Clinical

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

Clinical question: Is an oral direct factor Xa inhibitor an effective alternative to low-molecular-weight heparin (LMWH) in treating cancer related venous thromboembolism (VTE)?

Background: LMWH has been the standard of care for treatment in patients with VTE and cancer. A newer class of drug, the direct factor Xa inhibitors, have been shown to be noninferior to vitamin K antagonists (VKAs) in treatment of VTE in noncancer patients, but little is known about their use in patients with cancer.

Study Design: Randomized, open-label, multicenter pilot trial.

Setting: United Kingdom; patients were recruited through the Clinical Trials Unit at the University of Warwick, Coventry.

Synopsis: The authors randomly assigned 406 cancer patients with diagnosed VTE either to the LMWH group or to the oral direct factor Xa inhibitor group to evaluate the primary endpoint of VTE reoccurrence and secondary endpoints of major bleeding or clinically relevant but not major bleeding (CRNMB). Rivaroxaban was noninferior to dalteparin in preventing VTE reoccurrence, with a 6-month VTE reoccurrence rate for dalteparin of 11% (95% confidence interval, 7%-16%) and a reoccurrence rate of 6% for rivaroxaban (95% CI, 2%-9%). Rates of major bleeding events were similar, although patients with esophageal or gastroesophageal cancers tended to experience more major bleeds with rivaroxaban than with dalteparin (4 of 11 vs. 1 of 19). CRNMB was 4% for dalteparin and 13% for rivaroxaban (hazard ratio, 3.76; 95% CI, 1.64-8.69). Limitations include slow recruitment, high mortality rate, and the treatment length being only 6 months.

Bottom line: In this small study, rivaroxaban was equally effective at reducing the rate of reoccurrence of cancer related VTE at 6 months but had higher rates of CRNMB. Patients with GI cancers may be at higher risk for major GI bleeding with rivaroxaban.

Citation: Young AM et al. Comparison of an oral factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: Results of a randomized trial (SELECT-D). J Clin Oncol. 2018 Jul 10. 36(20):2017-23.

Dr. Marten is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Is an oral direct factor Xa inhibitor an effective alternative to low-molecular-weight heparin (LMWH) in treating cancer related venous thromboembolism (VTE)?

Background: LMWH has been the standard of care for treatment in patients with VTE and cancer. A newer class of drug, the direct factor Xa inhibitors, have been shown to be noninferior to vitamin K antagonists (VKAs) in treatment of VTE in noncancer patients, but little is known about their use in patients with cancer.

Study Design: Randomized, open-label, multicenter pilot trial.

Setting: United Kingdom; patients were recruited through the Clinical Trials Unit at the University of Warwick, Coventry.

Synopsis: The authors randomly assigned 406 cancer patients with diagnosed VTE either to the LMWH group or to the oral direct factor Xa inhibitor group to evaluate the primary endpoint of VTE reoccurrence and secondary endpoints of major bleeding or clinically relevant but not major bleeding (CRNMB). Rivaroxaban was noninferior to dalteparin in preventing VTE reoccurrence, with a 6-month VTE reoccurrence rate for dalteparin of 11% (95% confidence interval, 7%-16%) and a reoccurrence rate of 6% for rivaroxaban (95% CI, 2%-9%). Rates of major bleeding events were similar, although patients with esophageal or gastroesophageal cancers tended to experience more major bleeds with rivaroxaban than with dalteparin (4 of 11 vs. 1 of 19). CRNMB was 4% for dalteparin and 13% for rivaroxaban (hazard ratio, 3.76; 95% CI, 1.64-8.69). Limitations include slow recruitment, high mortality rate, and the treatment length being only 6 months.

Bottom line: In this small study, rivaroxaban was equally effective at reducing the rate of reoccurrence of cancer related VTE at 6 months but had higher rates of CRNMB. Patients with GI cancers may be at higher risk for major GI bleeding with rivaroxaban.

Citation: Young AM et al. Comparison of an oral factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: Results of a randomized trial (SELECT-D). J Clin Oncol. 2018 Jul 10. 36(20):2017-23.

Dr. Marten is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Is an oral direct factor Xa inhibitor an effective alternative to low-molecular-weight heparin (LMWH) in treating cancer related venous thromboembolism (VTE)?

Background: LMWH has been the standard of care for treatment in patients with VTE and cancer. A newer class of drug, the direct factor Xa inhibitors, have been shown to be noninferior to vitamin K antagonists (VKAs) in treatment of VTE in noncancer patients, but little is known about their use in patients with cancer.

Study Design: Randomized, open-label, multicenter pilot trial.

Setting: United Kingdom; patients were recruited through the Clinical Trials Unit at the University of Warwick, Coventry.

Synopsis: The authors randomly assigned 406 cancer patients with diagnosed VTE either to the LMWH group or to the oral direct factor Xa inhibitor group to evaluate the primary endpoint of VTE reoccurrence and secondary endpoints of major bleeding or clinically relevant but not major bleeding (CRNMB). Rivaroxaban was noninferior to dalteparin in preventing VTE reoccurrence, with a 6-month VTE reoccurrence rate for dalteparin of 11% (95% confidence interval, 7%-16%) and a reoccurrence rate of 6% for rivaroxaban (95% CI, 2%-9%). Rates of major bleeding events were similar, although patients with esophageal or gastroesophageal cancers tended to experience more major bleeds with rivaroxaban than with dalteparin (4 of 11 vs. 1 of 19). CRNMB was 4% for dalteparin and 13% for rivaroxaban (hazard ratio, 3.76; 95% CI, 1.64-8.69). Limitations include slow recruitment, high mortality rate, and the treatment length being only 6 months.

Bottom line: In this small study, rivaroxaban was equally effective at reducing the rate of reoccurrence of cancer related VTE at 6 months but had higher rates of CRNMB. Patients with GI cancers may be at higher risk for major GI bleeding with rivaroxaban.

Citation: Young AM et al. Comparison of an oral factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: Results of a randomized trial (SELECT-D). J Clin Oncol. 2018 Jul 10. 36(20):2017-23.

Dr. Marten is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Does early renal replacement therapy (RRT) initiation affect clinical outcomes in patients with severe acute kidney injury (AKI) in the setting of septic shock or acute respiratory distress syndrome (ARDS)?

Background: Critically ill patients with AKI can benefit from RRT via improvement of electrolyte abnormalities, volume overload, and acid-base status. Potential harm from RRT includes complications of central venous access, intradialytic hypotension, and the bleeding risk of anticoagulation. The optimal timing of the elective initiation of RRT for AKI in septic shock or ARDS is unknown.

Study design: A post hoc subgroup study of a randomized, controlled trial.

Setting: Thirty-one ICUs in France.

Synopsis: Using data from the Artificial Kidney Initiation in Kidney Injury trial, the authors evaluated 619 patients with severe AKI and requirement for catecholamine infusion and/or invasive mechanical ventilation. Patients were randomly given RRT in an early or a delayed time frame. The early strategy involved RRT as soon as possible after randomization. In addition to the other parameters, the patients in the delayed group were given RRT for the following: anuria/oliguria 72 hours after randomization, blood urea nitrogen greater than 112 mg/dL, serum potassium greater than 6 mmol/L, metabolic acidosis with pH less than 7.15, or pulmonary edema from fluid overload causing severe hypoxia.

Early RRT did not show significant improvement in 60-day mortality, length of mechanical ventilation, or length of stay, compared with delayed RRT. The delayed RRT strategy was significantly associated with renal function recovery, with hazard ratios of 1.7 in ARDS (P = .009) and 1.9 in septic shock (P less than .001). Additionally, the likelihood of adequate urinary output was greater in the delayed RRT group.

Bottom line: A delayed RRT strategy in those with severe AKI and septic shock or ARDS may safely afford time for renal recovery in some patients.

Citation: Gaudry S et al. Timing of renal support and outcome of septic shock and acute respiratory distress syndrome. A post hoc analysis of the AKIKI randomized clinical trial. Am J Respir Crit Care Med. 2018;198(1):58-66.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta.

Clinical question: Does early renal replacement therapy (RRT) initiation affect clinical outcomes in patients with severe acute kidney injury (AKI) in the setting of septic shock or acute respiratory distress syndrome (ARDS)?

Background: Critically ill patients with AKI can benefit from RRT via improvement of electrolyte abnormalities, volume overload, and acid-base status. Potential harm from RRT includes complications of central venous access, intradialytic hypotension, and the bleeding risk of anticoagulation. The optimal timing of the elective initiation of RRT for AKI in septic shock or ARDS is unknown.

Study design: A post hoc subgroup study of a randomized, controlled trial.

Setting: Thirty-one ICUs in France.

Synopsis: Using data from the Artificial Kidney Initiation in Kidney Injury trial, the authors evaluated 619 patients with severe AKI and requirement for catecholamine infusion and/or invasive mechanical ventilation. Patients were randomly given RRT in an early or a delayed time frame. The early strategy involved RRT as soon as possible after randomization. In addition to the other parameters, the patients in the delayed group were given RRT for the following: anuria/oliguria 72 hours after randomization, blood urea nitrogen greater than 112 mg/dL, serum potassium greater than 6 mmol/L, metabolic acidosis with pH less than 7.15, or pulmonary edema from fluid overload causing severe hypoxia.

Early RRT did not show significant improvement in 60-day mortality, length of mechanical ventilation, or length of stay, compared with delayed RRT. The delayed RRT strategy was significantly associated with renal function recovery, with hazard ratios of 1.7 in ARDS (P = .009) and 1.9 in septic shock (P less than .001). Additionally, the likelihood of adequate urinary output was greater in the delayed RRT group.

Bottom line: A delayed RRT strategy in those with severe AKI and septic shock or ARDS may safely afford time for renal recovery in some patients.

Citation: Gaudry S et al. Timing of renal support and outcome of septic shock and acute respiratory distress syndrome. A post hoc analysis of the AKIKI randomized clinical trial. Am J Respir Crit Care Med. 2018;198(1):58-66.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta.

Clinical question: Does early renal replacement therapy (RRT) initiation affect clinical outcomes in patients with severe acute kidney injury (AKI) in the setting of septic shock or acute respiratory distress syndrome (ARDS)?

Background: Critically ill patients with AKI can benefit from RRT via improvement of electrolyte abnormalities, volume overload, and acid-base status. Potential harm from RRT includes complications of central venous access, intradialytic hypotension, and the bleeding risk of anticoagulation. The optimal timing of the elective initiation of RRT for AKI in septic shock or ARDS is unknown.

Study design: A post hoc subgroup study of a randomized, controlled trial.

Setting: Thirty-one ICUs in France.

Synopsis: Using data from the Artificial Kidney Initiation in Kidney Injury trial, the authors evaluated 619 patients with severe AKI and requirement for catecholamine infusion and/or invasive mechanical ventilation. Patients were randomly given RRT in an early or a delayed time frame. The early strategy involved RRT as soon as possible after randomization. In addition to the other parameters, the patients in the delayed group were given RRT for the following: anuria/oliguria 72 hours after randomization, blood urea nitrogen greater than 112 mg/dL, serum potassium greater than 6 mmol/L, metabolic acidosis with pH less than 7.15, or pulmonary edema from fluid overload causing severe hypoxia.

Early RRT did not show significant improvement in 60-day mortality, length of mechanical ventilation, or length of stay, compared with delayed RRT. The delayed RRT strategy was significantly associated with renal function recovery, with hazard ratios of 1.7 in ARDS (P = .009) and 1.9 in septic shock (P less than .001). Additionally, the likelihood of adequate urinary output was greater in the delayed RRT group.

Bottom line: A delayed RRT strategy in those with severe AKI and septic shock or ARDS may safely afford time for renal recovery in some patients.

Citation: Gaudry S et al. Timing of renal support and outcome of septic shock and acute respiratory distress syndrome. A post hoc analysis of the AKIKI randomized clinical trial. Am J Respir Crit Care Med. 2018;198(1):58-66.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta.

NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.

Mitchel L. Zoler/MDedge News

Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.

He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).

The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.

“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.

“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.

Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.

[email protected]

NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.

Mitchel L. Zoler/MDedge News

Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.

He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).

The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.

“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.

“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.

Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.

[email protected]

NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.

Mitchel L. Zoler/MDedge News

Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.

He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).

The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.

“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.

“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.

Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.

[email protected]

The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.

The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.

Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.

“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.

Find the full statement by Dr. Throckmorton on the FDA website.

[email protected]

The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.

The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.

Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.

“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.

Find the full statement by Dr. Throckmorton on the FDA website.

[email protected]

The Food and Drug Administration is making changes to opioid analgesic labeling to give better information to clinicians on how to properly taper patients dependent on opioid use, according to Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has recently received reports that patients physically dependent on opioid pain medicines who are taken off their medication too quickly have experienced serious adverse events, such as withdrawal symptoms, uncontrolled pain, and suicide. Both the FDA and the Centers for Disease Control and Prevention offer guidelines on how to properly taper opioids, Dr. Throckmorton said, but more needs to be done to ensure that patients are being provided with the correct advice and care.

The changes to the labels will include expanded information to health care clinicians and are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage. When this is discussed, factors that should be considered include the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.

Other actions the FDA is pursuing to combat opioid use disorder include working with the National Academies of Sciences, Engineering, and Medicine on guidelines for the proper opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, and advancing policies that make immediate-release opioid formulations available in fixed-quantity packaging for 1 or 2 days.

“The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids,” Dr. Throckmorton said.

Find the full statement by Dr. Throckmorton on the FDA website.

[email protected]

Clinical question: Does sodium bicarbonate treatment improve clinical outcomes in critically ill patients with severe metabolic acidosis?

Background: Severe acidemia is associated with impaired cardiac function, decreased perfusion, and increased mortality. Many physicians use sodium bicarbonate to improve hemodynamic stability in critically ill patients with acidemia. However, the use of sodium bicarbonate in this role remains controversial because the evidence to support it is limited.

Study design: Multicenter, open-label, randomized, controlled trial.

Setting: Twenty-six ICUs in France.

Synopsis: Investigators randomized 389 adult patients with severe acidemia and Sequential Organ Failure Assessment (SOFA) scores of 4 or greater or serum lactate level of 2 mmol/L or greater to receive either no sodium bicarbonate or 4.2% intravenous sodium bicarbonate. The primary composite outcome was at least organ failure at day 7 or mortality by day 28.

When compared as a whole, the treatment group did not demonstrate improvement in the primary outcome. However, patients with Acute Kidney Injury Network scores of 2 or 3 at enrollment who received bicarbonate had lower rates of the composite primary outcome (70% vs. 82%; P = .462). Additionally, 35% of the treatment group utilized a renal replacement therapy (RRT) during their ICU stay versus 52% of the control group (P = .0009).

Limitations of the study included unblinding of the ICU physicians and the lack of a control intravenous solution. Notably, 47 of the 194 patients in the control group received sodium bicarbonate as salvage therapy.

Bottom line: Sodium bicarbonate treatment may decrease the need for RRT in patients with significant metabolic acidemia and may decrease the likelihood of death or organ failure in those with severe acute kidney injury.

Citation: Jaber S et al. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): A multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018;392(10141):31-40.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta

Clinical question: Does sodium bicarbonate treatment improve clinical outcomes in critically ill patients with severe metabolic acidosis?

Background: Severe acidemia is associated with impaired cardiac function, decreased perfusion, and increased mortality. Many physicians use sodium bicarbonate to improve hemodynamic stability in critically ill patients with acidemia. However, the use of sodium bicarbonate in this role remains controversial because the evidence to support it is limited.

Study design: Multicenter, open-label, randomized, controlled trial.

Setting: Twenty-six ICUs in France.

Synopsis: Investigators randomized 389 adult patients with severe acidemia and Sequential Organ Failure Assessment (SOFA) scores of 4 or greater or serum lactate level of 2 mmol/L or greater to receive either no sodium bicarbonate or 4.2% intravenous sodium bicarbonate. The primary composite outcome was at least organ failure at day 7 or mortality by day 28.

When compared as a whole, the treatment group did not demonstrate improvement in the primary outcome. However, patients with Acute Kidney Injury Network scores of 2 or 3 at enrollment who received bicarbonate had lower rates of the composite primary outcome (70% vs. 82%; P = .462). Additionally, 35% of the treatment group utilized a renal replacement therapy (RRT) during their ICU stay versus 52% of the control group (P = .0009).

Limitations of the study included unblinding of the ICU physicians and the lack of a control intravenous solution. Notably, 47 of the 194 patients in the control group received sodium bicarbonate as salvage therapy.

Bottom line: Sodium bicarbonate treatment may decrease the need for RRT in patients with significant metabolic acidemia and may decrease the likelihood of death or organ failure in those with severe acute kidney injury.

Citation: Jaber S et al. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): A multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018;392(10141):31-40.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta

Clinical question: Does sodium bicarbonate treatment improve clinical outcomes in critically ill patients with severe metabolic acidosis?

Background: Severe acidemia is associated with impaired cardiac function, decreased perfusion, and increased mortality. Many physicians use sodium bicarbonate to improve hemodynamic stability in critically ill patients with acidemia. However, the use of sodium bicarbonate in this role remains controversial because the evidence to support it is limited.

Study design: Multicenter, open-label, randomized, controlled trial.

Setting: Twenty-six ICUs in France.

Synopsis: Investigators randomized 389 adult patients with severe acidemia and Sequential Organ Failure Assessment (SOFA) scores of 4 or greater or serum lactate level of 2 mmol/L or greater to receive either no sodium bicarbonate or 4.2% intravenous sodium bicarbonate. The primary composite outcome was at least organ failure at day 7 or mortality by day 28.

When compared as a whole, the treatment group did not demonstrate improvement in the primary outcome. However, patients with Acute Kidney Injury Network scores of 2 or 3 at enrollment who received bicarbonate had lower rates of the composite primary outcome (70% vs. 82%; P = .462). Additionally, 35% of the treatment group utilized a renal replacement therapy (RRT) during their ICU stay versus 52% of the control group (P = .0009).

Limitations of the study included unblinding of the ICU physicians and the lack of a control intravenous solution. Notably, 47 of the 194 patients in the control group received sodium bicarbonate as salvage therapy.

Bottom line: Sodium bicarbonate treatment may decrease the need for RRT in patients with significant metabolic acidemia and may decrease the likelihood of death or organ failure in those with severe acute kidney injury.

Citation: Jaber S et al. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): A multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018;392(10141):31-40.

Dr. James is a hospitalist at Emory University Hospital Midtown and an assistant professor at Emory University, both in Atlanta

Presenter

Erin Shaughnessy, MD, MSHCM

Session title

Reaching Across the Aisle: Pediatric Co-Management with Surgery and Subspecialists

Session summary

Dr. Shaughnessy articulated a balanced approach to the importance of careful selection of patients needing to be co-managed by pediatric hospitalists. She compared two personal and very different experiences.

She initially managed a well-developed surgical co-management service at a quaternary, academic, free-standing children’s hospital, in which surgeons and subspecialists also admitted and managed patients to their own services. Currently, Dr. Shaughnessy is a division chief at Phoenix Children’s Hospital, a free-standing children’s hospital with a community hospital background, in which hospitalists admit most, if not all the patients, while subspecialty services have been transitioning only recently to having their own admitting services and employing the ideas of limited co-management.

She reminded the HM19 audience of the essential principles of co-management: shared responsibility, authority and accountability for the care of a hospitalized patient, discussing the scenarios, both from literature and real life, in which the line could become blurry at times.

Many pediatric programs are moving away from a traditional consultation model, Dr. Shaughnessy said, in which a consult is called for a new or a persistent problem with a patient, and where a consulting team signs off upon the resolved issue.

The more modern co-management model infuses a need for anticipatory and prevention-heavy approach, intertwined with fiscally responsible ideas that must be palatable for all: administration, hospitalists, and patients.

Dr. Shaughnessy reviewed a number of articles from both adult and pediatric literature with varied results, some that have shown decreased length of stay, decreased number of medical complications, decreased readmissions, decreased number of tests, but some that have also shown an increase in median hospital costs, emphasizing perhaps the importance of context in which one practices.

Finally, she identified patient selection, collaborative relationships, clear roles delineation, and excellence in communication as four main factors deciding the faith of a co-management model.
 

Key takeaways for HM

1. Careful selection of patients to be co-managed is essential and can prevent potential increase in costs and negative outcomes.

2. Success in medical and surgical co-management relies on well-delineated roles, collaborative culture, and immaculate communication.
 

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Presenter

Erin Shaughnessy, MD, MSHCM

Session title

Reaching Across the Aisle: Pediatric Co-Management with Surgery and Subspecialists

Session summary

Dr. Shaughnessy articulated a balanced approach to the importance of careful selection of patients needing to be co-managed by pediatric hospitalists. She compared two personal and very different experiences.

She initially managed a well-developed surgical co-management service at a quaternary, academic, free-standing children’s hospital, in which surgeons and subspecialists also admitted and managed patients to their own services. Currently, Dr. Shaughnessy is a division chief at Phoenix Children’s Hospital, a free-standing children’s hospital with a community hospital background, in which hospitalists admit most, if not all the patients, while subspecialty services have been transitioning only recently to having their own admitting services and employing the ideas of limited co-management.

She reminded the HM19 audience of the essential principles of co-management: shared responsibility, authority and accountability for the care of a hospitalized patient, discussing the scenarios, both from literature and real life, in which the line could become blurry at times.

Many pediatric programs are moving away from a traditional consultation model, Dr. Shaughnessy said, in which a consult is called for a new or a persistent problem with a patient, and where a consulting team signs off upon the resolved issue.

The more modern co-management model infuses a need for anticipatory and prevention-heavy approach, intertwined with fiscally responsible ideas that must be palatable for all: administration, hospitalists, and patients.

Dr. Shaughnessy reviewed a number of articles from both adult and pediatric literature with varied results, some that have shown decreased length of stay, decreased number of medical complications, decreased readmissions, decreased number of tests, but some that have also shown an increase in median hospital costs, emphasizing perhaps the importance of context in which one practices.

Finally, she identified patient selection, collaborative relationships, clear roles delineation, and excellence in communication as four main factors deciding the faith of a co-management model.
 

Key takeaways for HM

1. Careful selection of patients to be co-managed is essential and can prevent potential increase in costs and negative outcomes.

2. Success in medical and surgical co-management relies on well-delineated roles, collaborative culture, and immaculate communication.
 

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Presenter

Erin Shaughnessy, MD, MSHCM

Session title

Reaching Across the Aisle: Pediatric Co-Management with Surgery and Subspecialists

Session summary

Dr. Shaughnessy articulated a balanced approach to the importance of careful selection of patients needing to be co-managed by pediatric hospitalists. She compared two personal and very different experiences.

She initially managed a well-developed surgical co-management service at a quaternary, academic, free-standing children’s hospital, in which surgeons and subspecialists also admitted and managed patients to their own services. Currently, Dr. Shaughnessy is a division chief at Phoenix Children’s Hospital, a free-standing children’s hospital with a community hospital background, in which hospitalists admit most, if not all the patients, while subspecialty services have been transitioning only recently to having their own admitting services and employing the ideas of limited co-management.

She reminded the HM19 audience of the essential principles of co-management: shared responsibility, authority and accountability for the care of a hospitalized patient, discussing the scenarios, both from literature and real life, in which the line could become blurry at times.

Many pediatric programs are moving away from a traditional consultation model, Dr. Shaughnessy said, in which a consult is called for a new or a persistent problem with a patient, and where a consulting team signs off upon the resolved issue.

The more modern co-management model infuses a need for anticipatory and prevention-heavy approach, intertwined with fiscally responsible ideas that must be palatable for all: administration, hospitalists, and patients.

Dr. Shaughnessy reviewed a number of articles from both adult and pediatric literature with varied results, some that have shown decreased length of stay, decreased number of medical complications, decreased readmissions, decreased number of tests, but some that have also shown an increase in median hospital costs, emphasizing perhaps the importance of context in which one practices.

Finally, she identified patient selection, collaborative relationships, clear roles delineation, and excellence in communication as four main factors deciding the faith of a co-management model.
 

Key takeaways for HM

1. Careful selection of patients to be co-managed is essential and can prevent potential increase in costs and negative outcomes.

2. Success in medical and surgical co-management relies on well-delineated roles, collaborative culture, and immaculate communication.
 

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question: How does inferior vena cava (IVC) filter placement affect 30-day mortality in patients with venous thromboembolism (VTE) with increased risk of bleeding when anticoagulation is not feasible?

Background: Standard treatment for VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE), is anticoagulation. However, for patients with active bleeding or increased risk of bleeding, anticoagulation may be contraindicated. In these circumstances, placing an IVC filter is recommended by major professional societies; however, the mortality benefit of IVC filter placement is uncertain.

Study design: A retrospective cohort study.

Setting: State Inpatient and Emergency Department Databases from California, Florida, and New York hospitals from 2005 to 2012.

Synopsis: The authors compared the 30-day mortality rates in 45,771 hospitalized adult patients with inpatient diagnosis codes of PE and/or DVT, as well as a contraindication to anticoagulation, who underwent IVC filter placement with 80,259 similar patients who did not undergo IVC filter placement. Baseline characteristics and coexisting conditions were similar in the two populations. The authors found that patients with IVC filter placement had an increased risk of 30-day mortality, compared with patients without an IVC filter placed (HR, 1.18; 95% CI, 1.13-1.22; P less than .001).

This study used observational data derived from reimbursement codes, which lacked unmeasured confounders (for example, severity of VTE and fragility score), so randomized, controlled trials are required to confirm the results. Nevertheless, this study should prompt physicians to carefully consider decisions to place an IVC filter in the setting of a contraindication to anticoagulation.

Bottom line: IVC filter placement in patients with VTE and contraindication for anticoagulation was associated with an increased 30-day mortality. Randomized, controlled trials are required to confirm the observed results.

Citation: Turner TE et al. Association of inferior vena cava filter placement for venous thromboembolic disease and a contraindication to anticoagulation with 30-day mortality. JAMA Network Open. 2018;1(3):e180452.

Dr. Kobaidze is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: How does inferior vena cava (IVC) filter placement affect 30-day mortality in patients with venous thromboembolism (VTE) with increased risk of bleeding when anticoagulation is not feasible?

Background: Standard treatment for VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE), is anticoagulation. However, for patients with active bleeding or increased risk of bleeding, anticoagulation may be contraindicated. In these circumstances, placing an IVC filter is recommended by major professional societies; however, the mortality benefit of IVC filter placement is uncertain.

Study design: A retrospective cohort study.

Setting: State Inpatient and Emergency Department Databases from California, Florida, and New York hospitals from 2005 to 2012.

Synopsis: The authors compared the 30-day mortality rates in 45,771 hospitalized adult patients with inpatient diagnosis codes of PE and/or DVT, as well as a contraindication to anticoagulation, who underwent IVC filter placement with 80,259 similar patients who did not undergo IVC filter placement. Baseline characteristics and coexisting conditions were similar in the two populations. The authors found that patients with IVC filter placement had an increased risk of 30-day mortality, compared with patients without an IVC filter placed (HR, 1.18; 95% CI, 1.13-1.22; P less than .001).

This study used observational data derived from reimbursement codes, which lacked unmeasured confounders (for example, severity of VTE and fragility score), so randomized, controlled trials are required to confirm the results. Nevertheless, this study should prompt physicians to carefully consider decisions to place an IVC filter in the setting of a contraindication to anticoagulation.

Bottom line: IVC filter placement in patients with VTE and contraindication for anticoagulation was associated with an increased 30-day mortality. Randomized, controlled trials are required to confirm the observed results.

Citation: Turner TE et al. Association of inferior vena cava filter placement for venous thromboembolic disease and a contraindication to anticoagulation with 30-day mortality. JAMA Network Open. 2018;1(3):e180452.

Dr. Kobaidze is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: How does inferior vena cava (IVC) filter placement affect 30-day mortality in patients with venous thromboembolism (VTE) with increased risk of bleeding when anticoagulation is not feasible?

Background: Standard treatment for VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE), is anticoagulation. However, for patients with active bleeding or increased risk of bleeding, anticoagulation may be contraindicated. In these circumstances, placing an IVC filter is recommended by major professional societies; however, the mortality benefit of IVC filter placement is uncertain.

Study design: A retrospective cohort study.

Setting: State Inpatient and Emergency Department Databases from California, Florida, and New York hospitals from 2005 to 2012.

Synopsis: The authors compared the 30-day mortality rates in 45,771 hospitalized adult patients with inpatient diagnosis codes of PE and/or DVT, as well as a contraindication to anticoagulation, who underwent IVC filter placement with 80,259 similar patients who did not undergo IVC filter placement. Baseline characteristics and coexisting conditions were similar in the two populations. The authors found that patients with IVC filter placement had an increased risk of 30-day mortality, compared with patients without an IVC filter placed (HR, 1.18; 95% CI, 1.13-1.22; P less than .001).

This study used observational data derived from reimbursement codes, which lacked unmeasured confounders (for example, severity of VTE and fragility score), so randomized, controlled trials are required to confirm the results. Nevertheless, this study should prompt physicians to carefully consider decisions to place an IVC filter in the setting of a contraindication to anticoagulation.

Bottom line: IVC filter placement in patients with VTE and contraindication for anticoagulation was associated with an increased 30-day mortality. Randomized, controlled trials are required to confirm the observed results.

Citation: Turner TE et al. Association of inferior vena cava filter placement for venous thromboembolic disease and a contraindication to anticoagulation with 30-day mortality. JAMA Network Open. 2018;1(3):e180452.

Dr. Kobaidze is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?

BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.

STUDY DESIGN: Prospective cohort study.

SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.

At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.

The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.

BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.

CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.

Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?

BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.

STUDY DESIGN: Prospective cohort study.

SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.

At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.

The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.

BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.

CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.

Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?

BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.

STUDY DESIGN: Prospective cohort study.

SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.

At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.

The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.

BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.

CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.

Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.