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Revascularization in paraplegics best performed with PCI
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: Major adverse cardiovascular events at 30 days were lower after PCI than coronary artery bypass grafting (6% vs. 22%).
Data source: A nonrandomized retrospective analysis.
Disclosures: Dr. Dai reported no financial relationships to disclose. Source: Dai X. CRT 2018.
Buy the IBD, get the comorbidity for free
Chronic conditions, such as arthritis and respiratory disease, are significantly more common in adults with inflammatory bowel disease than in those without IBD, according to the Centers for Disease Control and Prevention.
The age-adjusted prevalence of arthritis in adults with IBD is 36.3%, compared with 21.1% for those without IBD, and the prevalence of respiratory disease is 27.3% for IBD patients and 16.6% for non-IBD patients, CDC investigators reported in the Morbidity and Mortality Weekly Report.
Other comorbid chronic conditions with a significantly higher prevalence in patients with IBD than in those without were ulcer (26% vs. 5.5%), cardiovascular disease (19.2% vs. 12%), and cancer (13.7% vs. 8.1%), said Fang Xu, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion and associates.
Serious psychological distress in the past 30 days was significantly more prevalent in adults with IBD (7.4%) than in those without it (3.4%), and those with IBD were also significantly more likely to report averaging less than 7 hours of sleep than were those without IBD (38.2% vs. 32.2%), according to their analysis of the 2015 and 2016 National Health Interview Surveys.
“Given the disease’s complexity and the effects of chronic conditions and symptoms, optimal IBD care might require a multidisciplinary approach that includes gastroenterologists, preventive medicine specialists, and other medical practitioners,” the investigators wrote.
SOURCE: Xu F et al. MMWR. 2018 Feb 16;67(6);190-5.
Chronic conditions, such as arthritis and respiratory disease, are significantly more common in adults with inflammatory bowel disease than in those without IBD, according to the Centers for Disease Control and Prevention.
The age-adjusted prevalence of arthritis in adults with IBD is 36.3%, compared with 21.1% for those without IBD, and the prevalence of respiratory disease is 27.3% for IBD patients and 16.6% for non-IBD patients, CDC investigators reported in the Morbidity and Mortality Weekly Report.
Other comorbid chronic conditions with a significantly higher prevalence in patients with IBD than in those without were ulcer (26% vs. 5.5%), cardiovascular disease (19.2% vs. 12%), and cancer (13.7% vs. 8.1%), said Fang Xu, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion and associates.
Serious psychological distress in the past 30 days was significantly more prevalent in adults with IBD (7.4%) than in those without it (3.4%), and those with IBD were also significantly more likely to report averaging less than 7 hours of sleep than were those without IBD (38.2% vs. 32.2%), according to their analysis of the 2015 and 2016 National Health Interview Surveys.
“Given the disease’s complexity and the effects of chronic conditions and symptoms, optimal IBD care might require a multidisciplinary approach that includes gastroenterologists, preventive medicine specialists, and other medical practitioners,” the investigators wrote.
SOURCE: Xu F et al. MMWR. 2018 Feb 16;67(6);190-5.
Chronic conditions, such as arthritis and respiratory disease, are significantly more common in adults with inflammatory bowel disease than in those without IBD, according to the Centers for Disease Control and Prevention.
The age-adjusted prevalence of arthritis in adults with IBD is 36.3%, compared with 21.1% for those without IBD, and the prevalence of respiratory disease is 27.3% for IBD patients and 16.6% for non-IBD patients, CDC investigators reported in the Morbidity and Mortality Weekly Report.
Other comorbid chronic conditions with a significantly higher prevalence in patients with IBD than in those without were ulcer (26% vs. 5.5%), cardiovascular disease (19.2% vs. 12%), and cancer (13.7% vs. 8.1%), said Fang Xu, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion and associates.
Serious psychological distress in the past 30 days was significantly more prevalent in adults with IBD (7.4%) than in those without it (3.4%), and those with IBD were also significantly more likely to report averaging less than 7 hours of sleep than were those without IBD (38.2% vs. 32.2%), according to their analysis of the 2015 and 2016 National Health Interview Surveys.
“Given the disease’s complexity and the effects of chronic conditions and symptoms, optimal IBD care might require a multidisciplinary approach that includes gastroenterologists, preventive medicine specialists, and other medical practitioners,” the investigators wrote.
SOURCE: Xu F et al. MMWR. 2018 Feb 16;67(6);190-5.
FROM MMWR
Death rate steady with pediatric early warning system
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
REPORTING FROM CCC47
Key clinical point: Use of a pediatric early warning system (BedsidePEWS) did not reduce rates of all-cause hospital mortality among hospitalized children, compared with usual care, but did reduce rates of significant clinical deterioration events.
Major finding: For hospitals implementing BedsidePEWS, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 at hospitals with usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96).
Study details: A multicenter cluster randomized trial of 144,539 patient discharges from 21 hospitals in seven countries providing pediatric care.
Disclosures: The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
Source: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
Opioid prescriptions got shorter in 2017
Use of opioids was down among enrollees of all types of payers in 2017, while the use of drugs to treat opioid dependence went up for three of the four payer categories, according to pharmacy benefits manager Express Scripts.
The days’ worth of opioids dispensed per person per year was down 16.6% from 2016 to 2017 for enrollees with plans on the health exchanges received managed by Express Scripts. Medicaid patients received 16% fewer days’ worth, patients with commercial plans received 10.3% fewer days’ worth, and Medicare patients received 4.9% fewer days’ worth, Express Scripts said in its 2017 Drug Trend Report, which was based on data for 34.3 million members of pharmacy benefits plans the company administers.
Plans that participated in Express Scripts’ Advanced Opioid Management solution, which was launched in September, experienced “a 60% reduction in the average days’ supply per initial fill, from 18.6 days to just 7.5 days,” according to the report.
Use of opioids was down among enrollees of all types of payers in 2017, while the use of drugs to treat opioid dependence went up for three of the four payer categories, according to pharmacy benefits manager Express Scripts.
The days’ worth of opioids dispensed per person per year was down 16.6% from 2016 to 2017 for enrollees with plans on the health exchanges received managed by Express Scripts. Medicaid patients received 16% fewer days’ worth, patients with commercial plans received 10.3% fewer days’ worth, and Medicare patients received 4.9% fewer days’ worth, Express Scripts said in its 2017 Drug Trend Report, which was based on data for 34.3 million members of pharmacy benefits plans the company administers.
Plans that participated in Express Scripts’ Advanced Opioid Management solution, which was launched in September, experienced “a 60% reduction in the average days’ supply per initial fill, from 18.6 days to just 7.5 days,” according to the report.
Use of opioids was down among enrollees of all types of payers in 2017, while the use of drugs to treat opioid dependence went up for three of the four payer categories, according to pharmacy benefits manager Express Scripts.
The days’ worth of opioids dispensed per person per year was down 16.6% from 2016 to 2017 for enrollees with plans on the health exchanges received managed by Express Scripts. Medicaid patients received 16% fewer days’ worth, patients with commercial plans received 10.3% fewer days’ worth, and Medicare patients received 4.9% fewer days’ worth, Express Scripts said in its 2017 Drug Trend Report, which was based on data for 34.3 million members of pharmacy benefits plans the company administers.
Plans that participated in Express Scripts’ Advanced Opioid Management solution, which was launched in September, experienced “a 60% reduction in the average days’ supply per initial fill, from 18.6 days to just 7.5 days,” according to the report.
Hemophilia A treatment gains approval in Europe
The European Commission has approved emicizumab for routine prophylaxis of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to emicizumab (Hemlibra) in January 2018 and it was approved by the Food and Drug Administration in November 2017.
The approvals are based on findings from the HAVEN 1 trial (in 109 adults and adolescents) and the HAVEN 2 trial (in children younger than age 12 years), according to the drug’s maker, Roche. In HAVEN 1 (NCT02622321), emicizumab showed a significant reduction in treatment bleeds (87%), compared with no prophylaxis. And the drug reduced treated bleeds by 79%, compared with previous treatment with bypassing agent prophylaxis. An interim analysis of HAVEN 2 (NCT02795767) of 23 children, showed that 87% of children who received emicizumab prophylaxis had zero treated bleeds, according to Roche.
The European Commission has approved emicizumab for routine prophylaxis of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to emicizumab (Hemlibra) in January 2018 and it was approved by the Food and Drug Administration in November 2017.
The approvals are based on findings from the HAVEN 1 trial (in 109 adults and adolescents) and the HAVEN 2 trial (in children younger than age 12 years), according to the drug’s maker, Roche. In HAVEN 1 (NCT02622321), emicizumab showed a significant reduction in treatment bleeds (87%), compared with no prophylaxis. And the drug reduced treated bleeds by 79%, compared with previous treatment with bypassing agent prophylaxis. An interim analysis of HAVEN 2 (NCT02795767) of 23 children, showed that 87% of children who received emicizumab prophylaxis had zero treated bleeds, according to Roche.
The European Commission has approved emicizumab for routine prophylaxis of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to emicizumab (Hemlibra) in January 2018 and it was approved by the Food and Drug Administration in November 2017.
The approvals are based on findings from the HAVEN 1 trial (in 109 adults and adolescents) and the HAVEN 2 trial (in children younger than age 12 years), according to the drug’s maker, Roche. In HAVEN 1 (NCT02622321), emicizumab showed a significant reduction in treatment bleeds (87%), compared with no prophylaxis. And the drug reduced treated bleeds by 79%, compared with previous treatment with bypassing agent prophylaxis. An interim analysis of HAVEN 2 (NCT02795767) of 23 children, showed that 87% of children who received emicizumab prophylaxis had zero treated bleeds, according to Roche.
Finding a groove helps patients move
Listening to uptempo music significantly improved patients’ compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.
Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.
The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).
Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.
In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.
More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.
Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.
Dr. Shami had no relevant financial conflicts to disclose.
Listening to uptempo music significantly improved patients’ compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.
Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.
The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).
Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.
In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.
More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.
Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.
Dr. Shami had no relevant financial conflicts to disclose.
Listening to uptempo music significantly improved patients’ compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.
Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.
The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).
Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.
In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.
More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.
Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.
Dr. Shami had no relevant financial conflicts to disclose.
FROM ACC 18
ACC Day 3: Finishing strong in Late-Breaking Clinical Trial Sessions
On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.
Blood Pressure Reductions in Black Barbershops
In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.
“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.
ANNEXA 4
An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.
ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.
The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.
On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.
Blood Pressure Reductions in Black Barbershops
In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.
“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.
ANNEXA 4
An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.
ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.
The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.
On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.
Blood Pressure Reductions in Black Barbershops
In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.
“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.
ANNEXA 4
An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.
ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.
The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.
Heart attacks soar in young IBD patients
Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.
The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.
“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.
Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.
The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).
In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.
The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.
The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.
“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.
Dr. Panhwar had no relevant financial conflicts to disclose.
SOURCE: Panhwar M. ACC 18.
Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.
The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.
“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.
Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.
The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).
In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.
The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.
The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.
“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.
Dr. Panhwar had no relevant financial conflicts to disclose.
SOURCE: Panhwar M. ACC 18.
Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.
The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.
“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.
Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.
The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).
In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.
The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.
The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.
“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.
Dr. Panhwar had no relevant financial conflicts to disclose.
SOURCE: Panhwar M. ACC 18.
FROM ACC 18
Key clinical point:
Major finding: The relative risk of MI was roughly twice as high in IBD patients compared with controls without IBD (5.9% vs. 3.5%).
Study details: Review of a nationwide medical records database of 17.5 million adults aged 18-65 years.
Disclosures: Dr. Panhwar had no relevant financial conflicts to disclose.
Source: Panhwar M. 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.
Strategies to reduce colorectal surgery complications
LAS VEGAS – Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Prehabilitation
The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.
Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
Frailty
Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).
Hemoglobin A1c
Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.
Smoking cessation
Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.
Anastomotic leak
Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).
Venous thromboembolic events
Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.
Timing
One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.
Postop ambulation
Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.
Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Prehabilitation
The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.
Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
Frailty
Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).
Hemoglobin A1c
Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.
Smoking cessation
Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.
Anastomotic leak
Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).
Venous thromboembolic events
Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.
Timing
One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.
Postop ambulation
Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.
Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Prehabilitation
The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.
Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
Frailty
Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).
Hemoglobin A1c
Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.
Smoking cessation
Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.
Anastomotic leak
Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).
Venous thromboembolic events
Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.
Timing
One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.
Postop ambulation
Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.
Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM MISS
