Multiple sclerosis patients and endovascular interventionalists were elated when Italian researchers reported in 2009 that they had found evidence of chronic cerebrospinal venous insufficiency in nearly every MS patient they had studied and that in many cases, balloon angioplasty and sometimes stent placement of central thoracic veins reduced or eliminated signs of the disease. Neurologists, on the other hand, suggested that hope might be eclipsing reason in the rush to advocate the vascular procedure, given the single-center study's small sample size and nonrandomized, uncontrolled design.

The opposing perspectives incited an apparent turf war within the MS community fueled by accusations on both sides, according to Dr. Jack Burks, chief medical officer of the Multiple Sclerosis Association of America. At issue, he said, is the validity not only of the study results but also of the underlying hypothesis that toxic iron overload in the brain due to chronic cerebrospinal venous insufficiency (CCSVI) might have a primary role in the pathogenesis of MS - a hypothesis that contradicts the compelling body of evidence suggesting that MS is primarily an autoimmune condition.

On one side of the debate are the MS patients and endovascular interventionalists, dubbed the "liberators" by Dr. Burks because of their unflappable advocacy for what has become known as the liberation procedure - the endovascular surgery designed to open the lesions causing the venous insufficiency, he said.

"Neurologists believe the interventionalists are overstating the possible value of CCSVI and that commercial interests are overriding scientific inquiry," according to Dr. Burks, a neurologist and clinical professor of medicine at the University of Nevada, Reno. Patients, armed with anecdotal evidence downloaded from the Internet, are certain that CCSVI surgery is the miracle they've been waiting for and perceive the hesitancy of U.S. and Canadian neurologists to embrace the treatment as evidence of a possible conspiracy with pharmaceutical companies who stand to lose billions of dollars if the surgery becomes a first-line treatment, he said. Further, he noted, advocates of CCSVI claim that neurologists who refuse patients' demands for diagnostic testing and surgical referral for CCSVI are jeopardizing the safety of those patients, who are traveling to foreign countries to get the care that they cannot receive in North America.

To date, the majority of the evidence regarding CCSVI diagnosis and treatment in MS is inconsistent, and can be confusing, Dr. Burks noted. In the initial study, Dr. Paolo Zamboni of the University of Ferrara in Italy, and colleagues, used Doppler ultrasound to examine venous drainage of the brain and spinal cord in 65 patients with different types of MS and 235 controls without MS and observed abnormal venous flow in all of the MS patients and none of the controls. The patterns of venous obstruction differed depending on MS stage and course, although there was no apparent relationship between disease severity and extent of venous obstruction, and MS treatment status did not influence the signs of CCSVI in any of the patients, the authors wrote (J. Neurol. Neurosurg. Psychiatry 2009;80:392-9).

The researchers went on to conduct an open pilot study to determine whether percutaneous transluminal angioplasty could safely and effectively treat the narrowing of the extracranial cerebrospinal veins in the 65 MS patients in which the condition was observed - 35 with relapsing-remitting MS, 20 with secondary progressive MS, and 10 with primary progressive MS. They reported significant improvements in MS clinical outcome measures, significant reductions in new brain lesions on MRI, and significant reductions in the number of relapses experienced by some of the patients.

The findings were limited, however, not only by the study design, but also by the fact that patients remained on their disease-modifying antirheumatic drug therapy during the study period and the timing and type of MRI scans varied among the patients, according to the authors. They also noted that restenosis of the internal jugular veins occurred in nearly half of the patients (J. Vasc. Surg. 2009;50:1348-58).

Since the initial paper, a number of CCSVI studies of various designs have been undertaken, with contradictory results. Following are some of the investigations reported within the past year:

P Researchers at the University of Buffalo found that up to 62% of the 280 patients with MS enrolled in the Combined Transcranial and Extracranial Venous Doppler Evaluation study - the first randomized clinical trial to evaluate MS patients for CCSVI - had the characteristic narrowing of the extracranial veins compared with approximately 22% of 220 healthy controls. While the results, which were reported at the annual meeting of the American Academy of Neurology, did not establish causation, they showed "that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis," principal investigator Dr. Robert Zivadinov said in a statement. He acknowledged that the finding of vascular narrowing in nearly a quarter of the healthy controls warranted additional investigation (www.buffalo.edu/news/fast-execute.cgi/article-page.html?article=109370009).

P In an open-label study of extracranial Doppler criteria of CCSVI in 70 MS patients in Poland - 49 with relapsing-remitting MS, 5 with primary progressive MS, and 16 with secondary progressive MS - investigators detected at least two of four extracranial criteria in 90% of the patients. They concluded that, while the extracranial abnormalities could exist in various combinations, "the most common pathology in our patients was the presence of an inverted valve or another pathologic structure [like membranaceous or netlike septum] in the area of junction of the [internal jugular vein] with the brachiocephalic vein (Int. Angiol. 2010;29:109-14).

P A comparison of the internal jugular vein hemodynamics and morphology in 25 patients with MS and 25 controls identified abnormal findings in 92% of the MS patients and 24% of the controls, and evidence of CCSVI in 84% of the MS patients and none of the controls, leading the investigators to conclude that both hemodynamic abnormalities and morphologic changes in the internal jugular vein "are strongly associated with MS" (Int. Angiol. 2010;29:115-20).

P An extended extra- and transcranial color-coded sonography study in 56 MS patients and 20 controls detected no internal jugular vein stenosis and normal blood flow direction in all but 1 patient. There were no between-group differences in intracranial veins and during Valsalva maneuver, and none of the patients fulfilled more than one CCSVI criterion, according to the authors. They concluded that their findings "challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS" (Ann. Neurol. 2010;68:173-83).

P Swedish investigators used phase-contrast MRI to study 21 relapsing-remitting MS patients and 20 healthy controls and found no differences in internal jugular venous outflow, aqueductal cerebrospinal fluid flow, or the presence of internal jugular blood reflux between the two groups. Although contrast-enhanced MR angiography showed internal jugular vein stenosis in 3 of the 21 MS patients, the authors stated they found no evidence "confirming the suggested vascular multiple sclerosis hypothesis" (Ann. Neurol. 2010;68:255-9).

P The authors of an MR venography and flow quantification study in The Netherlands compared the intracranial and extracranial venous anatomy and the intracerebral venous flow profiles of 20 MS patients and 20 age- and gender-matched controls, with image analysis performed by blinded interventional neuroradiologists. They identified venous system anomalies in 50% of the MS patients and 40% of the healthy controls and no venous backflow in either group. "Given the normal intracranial venous flow quantification results, it is likely that these findings reflect anatomical variants of venous drainage rather than clinically relevant venous outflow obstructions," the authors wrote (J. Neurol. Neurosurg. Psychiatry 2010 Oct. 27 [doi: 10.1136/jnnp.2010.223479]).

P Italian researchers investigating the occurrence of CCSVI in 50 consecutive patients with clinically isolated syndromes suggestive of MS reviewed the patients' extracranial and transcranial venous echo-color Doppler sonographs and compared the findings to those of 50 age- and gender-matched healthy controls as well as those of 60 patients with transient global amnesia (TGA) and 60 healthy controls matched to the TGA patients. They found extracranial Doppler sonographic abnormalities in 52% of patients with possible MS, 68.3% of patients with TGA, and 31.8% of the healthy controls. While eight of the patients with possible MS fulfilled the CCSVI criteria, selective phlebography showed no venous anomalies in seven of them. The authors concluded that there was no evidence of CCSVI at MS onset but recommended further studies to "clarify whether CCSVI is associated with later disease stages and characterizes the progressive forms of MS" (Ann. Neurol. 2011;69:90-9).

In a position statement, the Society of Interventional Radiology stated that at present, the published literature is "inconclusive on whether CCSVI is a clinically important factor and on whether balloon angioplasty and/or stent placement are effective in patients with MS" (J. Vasc. Interv. Radiol. 2010;21:1335-7).

Additionally, in a commentary on the treatment of CCSVI, representatives of the Cardiovascular and Interventional Radiological Society of Europe acknowledged that although several centers worldwide are promoting and performing balloon dilatation, with or without stenting for CCSVI, "We believe that until real scientific data are available for CCSVI and balloon dilatation, this treatment should not be offered to MS patients outside of a well designed clinical trial" (Cardiovasc. Intervent. Radiol. 2011;34:1-2).

Toward that end, the National Multiple Sclerosis Society of the United States and the MS Society of Canada have pledged $2.4 million in support of seven CCSVI research studies, including projects designed to evaluate venous abnormalities in children and teens with MS, patients with early and late stage MS, and those at risk for MS.

An international review panel comprising radiologists, vascular surgeons, and neurologists evaluated research applications via an expedited review process, according to the societies.

Dr. Burks disclosed relationships with various pharmaceutical companies. Dr. Baracchini had no relevant conflicts.

Multiple sclerosis patients and endovascular interventionalists were elated when Italian researchers reported in 2009 that they had found evidence of chronic cerebrospinal venous insufficiency in nearly every MS patient they had studied and that in many cases, balloon angioplasty and sometimes stent placement of central thoracic veins reduced or eliminated signs of the disease. Neurologists, on the other hand, suggested that hope might be eclipsing reason in the rush to advocate the vascular procedure, given the single-center study's small sample size and nonrandomized, uncontrolled design.

The opposing perspectives incited an apparent turf war within the MS community fueled by accusations on both sides, according to Dr. Jack Burks, chief medical officer of the Multiple Sclerosis Association of America. At issue, he said, is the validity not only of the study results but also of the underlying hypothesis that toxic iron overload in the brain due to chronic cerebrospinal venous insufficiency (CCSVI) might have a primary role in the pathogenesis of MS - a hypothesis that contradicts the compelling body of evidence suggesting that MS is primarily an autoimmune condition.

On one side of the debate are the MS patients and endovascular interventionalists, dubbed the "liberators" by Dr. Burks because of their unflappable advocacy for what has become known as the liberation procedure - the endovascular surgery designed to open the lesions causing the venous insufficiency, he said.

"Neurologists believe the interventionalists are overstating the possible value of CCSVI and that commercial interests are overriding scientific inquiry," according to Dr. Burks, a neurologist and clinical professor of medicine at the University of Nevada, Reno. Patients, armed with anecdotal evidence downloaded from the Internet, are certain that CCSVI surgery is the miracle they've been waiting for and perceive the hesitancy of U.S. and Canadian neurologists to embrace the treatment as evidence of a possible conspiracy with pharmaceutical companies who stand to lose billions of dollars if the surgery becomes a first-line treatment, he said. Further, he noted, advocates of CCSVI claim that neurologists who refuse patients' demands for diagnostic testing and surgical referral for CCSVI are jeopardizing the safety of those patients, who are traveling to foreign countries to get the care that they cannot receive in North America.

To date, the majority of the evidence regarding CCSVI diagnosis and treatment in MS is inconsistent, and can be confusing, Dr. Burks noted. In the initial study, Dr. Paolo Zamboni of the University of Ferrara in Italy, and colleagues, used Doppler ultrasound to examine venous drainage of the brain and spinal cord in 65 patients with different types of MS and 235 controls without MS and observed abnormal venous flow in all of the MS patients and none of the controls. The patterns of venous obstruction differed depending on MS stage and course, although there was no apparent relationship between disease severity and extent of venous obstruction, and MS treatment status did not influence the signs of CCSVI in any of the patients, the authors wrote (J. Neurol. Neurosurg. Psychiatry 2009;80:392-9).

The researchers went on to conduct an open pilot study to determine whether percutaneous transluminal angioplasty could safely and effectively treat the narrowing of the extracranial cerebrospinal veins in the 65 MS patients in which the condition was observed - 35 with relapsing-remitting MS, 20 with secondary progressive MS, and 10 with primary progressive MS. They reported significant improvements in MS clinical outcome measures, significant reductions in new brain lesions on MRI, and significant reductions in the number of relapses experienced by some of the patients.

The findings were limited, however, not only by the study design, but also by the fact that patients remained on their disease-modifying antirheumatic drug therapy during the study period and the timing and type of MRI scans varied among the patients, according to the authors. They also noted that restenosis of the internal jugular veins occurred in nearly half of the patients (J. Vasc. Surg. 2009;50:1348-58).

Since the initial paper, a number of CCSVI studies of various designs have been undertaken, with contradictory results. Following are some of the investigations reported within the past year:

P Researchers at the University of Buffalo found that up to 62% of the 280 patients with MS enrolled in the Combined Transcranial and Extracranial Venous Doppler Evaluation study - the first randomized clinical trial to evaluate MS patients for CCSVI - had the characteristic narrowing of the extracranial veins compared with approximately 22% of 220 healthy controls. While the results, which were reported at the annual meeting of the American Academy of Neurology, did not establish causation, they showed "that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis," principal investigator Dr. Robert Zivadinov said in a statement. He acknowledged that the finding of vascular narrowing in nearly a quarter of the healthy controls warranted additional investigation (www.buffalo.edu/news/fast-execute.cgi/article-page.html?article=109370009).

P In an open-label study of extracranial Doppler criteria of CCSVI in 70 MS patients in Poland - 49 with relapsing-remitting MS, 5 with primary progressive MS, and 16 with secondary progressive MS - investigators detected at least two of four extracranial criteria in 90% of the patients. They concluded that, while the extracranial abnormalities could exist in various combinations, "the most common pathology in our patients was the presence of an inverted valve or another pathologic structure [like membranaceous or netlike septum] in the area of junction of the [internal jugular vein] with the brachiocephalic vein (Int. Angiol. 2010;29:109-14).

P A comparison of the internal jugular vein hemodynamics and morphology in 25 patients with MS and 25 controls identified abnormal findings in 92% of the MS patients and 24% of the controls, and evidence of CCSVI in 84% of the MS patients and none of the controls, leading the investigators to conclude that both hemodynamic abnormalities and morphologic changes in the internal jugular vein "are strongly associated with MS" (Int. Angiol. 2010;29:115-20).

P An extended extra- and transcranial color-coded sonography study in 56 MS patients and 20 controls detected no internal jugular vein stenosis and normal blood flow direction in all but 1 patient. There were no between-group differences in intracranial veins and during Valsalva maneuver, and none of the patients fulfilled more than one CCSVI criterion, according to the authors. They concluded that their findings "challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS" (Ann. Neurol. 2010;68:173-83).

P Swedish investigators used phase-contrast MRI to study 21 relapsing-remitting MS patients and 20 healthy controls and found no differences in internal jugular venous outflow, aqueductal cerebrospinal fluid flow, or the presence of internal jugular blood reflux between the two groups. Although contrast-enhanced MR angiography showed internal jugular vein stenosis in 3 of the 21 MS patients, the authors stated they found no evidence "confirming the suggested vascular multiple sclerosis hypothesis" (Ann. Neurol. 2010;68:255-9).

P The authors of an MR venography and flow quantification study in The Netherlands compared the intracranial and extracranial venous anatomy and the intracerebral venous flow profiles of 20 MS patients and 20 age- and gender-matched controls, with image analysis performed by blinded interventional neuroradiologists. They identified venous system anomalies in 50% of the MS patients and 40% of the healthy controls and no venous backflow in either group. "Given the normal intracranial venous flow quantification results, it is likely that these findings reflect anatomical variants of venous drainage rather than clinically relevant venous outflow obstructions," the authors wrote (J. Neurol. Neurosurg. Psychiatry 2010 Oct. 27 [doi: 10.1136/jnnp.2010.223479]).

P Italian researchers investigating the occurrence of CCSVI in 50 consecutive patients with clinically isolated syndromes suggestive of MS reviewed the patients' extracranial and transcranial venous echo-color Doppler sonographs and compared the findings to those of 50 age- and gender-matched healthy controls as well as those of 60 patients with transient global amnesia (TGA) and 60 healthy controls matched to the TGA patients. They found extracranial Doppler sonographic abnormalities in 52% of patients with possible MS, 68.3% of patients with TGA, and 31.8% of the healthy controls. While eight of the patients with possible MS fulfilled the CCSVI criteria, selective phlebography showed no venous anomalies in seven of them. The authors concluded that there was no evidence of CCSVI at MS onset but recommended further studies to "clarify whether CCSVI is associated with later disease stages and characterizes the progressive forms of MS" (Ann. Neurol. 2011;69:90-9).

In a position statement, the Society of Interventional Radiology stated that at present, the published literature is "inconclusive on whether CCSVI is a clinically important factor and on whether balloon angioplasty and/or stent placement are effective in patients with MS" (J. Vasc. Interv. Radiol. 2010;21:1335-7).

Additionally, in a commentary on the treatment of CCSVI, representatives of the Cardiovascular and Interventional Radiological Society of Europe acknowledged that although several centers worldwide are promoting and performing balloon dilatation, with or without stenting for CCSVI, "We believe that until real scientific data are available for CCSVI and balloon dilatation, this treatment should not be offered to MS patients outside of a well designed clinical trial" (Cardiovasc. Intervent. Radiol. 2011;34:1-2).

Toward that end, the National Multiple Sclerosis Society of the United States and the MS Society of Canada have pledged $2.4 million in support of seven CCSVI research studies, including projects designed to evaluate venous abnormalities in children and teens with MS, patients with early and late stage MS, and those at risk for MS.

An international review panel comprising radiologists, vascular surgeons, and neurologists evaluated research applications via an expedited review process, according to the societies.

Dr. Burks disclosed relationships with various pharmaceutical companies. Dr. Baracchini had no relevant conflicts.

Multiple sclerosis patients and endovascular interventionalists were elated when Italian researchers reported in 2009 that they had found evidence of chronic cerebrospinal venous insufficiency in nearly every MS patient they had studied and that in many cases, balloon angioplasty and sometimes stent placement of central thoracic veins reduced or eliminated signs of the disease. Neurologists, on the other hand, suggested that hope might be eclipsing reason in the rush to advocate the vascular procedure, given the single-center study's small sample size and nonrandomized, uncontrolled design.

The opposing perspectives incited an apparent turf war within the MS community fueled by accusations on both sides, according to Dr. Jack Burks, chief medical officer of the Multiple Sclerosis Association of America. At issue, he said, is the validity not only of the study results but also of the underlying hypothesis that toxic iron overload in the brain due to chronic cerebrospinal venous insufficiency (CCSVI) might have a primary role in the pathogenesis of MS - a hypothesis that contradicts the compelling body of evidence suggesting that MS is primarily an autoimmune condition.

On one side of the debate are the MS patients and endovascular interventionalists, dubbed the "liberators" by Dr. Burks because of their unflappable advocacy for what has become known as the liberation procedure - the endovascular surgery designed to open the lesions causing the venous insufficiency, he said.

"Neurologists believe the interventionalists are overstating the possible value of CCSVI and that commercial interests are overriding scientific inquiry," according to Dr. Burks, a neurologist and clinical professor of medicine at the University of Nevada, Reno. Patients, armed with anecdotal evidence downloaded from the Internet, are certain that CCSVI surgery is the miracle they've been waiting for and perceive the hesitancy of U.S. and Canadian neurologists to embrace the treatment as evidence of a possible conspiracy with pharmaceutical companies who stand to lose billions of dollars if the surgery becomes a first-line treatment, he said. Further, he noted, advocates of CCSVI claim that neurologists who refuse patients' demands for diagnostic testing and surgical referral for CCSVI are jeopardizing the safety of those patients, who are traveling to foreign countries to get the care that they cannot receive in North America.

To date, the majority of the evidence regarding CCSVI diagnosis and treatment in MS is inconsistent, and can be confusing, Dr. Burks noted. In the initial study, Dr. Paolo Zamboni of the University of Ferrara in Italy, and colleagues, used Doppler ultrasound to examine venous drainage of the brain and spinal cord in 65 patients with different types of MS and 235 controls without MS and observed abnormal venous flow in all of the MS patients and none of the controls. The patterns of venous obstruction differed depending on MS stage and course, although there was no apparent relationship between disease severity and extent of venous obstruction, and MS treatment status did not influence the signs of CCSVI in any of the patients, the authors wrote (J. Neurol. Neurosurg. Psychiatry 2009;80:392-9).

The researchers went on to conduct an open pilot study to determine whether percutaneous transluminal angioplasty could safely and effectively treat the narrowing of the extracranial cerebrospinal veins in the 65 MS patients in which the condition was observed - 35 with relapsing-remitting MS, 20 with secondary progressive MS, and 10 with primary progressive MS. They reported significant improvements in MS clinical outcome measures, significant reductions in new brain lesions on MRI, and significant reductions in the number of relapses experienced by some of the patients.

The findings were limited, however, not only by the study design, but also by the fact that patients remained on their disease-modifying antirheumatic drug therapy during the study period and the timing and type of MRI scans varied among the patients, according to the authors. They also noted that restenosis of the internal jugular veins occurred in nearly half of the patients (J. Vasc. Surg. 2009;50:1348-58).

Since the initial paper, a number of CCSVI studies of various designs have been undertaken, with contradictory results. Following are some of the investigations reported within the past year:

P Researchers at the University of Buffalo found that up to 62% of the 280 patients with MS enrolled in the Combined Transcranial and Extracranial Venous Doppler Evaluation study - the first randomized clinical trial to evaluate MS patients for CCSVI - had the characteristic narrowing of the extracranial veins compared with approximately 22% of 220 healthy controls. While the results, which were reported at the annual meeting of the American Academy of Neurology, did not establish causation, they showed "that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis," principal investigator Dr. Robert Zivadinov said in a statement. He acknowledged that the finding of vascular narrowing in nearly a quarter of the healthy controls warranted additional investigation (www.buffalo.edu/news/fast-execute.cgi/article-page.html?article=109370009).

P In an open-label study of extracranial Doppler criteria of CCSVI in 70 MS patients in Poland - 49 with relapsing-remitting MS, 5 with primary progressive MS, and 16 with secondary progressive MS - investigators detected at least two of four extracranial criteria in 90% of the patients. They concluded that, while the extracranial abnormalities could exist in various combinations, "the most common pathology in our patients was the presence of an inverted valve or another pathologic structure [like membranaceous or netlike septum] in the area of junction of the [internal jugular vein] with the brachiocephalic vein (Int. Angiol. 2010;29:109-14).

P A comparison of the internal jugular vein hemodynamics and morphology in 25 patients with MS and 25 controls identified abnormal findings in 92% of the MS patients and 24% of the controls, and evidence of CCSVI in 84% of the MS patients and none of the controls, leading the investigators to conclude that both hemodynamic abnormalities and morphologic changes in the internal jugular vein "are strongly associated with MS" (Int. Angiol. 2010;29:115-20).

P An extended extra- and transcranial color-coded sonography study in 56 MS patients and 20 controls detected no internal jugular vein stenosis and normal blood flow direction in all but 1 patient. There were no between-group differences in intracranial veins and during Valsalva maneuver, and none of the patients fulfilled more than one CCSVI criterion, according to the authors. They concluded that their findings "challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS" (Ann. Neurol. 2010;68:173-83).

P Swedish investigators used phase-contrast MRI to study 21 relapsing-remitting MS patients and 20 healthy controls and found no differences in internal jugular venous outflow, aqueductal cerebrospinal fluid flow, or the presence of internal jugular blood reflux between the two groups. Although contrast-enhanced MR angiography showed internal jugular vein stenosis in 3 of the 21 MS patients, the authors stated they found no evidence "confirming the suggested vascular multiple sclerosis hypothesis" (Ann. Neurol. 2010;68:255-9).

P The authors of an MR venography and flow quantification study in The Netherlands compared the intracranial and extracranial venous anatomy and the intracerebral venous flow profiles of 20 MS patients and 20 age- and gender-matched controls, with image analysis performed by blinded interventional neuroradiologists. They identified venous system anomalies in 50% of the MS patients and 40% of the healthy controls and no venous backflow in either group. "Given the normal intracranial venous flow quantification results, it is likely that these findings reflect anatomical variants of venous drainage rather than clinically relevant venous outflow obstructions," the authors wrote (J. Neurol. Neurosurg. Psychiatry 2010 Oct. 27 [doi: 10.1136/jnnp.2010.223479]).

P Italian researchers investigating the occurrence of CCSVI in 50 consecutive patients with clinically isolated syndromes suggestive of MS reviewed the patients' extracranial and transcranial venous echo-color Doppler sonographs and compared the findings to those of 50 age- and gender-matched healthy controls as well as those of 60 patients with transient global amnesia (TGA) and 60 healthy controls matched to the TGA patients. They found extracranial Doppler sonographic abnormalities in 52% of patients with possible MS, 68.3% of patients with TGA, and 31.8% of the healthy controls. While eight of the patients with possible MS fulfilled the CCSVI criteria, selective phlebography showed no venous anomalies in seven of them. The authors concluded that there was no evidence of CCSVI at MS onset but recommended further studies to "clarify whether CCSVI is associated with later disease stages and characterizes the progressive forms of MS" (Ann. Neurol. 2011;69:90-9).

In a position statement, the Society of Interventional Radiology stated that at present, the published literature is "inconclusive on whether CCSVI is a clinically important factor and on whether balloon angioplasty and/or stent placement are effective in patients with MS" (J. Vasc. Interv. Radiol. 2010;21:1335-7).

Additionally, in a commentary on the treatment of CCSVI, representatives of the Cardiovascular and Interventional Radiological Society of Europe acknowledged that although several centers worldwide are promoting and performing balloon dilatation, with or without stenting for CCSVI, "We believe that until real scientific data are available for CCSVI and balloon dilatation, this treatment should not be offered to MS patients outside of a well designed clinical trial" (Cardiovasc. Intervent. Radiol. 2011;34:1-2).

Toward that end, the National Multiple Sclerosis Society of the United States and the MS Society of Canada have pledged $2.4 million in support of seven CCSVI research studies, including projects designed to evaluate venous abnormalities in children and teens with MS, patients with early and late stage MS, and those at risk for MS.

An international review panel comprising radiologists, vascular surgeons, and neurologists evaluated research applications via an expedited review process, according to the societies.

Dr. Burks disclosed relationships with various pharmaceutical companies. Dr. Baracchini had no relevant conflicts.

SILVER SPRING, MD. — Members of a Food and Drug Administration advisory panel were divided on whether the approved indication for fenofibric acid, when co-administered with a statin, should be revised based on trial results showing no benefit of the drug in reducing cardiovascular disease risk when added to a statin in patients with type 2 diabetes.

At a meeting May 19, 6 of the 13 members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agreed that the marketing of fenofibric acid should be allowed to continue, with the addition to the label of the main findings of the study – the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. Four panelists, however, voted to recommend that the co-administration indication be withdrawn, citing the lack of solid evidence to support the indication. The remaining three panelists voted to allow continued marketing with no changes to the label.

Fenofibric acid, marketed by Abbott Laboratories as Trilipix, was approved by the FDA in December 2008. The drug’s indication includes its use with a statin as an adjunct to diet to reduce serum triglyceride (TG) levels and increase serum HDL cholesterol levels in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on "optimal statin therapy" to achieve their LDL cholesterol goal. Fenofibric acid is the active ingredient of fenofibrate, a fibrate approved in 1993 that is now available in generic formulations.

The FDA convened the panel to review the co-administration indication of fenofibric acid in the context of the ACCORD Lipid study results. That study found no benefit of the combination treatment on major cardiovascular events, compared with treatment with simvastatin alone, over a mean of almost 5 years of follow-up. The study enrolled more than 5,500 patients with type 2 diabetes at high risk of cardiovascular disease, with a range of TG and HDL cholesterol levels. Among women in the study, the rate of major adverse cardiovascular events was higher than that among those on the statin alone. But in another subgroup of patients, those with elevated TG levels (204 mg/dL or higher) and reduced HDL cholesterol levels (34 mg/dL or lower), there was a suggestion of benefit with combination therapy (N. Engl. J. Med. 2010;362:1563-74).

Panelists at the meeting said they were not comfortable drawing any conclusions from analyses of patient subgroups in a negative trial. They voted 13-0 that the FDA should require Abbott to conduct a study to test the hypothesis that add-on therapy with fenofibric acid, compared with placebo, significantly lowers the risk of major adverse cardiovascular events in high-risk patients who have reached their LDL cholesterol goal with a statin but have residual high serum TG and low serum HDL cholesterol levels.

The ACCORD Lipid study was sponsored by the National Heart, Lung and Blood Institute.

The FDA usually follows the recommendations of its advisory panels. Members of FDA advisory panels have been cleared of potential conflicts of interest related to the topic of the meeting; occasionally, they may be given a waiver, but not at this meeting.

SILVER SPRING, MD. — Members of a Food and Drug Administration advisory panel were divided on whether the approved indication for fenofibric acid, when co-administered with a statin, should be revised based on trial results showing no benefit of the drug in reducing cardiovascular disease risk when added to a statin in patients with type 2 diabetes.

At a meeting May 19, 6 of the 13 members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agreed that the marketing of fenofibric acid should be allowed to continue, with the addition to the label of the main findings of the study – the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. Four panelists, however, voted to recommend that the co-administration indication be withdrawn, citing the lack of solid evidence to support the indication. The remaining three panelists voted to allow continued marketing with no changes to the label.

Fenofibric acid, marketed by Abbott Laboratories as Trilipix, was approved by the FDA in December 2008. The drug’s indication includes its use with a statin as an adjunct to diet to reduce serum triglyceride (TG) levels and increase serum HDL cholesterol levels in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on "optimal statin therapy" to achieve their LDL cholesterol goal. Fenofibric acid is the active ingredient of fenofibrate, a fibrate approved in 1993 that is now available in generic formulations.

The FDA convened the panel to review the co-administration indication of fenofibric acid in the context of the ACCORD Lipid study results. That study found no benefit of the combination treatment on major cardiovascular events, compared with treatment with simvastatin alone, over a mean of almost 5 years of follow-up. The study enrolled more than 5,500 patients with type 2 diabetes at high risk of cardiovascular disease, with a range of TG and HDL cholesterol levels. Among women in the study, the rate of major adverse cardiovascular events was higher than that among those on the statin alone. But in another subgroup of patients, those with elevated TG levels (204 mg/dL or higher) and reduced HDL cholesterol levels (34 mg/dL or lower), there was a suggestion of benefit with combination therapy (N. Engl. J. Med. 2010;362:1563-74).

Panelists at the meeting said they were not comfortable drawing any conclusions from analyses of patient subgroups in a negative trial. They voted 13-0 that the FDA should require Abbott to conduct a study to test the hypothesis that add-on therapy with fenofibric acid, compared with placebo, significantly lowers the risk of major adverse cardiovascular events in high-risk patients who have reached their LDL cholesterol goal with a statin but have residual high serum TG and low serum HDL cholesterol levels.

The ACCORD Lipid study was sponsored by the National Heart, Lung and Blood Institute.

The FDA usually follows the recommendations of its advisory panels. Members of FDA advisory panels have been cleared of potential conflicts of interest related to the topic of the meeting; occasionally, they may be given a waiver, but not at this meeting.

SILVER SPRING, MD. — Members of a Food and Drug Administration advisory panel were divided on whether the approved indication for fenofibric acid, when co-administered with a statin, should be revised based on trial results showing no benefit of the drug in reducing cardiovascular disease risk when added to a statin in patients with type 2 diabetes.

At a meeting May 19, 6 of the 13 members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agreed that the marketing of fenofibric acid should be allowed to continue, with the addition to the label of the main findings of the study – the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. Four panelists, however, voted to recommend that the co-administration indication be withdrawn, citing the lack of solid evidence to support the indication. The remaining three panelists voted to allow continued marketing with no changes to the label.

Fenofibric acid, marketed by Abbott Laboratories as Trilipix, was approved by the FDA in December 2008. The drug’s indication includes its use with a statin as an adjunct to diet to reduce serum triglyceride (TG) levels and increase serum HDL cholesterol levels in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on "optimal statin therapy" to achieve their LDL cholesterol goal. Fenofibric acid is the active ingredient of fenofibrate, a fibrate approved in 1993 that is now available in generic formulations.

The FDA convened the panel to review the co-administration indication of fenofibric acid in the context of the ACCORD Lipid study results. That study found no benefit of the combination treatment on major cardiovascular events, compared with treatment with simvastatin alone, over a mean of almost 5 years of follow-up. The study enrolled more than 5,500 patients with type 2 diabetes at high risk of cardiovascular disease, with a range of TG and HDL cholesterol levels. Among women in the study, the rate of major adverse cardiovascular events was higher than that among those on the statin alone. But in another subgroup of patients, those with elevated TG levels (204 mg/dL or higher) and reduced HDL cholesterol levels (34 mg/dL or lower), there was a suggestion of benefit with combination therapy (N. Engl. J. Med. 2010;362:1563-74).

Panelists at the meeting said they were not comfortable drawing any conclusions from analyses of patient subgroups in a negative trial. They voted 13-0 that the FDA should require Abbott to conduct a study to test the hypothesis that add-on therapy with fenofibric acid, compared with placebo, significantly lowers the risk of major adverse cardiovascular events in high-risk patients who have reached their LDL cholesterol goal with a statin but have residual high serum TG and low serum HDL cholesterol levels.

The ACCORD Lipid study was sponsored by the National Heart, Lung and Blood Institute.

The FDA usually follows the recommendations of its advisory panels. Members of FDA advisory panels have been cleared of potential conflicts of interest related to the topic of the meeting; occasionally, they may be given a waiver, but not at this meeting.

Being a good hospitalist means more than being an adroit clinician. But when it comes to teaching nonclinical aptitude, traditional residency programs often come up short, says Russell Holman, MD, MHM, former SHM president and chief clinical officer of Brentwood, Tenn.-based Cogent Healthcare. He and other HM experts recommend that boots-on-the-ground hospitalists acquire the following nonclinical skills in a purposeful manner as part of their ongoing learning and long-term career goals.

Communication

Hospitalists are the liaison between hospital administrators, managed-care companies, case managers, patients, patients’ families, and primary-care physicians (PCPs), says Isela Sotolongo, executive director of the Southeast region for North Hollywood, Calif.-based IPC: The Hospitalist Company. “A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient,” she says.

A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient.

—Isela Sotolongo, executive director, Southeast region, IPC: The Hospitalist Company, North Hollywood, Calif.

Hospitalists must quickly establish a relationship with patients and their families; manage specialists and ancillary personnel; brief a PCP on a patient’s needs after discharge; update case managers on a course of hospitalization; and demonstrate effective, efficient patient care to hospital administrators. Being able to express such information in a concise manner that is understood by others will reduce errors and save time and effort, Dr. Holman and Sotolongo say.

Quality Improvement (QI)

An awareness and working knowledge of QI methodologies should be part of a hospitalist’s everyday professional life, Dr. Holman says. QI helps reduce unwanted variation in patient care and enhances the process and outcomes of such care.

“Hospitalists are almost always looked to as being a linchpin in the hospital to improving quality,” he says. Therefore, while QI might not be a hospitalist’s special interest, it is still good to know the basics and how to apply them to actual HM practice, Dr. Holman says.

Leadership

“Even if a hospitalist is not serving as medical director of their hospital medicine group, they are considered to be a leader in their own right,” Dr. Holman says.

A hospitalist takes charge of the admission process and is the person who manages all aspects of a patient’s care throughout the hospital stay to the point of discharge, Sotolongo says. (Click here to listen to Isela Sotolongo discuss hospitalist leadership and communication in detail.)

Also, a hospitalist might be leading and participating in QI activities at the hospital or leading the discussion for a multidisciplinary team, Dr. Holman notes. Having leadership skills helps a hospitalist appreciate the work their medical director must do, or the work that hospital administrators are trying to accomplish, he says.

Teamwork

Teamwork is an essential skill for hospitalists, yet traditional medical training often teaches doctors to be more of a rugged individualist, Dr. Holman says. Hospitalists should make it a point to adopt new behaviors that are teamwork-friendly:

• Value other members of the healthcare team;
• Direct people’s talents to their highest and best use; and
• Delegate tasks to those who are best suited to accomplish those particular needs.

“Teamwork tends to place much more emphasis on the patient being the center of care and others on the healthcare team going to support those patient-centered interests,” Dr. Holman say.

The Patient Perspective

How a patient moves through the healthcare system in theory is often different from reality. A hospitalist should physically follow some of their patients as they move from the hospital back to their caregivers at home or to a rehabilitation center, nursing home, or other facility in order to watch the transition, says Jasen Gundersen, MD, MBA, CPE, SFHM, chief medical officer of the hospital medicine division in Fort Lauderdale, Fla., for Knoxville, Tenn.-based TeamHealth. By doing this, a hospitalist can see where problems arise during handoffs and how to resolve them so that hospital readmissions are reduced.

Teaching

Teaching skills can be applicable in any hospital environment, Dr. Holman adds. Hospitalists who work in nonteaching hospitals often serve as teachers to nursing staff, case management, pharmacists, discharge planners, and other ancillary staff in their daily interaction or over lunchtime educational programs. HM also can provide the bulk of a hospital’s grand rounds or other departmental educational sessions, he says.

“Let's not forget about patients and caregivers,” Dr. Holman adds. “The ability to teach patients and caregivers the necessary information and skills that they need for self-care, for follow-up care, and for compliance to a medical plan is important.”

Professional Evaluation

A hospitalist has to know on which metrics and measurements their success will be based, Dr. Holman says. Will it be patient satisfaction, length of stay, readmission rates, mortality rates, or some other measure?

“We have to be aware of what the hospital’s needs are, what the hospital’s key points are that they look for,” Sotolongo says.

Once the metrics are clear, a hospitalist can set goals to accomplish individually, as a member of an HM group, and partner with the hospital, Dr. Holman says.

Lisa Ryan is a freelance writer based in New Jersey.

Being a good hospitalist means more than being an adroit clinician. But when it comes to teaching nonclinical aptitude, traditional residency programs often come up short, says Russell Holman, MD, MHM, former SHM president and chief clinical officer of Brentwood, Tenn.-based Cogent Healthcare. He and other HM experts recommend that boots-on-the-ground hospitalists acquire the following nonclinical skills in a purposeful manner as part of their ongoing learning and long-term career goals.

Communication

Hospitalists are the liaison between hospital administrators, managed-care companies, case managers, patients, patients’ families, and primary-care physicians (PCPs), says Isela Sotolongo, executive director of the Southeast region for North Hollywood, Calif.-based IPC: The Hospitalist Company. “A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient,” she says.

A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient.

—Isela Sotolongo, executive director, Southeast region, IPC: The Hospitalist Company, North Hollywood, Calif.

Hospitalists must quickly establish a relationship with patients and their families; manage specialists and ancillary personnel; brief a PCP on a patient’s needs after discharge; update case managers on a course of hospitalization; and demonstrate effective, efficient patient care to hospital administrators. Being able to express such information in a concise manner that is understood by others will reduce errors and save time and effort, Dr. Holman and Sotolongo say.

Quality Improvement (QI)

An awareness and working knowledge of QI methodologies should be part of a hospitalist’s everyday professional life, Dr. Holman says. QI helps reduce unwanted variation in patient care and enhances the process and outcomes of such care.

“Hospitalists are almost always looked to as being a linchpin in the hospital to improving quality,” he says. Therefore, while QI might not be a hospitalist’s special interest, it is still good to know the basics and how to apply them to actual HM practice, Dr. Holman says.

Leadership

“Even if a hospitalist is not serving as medical director of their hospital medicine group, they are considered to be a leader in their own right,” Dr. Holman says.

A hospitalist takes charge of the admission process and is the person who manages all aspects of a patient’s care throughout the hospital stay to the point of discharge, Sotolongo says. (Click here to listen to Isela Sotolongo discuss hospitalist leadership and communication in detail.)

Also, a hospitalist might be leading and participating in QI activities at the hospital or leading the discussion for a multidisciplinary team, Dr. Holman notes. Having leadership skills helps a hospitalist appreciate the work their medical director must do, or the work that hospital administrators are trying to accomplish, he says.

Teamwork

Teamwork is an essential skill for hospitalists, yet traditional medical training often teaches doctors to be more of a rugged individualist, Dr. Holman says. Hospitalists should make it a point to adopt new behaviors that are teamwork-friendly:

• Value other members of the healthcare team;
• Direct people’s talents to their highest and best use; and
• Delegate tasks to those who are best suited to accomplish those particular needs.

“Teamwork tends to place much more emphasis on the patient being the center of care and others on the healthcare team going to support those patient-centered interests,” Dr. Holman say.

The Patient Perspective

How a patient moves through the healthcare system in theory is often different from reality. A hospitalist should physically follow some of their patients as they move from the hospital back to their caregivers at home or to a rehabilitation center, nursing home, or other facility in order to watch the transition, says Jasen Gundersen, MD, MBA, CPE, SFHM, chief medical officer of the hospital medicine division in Fort Lauderdale, Fla., for Knoxville, Tenn.-based TeamHealth. By doing this, a hospitalist can see where problems arise during handoffs and how to resolve them so that hospital readmissions are reduced.

Teaching

Teaching skills can be applicable in any hospital environment, Dr. Holman adds. Hospitalists who work in nonteaching hospitals often serve as teachers to nursing staff, case management, pharmacists, discharge planners, and other ancillary staff in their daily interaction or over lunchtime educational programs. HM also can provide the bulk of a hospital’s grand rounds or other departmental educational sessions, he says.

“Let's not forget about patients and caregivers,” Dr. Holman adds. “The ability to teach patients and caregivers the necessary information and skills that they need for self-care, for follow-up care, and for compliance to a medical plan is important.”

Professional Evaluation

A hospitalist has to know on which metrics and measurements their success will be based, Dr. Holman says. Will it be patient satisfaction, length of stay, readmission rates, mortality rates, or some other measure?

“We have to be aware of what the hospital’s needs are, what the hospital’s key points are that they look for,” Sotolongo says.

Once the metrics are clear, a hospitalist can set goals to accomplish individually, as a member of an HM group, and partner with the hospital, Dr. Holman says.

Lisa Ryan is a freelance writer based in New Jersey.

Being a good hospitalist means more than being an adroit clinician. But when it comes to teaching nonclinical aptitude, traditional residency programs often come up short, says Russell Holman, MD, MHM, former SHM president and chief clinical officer of Brentwood, Tenn.-based Cogent Healthcare. He and other HM experts recommend that boots-on-the-ground hospitalists acquire the following nonclinical skills in a purposeful manner as part of their ongoing learning and long-term career goals.

Communication

Hospitalists are the liaison between hospital administrators, managed-care companies, case managers, patients, patients’ families, and primary-care physicians (PCPs), says Isela Sotolongo, executive director of the Southeast region for North Hollywood, Calif.-based IPC: The Hospitalist Company. “A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient,” she says.

A lot of times, more time is spent communicating with all the individuals that are involved in the patient’s admission than is actually spent with the patient.

—Isela Sotolongo, executive director, Southeast region, IPC: The Hospitalist Company, North Hollywood, Calif.

Hospitalists must quickly establish a relationship with patients and their families; manage specialists and ancillary personnel; brief a PCP on a patient’s needs after discharge; update case managers on a course of hospitalization; and demonstrate effective, efficient patient care to hospital administrators. Being able to express such information in a concise manner that is understood by others will reduce errors and save time and effort, Dr. Holman and Sotolongo say.

Quality Improvement (QI)

An awareness and working knowledge of QI methodologies should be part of a hospitalist’s everyday professional life, Dr. Holman says. QI helps reduce unwanted variation in patient care and enhances the process and outcomes of such care.

“Hospitalists are almost always looked to as being a linchpin in the hospital to improving quality,” he says. Therefore, while QI might not be a hospitalist’s special interest, it is still good to know the basics and how to apply them to actual HM practice, Dr. Holman says.

Leadership

“Even if a hospitalist is not serving as medical director of their hospital medicine group, they are considered to be a leader in their own right,” Dr. Holman says.

A hospitalist takes charge of the admission process and is the person who manages all aspects of a patient’s care throughout the hospital stay to the point of discharge, Sotolongo says. (Click here to listen to Isela Sotolongo discuss hospitalist leadership and communication in detail.)

Also, a hospitalist might be leading and participating in QI activities at the hospital or leading the discussion for a multidisciplinary team, Dr. Holman notes. Having leadership skills helps a hospitalist appreciate the work their medical director must do, or the work that hospital administrators are trying to accomplish, he says.

Teamwork

Teamwork is an essential skill for hospitalists, yet traditional medical training often teaches doctors to be more of a rugged individualist, Dr. Holman says. Hospitalists should make it a point to adopt new behaviors that are teamwork-friendly:

• Value other members of the healthcare team;
• Direct people’s talents to their highest and best use; and
• Delegate tasks to those who are best suited to accomplish those particular needs.

“Teamwork tends to place much more emphasis on the patient being the center of care and others on the healthcare team going to support those patient-centered interests,” Dr. Holman say.

The Patient Perspective

How a patient moves through the healthcare system in theory is often different from reality. A hospitalist should physically follow some of their patients as they move from the hospital back to their caregivers at home or to a rehabilitation center, nursing home, or other facility in order to watch the transition, says Jasen Gundersen, MD, MBA, CPE, SFHM, chief medical officer of the hospital medicine division in Fort Lauderdale, Fla., for Knoxville, Tenn.-based TeamHealth. By doing this, a hospitalist can see where problems arise during handoffs and how to resolve them so that hospital readmissions are reduced.

Teaching

Teaching skills can be applicable in any hospital environment, Dr. Holman adds. Hospitalists who work in nonteaching hospitals often serve as teachers to nursing staff, case management, pharmacists, discharge planners, and other ancillary staff in their daily interaction or over lunchtime educational programs. HM also can provide the bulk of a hospital’s grand rounds or other departmental educational sessions, he says.

“Let's not forget about patients and caregivers,” Dr. Holman adds. “The ability to teach patients and caregivers the necessary information and skills that they need for self-care, for follow-up care, and for compliance to a medical plan is important.”

Professional Evaluation

A hospitalist has to know on which metrics and measurements their success will be based, Dr. Holman says. Will it be patient satisfaction, length of stay, readmission rates, mortality rates, or some other measure?

“We have to be aware of what the hospital’s needs are, what the hospital’s key points are that they look for,” Sotolongo says.

Once the metrics are clear, a hospitalist can set goals to accomplish individually, as a member of an HM group, and partner with the hospital, Dr. Holman says.

Lisa Ryan is a freelance writer based in New Jersey.

The vast majority of the more than 2,500 attendees last week at SHM's annual meeting in Grapevine, Texas, were already on their way to the airport when one last dedicated group discussed the future of the specialty.

The question-and-answer session took place at the annual SHM Town Hall, a chance for rank-and-file hospitalists to query society board members and leaders. Some 75 people took turns asking about internal-medicine residency programs, the challenges of maintaining robust society chapters, and HM's role in critical-care delivery. But the theme of the session kept coming back to whether hospitalists have a seat at the table in how healthcare reform is implemented.

Board member and former SHM Public Policy Committee chairman Eric Siegal, MD, SFHM, says that the society has quickly risen in stature in policy circles despite being a newer specialty. He adds that the field's prominence and credibility is helped by the recent appointment of Patrick Conway, MD, MSc, SFHM, a pediatric hospitalist and director of hospital medicine at Cincinnati Children’s Hospital Medical Center, as chief medical officer of the Centers for Medicare & Medicaid Services (CMS).

"We punch well above our weight class right now," says Dr. Siegal, a critical-care fellow at the University of Wisconsin School of Medicine and Public Health in Madison.

In an interesting twist, James Levy, PA-C, suggested that SHM expand its fellowship programs to nonphysician providers (NPPs) as a way of making them feel more included. Several board members nodded and said they would consider the notion.

"We are actually a big-tent society," says board member Daniel Dressler, MD, MSc, SFHM, associate professor and director of internal-medicine teaching services at Emory University Hospital in Atlanta.

The vast majority of the more than 2,500 attendees last week at SHM's annual meeting in Grapevine, Texas, were already on their way to the airport when one last dedicated group discussed the future of the specialty.

The question-and-answer session took place at the annual SHM Town Hall, a chance for rank-and-file hospitalists to query society board members and leaders. Some 75 people took turns asking about internal-medicine residency programs, the challenges of maintaining robust society chapters, and HM's role in critical-care delivery. But the theme of the session kept coming back to whether hospitalists have a seat at the table in how healthcare reform is implemented.

Board member and former SHM Public Policy Committee chairman Eric Siegal, MD, SFHM, says that the society has quickly risen in stature in policy circles despite being a newer specialty. He adds that the field's prominence and credibility is helped by the recent appointment of Patrick Conway, MD, MSc, SFHM, a pediatric hospitalist and director of hospital medicine at Cincinnati Children’s Hospital Medical Center, as chief medical officer of the Centers for Medicare & Medicaid Services (CMS).

"We punch well above our weight class right now," says Dr. Siegal, a critical-care fellow at the University of Wisconsin School of Medicine and Public Health in Madison.

In an interesting twist, James Levy, PA-C, suggested that SHM expand its fellowship programs to nonphysician providers (NPPs) as a way of making them feel more included. Several board members nodded and said they would consider the notion.

"We are actually a big-tent society," says board member Daniel Dressler, MD, MSc, SFHM, associate professor and director of internal-medicine teaching services at Emory University Hospital in Atlanta.

The vast majority of the more than 2,500 attendees last week at SHM's annual meeting in Grapevine, Texas, were already on their way to the airport when one last dedicated group discussed the future of the specialty.

The question-and-answer session took place at the annual SHM Town Hall, a chance for rank-and-file hospitalists to query society board members and leaders. Some 75 people took turns asking about internal-medicine residency programs, the challenges of maintaining robust society chapters, and HM's role in critical-care delivery. But the theme of the session kept coming back to whether hospitalists have a seat at the table in how healthcare reform is implemented.

Board member and former SHM Public Policy Committee chairman Eric Siegal, MD, SFHM, says that the society has quickly risen in stature in policy circles despite being a newer specialty. He adds that the field's prominence and credibility is helped by the recent appointment of Patrick Conway, MD, MSc, SFHM, a pediatric hospitalist and director of hospital medicine at Cincinnati Children’s Hospital Medical Center, as chief medical officer of the Centers for Medicare & Medicaid Services (CMS).

"We punch well above our weight class right now," says Dr. Siegal, a critical-care fellow at the University of Wisconsin School of Medicine and Public Health in Madison.

In an interesting twist, James Levy, PA-C, suggested that SHM expand its fellowship programs to nonphysician providers (NPPs) as a way of making them feel more included. Several board members nodded and said they would consider the notion.

"We are actually a big-tent society," says board member Daniel Dressler, MD, MSc, SFHM, associate professor and director of internal-medicine teaching services at Emory University Hospital in Atlanta.

Clinical Question: Is chest-compression-only bystander cardiopulmonary resuscitation (CPR) as effective as conventional CPR with rescue breathing for out-of-hospital cardiac arrest?

Background: Out-of-hospital cardiac arrest is a major public health problem, affecting approximately 300,000 people in the U.S. annually. Overall survival is generally less than 10% among those in whom resuscitation is attempted. Bystander CPR significantly improves outcomes but generally is performed in less than 30% of cases.

Study design: Prospective, observational cohort study.

Setting: Communities throughout the state of Arizona.

Synopsis: State officials undertook a multifaceted public service campaign to educate, inform, and encourage the use of compression-only CPR.

Over a period of four years, 5,272 adult out-of-hospital cardiac arrests were documented in Arizona. A total of 4,415 of these incidents met all of the inclusion criteria for analysis; 2,900 received no CPR, 666 received conventional CPR, and 849 received compression-only CPR. Rates of survival to hospital discharge were 5.2% for the no-CPR group, 7.8% for conventional CPR, and 13.3% for compression-only CPR.

Additionally, the successful public service campaign increased the use of lay rescuer conventional CPR by 10% and compression-only CPR by 56%.

Bottom line: Layperson, compression-only CPR was associated with an overall 6.1% increased survival compared with conventional CPR and no bystander CPR.

Citation: Bobrow BJ, Spaite DW, Berg RA, et al. Chest-compression-only CPR by lay rescuers and survival from out-of-hospital cardiac arrest. JAMA. 2010;304(13):1447-1454.

For more physician reviews of HM-related research, visit our website.

Clinical Question: Is chest-compression-only bystander cardiopulmonary resuscitation (CPR) as effective as conventional CPR with rescue breathing for out-of-hospital cardiac arrest?

Background: Out-of-hospital cardiac arrest is a major public health problem, affecting approximately 300,000 people in the U.S. annually. Overall survival is generally less than 10% among those in whom resuscitation is attempted. Bystander CPR significantly improves outcomes but generally is performed in less than 30% of cases.

Study design: Prospective, observational cohort study.

Setting: Communities throughout the state of Arizona.

Synopsis: State officials undertook a multifaceted public service campaign to educate, inform, and encourage the use of compression-only CPR.

Over a period of four years, 5,272 adult out-of-hospital cardiac arrests were documented in Arizona. A total of 4,415 of these incidents met all of the inclusion criteria for analysis; 2,900 received no CPR, 666 received conventional CPR, and 849 received compression-only CPR. Rates of survival to hospital discharge were 5.2% for the no-CPR group, 7.8% for conventional CPR, and 13.3% for compression-only CPR.

Additionally, the successful public service campaign increased the use of lay rescuer conventional CPR by 10% and compression-only CPR by 56%.

Bottom line: Layperson, compression-only CPR was associated with an overall 6.1% increased survival compared with conventional CPR and no bystander CPR.

Citation: Bobrow BJ, Spaite DW, Berg RA, et al. Chest-compression-only CPR by lay rescuers and survival from out-of-hospital cardiac arrest. JAMA. 2010;304(13):1447-1454.

For more physician reviews of HM-related research, visit our website.

Clinical Question: Is chest-compression-only bystander cardiopulmonary resuscitation (CPR) as effective as conventional CPR with rescue breathing for out-of-hospital cardiac arrest?

Background: Out-of-hospital cardiac arrest is a major public health problem, affecting approximately 300,000 people in the U.S. annually. Overall survival is generally less than 10% among those in whom resuscitation is attempted. Bystander CPR significantly improves outcomes but generally is performed in less than 30% of cases.

Study design: Prospective, observational cohort study.

Setting: Communities throughout the state of Arizona.

Synopsis: State officials undertook a multifaceted public service campaign to educate, inform, and encourage the use of compression-only CPR.

Over a period of four years, 5,272 adult out-of-hospital cardiac arrests were documented in Arizona. A total of 4,415 of these incidents met all of the inclusion criteria for analysis; 2,900 received no CPR, 666 received conventional CPR, and 849 received compression-only CPR. Rates of survival to hospital discharge were 5.2% for the no-CPR group, 7.8% for conventional CPR, and 13.3% for compression-only CPR.

Additionally, the successful public service campaign increased the use of lay rescuer conventional CPR by 10% and compression-only CPR by 56%.

Bottom line: Layperson, compression-only CPR was associated with an overall 6.1% increased survival compared with conventional CPR and no bystander CPR.

Citation: Bobrow BJ, Spaite DW, Berg RA, et al. Chest-compression-only CPR by lay rescuers and survival from out-of-hospital cardiac arrest. JAMA. 2010;304(13):1447-1454.

For more physician reviews of HM-related research, visit our website.

Neither aspirin nor simvastatin improved outcomes for patients with pulmonary arterial hypertension in a phase II safety and efficacy trial published online May 19 in Circulation and simultaneously presented at the annual meeting of the American Thoracic Society.

The primary end point of 6-minute walk distance did not increase after 6 months of aspirin therapy and actually decreased after 6 months of simvastatin therapy, indicating that neither agent should be used as an add-on therapy in PAH, said Dr. Steven M. Kawut of Penn Cardiovascular Institute, University of Pennsylvania, Philadelphia, and his associates.

A recent animal study showed that aspirin decreased pulmonary artery pressure, reduced right ventricular hypertrophy, and improved survival, and several recent studies showed that statins were effective in animal models of pulmonary hypertension. Dr. Kawut and his associates in the ASA-STAT Study Group designed their phase II clinical trial to test the safety and efficacy of both agents against matching placebos, intending to enroll 100 subjects with PAH.

The study, however, was terminated after only 65 subjects had been randomized because an interim analysis showed "a high likelihood of not rejecting the null hypothesis for the simvastatin arm even if fully recruited," they wrote. The investigators reported their findings for those 65 subjects.

The patients’ mean age was 50 years, and 86% were women. Approximately 52% had idiopathic PAH, 19% had PAH associated with systemic sclerosis, 15% had PAH associated with other connective tissue diseases, 9% had congenital systemic-to-pulmonary shunts, and 5% had heritable PAH.

The primary outcome measure was 6-minute walk distance after 6 months of treatment, after adjustment for 6-minute walk distance at baseline.

Patients who received aspirin therapy showed no improvement in this measure, compared with those who received placebo. They also showed no improvement in median Borg dyspnea scores after the walk test, in any scales of the SF-36, or in World Health Organization functional class. And there was no difference between the two groups in time to clinical worsening, Dr. Kawut and his associates said.

Similarly, patients who received simvastatin showed no improvement in 6-minute walk distance after 6 months of treatment, compared with those who received placebo. In fact, the active drug may have reduced this distance, although the number of subjects was not sufficient to detect a statistically significant difference. Moreover, the median Borg dyspnea scores after the walk test tended to be higher in subjects who took simvastatin than in those who took placebo, suggesting greater breathlessness.

As with aspirin, there were no differences on any scales of the SF-36 or in WHO functional class between the subjects who took simvastatin and those who took placebo, the investigators said (Circulation 2011 May 19 [doi:10.1161/CIRCULATIONAHA.110.015693]).

"There was a possible increased risk of major bleeding associated with aspirin use," they noted, but again, the number of subjects was not sufficient to make this determination definitively.

"On the basis of these finding, neither drug can be recommended for the treatment of PAH," Dr. Kawut and his colleagues said.

The study was funded by the National Institutes of Health and the National Center for Research Resources. Aspirin and matching placebo were provided free of charge by Bayer Healthcare. Additional support was provided by Merck. Dr. Kawut and his associates reported ties to numerous industry sources.

Neither aspirin nor simvastatin improved outcomes for patients with pulmonary arterial hypertension in a phase II safety and efficacy trial published online May 19 in Circulation and simultaneously presented at the annual meeting of the American Thoracic Society.

The primary end point of 6-minute walk distance did not increase after 6 months of aspirin therapy and actually decreased after 6 months of simvastatin therapy, indicating that neither agent should be used as an add-on therapy in PAH, said Dr. Steven M. Kawut of Penn Cardiovascular Institute, University of Pennsylvania, Philadelphia, and his associates.

A recent animal study showed that aspirin decreased pulmonary artery pressure, reduced right ventricular hypertrophy, and improved survival, and several recent studies showed that statins were effective in animal models of pulmonary hypertension. Dr. Kawut and his associates in the ASA-STAT Study Group designed their phase II clinical trial to test the safety and efficacy of both agents against matching placebos, intending to enroll 100 subjects with PAH.

The study, however, was terminated after only 65 subjects had been randomized because an interim analysis showed "a high likelihood of not rejecting the null hypothesis for the simvastatin arm even if fully recruited," they wrote. The investigators reported their findings for those 65 subjects.

The patients’ mean age was 50 years, and 86% were women. Approximately 52% had idiopathic PAH, 19% had PAH associated with systemic sclerosis, 15% had PAH associated with other connective tissue diseases, 9% had congenital systemic-to-pulmonary shunts, and 5% had heritable PAH.

The primary outcome measure was 6-minute walk distance after 6 months of treatment, after adjustment for 6-minute walk distance at baseline.

Patients who received aspirin therapy showed no improvement in this measure, compared with those who received placebo. They also showed no improvement in median Borg dyspnea scores after the walk test, in any scales of the SF-36, or in World Health Organization functional class. And there was no difference between the two groups in time to clinical worsening, Dr. Kawut and his associates said.

Similarly, patients who received simvastatin showed no improvement in 6-minute walk distance after 6 months of treatment, compared with those who received placebo. In fact, the active drug may have reduced this distance, although the number of subjects was not sufficient to detect a statistically significant difference. Moreover, the median Borg dyspnea scores after the walk test tended to be higher in subjects who took simvastatin than in those who took placebo, suggesting greater breathlessness.

As with aspirin, there were no differences on any scales of the SF-36 or in WHO functional class between the subjects who took simvastatin and those who took placebo, the investigators said (Circulation 2011 May 19 [doi:10.1161/CIRCULATIONAHA.110.015693]).

"There was a possible increased risk of major bleeding associated with aspirin use," they noted, but again, the number of subjects was not sufficient to make this determination definitively.

"On the basis of these finding, neither drug can be recommended for the treatment of PAH," Dr. Kawut and his colleagues said.

The study was funded by the National Institutes of Health and the National Center for Research Resources. Aspirin and matching placebo were provided free of charge by Bayer Healthcare. Additional support was provided by Merck. Dr. Kawut and his associates reported ties to numerous industry sources.

Neither aspirin nor simvastatin improved outcomes for patients with pulmonary arterial hypertension in a phase II safety and efficacy trial published online May 19 in Circulation and simultaneously presented at the annual meeting of the American Thoracic Society.

The primary end point of 6-minute walk distance did not increase after 6 months of aspirin therapy and actually decreased after 6 months of simvastatin therapy, indicating that neither agent should be used as an add-on therapy in PAH, said Dr. Steven M. Kawut of Penn Cardiovascular Institute, University of Pennsylvania, Philadelphia, and his associates.

A recent animal study showed that aspirin decreased pulmonary artery pressure, reduced right ventricular hypertrophy, and improved survival, and several recent studies showed that statins were effective in animal models of pulmonary hypertension. Dr. Kawut and his associates in the ASA-STAT Study Group designed their phase II clinical trial to test the safety and efficacy of both agents against matching placebos, intending to enroll 100 subjects with PAH.

The study, however, was terminated after only 65 subjects had been randomized because an interim analysis showed "a high likelihood of not rejecting the null hypothesis for the simvastatin arm even if fully recruited," they wrote. The investigators reported their findings for those 65 subjects.

The patients’ mean age was 50 years, and 86% were women. Approximately 52% had idiopathic PAH, 19% had PAH associated with systemic sclerosis, 15% had PAH associated with other connective tissue diseases, 9% had congenital systemic-to-pulmonary shunts, and 5% had heritable PAH.

The primary outcome measure was 6-minute walk distance after 6 months of treatment, after adjustment for 6-minute walk distance at baseline.

Patients who received aspirin therapy showed no improvement in this measure, compared with those who received placebo. They also showed no improvement in median Borg dyspnea scores after the walk test, in any scales of the SF-36, or in World Health Organization functional class. And there was no difference between the two groups in time to clinical worsening, Dr. Kawut and his associates said.

Similarly, patients who received simvastatin showed no improvement in 6-minute walk distance after 6 months of treatment, compared with those who received placebo. In fact, the active drug may have reduced this distance, although the number of subjects was not sufficient to detect a statistically significant difference. Moreover, the median Borg dyspnea scores after the walk test tended to be higher in subjects who took simvastatin than in those who took placebo, suggesting greater breathlessness.

As with aspirin, there were no differences on any scales of the SF-36 or in WHO functional class between the subjects who took simvastatin and those who took placebo, the investigators said (Circulation 2011 May 19 [doi:10.1161/CIRCULATIONAHA.110.015693]).

"There was a possible increased risk of major bleeding associated with aspirin use," they noted, but again, the number of subjects was not sufficient to make this determination definitively.

"On the basis of these finding, neither drug can be recommended for the treatment of PAH," Dr. Kawut and his colleagues said.

The study was funded by the National Institutes of Health and the National Center for Research Resources. Aspirin and matching placebo were provided free of charge by Bayer Healthcare. Additional support was provided by Merck. Dr. Kawut and his associates reported ties to numerous industry sources.

LONDON – Low-dose irradiation of the stomach in patients with gastric MALT lymphoma absent or independent of infection by Helicobacter pylori is associated with a 93% disease control rate after 10 years.

As presented by Dr. Joachim Yahalom, a radiation oncologist at Memorial Sloan-Kettering Cancer Center in New York, these long-term study findings highlight the high disease-control rates that can be obtained using low-dose involved field radiotherapy (IFRT).

Low-dose IFRT has now become a standard of care in the United States, although approaches still vary in Europe, he reported May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference.

Indeed, the latest guidelines set by the National Comprehensive Cancer Network on non-Hodgkin’s lymphomas – which includes gastric MALT (mucosa-associated lymphoid tissue) lymphoma of the stomach – recommend the use of radiotherapy as a first-line option when patients have early (stage I/II) H. pylori–negative disease.

"We started using this [low-dose irradiation] treatment approach in the early 90s. Until then, the standard treatment for this lymphoma in the stomach was total gastrectomy, and sometimes it was followed by radiation therapy," said Dr. Yahalom, a professor of radiation oncology at Cornell University in New York. He added that chemotherapy and rituximab (Rituxan) were not generally very effective.

"Obviously the treatment of choice is to give antibiotics if H. pylori is present," Dr. Yahalom added, noting that substantial regression of MALT lymphoma can occur via treatment with antibiotics that target the gastric bacterium in positive cases. However, when H. pylori is not present, or if there is a lack of response to or residual lymphoma after complete response to antibiotic therapy, then radiotherapy is the recommended next step.

Dr. Yahalom presented data representing 16 years of experience in treating 103 patients (60 women and 43 men) with gastric MALT lymphoma in 1992-2009. The majority of patients (76%) had stage I disease, with 19% having stage II, and fewer than 5% having stage IV.

The median age of the patients was 62 years (range, 25-91 years). Symptoms were relatively mild at presentation, Dr. Yahalom observed: In all, 52% had epigastric pain, 36% had nausea, 29% had gastric bleeding, 18% had anorexia, 15% had anemia, and 10% had unknown or no obvious symptoms.

Almost two-thirds of patients were H. pylori negative. This included four patients who had relapsed after a complete response to antibiotic therapy. A further 20% of patients had persistent lymphoma after H. pylori eradication therapy. Another 15% had H. pylori and lymphoma remaining after antibiotic treatment, but had progressive symptoms or disease that could not wait for another antibiotics trial.

Prior to being treated with IFRT, six patients had undergone surgery, and seven had received medications that failed to control their disease.

Approximately 90% of patients were given IFRT at a median dose of 30 Gy in 1.5 Gy fractions for 4 weeks. The lowest and highest total radiation doses administered were 22.5 Gy and 43.5 Gy.

Patients received regular follow up via endoscopic biopsies, and after a median of 5.5 years, the disease control rate was 98%. One-fifth of patients had been followed for 10 years, and the 10-year freedom from local failure was 93%; the 10-year overall survival rate was 74%.

There were no significant acute or late adverse events, Dr. Yahalom noted, and just eight patients relapsed (six with gastric MALT lymphoma and two with diffuse large B-cell lymphoma). Subsequent other cancers included lymphoma in extragastric sites (eight patients), adenocarcinoma of the stomach (two), and second tumors close to the radiotherapy field (one in the colon and two in the pancreas). "Other deaths appeared unrelated to disease or treatment," he said.

Based on this experience, Dr. Yahalom concluded that "low-dose irradiation of the stomach provides excellent long-term disease control [and] is safe and simple.

"Radiation therapy, in our opinion, is the treatment of choice for patients with MALT lymphoma that have exhausted their antibiotic options or are unlikely to respond to it."

Dr. Yahalom said he had no financial conflicts of interest.

LONDON – Low-dose irradiation of the stomach in patients with gastric MALT lymphoma absent or independent of infection by Helicobacter pylori is associated with a 93% disease control rate after 10 years.

As presented by Dr. Joachim Yahalom, a radiation oncologist at Memorial Sloan-Kettering Cancer Center in New York, these long-term study findings highlight the high disease-control rates that can be obtained using low-dose involved field radiotherapy (IFRT).

Low-dose IFRT has now become a standard of care in the United States, although approaches still vary in Europe, he reported May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference.

Indeed, the latest guidelines set by the National Comprehensive Cancer Network on non-Hodgkin’s lymphomas – which includes gastric MALT (mucosa-associated lymphoid tissue) lymphoma of the stomach – recommend the use of radiotherapy as a first-line option when patients have early (stage I/II) H. pylori–negative disease.

"We started using this [low-dose irradiation] treatment approach in the early 90s. Until then, the standard treatment for this lymphoma in the stomach was total gastrectomy, and sometimes it was followed by radiation therapy," said Dr. Yahalom, a professor of radiation oncology at Cornell University in New York. He added that chemotherapy and rituximab (Rituxan) were not generally very effective.

"Obviously the treatment of choice is to give antibiotics if H. pylori is present," Dr. Yahalom added, noting that substantial regression of MALT lymphoma can occur via treatment with antibiotics that target the gastric bacterium in positive cases. However, when H. pylori is not present, or if there is a lack of response to or residual lymphoma after complete response to antibiotic therapy, then radiotherapy is the recommended next step.

Dr. Yahalom presented data representing 16 years of experience in treating 103 patients (60 women and 43 men) with gastric MALT lymphoma in 1992-2009. The majority of patients (76%) had stage I disease, with 19% having stage II, and fewer than 5% having stage IV.

The median age of the patients was 62 years (range, 25-91 years). Symptoms were relatively mild at presentation, Dr. Yahalom observed: In all, 52% had epigastric pain, 36% had nausea, 29% had gastric bleeding, 18% had anorexia, 15% had anemia, and 10% had unknown or no obvious symptoms.

Almost two-thirds of patients were H. pylori negative. This included four patients who had relapsed after a complete response to antibiotic therapy. A further 20% of patients had persistent lymphoma after H. pylori eradication therapy. Another 15% had H. pylori and lymphoma remaining after antibiotic treatment, but had progressive symptoms or disease that could not wait for another antibiotics trial.

Prior to being treated with IFRT, six patients had undergone surgery, and seven had received medications that failed to control their disease.

Approximately 90% of patients were given IFRT at a median dose of 30 Gy in 1.5 Gy fractions for 4 weeks. The lowest and highest total radiation doses administered were 22.5 Gy and 43.5 Gy.

Patients received regular follow up via endoscopic biopsies, and after a median of 5.5 years, the disease control rate was 98%. One-fifth of patients had been followed for 10 years, and the 10-year freedom from local failure was 93%; the 10-year overall survival rate was 74%.

There were no significant acute or late adverse events, Dr. Yahalom noted, and just eight patients relapsed (six with gastric MALT lymphoma and two with diffuse large B-cell lymphoma). Subsequent other cancers included lymphoma in extragastric sites (eight patients), adenocarcinoma of the stomach (two), and second tumors close to the radiotherapy field (one in the colon and two in the pancreas). "Other deaths appeared unrelated to disease or treatment," he said.

Based on this experience, Dr. Yahalom concluded that "low-dose irradiation of the stomach provides excellent long-term disease control [and] is safe and simple.

"Radiation therapy, in our opinion, is the treatment of choice for patients with MALT lymphoma that have exhausted their antibiotic options or are unlikely to respond to it."

Dr. Yahalom said he had no financial conflicts of interest.

LONDON – Low-dose irradiation of the stomach in patients with gastric MALT lymphoma absent or independent of infection by Helicobacter pylori is associated with a 93% disease control rate after 10 years.

As presented by Dr. Joachim Yahalom, a radiation oncologist at Memorial Sloan-Kettering Cancer Center in New York, these long-term study findings highlight the high disease-control rates that can be obtained using low-dose involved field radiotherapy (IFRT).

Low-dose IFRT has now become a standard of care in the United States, although approaches still vary in Europe, he reported May 9 at the European Society for Therapeutic Radiation Oncology Anniversary Conference.

Indeed, the latest guidelines set by the National Comprehensive Cancer Network on non-Hodgkin’s lymphomas – which includes gastric MALT (mucosa-associated lymphoid tissue) lymphoma of the stomach – recommend the use of radiotherapy as a first-line option when patients have early (stage I/II) H. pylori–negative disease.

"We started using this [low-dose irradiation] treatment approach in the early 90s. Until then, the standard treatment for this lymphoma in the stomach was total gastrectomy, and sometimes it was followed by radiation therapy," said Dr. Yahalom, a professor of radiation oncology at Cornell University in New York. He added that chemotherapy and rituximab (Rituxan) were not generally very effective.

"Obviously the treatment of choice is to give antibiotics if H. pylori is present," Dr. Yahalom added, noting that substantial regression of MALT lymphoma can occur via treatment with antibiotics that target the gastric bacterium in positive cases. However, when H. pylori is not present, or if there is a lack of response to or residual lymphoma after complete response to antibiotic therapy, then radiotherapy is the recommended next step.

Dr. Yahalom presented data representing 16 years of experience in treating 103 patients (60 women and 43 men) with gastric MALT lymphoma in 1992-2009. The majority of patients (76%) had stage I disease, with 19% having stage II, and fewer than 5% having stage IV.

The median age of the patients was 62 years (range, 25-91 years). Symptoms were relatively mild at presentation, Dr. Yahalom observed: In all, 52% had epigastric pain, 36% had nausea, 29% had gastric bleeding, 18% had anorexia, 15% had anemia, and 10% had unknown or no obvious symptoms.

Almost two-thirds of patients were H. pylori negative. This included four patients who had relapsed after a complete response to antibiotic therapy. A further 20% of patients had persistent lymphoma after H. pylori eradication therapy. Another 15% had H. pylori and lymphoma remaining after antibiotic treatment, but had progressive symptoms or disease that could not wait for another antibiotics trial.

Prior to being treated with IFRT, six patients had undergone surgery, and seven had received medications that failed to control their disease.

Approximately 90% of patients were given IFRT at a median dose of 30 Gy in 1.5 Gy fractions for 4 weeks. The lowest and highest total radiation doses administered were 22.5 Gy and 43.5 Gy.

Patients received regular follow up via endoscopic biopsies, and after a median of 5.5 years, the disease control rate was 98%. One-fifth of patients had been followed for 10 years, and the 10-year freedom from local failure was 93%; the 10-year overall survival rate was 74%.

There were no significant acute or late adverse events, Dr. Yahalom noted, and just eight patients relapsed (six with gastric MALT lymphoma and two with diffuse large B-cell lymphoma). Subsequent other cancers included lymphoma in extragastric sites (eight patients), adenocarcinoma of the stomach (two), and second tumors close to the radiotherapy field (one in the colon and two in the pancreas). "Other deaths appeared unrelated to disease or treatment," he said.

Based on this experience, Dr. Yahalom concluded that "low-dose irradiation of the stomach provides excellent long-term disease control [and] is safe and simple.

"Radiation therapy, in our opinion, is the treatment of choice for patients with MALT lymphoma that have exhausted their antibiotic options or are unlikely to respond to it."

Dr. Yahalom said he had no financial conflicts of interest.

LONDON – Proton beam therapy for non–small cell lung cancer is associated with fewer radiation-induced side effects than are conventional radiotherapy methods when combined with chemotherapy, according to preliminary data from two retrospective studies conducted at the University of Texas M.D. Anderson Cancer Center in Houston.

Significantly less esophagitis, pneumonitis, and bone marrow toxicity were observed with proton beam therapy (PBT) than with intensity-modulated radiotherapy (IMRT), Dr. Ritsuko Komaki reported May 10, at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference.

Photo credit: M.D. Anderson Cancer Center

Proton beam therapy also significantly reduced the incidence of esophagitis when compared with IMRT and three-dimensional conformal radiotherapy (3D-CRT). A mean esophageal dose of 40 Gy or higher was identified as the cut-off point for high-grade esophagitis occurring with any method.

"Radiation dose escalation improves local control but increases toxicity, especially when combined with concurrent chemotherapy for non–small cell lung cancer [NSCLC] or even small cell lung cancer," said Dr. Komaki, a professor of radiation oncology at M.D. Anderson, which opened its 94,000-square-foot Proton Therapy Center in 2006. As such, "radiation chemotherapy is a double-edged sword," she observed. "It will kill cancer cells, but it also kills normal tissues, and more targeted treatment is needed."

"One of the most important benefits of PBT is that there is no exit dose," Dr. Komaki added in an interview with Elsevier Global Medical News. "The protons stop after penetrating the tumor, and there is no dose of radiation beyond it."

This has the potential to spare surrounding cells and organs from damage, she observed. Normal tissues that might be affected by radiation therapy for NSCLC include the lungs, esophagus, heart, and bone marrow, which cannot always be avoided by the use of 3D-CRT or even IMRT.

An expensive new technology that delivers highly targeted radiation with electrically charged particles, proton beam therapy is promising but unproven, according to a 2009 review commissioned by the Agency for Healthcare Research and Quality (AHRQ). The authors found few comparative studies to establish effectiveness or safety for the technology, which is housed in a small but growing number of proton beam centers that can cost $100 million to $225 million to build (Ann. Intern. Med. 2009;151:556-65).

Dr. Komaki and her associates are recruiting patients into the first, prospective randomized trial to directly compare proton beam therapy with IMRT in unresectable stage II /III NSCLC. The phase II trial is supported by a grant from the National Cancer Institute, and involves treatment with 74 Gy proton beam therapy or IMRT with concurrent carboplatin and paclitaxel. To date, 107 of the planned 168 patients have been enrolled in the study at the Texas institution and at the Massachusetts General Hospital in Boston, the other participating center, she said.

A recent report from the M.D. Anderson showed that higher doses of proton radiation could be delivered to lung tumors with a lower risk of esophagitis and pneumonitis than either IMRT or 3D-CRT (Cancer 2011;doi.org/10.1002/cncr.25848).

The new data presented by Dr. Komaki showed significantly reduced rates of grade 2 or higher esophagitis (P less than .0001), pneumonitis (P less than .002), hematologic toxicities (P less than .0001 for neutrophil toxicity and P less than .001 for hemoglobin and white blood cell toxicities), and fatigue (P less than.0001) in 60 patients treated with proton beam therapy compared with 75 patients treated with IMRT (Radiother. Oncol. 2011;99:S89-90, abstract 233).

Other research from the M.D. Anderson team focused on esophagitis, and examined dosimetric and clinical factors that could lead to this side effect following proton beam therapy, IMRT, or 3D-CRT for definitive NSCLC treatment (Radiother. Oncol. 2011;99[Suppl.1]:S210, abstract 518).

Dr. Daniel Gomez, a radiation oncologist at M.D. Anderson, presented data on 678 patients treated at the institution between 1999 and 2008. Dr. Gomez explained that the type of radiation therapy received had altered over the years, with 463 patients treated with 3D-CRT between 1999 and 2005, 122 with IMRT between 2005 and 2007, and 94 patients treated with proton beam therapy between 2006 and 2008.

"Esophagitis is a common toxicity in the treatment of NSCLC with definitive radiation," Dr. Gomez observed. Although studies have looked at what factors might predict this life-limiting side effect, conflicting results have been obtained.

Data show, for example, that the presence of acute toxicity is a predictor of late toxicity (Int. J. Radiat. Oncol. Biol. Phys. 2005,61:335-47), but a variety of dosimetric parameters have been noted and there does not appear to be a single threshold at which a toxic effect is or is not likely to be observed (Int. J. Radiat. Oncol. Biol. Phys. 2010;76:S86-93).

Data presented by Dr. Gomez, however, suggest that a mean delivered esophageal dose of above 40 Gy may be predictive of high-grade inflammation regardless of whether proton beams, IMRT or 3D-CRT is used. This research might eventually help develop dosing guides for clinicians to use in routine practice, he suggested.

"Patients receiving IMRT had a higher rate of esophagitis in all grades, including grade 3," Dr. Gomez said. In contrast, "patients receiving proton therapy had lower rates of esophagitis at all grades." The incidence of grade 3 or higher esophagitis was 14% (n = 65) for 3D-CRT, 27% (n = 33) for IMRT, and 6% (n = 6) for proton beam therapy.

Dr. Gomez also reported that grade 3 or higher esophagitis was more likely in patients who received concurrent chemotherapy than in those who did not (18.4% vs. 7.4%, P less than .001). The mean esophageal dose of radiation delivered to patients given concurrent chemotherapy also was, significantly higher (32.2 Gy vs. 15.8 Gy, P less than .001), however.

The M.D. Anderson investigators said they have just finished (May 12) recruiting patients into a phase III trial (Radiation Therapy Oncology Group [RTOG] 0617) that will compare conventional (60 Gy in 6 weeks) vs. high dose (74 Gy in 7.5 weeks) radiation therapy in combination with paclitaxel and carboplatin, with or without the addition of cetuximab (Erbitux) in 500 patients with NSCLC.

Although the trial is not directly comparing the type of radiation treatment used, it should still be possible to retrospectively analyze the results to determine the individual effects of the radiation modalities used at each participating center, Dr. Komaki noted.

"When we started this trial, it was not acquiring patients because some of the radiation and medical oncologists said that it was obvious that patients given 60 Gy would do worse compared to 74 Gy," she added in the interview. "When we included cetuximab based on the results of the RTOG 0324 trial, however, recruitment started to rocket." The RTOG 0324 trial showed the feasibility of combining cetuximab with chemoradiation in NSCLC (J. Clin. Oncol. 2011 May 9 [Epub ahead of print, doi: 10.1200/JCO.2010.31.7875]).

Discussing the downsides of proton beam therapy vs. IMRT, Dr. Komaki conceded that the newer method involved a lot more sophisticated planning and was more expensive. There is also concern that the sharp drop-off of radiation received with proton beam therapy might mean that important areas of the tumor are missed – although this may explain the lower rate of side effects seen with PBT to date. "There is no give," Dr. Komaki said.

As relatively few proton beam facilities are in operation, large cooperative trials are difficult to perform. The prospective phase II trial comparing proton beam therapy and IMRT now being conducted at M.D. Anderson and the Massachusetts General Hospital will be the proof that such trials are possible, and provide valuable information on the comparative safety and efficacy of the two procedures.

Dr. Komaki and Dr. Gomez said they had no financial conflicts of interest.

LONDON – Proton beam therapy for non–small cell lung cancer is associated with fewer radiation-induced side effects than are conventional radiotherapy methods when combined with chemotherapy, according to preliminary data from two retrospective studies conducted at the University of Texas M.D. Anderson Cancer Center in Houston.

Significantly less esophagitis, pneumonitis, and bone marrow toxicity were observed with proton beam therapy (PBT) than with intensity-modulated radiotherapy (IMRT), Dr. Ritsuko Komaki reported May 10, at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference.

Photo credit: M.D. Anderson Cancer Center

Proton beam therapy also significantly reduced the incidence of esophagitis when compared with IMRT and three-dimensional conformal radiotherapy (3D-CRT). A mean esophageal dose of 40 Gy or higher was identified as the cut-off point for high-grade esophagitis occurring with any method.

"Radiation dose escalation improves local control but increases toxicity, especially when combined with concurrent chemotherapy for non–small cell lung cancer [NSCLC] or even small cell lung cancer," said Dr. Komaki, a professor of radiation oncology at M.D. Anderson, which opened its 94,000-square-foot Proton Therapy Center in 2006. As such, "radiation chemotherapy is a double-edged sword," she observed. "It will kill cancer cells, but it also kills normal tissues, and more targeted treatment is needed."

"One of the most important benefits of PBT is that there is no exit dose," Dr. Komaki added in an interview with Elsevier Global Medical News. "The protons stop after penetrating the tumor, and there is no dose of radiation beyond it."

This has the potential to spare surrounding cells and organs from damage, she observed. Normal tissues that might be affected by radiation therapy for NSCLC include the lungs, esophagus, heart, and bone marrow, which cannot always be avoided by the use of 3D-CRT or even IMRT.

An expensive new technology that delivers highly targeted radiation with electrically charged particles, proton beam therapy is promising but unproven, according to a 2009 review commissioned by the Agency for Healthcare Research and Quality (AHRQ). The authors found few comparative studies to establish effectiveness or safety for the technology, which is housed in a small but growing number of proton beam centers that can cost $100 million to $225 million to build (Ann. Intern. Med. 2009;151:556-65).

Dr. Komaki and her associates are recruiting patients into the first, prospective randomized trial to directly compare proton beam therapy with IMRT in unresectable stage II /III NSCLC. The phase II trial is supported by a grant from the National Cancer Institute, and involves treatment with 74 Gy proton beam therapy or IMRT with concurrent carboplatin and paclitaxel. To date, 107 of the planned 168 patients have been enrolled in the study at the Texas institution and at the Massachusetts General Hospital in Boston, the other participating center, she said.

A recent report from the M.D. Anderson showed that higher doses of proton radiation could be delivered to lung tumors with a lower risk of esophagitis and pneumonitis than either IMRT or 3D-CRT (Cancer 2011;doi.org/10.1002/cncr.25848).

The new data presented by Dr. Komaki showed significantly reduced rates of grade 2 or higher esophagitis (P less than .0001), pneumonitis (P less than .002), hematologic toxicities (P less than .0001 for neutrophil toxicity and P less than .001 for hemoglobin and white blood cell toxicities), and fatigue (P less than.0001) in 60 patients treated with proton beam therapy compared with 75 patients treated with IMRT (Radiother. Oncol. 2011;99:S89-90, abstract 233).

Other research from the M.D. Anderson team focused on esophagitis, and examined dosimetric and clinical factors that could lead to this side effect following proton beam therapy, IMRT, or 3D-CRT for definitive NSCLC treatment (Radiother. Oncol. 2011;99[Suppl.1]:S210, abstract 518).

Dr. Daniel Gomez, a radiation oncologist at M.D. Anderson, presented data on 678 patients treated at the institution between 1999 and 2008. Dr. Gomez explained that the type of radiation therapy received had altered over the years, with 463 patients treated with 3D-CRT between 1999 and 2005, 122 with IMRT between 2005 and 2007, and 94 patients treated with proton beam therapy between 2006 and 2008.

"Esophagitis is a common toxicity in the treatment of NSCLC with definitive radiation," Dr. Gomez observed. Although studies have looked at what factors might predict this life-limiting side effect, conflicting results have been obtained.

Data show, for example, that the presence of acute toxicity is a predictor of late toxicity (Int. J. Radiat. Oncol. Biol. Phys. 2005,61:335-47), but a variety of dosimetric parameters have been noted and there does not appear to be a single threshold at which a toxic effect is or is not likely to be observed (Int. J. Radiat. Oncol. Biol. Phys. 2010;76:S86-93).

Data presented by Dr. Gomez, however, suggest that a mean delivered esophageal dose of above 40 Gy may be predictive of high-grade inflammation regardless of whether proton beams, IMRT or 3D-CRT is used. This research might eventually help develop dosing guides for clinicians to use in routine practice, he suggested.

"Patients receiving IMRT had a higher rate of esophagitis in all grades, including grade 3," Dr. Gomez said. In contrast, "patients receiving proton therapy had lower rates of esophagitis at all grades." The incidence of grade 3 or higher esophagitis was 14% (n = 65) for 3D-CRT, 27% (n = 33) for IMRT, and 6% (n = 6) for proton beam therapy.

Dr. Gomez also reported that grade 3 or higher esophagitis was more likely in patients who received concurrent chemotherapy than in those who did not (18.4% vs. 7.4%, P less than .001). The mean esophageal dose of radiation delivered to patients given concurrent chemotherapy also was, significantly higher (32.2 Gy vs. 15.8 Gy, P less than .001), however.

The M.D. Anderson investigators said they have just finished (May 12) recruiting patients into a phase III trial (Radiation Therapy Oncology Group [RTOG] 0617) that will compare conventional (60 Gy in 6 weeks) vs. high dose (74 Gy in 7.5 weeks) radiation therapy in combination with paclitaxel and carboplatin, with or without the addition of cetuximab (Erbitux) in 500 patients with NSCLC.

Although the trial is not directly comparing the type of radiation treatment used, it should still be possible to retrospectively analyze the results to determine the individual effects of the radiation modalities used at each participating center, Dr. Komaki noted.

"When we started this trial, it was not acquiring patients because some of the radiation and medical oncologists said that it was obvious that patients given 60 Gy would do worse compared to 74 Gy," she added in the interview. "When we included cetuximab based on the results of the RTOG 0324 trial, however, recruitment started to rocket." The RTOG 0324 trial showed the feasibility of combining cetuximab with chemoradiation in NSCLC (J. Clin. Oncol. 2011 May 9 [Epub ahead of print, doi: 10.1200/JCO.2010.31.7875]).

Discussing the downsides of proton beam therapy vs. IMRT, Dr. Komaki conceded that the newer method involved a lot more sophisticated planning and was more expensive. There is also concern that the sharp drop-off of radiation received with proton beam therapy might mean that important areas of the tumor are missed – although this may explain the lower rate of side effects seen with PBT to date. "There is no give," Dr. Komaki said.

As relatively few proton beam facilities are in operation, large cooperative trials are difficult to perform. The prospective phase II trial comparing proton beam therapy and IMRT now being conducted at M.D. Anderson and the Massachusetts General Hospital will be the proof that such trials are possible, and provide valuable information on the comparative safety and efficacy of the two procedures.

Dr. Komaki and Dr. Gomez said they had no financial conflicts of interest.

LONDON – Proton beam therapy for non–small cell lung cancer is associated with fewer radiation-induced side effects than are conventional radiotherapy methods when combined with chemotherapy, according to preliminary data from two retrospective studies conducted at the University of Texas M.D. Anderson Cancer Center in Houston.

Significantly less esophagitis, pneumonitis, and bone marrow toxicity were observed with proton beam therapy (PBT) than with intensity-modulated radiotherapy (IMRT), Dr. Ritsuko Komaki reported May 10, at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference.

Photo credit: M.D. Anderson Cancer Center

Proton beam therapy also significantly reduced the incidence of esophagitis when compared with IMRT and three-dimensional conformal radiotherapy (3D-CRT). A mean esophageal dose of 40 Gy or higher was identified as the cut-off point for high-grade esophagitis occurring with any method.

"Radiation dose escalation improves local control but increases toxicity, especially when combined with concurrent chemotherapy for non–small cell lung cancer [NSCLC] or even small cell lung cancer," said Dr. Komaki, a professor of radiation oncology at M.D. Anderson, which opened its 94,000-square-foot Proton Therapy Center in 2006. As such, "radiation chemotherapy is a double-edged sword," she observed. "It will kill cancer cells, but it also kills normal tissues, and more targeted treatment is needed."

"One of the most important benefits of PBT is that there is no exit dose," Dr. Komaki added in an interview with Elsevier Global Medical News. "The protons stop after penetrating the tumor, and there is no dose of radiation beyond it."

This has the potential to spare surrounding cells and organs from damage, she observed. Normal tissues that might be affected by radiation therapy for NSCLC include the lungs, esophagus, heart, and bone marrow, which cannot always be avoided by the use of 3D-CRT or even IMRT.

An expensive new technology that delivers highly targeted radiation with electrically charged particles, proton beam therapy is promising but unproven, according to a 2009 review commissioned by the Agency for Healthcare Research and Quality (AHRQ). The authors found few comparative studies to establish effectiveness or safety for the technology, which is housed in a small but growing number of proton beam centers that can cost $100 million to $225 million to build (Ann. Intern. Med. 2009;151:556-65).

Dr. Komaki and her associates are recruiting patients into the first, prospective randomized trial to directly compare proton beam therapy with IMRT in unresectable stage II /III NSCLC. The phase II trial is supported by a grant from the National Cancer Institute, and involves treatment with 74 Gy proton beam therapy or IMRT with concurrent carboplatin and paclitaxel. To date, 107 of the planned 168 patients have been enrolled in the study at the Texas institution and at the Massachusetts General Hospital in Boston, the other participating center, she said.

A recent report from the M.D. Anderson showed that higher doses of proton radiation could be delivered to lung tumors with a lower risk of esophagitis and pneumonitis than either IMRT or 3D-CRT (Cancer 2011;doi.org/10.1002/cncr.25848).

The new data presented by Dr. Komaki showed significantly reduced rates of grade 2 or higher esophagitis (P less than .0001), pneumonitis (P less than .002), hematologic toxicities (P less than .0001 for neutrophil toxicity and P less than .001 for hemoglobin and white blood cell toxicities), and fatigue (P less than.0001) in 60 patients treated with proton beam therapy compared with 75 patients treated with IMRT (Radiother. Oncol. 2011;99:S89-90, abstract 233).

Other research from the M.D. Anderson team focused on esophagitis, and examined dosimetric and clinical factors that could lead to this side effect following proton beam therapy, IMRT, or 3D-CRT for definitive NSCLC treatment (Radiother. Oncol. 2011;99[Suppl.1]:S210, abstract 518).

Dr. Daniel Gomez, a radiation oncologist at M.D. Anderson, presented data on 678 patients treated at the institution between 1999 and 2008. Dr. Gomez explained that the type of radiation therapy received had altered over the years, with 463 patients treated with 3D-CRT between 1999 and 2005, 122 with IMRT between 2005 and 2007, and 94 patients treated with proton beam therapy between 2006 and 2008.

"Esophagitis is a common toxicity in the treatment of NSCLC with definitive radiation," Dr. Gomez observed. Although studies have looked at what factors might predict this life-limiting side effect, conflicting results have been obtained.

Data show, for example, that the presence of acute toxicity is a predictor of late toxicity (Int. J. Radiat. Oncol. Biol. Phys. 2005,61:335-47), but a variety of dosimetric parameters have been noted and there does not appear to be a single threshold at which a toxic effect is or is not likely to be observed (Int. J. Radiat. Oncol. Biol. Phys. 2010;76:S86-93).

Data presented by Dr. Gomez, however, suggest that a mean delivered esophageal dose of above 40 Gy may be predictive of high-grade inflammation regardless of whether proton beams, IMRT or 3D-CRT is used. This research might eventually help develop dosing guides for clinicians to use in routine practice, he suggested.

"Patients receiving IMRT had a higher rate of esophagitis in all grades, including grade 3," Dr. Gomez said. In contrast, "patients receiving proton therapy had lower rates of esophagitis at all grades." The incidence of grade 3 or higher esophagitis was 14% (n = 65) for 3D-CRT, 27% (n = 33) for IMRT, and 6% (n = 6) for proton beam therapy.

Dr. Gomez also reported that grade 3 or higher esophagitis was more likely in patients who received concurrent chemotherapy than in those who did not (18.4% vs. 7.4%, P less than .001). The mean esophageal dose of radiation delivered to patients given concurrent chemotherapy also was, significantly higher (32.2 Gy vs. 15.8 Gy, P less than .001), however.

The M.D. Anderson investigators said they have just finished (May 12) recruiting patients into a phase III trial (Radiation Therapy Oncology Group [RTOG] 0617) that will compare conventional (60 Gy in 6 weeks) vs. high dose (74 Gy in 7.5 weeks) radiation therapy in combination with paclitaxel and carboplatin, with or without the addition of cetuximab (Erbitux) in 500 patients with NSCLC.

Although the trial is not directly comparing the type of radiation treatment used, it should still be possible to retrospectively analyze the results to determine the individual effects of the radiation modalities used at each participating center, Dr. Komaki noted.

"When we started this trial, it was not acquiring patients because some of the radiation and medical oncologists said that it was obvious that patients given 60 Gy would do worse compared to 74 Gy," she added in the interview. "When we included cetuximab based on the results of the RTOG 0324 trial, however, recruitment started to rocket." The RTOG 0324 trial showed the feasibility of combining cetuximab with chemoradiation in NSCLC (J. Clin. Oncol. 2011 May 9 [Epub ahead of print, doi: 10.1200/JCO.2010.31.7875]).

Discussing the downsides of proton beam therapy vs. IMRT, Dr. Komaki conceded that the newer method involved a lot more sophisticated planning and was more expensive. There is also concern that the sharp drop-off of radiation received with proton beam therapy might mean that important areas of the tumor are missed – although this may explain the lower rate of side effects seen with PBT to date. "There is no give," Dr. Komaki said.

As relatively few proton beam facilities are in operation, large cooperative trials are difficult to perform. The prospective phase II trial comparing proton beam therapy and IMRT now being conducted at M.D. Anderson and the Massachusetts General Hospital will be the proof that such trials are possible, and provide valuable information on the comparative safety and efficacy of the two procedures.

Dr. Komaki and Dr. Gomez said they had no financial conflicts of interest.

GRAPEVINE, Texas–ED crowding may not seem like the hospitalist's purview, but an HM leader speaking at HM11 says think again.

Boarding, the term for admitted patients who are held in the ED, makes the issue particularly relevant to HM, says Eric Howell, MD, SFHM, associate professor of medicine at Johns Hopkins University and director of Johns Hopkins Bayview Medical Center's HM division.

"Almost everyone is equating boarding of admitted patients now with ED crowding," says Dr. Howell, an SHM board member. "And who do you think they're going to come to for help with all the boarded patients? They're going to come to you."

Dr. Howell says that although HM leaders might think of bed management mostly as a discharge issue, hospitalists would be well served to work with their respective ED colleagues to manage emergency throughput better. He suggests two initial approaches:

1. Round on boarders. In some practices, including at Johns Hopkins Bayview, a hospitalist can be dedicated to the practice of seeing admitted patients held in the ED. If a dedicated staffer is unavailable, group members can rotate the service.

2. Add capacity. Virtual capacity can be added by initiatives that lower LOS and therefore effectively create more bed space. Capacity can be added physically via something as ambitious as the creation of a unit, or techniques as simple as placing admitted patients in hallways.

"Targeting the ED alone doesn’t work," Dr. Howell says. "Patients boarding in the ED needs to be solved. … People are looking for good hospitalists to solve the problem."

GRAPEVINE, Texas–ED crowding may not seem like the hospitalist's purview, but an HM leader speaking at HM11 says think again.

Boarding, the term for admitted patients who are held in the ED, makes the issue particularly relevant to HM, says Eric Howell, MD, SFHM, associate professor of medicine at Johns Hopkins University and director of Johns Hopkins Bayview Medical Center's HM division.

"Almost everyone is equating boarding of admitted patients now with ED crowding," says Dr. Howell, an SHM board member. "And who do you think they're going to come to for help with all the boarded patients? They're going to come to you."

Dr. Howell says that although HM leaders might think of bed management mostly as a discharge issue, hospitalists would be well served to work with their respective ED colleagues to manage emergency throughput better. He suggests two initial approaches:

1. Round on boarders. In some practices, including at Johns Hopkins Bayview, a hospitalist can be dedicated to the practice of seeing admitted patients held in the ED. If a dedicated staffer is unavailable, group members can rotate the service.

2. Add capacity. Virtual capacity can be added by initiatives that lower LOS and therefore effectively create more bed space. Capacity can be added physically via something as ambitious as the creation of a unit, or techniques as simple as placing admitted patients in hallways.

"Targeting the ED alone doesn’t work," Dr. Howell says. "Patients boarding in the ED needs to be solved. … People are looking for good hospitalists to solve the problem."

GRAPEVINE, Texas–ED crowding may not seem like the hospitalist's purview, but an HM leader speaking at HM11 says think again.

Boarding, the term for admitted patients who are held in the ED, makes the issue particularly relevant to HM, says Eric Howell, MD, SFHM, associate professor of medicine at Johns Hopkins University and director of Johns Hopkins Bayview Medical Center's HM division.

"Almost everyone is equating boarding of admitted patients now with ED crowding," says Dr. Howell, an SHM board member. "And who do you think they're going to come to for help with all the boarded patients? They're going to come to you."

Dr. Howell says that although HM leaders might think of bed management mostly as a discharge issue, hospitalists would be well served to work with their respective ED colleagues to manage emergency throughput better. He suggests two initial approaches:

1. Round on boarders. In some practices, including at Johns Hopkins Bayview, a hospitalist can be dedicated to the practice of seeing admitted patients held in the ED. If a dedicated staffer is unavailable, group members can rotate the service.

2. Add capacity. Virtual capacity can be added by initiatives that lower LOS and therefore effectively create more bed space. Capacity can be added physically via something as ambitious as the creation of a unit, or techniques as simple as placing admitted patients in hallways.

"Targeting the ED alone doesn’t work," Dr. Howell says. "Patients boarding in the ED needs to be solved. … People are looking for good hospitalists to solve the problem."

Take your time, gather pertinent data, and know what you are dealing with before making kneejerk decisions, a national infectious-disease expert told hundreds of hospitalists this morning at HM11.

Shanta Zimmer, MD, associate professor of medicine and director of the internal-medicine residency program at the University of Pittsburgh Medical School walked hospitalists through a half dozen common and uncommon patients, cases ranging from Staphylococcus aureus to Candida albicans to zygomycosis.

Her main message to hospitalists:

• Not all fevers are infectious.
• Get or repeat blood cultures before starting antibiotics, because although administering antibiotics might be the right thing to do, the effects of the drugs makes it difficult to determine the origin. “Then you have to play the guessing game whether or not to treat,” she said. “There also is a lot of morbidity associated with long-term antibiotic therapy.”
• Remove lines when you are able to do so.
• Hold off on antibiotics when a patient is stable and infectious ediology is unknown.
• Take your time, as “very few things in medicine are an emergency; we often have time to think and make a decision,” she said.
• Narrow antibiotic coverage, when possible.

Dr. Zimmer also warned hospitalists to respect S. aureus, which she says remains a large percentage of her caseload. “It never ceases to amaze me how virulent and aggressive it can be,” she said. “It frightens me."

Take your time, gather pertinent data, and know what you are dealing with before making kneejerk decisions, a national infectious-disease expert told hundreds of hospitalists this morning at HM11.

Shanta Zimmer, MD, associate professor of medicine and director of the internal-medicine residency program at the University of Pittsburgh Medical School walked hospitalists through a half dozen common and uncommon patients, cases ranging from Staphylococcus aureus to Candida albicans to zygomycosis.

Her main message to hospitalists:

• Not all fevers are infectious.
• Get or repeat blood cultures before starting antibiotics, because although administering antibiotics might be the right thing to do, the effects of the drugs makes it difficult to determine the origin. “Then you have to play the guessing game whether or not to treat,” she said. “There also is a lot of morbidity associated with long-term antibiotic therapy.”
• Remove lines when you are able to do so.
• Hold off on antibiotics when a patient is stable and infectious ediology is unknown.
• Take your time, as “very few things in medicine are an emergency; we often have time to think and make a decision,” she said.
• Narrow antibiotic coverage, when possible.

Dr. Zimmer also warned hospitalists to respect S. aureus, which she says remains a large percentage of her caseload. “It never ceases to amaze me how virulent and aggressive it can be,” she said. “It frightens me."

Take your time, gather pertinent data, and know what you are dealing with before making kneejerk decisions, a national infectious-disease expert told hundreds of hospitalists this morning at HM11.

Shanta Zimmer, MD, associate professor of medicine and director of the internal-medicine residency program at the University of Pittsburgh Medical School walked hospitalists through a half dozen common and uncommon patients, cases ranging from Staphylococcus aureus to Candida albicans to zygomycosis.

Her main message to hospitalists:

• Not all fevers are infectious.
• Get or repeat blood cultures before starting antibiotics, because although administering antibiotics might be the right thing to do, the effects of the drugs makes it difficult to determine the origin. “Then you have to play the guessing game whether or not to treat,” she said. “There also is a lot of morbidity associated with long-term antibiotic therapy.”
• Remove lines when you are able to do so.
• Hold off on antibiotics when a patient is stable and infectious ediology is unknown.
• Take your time, as “very few things in medicine are an emergency; we often have time to think and make a decision,” she said.
• Narrow antibiotic coverage, when possible.

Dr. Zimmer also warned hospitalists to respect S. aureus, which she says remains a large percentage of her caseload. “It never ceases to amaze me how virulent and aggressive it can be,” she said. “It frightens me."