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Clinical question: Does palliative chemotherapy improve quality of life (QOL) in patients with end-stage cancer, regardless of performance status?

Background: There is continued debate about the benefit of palliative chemotherapy at the end of life. Guidelines recommend a good performance score as an indicator of appropriate use of therapy; however, little is known about the benefits and harms of chemotherapy in metastatic cancer patients stratified by performance status.

Study design: Longitudinal, prospective cohort study.

Setting: Multi-institutional in the United States.

Synopsis: Five U.S. institutions enrolled 661 patients with metastatic cancer and estimated life expectancy less than six months; 312 patients who died during the study period were included in the final analysis of postmortem questionnaires of caretakers regarding QOL in the patients’ last week of life. Contrary to current thought, the study demonstrated that patients undergoing end-of-life palliative chemotherapy with good ECOG performance status (0-1) had significantly worse QOL than those avoiding palliative chemotherapy. There was no difference in QOL in patients with worse performance status (ECOG 2-3).

This study is one of the first prospective investigations of this topic and makes a compelling case for withholding palliative chemotherapy at the end of life regardless of performance status. The study is somewhat limited in that the QOL measurement is only for the last week of life and the patients were not randomized into the chemotherapy arm, which could bias results.

Bottom line: Palliative chemotherapy does not improve QOL near death, and may actually worsen QOL in patients with good performance status.

Citation: Prigerson HG, Bao Y, Shah MA, et al. Chemotherapy use, performance status, and quality of life at the end of life. JAMA Oncol. 2015;1(6):778-784.

Clinical question: Does palliative chemotherapy improve quality of life (QOL) in patients with end-stage cancer, regardless of performance status?

Background: There is continued debate about the benefit of palliative chemotherapy at the end of life. Guidelines recommend a good performance score as an indicator of appropriate use of therapy; however, little is known about the benefits and harms of chemotherapy in metastatic cancer patients stratified by performance status.

Study design: Longitudinal, prospective cohort study.

Setting: Multi-institutional in the United States.

Synopsis: Five U.S. institutions enrolled 661 patients with metastatic cancer and estimated life expectancy less than six months; 312 patients who died during the study period were included in the final analysis of postmortem questionnaires of caretakers regarding QOL in the patients’ last week of life. Contrary to current thought, the study demonstrated that patients undergoing end-of-life palliative chemotherapy with good ECOG performance status (0-1) had significantly worse QOL than those avoiding palliative chemotherapy. There was no difference in QOL in patients with worse performance status (ECOG 2-3).

This study is one of the first prospective investigations of this topic and makes a compelling case for withholding palliative chemotherapy at the end of life regardless of performance status. The study is somewhat limited in that the QOL measurement is only for the last week of life and the patients were not randomized into the chemotherapy arm, which could bias results.

Bottom line: Palliative chemotherapy does not improve QOL near death, and may actually worsen QOL in patients with good performance status.

Citation: Prigerson HG, Bao Y, Shah MA, et al. Chemotherapy use, performance status, and quality of life at the end of life. JAMA Oncol. 2015;1(6):778-784.

Clinical question: Does palliative chemotherapy improve quality of life (QOL) in patients with end-stage cancer, regardless of performance status?

Background: There is continued debate about the benefit of palliative chemotherapy at the end of life. Guidelines recommend a good performance score as an indicator of appropriate use of therapy; however, little is known about the benefits and harms of chemotherapy in metastatic cancer patients stratified by performance status.

Study design: Longitudinal, prospective cohort study.

Setting: Multi-institutional in the United States.

Synopsis: Five U.S. institutions enrolled 661 patients with metastatic cancer and estimated life expectancy less than six months; 312 patients who died during the study period were included in the final analysis of postmortem questionnaires of caretakers regarding QOL in the patients’ last week of life. Contrary to current thought, the study demonstrated that patients undergoing end-of-life palliative chemotherapy with good ECOG performance status (0-1) had significantly worse QOL than those avoiding palliative chemotherapy. There was no difference in QOL in patients with worse performance status (ECOG 2-3).

This study is one of the first prospective investigations of this topic and makes a compelling case for withholding palliative chemotherapy at the end of life regardless of performance status. The study is somewhat limited in that the QOL measurement is only for the last week of life and the patients were not randomized into the chemotherapy arm, which could bias results.

Bottom line: Palliative chemotherapy does not improve QOL near death, and may actually worsen QOL in patients with good performance status.

Citation: Prigerson HG, Bao Y, Shah MA, et al. Chemotherapy use, performance status, and quality of life at the end of life. JAMA Oncol. 2015;1(6):778-784.

Clinical question: Does the use of sliding-scale insulin improve blood glucose control in hospitalized patients?

Bottom line: Sliding-scale insulin is commonly used to manage hyperglycemia in hospitalized patients. The evidence suggests that this regimen does not result in better blood glucose control. (LOE = 1a-)

Reference: Lee Y, Lin Y, Leu W et al. Sliding-scale insulin used for blood glucose control: a meta-analysis of randomized controlled trials. Metabolism 2015;64:1183-1192.

Study design: Meta-analysis (randomized controlled trials)

Funding source: Government

Allocation: Uncertain

Setting: Inpatient (any location)

Synopsis: These investigators searched multiple databases including PubMed, EMBASE, and the Cochrane Library to find randomized controlled trials that evaluated the efficacy of sliding-scale insulin to manage hyperglycemia in hospitalized patients. Two authors independently evaluated the studies for inclusion, extracted the data, and performed quality assessments.

Eight of the 11 included studies compared regular insulin sliding scale (RISS) regimens with non–sliding-scale regimens. All RISS regimens consisted of subcutaneous regular insulin injections according to patients' blood glucose levels. Non–sliding-scale regimens consisted of basal-bolus or basal insulin regimens, continuous intravenous insulin infusions, and closed-loop artificial pancreas systems. Target blood glucose levels for individual studies varied greatly and included a range of 100 mg/dL to 150 mg/dL, a goal of less than 140 mg/dL, and a goal of less than 180 mg/dL. Hypoglycemia was generally defined as a glucose level of less than 70 mg/dL, though three of the studies had an even lower cut-off.

In the two studies that evaluated hyperglycemia, one defined it as a glucose level greater than 180 mg/dL while the other defined it as greater than 240 mg/dL. A meta-analysis of relevant data showed no significant difference in the percentage of patients who achieved an average blood glucose level in the target range when comparing RISS with non–sliding-scale regimens. The trend, however, favored the non–sliding-scale group and the difference became significant (relative risk 1.48, 95% CI 1.09-2.02) after one study with a very wide confidence interval was removed. Furthermore, the incidence of hyperglycemia and the mean blood glucose levels were significantly higher in the RISS group.

Although overall hypoglycemic episodes occurred more frequently in the non–sliding-scale group, there was no significant difference detected in the incidence of severe or symptomatic hypoglycemia. Length of hospital stay was also similar in both groups. Finally, one study compared the use of routine diabetes medications plus RISS with routine diabetes medications alone and found no difference in the number of hypoglycemic or hyperglycemic events.

Significant heterogeneity was detected in the results of this meta-analysis and can be attributed to the differing patient populations, insulin regimens, and working definitions in the individual studies as noted above.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Does the use of sliding-scale insulin improve blood glucose control in hospitalized patients?

Bottom line: Sliding-scale insulin is commonly used to manage hyperglycemia in hospitalized patients. The evidence suggests that this regimen does not result in better blood glucose control. (LOE = 1a-)

Reference: Lee Y, Lin Y, Leu W et al. Sliding-scale insulin used for blood glucose control: a meta-analysis of randomized controlled trials. Metabolism 2015;64:1183-1192.

Study design: Meta-analysis (randomized controlled trials)

Funding source: Government

Allocation: Uncertain

Setting: Inpatient (any location)

Synopsis: These investigators searched multiple databases including PubMed, EMBASE, and the Cochrane Library to find randomized controlled trials that evaluated the efficacy of sliding-scale insulin to manage hyperglycemia in hospitalized patients. Two authors independently evaluated the studies for inclusion, extracted the data, and performed quality assessments.

Eight of the 11 included studies compared regular insulin sliding scale (RISS) regimens with non–sliding-scale regimens. All RISS regimens consisted of subcutaneous regular insulin injections according to patients' blood glucose levels. Non–sliding-scale regimens consisted of basal-bolus or basal insulin regimens, continuous intravenous insulin infusions, and closed-loop artificial pancreas systems. Target blood glucose levels for individual studies varied greatly and included a range of 100 mg/dL to 150 mg/dL, a goal of less than 140 mg/dL, and a goal of less than 180 mg/dL. Hypoglycemia was generally defined as a glucose level of less than 70 mg/dL, though three of the studies had an even lower cut-off.

In the two studies that evaluated hyperglycemia, one defined it as a glucose level greater than 180 mg/dL while the other defined it as greater than 240 mg/dL. A meta-analysis of relevant data showed no significant difference in the percentage of patients who achieved an average blood glucose level in the target range when comparing RISS with non–sliding-scale regimens. The trend, however, favored the non–sliding-scale group and the difference became significant (relative risk 1.48, 95% CI 1.09-2.02) after one study with a very wide confidence interval was removed. Furthermore, the incidence of hyperglycemia and the mean blood glucose levels were significantly higher in the RISS group.

Although overall hypoglycemic episodes occurred more frequently in the non–sliding-scale group, there was no significant difference detected in the incidence of severe or symptomatic hypoglycemia. Length of hospital stay was also similar in both groups. Finally, one study compared the use of routine diabetes medications plus RISS with routine diabetes medications alone and found no difference in the number of hypoglycemic or hyperglycemic events.

Significant heterogeneity was detected in the results of this meta-analysis and can be attributed to the differing patient populations, insulin regimens, and working definitions in the individual studies as noted above.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Does the use of sliding-scale insulin improve blood glucose control in hospitalized patients?

Bottom line: Sliding-scale insulin is commonly used to manage hyperglycemia in hospitalized patients. The evidence suggests that this regimen does not result in better blood glucose control. (LOE = 1a-)

Reference: Lee Y, Lin Y, Leu W et al. Sliding-scale insulin used for blood glucose control: a meta-analysis of randomized controlled trials. Metabolism 2015;64:1183-1192.

Study design: Meta-analysis (randomized controlled trials)

Funding source: Government

Allocation: Uncertain

Setting: Inpatient (any location)

Synopsis: These investigators searched multiple databases including PubMed, EMBASE, and the Cochrane Library to find randomized controlled trials that evaluated the efficacy of sliding-scale insulin to manage hyperglycemia in hospitalized patients. Two authors independently evaluated the studies for inclusion, extracted the data, and performed quality assessments.

Eight of the 11 included studies compared regular insulin sliding scale (RISS) regimens with non–sliding-scale regimens. All RISS regimens consisted of subcutaneous regular insulin injections according to patients' blood glucose levels. Non–sliding-scale regimens consisted of basal-bolus or basal insulin regimens, continuous intravenous insulin infusions, and closed-loop artificial pancreas systems. Target blood glucose levels for individual studies varied greatly and included a range of 100 mg/dL to 150 mg/dL, a goal of less than 140 mg/dL, and a goal of less than 180 mg/dL. Hypoglycemia was generally defined as a glucose level of less than 70 mg/dL, though three of the studies had an even lower cut-off.

In the two studies that evaluated hyperglycemia, one defined it as a glucose level greater than 180 mg/dL while the other defined it as greater than 240 mg/dL. A meta-analysis of relevant data showed no significant difference in the percentage of patients who achieved an average blood glucose level in the target range when comparing RISS with non–sliding-scale regimens. The trend, however, favored the non–sliding-scale group and the difference became significant (relative risk 1.48, 95% CI 1.09-2.02) after one study with a very wide confidence interval was removed. Furthermore, the incidence of hyperglycemia and the mean blood glucose levels were significantly higher in the RISS group.

Although overall hypoglycemic episodes occurred more frequently in the non–sliding-scale group, there was no significant difference detected in the incidence of severe or symptomatic hypoglycemia. Length of hospital stay was also similar in both groups. Finally, one study compared the use of routine diabetes medications plus RISS with routine diabetes medications alone and found no difference in the number of hypoglycemic or hyperglycemic events.

Significant heterogeneity was detected in the results of this meta-analysis and can be attributed to the differing patient populations, insulin regimens, and working definitions in the individual studies as noted above.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Which insertion site for central venous catheterization results in fewer complications?

Bottom line: Central venous catheterization via a subclavian insertion site, as compared with femoral and jugular sites, decreases the risk of bloodstream infections and symptomatic deep vein thromboses (DVTs), but results in more pneumothoraces. This risk could potentially be mitigated with the use of ultrasound guidance during catheter insertion. ((LOE = 1b)

Reference: Parienti JJ, Mongardon N, Mégarbane B, et al. Intravascular complications of central venous catheterization by insertion site. N Engl J Med 2015;373(13):1220-1229.

Study design: Randomized controlled trial (nonblinded)

Funding source: Government

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis

These investigators randomized 3027 patients in the intensive care unit who required nontunneled central venous access to receive 3471 intravenous catheters at one of three insertion sites: subclavian, jugular, or femoral. The catheters were placed by residents or staff physicians who had prior experience in the procedure. All patients had peripheral blood cultures and catheter tip cultures sent at the time of catheter removal. Patients also underwent compression ultrasonography at the insertion site within two days of catheter removal to assess for DVT. The three groups were well-balanced at baseline and the median duration of catheter use was five days. Analysis was by intention to treat.

The primary composite endpoint of catheter-related bloodstream infections and symptomatic DVTs occurred less frequently in the subclavian group than in the other two groups (1.5 events per 1000 catheter-days in the subclavian group, 3.6 in the jugular group, 4.6 in the femoral group). The risk of this outcome was greater in both the femoral and jugular groups when compared directly with the subclavian group (femoral vs subclavian: hazard ratio [HR] = 3.5; 95% CI 1.5-7.8; P = .003; femoral vs jugular: HR = 2.1; 1.0-4.3; P = .04). The subclavian group, however, did have the highest risk of mechanical complications, mainly pneumothoraces.

When all three bad outcomes (infections, DVTs, mechanical complications) are pooled together, the differences between the three groups are not as compelling (percentage of catheters with overall complications: 3.1% subclavian, 3.7% jugular, 3.4% femoral).

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Which insertion site for central venous catheterization results in fewer complications?

Bottom line: Central venous catheterization via a subclavian insertion site, as compared with femoral and jugular sites, decreases the risk of bloodstream infections and symptomatic deep vein thromboses (DVTs), but results in more pneumothoraces. This risk could potentially be mitigated with the use of ultrasound guidance during catheter insertion. ((LOE = 1b)

Reference: Parienti JJ, Mongardon N, Mégarbane B, et al. Intravascular complications of central venous catheterization by insertion site. N Engl J Med 2015;373(13):1220-1229.

Study design: Randomized controlled trial (nonblinded)

Funding source: Government

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis

These investigators randomized 3027 patients in the intensive care unit who required nontunneled central venous access to receive 3471 intravenous catheters at one of three insertion sites: subclavian, jugular, or femoral. The catheters were placed by residents or staff physicians who had prior experience in the procedure. All patients had peripheral blood cultures and catheter tip cultures sent at the time of catheter removal. Patients also underwent compression ultrasonography at the insertion site within two days of catheter removal to assess for DVT. The three groups were well-balanced at baseline and the median duration of catheter use was five days. Analysis was by intention to treat.

The primary composite endpoint of catheter-related bloodstream infections and symptomatic DVTs occurred less frequently in the subclavian group than in the other two groups (1.5 events per 1000 catheter-days in the subclavian group, 3.6 in the jugular group, 4.6 in the femoral group). The risk of this outcome was greater in both the femoral and jugular groups when compared directly with the subclavian group (femoral vs subclavian: hazard ratio [HR] = 3.5; 95% CI 1.5-7.8; P = .003; femoral vs jugular: HR = 2.1; 1.0-4.3; P = .04). The subclavian group, however, did have the highest risk of mechanical complications, mainly pneumothoraces.

When all three bad outcomes (infections, DVTs, mechanical complications) are pooled together, the differences between the three groups are not as compelling (percentage of catheters with overall complications: 3.1% subclavian, 3.7% jugular, 3.4% femoral).

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Which insertion site for central venous catheterization results in fewer complications?

Bottom line: Central venous catheterization via a subclavian insertion site, as compared with femoral and jugular sites, decreases the risk of bloodstream infections and symptomatic deep vein thromboses (DVTs), but results in more pneumothoraces. This risk could potentially be mitigated with the use of ultrasound guidance during catheter insertion. ((LOE = 1b)

Reference: Parienti JJ, Mongardon N, Mégarbane B, et al. Intravascular complications of central venous catheterization by insertion site. N Engl J Med 2015;373(13):1220-1229.

Study design: Randomized controlled trial (nonblinded)

Funding source: Government

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis

These investigators randomized 3027 patients in the intensive care unit who required nontunneled central venous access to receive 3471 intravenous catheters at one of three insertion sites: subclavian, jugular, or femoral. The catheters were placed by residents or staff physicians who had prior experience in the procedure. All patients had peripheral blood cultures and catheter tip cultures sent at the time of catheter removal. Patients also underwent compression ultrasonography at the insertion site within two days of catheter removal to assess for DVT. The three groups were well-balanced at baseline and the median duration of catheter use was five days. Analysis was by intention to treat.

The primary composite endpoint of catheter-related bloodstream infections and symptomatic DVTs occurred less frequently in the subclavian group than in the other two groups (1.5 events per 1000 catheter-days in the subclavian group, 3.6 in the jugular group, 4.6 in the femoral group). The risk of this outcome was greater in both the femoral and jugular groups when compared directly with the subclavian group (femoral vs subclavian: hazard ratio [HR] = 3.5; 95% CI 1.5-7.8; P = .003; femoral vs jugular: HR = 2.1; 1.0-4.3; P = .04). The subclavian group, however, did have the highest risk of mechanical complications, mainly pneumothoraces.

When all three bad outcomes (infections, DVTs, mechanical complications) are pooled together, the differences between the three groups are not as compelling (percentage of catheters with overall complications: 3.1% subclavian, 3.7% jugular, 3.4% femoral).

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

On November 13, the Centers for Medicare & Medicaid Services (CMS) is scheduled to publish its final OPPS rule for 2016. One of the biggest impacts for hospitalists is the update to the two-midnight rule. Here are six areas of interest to hospitalists:

1. The two-midnight rule became effective just over two years ago, on October 1, 2013. The purpose of the rule is to define which Medicare beneficiary hospital stays are appropriate for Medicare Part A payment.

2. The original rule stated that if the physician (or other practitioner) expects the patient to stay for fewer than two midnights, then the services should be billed as outpatient (Medicare Part B), and not inpatient.

3. In the first two years of this rule, the only exception was for those diagnoses that CMS designates as “inpatient only.”

4. The new rule modifies the exceptions to the two-midnight rule. Under the new rule, the exception can now be determined by the physician (or other practitioner) on a “case-by-case basis.” Every case can still be subjected to medical review.

5. Another change is that short stays will no longer be reviewed by Medicare administrative contractors or recovery audit contractors, which are usually funded on a contingency basis. Under the updated rule, the quality improvement organization contractors will review short inpatient stays. This went into effect on October 1, 2015.

6. Additionally, the new rule does state “we [CMS] continue to expect that stays under 24 hours would rarely qualify for an exception to the two-midnight benchmark.”

On November 13, the Centers for Medicare & Medicaid Services (CMS) is scheduled to publish its final OPPS rule for 2016. One of the biggest impacts for hospitalists is the update to the two-midnight rule. Here are six areas of interest to hospitalists:

1. The two-midnight rule became effective just over two years ago, on October 1, 2013. The purpose of the rule is to define which Medicare beneficiary hospital stays are appropriate for Medicare Part A payment.

2. The original rule stated that if the physician (or other practitioner) expects the patient to stay for fewer than two midnights, then the services should be billed as outpatient (Medicare Part B), and not inpatient.

3. In the first two years of this rule, the only exception was for those diagnoses that CMS designates as “inpatient only.”

4. The new rule modifies the exceptions to the two-midnight rule. Under the new rule, the exception can now be determined by the physician (or other practitioner) on a “case-by-case basis.” Every case can still be subjected to medical review.

5. Another change is that short stays will no longer be reviewed by Medicare administrative contractors or recovery audit contractors, which are usually funded on a contingency basis. Under the updated rule, the quality improvement organization contractors will review short inpatient stays. This went into effect on October 1, 2015.

6. Additionally, the new rule does state “we [CMS] continue to expect that stays under 24 hours would rarely qualify for an exception to the two-midnight benchmark.”

On November 13, the Centers for Medicare & Medicaid Services (CMS) is scheduled to publish its final OPPS rule for 2016. One of the biggest impacts for hospitalists is the update to the two-midnight rule. Here are six areas of interest to hospitalists:

1. The two-midnight rule became effective just over two years ago, on October 1, 2013. The purpose of the rule is to define which Medicare beneficiary hospital stays are appropriate for Medicare Part A payment.

2. The original rule stated that if the physician (or other practitioner) expects the patient to stay for fewer than two midnights, then the services should be billed as outpatient (Medicare Part B), and not inpatient.

3. In the first two years of this rule, the only exception was for those diagnoses that CMS designates as “inpatient only.”

4. The new rule modifies the exceptions to the two-midnight rule. Under the new rule, the exception can now be determined by the physician (or other practitioner) on a “case-by-case basis.” Every case can still be subjected to medical review.

5. Another change is that short stays will no longer be reviewed by Medicare administrative contractors or recovery audit contractors, which are usually funded on a contingency basis. Under the updated rule, the quality improvement organization contractors will review short inpatient stays. This went into effect on October 1, 2015.

6. Additionally, the new rule does state “we [CMS] continue to expect that stays under 24 hours would rarely qualify for an exception to the two-midnight benchmark.”

When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.

"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.

Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.

"Providers often are reluctant to communicate grim news, as anyone would be," she said.

The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.

Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.

The patients also described their relationship with their doctors.

Half of the patients survived for less than six months after the study began.

About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.

Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.

Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.

Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.

Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.

"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.

"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.

Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.

"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."

When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.

"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.

Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.

"Providers often are reluctant to communicate grim news, as anyone would be," she said.

The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.

Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.

The patients also described their relationship with their doctors.

Half of the patients survived for less than six months after the study began.

About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.

Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.

Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.

Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.

Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.

"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.

"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.

Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.

"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."

When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.

"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.

Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.

"Providers often are reluctant to communicate grim news, as anyone would be," she said.

The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.

Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.

The patients also described their relationship with their doctors.

Half of the patients survived for less than six months after the study began.

About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.

Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.

Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.

Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.

Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.

"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.

"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.

Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.

"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."

NEW YORK  - People with long-term exposure to loud noise at work or in leisure activities may be at increased risk of heart disease, a U.S. study finds.

Researchers found the strongest link in working-age people with high-frequency hearing loss, which is typically the result of chronic noise exposure.

"Compared with people with normal high-frequency hearing, people with bilateral high-frequency hearing loss were approximately two times more likely to have coronary heart disease," Dr. Wen Qi Gan of the University of Kentucky College of Public Health in Lexington, said by email.

Past research has already linked noise exposure, especially in workplaces, to coronary heart disease, hypertension, and other illnesses, Dr. Gan and his colleagues noted online September 15 in Occupational and Environmental Medicine. But many of these studies lacked individual information about actual noise exposure, relying instead on average decibel levels in the person's environment.

High-frequency hearing loss, the researchers wrote, is a better indicator of exposure to loud noise over time. To investigate the connection with heart disease, the researchers looked at data on 5223 individuals, ages 20 to 69, who participated in national health surveys between 1999 and 2004.

Overall, people with bilateral high-frequency hearing loss were about twice as likely to have coronary heart disease compared to those with normal high-frequency hearing. Among those age 50 and under, who were also most likely to be exposed to loud noise at work, the heart disease risk was increased four-fold.

There was no link to heart disease among people with one-sided hearing loss or loss of lower-frequency hearing, the study team noted, further supporting the idea that noise exposure is the culprit.

The study only looked at people at one time point, however, and cannot prove that noise or hearing loss are direct causes of heart disease. The researchers also acknowledged that they relied on study participants' own recollections about their work and leisure-time noise exposure.

Nonetheless, Dr. Gan said, accumulating evidence suggests that exposure to loud noise can increase the risk of coronary heart disease.

NEW YORK  - People with long-term exposure to loud noise at work or in leisure activities may be at increased risk of heart disease, a U.S. study finds.

Researchers found the strongest link in working-age people with high-frequency hearing loss, which is typically the result of chronic noise exposure.

"Compared with people with normal high-frequency hearing, people with bilateral high-frequency hearing loss were approximately two times more likely to have coronary heart disease," Dr. Wen Qi Gan of the University of Kentucky College of Public Health in Lexington, said by email.

Past research has already linked noise exposure, especially in workplaces, to coronary heart disease, hypertension, and other illnesses, Dr. Gan and his colleagues noted online September 15 in Occupational and Environmental Medicine. But many of these studies lacked individual information about actual noise exposure, relying instead on average decibel levels in the person's environment.

High-frequency hearing loss, the researchers wrote, is a better indicator of exposure to loud noise over time. To investigate the connection with heart disease, the researchers looked at data on 5223 individuals, ages 20 to 69, who participated in national health surveys between 1999 and 2004.

Overall, people with bilateral high-frequency hearing loss were about twice as likely to have coronary heart disease compared to those with normal high-frequency hearing. Among those age 50 and under, who were also most likely to be exposed to loud noise at work, the heart disease risk was increased four-fold.

There was no link to heart disease among people with one-sided hearing loss or loss of lower-frequency hearing, the study team noted, further supporting the idea that noise exposure is the culprit.

The study only looked at people at one time point, however, and cannot prove that noise or hearing loss are direct causes of heart disease. The researchers also acknowledged that they relied on study participants' own recollections about their work and leisure-time noise exposure.

Nonetheless, Dr. Gan said, accumulating evidence suggests that exposure to loud noise can increase the risk of coronary heart disease.

NEW YORK  - People with long-term exposure to loud noise at work or in leisure activities may be at increased risk of heart disease, a U.S. study finds.

Researchers found the strongest link in working-age people with high-frequency hearing loss, which is typically the result of chronic noise exposure.

"Compared with people with normal high-frequency hearing, people with bilateral high-frequency hearing loss were approximately two times more likely to have coronary heart disease," Dr. Wen Qi Gan of the University of Kentucky College of Public Health in Lexington, said by email.

Past research has already linked noise exposure, especially in workplaces, to coronary heart disease, hypertension, and other illnesses, Dr. Gan and his colleagues noted online September 15 in Occupational and Environmental Medicine. But many of these studies lacked individual information about actual noise exposure, relying instead on average decibel levels in the person's environment.

High-frequency hearing loss, the researchers wrote, is a better indicator of exposure to loud noise over time. To investigate the connection with heart disease, the researchers looked at data on 5223 individuals, ages 20 to 69, who participated in national health surveys between 1999 and 2004.

Overall, people with bilateral high-frequency hearing loss were about twice as likely to have coronary heart disease compared to those with normal high-frequency hearing. Among those age 50 and under, who were also most likely to be exposed to loud noise at work, the heart disease risk was increased four-fold.

There was no link to heart disease among people with one-sided hearing loss or loss of lower-frequency hearing, the study team noted, further supporting the idea that noise exposure is the culprit.

The study only looked at people at one time point, however, and cannot prove that noise or hearing loss are direct causes of heart disease. The researchers also acknowledged that they relied on study participants' own recollections about their work and leisure-time noise exposure.

Nonetheless, Dr. Gan said, accumulating evidence suggests that exposure to loud noise can increase the risk of coronary heart disease.

Florescent lotion and black light revealed that health care workers often contaminate their skin and clothing while removing their protective gear, researchers say.

"It was surprising for the participants in the study to see that they frequently contaminated themselves during [personal protective equipment] removal," said senior author Dr. Curtis J. Donskey of the Cleveland Veterans Affairs Medical Center.

"Most of the participants appeared to be unaware of the high risk for contamination and many reported receiving minimal or no training in putting on and taking off [personal protective equipment]," he said by email.

The researchers recruited doctors, nurses and ancillary personnel such as phlebotomists and physical therapists at four Cleveland-area hospitals to participate in the simulations. More than half of the 435 simulations were performed by nurses.

As reported online October 12 in JAMA Internal Medicine, the participants put on protective gowns and gloves in their usual manner and then had a small amount of fluorescent lotion placed in the palm of their hands, which they then rubbed between their hands for 15 seconds to simulate dirtied gloves, then smeared the gloves over the chest and abdomen area of the gown. Then the gloves were exchanged for clean ones.

After they removed their gloves and gowns in their usual manners, researchers used a black light to check for lotion contamination of the hands, forearms, neck, face, hair or clothing.

Skin or clothing contamination happened 46% of the time, more frequently during glove removal.

Researchers also noted whether participants had used proper protective equipment technique, e.g., wearing gloves extended over the wrists of the gown, gown removed first by pulling away from the neck and body, and gloves removed second. Contamination happened 70% of the time when proper technique was not followed, compared to 30% of the time when it was followed.

"When dealing with pathogens that are potentially fatal, the goal has to be zero contamination," Dr. Donskey said. "In routine care settings, we would like personnel to be well trained and confident that they can minimize contamination, but would not insist on zero contamination."

It is important for personnel to perform hand hygiene after removing gloves and gowns, he said.

The researchers also conducted these tests with a group of personnel who had attended special infection control sessions, with a 10-minute video presentation and 20 minutes of demonstrations and practice in using and removing protective gear.

Before the training sessions, these individuals contaminated themselves 60% of the time, compared to roughly 19% after the sessions. The improvements were still seen at re-tests done one and three months later.

"This suggests that training using fluorescent lotion can be useful to identify minor deficiencies in technique that lead to contamination," Donskey said.

Recent experience with the Ebola virus in the U.S. showed that self-contamination during removal of protective equipment does occur, but this study exposes a more widespread issue that may be happening during routine patient care, said Dr. Michelle Doll of Virginia Commonwealth University in Richmond who coauthored a commentary on the new study.

"Use of gowns and gloves for contact precautions on a busy inpatient unit is costly on multiple levels," Doll said by email. "In situations when we do decide to use these tools for infection prevention, we need to optimize techniques to achieve the best efficacy possible. Otherwise it is wasteful of healthcare worker efforts and hospital resources."

The sight of fluorescent dye on one's face and hands would be a powerful and lasting lesson, she said.

"Being able to see where contamination occurs allows personnel to make adjustments in their technique," Dr. Donskey said. "Because training alone did not result in zero contamination, there is a need for other approaches such as improving [equipment] design or disinfection of [equipment] prior to removal."

Florescent lotion and black light revealed that health care workers often contaminate their skin and clothing while removing their protective gear, researchers say.

"It was surprising for the participants in the study to see that they frequently contaminated themselves during [personal protective equipment] removal," said senior author Dr. Curtis J. Donskey of the Cleveland Veterans Affairs Medical Center.

"Most of the participants appeared to be unaware of the high risk for contamination and many reported receiving minimal or no training in putting on and taking off [personal protective equipment]," he said by email.

The researchers recruited doctors, nurses and ancillary personnel such as phlebotomists and physical therapists at four Cleveland-area hospitals to participate in the simulations. More than half of the 435 simulations were performed by nurses.

As reported online October 12 in JAMA Internal Medicine, the participants put on protective gowns and gloves in their usual manner and then had a small amount of fluorescent lotion placed in the palm of their hands, which they then rubbed between their hands for 15 seconds to simulate dirtied gloves, then smeared the gloves over the chest and abdomen area of the gown. Then the gloves were exchanged for clean ones.

After they removed their gloves and gowns in their usual manners, researchers used a black light to check for lotion contamination of the hands, forearms, neck, face, hair or clothing.

Skin or clothing contamination happened 46% of the time, more frequently during glove removal.

Researchers also noted whether participants had used proper protective equipment technique, e.g., wearing gloves extended over the wrists of the gown, gown removed first by pulling away from the neck and body, and gloves removed second. Contamination happened 70% of the time when proper technique was not followed, compared to 30% of the time when it was followed.

"When dealing with pathogens that are potentially fatal, the goal has to be zero contamination," Dr. Donskey said. "In routine care settings, we would like personnel to be well trained and confident that they can minimize contamination, but would not insist on zero contamination."

It is important for personnel to perform hand hygiene after removing gloves and gowns, he said.

The researchers also conducted these tests with a group of personnel who had attended special infection control sessions, with a 10-minute video presentation and 20 minutes of demonstrations and practice in using and removing protective gear.

Before the training sessions, these individuals contaminated themselves 60% of the time, compared to roughly 19% after the sessions. The improvements were still seen at re-tests done one and three months later.

"This suggests that training using fluorescent lotion can be useful to identify minor deficiencies in technique that lead to contamination," Donskey said.

Recent experience with the Ebola virus in the U.S. showed that self-contamination during removal of protective equipment does occur, but this study exposes a more widespread issue that may be happening during routine patient care, said Dr. Michelle Doll of Virginia Commonwealth University in Richmond who coauthored a commentary on the new study.

"Use of gowns and gloves for contact precautions on a busy inpatient unit is costly on multiple levels," Doll said by email. "In situations when we do decide to use these tools for infection prevention, we need to optimize techniques to achieve the best efficacy possible. Otherwise it is wasteful of healthcare worker efforts and hospital resources."

The sight of fluorescent dye on one's face and hands would be a powerful and lasting lesson, she said.

"Being able to see where contamination occurs allows personnel to make adjustments in their technique," Dr. Donskey said. "Because training alone did not result in zero contamination, there is a need for other approaches such as improving [equipment] design or disinfection of [equipment] prior to removal."

Florescent lotion and black light revealed that health care workers often contaminate their skin and clothing while removing their protective gear, researchers say.

"It was surprising for the participants in the study to see that they frequently contaminated themselves during [personal protective equipment] removal," said senior author Dr. Curtis J. Donskey of the Cleveland Veterans Affairs Medical Center.

"Most of the participants appeared to be unaware of the high risk for contamination and many reported receiving minimal or no training in putting on and taking off [personal protective equipment]," he said by email.

The researchers recruited doctors, nurses and ancillary personnel such as phlebotomists and physical therapists at four Cleveland-area hospitals to participate in the simulations. More than half of the 435 simulations were performed by nurses.

As reported online October 12 in JAMA Internal Medicine, the participants put on protective gowns and gloves in their usual manner and then had a small amount of fluorescent lotion placed in the palm of their hands, which they then rubbed between their hands for 15 seconds to simulate dirtied gloves, then smeared the gloves over the chest and abdomen area of the gown. Then the gloves were exchanged for clean ones.

After they removed their gloves and gowns in their usual manners, researchers used a black light to check for lotion contamination of the hands, forearms, neck, face, hair or clothing.

Skin or clothing contamination happened 46% of the time, more frequently during glove removal.

Researchers also noted whether participants had used proper protective equipment technique, e.g., wearing gloves extended over the wrists of the gown, gown removed first by pulling away from the neck and body, and gloves removed second. Contamination happened 70% of the time when proper technique was not followed, compared to 30% of the time when it was followed.

"When dealing with pathogens that are potentially fatal, the goal has to be zero contamination," Dr. Donskey said. "In routine care settings, we would like personnel to be well trained and confident that they can minimize contamination, but would not insist on zero contamination."

It is important for personnel to perform hand hygiene after removing gloves and gowns, he said.

The researchers also conducted these tests with a group of personnel who had attended special infection control sessions, with a 10-minute video presentation and 20 minutes of demonstrations and practice in using and removing protective gear.

Before the training sessions, these individuals contaminated themselves 60% of the time, compared to roughly 19% after the sessions. The improvements were still seen at re-tests done one and three months later.

"This suggests that training using fluorescent lotion can be useful to identify minor deficiencies in technique that lead to contamination," Donskey said.

Recent experience with the Ebola virus in the U.S. showed that self-contamination during removal of protective equipment does occur, but this study exposes a more widespread issue that may be happening during routine patient care, said Dr. Michelle Doll of Virginia Commonwealth University in Richmond who coauthored a commentary on the new study.

"Use of gowns and gloves for contact precautions on a busy inpatient unit is costly on multiple levels," Doll said by email. "In situations when we do decide to use these tools for infection prevention, we need to optimize techniques to achieve the best efficacy possible. Otherwise it is wasteful of healthcare worker efforts and hospital resources."

The sight of fluorescent dye on one's face and hands would be a powerful and lasting lesson, she said.

"Being able to see where contamination occurs allows personnel to make adjustments in their technique," Dr. Donskey said. "Because training alone did not result in zero contamination, there is a need for other approaches such as improving [equipment] design or disinfection of [equipment] prior to removal."

Have you had successes with improving the patient experience at your hospital? Or have you had a challenge or question? SHM’s new Patient Experience community on HMX is a great way to find answers and share your stories. In just the first few days of the community, participants are talking about the impact of computers and smartphones on the patient experience. To join the conversation, SHM members can find the Patient Experience community in HMX.

Have you had successes with improving the patient experience at your hospital? Or have you had a challenge or question? SHM’s new Patient Experience community on HMX is a great way to find answers and share your stories. In just the first few days of the community, participants are talking about the impact of computers and smartphones on the patient experience. To join the conversation, SHM members can find the Patient Experience community in HMX.

Have you had successes with improving the patient experience at your hospital? Or have you had a challenge or question? SHM’s new Patient Experience community on HMX is a great way to find answers and share your stories. In just the first few days of the community, participants are talking about the impact of computers and smartphones on the patient experience. To join the conversation, SHM members can find the Patient Experience community in HMX.

Clinical question: Do transfusions affect post-operative outcomes after noncardiac surgery?

Background: Studies have demonstrated that a restrictive transfusion strategy is probably superior to a liberal transfusion strategy in many clinical settings. Despite this data, there continues to be wide variation in the use of blood transfusions in the peri-operative setting.

Study design: Retrospective cohort study.

Setting: Fifty-two community and academic hospitals in Michigan.

Synopsis: Demographic, operative, and outcomes data were extracted from the Michigan Surgical Quality Collaborative and reviewed for 48,720 patients who underwent noncardiac surgery between 2012-2014. A total of 4.6% of patients received a blood transfusion within 72 hours after surgery. The patients who received blood products were at increased risk for death at 30 days (3.6% excess absolute risk), for infectious complications (1% excess absolute risk), and for having at least one post-operative noninfectious complication (4.4% increased absolute risk).

Bottom line: Although observational in nature, this study adds to the increasing body of evidence supporting an increase in surgical morbidity and mortality associated with blood transfusions.

Citation: Abdelsattar ZM, Hendren S, Wong SL, Campbell DA Jr, Henke P. Variation in transfusion practices and the effect on outcomes after noncardiac surgery. Ann Surg. 2015;262(1):1-6.

Clinical question: Do transfusions affect post-operative outcomes after noncardiac surgery?

Background: Studies have demonstrated that a restrictive transfusion strategy is probably superior to a liberal transfusion strategy in many clinical settings. Despite this data, there continues to be wide variation in the use of blood transfusions in the peri-operative setting.

Study design: Retrospective cohort study.

Setting: Fifty-two community and academic hospitals in Michigan.

Synopsis: Demographic, operative, and outcomes data were extracted from the Michigan Surgical Quality Collaborative and reviewed for 48,720 patients who underwent noncardiac surgery between 2012-2014. A total of 4.6% of patients received a blood transfusion within 72 hours after surgery. The patients who received blood products were at increased risk for death at 30 days (3.6% excess absolute risk), for infectious complications (1% excess absolute risk), and for having at least one post-operative noninfectious complication (4.4% increased absolute risk).

Bottom line: Although observational in nature, this study adds to the increasing body of evidence supporting an increase in surgical morbidity and mortality associated with blood transfusions.

Citation: Abdelsattar ZM, Hendren S, Wong SL, Campbell DA Jr, Henke P. Variation in transfusion practices and the effect on outcomes after noncardiac surgery. Ann Surg. 2015;262(1):1-6.

Clinical question: Do transfusions affect post-operative outcomes after noncardiac surgery?

Background: Studies have demonstrated that a restrictive transfusion strategy is probably superior to a liberal transfusion strategy in many clinical settings. Despite this data, there continues to be wide variation in the use of blood transfusions in the peri-operative setting.

Study design: Retrospective cohort study.

Setting: Fifty-two community and academic hospitals in Michigan.

Synopsis: Demographic, operative, and outcomes data were extracted from the Michigan Surgical Quality Collaborative and reviewed for 48,720 patients who underwent noncardiac surgery between 2012-2014. A total of 4.6% of patients received a blood transfusion within 72 hours after surgery. The patients who received blood products were at increased risk for death at 30 days (3.6% excess absolute risk), for infectious complications (1% excess absolute risk), and for having at least one post-operative noninfectious complication (4.4% increased absolute risk).

Bottom line: Although observational in nature, this study adds to the increasing body of evidence supporting an increase in surgical morbidity and mortality associated with blood transfusions.

Citation: Abdelsattar ZM, Hendren S, Wong SL, Campbell DA Jr, Henke P. Variation in transfusion practices and the effect on outcomes after noncardiac surgery. Ann Surg. 2015;262(1):1-6.

Clinical question: Is there a favorable risk-benefit ratio for left atrial appendage closure (LAAC) compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation?

Background: LAAC with the WATCHMAN device was shown to be noninferior to warfarin for the prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation in two trials: PROTECT AF and PREVAIL. Further efficacy concerns were raised following routine regulatory filings, leading to the need for continued evaluation.

Study design: Meta-analysis.

Setting: Patient-level data were combined and analyzed from the PROTECT AF and PREVAIL trails and two nonrandomized registries of LAAC with the WATCHMAN device: the Continued Access PROTECT AF registry (CAP) and the Continued Access to PREVAIL registry (CAP2).

Synopsis: A total of 2,406 patients were enrolled from all four data sets from 2005-2014. Of those, 1,877 were treated with the WATCHMAN device and 382 were treated with warfarin. Annualized risk of stroke if untreated with anticoagulation for all patients was 5.7% to 7.6%, indicating that all were eligible to be treated with warfarin. Ninety percent of patients had moderate to high risk of bleeding. Analysis showed that LAAC was noninferior to warfarin for stroke, systemic embolism, and cardiovascular death.

A slight increase in ischemic stroke in the LAAC group was counterbalanced by the significant reduction in hemorrhagic stroke in the LAAC group versus the warfarin group. Cardiovascular deaths were significantly fewer in the LAAC cohort; all-cause mortality favored LAAC but did not reach statistical significance. There was also a significant reduction in nonprocedure-related major bleeding in the LAAC group. Limitations of this study include the limited number of patients treated with warfarin and lack of comparison to new oral anticoagulants (NOACs).

Bottom line: Patients with increased stroke risk from nonvalvular atrial fibrillation treated with the WATCHMAN device for LAAC have significant reductions in hemorrhagic stroke, cardiovascular death, and nonprocedure-related major bleeding, but slightly increased risk of ischemic stroke compared to those treated with warfarin.

Citaiton: Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.

Clinical question: Is there a favorable risk-benefit ratio for left atrial appendage closure (LAAC) compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation?

Background: LAAC with the WATCHMAN device was shown to be noninferior to warfarin for the prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation in two trials: PROTECT AF and PREVAIL. Further efficacy concerns were raised following routine regulatory filings, leading to the need for continued evaluation.

Study design: Meta-analysis.

Setting: Patient-level data were combined and analyzed from the PROTECT AF and PREVAIL trails and two nonrandomized registries of LAAC with the WATCHMAN device: the Continued Access PROTECT AF registry (CAP) and the Continued Access to PREVAIL registry (CAP2).

Synopsis: A total of 2,406 patients were enrolled from all four data sets from 2005-2014. Of those, 1,877 were treated with the WATCHMAN device and 382 were treated with warfarin. Annualized risk of stroke if untreated with anticoagulation for all patients was 5.7% to 7.6%, indicating that all were eligible to be treated with warfarin. Ninety percent of patients had moderate to high risk of bleeding. Analysis showed that LAAC was noninferior to warfarin for stroke, systemic embolism, and cardiovascular death.

A slight increase in ischemic stroke in the LAAC group was counterbalanced by the significant reduction in hemorrhagic stroke in the LAAC group versus the warfarin group. Cardiovascular deaths were significantly fewer in the LAAC cohort; all-cause mortality favored LAAC but did not reach statistical significance. There was also a significant reduction in nonprocedure-related major bleeding in the LAAC group. Limitations of this study include the limited number of patients treated with warfarin and lack of comparison to new oral anticoagulants (NOACs).

Bottom line: Patients with increased stroke risk from nonvalvular atrial fibrillation treated with the WATCHMAN device for LAAC have significant reductions in hemorrhagic stroke, cardiovascular death, and nonprocedure-related major bleeding, but slightly increased risk of ischemic stroke compared to those treated with warfarin.

Citaiton: Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.

Clinical question: Is there a favorable risk-benefit ratio for left atrial appendage closure (LAAC) compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation?

Background: LAAC with the WATCHMAN device was shown to be noninferior to warfarin for the prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation in two trials: PROTECT AF and PREVAIL. Further efficacy concerns were raised following routine regulatory filings, leading to the need for continued evaluation.

Study design: Meta-analysis.

Setting: Patient-level data were combined and analyzed from the PROTECT AF and PREVAIL trails and two nonrandomized registries of LAAC with the WATCHMAN device: the Continued Access PROTECT AF registry (CAP) and the Continued Access to PREVAIL registry (CAP2).

Synopsis: A total of 2,406 patients were enrolled from all four data sets from 2005-2014. Of those, 1,877 were treated with the WATCHMAN device and 382 were treated with warfarin. Annualized risk of stroke if untreated with anticoagulation for all patients was 5.7% to 7.6%, indicating that all were eligible to be treated with warfarin. Ninety percent of patients had moderate to high risk of bleeding. Analysis showed that LAAC was noninferior to warfarin for stroke, systemic embolism, and cardiovascular death.

A slight increase in ischemic stroke in the LAAC group was counterbalanced by the significant reduction in hemorrhagic stroke in the LAAC group versus the warfarin group. Cardiovascular deaths were significantly fewer in the LAAC cohort; all-cause mortality favored LAAC but did not reach statistical significance. There was also a significant reduction in nonprocedure-related major bleeding in the LAAC group. Limitations of this study include the limited number of patients treated with warfarin and lack of comparison to new oral anticoagulants (NOACs).

Bottom line: Patients with increased stroke risk from nonvalvular atrial fibrillation treated with the WATCHMAN device for LAAC have significant reductions in hemorrhagic stroke, cardiovascular death, and nonprocedure-related major bleeding, but slightly increased risk of ischemic stroke compared to those treated with warfarin.

Citaiton: Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.