Perioperative Medicine

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge."

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris. "Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge."

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris. "Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

CHICAGO – Approximately one-third of surgical complications were diagnosed after patients left the hospital, based on data from nearly 60,000 procedures performed at 112 hospitals.

Reporting postoperative complications, including surgical site infections, has become a mandatory quality reporting initiative for hospitals, and the Affordable Care Act requires reporting of readmissions, said Dr. Melanie Morris of the University of Alabama at Birmingham.

"Some postoperative complications may lead to readmissions, but this may not tell the whole story," she noted at the annual clinical congress of the American College of Surgeons.

To determine the timing of postoperative complications and the nature of readmissions, Dr. Morris and her colleagues reviewed Veterans Affairs data from the noncardiac Surgical Care Improvement Project (SCIP) cohort from 2005 to 2009 for 59,464 surgical procedures in which there was at least one complication.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge."

Surgical cases were classified by specialty into gastrointestinal, gynecologic, orthopedic, and vascular. Complications were grouped into organ-based systems. For example, urinary complications included renal failure, renal insufficiency, and urinary tract infections; respiratory complications included failure to wean, pneumonia, and reintubation; and surgical site infections (SSIs) included both deep and superficial wounds.

The overall complication rate was approximately 15%, and 32% of complications were diagnosed after hospital discharge, Dr. Morris said. More than half (56%) of all SSIs were diagnosed after discharge, she added.

A statistically significant difference appeared in postdischarge complications by surgical specialty. The SSI rate was 5.4%, followed by respiratory complications (5.0%), urinary tract infection (4.9%), cardiac complications (3.2%), and venous thromboembolism (1.2%).

"Our GI surgical patients had the highest overall complication rate," Dr. Morris noted. Among GI patients, colectomy patients had the highest SSI rate (11%), and 23% of the GI complications were diagnosed after hospital discharge.

In addition, 78% of SSIs in orthopedic patients were diagnosed after discharge, as were 39% of SSIs in GI patients, 77% of SSIs in vascular surgery patients, and 95% of SSIs in gynecologic patients, said Dr. Morris.

There were no significant differences in length of hospital stay based on complications, Dr. Morris said.

The overall readmission rate was 11.9%, and 70% of these patients had no identifiable postoperative complication. Of those who did have an identifiable postop complication, 72% were diagnosed before discharge from the hospital.

The probability of being readmitted to the hospital over time was highest in patients with a postdischarge diagnosis of a complication. The overall length of stay was 5 days, and the average length of stay for patients with any complication was 9 days.

Patient-specific factors associated with an increased risk of readmission included a history of heart failure, renal failure, diabetes, weight loss, and smoking. Procedure-specific factors associated with an increased risk of readmission included a longer operating time, a more contaminated wound, and a higher ASA (American Society of Anesthesiologists) class.

Length of stay was slightly protective for readmission, and the presence of any complication was associated with a high risk of readmission.

"It’s very important that patients are accurately educated on the signs and symptoms of complications so they know to seek timely care after discharge," said Dr. Morris. "Postoperative complications must be measured beyond hospital discharge to capture the whole story.

"Systematic collection of postoperative complications must include postdischarge data as well as readmissions to accurately measure quality," she said.

Dr. Morris said she had no relevant financial disclosures.

The 2008 Medicare policy to withhold payment for treating certain hospital-acquired infections failed to decrease infection rates in U.S. hospitals, according to a report published online Oct. 10 in the New England Journal of Medicine.

In a study involving 398 hospitals or medical systems across the country, implementing a Centers for Medicare and Medicaid Services policy of nonpayment for the treatment of preventable catheter-associated bloodstream infections and catheter-associated urinary tract infections appeared to have no impact at all on the acquisition of those infections, according to Dr. Ashish K. Jha of the department of health policy and management, Harvard School of Public Health, Boston, and his associates.

"As CMS continues to expand this policy to cover Medicaid through the Affordable Care Act, require public reporting of National Healthcare Safety Network [NHSN] data through the Hospital Compare website, and impose greater financial penalties on hospitals that perform poorly on these measures, careful evaluation is needed to determine when these programs work, when they have unintended consequences, and what might be done to improve patient outcomes," Dr. Jha noted.

Dr. Jha and his colleagues assessed data from the NHSN, a public health surveillance program for monitoring health care–associated infections across the country. A total of 1,166 nonfederal acute-care hospitals report their infection rates to this Centers for Disease Control and Prevention–sponsored network every month.

Dr. Jha and his colleagues assessed NHSN data on three types of infection at 398 of those hospitals in 41 states. They examined central catheter–associated bloodstream and catheter-associated urinary tract infections because these are the two hospital-acquired infections for which CMS currently does not pay. They also looked at ventilator-associated pneumonia, which is not targeted by the CMS policy, as a control.

Rates of central catheter–associated bloodstream infections were already decreasing at the time the CMS policy was implemented, likely because the federal government, national organizations, and accrediting agencies had already focused attention on preventing these nosocomial infections. The rate of these infections was 4.8% per quarter before the policy was implemented and 4.7% afterward, a nonsignificant difference, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMsa1202419]).

This pattern also was seen with catheter-associated UTIs, in which there was a small, nonsignificant increase in the infection rate after implementation of the CMS policy. For the control condition of ventilator-associated pneumonia, the infection rate was 7.3% before implementation and 8.2% after implementation of the policy, also showing no significant impact on infection rates.

These findings were consistent across all hospital types, regardless of size, regional location, type of ownership, or teaching status.

To assess whether any benefit of the nonpayment policy may have been offset by strategies to lower infection rates, such as mandatory reporting, the researchers performed a separate analysis involving only the hospital units located in states that didn’t have mandatory reporting. Again, no demonstrable effect on infection rates was seen.

To allow more time for hospitals to adapt to the policy change, the investigators performed a sensitivity analysis comparing infection rates 2 years after implementation with those before implementation. Again, they found no further decreases in the rates of any infections.

A possible explanation for these findings is that the amount of this financial disincentive was quite small. "Reductions in payment may have been equivalent to as little as 0.6% of Medicare revenue for the average hospital," Dr. Jha and his associates said. "Greater financial penalties might induce a greater change in hospital responsiveness to the CMS policy."

The study results are particularly important given the increasing use of financial disincentives to improve the quality of healthcare. There is very little evidence that this strategy, or other pay-for-performance strategies, actually improves patient outcomes, they said.

This study was supported by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

The 2008 Medicare policy to withhold payment for treating certain hospital-acquired infections failed to decrease infection rates in U.S. hospitals, according to a report published online Oct. 10 in the New England Journal of Medicine.

In a study involving 398 hospitals or medical systems across the country, implementing a Centers for Medicare and Medicaid Services policy of nonpayment for the treatment of preventable catheter-associated bloodstream infections and catheter-associated urinary tract infections appeared to have no impact at all on the acquisition of those infections, according to Dr. Ashish K. Jha of the department of health policy and management, Harvard School of Public Health, Boston, and his associates.

"As CMS continues to expand this policy to cover Medicaid through the Affordable Care Act, require public reporting of National Healthcare Safety Network [NHSN] data through the Hospital Compare website, and impose greater financial penalties on hospitals that perform poorly on these measures, careful evaluation is needed to determine when these programs work, when they have unintended consequences, and what might be done to improve patient outcomes," Dr. Jha noted.

Dr. Jha and his colleagues assessed data from the NHSN, a public health surveillance program for monitoring health care–associated infections across the country. A total of 1,166 nonfederal acute-care hospitals report their infection rates to this Centers for Disease Control and Prevention–sponsored network every month.

Dr. Jha and his colleagues assessed NHSN data on three types of infection at 398 of those hospitals in 41 states. They examined central catheter–associated bloodstream and catheter-associated urinary tract infections because these are the two hospital-acquired infections for which CMS currently does not pay. They also looked at ventilator-associated pneumonia, which is not targeted by the CMS policy, as a control.

Rates of central catheter–associated bloodstream infections were already decreasing at the time the CMS policy was implemented, likely because the federal government, national organizations, and accrediting agencies had already focused attention on preventing these nosocomial infections. The rate of these infections was 4.8% per quarter before the policy was implemented and 4.7% afterward, a nonsignificant difference, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMsa1202419]).

This pattern also was seen with catheter-associated UTIs, in which there was a small, nonsignificant increase in the infection rate after implementation of the CMS policy. For the control condition of ventilator-associated pneumonia, the infection rate was 7.3% before implementation and 8.2% after implementation of the policy, also showing no significant impact on infection rates.

These findings were consistent across all hospital types, regardless of size, regional location, type of ownership, or teaching status.

To assess whether any benefit of the nonpayment policy may have been offset by strategies to lower infection rates, such as mandatory reporting, the researchers performed a separate analysis involving only the hospital units located in states that didn’t have mandatory reporting. Again, no demonstrable effect on infection rates was seen.

To allow more time for hospitals to adapt to the policy change, the investigators performed a sensitivity analysis comparing infection rates 2 years after implementation with those before implementation. Again, they found no further decreases in the rates of any infections.

A possible explanation for these findings is that the amount of this financial disincentive was quite small. "Reductions in payment may have been equivalent to as little as 0.6% of Medicare revenue for the average hospital," Dr. Jha and his associates said. "Greater financial penalties might induce a greater change in hospital responsiveness to the CMS policy."

The study results are particularly important given the increasing use of financial disincentives to improve the quality of healthcare. There is very little evidence that this strategy, or other pay-for-performance strategies, actually improves patient outcomes, they said.

This study was supported by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

The 2008 Medicare policy to withhold payment for treating certain hospital-acquired infections failed to decrease infection rates in U.S. hospitals, according to a report published online Oct. 10 in the New England Journal of Medicine.

In a study involving 398 hospitals or medical systems across the country, implementing a Centers for Medicare and Medicaid Services policy of nonpayment for the treatment of preventable catheter-associated bloodstream infections and catheter-associated urinary tract infections appeared to have no impact at all on the acquisition of those infections, according to Dr. Ashish K. Jha of the department of health policy and management, Harvard School of Public Health, Boston, and his associates.

"As CMS continues to expand this policy to cover Medicaid through the Affordable Care Act, require public reporting of National Healthcare Safety Network [NHSN] data through the Hospital Compare website, and impose greater financial penalties on hospitals that perform poorly on these measures, careful evaluation is needed to determine when these programs work, when they have unintended consequences, and what might be done to improve patient outcomes," Dr. Jha noted.

Dr. Jha and his colleagues assessed data from the NHSN, a public health surveillance program for monitoring health care–associated infections across the country. A total of 1,166 nonfederal acute-care hospitals report their infection rates to this Centers for Disease Control and Prevention–sponsored network every month.

Dr. Jha and his colleagues assessed NHSN data on three types of infection at 398 of those hospitals in 41 states. They examined central catheter–associated bloodstream and catheter-associated urinary tract infections because these are the two hospital-acquired infections for which CMS currently does not pay. They also looked at ventilator-associated pneumonia, which is not targeted by the CMS policy, as a control.

Rates of central catheter–associated bloodstream infections were already decreasing at the time the CMS policy was implemented, likely because the federal government, national organizations, and accrediting agencies had already focused attention on preventing these nosocomial infections. The rate of these infections was 4.8% per quarter before the policy was implemented and 4.7% afterward, a nonsignificant difference, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMsa1202419]).

This pattern also was seen with catheter-associated UTIs, in which there was a small, nonsignificant increase in the infection rate after implementation of the CMS policy. For the control condition of ventilator-associated pneumonia, the infection rate was 7.3% before implementation and 8.2% after implementation of the policy, also showing no significant impact on infection rates.

These findings were consistent across all hospital types, regardless of size, regional location, type of ownership, or teaching status.

To assess whether any benefit of the nonpayment policy may have been offset by strategies to lower infection rates, such as mandatory reporting, the researchers performed a separate analysis involving only the hospital units located in states that didn’t have mandatory reporting. Again, no demonstrable effect on infection rates was seen.

To allow more time for hospitals to adapt to the policy change, the investigators performed a sensitivity analysis comparing infection rates 2 years after implementation with those before implementation. Again, they found no further decreases in the rates of any infections.

A possible explanation for these findings is that the amount of this financial disincentive was quite small. "Reductions in payment may have been equivalent to as little as 0.6% of Medicare revenue for the average hospital," Dr. Jha and his associates said. "Greater financial penalties might induce a greater change in hospital responsiveness to the CMS policy."

The study results are particularly important given the increasing use of financial disincentives to improve the quality of healthcare. There is very little evidence that this strategy, or other pay-for-performance strategies, actually improves patient outcomes, they said.

This study was supported by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

An approach to sedating intubated patients in the intensive care unit, designed to minimize continuous analgesic and sedative infusions, was associated with better outcomes than was the sedation interruption regimen previously used, according to a retrospective study of almost 1,500 patients.

The new approach resulted in a nearly 80% reduction in the overall use of sedatives and narcotics, as well as fewer infections and days spent on a ventilator – with no increase in patient discomfort, falls, or unintended extubations, Brenton J. LaRiccia, RPA, lead physician assistant in the Kessler Family Burn Trauma Intensive Care Unit (BTICU) at Strong Memorial Hospital, Rochester, N.Y., reported at the annual meeting of the American Association for the Surgery of Trauma.

Courtesy Kessler Trauma Center

Protocols that address the worse outcomes associated with oversedation of mechanically ventilated patients include sedation interruption (SI) regimens. While the interruption regimens have been shown to reduce sedation use in medical ICUs, their regimens in trauma ICUs have been unclear, said Mr. LaRiccia, who is also in the division of acute care surgery at the University of Rochester (N.Y.).

In 2011, a protocol designed to minimize the use of continuous infusions was implemented at the BTICU at Strong Memorial Hospital, which he described as "aggressive upfront bolus dosing" of analgesic and sedative medications during the first hour of admission, continuous infusions if the bolus dosing was not effective, followed by "nursing-driven regimented weaning of all medications," both intermittently dosed and continuous medications.

The study compared outcomes associated with this approach among 749 patients admitted to the trauma ICU in 2011 with outcomes among 743 patients in 2009, when the SI protocol was still used. The patients (average age 55-57 years) were all ventilated and had similar APACHE II scores; burn patients and those who required hourly neurologic checks were not included.

Compared with the SI regimen, the new regimen was associated with significantly fewer sedation days (a total of 344 vs. 1,784 days) and significantly fewer days on a ventilator (an average of 6.2 vs. 8.4 days ). In addition, about one-fourth of those on the new protocol never required a continuous infusion of a sedative or analgesic, which "was in stark contrast to our prior sedation interruption–based practice where almost all intubated patients were placed on continuous infusions on arrival to the BTICU," Mr. LaRiccia said. (Among those on the SI protocol, 11% never required continuous sedatives and 13% never required continuous narcotics, compared with 25% and 27%, respectively, of those on the new protocol, statistically significant differences).

Mortality (18%-19%) and the average ICU length of stay (almost 10 days), as well as pain scores and the total number of falls and self-extubation rates, were similar between the two groups. Limitations of the study include the retrospective analysis, the single ICU setting, and the relatively small sample size and lack of long-term data, and more studies are needed to confirm these results, he pointed out.

The results indicate that an analgesia-based protocol implemented on ICU admission, which "focuses on front loading analgesia with upfront use of intermittent pain medications and sedation medications, instead of continuous infusions with sedation, greatly decreases ICU sedation use," and is well-tolerated by patients, reduces ICU infection rates and ventilator days without significant complications, Mr. LaRiccia concluded.

"By moving beyond the sedation interruption mindset, we change our goal from being ‘When can this sedation be stopped?’ to ‘Does this sedation even need to be started?’ – thereby truly optimizing patient care," he added, emphasizing that a multidisciplinary effort is needed to ensure that the protocol is implemented properly.

He and his coinvestigators reported having no relevant financial conflicts.

An approach to sedating intubated patients in the intensive care unit, designed to minimize continuous analgesic and sedative infusions, was associated with better outcomes than was the sedation interruption regimen previously used, according to a retrospective study of almost 1,500 patients.

The new approach resulted in a nearly 80% reduction in the overall use of sedatives and narcotics, as well as fewer infections and days spent on a ventilator – with no increase in patient discomfort, falls, or unintended extubations, Brenton J. LaRiccia, RPA, lead physician assistant in the Kessler Family Burn Trauma Intensive Care Unit (BTICU) at Strong Memorial Hospital, Rochester, N.Y., reported at the annual meeting of the American Association for the Surgery of Trauma.

Courtesy Kessler Trauma Center

Protocols that address the worse outcomes associated with oversedation of mechanically ventilated patients include sedation interruption (SI) regimens. While the interruption regimens have been shown to reduce sedation use in medical ICUs, their regimens in trauma ICUs have been unclear, said Mr. LaRiccia, who is also in the division of acute care surgery at the University of Rochester (N.Y.).

In 2011, a protocol designed to minimize the use of continuous infusions was implemented at the BTICU at Strong Memorial Hospital, which he described as "aggressive upfront bolus dosing" of analgesic and sedative medications during the first hour of admission, continuous infusions if the bolus dosing was not effective, followed by "nursing-driven regimented weaning of all medications," both intermittently dosed and continuous medications.

The study compared outcomes associated with this approach among 749 patients admitted to the trauma ICU in 2011 with outcomes among 743 patients in 2009, when the SI protocol was still used. The patients (average age 55-57 years) were all ventilated and had similar APACHE II scores; burn patients and those who required hourly neurologic checks were not included.

Compared with the SI regimen, the new regimen was associated with significantly fewer sedation days (a total of 344 vs. 1,784 days) and significantly fewer days on a ventilator (an average of 6.2 vs. 8.4 days ). In addition, about one-fourth of those on the new protocol never required a continuous infusion of a sedative or analgesic, which "was in stark contrast to our prior sedation interruption–based practice where almost all intubated patients were placed on continuous infusions on arrival to the BTICU," Mr. LaRiccia said. (Among those on the SI protocol, 11% never required continuous sedatives and 13% never required continuous narcotics, compared with 25% and 27%, respectively, of those on the new protocol, statistically significant differences).

Mortality (18%-19%) and the average ICU length of stay (almost 10 days), as well as pain scores and the total number of falls and self-extubation rates, were similar between the two groups. Limitations of the study include the retrospective analysis, the single ICU setting, and the relatively small sample size and lack of long-term data, and more studies are needed to confirm these results, he pointed out.

The results indicate that an analgesia-based protocol implemented on ICU admission, which "focuses on front loading analgesia with upfront use of intermittent pain medications and sedation medications, instead of continuous infusions with sedation, greatly decreases ICU sedation use," and is well-tolerated by patients, reduces ICU infection rates and ventilator days without significant complications, Mr. LaRiccia concluded.

"By moving beyond the sedation interruption mindset, we change our goal from being ‘When can this sedation be stopped?’ to ‘Does this sedation even need to be started?’ – thereby truly optimizing patient care," he added, emphasizing that a multidisciplinary effort is needed to ensure that the protocol is implemented properly.

He and his coinvestigators reported having no relevant financial conflicts.

An approach to sedating intubated patients in the intensive care unit, designed to minimize continuous analgesic and sedative infusions, was associated with better outcomes than was the sedation interruption regimen previously used, according to a retrospective study of almost 1,500 patients.

The new approach resulted in a nearly 80% reduction in the overall use of sedatives and narcotics, as well as fewer infections and days spent on a ventilator – with no increase in patient discomfort, falls, or unintended extubations, Brenton J. LaRiccia, RPA, lead physician assistant in the Kessler Family Burn Trauma Intensive Care Unit (BTICU) at Strong Memorial Hospital, Rochester, N.Y., reported at the annual meeting of the American Association for the Surgery of Trauma.

Courtesy Kessler Trauma Center

Protocols that address the worse outcomes associated with oversedation of mechanically ventilated patients include sedation interruption (SI) regimens. While the interruption regimens have been shown to reduce sedation use in medical ICUs, their regimens in trauma ICUs have been unclear, said Mr. LaRiccia, who is also in the division of acute care surgery at the University of Rochester (N.Y.).

In 2011, a protocol designed to minimize the use of continuous infusions was implemented at the BTICU at Strong Memorial Hospital, which he described as "aggressive upfront bolus dosing" of analgesic and sedative medications during the first hour of admission, continuous infusions if the bolus dosing was not effective, followed by "nursing-driven regimented weaning of all medications," both intermittently dosed and continuous medications.

The study compared outcomes associated with this approach among 749 patients admitted to the trauma ICU in 2011 with outcomes among 743 patients in 2009, when the SI protocol was still used. The patients (average age 55-57 years) were all ventilated and had similar APACHE II scores; burn patients and those who required hourly neurologic checks were not included.

Compared with the SI regimen, the new regimen was associated with significantly fewer sedation days (a total of 344 vs. 1,784 days) and significantly fewer days on a ventilator (an average of 6.2 vs. 8.4 days ). In addition, about one-fourth of those on the new protocol never required a continuous infusion of a sedative or analgesic, which "was in stark contrast to our prior sedation interruption–based practice where almost all intubated patients were placed on continuous infusions on arrival to the BTICU," Mr. LaRiccia said. (Among those on the SI protocol, 11% never required continuous sedatives and 13% never required continuous narcotics, compared with 25% and 27%, respectively, of those on the new protocol, statistically significant differences).

Mortality (18%-19%) and the average ICU length of stay (almost 10 days), as well as pain scores and the total number of falls and self-extubation rates, were similar between the two groups. Limitations of the study include the retrospective analysis, the single ICU setting, and the relatively small sample size and lack of long-term data, and more studies are needed to confirm these results, he pointed out.

The results indicate that an analgesia-based protocol implemented on ICU admission, which "focuses on front loading analgesia with upfront use of intermittent pain medications and sedation medications, instead of continuous infusions with sedation, greatly decreases ICU sedation use," and is well-tolerated by patients, reduces ICU infection rates and ventilator days without significant complications, Mr. LaRiccia concluded.

"By moving beyond the sedation interruption mindset, we change our goal from being ‘When can this sedation be stopped?’ to ‘Does this sedation even need to be started?’ – thereby truly optimizing patient care," he added, emphasizing that a multidisciplinary effort is needed to ensure that the protocol is implemented properly.

He and his coinvestigators reported having no relevant financial conflicts.

MUNICH – Patients who require chronic oral anticoagulant treatment and received a coronary stent had significantly fewer bleeding events and better outcomes if they received only added clopidogrel than if they were treated with clopidogrel plus aspirin on top of their anticoagulant in the WOEST trial.

As the first study to prospectively test the best combination of antiplatelet drugs to use on top of anticoagulant treatment in patients following coronary stenting, experts hailed the finding as important evidence to address a common and vexing clinical situation.

Mitchel L. Zoler/IMNG Medical Media

"We propose that a strategy of oral anticoagulants plus clopidogrel, but without aspirin could be applied in this group of high-risk patients who are on an oral anticoagulant and undergo percutaneous coronary intervention," said Dr. Willem Dewilde, lead investigator for the study, at the Annual Congress of the European Society of Cardiology.

"We are faced with a huge clinical problem, with an increasing number of patients with atrial fibrillation who undergo stent procedures, so this finding has major implications," commented Dr. David R. Holmes Jr., professor of medicine and a cardiologist at the Mayo Clinic in Rochester, Minn. "Bleeding is such a huge issue, and we now have scientific data that says [withholding aspirin] is safe and produces less bleeding."

"The taboo against discontinuing or omitting aspirin has been broken," commented Dr. Marco Valgimigli, director of the coronary catheterization laboratory at the University Hospital of Ferrara (Italy).

The WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting) trial enrolled 573 patients who required chronic oral anticoagulant treatment and were scheduled for coronary stenting at 15 centers in the Netherlands and Belgium. The patients averaged about 70 years of age, and about 80% were men. A total of 70% received daily, oral treatment with an anticoagulant for atrial fibrillation or flutter, about 10% for a mechanical valve, and the remaining 20% had other reasons for their regimen, including treatment of a pulmonary embolus. All patients received warfarin or another oral anticoagulant such as acenocoumarol. About two-thirds of the patients received a drug-eluting coronary stent, with the remainder receiving a bare-metal stent.

Following stenting, the researchers randomized patients to a regimen of their oral anticoagulant plus 75 mg clopidogrel daily (dual therapy), or their oral anticoagulant, clopidogrel, and 80 mg aspirin daily (triple therapy). The antiplatelet part of the regimen continued for at least 1 month in patients who received a bare-metal stent and for a year in those who got a drug-eluting stent.

Mitchel L. Zoler/IMNG Medical Media

After a year of follow-up, the incidence of the primary end point – total bleeding events – occurred in 20% of the 279 evaluable patients who received dual therapy and in 45% of 284 evaluable patients on triple therapy, a statistically significant difference, reported Dr. Dewilde, a cardiologist at TweeSteden Hospital in Tilberg, the Netherlands. The study’s secondary end point – the combined rate of death, myocardial infarction, target vessel revascularization, stroke, or stent thrombosis – occurred in 11% of patients on double therapy and 18% of those on triple therapy, a statistically significant difference.

Patients on dual therapy had a significantly lower rate of all-cause death, compared with the triple-therapy patients, 3% compared with 6%, and numerically lower levels of stent thrombosis, stroke, and myocardial infarction, although the differences for these individual end points were not statistically significant.

The dual-therapy patients also had significantly lower rates of minimal or minor bleeds, measured by the TIMI (Thrombolysis in Myocardial Infarction) criteria, and the rate of TIMI major bleeds was also lower on dual therapy, but not significantly. The dual-therapy patients had strikingly lower numbers of bleeds at gastrointestinal sites and skin sites, compared with the triple-therapy patients.

"TIMI minimal and minor bleeds are anything but minor from a clinical standpoint," noted Dr. Valgimigli. "Double therapy with clopidogrel and warfarin seems a very reasonable therapy based on WOEST, especially in DES-treated patients."

Dr. Dewilde and Dr. Holmes said that they had no disclosures. Dr. Valgimigli said that he has served on the speakers bureau for AstraZeneca, Eli Lilly, Iroko, and other companies that market vascular devices. He has also been on advisory boards for Eli Lilly, and several companies that make vascular devices. Dr. Smith said that he had no disclosures.

MUNICH – Patients who require chronic oral anticoagulant treatment and received a coronary stent had significantly fewer bleeding events and better outcomes if they received only added clopidogrel than if they were treated with clopidogrel plus aspirin on top of their anticoagulant in the WOEST trial.

As the first study to prospectively test the best combination of antiplatelet drugs to use on top of anticoagulant treatment in patients following coronary stenting, experts hailed the finding as important evidence to address a common and vexing clinical situation.

Mitchel L. Zoler/IMNG Medical Media

"We propose that a strategy of oral anticoagulants plus clopidogrel, but without aspirin could be applied in this group of high-risk patients who are on an oral anticoagulant and undergo percutaneous coronary intervention," said Dr. Willem Dewilde, lead investigator for the study, at the Annual Congress of the European Society of Cardiology.

"We are faced with a huge clinical problem, with an increasing number of patients with atrial fibrillation who undergo stent procedures, so this finding has major implications," commented Dr. David R. Holmes Jr., professor of medicine and a cardiologist at the Mayo Clinic in Rochester, Minn. "Bleeding is such a huge issue, and we now have scientific data that says [withholding aspirin] is safe and produces less bleeding."

"The taboo against discontinuing or omitting aspirin has been broken," commented Dr. Marco Valgimigli, director of the coronary catheterization laboratory at the University Hospital of Ferrara (Italy).

The WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting) trial enrolled 573 patients who required chronic oral anticoagulant treatment and were scheduled for coronary stenting at 15 centers in the Netherlands and Belgium. The patients averaged about 70 years of age, and about 80% were men. A total of 70% received daily, oral treatment with an anticoagulant for atrial fibrillation or flutter, about 10% for a mechanical valve, and the remaining 20% had other reasons for their regimen, including treatment of a pulmonary embolus. All patients received warfarin or another oral anticoagulant such as acenocoumarol. About two-thirds of the patients received a drug-eluting coronary stent, with the remainder receiving a bare-metal stent.

Following stenting, the researchers randomized patients to a regimen of their oral anticoagulant plus 75 mg clopidogrel daily (dual therapy), or their oral anticoagulant, clopidogrel, and 80 mg aspirin daily (triple therapy). The antiplatelet part of the regimen continued for at least 1 month in patients who received a bare-metal stent and for a year in those who got a drug-eluting stent.

Mitchel L. Zoler/IMNG Medical Media

After a year of follow-up, the incidence of the primary end point – total bleeding events – occurred in 20% of the 279 evaluable patients who received dual therapy and in 45% of 284 evaluable patients on triple therapy, a statistically significant difference, reported Dr. Dewilde, a cardiologist at TweeSteden Hospital in Tilberg, the Netherlands. The study’s secondary end point – the combined rate of death, myocardial infarction, target vessel revascularization, stroke, or stent thrombosis – occurred in 11% of patients on double therapy and 18% of those on triple therapy, a statistically significant difference.

Patients on dual therapy had a significantly lower rate of all-cause death, compared with the triple-therapy patients, 3% compared with 6%, and numerically lower levels of stent thrombosis, stroke, and myocardial infarction, although the differences for these individual end points were not statistically significant.

The dual-therapy patients also had significantly lower rates of minimal or minor bleeds, measured by the TIMI (Thrombolysis in Myocardial Infarction) criteria, and the rate of TIMI major bleeds was also lower on dual therapy, but not significantly. The dual-therapy patients had strikingly lower numbers of bleeds at gastrointestinal sites and skin sites, compared with the triple-therapy patients.

"TIMI minimal and minor bleeds are anything but minor from a clinical standpoint," noted Dr. Valgimigli. "Double therapy with clopidogrel and warfarin seems a very reasonable therapy based on WOEST, especially in DES-treated patients."

Dr. Dewilde and Dr. Holmes said that they had no disclosures. Dr. Valgimigli said that he has served on the speakers bureau for AstraZeneca, Eli Lilly, Iroko, and other companies that market vascular devices. He has also been on advisory boards for Eli Lilly, and several companies that make vascular devices. Dr. Smith said that he had no disclosures.

MUNICH – Patients who require chronic oral anticoagulant treatment and received a coronary stent had significantly fewer bleeding events and better outcomes if they received only added clopidogrel than if they were treated with clopidogrel plus aspirin on top of their anticoagulant in the WOEST trial.

As the first study to prospectively test the best combination of antiplatelet drugs to use on top of anticoagulant treatment in patients following coronary stenting, experts hailed the finding as important evidence to address a common and vexing clinical situation.

Mitchel L. Zoler/IMNG Medical Media

"We propose that a strategy of oral anticoagulants plus clopidogrel, but without aspirin could be applied in this group of high-risk patients who are on an oral anticoagulant and undergo percutaneous coronary intervention," said Dr. Willem Dewilde, lead investigator for the study, at the Annual Congress of the European Society of Cardiology.

"We are faced with a huge clinical problem, with an increasing number of patients with atrial fibrillation who undergo stent procedures, so this finding has major implications," commented Dr. David R. Holmes Jr., professor of medicine and a cardiologist at the Mayo Clinic in Rochester, Minn. "Bleeding is such a huge issue, and we now have scientific data that says [withholding aspirin] is safe and produces less bleeding."

"The taboo against discontinuing or omitting aspirin has been broken," commented Dr. Marco Valgimigli, director of the coronary catheterization laboratory at the University Hospital of Ferrara (Italy).

The WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting) trial enrolled 573 patients who required chronic oral anticoagulant treatment and were scheduled for coronary stenting at 15 centers in the Netherlands and Belgium. The patients averaged about 70 years of age, and about 80% were men. A total of 70% received daily, oral treatment with an anticoagulant for atrial fibrillation or flutter, about 10% for a mechanical valve, and the remaining 20% had other reasons for their regimen, including treatment of a pulmonary embolus. All patients received warfarin or another oral anticoagulant such as acenocoumarol. About two-thirds of the patients received a drug-eluting coronary stent, with the remainder receiving a bare-metal stent.

Following stenting, the researchers randomized patients to a regimen of their oral anticoagulant plus 75 mg clopidogrel daily (dual therapy), or their oral anticoagulant, clopidogrel, and 80 mg aspirin daily (triple therapy). The antiplatelet part of the regimen continued for at least 1 month in patients who received a bare-metal stent and for a year in those who got a drug-eluting stent.

Mitchel L. Zoler/IMNG Medical Media

After a year of follow-up, the incidence of the primary end point – total bleeding events – occurred in 20% of the 279 evaluable patients who received dual therapy and in 45% of 284 evaluable patients on triple therapy, a statistically significant difference, reported Dr. Dewilde, a cardiologist at TweeSteden Hospital in Tilberg, the Netherlands. The study’s secondary end point – the combined rate of death, myocardial infarction, target vessel revascularization, stroke, or stent thrombosis – occurred in 11% of patients on double therapy and 18% of those on triple therapy, a statistically significant difference.

Patients on dual therapy had a significantly lower rate of all-cause death, compared with the triple-therapy patients, 3% compared with 6%, and numerically lower levels of stent thrombosis, stroke, and myocardial infarction, although the differences for these individual end points were not statistically significant.

The dual-therapy patients also had significantly lower rates of minimal or minor bleeds, measured by the TIMI (Thrombolysis in Myocardial Infarction) criteria, and the rate of TIMI major bleeds was also lower on dual therapy, but not significantly. The dual-therapy patients had strikingly lower numbers of bleeds at gastrointestinal sites and skin sites, compared with the triple-therapy patients.

"TIMI minimal and minor bleeds are anything but minor from a clinical standpoint," noted Dr. Valgimigli. "Double therapy with clopidogrel and warfarin seems a very reasonable therapy based on WOEST, especially in DES-treated patients."

Dr. Dewilde and Dr. Holmes said that they had no disclosures. Dr. Valgimigli said that he has served on the speakers bureau for AstraZeneca, Eli Lilly, Iroko, and other companies that market vascular devices. He has also been on advisory boards for Eli Lilly, and several companies that make vascular devices. Dr. Smith said that he had no disclosures.

SILVER SPRING, MD. – Intravenous phenylephrine, used widely for decades to increase blood pressure in patients who become hypotensive during anesthesia, in intensive care, and in other situations, should be approved for use to increase blood pressure in patients who become hypotensive during neuraxial anesthesia, a Food and Drug Administration advisory panel unanimously agreed at a meeting on Sept. 13.

However, at the meeting the Cardiovascular and Renal Drugs Advisory Committee voted 8 to 2 against recommending approval of IV phenylephrine as a treatment to increase blood pressure in acute hypotensive states, such as shock, because more studies are needed.

IV phenylephrine, a selective alpha₁-adrenergic receptor agonist, has been used for decades without being approved by the FDA, since it was available before the current drug approval process was established, and is one of the unapproved products that the FDA considers medically necessary.

As a result of the FDA’s Unapproved Drugs Initiative, West-Ward Pharmaceuticals submitted an application for approval of intravenous phenylephrine "to increase blood pressure in acute hypotensive states, such as shock and perioperative hypotension." The application included 50 published studies, mostly of low-risk women who had neuraxial anesthesia during cesarean delivery.

At the meeting, company officials and clinicians who spoke on behalf of the company summarized the results of these studies, published from the 1980s through 2010.

Only eight studies were in patients with sepsis or septic shock, so the benefits and risks of IV phenylephrine for this use were limited, and there were no studies on the use of IV phenylephrine as a treatment for other types of shock, according to the FDA.

For indications other than neuraxial anesthesia, more data are needed before approval, including more data on efficacy and the impact of treatment on end-organ damage, said panel chair Dr. A. Michael Lincoff, professor of medicine at the Cleveland Clinic.

One of the two panelists voting in favor of approval for the full indication (including acute hypotensive episodes due to shock), Dr. Joseph Tobin, professor of anesthesiology and pediatrics at Wake Forest Baptist Health, Winston-Salem, N.C., said that he felt comfortable after 30 years of use with this drug for the full indication, as proposed by the company.

The FDA usually follows the recommendations of its advisory panels. Panel members had no conflicts to disclose.

SILVER SPRING, MD. – Intravenous phenylephrine, used widely for decades to increase blood pressure in patients who become hypotensive during anesthesia, in intensive care, and in other situations, should be approved for use to increase blood pressure in patients who become hypotensive during neuraxial anesthesia, a Food and Drug Administration advisory panel unanimously agreed at a meeting on Sept. 13.

However, at the meeting the Cardiovascular and Renal Drugs Advisory Committee voted 8 to 2 against recommending approval of IV phenylephrine as a treatment to increase blood pressure in acute hypotensive states, such as shock, because more studies are needed.

IV phenylephrine, a selective alpha₁-adrenergic receptor agonist, has been used for decades without being approved by the FDA, since it was available before the current drug approval process was established, and is one of the unapproved products that the FDA considers medically necessary.

As a result of the FDA’s Unapproved Drugs Initiative, West-Ward Pharmaceuticals submitted an application for approval of intravenous phenylephrine "to increase blood pressure in acute hypotensive states, such as shock and perioperative hypotension." The application included 50 published studies, mostly of low-risk women who had neuraxial anesthesia during cesarean delivery.

At the meeting, company officials and clinicians who spoke on behalf of the company summarized the results of these studies, published from the 1980s through 2010.

Only eight studies were in patients with sepsis or septic shock, so the benefits and risks of IV phenylephrine for this use were limited, and there were no studies on the use of IV phenylephrine as a treatment for other types of shock, according to the FDA.

For indications other than neuraxial anesthesia, more data are needed before approval, including more data on efficacy and the impact of treatment on end-organ damage, said panel chair Dr. A. Michael Lincoff, professor of medicine at the Cleveland Clinic.

One of the two panelists voting in favor of approval for the full indication (including acute hypotensive episodes due to shock), Dr. Joseph Tobin, professor of anesthesiology and pediatrics at Wake Forest Baptist Health, Winston-Salem, N.C., said that he felt comfortable after 30 years of use with this drug for the full indication, as proposed by the company.

The FDA usually follows the recommendations of its advisory panels. Panel members had no conflicts to disclose.

SILVER SPRING, MD. – Intravenous phenylephrine, used widely for decades to increase blood pressure in patients who become hypotensive during anesthesia, in intensive care, and in other situations, should be approved for use to increase blood pressure in patients who become hypotensive during neuraxial anesthesia, a Food and Drug Administration advisory panel unanimously agreed at a meeting on Sept. 13.

However, at the meeting the Cardiovascular and Renal Drugs Advisory Committee voted 8 to 2 against recommending approval of IV phenylephrine as a treatment to increase blood pressure in acute hypotensive states, such as shock, because more studies are needed.

IV phenylephrine, a selective alpha₁-adrenergic receptor agonist, has been used for decades without being approved by the FDA, since it was available before the current drug approval process was established, and is one of the unapproved products that the FDA considers medically necessary.

As a result of the FDA’s Unapproved Drugs Initiative, West-Ward Pharmaceuticals submitted an application for approval of intravenous phenylephrine "to increase blood pressure in acute hypotensive states, such as shock and perioperative hypotension." The application included 50 published studies, mostly of low-risk women who had neuraxial anesthesia during cesarean delivery.

At the meeting, company officials and clinicians who spoke on behalf of the company summarized the results of these studies, published from the 1980s through 2010.

Only eight studies were in patients with sepsis or septic shock, so the benefits and risks of IV phenylephrine for this use were limited, and there were no studies on the use of IV phenylephrine as a treatment for other types of shock, according to the FDA.

For indications other than neuraxial anesthesia, more data are needed before approval, including more data on efficacy and the impact of treatment on end-organ damage, said panel chair Dr. A. Michael Lincoff, professor of medicine at the Cleveland Clinic.

One of the two panelists voting in favor of approval for the full indication (including acute hypotensive episodes due to shock), Dr. Joseph Tobin, professor of anesthesiology and pediatrics at Wake Forest Baptist Health, Winston-Salem, N.C., said that he felt comfortable after 30 years of use with this drug for the full indication, as proposed by the company.

The FDA usually follows the recommendations of its advisory panels. Panel members had no conflicts to disclose.

For patients discharged after hospitalization for heart failure, case-management interventions led by a specialist nurse reduce HF-related readmissions, HF-related mortality, and all-cause mortality, according to an update published online Sept. 11 in the Cochrane Database of Systematic Reviews.

© Dron/Fotolia.com

The initial Cochrane Review that addressed the effectiveness of three different types of follow-up care (case-management, clinic-based, and multidisciplinary) after hospitalization for HF was published in 2005, and found mixed and inconclusive results for all three (Cochrane Database Syst. Rev. 2005 8;(2):CD002752).

Since then, several new clinical trials have been performed, and "there is now strong evidence that case-management interventions are associated with a substantial, statistically significant reduction in all-cause mortality" as well as HF mortality and rehospitalization, said Dr. Andrea Takeda of Queen Mary University, London, and her associates in the Cochrane Collaboration.

In contrast, the evidence doesn’t support interventions in which the major component is follow-up in a hospital HF clinic. And the evidence for multidisciplinary interventions is too sparse to be conclusive because only two high-quality studies have examined these approaches, the investigators wrote (Cochrane Database of Systematic Reviews 2012 [doi:101002/14651858.CD002752.pub3]).

Case-management programs led by personnel other than nurses specializing in HF, such as hospital-based or community pharmacists, nonspecialist nurses, or interdisciplinary teams, were not as successful as those led by specialist nurses, they added.

Dr. Takeda and her colleagues reviewed 25 randomized clinical trials of at least 6 months’ duration that compared the three types of interventions against usual care in 5,942 adults who had been hospitalized for HF. They excluded interventions that focused on patient education only, exercise only, telemedicine (which was examined in a separate Cochrane Review), or cardiac rehabilitation.

Most of the clinical trials had 100-350 study subjects, but some had fewer than 100 and one had over 1,000 subjects. They were conducted in Europe, the United States, Canada, Australia, and China.

Seventeen studies assessed case-management interventions. Pooling the results demonstrated that these interventions produced a substantial and highly significant reduction in all-cause mortality, HF-related mortality, and HF-related rehospitalization at 12 months. Although the overall impact of the interventions on inpatient days was "not clear," the researchers wrote, there was "a strong suggestion" that these interventions decreased hospital length of stay.

However, case-management interventions did not appear to improve event-free survival. They also did not appear to improve health-related quality of life, but few studies examined this outcome and those that did suffered from high dropout rates, so the data were inconclusive.

Only six clinical trials involving 1,486 patients assessed clinic-based interventions. They showed no reduction in readmissions, mortality, inpatient days, event-free survival, or health-related quality of life.

Only two clinical trials involving 403 patients assessed multidisciplinary programs. The data were inadequate to establish conclusive results, Dr. Takeda and her associates wrote.

In a post hoc analysis, the intensity of various interventions did not appear to influence their effectiveness. Studies of the most intensive, moderately intensive, and low-intensity interventions all showed some reductions in mortality and rehospitalization, the researchers added.

No financial conflicts of interest were reported.

For patients discharged after hospitalization for heart failure, case-management interventions led by a specialist nurse reduce HF-related readmissions, HF-related mortality, and all-cause mortality, according to an update published online Sept. 11 in the Cochrane Database of Systematic Reviews.

© Dron/Fotolia.com

The initial Cochrane Review that addressed the effectiveness of three different types of follow-up care (case-management, clinic-based, and multidisciplinary) after hospitalization for HF was published in 2005, and found mixed and inconclusive results for all three (Cochrane Database Syst. Rev. 2005 8;(2):CD002752).

Since then, several new clinical trials have been performed, and "there is now strong evidence that case-management interventions are associated with a substantial, statistically significant reduction in all-cause mortality" as well as HF mortality and rehospitalization, said Dr. Andrea Takeda of Queen Mary University, London, and her associates in the Cochrane Collaboration.

In contrast, the evidence doesn’t support interventions in which the major component is follow-up in a hospital HF clinic. And the evidence for multidisciplinary interventions is too sparse to be conclusive because only two high-quality studies have examined these approaches, the investigators wrote (Cochrane Database of Systematic Reviews 2012 [doi:101002/14651858.CD002752.pub3]).

Case-management programs led by personnel other than nurses specializing in HF, such as hospital-based or community pharmacists, nonspecialist nurses, or interdisciplinary teams, were not as successful as those led by specialist nurses, they added.

Dr. Takeda and her colleagues reviewed 25 randomized clinical trials of at least 6 months’ duration that compared the three types of interventions against usual care in 5,942 adults who had been hospitalized for HF. They excluded interventions that focused on patient education only, exercise only, telemedicine (which was examined in a separate Cochrane Review), or cardiac rehabilitation.

Most of the clinical trials had 100-350 study subjects, but some had fewer than 100 and one had over 1,000 subjects. They were conducted in Europe, the United States, Canada, Australia, and China.

Seventeen studies assessed case-management interventions. Pooling the results demonstrated that these interventions produced a substantial and highly significant reduction in all-cause mortality, HF-related mortality, and HF-related rehospitalization at 12 months. Although the overall impact of the interventions on inpatient days was "not clear," the researchers wrote, there was "a strong suggestion" that these interventions decreased hospital length of stay.

However, case-management interventions did not appear to improve event-free survival. They also did not appear to improve health-related quality of life, but few studies examined this outcome and those that did suffered from high dropout rates, so the data were inconclusive.

Only six clinical trials involving 1,486 patients assessed clinic-based interventions. They showed no reduction in readmissions, mortality, inpatient days, event-free survival, or health-related quality of life.

Only two clinical trials involving 403 patients assessed multidisciplinary programs. The data were inadequate to establish conclusive results, Dr. Takeda and her associates wrote.

In a post hoc analysis, the intensity of various interventions did not appear to influence their effectiveness. Studies of the most intensive, moderately intensive, and low-intensity interventions all showed some reductions in mortality and rehospitalization, the researchers added.

No financial conflicts of interest were reported.

For patients discharged after hospitalization for heart failure, case-management interventions led by a specialist nurse reduce HF-related readmissions, HF-related mortality, and all-cause mortality, according to an update published online Sept. 11 in the Cochrane Database of Systematic Reviews.

© Dron/Fotolia.com

The initial Cochrane Review that addressed the effectiveness of three different types of follow-up care (case-management, clinic-based, and multidisciplinary) after hospitalization for HF was published in 2005, and found mixed and inconclusive results for all three (Cochrane Database Syst. Rev. 2005 8;(2):CD002752).

Since then, several new clinical trials have been performed, and "there is now strong evidence that case-management interventions are associated with a substantial, statistically significant reduction in all-cause mortality" as well as HF mortality and rehospitalization, said Dr. Andrea Takeda of Queen Mary University, London, and her associates in the Cochrane Collaboration.

In contrast, the evidence doesn’t support interventions in which the major component is follow-up in a hospital HF clinic. And the evidence for multidisciplinary interventions is too sparse to be conclusive because only two high-quality studies have examined these approaches, the investigators wrote (Cochrane Database of Systematic Reviews 2012 [doi:101002/14651858.CD002752.pub3]).

Case-management programs led by personnel other than nurses specializing in HF, such as hospital-based or community pharmacists, nonspecialist nurses, or interdisciplinary teams, were not as successful as those led by specialist nurses, they added.

Dr. Takeda and her colleagues reviewed 25 randomized clinical trials of at least 6 months’ duration that compared the three types of interventions against usual care in 5,942 adults who had been hospitalized for HF. They excluded interventions that focused on patient education only, exercise only, telemedicine (which was examined in a separate Cochrane Review), or cardiac rehabilitation.

Most of the clinical trials had 100-350 study subjects, but some had fewer than 100 and one had over 1,000 subjects. They were conducted in Europe, the United States, Canada, Australia, and China.

Seventeen studies assessed case-management interventions. Pooling the results demonstrated that these interventions produced a substantial and highly significant reduction in all-cause mortality, HF-related mortality, and HF-related rehospitalization at 12 months. Although the overall impact of the interventions on inpatient days was "not clear," the researchers wrote, there was "a strong suggestion" that these interventions decreased hospital length of stay.

However, case-management interventions did not appear to improve event-free survival. They also did not appear to improve health-related quality of life, but few studies examined this outcome and those that did suffered from high dropout rates, so the data were inconclusive.

Only six clinical trials involving 1,486 patients assessed clinic-based interventions. They showed no reduction in readmissions, mortality, inpatient days, event-free survival, or health-related quality of life.

Only two clinical trials involving 403 patients assessed multidisciplinary programs. The data were inadequate to establish conclusive results, Dr. Takeda and her associates wrote.

In a post hoc analysis, the intensity of various interventions did not appear to influence their effectiveness. Studies of the most intensive, moderately intensive, and low-intensity interventions all showed some reductions in mortality and rehospitalization, the researchers added.

No financial conflicts of interest were reported.

An observational study of nearly 1 million adults undergoing major surgery has found that those with hyponatremia saw a 44% increased risk of death within 30 days of surgery, compared with subjects without the disorder.

Hyponatremia is already a known negative prognostic factor in heart failure, liver disease, kidney disease, and pneumonia. The new study, published online Sept. 10 in Archives of Internal Medicine (doi:10.1001/archinternmed.2012.3992), marks the first time that hyponatremia has been linked to higher risk of postsurgical mortality. Patients with any degree of hyponatremia before surgery saw a 5.2% risk of death, compared with 1.3% for patients without the disorder, even after the researchers adjusted for potential confounders (adjusted odds ratio 1.44; 95% confidence interval, 1.38-1.50).

Adding to this stark finding was the fact that among patients undergoing elective surgery, the mortality risk associated with hyponatremia was even higher (aOR 1.59; 95% CI 1.50-1.69) and more pronounced still among a subgroup of subjects considered the healthiest preoperative candidates, those with a class 1 or 2 status according to American Society of Anesthesiologists criteria (aOR 1.93; 1.57-2.36).

For their research, investigators Dr. Alexander A. Leung of Brigham and Women’s Hospital, Boston, and his colleagues, identified 964,263 adults undergoing major surgery from more than 200 hospitals between from January 2005 through December 2010 and evaluated their 30-day perioperative outcomes. Presurgery serum sodium levels were available for all patients included in the study.

Hyponatremia, defined as a serum sodium level of less than 135 mEq/L, occurred in 7.8% of all study patients, with 89% of these cases classified as "mild."

Dr. Leung and his colleagues wrote that their findings show that even mild hyponatremia preceding surgery is "not inconsequential and should not be ignored." In addition to the increased mortality risk, the investigators also found the presence of hyponatremia to be associated with significantly increased risk of morbidity, including major coronary events (1.8% vs. 0.7%; aOR 1.21; 95% CI 1.14-1.29), wound infections (7.4% vs. 4.6%; 1.24; 1.20-1.28), and pneumonia (3.7% vs. 1.5%; 1.17; 1.12-1.22).

Also, median length of hospital stay was prolonged by approximately 1 day among subjects with hyponatremia.

Dr. Leung and his colleagues wrote in their analysis that further research was needed to clarify whether hyponatremia caused adverse events or whether it merely indicated the presence of other serious underlying conditions contributing to morbidity and mortality.

The authors stopped short of making explicit clinical recommendations about correcting hyponatremia when it is detected prior to surgery.

Inducing rapid changes to sodium levels in a short period of time "can be potentially disastrous," the investigators wrote. However, "if monitored correction of hyponatremia is found to be safe and beneficial, it would strengthen causal inference and would be transformative to routine care since serum sodium is not presently recognized as an independent and reversible risk factor for perioperative complications."

Until further studies establish that reversing hyponatremia before surgery does in fact reduce risk, "one reasonable approach is to monitor for perioperative complications in all patients at risk and to selectively treat hyponatremia before nonemergency surgical procedures when a reversible cause is found," Dr. Leung and his colleagues wrote.

The investigators noted among the weaknesses of their study its observational design, the potential existence of unmeasured confounders, and a lack of medication data that did not allow them to determine how risk may vary according to different drug exposures.

Dr. Leung and his colleagues’ study was supported in part by Alberta Innovates–Health Solutions and the Canadian Institutes for Health Research. They reported having no relevant conflicts of interest.

An observational study of nearly 1 million adults undergoing major surgery has found that those with hyponatremia saw a 44% increased risk of death within 30 days of surgery, compared with subjects without the disorder.

Hyponatremia is already a known negative prognostic factor in heart failure, liver disease, kidney disease, and pneumonia. The new study, published online Sept. 10 in Archives of Internal Medicine (doi:10.1001/archinternmed.2012.3992), marks the first time that hyponatremia has been linked to higher risk of postsurgical mortality. Patients with any degree of hyponatremia before surgery saw a 5.2% risk of death, compared with 1.3% for patients without the disorder, even after the researchers adjusted for potential confounders (adjusted odds ratio 1.44; 95% confidence interval, 1.38-1.50).

Adding to this stark finding was the fact that among patients undergoing elective surgery, the mortality risk associated with hyponatremia was even higher (aOR 1.59; 95% CI 1.50-1.69) and more pronounced still among a subgroup of subjects considered the healthiest preoperative candidates, those with a class 1 or 2 status according to American Society of Anesthesiologists criteria (aOR 1.93; 1.57-2.36).

For their research, investigators Dr. Alexander A. Leung of Brigham and Women’s Hospital, Boston, and his colleagues, identified 964,263 adults undergoing major surgery from more than 200 hospitals between from January 2005 through December 2010 and evaluated their 30-day perioperative outcomes. Presurgery serum sodium levels were available for all patients included in the study.

Hyponatremia, defined as a serum sodium level of less than 135 mEq/L, occurred in 7.8% of all study patients, with 89% of these cases classified as "mild."

Dr. Leung and his colleagues wrote that their findings show that even mild hyponatremia preceding surgery is "not inconsequential and should not be ignored." In addition to the increased mortality risk, the investigators also found the presence of hyponatremia to be associated with significantly increased risk of morbidity, including major coronary events (1.8% vs. 0.7%; aOR 1.21; 95% CI 1.14-1.29), wound infections (7.4% vs. 4.6%; 1.24; 1.20-1.28), and pneumonia (3.7% vs. 1.5%; 1.17; 1.12-1.22).

Also, median length of hospital stay was prolonged by approximately 1 day among subjects with hyponatremia.

Dr. Leung and his colleagues wrote in their analysis that further research was needed to clarify whether hyponatremia caused adverse events or whether it merely indicated the presence of other serious underlying conditions contributing to morbidity and mortality.

The authors stopped short of making explicit clinical recommendations about correcting hyponatremia when it is detected prior to surgery.

Inducing rapid changes to sodium levels in a short period of time "can be potentially disastrous," the investigators wrote. However, "if monitored correction of hyponatremia is found to be safe and beneficial, it would strengthen causal inference and would be transformative to routine care since serum sodium is not presently recognized as an independent and reversible risk factor for perioperative complications."

Until further studies establish that reversing hyponatremia before surgery does in fact reduce risk, "one reasonable approach is to monitor for perioperative complications in all patients at risk and to selectively treat hyponatremia before nonemergency surgical procedures when a reversible cause is found," Dr. Leung and his colleagues wrote.

The investigators noted among the weaknesses of their study its observational design, the potential existence of unmeasured confounders, and a lack of medication data that did not allow them to determine how risk may vary according to different drug exposures.

Dr. Leung and his colleagues’ study was supported in part by Alberta Innovates–Health Solutions and the Canadian Institutes for Health Research. They reported having no relevant conflicts of interest.

An observational study of nearly 1 million adults undergoing major surgery has found that those with hyponatremia saw a 44% increased risk of death within 30 days of surgery, compared with subjects without the disorder.

Hyponatremia is already a known negative prognostic factor in heart failure, liver disease, kidney disease, and pneumonia. The new study, published online Sept. 10 in Archives of Internal Medicine (doi:10.1001/archinternmed.2012.3992), marks the first time that hyponatremia has been linked to higher risk of postsurgical mortality. Patients with any degree of hyponatremia before surgery saw a 5.2% risk of death, compared with 1.3% for patients without the disorder, even after the researchers adjusted for potential confounders (adjusted odds ratio 1.44; 95% confidence interval, 1.38-1.50).

Adding to this stark finding was the fact that among patients undergoing elective surgery, the mortality risk associated with hyponatremia was even higher (aOR 1.59; 95% CI 1.50-1.69) and more pronounced still among a subgroup of subjects considered the healthiest preoperative candidates, those with a class 1 or 2 status according to American Society of Anesthesiologists criteria (aOR 1.93; 1.57-2.36).

For their research, investigators Dr. Alexander A. Leung of Brigham and Women’s Hospital, Boston, and his colleagues, identified 964,263 adults undergoing major surgery from more than 200 hospitals between from January 2005 through December 2010 and evaluated their 30-day perioperative outcomes. Presurgery serum sodium levels were available for all patients included in the study.

Hyponatremia, defined as a serum sodium level of less than 135 mEq/L, occurred in 7.8% of all study patients, with 89% of these cases classified as "mild."

Dr. Leung and his colleagues wrote that their findings show that even mild hyponatremia preceding surgery is "not inconsequential and should not be ignored." In addition to the increased mortality risk, the investigators also found the presence of hyponatremia to be associated with significantly increased risk of morbidity, including major coronary events (1.8% vs. 0.7%; aOR 1.21; 95% CI 1.14-1.29), wound infections (7.4% vs. 4.6%; 1.24; 1.20-1.28), and pneumonia (3.7% vs. 1.5%; 1.17; 1.12-1.22).

Also, median length of hospital stay was prolonged by approximately 1 day among subjects with hyponatremia.

Dr. Leung and his colleagues wrote in their analysis that further research was needed to clarify whether hyponatremia caused adverse events or whether it merely indicated the presence of other serious underlying conditions contributing to morbidity and mortality.

The authors stopped short of making explicit clinical recommendations about correcting hyponatremia when it is detected prior to surgery.

Inducing rapid changes to sodium levels in a short period of time "can be potentially disastrous," the investigators wrote. However, "if monitored correction of hyponatremia is found to be safe and beneficial, it would strengthen causal inference and would be transformative to routine care since serum sodium is not presently recognized as an independent and reversible risk factor for perioperative complications."

Until further studies establish that reversing hyponatremia before surgery does in fact reduce risk, "one reasonable approach is to monitor for perioperative complications in all patients at risk and to selectively treat hyponatremia before nonemergency surgical procedures when a reversible cause is found," Dr. Leung and his colleagues wrote.

The investigators noted among the weaknesses of their study its observational design, the potential existence of unmeasured confounders, and a lack of medication data that did not allow them to determine how risk may vary according to different drug exposures.

Dr. Leung and his colleagues’ study was supported in part by Alberta Innovates–Health Solutions and the Canadian Institutes for Health Research. They reported having no relevant conflicts of interest.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to a report published Sept. 4 in The Lancet.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates.

Yuri_Arcurs/iStockphoto.com

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines-Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

The study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to a report published Sept. 4 in The Lancet.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates.

Yuri_Arcurs/iStockphoto.com

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines-Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

The study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to a report published Sept. 4 in The Lancet.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates.

Yuri_Arcurs/iStockphoto.com

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines-Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

The study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

HOUSTON – Nurses using a computerized algorithm maintained better glycemic control, compared with expert nursing care without the algorithm, in a prospective, randomized study of 300 patients in one institution’s ICU.

Baseline characteristics did not differ between the 151 patients randomized to nursing care and the 149 patients cared for by nurses using the LOGIC-Insulin computerized algorithm developed by Dr. Dieter Mesotten and his associates at Catholic University of Leuven, Belgium. Mean blood glucose levels during ICU care also were similar between groups: 106 mg/dL in both groups.

Sherry Boschert/IMNG Medical Media

On other measures of glycemic control, however, the LOGIC group scored significantly better than did the nurses group, he reported in a poster presentation at the annual meeting of the Endocrine Society. The LOGIC group had a significantly lower mean score on the Glycemic Penalty Index, a marker of efficacy of blood glucose control that was the primary outcome measure of efficacy in the study: 9.8 vs. 12.4 in the nurses group.

Patients in the LOGIC group were less likely to develop critically low glucose levels, they spent more time in the study’s target range of 80-110mg/dL, and they had narrower swings between minimum and maximum blood-sugar measurements, indicating less blood glucose variability.

Mean scores on the Hyperglycemic Index were significantly lower in the LOGIC group (2.5 mg/dL), compared with the nurses group (4.2 mg/dL). Patients in the LOGIC group reached the target range of 80-110 mg/dL faster (in 2 hours on average instead of 3 hours in the nurses group) and were within the target range 69% of the time while in the ICU, compared with 60% of the time for patients in the nurses group. The mean daily difference between minimum and maximum blood glucose levels was 31 mg/dL in the LOGIC group and 37 mg/dL in the nurses group, Dr. Mesotten reported.

The patients had been admitted to the ICU after cardiac surgery (49% in the nurses group and 51% in the LOGIC group), following transplantation (17% and 13%, respectively), because of medical problems (15% and 17%), respectively, or for other reasons.

In general, maintaining tight blood control in critically ill patients is labor intensive and difficult. The LOGIC algorithm may have made this task more successful but also appeared to add a bit to the nursing team’s workload by increasing the frequency of glucose measurements. Nurses in the LOGIC group measured blood glucose levels every 2.2 hours on average, compared with every 2.5 hours in the nursing-only group, a statistically significant difference.

Patients averaged 64 years in age, 60% were male, and 21% had diabetes when admitted to the ICU.

Dr. Mesotten reported having no financial disclosures. Belgian public agencies funded the study.

HOUSTON – Nurses using a computerized algorithm maintained better glycemic control, compared with expert nursing care without the algorithm, in a prospective, randomized study of 300 patients in one institution’s ICU.

Baseline characteristics did not differ between the 151 patients randomized to nursing care and the 149 patients cared for by nurses using the LOGIC-Insulin computerized algorithm developed by Dr. Dieter Mesotten and his associates at Catholic University of Leuven, Belgium. Mean blood glucose levels during ICU care also were similar between groups: 106 mg/dL in both groups.

Sherry Boschert/IMNG Medical Media

On other measures of glycemic control, however, the LOGIC group scored significantly better than did the nurses group, he reported in a poster presentation at the annual meeting of the Endocrine Society. The LOGIC group had a significantly lower mean score on the Glycemic Penalty Index, a marker of efficacy of blood glucose control that was the primary outcome measure of efficacy in the study: 9.8 vs. 12.4 in the nurses group.

Patients in the LOGIC group were less likely to develop critically low glucose levels, they spent more time in the study’s target range of 80-110mg/dL, and they had narrower swings between minimum and maximum blood-sugar measurements, indicating less blood glucose variability.

Mean scores on the Hyperglycemic Index were significantly lower in the LOGIC group (2.5 mg/dL), compared with the nurses group (4.2 mg/dL). Patients in the LOGIC group reached the target range of 80-110 mg/dL faster (in 2 hours on average instead of 3 hours in the nurses group) and were within the target range 69% of the time while in the ICU, compared with 60% of the time for patients in the nurses group. The mean daily difference between minimum and maximum blood glucose levels was 31 mg/dL in the LOGIC group and 37 mg/dL in the nurses group, Dr. Mesotten reported.

The patients had been admitted to the ICU after cardiac surgery (49% in the nurses group and 51% in the LOGIC group), following transplantation (17% and 13%, respectively), because of medical problems (15% and 17%), respectively, or for other reasons.

In general, maintaining tight blood control in critically ill patients is labor intensive and difficult. The LOGIC algorithm may have made this task more successful but also appeared to add a bit to the nursing team’s workload by increasing the frequency of glucose measurements. Nurses in the LOGIC group measured blood glucose levels every 2.2 hours on average, compared with every 2.5 hours in the nursing-only group, a statistically significant difference.

Patients averaged 64 years in age, 60% were male, and 21% had diabetes when admitted to the ICU.

Dr. Mesotten reported having no financial disclosures. Belgian public agencies funded the study.

HOUSTON – Nurses using a computerized algorithm maintained better glycemic control, compared with expert nursing care without the algorithm, in a prospective, randomized study of 300 patients in one institution’s ICU.

Baseline characteristics did not differ between the 151 patients randomized to nursing care and the 149 patients cared for by nurses using the LOGIC-Insulin computerized algorithm developed by Dr. Dieter Mesotten and his associates at Catholic University of Leuven, Belgium. Mean blood glucose levels during ICU care also were similar between groups: 106 mg/dL in both groups.

Sherry Boschert/IMNG Medical Media

On other measures of glycemic control, however, the LOGIC group scored significantly better than did the nurses group, he reported in a poster presentation at the annual meeting of the Endocrine Society. The LOGIC group had a significantly lower mean score on the Glycemic Penalty Index, a marker of efficacy of blood glucose control that was the primary outcome measure of efficacy in the study: 9.8 vs. 12.4 in the nurses group.

Patients in the LOGIC group were less likely to develop critically low glucose levels, they spent more time in the study’s target range of 80-110mg/dL, and they had narrower swings between minimum and maximum blood-sugar measurements, indicating less blood glucose variability.

Mean scores on the Hyperglycemic Index were significantly lower in the LOGIC group (2.5 mg/dL), compared with the nurses group (4.2 mg/dL). Patients in the LOGIC group reached the target range of 80-110 mg/dL faster (in 2 hours on average instead of 3 hours in the nurses group) and were within the target range 69% of the time while in the ICU, compared with 60% of the time for patients in the nurses group. The mean daily difference between minimum and maximum blood glucose levels was 31 mg/dL in the LOGIC group and 37 mg/dL in the nurses group, Dr. Mesotten reported.

The patients had been admitted to the ICU after cardiac surgery (49% in the nurses group and 51% in the LOGIC group), following transplantation (17% and 13%, respectively), because of medical problems (15% and 17%), respectively, or for other reasons.

In general, maintaining tight blood control in critically ill patients is labor intensive and difficult. The LOGIC algorithm may have made this task more successful but also appeared to add a bit to the nursing team’s workload by increasing the frequency of glucose measurements. Nurses in the LOGIC group measured blood glucose levels every 2.2 hours on average, compared with every 2.5 hours in the nursing-only group, a statistically significant difference.

Patients averaged 64 years in age, 60% were male, and 21% had diabetes when admitted to the ICU.

Dr. Mesotten reported having no financial disclosures. Belgian public agencies funded the study.

SAN DIEGO – Of the many scales at a clinician’s disposal to measure acute pain, the three most commonly used are the Numerical Rating Scale, the Verbal Rating Scale, and the Visual Analog Scale, Dr. Jeffrey A. Stone said at the annual meeting of the Society of Neurointerventional Surgery.

"All of these scales have been shown to be statistically reliable and valid," said Dr. Stone, associate professor of neurointerventional surgery in the radiology department at the Mayo Clinic, Jacksonville, Fla. In his clinical experience, most patients prefer the Numerical Rating Scale (NRS) and the Verbal Rating Scale (VRS) because they are easy to use. "The other advantage is that these can be conducted by telephone or electronic diaries," he said.

The NRS is a familiar and commonly used 0-10 scale, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. "If patients tell you, ‘I’m a 5 out of 10,’ that can be difficult to gauge, particularly in the elderly," Dr. Stone said. "The VRS, a four-scale system ranging from no pain up to severe pain, is somewhat simpler and correlates well with the NRS."

With the Visual Analog Scale, patients are asked to make a vertical slash on a 100-mm line to denote their level of pain. "I use this scale a lot, but it can be cumbersome, particularly with follow-up," he said.

Factors to consider in the backdrop of pain intensity include rescue analgesics, which may be prescribed by other physicians for sleep or anxiety, or may be used to prevent pain from increased activity or to treat unrelated pain. "Another factor is concomitant pain treatments, such as acupuncture and chiropractic treatments," Dr. Stone said. "In addition, patients enrolled in the placebo group of a clinical trial are generally expected to have more pain medication use compared with those in an efficacious treatment group."

Other distinct components of pain include pain sensation and pain affect. Pain sensation "is the quality of the pain, such as burning, throbbing, or sharp pain versus dull pain," Dr. Stone said. "There are also temporal aspects to pain, such as variability of intensity over time; time to onset of meaningful pain relief; durability of pain relief; and the frequency, duration, and intensity of pain episodes. Pain affect is the mental distress caused by the pain."

Global pain assessments for pain sensation and pain affect include a modification of the McGill Pain Questionnaire (MPQ), known as the short-form MPQ, and the Brief Pain Inventory (BPI), which was adapted from the Wisconsin Brief Pain Questionnaire. The short-form MPQ contains 15 sensory and affective descriptors, while the BPI "does a much better job measuring the temporal aspect of pain and is often used in conjunction with the short-form MPQ," Dr. Stone said.

Two other core pain outcome domains are physical function and emotional function. Effective outcome measures for these domains include the Oswestry Disability Index (ODI), the Short Form-36 (SF-36), the Roland-Morris Disability Questionnaire (RMQ) and the Pain Disability Index (PDI).

The ODI, a 10-item questionnaire, "has been used in many pain trials," he said. "It looks at pain intensity but also other things such as lifting, the ability to walk, social life, sexual activity, and sleep cycle. It is a very accurate way to look at a patient’s global disability from pain."

He described the SF-36 as "a little bit more cumbersome for patients to complete" in measuring physical and emotional function. This tool provides an eight-scale profile of functional health and well-being scores, as well as a psychometric-based physical and mental health summary.

The 24-item RMQ consists of yes/no questions intended to measure self-perceived disability, while the 7-question PDI measures pain interference in physical and psychosocial role performance.

In a later interview, Dr. Stone said that the NRS, VRS, and VAS instruments can be used in hospitalized patients. Outcome measures such as the ODI and the RMQ "would not be very useful, as they ask many functional questions such as sex life [and] activity level, which would not be applicable to a hospitalized patient."

Dr. Stone said that he had no relevant financial disclosures to make.

SAN DIEGO – Of the many scales at a clinician’s disposal to measure acute pain, the three most commonly used are the Numerical Rating Scale, the Verbal Rating Scale, and the Visual Analog Scale, Dr. Jeffrey A. Stone said at the annual meeting of the Society of Neurointerventional Surgery.

"All of these scales have been shown to be statistically reliable and valid," said Dr. Stone, associate professor of neurointerventional surgery in the radiology department at the Mayo Clinic, Jacksonville, Fla. In his clinical experience, most patients prefer the Numerical Rating Scale (NRS) and the Verbal Rating Scale (VRS) because they are easy to use. "The other advantage is that these can be conducted by telephone or electronic diaries," he said.

The NRS is a familiar and commonly used 0-10 scale, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. "If patients tell you, ‘I’m a 5 out of 10,’ that can be difficult to gauge, particularly in the elderly," Dr. Stone said. "The VRS, a four-scale system ranging from no pain up to severe pain, is somewhat simpler and correlates well with the NRS."

With the Visual Analog Scale, patients are asked to make a vertical slash on a 100-mm line to denote their level of pain. "I use this scale a lot, but it can be cumbersome, particularly with follow-up," he said.

Factors to consider in the backdrop of pain intensity include rescue analgesics, which may be prescribed by other physicians for sleep or anxiety, or may be used to prevent pain from increased activity or to treat unrelated pain. "Another factor is concomitant pain treatments, such as acupuncture and chiropractic treatments," Dr. Stone said. "In addition, patients enrolled in the placebo group of a clinical trial are generally expected to have more pain medication use compared with those in an efficacious treatment group."

Other distinct components of pain include pain sensation and pain affect. Pain sensation "is the quality of the pain, such as burning, throbbing, or sharp pain versus dull pain," Dr. Stone said. "There are also temporal aspects to pain, such as variability of intensity over time; time to onset of meaningful pain relief; durability of pain relief; and the frequency, duration, and intensity of pain episodes. Pain affect is the mental distress caused by the pain."

Global pain assessments for pain sensation and pain affect include a modification of the McGill Pain Questionnaire (MPQ), known as the short-form MPQ, and the Brief Pain Inventory (BPI), which was adapted from the Wisconsin Brief Pain Questionnaire. The short-form MPQ contains 15 sensory and affective descriptors, while the BPI "does a much better job measuring the temporal aspect of pain and is often used in conjunction with the short-form MPQ," Dr. Stone said.

Two other core pain outcome domains are physical function and emotional function. Effective outcome measures for these domains include the Oswestry Disability Index (ODI), the Short Form-36 (SF-36), the Roland-Morris Disability Questionnaire (RMQ) and the Pain Disability Index (PDI).

The ODI, a 10-item questionnaire, "has been used in many pain trials," he said. "It looks at pain intensity but also other things such as lifting, the ability to walk, social life, sexual activity, and sleep cycle. It is a very accurate way to look at a patient’s global disability from pain."

He described the SF-36 as "a little bit more cumbersome for patients to complete" in measuring physical and emotional function. This tool provides an eight-scale profile of functional health and well-being scores, as well as a psychometric-based physical and mental health summary.

The 24-item RMQ consists of yes/no questions intended to measure self-perceived disability, while the 7-question PDI measures pain interference in physical and psychosocial role performance.

In a later interview, Dr. Stone said that the NRS, VRS, and VAS instruments can be used in hospitalized patients. Outcome measures such as the ODI and the RMQ "would not be very useful, as they ask many functional questions such as sex life [and] activity level, which would not be applicable to a hospitalized patient."

Dr. Stone said that he had no relevant financial disclosures to make.

SAN DIEGO – Of the many scales at a clinician’s disposal to measure acute pain, the three most commonly used are the Numerical Rating Scale, the Verbal Rating Scale, and the Visual Analog Scale, Dr. Jeffrey A. Stone said at the annual meeting of the Society of Neurointerventional Surgery.

"All of these scales have been shown to be statistically reliable and valid," said Dr. Stone, associate professor of neurointerventional surgery in the radiology department at the Mayo Clinic, Jacksonville, Fla. In his clinical experience, most patients prefer the Numerical Rating Scale (NRS) and the Verbal Rating Scale (VRS) because they are easy to use. "The other advantage is that these can be conducted by telephone or electronic diaries," he said.

The NRS is a familiar and commonly used 0-10 scale, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. "If patients tell you, ‘I’m a 5 out of 10,’ that can be difficult to gauge, particularly in the elderly," Dr. Stone said. "The VRS, a four-scale system ranging from no pain up to severe pain, is somewhat simpler and correlates well with the NRS."

With the Visual Analog Scale, patients are asked to make a vertical slash on a 100-mm line to denote their level of pain. "I use this scale a lot, but it can be cumbersome, particularly with follow-up," he said.

Factors to consider in the backdrop of pain intensity include rescue analgesics, which may be prescribed by other physicians for sleep or anxiety, or may be used to prevent pain from increased activity or to treat unrelated pain. "Another factor is concomitant pain treatments, such as acupuncture and chiropractic treatments," Dr. Stone said. "In addition, patients enrolled in the placebo group of a clinical trial are generally expected to have more pain medication use compared with those in an efficacious treatment group."

Other distinct components of pain include pain sensation and pain affect. Pain sensation "is the quality of the pain, such as burning, throbbing, or sharp pain versus dull pain," Dr. Stone said. "There are also temporal aspects to pain, such as variability of intensity over time; time to onset of meaningful pain relief; durability of pain relief; and the frequency, duration, and intensity of pain episodes. Pain affect is the mental distress caused by the pain."

Global pain assessments for pain sensation and pain affect include a modification of the McGill Pain Questionnaire (MPQ), known as the short-form MPQ, and the Brief Pain Inventory (BPI), which was adapted from the Wisconsin Brief Pain Questionnaire. The short-form MPQ contains 15 sensory and affective descriptors, while the BPI "does a much better job measuring the temporal aspect of pain and is often used in conjunction with the short-form MPQ," Dr. Stone said.

Two other core pain outcome domains are physical function and emotional function. Effective outcome measures for these domains include the Oswestry Disability Index (ODI), the Short Form-36 (SF-36), the Roland-Morris Disability Questionnaire (RMQ) and the Pain Disability Index (PDI).

The ODI, a 10-item questionnaire, "has been used in many pain trials," he said. "It looks at pain intensity but also other things such as lifting, the ability to walk, social life, sexual activity, and sleep cycle. It is a very accurate way to look at a patient’s global disability from pain."

He described the SF-36 as "a little bit more cumbersome for patients to complete" in measuring physical and emotional function. This tool provides an eight-scale profile of functional health and well-being scores, as well as a psychometric-based physical and mental health summary.

The 24-item RMQ consists of yes/no questions intended to measure self-perceived disability, while the 7-question PDI measures pain interference in physical and psychosocial role performance.

In a later interview, Dr. Stone said that the NRS, VRS, and VAS instruments can be used in hospitalized patients. Outcome measures such as the ODI and the RMQ "would not be very useful, as they ask many functional questions such as sex life [and] activity level, which would not be applicable to a hospitalized patient."

Dr. Stone said that he had no relevant financial disclosures to make.