The Hospitalist

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

WASHINGTON – As unpopular as the new Quality Payment Program may be, repealing all or part of it at this stage will be a tough sell.

That was the message heard by members of the Medicare Payment Advisory Commission (MedPAC) during public comments at their Jan. 11 meeting. Comments followed a 14-2 vote by commissioners in favor of recommending that Congress scrap the Merit-Based Incentive Payment System (MIPS) track of the QPP.

“We do agree that there are problems with MIPS,” said Sharon McIlrath, assistant director of federal affairs and coalitions at the American Medical Association. “We would like to fix it rather than kill it, and partly that’s because we don’t want to send shifting messages to physicians. Are they going to invest in building an infrastructure on shifting ground?”

She also questioned whether this proposal could gain any traction at all in Congress.

“We don’t think that it is politically viable to think that you are going to go up there and get the Hill to kill MIPS,” she said.

The Alliance of Specialty Medicine in a Jan. 9 letter to MedPAC also voiced its objections to the commission’s plan to recommend the end of MIPS.

“Our efforts to work with CMS and congressional leaders to improve MIPS and allow for more meaningful and robust engagement are ongoing. We urge you to withdraw your forthcoming recommendation, which diminishes the important role of specialty medicine in Medicare,” alliance members wrote to MedPAC Chairman Francis J. Crosson, MD. “Instead, the commission and staff, under your leadership, should work toward a new recommendation that would improve aspects of the MIPS program that remain a challenge for all clinicians.”

MedPAC had been working on its recommendations regarding MIPS since the program was launched, but ultimately came to the conclusion that it was not fixable. During a presentation on the draft recommendation, MedPAC staff listed a variety of reasons why MIPS “cannot succeed,” including how it replicates flaws of previous value-based purchasing plans and is burdensome and complex, the information reported is not meaningful, scores are not comparable across clinicians, and the payment adjustments, while minimal early on, could vary widely from year to year with even the smallest of MIPS score changes.

Instead, current draft MedPAC recommendations put forward a voluntary value program (VVP) to replace MIPS. VVP would withhold a specific percentage of Medicare pay for physicians who are not involved in a QPP advanced Alternative Payment Model (APM).

Physicians would be able to earn back the withheld pay, plus be eligible for potential bonuses by voluntarily participating in virtual groups. Those groups would be scored on population-based measures.

As was the case across previous meetings where this was discussed, commissioners David Nerenz, PhD, of the Henry Ford Health System of Detroit, and Alice Coombs, MD, of South Shore Hospital, Weymouth, Mass., continued to voice their objections about repealing MIPS and ultimately voted against the recommendation.

The MIPS recommendation will be included in MedPAC’s June report to Congress; it then will be up to Congress to decide whether to act on it.

[email protected]

WASHINGTON – As unpopular as the new Quality Payment Program may be, repealing all or part of it at this stage will be a tough sell.

That was the message heard by members of the Medicare Payment Advisory Commission (MedPAC) during public comments at their Jan. 11 meeting. Comments followed a 14-2 vote by commissioners in favor of recommending that Congress scrap the Merit-Based Incentive Payment System (MIPS) track of the QPP.

“We do agree that there are problems with MIPS,” said Sharon McIlrath, assistant director of federal affairs and coalitions at the American Medical Association. “We would like to fix it rather than kill it, and partly that’s because we don’t want to send shifting messages to physicians. Are they going to invest in building an infrastructure on shifting ground?”

She also questioned whether this proposal could gain any traction at all in Congress.

“We don’t think that it is politically viable to think that you are going to go up there and get the Hill to kill MIPS,” she said.

The Alliance of Specialty Medicine in a Jan. 9 letter to MedPAC also voiced its objections to the commission’s plan to recommend the end of MIPS.

“Our efforts to work with CMS and congressional leaders to improve MIPS and allow for more meaningful and robust engagement are ongoing. We urge you to withdraw your forthcoming recommendation, which diminishes the important role of specialty medicine in Medicare,” alliance members wrote to MedPAC Chairman Francis J. Crosson, MD. “Instead, the commission and staff, under your leadership, should work toward a new recommendation that would improve aspects of the MIPS program that remain a challenge for all clinicians.”

MedPAC had been working on its recommendations regarding MIPS since the program was launched, but ultimately came to the conclusion that it was not fixable. During a presentation on the draft recommendation, MedPAC staff listed a variety of reasons why MIPS “cannot succeed,” including how it replicates flaws of previous value-based purchasing plans and is burdensome and complex, the information reported is not meaningful, scores are not comparable across clinicians, and the payment adjustments, while minimal early on, could vary widely from year to year with even the smallest of MIPS score changes.

Instead, current draft MedPAC recommendations put forward a voluntary value program (VVP) to replace MIPS. VVP would withhold a specific percentage of Medicare pay for physicians who are not involved in a QPP advanced Alternative Payment Model (APM).

Physicians would be able to earn back the withheld pay, plus be eligible for potential bonuses by voluntarily participating in virtual groups. Those groups would be scored on population-based measures.

As was the case across previous meetings where this was discussed, commissioners David Nerenz, PhD, of the Henry Ford Health System of Detroit, and Alice Coombs, MD, of South Shore Hospital, Weymouth, Mass., continued to voice their objections about repealing MIPS and ultimately voted against the recommendation.

The MIPS recommendation will be included in MedPAC’s June report to Congress; it then will be up to Congress to decide whether to act on it.

[email protected]

WASHINGTON – As unpopular as the new Quality Payment Program may be, repealing all or part of it at this stage will be a tough sell.

That was the message heard by members of the Medicare Payment Advisory Commission (MedPAC) during public comments at their Jan. 11 meeting. Comments followed a 14-2 vote by commissioners in favor of recommending that Congress scrap the Merit-Based Incentive Payment System (MIPS) track of the QPP.

“We do agree that there are problems with MIPS,” said Sharon McIlrath, assistant director of federal affairs and coalitions at the American Medical Association. “We would like to fix it rather than kill it, and partly that’s because we don’t want to send shifting messages to physicians. Are they going to invest in building an infrastructure on shifting ground?”

She also questioned whether this proposal could gain any traction at all in Congress.

“We don’t think that it is politically viable to think that you are going to go up there and get the Hill to kill MIPS,” she said.

The Alliance of Specialty Medicine in a Jan. 9 letter to MedPAC also voiced its objections to the commission’s plan to recommend the end of MIPS.

“Our efforts to work with CMS and congressional leaders to improve MIPS and allow for more meaningful and robust engagement are ongoing. We urge you to withdraw your forthcoming recommendation, which diminishes the important role of specialty medicine in Medicare,” alliance members wrote to MedPAC Chairman Francis J. Crosson, MD. “Instead, the commission and staff, under your leadership, should work toward a new recommendation that would improve aspects of the MIPS program that remain a challenge for all clinicians.”

MedPAC had been working on its recommendations regarding MIPS since the program was launched, but ultimately came to the conclusion that it was not fixable. During a presentation on the draft recommendation, MedPAC staff listed a variety of reasons why MIPS “cannot succeed,” including how it replicates flaws of previous value-based purchasing plans and is burdensome and complex, the information reported is not meaningful, scores are not comparable across clinicians, and the payment adjustments, while minimal early on, could vary widely from year to year with even the smallest of MIPS score changes.

Instead, current draft MedPAC recommendations put forward a voluntary value program (VVP) to replace MIPS. VVP would withhold a specific percentage of Medicare pay for physicians who are not involved in a QPP advanced Alternative Payment Model (APM).

Physicians would be able to earn back the withheld pay, plus be eligible for potential bonuses by voluntarily participating in virtual groups. Those groups would be scored on population-based measures.

As was the case across previous meetings where this was discussed, commissioners David Nerenz, PhD, of the Henry Ford Health System of Detroit, and Alice Coombs, MD, of South Shore Hospital, Weymouth, Mass., continued to voice their objections about repealing MIPS and ultimately voted against the recommendation.

The MIPS recommendation will be included in MedPAC’s June report to Congress; it then will be up to Congress to decide whether to act on it.

[email protected]

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

Clinical question: In patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention (PCI), is dabigatran plus a P2Y12 inhibitor safer than, and as efficacious as, triple therapy with warfarin?

Background: Recent studies have shown that patients on long-term anticoagulation who undergo PCI can be managed on oral anticoagulants and P2Y12 inhibitors with lower bleeding rates than do those who receive triple therapy.

Study design: Randomized, controlled trial.

Setting: 414 sites in 41 countries.

Synopsis: In 2,725 patients with nonvalvular atrial fibrillation undergoing PCI, low-dose (110 mg, twice daily) and high-dose (150 mg, twice daily) dabigatran plus a P2Y12 inhibitor lowered absolute bleeding risk by 11.5% and 5.5%, respectively, compared with triple therapy. Rates of thrombosis, death, and unexpected revascularization as a composite endpoint were noninferior to triple therapy for both dabigatran doses studied. In patients on dabigatran for atrial fibrillation, it is reasonable to continue dabigatran and add a single P2Y12 inhibitor (clopidogrel or ticagrelor) but not aspirin after PCI. In patients at high risk for bleeding complications, it may be reasonable to dose reduce the dabigatran from 150 mg twice daily to 110 mg twice daily before starting antiplatelet therapy, although the study was underpowered to examine this.

Bottom line: In patients with atrial fibrillation undergoing PCI, dabigatran plus clopidogrel or ticagrelor had lower bleeding rates and was noninferior with respect to the risk of thromboembolic events when compared with triple therapy with warfarin.

Citation: Cannon CP et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med. 2017 Oct 19. doi: 10.1056/NEJMoa1708454.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

Clinical question: In patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention (PCI), is dabigatran plus a P2Y12 inhibitor safer than, and as efficacious as, triple therapy with warfarin?

Background: Recent studies have shown that patients on long-term anticoagulation who undergo PCI can be managed on oral anticoagulants and P2Y12 inhibitors with lower bleeding rates than do those who receive triple therapy.

Study design: Randomized, controlled trial.

Setting: 414 sites in 41 countries.

Synopsis: In 2,725 patients with nonvalvular atrial fibrillation undergoing PCI, low-dose (110 mg, twice daily) and high-dose (150 mg, twice daily) dabigatran plus a P2Y12 inhibitor lowered absolute bleeding risk by 11.5% and 5.5%, respectively, compared with triple therapy. Rates of thrombosis, death, and unexpected revascularization as a composite endpoint were noninferior to triple therapy for both dabigatran doses studied. In patients on dabigatran for atrial fibrillation, it is reasonable to continue dabigatran and add a single P2Y12 inhibitor (clopidogrel or ticagrelor) but not aspirin after PCI. In patients at high risk for bleeding complications, it may be reasonable to dose reduce the dabigatran from 150 mg twice daily to 110 mg twice daily before starting antiplatelet therapy, although the study was underpowered to examine this.

Bottom line: In patients with atrial fibrillation undergoing PCI, dabigatran plus clopidogrel or ticagrelor had lower bleeding rates and was noninferior with respect to the risk of thromboembolic events when compared with triple therapy with warfarin.

Citation: Cannon CP et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med. 2017 Oct 19. doi: 10.1056/NEJMoa1708454.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

Clinical question: In patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention (PCI), is dabigatran plus a P2Y12 inhibitor safer than, and as efficacious as, triple therapy with warfarin?

Background: Recent studies have shown that patients on long-term anticoagulation who undergo PCI can be managed on oral anticoagulants and P2Y12 inhibitors with lower bleeding rates than do those who receive triple therapy.

Study design: Randomized, controlled trial.

Setting: 414 sites in 41 countries.

Synopsis: In 2,725 patients with nonvalvular atrial fibrillation undergoing PCI, low-dose (110 mg, twice daily) and high-dose (150 mg, twice daily) dabigatran plus a P2Y12 inhibitor lowered absolute bleeding risk by 11.5% and 5.5%, respectively, compared with triple therapy. Rates of thrombosis, death, and unexpected revascularization as a composite endpoint were noninferior to triple therapy for both dabigatran doses studied. In patients on dabigatran for atrial fibrillation, it is reasonable to continue dabigatran and add a single P2Y12 inhibitor (clopidogrel or ticagrelor) but not aspirin after PCI. In patients at high risk for bleeding complications, it may be reasonable to dose reduce the dabigatran from 150 mg twice daily to 110 mg twice daily before starting antiplatelet therapy, although the study was underpowered to examine this.

Bottom line: In patients with atrial fibrillation undergoing PCI, dabigatran plus clopidogrel or ticagrelor had lower bleeding rates and was noninferior with respect to the risk of thromboembolic events when compared with triple therapy with warfarin.

Citation: Cannon CP et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med. 2017 Oct 19. doi: 10.1056/NEJMoa1708454.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

Clinical question: Is rivaroxaban alone or in combination with aspirin more effective than is aspirin alone in preventing cardiovascular events in patients with stable atherosclerotic disease?

Background: Previous studies have shown that, among patients with stable atherosclerosis, anticoagulation with a vitamin-K antagonist (VKA) plus aspirin is superior to aspirin alone for secondary prevention but has increased rates of major bleeding.

Study design: Randomized controlled trial.

Setting: 602 sites in 33 countries.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

Clinical question: Is rivaroxaban alone or in combination with aspirin more effective than is aspirin alone in preventing cardiovascular events in patients with stable atherosclerotic disease?

Background: Previous studies have shown that, among patients with stable atherosclerosis, anticoagulation with a vitamin-K antagonist (VKA) plus aspirin is superior to aspirin alone for secondary prevention but has increased rates of major bleeding.

Study design: Randomized controlled trial.

Setting: 602 sites in 33 countries.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

Clinical question: Is rivaroxaban alone or in combination with aspirin more effective than is aspirin alone in preventing cardiovascular events in patients with stable atherosclerotic disease?

Background: Previous studies have shown that, among patients with stable atherosclerosis, anticoagulation with a vitamin-K antagonist (VKA) plus aspirin is superior to aspirin alone for secondary prevention but has increased rates of major bleeding.

Study design: Randomized controlled trial.

Setting: 602 sites in 33 countries.

Dr. Theobald is a hospitalist at the University of Colorado School of Medicine.

ORLANDO – Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

[email protected]

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

ORLANDO – Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

[email protected]

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

ORLANDO – Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

[email protected]

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.

The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.

DavidWhalen/Thinkstock

[email protected]

New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.

The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.

DavidWhalen/Thinkstock

[email protected]

New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.

The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.

DavidWhalen/Thinkstock

[email protected]

Clinical question: What is the relationship between timing of measurement of postural blood pressure (BP) and adverse clinical outcomes?

Background: Guidelines recommend measuring postural BP after 3 minutes of standing to avoid potentially false-positive readings obtained before that interval. In SPRINT, orthostatic hypotension (OH) determined at 1 minute was associated with higher risk of emergency department visits for OH and syncope. Whether that finding was because of the shortened interval of measurement is uncertain.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

Clinical question: What is the relationship between timing of measurement of postural blood pressure (BP) and adverse clinical outcomes?

Background: Guidelines recommend measuring postural BP after 3 minutes of standing to avoid potentially false-positive readings obtained before that interval. In SPRINT, orthostatic hypotension (OH) determined at 1 minute was associated with higher risk of emergency department visits for OH and syncope. Whether that finding was because of the shortened interval of measurement is uncertain.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

Clinical question: What is the relationship between timing of measurement of postural blood pressure (BP) and adverse clinical outcomes?

Background: Guidelines recommend measuring postural BP after 3 minutes of standing to avoid potentially false-positive readings obtained before that interval. In SPRINT, orthostatic hypotension (OH) determined at 1 minute was associated with higher risk of emergency department visits for OH and syncope. Whether that finding was because of the shortened interval of measurement is uncertain.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.

The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”

TheaDesign/Thinkstock

• Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
• Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
• Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.

CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.

Applications for participation will be accepted through March 12.

[email protected]

The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.

The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”

TheaDesign/Thinkstock

• Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
• Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
• Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.

CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.

Applications for participation will be accepted through March 12.

[email protected]

The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.

The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”

TheaDesign/Thinkstock

• Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
• Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
• Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.

CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.

Applications for participation will be accepted through March 12.

[email protected]