Perioperative Medicine

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

A new program being spearheaded by surgeons at Johns Hopkins University, Baltimore, and patient safety experts aims to dramatically reduce surgical site infections, which occur in almost a third of colorectal procedures and are a major reason for readmissions.

According to a fact sheet on the Surgical Unit-Based Safety Program (SUSP), each year about 50 million people undergo surgery in the United States. Of those, 1 million develop serious complications and more than 150,000 die within 30 days.

The goals of SUSP are to reduce surgical site infections (SSIs), to document use of checklistlike methods to improve safety, and to document the culture of safety through use of the Hospital Survey of Patient Safety Culture.

SUSP is designed to build on the success of the Comprehensive Unit-Based Safety Program (CUSP), which was developed by the Johns Hopkins Armstrong Institute for Patient Safety and Quality. Results of the CUSP program were recently reported in the Journal of the American College of Surgeons.

The CUSP Study

After CUSP was adopted in 2009 by colorectal surgeons at Johns Hopkins, colorectal surgical site infections were reduced by a third in the first year and saved the hospital $168,000-$280,000, according to the study (J. Am. Coll. Surg. 2012;215:193-200).

Surgical site infections occur in 15%-30% of colorectal procedures and lead to as much as $1 billion in costs for longer admissions, readmissions, and treatment.

"Until now, there’s been little evidence on how to effectively address SSIs among this group of patients," said Dr. Elizabeth Wick of the department of surgery at Johns Hopkins, who was the lead investigator.

Dr. Wick and her associates analyzed outcomes after implementation of CUSP, which was developed by Dr. Peter Pronovost, director of the Armstrong Institute at Hopkins

The Hopkins colorectal CUSP team of 36 people included a representative from surgery, nursing, and anesthesia; a team coach; and a hospital executive who was committed to helping the project, according to the researchers.

After attending a lecture on patient safety, all members of the team completed an anonymous two-question assessment that asked how an SSI might develop in the next patient and what could be done to prevent it.

The team identified 95 areas of concern and picked six interventions to focus on to improve care: standardization of skin preparation and prescription of chlorhexidine showers; restricted use of oral bowel-cleansing solution before a procedure; warming of patients in the preanesthesia area; adoption of enhanced sterile techniques for bowel and skin; and addressing lapses in preoperative prophylactic antibiotics.

The team met monthly, using checklists and monitoring progress to address problems quickly. "The benefits of a bottom-up vs. a top-down approach to patient safety were immediately obvious," said Dr. Wick in a statement.

The study consisted of all consecutive colorectal surgery patients who were included in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) from July 2009 to July 2011. Procedures included open and laparoscopic colectomies and proctectomies, but not abdominal perineal resections. SSI rates that were collected using NSQIP were compared from the first year (2009-2010) to the second year (2010-2011); there were 278 patients in the first cohort and 324 in the second.

During that first year, the 27% (76) of patients had an SSI. By the second year, only 18% (59) of patients had an infection, for a decrease of 33%.

The authors said that CUSP seems to be effective, in part because it bridges the divide between frontline staff and senior leaders. The NSQIP outcome measures also helped the team to effectively monitor SSI rates, said the authors.

CUSP/SUSP in Practice

The CUSP model has been applied successfully to decrease central line–associated bloodstream infections in the intensive care unit, as well as to cut mortality and length of stay in a statewide program, the MHA (Michigan Health and Hospital Association) Keystone Intensive Care Unit project.

The elements of CUSP are not well validated in the operating room, however, and there’s little data on how the program could potentially impact other types of infections or complications – even though the program is in use at 1,200 ICUs in 47 states, said Dr. Sean M. Berenholtz, physician director of inpatient quality and safety at the Armstrong Institute. The aim of the SUSP is to adapt the CUSP practices to the OR, Dr. Berenholtz said in an interview.

Project teams consisting of experts from the Agency for Healthcare Research and Quality (AHRQ), the Armstrong Institute, the American College of Surgeons, the University of Pennsylvania in Philadelphia, and the World Health Organization’s Patient Safety Programme will assist SUSP participants.

The CUSP model combines knowledge from both clinical science and social science. The first step is to educate staff on the science of patient safety – most importantly, communicating the idea that "the vast majority of preventable complications don’t belong to an individual surgeon or an individual nurse," but occur within the organization of the health care system, Dr. Berenholtz said.

The project leaders then ask the staff to complete an anonymous, two-question assessment that gauges their experience of how complications develop and what might be done to prevent them. Next, a unit-based improvement team is assigned an executive partner from the Armstrong Institute who meets with the team at least monthly to help prioritize improvement efforts and lead them through any bureaucratic hurdles they may face at their hospitals. Goals are set and agreed upon.

The team then tries to learn from "defects" within the process, and identifies ways to prevent mistakes, especially among the surgeons, nurses, anesthesiologists, and technicians who work in the OR. Finally, tools such as checklists are used to foster teamwork and improvement. SUSP leaders will ask improvement teams to use "briefings" and "debriefings" to learn from mistakes and move forward.

There’s plenty of motivation for hospitals to want to reduce SSIs. The Centers for Medicare and Medicaid Services, as part of the Surgical Care Improvement Project (SCIP), requires public reporting of surgical quality measures, including SSIs.

For instance, hospitals are supposed to report whether patients are given the right antibiotic at the right time. But the measure doesn’t tell anyone whether the patient’s outcome actually improved, noted Dr. Berenholtz. The SUSP goes beyond those SCIP measures to determine which factors at the local level might lead to SSIs at that particular facility, and to identify what intervention works at that particular location.

"It’s clear that there is no single fix for surgical site infections in colorectal surgery," said Dr. Wick, who has worked on content for the SUSP and has helped to present it to interested facilities.

"There are best practices, but not a clear-cut bundle; so for each hospital, whatever they implement will be a little different," she said, adding that the SUSP allows each facility to tailor interventions and improvements to its particular environment.

The AHRQ is funding the 4-year SUSP initiative. Initially, the focus will be on colorectal surgery, but the program will expand to other surgical specialties with the aim of preventing harm from complications such as pneumonia, pulmonary embolisms, and deep vein thrombosis, said Dr. Berenholtz, who is also with the department of surgery and the department of anesthesia and critical care medicine at Johns Hopkins.

The first cohort of hospitals to participate in the SUSP will be in Tennessee, Colorado, and Florida, with a second cohort slated to begin in September. It is not clear exactly how many hospitals will be involved; SUSP organizers are waiting to receive all final letters of commitment, Dr. Berenholtz said. The aim is to reach as many hospitals as possible; there is no upper limit on participants.

An electronic health record is not required for participation, but hospitals need to be able to collect data on the incidence of SSIs.

The organizers are primarily going through the CMS-funded Hospital Engagement Networks (HENs). These are state, local, and regional networks that began forming in December 2011 and will work to develop learning collaboratives for hospitals, as well as provide patient safety initiatives such as the SUSP.

At the end of the 4 years, it is hoped that the HENs will continue to find ways to reduce complications and improve patient safety, Dr. Berenholtz said.

"We hope it ends up that hundreds – if not thousands – of lives will be saved," he said.

Dr. Berenholtz disclosed that he receives grant funding from the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Robert Wood Johnson Foundation, and that he has received speaking honoraria from various hospitals related to patient safety and quality. Dr. Wick and her coauthors reported no conflicts.

A new program being spearheaded by surgeons at Johns Hopkins University, Baltimore, and patient safety experts aims to dramatically reduce surgical site infections, which occur in almost a third of colorectal procedures and are a major reason for readmissions.

According to a fact sheet on the Surgical Unit-Based Safety Program (SUSP), each year about 50 million people undergo surgery in the United States. Of those, 1 million develop serious complications and more than 150,000 die within 30 days.

The goals of SUSP are to reduce surgical site infections (SSIs), to document use of checklistlike methods to improve safety, and to document the culture of safety through use of the Hospital Survey of Patient Safety Culture.

SUSP is designed to build on the success of the Comprehensive Unit-Based Safety Program (CUSP), which was developed by the Johns Hopkins Armstrong Institute for Patient Safety and Quality. Results of the CUSP program were recently reported in the Journal of the American College of Surgeons.

The CUSP Study

After CUSP was adopted in 2009 by colorectal surgeons at Johns Hopkins, colorectal surgical site infections were reduced by a third in the first year and saved the hospital $168,000-$280,000, according to the study (J. Am. Coll. Surg. 2012;215:193-200).

Surgical site infections occur in 15%-30% of colorectal procedures and lead to as much as $1 billion in costs for longer admissions, readmissions, and treatment.

"Until now, there’s been little evidence on how to effectively address SSIs among this group of patients," said Dr. Elizabeth Wick of the department of surgery at Johns Hopkins, who was the lead investigator.

Dr. Wick and her associates analyzed outcomes after implementation of CUSP, which was developed by Dr. Peter Pronovost, director of the Armstrong Institute at Hopkins

The Hopkins colorectal CUSP team of 36 people included a representative from surgery, nursing, and anesthesia; a team coach; and a hospital executive who was committed to helping the project, according to the researchers.

After attending a lecture on patient safety, all members of the team completed an anonymous two-question assessment that asked how an SSI might develop in the next patient and what could be done to prevent it.

The team identified 95 areas of concern and picked six interventions to focus on to improve care: standardization of skin preparation and prescription of chlorhexidine showers; restricted use of oral bowel-cleansing solution before a procedure; warming of patients in the preanesthesia area; adoption of enhanced sterile techniques for bowel and skin; and addressing lapses in preoperative prophylactic antibiotics.

The team met monthly, using checklists and monitoring progress to address problems quickly. "The benefits of a bottom-up vs. a top-down approach to patient safety were immediately obvious," said Dr. Wick in a statement.

The study consisted of all consecutive colorectal surgery patients who were included in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) from July 2009 to July 2011. Procedures included open and laparoscopic colectomies and proctectomies, but not abdominal perineal resections. SSI rates that were collected using NSQIP were compared from the first year (2009-2010) to the second year (2010-2011); there were 278 patients in the first cohort and 324 in the second.

During that first year, the 27% (76) of patients had an SSI. By the second year, only 18% (59) of patients had an infection, for a decrease of 33%.

The authors said that CUSP seems to be effective, in part because it bridges the divide between frontline staff and senior leaders. The NSQIP outcome measures also helped the team to effectively monitor SSI rates, said the authors.

CUSP/SUSP in Practice

The CUSP model has been applied successfully to decrease central line–associated bloodstream infections in the intensive care unit, as well as to cut mortality and length of stay in a statewide program, the MHA (Michigan Health and Hospital Association) Keystone Intensive Care Unit project.

The elements of CUSP are not well validated in the operating room, however, and there’s little data on how the program could potentially impact other types of infections or complications – even though the program is in use at 1,200 ICUs in 47 states, said Dr. Sean M. Berenholtz, physician director of inpatient quality and safety at the Armstrong Institute. The aim of the SUSP is to adapt the CUSP practices to the OR, Dr. Berenholtz said in an interview.

Project teams consisting of experts from the Agency for Healthcare Research and Quality (AHRQ), the Armstrong Institute, the American College of Surgeons, the University of Pennsylvania in Philadelphia, and the World Health Organization’s Patient Safety Programme will assist SUSP participants.

The CUSP model combines knowledge from both clinical science and social science. The first step is to educate staff on the science of patient safety – most importantly, communicating the idea that "the vast majority of preventable complications don’t belong to an individual surgeon or an individual nurse," but occur within the organization of the health care system, Dr. Berenholtz said.

The project leaders then ask the staff to complete an anonymous, two-question assessment that gauges their experience of how complications develop and what might be done to prevent them. Next, a unit-based improvement team is assigned an executive partner from the Armstrong Institute who meets with the team at least monthly to help prioritize improvement efforts and lead them through any bureaucratic hurdles they may face at their hospitals. Goals are set and agreed upon.

The team then tries to learn from "defects" within the process, and identifies ways to prevent mistakes, especially among the surgeons, nurses, anesthesiologists, and technicians who work in the OR. Finally, tools such as checklists are used to foster teamwork and improvement. SUSP leaders will ask improvement teams to use "briefings" and "debriefings" to learn from mistakes and move forward.

There’s plenty of motivation for hospitals to want to reduce SSIs. The Centers for Medicare and Medicaid Services, as part of the Surgical Care Improvement Project (SCIP), requires public reporting of surgical quality measures, including SSIs.

For instance, hospitals are supposed to report whether patients are given the right antibiotic at the right time. But the measure doesn’t tell anyone whether the patient’s outcome actually improved, noted Dr. Berenholtz. The SUSP goes beyond those SCIP measures to determine which factors at the local level might lead to SSIs at that particular facility, and to identify what intervention works at that particular location.

"It’s clear that there is no single fix for surgical site infections in colorectal surgery," said Dr. Wick, who has worked on content for the SUSP and has helped to present it to interested facilities.

"There are best practices, but not a clear-cut bundle; so for each hospital, whatever they implement will be a little different," she said, adding that the SUSP allows each facility to tailor interventions and improvements to its particular environment.

The AHRQ is funding the 4-year SUSP initiative. Initially, the focus will be on colorectal surgery, but the program will expand to other surgical specialties with the aim of preventing harm from complications such as pneumonia, pulmonary embolisms, and deep vein thrombosis, said Dr. Berenholtz, who is also with the department of surgery and the department of anesthesia and critical care medicine at Johns Hopkins.

The first cohort of hospitals to participate in the SUSP will be in Tennessee, Colorado, and Florida, with a second cohort slated to begin in September. It is not clear exactly how many hospitals will be involved; SUSP organizers are waiting to receive all final letters of commitment, Dr. Berenholtz said. The aim is to reach as many hospitals as possible; there is no upper limit on participants.

An electronic health record is not required for participation, but hospitals need to be able to collect data on the incidence of SSIs.

The organizers are primarily going through the CMS-funded Hospital Engagement Networks (HENs). These are state, local, and regional networks that began forming in December 2011 and will work to develop learning collaboratives for hospitals, as well as provide patient safety initiatives such as the SUSP.

At the end of the 4 years, it is hoped that the HENs will continue to find ways to reduce complications and improve patient safety, Dr. Berenholtz said.

"We hope it ends up that hundreds – if not thousands – of lives will be saved," he said.

Dr. Berenholtz disclosed that he receives grant funding from the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Robert Wood Johnson Foundation, and that he has received speaking honoraria from various hospitals related to patient safety and quality. Dr. Wick and her coauthors reported no conflicts.

A new program being spearheaded by surgeons at Johns Hopkins University, Baltimore, and patient safety experts aims to dramatically reduce surgical site infections, which occur in almost a third of colorectal procedures and are a major reason for readmissions.

According to a fact sheet on the Surgical Unit-Based Safety Program (SUSP), each year about 50 million people undergo surgery in the United States. Of those, 1 million develop serious complications and more than 150,000 die within 30 days.

The goals of SUSP are to reduce surgical site infections (SSIs), to document use of checklistlike methods to improve safety, and to document the culture of safety through use of the Hospital Survey of Patient Safety Culture.

SUSP is designed to build on the success of the Comprehensive Unit-Based Safety Program (CUSP), which was developed by the Johns Hopkins Armstrong Institute for Patient Safety and Quality. Results of the CUSP program were recently reported in the Journal of the American College of Surgeons.

The CUSP Study

After CUSP was adopted in 2009 by colorectal surgeons at Johns Hopkins, colorectal surgical site infections were reduced by a third in the first year and saved the hospital $168,000-$280,000, according to the study (J. Am. Coll. Surg. 2012;215:193-200).

Surgical site infections occur in 15%-30% of colorectal procedures and lead to as much as $1 billion in costs for longer admissions, readmissions, and treatment.

"Until now, there’s been little evidence on how to effectively address SSIs among this group of patients," said Dr. Elizabeth Wick of the department of surgery at Johns Hopkins, who was the lead investigator.

Dr. Wick and her associates analyzed outcomes after implementation of CUSP, which was developed by Dr. Peter Pronovost, director of the Armstrong Institute at Hopkins

The Hopkins colorectal CUSP team of 36 people included a representative from surgery, nursing, and anesthesia; a team coach; and a hospital executive who was committed to helping the project, according to the researchers.

After attending a lecture on patient safety, all members of the team completed an anonymous two-question assessment that asked how an SSI might develop in the next patient and what could be done to prevent it.

The team identified 95 areas of concern and picked six interventions to focus on to improve care: standardization of skin preparation and prescription of chlorhexidine showers; restricted use of oral bowel-cleansing solution before a procedure; warming of patients in the preanesthesia area; adoption of enhanced sterile techniques for bowel and skin; and addressing lapses in preoperative prophylactic antibiotics.

The team met monthly, using checklists and monitoring progress to address problems quickly. "The benefits of a bottom-up vs. a top-down approach to patient safety were immediately obvious," said Dr. Wick in a statement.

The study consisted of all consecutive colorectal surgery patients who were included in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) from July 2009 to July 2011. Procedures included open and laparoscopic colectomies and proctectomies, but not abdominal perineal resections. SSI rates that were collected using NSQIP were compared from the first year (2009-2010) to the second year (2010-2011); there were 278 patients in the first cohort and 324 in the second.

During that first year, the 27% (76) of patients had an SSI. By the second year, only 18% (59) of patients had an infection, for a decrease of 33%.

The authors said that CUSP seems to be effective, in part because it bridges the divide between frontline staff and senior leaders. The NSQIP outcome measures also helped the team to effectively monitor SSI rates, said the authors.

CUSP/SUSP in Practice

The CUSP model has been applied successfully to decrease central line–associated bloodstream infections in the intensive care unit, as well as to cut mortality and length of stay in a statewide program, the MHA (Michigan Health and Hospital Association) Keystone Intensive Care Unit project.

The elements of CUSP are not well validated in the operating room, however, and there’s little data on how the program could potentially impact other types of infections or complications – even though the program is in use at 1,200 ICUs in 47 states, said Dr. Sean M. Berenholtz, physician director of inpatient quality and safety at the Armstrong Institute. The aim of the SUSP is to adapt the CUSP practices to the OR, Dr. Berenholtz said in an interview.

Project teams consisting of experts from the Agency for Healthcare Research and Quality (AHRQ), the Armstrong Institute, the American College of Surgeons, the University of Pennsylvania in Philadelphia, and the World Health Organization’s Patient Safety Programme will assist SUSP participants.

The CUSP model combines knowledge from both clinical science and social science. The first step is to educate staff on the science of patient safety – most importantly, communicating the idea that "the vast majority of preventable complications don’t belong to an individual surgeon or an individual nurse," but occur within the organization of the health care system, Dr. Berenholtz said.

The project leaders then ask the staff to complete an anonymous, two-question assessment that gauges their experience of how complications develop and what might be done to prevent them. Next, a unit-based improvement team is assigned an executive partner from the Armstrong Institute who meets with the team at least monthly to help prioritize improvement efforts and lead them through any bureaucratic hurdles they may face at their hospitals. Goals are set and agreed upon.

The team then tries to learn from "defects" within the process, and identifies ways to prevent mistakes, especially among the surgeons, nurses, anesthesiologists, and technicians who work in the OR. Finally, tools such as checklists are used to foster teamwork and improvement. SUSP leaders will ask improvement teams to use "briefings" and "debriefings" to learn from mistakes and move forward.

There’s plenty of motivation for hospitals to want to reduce SSIs. The Centers for Medicare and Medicaid Services, as part of the Surgical Care Improvement Project (SCIP), requires public reporting of surgical quality measures, including SSIs.

For instance, hospitals are supposed to report whether patients are given the right antibiotic at the right time. But the measure doesn’t tell anyone whether the patient’s outcome actually improved, noted Dr. Berenholtz. The SUSP goes beyond those SCIP measures to determine which factors at the local level might lead to SSIs at that particular facility, and to identify what intervention works at that particular location.

"It’s clear that there is no single fix for surgical site infections in colorectal surgery," said Dr. Wick, who has worked on content for the SUSP and has helped to present it to interested facilities.

"There are best practices, but not a clear-cut bundle; so for each hospital, whatever they implement will be a little different," she said, adding that the SUSP allows each facility to tailor interventions and improvements to its particular environment.

The AHRQ is funding the 4-year SUSP initiative. Initially, the focus will be on colorectal surgery, but the program will expand to other surgical specialties with the aim of preventing harm from complications such as pneumonia, pulmonary embolisms, and deep vein thrombosis, said Dr. Berenholtz, who is also with the department of surgery and the department of anesthesia and critical care medicine at Johns Hopkins.

The first cohort of hospitals to participate in the SUSP will be in Tennessee, Colorado, and Florida, with a second cohort slated to begin in September. It is not clear exactly how many hospitals will be involved; SUSP organizers are waiting to receive all final letters of commitment, Dr. Berenholtz said. The aim is to reach as many hospitals as possible; there is no upper limit on participants.

An electronic health record is not required for participation, but hospitals need to be able to collect data on the incidence of SSIs.

The organizers are primarily going through the CMS-funded Hospital Engagement Networks (HENs). These are state, local, and regional networks that began forming in December 2011 and will work to develop learning collaboratives for hospitals, as well as provide patient safety initiatives such as the SUSP.

At the end of the 4 years, it is hoped that the HENs will continue to find ways to reduce complications and improve patient safety, Dr. Berenholtz said.

"We hope it ends up that hundreds – if not thousands – of lives will be saved," he said.

Dr. Berenholtz disclosed that he receives grant funding from the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Robert Wood Johnson Foundation, and that he has received speaking honoraria from various hospitals related to patient safety and quality. Dr. Wick and her coauthors reported no conflicts.

The risks of death, postoperative infection, and other adverse clinical outcomes were significantly increased among patients undergoing colorectal cancer surgery who received perioperative allogeneic blood transfusions, according to a meta-analysis of 55 studies published in the August issue of Annals of Surgery.

Dr. Austin G. Acheson of the Nottingham (England) Digestive Disease Center at Queen’s Medical Centre and his associates reviewed 12 prospective studies and 43 retrospective cohort studies published between December 2004 and October 2010. The studies included 20,795 patients who were followed for a mean of about 5 years after undergoing surgery for colorectal cancer. Almost 60% (12,242) of these patients received a mean of three units of allogeneic red blood cells (Ann. Surg. 2012;256:235-44).

©Andrei Malov/iStockphoto.com

Patients who were transfused tended to be older, and the transfusion rate was significantly higher in women, those undergoing rectal surgery (compared with those undergoing right or left colon surgery), those with greater surgical blood loss, and those with worsening Duke's stage.

All associations between ABT and the adverse clinical outcomes described below were statistically significant.

The rates of all-cause mortality in the 29 studies that looked at this outcome were 45% among the patients who received blood transfusions vs. 35% of those who did not, a significant difference that represented a 72% increased risk. After adjusting for the duration of the observation period, the investigators found that the annual incidence of all-cause mortality was almost 9% among the transfused patients vs. 6.5% among those who were not transfused.

The rate of cancer-related mortality was 31% vs. 24% in the 17 studies that measured this outcome, a 71% increased risk. After adjusting for the length of observation, the investigators said the annual incidence of cancer-related mortality was 5.4% of those transfused and 4% of those who were not.

The rate of the combined end point of death resulting from recurrence/metastasis was 43% of those who were transfused vs. 33% of those who were not transfused – a 66% increase in risk – in the 19 studies that measured this outcome.

The risk of postoperative infections in the 12 studies that measured this outcome was 29% among those who were transfused vs. 11% of those who were not transfused, which was more than a threefold increased risk. In the two studies that measured the need for surgical reintervention, the risk was increased fourfold among those who were transfused.

In the four studies that measured the length of hospitalization, the hospital stay was a mean of almost 18 days among those who received transfusions, compared with 14 days among those who did not.

Based on evidence in this meta-analysis and other studies showing that preoperative anemia is an independent risk factor for a worse prognosis after colon surgery, and based on the association between ABTs and poorer clinical outcomes in this meta-analysis, the authors wrote that "appropriate blood management measures should, therefore, be given an important place in the care of patients with CRC [colorectal cancer] undergoing elective surgery."

The use of ABT has dropped over the past 25 years because of improvements in patient care, and the authors stated that they believe efforts should be made to further minimize ABT use. Well-designed studies are needed "to determine whether and in which patients preoperative corrective measures of anemia, other than ABTs, will contribute not only in the field of colorectal surgery but also to improve clinical outcomes," they added.

The study was supported by an unrestricted research grant from Vifor Pharma AG, a specialty pharmaceuticals company focused on the treatment of iron deficiency, according to its website. The authors disclosed receiving honoraria and/or travel support for consulting or lecturing for companies that include Vifor, Ethicon Endosurgery, Johnson & Johnson, and AstraZeneca AG; their research departments received grant support from companies that included Vifor.

The risks of death, postoperative infection, and other adverse clinical outcomes were significantly increased among patients undergoing colorectal cancer surgery who received perioperative allogeneic blood transfusions, according to a meta-analysis of 55 studies published in the August issue of Annals of Surgery.

Dr. Austin G. Acheson of the Nottingham (England) Digestive Disease Center at Queen’s Medical Centre and his associates reviewed 12 prospective studies and 43 retrospective cohort studies published between December 2004 and October 2010. The studies included 20,795 patients who were followed for a mean of about 5 years after undergoing surgery for colorectal cancer. Almost 60% (12,242) of these patients received a mean of three units of allogeneic red blood cells (Ann. Surg. 2012;256:235-44).

©Andrei Malov/iStockphoto.com

Patients who were transfused tended to be older, and the transfusion rate was significantly higher in women, those undergoing rectal surgery (compared with those undergoing right or left colon surgery), those with greater surgical blood loss, and those with worsening Duke's stage.

All associations between ABT and the adverse clinical outcomes described below were statistically significant.

The rates of all-cause mortality in the 29 studies that looked at this outcome were 45% among the patients who received blood transfusions vs. 35% of those who did not, a significant difference that represented a 72% increased risk. After adjusting for the duration of the observation period, the investigators found that the annual incidence of all-cause mortality was almost 9% among the transfused patients vs. 6.5% among those who were not transfused.

The rate of cancer-related mortality was 31% vs. 24% in the 17 studies that measured this outcome, a 71% increased risk. After adjusting for the length of observation, the investigators said the annual incidence of cancer-related mortality was 5.4% of those transfused and 4% of those who were not.

The rate of the combined end point of death resulting from recurrence/metastasis was 43% of those who were transfused vs. 33% of those who were not transfused – a 66% increase in risk – in the 19 studies that measured this outcome.

The risk of postoperative infections in the 12 studies that measured this outcome was 29% among those who were transfused vs. 11% of those who were not transfused, which was more than a threefold increased risk. In the two studies that measured the need for surgical reintervention, the risk was increased fourfold among those who were transfused.

In the four studies that measured the length of hospitalization, the hospital stay was a mean of almost 18 days among those who received transfusions, compared with 14 days among those who did not.

Based on evidence in this meta-analysis and other studies showing that preoperative anemia is an independent risk factor for a worse prognosis after colon surgery, and based on the association between ABTs and poorer clinical outcomes in this meta-analysis, the authors wrote that "appropriate blood management measures should, therefore, be given an important place in the care of patients with CRC [colorectal cancer] undergoing elective surgery."

The use of ABT has dropped over the past 25 years because of improvements in patient care, and the authors stated that they believe efforts should be made to further minimize ABT use. Well-designed studies are needed "to determine whether and in which patients preoperative corrective measures of anemia, other than ABTs, will contribute not only in the field of colorectal surgery but also to improve clinical outcomes," they added.

The study was supported by an unrestricted research grant from Vifor Pharma AG, a specialty pharmaceuticals company focused on the treatment of iron deficiency, according to its website. The authors disclosed receiving honoraria and/or travel support for consulting or lecturing for companies that include Vifor, Ethicon Endosurgery, Johnson & Johnson, and AstraZeneca AG; their research departments received grant support from companies that included Vifor.

The risks of death, postoperative infection, and other adverse clinical outcomes were significantly increased among patients undergoing colorectal cancer surgery who received perioperative allogeneic blood transfusions, according to a meta-analysis of 55 studies published in the August issue of Annals of Surgery.

Dr. Austin G. Acheson of the Nottingham (England) Digestive Disease Center at Queen’s Medical Centre and his associates reviewed 12 prospective studies and 43 retrospective cohort studies published between December 2004 and October 2010. The studies included 20,795 patients who were followed for a mean of about 5 years after undergoing surgery for colorectal cancer. Almost 60% (12,242) of these patients received a mean of three units of allogeneic red blood cells (Ann. Surg. 2012;256:235-44).

©Andrei Malov/iStockphoto.com

Patients who were transfused tended to be older, and the transfusion rate was significantly higher in women, those undergoing rectal surgery (compared with those undergoing right or left colon surgery), those with greater surgical blood loss, and those with worsening Duke's stage.

All associations between ABT and the adverse clinical outcomes described below were statistically significant.

The rates of all-cause mortality in the 29 studies that looked at this outcome were 45% among the patients who received blood transfusions vs. 35% of those who did not, a significant difference that represented a 72% increased risk. After adjusting for the duration of the observation period, the investigators found that the annual incidence of all-cause mortality was almost 9% among the transfused patients vs. 6.5% among those who were not transfused.

The rate of cancer-related mortality was 31% vs. 24% in the 17 studies that measured this outcome, a 71% increased risk. After adjusting for the length of observation, the investigators said the annual incidence of cancer-related mortality was 5.4% of those transfused and 4% of those who were not.

The rate of the combined end point of death resulting from recurrence/metastasis was 43% of those who were transfused vs. 33% of those who were not transfused – a 66% increase in risk – in the 19 studies that measured this outcome.

The risk of postoperative infections in the 12 studies that measured this outcome was 29% among those who were transfused vs. 11% of those who were not transfused, which was more than a threefold increased risk. In the two studies that measured the need for surgical reintervention, the risk was increased fourfold among those who were transfused.

In the four studies that measured the length of hospitalization, the hospital stay was a mean of almost 18 days among those who received transfusions, compared with 14 days among those who did not.

Based on evidence in this meta-analysis and other studies showing that preoperative anemia is an independent risk factor for a worse prognosis after colon surgery, and based on the association between ABTs and poorer clinical outcomes in this meta-analysis, the authors wrote that "appropriate blood management measures should, therefore, be given an important place in the care of patients with CRC [colorectal cancer] undergoing elective surgery."

The use of ABT has dropped over the past 25 years because of improvements in patient care, and the authors stated that they believe efforts should be made to further minimize ABT use. Well-designed studies are needed "to determine whether and in which patients preoperative corrective measures of anemia, other than ABTs, will contribute not only in the field of colorectal surgery but also to improve clinical outcomes," they added.

The study was supported by an unrestricted research grant from Vifor Pharma AG, a specialty pharmaceuticals company focused on the treatment of iron deficiency, according to its website. The authors disclosed receiving honoraria and/or travel support for consulting or lecturing for companies that include Vifor, Ethicon Endosurgery, Johnson & Johnson, and AstraZeneca AG; their research departments received grant support from companies that included Vifor.

HOUSTON – Laparoscopic sleeve gastrectomy with ileal interposition sent diabetes into remission in 20 of 43 adults and reduced the need for diabetes medications in the other 23 patients during an average of 20 months of follow-up.

Among the 30 obese (defined as having a body mass index greater than 27 kg/m²) patients in the study, 26 showed remission of diabetes – an 86% success rate that’s similar to results reported for gastric bypass surgery, Dr. Kirtikumar D. Modi said in a press briefing at the annual meeting of the Endocrine Society.

Patients had an average disease duration of 10 years and an average BMI of 33. In laparoscopic sleeve gastrectomy with ileal interposition, stapling reduces the size of the stomach, and a segment of the ileum is shifted to the jejunal area closer to the stomach. The average BMI fell to 26 after surgery. Among 30 patients who had hypertension before surgery, 27 had no hypertension postoperatively.

The surgery seemed to have no significant effect on lipid levels, "maybe because [the patients] were already on lipid-lowering drugs," said Dr. Modi, chief endocrinologist at Medwin Hospital in Hyderabad, India.

There were few complications; approximately 25% of patients had nausea and loss of appetite during the first postoperative month. Difficulty with rapid swallowing in six patients subsided over 2 weeks.

In a second series, Dr. Modi and his associates performed a laparoscopic diverted sleeve gastrectomy with ileal interposition on 17 additional patients who were not obese and had had diabetes longer than 10 years – the characteristics of patients who responded less well to the sleeve gastrectomy with ileal interposition in the first series.

Laparoscopic diverted sleeve gastrectomy diverts food away from parts of the small intestine, including the duodenum, where the absorption of nutrients begins, and the ileal segment is shifted more proximally. Patients who underwent this procedure had had diabetes for 15 years on average, and they had an average BMI of 29 as well as stimulated C-peptide levels greater than 4 ng/mL.

As expected, the mean BMI decreased to 23 over 18 months, he said. Of the eight patients who had hypertension before surgery, seven (88%) had no hypertension afterward. This time, treatment produced significant decreases in glycemic, lipid, and microalbuminuria levels.

At 9 months after surgery, diabetes was in remission in 12 (70%) of the 17 patients, and the other 5 patients needed fewer oral hyperglycemic medications than did those in the first series.

All patients in both studies had poorly controlled diabetes. The investigators defined diabetes remission as a hemoglobin A_1c level less than 6.5% and no further need for insulin or oral hypoglycemic agents.

The reduction in hemoglobin A_1c was disproportionately greater than the decline in BMI, suggesting benefits that are "much more than the weight improvement," he said.

More complications were seen in the second series, including three patients with minor intraoperative complications. Another patient developed ileus with ileal perforation 2 weeks after surgery and underwent laparotomy for repair. Three patients experienced nausea and anorexia for 2 weeks. Two patients developed vitamin B₁₂ deficiency at 12 months.

A previous study of 150 patients with uncontrolled type 2 diabetes reported better glycemic control in patients who were randomized to 12 months of medical therapy plus bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass), compared with those on medical treatment alone, Dr. Modi noted (N. Engl. J. Med. 2012;366:1567-76).

A separate retrospective study of 271,726 patients in the Bariatric Outcomes Longitudinal Database found that the efficacy and safety of laparoscopic sleeve gastrectomy fell between those of gastric banding and laparoscopic gastric bypass.

Dr. Modi reported having no financial disclosures.

HOUSTON – Laparoscopic sleeve gastrectomy with ileal interposition sent diabetes into remission in 20 of 43 adults and reduced the need for diabetes medications in the other 23 patients during an average of 20 months of follow-up.

Among the 30 obese (defined as having a body mass index greater than 27 kg/m²) patients in the study, 26 showed remission of diabetes – an 86% success rate that’s similar to results reported for gastric bypass surgery, Dr. Kirtikumar D. Modi said in a press briefing at the annual meeting of the Endocrine Society.

Patients had an average disease duration of 10 years and an average BMI of 33. In laparoscopic sleeve gastrectomy with ileal interposition, stapling reduces the size of the stomach, and a segment of the ileum is shifted to the jejunal area closer to the stomach. The average BMI fell to 26 after surgery. Among 30 patients who had hypertension before surgery, 27 had no hypertension postoperatively.

The surgery seemed to have no significant effect on lipid levels, "maybe because [the patients] were already on lipid-lowering drugs," said Dr. Modi, chief endocrinologist at Medwin Hospital in Hyderabad, India.

There were few complications; approximately 25% of patients had nausea and loss of appetite during the first postoperative month. Difficulty with rapid swallowing in six patients subsided over 2 weeks.

In a second series, Dr. Modi and his associates performed a laparoscopic diverted sleeve gastrectomy with ileal interposition on 17 additional patients who were not obese and had had diabetes longer than 10 years – the characteristics of patients who responded less well to the sleeve gastrectomy with ileal interposition in the first series.

Laparoscopic diverted sleeve gastrectomy diverts food away from parts of the small intestine, including the duodenum, where the absorption of nutrients begins, and the ileal segment is shifted more proximally. Patients who underwent this procedure had had diabetes for 15 years on average, and they had an average BMI of 29 as well as stimulated C-peptide levels greater than 4 ng/mL.

As expected, the mean BMI decreased to 23 over 18 months, he said. Of the eight patients who had hypertension before surgery, seven (88%) had no hypertension afterward. This time, treatment produced significant decreases in glycemic, lipid, and microalbuminuria levels.

At 9 months after surgery, diabetes was in remission in 12 (70%) of the 17 patients, and the other 5 patients needed fewer oral hyperglycemic medications than did those in the first series.

All patients in both studies had poorly controlled diabetes. The investigators defined diabetes remission as a hemoglobin A_1c level less than 6.5% and no further need for insulin or oral hypoglycemic agents.

The reduction in hemoglobin A_1c was disproportionately greater than the decline in BMI, suggesting benefits that are "much more than the weight improvement," he said.

More complications were seen in the second series, including three patients with minor intraoperative complications. Another patient developed ileus with ileal perforation 2 weeks after surgery and underwent laparotomy for repair. Three patients experienced nausea and anorexia for 2 weeks. Two patients developed vitamin B₁₂ deficiency at 12 months.

A previous study of 150 patients with uncontrolled type 2 diabetes reported better glycemic control in patients who were randomized to 12 months of medical therapy plus bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass), compared with those on medical treatment alone, Dr. Modi noted (N. Engl. J. Med. 2012;366:1567-76).

A separate retrospective study of 271,726 patients in the Bariatric Outcomes Longitudinal Database found that the efficacy and safety of laparoscopic sleeve gastrectomy fell between those of gastric banding and laparoscopic gastric bypass.

Dr. Modi reported having no financial disclosures.

HOUSTON – Laparoscopic sleeve gastrectomy with ileal interposition sent diabetes into remission in 20 of 43 adults and reduced the need for diabetes medications in the other 23 patients during an average of 20 months of follow-up.

Among the 30 obese (defined as having a body mass index greater than 27 kg/m²) patients in the study, 26 showed remission of diabetes – an 86% success rate that’s similar to results reported for gastric bypass surgery, Dr. Kirtikumar D. Modi said in a press briefing at the annual meeting of the Endocrine Society.

Patients had an average disease duration of 10 years and an average BMI of 33. In laparoscopic sleeve gastrectomy with ileal interposition, stapling reduces the size of the stomach, and a segment of the ileum is shifted to the jejunal area closer to the stomach. The average BMI fell to 26 after surgery. Among 30 patients who had hypertension before surgery, 27 had no hypertension postoperatively.

The surgery seemed to have no significant effect on lipid levels, "maybe because [the patients] were already on lipid-lowering drugs," said Dr. Modi, chief endocrinologist at Medwin Hospital in Hyderabad, India.

There were few complications; approximately 25% of patients had nausea and loss of appetite during the first postoperative month. Difficulty with rapid swallowing in six patients subsided over 2 weeks.

In a second series, Dr. Modi and his associates performed a laparoscopic diverted sleeve gastrectomy with ileal interposition on 17 additional patients who were not obese and had had diabetes longer than 10 years – the characteristics of patients who responded less well to the sleeve gastrectomy with ileal interposition in the first series.

Laparoscopic diverted sleeve gastrectomy diverts food away from parts of the small intestine, including the duodenum, where the absorption of nutrients begins, and the ileal segment is shifted more proximally. Patients who underwent this procedure had had diabetes for 15 years on average, and they had an average BMI of 29 as well as stimulated C-peptide levels greater than 4 ng/mL.

As expected, the mean BMI decreased to 23 over 18 months, he said. Of the eight patients who had hypertension before surgery, seven (88%) had no hypertension afterward. This time, treatment produced significant decreases in glycemic, lipid, and microalbuminuria levels.

At 9 months after surgery, diabetes was in remission in 12 (70%) of the 17 patients, and the other 5 patients needed fewer oral hyperglycemic medications than did those in the first series.

All patients in both studies had poorly controlled diabetes. The investigators defined diabetes remission as a hemoglobin A_1c level less than 6.5% and no further need for insulin or oral hypoglycemic agents.

The reduction in hemoglobin A_1c was disproportionately greater than the decline in BMI, suggesting benefits that are "much more than the weight improvement," he said.

More complications were seen in the second series, including three patients with minor intraoperative complications. Another patient developed ileus with ileal perforation 2 weeks after surgery and underwent laparotomy for repair. Three patients experienced nausea and anorexia for 2 weeks. Two patients developed vitamin B₁₂ deficiency at 12 months.

A previous study of 150 patients with uncontrolled type 2 diabetes reported better glycemic control in patients who were randomized to 12 months of medical therapy plus bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass), compared with those on medical treatment alone, Dr. Modi noted (N. Engl. J. Med. 2012;366:1567-76).

A separate retrospective study of 271,726 patients in the Bariatric Outcomes Longitudinal Database found that the efficacy and safety of laparoscopic sleeve gastrectomy fell between those of gastric banding and laparoscopic gastric bypass.

Dr. Modi reported having no financial disclosures.

SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.

"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."

For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.

Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.

Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).

The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.

Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.

Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m² vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).

To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.

"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.

In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.

Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.

"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."

Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.

SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.

"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."

For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.

Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.

Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).

The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.

Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.

Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m² vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).

To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.

"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.

In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.

Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.

"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."

Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.

SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.

"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."

For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.

Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.

Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).

The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.

Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.

Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m² vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).

To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.

"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.

In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.

Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.

"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."

Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.

Rankings of hospital performance in treating acute ischemic stroke must take into consideration the severity of each case, or the rankings will be extremely inaccurate, researchers say in the July 18 issue of JAMA.

Unfortunately, the rankings that are currently used by accreditation organizations, the Centers for Medicare and Medicaid Services (CMS), and other payers do not incorporate stroke severity. A study that corrected for this oversight found that close to half of the U.S. hospitals ranked in the top or bottom 5%, according to stroke patients’ 30-day mortality, should be reclassified into the middle range of the rankings.

© forestpath - Fotolia.com

For the 782 hospitals included in this study, the median change in rank position was 79 places when stroke severity was incorporated into the statistical model, said Dr. Gregg C. Fonarow of the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and his associates.

When stroke severity is not considered, the rankings systematically favor hospitals that care for patients with less severe illness, regardless of whether the patient care at these hospitals produces better or worse patient outcomes.

If reliance on inaccurate rankings persists, hospitals that want to improve their ranking may consider turning away patients with more severe strokes or transferring them to other hospitals after emergency department assessment, to avoid being classified as low performance, Dr. Fonarow and his associates said.

The researchers used data from the Get With the Guidelines–Stroke Registry and from CMS inpatient claims files to create a risk-adjustment model that incorporated stroke severity, as measured by the NIHSS (National Institutes of Health Stroke Scale), into hospitals’ 30-day mortality profiling. The NIHSS is a 15-item scale that assesses the effect of acute stroke on level of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.

All types of hospitals in all regions of the United States were represented. The study population included 127,950 patients aged 65 years and older who had acute ischemic stroke and were treated at 782 hospitals participating in the Get With the Guidelines program from April 2003 to December 2009.

The median patient age was 80 years; 57% were women and 86% were white. Patients frequently had serious comorbidities, including hypertension (83%), diabetes (29%), coronary artery disease or prior myocardial infarction (34%), and a history of atrial fibrillation or flutter (27%).

There were 18,186 deaths within 30 days of admission.

The statistical model that incorporated stroke severity into its assessment of hospital performance "demonstrated substantially more accurate classification of hospital 30-day mortality" than did the model currently in use. When hospitals were ranked according to this more accurate profile, their rank position changed by a median of 79 places.

Overall, 206 of the 782 hospitals (26%) ended up in a different performance category once the NIHSS score was incorporated into the model.

Of the 39 hospitals that had been categorized as top performers using the standard model, only 23 remained top performers using the more accurate model. And another 16 hospitals that hadn’t made the grade with the standard model were reclassified as top performers with the more accurate model.

"There was even greater disagreement about the bottom-performing hospitals," Dr. Fonarow and his colleagues said (JAMA 2012;308:257-64).

Of the 40 worst-performing hospitals according to the standard model, nearly half (19) were reclassified as having a middling performance with the more accurate model.

"These findings highlight the importance of including a valid specific measure of stroke severity in hospital risk models for mortality after acute ischemic stroke. ... Furthermore, this study suggests that inclusion of admission stroke severity may be essential for optimal ranking of hospitals with respect to 30-day mortality," they said.

This study was supported by the American Heart Association, American Stroke Association, and Janssen Pharmaceutical Companies of Johnson & Johnson. Dr. Fonarow is an employee of the University of California, which holds a patent on retriever devices for stroke. His associates reported ties to numerous industry sources.

Rankings of hospital performance in treating acute ischemic stroke must take into consideration the severity of each case, or the rankings will be extremely inaccurate, researchers say in the July 18 issue of JAMA.

Unfortunately, the rankings that are currently used by accreditation organizations, the Centers for Medicare and Medicaid Services (CMS), and other payers do not incorporate stroke severity. A study that corrected for this oversight found that close to half of the U.S. hospitals ranked in the top or bottom 5%, according to stroke patients’ 30-day mortality, should be reclassified into the middle range of the rankings.

© forestpath - Fotolia.com

For the 782 hospitals included in this study, the median change in rank position was 79 places when stroke severity was incorporated into the statistical model, said Dr. Gregg C. Fonarow of the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and his associates.

When stroke severity is not considered, the rankings systematically favor hospitals that care for patients with less severe illness, regardless of whether the patient care at these hospitals produces better or worse patient outcomes.

If reliance on inaccurate rankings persists, hospitals that want to improve their ranking may consider turning away patients with more severe strokes or transferring them to other hospitals after emergency department assessment, to avoid being classified as low performance, Dr. Fonarow and his associates said.

The researchers used data from the Get With the Guidelines–Stroke Registry and from CMS inpatient claims files to create a risk-adjustment model that incorporated stroke severity, as measured by the NIHSS (National Institutes of Health Stroke Scale), into hospitals’ 30-day mortality profiling. The NIHSS is a 15-item scale that assesses the effect of acute stroke on level of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.

All types of hospitals in all regions of the United States were represented. The study population included 127,950 patients aged 65 years and older who had acute ischemic stroke and were treated at 782 hospitals participating in the Get With the Guidelines program from April 2003 to December 2009.

The median patient age was 80 years; 57% were women and 86% were white. Patients frequently had serious comorbidities, including hypertension (83%), diabetes (29%), coronary artery disease or prior myocardial infarction (34%), and a history of atrial fibrillation or flutter (27%).

There were 18,186 deaths within 30 days of admission.

The statistical model that incorporated stroke severity into its assessment of hospital performance "demonstrated substantially more accurate classification of hospital 30-day mortality" than did the model currently in use. When hospitals were ranked according to this more accurate profile, their rank position changed by a median of 79 places.

Overall, 206 of the 782 hospitals (26%) ended up in a different performance category once the NIHSS score was incorporated into the model.

Of the 39 hospitals that had been categorized as top performers using the standard model, only 23 remained top performers using the more accurate model. And another 16 hospitals that hadn’t made the grade with the standard model were reclassified as top performers with the more accurate model.

"There was even greater disagreement about the bottom-performing hospitals," Dr. Fonarow and his colleagues said (JAMA 2012;308:257-64).

Of the 40 worst-performing hospitals according to the standard model, nearly half (19) were reclassified as having a middling performance with the more accurate model.

"These findings highlight the importance of including a valid specific measure of stroke severity in hospital risk models for mortality after acute ischemic stroke. ... Furthermore, this study suggests that inclusion of admission stroke severity may be essential for optimal ranking of hospitals with respect to 30-day mortality," they said.

This study was supported by the American Heart Association, American Stroke Association, and Janssen Pharmaceutical Companies of Johnson & Johnson. Dr. Fonarow is an employee of the University of California, which holds a patent on retriever devices for stroke. His associates reported ties to numerous industry sources.

Rankings of hospital performance in treating acute ischemic stroke must take into consideration the severity of each case, or the rankings will be extremely inaccurate, researchers say in the July 18 issue of JAMA.

Unfortunately, the rankings that are currently used by accreditation organizations, the Centers for Medicare and Medicaid Services (CMS), and other payers do not incorporate stroke severity. A study that corrected for this oversight found that close to half of the U.S. hospitals ranked in the top or bottom 5%, according to stroke patients’ 30-day mortality, should be reclassified into the middle range of the rankings.

© forestpath - Fotolia.com

For the 782 hospitals included in this study, the median change in rank position was 79 places when stroke severity was incorporated into the statistical model, said Dr. Gregg C. Fonarow of the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and his associates.

When stroke severity is not considered, the rankings systematically favor hospitals that care for patients with less severe illness, regardless of whether the patient care at these hospitals produces better or worse patient outcomes.

If reliance on inaccurate rankings persists, hospitals that want to improve their ranking may consider turning away patients with more severe strokes or transferring them to other hospitals after emergency department assessment, to avoid being classified as low performance, Dr. Fonarow and his associates said.

The researchers used data from the Get With the Guidelines–Stroke Registry and from CMS inpatient claims files to create a risk-adjustment model that incorporated stroke severity, as measured by the NIHSS (National Institutes of Health Stroke Scale), into hospitals’ 30-day mortality profiling. The NIHSS is a 15-item scale that assesses the effect of acute stroke on level of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.

All types of hospitals in all regions of the United States were represented. The study population included 127,950 patients aged 65 years and older who had acute ischemic stroke and were treated at 782 hospitals participating in the Get With the Guidelines program from April 2003 to December 2009.

The median patient age was 80 years; 57% were women and 86% were white. Patients frequently had serious comorbidities, including hypertension (83%), diabetes (29%), coronary artery disease or prior myocardial infarction (34%), and a history of atrial fibrillation or flutter (27%).

There were 18,186 deaths within 30 days of admission.

The statistical model that incorporated stroke severity into its assessment of hospital performance "demonstrated substantially more accurate classification of hospital 30-day mortality" than did the model currently in use. When hospitals were ranked according to this more accurate profile, their rank position changed by a median of 79 places.

Overall, 206 of the 782 hospitals (26%) ended up in a different performance category once the NIHSS score was incorporated into the model.

Of the 39 hospitals that had been categorized as top performers using the standard model, only 23 remained top performers using the more accurate model. And another 16 hospitals that hadn’t made the grade with the standard model were reclassified as top performers with the more accurate model.

"There was even greater disagreement about the bottom-performing hospitals," Dr. Fonarow and his colleagues said (JAMA 2012;308:257-64).

Of the 40 worst-performing hospitals according to the standard model, nearly half (19) were reclassified as having a middling performance with the more accurate model.

"These findings highlight the importance of including a valid specific measure of stroke severity in hospital risk models for mortality after acute ischemic stroke. ... Furthermore, this study suggests that inclusion of admission stroke severity may be essential for optimal ranking of hospitals with respect to 30-day mortality," they said.

This study was supported by the American Heart Association, American Stroke Association, and Janssen Pharmaceutical Companies of Johnson & Johnson. Dr. Fonarow is an employee of the University of California, which holds a patent on retriever devices for stroke. His associates reported ties to numerous industry sources.

Another option for colon cleansing before colonoscopy is available, with the approval of a powder-based product that is dissolved in water and administered in two doses.

The product will be marketed as Prepopik by Ferring Pharmaceuticals, and will be available in October 2012, the company statement said.

The product is a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide with anhydrous citric acid, which form magnesium citrate, an osmotic laxative. The patient receives two packets of powder to be dissolved in cold water and consumed at two different times, according to the Food and Drug Administration statement announcing the approval on July 17.

There are two options for when the product can be consumed in relation to the procedure time, according to the prescribing information. The "split-dose" method is preferred, and this involves taking the first dose the night before the colonoscopy and the second in the morning before the colonoscopy. Another option is to take the two doses in the afternoon and evening of the day before the procedure, with 6 hours between doses, known as the "day-before" method, the statement said. Additional clear fluids should be consumed after both dosing regimens.

Approval was based on two randomized clinical studies of about 1,200 adults undergoing a colonoscopy, who were assigned to the split-dose Prepopik regimen, the day-before Prepopik regimen, or a control regimen of polyethylene glycol plus electrolytes (PEG+E) with two 5-mg bisacodyl tablets taken the day before the colonoscopy.

In both studies, the use of Prepopik was as effective as the control preparation in cleansing the colon, but in the study that evaluated the split-dose regimen, this regimen was superior to the control preparation, the statement said.

The most common adverse events associated with Prepopik were nausea, vomiting, and headache. With split-dose Prepopik, the rates of nausea, vomiting, and headache were 2.6%, 1%, and 1.6%, respectively, compared with 3.7%, 3.4%, and 1.7% for the control regimen. With day-before Prepopik, rates of nausea, vomiting, and headache were 3%, 1.4%, and 2.7%, compared with 4.3%, 2%, and 1.7% for the control regimen.

On the day of colonoscopy, the rates of abnormal electrolyte shifts were numerically higher among those who used Prepopik, but the shifts were "transient in nature," according to the prescribing information.

In the statement, Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, "The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences."

As a condition of approval, Ferring is required to conduct studies to determine if the product is safe and effective in children.

Another option for colon cleansing before colonoscopy is available, with the approval of a powder-based product that is dissolved in water and administered in two doses.

The product will be marketed as Prepopik by Ferring Pharmaceuticals, and will be available in October 2012, the company statement said.

The product is a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide with anhydrous citric acid, which form magnesium citrate, an osmotic laxative. The patient receives two packets of powder to be dissolved in cold water and consumed at two different times, according to the Food and Drug Administration statement announcing the approval on July 17.

There are two options for when the product can be consumed in relation to the procedure time, according to the prescribing information. The "split-dose" method is preferred, and this involves taking the first dose the night before the colonoscopy and the second in the morning before the colonoscopy. Another option is to take the two doses in the afternoon and evening of the day before the procedure, with 6 hours between doses, known as the "day-before" method, the statement said. Additional clear fluids should be consumed after both dosing regimens.

Approval was based on two randomized clinical studies of about 1,200 adults undergoing a colonoscopy, who were assigned to the split-dose Prepopik regimen, the day-before Prepopik regimen, or a control regimen of polyethylene glycol plus electrolytes (PEG+E) with two 5-mg bisacodyl tablets taken the day before the colonoscopy.

In both studies, the use of Prepopik was as effective as the control preparation in cleansing the colon, but in the study that evaluated the split-dose regimen, this regimen was superior to the control preparation, the statement said.

The most common adverse events associated with Prepopik were nausea, vomiting, and headache. With split-dose Prepopik, the rates of nausea, vomiting, and headache were 2.6%, 1%, and 1.6%, respectively, compared with 3.7%, 3.4%, and 1.7% for the control regimen. With day-before Prepopik, rates of nausea, vomiting, and headache were 3%, 1.4%, and 2.7%, compared with 4.3%, 2%, and 1.7% for the control regimen.

On the day of colonoscopy, the rates of abnormal electrolyte shifts were numerically higher among those who used Prepopik, but the shifts were "transient in nature," according to the prescribing information.

In the statement, Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, "The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences."

As a condition of approval, Ferring is required to conduct studies to determine if the product is safe and effective in children.

Another option for colon cleansing before colonoscopy is available, with the approval of a powder-based product that is dissolved in water and administered in two doses.

The product will be marketed as Prepopik by Ferring Pharmaceuticals, and will be available in October 2012, the company statement said.

The product is a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide with anhydrous citric acid, which form magnesium citrate, an osmotic laxative. The patient receives two packets of powder to be dissolved in cold water and consumed at two different times, according to the Food and Drug Administration statement announcing the approval on July 17.

There are two options for when the product can be consumed in relation to the procedure time, according to the prescribing information. The "split-dose" method is preferred, and this involves taking the first dose the night before the colonoscopy and the second in the morning before the colonoscopy. Another option is to take the two doses in the afternoon and evening of the day before the procedure, with 6 hours between doses, known as the "day-before" method, the statement said. Additional clear fluids should be consumed after both dosing regimens.

Approval was based on two randomized clinical studies of about 1,200 adults undergoing a colonoscopy, who were assigned to the split-dose Prepopik regimen, the day-before Prepopik regimen, or a control regimen of polyethylene glycol plus electrolytes (PEG+E) with two 5-mg bisacodyl tablets taken the day before the colonoscopy.

In both studies, the use of Prepopik was as effective as the control preparation in cleansing the colon, but in the study that evaluated the split-dose regimen, this regimen was superior to the control preparation, the statement said.

The most common adverse events associated with Prepopik were nausea, vomiting, and headache. With split-dose Prepopik, the rates of nausea, vomiting, and headache were 2.6%, 1%, and 1.6%, respectively, compared with 3.7%, 3.4%, and 1.7% for the control regimen. With day-before Prepopik, rates of nausea, vomiting, and headache were 3%, 1.4%, and 2.7%, compared with 4.3%, 2%, and 1.7% for the control regimen.

On the day of colonoscopy, the rates of abnormal electrolyte shifts were numerically higher among those who used Prepopik, but the shifts were "transient in nature," according to the prescribing information.

In the statement, Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, "The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences."

As a condition of approval, Ferring is required to conduct studies to determine if the product is safe and effective in children.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.