The Hospitalist

Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.

Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.

Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.

Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.

Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.

Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.

Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.

Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.

Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.

Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.

Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.

Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.

Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.

Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.

Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.

Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.

Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.

Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.

Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.

Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.

Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.

Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.

Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.

Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.

Background: The association between platelet counts, risk of bleeding, and transfusions in patients with thrombocytopenia related to stem cell transplant (SCT) or chemotherapy is not clear, except at very low platelet counts.

Study design: Secondary analysis of a multicenter, randomized controlled trial, stratified by cause of thrombocytopenia: autologous or syngeneic SCT (AUTO), allogeneic SCT (ALLO), or chemotherapy for hematologic malignancy without SCT (CHEMO).

Setting: Twenty-six hospitals from 2004 to 2007.

Synopsis: The PLADO trial enrolled more than 1,200 patients aged 18 years and older expected to experience a period of hypoproliferative thrombocytopenia as a result of chemotherapy or SCT, and randomized them to low, medium, or high doses of prophylactic platelets. This secondary analysis assessed laboratory predictors of bleeding, and the effect of transfusion.

Of 1,077 patients who received platelet transfusions, there were no differences between dose groups for any bleeding outcomes. Over a wide range of platelet counts, the ALLO stratum had a higher risk of bleeding than other strata, with clinically significant bleeding on 21% of patient-days in the ALLO stratum, compared with 19% in the AUTO stratum and 11% in the CHEMO stratum (P less than .001). Risk for bleeding was significantly higher at platelet counts of equal to or less than 5x109/L compared with platelet counts greater than or equal to 81x109/L. Higher aPTT and INR were also associated with higher risk of clinically significant bleeding. In a multipredictor model, only hematocrit was significantly associated with more severe bleeding. Neither platelet transfusion nor RBC transfusion reduced the risk of bleeding on the following day, although the authors note some possibility of confounding by indication.

Bottom line: Predictors of overall increased risk for bleeding in patients with secondary hypoproliferative thrombocytopenia were treatment stratum, platelet counts less than or equal to 5x109/L, hematocrit less than 25%, INR greater than 1.2, and aPTT greater than 30 seconds. This study challenges the conventional wisdom that transfusions reduce bleeding risk in patients with secondary hypoproliferative thrombocytopenia.

Citation: Uhl L, Assmann SF, Hamza TH, et al. Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood. 2017;130(10):1247-58.

Background: The association between platelet counts, risk of bleeding, and transfusions in patients with thrombocytopenia related to stem cell transplant (SCT) or chemotherapy is not clear, except at very low platelet counts.

Study design: Secondary analysis of a multicenter, randomized controlled trial, stratified by cause of thrombocytopenia: autologous or syngeneic SCT (AUTO), allogeneic SCT (ALLO), or chemotherapy for hematologic malignancy without SCT (CHEMO).

Setting: Twenty-six hospitals from 2004 to 2007.

Synopsis: The PLADO trial enrolled more than 1,200 patients aged 18 years and older expected to experience a period of hypoproliferative thrombocytopenia as a result of chemotherapy or SCT, and randomized them to low, medium, or high doses of prophylactic platelets. This secondary analysis assessed laboratory predictors of bleeding, and the effect of transfusion.

Of 1,077 patients who received platelet transfusions, there were no differences between dose groups for any bleeding outcomes. Over a wide range of platelet counts, the ALLO stratum had a higher risk of bleeding than other strata, with clinically significant bleeding on 21% of patient-days in the ALLO stratum, compared with 19% in the AUTO stratum and 11% in the CHEMO stratum (P less than .001). Risk for bleeding was significantly higher at platelet counts of equal to or less than 5x109/L compared with platelet counts greater than or equal to 81x109/L. Higher aPTT and INR were also associated with higher risk of clinically significant bleeding. In a multipredictor model, only hematocrit was significantly associated with more severe bleeding. Neither platelet transfusion nor RBC transfusion reduced the risk of bleeding on the following day, although the authors note some possibility of confounding by indication.

Bottom line: Predictors of overall increased risk for bleeding in patients with secondary hypoproliferative thrombocytopenia were treatment stratum, platelet counts less than or equal to 5x109/L, hematocrit less than 25%, INR greater than 1.2, and aPTT greater than 30 seconds. This study challenges the conventional wisdom that transfusions reduce bleeding risk in patients with secondary hypoproliferative thrombocytopenia.

Citation: Uhl L, Assmann SF, Hamza TH, et al. Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood. 2017;130(10):1247-58.

Background: The association between platelet counts, risk of bleeding, and transfusions in patients with thrombocytopenia related to stem cell transplant (SCT) or chemotherapy is not clear, except at very low platelet counts.

Study design: Secondary analysis of a multicenter, randomized controlled trial, stratified by cause of thrombocytopenia: autologous or syngeneic SCT (AUTO), allogeneic SCT (ALLO), or chemotherapy for hematologic malignancy without SCT (CHEMO).

Setting: Twenty-six hospitals from 2004 to 2007.

Synopsis: The PLADO trial enrolled more than 1,200 patients aged 18 years and older expected to experience a period of hypoproliferative thrombocytopenia as a result of chemotherapy or SCT, and randomized them to low, medium, or high doses of prophylactic platelets. This secondary analysis assessed laboratory predictors of bleeding, and the effect of transfusion.

Of 1,077 patients who received platelet transfusions, there were no differences between dose groups for any bleeding outcomes. Over a wide range of platelet counts, the ALLO stratum had a higher risk of bleeding than other strata, with clinically significant bleeding on 21% of patient-days in the ALLO stratum, compared with 19% in the AUTO stratum and 11% in the CHEMO stratum (P less than .001). Risk for bleeding was significantly higher at platelet counts of equal to or less than 5x109/L compared with platelet counts greater than or equal to 81x109/L. Higher aPTT and INR were also associated with higher risk of clinically significant bleeding. In a multipredictor model, only hematocrit was significantly associated with more severe bleeding. Neither platelet transfusion nor RBC transfusion reduced the risk of bleeding on the following day, although the authors note some possibility of confounding by indication.

Bottom line: Predictors of overall increased risk for bleeding in patients with secondary hypoproliferative thrombocytopenia were treatment stratum, platelet counts less than or equal to 5x109/L, hematocrit less than 25%, INR greater than 1.2, and aPTT greater than 30 seconds. This study challenges the conventional wisdom that transfusions reduce bleeding risk in patients with secondary hypoproliferative thrombocytopenia.

Citation: Uhl L, Assmann SF, Hamza TH, et al. Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood. 2017;130(10):1247-58.

Hospitalized patients with obstructive sleep apnea (OSA) who were nonadherent to continuous positive airway pressure (CPAP) treatment were more than three times as likely to be readmitted for complications, according to a study.

Since preventable causes of readmission like congestive heart failure, obstructive lung disease, and diabetes are connected to OSA, boosting adherence rates to sleep apnea treatment could be an effective way to mitigate these risks.

viola83181/iStockphoto

[email protected]

SOURCE: K. Truong et al. J Clin Sleep Med. 2018;14(2):183–9.

Hospitalized patients with obstructive sleep apnea (OSA) who were nonadherent to continuous positive airway pressure (CPAP) treatment were more than three times as likely to be readmitted for complications, according to a study.

Since preventable causes of readmission like congestive heart failure, obstructive lung disease, and diabetes are connected to OSA, boosting adherence rates to sleep apnea treatment could be an effective way to mitigate these risks.

viola83181/iStockphoto

[email protected]

SOURCE: K. Truong et al. J Clin Sleep Med. 2018;14(2):183–9.

Hospitalized patients with obstructive sleep apnea (OSA) who were nonadherent to continuous positive airway pressure (CPAP) treatment were more than three times as likely to be readmitted for complications, according to a study.

Since preventable causes of readmission like congestive heart failure, obstructive lung disease, and diabetes are connected to OSA, boosting adherence rates to sleep apnea treatment could be an effective way to mitigate these risks.

viola83181/iStockphoto

[email protected]

SOURCE: K. Truong et al. J Clin Sleep Med. 2018;14(2):183–9.

Clinical question: Is there a simplified risk prediction model to identify those with low risk pulmonary embolism (PE) who can be treated as outpatients?

Background: Existing prognostic models for patients with acute PE are dependent on comorbidities, which can be challenging to use in a scoring system. Models that make use of acute clinical variables to predict morbidity or mortality may be of greater clinical utility.

Study design: Retrospective chart review with derivation and validation analysis.

Setting: Tertiary care hospital in Chennai, India.

Synopsis: The authors identified 400 patients with acute PE who met inclusion criteria. Using logistic regression and readily accessible clinical variables previously shown to be associated with acute PE mortality, the authors created the HOPPE prediction score: heart rate, PaO₂, systolic blood pressure, diastolic blood pressure, and ECG score. Each variable was classified into three groups and assigned a point value that could be summed to a cumulative 30-day mortality risk score. In the derivation and validation cohorts, the low, intermediate, and high HOPPE scores were associated with a 30-day mortality of 0%, 7.5-8.5%, and 18.2-18.8%, respectively, with similar trends for secondary outcomes including right ventricular dysfunction, nonfatal cardiogenic shock, and cardiorespiratory arrest.

In comparison with the previously validated PESI score, the HOPPE score had significantly higher sensitivity, specificity, and discriminative power. The conclusions from this study were limited by its single institutional design.

Bottom line: The HOPPE score provides a risk assessment tool to identify those patients with acute PE who are at lowest and highest risk for morbidity and mortality.

Citation: Subramanian M et al. Derivation and validation of a novel prediction model to identify low-risk patients with acute pulmonary embolism. Am J Cardiol. 2017;120(4):676-81.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
 

Clinical question: Is there a simplified risk prediction model to identify those with low risk pulmonary embolism (PE) who can be treated as outpatients?

Background: Existing prognostic models for patients with acute PE are dependent on comorbidities, which can be challenging to use in a scoring system. Models that make use of acute clinical variables to predict morbidity or mortality may be of greater clinical utility.

Study design: Retrospective chart review with derivation and validation analysis.

Setting: Tertiary care hospital in Chennai, India.

Synopsis: The authors identified 400 patients with acute PE who met inclusion criteria. Using logistic regression and readily accessible clinical variables previously shown to be associated with acute PE mortality, the authors created the HOPPE prediction score: heart rate, PaO₂, systolic blood pressure, diastolic blood pressure, and ECG score. Each variable was classified into three groups and assigned a point value that could be summed to a cumulative 30-day mortality risk score. In the derivation and validation cohorts, the low, intermediate, and high HOPPE scores were associated with a 30-day mortality of 0%, 7.5-8.5%, and 18.2-18.8%, respectively, with similar trends for secondary outcomes including right ventricular dysfunction, nonfatal cardiogenic shock, and cardiorespiratory arrest.

In comparison with the previously validated PESI score, the HOPPE score had significantly higher sensitivity, specificity, and discriminative power. The conclusions from this study were limited by its single institutional design.

Bottom line: The HOPPE score provides a risk assessment tool to identify those patients with acute PE who are at lowest and highest risk for morbidity and mortality.

Citation: Subramanian M et al. Derivation and validation of a novel prediction model to identify low-risk patients with acute pulmonary embolism. Am J Cardiol. 2017;120(4):676-81.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
 

Clinical question: Is there a simplified risk prediction model to identify those with low risk pulmonary embolism (PE) who can be treated as outpatients?

Background: Existing prognostic models for patients with acute PE are dependent on comorbidities, which can be challenging to use in a scoring system. Models that make use of acute clinical variables to predict morbidity or mortality may be of greater clinical utility.

Study design: Retrospective chart review with derivation and validation analysis.

Setting: Tertiary care hospital in Chennai, India.

Synopsis: The authors identified 400 patients with acute PE who met inclusion criteria. Using logistic regression and readily accessible clinical variables previously shown to be associated with acute PE mortality, the authors created the HOPPE prediction score: heart rate, PaO₂, systolic blood pressure, diastolic blood pressure, and ECG score. Each variable was classified into three groups and assigned a point value that could be summed to a cumulative 30-day mortality risk score. In the derivation and validation cohorts, the low, intermediate, and high HOPPE scores were associated with a 30-day mortality of 0%, 7.5-8.5%, and 18.2-18.8%, respectively, with similar trends for secondary outcomes including right ventricular dysfunction, nonfatal cardiogenic shock, and cardiorespiratory arrest.

In comparison with the previously validated PESI score, the HOPPE score had significantly higher sensitivity, specificity, and discriminative power. The conclusions from this study were limited by its single institutional design.

Bottom line: The HOPPE score provides a risk assessment tool to identify those patients with acute PE who are at lowest and highest risk for morbidity and mortality.

Citation: Subramanian M et al. Derivation and validation of a novel prediction model to identify low-risk patients with acute pulmonary embolism. Am J Cardiol. 2017;120(4):676-81.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
 

Clinical question: What is the frequency of diagnostic delays in epidural abscesses, and what factors may contribute to these delays?

Background: Diagnostic evaluation of back pain can be challenging. Missed diagnosis of serious conditions such as epidural abscesses can lead to significant morbidity.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: What is the frequency of diagnostic delays in epidural abscesses, and what factors may contribute to these delays?

Background: Diagnostic evaluation of back pain can be challenging. Missed diagnosis of serious conditions such as epidural abscesses can lead to significant morbidity.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: What is the frequency of diagnostic delays in epidural abscesses, and what factors may contribute to these delays?

Background: Diagnostic evaluation of back pain can be challenging. Missed diagnosis of serious conditions such as epidural abscesses can lead to significant morbidity.

Dr. Pizza is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Background: Clinical guidelines recommend supplemental oxygen in patients with suspected acute myocardial infarction but data to support its use in patients without hypoxemia are limited. 
Study design: Open-label, registry based randomized clinical trial. 
Setting: Thirty-five hospitals in Sweden with acute cardiac care facilities. 
Synopsis: Authors included 6,629 patients aged 30 and older who presented with symptoms suggestive of myocardial infarction. Patients with oxygen saturations 90% or greater were enrolled in the study and randomly assigned to either 6 liters per minute of face mask oxygen for 6-12 hours or ambient air. Median oxygen saturation was 99% in the treatment group and 97% in the ambient air group (P less than .0001). In an intention-to-treat model, 1 year after randomization there was no significant difference in all-cause mortality between the oxygen (5.0%) and ambient air (5.1%) groups (P = .80). There was  no difference in the rate of rehospitalization with myocardial infarction or the composite endpoint of all-cause mortality and rehospitalizations for myocardial infarction at 30 days and 1 year. Limitations of this study include lower power than anticipated since calculations were based on a higher mortality rate than observed in this study, and the open-label protocol.   
Bottom line: In patients who present with a suspected myocardial infarction without hypoxemia, oxygen therapy is not associated with improved all-cause mortality or decreased rehospitalizations for myocardial infarction. 
Citation: Hofmann R, Jernberg T, Erlinge D, et al. Oxygen therapy in suspected acute myocardial infarction. N Engl J Med. 2017;377:1240-9. 
 

Background: Clinical guidelines recommend supplemental oxygen in patients with suspected acute myocardial infarction but data to support its use in patients without hypoxemia are limited. 
Study design: Open-label, registry based randomized clinical trial. 
Setting: Thirty-five hospitals in Sweden with acute cardiac care facilities. 
Synopsis: Authors included 6,629 patients aged 30 and older who presented with symptoms suggestive of myocardial infarction. Patients with oxygen saturations 90% or greater were enrolled in the study and randomly assigned to either 6 liters per minute of face mask oxygen for 6-12 hours or ambient air. Median oxygen saturation was 99% in the treatment group and 97% in the ambient air group (P less than .0001). In an intention-to-treat model, 1 year after randomization there was no significant difference in all-cause mortality between the oxygen (5.0%) and ambient air (5.1%) groups (P = .80). There was  no difference in the rate of rehospitalization with myocardial infarction or the composite endpoint of all-cause mortality and rehospitalizations for myocardial infarction at 30 days and 1 year. Limitations of this study include lower power than anticipated since calculations were based on a higher mortality rate than observed in this study, and the open-label protocol.   
Bottom line: In patients who present with a suspected myocardial infarction without hypoxemia, oxygen therapy is not associated with improved all-cause mortality or decreased rehospitalizations for myocardial infarction. 
Citation: Hofmann R, Jernberg T, Erlinge D, et al. Oxygen therapy in suspected acute myocardial infarction. N Engl J Med. 2017;377:1240-9. 
 

Background: Clinical guidelines recommend supplemental oxygen in patients with suspected acute myocardial infarction but data to support its use in patients without hypoxemia are limited. 
Study design: Open-label, registry based randomized clinical trial. 
Setting: Thirty-five hospitals in Sweden with acute cardiac care facilities. 
Synopsis: Authors included 6,629 patients aged 30 and older who presented with symptoms suggestive of myocardial infarction. Patients with oxygen saturations 90% or greater were enrolled in the study and randomly assigned to either 6 liters per minute of face mask oxygen for 6-12 hours or ambient air. Median oxygen saturation was 99% in the treatment group and 97% in the ambient air group (P less than .0001). In an intention-to-treat model, 1 year after randomization there was no significant difference in all-cause mortality between the oxygen (5.0%) and ambient air (5.1%) groups (P = .80). There was  no difference in the rate of rehospitalization with myocardial infarction or the composite endpoint of all-cause mortality and rehospitalizations for myocardial infarction at 30 days and 1 year. Limitations of this study include lower power than anticipated since calculations were based on a higher mortality rate than observed in this study, and the open-label protocol.   
Bottom line: In patients who present with a suspected myocardial infarction without hypoxemia, oxygen therapy is not associated with improved all-cause mortality or decreased rehospitalizations for myocardial infarction. 
Citation: Hofmann R, Jernberg T, Erlinge D, et al. Oxygen therapy in suspected acute myocardial infarction. N Engl J Med. 2017;377:1240-9. 
 

A bit of revisionist history has outpatient influenza activity at a lower level than was reported last week, even though it hasn’t dropped.

The proportion of outpatient visits for influenza-like illness (ILI) for the week ending Feb. 10 was 7.5%, according to the Centers for Disease Control. That is lower than the 7.7% previously reported for the week ending Feb. 3, which would seem to be a drop, but the CDC also has revised that earlier number to 7.5%, so there is no change. (This is not the first time an earlier ILI level has been retroactively lowered: The figure reported for the week ending Jan. 13 was revised in the following report from 6.3% down to 6.0%.)

[email protected]

A bit of revisionist history has outpatient influenza activity at a lower level than was reported last week, even though it hasn’t dropped.

The proportion of outpatient visits for influenza-like illness (ILI) for the week ending Feb. 10 was 7.5%, according to the Centers for Disease Control. That is lower than the 7.7% previously reported for the week ending Feb. 3, which would seem to be a drop, but the CDC also has revised that earlier number to 7.5%, so there is no change. (This is not the first time an earlier ILI level has been retroactively lowered: The figure reported for the week ending Jan. 13 was revised in the following report from 6.3% down to 6.0%.)

[email protected]

A bit of revisionist history has outpatient influenza activity at a lower level than was reported last week, even though it hasn’t dropped.

The proportion of outpatient visits for influenza-like illness (ILI) for the week ending Feb. 10 was 7.5%, according to the Centers for Disease Control. That is lower than the 7.7% previously reported for the week ending Feb. 3, which would seem to be a drop, but the CDC also has revised that earlier number to 7.5%, so there is no change. (This is not the first time an earlier ILI level has been retroactively lowered: The figure reported for the week ending Jan. 13 was revised in the following report from 6.3% down to 6.0%.)

[email protected]

Background: Data on the efficacy of anticoagulation to reduce stroke risk in patients with new-onset atrial fibrillation due to acute coronary syndrome (ACS), acute pulmonary disease (APD), and sepsis are limited.

Study design: Retrospective cohort study.

Setting: All hospitals in Quebec.

Synopsis: Authors included 2,304 patients aged 65 and older with new atrial fibrillation secondary to ACS, APD, and sepsis. Anticoagulation was started for 38.4%, 34.1%, and 27.7% of these patients and the incidence of stroke was 5.4%, 3.9%, and 5.8% in the ACS, APD, and sepsis populations, respectively. After 3 years, anticoagulation use was not associated with a lower risk of ischemic stroke in any cohort. In a multivariate analysis adjusted for the HAS-BLED score, anticoagulation was associated with a higher risk of bleeding in patients with APD (odds ratio, 1.72; 95% confidence interval, 1.23-2.39) but not in ACS or sepsis.

The major limitation of this study was the reliance on administrative data alone, making it difficult to confirm and capture all patients with transient atrial fibrillation.

Bottom line: Anticoagulation use in patients with secondary atrial fibrillation may not be associated with a reduction in ischemic strokes, but may be associated with an increased bleeding risk in patients with atrial fibrillation secondary to acute pulmonary disease.

Citation: Quon MJ et al. Anticoagulant use and risk of ischemic stroke and bleeding in patients with secondary atrial fibrillation associated with acute coronary syndromes, acute pulmonary disease, or sepsis. JACC: Clinical Electrophysiology. Article in Press.

Dr. Gala is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston. 

Background: Data on the efficacy of anticoagulation to reduce stroke risk in patients with new-onset atrial fibrillation due to acute coronary syndrome (ACS), acute pulmonary disease (APD), and sepsis are limited.

Study design: Retrospective cohort study.

Setting: All hospitals in Quebec.

Synopsis: Authors included 2,304 patients aged 65 and older with new atrial fibrillation secondary to ACS, APD, and sepsis. Anticoagulation was started for 38.4%, 34.1%, and 27.7% of these patients and the incidence of stroke was 5.4%, 3.9%, and 5.8% in the ACS, APD, and sepsis populations, respectively. After 3 years, anticoagulation use was not associated with a lower risk of ischemic stroke in any cohort. In a multivariate analysis adjusted for the HAS-BLED score, anticoagulation was associated with a higher risk of bleeding in patients with APD (odds ratio, 1.72; 95% confidence interval, 1.23-2.39) but not in ACS or sepsis.

The major limitation of this study was the reliance on administrative data alone, making it difficult to confirm and capture all patients with transient atrial fibrillation.

Bottom line: Anticoagulation use in patients with secondary atrial fibrillation may not be associated with a reduction in ischemic strokes, but may be associated with an increased bleeding risk in patients with atrial fibrillation secondary to acute pulmonary disease.

Citation: Quon MJ et al. Anticoagulant use and risk of ischemic stroke and bleeding in patients with secondary atrial fibrillation associated with acute coronary syndromes, acute pulmonary disease, or sepsis. JACC: Clinical Electrophysiology. Article in Press.

Dr. Gala is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston. 

Background: Data on the efficacy of anticoagulation to reduce stroke risk in patients with new-onset atrial fibrillation due to acute coronary syndrome (ACS), acute pulmonary disease (APD), and sepsis are limited.

Study design: Retrospective cohort study.

Setting: All hospitals in Quebec.

Synopsis: Authors included 2,304 patients aged 65 and older with new atrial fibrillation secondary to ACS, APD, and sepsis. Anticoagulation was started for 38.4%, 34.1%, and 27.7% of these patients and the incidence of stroke was 5.4%, 3.9%, and 5.8% in the ACS, APD, and sepsis populations, respectively. After 3 years, anticoagulation use was not associated with a lower risk of ischemic stroke in any cohort. In a multivariate analysis adjusted for the HAS-BLED score, anticoagulation was associated with a higher risk of bleeding in patients with APD (odds ratio, 1.72; 95% confidence interval, 1.23-2.39) but not in ACS or sepsis.

The major limitation of this study was the reliance on administrative data alone, making it difficult to confirm and capture all patients with transient atrial fibrillation.

Bottom line: Anticoagulation use in patients with secondary atrial fibrillation may not be associated with a reduction in ischemic strokes, but may be associated with an increased bleeding risk in patients with atrial fibrillation secondary to acute pulmonary disease.

Citation: Quon MJ et al. Anticoagulant use and risk of ischemic stroke and bleeding in patients with secondary atrial fibrillation associated with acute coronary syndromes, acute pulmonary disease, or sepsis. JACC: Clinical Electrophysiology. Article in Press.

Dr. Gala is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston. 

Since 2010, when Democrats passed the Affordable Care Act – also known as Obamacare – without a single Republican vote, the GOP has vowed to repeal and replace it. With the election of Donald Trump in November 2016, Republicans gained control of the presidency and Congress and hoped to put Obamacare on the chopping block.

Although the Affordable Care Act’s (ACA’s) individual mandate was eliminated in the Tax Cuts and Jobs Act passed in late 2017, Republican leaders have been unable to secure the votes they need for a full repeal of Obamacare and a complete reboot of the American health care system. That may be, in part, because in the search for a better American health care system, there is no single right answer. In few places is that more clear than when making comparisons of health care systems across the world.

“Comparisons are fun, and everyone loves rankings,” said Ashish Jha, MD, MPH, a physician with the Harvard T.H. Chan School of Public Health and director of the Harvard Global Health Institute in Cambridge, Mass. Last fall Shah published an analysis on his personal blog comparing health care in the United States with that in seven high-income nations.¹ It was prompted by a similar side-by-side comparison he participated in with other experts for the New York Times.² “The most important part is we get to ask questions about things we care about, like ‘What do other countries do when they’re better than us?’ We’re not going to adopt any country’s model wholesale, but we can learn from them,” he said.

For instance, just 7.4% of people in Switzerland (according to data from the Organisation for Economic Cooperation and Development) skip medical tests, treatments, or follow-ups because of costs, compared with 21.3% in the United States. Meanwhile, the United States leads in innovation, producing 57% of new drugs (according to the Milken Institute), which is more than Switzerland’s 13% and Germany’s 6%.¹

Although many Americans tend to think that health care in other developed nations is entirely single payer or government run, systems across Europe and the rest of the globe vary immensely in how they approach health care. One thing common among high-income nations, however, is some form of universal health care. In Canada, for example, the government funds health insurance for care delivered in the private sector. In Australia, public hospitals provide free inpatient care. In France, the Ministry of Health sets prices, budgets, and funding levels.²

“There are really two main purposes” when it comes to international comparisons, said Eric Schneider, MD, senior vice president for policy and research for the Commonwealth Fund. “The first is to understand how other countries perform, and the second is what lessons can we learn from the way care is financed, organized, and delivered in other nations and how we might import some of those ideas to the U.S. and improve policies here.”

The Affordable Care Act, Dr. Jha said, was something of the ultimate test for applying lessons learned in other countries and those put forward over the past decades in the United States by policy experts and leaders in health care thinking.

“The Affordable Care Act includes several ideas that are prevalent in other countries, particularly around how to expand insurance coverage and how to subsidize the poor so they can have good insurance coverage, too,” said Dr. Schneider. “The notion of essential health benefits, the mandate for insurance, the notion of subsidies, in some ways, these were all borrowed from abroad.”

For instance, health care in The Netherlands – which, like the United States, also relies on private health insurers – ranked among the highest of other high-income countries in the world in The Commonwealth Fund’s 2017 international comparison, published in July 2017.³ The Dutch have standardized their health benefits, reducing administrative burden for providers and making copayments more predictable for patients.

Dr. Schneider believes that the United States should continue to build on the progress of the Affordable Care Act – particularly since more than 20 million Americans have gained insurance coverage since the passage of the law (91% of Americans are insured today).⁴ And the ACA has renewed focus in the United States on improving and strengthening primary care and changing the incentives around care delivery.

Some Democrats and Republicans in Congress have started working on bipartisan solutions to solve some of the problems inherent in the ACA – or those engineered by those who oppose it.

References

1. Jha A. Judging health systems: focusing on what matters. An Ounce of Evidence. Published Sep 18, 2017. Last accessed Oct 19, 2017. https://blogs.sph.harvard.edu/ashish-jha/.

2. Carroll AE et al. The best health care system in the world: Which one would you pick? New York Times. Published Sep 18, 2017. Accessed Oct 19, 2017. https://www.nytimes.com/interactive/2017/09/18/upshot/best-health-care-system-country-bracket.html?action=click&contentCollection=upshot&region=rank&module=package&version=highlights&contentPlacement=1&pgtype=sectionfront.

3. Schneider EC et al. Mirror, mirror 2017: International comparison reflects flaws and opportunities for better U.S. health care. The Commonwealth Fund. Published Jul 14, 2017. Accessed Oct 19, 2017. http://www.commonwealthfund.org/publications/fund-reports/2017/jul/mirror-mirror-international-comparisons-2017.

4. Martinez ME et al. Health insurance coverage: Early release of estimates from the national health interview survey, January-September 2016. Centers for Disease Control and Prevention, Division of Health Interview Statistics, National Center for Health Statistics. Published Feb, 2017. Accessed Oct 19, 2017. https://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201702.pdf.

5. Papanicolas I et al. Challenges in international comparison of health care systems. JAMA. 2017 Aug 8;318(6):515-6. https://jamanetwork.com/journals/jama/article-abstract/2646461.

6. Schneider EC et al. From last to first – Could the U.S. health care system become the best in the world? N Engl J Med. 2017 Sep 7; 377(10):901-4.

Since 2010, when Democrats passed the Affordable Care Act – also known as Obamacare – without a single Republican vote, the GOP has vowed to repeal and replace it. With the election of Donald Trump in November 2016, Republicans gained control of the presidency and Congress and hoped to put Obamacare on the chopping block.

Although the Affordable Care Act’s (ACA’s) individual mandate was eliminated in the Tax Cuts and Jobs Act passed in late 2017, Republican leaders have been unable to secure the votes they need for a full repeal of Obamacare and a complete reboot of the American health care system. That may be, in part, because in the search for a better American health care system, there is no single right answer. In few places is that more clear than when making comparisons of health care systems across the world.

“Comparisons are fun, and everyone loves rankings,” said Ashish Jha, MD, MPH, a physician with the Harvard T.H. Chan School of Public Health and director of the Harvard Global Health Institute in Cambridge, Mass. Last fall Shah published an analysis on his personal blog comparing health care in the United States with that in seven high-income nations.¹ It was prompted by a similar side-by-side comparison he participated in with other experts for the New York Times.² “The most important part is we get to ask questions about things we care about, like ‘What do other countries do when they’re better than us?’ We’re not going to adopt any country’s model wholesale, but we can learn from them,” he said.

For instance, just 7.4% of people in Switzerland (according to data from the Organisation for Economic Cooperation and Development) skip medical tests, treatments, or follow-ups because of costs, compared with 21.3% in the United States. Meanwhile, the United States leads in innovation, producing 57% of new drugs (according to the Milken Institute), which is more than Switzerland’s 13% and Germany’s 6%.¹

Although many Americans tend to think that health care in other developed nations is entirely single payer or government run, systems across Europe and the rest of the globe vary immensely in how they approach health care. One thing common among high-income nations, however, is some form of universal health care. In Canada, for example, the government funds health insurance for care delivered in the private sector. In Australia, public hospitals provide free inpatient care. In France, the Ministry of Health sets prices, budgets, and funding levels.²

“There are really two main purposes” when it comes to international comparisons, said Eric Schneider, MD, senior vice president for policy and research for the Commonwealth Fund. “The first is to understand how other countries perform, and the second is what lessons can we learn from the way care is financed, organized, and delivered in other nations and how we might import some of those ideas to the U.S. and improve policies here.”

The Affordable Care Act, Dr. Jha said, was something of the ultimate test for applying lessons learned in other countries and those put forward over the past decades in the United States by policy experts and leaders in health care thinking.

“The Affordable Care Act includes several ideas that are prevalent in other countries, particularly around how to expand insurance coverage and how to subsidize the poor so they can have good insurance coverage, too,” said Dr. Schneider. “The notion of essential health benefits, the mandate for insurance, the notion of subsidies, in some ways, these were all borrowed from abroad.”

For instance, health care in The Netherlands – which, like the United States, also relies on private health insurers – ranked among the highest of other high-income countries in the world in The Commonwealth Fund’s 2017 international comparison, published in July 2017.³ The Dutch have standardized their health benefits, reducing administrative burden for providers and making copayments more predictable for patients.

Dr. Schneider believes that the United States should continue to build on the progress of the Affordable Care Act – particularly since more than 20 million Americans have gained insurance coverage since the passage of the law (91% of Americans are insured today).⁴ And the ACA has renewed focus in the United States on improving and strengthening primary care and changing the incentives around care delivery.

Some Democrats and Republicans in Congress have started working on bipartisan solutions to solve some of the problems inherent in the ACA – or those engineered by those who oppose it.

References

1. Jha A. Judging health systems: focusing on what matters. An Ounce of Evidence. Published Sep 18, 2017. Last accessed Oct 19, 2017. https://blogs.sph.harvard.edu/ashish-jha/.

2. Carroll AE et al. The best health care system in the world: Which one would you pick? New York Times. Published Sep 18, 2017. Accessed Oct 19, 2017. https://www.nytimes.com/interactive/2017/09/18/upshot/best-health-care-system-country-bracket.html?action=click&contentCollection=upshot&region=rank&module=package&version=highlights&contentPlacement=1&pgtype=sectionfront.

3. Schneider EC et al. Mirror, mirror 2017: International comparison reflects flaws and opportunities for better U.S. health care. The Commonwealth Fund. Published Jul 14, 2017. Accessed Oct 19, 2017. http://www.commonwealthfund.org/publications/fund-reports/2017/jul/mirror-mirror-international-comparisons-2017.

4. Martinez ME et al. Health insurance coverage: Early release of estimates from the national health interview survey, January-September 2016. Centers for Disease Control and Prevention, Division of Health Interview Statistics, National Center for Health Statistics. Published Feb, 2017. Accessed Oct 19, 2017. https://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201702.pdf.

5. Papanicolas I et al. Challenges in international comparison of health care systems. JAMA. 2017 Aug 8;318(6):515-6. https://jamanetwork.com/journals/jama/article-abstract/2646461.

6. Schneider EC et al. From last to first – Could the U.S. health care system become the best in the world? N Engl J Med. 2017 Sep 7; 377(10):901-4.

Since 2010, when Democrats passed the Affordable Care Act – also known as Obamacare – without a single Republican vote, the GOP has vowed to repeal and replace it. With the election of Donald Trump in November 2016, Republicans gained control of the presidency and Congress and hoped to put Obamacare on the chopping block.

Although the Affordable Care Act’s (ACA’s) individual mandate was eliminated in the Tax Cuts and Jobs Act passed in late 2017, Republican leaders have been unable to secure the votes they need for a full repeal of Obamacare and a complete reboot of the American health care system. That may be, in part, because in the search for a better American health care system, there is no single right answer. In few places is that more clear than when making comparisons of health care systems across the world.

“Comparisons are fun, and everyone loves rankings,” said Ashish Jha, MD, MPH, a physician with the Harvard T.H. Chan School of Public Health and director of the Harvard Global Health Institute in Cambridge, Mass. Last fall Shah published an analysis on his personal blog comparing health care in the United States with that in seven high-income nations.¹ It was prompted by a similar side-by-side comparison he participated in with other experts for the New York Times.² “The most important part is we get to ask questions about things we care about, like ‘What do other countries do when they’re better than us?’ We’re not going to adopt any country’s model wholesale, but we can learn from them,” he said.

For instance, just 7.4% of people in Switzerland (according to data from the Organisation for Economic Cooperation and Development) skip medical tests, treatments, or follow-ups because of costs, compared with 21.3% in the United States. Meanwhile, the United States leads in innovation, producing 57% of new drugs (according to the Milken Institute), which is more than Switzerland’s 13% and Germany’s 6%.¹

Although many Americans tend to think that health care in other developed nations is entirely single payer or government run, systems across Europe and the rest of the globe vary immensely in how they approach health care. One thing common among high-income nations, however, is some form of universal health care. In Canada, for example, the government funds health insurance for care delivered in the private sector. In Australia, public hospitals provide free inpatient care. In France, the Ministry of Health sets prices, budgets, and funding levels.²

“There are really two main purposes” when it comes to international comparisons, said Eric Schneider, MD, senior vice president for policy and research for the Commonwealth Fund. “The first is to understand how other countries perform, and the second is what lessons can we learn from the way care is financed, organized, and delivered in other nations and how we might import some of those ideas to the U.S. and improve policies here.”

The Affordable Care Act, Dr. Jha said, was something of the ultimate test for applying lessons learned in other countries and those put forward over the past decades in the United States by policy experts and leaders in health care thinking.

“The Affordable Care Act includes several ideas that are prevalent in other countries, particularly around how to expand insurance coverage and how to subsidize the poor so they can have good insurance coverage, too,” said Dr. Schneider. “The notion of essential health benefits, the mandate for insurance, the notion of subsidies, in some ways, these were all borrowed from abroad.”

For instance, health care in The Netherlands – which, like the United States, also relies on private health insurers – ranked among the highest of other high-income countries in the world in The Commonwealth Fund’s 2017 international comparison, published in July 2017.³ The Dutch have standardized their health benefits, reducing administrative burden for providers and making copayments more predictable for patients.

Dr. Schneider believes that the United States should continue to build on the progress of the Affordable Care Act – particularly since more than 20 million Americans have gained insurance coverage since the passage of the law (91% of Americans are insured today).⁴ And the ACA has renewed focus in the United States on improving and strengthening primary care and changing the incentives around care delivery.

Some Democrats and Republicans in Congress have started working on bipartisan solutions to solve some of the problems inherent in the ACA – or those engineered by those who oppose it.

References

1. Jha A. Judging health systems: focusing on what matters. An Ounce of Evidence. Published Sep 18, 2017. Last accessed Oct 19, 2017. https://blogs.sph.harvard.edu/ashish-jha/.

2. Carroll AE et al. The best health care system in the world: Which one would you pick? New York Times. Published Sep 18, 2017. Accessed Oct 19, 2017. https://www.nytimes.com/interactive/2017/09/18/upshot/best-health-care-system-country-bracket.html?action=click&contentCollection=upshot&region=rank&module=package&version=highlights&contentPlacement=1&pgtype=sectionfront.

3. Schneider EC et al. Mirror, mirror 2017: International comparison reflects flaws and opportunities for better U.S. health care. The Commonwealth Fund. Published Jul 14, 2017. Accessed Oct 19, 2017. http://www.commonwealthfund.org/publications/fund-reports/2017/jul/mirror-mirror-international-comparisons-2017.

4. Martinez ME et al. Health insurance coverage: Early release of estimates from the national health interview survey, January-September 2016. Centers for Disease Control and Prevention, Division of Health Interview Statistics, National Center for Health Statistics. Published Feb, 2017. Accessed Oct 19, 2017. https://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201702.pdf.

5. Papanicolas I et al. Challenges in international comparison of health care systems. JAMA. 2017 Aug 8;318(6):515-6. https://jamanetwork.com/journals/jama/article-abstract/2646461.

6. Schneider EC et al. From last to first – Could the U.S. health care system become the best in the world? N Engl J Med. 2017 Sep 7; 377(10):901-4.

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]