Alice Goodman

WASHINGTON – A longitudinal study of patients with previously diagnosed endometrial polyps found that about 75% of the polyps either decreased in size or remained the same size, while about one-quarter increased with up to 3.5 years of follow-up, leading the authors to suggest that the practice of automatic treatment of benign-appearing endometrial polyps should be re-evaluated.

"The current practice is to treat endometrial polyps that are found, especially if the patient is undergoing fertility procedures or is postmenopausal. This study shows that routine treatment of endometrial polyps may not always be necessary. Polyps should be triaged based on their appearance, size, patient’s age, and whether there is increased blood flow in the polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study included 300 consecutive patients aged 22-78 years who underwent sonohysterography from January to July of 2010. All patients were diagnosed with polyps from 1 to 43 months previously, and none had an intervention for the polyps.

Results showed that 34% of the polyps decreased in size (41 resolved [14%], and 61 [20%] decreased more than 1 mm); 41.7% had no significant change from time of diagnosis, and 24.3% showed an increase in size (16% showed an increase of more than 1 mm, and 8% had an increase of greater than or equal to 50%). Independent t-tests showed that the change in polyp size was significantly associated with menopausal status and blood flow, but failed to find an association between increased size and polyp location and abnormal uterine bleeding. Univariate linear regression found no association between change in polyp size and patient age, time between scans, and endometrial thickness.

Dr. Hartman said in an interview: "In common practice, polyps found in a postmenopausal woman that cause bleeding and polyps with increased vascularity should be treated. Treatment of all polyps without these features should be re-evaluated." He noted that his impression is that smaller polyps and those in women of reproductive age may not require treatment and may instead be monitored.

Dr. Hartman said he had no relevant financial disclosures.

WASHINGTON – A longitudinal study of patients with previously diagnosed endometrial polyps found that about 75% of the polyps either decreased in size or remained the same size, while about one-quarter increased with up to 3.5 years of follow-up, leading the authors to suggest that the practice of automatic treatment of benign-appearing endometrial polyps should be re-evaluated.

"The current practice is to treat endometrial polyps that are found, especially if the patient is undergoing fertility procedures or is postmenopausal. This study shows that routine treatment of endometrial polyps may not always be necessary. Polyps should be triaged based on their appearance, size, patient’s age, and whether there is increased blood flow in the polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study included 300 consecutive patients aged 22-78 years who underwent sonohysterography from January to July of 2010. All patients were diagnosed with polyps from 1 to 43 months previously, and none had an intervention for the polyps.

Results showed that 34% of the polyps decreased in size (41 resolved [14%], and 61 [20%] decreased more than 1 mm); 41.7% had no significant change from time of diagnosis, and 24.3% showed an increase in size (16% showed an increase of more than 1 mm, and 8% had an increase of greater than or equal to 50%). Independent t-tests showed that the change in polyp size was significantly associated with menopausal status and blood flow, but failed to find an association between increased size and polyp location and abnormal uterine bleeding. Univariate linear regression found no association between change in polyp size and patient age, time between scans, and endometrial thickness.

Dr. Hartman said in an interview: "In common practice, polyps found in a postmenopausal woman that cause bleeding and polyps with increased vascularity should be treated. Treatment of all polyps without these features should be re-evaluated." He noted that his impression is that smaller polyps and those in women of reproductive age may not require treatment and may instead be monitored.

Dr. Hartman said he had no relevant financial disclosures.

WASHINGTON – A longitudinal study of patients with previously diagnosed endometrial polyps found that about 75% of the polyps either decreased in size or remained the same size, while about one-quarter increased with up to 3.5 years of follow-up, leading the authors to suggest that the practice of automatic treatment of benign-appearing endometrial polyps should be re-evaluated.

"The current practice is to treat endometrial polyps that are found, especially if the patient is undergoing fertility procedures or is postmenopausal. This study shows that routine treatment of endometrial polyps may not always be necessary. Polyps should be triaged based on their appearance, size, patient’s age, and whether there is increased blood flow in the polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study included 300 consecutive patients aged 22-78 years who underwent sonohysterography from January to July of 2010. All patients were diagnosed with polyps from 1 to 43 months previously, and none had an intervention for the polyps.

Results showed that 34% of the polyps decreased in size (41 resolved [14%], and 61 [20%] decreased more than 1 mm); 41.7% had no significant change from time of diagnosis, and 24.3% showed an increase in size (16% showed an increase of more than 1 mm, and 8% had an increase of greater than or equal to 50%). Independent t-tests showed that the change in polyp size was significantly associated with menopausal status and blood flow, but failed to find an association between increased size and polyp location and abnormal uterine bleeding. Univariate linear regression found no association between change in polyp size and patient age, time between scans, and endometrial thickness.

Dr. Hartman said in an interview: "In common practice, polyps found in a postmenopausal woman that cause bleeding and polyps with increased vascularity should be treated. Treatment of all polyps without these features should be re-evaluated." He noted that his impression is that smaller polyps and those in women of reproductive age may not require treatment and may instead be monitored.

Dr. Hartman said he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – A small but important percentage of postmenopausal women not taking hormone replacement therapy have an endometrial lining that is suspicious for polyps, according to a prospective study of 1,500 consecutive asymptomatic women.

"We found no suspicion of polyps in the vast majority of asymptomatic postmenopausal women not taking HRT [hormone replacement therapy]; but we did find a suspicion of polyps in 6.7% of all patients. The appearance of a nonhomogeneous endometrial lining on ultrasound increased our suspicion of polyp," Dr. Michael Hartman of Memorial University of Newfoundland, St. John’s, Canada, said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists. "The number of women with suspicion of polyps was higher than expected and indicates there are a large number of asymptomatic postmenopausal women with endometrial polyps."

Dr. Hartman explained in an interview: "Any woman can develop polyps, whether or not she is on exogenous hormones. Estrogen can affect the lining of the uterus after menopause since it is produced in fat cells and not just the ovaries."

In a study of women aged 45-95 years (mean age, 62.7 years) who underwent transvaginal ultrasound from January to August 2010, 77.1% had an endometrial thickness of less than or equal to 4 mm, and 92% had an endometrial thickness of less than 5 mm. Polyps were suspected in 101 (6.7%) of these patients based on the ultrasound appearance of the endometrial lining.

Independent t-tests of age and endometrial thickening were performed, comparing the patients with a normal appearing endometrium with those whose endometrial thickening was suspicious for polyps. A significant difference was observed between the groups, with older age and mean endometrial thickness having a significant association with suspicion of polyps. Polyps were significantly more likely to be found in older patients, with a mean age of 67.7 years, than in younger patients (mean age of 62 years). Patients with a lining suspicious for polyps had a thicker endometrium (mean of 8.02 mm) than did patients who did not have a lining suspicious for a polyp (mean of 3.40 mm).

These findings do not support routine ultrasound screening of older asymptomatic women. "In fact, I would say that the finding of polyps in 6.7% of women does not necessarily signal the presence of cancerous or precancerous growths. Further clinical investigation is required to determine the natural history of these polyps," Dr. Hartman stated.

Dr. Hartman said that he had no relevant financial disclosures.

WASHINGTON – It appears that only one postpartum visit is necessary for IUD placement, according to Dr. David R. Kattan.

A common protocol for placement of an IUD includes two postpartum visits: one for testing for STDs and a second to place the IUD, with the goal of preventing the development of pelvic inflammatory disease (PID). A retrospective study found that the rates of STDs were below 1% in women who requested an IUD, and that positivity for STDs in the postpartum period did not predict the development of pelvic inflammatory disease.

"Eliminating one of the two postpartum visits promises to increase the rate of IUD placement in women who seek a reliable contraceptive method post partum," said Dr. Kattan of the University of Colorado at Denver.

"Two postpartum visits for IUD insertion are unnecessary. Adopt what the American College of Obstetricians and Gynecologists already supports, which is a single-visit protocol for postpartum IUD insertion," he emphasized.

For women with no health insurance and little financial means, the postpartum visit may be the last time they see a doctor before proceeding with a second pregnancy. An IUD is an effective means of preventing unwanted pregnancy, yet many women who request an IUD fail to have one placed. Factors implicated in the failure to have an IUD placed include being counseled against using one, getting pregnant before having an IUD placed, and being lost to follow-up, Dr. Kattan explained.

Dr. Kattan and his colleagues hypothesized in their poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists that conflating testing for Chlamydia trachomatis and Neisseria gonorrhoeae with immediate IUD placement at one visit can improve the success rate of having an IUD implanted without increasing the rate of PID.

The study included 1,417 women receiving an IUD in the year 2008 at Denver Health Medical Center; of these, 629 (44%) met the inclusion criterion of having given birth within the previous 3 months. The average age was 25.3 years, and the average parity was 2.3.

At the preinsertion screening visit, five (0.8%) tested positive for chlamydia and one (0.16%) tested positive for gonorrhea. None of these six women developed PID. Three women did develop PID, and none of them tested positive for either of these organisms during pregnancy, the postpartum period, or at the time of PID diagnosis. None of these three women required hospitalization or removal of their IUD.

"Based on these data showing that a separate screening visit was unnecessary, practice at Denver Health Medical Center and the University of Colorado has changed. Residents at both sites are now taught one-visit IUD placement protocol," Dr. Kattan said. "One of the side benefits of adopting this protocol is the availability of a clinic appointment that would have otherwise been used for a second IUD placement visit. In a busy resident clinic, this means that women seeking gynecology care can be seen more quickly because an unnecessary clinic visit has been eliminated. One of the aims of my study is to reinforce a single-visit practice as the standard of care at other programs across the [United States]. Despite ACOG’s recommendations, practice is still sometimes slow to change."

Dr. Kattan said he had no relevant financial disclosures.

WASHINGTON – It appears that only one postpartum visit is necessary for IUD placement, according to Dr. David R. Kattan.

A common protocol for placement of an IUD includes two postpartum visits: one for testing for STDs and a second to place the IUD, with the goal of preventing the development of pelvic inflammatory disease (PID). A retrospective study found that the rates of STDs were below 1% in women who requested an IUD, and that positivity for STDs in the postpartum period did not predict the development of pelvic inflammatory disease.

"Eliminating one of the two postpartum visits promises to increase the rate of IUD placement in women who seek a reliable contraceptive method post partum," said Dr. Kattan of the University of Colorado at Denver.

"Two postpartum visits for IUD insertion are unnecessary. Adopt what the American College of Obstetricians and Gynecologists already supports, which is a single-visit protocol for postpartum IUD insertion," he emphasized.

For women with no health insurance and little financial means, the postpartum visit may be the last time they see a doctor before proceeding with a second pregnancy. An IUD is an effective means of preventing unwanted pregnancy, yet many women who request an IUD fail to have one placed. Factors implicated in the failure to have an IUD placed include being counseled against using one, getting pregnant before having an IUD placed, and being lost to follow-up, Dr. Kattan explained.

Dr. Kattan and his colleagues hypothesized in their poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists that conflating testing for Chlamydia trachomatis and Neisseria gonorrhoeae with immediate IUD placement at one visit can improve the success rate of having an IUD implanted without increasing the rate of PID.

The study included 1,417 women receiving an IUD in the year 2008 at Denver Health Medical Center; of these, 629 (44%) met the inclusion criterion of having given birth within the previous 3 months. The average age was 25.3 years, and the average parity was 2.3.

At the preinsertion screening visit, five (0.8%) tested positive for chlamydia and one (0.16%) tested positive for gonorrhea. None of these six women developed PID. Three women did develop PID, and none of them tested positive for either of these organisms during pregnancy, the postpartum period, or at the time of PID diagnosis. None of these three women required hospitalization or removal of their IUD.

"Based on these data showing that a separate screening visit was unnecessary, practice at Denver Health Medical Center and the University of Colorado has changed. Residents at both sites are now taught one-visit IUD placement protocol," Dr. Kattan said. "One of the side benefits of adopting this protocol is the availability of a clinic appointment that would have otherwise been used for a second IUD placement visit. In a busy resident clinic, this means that women seeking gynecology care can be seen more quickly because an unnecessary clinic visit has been eliminated. One of the aims of my study is to reinforce a single-visit practice as the standard of care at other programs across the [United States]. Despite ACOG’s recommendations, practice is still sometimes slow to change."

Dr. Kattan said he had no relevant financial disclosures.

WASHINGTON – It appears that only one postpartum visit is necessary for IUD placement, according to Dr. David R. Kattan.

A common protocol for placement of an IUD includes two postpartum visits: one for testing for STDs and a second to place the IUD, with the goal of preventing the development of pelvic inflammatory disease (PID). A retrospective study found that the rates of STDs were below 1% in women who requested an IUD, and that positivity for STDs in the postpartum period did not predict the development of pelvic inflammatory disease.

"Eliminating one of the two postpartum visits promises to increase the rate of IUD placement in women who seek a reliable contraceptive method post partum," said Dr. Kattan of the University of Colorado at Denver.

"Two postpartum visits for IUD insertion are unnecessary. Adopt what the American College of Obstetricians and Gynecologists already supports, which is a single-visit protocol for postpartum IUD insertion," he emphasized.

For women with no health insurance and little financial means, the postpartum visit may be the last time they see a doctor before proceeding with a second pregnancy. An IUD is an effective means of preventing unwanted pregnancy, yet many women who request an IUD fail to have one placed. Factors implicated in the failure to have an IUD placed include being counseled against using one, getting pregnant before having an IUD placed, and being lost to follow-up, Dr. Kattan explained.

Dr. Kattan and his colleagues hypothesized in their poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists that conflating testing for Chlamydia trachomatis and Neisseria gonorrhoeae with immediate IUD placement at one visit can improve the success rate of having an IUD implanted without increasing the rate of PID.

The study included 1,417 women receiving an IUD in the year 2008 at Denver Health Medical Center; of these, 629 (44%) met the inclusion criterion of having given birth within the previous 3 months. The average age was 25.3 years, and the average parity was 2.3.

At the preinsertion screening visit, five (0.8%) tested positive for chlamydia and one (0.16%) tested positive for gonorrhea. None of these six women developed PID. Three women did develop PID, and none of them tested positive for either of these organisms during pregnancy, the postpartum period, or at the time of PID diagnosis. None of these three women required hospitalization or removal of their IUD.

"Based on these data showing that a separate screening visit was unnecessary, practice at Denver Health Medical Center and the University of Colorado has changed. Residents at both sites are now taught one-visit IUD placement protocol," Dr. Kattan said. "One of the side benefits of adopting this protocol is the availability of a clinic appointment that would have otherwise been used for a second IUD placement visit. In a busy resident clinic, this means that women seeking gynecology care can be seen more quickly because an unnecessary clinic visit has been eliminated. One of the aims of my study is to reinforce a single-visit practice as the standard of care at other programs across the [United States]. Despite ACOG’s recommendations, practice is still sometimes slow to change."

Dr. Kattan said he had no relevant financial disclosures.

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, according to a retrospective study.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new about this study is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at a press conference during the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder, which is characterized by involuntary jerking movements during sleep. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass (P = .01), mass index (P = .002), and posterior wall thickness (P = .01), indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, high cholesterol level, or renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index greater than 116g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

“This is a retrospective study that points out an interesting association between RLS and LVH. This could be an important observation, but the findings need to be validated in a prospective study,” commented Dr. William Zoghbi, who chaired the press conference and is the chair of cardiovascular imaging at the Methodist DeBakey Heart and Vascular Center in Houston.

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, according to a retrospective study.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new about this study is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at a press conference during the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder, which is characterized by involuntary jerking movements during sleep. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass (P = .01), mass index (P = .002), and posterior wall thickness (P = .01), indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, high cholesterol level, or renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index greater than 116g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

“This is a retrospective study that points out an interesting association between RLS and LVH. This could be an important observation, but the findings need to be validated in a prospective study,” commented Dr. William Zoghbi, who chaired the press conference and is the chair of cardiovascular imaging at the Methodist DeBakey Heart and Vascular Center in Houston.

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, according to a retrospective study.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new about this study is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at a press conference during the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder, which is characterized by involuntary jerking movements during sleep. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass (P = .01), mass index (P = .002), and posterior wall thickness (P = .01), indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, high cholesterol level, or renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index greater than 116g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

“This is a retrospective study that points out an interesting association between RLS and LVH. This could be an important observation, but the findings need to be validated in a prospective study,” commented Dr. William Zoghbi, who chaired the press conference and is the chair of cardiovascular imaging at the Methodist DeBakey Heart and Vascular Center in Houston.

Major Finding: Pulse pressure was correlated with a systolic white coat effect (r = 0.063, P less than .001) and a diastolic white coat effect (0.037, P less than .001).

Data Source: The study enrolled 1,087 patients undergoing treatment for chronic hypertension in outpatient academic hospital settings.

Disclosures: The study was funded by the Korean Institute of Medicine; the Korea Healthcare Technology R&D Project; the Korean Ministry of Health, Welfare, & Family Affairs; and the Republic of Korea.

NEW ORLEANS – Pulse pressure measured by a physician may help discriminate between patients with white coat hypertension and true hypertension, according to a South Korean study.

About a third of the more than 1,000 patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension (WCH), suggesting that the costs and potential side effects of drug therapy could have been avoided in these patients, said Dr. Young Keun Ahn of the Chonnam National University Hospital, Gwangju, South Korea, and associates.

Twenty-four hour ambulatory blood pressure monitoring or self-blood pressure monitoring can diagnose white coat hypertension, he said, but pulse pressure is simpler to use and is suitable for patients without aortic valvular insufficiency or aortic disease, he added.

Dr. Ahn and his colleagues found that pulse pressure as measured by a physician was more significantly related to WCH than was systolic blood pressure, a value that had been shown in earlier studies to be helpful in identifying patients with WCH.

The study enrolled 1,087 patients being treated for chronic hypertension in outpatient academic hospitals settings. Patients were trained to self-measure their blood pressure twice a day and record it every morning and evening for 2 weeks.

Thirty-one percent of patients were found to have WCH, which was defined as a difference above 20 mm Hg in systole or 10 mm Hg in diastole.

Pulse pressure was positively correlated with a systolic white coat effect (r = 0.063, P less than .001) and diastolic white coat effect (0.037, P less than .001).

No association was found between a white coat effect and age or gender. However, patients with a family history of premature heart disease were more likely to experience white coat hypertension. Patients with diabetes and smokers, were less likely to have it.

Dr. William Zoghbi noted that “if a stressful encounter like seeing a doctor can cause white coat hypertension, then perhaps this response would be replicated in other stressful situations. It would be useful to monitor these patients to determine if they are at risk for ongoing hypertension.”

Dr. Zoghbi is the chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston.

About a third of the patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension.

Source ©Dr. Heinz Linke/iStockphoto.com

Major Finding: Pulse pressure was correlated with a systolic white coat effect (r = 0.063, P less than .001) and a diastolic white coat effect (0.037, P less than .001).

Data Source: The study enrolled 1,087 patients undergoing treatment for chronic hypertension in outpatient academic hospital settings.

Disclosures: The study was funded by the Korean Institute of Medicine; the Korea Healthcare Technology R&D Project; the Korean Ministry of Health, Welfare, & Family Affairs; and the Republic of Korea.

NEW ORLEANS – Pulse pressure measured by a physician may help discriminate between patients with white coat hypertension and true hypertension, according to a South Korean study.

About a third of the more than 1,000 patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension (WCH), suggesting that the costs and potential side effects of drug therapy could have been avoided in these patients, said Dr. Young Keun Ahn of the Chonnam National University Hospital, Gwangju, South Korea, and associates.

Twenty-four hour ambulatory blood pressure monitoring or self-blood pressure monitoring can diagnose white coat hypertension, he said, but pulse pressure is simpler to use and is suitable for patients without aortic valvular insufficiency or aortic disease, he added.

Dr. Ahn and his colleagues found that pulse pressure as measured by a physician was more significantly related to WCH than was systolic blood pressure, a value that had been shown in earlier studies to be helpful in identifying patients with WCH.

The study enrolled 1,087 patients being treated for chronic hypertension in outpatient academic hospitals settings. Patients were trained to self-measure their blood pressure twice a day and record it every morning and evening for 2 weeks.

Thirty-one percent of patients were found to have WCH, which was defined as a difference above 20 mm Hg in systole or 10 mm Hg in diastole.

Pulse pressure was positively correlated with a systolic white coat effect (r = 0.063, P less than .001) and diastolic white coat effect (0.037, P less than .001).

No association was found between a white coat effect and age or gender. However, patients with a family history of premature heart disease were more likely to experience white coat hypertension. Patients with diabetes and smokers, were less likely to have it.

Dr. William Zoghbi noted that “if a stressful encounter like seeing a doctor can cause white coat hypertension, then perhaps this response would be replicated in other stressful situations. It would be useful to monitor these patients to determine if they are at risk for ongoing hypertension.”

Dr. Zoghbi is the chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston.

About a third of the patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension.

Source ©Dr. Heinz Linke/iStockphoto.com

Major Finding: Pulse pressure was correlated with a systolic white coat effect (r = 0.063, P less than .001) and a diastolic white coat effect (0.037, P less than .001).

Data Source: The study enrolled 1,087 patients undergoing treatment for chronic hypertension in outpatient academic hospital settings.

Disclosures: The study was funded by the Korean Institute of Medicine; the Korea Healthcare Technology R&D Project; the Korean Ministry of Health, Welfare, & Family Affairs; and the Republic of Korea.

NEW ORLEANS – Pulse pressure measured by a physician may help discriminate between patients with white coat hypertension and true hypertension, according to a South Korean study.

About a third of the more than 1,000 patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension (WCH), suggesting that the costs and potential side effects of drug therapy could have been avoided in these patients, said Dr. Young Keun Ahn of the Chonnam National University Hospital, Gwangju, South Korea, and associates.

Twenty-four hour ambulatory blood pressure monitoring or self-blood pressure monitoring can diagnose white coat hypertension, he said, but pulse pressure is simpler to use and is suitable for patients without aortic valvular insufficiency or aortic disease, he added.

Dr. Ahn and his colleagues found that pulse pressure as measured by a physician was more significantly related to WCH than was systolic blood pressure, a value that had been shown in earlier studies to be helpful in identifying patients with WCH.

The study enrolled 1,087 patients being treated for chronic hypertension in outpatient academic hospitals settings. Patients were trained to self-measure their blood pressure twice a day and record it every morning and evening for 2 weeks.

Thirty-one percent of patients were found to have WCH, which was defined as a difference above 20 mm Hg in systole or 10 mm Hg in diastole.

Pulse pressure was positively correlated with a systolic white coat effect (r = 0.063, P less than .001) and diastolic white coat effect (0.037, P less than .001).

No association was found between a white coat effect and age or gender. However, patients with a family history of premature heart disease were more likely to experience white coat hypertension. Patients with diabetes and smokers, were less likely to have it.

Dr. William Zoghbi noted that “if a stressful encounter like seeing a doctor can cause white coat hypertension, then perhaps this response would be replicated in other stressful situations. It would be useful to monitor these patients to determine if they are at risk for ongoing hypertension.”

Dr. Zoghbi is the chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston.

About a third of the patients in the study who were receiving ongoing antihypertensive treatment actually had white coat hypertension.

Source ©Dr. Heinz Linke/iStockphoto.com

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.