he said.

Dr. Tobler said the triage system is applicable to smaller practices and is now in use even in three-person practices.

CHICAGO — A new triage system that puts critical information about patients with spinal symptoms before the eyes of a neurosurgeon early in the triage process dramatically improved patient access to neurosurgeons and spine specialists, William D. Tobler, M.D., reported in a poster presentation at the annual meeting of the North American Spine Society.

“It's helped us sift out the patients who really don't need to be seen by a surgeon,” Dr. Tobler, a neurosurgeon at the Mayfield Clinic in Cincinnati, told CLINICAL NEUROLOGY NEWS. “There are patients who have a whiplash injury that are told by their chiropractor to see a neurosurgeon. But when we review the x-rays, it's obvious [these patients] need to be seen by a rehabilitation therapist. It takes 45 minutes to see a patient and if you see six or eight [patients] a week who are clearly nonsurgical, you've occupied a significant part of that surgeon's time.”

The overall surgery rate for all new patients seen by a neurosurgeon has doubled from 22% to 44% since the Mayfield Clinic implemented the new triage system.

Under the “Priority Consult” triage system, intake specialists take scripted medical histories from new patients with spinal symptoms over the telephone and enter the information in a secure database. The patients are told to take any relevant imaging studies to the clinic in advance of any appointment.

Among clinic patients, 90% already have MRI or CT scans available and frequently use couriers, although electronic transmission is gaining ground.

A neurosurgeon then reviews the patient's history and imaging studies, if available, and determines whether the patient should undergo additional tests, receive treatment from a nonsurgical spine physician, or have an in-office consultation with a surgeon. Once the neurosurgeon has noted electronically which step should be taken next, the staff makes the appropriate arrangements for the patient, whether it be tests, treatment, or surgical consultation.

From January 2002 to July 2003, 8,783 new patient histories were entered into the database at the Mayfield Clinic. After the triage system was implemented, 3,213 patients (37%) were seen initially by a spine surgeon, of whom 1,354 (42%) required surgery.

Of 5,570 patients (63%) referred for treatment or nonsurgical evaluation, 4,233 (76%) were discharged without needing a surgical consultation.

Surgeons reviewed medical histories and imaging studies within 72 hours of an appointment request or of receiving the studies, compared with 30 days previously.

The average wait time for an initial appointment with a neurosurgeon decreased from about 6-8 weeks to 20 days, Dr. Tobler said. Because of the streamlined process, the average time it took to review a new spine patient's information also dropped from the previous average of 30-45 minutes to just about 5 minutes.

Of the 5,570 patients initially referred for nonsurgical consultation, 1,337 (24%) were eventually referred back to the surgeon for a surgical consult. Of these, 638 (47%) had surgery.

Not only does the system free up neurosurgeons, but it also takes pressure off primary care physicians, said Dr. Tobler, who is a shareholder in the Mayfield Clinic.

“The process begins to bottleneck for everyone. The primary care physicians start having to deal with patients who are unhappy because they can't be seen for weeks by the doctor they were referred to. This [triage system] gives the referring physicians some satisfaction because the problems are being taken care of,” he said.

Dr. Tobler said the triage system is applicable to smaller practices and is now in use even in three-person practices.

CHICAGO — A new triage system that puts critical information about patients with spinal symptoms before the eyes of a neurosurgeon early in the triage process dramatically improved patient access to neurosurgeons and spine specialists, William D. Tobler, M.D., reported in a poster presentation at the annual meeting of the North American Spine Society.

“It's helped us sift out the patients who really don't need to be seen by a surgeon,” Dr. Tobler, a neurosurgeon at the Mayfield Clinic in Cincinnati, told CLINICAL NEUROLOGY NEWS. “There are patients who have a whiplash injury that are told by their chiropractor to see a neurosurgeon. But when we review the x-rays, it's obvious [these patients] need to be seen by a rehabilitation therapist. It takes 45 minutes to see a patient and if you see six or eight [patients] a week who are clearly nonsurgical, you've occupied a significant part of that surgeon's time.”

The overall surgery rate for all new patients seen by a neurosurgeon has doubled from 22% to 44% since the Mayfield Clinic implemented the new triage system.

Under the “Priority Consult” triage system, intake specialists take scripted medical histories from new patients with spinal symptoms over the telephone and enter the information in a secure database. The patients are told to take any relevant imaging studies to the clinic in advance of any appointment.

Among clinic patients, 90% already have MRI or CT scans available and frequently use couriers, although electronic transmission is gaining ground.

A neurosurgeon then reviews the patient's history and imaging studies, if available, and determines whether the patient should undergo additional tests, receive treatment from a nonsurgical spine physician, or have an in-office consultation with a surgeon. Once the neurosurgeon has noted electronically which step should be taken next, the staff makes the appropriate arrangements for the patient, whether it be tests, treatment, or surgical consultation.

From January 2002 to July 2003, 8,783 new patient histories were entered into the database at the Mayfield Clinic. After the triage system was implemented, 3,213 patients (37%) were seen initially by a spine surgeon, of whom 1,354 (42%) required surgery.

Of 5,570 patients (63%) referred for treatment or nonsurgical evaluation, 4,233 (76%) were discharged without needing a surgical consultation.

Surgeons reviewed medical histories and imaging studies within 72 hours of an appointment request or of receiving the studies, compared with 30 days previously.

The average wait time for an initial appointment with a neurosurgeon decreased from about 6-8 weeks to 20 days, Dr. Tobler said. Because of the streamlined process, the average time it took to review a new spine patient's information also dropped from the previous average of 30-45 minutes to just about 5 minutes.

Of the 5,570 patients initially referred for nonsurgical consultation, 1,337 (24%) were eventually referred back to the surgeon for a surgical consult. Of these, 638 (47%) had surgery.

Not only does the system free up neurosurgeons, but it also takes pressure off primary care physicians, said Dr. Tobler, who is a shareholder in the Mayfield Clinic.

“The process begins to bottleneck for everyone. The primary care physicians start having to deal with patients who are unhappy because they can't be seen for weeks by the doctor they were referred to. This [triage system] gives the referring physicians some satisfaction because the problems are being taken care of,” he said.

Dr. Tobler said the triage system is applicable to smaller practices and is now in use even in three-person practices.

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery.

The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Lower extremity musculoskeletal symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints.

Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss); ankle/foot (46% vs. 8%); shoulder (40% vs. 27%); lumbar spine (38% vs. 15%); hand (35% vs. 21%); carpal tunnel syndrome (31% vs. 15%); hip joint (23% vs. 15%); trochanteric bursitis (29% vs. 17%); and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said.

“The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery.

The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Lower extremity musculoskeletal symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints.

Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss); ankle/foot (46% vs. 8%); shoulder (40% vs. 27%); lumbar spine (38% vs. 15%); hand (35% vs. 21%); carpal tunnel syndrome (31% vs. 15%); hip joint (23% vs. 15%); trochanteric bursitis (29% vs. 17%); and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said.

“The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery.

The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Lower extremity musculoskeletal symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints.

Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss); ankle/foot (46% vs. 8%); shoulder (40% vs. 27%); lumbar spine (38% vs. 15%); hand (35% vs. 21%); carpal tunnel syndrome (31% vs. 15%); hip joint (23% vs. 15%); trochanteric bursitis (29% vs. 17%); and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said.

“The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — The presence of an impaired metabolism exacerbates the impact of obesity as a risk factor for developing knee osteoarthritis and is associated with reduced physical functioning, Mary Fran Sowers, Ph.D., reported at the 2004 World Congress on Osteoarthritis.

Such findings suggest that “the role of obesity with respect to osteoarthritis and functioning may extend mechanistically beyond that of just simple joint loading,” said Dr. Sowers, an epidemiology professor at the University of Michigan, Ann Arbor.

Current OA treatments should be evaluated for their potential to exacerbate these metabolic derangements, because this exacerbation is likely to diminish treatment efficacy. “An understanding of the added contribution of the obesity subtypes could be very useful in guiding primary and secondary treatment efforts,” Dr. Sowers added at the meeting, sponsored by the Osteoarthritis Research Society International.

Researchers have identified several obesity subtypes, including individuals who are obese but metabolically healthy. This may occur in about 20% of obese persons and is characterized by large amounts of fat mass but normal insulin levels and favorable cardiovascular risk factor profiles.

Another risk group comprises individuals of normal weight who have metabolic profiles more typically seen in the obese. This risk group may account for about 15% of the general population and is characterized by low HDL cholesterol, higher triglyceride levels, and higher levels of inflammatory markers.

A community-based cohort of 775 women aged 43–53 years was evaluated for metabolic obesity, defined on the basis of three body mass index (BMI) cutoff points and the presence of two or more of the following metabolic derangements: diabetes or fasting glucose greater than 125 mg/dL, serum C-reactive protein greater than 2 mg/L, HDL less than 45 mg/dL, triglycerides greater than 200 mg/dL, or a waist-hip ratio greater than 0.81 cm.

The investigators found that 34% of the women were not obese (BMI less than 26 kg/m

Another 31% of the participants were overweight to obese (BMI 26–34 kg/m

Finally, 12% were very obese (BMI greater than 34 kg/m

Among those without a metabolic derangement, the odds of having knee OA were increased among women who were either overweight/obese (odds ratio 1.9) or very obese (OR 7.0), compared with women who were not obese and had no metabolic derangement.

But when obesity was associated with a metabolic derangement, the risk of knee OA was three times higher in overweight or obese women (OR 3.3) and nine times higher in very obese women (OR 9.0), compared with women who were not obese and had no metabolic derangement.

The impact of metabolic disorders and weight on OA risk was consistent across all four of the physical tests: speed measured during walking on gait mats, grip strength, timed walk, and timed stair climbing.

There was no loss in leg strength unless women had an impaired metabolism, and then the loss was most pronounced in individuals with the highest BMI.

Dr. Sowers proposed that metabolic disorders and obesity may affect leg strength by altering glycation products in the muscles, by allowing fatty infiltration of muscle tissue and compromising selective muscle fibers, or by causing innervation problems.

CHICAGO — The presence of an impaired metabolism exacerbates the impact of obesity as a risk factor for developing knee osteoarthritis and is associated with reduced physical functioning, Mary Fran Sowers, Ph.D., reported at the 2004 World Congress on Osteoarthritis.

Such findings suggest that “the role of obesity with respect to osteoarthritis and functioning may extend mechanistically beyond that of just simple joint loading,” said Dr. Sowers, an epidemiology professor at the University of Michigan, Ann Arbor.

Current OA treatments should be evaluated for their potential to exacerbate these metabolic derangements, because this exacerbation is likely to diminish treatment efficacy. “An understanding of the added contribution of the obesity subtypes could be very useful in guiding primary and secondary treatment efforts,” Dr. Sowers added at the meeting, sponsored by the Osteoarthritis Research Society International.

Researchers have identified several obesity subtypes, including individuals who are obese but metabolically healthy. This may occur in about 20% of obese persons and is characterized by large amounts of fat mass but normal insulin levels and favorable cardiovascular risk factor profiles.

Another risk group comprises individuals of normal weight who have metabolic profiles more typically seen in the obese. This risk group may account for about 15% of the general population and is characterized by low HDL cholesterol, higher triglyceride levels, and higher levels of inflammatory markers.

A community-based cohort of 775 women aged 43–53 years was evaluated for metabolic obesity, defined on the basis of three body mass index (BMI) cutoff points and the presence of two or more of the following metabolic derangements: diabetes or fasting glucose greater than 125 mg/dL, serum C-reactive protein greater than 2 mg/L, HDL less than 45 mg/dL, triglycerides greater than 200 mg/dL, or a waist-hip ratio greater than 0.81 cm.

The investigators found that 34% of the women were not obese (BMI less than 26 kg/m

Another 31% of the participants were overweight to obese (BMI 26–34 kg/m

Finally, 12% were very obese (BMI greater than 34 kg/m

Among those without a metabolic derangement, the odds of having knee OA were increased among women who were either overweight/obese (odds ratio 1.9) or very obese (OR 7.0), compared with women who were not obese and had no metabolic derangement.

But when obesity was associated with a metabolic derangement, the risk of knee OA was three times higher in overweight or obese women (OR 3.3) and nine times higher in very obese women (OR 9.0), compared with women who were not obese and had no metabolic derangement.

The impact of metabolic disorders and weight on OA risk was consistent across all four of the physical tests: speed measured during walking on gait mats, grip strength, timed walk, and timed stair climbing.

There was no loss in leg strength unless women had an impaired metabolism, and then the loss was most pronounced in individuals with the highest BMI.

Dr. Sowers proposed that metabolic disorders and obesity may affect leg strength by altering glycation products in the muscles, by allowing fatty infiltration of muscle tissue and compromising selective muscle fibers, or by causing innervation problems.

CHICAGO — The presence of an impaired metabolism exacerbates the impact of obesity as a risk factor for developing knee osteoarthritis and is associated with reduced physical functioning, Mary Fran Sowers, Ph.D., reported at the 2004 World Congress on Osteoarthritis.

Such findings suggest that “the role of obesity with respect to osteoarthritis and functioning may extend mechanistically beyond that of just simple joint loading,” said Dr. Sowers, an epidemiology professor at the University of Michigan, Ann Arbor.

Current OA treatments should be evaluated for their potential to exacerbate these metabolic derangements, because this exacerbation is likely to diminish treatment efficacy. “An understanding of the added contribution of the obesity subtypes could be very useful in guiding primary and secondary treatment efforts,” Dr. Sowers added at the meeting, sponsored by the Osteoarthritis Research Society International.

Researchers have identified several obesity subtypes, including individuals who are obese but metabolically healthy. This may occur in about 20% of obese persons and is characterized by large amounts of fat mass but normal insulin levels and favorable cardiovascular risk factor profiles.

Another risk group comprises individuals of normal weight who have metabolic profiles more typically seen in the obese. This risk group may account for about 15% of the general population and is characterized by low HDL cholesterol, higher triglyceride levels, and higher levels of inflammatory markers.

A community-based cohort of 775 women aged 43–53 years was evaluated for metabolic obesity, defined on the basis of three body mass index (BMI) cutoff points and the presence of two or more of the following metabolic derangements: diabetes or fasting glucose greater than 125 mg/dL, serum C-reactive protein greater than 2 mg/L, HDL less than 45 mg/dL, triglycerides greater than 200 mg/dL, or a waist-hip ratio greater than 0.81 cm.

The investigators found that 34% of the women were not obese (BMI less than 26 kg/m

Another 31% of the participants were overweight to obese (BMI 26–34 kg/m

Finally, 12% were very obese (BMI greater than 34 kg/m

Among those without a metabolic derangement, the odds of having knee OA were increased among women who were either overweight/obese (odds ratio 1.9) or very obese (OR 7.0), compared with women who were not obese and had no metabolic derangement.

But when obesity was associated with a metabolic derangement, the risk of knee OA was three times higher in overweight or obese women (OR 3.3) and nine times higher in very obese women (OR 9.0), compared with women who were not obese and had no metabolic derangement.

The impact of metabolic disorders and weight on OA risk was consistent across all four of the physical tests: speed measured during walking on gait mats, grip strength, timed walk, and timed stair climbing.

There was no loss in leg strength unless women had an impaired metabolism, and then the loss was most pronounced in individuals with the highest BMI.

Dr. Sowers proposed that metabolic disorders and obesity may affect leg strength by altering glycation products in the muscles, by allowing fatty infiltration of muscle tissue and compromising selective muscle fibers, or by causing innervation problems.