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Fluid administration in sepsis did not increase need for dialysis
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: For every 1 mL/kg of fluid administered, the likelihood of dialysis decreased by 8.5% (OR, 0.915; 95% CI, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis.
Data source: A review of 164 septic patients.
Disclosures: The investigators had no relevant financial disclosures.
Surgical infections, early discharge hike readmissions in extrahepatic cholangiocarcinoma
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
Key clinical point:
Major finding: Organ space infections and a shorter length of stay both quadrupled the risk of a readmission.
Data source: The database review comprised 422 patients.
Disclosures: Dr. Mavros had no financial disclosures.
New mechanical ventilation guidelines unveiled
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
AT CHEST 2016
Doctors have at least seven APM options in 2017
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Study finds nonoperative management of blunt splenic injuries in elderly safe
WAIKOLOA, HAWAII – Nonoperative management of blunt splenic injuries in the geriatric population is safe, based on results from a study of national data.
Although the efficacy and safety of nonoperative management of blunt splenic injuries in adults is well established, “early recommendations stated that advanced age was a contraindication to nonoperative management of blunt splenic injuries due to high reported failure rates,” researchers led by Marc Trust, MD, wrote in an abstract presented at the annual meeting of the American Association for the Surgery of Trauma. “Although more recent literature has shown lower and acceptable failure rates, this population continues to fail more often compared to younger patients. Published data suffers from low patient numbers and is conflicting regarding future rate and safety.”
In an effort to obtain well powered, nationwide data to evaluate the recent failure rates and effect on morality among geriatric patients, Dr. Trust of the University of Texas at Austin and his associates retrospectively reviewed the 2014 National Trauma Databank to identify patients with blunt splenic injury. Those who did not receive splenectomy within 6 hours of admission were considered to have undergone nonoperative management. Failure of nonoperative management was defined as requiring splenectomy during the same hospitalization. The primary endpoints were failure of nonoperative management and mortality.
Of the 18,917 total patients identified with a blunt splenic injury 2,240 (12%) were aged 65 years and older. Geriatric patients failed nonoperative management more often than did younger patients (6% vs. 4%; P less than .0001). Having an Injury Severity Score of 16 or greater was the only independent risk factor associated with failure of nonoperative management in geriatric patients (odds ratio, 2.8; P less than .0001). No difference in mortality was observed in geriatric patients who had successful versus failed nonoperative management (11% vs. 15%; P = .22). Independent risk factors for mortality in geriatric patients who underwent nonoperative management included admission hypotension (OR, 1.5; P = .048), high ISS (OR, 3.8; P less than .0001), low Glasgow Coma Scale (OR, 5.0; P less than .0001), and preexisting cardiac disease (OR, 3.6; P less than .0001). However, failure of nonoperative management was not independently associated with mortality (OR, 1.4; P = .3).
In their abstract, the researchers characterized the increased failure rates of nonoperative blunt splenic injuries in geriatric patients, compared with their counterparts as “acceptable” and noted that they were lower than previously reported in published literature. They reported having no financial disclosures.
WAIKOLOA, HAWAII – Nonoperative management of blunt splenic injuries in the geriatric population is safe, based on results from a study of national data.
Although the efficacy and safety of nonoperative management of blunt splenic injuries in adults is well established, “early recommendations stated that advanced age was a contraindication to nonoperative management of blunt splenic injuries due to high reported failure rates,” researchers led by Marc Trust, MD, wrote in an abstract presented at the annual meeting of the American Association for the Surgery of Trauma. “Although more recent literature has shown lower and acceptable failure rates, this population continues to fail more often compared to younger patients. Published data suffers from low patient numbers and is conflicting regarding future rate and safety.”
In an effort to obtain well powered, nationwide data to evaluate the recent failure rates and effect on morality among geriatric patients, Dr. Trust of the University of Texas at Austin and his associates retrospectively reviewed the 2014 National Trauma Databank to identify patients with blunt splenic injury. Those who did not receive splenectomy within 6 hours of admission were considered to have undergone nonoperative management. Failure of nonoperative management was defined as requiring splenectomy during the same hospitalization. The primary endpoints were failure of nonoperative management and mortality.
Of the 18,917 total patients identified with a blunt splenic injury 2,240 (12%) were aged 65 years and older. Geriatric patients failed nonoperative management more often than did younger patients (6% vs. 4%; P less than .0001). Having an Injury Severity Score of 16 or greater was the only independent risk factor associated with failure of nonoperative management in geriatric patients (odds ratio, 2.8; P less than .0001). No difference in mortality was observed in geriatric patients who had successful versus failed nonoperative management (11% vs. 15%; P = .22). Independent risk factors for mortality in geriatric patients who underwent nonoperative management included admission hypotension (OR, 1.5; P = .048), high ISS (OR, 3.8; P less than .0001), low Glasgow Coma Scale (OR, 5.0; P less than .0001), and preexisting cardiac disease (OR, 3.6; P less than .0001). However, failure of nonoperative management was not independently associated with mortality (OR, 1.4; P = .3).
In their abstract, the researchers characterized the increased failure rates of nonoperative blunt splenic injuries in geriatric patients, compared with their counterparts as “acceptable” and noted that they were lower than previously reported in published literature. They reported having no financial disclosures.
WAIKOLOA, HAWAII – Nonoperative management of blunt splenic injuries in the geriatric population is safe, based on results from a study of national data.
Although the efficacy and safety of nonoperative management of blunt splenic injuries in adults is well established, “early recommendations stated that advanced age was a contraindication to nonoperative management of blunt splenic injuries due to high reported failure rates,” researchers led by Marc Trust, MD, wrote in an abstract presented at the annual meeting of the American Association for the Surgery of Trauma. “Although more recent literature has shown lower and acceptable failure rates, this population continues to fail more often compared to younger patients. Published data suffers from low patient numbers and is conflicting regarding future rate and safety.”
In an effort to obtain well powered, nationwide data to evaluate the recent failure rates and effect on morality among geriatric patients, Dr. Trust of the University of Texas at Austin and his associates retrospectively reviewed the 2014 National Trauma Databank to identify patients with blunt splenic injury. Those who did not receive splenectomy within 6 hours of admission were considered to have undergone nonoperative management. Failure of nonoperative management was defined as requiring splenectomy during the same hospitalization. The primary endpoints were failure of nonoperative management and mortality.
Of the 18,917 total patients identified with a blunt splenic injury 2,240 (12%) were aged 65 years and older. Geriatric patients failed nonoperative management more often than did younger patients (6% vs. 4%; P less than .0001). Having an Injury Severity Score of 16 or greater was the only independent risk factor associated with failure of nonoperative management in geriatric patients (odds ratio, 2.8; P less than .0001). No difference in mortality was observed in geriatric patients who had successful versus failed nonoperative management (11% vs. 15%; P = .22). Independent risk factors for mortality in geriatric patients who underwent nonoperative management included admission hypotension (OR, 1.5; P = .048), high ISS (OR, 3.8; P less than .0001), low Glasgow Coma Scale (OR, 5.0; P less than .0001), and preexisting cardiac disease (OR, 3.6; P less than .0001). However, failure of nonoperative management was not independently associated with mortality (OR, 1.4; P = .3).
In their abstract, the researchers characterized the increased failure rates of nonoperative blunt splenic injuries in geriatric patients, compared with their counterparts as “acceptable” and noted that they were lower than previously reported in published literature. They reported having no financial disclosures.
AT THE AAST ANNUAL MEETING
Growth in hospital-employed physicians shows no signs of slowing
The parade of doctors leaving private practice for an employee position shows no sign of slowing.
In July 2012, an estimated 95,000 physicians (26%) were hospital employed. By July 2015, that number grew to 141,000 (38%), according to study conducted by Avalere for the Physicians Advocacy Institute. The biggest leap occurred between July 2014, when 114,000 physicians were listed as employees, to January 2015, when 133,000 were listed.
“They [most physicians] know a physician or two or a practice that has made that move to become employed, but I think many of them are quite surprised, if not shocked to see the tremendous transition over such a short period of time,” said Matthew Katz, PAI board member and CEO of the Connecticut State Medical Society.
Similarly, the number of hospital-owned physician practices grew from 36,000 (14%) in July 2012 to 67,000 (26%) in July 2015.
Regionally, by July 2015, almost half (49%) of Midwest physicians were hospital employed, while just over a quarter (27%) were in Alaska and Hawaii.
Mr. Katz said that he is hearing that the shift is having an impact on the practice of medicine. While certain aspects, such as physician autonomy, are among common issues raised with employment, he noted that referrals can also be an issue as doctors move from private practice to an employed status.
Many of the physicians he spoke with “have said that it is in some respects limiting them in what they can do and who they can refer to because they are losing their referral base in the community. When physicians become employed, they may no longer be accessible to those community-practicing physicians.”
He continued: “I have not talked to those physicians who have recently become employed to see what they think of their transition, but in talking to the physicians who remain in the community, they are concerned about the loss of those community physicians, the loss of the referral base, the loss of who to send their patients to who are no longer in the community and are now employed and working for the hospital. They seem to, in some respects, have lost touch with some of them once they transitioned to an employment status.”
Kelly Kenney, executive VP at PAI, said that there are some benefits to moving toward hospital-based employment, particularly with the reporting requirements attached to the many quality programs and the IT infrastructure that is a necessary part of it.
“Some physicians who have moved to employment say it just got to be too much,” Ms. Kenney said.
Mr. Katz added that private practice remains an option for most.
“We are still seeing some physicians, at least here in Connecticut and in other places around the country going into private practice trying to make a go of it,” he said. “I don’t think this is the death knell of private practice. I think that the pendulum definitely has swung in one direction, and I believe it will swing back a bit. I think that this will highlight what private practice physicians are facing and the barriers that exist today that did not exist a few years ago.”
He said that he hopes regulators, medical societies, and others step up in education efforts and other assistance to help small and solo practitioners navigate the value-based payment waters and give them the tools to stay in private practice.
Ms. Kenney noted that the flexibility of when physicians can start to meet reporting requirements under MACRA will help.
Mr. Katz added that the Department of Justice can do its part to help the small and solo practices by blocking the any of the mega-insurance mergers that are being proposed. He expressed concern that as insurers get bigger, the ability for small and solo practices to negotiate with them goes away and could be another driver to send physicians into employed situations.
The parade of doctors leaving private practice for an employee position shows no sign of slowing.
In July 2012, an estimated 95,000 physicians (26%) were hospital employed. By July 2015, that number grew to 141,000 (38%), according to study conducted by Avalere for the Physicians Advocacy Institute. The biggest leap occurred between July 2014, when 114,000 physicians were listed as employees, to January 2015, when 133,000 were listed.
“They [most physicians] know a physician or two or a practice that has made that move to become employed, but I think many of them are quite surprised, if not shocked to see the tremendous transition over such a short period of time,” said Matthew Katz, PAI board member and CEO of the Connecticut State Medical Society.
Similarly, the number of hospital-owned physician practices grew from 36,000 (14%) in July 2012 to 67,000 (26%) in July 2015.
Regionally, by July 2015, almost half (49%) of Midwest physicians were hospital employed, while just over a quarter (27%) were in Alaska and Hawaii.
Mr. Katz said that he is hearing that the shift is having an impact on the practice of medicine. While certain aspects, such as physician autonomy, are among common issues raised with employment, he noted that referrals can also be an issue as doctors move from private practice to an employed status.
Many of the physicians he spoke with “have said that it is in some respects limiting them in what they can do and who they can refer to because they are losing their referral base in the community. When physicians become employed, they may no longer be accessible to those community-practicing physicians.”
He continued: “I have not talked to those physicians who have recently become employed to see what they think of their transition, but in talking to the physicians who remain in the community, they are concerned about the loss of those community physicians, the loss of the referral base, the loss of who to send their patients to who are no longer in the community and are now employed and working for the hospital. They seem to, in some respects, have lost touch with some of them once they transitioned to an employment status.”
Kelly Kenney, executive VP at PAI, said that there are some benefits to moving toward hospital-based employment, particularly with the reporting requirements attached to the many quality programs and the IT infrastructure that is a necessary part of it.
“Some physicians who have moved to employment say it just got to be too much,” Ms. Kenney said.
Mr. Katz added that private practice remains an option for most.
“We are still seeing some physicians, at least here in Connecticut and in other places around the country going into private practice trying to make a go of it,” he said. “I don’t think this is the death knell of private practice. I think that the pendulum definitely has swung in one direction, and I believe it will swing back a bit. I think that this will highlight what private practice physicians are facing and the barriers that exist today that did not exist a few years ago.”
He said that he hopes regulators, medical societies, and others step up in education efforts and other assistance to help small and solo practitioners navigate the value-based payment waters and give them the tools to stay in private practice.
Ms. Kenney noted that the flexibility of when physicians can start to meet reporting requirements under MACRA will help.
Mr. Katz added that the Department of Justice can do its part to help the small and solo practices by blocking the any of the mega-insurance mergers that are being proposed. He expressed concern that as insurers get bigger, the ability for small and solo practices to negotiate with them goes away and could be another driver to send physicians into employed situations.
The parade of doctors leaving private practice for an employee position shows no sign of slowing.
In July 2012, an estimated 95,000 physicians (26%) were hospital employed. By July 2015, that number grew to 141,000 (38%), according to study conducted by Avalere for the Physicians Advocacy Institute. The biggest leap occurred between July 2014, when 114,000 physicians were listed as employees, to January 2015, when 133,000 were listed.
“They [most physicians] know a physician or two or a practice that has made that move to become employed, but I think many of them are quite surprised, if not shocked to see the tremendous transition over such a short period of time,” said Matthew Katz, PAI board member and CEO of the Connecticut State Medical Society.
Similarly, the number of hospital-owned physician practices grew from 36,000 (14%) in July 2012 to 67,000 (26%) in July 2015.
Regionally, by July 2015, almost half (49%) of Midwest physicians were hospital employed, while just over a quarter (27%) were in Alaska and Hawaii.
Mr. Katz said that he is hearing that the shift is having an impact on the practice of medicine. While certain aspects, such as physician autonomy, are among common issues raised with employment, he noted that referrals can also be an issue as doctors move from private practice to an employed status.
Many of the physicians he spoke with “have said that it is in some respects limiting them in what they can do and who they can refer to because they are losing their referral base in the community. When physicians become employed, they may no longer be accessible to those community-practicing physicians.”
He continued: “I have not talked to those physicians who have recently become employed to see what they think of their transition, but in talking to the physicians who remain in the community, they are concerned about the loss of those community physicians, the loss of the referral base, the loss of who to send their patients to who are no longer in the community and are now employed and working for the hospital. They seem to, in some respects, have lost touch with some of them once they transitioned to an employment status.”
Kelly Kenney, executive VP at PAI, said that there are some benefits to moving toward hospital-based employment, particularly with the reporting requirements attached to the many quality programs and the IT infrastructure that is a necessary part of it.
“Some physicians who have moved to employment say it just got to be too much,” Ms. Kenney said.
Mr. Katz added that private practice remains an option for most.
“We are still seeing some physicians, at least here in Connecticut and in other places around the country going into private practice trying to make a go of it,” he said. “I don’t think this is the death knell of private practice. I think that the pendulum definitely has swung in one direction, and I believe it will swing back a bit. I think that this will highlight what private practice physicians are facing and the barriers that exist today that did not exist a few years ago.”
He said that he hopes regulators, medical societies, and others step up in education efforts and other assistance to help small and solo practitioners navigate the value-based payment waters and give them the tools to stay in private practice.
Ms. Kenney noted that the flexibility of when physicians can start to meet reporting requirements under MACRA will help.
Mr. Katz added that the Department of Justice can do its part to help the small and solo practices by blocking the any of the mega-insurance mergers that are being proposed. He expressed concern that as insurers get bigger, the ability for small and solo practices to negotiate with them goes away and could be another driver to send physicians into employed situations.
Inhaled antibiotic for bronchiectasis shows promise
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
Key clinical point:
Major finding: Compared with patients in the placebo arm, those in the ciprofloxacin 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days vs. 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005).
Data source: A multicenter study of 416 patients who were randomized 2:1 to ciprofloxacin 32.5 mg or placebo administered twice per day using a pocket-sized inhaler as a cyclical regimen of either 14 days on/off drug or 28 days on/off drug, for 48 weeks.
Disclosures: RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
Lung cancer screening found effective in a community hospital
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Of nine lung cancers detected, seven (78%) were stage I or II lung cancers and the remaining two (22%) were stage II or IV.
Data source: Results from 514 patients enrolled in a community hospital–based lung cancer screening program between July 2013 and December 2015.
Disclosures: Dr. Salzano reported having no relevant financial disclosures.
Joint European atrial fibrillation guidelines break new ground
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
ROME – The 2016 joint European guidelines on management of atrial fibrillation break new ground by declaring as a strong Class IA recommendation that the novel oral anticoagulants are now the drugs of choice – preferred over warfarin – for stroke prevention.
The joint guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery recommend that warfarin’s use be reserved for the relatively small proportion of atrial fibrillation (AF) patients who are ineligible for the four commercially available novel oral anticoagulants (NOACs). That’s mainly patients with mechanical heart valves, moderate to severe mitral stenosis, or severe chronic kidney disease.
The ESC/EACTS guidelines, taken together with the American College of Chest Physicians guidelines on antithrombotic therapy for venous thromboembolic disease released earlier in the year, suggest that the old war horse warfarin is being eased out to pasture. The ACCP guidelines recommend any of the four NOACS – apixaban, dabigatran, edoxaban, or rivaroxaban – be used preferentially over warfarin in the treatment of venous thromboembolism (Chest 2016 Feb;149[2]:315-52). Both sets of guidelines cite compelling evidence that the NOACs are significantly safer than warfarin yet equally effective.
The ESC/EACTS guidelines are a full rewrite containing numerous departures from the previous 2012 AF management guidelines as well as from current ACC/AHA guidelines. The report includes more than 1,000 references. Eighty percent of the 154 recommendations provide Class I or IIa guidance. Two-thirds of the recommendations are Level of Evidence A or B, task force chairperson Paulus Kirchhof, MD, said at the annual congress of the European Society of Cardiology.
He and co-chairperson Stefano Benussi, MD, presented some of the highlights.
The guidelines issue a strong call for greater use of targeted ECG screening in populations at risk for silent AF, including stroke survivors and the elderly. And AF should always be documented before starting treatment, given that all of the treatments carry risk, said Dr. Kirchhof, professor of cardiovascular medicine at the University of Birmingham (England).
Once the diagnosis is established, it’s essential to address in a structured way five domains of management: acute rate and rhythm control; management of precipitating factors, including underlying cardiovascular conditions such as hypertension or valvular heart disease; assessment of stroke risk using the CHA2DS2-VASc scoring system; assessment of heart rate; and evaluation of the impact of AF symptoms on the patient’s life, including fatigue and breathlessness, using a structured instrument such as the modified European Heart Rhythm Association symptom scale.
Men with a CHA2DS2-VASc score of 1 and women with a score of 2 should be considered for anticoagulation. And the treatment should be recommended – not merely considered – for men with a score of 2 or more and women with a score of 3; that’s a Class Ia recommendation, Dr. Kirchhof continued.
The use of a specific bleeding risk score is no longer recommended in AF patients on oral anticoagulation. The emphasis has shifted to reduction of modifiable bleeding risk factors, including limiting alcohol intake to fewer than 8 drinks per week, control of hypertension, and discontinuing antiplatelet and anti-inflammatory agents.
Consideration of left atrial appendage occlusion devices should be reserved for the small percentage of patients who have clear contraindications to all forms of oral anticoagulation.
The task force concluded that patients who have bleeding on oral anticoagulation can often be managed with local therapy and discontinuation of anticoagulation therapy for a day or two before resumption. However, decisions regarding resumption of a NOAC or warfarin after an intracranial bleed should be handled by an interdisciplinary panel composed of a stroke neurologist, a cardiologist, a neuroradiologist, and a neurosurgeon.
Evidence-based treatment options in patients with symptomatic AF after failed catheter ablation include minimally invasive surgery with epicardial pulmonary vein isolation, more extensive catheter ablation, and hybrid procedures, according to Dr. Benussi, who is codirector of clinical cardiovascular surgery at University Hospital in Zurich.
The guidelines state that the data supporting catheter ablation to achieve long-term rhythm control are now sufficiently strong that this intervention should be considered as a first-line option alongside antiarrhythmic drugs as a matter of patient preference in the setting of symptomatic paroxysmal AF regardless of whether the patient has CAD, heart failure, valvular heart disease, or no structural heart disease.
Catheter ablation using radiofrequency energy or cryoablation should target complete isolation of the pulmonary veins.
“Additional ablation lines do not provide demonstrable clinical benefit and increase the risk of postablation left atrial arrhythmias,” the surgeon said.
Maze surgery, preferably biatrial, received a favorable Class IIa, Level of Evidence A recommendation as worthy of consideration in patients with symptomatic AF who are already undergoing cardiac surgery. This recommendation was based upon an external review by the Cochrane group which was commissioned by the guidelines task force. The Cochrane review of eight published studies concluded that Maze surgery under such circumstances was associated with a twofold increased freedom from AF, atrial flutter, and atrial tachycardia (Cochrane Database of Systematic Reviews 2016;8: CD012088. doi: 10.1002/14651858.CD012088.pub2).
The AF management guidelines are supported by the ESC Pocket Guidelines app, which includes an overall AF treatment manager developed by the European Union–funded CATCH ME (Characterizing Atrial Fibrillation by Translating its Causes Into Health Modifiers in the Elderly) project.
The multidisciplinary 17-member AF management task force was drawn from cardiology, stroke neurology, cardiac surgery, and specialist nursing. Dr. Kirchhof stressed that only recommendations supported by at least 75% of task force members made it into the guidelines (Eur Heart J. 2016 Aug 27. pii: ehw210. [Epub ahead of print] doi: 10.1093/eurheartj/ehw210).
Age of blood did not affect mortality in transfused patients
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
The results of the INFORM trial should end the debate regarding whether short-term or long-term storage of blood is advantageous. However, questions remain about whether red cells transfused during the last allowed week of storage (35-42 days) pose more risk. Observational studies continue to raise concerns about the use of the oldest blood.
The INFORM trial, with its large numbers of patients, should permit researchers to analyze enough data to address this remaining issue. The transfusion medicine community needs to know whether the storage period should be reduced to less than 35 and whether new preservative solutions should be sought.
Aaron A.R. Tobian, MD, PhD, and Paul M. Ness, MD, are with the division of transfusion medicine, department of pathology, Johns Hopkins University, Baltimore. They had no relevant financial conflicts of interest and made their remarks in an editorial (10.1056/NEJMe1612444) that accompanied the published study.
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.
While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.
Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).
Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.
There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.
An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.
INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.
[email protected]
On Twitter @maryjodales
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group.
Data source: The randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial.
Disclosures: INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.