David Monagan

LONDON — A small, randomized trial suggests that fish oil given in tablet form as eicosapentaenoic acid may have chemopreventive effects, reducing the number and size of precancerous rectal polyps in patients with familial adenomatous polyposis.

The theory that this approach may have benefits in retarding cell proliferation has been tested in a number of other settings, including prevention of pancreatic, kidney, and esophageal cancers. But data on free fatty acid supplementation in the setting of familial adenomatous polyposis (FAP) have generally been confined to animal studies and anecdotal patient reports.

The new study was reported by Dr. N.J. West of St. Mark's Hospital Harrow, England, at the 13th World Congress of Gastroenterology. The goal was to examine whether eicosapentaenoic acid (EPA) supplementation reduced polyp burden in the setting of FAP, as assessed by blinded outside endoscopists.

The researchers randomized a total of 55 patients into two groups: EPA (28 patients who took a 500-mg capsule twice daily) or placebo (27 patients). All participants first underwent sigmoidoscopy, in which a focal area of rectum was tattooed for identification of baseline polyp number and size by endoscopists blinded to each subject's intended therapy. The patients also underwent rectal biopsies to determine the fatty acid content in their rectal tissue.

After 6 months, patients underwent a second blinded endoscopy, and the results “were highly statistically significant” in favor of EPA supplementation. EPA patients had a 12.6% reduction of their polyp burden in the targeted area. In contrast, placebo patients showed a 22.4% increase in their polyp count.

The difference between the groups amounted to an overall 24% relative retardation in polyp growth with EPA supplementation. Moreover, the blinded endoscopists found a 30% smaller mean polyp size in patients receiving the fish oil. In addition, EPA levels in the rectal mucosa increased by 159% in the EPA group, compared with the placebo group.

“Compared to placebo, EPA decreased the polyp burden in treated patients and decreased the polyp size at 6 months. The treatment was safe and well tolerated, and may deserve serious consideration as an alternative therapy for FAP,” Dr. West concluded.

Dr. Douglas K. Rex commented in an interview that “sulindac remains the cornerstone of chemoprevention in FAP. Celecoxib is an alternative when there is low cardiac risk and high risk of GI toxicity from NSAIDs. Fish oil is attractive because of its low risk profile, and it could be offered to FAP patients for this reason pending the results of additional studies of efficacy.”

“Endoscopists should remember that no chemopreventive treatment replaces endoscopic monitoring in FAP, and no chemopreventive therapy clearly prevents cancer in FAP,” cautioned Dr. Rex, who is distinguished professor of medicine at Indiana University, Indianapolis, and director of endoscopy at Indiana University Hospital.

Dr. West acknowledged that this trial was limited by its size and duration, and thus could not show whether changes in polyp burden following EPA could actually reduce the likelihood of future colorectal cancer. Nor could it answer the question of how long such therapy might need to be delivered to prevent colorectal cancer.

But he noted that EPA supplementation involves fewer side effects (and less expense) than was seen in trials of the COX-2 inhibitor celecoxib, which has been associated with adverse inflammatory and cardiovascular effects. “Free fatty acid has the potential to serve as an important therapeutic option if these results can be borne out by larger trials,” he observed.

Disclosures: The study is an offshoot of a British polyp registry that was developed, with support from the National Cancer Institute, Pfizer, and Ilex Oncology, to conduct clinical trials of agents of interest.

LONDON — A small, randomized trial suggests that fish oil given in tablet form as eicosapentaenoic acid may have chemopreventive effects, reducing the number and size of precancerous rectal polyps in patients with familial adenomatous polyposis.

The theory that this approach may have benefits in retarding cell proliferation has been tested in a number of other settings, including prevention of pancreatic, kidney, and esophageal cancers. But data on free fatty acid supplementation in the setting of familial adenomatous polyposis (FAP) have generally been confined to animal studies and anecdotal patient reports.

The new study was reported by Dr. N.J. West of St. Mark's Hospital Harrow, England, at the 13th World Congress of Gastroenterology. The goal was to examine whether eicosapentaenoic acid (EPA) supplementation reduced polyp burden in the setting of FAP, as assessed by blinded outside endoscopists.

The researchers randomized a total of 55 patients into two groups: EPA (28 patients who took a 500-mg capsule twice daily) or placebo (27 patients). All participants first underwent sigmoidoscopy, in which a focal area of rectum was tattooed for identification of baseline polyp number and size by endoscopists blinded to each subject's intended therapy. The patients also underwent rectal biopsies to determine the fatty acid content in their rectal tissue.

After 6 months, patients underwent a second blinded endoscopy, and the results “were highly statistically significant” in favor of EPA supplementation. EPA patients had a 12.6% reduction of their polyp burden in the targeted area. In contrast, placebo patients showed a 22.4% increase in their polyp count.

The difference between the groups amounted to an overall 24% relative retardation in polyp growth with EPA supplementation. Moreover, the blinded endoscopists found a 30% smaller mean polyp size in patients receiving the fish oil. In addition, EPA levels in the rectal mucosa increased by 159% in the EPA group, compared with the placebo group.

“Compared to placebo, EPA decreased the polyp burden in treated patients and decreased the polyp size at 6 months. The treatment was safe and well tolerated, and may deserve serious consideration as an alternative therapy for FAP,” Dr. West concluded.

Dr. Douglas K. Rex commented in an interview that “sulindac remains the cornerstone of chemoprevention in FAP. Celecoxib is an alternative when there is low cardiac risk and high risk of GI toxicity from NSAIDs. Fish oil is attractive because of its low risk profile, and it could be offered to FAP patients for this reason pending the results of additional studies of efficacy.”

“Endoscopists should remember that no chemopreventive treatment replaces endoscopic monitoring in FAP, and no chemopreventive therapy clearly prevents cancer in FAP,” cautioned Dr. Rex, who is distinguished professor of medicine at Indiana University, Indianapolis, and director of endoscopy at Indiana University Hospital.

Dr. West acknowledged that this trial was limited by its size and duration, and thus could not show whether changes in polyp burden following EPA could actually reduce the likelihood of future colorectal cancer. Nor could it answer the question of how long such therapy might need to be delivered to prevent colorectal cancer.

But he noted that EPA supplementation involves fewer side effects (and less expense) than was seen in trials of the COX-2 inhibitor celecoxib, which has been associated with adverse inflammatory and cardiovascular effects. “Free fatty acid has the potential to serve as an important therapeutic option if these results can be borne out by larger trials,” he observed.

Disclosures: The study is an offshoot of a British polyp registry that was developed, with support from the National Cancer Institute, Pfizer, and Ilex Oncology, to conduct clinical trials of agents of interest.

LONDON — A small, randomized trial suggests that fish oil given in tablet form as eicosapentaenoic acid may have chemopreventive effects, reducing the number and size of precancerous rectal polyps in patients with familial adenomatous polyposis.

The theory that this approach may have benefits in retarding cell proliferation has been tested in a number of other settings, including prevention of pancreatic, kidney, and esophageal cancers. But data on free fatty acid supplementation in the setting of familial adenomatous polyposis (FAP) have generally been confined to animal studies and anecdotal patient reports.

The new study was reported by Dr. N.J. West of St. Mark's Hospital Harrow, England, at the 13th World Congress of Gastroenterology. The goal was to examine whether eicosapentaenoic acid (EPA) supplementation reduced polyp burden in the setting of FAP, as assessed by blinded outside endoscopists.

The researchers randomized a total of 55 patients into two groups: EPA (28 patients who took a 500-mg capsule twice daily) or placebo (27 patients). All participants first underwent sigmoidoscopy, in which a focal area of rectum was tattooed for identification of baseline polyp number and size by endoscopists blinded to each subject's intended therapy. The patients also underwent rectal biopsies to determine the fatty acid content in their rectal tissue.

After 6 months, patients underwent a second blinded endoscopy, and the results “were highly statistically significant” in favor of EPA supplementation. EPA patients had a 12.6% reduction of their polyp burden in the targeted area. In contrast, placebo patients showed a 22.4% increase in their polyp count.

The difference between the groups amounted to an overall 24% relative retardation in polyp growth with EPA supplementation. Moreover, the blinded endoscopists found a 30% smaller mean polyp size in patients receiving the fish oil. In addition, EPA levels in the rectal mucosa increased by 159% in the EPA group, compared with the placebo group.

“Compared to placebo, EPA decreased the polyp burden in treated patients and decreased the polyp size at 6 months. The treatment was safe and well tolerated, and may deserve serious consideration as an alternative therapy for FAP,” Dr. West concluded.

Dr. Douglas K. Rex commented in an interview that “sulindac remains the cornerstone of chemoprevention in FAP. Celecoxib is an alternative when there is low cardiac risk and high risk of GI toxicity from NSAIDs. Fish oil is attractive because of its low risk profile, and it could be offered to FAP patients for this reason pending the results of additional studies of efficacy.”

“Endoscopists should remember that no chemopreventive treatment replaces endoscopic monitoring in FAP, and no chemopreventive therapy clearly prevents cancer in FAP,” cautioned Dr. Rex, who is distinguished professor of medicine at Indiana University, Indianapolis, and director of endoscopy at Indiana University Hospital.

Dr. West acknowledged that this trial was limited by its size and duration, and thus could not show whether changes in polyp burden following EPA could actually reduce the likelihood of future colorectal cancer. Nor could it answer the question of how long such therapy might need to be delivered to prevent colorectal cancer.

But he noted that EPA supplementation involves fewer side effects (and less expense) than was seen in trials of the COX-2 inhibitor celecoxib, which has been associated with adverse inflammatory and cardiovascular effects. “Free fatty acid has the potential to serve as an important therapeutic option if these results can be borne out by larger trials,” he observed.

Disclosures: The study is an offshoot of a British polyp registry that was developed, with support from the National Cancer Institute, Pfizer, and Ilex Oncology, to conduct clinical trials of agents of interest.

LONDON — In a French study of 545 patients, wireless capsule colonoscopy achieved an overall sensitivity of only 39% and a positive predictive value of just 46%, Dr. Jean Paul Galmiche reported at the 13th World Congress of Gastroenterology.

The 16-center study was designed to discover the reliability of the colon capsule (Pillcam, Given Imaging Ltd.)—which travels through the GI tract equipped with a tiny camera—for finding colon polyps of at least 6 mm. Two cohorts were studied: asymptomatic patients aged 50-74 years needing routine screening (30% of subjects), and patients at increased risk for colorectal cancer because of a personal or family history of colon polyps or cancer (70% of subjects). The patients' mean age was 60 years.

The colon capsule results were compared with results from conventional colonoscopy performed the following day by colonoscopists who were blinded to the capsule findings. Images obtained during the two procedures underwent subsequent examination by an outside panel of experts.

The interim analysis by Dr. Galmiche's group at the University Hospital Nantes, France, showed that the wireless capsule colonoscopy (WCC) results achieved an overall sensitivity of 39% and a positive predictive value of 46% in terms of the total number of polyps correctly identified.

This was no match for conventional colonoscopy, which had a positive predictive value of 57% and a sensitivity of about 85% for all polyps regardless of size.

“At this stage of the development of the technology, WCC cannot replace colonoscopy for screening and surveillance of patients at risk for colon cancer,” Dr. Galmiche said in an interview.

“Future research should focus on better preparation and improved technology, that is to say, a new capsule generation,” he added.

The primary problem is that, despite rigorous attempts at preprocedure cleansing, colonic debris frequently obscured the wireless capsule's capacity to transmit reliable images. Only 52% of the 377 WCC patients were judged to have sufficiently “good to excellent” colon cleansing to allow full visualization from the technology.

In contrast, more than 85% of the 183 colonoscopy patients in the study achieved the same “good to excellent” bowel prep results.

The study began with patients on a 3-day low-residue diet, with 3 L of polyethylene glycol solution taken the night before the procedure, and another liter taken the following morning. Domperidone and a laxative booster were used to ensure prompt expulsion of the video capsule—which occurred within 10 hours in 93% of the patients.

About one-quarter of the way through the study, the 3-day low-residue diet was replaced with an all-liquid diet for the remaining patients, to improve visualization.

“Somewhat better results have been achieved with this newer approach to preparation,” Dr. Galmiche said.

In addition to the drawback of the high cost of WCC, the noninvasive procedure was associated with 20 adverse events, chiefly excessive abdominal pain and vomiting. However, these effects were all considered related to the bowel prep used before swallowing the video capsule, rather than mishaps with the capsule itself.

Dr. Galmiche noted that the WCC procedure had a negative predictive value of 88% for identifying polyps larger than 10 mm.

But he concluded by saying its sensitivity was “not optimal” and that a new iteration of the technology would need to have dramatic improvements before it could contend with colonoscopy as a gold standard screening tool for colorectal cancer.

The Nantes group's presentation was formally cited as one of the two Best Abstracts at the meeting.

Disclosures: Dr. Galmiche disclosed that he is on the advisory board of Given Imaging but has no financial links. The study was sponsored by a National Research Grant.

LONDON — In a French study of 545 patients, wireless capsule colonoscopy achieved an overall sensitivity of only 39% and a positive predictive value of just 46%, Dr. Jean Paul Galmiche reported at the 13th World Congress of Gastroenterology.

The 16-center study was designed to discover the reliability of the colon capsule (Pillcam, Given Imaging Ltd.)—which travels through the GI tract equipped with a tiny camera—for finding colon polyps of at least 6 mm. Two cohorts were studied: asymptomatic patients aged 50-74 years needing routine screening (30% of subjects), and patients at increased risk for colorectal cancer because of a personal or family history of colon polyps or cancer (70% of subjects). The patients' mean age was 60 years.

The colon capsule results were compared with results from conventional colonoscopy performed the following day by colonoscopists who were blinded to the capsule findings. Images obtained during the two procedures underwent subsequent examination by an outside panel of experts.

The interim analysis by Dr. Galmiche's group at the University Hospital Nantes, France, showed that the wireless capsule colonoscopy (WCC) results achieved an overall sensitivity of 39% and a positive predictive value of 46% in terms of the total number of polyps correctly identified.

This was no match for conventional colonoscopy, which had a positive predictive value of 57% and a sensitivity of about 85% for all polyps regardless of size.

“At this stage of the development of the technology, WCC cannot replace colonoscopy for screening and surveillance of patients at risk for colon cancer,” Dr. Galmiche said in an interview.

“Future research should focus on better preparation and improved technology, that is to say, a new capsule generation,” he added.

The primary problem is that, despite rigorous attempts at preprocedure cleansing, colonic debris frequently obscured the wireless capsule's capacity to transmit reliable images. Only 52% of the 377 WCC patients were judged to have sufficiently “good to excellent” colon cleansing to allow full visualization from the technology.

In contrast, more than 85% of the 183 colonoscopy patients in the study achieved the same “good to excellent” bowel prep results.

The study began with patients on a 3-day low-residue diet, with 3 L of polyethylene glycol solution taken the night before the procedure, and another liter taken the following morning. Domperidone and a laxative booster were used to ensure prompt expulsion of the video capsule—which occurred within 10 hours in 93% of the patients.

About one-quarter of the way through the study, the 3-day low-residue diet was replaced with an all-liquid diet for the remaining patients, to improve visualization.

“Somewhat better results have been achieved with this newer approach to preparation,” Dr. Galmiche said.

In addition to the drawback of the high cost of WCC, the noninvasive procedure was associated with 20 adverse events, chiefly excessive abdominal pain and vomiting. However, these effects were all considered related to the bowel prep used before swallowing the video capsule, rather than mishaps with the capsule itself.

Dr. Galmiche noted that the WCC procedure had a negative predictive value of 88% for identifying polyps larger than 10 mm.

But he concluded by saying its sensitivity was “not optimal” and that a new iteration of the technology would need to have dramatic improvements before it could contend with colonoscopy as a gold standard screening tool for colorectal cancer.

The Nantes group's presentation was formally cited as one of the two Best Abstracts at the meeting.

Disclosures: Dr. Galmiche disclosed that he is on the advisory board of Given Imaging but has no financial links. The study was sponsored by a National Research Grant.

LONDON — In a French study of 545 patients, wireless capsule colonoscopy achieved an overall sensitivity of only 39% and a positive predictive value of just 46%, Dr. Jean Paul Galmiche reported at the 13th World Congress of Gastroenterology.

The 16-center study was designed to discover the reliability of the colon capsule (Pillcam, Given Imaging Ltd.)—which travels through the GI tract equipped with a tiny camera—for finding colon polyps of at least 6 mm. Two cohorts were studied: asymptomatic patients aged 50-74 years needing routine screening (30% of subjects), and patients at increased risk for colorectal cancer because of a personal or family history of colon polyps or cancer (70% of subjects). The patients' mean age was 60 years.

The colon capsule results were compared with results from conventional colonoscopy performed the following day by colonoscopists who were blinded to the capsule findings. Images obtained during the two procedures underwent subsequent examination by an outside panel of experts.

The interim analysis by Dr. Galmiche's group at the University Hospital Nantes, France, showed that the wireless capsule colonoscopy (WCC) results achieved an overall sensitivity of 39% and a positive predictive value of 46% in terms of the total number of polyps correctly identified.

This was no match for conventional colonoscopy, which had a positive predictive value of 57% and a sensitivity of about 85% for all polyps regardless of size.

“At this stage of the development of the technology, WCC cannot replace colonoscopy for screening and surveillance of patients at risk for colon cancer,” Dr. Galmiche said in an interview.

“Future research should focus on better preparation and improved technology, that is to say, a new capsule generation,” he added.

The primary problem is that, despite rigorous attempts at preprocedure cleansing, colonic debris frequently obscured the wireless capsule's capacity to transmit reliable images. Only 52% of the 377 WCC patients were judged to have sufficiently “good to excellent” colon cleansing to allow full visualization from the technology.

In contrast, more than 85% of the 183 colonoscopy patients in the study achieved the same “good to excellent” bowel prep results.

The study began with patients on a 3-day low-residue diet, with 3 L of polyethylene glycol solution taken the night before the procedure, and another liter taken the following morning. Domperidone and a laxative booster were used to ensure prompt expulsion of the video capsule—which occurred within 10 hours in 93% of the patients.

About one-quarter of the way through the study, the 3-day low-residue diet was replaced with an all-liquid diet for the remaining patients, to improve visualization.

“Somewhat better results have been achieved with this newer approach to preparation,” Dr. Galmiche said.

In addition to the drawback of the high cost of WCC, the noninvasive procedure was associated with 20 adverse events, chiefly excessive abdominal pain and vomiting. However, these effects were all considered related to the bowel prep used before swallowing the video capsule, rather than mishaps with the capsule itself.

Dr. Galmiche noted that the WCC procedure had a negative predictive value of 88% for identifying polyps larger than 10 mm.

But he concluded by saying its sensitivity was “not optimal” and that a new iteration of the technology would need to have dramatic improvements before it could contend with colonoscopy as a gold standard screening tool for colorectal cancer.

The Nantes group's presentation was formally cited as one of the two Best Abstracts at the meeting.

Disclosures: Dr. Galmiche disclosed that he is on the advisory board of Given Imaging but has no financial links. The study was sponsored by a National Research Grant.

LONDON — Capsule endoscopy received positive reviews in several presentations at the 13th World Congress of Gastroenterology, with speakers championing new applications and technological improvements.

In one of several “state of the art” presentations, Dr. Martin Keuchel of the Asklepios Clinic in Hamburg, Germany, asserted that the minimally invasive technology should already be viewed as a successful first-line screening approach for detection of suspected Crohn's disease associated with obscure gastrointestinal bleeding.

“We have been able to identify nearly 80% of small bowel tumors by capsule endoscopy alone, including those undetectable by other methods. It can be useful for screening for early-stage Crohn's disease, both by stratifying larger tumors needing surgical removal and identifying clusters of smaller polyps and adenomas needing ongoing surveillance,” Dr. Keuchel commented.

Multicenter German trials have shown that the technology detected an overall 2.4% incidence of primary tumors of the small bowel, Dr. Keuchel said. But he acknowledged that one of the main concerns in this setting was the risk of retention, potentially requiring surgical retrieval.

Interestingly, the gastroenterologist observed that this risk was low in early-stage patients who were only suspected of having Crohn's disease. In this situation, when screening was prompted by obscure GI bleeding, the retention rate in the German analysis was only 1.5%, or 10 out of 664 patients.

However, the rate of capsule retention rose to 13% among patients who already had established Crohn's disease.

In an attempt to stave off capsule retention problems, Dr. Keuchel and colleagues tried first using dummy patency capsules in 106 patients with a known stenosis.

These patency capsules have a permeable membrane that allows them to dissolve within 48 hours.

About 50% of the patients were able to quickly excrete the patency capsule, providing evidence that the actual diagnostic capsule was likely to pass as well. But 11 patients reported significant pain from initial retention of the patency capsule; this pain was generally resolved by the capsule's dissolution within 48 hours. One surgical extraction was required, however.

“Small bowel capsule endoscopy has become an accepted first-line diagnostic tool for obscure GI bleeding,” Dr. Keuchel said in summarizing the findings. “It may be the best test for suspected small bowel Crohn's disease, whereas in established Crohn's disease there is a significant risk of retention to be considered, although prior testing with patency capsules appears to reduce this risk significantly.”

“The capsule has clearly revolutionized small bowel imaging, but imaging the colon can be a lot more difficult,” Dr. André Van Gossum of Erasmus Hospital in Brussels said while discussing the next-generation twist for the technology—a so-called “wake-up” capsule that shuts off 3 minutes after ingestion to preserve its battery power for reactivation during its eventual slow pass through the colon.

The capsule is timed to reactivate image broadcasting after 1 hour 45 minutes, when it is predicted to enter the terminal ileum. It can then transmit images during its entire pass through the colon.

Dr. Van Gossum reported on twin pilot studies and a new multicenter trial that appear to show increasing efficacy for the new technology.

He acknowledged that an initial Israeli pilot study of capsule endoscopy in 91 patients, which was first reported in the journal Endoscopy in 2006, had achieved mixed results, with an overall sensitivity of 50%. He ascribed those disappointing results to inadequate preprocedure bowel cleansing.

A second pilot study of 48 patients conducted in Belgium raised sensitivity to 75% by employing a laxative boost to achieve enhanced bowel cleansing and better resultant imaging, the utility of which was further improved by the use of expert readers to interpret the results.

Dr. Van Gossum also noted that his eight-center European trial of 320 patients, first reported in October, had further supported the broad utility of the “wake-up” colon capsule (N. Engl. J. Med. 2009;361:264-70).

The double-headed wake-up camera became activated just as it reached the ileum in 97% of these patients.

And in 93% of the procedures, the capsule was rapidly excreted without retention problems.

The investigator did note that 8% of the patients experienced a variety of adverse events, including nausea, vomiting, and headaches during their preparation.

“In our study, the technology was shown to have a negative predictive value of over 80%, and detected several lesions not seen on colonoscopy. The endoscopy capsule may be considered a complementary tool to colonoscopy or an alternative for patients who resist further probes with colonoscopy—which may occur in 70%. The capsule may soon offer a view of the entire esophageal tract,” Dr. Van Gossum said.

Disclosures: Dr. Keuchel disclosed that he has received research support from Given Imaging and will receive research support from IntroMedic. He has received speakers fees for other presentations and educational capsule endoscopy courses from Given and Olympus, as well as travel support for other conferences.

LONDON — Capsule endoscopy received positive reviews in several presentations at the 13th World Congress of Gastroenterology, with speakers championing new applications and technological improvements.

In one of several “state of the art” presentations, Dr. Martin Keuchel of the Asklepios Clinic in Hamburg, Germany, asserted that the minimally invasive technology should already be viewed as a successful first-line screening approach for detection of suspected Crohn's disease associated with obscure gastrointestinal bleeding.

“We have been able to identify nearly 80% of small bowel tumors by capsule endoscopy alone, including those undetectable by other methods. It can be useful for screening for early-stage Crohn's disease, both by stratifying larger tumors needing surgical removal and identifying clusters of smaller polyps and adenomas needing ongoing surveillance,” Dr. Keuchel commented.

Multicenter German trials have shown that the technology detected an overall 2.4% incidence of primary tumors of the small bowel, Dr. Keuchel said. But he acknowledged that one of the main concerns in this setting was the risk of retention, potentially requiring surgical retrieval.

Interestingly, the gastroenterologist observed that this risk was low in early-stage patients who were only suspected of having Crohn's disease. In this situation, when screening was prompted by obscure GI bleeding, the retention rate in the German analysis was only 1.5%, or 10 out of 664 patients.

However, the rate of capsule retention rose to 13% among patients who already had established Crohn's disease.

In an attempt to stave off capsule retention problems, Dr. Keuchel and colleagues tried first using dummy patency capsules in 106 patients with a known stenosis.

These patency capsules have a permeable membrane that allows them to dissolve within 48 hours.

About 50% of the patients were able to quickly excrete the patency capsule, providing evidence that the actual diagnostic capsule was likely to pass as well. But 11 patients reported significant pain from initial retention of the patency capsule; this pain was generally resolved by the capsule's dissolution within 48 hours. One surgical extraction was required, however.

“Small bowel capsule endoscopy has become an accepted first-line diagnostic tool for obscure GI bleeding,” Dr. Keuchel said in summarizing the findings. “It may be the best test for suspected small bowel Crohn's disease, whereas in established Crohn's disease there is a significant risk of retention to be considered, although prior testing with patency capsules appears to reduce this risk significantly.”

“The capsule has clearly revolutionized small bowel imaging, but imaging the colon can be a lot more difficult,” Dr. André Van Gossum of Erasmus Hospital in Brussels said while discussing the next-generation twist for the technology—a so-called “wake-up” capsule that shuts off 3 minutes after ingestion to preserve its battery power for reactivation during its eventual slow pass through the colon.

The capsule is timed to reactivate image broadcasting after 1 hour 45 minutes, when it is predicted to enter the terminal ileum. It can then transmit images during its entire pass through the colon.

Dr. Van Gossum reported on twin pilot studies and a new multicenter trial that appear to show increasing efficacy for the new technology.

He acknowledged that an initial Israeli pilot study of capsule endoscopy in 91 patients, which was first reported in the journal Endoscopy in 2006, had achieved mixed results, with an overall sensitivity of 50%. He ascribed those disappointing results to inadequate preprocedure bowel cleansing.

A second pilot study of 48 patients conducted in Belgium raised sensitivity to 75% by employing a laxative boost to achieve enhanced bowel cleansing and better resultant imaging, the utility of which was further improved by the use of expert readers to interpret the results.

Dr. Van Gossum also noted that his eight-center European trial of 320 patients, first reported in October, had further supported the broad utility of the “wake-up” colon capsule (N. Engl. J. Med. 2009;361:264-70).

The double-headed wake-up camera became activated just as it reached the ileum in 97% of these patients.

And in 93% of the procedures, the capsule was rapidly excreted without retention problems.

The investigator did note that 8% of the patients experienced a variety of adverse events, including nausea, vomiting, and headaches during their preparation.

“In our study, the technology was shown to have a negative predictive value of over 80%, and detected several lesions not seen on colonoscopy. The endoscopy capsule may be considered a complementary tool to colonoscopy or an alternative for patients who resist further probes with colonoscopy—which may occur in 70%. The capsule may soon offer a view of the entire esophageal tract,” Dr. Van Gossum said.

Disclosures: Dr. Keuchel disclosed that he has received research support from Given Imaging and will receive research support from IntroMedic. He has received speakers fees for other presentations and educational capsule endoscopy courses from Given and Olympus, as well as travel support for other conferences.

LONDON — Capsule endoscopy received positive reviews in several presentations at the 13th World Congress of Gastroenterology, with speakers championing new applications and technological improvements.

In one of several “state of the art” presentations, Dr. Martin Keuchel of the Asklepios Clinic in Hamburg, Germany, asserted that the minimally invasive technology should already be viewed as a successful first-line screening approach for detection of suspected Crohn's disease associated with obscure gastrointestinal bleeding.

“We have been able to identify nearly 80% of small bowel tumors by capsule endoscopy alone, including those undetectable by other methods. It can be useful for screening for early-stage Crohn's disease, both by stratifying larger tumors needing surgical removal and identifying clusters of smaller polyps and adenomas needing ongoing surveillance,” Dr. Keuchel commented.

Multicenter German trials have shown that the technology detected an overall 2.4% incidence of primary tumors of the small bowel, Dr. Keuchel said. But he acknowledged that one of the main concerns in this setting was the risk of retention, potentially requiring surgical retrieval.

Interestingly, the gastroenterologist observed that this risk was low in early-stage patients who were only suspected of having Crohn's disease. In this situation, when screening was prompted by obscure GI bleeding, the retention rate in the German analysis was only 1.5%, or 10 out of 664 patients.

However, the rate of capsule retention rose to 13% among patients who already had established Crohn's disease.

In an attempt to stave off capsule retention problems, Dr. Keuchel and colleagues tried first using dummy patency capsules in 106 patients with a known stenosis.

These patency capsules have a permeable membrane that allows them to dissolve within 48 hours.

About 50% of the patients were able to quickly excrete the patency capsule, providing evidence that the actual diagnostic capsule was likely to pass as well. But 11 patients reported significant pain from initial retention of the patency capsule; this pain was generally resolved by the capsule's dissolution within 48 hours. One surgical extraction was required, however.

“Small bowel capsule endoscopy has become an accepted first-line diagnostic tool for obscure GI bleeding,” Dr. Keuchel said in summarizing the findings. “It may be the best test for suspected small bowel Crohn's disease, whereas in established Crohn's disease there is a significant risk of retention to be considered, although prior testing with patency capsules appears to reduce this risk significantly.”

“The capsule has clearly revolutionized small bowel imaging, but imaging the colon can be a lot more difficult,” Dr. André Van Gossum of Erasmus Hospital in Brussels said while discussing the next-generation twist for the technology—a so-called “wake-up” capsule that shuts off 3 minutes after ingestion to preserve its battery power for reactivation during its eventual slow pass through the colon.

The capsule is timed to reactivate image broadcasting after 1 hour 45 minutes, when it is predicted to enter the terminal ileum. It can then transmit images during its entire pass through the colon.

Dr. Van Gossum reported on twin pilot studies and a new multicenter trial that appear to show increasing efficacy for the new technology.

He acknowledged that an initial Israeli pilot study of capsule endoscopy in 91 patients, which was first reported in the journal Endoscopy in 2006, had achieved mixed results, with an overall sensitivity of 50%. He ascribed those disappointing results to inadequate preprocedure bowel cleansing.

A second pilot study of 48 patients conducted in Belgium raised sensitivity to 75% by employing a laxative boost to achieve enhanced bowel cleansing and better resultant imaging, the utility of which was further improved by the use of expert readers to interpret the results.

Dr. Van Gossum also noted that his eight-center European trial of 320 patients, first reported in October, had further supported the broad utility of the “wake-up” colon capsule (N. Engl. J. Med. 2009;361:264-70).

The double-headed wake-up camera became activated just as it reached the ileum in 97% of these patients.

And in 93% of the procedures, the capsule was rapidly excreted without retention problems.

The investigator did note that 8% of the patients experienced a variety of adverse events, including nausea, vomiting, and headaches during their preparation.

“In our study, the technology was shown to have a negative predictive value of over 80%, and detected several lesions not seen on colonoscopy. The endoscopy capsule may be considered a complementary tool to colonoscopy or an alternative for patients who resist further probes with colonoscopy—which may occur in 70%. The capsule may soon offer a view of the entire esophageal tract,” Dr. Van Gossum said.

Disclosures: Dr. Keuchel disclosed that he has received research support from Given Imaging and will receive research support from IntroMedic. He has received speakers fees for other presentations and educational capsule endoscopy courses from Given and Olympus, as well as travel support for other conferences.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms. But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP study (Colorectal Research in Symptom Prediction) performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris said. “Basic screening tests have much higher predictive value of co-lorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy. A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer. “We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said.

Only one predictive factor stood out: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of a cancer diagnosis upon colonoscopy. A history of previously diagnosed rectal polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis. Heavy smoking also slightly increased the likelihood of a cancer diagnosis.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months. In women, these symptoms had low predictive value for a cancer diagnosis.

Dr. Katelaris noted that 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” they said.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms. But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP study (Colorectal Research in Symptom Prediction) performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris said. “Basic screening tests have much higher predictive value of co-lorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy. A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer. “We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said.

Only one predictive factor stood out: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of a cancer diagnosis upon colonoscopy. A history of previously diagnosed rectal polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis. Heavy smoking also slightly increased the likelihood of a cancer diagnosis.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months. In women, these symptoms had low predictive value for a cancer diagnosis.

Dr. Katelaris noted that 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” they said.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms. But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP study (Colorectal Research in Symptom Prediction) performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris said. “Basic screening tests have much higher predictive value of co-lorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy. A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer. “We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said.

Only one predictive factor stood out: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of a cancer diagnosis upon colonoscopy. A history of previously diagnosed rectal polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis. Heavy smoking also slightly increased the likelihood of a cancer diagnosis.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months. In women, these symptoms had low predictive value for a cancer diagnosis.

Dr. Katelaris noted that 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” they said.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms.

But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies being undertaken at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP (Colorectal Research in Symptom Prediction) study performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris remarked.

“Basic screening tests have much higher predictive value of colorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy.

A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer.

“We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said at the meeting.

Only one predictive factor stood out in CRISP: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of receiving a cancer diagnosis after undergoing colonoscopy.

A history of previously diagnosed polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis.

Heavy smoking also slightly increased the likelihood of a cancer diagnosis, when combined with other factors.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months.

In women, these symptoms had particularly low predictive value for a cancer diagnosis.

In fact, Dr. Katelaris noted, 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” Dr. Katelaris and his coauthors said.

“Colonoscopy can be avoided in people at low risk; in our study, 95% of cancers could have been detected by doing only 60% of the colonoscopies,” the researchers said.

My Take

Screening Can't Rely on Signs

These findings underscore that a screening test is one performed on asymptomatic patients. Effective colorectal cancer prevention relies on screening patients of a certain age or risk profile, independent of symptoms.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms.

But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies being undertaken at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP (Colorectal Research in Symptom Prediction) study performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris remarked.

“Basic screening tests have much higher predictive value of colorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy.

A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer.

“We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said at the meeting.

Only one predictive factor stood out in CRISP: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of receiving a cancer diagnosis after undergoing colonoscopy.

A history of previously diagnosed polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis.

Heavy smoking also slightly increased the likelihood of a cancer diagnosis, when combined with other factors.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months.

In women, these symptoms had particularly low predictive value for a cancer diagnosis.

In fact, Dr. Katelaris noted, 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” Dr. Katelaris and his coauthors said.

“Colonoscopy can be avoided in people at low risk; in our study, 95% of cancers could have been detected by doing only 60% of the colonoscopies,” the researchers said.

My Take

Screening Can't Rely on Signs

These findings underscore that a screening test is one performed on asymptomatic patients. Effective colorectal cancer prevention relies on screening patients of a certain age or risk profile, independent of symptoms.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

LONDON — Clinical symptoms are of little value in the selection of appropriate patients for colonoscopy for the purpose of early detection of colorectal cancer, despite common beliefs to the contrary.

These were the disappointing results of a large Australian retrospective analysis presented at the 13th World Congress of Gastroenterology meeting.

The early warning signs for colorectal cancer are well known—recurrent abdominal pain, rectal bleeding or pain or excretion of mucus, or radical alteration in bowel habits, among other symptoms.

But most of these symptoms have little predictive value and, when considered in isolation, these symptoms may lead to thousands of unnecessary colonoscopies being undertaken at great cost, according to Dr. Peter Katelaris, one of the lead researchers of the CRISP (Colorectal Research in Symptom Prediction) study performed at the Concord Repatriation General Hospital in Sydney.

“Most symptoms are not predictive of bowel cancer and are a poor guide to the best use of colonoscopy,” Dr. Katelaris remarked.

“Basic screening tests have much higher predictive value of colorectal cancer than [do] patient symptoms. Perhaps it is time for a reappraisal,” said Dr. Katelaris, clinical associate professor in the department of gastroenterology at the University of Sydney.

The CRISP analysis of 5,577 patients compared their self-reported symptoms on a presenting questionnaire and their medical histories against their diagnosis based on colonoscopy.

A total of 159 patients (3%) were confirmed to have cancer. Yet a similar population of the same median age would generally have had a 2% rate of colon cancer.

“We are talking about an absolute increase of 1%, which is not very useful for interventions on this scale. We're wasting a lot of colonoscopy resources on this,” Dr. Katelaris said at the meeting.

Only one predictive factor stood out in CRISP: patient age. Those aged 70 years and older showed an 8.6% increased likelihood of receiving a cancer diagnosis after undergoing colonoscopy.

A history of previously diagnosed polyps or having undergone colonoscopy in the preceding 10 years also indicated increased risk of a colon cancer diagnosis.

Heavy smoking also slightly increased the likelihood of a cancer diagnosis, when combined with other factors.

But the most common triggers for colonoscopy referral—abdominal pain, rectal bleeding, and related bowel irregularities—showed almost no correlation with histologic findings, unless symptoms had persisted for months.

In women, these symptoms had particularly low predictive value for a cancer diagnosis.

In fact, Dr. Katelaris noted, 20% of those patients diagnosed with cancer upon colonoscopy in this cohort showed no symptoms whatsoever.

“Colonoscopy to detect cancer need not be done for many bowel symptoms [that] are currently considered to be indications,” Dr. Katelaris and his coauthors said.

“Colonoscopy can be avoided in people at low risk; in our study, 95% of cancers could have been detected by doing only 60% of the colonoscopies,” the researchers said.

My Take

Screening Can't Rely on Signs

These findings underscore that a screening test is one performed on asymptomatic patients. Effective colorectal cancer prevention relies on screening patients of a certain age or risk profile, independent of symptoms.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care.

The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546-53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his fellow authors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of GWTG, was achieved by 15 of the 3,909 hospitals in the program.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care.

The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546-53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his fellow authors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of GWTG, was achieved by 15 of the 3,909 hospitals in the program.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care.

The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546-53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his fellow authors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of GWTG, was achieved by 15 of the 3,909 hospitals in the program.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 hospitals (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care. The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546–53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his coauthors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of the GWTG program, was achieved by 15 of the 3,909 participating hospitals.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

But Dr. Heidenreich defended the program's worth, particularly citing evidence that it encouraged hospitals to more widely prescribe ACE inhibitors.

“Hospitals enrolled in the GWTG program have demonstrated steady improvement in their process of care,” Dr. Heidenreich and his colleagues wrote. “These results are consistent with prior studies indicating better survival at hospitals with better processes of care for acute myocardial infarction and heart failure.”

The authors noted that even marginal reductions in 30-day risk-adjusted mortality of 0.1%–0.2% as achieved by the top hospitals in this comparative, nonrandomized analysis could potentially save 1,800–3,500 lives if optimum standards were made the rule nationwide.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 hospitals (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care. The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546–53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his coauthors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of the GWTG program, was achieved by 15 of the 3,909 participating hospitals.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

But Dr. Heidenreich defended the program's worth, particularly citing evidence that it encouraged hospitals to more widely prescribe ACE inhibitors.

“Hospitals enrolled in the GWTG program have demonstrated steady improvement in their process of care,” Dr. Heidenreich and his colleagues wrote. “These results are consistent with prior studies indicating better survival at hospitals with better processes of care for acute myocardial infarction and heart failure.”

The authors noted that even marginal reductions in 30-day risk-adjusted mortality of 0.1%–0.2% as achieved by the top hospitals in this comparative, nonrandomized analysis could potentially save 1,800–3,500 lives if optimum standards were made the rule nationwide.

After 9 years and tens of millions of dollars, Get With the Guidelines—the American Heart Association's push for new standards of excellence for follow-up treatment of acute cardiovascular events—appears to have yielded murky gains at best in terms of saving lives, according to a new analysis.

A total of 3,909 medical centers participated in the Get With the Guidelines (GWTG) program. Of these, 355 hospitals (9%) received a nonmonetary achievement award for either heart failure or acute myocardial infarction (AMI) follow-up care. The report compared the risk-adjusted 30-day mortality figures for the top 355 hospitals with those of the remaining participating centers, and found no statistically significant difference in heart failure mortality. A modest 0.19% superiority in the top hospitals' survival rates following AMI was reduced by 43% after the data were adjusted for confounding factors (Am. Heart J. 2009;158:546–53).

Dr. Paul A. Heidenreich of the Veterans Affairs Palo Alto (Calif.) Health Care System and his coauthors, all from the GWTG steering committee, acknowledged that the best-performing hospitals tended to be ones that were exceptionally well funded before the program began. Overall, “it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care,” they wrote.

Further, differentials in the 30-day mortality for the third component of GWTG—follow-up-care for stroke—were unclear. Recognition on all three measures of excellence, the core aim of the GWTG program, was achieved by 15 of the 3,909 participating hospitals.

The program now costs as much as $12 million per year. At the AHA scientific sessions in 2005, Dr. Gray Ellrodt, lead author of an interim review of the initiative, said the program was the start of a new era of systematic excellence in cardiovascular care. “Men and women, young and old, showed dramatic improvements in care,” said Dr. Ellrodt, an internist at Berkshire Medical Center, Pittsfield, Mass.

In an interview, Dr. Heidenreich called this claim “an accurate statement. The improvements in process of care were dramatic given that many quality interventions have no improvement.”

Yet despite dramatic changes in care—including greater assessment of left ventricular function, use of ACE inhibitors, and rigorous discharge counseling for heart failure patients; rapid onset of thrombolytics for MI patients and emergency percutaneous coronary intervention where necessary; and more consistent use of aspirin and beta-blockers at every stage—the benefits in terms of improved mortality remained small.

But Dr. Heidenreich defended the program's worth, particularly citing evidence that it encouraged hospitals to more widely prescribe ACE inhibitors.

“Hospitals enrolled in the GWTG program have demonstrated steady improvement in their process of care,” Dr. Heidenreich and his colleagues wrote. “These results are consistent with prior studies indicating better survival at hospitals with better processes of care for acute myocardial infarction and heart failure.”

The authors noted that even marginal reductions in 30-day risk-adjusted mortality of 0.1%–0.2% as achieved by the top hospitals in this comparative, nonrandomized analysis could potentially save 1,800–3,500 lives if optimum standards were made the rule nationwide.