ACS Surgery News

More than 18% of smokers who were inpatients at a large urban teaching hospital reported that they smoked during their stay, even though smoking was prohibited in the hospital buildings, according to a report published online Nov. 5 in the Archives of Internal Medicine.

Receiving nicotine replacement therapy at admission delayed but did not prevent these patients from smoking eventually, said Susan Regan, Ph.D., of the tobacco research and treatment center at Massachusetts General Hospital, Boston, and her associates.

©kutay tanir/iStockphoto.com

Virtually all hospitals now prohibit smoking indoors, but many allow patients, as well as staff, to smoke outdoors on the hospital grounds. "The fact that patients may go outside to smoke, especially without supervision or in inclement weather, raises safety concerns," the investigators said.

It also may compromise quality of care and hospital efficiency if patients aren’t available for assessments or treatments because they’re outside smoking. And smoking during a hospitalization can delay recovery and impair wound healing. In addition, inpatients who duck outside to smoke "deprive themselves of an opportunity to initiate a quit attempt in a supportive, smoke-free environment," Dr. Regan and her colleagues said.

They studied inpatient smoking during a 3-year period at the hospital, where smoking is banned indoors and outdoors except for two outdoor shelters. The study subjects were 2,185 adult inpatients who were automatically referred to the facility’s tobacco treatment service at admission, which facilitated the ordering of nicotine replacement therapy and provided a bedside counselor to assist in managing nicotine withdrawal.

The counselor also gave brief (5 minutes or less) advice on quitting smoking, as well as longer (20 minutes) cessation counseling for patients who expressed interest in quitting. The counseling included motivational interviewing, plus discussion of behavioral strategies and the use of medications to maintain smoking abstinence.

Patients’ in-hospital smoking was assessed by self-report during their hospital stays and telephone follow-up in the 2 weeks after discharge. Median length of stay was 5 days, and 62% of the subjects received nicotine replacement therapy; one-third received the therapy on the first day of their stay. The mean patient age was 53 years, and 58% of the study subjects were men.

Overall, 18.4% of these patients reported that they smoked at some time during their hospital stay. Patients were more likely to report such smoking if they were younger, had longer hospitalizations, and had no plans to quit.

Patients who received nicotine replacement therapy on admission were less likely to smoke early in their hospital stay, but they resumed smoking later on in their stay at the same rate as did patients who never received the treatment. "Patients with longer stays might require increasing nicotine dose or supplementation of patch with shorter-acting forms of nicotine replacement therapy" such as nicotine gum or lozenges, the investigators said (Arch. Intern. Med. 2012 [doi:10.1001/2013.jamainternmend.300]).

The number of cigarettes that subjects typically smoked was not as predictive of smoking during hospitalization as was the intensity of their cigarette cravings.

"It may be difficult to predict the intensity of cravings during an admission from preadmission smoking level, due to individual variability in response to illness and the hospital environment. Routine ongoing assessment of cigarette craving, although more time-consuming, might be a more effective means of identifying patients who will have difficulty remaining abstinent during their hospital stay and assist in titrating nicotine dose for patients already receiving nicotine replacement therapy," Dr. Regan and her associates said.

Patients hospitalized during the winter months were less likely to smoke (14.4%) than were those hospitalized during the other seasons (19.7%). This is probably because of the severity of Boston’s winters, but it also may be related to a seasonal difference in case mix, researchers said. This study did not assess discharge diagnoses, so the latter possibility couldn’t be examined, they noted.

This study was limited in that it relied on patient self-report and subjects may have been reluctant to disclose their smoking or may not have remembered it accurately. In addition, the study was restricted to patients who received counseling from the hospital’s tobacco treatment service and who responded to telephone follow-up, which likely introduced a response bias to the data.

This study was supported by the National Heart, Lung, and Blood Institute. Dr. Regan reported no financial conflicts of interest, but one of her associates reported ties to Nabi Biopharmaceuticals, Pfizer, and Alere Wellbeing.

More than 18% of smokers who were inpatients at a large urban teaching hospital reported that they smoked during their stay, even though smoking was prohibited in the hospital buildings, according to a report published online Nov. 5 in the Archives of Internal Medicine.

Receiving nicotine replacement therapy at admission delayed but did not prevent these patients from smoking eventually, said Susan Regan, Ph.D., of the tobacco research and treatment center at Massachusetts General Hospital, Boston, and her associates.

©kutay tanir/iStockphoto.com

Virtually all hospitals now prohibit smoking indoors, but many allow patients, as well as staff, to smoke outdoors on the hospital grounds. "The fact that patients may go outside to smoke, especially without supervision or in inclement weather, raises safety concerns," the investigators said.

It also may compromise quality of care and hospital efficiency if patients aren’t available for assessments or treatments because they’re outside smoking. And smoking during a hospitalization can delay recovery and impair wound healing. In addition, inpatients who duck outside to smoke "deprive themselves of an opportunity to initiate a quit attempt in a supportive, smoke-free environment," Dr. Regan and her colleagues said.

They studied inpatient smoking during a 3-year period at the hospital, where smoking is banned indoors and outdoors except for two outdoor shelters. The study subjects were 2,185 adult inpatients who were automatically referred to the facility’s tobacco treatment service at admission, which facilitated the ordering of nicotine replacement therapy and provided a bedside counselor to assist in managing nicotine withdrawal.

The counselor also gave brief (5 minutes or less) advice on quitting smoking, as well as longer (20 minutes) cessation counseling for patients who expressed interest in quitting. The counseling included motivational interviewing, plus discussion of behavioral strategies and the use of medications to maintain smoking abstinence.

Patients’ in-hospital smoking was assessed by self-report during their hospital stays and telephone follow-up in the 2 weeks after discharge. Median length of stay was 5 days, and 62% of the subjects received nicotine replacement therapy; one-third received the therapy on the first day of their stay. The mean patient age was 53 years, and 58% of the study subjects were men.

Overall, 18.4% of these patients reported that they smoked at some time during their hospital stay. Patients were more likely to report such smoking if they were younger, had longer hospitalizations, and had no plans to quit.

Patients who received nicotine replacement therapy on admission were less likely to smoke early in their hospital stay, but they resumed smoking later on in their stay at the same rate as did patients who never received the treatment. "Patients with longer stays might require increasing nicotine dose or supplementation of patch with shorter-acting forms of nicotine replacement therapy" such as nicotine gum or lozenges, the investigators said (Arch. Intern. Med. 2012 [doi:10.1001/2013.jamainternmend.300]).

The number of cigarettes that subjects typically smoked was not as predictive of smoking during hospitalization as was the intensity of their cigarette cravings.

"It may be difficult to predict the intensity of cravings during an admission from preadmission smoking level, due to individual variability in response to illness and the hospital environment. Routine ongoing assessment of cigarette craving, although more time-consuming, might be a more effective means of identifying patients who will have difficulty remaining abstinent during their hospital stay and assist in titrating nicotine dose for patients already receiving nicotine replacement therapy," Dr. Regan and her associates said.

Patients hospitalized during the winter months were less likely to smoke (14.4%) than were those hospitalized during the other seasons (19.7%). This is probably because of the severity of Boston’s winters, but it also may be related to a seasonal difference in case mix, researchers said. This study did not assess discharge diagnoses, so the latter possibility couldn’t be examined, they noted.

This study was limited in that it relied on patient self-report and subjects may have been reluctant to disclose their smoking or may not have remembered it accurately. In addition, the study was restricted to patients who received counseling from the hospital’s tobacco treatment service and who responded to telephone follow-up, which likely introduced a response bias to the data.

This study was supported by the National Heart, Lung, and Blood Institute. Dr. Regan reported no financial conflicts of interest, but one of her associates reported ties to Nabi Biopharmaceuticals, Pfizer, and Alere Wellbeing.

More than 18% of smokers who were inpatients at a large urban teaching hospital reported that they smoked during their stay, even though smoking was prohibited in the hospital buildings, according to a report published online Nov. 5 in the Archives of Internal Medicine.

Receiving nicotine replacement therapy at admission delayed but did not prevent these patients from smoking eventually, said Susan Regan, Ph.D., of the tobacco research and treatment center at Massachusetts General Hospital, Boston, and her associates.

©kutay tanir/iStockphoto.com

Virtually all hospitals now prohibit smoking indoors, but many allow patients, as well as staff, to smoke outdoors on the hospital grounds. "The fact that patients may go outside to smoke, especially without supervision or in inclement weather, raises safety concerns," the investigators said.

It also may compromise quality of care and hospital efficiency if patients aren’t available for assessments or treatments because they’re outside smoking. And smoking during a hospitalization can delay recovery and impair wound healing. In addition, inpatients who duck outside to smoke "deprive themselves of an opportunity to initiate a quit attempt in a supportive, smoke-free environment," Dr. Regan and her colleagues said.

They studied inpatient smoking during a 3-year period at the hospital, where smoking is banned indoors and outdoors except for two outdoor shelters. The study subjects were 2,185 adult inpatients who were automatically referred to the facility’s tobacco treatment service at admission, which facilitated the ordering of nicotine replacement therapy and provided a bedside counselor to assist in managing nicotine withdrawal.

The counselor also gave brief (5 minutes or less) advice on quitting smoking, as well as longer (20 minutes) cessation counseling for patients who expressed interest in quitting. The counseling included motivational interviewing, plus discussion of behavioral strategies and the use of medications to maintain smoking abstinence.

Patients’ in-hospital smoking was assessed by self-report during their hospital stays and telephone follow-up in the 2 weeks after discharge. Median length of stay was 5 days, and 62% of the subjects received nicotine replacement therapy; one-third received the therapy on the first day of their stay. The mean patient age was 53 years, and 58% of the study subjects were men.

Overall, 18.4% of these patients reported that they smoked at some time during their hospital stay. Patients were more likely to report such smoking if they were younger, had longer hospitalizations, and had no plans to quit.

Patients who received nicotine replacement therapy on admission were less likely to smoke early in their hospital stay, but they resumed smoking later on in their stay at the same rate as did patients who never received the treatment. "Patients with longer stays might require increasing nicotine dose or supplementation of patch with shorter-acting forms of nicotine replacement therapy" such as nicotine gum or lozenges, the investigators said (Arch. Intern. Med. 2012 [doi:10.1001/2013.jamainternmend.300]).

The number of cigarettes that subjects typically smoked was not as predictive of smoking during hospitalization as was the intensity of their cigarette cravings.

"It may be difficult to predict the intensity of cravings during an admission from preadmission smoking level, due to individual variability in response to illness and the hospital environment. Routine ongoing assessment of cigarette craving, although more time-consuming, might be a more effective means of identifying patients who will have difficulty remaining abstinent during their hospital stay and assist in titrating nicotine dose for patients already receiving nicotine replacement therapy," Dr. Regan and her associates said.

Patients hospitalized during the winter months were less likely to smoke (14.4%) than were those hospitalized during the other seasons (19.7%). This is probably because of the severity of Boston’s winters, but it also may be related to a seasonal difference in case mix, researchers said. This study did not assess discharge diagnoses, so the latter possibility couldn’t be examined, they noted.

This study was limited in that it relied on patient self-report and subjects may have been reluctant to disclose their smoking or may not have remembered it accurately. In addition, the study was restricted to patients who received counseling from the hospital’s tobacco treatment service and who responded to telephone follow-up, which likely introduced a response bias to the data.

This study was supported by the National Heart, Lung, and Blood Institute. Dr. Regan reported no financial conflicts of interest, but one of her associates reported ties to Nabi Biopharmaceuticals, Pfizer, and Alere Wellbeing.

Perioperative supplementation with fish oil–derived fatty acids did not prevent postoperative atrial fibrillation in patients undergoing cardiac surgery, according to results from a large, randomized controlled trial.

Atrial fibrillation (AF) affects approximately one-third of patients who undergo cardiac surgery. Animal studies have suggested that the long-chain n-3-polyunsaturated fatty acids (PUFAs) found in fish oil have antiarrhythmic activity, and clinical trials have shown that habitual consumption of fish oil favorably affects physiological pathways that influence AF as well as overall cardiac mortality risk (J. Am. Coll. Cardiol. 2011;58:2047-67).

The new study, published online Nov. 5 in JAMA (doi:10.1001/jama.2012.28733) and presented simultaneously at the annual scientific sessions of the American Heart Association, demonstrated that fish oil supplementation beginning 2-5 days prior to cardiac surgery and continuing until hospital discharge did not reduce risk of postoperative atrial fibrillation.

©Clayton Hansen/iStockphoto

For their research, Dr. Dariush Mozaffarian of the Harvard School of Public Health, Boston, and Dr. Roberto Marchioli of Consorzio Mario Negri Sud in Santa Maria Imbaro, Italy, and their colleagues randomized to fish oil capsules or placebo 1,516 patients who were scheduled for cardiac surgery at 28 centers in the United States, Italy, and Argentina.

Patients took 10 capsules, each 1-g capsule containing at least 840 mg of n-3-PUFAs, eicosapentaenoic acid (approximately 465 mg) plus docosahexaenoic acid (approximately 375 mg) as ethyl esters (Omacor) or matched placebo (olive oil) over 3-5 days before surgery, followed by two capsules per day until discharge or day 10 post surgery, whichever came first. The subjects’ average age was 64 years; 72% were men. Patients who took fish oil regularly were excluded from the study.

Centers were encouraged to use continuous electrocardiographic monitoring for at least 5 days post surgery. Twelve-lead ECGs were recommended daily and more frequently at the discretion of the treating physicians for symptoms or clinically suspected arrhythmia. Confirmatory rhythm strips or 12-lead ECGs were collected for all postoperative arrhythmias of at least 30 seconds’ duration.

AF episodes lasting 30 seconds or longer occurred after surgery in 233 (30.7%) controls and in 227 (30%) subjects given fish oil (odds ratio, 0.96 [95% confidence interval, 0.77-1.20]; P = .74). The two groups did not differ significantly in the number of AF episodes or the incidence of sustained AF episodes. Also, there was no significant difference in the risk of clinical bleeding, even though more than half of the study patients were also taking aspirin or other anticoagulants, the investigators reported.

Though the investigators hypothesized that they would see stronger efficacy of treatment among patients who consumed less than two servings a week of oily fish or those who had lower (<4%) plasma-PUFA levels at enrollment, no significant differences were found in those subgroups, they wrote.

Patients were identified and assigned to receive fish oil capsules for different durations (ranging from 2 to 5 days) prior to surgery, which could have resulted in the shorter durations being less effective, the investigators acknowledged. Subgroup analyses, however, did not detect significantly greater risk reduction associated with more days of fish oil before surgery.

The researchers noted that current best-practice guidelines for preventing postoperative AF were recommended to all participating surgical centers, "which could have reduced the influence of any additional therapy on risk of postoperative AF." Further, the supplement doses may have been too low to produce a benefit, even though phospholipid n-3-PUFA levels increased by an average of 40% by the time of surgery, "providing novel evidence that even short-term supplementation significantly influences circulating levels," they said.

Because of the known benefits of n-3-PUFAs on cardiovascular risk factors and physiologic pathways, "a more promising strategy may be long-term consumption to reduce the primary incidence of AF among ambulatory elderly adults with hypertension or other risk factors; such an approach should be tested in appropriately designed and powered clinical trials," the investigators wrote in their analysis.

The study was funded with grants from the National Institutes of Health, GlaxoSmithKline, Sigma Tau, and Pronova BioPharma, which also provided the capsules used in the study. None of the investigators declared conflicts of interest.

Perioperative supplementation with fish oil–derived fatty acids did not prevent postoperative atrial fibrillation in patients undergoing cardiac surgery, according to results from a large, randomized controlled trial.

Atrial fibrillation (AF) affects approximately one-third of patients who undergo cardiac surgery. Animal studies have suggested that the long-chain n-3-polyunsaturated fatty acids (PUFAs) found in fish oil have antiarrhythmic activity, and clinical trials have shown that habitual consumption of fish oil favorably affects physiological pathways that influence AF as well as overall cardiac mortality risk (J. Am. Coll. Cardiol. 2011;58:2047-67).

The new study, published online Nov. 5 in JAMA (doi:10.1001/jama.2012.28733) and presented simultaneously at the annual scientific sessions of the American Heart Association, demonstrated that fish oil supplementation beginning 2-5 days prior to cardiac surgery and continuing until hospital discharge did not reduce risk of postoperative atrial fibrillation.

©Clayton Hansen/iStockphoto

For their research, Dr. Dariush Mozaffarian of the Harvard School of Public Health, Boston, and Dr. Roberto Marchioli of Consorzio Mario Negri Sud in Santa Maria Imbaro, Italy, and their colleagues randomized to fish oil capsules or placebo 1,516 patients who were scheduled for cardiac surgery at 28 centers in the United States, Italy, and Argentina.

Patients took 10 capsules, each 1-g capsule containing at least 840 mg of n-3-PUFAs, eicosapentaenoic acid (approximately 465 mg) plus docosahexaenoic acid (approximately 375 mg) as ethyl esters (Omacor) or matched placebo (olive oil) over 3-5 days before surgery, followed by two capsules per day until discharge or day 10 post surgery, whichever came first. The subjects’ average age was 64 years; 72% were men. Patients who took fish oil regularly were excluded from the study.

Centers were encouraged to use continuous electrocardiographic monitoring for at least 5 days post surgery. Twelve-lead ECGs were recommended daily and more frequently at the discretion of the treating physicians for symptoms or clinically suspected arrhythmia. Confirmatory rhythm strips or 12-lead ECGs were collected for all postoperative arrhythmias of at least 30 seconds’ duration.

AF episodes lasting 30 seconds or longer occurred after surgery in 233 (30.7%) controls and in 227 (30%) subjects given fish oil (odds ratio, 0.96 [95% confidence interval, 0.77-1.20]; P = .74). The two groups did not differ significantly in the number of AF episodes or the incidence of sustained AF episodes. Also, there was no significant difference in the risk of clinical bleeding, even though more than half of the study patients were also taking aspirin or other anticoagulants, the investigators reported.

Though the investigators hypothesized that they would see stronger efficacy of treatment among patients who consumed less than two servings a week of oily fish or those who had lower (<4%) plasma-PUFA levels at enrollment, no significant differences were found in those subgroups, they wrote.

Patients were identified and assigned to receive fish oil capsules for different durations (ranging from 2 to 5 days) prior to surgery, which could have resulted in the shorter durations being less effective, the investigators acknowledged. Subgroup analyses, however, did not detect significantly greater risk reduction associated with more days of fish oil before surgery.

The researchers noted that current best-practice guidelines for preventing postoperative AF were recommended to all participating surgical centers, "which could have reduced the influence of any additional therapy on risk of postoperative AF." Further, the supplement doses may have been too low to produce a benefit, even though phospholipid n-3-PUFA levels increased by an average of 40% by the time of surgery, "providing novel evidence that even short-term supplementation significantly influences circulating levels," they said.

Because of the known benefits of n-3-PUFAs on cardiovascular risk factors and physiologic pathways, "a more promising strategy may be long-term consumption to reduce the primary incidence of AF among ambulatory elderly adults with hypertension or other risk factors; such an approach should be tested in appropriately designed and powered clinical trials," the investigators wrote in their analysis.

The study was funded with grants from the National Institutes of Health, GlaxoSmithKline, Sigma Tau, and Pronova BioPharma, which also provided the capsules used in the study. None of the investigators declared conflicts of interest.

Perioperative supplementation with fish oil–derived fatty acids did not prevent postoperative atrial fibrillation in patients undergoing cardiac surgery, according to results from a large, randomized controlled trial.

Atrial fibrillation (AF) affects approximately one-third of patients who undergo cardiac surgery. Animal studies have suggested that the long-chain n-3-polyunsaturated fatty acids (PUFAs) found in fish oil have antiarrhythmic activity, and clinical trials have shown that habitual consumption of fish oil favorably affects physiological pathways that influence AF as well as overall cardiac mortality risk (J. Am. Coll. Cardiol. 2011;58:2047-67).

The new study, published online Nov. 5 in JAMA (doi:10.1001/jama.2012.28733) and presented simultaneously at the annual scientific sessions of the American Heart Association, demonstrated that fish oil supplementation beginning 2-5 days prior to cardiac surgery and continuing until hospital discharge did not reduce risk of postoperative atrial fibrillation.

©Clayton Hansen/iStockphoto

For their research, Dr. Dariush Mozaffarian of the Harvard School of Public Health, Boston, and Dr. Roberto Marchioli of Consorzio Mario Negri Sud in Santa Maria Imbaro, Italy, and their colleagues randomized to fish oil capsules or placebo 1,516 patients who were scheduled for cardiac surgery at 28 centers in the United States, Italy, and Argentina.

Patients took 10 capsules, each 1-g capsule containing at least 840 mg of n-3-PUFAs, eicosapentaenoic acid (approximately 465 mg) plus docosahexaenoic acid (approximately 375 mg) as ethyl esters (Omacor) or matched placebo (olive oil) over 3-5 days before surgery, followed by two capsules per day until discharge or day 10 post surgery, whichever came first. The subjects’ average age was 64 years; 72% were men. Patients who took fish oil regularly were excluded from the study.

Centers were encouraged to use continuous electrocardiographic monitoring for at least 5 days post surgery. Twelve-lead ECGs were recommended daily and more frequently at the discretion of the treating physicians for symptoms or clinically suspected arrhythmia. Confirmatory rhythm strips or 12-lead ECGs were collected for all postoperative arrhythmias of at least 30 seconds’ duration.

AF episodes lasting 30 seconds or longer occurred after surgery in 233 (30.7%) controls and in 227 (30%) subjects given fish oil (odds ratio, 0.96 [95% confidence interval, 0.77-1.20]; P = .74). The two groups did not differ significantly in the number of AF episodes or the incidence of sustained AF episodes. Also, there was no significant difference in the risk of clinical bleeding, even though more than half of the study patients were also taking aspirin or other anticoagulants, the investigators reported.

Though the investigators hypothesized that they would see stronger efficacy of treatment among patients who consumed less than two servings a week of oily fish or those who had lower (<4%) plasma-PUFA levels at enrollment, no significant differences were found in those subgroups, they wrote.

Patients were identified and assigned to receive fish oil capsules for different durations (ranging from 2 to 5 days) prior to surgery, which could have resulted in the shorter durations being less effective, the investigators acknowledged. Subgroup analyses, however, did not detect significantly greater risk reduction associated with more days of fish oil before surgery.

The researchers noted that current best-practice guidelines for preventing postoperative AF were recommended to all participating surgical centers, "which could have reduced the influence of any additional therapy on risk of postoperative AF." Further, the supplement doses may have been too low to produce a benefit, even though phospholipid n-3-PUFA levels increased by an average of 40% by the time of surgery, "providing novel evidence that even short-term supplementation significantly influences circulating levels," they said.

Because of the known benefits of n-3-PUFAs on cardiovascular risk factors and physiologic pathways, "a more promising strategy may be long-term consumption to reduce the primary incidence of AF among ambulatory elderly adults with hypertension or other risk factors; such an approach should be tested in appropriately designed and powered clinical trials," the investigators wrote in their analysis.

The study was funded with grants from the National Institutes of Health, GlaxoSmithKline, Sigma Tau, and Pronova BioPharma, which also provided the capsules used in the study. None of the investigators declared conflicts of interest.

Doctors can look forward to getting paid for coordinating care for patients just out of the hospital or nursing home, thanks to new codes in the 2013 Medicare Physician Fee Schedule.

The final fee schedule rule – issued Nov. 1 – also pays certain physicians at the Medicare level for certain services provided under Medicaid. But, there’s a downside too – the final rule calls for a 26.5% cut to their Medicare payment on Jan. 1, unless Congress jumps in to delay or fix the Sustainable Growth Rate formula.

Meanwhile, Election Day will decide the future of health reform – either President Obama will be able to continue implementation of the Affordable Care Act or Governor Romney will have the opportunity to repeal the law on Day 1, as he has vowed.

While the economy remains a high priority for voters, health care is important too, according to a recent tracking poll from the Kaiser Family Foundation. The poll showed that more than 60% of likely voters would prefer Medicare keep its current form, rather than shifting a premium support model.

For that and more, listen to this week’s Policy & Practice Podcast.

--Frances Correa (@fmcreporting)

Doctors can look forward to getting paid for coordinating care for patients just out of the hospital or nursing home, thanks to new codes in the 2013 Medicare Physician Fee Schedule.

The final fee schedule rule – issued Nov. 1 – also pays certain physicians at the Medicare level for certain services provided under Medicaid. But, there’s a downside too – the final rule calls for a 26.5% cut to their Medicare payment on Jan. 1, unless Congress jumps in to delay or fix the Sustainable Growth Rate formula.

Meanwhile, Election Day will decide the future of health reform – either President Obama will be able to continue implementation of the Affordable Care Act or Governor Romney will have the opportunity to repeal the law on Day 1, as he has vowed.

While the economy remains a high priority for voters, health care is important too, according to a recent tracking poll from the Kaiser Family Foundation. The poll showed that more than 60% of likely voters would prefer Medicare keep its current form, rather than shifting a premium support model.

For that and more, listen to this week’s Policy & Practice Podcast.

--Frances Correa (@fmcreporting)

Doctors can look forward to getting paid for coordinating care for patients just out of the hospital or nursing home, thanks to new codes in the 2013 Medicare Physician Fee Schedule.

The final fee schedule rule – issued Nov. 1 – also pays certain physicians at the Medicare level for certain services provided under Medicaid. But, there’s a downside too – the final rule calls for a 26.5% cut to their Medicare payment on Jan. 1, unless Congress jumps in to delay or fix the Sustainable Growth Rate formula.

Meanwhile, Election Day will decide the future of health reform – either President Obama will be able to continue implementation of the Affordable Care Act or Governor Romney will have the opportunity to repeal the law on Day 1, as he has vowed.

While the economy remains a high priority for voters, health care is important too, according to a recent tracking poll from the Kaiser Family Foundation. The poll showed that more than 60% of likely voters would prefer Medicare keep its current form, rather than shifting a premium support model.

For that and more, listen to this week’s Policy & Practice Podcast.

--Frances Correa (@fmcreporting)

LOS ANGELES – Coronary artery bypass graft surgery not only provides better clinical outcomes than percutaneous coronary intervention in diabetic patients with multivessel disease, but it does so in a highly cost-effective manner, according to an economic analysis of the FREEDOM trial.

"The benefits are achieved at an overall cost that represents an attractive use of societal health care resources," Elizabeth A. Magnuson, Sc.D., said at the annual scientific sessions of the American Heart Association.

FREEDOM was a randomized international trial that compared the effectiveness of CABG with percutaneous coronary intervention (PCI) using drug-eluting stents in 1,900 diabetic patients with multivessel coronary artery disease who were candidates for both procedures.

The initial hospitalization for revascularization cost an average of $34,467 in the CABG group, $8,622 more than for PCI-treated patients. But during the next 5 years of follow-up, both repeat revascularizations and mortality were significantly more common in the PCI group.

Based on a conservative model of projected survival that assumed a gradual attenuation of CABG’s clinical benefits over time, bypass surgery was associated with an incremental cost-effectiveness ratio of $8,132 per quality-adjusted year of life (QALY) gained. That’s well below the figure of $50,000 per QALY widely accepted by health policy makers as defining the upper boundary of cost effectiveness, noted Dr. Magnuson, director of health economics and technology assessment at Saint Luke’s Mid-America Heart Institute, Kansas City, Mo.

"Even if we assume no further benefit beyond the trial period and we just captured the life-years lost due to the in-trial death events, we still get very favorable results for CABG, with an incremental cost-effectiveness ratio of roughly $27,000 per QALY," she said.

Discussant Dr. Mark A. Hlatky agreed with Dr. Magnuson that this was a very conservative analysis and said that the actual cost effectiveness of CABG in diabetes patients with multivessel disease might well be even more favorable than she projected.

"The cost-effectiveness results are quite good. This looks like a very economically attractive therapy for patients who have diabetes with multivessel disease," concluded Dr. Hlatky, professor of health research and policy and of cardiovascular medicine at Stanford (Calif.) University.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Magnuson and Dr. Hlatky reported having no relevant financial conflicts.

LOS ANGELES – Coronary artery bypass graft surgery not only provides better clinical outcomes than percutaneous coronary intervention in diabetic patients with multivessel disease, but it does so in a highly cost-effective manner, according to an economic analysis of the FREEDOM trial.

"The benefits are achieved at an overall cost that represents an attractive use of societal health care resources," Elizabeth A. Magnuson, Sc.D., said at the annual scientific sessions of the American Heart Association.

FREEDOM was a randomized international trial that compared the effectiveness of CABG with percutaneous coronary intervention (PCI) using drug-eluting stents in 1,900 diabetic patients with multivessel coronary artery disease who were candidates for both procedures.

The initial hospitalization for revascularization cost an average of $34,467 in the CABG group, $8,622 more than for PCI-treated patients. But during the next 5 years of follow-up, both repeat revascularizations and mortality were significantly more common in the PCI group.

Based on a conservative model of projected survival that assumed a gradual attenuation of CABG’s clinical benefits over time, bypass surgery was associated with an incremental cost-effectiveness ratio of $8,132 per quality-adjusted year of life (QALY) gained. That’s well below the figure of $50,000 per QALY widely accepted by health policy makers as defining the upper boundary of cost effectiveness, noted Dr. Magnuson, director of health economics and technology assessment at Saint Luke’s Mid-America Heart Institute, Kansas City, Mo.

"Even if we assume no further benefit beyond the trial period and we just captured the life-years lost due to the in-trial death events, we still get very favorable results for CABG, with an incremental cost-effectiveness ratio of roughly $27,000 per QALY," she said.

Discussant Dr. Mark A. Hlatky agreed with Dr. Magnuson that this was a very conservative analysis and said that the actual cost effectiveness of CABG in diabetes patients with multivessel disease might well be even more favorable than she projected.

"The cost-effectiveness results are quite good. This looks like a very economically attractive therapy for patients who have diabetes with multivessel disease," concluded Dr. Hlatky, professor of health research and policy and of cardiovascular medicine at Stanford (Calif.) University.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Magnuson and Dr. Hlatky reported having no relevant financial conflicts.

LOS ANGELES – Coronary artery bypass graft surgery not only provides better clinical outcomes than percutaneous coronary intervention in diabetic patients with multivessel disease, but it does so in a highly cost-effective manner, according to an economic analysis of the FREEDOM trial.

"The benefits are achieved at an overall cost that represents an attractive use of societal health care resources," Elizabeth A. Magnuson, Sc.D., said at the annual scientific sessions of the American Heart Association.

FREEDOM was a randomized international trial that compared the effectiveness of CABG with percutaneous coronary intervention (PCI) using drug-eluting stents in 1,900 diabetic patients with multivessel coronary artery disease who were candidates for both procedures.

The initial hospitalization for revascularization cost an average of $34,467 in the CABG group, $8,622 more than for PCI-treated patients. But during the next 5 years of follow-up, both repeat revascularizations and mortality were significantly more common in the PCI group.

Based on a conservative model of projected survival that assumed a gradual attenuation of CABG’s clinical benefits over time, bypass surgery was associated with an incremental cost-effectiveness ratio of $8,132 per quality-adjusted year of life (QALY) gained. That’s well below the figure of $50,000 per QALY widely accepted by health policy makers as defining the upper boundary of cost effectiveness, noted Dr. Magnuson, director of health economics and technology assessment at Saint Luke’s Mid-America Heart Institute, Kansas City, Mo.

"Even if we assume no further benefit beyond the trial period and we just captured the life-years lost due to the in-trial death events, we still get very favorable results for CABG, with an incremental cost-effectiveness ratio of roughly $27,000 per QALY," she said.

Discussant Dr. Mark A. Hlatky agreed with Dr. Magnuson that this was a very conservative analysis and said that the actual cost effectiveness of CABG in diabetes patients with multivessel disease might well be even more favorable than she projected.

"The cost-effectiveness results are quite good. This looks like a very economically attractive therapy for patients who have diabetes with multivessel disease," concluded Dr. Hlatky, professor of health research and policy and of cardiovascular medicine at Stanford (Calif.) University.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Magnuson and Dr. Hlatky reported having no relevant financial conflicts.

DENVER – Look for some big changes ahead in the forthcoming update of the Surviving Sepsis Campaign international guidelines.

In the 4 years since the last version of the guidelines came out, major studies have been released that resolved hot debates regarding sepsis management and in some cases overturned established dogma. At the annual American College of Emergency Physicians (ACEP) meeting, emergency physicians deeply involved in crafting the Surviving Sepsis Campaign 2012 guidelines provided a preview of what’s to come.

Among the areas that will see key new recommendations are antibiotic therapy, fluid resuscitation, vasopressors, and lactate monitoring.

• Antibiotics ASAP. The critical importance of getting empiric antibiotics on board within 6 hours after recognizing that a patient has sepsis has been effectively hammered home over the years. But how fast is fast enough? Several recent small studies have reached conflicting conclusions. Now, however, an 800-lb gorilla of a study has provided a definitive answer.

This study, now in press, involved 14,895 patients enrolled in the Surviving Sepsis Campaign’s worldwide database. All had severe sepsis or septic shock, and all received antibiotics within the first 6 hours, explained Dr. Tiffany M. Osborn, a coauthor of the study and of the forthcoming guidelines.

"This was a big question for us. The results strengthen the importance of getting antibiotics started as soon as possible – within the first hour if possible. We found there’s about a 4% increase in mortality for every hour delay. And it’s cumulative: it’s 4% after the first hour, 8% after the second, 12% after the third, and so on," according to Dr. Osborn of Washington University at St. Louis.

A similar time-dependent increase in mortality was observed in patients with severe sepsis as well as in those in septic shock, she added.

• Fluid resuscitation. The initial fluid of choice for resuscitation in severe sepsis and septic shock remains crystalloids, as before. That’s a grade 1A recommendation. What’s brand new is a recommendation to consider adding albumin in the initial fluid resuscitation (grade 2B). This guidance was heavily influenced by a meta-analysis of 17 studies involving close to 2,000 patients that demonstrated a significant protective effect for the use of albumin as an initial resuscitation fluid (Crit. Care Med. 2011;39:386-91).

At this late date, Dr. Osborn said, the guideline panel is strongly leaning toward a recommendation against the use of low-molecular-weight colloids or starches such as hydroxyethyl starch 130/0.42. That would be ground shaking, as synthetic colloids or starches, particularly those of low molecular weight, are a very popular resuscitation fluid both in the United States and abroad. However, recent studies implicate these fluids in increased risks of 90-day mortality and renal failure, compared with the use of Ringer’s lactate.

"Having said this, there are two other trials currently pending. Any month now the results will come out, and we’ll see where we are at that point. But at this time, we’re thinking stay away from low-molecular-weight starches for resuscitation," Dr. Osborn said.

One of the main reasons the Surviving Sepsis Campaign 2012 guidelines won’t actually be published before January 2013 is the guideline panel’s eagerness to see the results of those two studies, she added.

• Vasopressor therapy. The initial target remains, as before, a mean arterial pressure of at least 65 mm Hg. But while the 2008 guidelines recommended either norepinephrine or dopamine as the first-choice vasopressor to correct hypotension in patients not sufficiently responsive to fluid resuscitation, the new guidelines will state that norepinephrine is the preferred agent (grade 1B). That’s a major change. Dopamine has been essentially kicked to the curb in response to multiple studies in the last 4 years implicating it in an increased incidence of arrhythmias and, in some studies, higher mortality.

The final nail in dopamine’s coffin for use in patients with severe sepsis or septic shock was a recent meta-analysis involving five observational and six interventional studies totaling nearly 2,800 patients (Crit. Care Med. 2012;40:725-30).

"Dopamine has actually fallen by the wayside. By far and away, I’m going to choose norepinephrine as the initial vasopressor agent," declared Dr. Michael E. Winters of the University of Maryland, Baltimore.

The new guidelines will suggest that be reserved for highly selected patients: those at very low arrhythmia risk and with a low cardiac output and/or low heart rate (grade 2C), he noted.

Another change in the new guidelines will be a recommendation that epinephrine be added when an additional agent is needed in order to maintain adequate blood pressure (grade 2B).

• Don’t overdo the fluids. "We want to give patients what they need but not more," Dr. Osborn explained. The 2012 guidelines will recommend that physicians use some sort of fluid challenge test while administering fluid boluses. The goal is to keep giving fluid only so long as hemodynamic improvement is seen in response. This can be achieved in a variety of ways, including monitoring change in pulse pressure, stroke volume variation, heart rate, or arterial pressure.

• Lactate clearance. Serum lactate is recognized as an indicator of global organ hypoperfusion and shock. But incorporating lactate clearance as one of the goals of early sepsis therapy has been "a very hot topic," Dr. Winters observed.

Improved clarity was provided by a prospective 556-patient quality improvement study by investigators in the Asian Network to Regulate Sepsis Care. Patients who got the primary severe sepsis management bundle of care as recommended in the 2008 Surviving Sepsis Campaign guidelines had an unadjusted mortality of 43.6%. This bundle includes early antibiotic administration, hemodynamic monitoring and support, and achievement of a central venous oxygen saturation level greater than 70% by 6 hours. However, patients who got the bundle plus lactate clearance had a 20.5% mortality rate (Crit. Care 2011;15:R229 [doi:10.1186/cc10469]).

The importance of lactate clearance was further underscored by the findings in the GENESIS Project (Generalized Early Sepsis Intervention Strategies). This quality improvement initiative, conducted at five 5 U.S. community hospitals and six tertiary centers, showed a 42.8% mortality in 1,554 historical controls treated for sepsis before implementation of the Surviving Sepsis Campaign resuscitation bundle. In another 4,801 patients who got the bundle, mortality was significantly lower at 28.8%. And, in those who received the bundle plus lactate clearance, mortality further fell to about 22% (J. Intensive Care Med. 2012 [doi:10.1177/0885066612453025]).

Thus, the coming Surviving Sepsis Campaign 2012 guidelines will suggest that in patients with elevated lactate levels as a marker of hypoperfusion, resuscitation should be targeted at normalizing lactate as rapidly as possible (grade 2C). Having said that, however, a normal lactate doesn’t indicate absence of shock. Other factors, such as the patient’s central venous oxygen saturation level, need to be considered as well, the physicians emphasized.

The Surviving Sepsis Campaign guidelines are sponsored by 27 medical organizations. Among them are the Society of Critical Care Medicine, ACEP, the Society of Hospital Medicine, the American College of Chest Physicians, the American Thoracic Society, the Infectious Diseases Society of America, the Surgical Infection Society, the Pediatric Acute Lung Injury and Sepsis Investigators, and a host of international groups.

Dr. Osborn and Dr. Winter reported having no financial conflicts.

DENVER – Look for some big changes ahead in the forthcoming update of the Surviving Sepsis Campaign international guidelines.

In the 4 years since the last version of the guidelines came out, major studies have been released that resolved hot debates regarding sepsis management and in some cases overturned established dogma. At the annual American College of Emergency Physicians (ACEP) meeting, emergency physicians deeply involved in crafting the Surviving Sepsis Campaign 2012 guidelines provided a preview of what’s to come.

Among the areas that will see key new recommendations are antibiotic therapy, fluid resuscitation, vasopressors, and lactate monitoring.

• Antibiotics ASAP. The critical importance of getting empiric antibiotics on board within 6 hours after recognizing that a patient has sepsis has been effectively hammered home over the years. But how fast is fast enough? Several recent small studies have reached conflicting conclusions. Now, however, an 800-lb gorilla of a study has provided a definitive answer.

This study, now in press, involved 14,895 patients enrolled in the Surviving Sepsis Campaign’s worldwide database. All had severe sepsis or septic shock, and all received antibiotics within the first 6 hours, explained Dr. Tiffany M. Osborn, a coauthor of the study and of the forthcoming guidelines.

"This was a big question for us. The results strengthen the importance of getting antibiotics started as soon as possible – within the first hour if possible. We found there’s about a 4% increase in mortality for every hour delay. And it’s cumulative: it’s 4% after the first hour, 8% after the second, 12% after the third, and so on," according to Dr. Osborn of Washington University at St. Louis.

A similar time-dependent increase in mortality was observed in patients with severe sepsis as well as in those in septic shock, she added.

• Fluid resuscitation. The initial fluid of choice for resuscitation in severe sepsis and septic shock remains crystalloids, as before. That’s a grade 1A recommendation. What’s brand new is a recommendation to consider adding albumin in the initial fluid resuscitation (grade 2B). This guidance was heavily influenced by a meta-analysis of 17 studies involving close to 2,000 patients that demonstrated a significant protective effect for the use of albumin as an initial resuscitation fluid (Crit. Care Med. 2011;39:386-91).

At this late date, Dr. Osborn said, the guideline panel is strongly leaning toward a recommendation against the use of low-molecular-weight colloids or starches such as hydroxyethyl starch 130/0.42. That would be ground shaking, as synthetic colloids or starches, particularly those of low molecular weight, are a very popular resuscitation fluid both in the United States and abroad. However, recent studies implicate these fluids in increased risks of 90-day mortality and renal failure, compared with the use of Ringer’s lactate.

"Having said this, there are two other trials currently pending. Any month now the results will come out, and we’ll see where we are at that point. But at this time, we’re thinking stay away from low-molecular-weight starches for resuscitation," Dr. Osborn said.

One of the main reasons the Surviving Sepsis Campaign 2012 guidelines won’t actually be published before January 2013 is the guideline panel’s eagerness to see the results of those two studies, she added.

• Vasopressor therapy. The initial target remains, as before, a mean arterial pressure of at least 65 mm Hg. But while the 2008 guidelines recommended either norepinephrine or dopamine as the first-choice vasopressor to correct hypotension in patients not sufficiently responsive to fluid resuscitation, the new guidelines will state that norepinephrine is the preferred agent (grade 1B). That’s a major change. Dopamine has been essentially kicked to the curb in response to multiple studies in the last 4 years implicating it in an increased incidence of arrhythmias and, in some studies, higher mortality.

The final nail in dopamine’s coffin for use in patients with severe sepsis or septic shock was a recent meta-analysis involving five observational and six interventional studies totaling nearly 2,800 patients (Crit. Care Med. 2012;40:725-30).

"Dopamine has actually fallen by the wayside. By far and away, I’m going to choose norepinephrine as the initial vasopressor agent," declared Dr. Michael E. Winters of the University of Maryland, Baltimore.

The new guidelines will suggest that be reserved for highly selected patients: those at very low arrhythmia risk and with a low cardiac output and/or low heart rate (grade 2C), he noted.

Another change in the new guidelines will be a recommendation that epinephrine be added when an additional agent is needed in order to maintain adequate blood pressure (grade 2B).

• Don’t overdo the fluids. "We want to give patients what they need but not more," Dr. Osborn explained. The 2012 guidelines will recommend that physicians use some sort of fluid challenge test while administering fluid boluses. The goal is to keep giving fluid only so long as hemodynamic improvement is seen in response. This can be achieved in a variety of ways, including monitoring change in pulse pressure, stroke volume variation, heart rate, or arterial pressure.

• Lactate clearance. Serum lactate is recognized as an indicator of global organ hypoperfusion and shock. But incorporating lactate clearance as one of the goals of early sepsis therapy has been "a very hot topic," Dr. Winters observed.

Improved clarity was provided by a prospective 556-patient quality improvement study by investigators in the Asian Network to Regulate Sepsis Care. Patients who got the primary severe sepsis management bundle of care as recommended in the 2008 Surviving Sepsis Campaign guidelines had an unadjusted mortality of 43.6%. This bundle includes early antibiotic administration, hemodynamic monitoring and support, and achievement of a central venous oxygen saturation level greater than 70% by 6 hours. However, patients who got the bundle plus lactate clearance had a 20.5% mortality rate (Crit. Care 2011;15:R229 [doi:10.1186/cc10469]).

The importance of lactate clearance was further underscored by the findings in the GENESIS Project (Generalized Early Sepsis Intervention Strategies). This quality improvement initiative, conducted at five 5 U.S. community hospitals and six tertiary centers, showed a 42.8% mortality in 1,554 historical controls treated for sepsis before implementation of the Surviving Sepsis Campaign resuscitation bundle. In another 4,801 patients who got the bundle, mortality was significantly lower at 28.8%. And, in those who received the bundle plus lactate clearance, mortality further fell to about 22% (J. Intensive Care Med. 2012 [doi:10.1177/0885066612453025]).

Thus, the coming Surviving Sepsis Campaign 2012 guidelines will suggest that in patients with elevated lactate levels as a marker of hypoperfusion, resuscitation should be targeted at normalizing lactate as rapidly as possible (grade 2C). Having said that, however, a normal lactate doesn’t indicate absence of shock. Other factors, such as the patient’s central venous oxygen saturation level, need to be considered as well, the physicians emphasized.

The Surviving Sepsis Campaign guidelines are sponsored by 27 medical organizations. Among them are the Society of Critical Care Medicine, ACEP, the Society of Hospital Medicine, the American College of Chest Physicians, the American Thoracic Society, the Infectious Diseases Society of America, the Surgical Infection Society, the Pediatric Acute Lung Injury and Sepsis Investigators, and a host of international groups.

Dr. Osborn and Dr. Winter reported having no financial conflicts.

DENVER – Look for some big changes ahead in the forthcoming update of the Surviving Sepsis Campaign international guidelines.

In the 4 years since the last version of the guidelines came out, major studies have been released that resolved hot debates regarding sepsis management and in some cases overturned established dogma. At the annual American College of Emergency Physicians (ACEP) meeting, emergency physicians deeply involved in crafting the Surviving Sepsis Campaign 2012 guidelines provided a preview of what’s to come.

Among the areas that will see key new recommendations are antibiotic therapy, fluid resuscitation, vasopressors, and lactate monitoring.

• Antibiotics ASAP. The critical importance of getting empiric antibiotics on board within 6 hours after recognizing that a patient has sepsis has been effectively hammered home over the years. But how fast is fast enough? Several recent small studies have reached conflicting conclusions. Now, however, an 800-lb gorilla of a study has provided a definitive answer.

This study, now in press, involved 14,895 patients enrolled in the Surviving Sepsis Campaign’s worldwide database. All had severe sepsis or septic shock, and all received antibiotics within the first 6 hours, explained Dr. Tiffany M. Osborn, a coauthor of the study and of the forthcoming guidelines.

"This was a big question for us. The results strengthen the importance of getting antibiotics started as soon as possible – within the first hour if possible. We found there’s about a 4% increase in mortality for every hour delay. And it’s cumulative: it’s 4% after the first hour, 8% after the second, 12% after the third, and so on," according to Dr. Osborn of Washington University at St. Louis.

A similar time-dependent increase in mortality was observed in patients with severe sepsis as well as in those in septic shock, she added.

• Fluid resuscitation. The initial fluid of choice for resuscitation in severe sepsis and septic shock remains crystalloids, as before. That’s a grade 1A recommendation. What’s brand new is a recommendation to consider adding albumin in the initial fluid resuscitation (grade 2B). This guidance was heavily influenced by a meta-analysis of 17 studies involving close to 2,000 patients that demonstrated a significant protective effect for the use of albumin as an initial resuscitation fluid (Crit. Care Med. 2011;39:386-91).

At this late date, Dr. Osborn said, the guideline panel is strongly leaning toward a recommendation against the use of low-molecular-weight colloids or starches such as hydroxyethyl starch 130/0.42. That would be ground shaking, as synthetic colloids or starches, particularly those of low molecular weight, are a very popular resuscitation fluid both in the United States and abroad. However, recent studies implicate these fluids in increased risks of 90-day mortality and renal failure, compared with the use of Ringer’s lactate.

"Having said this, there are two other trials currently pending. Any month now the results will come out, and we’ll see where we are at that point. But at this time, we’re thinking stay away from low-molecular-weight starches for resuscitation," Dr. Osborn said.

One of the main reasons the Surviving Sepsis Campaign 2012 guidelines won’t actually be published before January 2013 is the guideline panel’s eagerness to see the results of those two studies, she added.

• Vasopressor therapy. The initial target remains, as before, a mean arterial pressure of at least 65 mm Hg. But while the 2008 guidelines recommended either norepinephrine or dopamine as the first-choice vasopressor to correct hypotension in patients not sufficiently responsive to fluid resuscitation, the new guidelines will state that norepinephrine is the preferred agent (grade 1B). That’s a major change. Dopamine has been essentially kicked to the curb in response to multiple studies in the last 4 years implicating it in an increased incidence of arrhythmias and, in some studies, higher mortality.

The final nail in dopamine’s coffin for use in patients with severe sepsis or septic shock was a recent meta-analysis involving five observational and six interventional studies totaling nearly 2,800 patients (Crit. Care Med. 2012;40:725-30).

"Dopamine has actually fallen by the wayside. By far and away, I’m going to choose norepinephrine as the initial vasopressor agent," declared Dr. Michael E. Winters of the University of Maryland, Baltimore.

The new guidelines will suggest that be reserved for highly selected patients: those at very low arrhythmia risk and with a low cardiac output and/or low heart rate (grade 2C), he noted.

Another change in the new guidelines will be a recommendation that epinephrine be added when an additional agent is needed in order to maintain adequate blood pressure (grade 2B).

• Don’t overdo the fluids. "We want to give patients what they need but not more," Dr. Osborn explained. The 2012 guidelines will recommend that physicians use some sort of fluid challenge test while administering fluid boluses. The goal is to keep giving fluid only so long as hemodynamic improvement is seen in response. This can be achieved in a variety of ways, including monitoring change in pulse pressure, stroke volume variation, heart rate, or arterial pressure.

• Lactate clearance. Serum lactate is recognized as an indicator of global organ hypoperfusion and shock. But incorporating lactate clearance as one of the goals of early sepsis therapy has been "a very hot topic," Dr. Winters observed.

Improved clarity was provided by a prospective 556-patient quality improvement study by investigators in the Asian Network to Regulate Sepsis Care. Patients who got the primary severe sepsis management bundle of care as recommended in the 2008 Surviving Sepsis Campaign guidelines had an unadjusted mortality of 43.6%. This bundle includes early antibiotic administration, hemodynamic monitoring and support, and achievement of a central venous oxygen saturation level greater than 70% by 6 hours. However, patients who got the bundle plus lactate clearance had a 20.5% mortality rate (Crit. Care 2011;15:R229 [doi:10.1186/cc10469]).

The importance of lactate clearance was further underscored by the findings in the GENESIS Project (Generalized Early Sepsis Intervention Strategies). This quality improvement initiative, conducted at five 5 U.S. community hospitals and six tertiary centers, showed a 42.8% mortality in 1,554 historical controls treated for sepsis before implementation of the Surviving Sepsis Campaign resuscitation bundle. In another 4,801 patients who got the bundle, mortality was significantly lower at 28.8%. And, in those who received the bundle plus lactate clearance, mortality further fell to about 22% (J. Intensive Care Med. 2012 [doi:10.1177/0885066612453025]).

Thus, the coming Surviving Sepsis Campaign 2012 guidelines will suggest that in patients with elevated lactate levels as a marker of hypoperfusion, resuscitation should be targeted at normalizing lactate as rapidly as possible (grade 2C). Having said that, however, a normal lactate doesn’t indicate absence of shock. Other factors, such as the patient’s central venous oxygen saturation level, need to be considered as well, the physicians emphasized.

The Surviving Sepsis Campaign guidelines are sponsored by 27 medical organizations. Among them are the Society of Critical Care Medicine, ACEP, the Society of Hospital Medicine, the American College of Chest Physicians, the American Thoracic Society, the Infectious Diseases Society of America, the Surgical Infection Society, the Pediatric Acute Lung Injury and Sepsis Investigators, and a host of international groups.

Dr. Osborn and Dr. Winter reported having no financial conflicts.

SAN FRANCISCO – Interferon-gamma release assay tests appear to be better than tuberculin skin tests for picking up latent TB in solid organ transplant candidates, according to Dr. Shimon Kusne.

It’s not just because of IGRA’s well-known benefits—as a blood test, results are known after one visit so patients don’t need to return for skin spots to be read, and there are no false positives in patients vaccinated against TB or exposed to environmental strains of mycobacterium.

Instead, IGRA tests simply seem to be better at picking up latent TB, Dr. Kusne, professor of medicine in the division of infectious diseases at the Mayo Clinic Hospital in Phoenix, said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

He and his colleagues gave 179 kidney, liver, or heart transplant candidates TB skin prick tests and two IGRA tests, the QuantiFERON-TB Gold In-Tube test (QFT-GIT) and the T-Spot test.

QFT-GIT was 2.74 times more likely to be positive than tuberculin purified protein derivative skin tests and T-Spots were 3.10 times more likely to be positive. The findings were statistically significant.

"It may be that IGRA is better in these immune-suppressed hosts. Time will tell," said Dr. Kusne, because these tests are relatively new.

IGRA tests appear to be a fine-toothed comb; positive tests might turn negative the second time around in a small minority of patients. What that means, exactly, still needs to be worked out (Chest 2012;142:55-62). For now, the Centers for Disease Control and Prevention is okay with hospitals checking for latent TB with either IGRA or skin tests in most cases, he said.

Even so, the Mayo Clinic has moved away from skin tests in transplant candidates. "I think mainly it’s because CDC has said it’s okay to use either and because many [patients] come to get their [skin test] and then disappear," Dr. Kusne said.

"But cost is always a consideration, too. It’s very cheap" to do a skin test, he said at the meeting, which was sponsored by the American Society for Microbiology.

Dr. Kusne said he had no relevant financial disclosures.

SAN FRANCISCO – Interferon-gamma release assay tests appear to be better than tuberculin skin tests for picking up latent TB in solid organ transplant candidates, according to Dr. Shimon Kusne.

It’s not just because of IGRA’s well-known benefits—as a blood test, results are known after one visit so patients don’t need to return for skin spots to be read, and there are no false positives in patients vaccinated against TB or exposed to environmental strains of mycobacterium.

Instead, IGRA tests simply seem to be better at picking up latent TB, Dr. Kusne, professor of medicine in the division of infectious diseases at the Mayo Clinic Hospital in Phoenix, said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

He and his colleagues gave 179 kidney, liver, or heart transplant candidates TB skin prick tests and two IGRA tests, the QuantiFERON-TB Gold In-Tube test (QFT-GIT) and the T-Spot test.

QFT-GIT was 2.74 times more likely to be positive than tuberculin purified protein derivative skin tests and T-Spots were 3.10 times more likely to be positive. The findings were statistically significant.

"It may be that IGRA is better in these immune-suppressed hosts. Time will tell," said Dr. Kusne, because these tests are relatively new.

IGRA tests appear to be a fine-toothed comb; positive tests might turn negative the second time around in a small minority of patients. What that means, exactly, still needs to be worked out (Chest 2012;142:55-62). For now, the Centers for Disease Control and Prevention is okay with hospitals checking for latent TB with either IGRA or skin tests in most cases, he said.

Even so, the Mayo Clinic has moved away from skin tests in transplant candidates. "I think mainly it’s because CDC has said it’s okay to use either and because many [patients] come to get their [skin test] and then disappear," Dr. Kusne said.

"But cost is always a consideration, too. It’s very cheap" to do a skin test, he said at the meeting, which was sponsored by the American Society for Microbiology.

Dr. Kusne said he had no relevant financial disclosures.

SAN FRANCISCO – Interferon-gamma release assay tests appear to be better than tuberculin skin tests for picking up latent TB in solid organ transplant candidates, according to Dr. Shimon Kusne.

It’s not just because of IGRA’s well-known benefits—as a blood test, results are known after one visit so patients don’t need to return for skin spots to be read, and there are no false positives in patients vaccinated against TB or exposed to environmental strains of mycobacterium.

Instead, IGRA tests simply seem to be better at picking up latent TB, Dr. Kusne, professor of medicine in the division of infectious diseases at the Mayo Clinic Hospital in Phoenix, said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

He and his colleagues gave 179 kidney, liver, or heart transplant candidates TB skin prick tests and two IGRA tests, the QuantiFERON-TB Gold In-Tube test (QFT-GIT) and the T-Spot test.

QFT-GIT was 2.74 times more likely to be positive than tuberculin purified protein derivative skin tests and T-Spots were 3.10 times more likely to be positive. The findings were statistically significant.

"It may be that IGRA is better in these immune-suppressed hosts. Time will tell," said Dr. Kusne, because these tests are relatively new.

IGRA tests appear to be a fine-toothed comb; positive tests might turn negative the second time around in a small minority of patients. What that means, exactly, still needs to be worked out (Chest 2012;142:55-62). For now, the Centers for Disease Control and Prevention is okay with hospitals checking for latent TB with either IGRA or skin tests in most cases, he said.

Even so, the Mayo Clinic has moved away from skin tests in transplant candidates. "I think mainly it’s because CDC has said it’s okay to use either and because many [patients] come to get their [skin test] and then disappear," Dr. Kusne said.

"But cost is always a consideration, too. It’s very cheap" to do a skin test, he said at the meeting, which was sponsored by the American Society for Microbiology.

Dr. Kusne said he had no relevant financial disclosures.

ATLANTA – The implantation of nitinol coils that grab and compress diseased lung tissue, thereby allowing for better functioning of healthy tissue, significantly improved quality of life, exercise capacity, and pulmonary lung function in a randomized controlled trial of patients with severe emphysema and hyperinflation.

Specifically, use of the investigational self-actuating, implantable devices in the RESET (Randomized Controlled Trial of RePneu Endobronchial Coils for the Treatment of Severe Emphysema with Hyperinflation) study was associated with a significantly improved mean St. George’s Respiratory Questionnaire score at 90 days after the final treatment in 23 patients who received active treatment, compared with 24 controls who received best medical care.

After adjustment for baseline variables, the between-group difference in the scores was 8.35 points in favor of the treatment group, Dr. Zaid Zoumot reported at the annual meeting of the American College of Chest Physicians.

PneumRx, Inc.

The lung-volume reduction coils also were associated with significant improvements in mean 6-minute walk distance (mean between-group difference of 63.5 m in favor of the treatment group) and forced expiratory volume in 1 second (FEV₁, mean between-group difference of 12% in favor of the treatment group), said Dr. Zoumot of Royal Brompton and Harefield Hospital Trust, London.

The between-group difference in change in mean residual volume did not reach statistical significance, despite a 0.64-L reduction in the treatment group compared with the control group, he noted.

RESET participants were adults with severe emphysema and hyperinflation with significant dyspnea and gas trapping who were screened at three participating centers in the United Kingdom. Those randomized to the treatment group initially underwent implantation of the coils in one lung, with treatment of the contralateral lung after 1 month if appropriate.

Treatment was generally safe and well tolerated; three patients in the treatment group had pneumothoraces, which were picked up on chest x-ray routinely performed 1 hour following the procedure and treated successfully, Dr. Zoumot said. No differences in adverse effects occurred between the groups after the first month of follow-up, including in exacerbations of chronic obstructive pulmonary disorder, he added.

"The safety profile was definitely acceptable, and in fact, the procedures were a lot safer than other endobronchial lung-volume reduction devices at this same stage of development, and certainly a lot safer than lung-volume reduction surgery, which has a quite high morbidity and mortality rate," he said.

The findings are encouraging given the limited therapeutic options for patients with severe emphysema with gas trapping and hyperinflation – particularly those with heterogeneous disease, he said.

Drug therapy is typically of little benefit in these patients, and although lung-volume reduction surgery and endobronchial valve treatment can be helpful in some patients, their use is precluded in many patients, including those with heterogeneous disease in the absence of collateral ventilation, he explained.

The RePneu lung-volume reduction coils, however, provide a minimally invasive mechanical approach to lung-volume reduction that is effective in both homogeneous and heterogeneous emphysema, with benefits unaffected by collateral ventilation, he said. 

The coils, which are made entirely of nitinol – a highly biocompatible "shape memory" material used in numerous implantable devices – are deployed to the lung bronchoscopically using a proprietary delivery system. Initially, the coils are encased in a sheath to allow delivery in a straight configuration, but once they are in place they return to their original coil configuration, gathering and compressing the diseased tissue as they recoil.

The goal is to implant 10 coils per lobe in a fanlike distribution, Dr. Zoumot said. The procedure, which took about 45 minutes on average in this study, is typically performed under conscious sedation, he added.

Patients in the current study will be followed until 12 months after their final treatment, with results reported at both 6 and 12 months. A larger, multicenter randomized controlled trial with longer follow-up is also set to begin recruiting, Dr. Zoumot said.

This study was funded by PneumRx, the maker of the RePneu coils, and the study sites. Dr. Zoumot reported receiving grant funding and payment for travel expenses from PneumRx.

ATLANTA – The implantation of nitinol coils that grab and compress diseased lung tissue, thereby allowing for better functioning of healthy tissue, significantly improved quality of life, exercise capacity, and pulmonary lung function in a randomized controlled trial of patients with severe emphysema and hyperinflation.

Specifically, use of the investigational self-actuating, implantable devices in the RESET (Randomized Controlled Trial of RePneu Endobronchial Coils for the Treatment of Severe Emphysema with Hyperinflation) study was associated with a significantly improved mean St. George’s Respiratory Questionnaire score at 90 days after the final treatment in 23 patients who received active treatment, compared with 24 controls who received best medical care.

After adjustment for baseline variables, the between-group difference in the scores was 8.35 points in favor of the treatment group, Dr. Zaid Zoumot reported at the annual meeting of the American College of Chest Physicians.

PneumRx, Inc.

The lung-volume reduction coils also were associated with significant improvements in mean 6-minute walk distance (mean between-group difference of 63.5 m in favor of the treatment group) and forced expiratory volume in 1 second (FEV₁, mean between-group difference of 12% in favor of the treatment group), said Dr. Zoumot of Royal Brompton and Harefield Hospital Trust, London.

The between-group difference in change in mean residual volume did not reach statistical significance, despite a 0.64-L reduction in the treatment group compared with the control group, he noted.

RESET participants were adults with severe emphysema and hyperinflation with significant dyspnea and gas trapping who were screened at three participating centers in the United Kingdom. Those randomized to the treatment group initially underwent implantation of the coils in one lung, with treatment of the contralateral lung after 1 month if appropriate.

Treatment was generally safe and well tolerated; three patients in the treatment group had pneumothoraces, which were picked up on chest x-ray routinely performed 1 hour following the procedure and treated successfully, Dr. Zoumot said. No differences in adverse effects occurred between the groups after the first month of follow-up, including in exacerbations of chronic obstructive pulmonary disorder, he added.

"The safety profile was definitely acceptable, and in fact, the procedures were a lot safer than other endobronchial lung-volume reduction devices at this same stage of development, and certainly a lot safer than lung-volume reduction surgery, which has a quite high morbidity and mortality rate," he said.

The findings are encouraging given the limited therapeutic options for patients with severe emphysema with gas trapping and hyperinflation – particularly those with heterogeneous disease, he said.

Drug therapy is typically of little benefit in these patients, and although lung-volume reduction surgery and endobronchial valve treatment can be helpful in some patients, their use is precluded in many patients, including those with heterogeneous disease in the absence of collateral ventilation, he explained.

The RePneu lung-volume reduction coils, however, provide a minimally invasive mechanical approach to lung-volume reduction that is effective in both homogeneous and heterogeneous emphysema, with benefits unaffected by collateral ventilation, he said. 

The coils, which are made entirely of nitinol – a highly biocompatible "shape memory" material used in numerous implantable devices – are deployed to the lung bronchoscopically using a proprietary delivery system. Initially, the coils are encased in a sheath to allow delivery in a straight configuration, but once they are in place they return to their original coil configuration, gathering and compressing the diseased tissue as they recoil.

The goal is to implant 10 coils per lobe in a fanlike distribution, Dr. Zoumot said. The procedure, which took about 45 minutes on average in this study, is typically performed under conscious sedation, he added.

Patients in the current study will be followed until 12 months after their final treatment, with results reported at both 6 and 12 months. A larger, multicenter randomized controlled trial with longer follow-up is also set to begin recruiting, Dr. Zoumot said.

This study was funded by PneumRx, the maker of the RePneu coils, and the study sites. Dr. Zoumot reported receiving grant funding and payment for travel expenses from PneumRx.

ATLANTA – The implantation of nitinol coils that grab and compress diseased lung tissue, thereby allowing for better functioning of healthy tissue, significantly improved quality of life, exercise capacity, and pulmonary lung function in a randomized controlled trial of patients with severe emphysema and hyperinflation.

Specifically, use of the investigational self-actuating, implantable devices in the RESET (Randomized Controlled Trial of RePneu Endobronchial Coils for the Treatment of Severe Emphysema with Hyperinflation) study was associated with a significantly improved mean St. George’s Respiratory Questionnaire score at 90 days after the final treatment in 23 patients who received active treatment, compared with 24 controls who received best medical care.

After adjustment for baseline variables, the between-group difference in the scores was 8.35 points in favor of the treatment group, Dr. Zaid Zoumot reported at the annual meeting of the American College of Chest Physicians.

PneumRx, Inc.

The lung-volume reduction coils also were associated with significant improvements in mean 6-minute walk distance (mean between-group difference of 63.5 m in favor of the treatment group) and forced expiratory volume in 1 second (FEV₁, mean between-group difference of 12% in favor of the treatment group), said Dr. Zoumot of Royal Brompton and Harefield Hospital Trust, London.

The between-group difference in change in mean residual volume did not reach statistical significance, despite a 0.64-L reduction in the treatment group compared with the control group, he noted.

RESET participants were adults with severe emphysema and hyperinflation with significant dyspnea and gas trapping who were screened at three participating centers in the United Kingdom. Those randomized to the treatment group initially underwent implantation of the coils in one lung, with treatment of the contralateral lung after 1 month if appropriate.

Treatment was generally safe and well tolerated; three patients in the treatment group had pneumothoraces, which were picked up on chest x-ray routinely performed 1 hour following the procedure and treated successfully, Dr. Zoumot said. No differences in adverse effects occurred between the groups after the first month of follow-up, including in exacerbations of chronic obstructive pulmonary disorder, he added.

"The safety profile was definitely acceptable, and in fact, the procedures were a lot safer than other endobronchial lung-volume reduction devices at this same stage of development, and certainly a lot safer than lung-volume reduction surgery, which has a quite high morbidity and mortality rate," he said.

The findings are encouraging given the limited therapeutic options for patients with severe emphysema with gas trapping and hyperinflation – particularly those with heterogeneous disease, he said.

Drug therapy is typically of little benefit in these patients, and although lung-volume reduction surgery and endobronchial valve treatment can be helpful in some patients, their use is precluded in many patients, including those with heterogeneous disease in the absence of collateral ventilation, he explained.

The RePneu lung-volume reduction coils, however, provide a minimally invasive mechanical approach to lung-volume reduction that is effective in both homogeneous and heterogeneous emphysema, with benefits unaffected by collateral ventilation, he said. 

The coils, which are made entirely of nitinol – a highly biocompatible "shape memory" material used in numerous implantable devices – are deployed to the lung bronchoscopically using a proprietary delivery system. Initially, the coils are encased in a sheath to allow delivery in a straight configuration, but once they are in place they return to their original coil configuration, gathering and compressing the diseased tissue as they recoil.

The goal is to implant 10 coils per lobe in a fanlike distribution, Dr. Zoumot said. The procedure, which took about 45 minutes on average in this study, is typically performed under conscious sedation, he added.

Patients in the current study will be followed until 12 months after their final treatment, with results reported at both 6 and 12 months. A larger, multicenter randomized controlled trial with longer follow-up is also set to begin recruiting, Dr. Zoumot said.

This study was funded by PneumRx, the maker of the RePneu coils, and the study sites. Dr. Zoumot reported receiving grant funding and payment for travel expenses from PneumRx.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

CHICAGO – Surgical patients receiving care at the least complex hospitals had a 50% increased risk of death compared with those treated at more complex hospitals, based on data from more than 400,000 patients.

Data from previous research suggest that the characteristics of individual hospitals predict surgical outcomes, but the relationship between hospital complexity and surgical mortality has not been well studied, Dr. Marta McCrum said at the annual clinical congress of the American College of Surgeons.

She and her colleagues reviewed Medicare administrative claims data from 2008-2009 and information on hospital characteristics from the American Hospital Association Survey 2009 on 2,695 hospitals. The hospitals were divided into quintiles based on complexity, which for purposes of this study was defined as the number of unique diagnoses and procedures performed at each facility.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals."

"Hospitals that see a wide variety of conditions (common problems but also very rare or complicated diagnoses) would be equipped with the wide range of services and resources needed to support them – that is, they would be complex. Similarly, hospitals that perform the widest range of unique procedures would also have the greatest diversity of services and technology," Dr. McCrum of Harvard University, Boston, explained in an interview.

"We therefore ranked the hospitals separately based on the number of unique diagnoses and procedures they saw, and then summed the ranks to assign a numeric value to the complexity of that hospital in comparison to the others. For the analysis, we separated the hospitals into quintiles based on this value."

Not surprisingly, low-complexity hospitals tended to be smaller, more rural, and located in lower-income areas, and the more complex hospitals tended to be larger, urban, and in higher-income areas, she said.

"Of note, the surgical mortality rate of the highest-complexity hospitals was 7.3%, versus 12.6% at the lowest-complexity hospitals," for an absolute risk reduction of 5.3%, she said.

The researchers controlled for hospital and population characteristics, including total number of hospital discharges, public/private ownership, percentage of Medicare patients, urban location, and county income. Hospital complexity remained a significant predictor of mortality between each quintile compared with the highest-complexity quintile.

"The average aggregate mortality rate at the lowest-complexity hospitals is 46% higher than that of the highest-complexity hospitals," said Dr. McCrum.

Overall, the research model explained 28% of the variability in mortality rates, and within the model, hospital complexity explained the greatest proportion of variability in mortality rates. Although hospital volume was a statistically significant predictor of mortality, the effect was small, she noted.

The study was limited by the fact that approximately two-thirds of the variability remained unexplained, likely due to a combination of patient factors and hospital factors, she said. Additional limitations included the lack of an existing metric to measure hospital complexity, and the limitations of using administrative claims data.

"Our research suggests that outcomes for certain surgical procedures are better at more complex hospitals," Dr. McCrum said in an interview. "This might be due in part to the expanded capabilities and systems of care present at these centers. By identifying these lifesaving elements that are cultivated in complex centers, and making them available in lower-complexity hospitals, we can ensure that all surgical procedures take place in facilities with the appropriate systems to support them," she said.

Dr. McCrum had no financial conflicts to disclose.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

Patients with Zollinger-Ellison syndrome who also have multiple endocrine neoplasia type 1 usually follow an indolent clinical course that rarely results in disease-related death, unlike those who have the sporadic form of the syndrome, Dr. Maneesh H. Singh and his colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

This finding, from a retrospective study of 49 patients treated at a single tertiary care center since 1994, argues against surgery for the estimated 25%-50% of Zollinger-Ellison syndrome (ZES) patients who have multiple endocrine neoplasia type 1 (MEN-1). "Given these results, we support a conservative approach to disease management ... focusing on symptom control with pharmacologic agents," the investigators wrote (Clin. Gastroenterol. Hepatol. 2012 Aug. 20 [doi:10.1016/j.cgh.2012.08.014]).

Early and aggressive surgery is recommended for sporadic ZES because it improves survival and can be curative. But surgery’s role in those with MEN-1 has been contentious because it doesn’t appear to improve survival in these patients. Only the most radical surgery, which carries a 40% complication rate, appears to be curative in those with MEN-1,reported Dr. Singh and his colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Because ZES is such a rare disorder, this follow-up study of 34 ZES patients who underwent surgery and 15 who did not "represents one of the largest long-term studies of surgical outcomes from a tertiary care hospital" conducted to date, they wrote.

The study subjects’ mean age at diagnosis was 47 years. The mean duration of follow-up from the time of diagnosis was 7 years, ranging from 0 to 5 years for 19 patients, from 5 to 10 years for 10, from 10 to 20 years for 15, and for more than 20 years for 5.

Of the 15 patients who did not undergo surgery, 5 declined after a discussion of the risks and benefits of the procedure, 2 because they had no lesions greater than 2 cm in diameter in imaging studies, 3 because of extensive liver involvement that was deemed unresectable, and 5 because they had unrelated comorbidities that made them poor surgical candidates.

A total of 33 subjects had sporadic ZES, while the other 16 had associated MEN-1. In the latter group, there was no significant difference between the median survival for the nine who underwent surgery (22.4 years) and for the seven who did not (25.5 years).

Standard gastrinoma resection with duodenotomy did not achieve a cure in any of the ZES patients with accompanying MEN-1.

In contrast, surgery improved both disease-related and all-cause mortality in the sporadic form of the disorder, and surgery was deemed curative in 6 (32%) of the patients with sporadic ZES.

None of the patients with MEN-1died of progressive ZES, compared with 28 (85%) of the patients with sporadic ZES. Thus, the form of the disease associated with MEN-1 appears to have a much more benign course than the sporadic form, Dr. Singh and his associates reported.

ZES associated with MEN-1 also tends to have an earlier symptom onset than does sporadic ZES, but because it is more indolent, the mean age at death was nearly identical between the two groups.

In this study, ZES patients with MEN-1had rates of liver involvement at diagnosis and rates of later liver metastases that were similar to those of patients with sporadic ZES. But again, this did not reduce their survival as it did with sporadic ZES.

This finding suggests that there may be a fundamental difference in the basic tumor biology between the two forms of the disease. It supports the theory that sporadic ZES is "a rapidly progressive, malignant form of gastrinoma that defies prediction and advocates for swift surgical intervention," the researchers wrote.

They reported no industry support for this study and no other financial conflicts.

Patients with Zollinger-Ellison syndrome who also have multiple endocrine neoplasia type 1 usually follow an indolent clinical course that rarely results in disease-related death, unlike those who have the sporadic form of the syndrome, Dr. Maneesh H. Singh and his colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

This finding, from a retrospective study of 49 patients treated at a single tertiary care center since 1994, argues against surgery for the estimated 25%-50% of Zollinger-Ellison syndrome (ZES) patients who have multiple endocrine neoplasia type 1 (MEN-1). "Given these results, we support a conservative approach to disease management ... focusing on symptom control with pharmacologic agents," the investigators wrote (Clin. Gastroenterol. Hepatol. 2012 Aug. 20 [doi:10.1016/j.cgh.2012.08.014]).

Early and aggressive surgery is recommended for sporadic ZES because it improves survival and can be curative. But surgery’s role in those with MEN-1 has been contentious because it doesn’t appear to improve survival in these patients. Only the most radical surgery, which carries a 40% complication rate, appears to be curative in those with MEN-1,reported Dr. Singh and his colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Because ZES is such a rare disorder, this follow-up study of 34 ZES patients who underwent surgery and 15 who did not "represents one of the largest long-term studies of surgical outcomes from a tertiary care hospital" conducted to date, they wrote.

The study subjects’ mean age at diagnosis was 47 years. The mean duration of follow-up from the time of diagnosis was 7 years, ranging from 0 to 5 years for 19 patients, from 5 to 10 years for 10, from 10 to 20 years for 15, and for more than 20 years for 5.

Of the 15 patients who did not undergo surgery, 5 declined after a discussion of the risks and benefits of the procedure, 2 because they had no lesions greater than 2 cm in diameter in imaging studies, 3 because of extensive liver involvement that was deemed unresectable, and 5 because they had unrelated comorbidities that made them poor surgical candidates.

A total of 33 subjects had sporadic ZES, while the other 16 had associated MEN-1. In the latter group, there was no significant difference between the median survival for the nine who underwent surgery (22.4 years) and for the seven who did not (25.5 years).

Standard gastrinoma resection with duodenotomy did not achieve a cure in any of the ZES patients with accompanying MEN-1.

In contrast, surgery improved both disease-related and all-cause mortality in the sporadic form of the disorder, and surgery was deemed curative in 6 (32%) of the patients with sporadic ZES.

None of the patients with MEN-1died of progressive ZES, compared with 28 (85%) of the patients with sporadic ZES. Thus, the form of the disease associated with MEN-1 appears to have a much more benign course than the sporadic form, Dr. Singh and his associates reported.

ZES associated with MEN-1 also tends to have an earlier symptom onset than does sporadic ZES, but because it is more indolent, the mean age at death was nearly identical between the two groups.

In this study, ZES patients with MEN-1had rates of liver involvement at diagnosis and rates of later liver metastases that were similar to those of patients with sporadic ZES. But again, this did not reduce their survival as it did with sporadic ZES.

This finding suggests that there may be a fundamental difference in the basic tumor biology between the two forms of the disease. It supports the theory that sporadic ZES is "a rapidly progressive, malignant form of gastrinoma that defies prediction and advocates for swift surgical intervention," the researchers wrote.

They reported no industry support for this study and no other financial conflicts.

Patients with Zollinger-Ellison syndrome who also have multiple endocrine neoplasia type 1 usually follow an indolent clinical course that rarely results in disease-related death, unlike those who have the sporadic form of the syndrome, Dr. Maneesh H. Singh and his colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

This finding, from a retrospective study of 49 patients treated at a single tertiary care center since 1994, argues against surgery for the estimated 25%-50% of Zollinger-Ellison syndrome (ZES) patients who have multiple endocrine neoplasia type 1 (MEN-1). "Given these results, we support a conservative approach to disease management ... focusing on symptom control with pharmacologic agents," the investigators wrote (Clin. Gastroenterol. Hepatol. 2012 Aug. 20 [doi:10.1016/j.cgh.2012.08.014]).

Early and aggressive surgery is recommended for sporadic ZES because it improves survival and can be curative. But surgery’s role in those with MEN-1 has been contentious because it doesn’t appear to improve survival in these patients. Only the most radical surgery, which carries a 40% complication rate, appears to be curative in those with MEN-1,reported Dr. Singh and his colleagues at the Hospital of the University of Pennsylvania, Philadelphia.

Because ZES is such a rare disorder, this follow-up study of 34 ZES patients who underwent surgery and 15 who did not "represents one of the largest long-term studies of surgical outcomes from a tertiary care hospital" conducted to date, they wrote.

The study subjects’ mean age at diagnosis was 47 years. The mean duration of follow-up from the time of diagnosis was 7 years, ranging from 0 to 5 years for 19 patients, from 5 to 10 years for 10, from 10 to 20 years for 15, and for more than 20 years for 5.

Of the 15 patients who did not undergo surgery, 5 declined after a discussion of the risks and benefits of the procedure, 2 because they had no lesions greater than 2 cm in diameter in imaging studies, 3 because of extensive liver involvement that was deemed unresectable, and 5 because they had unrelated comorbidities that made them poor surgical candidates.

A total of 33 subjects had sporadic ZES, while the other 16 had associated MEN-1. In the latter group, there was no significant difference between the median survival for the nine who underwent surgery (22.4 years) and for the seven who did not (25.5 years).

Standard gastrinoma resection with duodenotomy did not achieve a cure in any of the ZES patients with accompanying MEN-1.

In contrast, surgery improved both disease-related and all-cause mortality in the sporadic form of the disorder, and surgery was deemed curative in 6 (32%) of the patients with sporadic ZES.

None of the patients with MEN-1died of progressive ZES, compared with 28 (85%) of the patients with sporadic ZES. Thus, the form of the disease associated with MEN-1 appears to have a much more benign course than the sporadic form, Dr. Singh and his associates reported.

ZES associated with MEN-1 also tends to have an earlier symptom onset than does sporadic ZES, but because it is more indolent, the mean age at death was nearly identical between the two groups.

In this study, ZES patients with MEN-1had rates of liver involvement at diagnosis and rates of later liver metastases that were similar to those of patients with sporadic ZES. But again, this did not reduce their survival as it did with sporadic ZES.

This finding suggests that there may be a fundamental difference in the basic tumor biology between the two forms of the disease. It supports the theory that sporadic ZES is "a rapidly progressive, malignant form of gastrinoma that defies prediction and advocates for swift surgical intervention," the researchers wrote.

They reported no industry support for this study and no other financial conflicts.