SAN ANTONIO – A combination of a PI3K inhibitor and selective estrogen receptor down-regulator (SERD) met its primary endpoint of 2.1 months better progression-free survival (PFS) in postmenopausal women with locally advanced or metastatic breast cancer who were quickly running out of other treatment options.

Yet the small gain in PFS came at a very high price in terms of toxicities, including mood disorders that may have led to patient suicide attempts, according to investigators.

The BELLE-3 trial looked at the combination of the SERD fulvestrant (Faslodex) and an experimental inhibitor of the PI3 kinase, buparlisib, in postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor–2 (HER2)-negative breast cancer treated with an aromatase inhibitor (AI) who experienced disease progression either on or after receiving therapy with an inhibitor of the mammalian target of rapamycin complex 1 (mTORC1).

The combination of fulvestrant and buparlisib was associated with a median PFS of 3.9 months, compared with 1.8 months for fulvestrant and placebo (P less than .001), Angelo Di Leo, MD, of Ospedale Misericordia e Dolce in Prato, Italy, reported at the San Antonio Breast Cancer Symposium,

Objective response rates (ORR) were low, at 7.8% in the combination arm, and 2.1% in the fulvestrant-plus-placebo arm.

Although the PFS difference was statistically significant, “the higher rate of toxicity in patients receiving buparlisib and fulvestrant, including transaminase elevations and mood disorders, may represent a clinically relevant challenge for future development of this compound in this particular group of patients,” Dr. Di Leo said.
 

Blocks AKT pathway

The preclinical rationale for the use of a P13K inhibitor after disease progression on mTORC1 inhibitor is that current mTOR inhibitors such as everolimus have a feedback mechanism that activates the AKT pathway, and that the use of P13K inhibitors can “abrogate or attenuate this activation, potentially blocking that pathway,” explained coinvestigator Ruth O’Regan, MD, head of the division of hematology and oncology at the University of Wisconsin–Madison School of Medicine and Public Health. Dr. O’Regan discussed the BELLE-3 findings in a briefing prior to Dr. Di Leo’s presentation of the data in general session.

In BELLE-3, 432 postmenopausal women with HR+/HER2-, AI-pretreated, locally advanced or metastatic breast cancer that had progressed on or after treatment with an mTOR inhibitor as the last line of therapy were enrolled. The patients were stratified by the presence or absence of visceral disease and then randomized on a 2:1 basis to fulvestrant 500 mg daily plus either buparlisib 100 mg/day (289 patients), or placebo (143).

As noted, the primary endpoint of investigator-assessed PFS favored the addition of buparlisib, with a hazard ratio for progression of 0.67 (P less than .001). PFS results by independent central review were similar (HR 0.57, P less than .001).

The ORR for the buparlisib/fulvestrant combination, 7.6%, consisted of 0.3% complete responses, and 7.3% partial responses. The ORR for placebo/fulvestrant, 2.1%, was composed entirely of partial responses. The respective clinical benefit rates, defined as a combination of complete and partial responses and stable disease, were 24.6% and 15.4.

The benefit of buparlisib was evidently entirely among patients with visceral disease, with a PFS of 3.1 vs. 1.5 months. In contrast, PFS among patients with no visceral disease was 4.2 vs. 4.1 months, respectively, and was not significant.

In addition, the P13K inhibitor seemed to benefit patients with PIK3CA mutations detected in either the primary tumor or in circulating DNA samples, but not patients with wild-type PIK3CA.
 

Depression, anxiety with combination

Patients assigned to buparlisib/fulvestrant had substantially higher proportions of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations compared with patients on placebo fulvestrant, as well as more reported depression and anxiety. Three patients in the buparlisib arm attempted suicide. There were no reported suicide attempts in the placebo arm.

Dr. O’Regan said at the briefing that mood disorders are known adverse events associated with buparlisib, and that patients with psychiatric disorders were excluded from the trial.

Carlos Arteaga, MD, co-leader of the Breast Cancer Research Program at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., who moderated the briefing, said in an interview that PI kinase mutations do not appear to be a good target, and that a pan-PIK3 inhibitor such as buparlisib may be hitting too many targets at once.

Inhibiting all of the PIK3 isoforms – alpha, beta, gamma, and delta – “may be a little too tough,” he said.

The trial should serve as impetus for developing agents that inhibit only the alpha isoform of PIK3 which mutates and appears to be the driver of some types of breast cancer, he said.

Following Dr. Di Leo’s presentation, perennial SABCS gadfly Steven Vogl, MD, New York, told the speaker that “you presented this very nicely, it’s very interesting biology. I don’t think you’d want to do this again to a human, right? Three month prolongation in PFS, miserable, with diarrhea, depression – you don’t want to do this again, is that correct?”

“I think buparlisib is probably not the best compound to be used in this particular setting of patients,” Dr. Di Leo said, but added that a better-tolerated PI3K inhibitor might be more effective.

“Actually, the study is raising an important question: Should we use the PI3K inhibitor in place of the mTOR inhibitor, or perhaps, as the study suggests, should we use the P13K inhibitors sequentially, after the mTOR inhibitor. This is an open question,” he replied.

Novartis sponsored the study. Dr. Di Leo disclosed consulting and lecture fees from the company, and Dr. O’Regan disclosed contracted research support. Dr. Arteaga reported no disclosures relevant to the study.

[email protected]

SAN ANTONIO – A combination of a PI3K inhibitor and selective estrogen receptor down-regulator (SERD) met its primary endpoint of 2.1 months better progression-free survival (PFS) in postmenopausal women with locally advanced or metastatic breast cancer who were quickly running out of other treatment options.

Yet the small gain in PFS came at a very high price in terms of toxicities, including mood disorders that may have led to patient suicide attempts, according to investigators.

The BELLE-3 trial looked at the combination of the SERD fulvestrant (Faslodex) and an experimental inhibitor of the PI3 kinase, buparlisib, in postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor–2 (HER2)-negative breast cancer treated with an aromatase inhibitor (AI) who experienced disease progression either on or after receiving therapy with an inhibitor of the mammalian target of rapamycin complex 1 (mTORC1).

The combination of fulvestrant and buparlisib was associated with a median PFS of 3.9 months, compared with 1.8 months for fulvestrant and placebo (P less than .001), Angelo Di Leo, MD, of Ospedale Misericordia e Dolce in Prato, Italy, reported at the San Antonio Breast Cancer Symposium,

Objective response rates (ORR) were low, at 7.8% in the combination arm, and 2.1% in the fulvestrant-plus-placebo arm.

Although the PFS difference was statistically significant, “the higher rate of toxicity in patients receiving buparlisib and fulvestrant, including transaminase elevations and mood disorders, may represent a clinically relevant challenge for future development of this compound in this particular group of patients,” Dr. Di Leo said.
 

Blocks AKT pathway

The preclinical rationale for the use of a P13K inhibitor after disease progression on mTORC1 inhibitor is that current mTOR inhibitors such as everolimus have a feedback mechanism that activates the AKT pathway, and that the use of P13K inhibitors can “abrogate or attenuate this activation, potentially blocking that pathway,” explained coinvestigator Ruth O’Regan, MD, head of the division of hematology and oncology at the University of Wisconsin–Madison School of Medicine and Public Health. Dr. O’Regan discussed the BELLE-3 findings in a briefing prior to Dr. Di Leo’s presentation of the data in general session.

In BELLE-3, 432 postmenopausal women with HR+/HER2-, AI-pretreated, locally advanced or metastatic breast cancer that had progressed on or after treatment with an mTOR inhibitor as the last line of therapy were enrolled. The patients were stratified by the presence or absence of visceral disease and then randomized on a 2:1 basis to fulvestrant 500 mg daily plus either buparlisib 100 mg/day (289 patients), or placebo (143).

As noted, the primary endpoint of investigator-assessed PFS favored the addition of buparlisib, with a hazard ratio for progression of 0.67 (P less than .001). PFS results by independent central review were similar (HR 0.57, P less than .001).

The ORR for the buparlisib/fulvestrant combination, 7.6%, consisted of 0.3% complete responses, and 7.3% partial responses. The ORR for placebo/fulvestrant, 2.1%, was composed entirely of partial responses. The respective clinical benefit rates, defined as a combination of complete and partial responses and stable disease, were 24.6% and 15.4.

The benefit of buparlisib was evidently entirely among patients with visceral disease, with a PFS of 3.1 vs. 1.5 months. In contrast, PFS among patients with no visceral disease was 4.2 vs. 4.1 months, respectively, and was not significant.

In addition, the P13K inhibitor seemed to benefit patients with PIK3CA mutations detected in either the primary tumor or in circulating DNA samples, but not patients with wild-type PIK3CA.
 

Depression, anxiety with combination

Patients assigned to buparlisib/fulvestrant had substantially higher proportions of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations compared with patients on placebo fulvestrant, as well as more reported depression and anxiety. Three patients in the buparlisib arm attempted suicide. There were no reported suicide attempts in the placebo arm.

Dr. O’Regan said at the briefing that mood disorders are known adverse events associated with buparlisib, and that patients with psychiatric disorders were excluded from the trial.

Carlos Arteaga, MD, co-leader of the Breast Cancer Research Program at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., who moderated the briefing, said in an interview that PI kinase mutations do not appear to be a good target, and that a pan-PIK3 inhibitor such as buparlisib may be hitting too many targets at once.

Inhibiting all of the PIK3 isoforms – alpha, beta, gamma, and delta – “may be a little too tough,” he said.

The trial should serve as impetus for developing agents that inhibit only the alpha isoform of PIK3 which mutates and appears to be the driver of some types of breast cancer, he said.

Following Dr. Di Leo’s presentation, perennial SABCS gadfly Steven Vogl, MD, New York, told the speaker that “you presented this very nicely, it’s very interesting biology. I don’t think you’d want to do this again to a human, right? Three month prolongation in PFS, miserable, with diarrhea, depression – you don’t want to do this again, is that correct?”

“I think buparlisib is probably not the best compound to be used in this particular setting of patients,” Dr. Di Leo said, but added that a better-tolerated PI3K inhibitor might be more effective.

“Actually, the study is raising an important question: Should we use the PI3K inhibitor in place of the mTOR inhibitor, or perhaps, as the study suggests, should we use the P13K inhibitors sequentially, after the mTOR inhibitor. This is an open question,” he replied.

Novartis sponsored the study. Dr. Di Leo disclosed consulting and lecture fees from the company, and Dr. O’Regan disclosed contracted research support. Dr. Arteaga reported no disclosures relevant to the study.

[email protected]

SAN ANTONIO – A combination of a PI3K inhibitor and selective estrogen receptor down-regulator (SERD) met its primary endpoint of 2.1 months better progression-free survival (PFS) in postmenopausal women with locally advanced or metastatic breast cancer who were quickly running out of other treatment options.

Yet the small gain in PFS came at a very high price in terms of toxicities, including mood disorders that may have led to patient suicide attempts, according to investigators.

The BELLE-3 trial looked at the combination of the SERD fulvestrant (Faslodex) and an experimental inhibitor of the PI3 kinase, buparlisib, in postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor–2 (HER2)-negative breast cancer treated with an aromatase inhibitor (AI) who experienced disease progression either on or after receiving therapy with an inhibitor of the mammalian target of rapamycin complex 1 (mTORC1).

The combination of fulvestrant and buparlisib was associated with a median PFS of 3.9 months, compared with 1.8 months for fulvestrant and placebo (P less than .001), Angelo Di Leo, MD, of Ospedale Misericordia e Dolce in Prato, Italy, reported at the San Antonio Breast Cancer Symposium,

Objective response rates (ORR) were low, at 7.8% in the combination arm, and 2.1% in the fulvestrant-plus-placebo arm.

Although the PFS difference was statistically significant, “the higher rate of toxicity in patients receiving buparlisib and fulvestrant, including transaminase elevations and mood disorders, may represent a clinically relevant challenge for future development of this compound in this particular group of patients,” Dr. Di Leo said.
 

Blocks AKT pathway

The preclinical rationale for the use of a P13K inhibitor after disease progression on mTORC1 inhibitor is that current mTOR inhibitors such as everolimus have a feedback mechanism that activates the AKT pathway, and that the use of P13K inhibitors can “abrogate or attenuate this activation, potentially blocking that pathway,” explained coinvestigator Ruth O’Regan, MD, head of the division of hematology and oncology at the University of Wisconsin–Madison School of Medicine and Public Health. Dr. O’Regan discussed the BELLE-3 findings in a briefing prior to Dr. Di Leo’s presentation of the data in general session.

In BELLE-3, 432 postmenopausal women with HR+/HER2-, AI-pretreated, locally advanced or metastatic breast cancer that had progressed on or after treatment with an mTOR inhibitor as the last line of therapy were enrolled. The patients were stratified by the presence or absence of visceral disease and then randomized on a 2:1 basis to fulvestrant 500 mg daily plus either buparlisib 100 mg/day (289 patients), or placebo (143).

As noted, the primary endpoint of investigator-assessed PFS favored the addition of buparlisib, with a hazard ratio for progression of 0.67 (P less than .001). PFS results by independent central review were similar (HR 0.57, P less than .001).

The ORR for the buparlisib/fulvestrant combination, 7.6%, consisted of 0.3% complete responses, and 7.3% partial responses. The ORR for placebo/fulvestrant, 2.1%, was composed entirely of partial responses. The respective clinical benefit rates, defined as a combination of complete and partial responses and stable disease, were 24.6% and 15.4.

The benefit of buparlisib was evidently entirely among patients with visceral disease, with a PFS of 3.1 vs. 1.5 months. In contrast, PFS among patients with no visceral disease was 4.2 vs. 4.1 months, respectively, and was not significant.

In addition, the P13K inhibitor seemed to benefit patients with PIK3CA mutations detected in either the primary tumor or in circulating DNA samples, but not patients with wild-type PIK3CA.
 

Depression, anxiety with combination

Patients assigned to buparlisib/fulvestrant had substantially higher proportions of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations compared with patients on placebo fulvestrant, as well as more reported depression and anxiety. Three patients in the buparlisib arm attempted suicide. There were no reported suicide attempts in the placebo arm.

Dr. O’Regan said at the briefing that mood disorders are known adverse events associated with buparlisib, and that patients with psychiatric disorders were excluded from the trial.

Carlos Arteaga, MD, co-leader of the Breast Cancer Research Program at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., who moderated the briefing, said in an interview that PI kinase mutations do not appear to be a good target, and that a pan-PIK3 inhibitor such as buparlisib may be hitting too many targets at once.

Inhibiting all of the PIK3 isoforms – alpha, beta, gamma, and delta – “may be a little too tough,” he said.

The trial should serve as impetus for developing agents that inhibit only the alpha isoform of PIK3 which mutates and appears to be the driver of some types of breast cancer, he said.

Following Dr. Di Leo’s presentation, perennial SABCS gadfly Steven Vogl, MD, New York, told the speaker that “you presented this very nicely, it’s very interesting biology. I don’t think you’d want to do this again to a human, right? Three month prolongation in PFS, miserable, with diarrhea, depression – you don’t want to do this again, is that correct?”

“I think buparlisib is probably not the best compound to be used in this particular setting of patients,” Dr. Di Leo said, but added that a better-tolerated PI3K inhibitor might be more effective.

“Actually, the study is raising an important question: Should we use the PI3K inhibitor in place of the mTOR inhibitor, or perhaps, as the study suggests, should we use the P13K inhibitors sequentially, after the mTOR inhibitor. This is an open question,” he replied.

Novartis sponsored the study. Dr. Di Leo disclosed consulting and lecture fees from the company, and Dr. O’Regan disclosed contracted research support. Dr. Arteaga reported no disclosures relevant to the study.

[email protected]

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

The Patient INFO Center, AGA’s digital library of patient education, continues to grow and expand. As new topics and educational resources are added, there are also opportunities to enhance the experience of using the library to better connect with patients.

In addition to electronic health record systems Athena, Cerner, and EPIC, you can now integrate AGA’s patient education materials into gMed. Based on member feedback and popular demand, AGA created instructions with gMed consultants and tested them with members to ensure accuracy and ease of use.

Check out the newly added gMed instructions and everything else the Patient INFO Center has to offer.

Have thoughts on the Patient INFO Center? Email [email protected].
 

[email protected]

The Patient INFO Center, AGA’s digital library of patient education, continues to grow and expand. As new topics and educational resources are added, there are also opportunities to enhance the experience of using the library to better connect with patients.

In addition to electronic health record systems Athena, Cerner, and EPIC, you can now integrate AGA’s patient education materials into gMed. Based on member feedback and popular demand, AGA created instructions with gMed consultants and tested them with members to ensure accuracy and ease of use.

Check out the newly added gMed instructions and everything else the Patient INFO Center has to offer.

Have thoughts on the Patient INFO Center? Email [email protected].
 

[email protected]

The Patient INFO Center, AGA’s digital library of patient education, continues to grow and expand. As new topics and educational resources are added, there are also opportunities to enhance the experience of using the library to better connect with patients.

In addition to electronic health record systems Athena, Cerner, and EPIC, you can now integrate AGA’s patient education materials into gMed. Based on member feedback and popular demand, AGA created instructions with gMed consultants and tested them with members to ensure accuracy and ease of use.

Check out the newly added gMed instructions and everything else the Patient INFO Center has to offer.

Have thoughts on the Patient INFO Center? Email [email protected].
 

[email protected]

As many as one in six patients with early-onset colorectal cancer (CRC) have a pathogenic genetic mutation, but around one-third of these patients may not have met the criteria for genetic testing for at least one of their mutations under current guidelines, researchers say.

Rachel Pearlman, MS, CGC, of The Ohio State University Comprehensive Cancer Center, and her coauthors reported the results of multigene panel testing of 450 patients aged under 50 years, from 51 institutions, who had been diagnosed with CRC (JAMA Oncol 2016 Dec 15. doi: 10.1001/jamaoncol.2016.5194).
 

Overall, 16% of patients were found to have a pathogenic or likely pathogenic cancer susceptibility gene mutations, with 83.3% having at least one gene mutation.

Thirty-seven patients had Lynch syndrome; 13 were MLH1, 16 were LSH2, 1 patient was MSH2/monoallelic MUTYH; 2 were MSH6, and 5 were PMS2.

“While the prevalence of Lynch syndrome reported herein (8.4%) is consistent with previous publications, this is the first study to our knowledge to determine the prevalence and spectrum of other hereditary cancer syndromes (8%) found in an unselected series of patients with early-onset CRC,” the authors wrote.

copyright kgtoh/Thinkstock

As many as one in six patients with early-onset colorectal cancer (CRC) have a pathogenic genetic mutation, but around one-third of these patients may not have met the criteria for genetic testing for at least one of their mutations under current guidelines, researchers say.

Rachel Pearlman, MS, CGC, of The Ohio State University Comprehensive Cancer Center, and her coauthors reported the results of multigene panel testing of 450 patients aged under 50 years, from 51 institutions, who had been diagnosed with CRC (JAMA Oncol 2016 Dec 15. doi: 10.1001/jamaoncol.2016.5194).
 

Overall, 16% of patients were found to have a pathogenic or likely pathogenic cancer susceptibility gene mutations, with 83.3% having at least one gene mutation.

Thirty-seven patients had Lynch syndrome; 13 were MLH1, 16 were LSH2, 1 patient was MSH2/monoallelic MUTYH; 2 were MSH6, and 5 were PMS2.

“While the prevalence of Lynch syndrome reported herein (8.4%) is consistent with previous publications, this is the first study to our knowledge to determine the prevalence and spectrum of other hereditary cancer syndromes (8%) found in an unselected series of patients with early-onset CRC,” the authors wrote.

copyright kgtoh/Thinkstock

As many as one in six patients with early-onset colorectal cancer (CRC) have a pathogenic genetic mutation, but around one-third of these patients may not have met the criteria for genetic testing for at least one of their mutations under current guidelines, researchers say.

Rachel Pearlman, MS, CGC, of The Ohio State University Comprehensive Cancer Center, and her coauthors reported the results of multigene panel testing of 450 patients aged under 50 years, from 51 institutions, who had been diagnosed with CRC (JAMA Oncol 2016 Dec 15. doi: 10.1001/jamaoncol.2016.5194).
 

Overall, 16% of patients were found to have a pathogenic or likely pathogenic cancer susceptibility gene mutations, with 83.3% having at least one gene mutation.

Thirty-seven patients had Lynch syndrome; 13 were MLH1, 16 were LSH2, 1 patient was MSH2/monoallelic MUTYH; 2 were MSH6, and 5 were PMS2.

“While the prevalence of Lynch syndrome reported herein (8.4%) is consistent with previous publications, this is the first study to our knowledge to determine the prevalence and spectrum of other hereditary cancer syndromes (8%) found in an unselected series of patients with early-onset CRC,” the authors wrote.

copyright kgtoh/Thinkstock

While type 2 diabetes (T2D) is commonly seen in primary care, it is difficult to manage successfully over time. This series offers brief eNewsletters written by clinical experts that are designed to assist in the clinical management of patients with T2D.

Click here to read the supplement

While type 2 diabetes (T2D) is commonly seen in primary care, it is difficult to manage successfully over time. This series offers brief eNewsletters written by clinical experts that are designed to assist in the clinical management of patients with T2D.

Click here to read the supplement

While type 2 diabetes (T2D) is commonly seen in primary care, it is difficult to manage successfully over time. This series offers brief eNewsletters written by clinical experts that are designed to assist in the clinical management of patients with T2D.

Click here to read the supplement

Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

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Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

[email protected]

Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

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As we start off 2017, you’re probably thinking about how to plan for the implementation of MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which begins Jan. 1. While the process might seem overwhelming, AGA is here to provide five steps that you can take to prepare yourself and your practice.

1. Meet 2016 Physician Quality Reporting System (PQRS) reporting requirements.

2. Review your practice’s Quality and Resource Use Reports (QRURs) for 2015 and the first part of 2016. The QRUR will help you understand how you are currently being rated on cost and quality.

3. Watch your mail for a CMS letter alerting you if you’ll be considered a low-volume provider for 2017 under the Merit-based Incentive Program (MIPs) and exempt from MACRA in 2017.

4. Check Medicare Physician Compare, which will allow patients to compare providers in ways they haven’t been able to before. Brainstorm ways to improve patient communication and discover whether outside resources may need to be added to help patients stay healthy ... and happy.

5. Visit www.gastro.org/MACRA for prerecorded webinars and other AGA resources designed to help make MACRA implementation as seamless as possible.

To learn more about MACRA, visit www.gastro.org/MACRA.
 

[email protected]

As we start off 2017, you’re probably thinking about how to plan for the implementation of MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which begins Jan. 1. While the process might seem overwhelming, AGA is here to provide five steps that you can take to prepare yourself and your practice.

1. Meet 2016 Physician Quality Reporting System (PQRS) reporting requirements.

2. Review your practice’s Quality and Resource Use Reports (QRURs) for 2015 and the first part of 2016. The QRUR will help you understand how you are currently being rated on cost and quality.

3. Watch your mail for a CMS letter alerting you if you’ll be considered a low-volume provider for 2017 under the Merit-based Incentive Program (MIPs) and exempt from MACRA in 2017.

4. Check Medicare Physician Compare, which will allow patients to compare providers in ways they haven’t been able to before. Brainstorm ways to improve patient communication and discover whether outside resources may need to be added to help patients stay healthy ... and happy.

5. Visit www.gastro.org/MACRA for prerecorded webinars and other AGA resources designed to help make MACRA implementation as seamless as possible.

To learn more about MACRA, visit www.gastro.org/MACRA.
 

[email protected]

As we start off 2017, you’re probably thinking about how to plan for the implementation of MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which begins Jan. 1. While the process might seem overwhelming, AGA is here to provide five steps that you can take to prepare yourself and your practice.

1. Meet 2016 Physician Quality Reporting System (PQRS) reporting requirements.

2. Review your practice’s Quality and Resource Use Reports (QRURs) for 2015 and the first part of 2016. The QRUR will help you understand how you are currently being rated on cost and quality.

3. Watch your mail for a CMS letter alerting you if you’ll be considered a low-volume provider for 2017 under the Merit-based Incentive Program (MIPs) and exempt from MACRA in 2017.

4. Check Medicare Physician Compare, which will allow patients to compare providers in ways they haven’t been able to before. Brainstorm ways to improve patient communication and discover whether outside resources may need to be added to help patients stay healthy ... and happy.

5. Visit www.gastro.org/MACRA for prerecorded webinars and other AGA resources designed to help make MACRA implementation as seamless as possible.

To learn more about MACRA, visit www.gastro.org/MACRA.
 

[email protected]