DÜSSELDORF, GERMANY — The anti-inflammatory compound hydroxychloroquine appears to be relatively safe during pregnancy, according to a small number of studies totaling about 250 patients.

But these studies have not provided overwhelming evidence proving the safety of hydroxychloroquine, Jean-Charles Piette, M.D., said at an international conference on cutaneous lupus erythematosus.

Until 1995, nearly all physicians stopped hydroxychloroquine (Plaquenil) when a patient with lupus erythematosus (LE) became pregnant because there were no data on whether the drug was safe during pregnancy, said Dr. Piette of Hôpital Pitié-Salpétrière, Paris.

Now, many physicians who treat about four to five pregnant women with connective tissue disorder each year regularly prescribe antimalarials to such patients despite a lack of evidence officially establishing the safety of the drugs during pregnancy. In fact, 69% of 52 physicians who responded to a survey about the use of antimalarials during pregnancy said they continued antimalarials in pregnancy sometimes, often, or always (J. Rheumatol. 2002;29:700–6).

Hydroxychloroquine (HCQ) is known to cross the placenta and is present in similar concentrations in blood from the umbilical cord and the mother (Arthritis Rheum. 2002;46:1123–4).

In one study, 33 women with LE who were exposed to HCQ during 36 pregnancies had similar obstetric outcomes and levels of lupus activity, compared with 53 unexposed pregnant women with LE from the same lupus pregnancy center (Ann. Rheum. Dis. 1996;55:486–8). The investigators in the trial concluded that the continuation of HCQ “is probably safe during pregnancy,” Dr. Piette noted.

In a separate study, HCQ did not cause any disease flares in a group of eight women with systemic LE and two with discoid LE, whereas three patients had flare-ups in a placebo group of nine patients with systemic LE and one with discoid LE. None of the infants born to women taking HCQ had congenital abnormalities, and all of them had normal auditory and neuroophthalmologic evaluations at 1.5–3 years of age (Lupus 2001;10:401–4).

No unusual side effects occurred in another series of 53 pregnancies in women with LE that resulted in live births.

A study conducted by Dr. Piette and his colleagues compared 133 consecutive pregnancies in 90 women with connective tissue disease who took HCQ with 70 consecutive pregnancies in 53 control women with similar disorders who did not take HCQ. Of the pregnancies in women who received HCQ, 122 were exposed to 400 mg/day, and the remaining 11 received 200 mg/day.

Three malformations occurred in exposed infants, while four developed in the infants of control women. One child died as a result of prematurity in each group.

After the last follow-up of children at a mean age of 26 months (age ranging from 12 to 108 months), none of the children exposed to HCQ had visual, hearing, growth, or developmental abnormalities (Arthritis Rheum. 2003;48:3207–11).

Despite data that show no teratogenicity with HCQ, the Physicians' Desk Reference Web site for patients advises pregnant patients to avoid HCQ except in the suppression or treatment of malaria when the benefit outweighs any possible hazards.

HCQ exists at low levels in breast milk—344 ng/mL and 1,424 ng/mL in a report on two mothers—and is delivered in extremely low levels to breast-feeding children.

DÜSSELDORF, GERMANY — The anti-inflammatory compound hydroxychloroquine appears to be relatively safe during pregnancy, according to a small number of studies totaling about 250 patients.

But these studies have not provided overwhelming evidence proving the safety of hydroxychloroquine, Jean-Charles Piette, M.D., said at an international conference on cutaneous lupus erythematosus.

Until 1995, nearly all physicians stopped hydroxychloroquine (Plaquenil) when a patient with lupus erythematosus (LE) became pregnant because there were no data on whether the drug was safe during pregnancy, said Dr. Piette of Hôpital Pitié-Salpétrière, Paris.

Now, many physicians who treat about four to five pregnant women with connective tissue disorder each year regularly prescribe antimalarials to such patients despite a lack of evidence officially establishing the safety of the drugs during pregnancy. In fact, 69% of 52 physicians who responded to a survey about the use of antimalarials during pregnancy said they continued antimalarials in pregnancy sometimes, often, or always (J. Rheumatol. 2002;29:700–6).

Hydroxychloroquine (HCQ) is known to cross the placenta and is present in similar concentrations in blood from the umbilical cord and the mother (Arthritis Rheum. 2002;46:1123–4).

In one study, 33 women with LE who were exposed to HCQ during 36 pregnancies had similar obstetric outcomes and levels of lupus activity, compared with 53 unexposed pregnant women with LE from the same lupus pregnancy center (Ann. Rheum. Dis. 1996;55:486–8). The investigators in the trial concluded that the continuation of HCQ “is probably safe during pregnancy,” Dr. Piette noted.

In a separate study, HCQ did not cause any disease flares in a group of eight women with systemic LE and two with discoid LE, whereas three patients had flare-ups in a placebo group of nine patients with systemic LE and one with discoid LE. None of the infants born to women taking HCQ had congenital abnormalities, and all of them had normal auditory and neuroophthalmologic evaluations at 1.5–3 years of age (Lupus 2001;10:401–4).

No unusual side effects occurred in another series of 53 pregnancies in women with LE that resulted in live births.

A study conducted by Dr. Piette and his colleagues compared 133 consecutive pregnancies in 90 women with connective tissue disease who took HCQ with 70 consecutive pregnancies in 53 control women with similar disorders who did not take HCQ. Of the pregnancies in women who received HCQ, 122 were exposed to 400 mg/day, and the remaining 11 received 200 mg/day.

Three malformations occurred in exposed infants, while four developed in the infants of control women. One child died as a result of prematurity in each group.

After the last follow-up of children at a mean age of 26 months (age ranging from 12 to 108 months), none of the children exposed to HCQ had visual, hearing, growth, or developmental abnormalities (Arthritis Rheum. 2003;48:3207–11).

Despite data that show no teratogenicity with HCQ, the Physicians' Desk Reference Web site for patients advises pregnant patients to avoid HCQ except in the suppression or treatment of malaria when the benefit outweighs any possible hazards.

HCQ exists at low levels in breast milk—344 ng/mL and 1,424 ng/mL in a report on two mothers—and is delivered in extremely low levels to breast-feeding children.

DÜSSELDORF, GERMANY — The anti-inflammatory compound hydroxychloroquine appears to be relatively safe during pregnancy, according to a small number of studies totaling about 250 patients.

But these studies have not provided overwhelming evidence proving the safety of hydroxychloroquine, Jean-Charles Piette, M.D., said at an international conference on cutaneous lupus erythematosus.

Until 1995, nearly all physicians stopped hydroxychloroquine (Plaquenil) when a patient with lupus erythematosus (LE) became pregnant because there were no data on whether the drug was safe during pregnancy, said Dr. Piette of Hôpital Pitié-Salpétrière, Paris.

Now, many physicians who treat about four to five pregnant women with connective tissue disorder each year regularly prescribe antimalarials to such patients despite a lack of evidence officially establishing the safety of the drugs during pregnancy. In fact, 69% of 52 physicians who responded to a survey about the use of antimalarials during pregnancy said they continued antimalarials in pregnancy sometimes, often, or always (J. Rheumatol. 2002;29:700–6).

Hydroxychloroquine (HCQ) is known to cross the placenta and is present in similar concentrations in blood from the umbilical cord and the mother (Arthritis Rheum. 2002;46:1123–4).

In one study, 33 women with LE who were exposed to HCQ during 36 pregnancies had similar obstetric outcomes and levels of lupus activity, compared with 53 unexposed pregnant women with LE from the same lupus pregnancy center (Ann. Rheum. Dis. 1996;55:486–8). The investigators in the trial concluded that the continuation of HCQ “is probably safe during pregnancy,” Dr. Piette noted.

In a separate study, HCQ did not cause any disease flares in a group of eight women with systemic LE and two with discoid LE, whereas three patients had flare-ups in a placebo group of nine patients with systemic LE and one with discoid LE. None of the infants born to women taking HCQ had congenital abnormalities, and all of them had normal auditory and neuroophthalmologic evaluations at 1.5–3 years of age (Lupus 2001;10:401–4).

No unusual side effects occurred in another series of 53 pregnancies in women with LE that resulted in live births.

A study conducted by Dr. Piette and his colleagues compared 133 consecutive pregnancies in 90 women with connective tissue disease who took HCQ with 70 consecutive pregnancies in 53 control women with similar disorders who did not take HCQ. Of the pregnancies in women who received HCQ, 122 were exposed to 400 mg/day, and the remaining 11 received 200 mg/day.

Three malformations occurred in exposed infants, while four developed in the infants of control women. One child died as a result of prematurity in each group.

After the last follow-up of children at a mean age of 26 months (age ranging from 12 to 108 months), none of the children exposed to HCQ had visual, hearing, growth, or developmental abnormalities (Arthritis Rheum. 2003;48:3207–11).

Despite data that show no teratogenicity with HCQ, the Physicians' Desk Reference Web site for patients advises pregnant patients to avoid HCQ except in the suppression or treatment of malaria when the benefit outweighs any possible hazards.

HCQ exists at low levels in breast milk—344 ng/mL and 1,424 ng/mL in a report on two mothers—and is delivered in extremely low levels to breast-feeding children.

SAN ANTONIO — The use of high-dose pulsed intravenous glucocorticoid infusions may provide a means of effectively inducing remission in patients with giant cell arteritis, Mehrdad Mazlumzadeh, M.D., said at the annual meeting of the American College of Rheumatology.

First-line treatment for this condition, in which the arteries of the head and neck become inflamed, is with oral prednisone. This approach leads to rapid suppression of the inflammatory processes and resulting symptoms, which can include headache, fatigue, and even blindness. Inflammatory infiltrates persist in the temporal arteries, however, and many patients relapse.

And because extended courses of oral therapy typically are needed, patients are at risk for the many adverse effects associated with long-term steroid exposure, said Dr. Mazlumzadeh, a rheumatologist at the Mayo Clinic, Rochester, Minn.

In a study that included 27 patients with biopsy-proven giant cell arteritis, all participants received oral prednisone in a dose of 40 mg/day. They also were randomized to receive either pulse IV methylprednisolone, 15 mg/kg per day for 3 days, or intravenous saline.

The goal was to determine if high-dose pulse methylprednisolone as the initial treatment of giant cell arteritis would allow for more rapid tapering of oral prednisone without increasing the number of relapses. The primary outcome was reduction in the oral prednisone dose to no more than 5 mg/day after 34 weeks of therapy. “The results were impressive,” Dr. Mazlumzadeh said.

Of the 14 patients in the intravenous treatment group, 10 achieved the primary outcome vs. 2 of 13 in the control group—71% vs. 15%, a statistically significant difference.

Remission was defined as being off prednisone altogether with no recurrences for at least 2 months. Six of the active treatment patients were in remission at 18 months. None of the control patients achieved remission, he said.

There were 21 disease flares in the active treatment group and 34 in the control group. The rate of relapses per 100 person-months of treatment in the control group was 14.5, compared with 8.3 in the active treatment group.

The median cumulative dose of prednisone in the active treatment group was 4,853 mg, compared with 7,215 mg in the control group.

There were no differences between the groups in terms of the development of steroid-associated complications including osteoporosis, hypertension, hyperlipidemia, and diabetes.

No life-threatening disease-associated complications or vision loss occurred. One patient in the intravenous treatment group developed pyelonephritis 11 days after starting therapy.

SAN ANTONIO — The use of high-dose pulsed intravenous glucocorticoid infusions may provide a means of effectively inducing remission in patients with giant cell arteritis, Mehrdad Mazlumzadeh, M.D., said at the annual meeting of the American College of Rheumatology.

First-line treatment for this condition, in which the arteries of the head and neck become inflamed, is with oral prednisone. This approach leads to rapid suppression of the inflammatory processes and resulting symptoms, which can include headache, fatigue, and even blindness. Inflammatory infiltrates persist in the temporal arteries, however, and many patients relapse.

And because extended courses of oral therapy typically are needed, patients are at risk for the many adverse effects associated with long-term steroid exposure, said Dr. Mazlumzadeh, a rheumatologist at the Mayo Clinic, Rochester, Minn.

In a study that included 27 patients with biopsy-proven giant cell arteritis, all participants received oral prednisone in a dose of 40 mg/day. They also were randomized to receive either pulse IV methylprednisolone, 15 mg/kg per day for 3 days, or intravenous saline.

The goal was to determine if high-dose pulse methylprednisolone as the initial treatment of giant cell arteritis would allow for more rapid tapering of oral prednisone without increasing the number of relapses. The primary outcome was reduction in the oral prednisone dose to no more than 5 mg/day after 34 weeks of therapy. “The results were impressive,” Dr. Mazlumzadeh said.

Of the 14 patients in the intravenous treatment group, 10 achieved the primary outcome vs. 2 of 13 in the control group—71% vs. 15%, a statistically significant difference.

Remission was defined as being off prednisone altogether with no recurrences for at least 2 months. Six of the active treatment patients were in remission at 18 months. None of the control patients achieved remission, he said.

There were 21 disease flares in the active treatment group and 34 in the control group. The rate of relapses per 100 person-months of treatment in the control group was 14.5, compared with 8.3 in the active treatment group.

The median cumulative dose of prednisone in the active treatment group was 4,853 mg, compared with 7,215 mg in the control group.

There were no differences between the groups in terms of the development of steroid-associated complications including osteoporosis, hypertension, hyperlipidemia, and diabetes.

No life-threatening disease-associated complications or vision loss occurred. One patient in the intravenous treatment group developed pyelonephritis 11 days after starting therapy.

SAN ANTONIO — The use of high-dose pulsed intravenous glucocorticoid infusions may provide a means of effectively inducing remission in patients with giant cell arteritis, Mehrdad Mazlumzadeh, M.D., said at the annual meeting of the American College of Rheumatology.

First-line treatment for this condition, in which the arteries of the head and neck become inflamed, is with oral prednisone. This approach leads to rapid suppression of the inflammatory processes and resulting symptoms, which can include headache, fatigue, and even blindness. Inflammatory infiltrates persist in the temporal arteries, however, and many patients relapse.

And because extended courses of oral therapy typically are needed, patients are at risk for the many adverse effects associated with long-term steroid exposure, said Dr. Mazlumzadeh, a rheumatologist at the Mayo Clinic, Rochester, Minn.

In a study that included 27 patients with biopsy-proven giant cell arteritis, all participants received oral prednisone in a dose of 40 mg/day. They also were randomized to receive either pulse IV methylprednisolone, 15 mg/kg per day for 3 days, or intravenous saline.

The goal was to determine if high-dose pulse methylprednisolone as the initial treatment of giant cell arteritis would allow for more rapid tapering of oral prednisone without increasing the number of relapses. The primary outcome was reduction in the oral prednisone dose to no more than 5 mg/day after 34 weeks of therapy. “The results were impressive,” Dr. Mazlumzadeh said.

Of the 14 patients in the intravenous treatment group, 10 achieved the primary outcome vs. 2 of 13 in the control group—71% vs. 15%, a statistically significant difference.

Remission was defined as being off prednisone altogether with no recurrences for at least 2 months. Six of the active treatment patients were in remission at 18 months. None of the control patients achieved remission, he said.

There were 21 disease flares in the active treatment group and 34 in the control group. The rate of relapses per 100 person-months of treatment in the control group was 14.5, compared with 8.3 in the active treatment group.

The median cumulative dose of prednisone in the active treatment group was 4,853 mg, compared with 7,215 mg in the control group.

There were no differences between the groups in terms of the development of steroid-associated complications including osteoporosis, hypertension, hyperlipidemia, and diabetes.

No life-threatening disease-associated complications or vision loss occurred. One patient in the intravenous treatment group developed pyelonephritis 11 days after starting therapy.

SAN ANTONIO — The lengthening list of potential uses for rituximab may soon include the treatment of early and active Sjögren's syndrome—but with a caution.

In Sjögren's syndrome, high levels of B-cell autoreactivity are associated with high disease activity, systemic complications, and a markedly elevated risk for the development of B-cell lymphoma, Justin Pijpe, M.D., said at the annual meeting of the American College of Rheumatology.

Current treatment approaches for the autoimmune disease, including corticosteroids and hydroxychloroquine, have been largely unsuccessful in alleviating symptoms and have no impact on the course of disease.

Rituximab (Rituxan) is a monoclonal antibody that binds to the CD20 receptor on B cells, leading to B-cell depletion. The drug is now being investigated in a phase I/II study to determine if B-cell depletion may be a beneficial approach in Sjögren's syndrome, Dr. Pijpe reported in a poster session.

To date, six patients, all female and whose mean age is 50 years, have been treated with four infusions of rituximab, 375 mg/m

All had early disease that was characterized by B-cell hyperactivity, with IgG levels exceeding 15 g/L and had the autoantibodies IgM-Rf and anti-SSA/B. Patients with early disease—4 years' duration or less—typically still have substantial residual exocrine gland function, he explained.

Preliminary data on clinical efficacy suggest marked subjective improvement of fatigue, sicca complaints, and health status, as well as an increase in salivary gland function, said Dr. Pijpe of University Hospital Groningen (the Netherlands).

Analysis of saliva showed a decrease in inflammatory activity, and lacrimal gland function was unchanged or showed slight improvement.

Serologic analysis revealed a decrease in erythrocyte sedimentation rate and rheumatoid factor level, and levels of IgG remained stable or decreased.

Repeat biopsies of the parotid glands showed an increase in IgA:IgG plasma cell ratio, suggesting a specific decrease in IgG-producing B cells in the affected tissue.

Rituximab seems to be very effective in the treatment of early Sjögren's syndrome, Dr. Pijpe said.

But further investigation is needed, given that two patients developed a serum sickness-like clinical picture, necessitating treatment cessation.

“I was very surprised, because this type of adverse event is very rare,” he said. “Our patients showed a clinical presentation compatible with serum sickness, but serologic analysis was not fully characteristic for a type III hypersensitivity reaction,” he told this newspaper.

For example, there was no proteinuria, and the one patient who was tested for human antichimeric antibodies was negative.

On the other hand, there was an acute phase response and a slight increase of C3d in both patients, findings that are indicative of complement consumption, he said.

This type of reaction has not been reported in recent studies of rituximab in systemic lupus erythematosus and rheumatoid arthritis.

Only three cases of serum sickness after rituximab treatment have been reported previously, he said.

SAN ANTONIO — The lengthening list of potential uses for rituximab may soon include the treatment of early and active Sjögren's syndrome—but with a caution.

In Sjögren's syndrome, high levels of B-cell autoreactivity are associated with high disease activity, systemic complications, and a markedly elevated risk for the development of B-cell lymphoma, Justin Pijpe, M.D., said at the annual meeting of the American College of Rheumatology.

Current treatment approaches for the autoimmune disease, including corticosteroids and hydroxychloroquine, have been largely unsuccessful in alleviating symptoms and have no impact on the course of disease.

Rituximab (Rituxan) is a monoclonal antibody that binds to the CD20 receptor on B cells, leading to B-cell depletion. The drug is now being investigated in a phase I/II study to determine if B-cell depletion may be a beneficial approach in Sjögren's syndrome, Dr. Pijpe reported in a poster session.

To date, six patients, all female and whose mean age is 50 years, have been treated with four infusions of rituximab, 375 mg/m

All had early disease that was characterized by B-cell hyperactivity, with IgG levels exceeding 15 g/L and had the autoantibodies IgM-Rf and anti-SSA/B. Patients with early disease—4 years' duration or less—typically still have substantial residual exocrine gland function, he explained.

Preliminary data on clinical efficacy suggest marked subjective improvement of fatigue, sicca complaints, and health status, as well as an increase in salivary gland function, said Dr. Pijpe of University Hospital Groningen (the Netherlands).

Analysis of saliva showed a decrease in inflammatory activity, and lacrimal gland function was unchanged or showed slight improvement.

Serologic analysis revealed a decrease in erythrocyte sedimentation rate and rheumatoid factor level, and levels of IgG remained stable or decreased.

Repeat biopsies of the parotid glands showed an increase in IgA:IgG plasma cell ratio, suggesting a specific decrease in IgG-producing B cells in the affected tissue.

Rituximab seems to be very effective in the treatment of early Sjögren's syndrome, Dr. Pijpe said.

But further investigation is needed, given that two patients developed a serum sickness-like clinical picture, necessitating treatment cessation.

“I was very surprised, because this type of adverse event is very rare,” he said. “Our patients showed a clinical presentation compatible with serum sickness, but serologic analysis was not fully characteristic for a type III hypersensitivity reaction,” he told this newspaper.

For example, there was no proteinuria, and the one patient who was tested for human antichimeric antibodies was negative.

On the other hand, there was an acute phase response and a slight increase of C3d in both patients, findings that are indicative of complement consumption, he said.

This type of reaction has not been reported in recent studies of rituximab in systemic lupus erythematosus and rheumatoid arthritis.

Only three cases of serum sickness after rituximab treatment have been reported previously, he said.

SAN ANTONIO — The lengthening list of potential uses for rituximab may soon include the treatment of early and active Sjögren's syndrome—but with a caution.

In Sjögren's syndrome, high levels of B-cell autoreactivity are associated with high disease activity, systemic complications, and a markedly elevated risk for the development of B-cell lymphoma, Justin Pijpe, M.D., said at the annual meeting of the American College of Rheumatology.

Current treatment approaches for the autoimmune disease, including corticosteroids and hydroxychloroquine, have been largely unsuccessful in alleviating symptoms and have no impact on the course of disease.

Rituximab (Rituxan) is a monoclonal antibody that binds to the CD20 receptor on B cells, leading to B-cell depletion. The drug is now being investigated in a phase I/II study to determine if B-cell depletion may be a beneficial approach in Sjögren's syndrome, Dr. Pijpe reported in a poster session.

To date, six patients, all female and whose mean age is 50 years, have been treated with four infusions of rituximab, 375 mg/m

All had early disease that was characterized by B-cell hyperactivity, with IgG levels exceeding 15 g/L and had the autoantibodies IgM-Rf and anti-SSA/B. Patients with early disease—4 years' duration or less—typically still have substantial residual exocrine gland function, he explained.

Preliminary data on clinical efficacy suggest marked subjective improvement of fatigue, sicca complaints, and health status, as well as an increase in salivary gland function, said Dr. Pijpe of University Hospital Groningen (the Netherlands).

Analysis of saliva showed a decrease in inflammatory activity, and lacrimal gland function was unchanged or showed slight improvement.

Serologic analysis revealed a decrease in erythrocyte sedimentation rate and rheumatoid factor level, and levels of IgG remained stable or decreased.

Repeat biopsies of the parotid glands showed an increase in IgA:IgG plasma cell ratio, suggesting a specific decrease in IgG-producing B cells in the affected tissue.

Rituximab seems to be very effective in the treatment of early Sjögren's syndrome, Dr. Pijpe said.

But further investigation is needed, given that two patients developed a serum sickness-like clinical picture, necessitating treatment cessation.

“I was very surprised, because this type of adverse event is very rare,” he said. “Our patients showed a clinical presentation compatible with serum sickness, but serologic analysis was not fully characteristic for a type III hypersensitivity reaction,” he told this newspaper.

For example, there was no proteinuria, and the one patient who was tested for human antichimeric antibodies was negative.

On the other hand, there was an acute phase response and a slight increase of C3d in both patients, findings that are indicative of complement consumption, he said.

This type of reaction has not been reported in recent studies of rituximab in systemic lupus erythematosus and rheumatoid arthritis.

Only three cases of serum sickness after rituximab treatment have been reported previously, he said.

NEW ORLEANS — More than a third of the drug‐eluting stents placed in the first 9 months following marketing approval of the Cypher stent were for off‐label indications, according to data from the American College of Cardiology‐National Cardiovascular Data Registry.

The use of drug‐eluting stents rose rapidly during this period, and growth in the off‐label uses kept pace with the increase for the approved indication, Sunil V. Rao, M.D., said at the annual scientific sessions of the American Heart Association.

Dr. Rao presented a unique picture of the clinical adoption of a major new medical technology as reflected in a large national registry experience. The American College of Cardiology‐National Cardiovascular Data Registry (ACC‐NCDR) is an ACC‐initiated quality improvement project that to date includes more than 2 million admissions and 800,000 percutaneous coronary interventions (PCIs) at 528 participating U.S. sites.

The registry data are reassuring in that off‐label use of drug‐eluting stents (DESs) appeared to be safe, at least in terms of the very low associated periprocedural adverse event rate, said Dr. Rao of the Duke Clinical Research Institute, Durham, N.C. “However, long‐term safety and efficacy of drug‐eluting stent use in off‐label situations really should be evaluated in appropriately powered, randomized controlled trials,” he said.

For purposes of his study, Dr. Rao focused on PCIs involving only the Cypher stent, the first DES to reach the U.S. market between the device's April 2003 approval through the end of that year. PCIs involving placement of both a Cypher stent and one or more bare metal stents were excluded from consideration. Cypher‐only procedures comprised 30% of the nearly 163,000 PCIs entered into the registry during the study period.

The official Food and Drug Administration‐approved indication for the Cypher DES is for use in improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo coronary lesions less than 30 mm long in native arteries having a reference vessel diameter of 2.5‐3.5 mm, Dr. Rao said.

Dr. Rao focused on four specific off‐label applications: ST‐segment elevation MI, in‐stent restenosis, saphenous vein grafts, and chronic total occlusions. These four off‐label uses accounted for 33% of all DES procedures during the study period. This figure is actually an underestimate of the true proportion of DES procedures that were off label, since it doesn't include other possible off‐label indications, such as long lesions or bifurcations.

The fastest growth in off‐label use of the DES during the 9‐month study period was in cases of ST‐segment elevation MI, followed by in‐stent restenosis.

The incidences of in‐hospital mortality and unplanned coronary artery bypass surgery in connection with off‐label use of the Cypher stent were both well below 1%. Moreover, the postprocedural acute MI rate was similar to that seen with bare metal stents, Dr. Rao said.

Several audience members took issue with his call for randomized trials designed to expand the approved indications for DEs. Some observed that companies have little incentive to conduct such trials, since business is already booming. Others argued that at this point it would be unethical to randomize patients to bare metal stents for most off‐label uses and said that the FDA should rely on registry data to evaluate possible expanded indications for drug‐eluting stents.

Dr. Rao replied that it's highly unlikely the FDA would expand the indications on the basis of registry data, which after all are inferior to information gained from randomized trials. “The registry data have a tremendous amount of residual confounding that cannot be accounted for regardless of the statistical analyses used. I think registries are highly valuable for safety data. I don't think, however, we can accept efficacy data as reliable,” he said.

NEW ORLEANS — More than a third of the drug‐eluting stents placed in the first 9 months following marketing approval of the Cypher stent were for off‐label indications, according to data from the American College of Cardiology‐National Cardiovascular Data Registry.

The use of drug‐eluting stents rose rapidly during this period, and growth in the off‐label uses kept pace with the increase for the approved indication, Sunil V. Rao, M.D., said at the annual scientific sessions of the American Heart Association.

Dr. Rao presented a unique picture of the clinical adoption of a major new medical technology as reflected in a large national registry experience. The American College of Cardiology‐National Cardiovascular Data Registry (ACC‐NCDR) is an ACC‐initiated quality improvement project that to date includes more than 2 million admissions and 800,000 percutaneous coronary interventions (PCIs) at 528 participating U.S. sites.

The registry data are reassuring in that off‐label use of drug‐eluting stents (DESs) appeared to be safe, at least in terms of the very low associated periprocedural adverse event rate, said Dr. Rao of the Duke Clinical Research Institute, Durham, N.C. “However, long‐term safety and efficacy of drug‐eluting stent use in off‐label situations really should be evaluated in appropriately powered, randomized controlled trials,” he said.

For purposes of his study, Dr. Rao focused on PCIs involving only the Cypher stent, the first DES to reach the U.S. market between the device's April 2003 approval through the end of that year. PCIs involving placement of both a Cypher stent and one or more bare metal stents were excluded from consideration. Cypher‐only procedures comprised 30% of the nearly 163,000 PCIs entered into the registry during the study period.

The official Food and Drug Administration‐approved indication for the Cypher DES is for use in improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo coronary lesions less than 30 mm long in native arteries having a reference vessel diameter of 2.5‐3.5 mm, Dr. Rao said.

Dr. Rao focused on four specific off‐label applications: ST‐segment elevation MI, in‐stent restenosis, saphenous vein grafts, and chronic total occlusions. These four off‐label uses accounted for 33% of all DES procedures during the study period. This figure is actually an underestimate of the true proportion of DES procedures that were off label, since it doesn't include other possible off‐label indications, such as long lesions or bifurcations.

The fastest growth in off‐label use of the DES during the 9‐month study period was in cases of ST‐segment elevation MI, followed by in‐stent restenosis.

The incidences of in‐hospital mortality and unplanned coronary artery bypass surgery in connection with off‐label use of the Cypher stent were both well below 1%. Moreover, the postprocedural acute MI rate was similar to that seen with bare metal stents, Dr. Rao said.

Several audience members took issue with his call for randomized trials designed to expand the approved indications for DEs. Some observed that companies have little incentive to conduct such trials, since business is already booming. Others argued that at this point it would be unethical to randomize patients to bare metal stents for most off‐label uses and said that the FDA should rely on registry data to evaluate possible expanded indications for drug‐eluting stents.

Dr. Rao replied that it's highly unlikely the FDA would expand the indications on the basis of registry data, which after all are inferior to information gained from randomized trials. “The registry data have a tremendous amount of residual confounding that cannot be accounted for regardless of the statistical analyses used. I think registries are highly valuable for safety data. I don't think, however, we can accept efficacy data as reliable,” he said.

NEW ORLEANS — More than a third of the drug‐eluting stents placed in the first 9 months following marketing approval of the Cypher stent were for off‐label indications, according to data from the American College of Cardiology‐National Cardiovascular Data Registry.

The use of drug‐eluting stents rose rapidly during this period, and growth in the off‐label uses kept pace with the increase for the approved indication, Sunil V. Rao, M.D., said at the annual scientific sessions of the American Heart Association.

Dr. Rao presented a unique picture of the clinical adoption of a major new medical technology as reflected in a large national registry experience. The American College of Cardiology‐National Cardiovascular Data Registry (ACC‐NCDR) is an ACC‐initiated quality improvement project that to date includes more than 2 million admissions and 800,000 percutaneous coronary interventions (PCIs) at 528 participating U.S. sites.

The registry data are reassuring in that off‐label use of drug‐eluting stents (DESs) appeared to be safe, at least in terms of the very low associated periprocedural adverse event rate, said Dr. Rao of the Duke Clinical Research Institute, Durham, N.C. “However, long‐term safety and efficacy of drug‐eluting stent use in off‐label situations really should be evaluated in appropriately powered, randomized controlled trials,” he said.

For purposes of his study, Dr. Rao focused on PCIs involving only the Cypher stent, the first DES to reach the U.S. market between the device's April 2003 approval through the end of that year. PCIs involving placement of both a Cypher stent and one or more bare metal stents were excluded from consideration. Cypher‐only procedures comprised 30% of the nearly 163,000 PCIs entered into the registry during the study period.

The official Food and Drug Administration‐approved indication for the Cypher DES is for use in improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo coronary lesions less than 30 mm long in native arteries having a reference vessel diameter of 2.5‐3.5 mm, Dr. Rao said.

Dr. Rao focused on four specific off‐label applications: ST‐segment elevation MI, in‐stent restenosis, saphenous vein grafts, and chronic total occlusions. These four off‐label uses accounted for 33% of all DES procedures during the study period. This figure is actually an underestimate of the true proportion of DES procedures that were off label, since it doesn't include other possible off‐label indications, such as long lesions or bifurcations.

The fastest growth in off‐label use of the DES during the 9‐month study period was in cases of ST‐segment elevation MI, followed by in‐stent restenosis.

The incidences of in‐hospital mortality and unplanned coronary artery bypass surgery in connection with off‐label use of the Cypher stent were both well below 1%. Moreover, the postprocedural acute MI rate was similar to that seen with bare metal stents, Dr. Rao said.

Several audience members took issue with his call for randomized trials designed to expand the approved indications for DEs. Some observed that companies have little incentive to conduct such trials, since business is already booming. Others argued that at this point it would be unethical to randomize patients to bare metal stents for most off‐label uses and said that the FDA should rely on registry data to evaluate possible expanded indications for drug‐eluting stents.

Dr. Rao replied that it's highly unlikely the FDA would expand the indications on the basis of registry data, which after all are inferior to information gained from randomized trials. “The registry data have a tremendous amount of residual confounding that cannot be accounted for regardless of the statistical analyses used. I think registries are highly valuable for safety data. I don't think, however, we can accept efficacy data as reliable,” he said.

SAN FRANCISCO — Patients with at least two of five risk factors after a transient ischemic attack or acute ischemic stroke should be admitted to a hospital's telemetry bed, because they have a higher risk for a significant cardiac event, Peter D. Panagos, M.D., said.

A review of records on 27 patients seen after a transient ischemic attack (TIA) and 171 patients seen after an acute ischemic stroke (AIS) found that 16% developed a significant cardiac event within 48 hours of admission to the hospital, he said at the annual meeting of the American College of Emergency Physicians. A significant cardiac event consisted of ECG changes consistent with new‐onset arrhythmia or ischemia, elevated heart enzymes (troponin I), or cardiac‐related death.

Significant cardiac events were more likely to occur in patients with diabetes, hypertension, a current smoking habit, coronary artery disease, and/or a suspected cardioembolic stroke subtype, said Dr. Panagos of Brown University, Providence, R.I.

At his institution, if a post‐TIA or post‐AIS patient has two of these five risk factors, “we tend to admit these patients to telemetry beds instead of floor beds now,” he said.

Patients without these risk factors may not need high‐acuity beds, which could free up telemetry beds for those who need closer monitoring, he added.

Among all patients studied, 26% had diabetes, 70% were hypertensive, 27% were smokers, and 23% had cardiovascular disease. When the strokes were classified by subtypes, 26% were found to be cardioembolic, 32% were large‐artery atherothromboembolic, 32% were small‐vessel thrombotic, and 10% had other etiologies.

Demographic factors and other risk factors did not influence the risk for a significant cardiac event. Other risk factors included cerebrovascular disease (found in 35% of patients), hyperlipidemia (in 41%), atrial fibrillation (in 20%), and a family history of heart disease (in 30%). Patients in the study had a mean age of 70 years, and 55% were women.

The current study is one of the first to evaluate the short‐term risk for cardiac morbidity after a TIA or AIS.

Previous studies identified a 13% risk for a recurrent TIA or stroke within 90 days of the index event.

Dr. Panagos and his coinvestigator, Alyson J. McGregor, M.D., also of Brown University, plan to review more patient records to increase the size of this relatively small study.

SAN FRANCISCO — Patients with at least two of five risk factors after a transient ischemic attack or acute ischemic stroke should be admitted to a hospital's telemetry bed, because they have a higher risk for a significant cardiac event, Peter D. Panagos, M.D., said.

A review of records on 27 patients seen after a transient ischemic attack (TIA) and 171 patients seen after an acute ischemic stroke (AIS) found that 16% developed a significant cardiac event within 48 hours of admission to the hospital, he said at the annual meeting of the American College of Emergency Physicians. A significant cardiac event consisted of ECG changes consistent with new‐onset arrhythmia or ischemia, elevated heart enzymes (troponin I), or cardiac‐related death.

Significant cardiac events were more likely to occur in patients with diabetes, hypertension, a current smoking habit, coronary artery disease, and/or a suspected cardioembolic stroke subtype, said Dr. Panagos of Brown University, Providence, R.I.

At his institution, if a post‐TIA or post‐AIS patient has two of these five risk factors, “we tend to admit these patients to telemetry beds instead of floor beds now,” he said.

Patients without these risk factors may not need high‐acuity beds, which could free up telemetry beds for those who need closer monitoring, he added.

Among all patients studied, 26% had diabetes, 70% were hypertensive, 27% were smokers, and 23% had cardiovascular disease. When the strokes were classified by subtypes, 26% were found to be cardioembolic, 32% were large‐artery atherothromboembolic, 32% were small‐vessel thrombotic, and 10% had other etiologies.

Demographic factors and other risk factors did not influence the risk for a significant cardiac event. Other risk factors included cerebrovascular disease (found in 35% of patients), hyperlipidemia (in 41%), atrial fibrillation (in 20%), and a family history of heart disease (in 30%). Patients in the study had a mean age of 70 years, and 55% were women.

The current study is one of the first to evaluate the short‐term risk for cardiac morbidity after a TIA or AIS.

Previous studies identified a 13% risk for a recurrent TIA or stroke within 90 days of the index event.

Dr. Panagos and his coinvestigator, Alyson J. McGregor, M.D., also of Brown University, plan to review more patient records to increase the size of this relatively small study.

SAN FRANCISCO — Patients with at least two of five risk factors after a transient ischemic attack or acute ischemic stroke should be admitted to a hospital's telemetry bed, because they have a higher risk for a significant cardiac event, Peter D. Panagos, M.D., said.

A review of records on 27 patients seen after a transient ischemic attack (TIA) and 171 patients seen after an acute ischemic stroke (AIS) found that 16% developed a significant cardiac event within 48 hours of admission to the hospital, he said at the annual meeting of the American College of Emergency Physicians. A significant cardiac event consisted of ECG changes consistent with new‐onset arrhythmia or ischemia, elevated heart enzymes (troponin I), or cardiac‐related death.

Significant cardiac events were more likely to occur in patients with diabetes, hypertension, a current smoking habit, coronary artery disease, and/or a suspected cardioembolic stroke subtype, said Dr. Panagos of Brown University, Providence, R.I.

At his institution, if a post‐TIA or post‐AIS patient has two of these five risk factors, “we tend to admit these patients to telemetry beds instead of floor beds now,” he said.

Patients without these risk factors may not need high‐acuity beds, which could free up telemetry beds for those who need closer monitoring, he added.

Among all patients studied, 26% had diabetes, 70% were hypertensive, 27% were smokers, and 23% had cardiovascular disease. When the strokes were classified by subtypes, 26% were found to be cardioembolic, 32% were large‐artery atherothromboembolic, 32% were small‐vessel thrombotic, and 10% had other etiologies.

Demographic factors and other risk factors did not influence the risk for a significant cardiac event. Other risk factors included cerebrovascular disease (found in 35% of patients), hyperlipidemia (in 41%), atrial fibrillation (in 20%), and a family history of heart disease (in 30%). Patients in the study had a mean age of 70 years, and 55% were women.

The current study is one of the first to evaluate the short‐term risk for cardiac morbidity after a TIA or AIS.

Previous studies identified a 13% risk for a recurrent TIA or stroke within 90 days of the index event.

Dr. Panagos and his coinvestigator, Alyson J. McGregor, M.D., also of Brown University, plan to review more patient records to increase the size of this relatively small study.

NEW ORLEANS — Tweaking emergency dispatcher assessment protocols to add a few simple questions regarding agonal breathing markedly increases the rate of cardiac arrest detection over the phone, Ahamed H. Idris, M.D., reported at the annual scientific sessions of the American Heart Association.

The net result is a greater than 30% increased likelihood that CPR will be started by bystanders as a result of the 911 call, well before emergency medical services (EMS) personnel can arrive on the scene. And that in turn substantially increases the chances for survival, added Dr. Idris, professor of emergency medicine at the University of Texas, Dallas.

In a separate presentation, investigators described another novel approach to improving the rate of prompt CPR by lay rescuers in out‐of‐hospital cardiac arrest, this time through the use of a new, brief, self‐guided CPR video instruction method for the general public that takes only one‐eighth the time of the traditional 4‐hour CPR group class.

Dr. Idris noted that studies from Sweden, Seattle, and Dallas have independently shown that CPR is withheld from up to 40% of people with out‐of‐hospital cardiac arrest because potential rescuers or 911 dispatchers misinterpret agonal breathing as an indication that the individual is not in cardiac arrest.

In fact, agonal breathing‐‐a distinctively slow breathing pattern in which the collapsed person appears to be gasping for air‐‐is an extremely common occurrence shortly after the respiratory center in the brainstem becomes deprived of oxygen‐rich blood.

“That's the time when people are most likely to actually be saved if they receive intervention,” according to Dr. Idris, a member of the AHA Emergency Cardiovascular Care Committee.

He and coworkers in an AHA‐sponsored trial created a series of three simple questions to be added to emergency dispatcher protocols to better identify cardiac arrest through improved detection of agonal breathing over the phone. (See box.)

The investigators studied all 962 cases of dispatcher‐assisted out‐of‐hospital cardiac arrest in the Dallas area during the 8 months before and 4 months after implementation of the new dispatcher protocol that includes questioning about agonal breathing. They found that, prior to the change, 28% of all cardiac arrests were missed, as confirmed upon subsequent arrival of EMS personnel, compared with 18.8% after the protocol change.

That's a 32% reduction in missed cases‐‐and in the months after completion of the formal study, as emergency dispatchers grew more experienced in identifying agonal breathing, the percentage of missed cardiac arrests dropped even further, Dr. Idris said.

In a separate presentation, Bonnie C. Lynch, Ph.D., said that middle‐aged adults are the individuals most likely to witness a cardiac arrest, yet they are seriously underrepresented in the standard 4‐hour CPR Heartsaver training classes, which tend to attract a younger crowd.

The AHA has set an ambitious goal of training 20 million people per year and is now training 9 million. To train more members of the general public in CPR, the AHA commissioned the development of a 30‐minute CPR self‐training kit designed for home or work settings.

The kit was tested in a randomized controlled trial in 285 Portland, Ore. area 40‐ to 70‐year‐olds. Three‐fifths used the kit, one‐fifth took the standard 4‐hour CPR course, and the remainder received no training.

CPR skills testing by blinded evaluators immediately after the training demonstrated that the kit users were as skilled as those who had completed the standard class. When skills retention was tested 2 months later, the two groups remained closely comparable, said Dr. Lynch of RMC Research Corp., Portland.

The kit should be commercially available by midyear.

Cardiac Arrest Questionnaire

▸ Is the person awake and conscious?

▸ Is the person breathing normally? Count the breaths and describe what they sound like. (An interval of 10 or more seconds between breaths is a marker for agonal breathing and an indication to start CPR.)

▸ Is the person moving?

NEW ORLEANS — Tweaking emergency dispatcher assessment protocols to add a few simple questions regarding agonal breathing markedly increases the rate of cardiac arrest detection over the phone, Ahamed H. Idris, M.D., reported at the annual scientific sessions of the American Heart Association.

The net result is a greater than 30% increased likelihood that CPR will be started by bystanders as a result of the 911 call, well before emergency medical services (EMS) personnel can arrive on the scene. And that in turn substantially increases the chances for survival, added Dr. Idris, professor of emergency medicine at the University of Texas, Dallas.

In a separate presentation, investigators described another novel approach to improving the rate of prompt CPR by lay rescuers in out‐of‐hospital cardiac arrest, this time through the use of a new, brief, self‐guided CPR video instruction method for the general public that takes only one‐eighth the time of the traditional 4‐hour CPR group class.

Dr. Idris noted that studies from Sweden, Seattle, and Dallas have independently shown that CPR is withheld from up to 40% of people with out‐of‐hospital cardiac arrest because potential rescuers or 911 dispatchers misinterpret agonal breathing as an indication that the individual is not in cardiac arrest.

In fact, agonal breathing‐‐a distinctively slow breathing pattern in which the collapsed person appears to be gasping for air‐‐is an extremely common occurrence shortly after the respiratory center in the brainstem becomes deprived of oxygen‐rich blood.

“That's the time when people are most likely to actually be saved if they receive intervention,” according to Dr. Idris, a member of the AHA Emergency Cardiovascular Care Committee.

He and coworkers in an AHA‐sponsored trial created a series of three simple questions to be added to emergency dispatcher protocols to better identify cardiac arrest through improved detection of agonal breathing over the phone. (See box.)

The investigators studied all 962 cases of dispatcher‐assisted out‐of‐hospital cardiac arrest in the Dallas area during the 8 months before and 4 months after implementation of the new dispatcher protocol that includes questioning about agonal breathing. They found that, prior to the change, 28% of all cardiac arrests were missed, as confirmed upon subsequent arrival of EMS personnel, compared with 18.8% after the protocol change.

That's a 32% reduction in missed cases‐‐and in the months after completion of the formal study, as emergency dispatchers grew more experienced in identifying agonal breathing, the percentage of missed cardiac arrests dropped even further, Dr. Idris said.

In a separate presentation, Bonnie C. Lynch, Ph.D., said that middle‐aged adults are the individuals most likely to witness a cardiac arrest, yet they are seriously underrepresented in the standard 4‐hour CPR Heartsaver training classes, which tend to attract a younger crowd.

The AHA has set an ambitious goal of training 20 million people per year and is now training 9 million. To train more members of the general public in CPR, the AHA commissioned the development of a 30‐minute CPR self‐training kit designed for home or work settings.

The kit was tested in a randomized controlled trial in 285 Portland, Ore. area 40‐ to 70‐year‐olds. Three‐fifths used the kit, one‐fifth took the standard 4‐hour CPR course, and the remainder received no training.

CPR skills testing by blinded evaluators immediately after the training demonstrated that the kit users were as skilled as those who had completed the standard class. When skills retention was tested 2 months later, the two groups remained closely comparable, said Dr. Lynch of RMC Research Corp., Portland.

The kit should be commercially available by midyear.

Cardiac Arrest Questionnaire

▸ Is the person awake and conscious?

▸ Is the person breathing normally? Count the breaths and describe what they sound like. (An interval of 10 or more seconds between breaths is a marker for agonal breathing and an indication to start CPR.)

▸ Is the person moving?

NEW ORLEANS — Tweaking emergency dispatcher assessment protocols to add a few simple questions regarding agonal breathing markedly increases the rate of cardiac arrest detection over the phone, Ahamed H. Idris, M.D., reported at the annual scientific sessions of the American Heart Association.

The net result is a greater than 30% increased likelihood that CPR will be started by bystanders as a result of the 911 call, well before emergency medical services (EMS) personnel can arrive on the scene. And that in turn substantially increases the chances for survival, added Dr. Idris, professor of emergency medicine at the University of Texas, Dallas.

In a separate presentation, investigators described another novel approach to improving the rate of prompt CPR by lay rescuers in out‐of‐hospital cardiac arrest, this time through the use of a new, brief, self‐guided CPR video instruction method for the general public that takes only one‐eighth the time of the traditional 4‐hour CPR group class.

Dr. Idris noted that studies from Sweden, Seattle, and Dallas have independently shown that CPR is withheld from up to 40% of people with out‐of‐hospital cardiac arrest because potential rescuers or 911 dispatchers misinterpret agonal breathing as an indication that the individual is not in cardiac arrest.

In fact, agonal breathing‐‐a distinctively slow breathing pattern in which the collapsed person appears to be gasping for air‐‐is an extremely common occurrence shortly after the respiratory center in the brainstem becomes deprived of oxygen‐rich blood.

“That's the time when people are most likely to actually be saved if they receive intervention,” according to Dr. Idris, a member of the AHA Emergency Cardiovascular Care Committee.

He and coworkers in an AHA‐sponsored trial created a series of three simple questions to be added to emergency dispatcher protocols to better identify cardiac arrest through improved detection of agonal breathing over the phone. (See box.)

The investigators studied all 962 cases of dispatcher‐assisted out‐of‐hospital cardiac arrest in the Dallas area during the 8 months before and 4 months after implementation of the new dispatcher protocol that includes questioning about agonal breathing. They found that, prior to the change, 28% of all cardiac arrests were missed, as confirmed upon subsequent arrival of EMS personnel, compared with 18.8% after the protocol change.

That's a 32% reduction in missed cases‐‐and in the months after completion of the formal study, as emergency dispatchers grew more experienced in identifying agonal breathing, the percentage of missed cardiac arrests dropped even further, Dr. Idris said.

In a separate presentation, Bonnie C. Lynch, Ph.D., said that middle‐aged adults are the individuals most likely to witness a cardiac arrest, yet they are seriously underrepresented in the standard 4‐hour CPR Heartsaver training classes, which tend to attract a younger crowd.

The AHA has set an ambitious goal of training 20 million people per year and is now training 9 million. To train more members of the general public in CPR, the AHA commissioned the development of a 30‐minute CPR self‐training kit designed for home or work settings.

The kit was tested in a randomized controlled trial in 285 Portland, Ore. area 40‐ to 70‐year‐olds. Three‐fifths used the kit, one‐fifth took the standard 4‐hour CPR course, and the remainder received no training.

CPR skills testing by blinded evaluators immediately after the training demonstrated that the kit users were as skilled as those who had completed the standard class. When skills retention was tested 2 months later, the two groups remained closely comparable, said Dr. Lynch of RMC Research Corp., Portland.

The kit should be commercially available by midyear.

Cardiac Arrest Questionnaire

▸ Is the person awake and conscious?

▸ Is the person breathing normally? Count the breaths and describe what they sound like. (An interval of 10 or more seconds between breaths is a marker for agonal breathing and an indication to start CPR.)

▸ Is the person moving?

NEW ORLEANS — When thrombolysis fails to fully unblock the infarct‐related artery of a patient with an acute myocardial infarction, percutaneous coronary intervention is the best next step, according to the results of a controlled study with 427 patients.

Up to now, some physicians have treated MI patients who failed thrombolysis with percutaneous coronary intervention (PCI) because they intuitively believed that it was the right thing to do, but there was no evidence to back it up, Anthony H. Gershlick, M.B., said at the annual scientific sessions of the American Heart Association.

About 40% of patients who are treated with thrombolysis for an acute MI fail this initial treatment and do not show full resolution of their ST‐segment abnormality, said Dr. Gershlick, a cardiologist at University Hospital in Leicester, England. The results of the new study “tell us that you need to assess patients 90 minutes after thrombolysis with ECG to see if thrombolysis was successful.”

“These results should have an impact on practice,” commented Eric R. Bates, M.D., a professor of internal medicine at the University of Michigan in Ann Arbor. Community hospitals that use thrombolysis but lack a catheterization laboratory will need to collaborate with an angioplasty center that can treat their patients who fail thrombolysis, Dr. Bates said.

The study was done at 35 United Kingdom hospitals. Patients with an acute MI who received standard lytic therapy and aspirin underwent a repeat ECG 90 minutes after receiving their initial thrombolytic drug. (About 60% of patients received streptokinase, 27% received reteplase, and the remaining patients received other agents.) Patients with less than 50% resolution of their ST changes were randomized to one of three treatment strategies: conservative management in the hospital, repeat treatment with thrombolysis, or PCI (about 69% of the PCI‐treated patients received coronary stents).

The study's primary end point was the incidence of death, repeat MI, stroke, or severe heart failure at 6 months after treatment. This end point occurred in 15% of the 144 patients treated with PCI, 30% of 141 patients treated with conservative therapy, and 31% of 142 patients treated with repeat thrombolysis, a statistically significant difference in favor of PCI. PCI led to consistent reductions in death, repeat MI, and severe heart failure. Stroke incidence was similar in all three groups.

Treatment with PCI also led to a higher rate of major bleeding events, 19%, compared with 5% in the repeat lysis group and 2% in the conservatively managed group. Of the 27 patients with major bleeds in the PCI group, 22 cases involved sheath complications during coronary catheterization. The incidence of severe complications from bleeding were similar in the three groups.

The average time from the onset of pain to when patients received their first thrombolytic treatment was 140 minutes. Patients who received a second dose of a lytic drug got it an average of 190 minutes later; patients who received PCI were treated an average of 274 minutes later, an average delay of 84 minutes beyond the thrombolytic group.

Thus, the patients treated by rescue PCI got their definitive treatment nearly 7 hours after onset of chest pain. Despite this long delay to definitive treatment, these patients still did better than the comparator groups, Dr. Gershlick said.

NEW ORLEANS — When thrombolysis fails to fully unblock the infarct‐related artery of a patient with an acute myocardial infarction, percutaneous coronary intervention is the best next step, according to the results of a controlled study with 427 patients.

Up to now, some physicians have treated MI patients who failed thrombolysis with percutaneous coronary intervention (PCI) because they intuitively believed that it was the right thing to do, but there was no evidence to back it up, Anthony H. Gershlick, M.B., said at the annual scientific sessions of the American Heart Association.

About 40% of patients who are treated with thrombolysis for an acute MI fail this initial treatment and do not show full resolution of their ST‐segment abnormality, said Dr. Gershlick, a cardiologist at University Hospital in Leicester, England. The results of the new study “tell us that you need to assess patients 90 minutes after thrombolysis with ECG to see if thrombolysis was successful.”

“These results should have an impact on practice,” commented Eric R. Bates, M.D., a professor of internal medicine at the University of Michigan in Ann Arbor. Community hospitals that use thrombolysis but lack a catheterization laboratory will need to collaborate with an angioplasty center that can treat their patients who fail thrombolysis, Dr. Bates said.

The study was done at 35 United Kingdom hospitals. Patients with an acute MI who received standard lytic therapy and aspirin underwent a repeat ECG 90 minutes after receiving their initial thrombolytic drug. (About 60% of patients received streptokinase, 27% received reteplase, and the remaining patients received other agents.) Patients with less than 50% resolution of their ST changes were randomized to one of three treatment strategies: conservative management in the hospital, repeat treatment with thrombolysis, or PCI (about 69% of the PCI‐treated patients received coronary stents).

The study's primary end point was the incidence of death, repeat MI, stroke, or severe heart failure at 6 months after treatment. This end point occurred in 15% of the 144 patients treated with PCI, 30% of 141 patients treated with conservative therapy, and 31% of 142 patients treated with repeat thrombolysis, a statistically significant difference in favor of PCI. PCI led to consistent reductions in death, repeat MI, and severe heart failure. Stroke incidence was similar in all three groups.

Treatment with PCI also led to a higher rate of major bleeding events, 19%, compared with 5% in the repeat lysis group and 2% in the conservatively managed group. Of the 27 patients with major bleeds in the PCI group, 22 cases involved sheath complications during coronary catheterization. The incidence of severe complications from bleeding were similar in the three groups.

The average time from the onset of pain to when patients received their first thrombolytic treatment was 140 minutes. Patients who received a second dose of a lytic drug got it an average of 190 minutes later; patients who received PCI were treated an average of 274 minutes later, an average delay of 84 minutes beyond the thrombolytic group.

Thus, the patients treated by rescue PCI got their definitive treatment nearly 7 hours after onset of chest pain. Despite this long delay to definitive treatment, these patients still did better than the comparator groups, Dr. Gershlick said.

NEW ORLEANS — When thrombolysis fails to fully unblock the infarct‐related artery of a patient with an acute myocardial infarction, percutaneous coronary intervention is the best next step, according to the results of a controlled study with 427 patients.

Up to now, some physicians have treated MI patients who failed thrombolysis with percutaneous coronary intervention (PCI) because they intuitively believed that it was the right thing to do, but there was no evidence to back it up, Anthony H. Gershlick, M.B., said at the annual scientific sessions of the American Heart Association.

About 40% of patients who are treated with thrombolysis for an acute MI fail this initial treatment and do not show full resolution of their ST‐segment abnormality, said Dr. Gershlick, a cardiologist at University Hospital in Leicester, England. The results of the new study “tell us that you need to assess patients 90 minutes after thrombolysis with ECG to see if thrombolysis was successful.”

“These results should have an impact on practice,” commented Eric R. Bates, M.D., a professor of internal medicine at the University of Michigan in Ann Arbor. Community hospitals that use thrombolysis but lack a catheterization laboratory will need to collaborate with an angioplasty center that can treat their patients who fail thrombolysis, Dr. Bates said.

The study was done at 35 United Kingdom hospitals. Patients with an acute MI who received standard lytic therapy and aspirin underwent a repeat ECG 90 minutes after receiving their initial thrombolytic drug. (About 60% of patients received streptokinase, 27% received reteplase, and the remaining patients received other agents.) Patients with less than 50% resolution of their ST changes were randomized to one of three treatment strategies: conservative management in the hospital, repeat treatment with thrombolysis, or PCI (about 69% of the PCI‐treated patients received coronary stents).

The study's primary end point was the incidence of death, repeat MI, stroke, or severe heart failure at 6 months after treatment. This end point occurred in 15% of the 144 patients treated with PCI, 30% of 141 patients treated with conservative therapy, and 31% of 142 patients treated with repeat thrombolysis, a statistically significant difference in favor of PCI. PCI led to consistent reductions in death, repeat MI, and severe heart failure. Stroke incidence was similar in all three groups.

Treatment with PCI also led to a higher rate of major bleeding events, 19%, compared with 5% in the repeat lysis group and 2% in the conservatively managed group. Of the 27 patients with major bleeds in the PCI group, 22 cases involved sheath complications during coronary catheterization. The incidence of severe complications from bleeding were similar in the three groups.

The average time from the onset of pain to when patients received their first thrombolytic treatment was 140 minutes. Patients who received a second dose of a lytic drug got it an average of 190 minutes later; patients who received PCI were treated an average of 274 minutes later, an average delay of 84 minutes beyond the thrombolytic group.

Thus, the patients treated by rescue PCI got their definitive treatment nearly 7 hours after onset of chest pain. Despite this long delay to definitive treatment, these patients still did better than the comparator groups, Dr. Gershlick said.

Contact

Windy Lammers Stevenson, MD

Inpatient Pediatric Service

Doernbecher Children’s Hospital

Oregon Health & Science University

707 SW Gaines St. CDRCP

Portland, Oregon 97239

Phone: 503-494-6513 Fax: 503-494-4953

E-mail: [email protected]

Start Up

2003

Hospitalists

Tracy Bumsted, MD, MPH

Carrie Phillipi, MD, PhD

Windy Lammers Stevenson, MD

General Pediatricians

Cynthia Ferrell, MD, MSEd

Arthur Jaff e, MD

C. Wayne Sells, MD, MPH

Scott Shipman, MD, MPH

Joseph Zenel, MD

The Program

The pediatric inpatient service at Doernbecher Children’s Hospital is a newly formed multidisciplinary team designed to creatively approach the continually evolving challenges of providing excellent inpatient care in the current financial environment.

Three pediatric hospitalists have joined forces with four general pediatricians and an adolescent specialist to assume care for all patients on the general pediatric inpatient service at this tertiary care academic medical center. A pediatric case manager and a nursing director complete our team. The eight board-certified physicians are members of the Division of General Pediatrics in the Department of Pediatrics at Oregon Health & Science University.

Implementation

Our care model was introduced in a step-wise approach over 10 months beginning in the fall of 2003. Subspecialists who had been providing rotating coverage on the general pediatric service were replaced on the wards as each new hospitalist was hired. With staffing now complete, the subspecialists can focus on other clinical and research endeavors. Doernbecher’s open staff policy allows community physicians to admit and follow their own patients; however, most community providers choose to admit their patients to the hospitalist service.

Schedule

The three hospitalists are scheduled in blocks of 3-7 days, each attending the equivalent of 13 weeks per year, weekends included. The general pediatricians provide coverage for the remaining weeks. Average daily census is 6-12, with a peak-season census of 10-16. The hospitalists are the primary attendings for the general pediatric patients and are available for consultation to any of 12 pediatric subspecialty and surgery services, as well as the emergency department. House staff presence allows for nighttime call from home. Additional off-service clinical responsibilities include supervision of resident clinic and attending in the newborn nursery.

Teaching

Our hospitalists are committed to education. We are responsible for the inpatient education of third-year medical students as well as first- and third-year pediatric and family practice residents. We play key roles in clerkship direction. We welcome sub-interns from our own institution and from across the country. We have embarked on formal and informal education efforts for nurses, as well, and we are striving to provide all members of our team with quality feedback.

Successes

We are fortunate to have had the incredible support of an experienced case manager and talented nursing director in implementing change on the inpatient unit. Together we have decreased length of stay by 500 bed days in 11 months, redesigned morning flow on the wards, and tackled systems challenges. We are proud of our successes in solidifying a sense of identity on the unit, and improving morale for physicians, nurses, and ancillary staff. We are grateful for the continued support of our colleagues in the PICU, on our subspecialty and surgery teams, and on our Kaiser inpatient pediatric service.

Challenges

Progress toward long-term fiscal independence is one of our biggest challenges. Hospitalists are salaried through hospital and school of medicine funds; like most academic programs with teaching missions, ours will need continued support.

Marketing efforts are underway to facilitate excellent communication with our referring physicians, improve access to care at our institution, and improve payer mix.

Future Directions

We are excited about the continued development of our young program. We are working on increasing collaboration with our subspecialty and surgical colleagues, as well as using evidence-based methods to implement additional best-practice guidelines. We are about to launch our new computer program for notes, billing, and data collection, with hopes of continuing to document decreases in length of stay and other financial benefits for the hospital. We are enthusiastic about implementing competency-based education and evaluation, and we look forward to interactions with others contributing to the pediatric hospitalist movement.

Contact

Windy Lammers Stevenson, MD

Inpatient Pediatric Service

Doernbecher Children’s Hospital

Oregon Health & Science University

707 SW Gaines St. CDRCP

Portland, Oregon 97239

Phone: 503-494-6513 Fax: 503-494-4953

E-mail: [email protected]

Start Up

2003

Hospitalists

Tracy Bumsted, MD, MPH

Carrie Phillipi, MD, PhD

Windy Lammers Stevenson, MD

General Pediatricians

Cynthia Ferrell, MD, MSEd

Arthur Jaff e, MD

C. Wayne Sells, MD, MPH

Scott Shipman, MD, MPH

Joseph Zenel, MD

The Program

The pediatric inpatient service at Doernbecher Children’s Hospital is a newly formed multidisciplinary team designed to creatively approach the continually evolving challenges of providing excellent inpatient care in the current financial environment.

Three pediatric hospitalists have joined forces with four general pediatricians and an adolescent specialist to assume care for all patients on the general pediatric inpatient service at this tertiary care academic medical center. A pediatric case manager and a nursing director complete our team. The eight board-certified physicians are members of the Division of General Pediatrics in the Department of Pediatrics at Oregon Health & Science University.

Implementation

Our care model was introduced in a step-wise approach over 10 months beginning in the fall of 2003. Subspecialists who had been providing rotating coverage on the general pediatric service were replaced on the wards as each new hospitalist was hired. With staffing now complete, the subspecialists can focus on other clinical and research endeavors. Doernbecher’s open staff policy allows community physicians to admit and follow their own patients; however, most community providers choose to admit their patients to the hospitalist service.

Schedule

The three hospitalists are scheduled in blocks of 3-7 days, each attending the equivalent of 13 weeks per year, weekends included. The general pediatricians provide coverage for the remaining weeks. Average daily census is 6-12, with a peak-season census of 10-16. The hospitalists are the primary attendings for the general pediatric patients and are available for consultation to any of 12 pediatric subspecialty and surgery services, as well as the emergency department. House staff presence allows for nighttime call from home. Additional off-service clinical responsibilities include supervision of resident clinic and attending in the newborn nursery.

Teaching

Our hospitalists are committed to education. We are responsible for the inpatient education of third-year medical students as well as first- and third-year pediatric and family practice residents. We play key roles in clerkship direction. We welcome sub-interns from our own institution and from across the country. We have embarked on formal and informal education efforts for nurses, as well, and we are striving to provide all members of our team with quality feedback.

Successes

We are fortunate to have had the incredible support of an experienced case manager and talented nursing director in implementing change on the inpatient unit. Together we have decreased length of stay by 500 bed days in 11 months, redesigned morning flow on the wards, and tackled systems challenges. We are proud of our successes in solidifying a sense of identity on the unit, and improving morale for physicians, nurses, and ancillary staff. We are grateful for the continued support of our colleagues in the PICU, on our subspecialty and surgery teams, and on our Kaiser inpatient pediatric service.

Challenges

Progress toward long-term fiscal independence is one of our biggest challenges. Hospitalists are salaried through hospital and school of medicine funds; like most academic programs with teaching missions, ours will need continued support.

Marketing efforts are underway to facilitate excellent communication with our referring physicians, improve access to care at our institution, and improve payer mix.

Future Directions

We are excited about the continued development of our young program. We are working on increasing collaboration with our subspecialty and surgical colleagues, as well as using evidence-based methods to implement additional best-practice guidelines. We are about to launch our new computer program for notes, billing, and data collection, with hopes of continuing to document decreases in length of stay and other financial benefits for the hospital. We are enthusiastic about implementing competency-based education and evaluation, and we look forward to interactions with others contributing to the pediatric hospitalist movement.

Contact

Windy Lammers Stevenson, MD

Inpatient Pediatric Service

Doernbecher Children’s Hospital

Oregon Health & Science University

707 SW Gaines St. CDRCP

Portland, Oregon 97239

Phone: 503-494-6513 Fax: 503-494-4953

E-mail: [email protected]

Start Up

2003

Hospitalists

Tracy Bumsted, MD, MPH

Carrie Phillipi, MD, PhD

Windy Lammers Stevenson, MD

General Pediatricians

Cynthia Ferrell, MD, MSEd

Arthur Jaff e, MD

C. Wayne Sells, MD, MPH

Scott Shipman, MD, MPH

Joseph Zenel, MD

The Program

The pediatric inpatient service at Doernbecher Children’s Hospital is a newly formed multidisciplinary team designed to creatively approach the continually evolving challenges of providing excellent inpatient care in the current financial environment.

Three pediatric hospitalists have joined forces with four general pediatricians and an adolescent specialist to assume care for all patients on the general pediatric inpatient service at this tertiary care academic medical center. A pediatric case manager and a nursing director complete our team. The eight board-certified physicians are members of the Division of General Pediatrics in the Department of Pediatrics at Oregon Health & Science University.

Implementation

Our care model was introduced in a step-wise approach over 10 months beginning in the fall of 2003. Subspecialists who had been providing rotating coverage on the general pediatric service were replaced on the wards as each new hospitalist was hired. With staffing now complete, the subspecialists can focus on other clinical and research endeavors. Doernbecher’s open staff policy allows community physicians to admit and follow their own patients; however, most community providers choose to admit their patients to the hospitalist service.

Schedule

The three hospitalists are scheduled in blocks of 3-7 days, each attending the equivalent of 13 weeks per year, weekends included. The general pediatricians provide coverage for the remaining weeks. Average daily census is 6-12, with a peak-season census of 10-16. The hospitalists are the primary attendings for the general pediatric patients and are available for consultation to any of 12 pediatric subspecialty and surgery services, as well as the emergency department. House staff presence allows for nighttime call from home. Additional off-service clinical responsibilities include supervision of resident clinic and attending in the newborn nursery.

Teaching

Our hospitalists are committed to education. We are responsible for the inpatient education of third-year medical students as well as first- and third-year pediatric and family practice residents. We play key roles in clerkship direction. We welcome sub-interns from our own institution and from across the country. We have embarked on formal and informal education efforts for nurses, as well, and we are striving to provide all members of our team with quality feedback.

Successes

We are fortunate to have had the incredible support of an experienced case manager and talented nursing director in implementing change on the inpatient unit. Together we have decreased length of stay by 500 bed days in 11 months, redesigned morning flow on the wards, and tackled systems challenges. We are proud of our successes in solidifying a sense of identity on the unit, and improving morale for physicians, nurses, and ancillary staff. We are grateful for the continued support of our colleagues in the PICU, on our subspecialty and surgery teams, and on our Kaiser inpatient pediatric service.

Challenges

Progress toward long-term fiscal independence is one of our biggest challenges. Hospitalists are salaried through hospital and school of medicine funds; like most academic programs with teaching missions, ours will need continued support.

Marketing efforts are underway to facilitate excellent communication with our referring physicians, improve access to care at our institution, and improve payer mix.

Future Directions

We are excited about the continued development of our young program. We are working on increasing collaboration with our subspecialty and surgical colleagues, as well as using evidence-based methods to implement additional best-practice guidelines. We are about to launch our new computer program for notes, billing, and data collection, with hopes of continuing to document decreases in length of stay and other financial benefits for the hospital. We are enthusiastic about implementing competency-based education and evaluation, and we look forward to interactions with others contributing to the pediatric hospitalist movement.

1. Annane D, Bellissant E, Briegel J, et al. Corticosteroids for severe sepsis and septic shock: a systematic review and metaanalysis. BMJ. 2004;329:480.

Severe sepsis is a common cause of ICU admissions and continues to have mortality rates as high as 30%. As research has evolved, the role of corticosteroids in sepsis has changed. Annane and colleagues systematically reviewed corticosteroid treatment for severe sepsis and septic shock. The authors found 15 randomized trials that evaluated their main outcome of all-cause mortality at 28 days. When these results were pooled there was no significant improvement in mortality (RR 0.98; 0.87 to 1.10). However, the analysis showed very significant heterogeneity, so the authors appropriately performed a sensitivity analysis based on an a priori hypothesis that low-dose, long-course steroids (≤ 300 mg hydrocortisone/day and ≥ 5 days) would provide greater benefit than short-course, high-dose corticosteroids. The sensitivity analysis of five studies with low-dose, long-course corticosteroids showed a clear reduction in 28-day mortality (RR 0.80; 0.67 to 0.95) with no heterogeneity. There was no statistically significant difference in GI bleeds, superinfections, and hyperglycemia.

This is a very well-done review, which included an exhaustive search for all available evidence. The authors conclude based on the findings of an individual study in the review that patients with septic shock should undergo adrenal insufficiency testing prior to starting empiric therapy with low-dose hydrocortisone (200-300 mg/day). Hydrocortisone should then be stopped if there is no evidence of adrenal insufficiency. However, none of the studies in this review were limited to patients with adrenal insufficiency. Also, although none of the studies individually showed a statistically significant improvement with corticosteroids, they all favored the steroid treatment group with RRs < 1. Although there is good evidence that septic shock patients with adrenal insufficiency should be treated with corticosteroids, it remains unclear if therapy should be generalized to all septic patients. The ongoing European CORTICUS trial should help answer some of these questions.

2. Baddour L.,Yu, V. and the International Pneumococcal Study Group. Combination antibiotic therapy lowers mortality among severely ill patients with pneumococcal bacteremia. Am J Resp Crit Care Med; 2004;170:440-444.

Three retrospective studies indicate that patients with pneumococcal bacteremia are less likely to die if treated with combination antibiotics. The combination of a beta-lactam and a macrolide appear to be especially protective. Based upon this soft data, multiple societies now recommend combination antibiotic therapy with a beta-lactam and a macrolide as first-line therapy for hospitalized patients with CAP. This large, multi-center, prospective observational study analyzed outcomes for all patients with pneumococcal bacteremia. Critically ill patients were eight times more likely to die than non-critically ill patients (mortality: 54.6% vs. 7.3%, p=0.0001). Combination therapy was defined as any two or more antibiotics used concurrently: multiple different regimens were used. The 14-day mortality difference between pneumococcal bacteremic patients receiving monotherapy vs. those receiving combination therapy was not significant (10.4 vs. 11.5%, p-value not disclosed) However, in critically ill patients, combination antibiotic therapy was associated with a marked decrease in mortality (23.4 vs. 55.3%, p=0.0015).

This study has significant limitations. It is not randomized, combination therapy was broadly defined as any two or more antibiotics, and 16% of critically ill patients received only one antibiotic, a major deviation from the standard of care. Nonetheless, this is the first prospective trial that attempts to ascertain which patients with pneumococcal bacteremia benefit from combination therapy. The marked mortality reduction in critically ill patients who received combination therapy reinforces the current recommendation that septic patients with pneumococcal bacteremia should receive combination therapy. However, these findings also underscore the fact that current guidelines for the treatment of an exceedingly common and serious disease are based upon weak retrospective data. Further randomized prospective trials are needed to determine which patients with pneumococcal pneumonia may actually benefit from combination antimicrobial therapy and what combination is most efficacious.

3. Fernandez-Avilles F, Alsonso J, Castro-Beivas A, et al, on behalf of the GRACIA (Grupo de Analisis de la Cardiopatio Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1). Lancet;2004;364:045-1053

In the last ACC/AHA guidelines for acute myocardial infarction (1999), angioplasty soon after thrombolysis is strongly discouraged (class III) because studies to date showed no significant difference in outcomes and propensity for adverse events, i.e. bleeding. However, as stated in these last recommendations, the benefits of early post-thrombolysis percutaneous transluminal coronary angioplasty (PTCA) with stenting should be reassessed as interventional strategies mature. In the current era of stents and newer antiplatelet therapies, it looks as if now is the time to take another look.

The GRACIA-1 was a randomized, multi-centered trial to assess early intervention following thrombolysis in ST-elevation myocardial infarction (STEMI). Five hundred patients were enrolled and randomized to receive either fibrin-specific thrombolytics alone in the conservative group or thrombolysis combined with early PTCA. The primary endpoint was a combined rate of death, non-fatal reinfarction, or ischemia-induced revascularization at 1 year. Pre-discharge PTCA and stenting in those demonstrating recurrent ischemia in the conservative group (n=52) was analyzed as a secondary endpoint. One-year follow-up was completed in 98% of patients. Both groups had similar major cardiac events at 30 days, with the one-year endpoint demonstrating no difference in mortality. Significant differences were seen in the primary endpoint at one year [23 (9%) in the invasive group vs. 51 (21%) in the conservative group (RR-0.44, 95% CI 0.28-0.70 p=0.00008)].

A major limitation of this study was the low-risk profile of its patients, and the fact that it was not powered to differentiate between mortality and reinfarction. It will be interesting to see if these results are replicated in future studies (CARESS-2005) and their clinical impact on the management of acute myocardial infarction in centers without interventional support.

4. Hitcho EB, Krauss MJ, Birge S, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med.2004;19:732-739.

Falls in hospital patients are common and persistent problems in hospitals across the country, with significant impact on patient safety, morbidity, and health care cost. Previous studies have reported up to 30% of inpatient falls result in injury, with 4-6% resulting in serious injury. Most studies on falls are retrospective reviews. This paper detailed a prospective observational study designed to identify and analyze the patient characteristics or the circumstances that contribute to falls. Using an online adverse event reporting system, patient falls were identified. Once identified, additional data sources, including the patients’ medical records, electronic nursing records, and interviews with patient or family members and nurses, were used to collect information. A total of 183 patients fell during the study period, with 85% of the falls occurring in the patient’s room.

Half of the falls involved bowel or bladder elimination and were more likely to occur in patients over 65 years in age (adjusted odds ratio 2.4; 95% confidence interval 1.1 to 5.3). Most of the falls (59%) occurred during the evening/overnight. 58% of the patients who fell had received agents with central nervous system activity in the 24 hours prior to a fall. 12% of the patients who fell received sedative-hypnotics. Repeat fallers were more likely to be men than women (11/86 [13%] vs 4/97 [4%]; p=0.03). 42% of the falls resulted in some type of injury, ranging from pain/swelling (34%) to cardiac arrest/death (0.5%). In multivariate analysis, only elimination-related falls remained a significant predictor of being injured from a fall (aOR , 2.4; 95% CI 1.1 to 5.3). Interestingly, patients who were confused or disoriented were less likely to be injured than alert and oriented patients (crude OR, 0.5; 95% CI, 0.3 to 0.98). When examined by services, medicine and neurology had the highest fall rate at 6.12 falls per 1000 patient days and had the highest patient-to-nurse ratio of 6.5 and 5.3, respectively.

While specific independent risk factors for prevention of falls could not be determined in this study due to a lack of a control group, their findings are consistent with previously identified risk factors for falling, including weakness, poor cognitive status including medication-related changes, and altered elimination. Potential interventions to prevent falls include toileting schedules for high-risk elderly patients and review of medication lists to minimize centrally acting, psychotropic, or sedating agents.

5. Kagansky N, Knobler H, Rimon E, Ozer Z, Levy S. Safety of anticoagulation therapy in well-informed older patients. Arch Intern Med; 2004;164:2044-2050

Elderly patients are increasingly likely to require long-term anticoagulation. Despite this, physicians often withhold long-term anticoagulation due to perceived risk factors for bleeding, including age, comorbidity, and cognitive or functional impairment.

This combination retrospective and prospective observational study evaluated the safety and quality of anticoagulation in elderly patients. Over a three-year span, 323 elderly patients were discharged on warfarin from a large Israeli hospital. These patients were frail and potentially “at risk”; 54% were older than age 80, 81% were uneducated, and 84% had low income. 47% were considered cognitively intact (according to MMSE) and only 34% were functionally independent. Using a multivariate analysis, the authors determined that only poor quality of anticoagulation education (OR: 8.83; 95% CI: 2.0-50.2), polypharmacy (OR: 6.14; 95% CI 1.2-42.4) and INR >3 (OR: 1.08; 95% CI 1.03-1.14) were associated with major bleeding.

This study of a “real world” population of frail, at-risk elderly patients provides important insights into risks for major bleeding resulting from warfarin therapy. Surprisingly, advanced age, cognitive impairment and markers for frailty did not confer elevated risk for major bleeding. Importantly, the study did not explicitly address patient fall risk, an often-cited reason for withholding anticoagulation therapy. Supratherapeutic anticoagulation is associated with a statistically but not clinically significant bleeding risk. Polypharmacy is increasingly unavoidable in elderly patients. However, appropriate anticoagulation therapy should be the standard of care. This study makes it clear that we need to focus our efforts on ensuring that elderly patients and their caregivers receive appropriate anticoagulation education prior to discharge from the hospital.

6. Prinssen M, Verhoeven E, Buth J, et al. A Randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. NEJM. 2004;351:1607-18.

Endovascular repair of abdominal aortic aneurysm, which involves percutaneous introduction of a graft to bridge an aortic aneurysm, has been available since the early 1990s. This procedure was initially used in patients who were felt to be at high risk for the traditional open procedure. This selection bias may have affected the outcome of earlier studies. Therefore, the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was designed to assess outcomes in patients deemed fit to undergo either open or endovascular repair. The study was conducted at 24 centers in the Netherlands and four centers in Belgium. Three hundred and forty-five patients had abdominal aortic aneurysms of at least 5 cm and were considered eligible for either open or endovascular repair. Patients were then randomized to undergo one procedure or the other.

Surgeons experienced in both endovascular and open repair performed the procedures. Primary outcomes were 30-day mortality (defined as death during the primary hospital admission or within 30 days), severe complications, and the combination of the two. The operative mortality rate was 4.6% in the open-repair group and 1.2% in the endovascular repair group, with a risk ratio of 3.9 (95% CI, 0.9-32.9). The combined endpoint of mortality and severe complication was 9.8% in the open-repair group and 4.7% in the endovascular repair group, with a risk ratio of 2.1 (95% CI, 0.9 to 5.4). It should be noted that 90% of study patients were men. These findings indicate that endovascular repair of aortic aneurysm results in less short-term morbidity and mortality than open repair. Larger studies with longer follow up are indicated.

7. Spargias K, Alexopoulos E, Kyrzopoulos S. Ascorbic acid prevents contrast-mediated nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation.110(18)2837-42

In this study, a team of Greek researchers studied the use of vitamin C in patients with renal insufficiency (creatinine >1.2) undergoing coronary catheterization or intervention to determine if it prevented contrast-mediated nephropathy (CMN). Although the etiology of CMN is unknown, ischemic insults to the renal medulla and free radical release have been implicated. Since vitamin C has been shown in animal studies to attenuate nephropathy when administered with known renal toxins, a similar effect was postulated when administered with IV contrast.

Two hundred and twenty patients electively admitted for coronary catheterization or intervention were randomized to placebo or to receive 3 grams of vitamin C 2 hours prior to the dye load followed by 2 gm that night and the morning after. The two groups were balanced for presence of hypertension, diabetes, tobacco use, and use of commonly prescribed medications. Intravenous hydration was given to all at variable rates depending on left ventricular ejection fraction. The catheterization team chose the type of contrast agent. Creatinine was measured at baseline (up to 3 months prior to dye load) and 2-5 days afterwards. CMN was defined as a rise in total serum creatinine by 0.5 mg/dL or by 25%. Using these criteria, 9% of the vitamin C group developed CMN as opposed to 20% in the controls (NNT 9; 95% CI: 5-53). Logistical regression was performed to account for differences in age, initial serum creatinine, or both, and always yielded significant differences. The treatment group was slightly older, had higher rates of isoosmolar contrast administration (reno-protective), and had slightly higher baseline creatinines, so the true protective effect was thought even higher than reported.

This study is limited by small sample size, an overwhelmingly male patient base (90%), and the suspected presence of atherosclerotic heart disease in all patients. The amount and rate of delivery of contrast was not noted. The vitamin C preparation used was not described, implying that all preparations were bioequivalent. No mention was made of whether these results could be extrapolated to other procedures involving contrast. Given the low cost and high tolerability of vitamin C, however, further studies would certainly be welcome.

8. Yadav J, Wholey M, Kuntz R, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. NEJM.2004;351:1493-1501.

Carotid angioplasty has been available for the past decade, but, due to possible complications such as plaque embolization and stent compression, the procedure had been limited to patients unsuitable for surgical endarterectomy. Recently, the introduction of crush-resistant nitinol stents and emboli protection devices has made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year.

1. Annane D, Bellissant E, Briegel J, et al. Corticosteroids for severe sepsis and septic shock: a systematic review and metaanalysis. BMJ. 2004;329:480.

Severe sepsis is a common cause of ICU admissions and continues to have mortality rates as high as 30%. As research has evolved, the role of corticosteroids in sepsis has changed. Annane and colleagues systematically reviewed corticosteroid treatment for severe sepsis and septic shock. The authors found 15 randomized trials that evaluated their main outcome of all-cause mortality at 28 days. When these results were pooled there was no significant improvement in mortality (RR 0.98; 0.87 to 1.10). However, the analysis showed very significant heterogeneity, so the authors appropriately performed a sensitivity analysis based on an a priori hypothesis that low-dose, long-course steroids (≤ 300 mg hydrocortisone/day and ≥ 5 days) would provide greater benefit than short-course, high-dose corticosteroids. The sensitivity analysis of five studies with low-dose, long-course corticosteroids showed a clear reduction in 28-day mortality (RR 0.80; 0.67 to 0.95) with no heterogeneity. There was no statistically significant difference in GI bleeds, superinfections, and hyperglycemia.

This is a very well-done review, which included an exhaustive search for all available evidence. The authors conclude based on the findings of an individual study in the review that patients with septic shock should undergo adrenal insufficiency testing prior to starting empiric therapy with low-dose hydrocortisone (200-300 mg/day). Hydrocortisone should then be stopped if there is no evidence of adrenal insufficiency. However, none of the studies in this review were limited to patients with adrenal insufficiency. Also, although none of the studies individually showed a statistically significant improvement with corticosteroids, they all favored the steroid treatment group with RRs < 1. Although there is good evidence that septic shock patients with adrenal insufficiency should be treated with corticosteroids, it remains unclear if therapy should be generalized to all septic patients. The ongoing European CORTICUS trial should help answer some of these questions.

2. Baddour L.,Yu, V. and the International Pneumococcal Study Group. Combination antibiotic therapy lowers mortality among severely ill patients with pneumococcal bacteremia. Am J Resp Crit Care Med; 2004;170:440-444.

Three retrospective studies indicate that patients with pneumococcal bacteremia are less likely to die if treated with combination antibiotics. The combination of a beta-lactam and a macrolide appear to be especially protective. Based upon this soft data, multiple societies now recommend combination antibiotic therapy with a beta-lactam and a macrolide as first-line therapy for hospitalized patients with CAP. This large, multi-center, prospective observational study analyzed outcomes for all patients with pneumococcal bacteremia. Critically ill patients were eight times more likely to die than non-critically ill patients (mortality: 54.6% vs. 7.3%, p=0.0001). Combination therapy was defined as any two or more antibiotics used concurrently: multiple different regimens were used. The 14-day mortality difference between pneumococcal bacteremic patients receiving monotherapy vs. those receiving combination therapy was not significant (10.4 vs. 11.5%, p-value not disclosed) However, in critically ill patients, combination antibiotic therapy was associated with a marked decrease in mortality (23.4 vs. 55.3%, p=0.0015).

This study has significant limitations. It is not randomized, combination therapy was broadly defined as any two or more antibiotics, and 16% of critically ill patients received only one antibiotic, a major deviation from the standard of care. Nonetheless, this is the first prospective trial that attempts to ascertain which patients with pneumococcal bacteremia benefit from combination therapy. The marked mortality reduction in critically ill patients who received combination therapy reinforces the current recommendation that septic patients with pneumococcal bacteremia should receive combination therapy. However, these findings also underscore the fact that current guidelines for the treatment of an exceedingly common and serious disease are based upon weak retrospective data. Further randomized prospective trials are needed to determine which patients with pneumococcal pneumonia may actually benefit from combination antimicrobial therapy and what combination is most efficacious.

3. Fernandez-Avilles F, Alsonso J, Castro-Beivas A, et al, on behalf of the GRACIA (Grupo de Analisis de la Cardiopatio Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1). Lancet;2004;364:045-1053

In the last ACC/AHA guidelines for acute myocardial infarction (1999), angioplasty soon after thrombolysis is strongly discouraged (class III) because studies to date showed no significant difference in outcomes and propensity for adverse events, i.e. bleeding. However, as stated in these last recommendations, the benefits of early post-thrombolysis percutaneous transluminal coronary angioplasty (PTCA) with stenting should be reassessed as interventional strategies mature. In the current era of stents and newer antiplatelet therapies, it looks as if now is the time to take another look.

The GRACIA-1 was a randomized, multi-centered trial to assess early intervention following thrombolysis in ST-elevation myocardial infarction (STEMI). Five hundred patients were enrolled and randomized to receive either fibrin-specific thrombolytics alone in the conservative group or thrombolysis combined with early PTCA. The primary endpoint was a combined rate of death, non-fatal reinfarction, or ischemia-induced revascularization at 1 year. Pre-discharge PTCA and stenting in those demonstrating recurrent ischemia in the conservative group (n=52) was analyzed as a secondary endpoint. One-year follow-up was completed in 98% of patients. Both groups had similar major cardiac events at 30 days, with the one-year endpoint demonstrating no difference in mortality. Significant differences were seen in the primary endpoint at one year [23 (9%) in the invasive group vs. 51 (21%) in the conservative group (RR-0.44, 95% CI 0.28-0.70 p=0.00008)].

A major limitation of this study was the low-risk profile of its patients, and the fact that it was not powered to differentiate between mortality and reinfarction. It will be interesting to see if these results are replicated in future studies (CARESS-2005) and their clinical impact on the management of acute myocardial infarction in centers without interventional support.

4. Hitcho EB, Krauss MJ, Birge S, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med.2004;19:732-739.

Falls in hospital patients are common and persistent problems in hospitals across the country, with significant impact on patient safety, morbidity, and health care cost. Previous studies have reported up to 30% of inpatient falls result in injury, with 4-6% resulting in serious injury. Most studies on falls are retrospective reviews. This paper detailed a prospective observational study designed to identify and analyze the patient characteristics or the circumstances that contribute to falls. Using an online adverse event reporting system, patient falls were identified. Once identified, additional data sources, including the patients’ medical records, electronic nursing records, and interviews with patient or family members and nurses, were used to collect information. A total of 183 patients fell during the study period, with 85% of the falls occurring in the patient’s room.

Half of the falls involved bowel or bladder elimination and were more likely to occur in patients over 65 years in age (adjusted odds ratio 2.4; 95% confidence interval 1.1 to 5.3). Most of the falls (59%) occurred during the evening/overnight. 58% of the patients who fell had received agents with central nervous system activity in the 24 hours prior to a fall. 12% of the patients who fell received sedative-hypnotics. Repeat fallers were more likely to be men than women (11/86 [13%] vs 4/97 [4%]; p=0.03). 42% of the falls resulted in some type of injury, ranging from pain/swelling (34%) to cardiac arrest/death (0.5%). In multivariate analysis, only elimination-related falls remained a significant predictor of being injured from a fall (aOR , 2.4; 95% CI 1.1 to 5.3). Interestingly, patients who were confused or disoriented were less likely to be injured than alert and oriented patients (crude OR, 0.5; 95% CI, 0.3 to 0.98). When examined by services, medicine and neurology had the highest fall rate at 6.12 falls per 1000 patient days and had the highest patient-to-nurse ratio of 6.5 and 5.3, respectively.

While specific independent risk factors for prevention of falls could not be determined in this study due to a lack of a control group, their findings are consistent with previously identified risk factors for falling, including weakness, poor cognitive status including medication-related changes, and altered elimination. Potential interventions to prevent falls include toileting schedules for high-risk elderly patients and review of medication lists to minimize centrally acting, psychotropic, or sedating agents.

5. Kagansky N, Knobler H, Rimon E, Ozer Z, Levy S. Safety of anticoagulation therapy in well-informed older patients. Arch Intern Med; 2004;164:2044-2050

Elderly patients are increasingly likely to require long-term anticoagulation. Despite this, physicians often withhold long-term anticoagulation due to perceived risk factors for bleeding, including age, comorbidity, and cognitive or functional impairment.

This combination retrospective and prospective observational study evaluated the safety and quality of anticoagulation in elderly patients. Over a three-year span, 323 elderly patients were discharged on warfarin from a large Israeli hospital. These patients were frail and potentially “at risk”; 54% were older than age 80, 81% were uneducated, and 84% had low income. 47% were considered cognitively intact (according to MMSE) and only 34% were functionally independent. Using a multivariate analysis, the authors determined that only poor quality of anticoagulation education (OR: 8.83; 95% CI: 2.0-50.2), polypharmacy (OR: 6.14; 95% CI 1.2-42.4) and INR >3 (OR: 1.08; 95% CI 1.03-1.14) were associated with major bleeding.

This study of a “real world” population of frail, at-risk elderly patients provides important insights into risks for major bleeding resulting from warfarin therapy. Surprisingly, advanced age, cognitive impairment and markers for frailty did not confer elevated risk for major bleeding. Importantly, the study did not explicitly address patient fall risk, an often-cited reason for withholding anticoagulation therapy. Supratherapeutic anticoagulation is associated with a statistically but not clinically significant bleeding risk. Polypharmacy is increasingly unavoidable in elderly patients. However, appropriate anticoagulation therapy should be the standard of care. This study makes it clear that we need to focus our efforts on ensuring that elderly patients and their caregivers receive appropriate anticoagulation education prior to discharge from the hospital.

6. Prinssen M, Verhoeven E, Buth J, et al. A Randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. NEJM. 2004;351:1607-18.

Endovascular repair of abdominal aortic aneurysm, which involves percutaneous introduction of a graft to bridge an aortic aneurysm, has been available since the early 1990s. This procedure was initially used in patients who were felt to be at high risk for the traditional open procedure. This selection bias may have affected the outcome of earlier studies. Therefore, the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was designed to assess outcomes in patients deemed fit to undergo either open or endovascular repair. The study was conducted at 24 centers in the Netherlands and four centers in Belgium. Three hundred and forty-five patients had abdominal aortic aneurysms of at least 5 cm and were considered eligible for either open or endovascular repair. Patients were then randomized to undergo one procedure or the other.

Surgeons experienced in both endovascular and open repair performed the procedures. Primary outcomes were 30-day mortality (defined as death during the primary hospital admission or within 30 days), severe complications, and the combination of the two. The operative mortality rate was 4.6% in the open-repair group and 1.2% in the endovascular repair group, with a risk ratio of 3.9 (95% CI, 0.9-32.9). The combined endpoint of mortality and severe complication was 9.8% in the open-repair group and 4.7% in the endovascular repair group, with a risk ratio of 2.1 (95% CI, 0.9 to 5.4). It should be noted that 90% of study patients were men. These findings indicate that endovascular repair of aortic aneurysm results in less short-term morbidity and mortality than open repair. Larger studies with longer follow up are indicated.

7. Spargias K, Alexopoulos E, Kyrzopoulos S. Ascorbic acid prevents contrast-mediated nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation.110(18)2837-42

In this study, a team of Greek researchers studied the use of vitamin C in patients with renal insufficiency (creatinine >1.2) undergoing coronary catheterization or intervention to determine if it prevented contrast-mediated nephropathy (CMN). Although the etiology of CMN is unknown, ischemic insults to the renal medulla and free radical release have been implicated. Since vitamin C has been shown in animal studies to attenuate nephropathy when administered with known renal toxins, a similar effect was postulated when administered with IV contrast.

Two hundred and twenty patients electively admitted for coronary catheterization or intervention were randomized to placebo or to receive 3 grams of vitamin C 2 hours prior to the dye load followed by 2 gm that night and the morning after. The two groups were balanced for presence of hypertension, diabetes, tobacco use, and use of commonly prescribed medications. Intravenous hydration was given to all at variable rates depending on left ventricular ejection fraction. The catheterization team chose the type of contrast agent. Creatinine was measured at baseline (up to 3 months prior to dye load) and 2-5 days afterwards. CMN was defined as a rise in total serum creatinine by 0.5 mg/dL or by 25%. Using these criteria, 9% of the vitamin C group developed CMN as opposed to 20% in the controls (NNT 9; 95% CI: 5-53). Logistical regression was performed to account for differences in age, initial serum creatinine, or both, and always yielded significant differences. The treatment group was slightly older, had higher rates of isoosmolar contrast administration (reno-protective), and had slightly higher baseline creatinines, so the true protective effect was thought even higher than reported.

This study is limited by small sample size, an overwhelmingly male patient base (90%), and the suspected presence of atherosclerotic heart disease in all patients. The amount and rate of delivery of contrast was not noted. The vitamin C preparation used was not described, implying that all preparations were bioequivalent. No mention was made of whether these results could be extrapolated to other procedures involving contrast. Given the low cost and high tolerability of vitamin C, however, further studies would certainly be welcome.

8. Yadav J, Wholey M, Kuntz R, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. NEJM.2004;351:1493-1501.

Carotid angioplasty has been available for the past decade, but, due to possible complications such as plaque embolization and stent compression, the procedure had been limited to patients unsuitable for surgical endarterectomy. Recently, the introduction of crush-resistant nitinol stents and emboli protection devices has made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year.

1. Annane D, Bellissant E, Briegel J, et al. Corticosteroids for severe sepsis and septic shock: a systematic review and metaanalysis. BMJ. 2004;329:480.

Severe sepsis is a common cause of ICU admissions and continues to have mortality rates as high as 30%. As research has evolved, the role of corticosteroids in sepsis has changed. Annane and colleagues systematically reviewed corticosteroid treatment for severe sepsis and septic shock. The authors found 15 randomized trials that evaluated their main outcome of all-cause mortality at 28 days. When these results were pooled there was no significant improvement in mortality (RR 0.98; 0.87 to 1.10). However, the analysis showed very significant heterogeneity, so the authors appropriately performed a sensitivity analysis based on an a priori hypothesis that low-dose, long-course steroids (≤ 300 mg hydrocortisone/day and ≥ 5 days) would provide greater benefit than short-course, high-dose corticosteroids. The sensitivity analysis of five studies with low-dose, long-course corticosteroids showed a clear reduction in 28-day mortality (RR 0.80; 0.67 to 0.95) with no heterogeneity. There was no statistically significant difference in GI bleeds, superinfections, and hyperglycemia.

This is a very well-done review, which included an exhaustive search for all available evidence. The authors conclude based on the findings of an individual study in the review that patients with septic shock should undergo adrenal insufficiency testing prior to starting empiric therapy with low-dose hydrocortisone (200-300 mg/day). Hydrocortisone should then be stopped if there is no evidence of adrenal insufficiency. However, none of the studies in this review were limited to patients with adrenal insufficiency. Also, although none of the studies individually showed a statistically significant improvement with corticosteroids, they all favored the steroid treatment group with RRs < 1. Although there is good evidence that septic shock patients with adrenal insufficiency should be treated with corticosteroids, it remains unclear if therapy should be generalized to all septic patients. The ongoing European CORTICUS trial should help answer some of these questions.

2. Baddour L.,Yu, V. and the International Pneumococcal Study Group. Combination antibiotic therapy lowers mortality among severely ill patients with pneumococcal bacteremia. Am J Resp Crit Care Med; 2004;170:440-444.

Three retrospective studies indicate that patients with pneumococcal bacteremia are less likely to die if treated with combination antibiotics. The combination of a beta-lactam and a macrolide appear to be especially protective. Based upon this soft data, multiple societies now recommend combination antibiotic therapy with a beta-lactam and a macrolide as first-line therapy for hospitalized patients with CAP. This large, multi-center, prospective observational study analyzed outcomes for all patients with pneumococcal bacteremia. Critically ill patients were eight times more likely to die than non-critically ill patients (mortality: 54.6% vs. 7.3%, p=0.0001). Combination therapy was defined as any two or more antibiotics used concurrently: multiple different regimens were used. The 14-day mortality difference between pneumococcal bacteremic patients receiving monotherapy vs. those receiving combination therapy was not significant (10.4 vs. 11.5%, p-value not disclosed) However, in critically ill patients, combination antibiotic therapy was associated with a marked decrease in mortality (23.4 vs. 55.3%, p=0.0015).

This study has significant limitations. It is not randomized, combination therapy was broadly defined as any two or more antibiotics, and 16% of critically ill patients received only one antibiotic, a major deviation from the standard of care. Nonetheless, this is the first prospective trial that attempts to ascertain which patients with pneumococcal bacteremia benefit from combination therapy. The marked mortality reduction in critically ill patients who received combination therapy reinforces the current recommendation that septic patients with pneumococcal bacteremia should receive combination therapy. However, these findings also underscore the fact that current guidelines for the treatment of an exceedingly common and serious disease are based upon weak retrospective data. Further randomized prospective trials are needed to determine which patients with pneumococcal pneumonia may actually benefit from combination antimicrobial therapy and what combination is most efficacious.

3. Fernandez-Avilles F, Alsonso J, Castro-Beivas A, et al, on behalf of the GRACIA (Grupo de Analisis de la Cardiopatio Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1). Lancet;2004;364:045-1053

In the last ACC/AHA guidelines for acute myocardial infarction (1999), angioplasty soon after thrombolysis is strongly discouraged (class III) because studies to date showed no significant difference in outcomes and propensity for adverse events, i.e. bleeding. However, as stated in these last recommendations, the benefits of early post-thrombolysis percutaneous transluminal coronary angioplasty (PTCA) with stenting should be reassessed as interventional strategies mature. In the current era of stents and newer antiplatelet therapies, it looks as if now is the time to take another look.

The GRACIA-1 was a randomized, multi-centered trial to assess early intervention following thrombolysis in ST-elevation myocardial infarction (STEMI). Five hundred patients were enrolled and randomized to receive either fibrin-specific thrombolytics alone in the conservative group or thrombolysis combined with early PTCA. The primary endpoint was a combined rate of death, non-fatal reinfarction, or ischemia-induced revascularization at 1 year. Pre-discharge PTCA and stenting in those demonstrating recurrent ischemia in the conservative group (n=52) was analyzed as a secondary endpoint. One-year follow-up was completed in 98% of patients. Both groups had similar major cardiac events at 30 days, with the one-year endpoint demonstrating no difference in mortality. Significant differences were seen in the primary endpoint at one year [23 (9%) in the invasive group vs. 51 (21%) in the conservative group (RR-0.44, 95% CI 0.28-0.70 p=0.00008)].

A major limitation of this study was the low-risk profile of its patients, and the fact that it was not powered to differentiate between mortality and reinfarction. It will be interesting to see if these results are replicated in future studies (CARESS-2005) and their clinical impact on the management of acute myocardial infarction in centers without interventional support.

4. Hitcho EB, Krauss MJ, Birge S, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med.2004;19:732-739.

Falls in hospital patients are common and persistent problems in hospitals across the country, with significant impact on patient safety, morbidity, and health care cost. Previous studies have reported up to 30% of inpatient falls result in injury, with 4-6% resulting in serious injury. Most studies on falls are retrospective reviews. This paper detailed a prospective observational study designed to identify and analyze the patient characteristics or the circumstances that contribute to falls. Using an online adverse event reporting system, patient falls were identified. Once identified, additional data sources, including the patients’ medical records, electronic nursing records, and interviews with patient or family members and nurses, were used to collect information. A total of 183 patients fell during the study period, with 85% of the falls occurring in the patient’s room.

Half of the falls involved bowel or bladder elimination and were more likely to occur in patients over 65 years in age (adjusted odds ratio 2.4; 95% confidence interval 1.1 to 5.3). Most of the falls (59%) occurred during the evening/overnight. 58% of the patients who fell had received agents with central nervous system activity in the 24 hours prior to a fall. 12% of the patients who fell received sedative-hypnotics. Repeat fallers were more likely to be men than women (11/86 [13%] vs 4/97 [4%]; p=0.03). 42% of the falls resulted in some type of injury, ranging from pain/swelling (34%) to cardiac arrest/death (0.5%). In multivariate analysis, only elimination-related falls remained a significant predictor of being injured from a fall (aOR , 2.4; 95% CI 1.1 to 5.3). Interestingly, patients who were confused or disoriented were less likely to be injured than alert and oriented patients (crude OR, 0.5; 95% CI, 0.3 to 0.98). When examined by services, medicine and neurology had the highest fall rate at 6.12 falls per 1000 patient days and had the highest patient-to-nurse ratio of 6.5 and 5.3, respectively.

While specific independent risk factors for prevention of falls could not be determined in this study due to a lack of a control group, their findings are consistent with previously identified risk factors for falling, including weakness, poor cognitive status including medication-related changes, and altered elimination. Potential interventions to prevent falls include toileting schedules for high-risk elderly patients and review of medication lists to minimize centrally acting, psychotropic, or sedating agents.

5. Kagansky N, Knobler H, Rimon E, Ozer Z, Levy S. Safety of anticoagulation therapy in well-informed older patients. Arch Intern Med; 2004;164:2044-2050

Elderly patients are increasingly likely to require long-term anticoagulation. Despite this, physicians often withhold long-term anticoagulation due to perceived risk factors for bleeding, including age, comorbidity, and cognitive or functional impairment.

This combination retrospective and prospective observational study evaluated the safety and quality of anticoagulation in elderly patients. Over a three-year span, 323 elderly patients were discharged on warfarin from a large Israeli hospital. These patients were frail and potentially “at risk”; 54% were older than age 80, 81% were uneducated, and 84% had low income. 47% were considered cognitively intact (according to MMSE) and only 34% were functionally independent. Using a multivariate analysis, the authors determined that only poor quality of anticoagulation education (OR: 8.83; 95% CI: 2.0-50.2), polypharmacy (OR: 6.14; 95% CI 1.2-42.4) and INR >3 (OR: 1.08; 95% CI 1.03-1.14) were associated with major bleeding.

This study of a “real world” population of frail, at-risk elderly patients provides important insights into risks for major bleeding resulting from warfarin therapy. Surprisingly, advanced age, cognitive impairment and markers for frailty did not confer elevated risk for major bleeding. Importantly, the study did not explicitly address patient fall risk, an often-cited reason for withholding anticoagulation therapy. Supratherapeutic anticoagulation is associated with a statistically but not clinically significant bleeding risk. Polypharmacy is increasingly unavoidable in elderly patients. However, appropriate anticoagulation therapy should be the standard of care. This study makes it clear that we need to focus our efforts on ensuring that elderly patients and their caregivers receive appropriate anticoagulation education prior to discharge from the hospital.

6. Prinssen M, Verhoeven E, Buth J, et al. A Randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. NEJM. 2004;351:1607-18.

Endovascular repair of abdominal aortic aneurysm, which involves percutaneous introduction of a graft to bridge an aortic aneurysm, has been available since the early 1990s. This procedure was initially used in patients who were felt to be at high risk for the traditional open procedure. This selection bias may have affected the outcome of earlier studies. Therefore, the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was designed to assess outcomes in patients deemed fit to undergo either open or endovascular repair. The study was conducted at 24 centers in the Netherlands and four centers in Belgium. Three hundred and forty-five patients had abdominal aortic aneurysms of at least 5 cm and were considered eligible for either open or endovascular repair. Patients were then randomized to undergo one procedure or the other.

Surgeons experienced in both endovascular and open repair performed the procedures. Primary outcomes were 30-day mortality (defined as death during the primary hospital admission or within 30 days), severe complications, and the combination of the two. The operative mortality rate was 4.6% in the open-repair group and 1.2% in the endovascular repair group, with a risk ratio of 3.9 (95% CI, 0.9-32.9). The combined endpoint of mortality and severe complication was 9.8% in the open-repair group and 4.7% in the endovascular repair group, with a risk ratio of 2.1 (95% CI, 0.9 to 5.4). It should be noted that 90% of study patients were men. These findings indicate that endovascular repair of aortic aneurysm results in less short-term morbidity and mortality than open repair. Larger studies with longer follow up are indicated.

7. Spargias K, Alexopoulos E, Kyrzopoulos S. Ascorbic acid prevents contrast-mediated nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation.110(18)2837-42

In this study, a team of Greek researchers studied the use of vitamin C in patients with renal insufficiency (creatinine >1.2) undergoing coronary catheterization or intervention to determine if it prevented contrast-mediated nephropathy (CMN). Although the etiology of CMN is unknown, ischemic insults to the renal medulla and free radical release have been implicated. Since vitamin C has been shown in animal studies to attenuate nephropathy when administered with known renal toxins, a similar effect was postulated when administered with IV contrast.

Two hundred and twenty patients electively admitted for coronary catheterization or intervention were randomized to placebo or to receive 3 grams of vitamin C 2 hours prior to the dye load followed by 2 gm that night and the morning after. The two groups were balanced for presence of hypertension, diabetes, tobacco use, and use of commonly prescribed medications. Intravenous hydration was given to all at variable rates depending on left ventricular ejection fraction. The catheterization team chose the type of contrast agent. Creatinine was measured at baseline (up to 3 months prior to dye load) and 2-5 days afterwards. CMN was defined as a rise in total serum creatinine by 0.5 mg/dL or by 25%. Using these criteria, 9% of the vitamin C group developed CMN as opposed to 20% in the controls (NNT 9; 95% CI: 5-53). Logistical regression was performed to account for differences in age, initial serum creatinine, or both, and always yielded significant differences. The treatment group was slightly older, had higher rates of isoosmolar contrast administration (reno-protective), and had slightly higher baseline creatinines, so the true protective effect was thought even higher than reported.

This study is limited by small sample size, an overwhelmingly male patient base (90%), and the suspected presence of atherosclerotic heart disease in all patients. The amount and rate of delivery of contrast was not noted. The vitamin C preparation used was not described, implying that all preparations were bioequivalent. No mention was made of whether these results could be extrapolated to other procedures involving contrast. Given the low cost and high tolerability of vitamin C, however, further studies would certainly be welcome.

8. Yadav J, Wholey M, Kuntz R, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. NEJM.2004;351:1493-1501.

Carotid angioplasty has been available for the past decade, but, due to possible complications such as plaque embolization and stent compression, the procedure had been limited to patients unsuitable for surgical endarterectomy. Recently, the introduction of crush-resistant nitinol stents and emboli protection devices has made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year made the procedure safer. This study was designed to test the hypothesis that angioplasty and stenting is not inferior to endarterectomy. Three hundred and thirty-four patients at 29 centers had either a symptomatic carotid lesion greater than 50% or asymptomatic lesion greater than 80% and were deemed to be suitable candidates for either carotid endarterectomy or angioplasty. Patients were then randomized to one of the treatment groups. Surgeons, cardiologists, or interventional radiologists performed angioplasty. The primary endpoint was a composite of death, stroke, or MI within 30 days of the procedure, or death or stroke between 31 days and one year.

Secondary endpoints were the need for revascularization and cranial-nerve palsy at one year. During the first month after procedure, 4.8% of patients in the stent group and 9.8% of patients in the surgical group reached the primary endpoint. In the subsequent year, 12.2% of stent patients and 20.1% of surgical patients reached the primary endpoint (absolute risk reduction of 7.9, CI 0.7-16.4 and NNT 14). Cranial nerve palsy at one year was 0% vs. 4.9% in the stent vs. surgical group. Need for revascularization at one year was 0.6% vs. 4.3% for stent vs. surgical group. Although this study was designed to show the non-inferiority of angioplasty vs. carotid endarterectomy in patients deemed suitable for either procedure, it actually was statistically significant for superiority of stenting. It also implied a lower complication rate in terms of cranial nerve palsy and the need for revascularization at one year.

Contact Information

Stacy Goldsholl, MD, BC IM (1/03-present)

Medical Director, Covenant Healthcare Hospital Medicine Program

[email protected]

Covenant Healthcare

1447 North Harrison

Saginaw, MI 48602

Holly Krenz

Hospitalist Support Associate

[email protected]

Phone: 989-583-4220

Fax: 989-583-4287

Start Up

May 2003

Hospitals Served

Covenant HealthCare, Saginaw, Michigan

Physician Staff

Abdo Alward, MD, BC IM (8/04)

Anu Gollapudi, MD, BC IM (5/03)

Noel Lucas, DO, BC IM (5/03)

Iris Mangulabnan, MD BC IM (8/03)

Hassan Nasser, MD, BC IM (5/03-5/04)

Sayed Naqvi, MD, BC IM (4/04)

Shelene Ruggio, MD, BC, IM (9/03)

Devanshu Thakore, MD, BC FP (7/03-8/04)

Support Staff

Holly Krenz, Hospitalist Support Associate

Mary Burr, Certified Coder

Physician Training

Eight of the physicians are board certified in internal medicine; one is board certified in family practice.

The Health System

Covenant HealthCare is a nonprofit regional tertiary health care system serving 18 counties throughout East Central Michigan, offering high-quality medical care with 20 inpatient and outpatient facilities, including two acute care hospitals with 643 licensed beds and 40 adult critical care beds, 20 short-term skilled nursing beds, and 41 inpatient rehabilitation beds. A 30-bed long-term acute care hospital also rents space on the hospital main campus. Covenant’s new state-of-the-science Emergency Care Center provides critical and trauma care with an annual volume in excess of 73,000 patient visits and offers a helicopter service that was added in January 2004. Additionally, Covenant provides comprehensive medical services in cardiovascular, neurosciences, surgery, orthopedics, obstetrics, and all ancillary services. Covenant HealthCare also features Michigan’s northernmost regional neonatal and pediatric/pediatric intensive care units to serve the needs of children.

As Michigan’s sixth largest hospital and most comprehensive health care facility north of Detroit, Covenant HealthCare has been nationally recognized for its superior service, having received such distinctions as a Solucient Top 100 Hospital for cardiac care and orthopedics from 1999 to 2003. Covenant is the recipient of the 2003 Governor’s Award of Excellence for Improving Care in the Hospital and Emergency Department for Heart Attack, Heart Failure, and Pneumonia, and is a five-time recipient of the National Research Corporation’s Consumer’s Choice Award. Covenant HealthCare ranks among the top 5% of hospitals its size nationwide for patient satisfaction.

Employment Arrangement

All of the physicians and staff are employed by Covenant HealthCare. Pediatric services for the pediatric patients of the family practice physicians utilizing the hospitalist program are provided by a contractual arrangement with Synergy Medical Alliance Family Practice residency program, an affiliate of Michigan State University.

Management and Operational Structure

An on-site Medical Director is responsible for all administrative aspects of the Hospital Medicine Program. Clinical responsibilities vary according to the service needs. The Medical Director reports to the Vice President of Medical Affairs. All team members report directly to the program’s Medical Director.

A full-time support associate (M-F) is responsible for all communications with primary care physicians, other hospital departments, and general office maintenance. A part-time certified coder is available twice weekly for charge capture reconciliation, billing, and documentation audit and physician education.

Multidisciplinary rounds are conducted daily (M-F) at 9 a.m. with all rounding physicians, the program director, case managers, and liaisons from skilled nursing, inpatient rehabilitation units, and home health/hospice. During this time, patient status is updated, and discharge planning is initiated. Case managers also bring non-hospitalist patient medical necessity reviews to the director/hospitalists who also serve as physician advisors to case management.

Staffing

The CHC Hospital Medicine Program is a 24-hour in-house service that operates in a shift-based (7a-7p) block model. There is one nocturnalist that covers 15 night shifts per month. Hospitalists are scheduled 15-18 12-hour shifts per month and are paid for additional shift coverage. Sign-in/out is face-to-face at 7 a.m. and 7 p.m. Day-time shifts are covered by two physicians 7 days per week, with an additional 0.5 FTE available M-F (medical director). Night shifts have single-physician coverage. Beginning in January 2005, day-time coverage will expand by one FTE.

Compensation/Benefits

All physicians are salaried. An annual bonus of up to 10% base salary is available at each physician’s anniversary date. The bonus is based heavily upon quality/FCCS certification (30%), team and referral physician satisfaction (20%), Press Ganey Patient-Physician Satisfaction scores (15%), and operational efficiency/organizational benefit (35%).

Standard benefits are provided, including malpractice coverage with tail, health, dental, vision, life insurance, 403b and 457b plans, short- and long-term disability. CME/Professional fee allowances of $3000 are provided. Initially, all physicians received 37 days of paid time off while contracting for 18 shifts/month. This has evolved into a 15-shifts/month schedule with no additional PTO.

Patient Census/Population

Patients are admitted to the Covenant HealthCare Hospital Medicine Service from three main avenues: unassigned emergency department admissions, private admitting relationships, and direct regional referrals. The hospitalists cover approximately 85% off all ED unassigned admissions. In addition, the service admits exclusively (all-or-none) for 35 local and regional primary care physicians. Covenant HealthCare serves as the tertiary referral for a number of small rural and critical access hospitals. These regional partners have ease of access with a “one pager” call number for the admitting hospitalist. Additionally, the hospitalists co-manage patients with various surgical specialties (orthopedics, neurosurgery, general surgery) and offer a medical consultation service. All of the Covenant Hospitalists have ACLS and Fundamentals of Critical Care Support certification, allowing them to serve as intensivist extenders (ICUs are open). As such, the service acts as Code Blue attending and the Medical Response Team for pre-code emergencies.

The average daily census is 30 with an average of 8-10 admissions per day. The Case Mix Index is 1.2617.

Communication Strategies

Communication was emphasized as a priority with the development of this new program. The position of a hospitalist support associate was created to serve as the point person for all external and internal communication. This is a full-time equivalent Monday through Friday. Hospitalist dictations are expedited via medical records transcription and faxed to the hospitalist office. All primary care physicians receive a notification of patient admission by fax on the morning following admission. This notification identifies the hospitalist attending, accompanies the dictated history and physical, and makes a request for pertinent outpatient information. Follow-up appointments are arranged by the hospitalist support associate prior to patient discharge. Discharge summaries are completed in real-time and faxed to the primary care office at the time of discharge.

Each hospitalist carries their own designated pager. A universal pager is passed between day and night physicians and is the “one call” direct contact for both the hospitalists’ private admitting relationships and regional referrals. Primary care physicians also have the opportunity to identify their preferred subspecialty consultants on enrollment to the hospitalist service. Laboratory and Radiology also utilize the universal pager for communication of critical values.

In conjunction with business development, primary care physician enrollment packets, patient brochures, hospitalist fliers, a regional referral manual, and DVD have all been compiled to assist in the education of patients, staff, and physicians.

Challenges

The greatest challenge to our program has been the facilitation of a culture of direct communication between the hospitalists and the medical staff consultants. Additionally, in our system the emergency department physicians routinely write admitting orders (“bridging orders”) for the private medical staff attending admissions. It has been a shift in culture to request the emergency physicians not to write bridging orders for the hospitalist admissions but to allow the hospitalist physician the opportunity to evaluate and admit hospitalist patients in real time in the emergency department.

First-Year Experience (fiscal 2004)

Admissions: 1747

Discharges: 1541

Observation: 289

Code Blue (CPR/critical care): 107

The Covenant Hospital Medicine Program was initiated with single-physician (four MDs) coverage 24 hours per day, 7 days per week in May 2003. The Medical Director was on-site for institutional and medical staff education, consensus building, physician and practice recruitment, and program planning for 4 months prior to program opening. Initially, the service admitted 90% of all unassigned emergency department medical admissions and enrolled two family practices as private admitting relationships. Over the course of the first year, the service grew to attend for 25% of all internal medicine admissions, and expanded the private admitting relationships to over 30 physician practices. Three additional FTE hospitalist physicians were added by September of 2003. Length of stay (2.94 CMI) and cost per case was reduced by 33% and 14%, respectively, versus the internal medicine physician admissions (nonhospitalist). Hospitalist inpatient mortality was 17.5% less than expected mortality as calculated by the Michigan Hospital Association database. The hospitalist readmission rate was 25% less than the internal medicine physician group (non-hospitalist). Profitability, as defined by net patient revenue minus total cost, was $707 for each hospitalist case compared to-$80 for each patient cared for by general internal medicine (non-hospitalist).

An intensive outreach program to our rural regional hospitals and critical access hospitals resulted in growth of regional referrals from 5% to 15% of the total hospital medicine program census over the course of the first year. Additionally, the medical consultation service, which was not offered at the initial start-up in order to control growth, now accounts for an additional 15% of the service volume.

Hospitalist Retention

The Covenant Hospital Medicine Program has a 78% retention rate for hospitalists in the first year. No physicians recruited to the program have had previous hospitalist experience. Two of the physicians left after one year; one to join a large hospitalist group in the West and the other to initiate a hospitalist program on the East coast.

Goals and Future Plans

Physician recruitment is the rate-limiting step for further growth and expansion. Two FTE hospitalists will be starting in January 2005 to accommodate the growth of the service to date. Two additional physicians will allow expansion to our off-site transitional care unit and inpatient rehabilitation unit to further provide for continuity and quality of care over the continuum. A fifth hospitalist is also sought to serve as an emergency department designated hospitalist in attempt to maximize daytime physician workflow.

Contact Information

Stacy Goldsholl, MD, BC IM (1/03-present)

Medical Director, Covenant Healthcare Hospital Medicine Program

[email protected]

Covenant Healthcare

1447 North Harrison

Saginaw, MI 48602

Holly Krenz

Hospitalist Support Associate

[email protected]

Phone: 989-583-4220

Fax: 989-583-4287

Start Up

May 2003

Hospitals Served

Covenant HealthCare, Saginaw, Michigan

Physician Staff

Abdo Alward, MD, BC IM (8/04)

Anu Gollapudi, MD, BC IM (5/03)

Noel Lucas, DO, BC IM (5/03)

Iris Mangulabnan, MD BC IM (8/03)

Hassan Nasser, MD, BC IM (5/03-5/04)

Sayed Naqvi, MD, BC IM (4/04)

Shelene Ruggio, MD, BC, IM (9/03)

Devanshu Thakore, MD, BC FP (7/03-8/04)

Support Staff

Holly Krenz, Hospitalist Support Associate

Mary Burr, Certified Coder

Physician Training

Eight of the physicians are board certified in internal medicine; one is board certified in family practice.

The Health System

Covenant HealthCare is a nonprofit regional tertiary health care system serving 18 counties throughout East Central Michigan, offering high-quality medical care with 20 inpatient and outpatient facilities, including two acute care hospitals with 643 licensed beds and 40 adult critical care beds, 20 short-term skilled nursing beds, and 41 inpatient rehabilitation beds. A 30-bed long-term acute care hospital also rents space on the hospital main campus. Covenant’s new state-of-the-science Emergency Care Center provides critical and trauma care with an annual volume in excess of 73,000 patient visits and offers a helicopter service that was added in January 2004. Additionally, Covenant provides comprehensive medical services in cardiovascular, neurosciences, surgery, orthopedics, obstetrics, and all ancillary services. Covenant HealthCare also features Michigan’s northernmost regional neonatal and pediatric/pediatric intensive care units to serve the needs of children.

As Michigan’s sixth largest hospital and most comprehensive health care facility north of Detroit, Covenant HealthCare has been nationally recognized for its superior service, having received such distinctions as a Solucient Top 100 Hospital for cardiac care and orthopedics from 1999 to 2003. Covenant is the recipient of the 2003 Governor’s Award of Excellence for Improving Care in the Hospital and Emergency Department for Heart Attack, Heart Failure, and Pneumonia, and is a five-time recipient of the National Research Corporation’s Consumer’s Choice Award. Covenant HealthCare ranks among the top 5% of hospitals its size nationwide for patient satisfaction.

Employment Arrangement

All of the physicians and staff are employed by Covenant HealthCare. Pediatric services for the pediatric patients of the family practice physicians utilizing the hospitalist program are provided by a contractual arrangement with Synergy Medical Alliance Family Practice residency program, an affiliate of Michigan State University.

Management and Operational Structure

An on-site Medical Director is responsible for all administrative aspects of the Hospital Medicine Program. Clinical responsibilities vary according to the service needs. The Medical Director reports to the Vice President of Medical Affairs. All team members report directly to the program’s Medical Director.

A full-time support associate (M-F) is responsible for all communications with primary care physicians, other hospital departments, and general office maintenance. A part-time certified coder is available twice weekly for charge capture reconciliation, billing, and documentation audit and physician education.

Multidisciplinary rounds are conducted daily (M-F) at 9 a.m. with all rounding physicians, the program director, case managers, and liaisons from skilled nursing, inpatient rehabilitation units, and home health/hospice. During this time, patient status is updated, and discharge planning is initiated. Case managers also bring non-hospitalist patient medical necessity reviews to the director/hospitalists who also serve as physician advisors to case management.

Staffing

The CHC Hospital Medicine Program is a 24-hour in-house service that operates in a shift-based (7a-7p) block model. There is one nocturnalist that covers 15 night shifts per month. Hospitalists are scheduled 15-18 12-hour shifts per month and are paid for additional shift coverage. Sign-in/out is face-to-face at 7 a.m. and 7 p.m. Day-time shifts are covered by two physicians 7 days per week, with an additional 0.5 FTE available M-F (medical director). Night shifts have single-physician coverage. Beginning in January 2005, day-time coverage will expand by one FTE.

Compensation/Benefits

All physicians are salaried. An annual bonus of up to 10% base salary is available at each physician’s anniversary date. The bonus is based heavily upon quality/FCCS certification (30%), team and referral physician satisfaction (20%), Press Ganey Patient-Physician Satisfaction scores (15%), and operational efficiency/organizational benefit (35%).

Standard benefits are provided, including malpractice coverage with tail, health, dental, vision, life insurance, 403b and 457b plans, short- and long-term disability. CME/Professional fee allowances of $3000 are provided. Initially, all physicians received 37 days of paid time off while contracting for 18 shifts/month. This has evolved into a 15-shifts/month schedule with no additional PTO.

Patient Census/Population

Patients are admitted to the Covenant HealthCare Hospital Medicine Service from three main avenues: unassigned emergency department admissions, private admitting relationships, and direct regional referrals. The hospitalists cover approximately 85% off all ED unassigned admissions. In addition, the service admits exclusively (all-or-none) for 35 local and regional primary care physicians. Covenant HealthCare serves as the tertiary referral for a number of small rural and critical access hospitals. These regional partners have ease of access with a “one pager” call number for the admitting hospitalist. Additionally, the hospitalists co-manage patients with various surgical specialties (orthopedics, neurosurgery, general surgery) and offer a medical consultation service. All of the Covenant Hospitalists have ACLS and Fundamentals of Critical Care Support certification, allowing them to serve as intensivist extenders (ICUs are open). As such, the service acts as Code Blue attending and the Medical Response Team for pre-code emergencies.

The average daily census is 30 with an average of 8-10 admissions per day. The Case Mix Index is 1.2617.

Communication Strategies

Communication was emphasized as a priority with the development of this new program. The position of a hospitalist support associate was created to serve as the point person for all external and internal communication. This is a full-time equivalent Monday through Friday. Hospitalist dictations are expedited via medical records transcription and faxed to the hospitalist office. All primary care physicians receive a notification of patient admission by fax on the morning following admission. This notification identifies the hospitalist attending, accompanies the dictated history and physical, and makes a request for pertinent outpatient information. Follow-up appointments are arranged by the hospitalist support associate prior to patient discharge. Discharge summaries are completed in real-time and faxed to the primary care office at the time of discharge.

Each hospitalist carries their own designated pager. A universal pager is passed between day and night physicians and is the “one call” direct contact for both the hospitalists’ private admitting relationships and regional referrals. Primary care physicians also have the opportunity to identify their preferred subspecialty consultants on enrollment to the hospitalist service. Laboratory and Radiology also utilize the universal pager for communication of critical values.

In conjunction with business development, primary care physician enrollment packets, patient brochures, hospitalist fliers, a regional referral manual, and DVD have all been compiled to assist in the education of patients, staff, and physicians.

Challenges

The greatest challenge to our program has been the facilitation of a culture of direct communication between the hospitalists and the medical staff consultants. Additionally, in our system the emergency department physicians routinely write admitting orders (“bridging orders”) for the private medical staff attending admissions. It has been a shift in culture to request the emergency physicians not to write bridging orders for the hospitalist admissions but to allow the hospitalist physician the opportunity to evaluate and admit hospitalist patients in real time in the emergency department.

First-Year Experience (fiscal 2004)

Admissions: 1747

Discharges: 1541

Observation: 289

Code Blue (CPR/critical care): 107

The Covenant Hospital Medicine Program was initiated with single-physician (four MDs) coverage 24 hours per day, 7 days per week in May 2003. The Medical Director was on-site for institutional and medical staff education, consensus building, physician and practice recruitment, and program planning for 4 months prior to program opening. Initially, the service admitted 90% of all unassigned emergency department medical admissions and enrolled two family practices as private admitting relationships. Over the course of the first year, the service grew to attend for 25% of all internal medicine admissions, and expanded the private admitting relationships to over 30 physician practices. Three additional FTE hospitalist physicians were added by September of 2003. Length of stay (2.94 CMI) and cost per case was reduced by 33% and 14%, respectively, versus the internal medicine physician admissions (nonhospitalist). Hospitalist inpatient mortality was 17.5% less than expected mortality as calculated by the Michigan Hospital Association database. The hospitalist readmission rate was 25% less than the internal medicine physician group (non-hospitalist). Profitability, as defined by net patient revenue minus total cost, was $707 for each hospitalist case compared to-$80 for each patient cared for by general internal medicine (non-hospitalist).

An intensive outreach program to our rural regional hospitals and critical access hospitals resulted in growth of regional referrals from 5% to 15% of the total hospital medicine program census over the course of the first year. Additionally, the medical consultation service, which was not offered at the initial start-up in order to control growth, now accounts for an additional 15% of the service volume.

Hospitalist Retention

The Covenant Hospital Medicine Program has a 78% retention rate for hospitalists in the first year. No physicians recruited to the program have had previous hospitalist experience. Two of the physicians left after one year; one to join a large hospitalist group in the West and the other to initiate a hospitalist program on the East coast.

Goals and Future Plans

Physician recruitment is the rate-limiting step for further growth and expansion. Two FTE hospitalists will be starting in January 2005 to accommodate the growth of the service to date. Two additional physicians will allow expansion to our off-site transitional care unit and inpatient rehabilitation unit to further provide for continuity and quality of care over the continuum. A fifth hospitalist is also sought to serve as an emergency department designated hospitalist in attempt to maximize daytime physician workflow.

Contact Information

Stacy Goldsholl, MD, BC IM (1/03-present)

Medical Director, Covenant Healthcare Hospital Medicine Program

[email protected]

Covenant Healthcare

1447 North Harrison

Saginaw, MI 48602

Holly Krenz

Hospitalist Support Associate

[email protected]

Phone: 989-583-4220

Fax: 989-583-4287

Start Up

May 2003

Hospitals Served

Covenant HealthCare, Saginaw, Michigan

Physician Staff

Abdo Alward, MD, BC IM (8/04)

Anu Gollapudi, MD, BC IM (5/03)

Noel Lucas, DO, BC IM (5/03)

Iris Mangulabnan, MD BC IM (8/03)

Hassan Nasser, MD, BC IM (5/03-5/04)

Sayed Naqvi, MD, BC IM (4/04)

Shelene Ruggio, MD, BC, IM (9/03)

Devanshu Thakore, MD, BC FP (7/03-8/04)

Support Staff

Holly Krenz, Hospitalist Support Associate

Mary Burr, Certified Coder

Physician Training

Eight of the physicians are board certified in internal medicine; one is board certified in family practice.

The Health System

Covenant HealthCare is a nonprofit regional tertiary health care system serving 18 counties throughout East Central Michigan, offering high-quality medical care with 20 inpatient and outpatient facilities, including two acute care hospitals with 643 licensed beds and 40 adult critical care beds, 20 short-term skilled nursing beds, and 41 inpatient rehabilitation beds. A 30-bed long-term acute care hospital also rents space on the hospital main campus. Covenant’s new state-of-the-science Emergency Care Center provides critical and trauma care with an annual volume in excess of 73,000 patient visits and offers a helicopter service that was added in January 2004. Additionally, Covenant provides comprehensive medical services in cardiovascular, neurosciences, surgery, orthopedics, obstetrics, and all ancillary services. Covenant HealthCare also features Michigan’s northernmost regional neonatal and pediatric/pediatric intensive care units to serve the needs of children.

As Michigan’s sixth largest hospital and most comprehensive health care facility north of Detroit, Covenant HealthCare has been nationally recognized for its superior service, having received such distinctions as a Solucient Top 100 Hospital for cardiac care and orthopedics from 1999 to 2003. Covenant is the recipient of the 2003 Governor’s Award of Excellence for Improving Care in the Hospital and Emergency Department for Heart Attack, Heart Failure, and Pneumonia, and is a five-time recipient of the National Research Corporation’s Consumer’s Choice Award. Covenant HealthCare ranks among the top 5% of hospitals its size nationwide for patient satisfaction.

Employment Arrangement

All of the physicians and staff are employed by Covenant HealthCare. Pediatric services for the pediatric patients of the family practice physicians utilizing the hospitalist program are provided by a contractual arrangement with Synergy Medical Alliance Family Practice residency program, an affiliate of Michigan State University.

Management and Operational Structure

An on-site Medical Director is responsible for all administrative aspects of the Hospital Medicine Program. Clinical responsibilities vary according to the service needs. The Medical Director reports to the Vice President of Medical Affairs. All team members report directly to the program’s Medical Director.

A full-time support associate (M-F) is responsible for all communications with primary care physicians, other hospital departments, and general office maintenance. A part-time certified coder is available twice weekly for charge capture reconciliation, billing, and documentation audit and physician education.

Multidisciplinary rounds are conducted daily (M-F) at 9 a.m. with all rounding physicians, the program director, case managers, and liaisons from skilled nursing, inpatient rehabilitation units, and home health/hospice. During this time, patient status is updated, and discharge planning is initiated. Case managers also bring non-hospitalist patient medical necessity reviews to the director/hospitalists who also serve as physician advisors to case management.

Staffing

The CHC Hospital Medicine Program is a 24-hour in-house service that operates in a shift-based (7a-7p) block model. There is one nocturnalist that covers 15 night shifts per month. Hospitalists are scheduled 15-18 12-hour shifts per month and are paid for additional shift coverage. Sign-in/out is face-to-face at 7 a.m. and 7 p.m. Day-time shifts are covered by two physicians 7 days per week, with an additional 0.5 FTE available M-F (medical director). Night shifts have single-physician coverage. Beginning in January 2005, day-time coverage will expand by one FTE.

Compensation/Benefits

All physicians are salaried. An annual bonus of up to 10% base salary is available at each physician’s anniversary date. The bonus is based heavily upon quality/FCCS certification (30%), team and referral physician satisfaction (20%), Press Ganey Patient-Physician Satisfaction scores (15%), and operational efficiency/organizational benefit (35%).

Standard benefits are provided, including malpractice coverage with tail, health, dental, vision, life insurance, 403b and 457b plans, short- and long-term disability. CME/Professional fee allowances of $3000 are provided. Initially, all physicians received 37 days of paid time off while contracting for 18 shifts/month. This has evolved into a 15-shifts/month schedule with no additional PTO.

Patient Census/Population

Patients are admitted to the Covenant HealthCare Hospital Medicine Service from three main avenues: unassigned emergency department admissions, private admitting relationships, and direct regional referrals. The hospitalists cover approximately 85% off all ED unassigned admissions. In addition, the service admits exclusively (all-or-none) for 35 local and regional primary care physicians. Covenant HealthCare serves as the tertiary referral for a number of small rural and critical access hospitals. These regional partners have ease of access with a “one pager” call number for the admitting hospitalist. Additionally, the hospitalists co-manage patients with various surgical specialties (orthopedics, neurosurgery, general surgery) and offer a medical consultation service. All of the Covenant Hospitalists have ACLS and Fundamentals of Critical Care Support certification, allowing them to serve as intensivist extenders (ICUs are open). As such, the service acts as Code Blue attending and the Medical Response Team for pre-code emergencies.

The average daily census is 30 with an average of 8-10 admissions per day. The Case Mix Index is 1.2617.

Communication Strategies

Communication was emphasized as a priority with the development of this new program. The position of a hospitalist support associate was created to serve as the point person for all external and internal communication. This is a full-time equivalent Monday through Friday. Hospitalist dictations are expedited via medical records transcription and faxed to the hospitalist office. All primary care physicians receive a notification of patient admission by fax on the morning following admission. This notification identifies the hospitalist attending, accompanies the dictated history and physical, and makes a request for pertinent outpatient information. Follow-up appointments are arranged by the hospitalist support associate prior to patient discharge. Discharge summaries are completed in real-time and faxed to the primary care office at the time of discharge.

Each hospitalist carries their own designated pager. A universal pager is passed between day and night physicians and is the “one call” direct contact for both the hospitalists’ private admitting relationships and regional referrals. Primary care physicians also have the opportunity to identify their preferred subspecialty consultants on enrollment to the hospitalist service. Laboratory and Radiology also utilize the universal pager for communication of critical values.

In conjunction with business development, primary care physician enrollment packets, patient brochures, hospitalist fliers, a regional referral manual, and DVD have all been compiled to assist in the education of patients, staff, and physicians.

Challenges

The greatest challenge to our program has been the facilitation of a culture of direct communication between the hospitalists and the medical staff consultants. Additionally, in our system the emergency department physicians routinely write admitting orders (“bridging orders”) for the private medical staff attending admissions. It has been a shift in culture to request the emergency physicians not to write bridging orders for the hospitalist admissions but to allow the hospitalist physician the opportunity to evaluate and admit hospitalist patients in real time in the emergency department.

First-Year Experience (fiscal 2004)

Admissions: 1747

Discharges: 1541

Observation: 289

Code Blue (CPR/critical care): 107

The Covenant Hospital Medicine Program was initiated with single-physician (four MDs) coverage 24 hours per day, 7 days per week in May 2003. The Medical Director was on-site for institutional and medical staff education, consensus building, physician and practice recruitment, and program planning for 4 months prior to program opening. Initially, the service admitted 90% of all unassigned emergency department medical admissions and enrolled two family practices as private admitting relationships. Over the course of the first year, the service grew to attend for 25% of all internal medicine admissions, and expanded the private admitting relationships to over 30 physician practices. Three additional FTE hospitalist physicians were added by September of 2003. Length of stay (2.94 CMI) and cost per case was reduced by 33% and 14%, respectively, versus the internal medicine physician admissions (nonhospitalist). Hospitalist inpatient mortality was 17.5% less than expected mortality as calculated by the Michigan Hospital Association database. The hospitalist readmission rate was 25% less than the internal medicine physician group (non-hospitalist). Profitability, as defined by net patient revenue minus total cost, was $707 for each hospitalist case compared to-$80 for each patient cared for by general internal medicine (non-hospitalist).

An intensive outreach program to our rural regional hospitals and critical access hospitals resulted in growth of regional referrals from 5% to 15% of the total hospital medicine program census over the course of the first year. Additionally, the medical consultation service, which was not offered at the initial start-up in order to control growth, now accounts for an additional 15% of the service volume.

Hospitalist Retention

The Covenant Hospital Medicine Program has a 78% retention rate for hospitalists in the first year. No physicians recruited to the program have had previous hospitalist experience. Two of the physicians left after one year; one to join a large hospitalist group in the West and the other to initiate a hospitalist program on the East coast.

Goals and Future Plans

Physician recruitment is the rate-limiting step for further growth and expansion. Two FTE hospitalists will be starting in January 2005 to accommodate the growth of the service to date. Two additional physicians will allow expansion to our off-site transitional care unit and inpatient rehabilitation unit to further provide for continuity and quality of care over the continuum. A fifth hospitalist is also sought to serve as an emergency department designated hospitalist in attempt to maximize daytime physician workflow.