A 70-year old woman with hypertension, diabetes, nonischemic stroke, moderate renal insufficiency (creatinine clearance [CrCl] 45 mL/min), heart failure, and nonvalvular atrial fibrillation (AF) on warfarin is admitted because of a very supratherapeutic INR. She reports labile INR values despite strict adherence to her medication regimen. Her cancer screening tests had previously been unremarkable. She inquires about the risks and benefits of switching to a novel oral anticoagulant (NOAC) as advertised on television. Should you consider it while she is still in the hospital?
Brief overview of the issue
Lifelong anticoagulation therapy is common among patients with AF or recurrent venous thromboembolism (VTE). Until the advent of NOACs, a great majority of patients were prescribed warfarin, the oral vitamin K antagonist that requires regular blood tests for monitoring of the INR. In contrast to warfarin, NOACs are direct-acting agents (hence also known as “direct oral anticoagulants” or DOACs) that are selective for one specific coagulation factor, either thrombin (e.g., dabigatran) or factor Xa (e.g., rivaroxaban, apixaban, and edoxaban, all with an “X” in their names).
Dr. Farrin A. Manian
NOACS have been studied and approved by the Food and Drug Administration for nonvalvular AF, i.e., patients without rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or prior mitral valve repair. Compared to warfarin, NOACS have fewer drug or food interactions, have more predictable pharmacokinetics, and may be associated with reduced risk of major bleeding depending on the agent. The latter is a particularly attractive feature of NOAC therapy, especially when its use is considered among older patients at risk of intracranial hemorrhage (ICH), such as those with previous strokes, ICH, or reduced renal function. Unfortunately, data on the efficacy and safety of the use of NOACs in certain patient populations (e.g., those with severe renal insufficiency, active malignancy, the elderly, patients with suboptimal medication adherence) are generally lacking.
Overview of the data
There are no randomized controlled trials (RCTs) addressing the clinical benefits of switching from warfarin to NOAC therapy. However, based on a number of RCTs comparing warfarin to individual NOACs and their related meta-analyses, the following conclusions may be made about their attributes:
1. Noninferiority to warfarin in reducing the risk of ischemic stroke in AF.
2. Association with a lower rate of major bleeds (statistically significant or trend) and a lower rate of ICH and hemorrhagic strokes compared to warfarin.
3. Association with a higher rate of gastrointestinal bleeding compared to warfarin (except for apixaban, low-dose dabigatran, and edoxaban1).
4. Association with a decreased rate of all stroke and thromboembolism events compared to warfarin.
5. Association with a slightly decreased all-cause mortality in AF compared to warfarin in many studies,2-8 but not all.1,9
6. Noninferiority to warfarin in all-cause mortality in patients with VTE and for its secondary prevention.1,4 NOACS should be used with caution or avoided altogether in patients with severe liver disease or renal insufficiency (see Table 1).
Potential advantages and disadvantages of NOAC therapy are listed in Table 2.
It should be emphasized that in patients with cancer or hypercoagulable state, no clear efficacy or safety data are currently available for the use of NOACs.
Dr. Jeff E. Liao
The 2016 CHEST guideline on antithrombotic therapy for VTE recommends NOACs over warfarin.10 The 2012 European Society of Cardiology AF guidelines also recommend NOACs over warfarin.11 However, the 2014 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines on AF state that it is not necessary to change to a NOAC when patients are “stable, easily controlled, and satisfied with warfarin therapy.”12
Data from a relatively small, short-term study examining the safety of switching patients from warfarin to a NOAC suggest that although bleeding events are relatively common (12%) following such a switch, major bleeding and cardiac or cerebrovascular events are rare.10
Application of the data to our original case
Given a high calculated CHADS2VASC score of 8 in our patient, she has a clear indication for anticoagulation for AF. Her history of labile INRs, ischemic stroke, and moderate renal insufficiency place her at high risk for ICH.
A NOAC may reduce this risk but possibly at the expense of an increased risk for a gastrointestinal bleed. More importantly, however, she may be a good candidate for a switch to a NOAC because of her labile INRs despite good medication adherence. Her warfarin can be held while hospitalized and a NOAC may be initiated when the INR falls below 2.
Dr. Benjamin P. Geisler Prior to discharge, potential cost of the drug to the patient should be explored and discussed. It is also important to involve the primary care physician in the decision-making process. Ultimately, selection of an appropriate NOAC should be based on a careful review of its risks and benefits, clinical factors, patient preference, and shared decision making.
Bottom line
Hospitalists are in a great position to discuss a switch to a NOAC in selected patients with history of good medication adherence and labile INRs or ICH risk factors.
Dr. Geisler, Dr. Liao, and Dr. Manian are hospitalists at Massachusetts General Hospital in Boston.
References
1. Sharma M et al. Efficacy and harms of direct oral anticoagulants in the elderly for stroke prevention in atrial fibrillation and secondary prevention of venous thromboembolism: Systematic review and meta-analysis. Circulation. 2015;132(3):194-204.
2. Ruff CT et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62.
3. Dentali F et al. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: A systematic review and meta-analysis of the literature. Circulation. 2012;126(20):2381-91.
4. Adam SS et al. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: A systematic review. Ann Intern Med. 2012;157(11):796-807.
5. Bruins Slot KM and Berge E. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2013(8):CD008980.
6. Gomez-Outes A et al. Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of subgroups. Thrombosis. 2013;2013:640723.
7. Miller CS et al. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012;110(3):453-60.
8. Baker WL and Phung OJ. Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2012;5(5):711-19.
9. Ntaios G et al. Nonvitamin-K-antagonist oral anticoagulants in patients with atrial fibrillation and previous stroke or transient ischemic attack: A systematic review and meta-analysis of randomized controlled trials. Stroke. 2012;43(12):3298-304.
10. Kearon C et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149(2):315-52.
11. Camm AJ et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation – developed with the special contribution of the European Heart Rhythm Association. Europace. 2012;14(10):1385-413.
12. January CT et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-267.
Quiz
When considering a switch from warfarin to a NOAC, all the following factors should be considered a potential advantage, except:
A. No need for routing lab monitoring.
B. Lower risk of gastrointestinal bleeding.
C. Fewer drug interactions.
D. Lower rates of intracranial bleed and hemorrhagic stroke.
The correct answer is B. NOACs have been associated with lower risk of intracranial bleed and hemorrhagic stroke but not gastrointestinal bleed. Routine lab monitoring is not necessary during their use and they are associated with fewer drug interactions compared to warfarin.
Key Points
NOACs represent a clear advancement in our anticoagulation armamentarium.
Potential advantages of their use include lower rates of intracranial bleed and hemorrhagic strokes, fewer drug or food interactions, and lack of need for routing lab monitoring.
Potential disadvantages of their use include increased rates of gastrointestinal bleed with some agents, general lack of availability of reversal agents, higher drug cost, unsuitability in patients with poor medication compliance, and lack of efficacy data in certain patient populations.
Decision to switch from warfarin to a NOAC should thoroughly consider its pros and cons, clinical factors, and patient preferences.
Hospitalists must consider clinical factors and patient preferences
Hospitalists must consider clinical factors and patient preferences
Case
A 70-year old woman with hypertension, diabetes, nonischemic stroke, moderate renal insufficiency (creatinine clearance [CrCl] 45 mL/min), heart failure, and nonvalvular atrial fibrillation (AF) on warfarin is admitted because of a very supratherapeutic INR. She reports labile INR values despite strict adherence to her medication regimen. Her cancer screening tests had previously been unremarkable. She inquires about the risks and benefits of switching to a novel oral anticoagulant (NOAC) as advertised on television. Should you consider it while she is still in the hospital?
Brief overview of the issue
Lifelong anticoagulation therapy is common among patients with AF or recurrent venous thromboembolism (VTE). Until the advent of NOACs, a great majority of patients were prescribed warfarin, the oral vitamin K antagonist that requires regular blood tests for monitoring of the INR. In contrast to warfarin, NOACs are direct-acting agents (hence also known as “direct oral anticoagulants” or DOACs) that are selective for one specific coagulation factor, either thrombin (e.g., dabigatran) or factor Xa (e.g., rivaroxaban, apixaban, and edoxaban, all with an “X” in their names).
Dr. Farrin A. Manian
NOACS have been studied and approved by the Food and Drug Administration for nonvalvular AF, i.e., patients without rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or prior mitral valve repair. Compared to warfarin, NOACS have fewer drug or food interactions, have more predictable pharmacokinetics, and may be associated with reduced risk of major bleeding depending on the agent. The latter is a particularly attractive feature of NOAC therapy, especially when its use is considered among older patients at risk of intracranial hemorrhage (ICH), such as those with previous strokes, ICH, or reduced renal function. Unfortunately, data on the efficacy and safety of the use of NOACs in certain patient populations (e.g., those with severe renal insufficiency, active malignancy, the elderly, patients with suboptimal medication adherence) are generally lacking.
Overview of the data
There are no randomized controlled trials (RCTs) addressing the clinical benefits of switching from warfarin to NOAC therapy. However, based on a number of RCTs comparing warfarin to individual NOACs and their related meta-analyses, the following conclusions may be made about their attributes:
1. Noninferiority to warfarin in reducing the risk of ischemic stroke in AF.
2. Association with a lower rate of major bleeds (statistically significant or trend) and a lower rate of ICH and hemorrhagic strokes compared to warfarin.
3. Association with a higher rate of gastrointestinal bleeding compared to warfarin (except for apixaban, low-dose dabigatran, and edoxaban1).
4. Association with a decreased rate of all stroke and thromboembolism events compared to warfarin.
5. Association with a slightly decreased all-cause mortality in AF compared to warfarin in many studies,2-8 but not all.1,9
6. Noninferiority to warfarin in all-cause mortality in patients with VTE and for its secondary prevention.1,4 NOACS should be used with caution or avoided altogether in patients with severe liver disease or renal insufficiency (see Table 1).
Potential advantages and disadvantages of NOAC therapy are listed in Table 2.
It should be emphasized that in patients with cancer or hypercoagulable state, no clear efficacy or safety data are currently available for the use of NOACs.
Dr. Jeff E. Liao
The 2016 CHEST guideline on antithrombotic therapy for VTE recommends NOACs over warfarin.10 The 2012 European Society of Cardiology AF guidelines also recommend NOACs over warfarin.11 However, the 2014 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines on AF state that it is not necessary to change to a NOAC when patients are “stable, easily controlled, and satisfied with warfarin therapy.”12
Data from a relatively small, short-term study examining the safety of switching patients from warfarin to a NOAC suggest that although bleeding events are relatively common (12%) following such a switch, major bleeding and cardiac or cerebrovascular events are rare.10
Application of the data to our original case
Given a high calculated CHADS2VASC score of 8 in our patient, she has a clear indication for anticoagulation for AF. Her history of labile INRs, ischemic stroke, and moderate renal insufficiency place her at high risk for ICH.
A NOAC may reduce this risk but possibly at the expense of an increased risk for a gastrointestinal bleed. More importantly, however, she may be a good candidate for a switch to a NOAC because of her labile INRs despite good medication adherence. Her warfarin can be held while hospitalized and a NOAC may be initiated when the INR falls below 2.
Dr. Benjamin P. Geisler Prior to discharge, potential cost of the drug to the patient should be explored and discussed. It is also important to involve the primary care physician in the decision-making process. Ultimately, selection of an appropriate NOAC should be based on a careful review of its risks and benefits, clinical factors, patient preference, and shared decision making.
Bottom line
Hospitalists are in a great position to discuss a switch to a NOAC in selected patients with history of good medication adherence and labile INRs or ICH risk factors.
Dr. Geisler, Dr. Liao, and Dr. Manian are hospitalists at Massachusetts General Hospital in Boston.
References
1. Sharma M et al. Efficacy and harms of direct oral anticoagulants in the elderly for stroke prevention in atrial fibrillation and secondary prevention of venous thromboembolism: Systematic review and meta-analysis. Circulation. 2015;132(3):194-204.
2. Ruff CT et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62.
3. Dentali F et al. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: A systematic review and meta-analysis of the literature. Circulation. 2012;126(20):2381-91.
4. Adam SS et al. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: A systematic review. Ann Intern Med. 2012;157(11):796-807.
5. Bruins Slot KM and Berge E. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2013(8):CD008980.
6. Gomez-Outes A et al. Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of subgroups. Thrombosis. 2013;2013:640723.
7. Miller CS et al. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012;110(3):453-60.
8. Baker WL and Phung OJ. Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2012;5(5):711-19.
9. Ntaios G et al. Nonvitamin-K-antagonist oral anticoagulants in patients with atrial fibrillation and previous stroke or transient ischemic attack: A systematic review and meta-analysis of randomized controlled trials. Stroke. 2012;43(12):3298-304.
10. Kearon C et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149(2):315-52.
11. Camm AJ et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation – developed with the special contribution of the European Heart Rhythm Association. Europace. 2012;14(10):1385-413.
12. January CT et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-267.
Quiz
When considering a switch from warfarin to a NOAC, all the following factors should be considered a potential advantage, except:
A. No need for routing lab monitoring.
B. Lower risk of gastrointestinal bleeding.
C. Fewer drug interactions.
D. Lower rates of intracranial bleed and hemorrhagic stroke.
The correct answer is B. NOACs have been associated with lower risk of intracranial bleed and hemorrhagic stroke but not gastrointestinal bleed. Routine lab monitoring is not necessary during their use and they are associated with fewer drug interactions compared to warfarin.
Key Points
NOACs represent a clear advancement in our anticoagulation armamentarium.
Potential advantages of their use include lower rates of intracranial bleed and hemorrhagic strokes, fewer drug or food interactions, and lack of need for routing lab monitoring.
Potential disadvantages of their use include increased rates of gastrointestinal bleed with some agents, general lack of availability of reversal agents, higher drug cost, unsuitability in patients with poor medication compliance, and lack of efficacy data in certain patient populations.
Decision to switch from warfarin to a NOAC should thoroughly consider its pros and cons, clinical factors, and patient preferences.
Case
A 70-year old woman with hypertension, diabetes, nonischemic stroke, moderate renal insufficiency (creatinine clearance [CrCl] 45 mL/min), heart failure, and nonvalvular atrial fibrillation (AF) on warfarin is admitted because of a very supratherapeutic INR. She reports labile INR values despite strict adherence to her medication regimen. Her cancer screening tests had previously been unremarkable. She inquires about the risks and benefits of switching to a novel oral anticoagulant (NOAC) as advertised on television. Should you consider it while she is still in the hospital?
Brief overview of the issue
Lifelong anticoagulation therapy is common among patients with AF or recurrent venous thromboembolism (VTE). Until the advent of NOACs, a great majority of patients were prescribed warfarin, the oral vitamin K antagonist that requires regular blood tests for monitoring of the INR. In contrast to warfarin, NOACs are direct-acting agents (hence also known as “direct oral anticoagulants” or DOACs) that are selective for one specific coagulation factor, either thrombin (e.g., dabigatran) or factor Xa (e.g., rivaroxaban, apixaban, and edoxaban, all with an “X” in their names).
Dr. Farrin A. Manian
NOACS have been studied and approved by the Food and Drug Administration for nonvalvular AF, i.e., patients without rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or prior mitral valve repair. Compared to warfarin, NOACS have fewer drug or food interactions, have more predictable pharmacokinetics, and may be associated with reduced risk of major bleeding depending on the agent. The latter is a particularly attractive feature of NOAC therapy, especially when its use is considered among older patients at risk of intracranial hemorrhage (ICH), such as those with previous strokes, ICH, or reduced renal function. Unfortunately, data on the efficacy and safety of the use of NOACs in certain patient populations (e.g., those with severe renal insufficiency, active malignancy, the elderly, patients with suboptimal medication adherence) are generally lacking.
Overview of the data
There are no randomized controlled trials (RCTs) addressing the clinical benefits of switching from warfarin to NOAC therapy. However, based on a number of RCTs comparing warfarin to individual NOACs and their related meta-analyses, the following conclusions may be made about their attributes:
1. Noninferiority to warfarin in reducing the risk of ischemic stroke in AF.
2. Association with a lower rate of major bleeds (statistically significant or trend) and a lower rate of ICH and hemorrhagic strokes compared to warfarin.
3. Association with a higher rate of gastrointestinal bleeding compared to warfarin (except for apixaban, low-dose dabigatran, and edoxaban1).
4. Association with a decreased rate of all stroke and thromboembolism events compared to warfarin.
5. Association with a slightly decreased all-cause mortality in AF compared to warfarin in many studies,2-8 but not all.1,9
6. Noninferiority to warfarin in all-cause mortality in patients with VTE and for its secondary prevention.1,4 NOACS should be used with caution or avoided altogether in patients with severe liver disease or renal insufficiency (see Table 1).
Potential advantages and disadvantages of NOAC therapy are listed in Table 2.
It should be emphasized that in patients with cancer or hypercoagulable state, no clear efficacy or safety data are currently available for the use of NOACs.
Dr. Jeff E. Liao
The 2016 CHEST guideline on antithrombotic therapy for VTE recommends NOACs over warfarin.10 The 2012 European Society of Cardiology AF guidelines also recommend NOACs over warfarin.11 However, the 2014 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines on AF state that it is not necessary to change to a NOAC when patients are “stable, easily controlled, and satisfied with warfarin therapy.”12
Data from a relatively small, short-term study examining the safety of switching patients from warfarin to a NOAC suggest that although bleeding events are relatively common (12%) following such a switch, major bleeding and cardiac or cerebrovascular events are rare.10
Application of the data to our original case
Given a high calculated CHADS2VASC score of 8 in our patient, she has a clear indication for anticoagulation for AF. Her history of labile INRs, ischemic stroke, and moderate renal insufficiency place her at high risk for ICH.
A NOAC may reduce this risk but possibly at the expense of an increased risk for a gastrointestinal bleed. More importantly, however, she may be a good candidate for a switch to a NOAC because of her labile INRs despite good medication adherence. Her warfarin can be held while hospitalized and a NOAC may be initiated when the INR falls below 2.
Dr. Benjamin P. Geisler Prior to discharge, potential cost of the drug to the patient should be explored and discussed. It is also important to involve the primary care physician in the decision-making process. Ultimately, selection of an appropriate NOAC should be based on a careful review of its risks and benefits, clinical factors, patient preference, and shared decision making.
Bottom line
Hospitalists are in a great position to discuss a switch to a NOAC in selected patients with history of good medication adherence and labile INRs or ICH risk factors.
Dr. Geisler, Dr. Liao, and Dr. Manian are hospitalists at Massachusetts General Hospital in Boston.
References
1. Sharma M et al. Efficacy and harms of direct oral anticoagulants in the elderly for stroke prevention in atrial fibrillation and secondary prevention of venous thromboembolism: Systematic review and meta-analysis. Circulation. 2015;132(3):194-204.
2. Ruff CT et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62.
3. Dentali F et al. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: A systematic review and meta-analysis of the literature. Circulation. 2012;126(20):2381-91.
4. Adam SS et al. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: A systematic review. Ann Intern Med. 2012;157(11):796-807.
5. Bruins Slot KM and Berge E. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2013(8):CD008980.
6. Gomez-Outes A et al. Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of subgroups. Thrombosis. 2013;2013:640723.
7. Miller CS et al. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012;110(3):453-60.
8. Baker WL and Phung OJ. Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2012;5(5):711-19.
9. Ntaios G et al. Nonvitamin-K-antagonist oral anticoagulants in patients with atrial fibrillation and previous stroke or transient ischemic attack: A systematic review and meta-analysis of randomized controlled trials. Stroke. 2012;43(12):3298-304.
10. Kearon C et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149(2):315-52.
11. Camm AJ et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation – developed with the special contribution of the European Heart Rhythm Association. Europace. 2012;14(10):1385-413.
12. January CT et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-267.
Quiz
When considering a switch from warfarin to a NOAC, all the following factors should be considered a potential advantage, except:
A. No need for routing lab monitoring.
B. Lower risk of gastrointestinal bleeding.
C. Fewer drug interactions.
D. Lower rates of intracranial bleed and hemorrhagic stroke.
The correct answer is B. NOACs have been associated with lower risk of intracranial bleed and hemorrhagic stroke but not gastrointestinal bleed. Routine lab monitoring is not necessary during their use and they are associated with fewer drug interactions compared to warfarin.
Key Points
NOACs represent a clear advancement in our anticoagulation armamentarium.
Potential advantages of their use include lower rates of intracranial bleed and hemorrhagic strokes, fewer drug or food interactions, and lack of need for routing lab monitoring.
Potential disadvantages of their use include increased rates of gastrointestinal bleed with some agents, general lack of availability of reversal agents, higher drug cost, unsuitability in patients with poor medication compliance, and lack of efficacy data in certain patient populations.
Decision to switch from warfarin to a NOAC should thoroughly consider its pros and cons, clinical factors, and patient preferences.
NEW ORLEANS – A simple postural modification of the standard Valsalva maneuver is now the clearcut evidence-based first-line treatment for supraventricular tachycardia, according to Jeet Mehta, MD, a resident in the combined medicine/pediatrics program at the University of Kansas, Wichita.
The 2015 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines recommended vagal maneuvers as first-line treatment of supraventricular tachycardia, but added that there was no gold standard method. Since then, the situation has changed. Two well-conducted randomized clinical trials have been published that bring clarity as to the vagal maneuver of choice, Dr. Mehta reported at the annual meeting of the American College of Physicians.
He and his coinvestigators performed a meta-analysis of the three pre-2000 randomized controlled trials that compared the standard Valsalva maneuver to carotid sinus massage plus the two newer studies, both of which systematically compared a modified Valsalva maneuver with the standard version.
The clear winner in terms of efficacy was the modified Valsalva maneuver, in which patients with supraventricular tachycardia (SVT) performed a standardized strain while in a semirecumbent position, then immediately laid flat and had their legs raised to 45 degrees for 15 seconds before returning to the semirecumbent position. The purpose of this postural modification is to boost relaxation phase venous return and vagal stimulation.
In the 433-patient multicenter REVERT trial in the United Kingdom, 43% of those assigned to the modified Valsalva maneuver returned to sinus rhythm 1 minute after completing the task, compared with 17% of those randomized to the standard semirecumbent Valsalva maneuver. This resulted in significantly less need for adenosine and other treatments. Although REVERT investigators had the patients blow into a manometer at 40 mm Hg for 15 seconds, they noted that the same intensity of strain can be achieved more practically by blowing into a 10-mL syringe sufficient to just move the plunger (Lancet. 2015 Oct 31;386[10005]:1747-53).
The REVERT findings were confirmed by a second trial conducted by Turkish investigators, in which the modified Valsalva maneuver was successful in 43% of patients, compared with 11% in the standard Valsalva maneuver group (Am J Emerg Med. 2017 Nov;35[11]:1662-5).
Extrapolating from the published evidence, including a Cochrane Collaboration review (Cochrane Database Syst Rev. 2015 Feb 18;[2]:CD009502. doi: 10.1002/14651858.CD009502.pub3), Dr. Mehta and his coinvestigators ranked the likelihood of successful conversion of SVT to sinus rhythm from a high of 48% for the modified Valsalva maneuver, descending to 43% for a supine Valsalva maneuver, 36% for a standard semirecumbent Valsalva, 21% for a seated Valsalva, 19% for a standing one, and just 11% for carotid sinus massage.
“Based on evidence of high quality, we encourage that the modified Valsalva maneuver be done due its safety and low cost,” Dr. Mehta concluded.
He reported having no financial conflicts regarding his study, conducted free of commercial support.
NEW ORLEANS – A simple postural modification of the standard Valsalva maneuver is now the clearcut evidence-based first-line treatment for supraventricular tachycardia, according to Jeet Mehta, MD, a resident in the combined medicine/pediatrics program at the University of Kansas, Wichita.
The 2015 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines recommended vagal maneuvers as first-line treatment of supraventricular tachycardia, but added that there was no gold standard method. Since then, the situation has changed. Two well-conducted randomized clinical trials have been published that bring clarity as to the vagal maneuver of choice, Dr. Mehta reported at the annual meeting of the American College of Physicians.
He and his coinvestigators performed a meta-analysis of the three pre-2000 randomized controlled trials that compared the standard Valsalva maneuver to carotid sinus massage plus the two newer studies, both of which systematically compared a modified Valsalva maneuver with the standard version.
The clear winner in terms of efficacy was the modified Valsalva maneuver, in which patients with supraventricular tachycardia (SVT) performed a standardized strain while in a semirecumbent position, then immediately laid flat and had their legs raised to 45 degrees for 15 seconds before returning to the semirecumbent position. The purpose of this postural modification is to boost relaxation phase venous return and vagal stimulation.
In the 433-patient multicenter REVERT trial in the United Kingdom, 43% of those assigned to the modified Valsalva maneuver returned to sinus rhythm 1 minute after completing the task, compared with 17% of those randomized to the standard semirecumbent Valsalva maneuver. This resulted in significantly less need for adenosine and other treatments. Although REVERT investigators had the patients blow into a manometer at 40 mm Hg for 15 seconds, they noted that the same intensity of strain can be achieved more practically by blowing into a 10-mL syringe sufficient to just move the plunger (Lancet. 2015 Oct 31;386[10005]:1747-53).
The REVERT findings were confirmed by a second trial conducted by Turkish investigators, in which the modified Valsalva maneuver was successful in 43% of patients, compared with 11% in the standard Valsalva maneuver group (Am J Emerg Med. 2017 Nov;35[11]:1662-5).
Extrapolating from the published evidence, including a Cochrane Collaboration review (Cochrane Database Syst Rev. 2015 Feb 18;[2]:CD009502. doi: 10.1002/14651858.CD009502.pub3), Dr. Mehta and his coinvestigators ranked the likelihood of successful conversion of SVT to sinus rhythm from a high of 48% for the modified Valsalva maneuver, descending to 43% for a supine Valsalva maneuver, 36% for a standard semirecumbent Valsalva, 21% for a seated Valsalva, 19% for a standing one, and just 11% for carotid sinus massage.
“Based on evidence of high quality, we encourage that the modified Valsalva maneuver be done due its safety and low cost,” Dr. Mehta concluded.
He reported having no financial conflicts regarding his study, conducted free of commercial support.
NEW ORLEANS – A simple postural modification of the standard Valsalva maneuver is now the clearcut evidence-based first-line treatment for supraventricular tachycardia, according to Jeet Mehta, MD, a resident in the combined medicine/pediatrics program at the University of Kansas, Wichita.
The 2015 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines recommended vagal maneuvers as first-line treatment of supraventricular tachycardia, but added that there was no gold standard method. Since then, the situation has changed. Two well-conducted randomized clinical trials have been published that bring clarity as to the vagal maneuver of choice, Dr. Mehta reported at the annual meeting of the American College of Physicians.
He and his coinvestigators performed a meta-analysis of the three pre-2000 randomized controlled trials that compared the standard Valsalva maneuver to carotid sinus massage plus the two newer studies, both of which systematically compared a modified Valsalva maneuver with the standard version.
The clear winner in terms of efficacy was the modified Valsalva maneuver, in which patients with supraventricular tachycardia (SVT) performed a standardized strain while in a semirecumbent position, then immediately laid flat and had their legs raised to 45 degrees for 15 seconds before returning to the semirecumbent position. The purpose of this postural modification is to boost relaxation phase venous return and vagal stimulation.
In the 433-patient multicenter REVERT trial in the United Kingdom, 43% of those assigned to the modified Valsalva maneuver returned to sinus rhythm 1 minute after completing the task, compared with 17% of those randomized to the standard semirecumbent Valsalva maneuver. This resulted in significantly less need for adenosine and other treatments. Although REVERT investigators had the patients blow into a manometer at 40 mm Hg for 15 seconds, they noted that the same intensity of strain can be achieved more practically by blowing into a 10-mL syringe sufficient to just move the plunger (Lancet. 2015 Oct 31;386[10005]:1747-53).
The REVERT findings were confirmed by a second trial conducted by Turkish investigators, in which the modified Valsalva maneuver was successful in 43% of patients, compared with 11% in the standard Valsalva maneuver group (Am J Emerg Med. 2017 Nov;35[11]:1662-5).
Extrapolating from the published evidence, including a Cochrane Collaboration review (Cochrane Database Syst Rev. 2015 Feb 18;[2]:CD009502. doi: 10.1002/14651858.CD009502.pub3), Dr. Mehta and his coinvestigators ranked the likelihood of successful conversion of SVT to sinus rhythm from a high of 48% for the modified Valsalva maneuver, descending to 43% for a supine Valsalva maneuver, 36% for a standard semirecumbent Valsalva, 21% for a seated Valsalva, 19% for a standing one, and just 11% for carotid sinus massage.
“Based on evidence of high quality, we encourage that the modified Valsalva maneuver be done due its safety and low cost,” Dr. Mehta concluded.
He reported having no financial conflicts regarding his study, conducted free of commercial support.
Key clinical point: A simple postural modification to the standard Valsalva maneuver boosts conversion rate.
Major finding: Nearly half of patients in SVT converted to sinus rhythm in response to a modified Valsalva maneuver.
Study details: This was a meta-analysis of five randomized clinical trials of vagal maneuvers for conversion of supraventricular tachycardia to sinus rhythm.
Disclosures: The presenter reported having no financial conflicts regarding the study, conducted free of commercial support.
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A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.
Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.
A majority of patients said they were satisfied with outpatient care.
Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.
The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.
With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).
Results
The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.
Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.
Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.
The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.
“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”
Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”
He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.
The investigators reported no conflicts related to this study.
A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.
Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.
A majority of patients said they were satisfied with outpatient care.
Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.
The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.
With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).
Results
The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.
Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.
Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.
The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.
“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”
Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”
He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.
The investigators reported no conflicts related to this study.
A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.
Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.
A majority of patients said they were satisfied with outpatient care.
Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.
The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.
With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).
Results
The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.
Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.
Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.
The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.
“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”
Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”
He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.
The investigators reported no conflicts related to this study.
What is the optimal way to manage analgesia during neonatal circumcision?
Background
Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.
One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.
A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:
EMLA + sucrose.
EMLA + sucrose + RB.
EMLA + sucrose + DPNB (for any stage of the procedure).
The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
Bottom line
All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.
Citation
Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.
What is the optimal way to manage analgesia during neonatal circumcision?
Background
Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.
One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.
A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:
EMLA + sucrose.
EMLA + sucrose + RB.
EMLA + sucrose + DPNB (for any stage of the procedure).
The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
Bottom line
All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.
Citation
Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.
Clinical question
What is the optimal way to manage analgesia during neonatal circumcision?
Background
Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.
One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.
A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:
EMLA + sucrose.
EMLA + sucrose + RB.
EMLA + sucrose + DPNB (for any stage of the procedure).
The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
Bottom line
All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.
Citation
Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.
NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.
What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.
“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”
Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.
Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.
A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.
In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.
While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.
He reported having no financial conflicts regarding his study, which was conducted free of commercial support.
NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.
What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.
“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”
Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.
Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.
A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.
In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.
While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.
He reported having no financial conflicts regarding his study, which was conducted free of commercial support.
NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.
What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.
“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”
Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.
Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.
A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.
In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.
While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.
He reported having no financial conflicts regarding his study, which was conducted free of commercial support.
Key clinical point: The complete blood count contains data that outperforms the D-dimer test in suspected deep vein thrombosis (DVT).
Major finding: The neutrophil-to-lymphocyte ratio was better than the D-dimer test at helping to rule out DVT, while the platelet-to-lymphocyte ratio bested the D-dimer at ruling in DVT.
Study details: A retrospective study of 102 patients with suspected DVT.
Disclosures: Dr. Mouabbi reported no financial conflicts regarding his study, which was conducted free of commercial support.
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Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”
Dr. Mae Melvin/CDC
The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.
Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.
Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.
Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.
In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.
Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.
“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for
patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.
One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.
Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”
Dr. Mae Melvin/CDC
The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.
Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.
Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.
Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.
In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.
Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.
“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for
patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.
One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.
Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”
Dr. Mae Melvin/CDC
The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.
Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.
Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.
Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.
In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.
Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.
“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for
patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.
One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.
An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.
The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.
The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.
Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.
The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”
Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.
The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.
Provisional data will be updated on a monthly basis as additional records are received, the CDC said.
An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.
The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.
The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.
Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.
The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”
Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.
The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.
Provisional data will be updated on a monthly basis as additional records are received, the CDC said.
An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.
The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.
The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.
Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.
The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”
Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.
The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.
Provisional data will be updated on a monthly basis as additional records are received, the CDC said.
NEW ORLEANS – Nonalcoholic fatty liver disease is the 21st century epidemic in liver disease, Zobair M. Younossi, MD, declared at the annual meeting of the American College of Physicians.
Bruce Jancin/MDedge News
Dr. Zobair M. Younossi
The massive growth in nonalcoholic fatty liver disease (NAFLD) is being fueled to a great extent by the related epidemics of obesity and type 2 diabetes mellitus. While the overall prevalence of NAFLD worldwide is 24%, almost three-quarters of patients with NAFLD are obese. And the prevalence of NAFLD in individuals with T2DM was 58% in a recent meta-analysis of studies from 20 countries conducted by Dr. Younossi and his coinvestigators.
“The prevalence of NAFLD in U.S. kids is about 10%. This is of course part of the coming tsunami because our kids are getting obese, diabetic, and they’re going to have problems with NASH [nonalcoholic steatohepatitis],” said Dr. Younossi, a gastroenterologist who is professor and chairman of the department of medicine at the Inova Fairfax (Va.) campus of Virginia Commonwealth University.
NASH is the form of NAFLD that has the strongest prognostic implications. It can progress to cirrhosis, liver failure, or hepatocellular carcinoma. As Dr. Younossi and his coworkers have shown (Hepat Commun. 2017 Jun 6;1[5]:421-8), it is associated with a significantly greater risk of both liver-related and all-cause mortality than that of non-NASH NAFLD, although NAFLD also carries an increased risk of cardiovascular disease, the leading cause of death in that population.
In addition to highlighting the enormous clinical, economic, and quality-of-life implications of the NAFLD epidemic, Dr. Younossi offered practical tips on how busy primary care physicians can identify patients in their practice who have high-risk NAFLD. They have not done a very good job of this to date. That’s possibly due to lack of incentive, since in 2018 there is no approved drug for the treatment of NASH. He cited one representative retrospective study in which only about 15% of patients identified as having NAFLD received a recommendation for lifestyle modification involving diet and exercise, which is the standard evidence-based treatment, albeit admittedly difficult to sustain. And only 3% of patients with advanced liver fibrosis were referred to a specialist for management.
“So NAFLD is common, but its recognition and doing something about it is quite a challenge,” Dr. Younossi observed.
He argued that patients who have NASH deserve to know it because of its prognostic implications and also so they can have the chance to participate in one of the roughly two dozen ongoing clinical trials of potential therapies, some of which look quite promising. All of the trials required a liver biopsy as a condition for enrollment. Plus, once a patient is known to have stage 3 fibrosis, it’s time to start screening for hepatocellular carcinoma and esophageal varices.
The scope of the epidemic
NASH is the most rapidly growing indication for liver transplantation in the United States, with most of the increase coming from the baby boomer population. NASH is now the second most common indication for placement on the wait list. Meanwhile, liver transplantation due to the consequences of hepatitis C, the No. 1 indication, is declining as a result of the spectacular advances in medical treatment introduced a few years ago. It’s likely that in coming years NASH will take over the top spot, according to Dr. Younossi.
He was coauthor of a recent study that modeled the estimated trends for the NAFLD epidemic in the United States through 2030. The forecast is that the prevalence of NAFLD among adults will climb to 33.5% and the proportion of NAFLD categorized as NASH will increase from 20% at present to 27%. Moreover, this will result in a 168% jump in the incidence of decompensated cirrhosis, a 137% increase in the incidence of hepatocellular carcinoma, and a 178% increase in liver-related mortality, which will account for an estimated 78,300 deaths in 2030 (Hepatology. 2018 Jan;67[1]:123-33).
Practical ways to identify high-risk patients
The best noninvasive means of detecting NAFLD is by ultrasound showing a fatty liver. Often the condition is detected as an incidental finding on abdominal ultrasound ordered for another reason. Elevated liver enzymes can be a tipoff as well. Of course, alcoholic liver disease and other causes must be excluded.
But what’s most important is to identify patients with NASH. It’s a diagnosis made by biopsy. However, it is unthinkable to perform liver biopsies in the entire vast population with NAFLD, so there is a great deal of interest in developing noninvasive diagnostic modalities that can help zero in on the subset of high-risk NAFLD patients who should be considered for referral for liver biopsy.
One useful clue is the presence of comorbid metabolic syndrome in patients with NAFLD. It confers a substantially higher mortality risk – especially cardiovascular mortality – than does NAFLD without metabolic syndrome. Dr. Younossi and his coinvestigators have shown in a study of 3,613 NAFLD patients followed long-term that those with one component of the metabolic syndrome – either hypertension, central obesity, increased fasting plasma glucose, or hyperlipidemia – had 8- and 16-year all-cause mortality rates of 4.7% and 11.9%, nearly double the 2.6% and 6% rates in NAFLD patients with no elements of the metabolic syndrome.
Moreover, the magnitude of risk increased with each additional metabolic syndrome condition: a 3.57-fold increased mortality risk in NAFLD patients with two components of metabolic syndrome, a 5.87-fold increase in those with three, and a 13.09-fold increase in NAFLD patients with all four elements of metabolic syndrome (Medicine [Baltimore]. 2018 Mar;97[13]:e0214. doi: 10.1097/MD.0000000000010214).
Dr. Younossi was a member of the American Association for the Study of Liver Disease expert panel that developed the latest practice guidance regarding the diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57). He said that probably the best simple noninvasive scoring system for the detection of NASH with advanced fibrosis is the NAFLD fibrosis score, which is easily calculated using laboratory values and clinical parameters already in a patient’s chart.
A more sophisticated serum biomarker test known as ELF, or the Enhanced Liver Fibrosis test, combines serum levels of hyaluronic acid, tissue inhibitor of metalloproteinase I, and procollagen amino terminal peptide.
“ELF is a very, very good test. It’s approved in Europe and I suspect it will be in the U.S. within the next year or so,” said Dr. Younossi.
The most exciting noninvasive tests, however, involve imaging that measures liver stiffness, which provides a fairly accurate indication of the degree of scarring in the organ. There are two methods available: vibration wave transient elastography and magnetic resonance elastography.
Transient elastography using the FibroScan device is commercially available in the United States. “It’s a good test, very easy to do, noninvasive. I have a couple of these machines, and we use them all the time,” the gastroenterologist said.
MR elastography provides superior accuracy, but access is an issue.
“At our institution you sometimes have to wait for weeks to get an outpatient MRI, so if you have hundreds of patients with fatty liver disease it makes things difficult. So in our practice we use transient elastography,” he explained.
Both imaging modalities also measure the amount of fat in the liver.
Dr. Younossi uses transient elastography in patients who don’t have type 2 diabetes or frank insulin resistance. If the FibroScan score is 7 kiloPascals or more, he considers liver biopsy, since that’s the threshold for detection of earlier, potentially reversible stage 2 fibrosis. If, however, a patient has diabetes or insulin resistance along with a NAFLD fibrosis score suggesting a high possibility of fibrosis, he sends that patient for liver biopsy, since those endocrinologic disorders are known to be independent risk factors for mortality in the setting of NAFLD.
Dr. Younossi reported having no financial conflicts of interest regarding his presentation.
NEW ORLEANS – Nonalcoholic fatty liver disease is the 21st century epidemic in liver disease, Zobair M. Younossi, MD, declared at the annual meeting of the American College of Physicians.
Bruce Jancin/MDedge News
Dr. Zobair M. Younossi
The massive growth in nonalcoholic fatty liver disease (NAFLD) is being fueled to a great extent by the related epidemics of obesity and type 2 diabetes mellitus. While the overall prevalence of NAFLD worldwide is 24%, almost three-quarters of patients with NAFLD are obese. And the prevalence of NAFLD in individuals with T2DM was 58% in a recent meta-analysis of studies from 20 countries conducted by Dr. Younossi and his coinvestigators.
“The prevalence of NAFLD in U.S. kids is about 10%. This is of course part of the coming tsunami because our kids are getting obese, diabetic, and they’re going to have problems with NASH [nonalcoholic steatohepatitis],” said Dr. Younossi, a gastroenterologist who is professor and chairman of the department of medicine at the Inova Fairfax (Va.) campus of Virginia Commonwealth University.
NASH is the form of NAFLD that has the strongest prognostic implications. It can progress to cirrhosis, liver failure, or hepatocellular carcinoma. As Dr. Younossi and his coworkers have shown (Hepat Commun. 2017 Jun 6;1[5]:421-8), it is associated with a significantly greater risk of both liver-related and all-cause mortality than that of non-NASH NAFLD, although NAFLD also carries an increased risk of cardiovascular disease, the leading cause of death in that population.
In addition to highlighting the enormous clinical, economic, and quality-of-life implications of the NAFLD epidemic, Dr. Younossi offered practical tips on how busy primary care physicians can identify patients in their practice who have high-risk NAFLD. They have not done a very good job of this to date. That’s possibly due to lack of incentive, since in 2018 there is no approved drug for the treatment of NASH. He cited one representative retrospective study in which only about 15% of patients identified as having NAFLD received a recommendation for lifestyle modification involving diet and exercise, which is the standard evidence-based treatment, albeit admittedly difficult to sustain. And only 3% of patients with advanced liver fibrosis were referred to a specialist for management.
“So NAFLD is common, but its recognition and doing something about it is quite a challenge,” Dr. Younossi observed.
He argued that patients who have NASH deserve to know it because of its prognostic implications and also so they can have the chance to participate in one of the roughly two dozen ongoing clinical trials of potential therapies, some of which look quite promising. All of the trials required a liver biopsy as a condition for enrollment. Plus, once a patient is known to have stage 3 fibrosis, it’s time to start screening for hepatocellular carcinoma and esophageal varices.
The scope of the epidemic
NASH is the most rapidly growing indication for liver transplantation in the United States, with most of the increase coming from the baby boomer population. NASH is now the second most common indication for placement on the wait list. Meanwhile, liver transplantation due to the consequences of hepatitis C, the No. 1 indication, is declining as a result of the spectacular advances in medical treatment introduced a few years ago. It’s likely that in coming years NASH will take over the top spot, according to Dr. Younossi.
He was coauthor of a recent study that modeled the estimated trends for the NAFLD epidemic in the United States through 2030. The forecast is that the prevalence of NAFLD among adults will climb to 33.5% and the proportion of NAFLD categorized as NASH will increase from 20% at present to 27%. Moreover, this will result in a 168% jump in the incidence of decompensated cirrhosis, a 137% increase in the incidence of hepatocellular carcinoma, and a 178% increase in liver-related mortality, which will account for an estimated 78,300 deaths in 2030 (Hepatology. 2018 Jan;67[1]:123-33).
Practical ways to identify high-risk patients
The best noninvasive means of detecting NAFLD is by ultrasound showing a fatty liver. Often the condition is detected as an incidental finding on abdominal ultrasound ordered for another reason. Elevated liver enzymes can be a tipoff as well. Of course, alcoholic liver disease and other causes must be excluded.
But what’s most important is to identify patients with NASH. It’s a diagnosis made by biopsy. However, it is unthinkable to perform liver biopsies in the entire vast population with NAFLD, so there is a great deal of interest in developing noninvasive diagnostic modalities that can help zero in on the subset of high-risk NAFLD patients who should be considered for referral for liver biopsy.
One useful clue is the presence of comorbid metabolic syndrome in patients with NAFLD. It confers a substantially higher mortality risk – especially cardiovascular mortality – than does NAFLD without metabolic syndrome. Dr. Younossi and his coinvestigators have shown in a study of 3,613 NAFLD patients followed long-term that those with one component of the metabolic syndrome – either hypertension, central obesity, increased fasting plasma glucose, or hyperlipidemia – had 8- and 16-year all-cause mortality rates of 4.7% and 11.9%, nearly double the 2.6% and 6% rates in NAFLD patients with no elements of the metabolic syndrome.
Moreover, the magnitude of risk increased with each additional metabolic syndrome condition: a 3.57-fold increased mortality risk in NAFLD patients with two components of metabolic syndrome, a 5.87-fold increase in those with three, and a 13.09-fold increase in NAFLD patients with all four elements of metabolic syndrome (Medicine [Baltimore]. 2018 Mar;97[13]:e0214. doi: 10.1097/MD.0000000000010214).
Dr. Younossi was a member of the American Association for the Study of Liver Disease expert panel that developed the latest practice guidance regarding the diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57). He said that probably the best simple noninvasive scoring system for the detection of NASH with advanced fibrosis is the NAFLD fibrosis score, which is easily calculated using laboratory values and clinical parameters already in a patient’s chart.
A more sophisticated serum biomarker test known as ELF, or the Enhanced Liver Fibrosis test, combines serum levels of hyaluronic acid, tissue inhibitor of metalloproteinase I, and procollagen amino terminal peptide.
“ELF is a very, very good test. It’s approved in Europe and I suspect it will be in the U.S. within the next year or so,” said Dr. Younossi.
The most exciting noninvasive tests, however, involve imaging that measures liver stiffness, which provides a fairly accurate indication of the degree of scarring in the organ. There are two methods available: vibration wave transient elastography and magnetic resonance elastography.
Transient elastography using the FibroScan device is commercially available in the United States. “It’s a good test, very easy to do, noninvasive. I have a couple of these machines, and we use them all the time,” the gastroenterologist said.
MR elastography provides superior accuracy, but access is an issue.
“At our institution you sometimes have to wait for weeks to get an outpatient MRI, so if you have hundreds of patients with fatty liver disease it makes things difficult. So in our practice we use transient elastography,” he explained.
Both imaging modalities also measure the amount of fat in the liver.
Dr. Younossi uses transient elastography in patients who don’t have type 2 diabetes or frank insulin resistance. If the FibroScan score is 7 kiloPascals or more, he considers liver biopsy, since that’s the threshold for detection of earlier, potentially reversible stage 2 fibrosis. If, however, a patient has diabetes or insulin resistance along with a NAFLD fibrosis score suggesting a high possibility of fibrosis, he sends that patient for liver biopsy, since those endocrinologic disorders are known to be independent risk factors for mortality in the setting of NAFLD.
Dr. Younossi reported having no financial conflicts of interest regarding his presentation.
NEW ORLEANS – Nonalcoholic fatty liver disease is the 21st century epidemic in liver disease, Zobair M. Younossi, MD, declared at the annual meeting of the American College of Physicians.
Bruce Jancin/MDedge News
Dr. Zobair M. Younossi
The massive growth in nonalcoholic fatty liver disease (NAFLD) is being fueled to a great extent by the related epidemics of obesity and type 2 diabetes mellitus. While the overall prevalence of NAFLD worldwide is 24%, almost three-quarters of patients with NAFLD are obese. And the prevalence of NAFLD in individuals with T2DM was 58% in a recent meta-analysis of studies from 20 countries conducted by Dr. Younossi and his coinvestigators.
“The prevalence of NAFLD in U.S. kids is about 10%. This is of course part of the coming tsunami because our kids are getting obese, diabetic, and they’re going to have problems with NASH [nonalcoholic steatohepatitis],” said Dr. Younossi, a gastroenterologist who is professor and chairman of the department of medicine at the Inova Fairfax (Va.) campus of Virginia Commonwealth University.
NASH is the form of NAFLD that has the strongest prognostic implications. It can progress to cirrhosis, liver failure, or hepatocellular carcinoma. As Dr. Younossi and his coworkers have shown (Hepat Commun. 2017 Jun 6;1[5]:421-8), it is associated with a significantly greater risk of both liver-related and all-cause mortality than that of non-NASH NAFLD, although NAFLD also carries an increased risk of cardiovascular disease, the leading cause of death in that population.
In addition to highlighting the enormous clinical, economic, and quality-of-life implications of the NAFLD epidemic, Dr. Younossi offered practical tips on how busy primary care physicians can identify patients in their practice who have high-risk NAFLD. They have not done a very good job of this to date. That’s possibly due to lack of incentive, since in 2018 there is no approved drug for the treatment of NASH. He cited one representative retrospective study in which only about 15% of patients identified as having NAFLD received a recommendation for lifestyle modification involving diet and exercise, which is the standard evidence-based treatment, albeit admittedly difficult to sustain. And only 3% of patients with advanced liver fibrosis were referred to a specialist for management.
“So NAFLD is common, but its recognition and doing something about it is quite a challenge,” Dr. Younossi observed.
He argued that patients who have NASH deserve to know it because of its prognostic implications and also so they can have the chance to participate in one of the roughly two dozen ongoing clinical trials of potential therapies, some of which look quite promising. All of the trials required a liver biopsy as a condition for enrollment. Plus, once a patient is known to have stage 3 fibrosis, it’s time to start screening for hepatocellular carcinoma and esophageal varices.
The scope of the epidemic
NASH is the most rapidly growing indication for liver transplantation in the United States, with most of the increase coming from the baby boomer population. NASH is now the second most common indication for placement on the wait list. Meanwhile, liver transplantation due to the consequences of hepatitis C, the No. 1 indication, is declining as a result of the spectacular advances in medical treatment introduced a few years ago. It’s likely that in coming years NASH will take over the top spot, according to Dr. Younossi.
He was coauthor of a recent study that modeled the estimated trends for the NAFLD epidemic in the United States through 2030. The forecast is that the prevalence of NAFLD among adults will climb to 33.5% and the proportion of NAFLD categorized as NASH will increase from 20% at present to 27%. Moreover, this will result in a 168% jump in the incidence of decompensated cirrhosis, a 137% increase in the incidence of hepatocellular carcinoma, and a 178% increase in liver-related mortality, which will account for an estimated 78,300 deaths in 2030 (Hepatology. 2018 Jan;67[1]:123-33).
Practical ways to identify high-risk patients
The best noninvasive means of detecting NAFLD is by ultrasound showing a fatty liver. Often the condition is detected as an incidental finding on abdominal ultrasound ordered for another reason. Elevated liver enzymes can be a tipoff as well. Of course, alcoholic liver disease and other causes must be excluded.
But what’s most important is to identify patients with NASH. It’s a diagnosis made by biopsy. However, it is unthinkable to perform liver biopsies in the entire vast population with NAFLD, so there is a great deal of interest in developing noninvasive diagnostic modalities that can help zero in on the subset of high-risk NAFLD patients who should be considered for referral for liver biopsy.
One useful clue is the presence of comorbid metabolic syndrome in patients with NAFLD. It confers a substantially higher mortality risk – especially cardiovascular mortality – than does NAFLD without metabolic syndrome. Dr. Younossi and his coinvestigators have shown in a study of 3,613 NAFLD patients followed long-term that those with one component of the metabolic syndrome – either hypertension, central obesity, increased fasting plasma glucose, or hyperlipidemia – had 8- and 16-year all-cause mortality rates of 4.7% and 11.9%, nearly double the 2.6% and 6% rates in NAFLD patients with no elements of the metabolic syndrome.
Moreover, the magnitude of risk increased with each additional metabolic syndrome condition: a 3.57-fold increased mortality risk in NAFLD patients with two components of metabolic syndrome, a 5.87-fold increase in those with three, and a 13.09-fold increase in NAFLD patients with all four elements of metabolic syndrome (Medicine [Baltimore]. 2018 Mar;97[13]:e0214. doi: 10.1097/MD.0000000000010214).
Dr. Younossi was a member of the American Association for the Study of Liver Disease expert panel that developed the latest practice guidance regarding the diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57). He said that probably the best simple noninvasive scoring system for the detection of NASH with advanced fibrosis is the NAFLD fibrosis score, which is easily calculated using laboratory values and clinical parameters already in a patient’s chart.
A more sophisticated serum biomarker test known as ELF, or the Enhanced Liver Fibrosis test, combines serum levels of hyaluronic acid, tissue inhibitor of metalloproteinase I, and procollagen amino terminal peptide.
“ELF is a very, very good test. It’s approved in Europe and I suspect it will be in the U.S. within the next year or so,” said Dr. Younossi.
The most exciting noninvasive tests, however, involve imaging that measures liver stiffness, which provides a fairly accurate indication of the degree of scarring in the organ. There are two methods available: vibration wave transient elastography and magnetic resonance elastography.
Transient elastography using the FibroScan device is commercially available in the United States. “It’s a good test, very easy to do, noninvasive. I have a couple of these machines, and we use them all the time,” the gastroenterologist said.
MR elastography provides superior accuracy, but access is an issue.
“At our institution you sometimes have to wait for weeks to get an outpatient MRI, so if you have hundreds of patients with fatty liver disease it makes things difficult. So in our practice we use transient elastography,” he explained.
Both imaging modalities also measure the amount of fat in the liver.
Dr. Younossi uses transient elastography in patients who don’t have type 2 diabetes or frank insulin resistance. If the FibroScan score is 7 kiloPascals or more, he considers liver biopsy, since that’s the threshold for detection of earlier, potentially reversible stage 2 fibrosis. If, however, a patient has diabetes or insulin resistance along with a NAFLD fibrosis score suggesting a high possibility of fibrosis, he sends that patient for liver biopsy, since those endocrinologic disorders are known to be independent risk factors for mortality in the setting of NAFLD.
Dr. Younossi reported having no financial conflicts of interest regarding his presentation.
An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.
Dr. Curt J Daniels
Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.
The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.
“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.
Better road map
The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.
“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”
The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.
Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.
“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.
More than just anatomy
Dr. Robert Jaquiss
In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.
A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.
Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.
“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”
For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.
Research directions
Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.
For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.
“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.
The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.
Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.
“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”
Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.
They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.
“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.
For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.
Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”
In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.
For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.
In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).
The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.
And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”
No funding is reported for the death rates study. The study authors report no relevant disclosures.
The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.
Life expectancy in some high-income nations has declined, at least temporarily, in recent years for apparent causes such as flu epidemics and “deaths of despair” because of drug abuse and suicide. While these newer trends may be short lived, they’re worrisome because life expectancy reflects human progress. Meanwhile, some nations and subpopulations continue to lag behind high-income nations despite the benefits of the modern era. Moving forward, we must back up policies with better scientific evidence. Improvements are needed in areas such as timely national mortality data, comparable statistics, and reliable numbers.
Domantas Jasilionis, PhD, is with the Max Planck Institute for Demographic Research, Rostock, Germany
Life expectancy in some high-income nations has declined, at least temporarily, in recent years for apparent causes such as flu epidemics and “deaths of despair” because of drug abuse and suicide. While these newer trends may be short lived, they’re worrisome because life expectancy reflects human progress. Meanwhile, some nations and subpopulations continue to lag behind high-income nations despite the benefits of the modern era. Moving forward, we must back up policies with better scientific evidence. Improvements are needed in areas such as timely national mortality data, comparable statistics, and reliable numbers.
Domantas Jasilionis, PhD, is with the Max Planck Institute for Demographic Research, Rostock, Germany
Body
Life expectancy in some high-income nations has declined, at least temporarily, in recent years for apparent causes such as flu epidemics and “deaths of despair” because of drug abuse and suicide. While these newer trends may be short lived, they’re worrisome because life expectancy reflects human progress. Meanwhile, some nations and subpopulations continue to lag behind high-income nations despite the benefits of the modern era. Moving forward, we must back up policies with better scientific evidence. Improvements are needed in areas such as timely national mortality data, comparable statistics, and reliable numbers.
Domantas Jasilionis, PhD, is with the Max Planck Institute for Demographic Research, Rostock, Germany
Title
Life expectancy fluctuations should sound alarm bells
Life expectancy fluctuations should sound alarm bells
Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.
“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”
Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.
They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.
“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.
For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.
Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”
In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.
For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.
In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).
The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.
And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”
No funding is reported for the death rates study. The study authors report no relevant disclosures.
The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.
Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.
“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”
Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.
They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.
“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.
For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.
Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”
In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.
For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.
In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).
The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.
And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”
No funding is reported for the death rates study. The study authors report no relevant disclosures.
The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.
