Perioperative Medicine

SAN DIEGO – High-dose perioperative atorvastatin treatment did not reduce acute kidney injury following elective cardiac surgery, and it may increase risk in patients with chronic kidney disease (CKD) who are naive to statin treatment, results from a large, randomized trial showed.

“Despite advances in patient management that have reduced mortality during cardiac surgery, acute kidney injury continues to complicate the postoperative course in 20%-30% of patients,” Dr. Frederic Tremaine Billings said during a press briefing at a meeting sponsored by the American Society of Nephrology.

“Its diagnosis is independently associated with a fivefold increase in mortality following the surgery,” Dr. Tremaine added. “Statins affect several mechanisms underlying postoperative acute kidney injury. Widely prescribed to reduce cholesterol synthesis, these drugs also reduce lipid modification of intracellular signaling molecules, which have been shown to improve perfusion and reduce oxidative stress – both mechanisms important in acute kidney injury following cardiac surgery.”

Dr. Billings of the department of anesthesiology and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates tested the hypothesis that short-term, high-dose perioperative (preoperative, intraoperative, and postoperative) atorvastatin reduces acute kidney injury (AKI) following elective cardiac surgery.

The researchers randomly assigned preoperative statin-naive patients to 80 mg of atorvastatin on the morning before surgery, 40 mg on the morning of surgery, and 40 mg daily throughout hospitalization, or to a matching placebo regimen. In addition, they randomly assigned patients who were already using statins prior to surgery to 80 mg of atorvastatin the morning of surgery, and 40 mg on the morning after surgery, or to a matching placebo regimen.

“We felt it was important to not withhold statin treatment in patients already using statins prior to surgery, beyond what is typically done in clinical practice,” Dr. Billings explained. “For this reason, preoperative statin–using subjects continued their statin up until the day before surgery, and then resumed their statin use on postoperative day 2.”

The primary endpoint of the study was the incidence of AKI as determined by Acute Kidney Injury Network criteria (a 0.3 mg/dL increase in serum creatinine concentrations within 48 hours of surgery). Secondary endpoints included the maximum creatinine increase from baseline to 48 hours after surgery, ICU delirium diagnosed by the Confusion Assessment Method for the ICU, myocardial injury, and the incidence of atrial fibrillation, pneumonia, and stroke. Safety endpoints included liver toxicity, muscle toxicity, and adverse events.

The study was limited to adults having elective cardiac surgery and excluded those with statin intolerance, acute coronary syndrome, liver dysfunction, use of CYP3A4 inhibitors, kidney transplant recipients, those currently on dialysis, and those who were pregnant.

From November 2009 to October 2014, the researchers recruited 653 patients. But the trial was halted on recommendation of Vanderbilt’s data and safety monitoring board because of futility and an increased incidence of AKI among statin-naive patients with CKD randomized to atorvastatin.

Among all patients, AKI occurred in 20.8% of those randomized to atorvastatin, compared with 19.5% of those randomized to placebo, a difference that was neither clinically nor statistically significant (P = .75), Dr. Billings reported.

However, among the 199 patients who were statin naive, AKI occurred in 21.6% of those randomized to atorvastatin, compared with 13.4% of those randomized to placebo (P = .14). “An 8% difference in the incidence of AKI is of clinical importance, if true,” he said.

Among the 36 statin-naive patients with CKD, AKI occurred in 52.9% of those randomized to atorvastatin, compared with 15.8% of those randomized to placebo (P = .03). “While the number of patients in this subgroup is small, the magnitude of effect is striking,” Dr. Billings said.

Among the 416 patients who were using statins prior to surgery, AKI occurred in 20.4% of those randomized to atorvastatin, compared with 22.4% of those randomized to placebo (P = .63). Results were similar among the subset of those patients who had CKD (31.3% vs. 36.3%; P = .59).

Safety endpoints were similar between the two groups.

Strengths of the study, Dr. Billings said, include the fact that it’s the largest randomized, controlled trial to date to test this hypothesis, the pragmatic design of the protocol, and rigorous methodology.

Limitations include the “small number of patients in the statin-naive CKD subgroup,” he noted. “And the short duration of treatment among prestudy statin-using patients could limit the observation that short-term withdrawal is not harmful – although we felt it appropriate not to limit statins beyond what’s typical in clinical practice, based on prior reports that even short-term statin withdrawal may be harmful.”

The National Institutes of Health and the department of anesthesiology at Vanderbilt University supported the study. Dr. Billings reported having no financial disclosures.

[email protected]

SAN DIEGO – High-dose perioperative atorvastatin treatment did not reduce acute kidney injury following elective cardiac surgery, and it may increase risk in patients with chronic kidney disease (CKD) who are naive to statin treatment, results from a large, randomized trial showed.

“Despite advances in patient management that have reduced mortality during cardiac surgery, acute kidney injury continues to complicate the postoperative course in 20%-30% of patients,” Dr. Frederic Tremaine Billings said during a press briefing at a meeting sponsored by the American Society of Nephrology.

“Its diagnosis is independently associated with a fivefold increase in mortality following the surgery,” Dr. Tremaine added. “Statins affect several mechanisms underlying postoperative acute kidney injury. Widely prescribed to reduce cholesterol synthesis, these drugs also reduce lipid modification of intracellular signaling molecules, which have been shown to improve perfusion and reduce oxidative stress – both mechanisms important in acute kidney injury following cardiac surgery.”

Dr. Billings of the department of anesthesiology and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates tested the hypothesis that short-term, high-dose perioperative (preoperative, intraoperative, and postoperative) atorvastatin reduces acute kidney injury (AKI) following elective cardiac surgery.

The researchers randomly assigned preoperative statin-naive patients to 80 mg of atorvastatin on the morning before surgery, 40 mg on the morning of surgery, and 40 mg daily throughout hospitalization, or to a matching placebo regimen. In addition, they randomly assigned patients who were already using statins prior to surgery to 80 mg of atorvastatin the morning of surgery, and 40 mg on the morning after surgery, or to a matching placebo regimen.

“We felt it was important to not withhold statin treatment in patients already using statins prior to surgery, beyond what is typically done in clinical practice,” Dr. Billings explained. “For this reason, preoperative statin–using subjects continued their statin up until the day before surgery, and then resumed their statin use on postoperative day 2.”

The primary endpoint of the study was the incidence of AKI as determined by Acute Kidney Injury Network criteria (a 0.3 mg/dL increase in serum creatinine concentrations within 48 hours of surgery). Secondary endpoints included the maximum creatinine increase from baseline to 48 hours after surgery, ICU delirium diagnosed by the Confusion Assessment Method for the ICU, myocardial injury, and the incidence of atrial fibrillation, pneumonia, and stroke. Safety endpoints included liver toxicity, muscle toxicity, and adverse events.

The study was limited to adults having elective cardiac surgery and excluded those with statin intolerance, acute coronary syndrome, liver dysfunction, use of CYP3A4 inhibitors, kidney transplant recipients, those currently on dialysis, and those who were pregnant.

From November 2009 to October 2014, the researchers recruited 653 patients. But the trial was halted on recommendation of Vanderbilt’s data and safety monitoring board because of futility and an increased incidence of AKI among statin-naive patients with CKD randomized to atorvastatin.

Among all patients, AKI occurred in 20.8% of those randomized to atorvastatin, compared with 19.5% of those randomized to placebo, a difference that was neither clinically nor statistically significant (P = .75), Dr. Billings reported.

However, among the 199 patients who were statin naive, AKI occurred in 21.6% of those randomized to atorvastatin, compared with 13.4% of those randomized to placebo (P = .14). “An 8% difference in the incidence of AKI is of clinical importance, if true,” he said.

Among the 36 statin-naive patients with CKD, AKI occurred in 52.9% of those randomized to atorvastatin, compared with 15.8% of those randomized to placebo (P = .03). “While the number of patients in this subgroup is small, the magnitude of effect is striking,” Dr. Billings said.

Among the 416 patients who were using statins prior to surgery, AKI occurred in 20.4% of those randomized to atorvastatin, compared with 22.4% of those randomized to placebo (P = .63). Results were similar among the subset of those patients who had CKD (31.3% vs. 36.3%; P = .59).

Safety endpoints were similar between the two groups.

Strengths of the study, Dr. Billings said, include the fact that it’s the largest randomized, controlled trial to date to test this hypothesis, the pragmatic design of the protocol, and rigorous methodology.

Limitations include the “small number of patients in the statin-naive CKD subgroup,” he noted. “And the short duration of treatment among prestudy statin-using patients could limit the observation that short-term withdrawal is not harmful – although we felt it appropriate not to limit statins beyond what’s typical in clinical practice, based on prior reports that even short-term statin withdrawal may be harmful.”

The National Institutes of Health and the department of anesthesiology at Vanderbilt University supported the study. Dr. Billings reported having no financial disclosures.

[email protected]

SAN DIEGO – High-dose perioperative atorvastatin treatment did not reduce acute kidney injury following elective cardiac surgery, and it may increase risk in patients with chronic kidney disease (CKD) who are naive to statin treatment, results from a large, randomized trial showed.

“Despite advances in patient management that have reduced mortality during cardiac surgery, acute kidney injury continues to complicate the postoperative course in 20%-30% of patients,” Dr. Frederic Tremaine Billings said during a press briefing at a meeting sponsored by the American Society of Nephrology.

“Its diagnosis is independently associated with a fivefold increase in mortality following the surgery,” Dr. Tremaine added. “Statins affect several mechanisms underlying postoperative acute kidney injury. Widely prescribed to reduce cholesterol synthesis, these drugs also reduce lipid modification of intracellular signaling molecules, which have been shown to improve perfusion and reduce oxidative stress – both mechanisms important in acute kidney injury following cardiac surgery.”

Dr. Billings of the department of anesthesiology and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates tested the hypothesis that short-term, high-dose perioperative (preoperative, intraoperative, and postoperative) atorvastatin reduces acute kidney injury (AKI) following elective cardiac surgery.

The researchers randomly assigned preoperative statin-naive patients to 80 mg of atorvastatin on the morning before surgery, 40 mg on the morning of surgery, and 40 mg daily throughout hospitalization, or to a matching placebo regimen. In addition, they randomly assigned patients who were already using statins prior to surgery to 80 mg of atorvastatin the morning of surgery, and 40 mg on the morning after surgery, or to a matching placebo regimen.

“We felt it was important to not withhold statin treatment in patients already using statins prior to surgery, beyond what is typically done in clinical practice,” Dr. Billings explained. “For this reason, preoperative statin–using subjects continued their statin up until the day before surgery, and then resumed their statin use on postoperative day 2.”

The primary endpoint of the study was the incidence of AKI as determined by Acute Kidney Injury Network criteria (a 0.3 mg/dL increase in serum creatinine concentrations within 48 hours of surgery). Secondary endpoints included the maximum creatinine increase from baseline to 48 hours after surgery, ICU delirium diagnosed by the Confusion Assessment Method for the ICU, myocardial injury, and the incidence of atrial fibrillation, pneumonia, and stroke. Safety endpoints included liver toxicity, muscle toxicity, and adverse events.

The study was limited to adults having elective cardiac surgery and excluded those with statin intolerance, acute coronary syndrome, liver dysfunction, use of CYP3A4 inhibitors, kidney transplant recipients, those currently on dialysis, and those who were pregnant.

From November 2009 to October 2014, the researchers recruited 653 patients. But the trial was halted on recommendation of Vanderbilt’s data and safety monitoring board because of futility and an increased incidence of AKI among statin-naive patients with CKD randomized to atorvastatin.

Among all patients, AKI occurred in 20.8% of those randomized to atorvastatin, compared with 19.5% of those randomized to placebo, a difference that was neither clinically nor statistically significant (P = .75), Dr. Billings reported.

However, among the 199 patients who were statin naive, AKI occurred in 21.6% of those randomized to atorvastatin, compared with 13.4% of those randomized to placebo (P = .14). “An 8% difference in the incidence of AKI is of clinical importance, if true,” he said.

Among the 36 statin-naive patients with CKD, AKI occurred in 52.9% of those randomized to atorvastatin, compared with 15.8% of those randomized to placebo (P = .03). “While the number of patients in this subgroup is small, the magnitude of effect is striking,” Dr. Billings said.

Among the 416 patients who were using statins prior to surgery, AKI occurred in 20.4% of those randomized to atorvastatin, compared with 22.4% of those randomized to placebo (P = .63). Results were similar among the subset of those patients who had CKD (31.3% vs. 36.3%; P = .59).

Safety endpoints were similar between the two groups.

Strengths of the study, Dr. Billings said, include the fact that it’s the largest randomized, controlled trial to date to test this hypothesis, the pragmatic design of the protocol, and rigorous methodology.

Limitations include the “small number of patients in the statin-naive CKD subgroup,” he noted. “And the short duration of treatment among prestudy statin-using patients could limit the observation that short-term withdrawal is not harmful – although we felt it appropriate not to limit statins beyond what’s typical in clinical practice, based on prior reports that even short-term statin withdrawal may be harmful.”

The National Institutes of Health and the department of anesthesiology at Vanderbilt University supported the study. Dr. Billings reported having no financial disclosures.

[email protected]

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.

A hospital’s rate of postoperative Clostridium difficile infection is related to the number of preoperative antibiotics patients have taken, the complexity of their procedures, and the complexity of the hospital’s surgical program, in addition to known risk factors for the infection, according to a report published online in JAMA Surgery.

Several risk factors for postoperative C. difficile infection have already been identified, including advanced age and comorbidity. To examine known risk factors and identify possible new ones, researchers analyzed information from the Veterans Affairs Surgical Quality Improvement Program’s database, which documents all noncardiac operations at 134 VA medical centers each year.

The investigators focused on 468,386 procedures performed during a 4-year period. A total of 1,833 cases of C. difficile infection were diagnosed within 30 days of surgery, for an overall incidence of 0.4% in this predominantly male, elderly population, said Xinli Li, Ph.D., of the Veterans Health Administration, Washington, and associates.

As expected, patients who developed postoperative C. difficile infection were significantly older than those who didn’t (mean age, 67.4 vs. 60.6 years) and were significantly more likely to have comorbidities such as impaired functional status, heart failure, chronic obstructive pulmonary disease, ascites, renal failure, bleeding disorders, wound infection, and recent weight loss.

Unexpectedly, the number of different antibiotics taken during the 60 days preceding surgery also was significantly associated with C. difficile infection. Patients who had taken three or more antibiotics from different classes were nearly six times more likely to develop C. difficile than patients who had taken only one or no antibiotics, the investigators reported (JAMA Surg. 2015 Nov 25. doi: 10.1001/jamasurg.2015.4263).In addition, patients who underwent more complex surgical procedures were at increased risk of this complication, as were patients at hospitals that frequently handled complex procedures. “These factors reflect the illness of patients, duration of operation, and hospital setting; each is an established risk factor for C. difficile infection,” Dr. Li and associates wrote.

Patients with C. difficile infection had higher rates of postoperative other morbidity (86.0% vs. 7.1%) and 30-day mortality (5.3% vs. 1.0%) and longer postoperative hospital stays (17.9 days vs. 3.6 days).

Contrary to previous studies, this study did not show a temporal increase in C. difficile infection. The overall incidence, as well as the incidences at individual hospitals, remained constant during the entire 4-year study period, the investigators added.

The incidence of C. difficile varied substantially among the 134 VA medical centers, from 0% to 1.35% of all surgical patients. “Surgical administrators and clinical teams may consider the results of this study to target interventions for specific patients undergoing high-risk procedures. Such interventions include selective antibiotic administration, early testing of at-risk patients, hand hygiene with nonalcohol agents, early contact precautions, and specific environmental cleaning protocols,” Dr. Li and associates wrote.

This study was supported by the Veterans Health Administration. Dr. Li and associates reported having no relevant financial disclosures.

A hospital’s rate of postoperative Clostridium difficile infection is related to the number of preoperative antibiotics patients have taken, the complexity of their procedures, and the complexity of the hospital’s surgical program, in addition to known risk factors for the infection, according to a report published online in JAMA Surgery.

Several risk factors for postoperative C. difficile infection have already been identified, including advanced age and comorbidity. To examine known risk factors and identify possible new ones, researchers analyzed information from the Veterans Affairs Surgical Quality Improvement Program’s database, which documents all noncardiac operations at 134 VA medical centers each year.

The investigators focused on 468,386 procedures performed during a 4-year period. A total of 1,833 cases of C. difficile infection were diagnosed within 30 days of surgery, for an overall incidence of 0.4% in this predominantly male, elderly population, said Xinli Li, Ph.D., of the Veterans Health Administration, Washington, and associates.

As expected, patients who developed postoperative C. difficile infection were significantly older than those who didn’t (mean age, 67.4 vs. 60.6 years) and were significantly more likely to have comorbidities such as impaired functional status, heart failure, chronic obstructive pulmonary disease, ascites, renal failure, bleeding disorders, wound infection, and recent weight loss.

Unexpectedly, the number of different antibiotics taken during the 60 days preceding surgery also was significantly associated with C. difficile infection. Patients who had taken three or more antibiotics from different classes were nearly six times more likely to develop C. difficile than patients who had taken only one or no antibiotics, the investigators reported (JAMA Surg. 2015 Nov 25. doi: 10.1001/jamasurg.2015.4263).In addition, patients who underwent more complex surgical procedures were at increased risk of this complication, as were patients at hospitals that frequently handled complex procedures. “These factors reflect the illness of patients, duration of operation, and hospital setting; each is an established risk factor for C. difficile infection,” Dr. Li and associates wrote.

Patients with C. difficile infection had higher rates of postoperative other morbidity (86.0% vs. 7.1%) and 30-day mortality (5.3% vs. 1.0%) and longer postoperative hospital stays (17.9 days vs. 3.6 days).

Contrary to previous studies, this study did not show a temporal increase in C. difficile infection. The overall incidence, as well as the incidences at individual hospitals, remained constant during the entire 4-year study period, the investigators added.

The incidence of C. difficile varied substantially among the 134 VA medical centers, from 0% to 1.35% of all surgical patients. “Surgical administrators and clinical teams may consider the results of this study to target interventions for specific patients undergoing high-risk procedures. Such interventions include selective antibiotic administration, early testing of at-risk patients, hand hygiene with nonalcohol agents, early contact precautions, and specific environmental cleaning protocols,” Dr. Li and associates wrote.

This study was supported by the Veterans Health Administration. Dr. Li and associates reported having no relevant financial disclosures.

A hospital’s rate of postoperative Clostridium difficile infection is related to the number of preoperative antibiotics patients have taken, the complexity of their procedures, and the complexity of the hospital’s surgical program, in addition to known risk factors for the infection, according to a report published online in JAMA Surgery.

Several risk factors for postoperative C. difficile infection have already been identified, including advanced age and comorbidity. To examine known risk factors and identify possible new ones, researchers analyzed information from the Veterans Affairs Surgical Quality Improvement Program’s database, which documents all noncardiac operations at 134 VA medical centers each year.

The investigators focused on 468,386 procedures performed during a 4-year period. A total of 1,833 cases of C. difficile infection were diagnosed within 30 days of surgery, for an overall incidence of 0.4% in this predominantly male, elderly population, said Xinli Li, Ph.D., of the Veterans Health Administration, Washington, and associates.

As expected, patients who developed postoperative C. difficile infection were significantly older than those who didn’t (mean age, 67.4 vs. 60.6 years) and were significantly more likely to have comorbidities such as impaired functional status, heart failure, chronic obstructive pulmonary disease, ascites, renal failure, bleeding disorders, wound infection, and recent weight loss.

Unexpectedly, the number of different antibiotics taken during the 60 days preceding surgery also was significantly associated with C. difficile infection. Patients who had taken three or more antibiotics from different classes were nearly six times more likely to develop C. difficile than patients who had taken only one or no antibiotics, the investigators reported (JAMA Surg. 2015 Nov 25. doi: 10.1001/jamasurg.2015.4263).In addition, patients who underwent more complex surgical procedures were at increased risk of this complication, as were patients at hospitals that frequently handled complex procedures. “These factors reflect the illness of patients, duration of operation, and hospital setting; each is an established risk factor for C. difficile infection,” Dr. Li and associates wrote.

Patients with C. difficile infection had higher rates of postoperative other morbidity (86.0% vs. 7.1%) and 30-day mortality (5.3% vs. 1.0%) and longer postoperative hospital stays (17.9 days vs. 3.6 days).

Contrary to previous studies, this study did not show a temporal increase in C. difficile infection. The overall incidence, as well as the incidences at individual hospitals, remained constant during the entire 4-year study period, the investigators added.

The incidence of C. difficile varied substantially among the 134 VA medical centers, from 0% to 1.35% of all surgical patients. “Surgical administrators and clinical teams may consider the results of this study to target interventions for specific patients undergoing high-risk procedures. Such interventions include selective antibiotic administration, early testing of at-risk patients, hand hygiene with nonalcohol agents, early contact precautions, and specific environmental cleaning protocols,” Dr. Li and associates wrote.

This study was supported by the Veterans Health Administration. Dr. Li and associates reported having no relevant financial disclosures.

SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.

“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”

As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.

Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”

Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.

The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”

Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.

[email protected]

SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.

“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”

As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.

Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”

Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.

The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”

Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.

[email protected]

SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.

“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”

As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.

Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”

Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.

The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”

Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.

[email protected]

About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).

“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.

The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.

After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%

The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.

The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.

This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”

Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.

The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.

The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.

About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).

“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.

The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.

After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%

The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.

The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.

This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”

Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.

The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.

The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.

About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).

“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.

The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.

After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%

The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.

The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.

This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”

Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.

The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.

The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.