Many professional entities endorse the need to deliver cancer genetics risk assessment (CGRA) services through a multidisciplinary team that includes trained genetics professionals. However, market forces, a lack of regulation of genetic testing, patent laws, cost barriers, and a limited workforce in genetics have resulted in an increasing number of community practitioners who order and interpret genetic testing. In addition, varying state-level laws and licensure requirements for genetic counselors may contribute to the nonuniform delivery of CGRA services across the United States. Those who perform genetic testing without having adequate training or expertise may incur liability risks. Moreover, the patient might not enjoy the maximum benefit of testing at the hands of an inadequately trained individual. In the setting of a limited number of professional who are trained in CGRA and a dearth of education and training resources, it is a challenge to integrate genetic testing services into clinical care. With advances in genomics and the implementation of personalized medicine, the problem will only be magnified, and it is critical that there are more opportunities for high quality education and training in clinical cancer genetics free of commercial bias. Successful strategies for delivering comprehensive CGRA services include academic-community partnerships that focus on collaboration with nongenetics providers or the inclusion of a genetics professional in the community setting as part of multidisciplinary patient care. These approaches can leverage the expertise of genetics professionals while allowing patients to remain in their community and enjoy better access to resources for long-term follow-up care.

*Click on the link to the left for a PDF of the full article.

Many professional entities endorse the need to deliver cancer genetics risk assessment (CGRA) services through a multidisciplinary team that includes trained genetics professionals. However, market forces, a lack of regulation of genetic testing, patent laws, cost barriers, and a limited workforce in genetics have resulted in an increasing number of community practitioners who order and interpret genetic testing. In addition, varying state-level laws and licensure requirements for genetic counselors may contribute to the nonuniform delivery of CGRA services across the United States. Those who perform genetic testing without having adequate training or expertise may incur liability risks. Moreover, the patient might not enjoy the maximum benefit of testing at the hands of an inadequately trained individual. In the setting of a limited number of professional who are trained in CGRA and a dearth of education and training resources, it is a challenge to integrate genetic testing services into clinical care. With advances in genomics and the implementation of personalized medicine, the problem will only be magnified, and it is critical that there are more opportunities for high quality education and training in clinical cancer genetics free of commercial bias. Successful strategies for delivering comprehensive CGRA services include academic-community partnerships that focus on collaboration with nongenetics providers or the inclusion of a genetics professional in the community setting as part of multidisciplinary patient care. These approaches can leverage the expertise of genetics professionals while allowing patients to remain in their community and enjoy better access to resources for long-term follow-up care.

*Click on the link to the left for a PDF of the full article.

Many professional entities endorse the need to deliver cancer genetics risk assessment (CGRA) services through a multidisciplinary team that includes trained genetics professionals. However, market forces, a lack of regulation of genetic testing, patent laws, cost barriers, and a limited workforce in genetics have resulted in an increasing number of community practitioners who order and interpret genetic testing. In addition, varying state-level laws and licensure requirements for genetic counselors may contribute to the nonuniform delivery of CGRA services across the United States. Those who perform genetic testing without having adequate training or expertise may incur liability risks. Moreover, the patient might not enjoy the maximum benefit of testing at the hands of an inadequately trained individual. In the setting of a limited number of professional who are trained in CGRA and a dearth of education and training resources, it is a challenge to integrate genetic testing services into clinical care. With advances in genomics and the implementation of personalized medicine, the problem will only be magnified, and it is critical that there are more opportunities for high quality education and training in clinical cancer genetics free of commercial bias. Successful strategies for delivering comprehensive CGRA services include academic-community partnerships that focus on collaboration with nongenetics providers or the inclusion of a genetics professional in the community setting as part of multidisciplinary patient care. These approaches can leverage the expertise of genetics professionals while allowing patients to remain in their community and enjoy better access to resources for long-term follow-up care.

*Click on the link to the left for a PDF of the full article.

CHICAGO – Patients with high-risk, low-grade gliomas had 3-year survival rates significantly higher than those of historical controls when they were treated with a temozolomide-based chemoradiotherapy regimen, investigators reported at the annual meeting of the American Society of Clinical Oncology.

Preliminary results from the phase II RTOG 0424 trial showed a 73% overall survival rate for patients treated with temozolomide chemoradiotherapy, compared with 54% overall survival for historical controls (P less than .001), and exceeding the study’s hypothesized 65% overall survival, reported Dr. Barbara Fisher, a radiation oncologist at the University of Western Ontario in London.

At a median follow-up of 4 years, with a minimum potential follow-up of 3 years, median survival of patients has not been reached, and the median follow-up time for surviving patients is 5 years, Dr. Fisher noted.

Median progression-free survival was 4.5 years, and 3-year PFS was 59%. In contrast to historical controls, patients with four or five risk factors appeared to have an overall survival rate similar to that of patients with three risk factors, Dr. Fisher reported.

Although the trial was originally proposed in 2000 as a randomized controlled study, "there wasn’t much information about temozolomide and radiation at that point," Dr. Fisher said.

The control population comes from a 2002 study by Francesco Pignatti and his colleagues (J. Clin. Oncol. 2002;20:2076-84), which identified prognostic factors for survival in adults with low-grade glioma, based on data from two European Organization for Research and Treatment of Cancer (EORTC) trials conducted in the 1990s.

The risk factors are age 40 years and older; astrocytoma subtype; tumor crossing the midline; largest tumor diameter more than 6 cm preoperatively; and preoperative neurological function status (neurocognitive function greater than 1: moderate impairment).

A total of 136 patients were accrued, and 129 patients were eligible for the protocol, which consisted of temozolomide 75 mg/m² per day for 6 weeks with concurrent conformal radiotherapy, consisting of 54 Gy divided into 30 fractions delivered 5 days each week for 6 weeks, followed by temozolomide 150-200 mg/m² per day for days 1-5 of each 28-day cycle for a total of 12 cycles.

The patients had previously untreated, histologically proven supratentorial World Health Organization grade II astrocytoma (71 patients); oligodendroglioma (29) or oligoastrocytoma (29) confirmed by central pathology; and at least three of the aforementioned risk factors. The majority of patients (80%) were aged 40 years or older, 79% had tumors greater than 6 cm in the largest diameter, 53% had tumors that crossed the midline, 66% had a dominant astrocytoma subtype, and 50% had preoperative neurological function status scores greater than 1. In all, 89 patients had three risk factors, 32 had four, and 8 had five factors.

The investigators hypothesized that they would see a 43% relative increase in median survival, from 40.5 months in controls to 57.9 months, and a 20% improvement in 3-year survival, from 54% to 65%. As noted before, the survival rates exceeded their expectations.

In an analysis of survival by risk factors 5 years after trial registration, the authors found that 35 of the 89 patients with three risk factors (39%) had died, compared with 17 of the 40 patients with four or five risk factors (43%).

In all, 55 patients had grade 3 adverse events as their worst overall events, 13 had grade 4 toxicities, and 1 patient died of herpes simplex encephalitis, possibly related to treatment.

Grade 3 adverse events were seen in 43% of patients, and grade 4 toxicities in 10%. The most common toxicities were hematologic, constitutional, or gastrointestinal, including nausea and anorexia.

In her commentary, Dr. Helen Shih, the invited discussant, said that a randomized trial would have been preferable, but she acknowledged the difficulties the investigators had in designing and implementing the trial. Dr. Shih, of the radiation oncology department at Massachusetts General Hospital in Boston, also noted that the study used for control purposes "itself was conducted in a prior decade, when the management of radiation as well as surgery were slightly different, and perhaps those advancements also have affected overall survival of patients who are treated today."

In addition, the incidences of grade 3 and 4 toxicities in the study by Dr. Fisher and her colleagues were "not trivial, and should be kept in mind," Dr. Shih said.

The study was supported by the National Cancer Institute. Dr. Fisher and Dr. Shih reported having no relevant financial disclosures.

CHICAGO – Patients with high-risk, low-grade gliomas had 3-year survival rates significantly higher than those of historical controls when they were treated with a temozolomide-based chemoradiotherapy regimen, investigators reported at the annual meeting of the American Society of Clinical Oncology.

Preliminary results from the phase II RTOG 0424 trial showed a 73% overall survival rate for patients treated with temozolomide chemoradiotherapy, compared with 54% overall survival for historical controls (P less than .001), and exceeding the study’s hypothesized 65% overall survival, reported Dr. Barbara Fisher, a radiation oncologist at the University of Western Ontario in London.

At a median follow-up of 4 years, with a minimum potential follow-up of 3 years, median survival of patients has not been reached, and the median follow-up time for surviving patients is 5 years, Dr. Fisher noted.

Median progression-free survival was 4.5 years, and 3-year PFS was 59%. In contrast to historical controls, patients with four or five risk factors appeared to have an overall survival rate similar to that of patients with three risk factors, Dr. Fisher reported.

Although the trial was originally proposed in 2000 as a randomized controlled study, "there wasn’t much information about temozolomide and radiation at that point," Dr. Fisher said.

The control population comes from a 2002 study by Francesco Pignatti and his colleagues (J. Clin. Oncol. 2002;20:2076-84), which identified prognostic factors for survival in adults with low-grade glioma, based on data from two European Organization for Research and Treatment of Cancer (EORTC) trials conducted in the 1990s.

The risk factors are age 40 years and older; astrocytoma subtype; tumor crossing the midline; largest tumor diameter more than 6 cm preoperatively; and preoperative neurological function status (neurocognitive function greater than 1: moderate impairment).

A total of 136 patients were accrued, and 129 patients were eligible for the protocol, which consisted of temozolomide 75 mg/m² per day for 6 weeks with concurrent conformal radiotherapy, consisting of 54 Gy divided into 30 fractions delivered 5 days each week for 6 weeks, followed by temozolomide 150-200 mg/m² per day for days 1-5 of each 28-day cycle for a total of 12 cycles.

The patients had previously untreated, histologically proven supratentorial World Health Organization grade II astrocytoma (71 patients); oligodendroglioma (29) or oligoastrocytoma (29) confirmed by central pathology; and at least three of the aforementioned risk factors. The majority of patients (80%) were aged 40 years or older, 79% had tumors greater than 6 cm in the largest diameter, 53% had tumors that crossed the midline, 66% had a dominant astrocytoma subtype, and 50% had preoperative neurological function status scores greater than 1. In all, 89 patients had three risk factors, 32 had four, and 8 had five factors.

The investigators hypothesized that they would see a 43% relative increase in median survival, from 40.5 months in controls to 57.9 months, and a 20% improvement in 3-year survival, from 54% to 65%. As noted before, the survival rates exceeded their expectations.

In an analysis of survival by risk factors 5 years after trial registration, the authors found that 35 of the 89 patients with three risk factors (39%) had died, compared with 17 of the 40 patients with four or five risk factors (43%).

In all, 55 patients had grade 3 adverse events as their worst overall events, 13 had grade 4 toxicities, and 1 patient died of herpes simplex encephalitis, possibly related to treatment.

Grade 3 adverse events were seen in 43% of patients, and grade 4 toxicities in 10%. The most common toxicities were hematologic, constitutional, or gastrointestinal, including nausea and anorexia.

In her commentary, Dr. Helen Shih, the invited discussant, said that a randomized trial would have been preferable, but she acknowledged the difficulties the investigators had in designing and implementing the trial. Dr. Shih, of the radiation oncology department at Massachusetts General Hospital in Boston, also noted that the study used for control purposes "itself was conducted in a prior decade, when the management of radiation as well as surgery were slightly different, and perhaps those advancements also have affected overall survival of patients who are treated today."

In addition, the incidences of grade 3 and 4 toxicities in the study by Dr. Fisher and her colleagues were "not trivial, and should be kept in mind," Dr. Shih said.

The study was supported by the National Cancer Institute. Dr. Fisher and Dr. Shih reported having no relevant financial disclosures.

CHICAGO – Patients with high-risk, low-grade gliomas had 3-year survival rates significantly higher than those of historical controls when they were treated with a temozolomide-based chemoradiotherapy regimen, investigators reported at the annual meeting of the American Society of Clinical Oncology.

Preliminary results from the phase II RTOG 0424 trial showed a 73% overall survival rate for patients treated with temozolomide chemoradiotherapy, compared with 54% overall survival for historical controls (P less than .001), and exceeding the study’s hypothesized 65% overall survival, reported Dr. Barbara Fisher, a radiation oncologist at the University of Western Ontario in London.

At a median follow-up of 4 years, with a minimum potential follow-up of 3 years, median survival of patients has not been reached, and the median follow-up time for surviving patients is 5 years, Dr. Fisher noted.

Median progression-free survival was 4.5 years, and 3-year PFS was 59%. In contrast to historical controls, patients with four or five risk factors appeared to have an overall survival rate similar to that of patients with three risk factors, Dr. Fisher reported.

Although the trial was originally proposed in 2000 as a randomized controlled study, "there wasn’t much information about temozolomide and radiation at that point," Dr. Fisher said.

The control population comes from a 2002 study by Francesco Pignatti and his colleagues (J. Clin. Oncol. 2002;20:2076-84), which identified prognostic factors for survival in adults with low-grade glioma, based on data from two European Organization for Research and Treatment of Cancer (EORTC) trials conducted in the 1990s.

The risk factors are age 40 years and older; astrocytoma subtype; tumor crossing the midline; largest tumor diameter more than 6 cm preoperatively; and preoperative neurological function status (neurocognitive function greater than 1: moderate impairment).

A total of 136 patients were accrued, and 129 patients were eligible for the protocol, which consisted of temozolomide 75 mg/m² per day for 6 weeks with concurrent conformal radiotherapy, consisting of 54 Gy divided into 30 fractions delivered 5 days each week for 6 weeks, followed by temozolomide 150-200 mg/m² per day for days 1-5 of each 28-day cycle for a total of 12 cycles.

The patients had previously untreated, histologically proven supratentorial World Health Organization grade II astrocytoma (71 patients); oligodendroglioma (29) or oligoastrocytoma (29) confirmed by central pathology; and at least three of the aforementioned risk factors. The majority of patients (80%) were aged 40 years or older, 79% had tumors greater than 6 cm in the largest diameter, 53% had tumors that crossed the midline, 66% had a dominant astrocytoma subtype, and 50% had preoperative neurological function status scores greater than 1. In all, 89 patients had three risk factors, 32 had four, and 8 had five factors.

The investigators hypothesized that they would see a 43% relative increase in median survival, from 40.5 months in controls to 57.9 months, and a 20% improvement in 3-year survival, from 54% to 65%. As noted before, the survival rates exceeded their expectations.

In an analysis of survival by risk factors 5 years after trial registration, the authors found that 35 of the 89 patients with three risk factors (39%) had died, compared with 17 of the 40 patients with four or five risk factors (43%).

In all, 55 patients had grade 3 adverse events as their worst overall events, 13 had grade 4 toxicities, and 1 patient died of herpes simplex encephalitis, possibly related to treatment.

Grade 3 adverse events were seen in 43% of patients, and grade 4 toxicities in 10%. The most common toxicities were hematologic, constitutional, or gastrointestinal, including nausea and anorexia.

In her commentary, Dr. Helen Shih, the invited discussant, said that a randomized trial would have been preferable, but she acknowledged the difficulties the investigators had in designing and implementing the trial. Dr. Shih, of the radiation oncology department at Massachusetts General Hospital in Boston, also noted that the study used for control purposes "itself was conducted in a prior decade, when the management of radiation as well as surgery were slightly different, and perhaps those advancements also have affected overall survival of patients who are treated today."

In addition, the incidences of grade 3 and 4 toxicities in the study by Dr. Fisher and her colleagues were "not trivial, and should be kept in mind," Dr. Shih said.

The study was supported by the National Cancer Institute. Dr. Fisher and Dr. Shih reported having no relevant financial disclosures.

MINNEAPOLIS  – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.

Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.

©Martin Allred

When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.

"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.

The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.

The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.

In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.

Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.

Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.

Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).

Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).

The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.

In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).

Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.

Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).

Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.

Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.

pwendling@frontlinemedcom.com

MINNEAPOLIS  – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.

Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.

©Martin Allred

When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.

"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.

The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.

The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.

In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.

Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.

Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.

Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).

Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).

The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.

In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).

Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.

Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).

Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.

Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.

pwendling@frontlinemedcom.com

MINNEAPOLIS  – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.

Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.

©Martin Allred

When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.

"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.

The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.

The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.

In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.

Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.

Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.

Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).

Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).

The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.

In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).

Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.

Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).

Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.

Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.

pwendling@frontlinemedcom.com

The advent of BCR-ABL1 tyrosine kinase inhibitors (TKIs) for the treatment of chronic myeloid leukemia (CML) has dramatically changed the management of patients with CML. With continuous long-term TKI therapy, CML can be managed like a chronic condition, and most patients can expect to have a normal life expectancy. Given the prospect of lifelong therapy, however, issues related to adherence become particularly important and warrant greater attention since attainment of favorable long-term survival depends in large part on consistent, appropriate treatment administration over years, if not decades. As the multidisciplinary care team approach to cancer care has gained traction at academic centers and community practices, midlevel providers, including nurse practitioners and physician assistants, have taken on greater patient-related responsibilities. Midlevel providers have the potential to foster and maintain meaningful provider-patient relationships that may span years, and are well positioned to recognize and manage problems that patients may have with adherence. Here we discuss the importance of achieving and maintaining responses to TKI therapy, describe the clinical consequences of poor adherence to TKI therapy in CML, and outline factors behind poor adherence. We also share strategies that we use at our center to improve adherence to long-term TKI therapy for CML.

*Click on the link to the left for a PDF of the full article.  

The advent of BCR-ABL1 tyrosine kinase inhibitors (TKIs) for the treatment of chronic myeloid leukemia (CML) has dramatically changed the management of patients with CML. With continuous long-term TKI therapy, CML can be managed like a chronic condition, and most patients can expect to have a normal life expectancy. Given the prospect of lifelong therapy, however, issues related to adherence become particularly important and warrant greater attention since attainment of favorable long-term survival depends in large part on consistent, appropriate treatment administration over years, if not decades. As the multidisciplinary care team approach to cancer care has gained traction at academic centers and community practices, midlevel providers, including nurse practitioners and physician assistants, have taken on greater patient-related responsibilities. Midlevel providers have the potential to foster and maintain meaningful provider-patient relationships that may span years, and are well positioned to recognize and manage problems that patients may have with adherence. Here we discuss the importance of achieving and maintaining responses to TKI therapy, describe the clinical consequences of poor adherence to TKI therapy in CML, and outline factors behind poor adherence. We also share strategies that we use at our center to improve adherence to long-term TKI therapy for CML.

*Click on the link to the left for a PDF of the full article.  

The advent of BCR-ABL1 tyrosine kinase inhibitors (TKIs) for the treatment of chronic myeloid leukemia (CML) has dramatically changed the management of patients with CML. With continuous long-term TKI therapy, CML can be managed like a chronic condition, and most patients can expect to have a normal life expectancy. Given the prospect of lifelong therapy, however, issues related to adherence become particularly important and warrant greater attention since attainment of favorable long-term survival depends in large part on consistent, appropriate treatment administration over years, if not decades. As the multidisciplinary care team approach to cancer care has gained traction at academic centers and community practices, midlevel providers, including nurse practitioners and physician assistants, have taken on greater patient-related responsibilities. Midlevel providers have the potential to foster and maintain meaningful provider-patient relationships that may span years, and are well positioned to recognize and manage problems that patients may have with adherence. Here we discuss the importance of achieving and maintaining responses to TKI therapy, describe the clinical consequences of poor adherence to TKI therapy in CML, and outline factors behind poor adherence. We also share strategies that we use at our center to improve adherence to long-term TKI therapy for CML.

*Click on the link to the left for a PDF of the full article.  

Clinical question: Is the use of proton-pump inhibitors (PPIs) associated with risk of mortality or combined risk of death or rehospitalization in older patients discharged from acute-care hospitals?

Background: Previous studies have shown that the use of PPIs could be associated with increased mortality in institutionalized older people and in patients discharged from acute-care hospitals. Older patients could be more vulnerable to adverse effects of PPIs, such as drug-drug interactions and absorption of nutrients, because of the higher incidence of polypharmacy and malnutrition in the elderly.

Study design: Prospective cohort.

Setting: Eleven acute-care medical wards participating in the Italian study Pharmacosurveillance in the Elderly Care.

Synopsis: All patients aged 65 years or older consecutively admitted to participating wards from April to June 2007 underwent screening. Excluding patients who refused, died during hospitalization, or were admitted to long-term care or rehabilitation units, a total of 491 patients were analyzed. The study team administered questionnaires during admission and conducted follow-up visits every three months for one year after discharge. Outcomes included one-year survival of patients discharged from acute-care medical wards and the combined endpoint of death or rehospitalization.

Overall, 174 patients (35.4%) had PPI exposure. After adjusting for age, cognitive impairment, disability, comorbidities, nutritional status, and number of drugs prescribed, patients exposed to PPIs had a significantly increased risk of death (adjusted HR 1.51, 95% CI 1.03-2.77). This association was strongest among patients receiving high-dose PPIs. No such association was found when considering the combined endpoint (HR 1.49, 95% CI 0.98-2.17). Limitations of the study include observational design, small size, potential for confounding by indication for PPI, and indeterminate PPI use prior to index hospitalization. Finally, the finding of an association between PPIs and increased mortality does not equate to a causative relationship between the two variables.

Bottom line: Proton-pump inhibitor use in older patients discharged from acute-care hospitals is associated with increased all-cause mortality at one year.

Citation: Maggio M, Corsonello A, Ceda GP, et al. Proton-pump inhibitors and risk of 1-year mortality and rehospitalization in older patients discharged from acute care hospitals. JAMA Intern Med. 2013;173(7):518-523.

Clinical question: Is the use of proton-pump inhibitors (PPIs) associated with risk of mortality or combined risk of death or rehospitalization in older patients discharged from acute-care hospitals?

Background: Previous studies have shown that the use of PPIs could be associated with increased mortality in institutionalized older people and in patients discharged from acute-care hospitals. Older patients could be more vulnerable to adverse effects of PPIs, such as drug-drug interactions and absorption of nutrients, because of the higher incidence of polypharmacy and malnutrition in the elderly.

Study design: Prospective cohort.

Setting: Eleven acute-care medical wards participating in the Italian study Pharmacosurveillance in the Elderly Care.

Synopsis: All patients aged 65 years or older consecutively admitted to participating wards from April to June 2007 underwent screening. Excluding patients who refused, died during hospitalization, or were admitted to long-term care or rehabilitation units, a total of 491 patients were analyzed. The study team administered questionnaires during admission and conducted follow-up visits every three months for one year after discharge. Outcomes included one-year survival of patients discharged from acute-care medical wards and the combined endpoint of death or rehospitalization.

Overall, 174 patients (35.4%) had PPI exposure. After adjusting for age, cognitive impairment, disability, comorbidities, nutritional status, and number of drugs prescribed, patients exposed to PPIs had a significantly increased risk of death (adjusted HR 1.51, 95% CI 1.03-2.77). This association was strongest among patients receiving high-dose PPIs. No such association was found when considering the combined endpoint (HR 1.49, 95% CI 0.98-2.17). Limitations of the study include observational design, small size, potential for confounding by indication for PPI, and indeterminate PPI use prior to index hospitalization. Finally, the finding of an association between PPIs and increased mortality does not equate to a causative relationship between the two variables.

Bottom line: Proton-pump inhibitor use in older patients discharged from acute-care hospitals is associated with increased all-cause mortality at one year.

Citation: Maggio M, Corsonello A, Ceda GP, et al. Proton-pump inhibitors and risk of 1-year mortality and rehospitalization in older patients discharged from acute care hospitals. JAMA Intern Med. 2013;173(7):518-523.

Clinical question: Is the use of proton-pump inhibitors (PPIs) associated with risk of mortality or combined risk of death or rehospitalization in older patients discharged from acute-care hospitals?

Background: Previous studies have shown that the use of PPIs could be associated with increased mortality in institutionalized older people and in patients discharged from acute-care hospitals. Older patients could be more vulnerable to adverse effects of PPIs, such as drug-drug interactions and absorption of nutrients, because of the higher incidence of polypharmacy and malnutrition in the elderly.

Study design: Prospective cohort.

Setting: Eleven acute-care medical wards participating in the Italian study Pharmacosurveillance in the Elderly Care.

Synopsis: All patients aged 65 years or older consecutively admitted to participating wards from April to June 2007 underwent screening. Excluding patients who refused, died during hospitalization, or were admitted to long-term care or rehabilitation units, a total of 491 patients were analyzed. The study team administered questionnaires during admission and conducted follow-up visits every three months for one year after discharge. Outcomes included one-year survival of patients discharged from acute-care medical wards and the combined endpoint of death or rehospitalization.

Overall, 174 patients (35.4%) had PPI exposure. After adjusting for age, cognitive impairment, disability, comorbidities, nutritional status, and number of drugs prescribed, patients exposed to PPIs had a significantly increased risk of death (adjusted HR 1.51, 95% CI 1.03-2.77). This association was strongest among patients receiving high-dose PPIs. No such association was found when considering the combined endpoint (HR 1.49, 95% CI 0.98-2.17). Limitations of the study include observational design, small size, potential for confounding by indication for PPI, and indeterminate PPI use prior to index hospitalization. Finally, the finding of an association between PPIs and increased mortality does not equate to a causative relationship between the two variables.

Bottom line: Proton-pump inhibitor use in older patients discharged from acute-care hospitals is associated with increased all-cause mortality at one year.

Citation: Maggio M, Corsonello A, Ceda GP, et al. Proton-pump inhibitors and risk of 1-year mortality and rehospitalization in older patients discharged from acute care hospitals. JAMA Intern Med. 2013;173(7):518-523.

Clinical question: Does uncontrolled diabetes mellitus increase risk for post-operative complications after elective joint replacement surgery?

Background: Several previous studies suggested that patients with uncontrolled diabetes could be at higher risk of postoperative complications and have worse functional outcomes after joint replacement surgery than patients without diabetes. Preoperative glycemic control is a potentially modifiable risk factor in patients undergoing elective joint replacement surgery. Demand for elective joint replacement is expected to increase over time, and reducing the risk of postoperative complications is essential in order to optimize functional outcomes and reduce healthcare costs.

Study design: Retrospective cohort.

Setting: Five regions of the Kaiser Permanente healthcare system.

Synopsis: The study included 40,491 patients aged 18 years and older who underwent primary knee replacement between January 2001 and December 2009 in five regions of the Kaiser Permanente system. Patients were identified using the Kaiser Permanente Total Joint Replacement Registry. Clinical information on each patient was collected from two years before the procedure to one year after the procedure using Kaiser Permanente electronic health records. Subjects were classified as nondiabetic (81.3%), diabetic with good glycemic control (12.5%), or diabetic with poor glycemic control (6.2%). Glycemic control status was assessed using the latest hemoglobin A1c (HbA1c) value measured prior to the date of the index surgery, with HbA1c <7.0% defined as good glycemic control. Outcomes included revision arthroplasty, deep infection, DVT or PE, incident myocardial infarction, and rehospitalization.

There was no significant association identified between uncontrolled diabetes and any of the five outcomes.

Limitations of the study include retrospective design, rarity of all outcomes except all-cause rehospitalization, and the small number of patients with uncontrolled diabetes in the cohort. In addition, functional outcomes were not assessed in this study.

Bottom line: The effect of uncontrolled diabetes on the risk of adverse surgical outcomes following elective joint replacement remains unclear based on currently published data; more studies are needed.

Citation: Adams AL, Paxton EW, Wang JQ, et al. Surgical outcomes of total knee replacement according to diabetes status and glycemic control, 2001-2009. J Bone Joint Surg Am. 2013;95:481-487.

Clinical question: Does uncontrolled diabetes mellitus increase risk for post-operative complications after elective joint replacement surgery?

Background: Several previous studies suggested that patients with uncontrolled diabetes could be at higher risk of postoperative complications and have worse functional outcomes after joint replacement surgery than patients without diabetes. Preoperative glycemic control is a potentially modifiable risk factor in patients undergoing elective joint replacement surgery. Demand for elective joint replacement is expected to increase over time, and reducing the risk of postoperative complications is essential in order to optimize functional outcomes and reduce healthcare costs.

Study design: Retrospective cohort.

Setting: Five regions of the Kaiser Permanente healthcare system.

Synopsis: The study included 40,491 patients aged 18 years and older who underwent primary knee replacement between January 2001 and December 2009 in five regions of the Kaiser Permanente system. Patients were identified using the Kaiser Permanente Total Joint Replacement Registry. Clinical information on each patient was collected from two years before the procedure to one year after the procedure using Kaiser Permanente electronic health records. Subjects were classified as nondiabetic (81.3%), diabetic with good glycemic control (12.5%), or diabetic with poor glycemic control (6.2%). Glycemic control status was assessed using the latest hemoglobin A1c (HbA1c) value measured prior to the date of the index surgery, with HbA1c <7.0% defined as good glycemic control. Outcomes included revision arthroplasty, deep infection, DVT or PE, incident myocardial infarction, and rehospitalization.

There was no significant association identified between uncontrolled diabetes and any of the five outcomes.

Limitations of the study include retrospective design, rarity of all outcomes except all-cause rehospitalization, and the small number of patients with uncontrolled diabetes in the cohort. In addition, functional outcomes were not assessed in this study.

Bottom line: The effect of uncontrolled diabetes on the risk of adverse surgical outcomes following elective joint replacement remains unclear based on currently published data; more studies are needed.

Citation: Adams AL, Paxton EW, Wang JQ, et al. Surgical outcomes of total knee replacement according to diabetes status and glycemic control, 2001-2009. J Bone Joint Surg Am. 2013;95:481-487.

Clinical question: Does uncontrolled diabetes mellitus increase risk for post-operative complications after elective joint replacement surgery?

Background: Several previous studies suggested that patients with uncontrolled diabetes could be at higher risk of postoperative complications and have worse functional outcomes after joint replacement surgery than patients without diabetes. Preoperative glycemic control is a potentially modifiable risk factor in patients undergoing elective joint replacement surgery. Demand for elective joint replacement is expected to increase over time, and reducing the risk of postoperative complications is essential in order to optimize functional outcomes and reduce healthcare costs.

Study design: Retrospective cohort.

Setting: Five regions of the Kaiser Permanente healthcare system.

Synopsis: The study included 40,491 patients aged 18 years and older who underwent primary knee replacement between January 2001 and December 2009 in five regions of the Kaiser Permanente system. Patients were identified using the Kaiser Permanente Total Joint Replacement Registry. Clinical information on each patient was collected from two years before the procedure to one year after the procedure using Kaiser Permanente electronic health records. Subjects were classified as nondiabetic (81.3%), diabetic with good glycemic control (12.5%), or diabetic with poor glycemic control (6.2%). Glycemic control status was assessed using the latest hemoglobin A1c (HbA1c) value measured prior to the date of the index surgery, with HbA1c <7.0% defined as good glycemic control. Outcomes included revision arthroplasty, deep infection, DVT or PE, incident myocardial infarction, and rehospitalization.

There was no significant association identified between uncontrolled diabetes and any of the five outcomes.

Limitations of the study include retrospective design, rarity of all outcomes except all-cause rehospitalization, and the small number of patients with uncontrolled diabetes in the cohort. In addition, functional outcomes were not assessed in this study.

Bottom line: The effect of uncontrolled diabetes on the risk of adverse surgical outcomes following elective joint replacement remains unclear based on currently published data; more studies are needed.

Citation: Adams AL, Paxton EW, Wang JQ, et al. Surgical outcomes of total knee replacement according to diabetes status and glycemic control, 2001-2009. J Bone Joint Surg Am. 2013;95:481-487.

Clinical question: What are the effects of the 2011 resident duty-hour requirements on first-year residents’ well-being and patient safety?

Background: In an effort to reduce adverse consequences associated with extended shift length and sleep deprivation, the Accreditation Council for Graduate Medical Education (ACGME) released a new set of duty-hour requirements effective July 2011. To date, little is known about the effects of the 2011 reforms on resident and patient outcomes.

Study design: Prospective, longitudinal cohort with pre-post analysis.

Setting: Residency programs from university- and community-based medical centers.

Synopsis: Fifty-one residency programs from 10 university-based and four community-based GME institutions were included. Incoming interns during the 2009, 2010, and 2011 academic years were invited to participate, and 58% (n=2,323) agreed to take part. Participants completed online surveys two months before starting their first residency (intern) year and at three, six, nine, and 12 months of internship. Questions addressed work hours, sleep, medical errors, depressive symptoms, and subjective well-being.

No significant differences in baseline findings were found between the pre-implementation cohort (interns entering in 2009 and 2010) and the post-implementation cohort (interns starting in 2011, following the new duty-hour requirements). Interns in the post-implementation cohort worked fewer hours than those in the pre-implementation cohort (mean hours per week 64.3 vs. 67.0, P<0.001). There were no significant changes in reported hours of sleep, depressive symptom score, or well-being score between the pre- and post-implementation cohorts. The percentage of respondents who reported committing a serious medical error increased in the post-implementation group (23.3% vs. 19.9%, P=0.007).

Limitations include the self-reported nature of the responses and the modest participation rate. The authors concluded that although the 2011 reforms decreased the total number of hours worked, additional strategies could be needed to achieve the desired effects on intern well-being and patient safety.

Bottom line: Following implementation of the 2011 ACGME duty-hour reforms, interns from diverse specialties and institutions experienced reductions in self-reported work hours, without any associated improvements in sleep, depressive symptoms, or well-being and with an increase in reported medical errors.

Citation: Sen S, Kranzler HR, Didwania AK, et al. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013;173(8):657-662.

Clinical question: What are the effects of the 2011 resident duty-hour requirements on first-year residents’ well-being and patient safety?

Background: In an effort to reduce adverse consequences associated with extended shift length and sleep deprivation, the Accreditation Council for Graduate Medical Education (ACGME) released a new set of duty-hour requirements effective July 2011. To date, little is known about the effects of the 2011 reforms on resident and patient outcomes.

Study design: Prospective, longitudinal cohort with pre-post analysis.

Setting: Residency programs from university- and community-based medical centers.

Synopsis: Fifty-one residency programs from 10 university-based and four community-based GME institutions were included. Incoming interns during the 2009, 2010, and 2011 academic years were invited to participate, and 58% (n=2,323) agreed to take part. Participants completed online surveys two months before starting their first residency (intern) year and at three, six, nine, and 12 months of internship. Questions addressed work hours, sleep, medical errors, depressive symptoms, and subjective well-being.

No significant differences in baseline findings were found between the pre-implementation cohort (interns entering in 2009 and 2010) and the post-implementation cohort (interns starting in 2011, following the new duty-hour requirements). Interns in the post-implementation cohort worked fewer hours than those in the pre-implementation cohort (mean hours per week 64.3 vs. 67.0, P<0.001). There were no significant changes in reported hours of sleep, depressive symptom score, or well-being score between the pre- and post-implementation cohorts. The percentage of respondents who reported committing a serious medical error increased in the post-implementation group (23.3% vs. 19.9%, P=0.007).

Limitations include the self-reported nature of the responses and the modest participation rate. The authors concluded that although the 2011 reforms decreased the total number of hours worked, additional strategies could be needed to achieve the desired effects on intern well-being and patient safety.

Bottom line: Following implementation of the 2011 ACGME duty-hour reforms, interns from diverse specialties and institutions experienced reductions in self-reported work hours, without any associated improvements in sleep, depressive symptoms, or well-being and with an increase in reported medical errors.

Citation: Sen S, Kranzler HR, Didwania AK, et al. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013;173(8):657-662.

Clinical question: What are the effects of the 2011 resident duty-hour requirements on first-year residents’ well-being and patient safety?

Background: In an effort to reduce adverse consequences associated with extended shift length and sleep deprivation, the Accreditation Council for Graduate Medical Education (ACGME) released a new set of duty-hour requirements effective July 2011. To date, little is known about the effects of the 2011 reforms on resident and patient outcomes.

Study design: Prospective, longitudinal cohort with pre-post analysis.

Setting: Residency programs from university- and community-based medical centers.

Synopsis: Fifty-one residency programs from 10 university-based and four community-based GME institutions were included. Incoming interns during the 2009, 2010, and 2011 academic years were invited to participate, and 58% (n=2,323) agreed to take part. Participants completed online surveys two months before starting their first residency (intern) year and at three, six, nine, and 12 months of internship. Questions addressed work hours, sleep, medical errors, depressive symptoms, and subjective well-being.

No significant differences in baseline findings were found between the pre-implementation cohort (interns entering in 2009 and 2010) and the post-implementation cohort (interns starting in 2011, following the new duty-hour requirements). Interns in the post-implementation cohort worked fewer hours than those in the pre-implementation cohort (mean hours per week 64.3 vs. 67.0, P<0.001). There were no significant changes in reported hours of sleep, depressive symptom score, or well-being score between the pre- and post-implementation cohorts. The percentage of respondents who reported committing a serious medical error increased in the post-implementation group (23.3% vs. 19.9%, P=0.007).

Limitations include the self-reported nature of the responses and the modest participation rate. The authors concluded that although the 2011 reforms decreased the total number of hours worked, additional strategies could be needed to achieve the desired effects on intern well-being and patient safety.

Bottom line: Following implementation of the 2011 ACGME duty-hour reforms, interns from diverse specialties and institutions experienced reductions in self-reported work hours, without any associated improvements in sleep, depressive symptoms, or well-being and with an increase in reported medical errors.

Citation: Sen S, Kranzler HR, Didwania AK, et al. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013;173(8):657-662.

Clinical question: Are high plasma lactate levels associated with mortality and clinical deterioration among patients with acute pulmonary embolism (PE)?

Background: Prognostic clinical markers are limited in patients presenting with acute PE, especially among normotensive individuals. Plasma lactate concentration is a marker of tissue hypoperfusion that has been used to risk-stratify patients with sepsis and trauma. It is unknown whether elevated lactate levels predict poor outcomes in acute PE.

Study design: Prospective cohort.

Setting: ED in a large teaching hospital in Italy.

Synopsis: Consecutive adult patients with acute PE diagnosed by spiral computed tomography or lung scan were included. Plasma lactate levels were tested in all patients at presentation, and levels of ≥2 mmol/L were considered abnormal. The primary endpoint was all-cause death within 30 days, and the secondary endpoint was the composite of all-cause death and PE-related clinical deterioration and death.

Of the 270 patients, 81 (30%) had abnormal lactate levels, though only 12 (4.4%) had shock or hypotension. Patients with elevated lactate had higher mortality compared with patients with lower levels (17.3% vs. 1.6%, OR 12.95, 95% CI 3.43-58.73). Plasma lactate ≥2 mmol/L was associated with higher all-cause mortality (HR 11.67, 95% CI 3.32-41.03) and the composite endpoint (HR 8.14, 95% CI 3.83-17.34). This association was independent of the presence of hypotension, right ventricular dysfunction, or elevated troponin.

Limitations include the single study site (which limits generalizability of the findings) and that lactate levels were only checked once (which might not have fully reflected each patient’s clinical picture). The authors suggest that plasma lactate levels might have utility in determining which patients should be treated more aggressively for PE.

Bottom line: In patients presenting with acute PE, elevated plasma lactate levels are associated with increased risk of short-term mortality and morbidity, independent of the presence of hypotension or markers of right ventricular injury.

Citation: Vanni S, Viviani G, Baioni M, et al. Prognostic value of plasma lactate levels among patients with acute pulmonary embolism: the thrombo-embolism lactate outcome study. Ann Emerg Med. 2013;61:330-338.

Clinical question: Are high plasma lactate levels associated with mortality and clinical deterioration among patients with acute pulmonary embolism (PE)?

Background: Prognostic clinical markers are limited in patients presenting with acute PE, especially among normotensive individuals. Plasma lactate concentration is a marker of tissue hypoperfusion that has been used to risk-stratify patients with sepsis and trauma. It is unknown whether elevated lactate levels predict poor outcomes in acute PE.

Study design: Prospective cohort.

Setting: ED in a large teaching hospital in Italy.

Synopsis: Consecutive adult patients with acute PE diagnosed by spiral computed tomography or lung scan were included. Plasma lactate levels were tested in all patients at presentation, and levels of ≥2 mmol/L were considered abnormal. The primary endpoint was all-cause death within 30 days, and the secondary endpoint was the composite of all-cause death and PE-related clinical deterioration and death.

Of the 270 patients, 81 (30%) had abnormal lactate levels, though only 12 (4.4%) had shock or hypotension. Patients with elevated lactate had higher mortality compared with patients with lower levels (17.3% vs. 1.6%, OR 12.95, 95% CI 3.43-58.73). Plasma lactate ≥2 mmol/L was associated with higher all-cause mortality (HR 11.67, 95% CI 3.32-41.03) and the composite endpoint (HR 8.14, 95% CI 3.83-17.34). This association was independent of the presence of hypotension, right ventricular dysfunction, or elevated troponin.

Limitations include the single study site (which limits generalizability of the findings) and that lactate levels were only checked once (which might not have fully reflected each patient’s clinical picture). The authors suggest that plasma lactate levels might have utility in determining which patients should be treated more aggressively for PE.

Bottom line: In patients presenting with acute PE, elevated plasma lactate levels are associated with increased risk of short-term mortality and morbidity, independent of the presence of hypotension or markers of right ventricular injury.

Citation: Vanni S, Viviani G, Baioni M, et al. Prognostic value of plasma lactate levels among patients with acute pulmonary embolism: the thrombo-embolism lactate outcome study. Ann Emerg Med. 2013;61:330-338.

Clinical question: Are high plasma lactate levels associated with mortality and clinical deterioration among patients with acute pulmonary embolism (PE)?

Background: Prognostic clinical markers are limited in patients presenting with acute PE, especially among normotensive individuals. Plasma lactate concentration is a marker of tissue hypoperfusion that has been used to risk-stratify patients with sepsis and trauma. It is unknown whether elevated lactate levels predict poor outcomes in acute PE.

Study design: Prospective cohort.

Setting: ED in a large teaching hospital in Italy.

Synopsis: Consecutive adult patients with acute PE diagnosed by spiral computed tomography or lung scan were included. Plasma lactate levels were tested in all patients at presentation, and levels of ≥2 mmol/L were considered abnormal. The primary endpoint was all-cause death within 30 days, and the secondary endpoint was the composite of all-cause death and PE-related clinical deterioration and death.

Of the 270 patients, 81 (30%) had abnormal lactate levels, though only 12 (4.4%) had shock or hypotension. Patients with elevated lactate had higher mortality compared with patients with lower levels (17.3% vs. 1.6%, OR 12.95, 95% CI 3.43-58.73). Plasma lactate ≥2 mmol/L was associated with higher all-cause mortality (HR 11.67, 95% CI 3.32-41.03) and the composite endpoint (HR 8.14, 95% CI 3.83-17.34). This association was independent of the presence of hypotension, right ventricular dysfunction, or elevated troponin.

Limitations include the single study site (which limits generalizability of the findings) and that lactate levels were only checked once (which might not have fully reflected each patient’s clinical picture). The authors suggest that plasma lactate levels might have utility in determining which patients should be treated more aggressively for PE.

Bottom line: In patients presenting with acute PE, elevated plasma lactate levels are associated with increased risk of short-term mortality and morbidity, independent of the presence of hypotension or markers of right ventricular injury.

Citation: Vanni S, Viviani G, Baioni M, et al. Prognostic value of plasma lactate levels among patients with acute pulmonary embolism: the thrombo-embolism lactate outcome study. Ann Emerg Med. 2013;61:330-338.

Clinical question: How often do inpatient providers report direct communication with outpatient providers, and how is direct communication associated with 30-day readmissions?

Background: Studies have demonstrated that adverse events and errors occurring after hospital discharge can result from poor provider communication between the inpatient and outpatient setting.

Study design: Prospective cohort.

Setting: Johns Hopkins Hospital, Baltimore.

Synopsis: The presence or absence of direct communication between inpatient and outpatient healthcare providers was captured from a required field in an electronic discharge worksheet completed by the discharging physician. Of 6,635 hospitalizations studied, successful direct communication was reported in 36.7% of cases. Predictors of successful direct communication included patients cared for by hospitalists without house staff (OR 1.81, 95% CI 1.59-2.08), high expected 30-day readmission rate (OR 1.18, 95% CI 1.10-1.28), and insurance by Medicare (OR 1.35, 95% CI 1.16-1.56) and private insurance companies (OR 1.35, 95% CI 1.18-1.56). In adjusted analyses, direct communication between the inpatient and outpatient providers was not associated with 30-day readmissions (OR 1.08, 95% CI 0.92-1.26).

There were several limitations in this study. Only the primary team was surveyed; thus, it is not known if consulting providers might have contacted the outpatient providers. Only readmissions to the same medical center were studied, and therefore it is not known if patients were readmitted to other facilities. Additionally, information regarding discharge communication was self-reported, which might have introduced bias.

Bottom line: Self-reported direct communication between inpatient and outpatient providers occurred infrequently and was not associated with 30-day same-hospital readmission.

Citation: Oduyebo I, Lehmann C, Pollack C, et al. Association of self-reported hospital discharge handoffs with 30-day readmissions. JAMA Intern Med. 2013;173:624-629.

Clinical question: How often do inpatient providers report direct communication with outpatient providers, and how is direct communication associated with 30-day readmissions?

Background: Studies have demonstrated that adverse events and errors occurring after hospital discharge can result from poor provider communication between the inpatient and outpatient setting.

Study design: Prospective cohort.

Setting: Johns Hopkins Hospital, Baltimore.

Synopsis: The presence or absence of direct communication between inpatient and outpatient healthcare providers was captured from a required field in an electronic discharge worksheet completed by the discharging physician. Of 6,635 hospitalizations studied, successful direct communication was reported in 36.7% of cases. Predictors of successful direct communication included patients cared for by hospitalists without house staff (OR 1.81, 95% CI 1.59-2.08), high expected 30-day readmission rate (OR 1.18, 95% CI 1.10-1.28), and insurance by Medicare (OR 1.35, 95% CI 1.16-1.56) and private insurance companies (OR 1.35, 95% CI 1.18-1.56). In adjusted analyses, direct communication between the inpatient and outpatient providers was not associated with 30-day readmissions (OR 1.08, 95% CI 0.92-1.26).

There were several limitations in this study. Only the primary team was surveyed; thus, it is not known if consulting providers might have contacted the outpatient providers. Only readmissions to the same medical center were studied, and therefore it is not known if patients were readmitted to other facilities. Additionally, information regarding discharge communication was self-reported, which might have introduced bias.

Bottom line: Self-reported direct communication between inpatient and outpatient providers occurred infrequently and was not associated with 30-day same-hospital readmission.

Citation: Oduyebo I, Lehmann C, Pollack C, et al. Association of self-reported hospital discharge handoffs with 30-day readmissions. JAMA Intern Med. 2013;173:624-629.

Clinical question: How often do inpatient providers report direct communication with outpatient providers, and how is direct communication associated with 30-day readmissions?

Background: Studies have demonstrated that adverse events and errors occurring after hospital discharge can result from poor provider communication between the inpatient and outpatient setting.

Study design: Prospective cohort.

Setting: Johns Hopkins Hospital, Baltimore.

Synopsis: The presence or absence of direct communication between inpatient and outpatient healthcare providers was captured from a required field in an electronic discharge worksheet completed by the discharging physician. Of 6,635 hospitalizations studied, successful direct communication was reported in 36.7% of cases. Predictors of successful direct communication included patients cared for by hospitalists without house staff (OR 1.81, 95% CI 1.59-2.08), high expected 30-day readmission rate (OR 1.18, 95% CI 1.10-1.28), and insurance by Medicare (OR 1.35, 95% CI 1.16-1.56) and private insurance companies (OR 1.35, 95% CI 1.18-1.56). In adjusted analyses, direct communication between the inpatient and outpatient providers was not associated with 30-day readmissions (OR 1.08, 95% CI 0.92-1.26).

There were several limitations in this study. Only the primary team was surveyed; thus, it is not known if consulting providers might have contacted the outpatient providers. Only readmissions to the same medical center were studied, and therefore it is not known if patients were readmitted to other facilities. Additionally, information regarding discharge communication was self-reported, which might have introduced bias.

Bottom line: Self-reported direct communication between inpatient and outpatient providers occurred infrequently and was not associated with 30-day same-hospital readmission.

Citation: Oduyebo I, Lehmann C, Pollack C, et al. Association of self-reported hospital discharge handoffs with 30-day readmissions. JAMA Intern Med. 2013;173:624-629.