Noppon Setji, MD

 

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Study design: Retrospective use of the DAPT score in PRODIGY patients.

Setting: PCI patients in PRODIGY trial.

Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.

Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.

Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

 

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Study design: Retrospective use of the DAPT score in PRODIGY patients.

Setting: PCI patients in PRODIGY trial.

Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.

Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.

Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

 

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Study design: Retrospective use of the DAPT score in PRODIGY patients.

Setting: PCI patients in PRODIGY trial.

Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.

Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.

Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

 

Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?

Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.

Study design: International multicenter observational cohort design.

Setting: 7 tertiary centers from 4 European countries during 1996-2015.

Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.

Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.

Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

 

Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?

Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.

Study design: International multicenter observational cohort design.

Setting: 7 tertiary centers from 4 European countries during 1996-2015.

Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.

Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.

Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

 

Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?

Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.

Study design: International multicenter observational cohort design.

Setting: 7 tertiary centers from 4 European countries during 1996-2015.

Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.

Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.

Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

Clinical question: Is mechanical, left atrial appendage (LAA) closure as effective as warfarin therapy in preventing cardioembolic events in patients with nonvalvular atrial fibrillation (Afib)?

Background: Anticoagulation with warfarin has long been the standard therapy for prevention of thromboembolic complications of nonvalvular Afib; however, its use is limited by the need for monitoring and lifelong adherence, as well as its many dietary and medication interactions. Prior studies investigating the efficacy of a deployable device intended to close the LAA have shown noninferiority of the device when compared with standard warfarin anticoagulation. This study evaluated LAA closure device efficacy after a 3.8-year interval.

Study design: Randomized, unblinded controlled trial.

Setting: Fifty-nine centers in the U.S. and Europe.

Synopsis: Authors randomized 707 participants 18 years or older with nonvalvular Afib and CHADS2 score ≥1 in a 2:1 fashion to the intervention and warfarin therapy groups. The primary outcome was a composite endpoint including stroke, systemic embolism, and cardiovascular or unexplained death. The event rate in the device group was 2.3 per 100 patient-years, compared with 3.8 in the warfarin group. Rate ratio was 0.60, meeting noninferiority criteria. Primary safety events were not statistically different.

Although the authors concluded that LAA device closure was noninferior to warfarin therapy, it should be noted that there was a high dropout rate, especially in the warfarin group, motivated either by a desire to try a novel oral anticoagulant or the perception that warfarin therapy was not beneficial. It should also be noted that device placement involved not only a percutaneous procedure, but also 45 days of aspirin and warfarin therapy initially to promote endothelization, followed by six months of clopidogrel.

Bottom line: Percutaneous device closure of the LAA appears to be noninferior to warfarin therapy in the prevention of cardioembolic events over a period of several years, and might be superior.

Citation: Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.

Clinical question: Is mechanical, left atrial appendage (LAA) closure as effective as warfarin therapy in preventing cardioembolic events in patients with nonvalvular atrial fibrillation (Afib)?

Background: Anticoagulation with warfarin has long been the standard therapy for prevention of thromboembolic complications of nonvalvular Afib; however, its use is limited by the need for monitoring and lifelong adherence, as well as its many dietary and medication interactions. Prior studies investigating the efficacy of a deployable device intended to close the LAA have shown noninferiority of the device when compared with standard warfarin anticoagulation. This study evaluated LAA closure device efficacy after a 3.8-year interval.

Study design: Randomized, unblinded controlled trial.

Setting: Fifty-nine centers in the U.S. and Europe.

Synopsis: Authors randomized 707 participants 18 years or older with nonvalvular Afib and CHADS2 score ≥1 in a 2:1 fashion to the intervention and warfarin therapy groups. The primary outcome was a composite endpoint including stroke, systemic embolism, and cardiovascular or unexplained death. The event rate in the device group was 2.3 per 100 patient-years, compared with 3.8 in the warfarin group. Rate ratio was 0.60, meeting noninferiority criteria. Primary safety events were not statistically different.

Although the authors concluded that LAA device closure was noninferior to warfarin therapy, it should be noted that there was a high dropout rate, especially in the warfarin group, motivated either by a desire to try a novel oral anticoagulant or the perception that warfarin therapy was not beneficial. It should also be noted that device placement involved not only a percutaneous procedure, but also 45 days of aspirin and warfarin therapy initially to promote endothelization, followed by six months of clopidogrel.

Bottom line: Percutaneous device closure of the LAA appears to be noninferior to warfarin therapy in the prevention of cardioembolic events over a period of several years, and might be superior.

Citation: Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.

Clinical question: Is mechanical, left atrial appendage (LAA) closure as effective as warfarin therapy in preventing cardioembolic events in patients with nonvalvular atrial fibrillation (Afib)?

Background: Anticoagulation with warfarin has long been the standard therapy for prevention of thromboembolic complications of nonvalvular Afib; however, its use is limited by the need for monitoring and lifelong adherence, as well as its many dietary and medication interactions. Prior studies investigating the efficacy of a deployable device intended to close the LAA have shown noninferiority of the device when compared with standard warfarin anticoagulation. This study evaluated LAA closure device efficacy after a 3.8-year interval.

Study design: Randomized, unblinded controlled trial.

Setting: Fifty-nine centers in the U.S. and Europe.

Synopsis: Authors randomized 707 participants 18 years or older with nonvalvular Afib and CHADS2 score ≥1 in a 2:1 fashion to the intervention and warfarin therapy groups. The primary outcome was a composite endpoint including stroke, systemic embolism, and cardiovascular or unexplained death. The event rate in the device group was 2.3 per 100 patient-years, compared with 3.8 in the warfarin group. Rate ratio was 0.60, meeting noninferiority criteria. Primary safety events were not statistically different.

Although the authors concluded that LAA device closure was noninferior to warfarin therapy, it should be noted that there was a high dropout rate, especially in the warfarin group, motivated either by a desire to try a novel oral anticoagulant or the perception that warfarin therapy was not beneficial. It should also be noted that device placement involved not only a percutaneous procedure, but also 45 days of aspirin and warfarin therapy initially to promote endothelization, followed by six months of clopidogrel.

Bottom line: Percutaneous device closure of the LAA appears to be noninferior to warfarin therapy in the prevention of cardioembolic events over a period of several years, and might be superior.

Citation: Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.

Clinical question: Does tramadol increase rates of hospitalization from hypoglycemia compared to other opioids?

Background: As tramadol use has increased in the general population, there have been multiple reports of hypoglycemia after initiation of the painkiller, including in patients with no other known risk factors, such as diabetes mellitus.

Study design: Case control study.

Setting: United Kingdom.

Synopsis: Using the United Kingdom’s Clinical Practice Research Datalink, a cohort of 334,034 patients was identified, including 1,105 hospitalized for hypoglycemia. To compare incidence of hypoglycemia in patients taking tramadol versus nontramadol opioids, patients newly treated with tramadol for noncancer pain were compared with those treated with codeine.

Use of tramadol was associated with increase in hospitalization for treatment of hypoglycemia compared with codeine. Specifically, tramadol use had an odds ratio (OR) of 1.52 (95% confidence interval, 1.09-2.10). The risk of hypoglycemia was higher in the first 30 days of use, with an OR of 2.61 (95% confidence interval, 1.61-4.23).

Since tramadol prescribing has increased over the past 10 years, clinicians should be mindful of the potential association between tramadol and severe hypoglycemia requiring hospitalization. Although the details of the pathophysiology leading to this outcome remain unclear, evidence of a causal relationship is mounting. The association with hypoglycemia was seen particularly in the first 30 days of therapy. The incidence of less severe hypoglycemia not requiring hospitalization remains unknown.

Bottom line: Tramadol use is associated with increased rates of hypoglycemia requiring hospitalization.

Citation: Fournier JP, Azoulay L, Yin H, Montastruc JL, Suissa S. Tramadol use and the risk of hospitalization for hypoglycemia in patients with noncancer pain. JAMA Intern Med. 2015;175(2):186-193.

Clinical question: Does tramadol increase rates of hospitalization from hypoglycemia compared to other opioids?

Background: As tramadol use has increased in the general population, there have been multiple reports of hypoglycemia after initiation of the painkiller, including in patients with no other known risk factors, such as diabetes mellitus.

Study design: Case control study.

Setting: United Kingdom.

Synopsis: Using the United Kingdom’s Clinical Practice Research Datalink, a cohort of 334,034 patients was identified, including 1,105 hospitalized for hypoglycemia. To compare incidence of hypoglycemia in patients taking tramadol versus nontramadol opioids, patients newly treated with tramadol for noncancer pain were compared with those treated with codeine.

Use of tramadol was associated with increase in hospitalization for treatment of hypoglycemia compared with codeine. Specifically, tramadol use had an odds ratio (OR) of 1.52 (95% confidence interval, 1.09-2.10). The risk of hypoglycemia was higher in the first 30 days of use, with an OR of 2.61 (95% confidence interval, 1.61-4.23).

Since tramadol prescribing has increased over the past 10 years, clinicians should be mindful of the potential association between tramadol and severe hypoglycemia requiring hospitalization. Although the details of the pathophysiology leading to this outcome remain unclear, evidence of a causal relationship is mounting. The association with hypoglycemia was seen particularly in the first 30 days of therapy. The incidence of less severe hypoglycemia not requiring hospitalization remains unknown.

Bottom line: Tramadol use is associated with increased rates of hypoglycemia requiring hospitalization.

Citation: Fournier JP, Azoulay L, Yin H, Montastruc JL, Suissa S. Tramadol use and the risk of hospitalization for hypoglycemia in patients with noncancer pain. JAMA Intern Med. 2015;175(2):186-193.

Clinical question: Does tramadol increase rates of hospitalization from hypoglycemia compared to other opioids?

Background: As tramadol use has increased in the general population, there have been multiple reports of hypoglycemia after initiation of the painkiller, including in patients with no other known risk factors, such as diabetes mellitus.

Study design: Case control study.

Setting: United Kingdom.

Synopsis: Using the United Kingdom’s Clinical Practice Research Datalink, a cohort of 334,034 patients was identified, including 1,105 hospitalized for hypoglycemia. To compare incidence of hypoglycemia in patients taking tramadol versus nontramadol opioids, patients newly treated with tramadol for noncancer pain were compared with those treated with codeine.

Use of tramadol was associated with increase in hospitalization for treatment of hypoglycemia compared with codeine. Specifically, tramadol use had an odds ratio (OR) of 1.52 (95% confidence interval, 1.09-2.10). The risk of hypoglycemia was higher in the first 30 days of use, with an OR of 2.61 (95% confidence interval, 1.61-4.23).

Since tramadol prescribing has increased over the past 10 years, clinicians should be mindful of the potential association between tramadol and severe hypoglycemia requiring hospitalization. Although the details of the pathophysiology leading to this outcome remain unclear, evidence of a causal relationship is mounting. The association with hypoglycemia was seen particularly in the first 30 days of therapy. The incidence of less severe hypoglycemia not requiring hospitalization remains unknown.

Bottom line: Tramadol use is associated with increased rates of hypoglycemia requiring hospitalization.

Citation: Fournier JP, Azoulay L, Yin H, Montastruc JL, Suissa S. Tramadol use and the risk of hospitalization for hypoglycemia in patients with noncancer pain. JAMA Intern Med. 2015;175(2):186-193.

Clinical question: Does duration of surgical procedure influence venous thromboembolism (VTE) risk?

Background: The relationship between surgical procedure length and VTE risk has not been vigorously assessed, although it has been postulated that longer procedures are associated with increased VTE risk. Improved understanding of this relationship may be beneficial to surgeons deciding on VTE prophylaxis strategies or determining whether to perform coupled procedures.

Study design: Retrospective cohort study.

Setting: Data collected from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP).

Synopsis: Study authors divided 1,432,855 surgical cases during which general anesthesia was administered for a specified duration into five quintiles based on length of operative time, defined as the period during which a patient was under general anesthesia. The primary outcome was the development of a VTE within 30 days of the procedure, defined as deep venous thrombosis (DVT), pulmonary embolism (PE), or both. Logistic regression analyses were performed to assess the relationship between procedure length and VTE occurrence.

The middle quintile of procedures carried a VTE rate of 0.86%. There was a significant association between procedure duration and VTE risk when the first and second quintiles, and fourth and fifth quintiles, were compared to the middle quintile. The association was present across all surgical subspecialties.

Bottom line: Longer duration of surgical procedures is associated with increased VTE risk.

Citation: Kim JY, Khavanin N, Rambachan A, et al. Surgical duration and risk of venous thromboembolism [published online ahead of print December 3, 2014]. JAMA Surg. doi:10.1001/jamasurg.2014.1841.

Clinical question: Does duration of surgical procedure influence venous thromboembolism (VTE) risk?

Background: The relationship between surgical procedure length and VTE risk has not been vigorously assessed, although it has been postulated that longer procedures are associated with increased VTE risk. Improved understanding of this relationship may be beneficial to surgeons deciding on VTE prophylaxis strategies or determining whether to perform coupled procedures.

Study design: Retrospective cohort study.

Setting: Data collected from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP).

Synopsis: Study authors divided 1,432,855 surgical cases during which general anesthesia was administered for a specified duration into five quintiles based on length of operative time, defined as the period during which a patient was under general anesthesia. The primary outcome was the development of a VTE within 30 days of the procedure, defined as deep venous thrombosis (DVT), pulmonary embolism (PE), or both. Logistic regression analyses were performed to assess the relationship between procedure length and VTE occurrence.

The middle quintile of procedures carried a VTE rate of 0.86%. There was a significant association between procedure duration and VTE risk when the first and second quintiles, and fourth and fifth quintiles, were compared to the middle quintile. The association was present across all surgical subspecialties.

Bottom line: Longer duration of surgical procedures is associated with increased VTE risk.

Citation: Kim JY, Khavanin N, Rambachan A, et al. Surgical duration and risk of venous thromboembolism [published online ahead of print December 3, 2014]. JAMA Surg. doi:10.1001/jamasurg.2014.1841.

Clinical question: Does duration of surgical procedure influence venous thromboembolism (VTE) risk?

Background: The relationship between surgical procedure length and VTE risk has not been vigorously assessed, although it has been postulated that longer procedures are associated with increased VTE risk. Improved understanding of this relationship may be beneficial to surgeons deciding on VTE prophylaxis strategies or determining whether to perform coupled procedures.

Study design: Retrospective cohort study.

Setting: Data collected from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP).

Synopsis: Study authors divided 1,432,855 surgical cases during which general anesthesia was administered for a specified duration into five quintiles based on length of operative time, defined as the period during which a patient was under general anesthesia. The primary outcome was the development of a VTE within 30 days of the procedure, defined as deep venous thrombosis (DVT), pulmonary embolism (PE), or both. Logistic regression analyses were performed to assess the relationship between procedure length and VTE occurrence.

The middle quintile of procedures carried a VTE rate of 0.86%. There was a significant association between procedure duration and VTE risk when the first and second quintiles, and fourth and fifth quintiles, were compared to the middle quintile. The association was present across all surgical subspecialties.

Bottom line: Longer duration of surgical procedures is associated with increased VTE risk.

Citation: Kim JY, Khavanin N, Rambachan A, et al. Surgical duration and risk of venous thromboembolism [published online ahead of print December 3, 2014]. JAMA Surg. doi:10.1001/jamasurg.2014.1841.

Clinical question: Did the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour reforms change mortality rates or readmission rates at teaching hospitals?

Background: The 2011 ACGME duty hour reforms maintained the 80-hour weekly work limit for medical residents, decreased the number of continuous hours to 16 hours from 30 hours for interns, and decreased the number of continuous hours for residents to 24 hours, with an additional four hours allowed for transitions of care. These changes have raised concerns about increased handoffs and potential changes in patient safety.

Study design: Observational study of Medicare admissions before and after duty hour reforms.

Setting: Short-term, acute-care hospitals.

Synopsis: Investigators compared 4,325,854 inpatient Medicare admissions from the two years prior to duty hour reforms with 2,058,419 admissions the year after the reforms. For each time period, the 30-day mortality and 30-day readmission rates were assessed; outcomes from more intensive teaching hospitals were compared with the outcomes from less intensive teaching hospitals. Teaching intensity was assessed according to the resident-to-bed ratio, a measure that has been used in prior research.

No significant differences were found in the primary outcomes of 30-day all-location mortality or 30-day all-cause readmissions.

When looking at specific diagnoses, only stroke was found to have a higher risk of readmission in the post-reform period (OR 1.06, 95% CI 1.01-1.13).

Although 2011 duty hour reforms represented a large, national structural change in resident education, no significant positive or negative effect was found on these important patient safety measures, consistent with what has been found in prior reviews.

Bottom line: The 2011 ACGME duty hour reforms showed no significant changes in mortality or readmissions when comparing hospitals with intensive teaching roles to those with fewer trainees.

Citation: Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients. JAMA. 2014;312(22):2364-2373.

Clinical question: Did the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour reforms change mortality rates or readmission rates at teaching hospitals?

Background: The 2011 ACGME duty hour reforms maintained the 80-hour weekly work limit for medical residents, decreased the number of continuous hours to 16 hours from 30 hours for interns, and decreased the number of continuous hours for residents to 24 hours, with an additional four hours allowed for transitions of care. These changes have raised concerns about increased handoffs and potential changes in patient safety.

Study design: Observational study of Medicare admissions before and after duty hour reforms.

Setting: Short-term, acute-care hospitals.

Synopsis: Investigators compared 4,325,854 inpatient Medicare admissions from the two years prior to duty hour reforms with 2,058,419 admissions the year after the reforms. For each time period, the 30-day mortality and 30-day readmission rates were assessed; outcomes from more intensive teaching hospitals were compared with the outcomes from less intensive teaching hospitals. Teaching intensity was assessed according to the resident-to-bed ratio, a measure that has been used in prior research.

No significant differences were found in the primary outcomes of 30-day all-location mortality or 30-day all-cause readmissions.

When looking at specific diagnoses, only stroke was found to have a higher risk of readmission in the post-reform period (OR 1.06, 95% CI 1.01-1.13).

Although 2011 duty hour reforms represented a large, national structural change in resident education, no significant positive or negative effect was found on these important patient safety measures, consistent with what has been found in prior reviews.

Bottom line: The 2011 ACGME duty hour reforms showed no significant changes in mortality or readmissions when comparing hospitals with intensive teaching roles to those with fewer trainees.

Citation: Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients. JAMA. 2014;312(22):2364-2373.

Clinical question: Did the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour reforms change mortality rates or readmission rates at teaching hospitals?

Background: The 2011 ACGME duty hour reforms maintained the 80-hour weekly work limit for medical residents, decreased the number of continuous hours to 16 hours from 30 hours for interns, and decreased the number of continuous hours for residents to 24 hours, with an additional four hours allowed for transitions of care. These changes have raised concerns about increased handoffs and potential changes in patient safety.

Study design: Observational study of Medicare admissions before and after duty hour reforms.

Setting: Short-term, acute-care hospitals.

Synopsis: Investigators compared 4,325,854 inpatient Medicare admissions from the two years prior to duty hour reforms with 2,058,419 admissions the year after the reforms. For each time period, the 30-day mortality and 30-day readmission rates were assessed; outcomes from more intensive teaching hospitals were compared with the outcomes from less intensive teaching hospitals. Teaching intensity was assessed according to the resident-to-bed ratio, a measure that has been used in prior research.

No significant differences were found in the primary outcomes of 30-day all-location mortality or 30-day all-cause readmissions.

When looking at specific diagnoses, only stroke was found to have a higher risk of readmission in the post-reform period (OR 1.06, 95% CI 1.01-1.13).

Although 2011 duty hour reforms represented a large, national structural change in resident education, no significant positive or negative effect was found on these important patient safety measures, consistent with what has been found in prior reviews.

Bottom line: The 2011 ACGME duty hour reforms showed no significant changes in mortality or readmissions when comparing hospitals with intensive teaching roles to those with fewer trainees.

Citation: Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients. JAMA. 2014;312(22):2364-2373.

Clinical question: Does supervised learning in the ED lead to higher rates of resource utilization?

Background: Care at academic medical centers might be more expensive than nonteaching hospitals because of the increased testing and resource utilization that occurs among learners. Although there is a growing emphasis in training programs on cost-conscious care, little data has looked at resource use as an outcome.

Study design: Cross-sectional study of the National Hospital Ambulatory Medical Care Survey in 2010.

Setting: Probability sample of American EDs and ED visits.

Synopsis: Using the 2010 National Hospital Ambulatory Medical Care Survey ED sub-file, a probability sample of 29,182 ED visits was obtained—25,808 attending-only visits and 3,374 supervised visits.

Supervised visits were more likely to lead to hospital admissions (21% versus 14%), advanced imaging (28% vs. 21%), and a longer median ED stay, but not with more blood testing than attending-only ED visits. EDs were placed into three categories: “nonteaching”; “minor teaching,” where trainees are involved in fewer than 50% of visits; and “major teaching,” where trainees are involved in more than 50% of visits. Study results showed no increase in resource utilization in major teaching EDs, except for an increase in ED length of stay.

Although there was an attempt to adjust for biased selection and complexity, there is a risk that biased selection of “teaching cases” in minor teaching EDs could explain some of the higher resource use for these cases. This study does not imply causation; however, it suggests that further studies might be warranted to evaluate the relationship between learners and resource utilization.

Bottom line: Supervised visits were associated with increased hospital admissions, advanced imaging, and longer ED length of stay (LOS), but other than LOS, this relationship did not persist in major teaching EDs.

Citation: Pitts SR, Morgan SR, Schrager JD, Berger TJ. Emergency department resource use by supervised residents vs attending physicians alone. JAMA. 2014;312(22):2394-2400.

Clinical question: Does supervised learning in the ED lead to higher rates of resource utilization?

Background: Care at academic medical centers might be more expensive than nonteaching hospitals because of the increased testing and resource utilization that occurs among learners. Although there is a growing emphasis in training programs on cost-conscious care, little data has looked at resource use as an outcome.

Study design: Cross-sectional study of the National Hospital Ambulatory Medical Care Survey in 2010.

Setting: Probability sample of American EDs and ED visits.

Synopsis: Using the 2010 National Hospital Ambulatory Medical Care Survey ED sub-file, a probability sample of 29,182 ED visits was obtained—25,808 attending-only visits and 3,374 supervised visits.

Supervised visits were more likely to lead to hospital admissions (21% versus 14%), advanced imaging (28% vs. 21%), and a longer median ED stay, but not with more blood testing than attending-only ED visits. EDs were placed into three categories: “nonteaching”; “minor teaching,” where trainees are involved in fewer than 50% of visits; and “major teaching,” where trainees are involved in more than 50% of visits. Study results showed no increase in resource utilization in major teaching EDs, except for an increase in ED length of stay.

Although there was an attempt to adjust for biased selection and complexity, there is a risk that biased selection of “teaching cases” in minor teaching EDs could explain some of the higher resource use for these cases. This study does not imply causation; however, it suggests that further studies might be warranted to evaluate the relationship between learners and resource utilization.

Bottom line: Supervised visits were associated with increased hospital admissions, advanced imaging, and longer ED length of stay (LOS), but other than LOS, this relationship did not persist in major teaching EDs.

Citation: Pitts SR, Morgan SR, Schrager JD, Berger TJ. Emergency department resource use by supervised residents vs attending physicians alone. JAMA. 2014;312(22):2394-2400.

Clinical question: Does supervised learning in the ED lead to higher rates of resource utilization?

Background: Care at academic medical centers might be more expensive than nonteaching hospitals because of the increased testing and resource utilization that occurs among learners. Although there is a growing emphasis in training programs on cost-conscious care, little data has looked at resource use as an outcome.

Study design: Cross-sectional study of the National Hospital Ambulatory Medical Care Survey in 2010.

Setting: Probability sample of American EDs and ED visits.

Synopsis: Using the 2010 National Hospital Ambulatory Medical Care Survey ED sub-file, a probability sample of 29,182 ED visits was obtained—25,808 attending-only visits and 3,374 supervised visits.

Supervised visits were more likely to lead to hospital admissions (21% versus 14%), advanced imaging (28% vs. 21%), and a longer median ED stay, but not with more blood testing than attending-only ED visits. EDs were placed into three categories: “nonteaching”; “minor teaching,” where trainees are involved in fewer than 50% of visits; and “major teaching,” where trainees are involved in more than 50% of visits. Study results showed no increase in resource utilization in major teaching EDs, except for an increase in ED length of stay.

Although there was an attempt to adjust for biased selection and complexity, there is a risk that biased selection of “teaching cases” in minor teaching EDs could explain some of the higher resource use for these cases. This study does not imply causation; however, it suggests that further studies might be warranted to evaluate the relationship between learners and resource utilization.

Bottom line: Supervised visits were associated with increased hospital admissions, advanced imaging, and longer ED length of stay (LOS), but other than LOS, this relationship did not persist in major teaching EDs.

Citation: Pitts SR, Morgan SR, Schrager JD, Berger TJ. Emergency department resource use by supervised residents vs attending physicians alone. JAMA. 2014;312(22):2394-2400.

Clinical question: For primary care physicians (PCPs), does residency training area affect the pattern of physician spending after training is complete?

Background: Regional and system-level variations in the intensity of medical services provided are common in the U.S. Residency training practice patterns could explain these variations. This study examines the relationship between spending patterns in the region of residency training and individual physician practice spending patterns after training.

Study design: Secondary, multilevel, multivariable analysis of 2011 Medicare claims data.

Setting: Random, nationally representative sample of family and internal medicine physicians completing residency between 1992 and 2010, with Medicare patient panels of 40 or more patients.

Synopsis: Investigators randomly selected 2,851 PCPs who completed residency training from 1992-2010, providing care to 491,948 Medicare beneficiaries. Practice locations and residency training were matched with the Dartmouth Atlas Hospital Referral Region (HRR) files. Training and practice HRRs were categorized into low-, average-, and high-spending groups.

Physicians practicing in high-spending regions who trained in high-spending regions spent $1,926 more per Medicare beneficiary than those trained in low-spending regions. In average-spending regions, physicians who trained in high-spending regions spent an average of $897 higher than those who trained in low-spending regions. No differences were found in low-spending regions.

This association varied significantly according to years in practice. For physicians in the first seven years of practice, patient expenditures in the highest-spending training HRR were 29% greater than those in the lowest-spending training HRR. After 16 years of practice, this variation disappeared.

Although this study does not establish causality, there may be opportunities to control spending with focused interventions in residency.

Bottom line: Spending patterns vary even within HRRs; however, this study’s findings suggest that physicians’ practice patterns are developed in residency training and that training in high-spending regions likely leads to increased expenditures. Focusing on cost-conscious care during residency training could be a significant option for curtailing healthcare costs in the future.

Citation: Chen C, Petterson S, Phillips R, Bazemore A, Mullan F. Spending patterns in region of residency training and subsequent expenditures for care provided by practicing physicians for Medicare beneficiaries. JAMA. 2014;312(22):2385-2393.

Clinical question: For primary care physicians (PCPs), does residency training area affect the pattern of physician spending after training is complete?

Background: Regional and system-level variations in the intensity of medical services provided are common in the U.S. Residency training practice patterns could explain these variations. This study examines the relationship between spending patterns in the region of residency training and individual physician practice spending patterns after training.

Study design: Secondary, multilevel, multivariable analysis of 2011 Medicare claims data.

Setting: Random, nationally representative sample of family and internal medicine physicians completing residency between 1992 and 2010, with Medicare patient panels of 40 or more patients.

Synopsis: Investigators randomly selected 2,851 PCPs who completed residency training from 1992-2010, providing care to 491,948 Medicare beneficiaries. Practice locations and residency training were matched with the Dartmouth Atlas Hospital Referral Region (HRR) files. Training and practice HRRs were categorized into low-, average-, and high-spending groups.

Physicians practicing in high-spending regions who trained in high-spending regions spent $1,926 more per Medicare beneficiary than those trained in low-spending regions. In average-spending regions, physicians who trained in high-spending regions spent an average of $897 higher than those who trained in low-spending regions. No differences were found in low-spending regions.

This association varied significantly according to years in practice. For physicians in the first seven years of practice, patient expenditures in the highest-spending training HRR were 29% greater than those in the lowest-spending training HRR. After 16 years of practice, this variation disappeared.

Although this study does not establish causality, there may be opportunities to control spending with focused interventions in residency.

Bottom line: Spending patterns vary even within HRRs; however, this study’s findings suggest that physicians’ practice patterns are developed in residency training and that training in high-spending regions likely leads to increased expenditures. Focusing on cost-conscious care during residency training could be a significant option for curtailing healthcare costs in the future.

Citation: Chen C, Petterson S, Phillips R, Bazemore A, Mullan F. Spending patterns in region of residency training and subsequent expenditures for care provided by practicing physicians for Medicare beneficiaries. JAMA. 2014;312(22):2385-2393.

Clinical question: For primary care physicians (PCPs), does residency training area affect the pattern of physician spending after training is complete?

Background: Regional and system-level variations in the intensity of medical services provided are common in the U.S. Residency training practice patterns could explain these variations. This study examines the relationship between spending patterns in the region of residency training and individual physician practice spending patterns after training.

Study design: Secondary, multilevel, multivariable analysis of 2011 Medicare claims data.

Setting: Random, nationally representative sample of family and internal medicine physicians completing residency between 1992 and 2010, with Medicare patient panels of 40 or more patients.

Synopsis: Investigators randomly selected 2,851 PCPs who completed residency training from 1992-2010, providing care to 491,948 Medicare beneficiaries. Practice locations and residency training were matched with the Dartmouth Atlas Hospital Referral Region (HRR) files. Training and practice HRRs were categorized into low-, average-, and high-spending groups.

Physicians practicing in high-spending regions who trained in high-spending regions spent $1,926 more per Medicare beneficiary than those trained in low-spending regions. In average-spending regions, physicians who trained in high-spending regions spent an average of $897 higher than those who trained in low-spending regions. No differences were found in low-spending regions.

This association varied significantly according to years in practice. For physicians in the first seven years of practice, patient expenditures in the highest-spending training HRR were 29% greater than those in the lowest-spending training HRR. After 16 years of practice, this variation disappeared.

Although this study does not establish causality, there may be opportunities to control spending with focused interventions in residency.

Bottom line: Spending patterns vary even within HRRs; however, this study’s findings suggest that physicians’ practice patterns are developed in residency training and that training in high-spending regions likely leads to increased expenditures. Focusing on cost-conscious care during residency training could be a significant option for curtailing healthcare costs in the future.

Citation: Chen C, Petterson S, Phillips R, Bazemore A, Mullan F. Spending patterns in region of residency training and subsequent expenditures for care provided by practicing physicians for Medicare beneficiaries. JAMA. 2014;312(22):2385-2393.

Clinical question: Do malpractice reform policies shift physician practice patterns toward lower utilization of healthcare resources?

Background: Physician-reported fears of lawsuits lead to defensive medicine practices, which contribute to high healthcare costs. It is unclear whether malpractice reform legislation reduces these costly physician practice patterns. The ED is a high-risk environment that may promote defensive medicine practices and is the focus of recent malpractice reform legislation in Texas, Georgia, and South Carolina.

Study design: Case-control.

Setting: EDs in Texas, Georgia, South Carolina, and adjacent states.

Synopsis: Using a 5% random sample of Medicare claims from 1997-2011, the investigators evaluated the impact of recent malpractice reform legislation on intensity of practice by ED physicians, as defined by rates of use of advanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]), hospital admission, and average charges. ED claims from the three reform states (Texas, Ga., and S.C.) were compared to neighboring (control) states.

Adjusted analysis of 3,868,110 ED visits from 1,166 eligible hospitals demonstrated no significant reductions in CT/MRI utilization, rates of hospital admission, or (in two of the three reform states) average per-visit ED charges attributable to policy reforms.

Bottom line: Broadly protective malpractice reform had minimal impact on emergency physicians’ intensity of practice, as measured by rates of advanced imaging use, hospital admission, and average charges. Such “pro-physician” legal reforms may be inadequate in isolation to significantly reduce costs.

Citaton: Waxman DA, Greenberg MD, Ridgely MS, Kellermann AL, Heaton P. The effect of malpractice reform on emergency department care. N Engl J Med. 2014;371(16):1518-1525.

Clinical question: Do malpractice reform policies shift physician practice patterns toward lower utilization of healthcare resources?

Background: Physician-reported fears of lawsuits lead to defensive medicine practices, which contribute to high healthcare costs. It is unclear whether malpractice reform legislation reduces these costly physician practice patterns. The ED is a high-risk environment that may promote defensive medicine practices and is the focus of recent malpractice reform legislation in Texas, Georgia, and South Carolina.

Study design: Case-control.

Setting: EDs in Texas, Georgia, South Carolina, and adjacent states.

Synopsis: Using a 5% random sample of Medicare claims from 1997-2011, the investigators evaluated the impact of recent malpractice reform legislation on intensity of practice by ED physicians, as defined by rates of use of advanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]), hospital admission, and average charges. ED claims from the three reform states (Texas, Ga., and S.C.) were compared to neighboring (control) states.

Adjusted analysis of 3,868,110 ED visits from 1,166 eligible hospitals demonstrated no significant reductions in CT/MRI utilization, rates of hospital admission, or (in two of the three reform states) average per-visit ED charges attributable to policy reforms.

Bottom line: Broadly protective malpractice reform had minimal impact on emergency physicians’ intensity of practice, as measured by rates of advanced imaging use, hospital admission, and average charges. Such “pro-physician” legal reforms may be inadequate in isolation to significantly reduce costs.

Citaton: Waxman DA, Greenberg MD, Ridgely MS, Kellermann AL, Heaton P. The effect of malpractice reform on emergency department care. N Engl J Med. 2014;371(16):1518-1525.

Clinical question: Do malpractice reform policies shift physician practice patterns toward lower utilization of healthcare resources?

Background: Physician-reported fears of lawsuits lead to defensive medicine practices, which contribute to high healthcare costs. It is unclear whether malpractice reform legislation reduces these costly physician practice patterns. The ED is a high-risk environment that may promote defensive medicine practices and is the focus of recent malpractice reform legislation in Texas, Georgia, and South Carolina.

Study design: Case-control.

Setting: EDs in Texas, Georgia, South Carolina, and adjacent states.

Synopsis: Using a 5% random sample of Medicare claims from 1997-2011, the investigators evaluated the impact of recent malpractice reform legislation on intensity of practice by ED physicians, as defined by rates of use of advanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]), hospital admission, and average charges. ED claims from the three reform states (Texas, Ga., and S.C.) were compared to neighboring (control) states.

Adjusted analysis of 3,868,110 ED visits from 1,166 eligible hospitals demonstrated no significant reductions in CT/MRI utilization, rates of hospital admission, or (in two of the three reform states) average per-visit ED charges attributable to policy reforms.

Bottom line: Broadly protective malpractice reform had minimal impact on emergency physicians’ intensity of practice, as measured by rates of advanced imaging use, hospital admission, and average charges. Such “pro-physician” legal reforms may be inadequate in isolation to significantly reduce costs.

Citaton: Waxman DA, Greenberg MD, Ridgely MS, Kellermann AL, Heaton P. The effect of malpractice reform on emergency department care. N Engl J Med. 2014;371(16):1518-1525.