ACS Surgery News

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said, in presenting the results at an international conference of the American Thoracic Society.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

The work was funded by the Kaiser Foundation, the Department of Veterans Affairs, and others. One author disclosed personal fees from Pfizer, MedImmune, Eli Lilly, Ferring Pharmaceuticals, and Roche Diagnostics. Dr. Liu and the other authors said they had no financial disclosures.

[email protected]

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said, in presenting the results at an international conference of the American Thoracic Society.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

The work was funded by the Kaiser Foundation, the Department of Veterans Affairs, and others. One author disclosed personal fees from Pfizer, MedImmune, Eli Lilly, Ferring Pharmaceuticals, and Roche Diagnostics. Dr. Liu and the other authors said they had no financial disclosures.

[email protected]

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said, in presenting the results at an international conference of the American Thoracic Society.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

The work was funded by the Kaiser Foundation, the Department of Veterans Affairs, and others. One author disclosed personal fees from Pfizer, MedImmune, Eli Lilly, Ferring Pharmaceuticals, and Roche Diagnostics. Dr. Liu and the other authors said they had no financial disclosures.

[email protected]

Patients undergoing treatment with nonformulary drugs will soon get a speedier decision from their health plans about whether those drugs can be covered.

On May 16, the Health & Human Services (HHS) department released a final rule outlining standards for health plans participating in the Affordable Care Act’s insurance exchanges in 2015. The rule creates an expedited process for determining coverage for nonformulary drugs in emergency situations.

©Jan Mika/iStockphoto.com

In 2015, health plans in the ACA exchanges will have no more than 24 hours to make a decision on whether to cover a nonformulary drug when it is requested under "exigent circumstances." These situations include when a patient’s diagnosis may seriously jeopardize their life, health, or ability to regain maximum function. It also includes situations in which a patient is undergoing a current course of treatment using a nonformulary drug, according to the final rule.

Under the rule, patients or their designees – including prescribing physicians – can request coverage of a nonformulary drug.

HHS said the 24-hour review period begins as soon as a request is received, and cautioned insurers not to hold up the review if "largely procedural" information is missing from the request. The agency also instructed health plans not to require "irrelevant or overly burdensome information" in the application.

If a request for a nonformulary drug is approved, health plans must make it available for the duration of the emergency situation.

[email protected]

On Twitter @maryellenny

Patients undergoing treatment with nonformulary drugs will soon get a speedier decision from their health plans about whether those drugs can be covered.

On May 16, the Health & Human Services (HHS) department released a final rule outlining standards for health plans participating in the Affordable Care Act’s insurance exchanges in 2015. The rule creates an expedited process for determining coverage for nonformulary drugs in emergency situations.

©Jan Mika/iStockphoto.com

In 2015, health plans in the ACA exchanges will have no more than 24 hours to make a decision on whether to cover a nonformulary drug when it is requested under "exigent circumstances." These situations include when a patient’s diagnosis may seriously jeopardize their life, health, or ability to regain maximum function. It also includes situations in which a patient is undergoing a current course of treatment using a nonformulary drug, according to the final rule.

Under the rule, patients or their designees – including prescribing physicians – can request coverage of a nonformulary drug.

HHS said the 24-hour review period begins as soon as a request is received, and cautioned insurers not to hold up the review if "largely procedural" information is missing from the request. The agency also instructed health plans not to require "irrelevant or overly burdensome information" in the application.

If a request for a nonformulary drug is approved, health plans must make it available for the duration of the emergency situation.

[email protected]

On Twitter @maryellenny

Patients undergoing treatment with nonformulary drugs will soon get a speedier decision from their health plans about whether those drugs can be covered.

On May 16, the Health & Human Services (HHS) department released a final rule outlining standards for health plans participating in the Affordable Care Act’s insurance exchanges in 2015. The rule creates an expedited process for determining coverage for nonformulary drugs in emergency situations.

©Jan Mika/iStockphoto.com

In 2015, health plans in the ACA exchanges will have no more than 24 hours to make a decision on whether to cover a nonformulary drug when it is requested under "exigent circumstances." These situations include when a patient’s diagnosis may seriously jeopardize their life, health, or ability to regain maximum function. It also includes situations in which a patient is undergoing a current course of treatment using a nonformulary drug, according to the final rule.

Under the rule, patients or their designees – including prescribing physicians – can request coverage of a nonformulary drug.

HHS said the 24-hour review period begins as soon as a request is received, and cautioned insurers not to hold up the review if "largely procedural" information is missing from the request. The agency also instructed health plans not to require "irrelevant or overly burdensome information" in the application.

If a request for a nonformulary drug is approved, health plans must make it available for the duration of the emergency situation.

[email protected]

On Twitter @maryellenny

BALTIMORE – A study of patients with intraabdominal infection indicates that a shorter course of antibiotics is as effective as the standard, longer course, leading researchers to recommend a new standard of care.

The rates of recurrent infections and other outcomes were similar in patients with intraabdominal infections treated with antibiotics for 4 days following source control and among those who received a longer course of treatment based on when their clinical symptoms resolved, in a study reported at the annual meeting of the Surgical Infection Society.

The results support the use of the shorter treatment strategy in this setting, said Dr. Robert Sawyer, who presented the results of the study, SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection.

Elizabeth Mechcatie/Frontline Medical News

While antibiotics are used as an adjunct to treat intraabdominal infections, the appropriate duration of treatment is not clear, and reducing the time exposed to antibiotics "could be worthwhile," said Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville.

The randomized, multicenter, unblinded study compared a shorter vs. a longer course of antibiotic therapy in 518 patients with intraabdominal infections: 4 days in 258 patients or treatment that continued for 2 days after resolution of the patient’s fever, leukocytosis, and ileus, with a maximum of 10 days of treatment in total, in 260 patients. The patients had similar APACHE II scores; their mean age was in the early 50s; and the colon or rectum was the most common source of infection, followed by the appendix and the small bowel. Antibiotics were administered intravenously or orally. Patients with inadequate source control and a high risk of death within 72 hours were excluded.

Within 30 days, the primary outcome – a composite of surgical site infection, recurrent intraabdominal infection, and death – was similar between the two groups, at about 21.7% in the 4-day treatment group vs. 22.7% in the group treated for 2 days after symptoms resolved.

There were no significant differences in the individual endpoints between the two groups. There were also no differences in the composite endpoints in different subgroups, and when those with percutaneous drainage or patients whose source of infection was the appendix were excluded. Among sicker patients with APACHE scores of 10 or higher, there was a numerical benefit favoring those treated for 4 days (22.1% vs. 29.8% among those treated for the longer duration), but the difference was not statistically significant, although it was reassuring, Dr. Sawyer said.

There were no differences between the two groups in the rates of secondary infections or subsequent infection with resistant pathogens or Clostridium difficile, which were secondary endpoints.

Based on these results, "after source control is obtained, we recommend 4 days of antimicrobial therapy for all patients with intraabdominal infections as the new standard of care," Dr. Sawyer concluded.

Although they had positive comments about the study, several members of the audience commented that a larger study would be a better base for a recommendation to change the standard of care.

This study was one of several studies presented at the meeting that addressed the issue of reducing the time on antibiotic therapy in patients with surgical infections.

The study was sponsored by the National Institutes of Health. Dr. Sawyer had no disclosures.

[email protected]

BALTIMORE – A study of patients with intraabdominal infection indicates that a shorter course of antibiotics is as effective as the standard, longer course, leading researchers to recommend a new standard of care.

The rates of recurrent infections and other outcomes were similar in patients with intraabdominal infections treated with antibiotics for 4 days following source control and among those who received a longer course of treatment based on when their clinical symptoms resolved, in a study reported at the annual meeting of the Surgical Infection Society.

The results support the use of the shorter treatment strategy in this setting, said Dr. Robert Sawyer, who presented the results of the study, SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection.

Elizabeth Mechcatie/Frontline Medical News

While antibiotics are used as an adjunct to treat intraabdominal infections, the appropriate duration of treatment is not clear, and reducing the time exposed to antibiotics "could be worthwhile," said Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville.

The randomized, multicenter, unblinded study compared a shorter vs. a longer course of antibiotic therapy in 518 patients with intraabdominal infections: 4 days in 258 patients or treatment that continued for 2 days after resolution of the patient’s fever, leukocytosis, and ileus, with a maximum of 10 days of treatment in total, in 260 patients. The patients had similar APACHE II scores; their mean age was in the early 50s; and the colon or rectum was the most common source of infection, followed by the appendix and the small bowel. Antibiotics were administered intravenously or orally. Patients with inadequate source control and a high risk of death within 72 hours were excluded.

Within 30 days, the primary outcome – a composite of surgical site infection, recurrent intraabdominal infection, and death – was similar between the two groups, at about 21.7% in the 4-day treatment group vs. 22.7% in the group treated for 2 days after symptoms resolved.

There were no significant differences in the individual endpoints between the two groups. There were also no differences in the composite endpoints in different subgroups, and when those with percutaneous drainage or patients whose source of infection was the appendix were excluded. Among sicker patients with APACHE scores of 10 or higher, there was a numerical benefit favoring those treated for 4 days (22.1% vs. 29.8% among those treated for the longer duration), but the difference was not statistically significant, although it was reassuring, Dr. Sawyer said.

There were no differences between the two groups in the rates of secondary infections or subsequent infection with resistant pathogens or Clostridium difficile, which were secondary endpoints.

Based on these results, "after source control is obtained, we recommend 4 days of antimicrobial therapy for all patients with intraabdominal infections as the new standard of care," Dr. Sawyer concluded.

Although they had positive comments about the study, several members of the audience commented that a larger study would be a better base for a recommendation to change the standard of care.

This study was one of several studies presented at the meeting that addressed the issue of reducing the time on antibiotic therapy in patients with surgical infections.

The study was sponsored by the National Institutes of Health. Dr. Sawyer had no disclosures.

[email protected]

BALTIMORE – A study of patients with intraabdominal infection indicates that a shorter course of antibiotics is as effective as the standard, longer course, leading researchers to recommend a new standard of care.

The rates of recurrent infections and other outcomes were similar in patients with intraabdominal infections treated with antibiotics for 4 days following source control and among those who received a longer course of treatment based on when their clinical symptoms resolved, in a study reported at the annual meeting of the Surgical Infection Society.

The results support the use of the shorter treatment strategy in this setting, said Dr. Robert Sawyer, who presented the results of the study, SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection.

Elizabeth Mechcatie/Frontline Medical News

While antibiotics are used as an adjunct to treat intraabdominal infections, the appropriate duration of treatment is not clear, and reducing the time exposed to antibiotics "could be worthwhile," said Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville.

The randomized, multicenter, unblinded study compared a shorter vs. a longer course of antibiotic therapy in 518 patients with intraabdominal infections: 4 days in 258 patients or treatment that continued for 2 days after resolution of the patient’s fever, leukocytosis, and ileus, with a maximum of 10 days of treatment in total, in 260 patients. The patients had similar APACHE II scores; their mean age was in the early 50s; and the colon or rectum was the most common source of infection, followed by the appendix and the small bowel. Antibiotics were administered intravenously or orally. Patients with inadequate source control and a high risk of death within 72 hours were excluded.

Within 30 days, the primary outcome – a composite of surgical site infection, recurrent intraabdominal infection, and death – was similar between the two groups, at about 21.7% in the 4-day treatment group vs. 22.7% in the group treated for 2 days after symptoms resolved.

There were no significant differences in the individual endpoints between the two groups. There were also no differences in the composite endpoints in different subgroups, and when those with percutaneous drainage or patients whose source of infection was the appendix were excluded. Among sicker patients with APACHE scores of 10 or higher, there was a numerical benefit favoring those treated for 4 days (22.1% vs. 29.8% among those treated for the longer duration), but the difference was not statistically significant, although it was reassuring, Dr. Sawyer said.

There were no differences between the two groups in the rates of secondary infections or subsequent infection with resistant pathogens or Clostridium difficile, which were secondary endpoints.

Based on these results, "after source control is obtained, we recommend 4 days of antimicrobial therapy for all patients with intraabdominal infections as the new standard of care," Dr. Sawyer concluded.

Although they had positive comments about the study, several members of the audience commented that a larger study would be a better base for a recommendation to change the standard of care.

This study was one of several studies presented at the meeting that addressed the issue of reducing the time on antibiotic therapy in patients with surgical infections.

The study was sponsored by the National Institutes of Health. Dr. Sawyer had no disclosures.

[email protected]

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

[email protected]

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

[email protected]

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

[email protected]

PARIS – Combining e-mail and office-based technology garnered patient-reported outcomes from more than 90% of patients receiving orthopedic care, in an analysis of 18,073 physician-patient encounters.

"Integrating [patient-reported outcomes] measurement into orthopedic standard of care without interrupting clinical practice is possible and currently in use," Xiang Zhou, Ph.D., reported at the World Congress on Osteoarthritis.

Patient-reported outcomes, or PROs, have taken center stage in recent years as a way to measure the safety and effectiveness of total joint arthroplasty, with respect to both technical and patient satisfaction.

New York University Langone Medical Center implemented an IT system in May 2012 for all nine adult orthopedic reconstructive surgeons at its Center for Musculoskeletal Care. Patients with e-mail addresses on file were sent a link to a PRO questionnaire, individualized to their clinical needs, 3 days before their appointment. A reminder e-mail was sent the day before their visit if the questionnaire was not completed. Tablets were also distributed in the waiting room for patients who did not complete via e-mail. Real-time and previous PRO scores were available in the electronic health record for physicians to review during the examination.

PRO records were captured for 83% of 8,864 patients seen in 20 months. Of those, 72% had multiple, longitudinal PRO scores recorded, according to Dr. Zhou, a research scientist in NYU Langone’s orthopedic surgery department.

Of the 18,073 physician-patient encounters, 71% included a completed PRO score. Monthly completion rates ranged from a high of 91% to a low of 56%.

"Reaching more than a 90% PRO collection rate is possible with the support of participating physicians," he noted.

Patients under age 65 had a significantly higher overall PRO completion rate than did older patients (76% vs. 65%; P less than .001), as did males vs. females (73% vs. 70%; P less than .001), Dr. Zhou reported at the meeting, sponsored by the Osteoarthritis Research Society International.

In all, 55% of patients who provided an e-mail address completed their PRO questionnaires via e-mail. In that subset, no significant differences were seen by age (55% both groups; P = .996) or gender (56% male vs. 55% female; P = .752).

PRO scores are now included in the electronic health record and routinely captured and used by physicians.

"Routine real-time and longitudinal PRO reports are a valuable tool to stimulate patient-physician communication and inform treatment decisions," the authors concluded in the poster presentation.

Dr. Zhou reported having no financial disclosures.

[email protected]

PARIS – Combining e-mail and office-based technology garnered patient-reported outcomes from more than 90% of patients receiving orthopedic care, in an analysis of 18,073 physician-patient encounters.

"Integrating [patient-reported outcomes] measurement into orthopedic standard of care without interrupting clinical practice is possible and currently in use," Xiang Zhou, Ph.D., reported at the World Congress on Osteoarthritis.

Patient-reported outcomes, or PROs, have taken center stage in recent years as a way to measure the safety and effectiveness of total joint arthroplasty, with respect to both technical and patient satisfaction.

New York University Langone Medical Center implemented an IT system in May 2012 for all nine adult orthopedic reconstructive surgeons at its Center for Musculoskeletal Care. Patients with e-mail addresses on file were sent a link to a PRO questionnaire, individualized to their clinical needs, 3 days before their appointment. A reminder e-mail was sent the day before their visit if the questionnaire was not completed. Tablets were also distributed in the waiting room for patients who did not complete via e-mail. Real-time and previous PRO scores were available in the electronic health record for physicians to review during the examination.

PRO records were captured for 83% of 8,864 patients seen in 20 months. Of those, 72% had multiple, longitudinal PRO scores recorded, according to Dr. Zhou, a research scientist in NYU Langone’s orthopedic surgery department.

Of the 18,073 physician-patient encounters, 71% included a completed PRO score. Monthly completion rates ranged from a high of 91% to a low of 56%.

"Reaching more than a 90% PRO collection rate is possible with the support of participating physicians," he noted.

Patients under age 65 had a significantly higher overall PRO completion rate than did older patients (76% vs. 65%; P less than .001), as did males vs. females (73% vs. 70%; P less than .001), Dr. Zhou reported at the meeting, sponsored by the Osteoarthritis Research Society International.

In all, 55% of patients who provided an e-mail address completed their PRO questionnaires via e-mail. In that subset, no significant differences were seen by age (55% both groups; P = .996) or gender (56% male vs. 55% female; P = .752).

PRO scores are now included in the electronic health record and routinely captured and used by physicians.

"Routine real-time and longitudinal PRO reports are a valuable tool to stimulate patient-physician communication and inform treatment decisions," the authors concluded in the poster presentation.

Dr. Zhou reported having no financial disclosures.

[email protected]

PARIS – Combining e-mail and office-based technology garnered patient-reported outcomes from more than 90% of patients receiving orthopedic care, in an analysis of 18,073 physician-patient encounters.

"Integrating [patient-reported outcomes] measurement into orthopedic standard of care without interrupting clinical practice is possible and currently in use," Xiang Zhou, Ph.D., reported at the World Congress on Osteoarthritis.

Patient-reported outcomes, or PROs, have taken center stage in recent years as a way to measure the safety and effectiveness of total joint arthroplasty, with respect to both technical and patient satisfaction.

New York University Langone Medical Center implemented an IT system in May 2012 for all nine adult orthopedic reconstructive surgeons at its Center for Musculoskeletal Care. Patients with e-mail addresses on file were sent a link to a PRO questionnaire, individualized to their clinical needs, 3 days before their appointment. A reminder e-mail was sent the day before their visit if the questionnaire was not completed. Tablets were also distributed in the waiting room for patients who did not complete via e-mail. Real-time and previous PRO scores were available in the electronic health record for physicians to review during the examination.

PRO records were captured for 83% of 8,864 patients seen in 20 months. Of those, 72% had multiple, longitudinal PRO scores recorded, according to Dr. Zhou, a research scientist in NYU Langone’s orthopedic surgery department.

Of the 18,073 physician-patient encounters, 71% included a completed PRO score. Monthly completion rates ranged from a high of 91% to a low of 56%.

"Reaching more than a 90% PRO collection rate is possible with the support of participating physicians," he noted.

Patients under age 65 had a significantly higher overall PRO completion rate than did older patients (76% vs. 65%; P less than .001), as did males vs. females (73% vs. 70%; P less than .001), Dr. Zhou reported at the meeting, sponsored by the Osteoarthritis Research Society International.

In all, 55% of patients who provided an e-mail address completed their PRO questionnaires via e-mail. In that subset, no significant differences were seen by age (55% both groups; P = .996) or gender (56% male vs. 55% female; P = .752).

PRO scores are now included in the electronic health record and routinely captured and used by physicians.

"Routine real-time and longitudinal PRO reports are a valuable tool to stimulate patient-physician communication and inform treatment decisions," the authors concluded in the poster presentation.

Dr. Zhou reported having no financial disclosures.

[email protected]

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.

Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.

"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.

The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.

"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.

The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.

A literature review was conducted to ensure that current practices mirrored best practices.

Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.

The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.

The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.

Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk

LAS VEGAS – Seventeen percent of severely obese adolescents slated for bariatric surgery in the Teen-Longitudinal Assessment of Bariatric Surgery study already had micro- or macroalbuminuria.

At a meeting sponsored by the National Kidney Foundation, Dr. Nianzhou Xiao said that future reports from the ongoing Teen-LABS study will provide the answer to a critical question: Is this worrisome loss of kidney function so early in life reversible via surgical weight loss?

Dr. Xiao presented a cross-sectional baseline report on 242 severely obese adolescents with a median body mass index of 50.5 kg/m². Fourteen percent had microalbuminuria and another 3.1% had macroalbuminuria. Although the group’s mean estimated glomerular filtration rate was 107.6 mL/min per 1.73 m², 3% of the teens had an eGFR below 60 mL/min 1.73 m², which is the definition of stage 3 chronic kidney disease.

In addition, 45% of the teens were hypertensive before surgery, 74% were dyslipidemic, and 13.6% had diabetes. The group’s median serum ferritin was 37 mcg/L, noted Dr. Xiao of Cincinnati Children’s Hospital Medical Center.

Multivariate analysis identified two independent risk factors for an elevated albumin to creatinine ratio: female gender, with an associated 2.34-fold increased risk, and elevated serum ferritin. For every 10 mcg/L of ferritin, the likelihood of an elevated albumin-to-creatinine ratio rose by 7%.

An estimated 4%-6% of U.S. children and adolescents are severely obese, defined as a body mass index of 35 kg/m² or more or a body weight above the 120th percentile. The ongoing Teen-LABS study is the most comprehensive examination of kidney status in severely obese adolescents undergoing bariatric surgery.

Teen-LABS is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Xiao reported having no financial conflicts.

[email protected]

LAS VEGAS – Seventeen percent of severely obese adolescents slated for bariatric surgery in the Teen-Longitudinal Assessment of Bariatric Surgery study already had micro- or macroalbuminuria.

At a meeting sponsored by the National Kidney Foundation, Dr. Nianzhou Xiao said that future reports from the ongoing Teen-LABS study will provide the answer to a critical question: Is this worrisome loss of kidney function so early in life reversible via surgical weight loss?

Dr. Xiao presented a cross-sectional baseline report on 242 severely obese adolescents with a median body mass index of 50.5 kg/m². Fourteen percent had microalbuminuria and another 3.1% had macroalbuminuria. Although the group’s mean estimated glomerular filtration rate was 107.6 mL/min per 1.73 m², 3% of the teens had an eGFR below 60 mL/min 1.73 m², which is the definition of stage 3 chronic kidney disease.

In addition, 45% of the teens were hypertensive before surgery, 74% were dyslipidemic, and 13.6% had diabetes. The group’s median serum ferritin was 37 mcg/L, noted Dr. Xiao of Cincinnati Children’s Hospital Medical Center.

Multivariate analysis identified two independent risk factors for an elevated albumin to creatinine ratio: female gender, with an associated 2.34-fold increased risk, and elevated serum ferritin. For every 10 mcg/L of ferritin, the likelihood of an elevated albumin-to-creatinine ratio rose by 7%.

An estimated 4%-6% of U.S. children and adolescents are severely obese, defined as a body mass index of 35 kg/m² or more or a body weight above the 120th percentile. The ongoing Teen-LABS study is the most comprehensive examination of kidney status in severely obese adolescents undergoing bariatric surgery.

Teen-LABS is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Xiao reported having no financial conflicts.

[email protected]

LAS VEGAS – Seventeen percent of severely obese adolescents slated for bariatric surgery in the Teen-Longitudinal Assessment of Bariatric Surgery study already had micro- or macroalbuminuria.

At a meeting sponsored by the National Kidney Foundation, Dr. Nianzhou Xiao said that future reports from the ongoing Teen-LABS study will provide the answer to a critical question: Is this worrisome loss of kidney function so early in life reversible via surgical weight loss?

Dr. Xiao presented a cross-sectional baseline report on 242 severely obese adolescents with a median body mass index of 50.5 kg/m². Fourteen percent had microalbuminuria and another 3.1% had macroalbuminuria. Although the group’s mean estimated glomerular filtration rate was 107.6 mL/min per 1.73 m², 3% of the teens had an eGFR below 60 mL/min 1.73 m², which is the definition of stage 3 chronic kidney disease.

In addition, 45% of the teens were hypertensive before surgery, 74% were dyslipidemic, and 13.6% had diabetes. The group’s median serum ferritin was 37 mcg/L, noted Dr. Xiao of Cincinnati Children’s Hospital Medical Center.

Multivariate analysis identified two independent risk factors for an elevated albumin to creatinine ratio: female gender, with an associated 2.34-fold increased risk, and elevated serum ferritin. For every 10 mcg/L of ferritin, the likelihood of an elevated albumin-to-creatinine ratio rose by 7%.

An estimated 4%-6% of U.S. children and adolescents are severely obese, defined as a body mass index of 35 kg/m² or more or a body weight above the 120th percentile. The ongoing Teen-LABS study is the most comprehensive examination of kidney status in severely obese adolescents undergoing bariatric surgery.

Teen-LABS is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Xiao reported having no financial conflicts.

[email protected]