Alexander R. Carbo, MD, SFHM

Clinical question: Does peri-operative clonidine prevent myocardial infarction (MI)?

Background: A meta-analysis showed that peri-operative clonidine decreased death and MI compared to placebo in patients undergoing vascular surgery. It also showed that rates of death and MI were the same for patients taking clonidine vs. placebo undergoing nonvascular surgery without significant effects on hemodynamics.

Study design: Randomized controlled trial.

Setting: One hundred thirty-five centers across 23 countries.

Synopsis: The POISE-II [PeriOperative Ischemic Evaluation-II] study randomized 10,010 patients in a 1:1:1:1 fashion to analyze peri-operative clonidine and aspirin against placebo. This paper specifically examined the effects of peri-operative clonidine vs. placebo. The average age of the population was 69 years old. The most common comorbidities were diabetes (38%) and coronary artery disease (23%).

The outcomes showed that clonidine vs. placebo yielded insignificant results with respect to the primary endpoints (death, MI, or stroke: 7.6% vs. 7.0%; P=0.30); however, there were significantly higher rates of clinically significant hypotension (47.6% vs. 37.1%; P<0.001), bradycardia (12.0% vs. 8.1%; P<0.001), and nonfatal cardiac arrest (0.3% vs. 0.1%; P=0.02) in the clonidine group.

These results differ from previous, smaller studies, which suggested that there were no significant hemodynamic changes when patients received peri-operative clonidine.

Bottom line: Peri-operative clonidine does not affect the rate of MI but increases clinically significant hypotension, bradycardia, and nonfatal cardiac arrest.

Citation: Devereaux PJ, Sessler DI, Leslie K, et al. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014;370(16):1504-1513.

Clinical question: Does peri-operative clonidine prevent myocardial infarction (MI)?

Background: A meta-analysis showed that peri-operative clonidine decreased death and MI compared to placebo in patients undergoing vascular surgery. It also showed that rates of death and MI were the same for patients taking clonidine vs. placebo undergoing nonvascular surgery without significant effects on hemodynamics.

Study design: Randomized controlled trial.

Setting: One hundred thirty-five centers across 23 countries.

Synopsis: The POISE-II [PeriOperative Ischemic Evaluation-II] study randomized 10,010 patients in a 1:1:1:1 fashion to analyze peri-operative clonidine and aspirin against placebo. This paper specifically examined the effects of peri-operative clonidine vs. placebo. The average age of the population was 69 years old. The most common comorbidities were diabetes (38%) and coronary artery disease (23%).

The outcomes showed that clonidine vs. placebo yielded insignificant results with respect to the primary endpoints (death, MI, or stroke: 7.6% vs. 7.0%; P=0.30); however, there were significantly higher rates of clinically significant hypotension (47.6% vs. 37.1%; P<0.001), bradycardia (12.0% vs. 8.1%; P<0.001), and nonfatal cardiac arrest (0.3% vs. 0.1%; P=0.02) in the clonidine group.

These results differ from previous, smaller studies, which suggested that there were no significant hemodynamic changes when patients received peri-operative clonidine.

Bottom line: Peri-operative clonidine does not affect the rate of MI but increases clinically significant hypotension, bradycardia, and nonfatal cardiac arrest.

Citation: Devereaux PJ, Sessler DI, Leslie K, et al. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014;370(16):1504-1513.

Clinical question: Does peri-operative clonidine prevent myocardial infarction (MI)?

Background: A meta-analysis showed that peri-operative clonidine decreased death and MI compared to placebo in patients undergoing vascular surgery. It also showed that rates of death and MI were the same for patients taking clonidine vs. placebo undergoing nonvascular surgery without significant effects on hemodynamics.

Study design: Randomized controlled trial.

Setting: One hundred thirty-five centers across 23 countries.

Synopsis: The POISE-II [PeriOperative Ischemic Evaluation-II] study randomized 10,010 patients in a 1:1:1:1 fashion to analyze peri-operative clonidine and aspirin against placebo. This paper specifically examined the effects of peri-operative clonidine vs. placebo. The average age of the population was 69 years old. The most common comorbidities were diabetes (38%) and coronary artery disease (23%).

The outcomes showed that clonidine vs. placebo yielded insignificant results with respect to the primary endpoints (death, MI, or stroke: 7.6% vs. 7.0%; P=0.30); however, there were significantly higher rates of clinically significant hypotension (47.6% vs. 37.1%; P<0.001), bradycardia (12.0% vs. 8.1%; P<0.001), and nonfatal cardiac arrest (0.3% vs. 0.1%; P=0.02) in the clonidine group.

These results differ from previous, smaller studies, which suggested that there were no significant hemodynamic changes when patients received peri-operative clonidine.

Bottom line: Peri-operative clonidine does not affect the rate of MI but increases clinically significant hypotension, bradycardia, and nonfatal cardiac arrest.

Citation: Devereaux PJ, Sessler DI, Leslie K, et al. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014;370(16):1504-1513.

Clinical question: Can a delirium severity score that coincides with clinical outcomes be developed?

Background: Quantification of the severity of delirium is important. Building on the Confusion Assessment Method (CAM) scoring system, the CAM-S was developed to help evaluate the severity of delirium.

Study design: Validation analysis in two independent cohorts.

Setting: Three academic medical centers.

Synopsis: Two cohorts of patients were included. The sample from the SAGES [Successful Aging after Elective Surgery] study included 300 patients aged 70 years or older undergoing major surgery. The sample from the Project Recovery study included 919 medical patients aged 70 years or older. There was a predominance of women in both studies. Patients were excluded if they had delirium or dementia present at baseline, recent hospitalization, a terminal diagnosis, vision and auditory impairment, or inability to speak English. A short, four-item form and 10-item longer form were developed, and scores on forms were correlated with outcomes both in the hospital and after discharge.

A higher severity score in both short and long forms was associated with a higher length of stay, as well as relative risk of death and nursing home residence at 90 days.

Limitations to the study were that all patients in the study were 70 years and older and that the Project Recovery sample used an older data set from 1995-1998.

Bottom line: The CAM-S represents a new delirium severity measurement system; it is associated with several clinical outcomes.

Citation: Inouye SK, Kosar CM, Tommet D, et al. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014;160(8):526-533.

Clinical question: Can a delirium severity score that coincides with clinical outcomes be developed?

Background: Quantification of the severity of delirium is important. Building on the Confusion Assessment Method (CAM) scoring system, the CAM-S was developed to help evaluate the severity of delirium.

Study design: Validation analysis in two independent cohorts.

Setting: Three academic medical centers.

Synopsis: Two cohorts of patients were included. The sample from the SAGES [Successful Aging after Elective Surgery] study included 300 patients aged 70 years or older undergoing major surgery. The sample from the Project Recovery study included 919 medical patients aged 70 years or older. There was a predominance of women in both studies. Patients were excluded if they had delirium or dementia present at baseline, recent hospitalization, a terminal diagnosis, vision and auditory impairment, or inability to speak English. A short, four-item form and 10-item longer form were developed, and scores on forms were correlated with outcomes both in the hospital and after discharge.

A higher severity score in both short and long forms was associated with a higher length of stay, as well as relative risk of death and nursing home residence at 90 days.

Limitations to the study were that all patients in the study were 70 years and older and that the Project Recovery sample used an older data set from 1995-1998.

Bottom line: The CAM-S represents a new delirium severity measurement system; it is associated with several clinical outcomes.

Citation: Inouye SK, Kosar CM, Tommet D, et al. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014;160(8):526-533.

Clinical question: Can a delirium severity score that coincides with clinical outcomes be developed?

Background: Quantification of the severity of delirium is important. Building on the Confusion Assessment Method (CAM) scoring system, the CAM-S was developed to help evaluate the severity of delirium.

Study design: Validation analysis in two independent cohorts.

Setting: Three academic medical centers.

Synopsis: Two cohorts of patients were included. The sample from the SAGES [Successful Aging after Elective Surgery] study included 300 patients aged 70 years or older undergoing major surgery. The sample from the Project Recovery study included 919 medical patients aged 70 years or older. There was a predominance of women in both studies. Patients were excluded if they had delirium or dementia present at baseline, recent hospitalization, a terminal diagnosis, vision and auditory impairment, or inability to speak English. A short, four-item form and 10-item longer form were developed, and scores on forms were correlated with outcomes both in the hospital and after discharge.

A higher severity score in both short and long forms was associated with a higher length of stay, as well as relative risk of death and nursing home residence at 90 days.

Limitations to the study were that all patients in the study were 70 years and older and that the Project Recovery sample used an older data set from 1995-1998.

Bottom line: The CAM-S represents a new delirium severity measurement system; it is associated with several clinical outcomes.

Citation: Inouye SK, Kosar CM, Tommet D, et al. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014;160(8):526-533.

Clinical question: What are the risk factors identified at the onset of illness that are associated with recurrent C. diff infection?

Background: After initial infection, 10%-25% of patients experience recurrent C. diff infection (CDI). The identification of patients at high risk of recurrence would be beneficial for therapeutic decision making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection, defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence.

Four hundred twenty-five patients (10.1%) had recurrent infection. Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis.

Limitations of the study included potential confounding, use of observational data, and generalizability, given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423.

Clinical question: What are the risk factors identified at the onset of illness that are associated with recurrent C. diff infection?

Background: After initial infection, 10%-25% of patients experience recurrent C. diff infection (CDI). The identification of patients at high risk of recurrence would be beneficial for therapeutic decision making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection, defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence.

Four hundred twenty-five patients (10.1%) had recurrent infection. Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis.

Limitations of the study included potential confounding, use of observational data, and generalizability, given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423.

Clinical question: What are the risk factors identified at the onset of illness that are associated with recurrent C. diff infection?

Background: After initial infection, 10%-25% of patients experience recurrent C. diff infection (CDI). The identification of patients at high risk of recurrence would be beneficial for therapeutic decision making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection, defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence.

Four hundred twenty-five patients (10.1%) had recurrent infection. Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis.

Limitations of the study included potential confounding, use of observational data, and generalizability, given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423.

Background

Hospitalists commonly order red blood cell (RBC) transfusion as a therapy for patients with anemia resulting from a variety of clinical conditions. There has been lack of consensus on when to transfuse, because patients with anemia frequently have multiple co-morbidities, including coronary artery disease and congestive heart failure, which may influence their ability to tolerate a potentially ischemic state related to anemia or to accommodate volume fluctuations related to transfusion.

Furthermore, RBC transfusions are not without inherent risk. Life-threatening transfusion reactions occur in approximately seven per million transfused blood components, and transfusion-associated circulatory overload (TACO) can develop in one in 100 transfusions.¹

Recently published guidelines provide recommendations for management of hemodynamically stable adults with anemia.

Guideline Update

The AABB published guidelines in the Annals of Internal Medicine in 2012 addressing RBC transfusion thresholds.¹ The updated guideline makes a recommendation that clinicians utilize a restrictive transfusion strategy. Transfusion is strongly recommended for ICU patients with hemoglobin ≤7g/dL. In post-operative surgical patients and for post-operative patients with symptomatic anemia, transfusion is recommended for hemoglobin ≤8g/dL. The authors also made a weak recommendation to transfuse for hemoglobin ≤8g/dL or for symptoms in hospitalized hemodynamically stable patients with preexisting cardiovascular disease.

These recommendations draw from past literature, along with two more recent trials examining liberal or restrictive transfusion thresholds. The newer trials increased the total number of patients studied by nearly one third compared with prior reviews.^2,3 The authors also incorporated recently published systematic reviews in their analysis.

Although the definition of a restrictive transfusion threshold varied across trials, including hemoglobin ≤7g/dL and ≤8g/dL, the authors used the pooled data to provide several recommendations in the new guideline. Of note, the pooled data was underpowered to detect up to a twofold increase in risk of myocardial infarction in patients in the restrictive strategy group.¹

There were insufficient data for the authors to recommend for or against a restrictive transfusion strategy in patients with acute coronary syndrome, based on very low quality evidence.

Finally, the authors recommended that symptoms and hemoglobin level should both be used in determining transfusion criteria, based on low quality of evidence.

Analysis

The current AABB guidelines have two primary differences from earlier guidelines. First, the AABB authors used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology to formalize evidence-based practice in their analysis of the literature. The authors purposely used the GRADE methodology to systematically evaluate the quality of the evidence base and explicitly state the strength of the recommendation for a particular transfusion threshold.⁴

Second, the AABB guidelines incorporated data from the more recently published FOCUS (Functional Outcomes in Cardiovascular patients Undergoing Surgical repair of hip fracture) and TRACS (Transfusion Requirements After Cardiac Surgery) trials, resulting in a stronger recommendation supporting the use of a restrictive transfusion strategy in non-ICU and post-operative patients. The findings of the FOCUS trial are especially applicable to hospitalists, because many patients who undergo hip fracture repair are directly cared for or are co-managed by hospitalists.

The current guidelines built upon previous guidelines that advocated a restrictive strategy (hemoglobin ≤7g/dL) in hemodynamically stable, critically ill adult patients.⁵ In general, restrictive transfusion strategy led to nearly 40% fewer patients receiving transfusion compared with the use of a liberal transfusion strategy.1 No additional harm to patients was evidenced in the restrictive transfusion group, though the trials were not designed to answer this question; moreover, there was no statistically significant difference in mortality or functional outcome between the two groups.

The authors of the current AABB guidelines recognized the importance of replicating the current findings in a more diverse patient population. An area where further study is indicated is in the use of specific transfusion thresholds in patients with acute coronary syndrome. These guidelines did not clarify whether or not there is a physiologic difference between use of different restrictive transfusion thresholds such as <8g/dL and <7g/dL.

The authors of the AABB guidelines also commented that performing a future trial to compare RBC transfusion for symptoms vs. hemoglobin “trigger” would be useful; however, they recognized that this may not be feasible due to the need to blind providers in the trial to hemoglobin values. Various society guidelines currently call for different transfusion thresholds or do not make a specific recommendation at all.¹

Key Takeaways for Hospitalists

For the vast majority of medical patients, hospitalists can safely use a restrictive RBC transfusion threshold (≤7g/dL or ≤8g/dL), which can lead to a significant decrease in RBC transfusions without adversely affecting overall mortality.

Drs. Bortinger and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: a clinical practice guideline from the AABB. Ann Inter Med. 2012;157(1):49-58.
2. Carson AL, Terrin ML, Noveck H, et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011;367(26):2453-2462.
3. Hajjar LA, Vincent JL, Galas FR, et al. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010;304(14):1559-1567.
4. Carson JL, Carless PA, Herbert PC. Transfusion threshold and other strategies for guiding allogenic red blood cell transfusion. Cochrane Database Syst Rev. 2012;CD002042.
5. Napolitano LM, Kurek S, Luchette FA, et al. Clinical practice guideline: red blood cell transfusion in adult trauma and critical care. Crit Care Med. 2009;37(12):3124-3157.

Background

Hospitalists commonly order red blood cell (RBC) transfusion as a therapy for patients with anemia resulting from a variety of clinical conditions. There has been lack of consensus on when to transfuse, because patients with anemia frequently have multiple co-morbidities, including coronary artery disease and congestive heart failure, which may influence their ability to tolerate a potentially ischemic state related to anemia or to accommodate volume fluctuations related to transfusion.

Furthermore, RBC transfusions are not without inherent risk. Life-threatening transfusion reactions occur in approximately seven per million transfused blood components, and transfusion-associated circulatory overload (TACO) can develop in one in 100 transfusions.¹

Recently published guidelines provide recommendations for management of hemodynamically stable adults with anemia.

Guideline Update

The AABB published guidelines in the Annals of Internal Medicine in 2012 addressing RBC transfusion thresholds.¹ The updated guideline makes a recommendation that clinicians utilize a restrictive transfusion strategy. Transfusion is strongly recommended for ICU patients with hemoglobin ≤7g/dL. In post-operative surgical patients and for post-operative patients with symptomatic anemia, transfusion is recommended for hemoglobin ≤8g/dL. The authors also made a weak recommendation to transfuse for hemoglobin ≤8g/dL or for symptoms in hospitalized hemodynamically stable patients with preexisting cardiovascular disease.

These recommendations draw from past literature, along with two more recent trials examining liberal or restrictive transfusion thresholds. The newer trials increased the total number of patients studied by nearly one third compared with prior reviews.^2,3 The authors also incorporated recently published systematic reviews in their analysis.

Although the definition of a restrictive transfusion threshold varied across trials, including hemoglobin ≤7g/dL and ≤8g/dL, the authors used the pooled data to provide several recommendations in the new guideline. Of note, the pooled data was underpowered to detect up to a twofold increase in risk of myocardial infarction in patients in the restrictive strategy group.¹

There were insufficient data for the authors to recommend for or against a restrictive transfusion strategy in patients with acute coronary syndrome, based on very low quality evidence.

Finally, the authors recommended that symptoms and hemoglobin level should both be used in determining transfusion criteria, based on low quality of evidence.

Analysis

The current AABB guidelines have two primary differences from earlier guidelines. First, the AABB authors used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology to formalize evidence-based practice in their analysis of the literature. The authors purposely used the GRADE methodology to systematically evaluate the quality of the evidence base and explicitly state the strength of the recommendation for a particular transfusion threshold.⁴

Second, the AABB guidelines incorporated data from the more recently published FOCUS (Functional Outcomes in Cardiovascular patients Undergoing Surgical repair of hip fracture) and TRACS (Transfusion Requirements After Cardiac Surgery) trials, resulting in a stronger recommendation supporting the use of a restrictive transfusion strategy in non-ICU and post-operative patients. The findings of the FOCUS trial are especially applicable to hospitalists, because many patients who undergo hip fracture repair are directly cared for or are co-managed by hospitalists.

The current guidelines built upon previous guidelines that advocated a restrictive strategy (hemoglobin ≤7g/dL) in hemodynamically stable, critically ill adult patients.⁵ In general, restrictive transfusion strategy led to nearly 40% fewer patients receiving transfusion compared with the use of a liberal transfusion strategy.1 No additional harm to patients was evidenced in the restrictive transfusion group, though the trials were not designed to answer this question; moreover, there was no statistically significant difference in mortality or functional outcome between the two groups.

The authors of the current AABB guidelines recognized the importance of replicating the current findings in a more diverse patient population. An area where further study is indicated is in the use of specific transfusion thresholds in patients with acute coronary syndrome. These guidelines did not clarify whether or not there is a physiologic difference between use of different restrictive transfusion thresholds such as <8g/dL and <7g/dL.

The authors of the AABB guidelines also commented that performing a future trial to compare RBC transfusion for symptoms vs. hemoglobin “trigger” would be useful; however, they recognized that this may not be feasible due to the need to blind providers in the trial to hemoglobin values. Various society guidelines currently call for different transfusion thresholds or do not make a specific recommendation at all.¹

Key Takeaways for Hospitalists

For the vast majority of medical patients, hospitalists can safely use a restrictive RBC transfusion threshold (≤7g/dL or ≤8g/dL), which can lead to a significant decrease in RBC transfusions without adversely affecting overall mortality.

Drs. Bortinger and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: a clinical practice guideline from the AABB. Ann Inter Med. 2012;157(1):49-58.
2. Carson AL, Terrin ML, Noveck H, et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011;367(26):2453-2462.
3. Hajjar LA, Vincent JL, Galas FR, et al. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010;304(14):1559-1567.
4. Carson JL, Carless PA, Herbert PC. Transfusion threshold and other strategies for guiding allogenic red blood cell transfusion. Cochrane Database Syst Rev. 2012;CD002042.
5. Napolitano LM, Kurek S, Luchette FA, et al. Clinical practice guideline: red blood cell transfusion in adult trauma and critical care. Crit Care Med. 2009;37(12):3124-3157.

Background

Hospitalists commonly order red blood cell (RBC) transfusion as a therapy for patients with anemia resulting from a variety of clinical conditions. There has been lack of consensus on when to transfuse, because patients with anemia frequently have multiple co-morbidities, including coronary artery disease and congestive heart failure, which may influence their ability to tolerate a potentially ischemic state related to anemia or to accommodate volume fluctuations related to transfusion.

Furthermore, RBC transfusions are not without inherent risk. Life-threatening transfusion reactions occur in approximately seven per million transfused blood components, and transfusion-associated circulatory overload (TACO) can develop in one in 100 transfusions.¹

Recently published guidelines provide recommendations for management of hemodynamically stable adults with anemia.

Guideline Update

The AABB published guidelines in the Annals of Internal Medicine in 2012 addressing RBC transfusion thresholds.¹ The updated guideline makes a recommendation that clinicians utilize a restrictive transfusion strategy. Transfusion is strongly recommended for ICU patients with hemoglobin ≤7g/dL. In post-operative surgical patients and for post-operative patients with symptomatic anemia, transfusion is recommended for hemoglobin ≤8g/dL. The authors also made a weak recommendation to transfuse for hemoglobin ≤8g/dL or for symptoms in hospitalized hemodynamically stable patients with preexisting cardiovascular disease.

These recommendations draw from past literature, along with two more recent trials examining liberal or restrictive transfusion thresholds. The newer trials increased the total number of patients studied by nearly one third compared with prior reviews.^2,3 The authors also incorporated recently published systematic reviews in their analysis.

Although the definition of a restrictive transfusion threshold varied across trials, including hemoglobin ≤7g/dL and ≤8g/dL, the authors used the pooled data to provide several recommendations in the new guideline. Of note, the pooled data was underpowered to detect up to a twofold increase in risk of myocardial infarction in patients in the restrictive strategy group.¹

There were insufficient data for the authors to recommend for or against a restrictive transfusion strategy in patients with acute coronary syndrome, based on very low quality evidence.

Finally, the authors recommended that symptoms and hemoglobin level should both be used in determining transfusion criteria, based on low quality of evidence.

Analysis

The current AABB guidelines have two primary differences from earlier guidelines. First, the AABB authors used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology to formalize evidence-based practice in their analysis of the literature. The authors purposely used the GRADE methodology to systematically evaluate the quality of the evidence base and explicitly state the strength of the recommendation for a particular transfusion threshold.⁴

Second, the AABB guidelines incorporated data from the more recently published FOCUS (Functional Outcomes in Cardiovascular patients Undergoing Surgical repair of hip fracture) and TRACS (Transfusion Requirements After Cardiac Surgery) trials, resulting in a stronger recommendation supporting the use of a restrictive transfusion strategy in non-ICU and post-operative patients. The findings of the FOCUS trial are especially applicable to hospitalists, because many patients who undergo hip fracture repair are directly cared for or are co-managed by hospitalists.

The current guidelines built upon previous guidelines that advocated a restrictive strategy (hemoglobin ≤7g/dL) in hemodynamically stable, critically ill adult patients.⁵ In general, restrictive transfusion strategy led to nearly 40% fewer patients receiving transfusion compared with the use of a liberal transfusion strategy.1 No additional harm to patients was evidenced in the restrictive transfusion group, though the trials were not designed to answer this question; moreover, there was no statistically significant difference in mortality or functional outcome between the two groups.

The authors of the current AABB guidelines recognized the importance of replicating the current findings in a more diverse patient population. An area where further study is indicated is in the use of specific transfusion thresholds in patients with acute coronary syndrome. These guidelines did not clarify whether or not there is a physiologic difference between use of different restrictive transfusion thresholds such as <8g/dL and <7g/dL.

The authors of the AABB guidelines also commented that performing a future trial to compare RBC transfusion for symptoms vs. hemoglobin “trigger” would be useful; however, they recognized that this may not be feasible due to the need to blind providers in the trial to hemoglobin values. Various society guidelines currently call for different transfusion thresholds or do not make a specific recommendation at all.¹

Key Takeaways for Hospitalists

For the vast majority of medical patients, hospitalists can safely use a restrictive RBC transfusion threshold (≤7g/dL or ≤8g/dL), which can lead to a significant decrease in RBC transfusions without adversely affecting overall mortality.

Drs. Bortinger and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: a clinical practice guideline from the AABB. Ann Inter Med. 2012;157(1):49-58.
2. Carson AL, Terrin ML, Noveck H, et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011;367(26):2453-2462.
3. Hajjar LA, Vincent JL, Galas FR, et al. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010;304(14):1559-1567.
4. Carson JL, Carless PA, Herbert PC. Transfusion threshold and other strategies for guiding allogenic red blood cell transfusion. Cochrane Database Syst Rev. 2012;CD002042.
5. Napolitano LM, Kurek S, Luchette FA, et al. Clinical practice guideline: red blood cell transfusion in adult trauma and critical care. Crit Care Med. 2009;37(12):3124-3157.

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (within 91 to 365 days), or former (more than 365 days prior) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Visit our website for more physician reviews of recent HM-relevant literature.

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (within 91 to 365 days), or former (more than 365 days prior) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Visit our website for more physician reviews of recent HM-relevant literature.

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (within 91 to 365 days), or former (more than 365 days prior) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Visit our website for more physician reviews of recent HM-relevant literature.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Steroids may increase VTE risk
2. Mortality rates rise at critical-care hospitals
3. Physicians don’t discuss advance-care planning with elderly, families
4. Ultrasound imaging for lumbar puncture, epidural catheterization
5. Financial impact of surgical complications on hospitals
6. Lab test fees and frequency of test ordering
7. Inpatient elderly multidisciplinary teams reduce readmissions
8. Use of beta-blockers in high-risk patients during noncardiac surgery
9. Patient-centered decision-making and health-care outcomes
10. Adverse surgical outcomes in patients with schizophrenia

Steroids May Increase VTE Risk

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (91 to 365 days), or former (over 365 days) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Mortality Rates Rise at Critical-Access Hospitals

Clinical question: How have trends in mortality changed in the past decade at critical-access hospitals when compared to other hospitals?

Background: Hospitals are designated as critical-access hospitals (CAH) by meeting certain requirements—namely, rural setting, small number of beds, and minimum distance from the nearest hospital. Because of the intrinsic challenges they face, CAHs are exempt from certain quality measures. Little data exist on patient outcomes at CAHs.

Study design: Retrospective observational study.

Setting: All nonfederal hospitals in the U.S. that provide acute care to Medicare beneficiaries.

Synopsis: Using Medicare data, risk-adjusted 30-day mortality rates were calculated at critical-access hospitals and non-critical-access hospitals from 2002 to 2010 for three conditions: acute myocardial infarction, congestive heart failure, and pneumonia. Mortality trends across these conditions were compared at baseline and over time. In 2002, CAHs had mortality rates comparable with non-CAHs. From 2002 to 2010, mortality rates increased by 0.1% per year at CAHs and decreased by 0.2% per year at non-CAHs, resulting in a mortality difference between these two hospital groups at the end of the study period. The authors postulate that differences in policy initiatives, enforcement of quality measures, and access to technology may play a role.

This study is limited in its ability to explain the findings. Notably, within the CAHs, the authors found that 48% did improve from 2002 to 2010; there were no significant differences in hospital characteristics between the CAHs that did and did not improve. The reasons for the overall widening gap between CAHs and non-CAHs, therefore, merit further investigation.

Bottom line: From 2002 to 2010, mortality rates at U.S. critical-access hospitals rose while rates fell at non-critical access hospitals.

Citation: Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013;309(13):1379-1387.

Physicians Fail to Discuss Advance-Care Planning with Hospitalized Elderly, Relatives

Clinical question: Do elderly patients who are at high risk for death have documented advance-care plans, and do their physicians discuss goals of care with them?

Background: While studies indicate that most sick, elderly patients prefer a better quality of life to life-sustaining treatment, many patients still die in the hospital, often in the ICU. It is unclear whether this is due to the absence of advance-care planning or the lack of communicating goals of care.

Study design: Multicenter prospective cohort study.

Setting: Canada.

Synopsis: A validated questionnaire was used to evaluate advance-care planning both before hospitalization and on admission. Patients and their families were enrolled if they were considered at high risk for dying, including patients with advanced disease, or aged >80 years. Of the 278 patients enrolled, 76.3% had thought about advance-care planning. Approximately 47.9% of patients had written an advance-care plan, and 73.3% had formally documented a surrogate health-care decision-maker. Only a quarter of patients reported that they had been asked about advance-care planning on admission to the hospital. Patients’ stated preferences for end-of-life care were notably incongruent with goals-of-care orders documented in the hospital records. While 28% of patients preferred comfort-only care, this was documented in the hospital records for only 4.5% of patients.

In this study of mostly white, English-speaking hospitalized patients, many had considered and made advance-care plans but few had discussed this with their health-care providers. Not surprisingly, the goals-of-care orders that were documented did not match patients’ previously stated end-of-life preferences.

Bottom line: Physicians routinely fail to discuss patients’ advance-care planning, which may have profound effects on their inpatient care.

Citation: Heyland DK, Barwich D, Pichora D, et al. Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013;173(9):778-787.

Ultrasound Use Reduces Lumbar Puncture and Epidural Catheterization Failure

Clinical question: Does ultrasound imaging for lumbar puncture and epidural catheterization reduce risk of procedure failures?

Background: Numerous studies have compared ultrasound-guided lumbar puncture and epidural catheterization with standard techniques, but they have been underpowered to evaluate whether ultrasound use reduces lumbar puncture and epidural catheterization failure.

Study design: Systematic review and meta-analysis of randomized controlled trials.

Setting: Hospitals in North America, Europe, and Asia.

Synopsis: Among 14 trials, a total of 1,334 patients (including one pediatric study group) were randomly assigned either to receive ultrasound imaging or to a control group (using manual palpation or loss of resistance). Ultrasound imaging comprised a preprocedure marking approach, real-time visual guidance, or both. In the 12 trials in which the primary outcome was available, ultrasound imaging significantly reduced the risk of failed procedures with a risk ratio of 0.21 (95% confidence interval 0.10 to 0.43). A total of 16 ultrasound-guided procedures were needed to avoid one procedure failure. Ultrasound guidance also reduced the number of traumatic procedures, needle reinsertions, and needle redirections. These results were consistent across multiple subgroup analyses.

Only one of the studies included in the meta-analysis was double-blind, and in all of the studies, ultrasound imaging was performed by a clinician with high-level ultrasound experience. While this study suggests that ultrasound does reduce the frequency of procedure failure, the investigators did not include cost-effectiveness analyses.

Bottom line: Ultrasound imaging likely reduces the failure of lumbar puncture and epidural catheterization, but future research will be necessary to evaluate the cost-effectiveness of ultrasound use for these procedures.

Citation: Shaikh F, Brzezinski J, Alexander S, et al. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013;346:f1720.

Surgical Complications might Be Financially Advantageous for Hospitals

Clinical question: What is the impact of surgical complications on hospital finances?

Background: Surgical complications are common and lead to longer lengths of stay and higher costs. Strategies are available to reduce postsurgical complications but have not been universally adopted.

Study design: Observational study.

Setting: Twelve hospitals in one nonprofit Southern hospital system, which includes academic, nonacademic, and rural settings.

Synopsis: Researchers identified 34,526 patients who underwent surgery in 2010, excluding patients undergoing Caesarean section. Of those, 1,820 procedures (5.3%) were associated with at least one complication. The most frequent complications were surgical-site infection, other infections, pneumonia, and thromboembolic disease. The mortality rate for patients with complications was 12.3% compared with 0.6% for those without. Length of stay was four times longer for patients with complications.

Complications were associated with a higher total cost of hospitalization, with a differential of $37,917. This translated into a higher contribution to the margin. The cost differential varied by insurance type, with higher contributions under Medicare and private insurance but not with Medicaid.

The study had the benefit of using a large administrative database; however, this may have underestimated the actual rate of postoperative complications. The study supports the paradox in which quality-improvement (QI) programs that reduce surgical complications and improve postoperative mortality may negatively affect a hospital’s financial performance.

Bottom line: Surgical complications lead to higher mortality for patients but a financial benefit for hospitals.

Citation: Eappen S, Lane BH, Rosenberg B, et al. Relationship between occurrence of surgical complications and hospital finances. JAMA. 2013;309(5):1509-1606.

Showing Lab Test Fees May Decrease Frequency Of Test Ordering

Clinical question: Does information on the cost of a lab test lead to lowered ordering frequency among internal-medicine residents?

Background: Lab test overuse is common; some studies estimate that 70% of lab tests do not affect care. Strategies to reduce frequency of unnecessary lab tests are needed.

Study design: Randomized controlled trial.

Setting: Johns Hopkins Hospital, a 1,051-bed academic medical center in Baltimore.

Synopsis: Researchers used an administrative database to identify the 35 most frequently ordered and the 35 most expensive tests (each ordered at least 50 times). They randomized tests to an active arm, which displayed the Medicare allowable fee at the time of order entry within the computerized physician order entry, and a control arm. A total of 1,166,753 tests were ordered during the baseline and intervention period. Many more tests were ordered in the active group relative to the control group, a consequence of the randomization process. Relative to a six-month baseline period, tests in the active group were ordered 9.1% less frequently; control-group tests were ordered 5.1% more frequently. Charges decreased by $3.79 per patient-day in the active group and increased by $0.52 per patient-day in the control group.

This study reflects a low-cost strategy to reduce lab testing and associated costs. It is unknown whether only unnecessary tests were averted, or if there was any effect on the quality of care. The durability of the intervention and its applicability to other settings and with other types of providers is unclear.

Bottom line: Showing the fee associated with lab tests may decrease the frequency of ordering these tests and the resultant costs.

Citation: Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908.

Inpatient Elderly Multidisciplinary-Team-Based Unit Reduces Readmissions

Clinical question: Can an inpatient unit that uses interdisciplinary rounds and a team approach reduce 30-day readmissions and lower cost compared with usual care?

Background: Elderly patients are at risk for adverse outcomes including delirium, deconditioning, and undernutrition. The Acute Care for Elders (ACE) model is designed as a team-based approach to improve communication between clinicians and to begin discharge planning soon after admission. ACE units have been shown to improve specific outcomes in older adults, but the impact on cost is less clear.

Study design: Retrospective cohort study.

Setting: University of Alabama at Birmingham Acute Care for Elders unit.

Synopsis: The analysis of cost data extrapolated from administrative sources indicated an average of $371 in variable cost savings per patient, and therefore an expected $148,400 savings for 400 patients admitted to this unit. The rate of 30-day readmissions was significantly lower in the ACE model: 7.9% versus 12.8% in patients receiving usual care.

Limitations of this study relate both to its design and single-center location. It is unclear which aspect of this ACE unit was helpful in the studied outcomes, and how this specific program would be reproduced at another institution. There were also some costs associated with the ACE-unit staffing, which may have resulted in an overestimation of the cost savings.

Bottom line: ACE units appear to improve outcomes and may lower cost, but further investigation is needed.

Citation: Flood KL, MacLennan PA, McGrew D, Green D, Dodd C, Brown CJ. Effects of an acute care for elders unit on costs and 30-day readmissions. JAMA. 2013 April 22 [Epub ahead of print].

Continue Beta-Blockers in High-Risk Patients During Noncardiac Surgery

Clinical question: Does exposure to a beta-blocker at the time of noncardiac surgery have an association with mortality, cardiac arrest, or Q-wave myocardial infarction (MI)?

Background: Exposure to beta-blockers perioperatively is controversial. The authors suggest that a randomized trial would be difficult, as one might need to withhold beta-blockers from stable patients. The American Heart Association and American College of Cardiology currently recommend continuation of pre-existing beta-blockades perioperatively.

Study design: Retrospective, propensity-matched cohort analysis.

Setting: One hundred four Veterans Affairs (VA) medical centers from January 2005 to August 2010.

Synopsis: Exposure for any reason to beta-blockers around nonvascular surgery appears to lower the risk of mortality and cardiac arrest, particularly in patients with higher revised cardiac risk index factors. Stopping beta-blockers in this same period was associated with increased mortality. The reasons for beta-blocker use in the exposed cohort were not well-established or -stratified.

Limitations include that the exposed cohort had a higher rate of cardiovascular disease and comorbidities and were generally older. Duration of exposure to beta-blockers was mixed, although more than 75% had a prescription for more than three months, with less than 2% for several days. Some of the matched cohort appears to have had beta-blocker exposure, thus diminishing the potential impact.

Bottom line: In this retrospective analysis, there is an association between beta-blocker use during noncardiac, nonvascular surgery and lower mortality, as well as lower rates of cardiac arrest and Q-wave MI, particularly among higher-risk patients.

Citation: London MJ, Hur K, Schwartz G, Henderson WG. Association of perioperative beta-blockade with mortality and cardiovascular morbidity following major noncardiac surgery. JAMA. 2013;309(16):1704-1713.

Patient-Centered Decision-Making and Health-Care Outcomes

Clinical question: Does recognition of contextual domains in the care plan lead to resolution of patients’ presenting problems?

Background: Patient-centered decision-making, or contextualization of care, adapts best evidence to the care of the individual patient. Examples of contextual domains include access to care, social support, and financial situation. Contextual errors (e.g. unrecognized domains) are, on average, more costly than errors in evidenced-based medicine.

Study design: Observational study.

Setting: VA ambulatory-care centers.

Synopsis: A total of 548 patient-derived audio recordings of physician encounters that included contextual red flags (e.g. missed appointments, HbA1c >8%) were reviewed at two VA hospital ambulatory-care centers using the content coding for contextualization of care (4C) method. Prospectively determined good and poor outcomes were derived from specific red flags (e.g. keeping next appointment, decrease in HbA1c). Of the 548 red flags, 208 were associated with contextual domains using the 4C method. Some 59% of physicians recognized contextual domains in care-plan development, leading to good outcomes in 71% of red flags. As many as 41% of physicians did not recognize contextual domains, leading to poor outcomes in 54% of red-flag instances.

Hospitalists should be aware of contextual domains and red flags (e.g. readmissions), and this study provides a method of evaluating patient-centered decision-making in the hospital setting. However, the inherently subjective 4C method may underestimate the number of contextual domains.

Bottom line: Recognition and incorporation of contextual domains in care-plan development in the ambulatory setting are associated with improved contextual red flag outcomes.

Citation: Weiner SJ, Schwartz A, Sharma G, et al. Patient-centered decision making and health care outcomes: an observational study. Ann Intern Med. 2013;158:573-579.

Adverse Surgical Outcomes in Schizophrenia Patients

Clinical question: What is the full spectrum of postoperative complications and mortality in schizophrenic patients receiving in-hospital major surgery?

Background: Schizophrenia affects an estimated 4 to 7 per 1,000 persons worldwide, and patients with schizophrenia are at increased risk of diabetes, cardiovascular disease, and stroke with subsequent increased mortality risk. The correlation between severity of mental illness and postoperative in-hospital mortality has not been validated in previous studies.

Study design: Population-based, cross-sectional study.

Setting: Taiwan hospitals.

Synopsis: Using the Taiwan National Health Insurance Research Database, researchers examined claims from 2004 to 2007 and retrospectively identified 8,967 schizophrenic patients who underwent major inpatient surgery and were hospitalized for more than one day. Primary outcomes included acute myocardial infarction, acute renal failure, stroke, and in-hospital mortality within 30 days. Postoperative complications and mortality rates were compared between schizophrenic patients and patients without mental illness.

Schizophrenic patients had higher rates of many primary outcomes, including 30-day postoperative mortality, compared with patients without mental illness, after adjusting for sex, age, surgery type, and hospital setting. The risk for 30-day mortality rose with the number of preoperative schizophrenia-related services provided. Limitations include the nature of retrospective analysis and generalizability.

Bottom line: Compared to patients without mental illness, schizophrenic patients have an increased risk of acute renal failure, pneumonia, septicemia, and 30-day mortality in the postoperative setting, with higher mortality rates in schizophrenic patients with more severe disease.

Citation: Liao CC, Shen WW, Chang CC, Chang H, Chen T. Surgical adverse outcomes in patients with schizophrenia. Ann Surg. 2013;257:433-438.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Steroids may increase VTE risk
2. Mortality rates rise at critical-care hospitals
3. Physicians don’t discuss advance-care planning with elderly, families
4. Ultrasound imaging for lumbar puncture, epidural catheterization
5. Financial impact of surgical complications on hospitals
6. Lab test fees and frequency of test ordering
7. Inpatient elderly multidisciplinary teams reduce readmissions
8. Use of beta-blockers in high-risk patients during noncardiac surgery
9. Patient-centered decision-making and health-care outcomes
10. Adverse surgical outcomes in patients with schizophrenia

Steroids May Increase VTE Risk

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (91 to 365 days), or former (over 365 days) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Mortality Rates Rise at Critical-Access Hospitals

Clinical question: How have trends in mortality changed in the past decade at critical-access hospitals when compared to other hospitals?

Background: Hospitals are designated as critical-access hospitals (CAH) by meeting certain requirements—namely, rural setting, small number of beds, and minimum distance from the nearest hospital. Because of the intrinsic challenges they face, CAHs are exempt from certain quality measures. Little data exist on patient outcomes at CAHs.

Study design: Retrospective observational study.

Setting: All nonfederal hospitals in the U.S. that provide acute care to Medicare beneficiaries.

Synopsis: Using Medicare data, risk-adjusted 30-day mortality rates were calculated at critical-access hospitals and non-critical-access hospitals from 2002 to 2010 for three conditions: acute myocardial infarction, congestive heart failure, and pneumonia. Mortality trends across these conditions were compared at baseline and over time. In 2002, CAHs had mortality rates comparable with non-CAHs. From 2002 to 2010, mortality rates increased by 0.1% per year at CAHs and decreased by 0.2% per year at non-CAHs, resulting in a mortality difference between these two hospital groups at the end of the study period. The authors postulate that differences in policy initiatives, enforcement of quality measures, and access to technology may play a role.

This study is limited in its ability to explain the findings. Notably, within the CAHs, the authors found that 48% did improve from 2002 to 2010; there were no significant differences in hospital characteristics between the CAHs that did and did not improve. The reasons for the overall widening gap between CAHs and non-CAHs, therefore, merit further investigation.

Bottom line: From 2002 to 2010, mortality rates at U.S. critical-access hospitals rose while rates fell at non-critical access hospitals.

Citation: Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013;309(13):1379-1387.

Physicians Fail to Discuss Advance-Care Planning with Hospitalized Elderly, Relatives

Clinical question: Do elderly patients who are at high risk for death have documented advance-care plans, and do their physicians discuss goals of care with them?

Background: While studies indicate that most sick, elderly patients prefer a better quality of life to life-sustaining treatment, many patients still die in the hospital, often in the ICU. It is unclear whether this is due to the absence of advance-care planning or the lack of communicating goals of care.

Study design: Multicenter prospective cohort study.

Setting: Canada.

Synopsis: A validated questionnaire was used to evaluate advance-care planning both before hospitalization and on admission. Patients and their families were enrolled if they were considered at high risk for dying, including patients with advanced disease, or aged >80 years. Of the 278 patients enrolled, 76.3% had thought about advance-care planning. Approximately 47.9% of patients had written an advance-care plan, and 73.3% had formally documented a surrogate health-care decision-maker. Only a quarter of patients reported that they had been asked about advance-care planning on admission to the hospital. Patients’ stated preferences for end-of-life care were notably incongruent with goals-of-care orders documented in the hospital records. While 28% of patients preferred comfort-only care, this was documented in the hospital records for only 4.5% of patients.

In this study of mostly white, English-speaking hospitalized patients, many had considered and made advance-care plans but few had discussed this with their health-care providers. Not surprisingly, the goals-of-care orders that were documented did not match patients’ previously stated end-of-life preferences.

Bottom line: Physicians routinely fail to discuss patients’ advance-care planning, which may have profound effects on their inpatient care.

Citation: Heyland DK, Barwich D, Pichora D, et al. Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013;173(9):778-787.

Ultrasound Use Reduces Lumbar Puncture and Epidural Catheterization Failure

Clinical question: Does ultrasound imaging for lumbar puncture and epidural catheterization reduce risk of procedure failures?

Background: Numerous studies have compared ultrasound-guided lumbar puncture and epidural catheterization with standard techniques, but they have been underpowered to evaluate whether ultrasound use reduces lumbar puncture and epidural catheterization failure.

Study design: Systematic review and meta-analysis of randomized controlled trials.

Setting: Hospitals in North America, Europe, and Asia.

Synopsis: Among 14 trials, a total of 1,334 patients (including one pediatric study group) were randomly assigned either to receive ultrasound imaging or to a control group (using manual palpation or loss of resistance). Ultrasound imaging comprised a preprocedure marking approach, real-time visual guidance, or both. In the 12 trials in which the primary outcome was available, ultrasound imaging significantly reduced the risk of failed procedures with a risk ratio of 0.21 (95% confidence interval 0.10 to 0.43). A total of 16 ultrasound-guided procedures were needed to avoid one procedure failure. Ultrasound guidance also reduced the number of traumatic procedures, needle reinsertions, and needle redirections. These results were consistent across multiple subgroup analyses.

Only one of the studies included in the meta-analysis was double-blind, and in all of the studies, ultrasound imaging was performed by a clinician with high-level ultrasound experience. While this study suggests that ultrasound does reduce the frequency of procedure failure, the investigators did not include cost-effectiveness analyses.

Bottom line: Ultrasound imaging likely reduces the failure of lumbar puncture and epidural catheterization, but future research will be necessary to evaluate the cost-effectiveness of ultrasound use for these procedures.

Citation: Shaikh F, Brzezinski J, Alexander S, et al. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013;346:f1720.

Surgical Complications might Be Financially Advantageous for Hospitals

Clinical question: What is the impact of surgical complications on hospital finances?

Background: Surgical complications are common and lead to longer lengths of stay and higher costs. Strategies are available to reduce postsurgical complications but have not been universally adopted.

Study design: Observational study.

Setting: Twelve hospitals in one nonprofit Southern hospital system, which includes academic, nonacademic, and rural settings.

Synopsis: Researchers identified 34,526 patients who underwent surgery in 2010, excluding patients undergoing Caesarean section. Of those, 1,820 procedures (5.3%) were associated with at least one complication. The most frequent complications were surgical-site infection, other infections, pneumonia, and thromboembolic disease. The mortality rate for patients with complications was 12.3% compared with 0.6% for those without. Length of stay was four times longer for patients with complications.

Complications were associated with a higher total cost of hospitalization, with a differential of $37,917. This translated into a higher contribution to the margin. The cost differential varied by insurance type, with higher contributions under Medicare and private insurance but not with Medicaid.

The study had the benefit of using a large administrative database; however, this may have underestimated the actual rate of postoperative complications. The study supports the paradox in which quality-improvement (QI) programs that reduce surgical complications and improve postoperative mortality may negatively affect a hospital’s financial performance.

Bottom line: Surgical complications lead to higher mortality for patients but a financial benefit for hospitals.

Citation: Eappen S, Lane BH, Rosenberg B, et al. Relationship between occurrence of surgical complications and hospital finances. JAMA. 2013;309(5):1509-1606.

Showing Lab Test Fees May Decrease Frequency Of Test Ordering

Clinical question: Does information on the cost of a lab test lead to lowered ordering frequency among internal-medicine residents?

Background: Lab test overuse is common; some studies estimate that 70% of lab tests do not affect care. Strategies to reduce frequency of unnecessary lab tests are needed.

Study design: Randomized controlled trial.

Setting: Johns Hopkins Hospital, a 1,051-bed academic medical center in Baltimore.

Synopsis: Researchers used an administrative database to identify the 35 most frequently ordered and the 35 most expensive tests (each ordered at least 50 times). They randomized tests to an active arm, which displayed the Medicare allowable fee at the time of order entry within the computerized physician order entry, and a control arm. A total of 1,166,753 tests were ordered during the baseline and intervention period. Many more tests were ordered in the active group relative to the control group, a consequence of the randomization process. Relative to a six-month baseline period, tests in the active group were ordered 9.1% less frequently; control-group tests were ordered 5.1% more frequently. Charges decreased by $3.79 per patient-day in the active group and increased by $0.52 per patient-day in the control group.

This study reflects a low-cost strategy to reduce lab testing and associated costs. It is unknown whether only unnecessary tests were averted, or if there was any effect on the quality of care. The durability of the intervention and its applicability to other settings and with other types of providers is unclear.

Bottom line: Showing the fee associated with lab tests may decrease the frequency of ordering these tests and the resultant costs.

Citation: Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908.

Inpatient Elderly Multidisciplinary-Team-Based Unit Reduces Readmissions

Clinical question: Can an inpatient unit that uses interdisciplinary rounds and a team approach reduce 30-day readmissions and lower cost compared with usual care?

Background: Elderly patients are at risk for adverse outcomes including delirium, deconditioning, and undernutrition. The Acute Care for Elders (ACE) model is designed as a team-based approach to improve communication between clinicians and to begin discharge planning soon after admission. ACE units have been shown to improve specific outcomes in older adults, but the impact on cost is less clear.

Study design: Retrospective cohort study.

Setting: University of Alabama at Birmingham Acute Care for Elders unit.

Synopsis: The analysis of cost data extrapolated from administrative sources indicated an average of $371 in variable cost savings per patient, and therefore an expected $148,400 savings for 400 patients admitted to this unit. The rate of 30-day readmissions was significantly lower in the ACE model: 7.9% versus 12.8% in patients receiving usual care.

Limitations of this study relate both to its design and single-center location. It is unclear which aspect of this ACE unit was helpful in the studied outcomes, and how this specific program would be reproduced at another institution. There were also some costs associated with the ACE-unit staffing, which may have resulted in an overestimation of the cost savings.

Bottom line: ACE units appear to improve outcomes and may lower cost, but further investigation is needed.

Citation: Flood KL, MacLennan PA, McGrew D, Green D, Dodd C, Brown CJ. Effects of an acute care for elders unit on costs and 30-day readmissions. JAMA. 2013 April 22 [Epub ahead of print].

Continue Beta-Blockers in High-Risk Patients During Noncardiac Surgery

Clinical question: Does exposure to a beta-blocker at the time of noncardiac surgery have an association with mortality, cardiac arrest, or Q-wave myocardial infarction (MI)?

Background: Exposure to beta-blockers perioperatively is controversial. The authors suggest that a randomized trial would be difficult, as one might need to withhold beta-blockers from stable patients. The American Heart Association and American College of Cardiology currently recommend continuation of pre-existing beta-blockades perioperatively.

Study design: Retrospective, propensity-matched cohort analysis.

Setting: One hundred four Veterans Affairs (VA) medical centers from January 2005 to August 2010.

Synopsis: Exposure for any reason to beta-blockers around nonvascular surgery appears to lower the risk of mortality and cardiac arrest, particularly in patients with higher revised cardiac risk index factors. Stopping beta-blockers in this same period was associated with increased mortality. The reasons for beta-blocker use in the exposed cohort were not well-established or -stratified.

Limitations include that the exposed cohort had a higher rate of cardiovascular disease and comorbidities and were generally older. Duration of exposure to beta-blockers was mixed, although more than 75% had a prescription for more than three months, with less than 2% for several days. Some of the matched cohort appears to have had beta-blocker exposure, thus diminishing the potential impact.

Bottom line: In this retrospective analysis, there is an association between beta-blocker use during noncardiac, nonvascular surgery and lower mortality, as well as lower rates of cardiac arrest and Q-wave MI, particularly among higher-risk patients.

Citation: London MJ, Hur K, Schwartz G, Henderson WG. Association of perioperative beta-blockade with mortality and cardiovascular morbidity following major noncardiac surgery. JAMA. 2013;309(16):1704-1713.

Patient-Centered Decision-Making and Health-Care Outcomes

Clinical question: Does recognition of contextual domains in the care plan lead to resolution of patients’ presenting problems?

Background: Patient-centered decision-making, or contextualization of care, adapts best evidence to the care of the individual patient. Examples of contextual domains include access to care, social support, and financial situation. Contextual errors (e.g. unrecognized domains) are, on average, more costly than errors in evidenced-based medicine.

Study design: Observational study.

Setting: VA ambulatory-care centers.

Synopsis: A total of 548 patient-derived audio recordings of physician encounters that included contextual red flags (e.g. missed appointments, HbA1c >8%) were reviewed at two VA hospital ambulatory-care centers using the content coding for contextualization of care (4C) method. Prospectively determined good and poor outcomes were derived from specific red flags (e.g. keeping next appointment, decrease in HbA1c). Of the 548 red flags, 208 were associated with contextual domains using the 4C method. Some 59% of physicians recognized contextual domains in care-plan development, leading to good outcomes in 71% of red flags. As many as 41% of physicians did not recognize contextual domains, leading to poor outcomes in 54% of red-flag instances.

Hospitalists should be aware of contextual domains and red flags (e.g. readmissions), and this study provides a method of evaluating patient-centered decision-making in the hospital setting. However, the inherently subjective 4C method may underestimate the number of contextual domains.

Bottom line: Recognition and incorporation of contextual domains in care-plan development in the ambulatory setting are associated with improved contextual red flag outcomes.

Citation: Weiner SJ, Schwartz A, Sharma G, et al. Patient-centered decision making and health care outcomes: an observational study. Ann Intern Med. 2013;158:573-579.

Adverse Surgical Outcomes in Schizophrenia Patients

Clinical question: What is the full spectrum of postoperative complications and mortality in schizophrenic patients receiving in-hospital major surgery?

Background: Schizophrenia affects an estimated 4 to 7 per 1,000 persons worldwide, and patients with schizophrenia are at increased risk of diabetes, cardiovascular disease, and stroke with subsequent increased mortality risk. The correlation between severity of mental illness and postoperative in-hospital mortality has not been validated in previous studies.

Study design: Population-based, cross-sectional study.

Setting: Taiwan hospitals.

Synopsis: Using the Taiwan National Health Insurance Research Database, researchers examined claims from 2004 to 2007 and retrospectively identified 8,967 schizophrenic patients who underwent major inpatient surgery and were hospitalized for more than one day. Primary outcomes included acute myocardial infarction, acute renal failure, stroke, and in-hospital mortality within 30 days. Postoperative complications and mortality rates were compared between schizophrenic patients and patients without mental illness.

Schizophrenic patients had higher rates of many primary outcomes, including 30-day postoperative mortality, compared with patients without mental illness, after adjusting for sex, age, surgery type, and hospital setting. The risk for 30-day mortality rose with the number of preoperative schizophrenia-related services provided. Limitations include the nature of retrospective analysis and generalizability.

Bottom line: Compared to patients without mental illness, schizophrenic patients have an increased risk of acute renal failure, pneumonia, septicemia, and 30-day mortality in the postoperative setting, with higher mortality rates in schizophrenic patients with more severe disease.

Citation: Liao CC, Shen WW, Chang CC, Chang H, Chen T. Surgical adverse outcomes in patients with schizophrenia. Ann Surg. 2013;257:433-438.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Steroids may increase VTE risk
2. Mortality rates rise at critical-care hospitals
3. Physicians don’t discuss advance-care planning with elderly, families
4. Ultrasound imaging for lumbar puncture, epidural catheterization
5. Financial impact of surgical complications on hospitals
6. Lab test fees and frequency of test ordering
7. Inpatient elderly multidisciplinary teams reduce readmissions
8. Use of beta-blockers in high-risk patients during noncardiac surgery
9. Patient-centered decision-making and health-care outcomes
10. Adverse surgical outcomes in patients with schizophrenia

Steroids May Increase VTE Risk

Clinical question: Is exogenous glucocorticoid administration associated with an increased risk of VTE?

Background: Endogenous hypercortisolism is linked to increased VTE rates, and pathophysiologic data exist to suggest glucocorticoids increase clotting, but few studies have measured the clinical link between glucocorticoid administration and VTE events.

Study design: Case-control study.

Setting: Denmark.

Synopsis: The authors analyzed Danish national registries, which include information on diagnoses and prescriptions. The study selection period was Jan. 1, 2005, to Dec. 31, 2011. During this period, 38,675 cases of VTE (both DVT and pulmonary embolism) were identified in the population of Denmark. These cases were matched with 387,650 controls. Three routes of glucocorticoid use were studied: systemic (oral and intravenous), inhaled, and intestinal-acting. Cases were classified as present (within 90 days of VTE event), recent (91 to 365 days), or former (over 365 days) users of glucocorticoids. Categories were also created for new versus continuous users.

Glucocorticoid use was associated with a significant increase in VTE occurrence. The strongest link was in new and recent users, and the effect diminished over time. Key limitations of the study included its reliance on registry data, as well as the fact that cases had more comorbid conditions than controls (e.g. recent infection, chronic illnesses).

Bottom line: Recipients of glucocorticoids had an increased risk of VTE; the effect was strongest in new and recent users.

Citation: Johannesdottir SA, Horvath-Puho E, Dekkers OM, et al. Use of glucocorticoids and risk of venous thromboembolism. JAMA Intern Med. 2013;173(9):743-752.

Mortality Rates Rise at Critical-Access Hospitals

Clinical question: How have trends in mortality changed in the past decade at critical-access hospitals when compared to other hospitals?

Background: Hospitals are designated as critical-access hospitals (CAH) by meeting certain requirements—namely, rural setting, small number of beds, and minimum distance from the nearest hospital. Because of the intrinsic challenges they face, CAHs are exempt from certain quality measures. Little data exist on patient outcomes at CAHs.

Study design: Retrospective observational study.

Setting: All nonfederal hospitals in the U.S. that provide acute care to Medicare beneficiaries.

Synopsis: Using Medicare data, risk-adjusted 30-day mortality rates were calculated at critical-access hospitals and non-critical-access hospitals from 2002 to 2010 for three conditions: acute myocardial infarction, congestive heart failure, and pneumonia. Mortality trends across these conditions were compared at baseline and over time. In 2002, CAHs had mortality rates comparable with non-CAHs. From 2002 to 2010, mortality rates increased by 0.1% per year at CAHs and decreased by 0.2% per year at non-CAHs, resulting in a mortality difference between these two hospital groups at the end of the study period. The authors postulate that differences in policy initiatives, enforcement of quality measures, and access to technology may play a role.

This study is limited in its ability to explain the findings. Notably, within the CAHs, the authors found that 48% did improve from 2002 to 2010; there were no significant differences in hospital characteristics between the CAHs that did and did not improve. The reasons for the overall widening gap between CAHs and non-CAHs, therefore, merit further investigation.

Bottom line: From 2002 to 2010, mortality rates at U.S. critical-access hospitals rose while rates fell at non-critical access hospitals.

Citation: Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013;309(13):1379-1387.

Physicians Fail to Discuss Advance-Care Planning with Hospitalized Elderly, Relatives

Clinical question: Do elderly patients who are at high risk for death have documented advance-care plans, and do their physicians discuss goals of care with them?

Background: While studies indicate that most sick, elderly patients prefer a better quality of life to life-sustaining treatment, many patients still die in the hospital, often in the ICU. It is unclear whether this is due to the absence of advance-care planning or the lack of communicating goals of care.

Study design: Multicenter prospective cohort study.

Setting: Canada.

Synopsis: A validated questionnaire was used to evaluate advance-care planning both before hospitalization and on admission. Patients and their families were enrolled if they were considered at high risk for dying, including patients with advanced disease, or aged >80 years. Of the 278 patients enrolled, 76.3% had thought about advance-care planning. Approximately 47.9% of patients had written an advance-care plan, and 73.3% had formally documented a surrogate health-care decision-maker. Only a quarter of patients reported that they had been asked about advance-care planning on admission to the hospital. Patients’ stated preferences for end-of-life care were notably incongruent with goals-of-care orders documented in the hospital records. While 28% of patients preferred comfort-only care, this was documented in the hospital records for only 4.5% of patients.

In this study of mostly white, English-speaking hospitalized patients, many had considered and made advance-care plans but few had discussed this with their health-care providers. Not surprisingly, the goals-of-care orders that were documented did not match patients’ previously stated end-of-life preferences.

Bottom line: Physicians routinely fail to discuss patients’ advance-care planning, which may have profound effects on their inpatient care.

Citation: Heyland DK, Barwich D, Pichora D, et al. Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013;173(9):778-787.

Ultrasound Use Reduces Lumbar Puncture and Epidural Catheterization Failure

Clinical question: Does ultrasound imaging for lumbar puncture and epidural catheterization reduce risk of procedure failures?

Background: Numerous studies have compared ultrasound-guided lumbar puncture and epidural catheterization with standard techniques, but they have been underpowered to evaluate whether ultrasound use reduces lumbar puncture and epidural catheterization failure.

Study design: Systematic review and meta-analysis of randomized controlled trials.

Setting: Hospitals in North America, Europe, and Asia.

Synopsis: Among 14 trials, a total of 1,334 patients (including one pediatric study group) were randomly assigned either to receive ultrasound imaging or to a control group (using manual palpation or loss of resistance). Ultrasound imaging comprised a preprocedure marking approach, real-time visual guidance, or both. In the 12 trials in which the primary outcome was available, ultrasound imaging significantly reduced the risk of failed procedures with a risk ratio of 0.21 (95% confidence interval 0.10 to 0.43). A total of 16 ultrasound-guided procedures were needed to avoid one procedure failure. Ultrasound guidance also reduced the number of traumatic procedures, needle reinsertions, and needle redirections. These results were consistent across multiple subgroup analyses.

Only one of the studies included in the meta-analysis was double-blind, and in all of the studies, ultrasound imaging was performed by a clinician with high-level ultrasound experience. While this study suggests that ultrasound does reduce the frequency of procedure failure, the investigators did not include cost-effectiveness analyses.

Bottom line: Ultrasound imaging likely reduces the failure of lumbar puncture and epidural catheterization, but future research will be necessary to evaluate the cost-effectiveness of ultrasound use for these procedures.

Citation: Shaikh F, Brzezinski J, Alexander S, et al. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013;346:f1720.

Surgical Complications might Be Financially Advantageous for Hospitals

Clinical question: What is the impact of surgical complications on hospital finances?

Background: Surgical complications are common and lead to longer lengths of stay and higher costs. Strategies are available to reduce postsurgical complications but have not been universally adopted.

Study design: Observational study.

Setting: Twelve hospitals in one nonprofit Southern hospital system, which includes academic, nonacademic, and rural settings.

Synopsis: Researchers identified 34,526 patients who underwent surgery in 2010, excluding patients undergoing Caesarean section. Of those, 1,820 procedures (5.3%) were associated with at least one complication. The most frequent complications were surgical-site infection, other infections, pneumonia, and thromboembolic disease. The mortality rate for patients with complications was 12.3% compared with 0.6% for those without. Length of stay was four times longer for patients with complications.

Complications were associated with a higher total cost of hospitalization, with a differential of $37,917. This translated into a higher contribution to the margin. The cost differential varied by insurance type, with higher contributions under Medicare and private insurance but not with Medicaid.

The study had the benefit of using a large administrative database; however, this may have underestimated the actual rate of postoperative complications. The study supports the paradox in which quality-improvement (QI) programs that reduce surgical complications and improve postoperative mortality may negatively affect a hospital’s financial performance.

Bottom line: Surgical complications lead to higher mortality for patients but a financial benefit for hospitals.

Citation: Eappen S, Lane BH, Rosenberg B, et al. Relationship between occurrence of surgical complications and hospital finances. JAMA. 2013;309(5):1509-1606.

Showing Lab Test Fees May Decrease Frequency Of Test Ordering

Clinical question: Does information on the cost of a lab test lead to lowered ordering frequency among internal-medicine residents?

Background: Lab test overuse is common; some studies estimate that 70% of lab tests do not affect care. Strategies to reduce frequency of unnecessary lab tests are needed.

Study design: Randomized controlled trial.

Setting: Johns Hopkins Hospital, a 1,051-bed academic medical center in Baltimore.

Synopsis: Researchers used an administrative database to identify the 35 most frequently ordered and the 35 most expensive tests (each ordered at least 50 times). They randomized tests to an active arm, which displayed the Medicare allowable fee at the time of order entry within the computerized physician order entry, and a control arm. A total of 1,166,753 tests were ordered during the baseline and intervention period. Many more tests were ordered in the active group relative to the control group, a consequence of the randomization process. Relative to a six-month baseline period, tests in the active group were ordered 9.1% less frequently; control-group tests were ordered 5.1% more frequently. Charges decreased by $3.79 per patient-day in the active group and increased by $0.52 per patient-day in the control group.

This study reflects a low-cost strategy to reduce lab testing and associated costs. It is unknown whether only unnecessary tests were averted, or if there was any effect on the quality of care. The durability of the intervention and its applicability to other settings and with other types of providers is unclear.

Bottom line: Showing the fee associated with lab tests may decrease the frequency of ordering these tests and the resultant costs.

Citation: Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908.

Inpatient Elderly Multidisciplinary-Team-Based Unit Reduces Readmissions

Clinical question: Can an inpatient unit that uses interdisciplinary rounds and a team approach reduce 30-day readmissions and lower cost compared with usual care?

Background: Elderly patients are at risk for adverse outcomes including delirium, deconditioning, and undernutrition. The Acute Care for Elders (ACE) model is designed as a team-based approach to improve communication between clinicians and to begin discharge planning soon after admission. ACE units have been shown to improve specific outcomes in older adults, but the impact on cost is less clear.

Study design: Retrospective cohort study.

Setting: University of Alabama at Birmingham Acute Care for Elders unit.

Synopsis: The analysis of cost data extrapolated from administrative sources indicated an average of $371 in variable cost savings per patient, and therefore an expected $148,400 savings for 400 patients admitted to this unit. The rate of 30-day readmissions was significantly lower in the ACE model: 7.9% versus 12.8% in patients receiving usual care.

Limitations of this study relate both to its design and single-center location. It is unclear which aspect of this ACE unit was helpful in the studied outcomes, and how this specific program would be reproduced at another institution. There were also some costs associated with the ACE-unit staffing, which may have resulted in an overestimation of the cost savings.

Bottom line: ACE units appear to improve outcomes and may lower cost, but further investigation is needed.

Citation: Flood KL, MacLennan PA, McGrew D, Green D, Dodd C, Brown CJ. Effects of an acute care for elders unit on costs and 30-day readmissions. JAMA. 2013 April 22 [Epub ahead of print].

Continue Beta-Blockers in High-Risk Patients During Noncardiac Surgery

Clinical question: Does exposure to a beta-blocker at the time of noncardiac surgery have an association with mortality, cardiac arrest, or Q-wave myocardial infarction (MI)?

Background: Exposure to beta-blockers perioperatively is controversial. The authors suggest that a randomized trial would be difficult, as one might need to withhold beta-blockers from stable patients. The American Heart Association and American College of Cardiology currently recommend continuation of pre-existing beta-blockades perioperatively.

Study design: Retrospective, propensity-matched cohort analysis.

Setting: One hundred four Veterans Affairs (VA) medical centers from January 2005 to August 2010.

Synopsis: Exposure for any reason to beta-blockers around nonvascular surgery appears to lower the risk of mortality and cardiac arrest, particularly in patients with higher revised cardiac risk index factors. Stopping beta-blockers in this same period was associated with increased mortality. The reasons for beta-blocker use in the exposed cohort were not well-established or -stratified.

Limitations include that the exposed cohort had a higher rate of cardiovascular disease and comorbidities and were generally older. Duration of exposure to beta-blockers was mixed, although more than 75% had a prescription for more than three months, with less than 2% for several days. Some of the matched cohort appears to have had beta-blocker exposure, thus diminishing the potential impact.

Bottom line: In this retrospective analysis, there is an association between beta-blocker use during noncardiac, nonvascular surgery and lower mortality, as well as lower rates of cardiac arrest and Q-wave MI, particularly among higher-risk patients.

Citation: London MJ, Hur K, Schwartz G, Henderson WG. Association of perioperative beta-blockade with mortality and cardiovascular morbidity following major noncardiac surgery. JAMA. 2013;309(16):1704-1713.

Patient-Centered Decision-Making and Health-Care Outcomes

Clinical question: Does recognition of contextual domains in the care plan lead to resolution of patients’ presenting problems?

Background: Patient-centered decision-making, or contextualization of care, adapts best evidence to the care of the individual patient. Examples of contextual domains include access to care, social support, and financial situation. Contextual errors (e.g. unrecognized domains) are, on average, more costly than errors in evidenced-based medicine.

Study design: Observational study.

Setting: VA ambulatory-care centers.

Synopsis: A total of 548 patient-derived audio recordings of physician encounters that included contextual red flags (e.g. missed appointments, HbA1c >8%) were reviewed at two VA hospital ambulatory-care centers using the content coding for contextualization of care (4C) method. Prospectively determined good and poor outcomes were derived from specific red flags (e.g. keeping next appointment, decrease in HbA1c). Of the 548 red flags, 208 were associated with contextual domains using the 4C method. Some 59% of physicians recognized contextual domains in care-plan development, leading to good outcomes in 71% of red flags. As many as 41% of physicians did not recognize contextual domains, leading to poor outcomes in 54% of red-flag instances.

Hospitalists should be aware of contextual domains and red flags (e.g. readmissions), and this study provides a method of evaluating patient-centered decision-making in the hospital setting. However, the inherently subjective 4C method may underestimate the number of contextual domains.

Bottom line: Recognition and incorporation of contextual domains in care-plan development in the ambulatory setting are associated with improved contextual red flag outcomes.

Citation: Weiner SJ, Schwartz A, Sharma G, et al. Patient-centered decision making and health care outcomes: an observational study. Ann Intern Med. 2013;158:573-579.

Adverse Surgical Outcomes in Schizophrenia Patients

Clinical question: What is the full spectrum of postoperative complications and mortality in schizophrenic patients receiving in-hospital major surgery?

Background: Schizophrenia affects an estimated 4 to 7 per 1,000 persons worldwide, and patients with schizophrenia are at increased risk of diabetes, cardiovascular disease, and stroke with subsequent increased mortality risk. The correlation between severity of mental illness and postoperative in-hospital mortality has not been validated in previous studies.

Study design: Population-based, cross-sectional study.

Setting: Taiwan hospitals.

Synopsis: Using the Taiwan National Health Insurance Research Database, researchers examined claims from 2004 to 2007 and retrospectively identified 8,967 schizophrenic patients who underwent major inpatient surgery and were hospitalized for more than one day. Primary outcomes included acute myocardial infarction, acute renal failure, stroke, and in-hospital mortality within 30 days. Postoperative complications and mortality rates were compared between schizophrenic patients and patients without mental illness.

Schizophrenic patients had higher rates of many primary outcomes, including 30-day postoperative mortality, compared with patients without mental illness, after adjusting for sex, age, surgery type, and hospital setting. The risk for 30-day mortality rose with the number of preoperative schizophrenia-related services provided. Limitations include the nature of retrospective analysis and generalizability.

Bottom line: Compared to patients without mental illness, schizophrenic patients have an increased risk of acute renal failure, pneumonia, septicemia, and 30-day mortality in the postoperative setting, with higher mortality rates in schizophrenic patients with more severe disease.

Citation: Liao CC, Shen WW, Chang CC, Chang H, Chen T. Surgical adverse outcomes in patients with schizophrenia. Ann Surg. 2013;257:433-438.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Neutral head position safe for internal jugular vein cannulation
2. Thrombolysis decreases mortality in unstable patients with acute PE
3. Rectal indomethacin decreases incidence of post-ERCP pancreatitis
4. CHADS2-VASc and HAS-BLED as predictors in afib patients
5. No readmission, mortality decreases with self-supported COPD management
6. Medicare Premier P4P initiatives do not decrease mortality
7. In-hospital rate of DVT/PE after hip and knee arthroplasty
8. Sodium chloride prevents contrast-induced nephropathy

Neutral Head Position Is Safe for Internal Jugular Vein Cannulation

Clinical question: Is there a difference in the complication rate between neutral head position and 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation?

Background: Cannulation of the internal jugular vein using ultrasound decreases the rate of major complications (carotid artery puncture, pneumothorax, and hemothorax). The relative positions of the internal jugular vein and the carotid artery change based on degree of neck rotation. The optimal position for ultrasound-guided vein puncture has not been shown.

Study design: Prospective, randomized, controlled, non-blinded study.

Setting: Tertiary neurosurgical center in Milan, Italy.

Synopsis: One thousand, three hundred thirty-two patients undergoing major neurosurgical procedures who needed central venous catheter placement were randomized to a neutral head position (NH) or a 45-degree neck rotation (HT) during ultrasound-guided internal jugular vein cannulation. Exclusion criteria were consent refusal, age <12 years, and coagulopathy. Six experienced anesthesiologists performed the procedures; blinding was not possible.

There was no difference in the rate of major complications (carotid artery puncture, pneumothorax, or hemothorax) based on head position (0.9% in NH vs. 0.6% in HT). Minor complications (multiple skin punctures, multiple vein punctures, difficulty inserting the guidewire) were similar in the two groups (13.2% in NG vs. 12.6% in HT). Neck rotation was not associated with operator-reported difficulty or vascular access time.

Limitations of the study include the inability to blind the operator. Additionally, the study involved six experienced anesthesiologists at one center who performed the procedure on patients needing an elective central line. The ability to generalize the findings to other settings, less experienced providers, and patients who need an emergency line is not certain.

Bottom line: Neutral head position is as safe as 45-degree neck rotation for elective ultrasound-guided internal jugular vein cannulation.

Citation: Lamperti M, Subert M, Cortellazzi P, et al. Is a neutral head position safer than 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation? Results of a randomized controlled clinical trial. Anesth Analg. 2012;114:777-784.

Thrombolysis Decreases Mortality in Unstable Patients with Acute Pulmonary Embolism

Clinical question: Does thrombolytic therapy decrease mortality in unstable patients with acute pulmonary embolism (PE)?

Background: PE is a common problem; associated mortality is high. Despite this fact, the data supporting thrombolytic therapy in hemodynamically unstable patients are not robust, and randomized, controlled trials are unlikely to be performed.

Study design: Retrospective cohort study.

Setting: One thousand nonfederal, short-term U.S. hospitals.

Synopsis: Using data from the Nationwide Inpatient Sample database from 1999-2008, investigators found that thrombolysis decreased both all-cause and PE-specific mortality for unstable patients, defined as those either in shock or on a ventilator. Specifically for all-cause mortality, 15% of patients who received thrombolysis died vs. 47% of those who did not (RR 0.31, 95% CI 0.30-0.32). Placement of an inferior vena cava (IVC) filter further reduced mortality, to only 7.6% in patients who received both IVC filter and thrombolysis.

For PE-specific mortality, patients who received thrombolysis also had decreased rates, from 42% to 8.4% (RR 0.20; 95% CI 0.19-0.22). Across all age groups, patients who received thrombolysis had decreased all-cause and PE-specific mortality. Patients who did not receive thrombolysis had additional comorbidities.

As this study is retrospective, it might be affected by unknown confounding. In addition, it relies on coding data to identify patient stability and treatment. Despite this limitation, a randomized, controlled trial is unlikely to be performed at this stage. This study provides evidence to support use of thrombolysis in unstable patients.

Bottom line: Thrombolysis might reduce mortality in unstable patients with acute PE. In combination with IVC filters, the mortality reduction might be even greater.

Citation: Stein PD, Matta F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Am J Med. 2012;125(5):465-470.

Rectal Indomethacin Decreases Incidence of Post-ERCP Pancreatitis

Clinical question: Does rectal indomethacin reduce the incidence of pancreatitis after ERCP?

Background: Acute pancreatitis is the most common complication from endoscopic retrograde cholangiopancreatography (ERCP). No pharmacologic treatment has proven to reduce the incidence of pancreatitis. Preliminary studies, including a meta-analysis, suggest that the use of NSAIDs might reduce the incidence of post-ERCP pancreatitis.

Study design: Randomized, placebo-controlled, double-blind trial.

Setting: Multicenter trial at four university-affiliated medical centers in the U.S.

Synopsis: More than 600 patients at high risk for post-ERCP pancreatitis were randomized to receive either two 50-mg indomethacin suppositories or two identical-appearing placebo suppositories. Patients were considered at high risk for pancreatitis based on previously identified patient- and procedure-related risk factors. Most of the participants had sphincter of Oddi dysfunction (84.4% of the indomethacin group and 80.5% of the placebo group). Exclusion criteria included elevated creatinine and active peptic ulcer disease. The indomethacin or placebo suppositories were given immediately following the ERCP.

Post-ERCP pancreatitis, defined by upper abdominal pain, elevation of pancreatic enzymes, and hospitalization for at least two nights, was significantly higher in the placebo group compared with the indomethacin group (16.9% vs. 9.2%, P=0.005). Moderate or severe post-ERCP pancreatitis was significantly higher in the placebo group compared with the indomethacin group (8.8% vs. 4.4%, P=0.03).

There were no significant differences in the rates of clinically significant bleeding or acute renal failure between the two groups. The ability to generalize these findings to patients without risk factors for post-ERCP pancreatitis is not clear.

Bottom line: Rectal indomethacin decreases the rate of post-ERCP pancreatitis in patients who are at high risk for this complication.

Citation: Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012;366(15):1414-1422.

CHADS2-VASc and HAS-BLED Can Predict Thromboembolism and Bleeding Risk in Afib Patients

Clinical question: What are the risk factors for stroke/thromboembolism and bleeding from atrial fibrillation (afib), and how well do the CHADS2-VASc and HAS-BLED stroke and bleeding risk-assessment tools perform against other published stroke and bleeding risk-assessment tools (CHADS2 and HEMORR2HAGES) for patients with afib?

Background: In afib patients, the CHADS2-VASc tool might offer more comprehensive stroke assessment over the CHADS2 by identifying truly-low-risk patients with afib who might not even need antiplatelet therapy. HAS-BLED, a newer bleeding-risk-assessment tool, has been validated in previous trials and is more user-friendly than others. Use of CHADS2-VASc and HAS-BLED are recommended by the European Society of Cardiology to assess stroke and bleeding risks for patients with afib.

Study design: Prospective cohort study.

Setting: All hospitals in Sweden.

Synopsis: Investigators identified 182,678 afib patients via ICD-10 data from Sweden’s National Hospital Discharge Registry ICD-10 from 2005 to 2008. Approximately half the patients were not taking anticoagulants. Analysis assessed risk factors for stroke and bleeding and the performance of CHADS2-VASc and HAS-BLED against CHADS2 and HEMORR2HAGES stroke and bleeding risk-assessment tools.

Risk of composite thromboembolism (unspecified stroke, TIA, systemic embolism) was significantly higher in patients with increased age, peripheral arterial disease, prior myocardial infarction (MI), prior coronary artery bypass grafting (CABG), female gender, renal failure, and aspirin use, as well as hypertension, diabetes, prior thromboembolic event, or prior intracranial hemorrhage (ICH). Interestingly, a statistically increased risk was seen with aspirin use.

Conversely, history of heart failure, thyroid disease, and obesity were not associated with increased composite thromboembolic risk. The use of CHADS2-VASc was marginally better than CHADS2 in predicting stroke risk.

ICH risk was increased in patients with older age, prior ischemic stroke, prior ICH, and hypertension. Risk of composite bleeding (from ICH or other major bleeding) was significantly higher in patients with these risk factors, as well as renal failure, liver disease, anemia, dysfunctional platelets, alcohol use, and cancer. Ischemic heart disease was associated with a statistically significant lower risk of ICH, but not of composite bleeding risk.

HAS-BLED usage was as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk.

Bottom line: CHADS2-VASc might be better than CHADS2 in predicting truly-low-risk patients with nonvalvular afib; HAS-BLED is just as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk for patients with nonvalvular afib who are to receive antithrombotic therapy.

Citation: Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182,678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012;33(12):1500-10 [Epub 2012 Jan 13].

Supported Self-Management of COPD Does Not Decrease Readmission or Mortality Rates

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and death (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmission or death in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060 [Epub ahead of print].

Medicare Premier P4P Initiatives Do Not Decrease Mortality

Clinical question: Has the Medicare Premier Hospital Quality Incentive Demonstration (HQID) resulted in lower mortality?

Background: The Centers for Medicare & Medicaid Services’ (CMS) value-based purchasing program will expand to include 30-day mortality in 2013, but do pay-for-performance (P4P) initiatives result in improved mortality? Studies have demonstrated improvement in process of care but have not demonstrated mortality benefit thus far.

Study design: Cohort study.

Setting: Two hundred fifty-two hospitals participating in the Premier HQID compared with 3,363 control hospitals participating in the Hospital Compare program.

Synopsis: Researchers examined 30-day mortality for patients admitted with acute myocardial infarction, congestive heart failure, pneumonia, and for coronary artery bypass grafting (CABG) from 2003 to 2009. Results showed no difference in 30-day mortality rates over the six-year span of the program for any of the conditions studied in the Premier hospitals (participating in the voluntary pay-for-performance program) vs. non-Premier hospitals (11.82% vs. 11.74%). This held true for each condition measured individually, with a higher mortality rate for patients undergoing CABG at the Premier hospitals.

In addition, in the hospitals that underperformed initially, there was no difference with respect to rate of improvement when comparing Premier vs. non-Premier hospitals. Furthermore, mortality rate trends did not differ between those conditions that were incentivized (acute MI and CABG) compared with those that were not (congestive heart failure and pneumonia).

The authors concluded that there was “little evidence” that the Premier HQID pay-for-performance program resulted in reduced 30-day mortality.

Bottom line: Programs participating in the Medicare Premier HQID pay-for-performance program had similar 30-day mortality compared with nonparticipating programs.

Citation: Jha AK, Joynt KE, Orav EJ, Epstein AM. The long-term effect of premier pay for performance on patient outcomes. N Engl J Med. 2012;366:1606-1615.

In-Hospital Rate of DVT/PE After Hip and Knee Arthroplasty with Guideline-Recommended Prophylaxis

Clinical question: What is the rate of symptomatic DVT/PE after total or partial hip (TPHA) or knee (TPKA) arthroplasty using currently recommended prophylaxis?

Background: The rate of postoperative DVT/PE after TPHA/TPKA has dropped dramatically with use of pharmacologic prophylaxis. However, the current rate of symptomatic DVT/PE using current pharmacologic prophylaxis is not known. Such rates are needed for informed patient consent and development of patient safety benchmarks.

Study design: Systematic review.

Setting: Randomized clinical trials (RCTs) and observational studies worldwide of adult inpatients undergoing TPHA and/or TPKA from 1996 to 2011.

Synopsis: Forty-seven studies were included, of which 41 were RCTs and six were observational studies. Twenty-one studies evaluated rates after TPHA, 20 after TPKA, and six after both. More than 44,000 patients were included, with ages ranging from 58 to 74 years. The mean duration of prophylaxis was eight days, with a mean follow-up of 13 days.

In-hospital rates of symptomatic venous thromboembolism (VTE) were higher in patients undergoing TPKA than TPHA (1.09% vs. 0.53% for VTE, 0.63% vs. 0.26% for DVT, and 0.27% vs. 0.14% for PE). This is in contrast to the higher rates of VTE observed after TPHA when the post-discharge period is included. The pooled incidence of VTE was lower with use of direct inhibitors of Factors Xa or IIa when compared to low-molecular-weight heparin, although a direct efficacy comparison could not be made.

Because the majority of studies were RCTs with restrictive inclusion criteria, rates of DVT/PE in actual practice might be higher.

Bottom line: When informing patients of postoperative VTE risk, or establishing benchmarks to evaluate patient safety, one can anticipate an in-hospital VTE rate of 0.5% following TPHA and 1% following TPKA.

Citation: Januel JM, Chen G, Ruffieux C, et al. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA. 2012;307(3):294-303.

Sodium Chloride Prevents Contrast-Induced Nephropathy

Clinical question: Is sodium chloride more effective than sodium bicarbonate for preventing contrast-induced nephropathy?

Background: Contrast-induced nephropathy can be prevented with precontrast hydration. Study authors sought to compare sodium chloride administered over 24 hours with sodium bicarbonate administered over seven hours, and with sodium bicarbonate administered orally.

Study design: Randomized, open-label, controlled trial.

Setting: Three European medical centers.

Synopsis: The study examined 258 patients with an estimated glomerular filtration rate <60mL/min/1.73m2 undergoing intravenous or intra-arterial contrast procedure. Patients with Class III or IV heart failure were excluded. The remaining patients were randomized to receive one of three regimens: sodium chloride at 1 ml/kg/hr for 12 hours prior to and 12 hours following the procedure; intravenous sodium bicarbonate for one hour prior to and six hours following the procedure; or intravenous and oral sodium bicarbonate 20 minutes prior to the procedure.

The group that received saline had a lower incidence of contrast-induced nephropathy than the bicarbonate groups (1% vs. 9% vs. 10%). The oral bicarbonate strategy was noninferior to the seven-hour intravenous bicarbonate strategy.

The authors postulated that saline should be used for high-risk patients, but that given the overall low incidence of contrast-induced nephropathy, the short-term bicarbonate strategy (intravenous followed by oral) is a viable alternative for low-risk patients.

Bottom line: Sodium chloride is more effective than sodium bicarbonate for preventing contrast-induced nephropathy, but in light of the low incidence, a short course of sodium bicarbonate is a possible convenient alternative for low-risk patients.

Citation: Klima T, Christ A, Marana I, et al. Sodium chloride vs. sodium bicarbonate for the prevention of contrast medium-induced nephropathy: a randomized controlled trial. Eur Heart J. 2012 Jan 19 [Epub ahead of print].

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Neutral head position safe for internal jugular vein cannulation
2. Thrombolysis decreases mortality in unstable patients with acute PE
3. Rectal indomethacin decreases incidence of post-ERCP pancreatitis
4. CHADS2-VASc and HAS-BLED as predictors in afib patients
5. No readmission, mortality decreases with self-supported COPD management
6. Medicare Premier P4P initiatives do not decrease mortality
7. In-hospital rate of DVT/PE after hip and knee arthroplasty
8. Sodium chloride prevents contrast-induced nephropathy

Neutral Head Position Is Safe for Internal Jugular Vein Cannulation

Clinical question: Is there a difference in the complication rate between neutral head position and 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation?

Background: Cannulation of the internal jugular vein using ultrasound decreases the rate of major complications (carotid artery puncture, pneumothorax, and hemothorax). The relative positions of the internal jugular vein and the carotid artery change based on degree of neck rotation. The optimal position for ultrasound-guided vein puncture has not been shown.

Study design: Prospective, randomized, controlled, non-blinded study.

Setting: Tertiary neurosurgical center in Milan, Italy.

Synopsis: One thousand, three hundred thirty-two patients undergoing major neurosurgical procedures who needed central venous catheter placement were randomized to a neutral head position (NH) or a 45-degree neck rotation (HT) during ultrasound-guided internal jugular vein cannulation. Exclusion criteria were consent refusal, age <12 years, and coagulopathy. Six experienced anesthesiologists performed the procedures; blinding was not possible.

There was no difference in the rate of major complications (carotid artery puncture, pneumothorax, or hemothorax) based on head position (0.9% in NH vs. 0.6% in HT). Minor complications (multiple skin punctures, multiple vein punctures, difficulty inserting the guidewire) were similar in the two groups (13.2% in NG vs. 12.6% in HT). Neck rotation was not associated with operator-reported difficulty or vascular access time.

Limitations of the study include the inability to blind the operator. Additionally, the study involved six experienced anesthesiologists at one center who performed the procedure on patients needing an elective central line. The ability to generalize the findings to other settings, less experienced providers, and patients who need an emergency line is not certain.

Bottom line: Neutral head position is as safe as 45-degree neck rotation for elective ultrasound-guided internal jugular vein cannulation.

Citation: Lamperti M, Subert M, Cortellazzi P, et al. Is a neutral head position safer than 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation? Results of a randomized controlled clinical trial. Anesth Analg. 2012;114:777-784.

Thrombolysis Decreases Mortality in Unstable Patients with Acute Pulmonary Embolism

Clinical question: Does thrombolytic therapy decrease mortality in unstable patients with acute pulmonary embolism (PE)?

Background: PE is a common problem; associated mortality is high. Despite this fact, the data supporting thrombolytic therapy in hemodynamically unstable patients are not robust, and randomized, controlled trials are unlikely to be performed.

Study design: Retrospective cohort study.

Setting: One thousand nonfederal, short-term U.S. hospitals.

Synopsis: Using data from the Nationwide Inpatient Sample database from 1999-2008, investigators found that thrombolysis decreased both all-cause and PE-specific mortality for unstable patients, defined as those either in shock or on a ventilator. Specifically for all-cause mortality, 15% of patients who received thrombolysis died vs. 47% of those who did not (RR 0.31, 95% CI 0.30-0.32). Placement of an inferior vena cava (IVC) filter further reduced mortality, to only 7.6% in patients who received both IVC filter and thrombolysis.

For PE-specific mortality, patients who received thrombolysis also had decreased rates, from 42% to 8.4% (RR 0.20; 95% CI 0.19-0.22). Across all age groups, patients who received thrombolysis had decreased all-cause and PE-specific mortality. Patients who did not receive thrombolysis had additional comorbidities.

As this study is retrospective, it might be affected by unknown confounding. In addition, it relies on coding data to identify patient stability and treatment. Despite this limitation, a randomized, controlled trial is unlikely to be performed at this stage. This study provides evidence to support use of thrombolysis in unstable patients.

Bottom line: Thrombolysis might reduce mortality in unstable patients with acute PE. In combination with IVC filters, the mortality reduction might be even greater.

Citation: Stein PD, Matta F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Am J Med. 2012;125(5):465-470.

Rectal Indomethacin Decreases Incidence of Post-ERCP Pancreatitis

Clinical question: Does rectal indomethacin reduce the incidence of pancreatitis after ERCP?

Background: Acute pancreatitis is the most common complication from endoscopic retrograde cholangiopancreatography (ERCP). No pharmacologic treatment has proven to reduce the incidence of pancreatitis. Preliminary studies, including a meta-analysis, suggest that the use of NSAIDs might reduce the incidence of post-ERCP pancreatitis.

Study design: Randomized, placebo-controlled, double-blind trial.

Setting: Multicenter trial at four university-affiliated medical centers in the U.S.

Synopsis: More than 600 patients at high risk for post-ERCP pancreatitis were randomized to receive either two 50-mg indomethacin suppositories or two identical-appearing placebo suppositories. Patients were considered at high risk for pancreatitis based on previously identified patient- and procedure-related risk factors. Most of the participants had sphincter of Oddi dysfunction (84.4% of the indomethacin group and 80.5% of the placebo group). Exclusion criteria included elevated creatinine and active peptic ulcer disease. The indomethacin or placebo suppositories were given immediately following the ERCP.

Post-ERCP pancreatitis, defined by upper abdominal pain, elevation of pancreatic enzymes, and hospitalization for at least two nights, was significantly higher in the placebo group compared with the indomethacin group (16.9% vs. 9.2%, P=0.005). Moderate or severe post-ERCP pancreatitis was significantly higher in the placebo group compared with the indomethacin group (8.8% vs. 4.4%, P=0.03).

There were no significant differences in the rates of clinically significant bleeding or acute renal failure between the two groups. The ability to generalize these findings to patients without risk factors for post-ERCP pancreatitis is not clear.

Bottom line: Rectal indomethacin decreases the rate of post-ERCP pancreatitis in patients who are at high risk for this complication.

Citation: Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012;366(15):1414-1422.

CHADS2-VASc and HAS-BLED Can Predict Thromboembolism and Bleeding Risk in Afib Patients

Clinical question: What are the risk factors for stroke/thromboembolism and bleeding from atrial fibrillation (afib), and how well do the CHADS2-VASc and HAS-BLED stroke and bleeding risk-assessment tools perform against other published stroke and bleeding risk-assessment tools (CHADS2 and HEMORR2HAGES) for patients with afib?

Background: In afib patients, the CHADS2-VASc tool might offer more comprehensive stroke assessment over the CHADS2 by identifying truly-low-risk patients with afib who might not even need antiplatelet therapy. HAS-BLED, a newer bleeding-risk-assessment tool, has been validated in previous trials and is more user-friendly than others. Use of CHADS2-VASc and HAS-BLED are recommended by the European Society of Cardiology to assess stroke and bleeding risks for patients with afib.

Study design: Prospective cohort study.

Setting: All hospitals in Sweden.

Synopsis: Investigators identified 182,678 afib patients via ICD-10 data from Sweden’s National Hospital Discharge Registry ICD-10 from 2005 to 2008. Approximately half the patients were not taking anticoagulants. Analysis assessed risk factors for stroke and bleeding and the performance of CHADS2-VASc and HAS-BLED against CHADS2 and HEMORR2HAGES stroke and bleeding risk-assessment tools.

Risk of composite thromboembolism (unspecified stroke, TIA, systemic embolism) was significantly higher in patients with increased age, peripheral arterial disease, prior myocardial infarction (MI), prior coronary artery bypass grafting (CABG), female gender, renal failure, and aspirin use, as well as hypertension, diabetes, prior thromboembolic event, or prior intracranial hemorrhage (ICH). Interestingly, a statistically increased risk was seen with aspirin use.

Conversely, history of heart failure, thyroid disease, and obesity were not associated with increased composite thromboembolic risk. The use of CHADS2-VASc was marginally better than CHADS2 in predicting stroke risk.

ICH risk was increased in patients with older age, prior ischemic stroke, prior ICH, and hypertension. Risk of composite bleeding (from ICH or other major bleeding) was significantly higher in patients with these risk factors, as well as renal failure, liver disease, anemia, dysfunctional platelets, alcohol use, and cancer. Ischemic heart disease was associated with a statistically significant lower risk of ICH, but not of composite bleeding risk.

HAS-BLED usage was as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk.

Bottom line: CHADS2-VASc might be better than CHADS2 in predicting truly-low-risk patients with nonvalvular afib; HAS-BLED is just as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk for patients with nonvalvular afib who are to receive antithrombotic therapy.

Citation: Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182,678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012;33(12):1500-10 [Epub 2012 Jan 13].

Supported Self-Management of COPD Does Not Decrease Readmission or Mortality Rates

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and death (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmission or death in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060 [Epub ahead of print].

Medicare Premier P4P Initiatives Do Not Decrease Mortality

Clinical question: Has the Medicare Premier Hospital Quality Incentive Demonstration (HQID) resulted in lower mortality?

Background: The Centers for Medicare & Medicaid Services’ (CMS) value-based purchasing program will expand to include 30-day mortality in 2013, but do pay-for-performance (P4P) initiatives result in improved mortality? Studies have demonstrated improvement in process of care but have not demonstrated mortality benefit thus far.

Study design: Cohort study.

Setting: Two hundred fifty-two hospitals participating in the Premier HQID compared with 3,363 control hospitals participating in the Hospital Compare program.

Synopsis: Researchers examined 30-day mortality for patients admitted with acute myocardial infarction, congestive heart failure, pneumonia, and for coronary artery bypass grafting (CABG) from 2003 to 2009. Results showed no difference in 30-day mortality rates over the six-year span of the program for any of the conditions studied in the Premier hospitals (participating in the voluntary pay-for-performance program) vs. non-Premier hospitals (11.82% vs. 11.74%). This held true for each condition measured individually, with a higher mortality rate for patients undergoing CABG at the Premier hospitals.

In addition, in the hospitals that underperformed initially, there was no difference with respect to rate of improvement when comparing Premier vs. non-Premier hospitals. Furthermore, mortality rate trends did not differ between those conditions that were incentivized (acute MI and CABG) compared with those that were not (congestive heart failure and pneumonia).

The authors concluded that there was “little evidence” that the Premier HQID pay-for-performance program resulted in reduced 30-day mortality.

Bottom line: Programs participating in the Medicare Premier HQID pay-for-performance program had similar 30-day mortality compared with nonparticipating programs.

Citation: Jha AK, Joynt KE, Orav EJ, Epstein AM. The long-term effect of premier pay for performance on patient outcomes. N Engl J Med. 2012;366:1606-1615.

In-Hospital Rate of DVT/PE After Hip and Knee Arthroplasty with Guideline-Recommended Prophylaxis

Clinical question: What is the rate of symptomatic DVT/PE after total or partial hip (TPHA) or knee (TPKA) arthroplasty using currently recommended prophylaxis?

Background: The rate of postoperative DVT/PE after TPHA/TPKA has dropped dramatically with use of pharmacologic prophylaxis. However, the current rate of symptomatic DVT/PE using current pharmacologic prophylaxis is not known. Such rates are needed for informed patient consent and development of patient safety benchmarks.

Study design: Systematic review.

Setting: Randomized clinical trials (RCTs) and observational studies worldwide of adult inpatients undergoing TPHA and/or TPKA from 1996 to 2011.

Synopsis: Forty-seven studies were included, of which 41 were RCTs and six were observational studies. Twenty-one studies evaluated rates after TPHA, 20 after TPKA, and six after both. More than 44,000 patients were included, with ages ranging from 58 to 74 years. The mean duration of prophylaxis was eight days, with a mean follow-up of 13 days.

In-hospital rates of symptomatic venous thromboembolism (VTE) were higher in patients undergoing TPKA than TPHA (1.09% vs. 0.53% for VTE, 0.63% vs. 0.26% for DVT, and 0.27% vs. 0.14% for PE). This is in contrast to the higher rates of VTE observed after TPHA when the post-discharge period is included. The pooled incidence of VTE was lower with use of direct inhibitors of Factors Xa or IIa when compared to low-molecular-weight heparin, although a direct efficacy comparison could not be made.

Because the majority of studies were RCTs with restrictive inclusion criteria, rates of DVT/PE in actual practice might be higher.

Bottom line: When informing patients of postoperative VTE risk, or establishing benchmarks to evaluate patient safety, one can anticipate an in-hospital VTE rate of 0.5% following TPHA and 1% following TPKA.

Citation: Januel JM, Chen G, Ruffieux C, et al. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA. 2012;307(3):294-303.

Sodium Chloride Prevents Contrast-Induced Nephropathy

Clinical question: Is sodium chloride more effective than sodium bicarbonate for preventing contrast-induced nephropathy?

Background: Contrast-induced nephropathy can be prevented with precontrast hydration. Study authors sought to compare sodium chloride administered over 24 hours with sodium bicarbonate administered over seven hours, and with sodium bicarbonate administered orally.

Study design: Randomized, open-label, controlled trial.

Setting: Three European medical centers.

Synopsis: The study examined 258 patients with an estimated glomerular filtration rate <60mL/min/1.73m2 undergoing intravenous or intra-arterial contrast procedure. Patients with Class III or IV heart failure were excluded. The remaining patients were randomized to receive one of three regimens: sodium chloride at 1 ml/kg/hr for 12 hours prior to and 12 hours following the procedure; intravenous sodium bicarbonate for one hour prior to and six hours following the procedure; or intravenous and oral sodium bicarbonate 20 minutes prior to the procedure.

The group that received saline had a lower incidence of contrast-induced nephropathy than the bicarbonate groups (1% vs. 9% vs. 10%). The oral bicarbonate strategy was noninferior to the seven-hour intravenous bicarbonate strategy.

The authors postulated that saline should be used for high-risk patients, but that given the overall low incidence of contrast-induced nephropathy, the short-term bicarbonate strategy (intravenous followed by oral) is a viable alternative for low-risk patients.

Bottom line: Sodium chloride is more effective than sodium bicarbonate for preventing contrast-induced nephropathy, but in light of the low incidence, a short course of sodium bicarbonate is a possible convenient alternative for low-risk patients.

Citation: Klima T, Christ A, Marana I, et al. Sodium chloride vs. sodium bicarbonate for the prevention of contrast medium-induced nephropathy: a randomized controlled trial. Eur Heart J. 2012 Jan 19 [Epub ahead of print].

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Neutral head position safe for internal jugular vein cannulation
2. Thrombolysis decreases mortality in unstable patients with acute PE
3. Rectal indomethacin decreases incidence of post-ERCP pancreatitis
4. CHADS2-VASc and HAS-BLED as predictors in afib patients
5. No readmission, mortality decreases with self-supported COPD management
6. Medicare Premier P4P initiatives do not decrease mortality
7. In-hospital rate of DVT/PE after hip and knee arthroplasty
8. Sodium chloride prevents contrast-induced nephropathy

Neutral Head Position Is Safe for Internal Jugular Vein Cannulation

Clinical question: Is there a difference in the complication rate between neutral head position and 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation?

Background: Cannulation of the internal jugular vein using ultrasound decreases the rate of major complications (carotid artery puncture, pneumothorax, and hemothorax). The relative positions of the internal jugular vein and the carotid artery change based on degree of neck rotation. The optimal position for ultrasound-guided vein puncture has not been shown.

Study design: Prospective, randomized, controlled, non-blinded study.

Setting: Tertiary neurosurgical center in Milan, Italy.

Synopsis: One thousand, three hundred thirty-two patients undergoing major neurosurgical procedures who needed central venous catheter placement were randomized to a neutral head position (NH) or a 45-degree neck rotation (HT) during ultrasound-guided internal jugular vein cannulation. Exclusion criteria were consent refusal, age <12 years, and coagulopathy. Six experienced anesthesiologists performed the procedures; blinding was not possible.

There was no difference in the rate of major complications (carotid artery puncture, pneumothorax, or hemothorax) based on head position (0.9% in NH vs. 0.6% in HT). Minor complications (multiple skin punctures, multiple vein punctures, difficulty inserting the guidewire) were similar in the two groups (13.2% in NG vs. 12.6% in HT). Neck rotation was not associated with operator-reported difficulty or vascular access time.

Limitations of the study include the inability to blind the operator. Additionally, the study involved six experienced anesthesiologists at one center who performed the procedure on patients needing an elective central line. The ability to generalize the findings to other settings, less experienced providers, and patients who need an emergency line is not certain.

Bottom line: Neutral head position is as safe as 45-degree neck rotation for elective ultrasound-guided internal jugular vein cannulation.

Citation: Lamperti M, Subert M, Cortellazzi P, et al. Is a neutral head position safer than 45-degree neck rotation during ultrasound-guided internal jugular vein cannulation? Results of a randomized controlled clinical trial. Anesth Analg. 2012;114:777-784.

Thrombolysis Decreases Mortality in Unstable Patients with Acute Pulmonary Embolism

Clinical question: Does thrombolytic therapy decrease mortality in unstable patients with acute pulmonary embolism (PE)?

Background: PE is a common problem; associated mortality is high. Despite this fact, the data supporting thrombolytic therapy in hemodynamically unstable patients are not robust, and randomized, controlled trials are unlikely to be performed.

Study design: Retrospective cohort study.

Setting: One thousand nonfederal, short-term U.S. hospitals.

Synopsis: Using data from the Nationwide Inpatient Sample database from 1999-2008, investigators found that thrombolysis decreased both all-cause and PE-specific mortality for unstable patients, defined as those either in shock or on a ventilator. Specifically for all-cause mortality, 15% of patients who received thrombolysis died vs. 47% of those who did not (RR 0.31, 95% CI 0.30-0.32). Placement of an inferior vena cava (IVC) filter further reduced mortality, to only 7.6% in patients who received both IVC filter and thrombolysis.

For PE-specific mortality, patients who received thrombolysis also had decreased rates, from 42% to 8.4% (RR 0.20; 95% CI 0.19-0.22). Across all age groups, patients who received thrombolysis had decreased all-cause and PE-specific mortality. Patients who did not receive thrombolysis had additional comorbidities.

As this study is retrospective, it might be affected by unknown confounding. In addition, it relies on coding data to identify patient stability and treatment. Despite this limitation, a randomized, controlled trial is unlikely to be performed at this stage. This study provides evidence to support use of thrombolysis in unstable patients.

Bottom line: Thrombolysis might reduce mortality in unstable patients with acute PE. In combination with IVC filters, the mortality reduction might be even greater.

Citation: Stein PD, Matta F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Am J Med. 2012;125(5):465-470.

Rectal Indomethacin Decreases Incidence of Post-ERCP Pancreatitis

Clinical question: Does rectal indomethacin reduce the incidence of pancreatitis after ERCP?

Background: Acute pancreatitis is the most common complication from endoscopic retrograde cholangiopancreatography (ERCP). No pharmacologic treatment has proven to reduce the incidence of pancreatitis. Preliminary studies, including a meta-analysis, suggest that the use of NSAIDs might reduce the incidence of post-ERCP pancreatitis.

Study design: Randomized, placebo-controlled, double-blind trial.

Setting: Multicenter trial at four university-affiliated medical centers in the U.S.

Synopsis: More than 600 patients at high risk for post-ERCP pancreatitis were randomized to receive either two 50-mg indomethacin suppositories or two identical-appearing placebo suppositories. Patients were considered at high risk for pancreatitis based on previously identified patient- and procedure-related risk factors. Most of the participants had sphincter of Oddi dysfunction (84.4% of the indomethacin group and 80.5% of the placebo group). Exclusion criteria included elevated creatinine and active peptic ulcer disease. The indomethacin or placebo suppositories were given immediately following the ERCP.

Post-ERCP pancreatitis, defined by upper abdominal pain, elevation of pancreatic enzymes, and hospitalization for at least two nights, was significantly higher in the placebo group compared with the indomethacin group (16.9% vs. 9.2%, P=0.005). Moderate or severe post-ERCP pancreatitis was significantly higher in the placebo group compared with the indomethacin group (8.8% vs. 4.4%, P=0.03).

There were no significant differences in the rates of clinically significant bleeding or acute renal failure between the two groups. The ability to generalize these findings to patients without risk factors for post-ERCP pancreatitis is not clear.

Bottom line: Rectal indomethacin decreases the rate of post-ERCP pancreatitis in patients who are at high risk for this complication.

Citation: Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012;366(15):1414-1422.

CHADS2-VASc and HAS-BLED Can Predict Thromboembolism and Bleeding Risk in Afib Patients

Clinical question: What are the risk factors for stroke/thromboembolism and bleeding from atrial fibrillation (afib), and how well do the CHADS2-VASc and HAS-BLED stroke and bleeding risk-assessment tools perform against other published stroke and bleeding risk-assessment tools (CHADS2 and HEMORR2HAGES) for patients with afib?

Background: In afib patients, the CHADS2-VASc tool might offer more comprehensive stroke assessment over the CHADS2 by identifying truly-low-risk patients with afib who might not even need antiplatelet therapy. HAS-BLED, a newer bleeding-risk-assessment tool, has been validated in previous trials and is more user-friendly than others. Use of CHADS2-VASc and HAS-BLED are recommended by the European Society of Cardiology to assess stroke and bleeding risks for patients with afib.

Study design: Prospective cohort study.

Setting: All hospitals in Sweden.

Synopsis: Investigators identified 182,678 afib patients via ICD-10 data from Sweden’s National Hospital Discharge Registry ICD-10 from 2005 to 2008. Approximately half the patients were not taking anticoagulants. Analysis assessed risk factors for stroke and bleeding and the performance of CHADS2-VASc and HAS-BLED against CHADS2 and HEMORR2HAGES stroke and bleeding risk-assessment tools.

Risk of composite thromboembolism (unspecified stroke, TIA, systemic embolism) was significantly higher in patients with increased age, peripheral arterial disease, prior myocardial infarction (MI), prior coronary artery bypass grafting (CABG), female gender, renal failure, and aspirin use, as well as hypertension, diabetes, prior thromboembolic event, or prior intracranial hemorrhage (ICH). Interestingly, a statistically increased risk was seen with aspirin use.

Conversely, history of heart failure, thyroid disease, and obesity were not associated with increased composite thromboembolic risk. The use of CHADS2-VASc was marginally better than CHADS2 in predicting stroke risk.

ICH risk was increased in patients with older age, prior ischemic stroke, prior ICH, and hypertension. Risk of composite bleeding (from ICH or other major bleeding) was significantly higher in patients with these risk factors, as well as renal failure, liver disease, anemia, dysfunctional platelets, alcohol use, and cancer. Ischemic heart disease was associated with a statistically significant lower risk of ICH, but not of composite bleeding risk.

HAS-BLED usage was as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk.

Bottom line: CHADS2-VASc might be better than CHADS2 in predicting truly-low-risk patients with nonvalvular afib; HAS-BLED is just as good as, and easier to use than, HEMORR2HAGES in predicting bleeding risk for patients with nonvalvular afib who are to receive antithrombotic therapy.

Citation: Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182,678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012;33(12):1500-10 [Epub 2012 Jan 13].

Supported Self-Management of COPD Does Not Decrease Readmission or Mortality Rates

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and death (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmission or death in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060 [Epub ahead of print].

Medicare Premier P4P Initiatives Do Not Decrease Mortality

Clinical question: Has the Medicare Premier Hospital Quality Incentive Demonstration (HQID) resulted in lower mortality?

Background: The Centers for Medicare & Medicaid Services’ (CMS) value-based purchasing program will expand to include 30-day mortality in 2013, but do pay-for-performance (P4P) initiatives result in improved mortality? Studies have demonstrated improvement in process of care but have not demonstrated mortality benefit thus far.

Study design: Cohort study.

Setting: Two hundred fifty-two hospitals participating in the Premier HQID compared with 3,363 control hospitals participating in the Hospital Compare program.

Synopsis: Researchers examined 30-day mortality for patients admitted with acute myocardial infarction, congestive heart failure, pneumonia, and for coronary artery bypass grafting (CABG) from 2003 to 2009. Results showed no difference in 30-day mortality rates over the six-year span of the program for any of the conditions studied in the Premier hospitals (participating in the voluntary pay-for-performance program) vs. non-Premier hospitals (11.82% vs. 11.74%). This held true for each condition measured individually, with a higher mortality rate for patients undergoing CABG at the Premier hospitals.

In addition, in the hospitals that underperformed initially, there was no difference with respect to rate of improvement when comparing Premier vs. non-Premier hospitals. Furthermore, mortality rate trends did not differ between those conditions that were incentivized (acute MI and CABG) compared with those that were not (congestive heart failure and pneumonia).

The authors concluded that there was “little evidence” that the Premier HQID pay-for-performance program resulted in reduced 30-day mortality.

Bottom line: Programs participating in the Medicare Premier HQID pay-for-performance program had similar 30-day mortality compared with nonparticipating programs.

Citation: Jha AK, Joynt KE, Orav EJ, Epstein AM. The long-term effect of premier pay for performance on patient outcomes. N Engl J Med. 2012;366:1606-1615.

In-Hospital Rate of DVT/PE After Hip and Knee Arthroplasty with Guideline-Recommended Prophylaxis

Clinical question: What is the rate of symptomatic DVT/PE after total or partial hip (TPHA) or knee (TPKA) arthroplasty using currently recommended prophylaxis?

Background: The rate of postoperative DVT/PE after TPHA/TPKA has dropped dramatically with use of pharmacologic prophylaxis. However, the current rate of symptomatic DVT/PE using current pharmacologic prophylaxis is not known. Such rates are needed for informed patient consent and development of patient safety benchmarks.

Study design: Systematic review.

Setting: Randomized clinical trials (RCTs) and observational studies worldwide of adult inpatients undergoing TPHA and/or TPKA from 1996 to 2011.

Synopsis: Forty-seven studies were included, of which 41 were RCTs and six were observational studies. Twenty-one studies evaluated rates after TPHA, 20 after TPKA, and six after both. More than 44,000 patients were included, with ages ranging from 58 to 74 years. The mean duration of prophylaxis was eight days, with a mean follow-up of 13 days.

In-hospital rates of symptomatic venous thromboembolism (VTE) were higher in patients undergoing TPKA than TPHA (1.09% vs. 0.53% for VTE, 0.63% vs. 0.26% for DVT, and 0.27% vs. 0.14% for PE). This is in contrast to the higher rates of VTE observed after TPHA when the post-discharge period is included. The pooled incidence of VTE was lower with use of direct inhibitors of Factors Xa or IIa when compared to low-molecular-weight heparin, although a direct efficacy comparison could not be made.

Because the majority of studies were RCTs with restrictive inclusion criteria, rates of DVT/PE in actual practice might be higher.

Bottom line: When informing patients of postoperative VTE risk, or establishing benchmarks to evaluate patient safety, one can anticipate an in-hospital VTE rate of 0.5% following TPHA and 1% following TPKA.

Citation: Januel JM, Chen G, Ruffieux C, et al. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA. 2012;307(3):294-303.

Sodium Chloride Prevents Contrast-Induced Nephropathy

Clinical question: Is sodium chloride more effective than sodium bicarbonate for preventing contrast-induced nephropathy?

Background: Contrast-induced nephropathy can be prevented with precontrast hydration. Study authors sought to compare sodium chloride administered over 24 hours with sodium bicarbonate administered over seven hours, and with sodium bicarbonate administered orally.

Study design: Randomized, open-label, controlled trial.

Setting: Three European medical centers.

Synopsis: The study examined 258 patients with an estimated glomerular filtration rate <60mL/min/1.73m2 undergoing intravenous or intra-arterial contrast procedure. Patients with Class III or IV heart failure were excluded. The remaining patients were randomized to receive one of three regimens: sodium chloride at 1 ml/kg/hr for 12 hours prior to and 12 hours following the procedure; intravenous sodium bicarbonate for one hour prior to and six hours following the procedure; or intravenous and oral sodium bicarbonate 20 minutes prior to the procedure.

The group that received saline had a lower incidence of contrast-induced nephropathy than the bicarbonate groups (1% vs. 9% vs. 10%). The oral bicarbonate strategy was noninferior to the seven-hour intravenous bicarbonate strategy.

The authors postulated that saline should be used for high-risk patients, but that given the overall low incidence of contrast-induced nephropathy, the short-term bicarbonate strategy (intravenous followed by oral) is a viable alternative for low-risk patients.

Bottom line: Sodium chloride is more effective than sodium bicarbonate for preventing contrast-induced nephropathy, but in light of the low incidence, a short course of sodium bicarbonate is a possible convenient alternative for low-risk patients.

Citation: Klima T, Christ A, Marana I, et al. Sodium chloride vs. sodium bicarbonate for the prevention of contrast medium-induced nephropathy: a randomized controlled trial. Eur Heart J. 2012 Jan 19 [Epub ahead of print].

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission rates (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and deaths (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmissions or deaths in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060.

Check out more physician reviews of HM-relevant research.

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission rates (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and deaths (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmissions or deaths in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060.

Check out more physician reviews of HM-relevant research.

Clinical question: Does supported self-management of patients with chronic obstructive pulmonary disease (COPD) decrease COPD-related hospital readmission or death?

Clinical background: Supported self-management has benefited patients with such chronic diseases as heart failure and asthma. Evidence to support such a strategy for patients with COPD is relatively lacking.

Study design: Randomized, controlled trial.

Setting: Community-based care following urban hospitalization in western Scotland.

Synopsis: From June 2007 to May 2009, and following hospitalization for COPD exacerbation, 464 patients were randomized to receive routine community-based care with or without 12 months of support and training to detect, and promptly treat, recurrent exacerbations. Independent of disease severity or demographics, investigators found no difference in combined readmission rates (48% vs. 47%, 95% confidence interval [CI] 0.80-1.38) or death (10% vs. 7%, 95% CI 0.71-2.61).

Based on review of appropriateness of self-management strategies used by the intervention group, unplanned exploratory subgroup analysis classified a minority of the intervention group as “successful” (42%) supported self-managers, and demonstrated decreased COPD readmissions and deaths (27% vs. 49%, 95% CI 0.25-0.76, P=0.003) vs. “unsuccessful” self-managers. This successful group was younger and tended to live with others. Further research to define characteristics of patients who benefit from self-management is needed.

Bottom line: Supported self-management of COPD does not reduce COPD-related readmissions or deaths in a large population.

Citation: Bucknall CE, Miller G, Lloyd SM, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012;344:e1060.

Check out more physician reviews of HM-relevant research.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

Background

Atrial fibrillation (AF) is a common condition, affecting more than 2 million Americans.¹ Hospital admissions due to AF have increased 66% in the past two decades. Hospitalization accounts for 52% of the cost of AF management, and the mortality rate of patients with this arrhythmia is twice that of patients in sinus rhythm.1

AF management decisions include choices for rate control, rhythm control, and prevention of thromboembolism. The benefits of a rhythm-control versus a rate-control strategy continue to be evaluated, along with consideration regarding an appropriate heart-rate goal. The modifiable risk factor of stroke in atrial fibrillation also continues to be a target for intervention as atrial fibrillation accounts for one-sixth of all strokes.

Guideline Update

The American College of Cardiology Foundation and American Heart Association (ACC/AHA), in conjunction with the European Society of Cardiology, released practice guidelines on the management of patients with atrial fibrillation in 2006. The ACCF/AHA, writing with the Heart Rhythm Society, released focused updates in early 2011 to be incorporated into the previous guidelines, given new data from major clinical trials and the FDA approval of new medications with indications for AF treatment.^2,3

The new recommendations address components of all three major management decisions for AF: rate control, rhythm control, and prevention of thromboembolism.

When managing AF with a rate-control strategy, new guidelines no longer recommend the goal of a resting heart rate of <80 bpm or <115 bpm with activity. This is based on data from the RACE II trial that show no difference in meaningful outcomes with a more aggressive heart-rate goal. Achieving a resting heart rate of 110 bpm was deemed a reasonable approach, as long as the patient has stable ventricular function and acceptable symptoms.

The new drug dronedarone has been introduced in the algorithm for maintenance of sinus rhythm strategy, based on the DIONYSOS, ATHENA, and ANDROMEDA studies. The new algorithm excluded the use of dronedarone in patients with left ventricular hypertrophy, decompensated heart failure, or Class IV heart failure because it was shown to increase mortality in these groups. The guidelines also recommend that it should also be used with caution in patients with bradycardia, prolonged QT interval, increased creatinine, and in patients on agents that moderate CYP3A4 function.

The risks of interventions to decrease thromboembolism against bleeding risk continue to be evaluated in specified patient populations. Although dabigatran did not have FDA approval prior to submission of the 2011 updated guidelines, the 2011 “focused update” incorporated the results of the RE-LY trial. Publication of RE-LY resulted in a Class 1 recommendation for dabigatran as a useful alternative to warfarin in patients with nonvalvular AF without severe renal failure or advanced liver disease.³ However, there is no specific antidote, and dabigatran use is associated with higher rates of dyspepsia and a nonsignificant increase in rates of myocardial infarction. In patients for whom oral anticoagulation with warfarin is considered unsuitable, aspirin with clopidogrel may be considered, although warfarin therapy continues to be a superior therapy to this dual antiplatelet regimen based on the ACTIVE-W and ACTIVE-A studies.²

Established Guideline Analysis

Apart from the listed updates, the management of AF has not changed considerably in the past decade. Rate control continues to be the recommended strategy for older patients along with appropriate symptom control, particularly if they have hypertension or heart disease. Rhythm control is a frequent strategy in AF management, but several studies have not found any difference in quality of life, development or progression of heart failure, or stroke rates in patients for whom a rhythm-control strategy was chosen.

Additionally, these patients still require anticoagulation, and the side effects of anti-arrhythmic drugs might offset the benefits of sinus rhythm. Therefore, rate control is an appropriate strategy. The stroke rate and side-effect risks with anti-arrhythmics are considerably lower in younger patients or those with paroxysmal lone AF, and so a rhythm-control strategy in these groups is reasonable.

Stroke rate in AF increases with known high-risk factors (prior thromboembolism or rheumatic mitral stenosis) and moderate-risk factors (heart failure, hypertension, age over 75, and diabetes). Less validated risk factors include female gender, age 65-74, thyrotoxicosis, and the presence of coronary artery disease.

There are well-defined recommendations for how to anticoagulate specific subgroups that pose clinical challenges not directly addressed in studies, but the guidelines do assist with:

• Patients who have a stroke with a therapeutic INR: Rather than adding antiplatelet agents, INR goal can be raised to 3-3.5;
• Patients >75 years old who are at a high risk for bleeding: A target INR of 2.0 (target range 1.6-2.5) seems reasonable;1 and
• Patients with stable coronary artery disease and AF: Warfarin anticoagulation alone should provide satisfactory antithrombotic prophylaxis against cerebrovascular and coronary atheroembolic events.¹

Decisions involving perioperative management of anticoagulation in patients with AF frequently arise. Per the guidelines, in patients with nonvalvular AF, anticoagulation can be stopped for up to one week without bridging for surgical or diagnostic procedures, but bridging should be considered in high-risk patients.

HM Takeaways

Hospitalists are likely to manage AF, whether alone or in conjunction with cardiology consultation. These new comprehensive guidelines deal with rate control, rhythm control, and prevention of thromboembolism. Hospitalists should take particular interest in the guidelines regarding lenient rate control, dronedarone for rhythm control, and dabigatran as a new alternative for anticoagulation in appropriate populations.

Drs. Farrell and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Fuster V, Rydén LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011;57(11):e101-98.
2. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (Updating the 2006 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011;8(1):157-76.
3. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2011;57(11):1330-7.

Background

Atrial fibrillation (AF) is a common condition, affecting more than 2 million Americans.¹ Hospital admissions due to AF have increased 66% in the past two decades. Hospitalization accounts for 52% of the cost of AF management, and the mortality rate of patients with this arrhythmia is twice that of patients in sinus rhythm.1

AF management decisions include choices for rate control, rhythm control, and prevention of thromboembolism. The benefits of a rhythm-control versus a rate-control strategy continue to be evaluated, along with consideration regarding an appropriate heart-rate goal. The modifiable risk factor of stroke in atrial fibrillation also continues to be a target for intervention as atrial fibrillation accounts for one-sixth of all strokes.

Guideline Update

The American College of Cardiology Foundation and American Heart Association (ACC/AHA), in conjunction with the European Society of Cardiology, released practice guidelines on the management of patients with atrial fibrillation in 2006. The ACCF/AHA, writing with the Heart Rhythm Society, released focused updates in early 2011 to be incorporated into the previous guidelines, given new data from major clinical trials and the FDA approval of new medications with indications for AF treatment.^2,3

The new recommendations address components of all three major management decisions for AF: rate control, rhythm control, and prevention of thromboembolism.

When managing AF with a rate-control strategy, new guidelines no longer recommend the goal of a resting heart rate of <80 bpm or <115 bpm with activity. This is based on data from the RACE II trial that show no difference in meaningful outcomes with a more aggressive heart-rate goal. Achieving a resting heart rate of 110 bpm was deemed a reasonable approach, as long as the patient has stable ventricular function and acceptable symptoms.

The new drug dronedarone has been introduced in the algorithm for maintenance of sinus rhythm strategy, based on the DIONYSOS, ATHENA, and ANDROMEDA studies. The new algorithm excluded the use of dronedarone in patients with left ventricular hypertrophy, decompensated heart failure, or Class IV heart failure because it was shown to increase mortality in these groups. The guidelines also recommend that it should also be used with caution in patients with bradycardia, prolonged QT interval, increased creatinine, and in patients on agents that moderate CYP3A4 function.

The risks of interventions to decrease thromboembolism against bleeding risk continue to be evaluated in specified patient populations. Although dabigatran did not have FDA approval prior to submission of the 2011 updated guidelines, the 2011 “focused update” incorporated the results of the RE-LY trial. Publication of RE-LY resulted in a Class 1 recommendation for dabigatran as a useful alternative to warfarin in patients with nonvalvular AF without severe renal failure or advanced liver disease.³ However, there is no specific antidote, and dabigatran use is associated with higher rates of dyspepsia and a nonsignificant increase in rates of myocardial infarction. In patients for whom oral anticoagulation with warfarin is considered unsuitable, aspirin with clopidogrel may be considered, although warfarin therapy continues to be a superior therapy to this dual antiplatelet regimen based on the ACTIVE-W and ACTIVE-A studies.²

Established Guideline Analysis

Apart from the listed updates, the management of AF has not changed considerably in the past decade. Rate control continues to be the recommended strategy for older patients along with appropriate symptom control, particularly if they have hypertension or heart disease. Rhythm control is a frequent strategy in AF management, but several studies have not found any difference in quality of life, development or progression of heart failure, or stroke rates in patients for whom a rhythm-control strategy was chosen.

Additionally, these patients still require anticoagulation, and the side effects of anti-arrhythmic drugs might offset the benefits of sinus rhythm. Therefore, rate control is an appropriate strategy. The stroke rate and side-effect risks with anti-arrhythmics are considerably lower in younger patients or those with paroxysmal lone AF, and so a rhythm-control strategy in these groups is reasonable.

Stroke rate in AF increases with known high-risk factors (prior thromboembolism or rheumatic mitral stenosis) and moderate-risk factors (heart failure, hypertension, age over 75, and diabetes). Less validated risk factors include female gender, age 65-74, thyrotoxicosis, and the presence of coronary artery disease.

There are well-defined recommendations for how to anticoagulate specific subgroups that pose clinical challenges not directly addressed in studies, but the guidelines do assist with:

• Patients who have a stroke with a therapeutic INR: Rather than adding antiplatelet agents, INR goal can be raised to 3-3.5;
• Patients >75 years old who are at a high risk for bleeding: A target INR of 2.0 (target range 1.6-2.5) seems reasonable;1 and
• Patients with stable coronary artery disease and AF: Warfarin anticoagulation alone should provide satisfactory antithrombotic prophylaxis against cerebrovascular and coronary atheroembolic events.¹

Decisions involving perioperative management of anticoagulation in patients with AF frequently arise. Per the guidelines, in patients with nonvalvular AF, anticoagulation can be stopped for up to one week without bridging for surgical or diagnostic procedures, but bridging should be considered in high-risk patients.

HM Takeaways

Hospitalists are likely to manage AF, whether alone or in conjunction with cardiology consultation. These new comprehensive guidelines deal with rate control, rhythm control, and prevention of thromboembolism. Hospitalists should take particular interest in the guidelines regarding lenient rate control, dronedarone for rhythm control, and dabigatran as a new alternative for anticoagulation in appropriate populations.

Drs. Farrell and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Fuster V, Rydén LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011;57(11):e101-98.
2. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (Updating the 2006 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011;8(1):157-76.
3. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2011;57(11):1330-7.

Background

Atrial fibrillation (AF) is a common condition, affecting more than 2 million Americans.¹ Hospital admissions due to AF have increased 66% in the past two decades. Hospitalization accounts for 52% of the cost of AF management, and the mortality rate of patients with this arrhythmia is twice that of patients in sinus rhythm.1

AF management decisions include choices for rate control, rhythm control, and prevention of thromboembolism. The benefits of a rhythm-control versus a rate-control strategy continue to be evaluated, along with consideration regarding an appropriate heart-rate goal. The modifiable risk factor of stroke in atrial fibrillation also continues to be a target for intervention as atrial fibrillation accounts for one-sixth of all strokes.

Guideline Update

The American College of Cardiology Foundation and American Heart Association (ACC/AHA), in conjunction with the European Society of Cardiology, released practice guidelines on the management of patients with atrial fibrillation in 2006. The ACCF/AHA, writing with the Heart Rhythm Society, released focused updates in early 2011 to be incorporated into the previous guidelines, given new data from major clinical trials and the FDA approval of new medications with indications for AF treatment.^2,3

The new recommendations address components of all three major management decisions for AF: rate control, rhythm control, and prevention of thromboembolism.

When managing AF with a rate-control strategy, new guidelines no longer recommend the goal of a resting heart rate of <80 bpm or <115 bpm with activity. This is based on data from the RACE II trial that show no difference in meaningful outcomes with a more aggressive heart-rate goal. Achieving a resting heart rate of 110 bpm was deemed a reasonable approach, as long as the patient has stable ventricular function and acceptable symptoms.

The new drug dronedarone has been introduced in the algorithm for maintenance of sinus rhythm strategy, based on the DIONYSOS, ATHENA, and ANDROMEDA studies. The new algorithm excluded the use of dronedarone in patients with left ventricular hypertrophy, decompensated heart failure, or Class IV heart failure because it was shown to increase mortality in these groups. The guidelines also recommend that it should also be used with caution in patients with bradycardia, prolonged QT interval, increased creatinine, and in patients on agents that moderate CYP3A4 function.

The risks of interventions to decrease thromboembolism against bleeding risk continue to be evaluated in specified patient populations. Although dabigatran did not have FDA approval prior to submission of the 2011 updated guidelines, the 2011 “focused update” incorporated the results of the RE-LY trial. Publication of RE-LY resulted in a Class 1 recommendation for dabigatran as a useful alternative to warfarin in patients with nonvalvular AF without severe renal failure or advanced liver disease.³ However, there is no specific antidote, and dabigatran use is associated with higher rates of dyspepsia and a nonsignificant increase in rates of myocardial infarction. In patients for whom oral anticoagulation with warfarin is considered unsuitable, aspirin with clopidogrel may be considered, although warfarin therapy continues to be a superior therapy to this dual antiplatelet regimen based on the ACTIVE-W and ACTIVE-A studies.²

Established Guideline Analysis

Apart from the listed updates, the management of AF has not changed considerably in the past decade. Rate control continues to be the recommended strategy for older patients along with appropriate symptom control, particularly if they have hypertension or heart disease. Rhythm control is a frequent strategy in AF management, but several studies have not found any difference in quality of life, development or progression of heart failure, or stroke rates in patients for whom a rhythm-control strategy was chosen.

Additionally, these patients still require anticoagulation, and the side effects of anti-arrhythmic drugs might offset the benefits of sinus rhythm. Therefore, rate control is an appropriate strategy. The stroke rate and side-effect risks with anti-arrhythmics are considerably lower in younger patients or those with paroxysmal lone AF, and so a rhythm-control strategy in these groups is reasonable.

Stroke rate in AF increases with known high-risk factors (prior thromboembolism or rheumatic mitral stenosis) and moderate-risk factors (heart failure, hypertension, age over 75, and diabetes). Less validated risk factors include female gender, age 65-74, thyrotoxicosis, and the presence of coronary artery disease.

There are well-defined recommendations for how to anticoagulate specific subgroups that pose clinical challenges not directly addressed in studies, but the guidelines do assist with:

• Patients who have a stroke with a therapeutic INR: Rather than adding antiplatelet agents, INR goal can be raised to 3-3.5;
• Patients >75 years old who are at a high risk for bleeding: A target INR of 2.0 (target range 1.6-2.5) seems reasonable;1 and
• Patients with stable coronary artery disease and AF: Warfarin anticoagulation alone should provide satisfactory antithrombotic prophylaxis against cerebrovascular and coronary atheroembolic events.¹

Decisions involving perioperative management of anticoagulation in patients with AF frequently arise. Per the guidelines, in patients with nonvalvular AF, anticoagulation can be stopped for up to one week without bridging for surgical or diagnostic procedures, but bridging should be considered in high-risk patients.

HM Takeaways

Hospitalists are likely to manage AF, whether alone or in conjunction with cardiology consultation. These new comprehensive guidelines deal with rate control, rhythm control, and prevention of thromboembolism. Hospitalists should take particular interest in the guidelines regarding lenient rate control, dronedarone for rhythm control, and dabigatran as a new alternative for anticoagulation in appropriate populations.

Drs. Farrell and Carbo are hospitalists at Beth Israel Deaconess Medical Center in Boston.

References

1. Fuster V, Rydén LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011;57(11):e101-98.
2. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (Updating the 2006 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011;8(1):157-76.
3. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2011;57(11):1330-7.