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High-normal TSH linked to unexplained infertility
CHICAGO – Levels of thyroid stimulating hormone were significantly higher in women with unexplained infertility than in a cohort whose partners had severe male factor infertility, though TSH levels still fell within the reference range.
For women with unexplained infertility, thyroid stimulating hormone (TSH) averaged 1.95 mIU/mL (95% confidence interval, 1.54-2.61), compared with 1.66 mIU/mL for the group of women with severe male factor infertility, such as severe oligospermia or azoospermia (95% CI, 1.25-2.17; P = .003).
“We found, very interestingly, that in the unexplained group, TSH was higher in those women, compared with women whose partners had severe male factor infertility,” suggesting that , the study’s first author, Lindsay T. Fourman, MD, said in an interview at the annual meeting of the Endocrine Society.
In terms of TSH levels, “clearly, the cutoff of the upper limit of the normal range is controversial,” said Dr. Fourman. “Some studies have shown that 95% of the population has a TSH of less than 2.5.”
However, the numbers that guide treatment for hypothyroidism are different. “We use a cutoff, generally, of 4 or 5, but maybe that cutoff should be 2.5, and maybe that’s significant for some people,” Dr. Fourman said.
“Current guidelines do not recommend treatment of subclinical hypothyroidism among auto-antibody negative women attempting to conceive naturally,” wrote Dr. Fourman and her collaborators in the poster presenting their finding.
Twice as many women in the group with unexplained infertility had TSH levels in the upper half of the normal range – above 2.5 mIU/mL – than in the male factor infertility group, “again, suggesting this association with TSH and unexplained infertility,” Dr. Fourman said. The thyroid axis is known to play a role in oocyte development. Of women with unexplained infertility, 26.9% had a TSH above 5 mIU/mL, compared with 13.5% of those with severe male factor infertility (P less than .05).
The chart review of records from 187 women with unexplained fertility and 52 women whose partners had severe male factor infertility included women aged 18-39. The unexplained cohort included women for whom all causes of infertility were excluded “in the setting of a very thorough workup – and that would include any ovulatory issues, male factor issues, and by definition, these women had to have a normal FSH, TSH and prolactin,” said Dr. Fourman, an endocrine fellow at Massachusetts General Hospital, Boston.
Control patients were those who had TSH and prolactin levels available and whose partners were being seen for severe male factor infertility, meaning that their partner had severe oligospermia or azoospermia.
Dr. Fourman acknowledged that she and her and her collaborators couldn’t exclude some female factor infertility among the control group. “That is an assumption, but it’s an assumption that would bias us to the null,” strengthening the study’s findings.
Clinical characteristics were similar between study groups, though women with unexplained infertility were slightly older than those with severe male factor infertility (mean 31.5 years versus 30.1 years, P = .01); they also had slightly lower body mass indices (median 23 versus 24.4 kg/m2; P less than .04).
No association was found between prolactin levels, “which suggests that prolactin may not contribute to unexplained infertility in these women,” Dr. Fourman said.
The investigators were able to control for such potentially confounding variables as age, tobacco use, BMI; they excluded from analysis women who had positive thyroid peroxidase antibodies.
“This is very interesting, because it really raises the question of whether we should be treating TSH, even to the lower half of the normal range, to see if that can improve outcomes,” she said. “We are looking for modifiable things that we can treat to try to improve fertility, so if we can identify some cause – like a hormonal cause – we may be able to improve conception outcomes and reduce the need for invasive treatment.”
Based in part on the strength of these findings, Dr. Fourman said she and her collaborators are planning a prospective study to see whether treating women with infertility to achieve a TSH of less than 2.5 can speed time to conception and reduce the need for invasive infertility treatment.
Dr. Fourman reported no conflicts of interest and no external sources of funding.
SOURCE: Fourman, L, et al. ENDO 2018, Abstract SAT-288.
CHICAGO – Levels of thyroid stimulating hormone were significantly higher in women with unexplained infertility than in a cohort whose partners had severe male factor infertility, though TSH levels still fell within the reference range.
For women with unexplained infertility, thyroid stimulating hormone (TSH) averaged 1.95 mIU/mL (95% confidence interval, 1.54-2.61), compared with 1.66 mIU/mL for the group of women with severe male factor infertility, such as severe oligospermia or azoospermia (95% CI, 1.25-2.17; P = .003).
“We found, very interestingly, that in the unexplained group, TSH was higher in those women, compared with women whose partners had severe male factor infertility,” suggesting that , the study’s first author, Lindsay T. Fourman, MD, said in an interview at the annual meeting of the Endocrine Society.
In terms of TSH levels, “clearly, the cutoff of the upper limit of the normal range is controversial,” said Dr. Fourman. “Some studies have shown that 95% of the population has a TSH of less than 2.5.”
However, the numbers that guide treatment for hypothyroidism are different. “We use a cutoff, generally, of 4 or 5, but maybe that cutoff should be 2.5, and maybe that’s significant for some people,” Dr. Fourman said.
“Current guidelines do not recommend treatment of subclinical hypothyroidism among auto-antibody negative women attempting to conceive naturally,” wrote Dr. Fourman and her collaborators in the poster presenting their finding.
Twice as many women in the group with unexplained infertility had TSH levels in the upper half of the normal range – above 2.5 mIU/mL – than in the male factor infertility group, “again, suggesting this association with TSH and unexplained infertility,” Dr. Fourman said. The thyroid axis is known to play a role in oocyte development. Of women with unexplained infertility, 26.9% had a TSH above 5 mIU/mL, compared with 13.5% of those with severe male factor infertility (P less than .05).
The chart review of records from 187 women with unexplained fertility and 52 women whose partners had severe male factor infertility included women aged 18-39. The unexplained cohort included women for whom all causes of infertility were excluded “in the setting of a very thorough workup – and that would include any ovulatory issues, male factor issues, and by definition, these women had to have a normal FSH, TSH and prolactin,” said Dr. Fourman, an endocrine fellow at Massachusetts General Hospital, Boston.
Control patients were those who had TSH and prolactin levels available and whose partners were being seen for severe male factor infertility, meaning that their partner had severe oligospermia or azoospermia.
Dr. Fourman acknowledged that she and her and her collaborators couldn’t exclude some female factor infertility among the control group. “That is an assumption, but it’s an assumption that would bias us to the null,” strengthening the study’s findings.
Clinical characteristics were similar between study groups, though women with unexplained infertility were slightly older than those with severe male factor infertility (mean 31.5 years versus 30.1 years, P = .01); they also had slightly lower body mass indices (median 23 versus 24.4 kg/m2; P less than .04).
No association was found between prolactin levels, “which suggests that prolactin may not contribute to unexplained infertility in these women,” Dr. Fourman said.
The investigators were able to control for such potentially confounding variables as age, tobacco use, BMI; they excluded from analysis women who had positive thyroid peroxidase antibodies.
“This is very interesting, because it really raises the question of whether we should be treating TSH, even to the lower half of the normal range, to see if that can improve outcomes,” she said. “We are looking for modifiable things that we can treat to try to improve fertility, so if we can identify some cause – like a hormonal cause – we may be able to improve conception outcomes and reduce the need for invasive treatment.”
Based in part on the strength of these findings, Dr. Fourman said she and her collaborators are planning a prospective study to see whether treating women with infertility to achieve a TSH of less than 2.5 can speed time to conception and reduce the need for invasive infertility treatment.
Dr. Fourman reported no conflicts of interest and no external sources of funding.
SOURCE: Fourman, L, et al. ENDO 2018, Abstract SAT-288.
CHICAGO – Levels of thyroid stimulating hormone were significantly higher in women with unexplained infertility than in a cohort whose partners had severe male factor infertility, though TSH levels still fell within the reference range.
For women with unexplained infertility, thyroid stimulating hormone (TSH) averaged 1.95 mIU/mL (95% confidence interval, 1.54-2.61), compared with 1.66 mIU/mL for the group of women with severe male factor infertility, such as severe oligospermia or azoospermia (95% CI, 1.25-2.17; P = .003).
“We found, very interestingly, that in the unexplained group, TSH was higher in those women, compared with women whose partners had severe male factor infertility,” suggesting that , the study’s first author, Lindsay T. Fourman, MD, said in an interview at the annual meeting of the Endocrine Society.
In terms of TSH levels, “clearly, the cutoff of the upper limit of the normal range is controversial,” said Dr. Fourman. “Some studies have shown that 95% of the population has a TSH of less than 2.5.”
However, the numbers that guide treatment for hypothyroidism are different. “We use a cutoff, generally, of 4 or 5, but maybe that cutoff should be 2.5, and maybe that’s significant for some people,” Dr. Fourman said.
“Current guidelines do not recommend treatment of subclinical hypothyroidism among auto-antibody negative women attempting to conceive naturally,” wrote Dr. Fourman and her collaborators in the poster presenting their finding.
Twice as many women in the group with unexplained infertility had TSH levels in the upper half of the normal range – above 2.5 mIU/mL – than in the male factor infertility group, “again, suggesting this association with TSH and unexplained infertility,” Dr. Fourman said. The thyroid axis is known to play a role in oocyte development. Of women with unexplained infertility, 26.9% had a TSH above 5 mIU/mL, compared with 13.5% of those with severe male factor infertility (P less than .05).
The chart review of records from 187 women with unexplained fertility and 52 women whose partners had severe male factor infertility included women aged 18-39. The unexplained cohort included women for whom all causes of infertility were excluded “in the setting of a very thorough workup – and that would include any ovulatory issues, male factor issues, and by definition, these women had to have a normal FSH, TSH and prolactin,” said Dr. Fourman, an endocrine fellow at Massachusetts General Hospital, Boston.
Control patients were those who had TSH and prolactin levels available and whose partners were being seen for severe male factor infertility, meaning that their partner had severe oligospermia or azoospermia.
Dr. Fourman acknowledged that she and her and her collaborators couldn’t exclude some female factor infertility among the control group. “That is an assumption, but it’s an assumption that would bias us to the null,” strengthening the study’s findings.
Clinical characteristics were similar between study groups, though women with unexplained infertility were slightly older than those with severe male factor infertility (mean 31.5 years versus 30.1 years, P = .01); they also had slightly lower body mass indices (median 23 versus 24.4 kg/m2; P less than .04).
No association was found between prolactin levels, “which suggests that prolactin may not contribute to unexplained infertility in these women,” Dr. Fourman said.
The investigators were able to control for such potentially confounding variables as age, tobacco use, BMI; they excluded from analysis women who had positive thyroid peroxidase antibodies.
“This is very interesting, because it really raises the question of whether we should be treating TSH, even to the lower half of the normal range, to see if that can improve outcomes,” she said. “We are looking for modifiable things that we can treat to try to improve fertility, so if we can identify some cause – like a hormonal cause – we may be able to improve conception outcomes and reduce the need for invasive treatment.”
Based in part on the strength of these findings, Dr. Fourman said she and her collaborators are planning a prospective study to see whether treating women with infertility to achieve a TSH of less than 2.5 can speed time to conception and reduce the need for invasive infertility treatment.
Dr. Fourman reported no conflicts of interest and no external sources of funding.
SOURCE: Fourman, L, et al. ENDO 2018, Abstract SAT-288.
REPORTING FROM ENDO 2018
Barbershop intervention cuts blood pressure in black men
ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.
“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.
The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.
Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.
The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.
The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.
Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.
In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.
“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.
“We think the whole package was important,” he emphasized.
The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.
“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.
Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.
The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).
SOURCE: Victor R et al. ACC 2018.
ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.
“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.
The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.
Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.
The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.
The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.
Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.
In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.
“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.
“We think the whole package was important,” he emphasized.
The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.
“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.
Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.
The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).
SOURCE: Victor R et al. ACC 2018.
ORLANDO – Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.
“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.
The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.
Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.
The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.
The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.
Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.
In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.
“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.
“We think the whole package was important,” he emphasized.
The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.
“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.
Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.
The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).
SOURCE: Victor R et al. ACC 2018.
REPORTING FROM ACC 18
Key clinical point: Major finding: After 6 months, mean systolic blood pressure among men who received intervention dropped an average of 27 mm Hg, compared with 9 mm Hg in controls.
Study details: The data come from a cluster randomized trial including 319 black men who visited 52 barbershops.
Disclosures: The study was funded by the National Heart, Lung, and Blood Institute and others.
Source: Victor R et al. ACC 2018.
VIDEO: Dabigatran effective for myocardial injury after noncardiac surgery
ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.
“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.
Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.
The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.
Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.
The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.
After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.
MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.
SOURCE: Devereaux P et al. ACC 18.
Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.
Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.
Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.
Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.
Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.
Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.
ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.
“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.
Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.
The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.
Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.
The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.
After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.
MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.
SOURCE: Devereaux P et al. ACC 18.
ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.
“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.
Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.
The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.
Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.
The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.
After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.
MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.
SOURCE: Devereaux P et al. ACC 18.
REPORTING FROM ACC 18
Key clinical point: Dabigatran is the first intervention proven to benefit patients with MINS.
Major finding: Major vascular complications occurred in 11% of patients on dabigatran and 15% on placebo.
Study details: MANAGE, a multicenter, randomized trial with 1,754 patients.
Disclosures: MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.
Source: Devereaux P et al. ACC 18.
CECCY: Carvedilol didn’t curb cardiotoxicity in breast cancer patients
ORLANDO – Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.
“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.
In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.
Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.
However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.
“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.
Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.
“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.
Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.
The findings were published simultaneously in the Journal of the American College of Cardiology.
SOURCE: Avila, M. ACC 18
ORLANDO – Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.
“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.
In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.
Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.
However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.
“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.
Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.
“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.
Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.
The findings were published simultaneously in the Journal of the American College of Cardiology.
SOURCE: Avila, M. ACC 18
ORLANDO – Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.
“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.
In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.
Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.
However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.
“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.
Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.
“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.
Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.
The findings were published simultaneously in the Journal of the American College of Cardiology.
SOURCE: Avila, M. ACC 18
REPORTING FROM ACC 18
Key clinical point:
Major finding: Cardiotoxicity was roughly 14% in breast cancer patients treated with anthracycline whether they received carvedilol or placebo.
Study details: CECCY was a randomized, placebo-controlled trial of 200 patients with HER2-negative breast cancer tumor status.
Disclosures: Dr. Avila had no financial conflicts to disclose.
Source: Avila M. ACC 2018.
ODYSSEY Outcomes results build on FOURIER
ORLANDO – , but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.
That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.
However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.
Source: Deedwania P ACC 18.
ORLANDO – , but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.
That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.
However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.
Source: Deedwania P ACC 18.
ORLANDO – , but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.
That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.
However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.
Source: Deedwania P ACC 18.
REPORTING FROM acc 18
VEST: Closer tailoring might boost wearable cardioverter defibrillator’s benefit
ORLANDO – , the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.
The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.
The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.
VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
Source: Olgin J and Lakkireddy D ACC 18.
ORLANDO – , the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.
The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.
The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.
VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
Source: Olgin J and Lakkireddy D ACC 18.
ORLANDO – , the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.
The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.
The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.
VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
Source: Olgin J and Lakkireddy D ACC 18.
EXPERT ANALYSIS FROM ACC 18
Post-ACS death lowered in ODYSSEY Outcomes
ORLANDO – should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.
The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.
“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.
SOURCE: Steg G ACC 18.
ORLANDO – should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.
The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.
“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.
SOURCE: Steg G ACC 18.
ORLANDO – should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.
The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.
“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.
SOURCE: Steg G ACC 18.
REPORTING FROM ACC 18
VIDEO: Device-based therapy for onychomycosis
REPORTING FROM AAD 18
SAN DIEGO – which has been studied in two clinical trials and case series, Shari Lipner, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she presented on this topic.
“Something that we’re looking at is plasma treatment of onychomycosis basically using ionized gas,” which has been shown to inhibit the growth of Trichophyton rubrum in vitro, added Dr. Lipner of the department of dermatology, Cornell University, New York.
In a pilot study of 19 patients with onychomycosis, she and her associates found that the clinical cure with nonthermal plasma was about 50% and the mycological cure rate was 15%, “and we’re now trying to improve efficacy using this device,” she said (Clin Exp Dermatol. 2017 Apr;42[3]:295-8). With a dielectric insulator, “nonthermal plasma is created by short pulses (about 10 ns) of strong (about 20 kV/mm peak) electric field that ionizes air molecules, creating ions and electrons, as well as ozone, hydroxyl radicals and nitric oxide,” according to the description in the study.
Other device-based therapies include iontophoresis, using electrical currents to increase drug delivery, and creating small punch biopsies or using a device to create “microholes” in the nails to increase delivery of topical medication across the nail, Dr. Lipner said.
Patients often ask about another device-based treatment, laser therapy, which she pointed out is not approved by the Food and Drug Administration for cure, but for a temporary increase in clear nail in patients with onychomycosis, “very different” than the criteria used for topical and systemic medications, making it difficult to compare efficacy data between lasers and medications, she noted.
Dr. Lipner reported receiving grants/research funding from MOE Medical Devices.
REPORTING FROM AAD 18
SAN DIEGO – which has been studied in two clinical trials and case series, Shari Lipner, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she presented on this topic.
“Something that we’re looking at is plasma treatment of onychomycosis basically using ionized gas,” which has been shown to inhibit the growth of Trichophyton rubrum in vitro, added Dr. Lipner of the department of dermatology, Cornell University, New York.
In a pilot study of 19 patients with onychomycosis, she and her associates found that the clinical cure with nonthermal plasma was about 50% and the mycological cure rate was 15%, “and we’re now trying to improve efficacy using this device,” she said (Clin Exp Dermatol. 2017 Apr;42[3]:295-8). With a dielectric insulator, “nonthermal plasma is created by short pulses (about 10 ns) of strong (about 20 kV/mm peak) electric field that ionizes air molecules, creating ions and electrons, as well as ozone, hydroxyl radicals and nitric oxide,” according to the description in the study.
Other device-based therapies include iontophoresis, using electrical currents to increase drug delivery, and creating small punch biopsies or using a device to create “microholes” in the nails to increase delivery of topical medication across the nail, Dr. Lipner said.
Patients often ask about another device-based treatment, laser therapy, which she pointed out is not approved by the Food and Drug Administration for cure, but for a temporary increase in clear nail in patients with onychomycosis, “very different” than the criteria used for topical and systemic medications, making it difficult to compare efficacy data between lasers and medications, she noted.
Dr. Lipner reported receiving grants/research funding from MOE Medical Devices.
REPORTING FROM AAD 18
SAN DIEGO – which has been studied in two clinical trials and case series, Shari Lipner, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she presented on this topic.
“Something that we’re looking at is plasma treatment of onychomycosis basically using ionized gas,” which has been shown to inhibit the growth of Trichophyton rubrum in vitro, added Dr. Lipner of the department of dermatology, Cornell University, New York.
In a pilot study of 19 patients with onychomycosis, she and her associates found that the clinical cure with nonthermal plasma was about 50% and the mycological cure rate was 15%, “and we’re now trying to improve efficacy using this device,” she said (Clin Exp Dermatol. 2017 Apr;42[3]:295-8). With a dielectric insulator, “nonthermal plasma is created by short pulses (about 10 ns) of strong (about 20 kV/mm peak) electric field that ionizes air molecules, creating ions and electrons, as well as ozone, hydroxyl radicals and nitric oxide,” according to the description in the study.
Other device-based therapies include iontophoresis, using electrical currents to increase drug delivery, and creating small punch biopsies or using a device to create “microholes” in the nails to increase delivery of topical medication across the nail, Dr. Lipner said.
Patients often ask about another device-based treatment, laser therapy, which she pointed out is not approved by the Food and Drug Administration for cure, but for a temporary increase in clear nail in patients with onychomycosis, “very different” than the criteria used for topical and systemic medications, making it difficult to compare efficacy data between lasers and medications, she noted.
Dr. Lipner reported receiving grants/research funding from MOE Medical Devices.
Ketamine for mood disorders?
VIDEO: Model supports endoscopic resection for some T1b esophageal adenocarcinomas
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: A Markov model supports endoscopic resection for some T1b esophageal adenocarcinomas.
Major finding: Endoscopic resection was preferred in T1b patients who were more than 80 years old or had a Charlson comorbidity index of 1or 2.
Data source: A Markov model with Surveillance, Epidemiology, and End Results (SEER) Medicare mortality data and published cost data converted to 2017 U.S. dollars based on the national Consumer Price Index.
Disclosures: The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
Source: Chu JN et al. Clin Gastroenterol Hepatol .2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
