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What’s new in non-STEMI management
SNOWMASS, COLO. – An early invasive strategy is particularly beneficial in octogenarians with non–ST-segment elevation myocardial infarction, according to a recent study involving close to 1 million NSTEMI patients aged 80 years or older.
The very eldest are an understudied segment of the NSTEMI population, for whom an initial conservative strategy has been the dominant approach in daily practice.
"This is an important study. We can see that as you get older and older, by virtue of the fact that you have more and more coronary disease, probably you’re going to be better off with an invasive strategy, all other things being equal," Dr. David R. Holmes Jr. commented in highlighting the study at the Annual Cardiovascular Conference at Snowmass.
The study included 968,542 octogenarians hospitalized with NSTEMI during 2003-2010 and entered into the Nationwide Inpatient Sample. Eighty-three percent were managed via an initial conservative approach, with coronary angiography performed only in the event of hemodynamic or electrical instability, refractory angina despite optimal medical therapy, or a test result indicative of high risk. The other 17% underwent an early invasive approach, with angiography within 48 hours of presentation.
Octogenarians managed via an early invasive strategy were more often younger, obese, smokers, dyslipidemic, hypertensive, white, and male, and more likely to have known vascular disease. In a multivariate analysis adjusted for potential confounders, the early invasive strategy group had a 34% reduction in in-hospital mortality compared with the conservatively managed group. They also had a 37% lower rate of acute ischemic stroke, a 40% reduction in intracranial hemorrhage, a 37% lower risk of gastrointestinal bleeding, and a shorter length of stay by an average of half a day. On the other side of the ledger, they had a 2.1-fold increased rate of cardiogenic shock (Am. J. Med. 2013;126:1076-83).
Does time to cath lab matter?
Another recent study looked at the optimal time frame for taking an NSTEMI patient to the cardiac catheterization laboratory as part of an invasive strategy. This was a meta-analysis of seven randomized controlled trials totaling 5,370 NSTEMI patients, along with four observational studies with more than 77,000 NSTEMI patients. The conclusion: There is as yet no persuasive evidence that the time interval makes a difference in outcomes (Ann. Intern. Med. 2013;158:261-70).
"That’s the data that’s available. It doesn’t matter how quickly you get the patient to the cath lab within that first period of time. You just need to take them, whether it’s in 2 hours, 6 hours, or 18 hours," Dr. Holmes said.
This has important implications as we think about systems of care. If somebody comes into the hospital late on a Friday night, do you have to take them to the cath lab Friday night, or can you wait electively and take them tomorrow or potentially even Monday morning when everybody’s there?" commented Dr. Holmes, professor of medicine at the Mayo Clinic in Rochester, Minn.
GRACE and CRUSADE
The cornerstone of decision making as to whether to opt for an invasive versus a conservative strategy in a given NSTEMI patient involves application of a formal risk score. A plethora of these risk scoring systems are in use today. Which is the best choice for a cardiologist as an aid to decision making? A meta-analysis involving 36 studies with nearly 117,000 NSTEMI patients has concluded that the GRACE (Global Registry of Acute Cardiac Events) risk score (JAMA 2004;291:2727-33) is the best of the pack. It significantly outperformed the TIMI score, which is the other widely used scoring system, as well as others less widely known (Contemp. Clin. Trials 2012:33:507-14).
"GRACE looks like it performs better. We’ll need better ones in the future, of course. But at the present time, select GRACE for risk stratification," advised the cardiologist, adding that a Grace score app is available.
Despite the fact that physicians are diagnosing and treating NSTEMI earlier in its course, in large part because of the widespread use of troponin assays in the emergency department, NSTEMI is still associated with substantial long-term morbidity and mortality, particularly in the elderly. This was underscored in a recent analysis of 19,336 NSTEMI patients aged 65 years or older who underwent early catheterization and were included in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines) registry.
Twenty-one percent of patients received medical management alone, 60.8% underwent percutaneous coronary intervention, and 18.2% had coronary artery bypass graft surgery. The 5-year unadjusted all-cause mortality rate was 50% in the medically managed group, 33.5% in older patients who underwent PCI, and 24.2% in those who underwent CABG surgery. The unadjusted 5-year rate of a composite of death, readmission for MI, or readmission for stroke was 62.4% with medical management, 44.9% with PCI, and 33% with CABG. The investigators concluded that long-term outcomes in elderly NSTEMI patients appear to be better in this large registry when revascularization is accomplished via CABG than with PCI. This sets the stage for future confirmatory trials (Circ. Cardiovasc. Qual. Outcomes 2013;6:323-32).
Dr. Holmes noted that the incidence of NSTEMI has climbed steadily while that of STEMI has declined over the past couple of decades, not just in the United States but worldwide. In Australia, for example, during 1993-2010 the adjusted incidence of NSTEMI increased by a whopping 315%, from 67 to 182 cases per 100,000 person-years, while the adjusted incidence of STEMI fell by 30% (Am. J. Cardiol. 2013;112:169-73).
"NSTEMI is clearly an annuity for all of cardiology," Dr. Holmes said. "The growth rate is increasing and it will continue to increase as we get older."
He reported having no conflicts of interest.
These studies collectively offer guidance in key management decisions for an invasive strategy for our NSTEMI patients, namely, the factor of age, the impact of timing, and risk stratification scores. Currently, the "less is more" approach is often taken for octogenarians, but a large sample size from this registry shows better results across a spectrum of outcomes even while adjusting for cofounders. This should prompt a reevaluation of current practice. Although the timing of an invasive approach in STEMI is defined in prior studies, this large meta-analysis tells us that timing in NSTEMI does not correlate with outcomes as long as angiography is pursued at some point in time, a very important conclusion.
Finally, although TIMI scoring systems are used at most institutions, the GRACE score performed even better, a surprising finding.
Taken in sum, these key studies should be followed up by randomized controlled trials to definitively answer these important questions for our NSTEMI patients.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
These studies collectively offer guidance in key management decisions for an invasive strategy for our NSTEMI patients, namely, the factor of age, the impact of timing, and risk stratification scores. Currently, the "less is more" approach is often taken for octogenarians, but a large sample size from this registry shows better results across a spectrum of outcomes even while adjusting for cofounders. This should prompt a reevaluation of current practice. Although the timing of an invasive approach in STEMI is defined in prior studies, this large meta-analysis tells us that timing in NSTEMI does not correlate with outcomes as long as angiography is pursued at some point in time, a very important conclusion.
Finally, although TIMI scoring systems are used at most institutions, the GRACE score performed even better, a surprising finding.
Taken in sum, these key studies should be followed up by randomized controlled trials to definitively answer these important questions for our NSTEMI patients.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
These studies collectively offer guidance in key management decisions for an invasive strategy for our NSTEMI patients, namely, the factor of age, the impact of timing, and risk stratification scores. Currently, the "less is more" approach is often taken for octogenarians, but a large sample size from this registry shows better results across a spectrum of outcomes even while adjusting for cofounders. This should prompt a reevaluation of current practice. Although the timing of an invasive approach in STEMI is defined in prior studies, this large meta-analysis tells us that timing in NSTEMI does not correlate with outcomes as long as angiography is pursued at some point in time, a very important conclusion.
Finally, although TIMI scoring systems are used at most institutions, the GRACE score performed even better, a surprising finding.
Taken in sum, these key studies should be followed up by randomized controlled trials to definitively answer these important questions for our NSTEMI patients.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
SNOWMASS, COLO. – An early invasive strategy is particularly beneficial in octogenarians with non–ST-segment elevation myocardial infarction, according to a recent study involving close to 1 million NSTEMI patients aged 80 years or older.
The very eldest are an understudied segment of the NSTEMI population, for whom an initial conservative strategy has been the dominant approach in daily practice.
"This is an important study. We can see that as you get older and older, by virtue of the fact that you have more and more coronary disease, probably you’re going to be better off with an invasive strategy, all other things being equal," Dr. David R. Holmes Jr. commented in highlighting the study at the Annual Cardiovascular Conference at Snowmass.
The study included 968,542 octogenarians hospitalized with NSTEMI during 2003-2010 and entered into the Nationwide Inpatient Sample. Eighty-three percent were managed via an initial conservative approach, with coronary angiography performed only in the event of hemodynamic or electrical instability, refractory angina despite optimal medical therapy, or a test result indicative of high risk. The other 17% underwent an early invasive approach, with angiography within 48 hours of presentation.
Octogenarians managed via an early invasive strategy were more often younger, obese, smokers, dyslipidemic, hypertensive, white, and male, and more likely to have known vascular disease. In a multivariate analysis adjusted for potential confounders, the early invasive strategy group had a 34% reduction in in-hospital mortality compared with the conservatively managed group. They also had a 37% lower rate of acute ischemic stroke, a 40% reduction in intracranial hemorrhage, a 37% lower risk of gastrointestinal bleeding, and a shorter length of stay by an average of half a day. On the other side of the ledger, they had a 2.1-fold increased rate of cardiogenic shock (Am. J. Med. 2013;126:1076-83).
Does time to cath lab matter?
Another recent study looked at the optimal time frame for taking an NSTEMI patient to the cardiac catheterization laboratory as part of an invasive strategy. This was a meta-analysis of seven randomized controlled trials totaling 5,370 NSTEMI patients, along with four observational studies with more than 77,000 NSTEMI patients. The conclusion: There is as yet no persuasive evidence that the time interval makes a difference in outcomes (Ann. Intern. Med. 2013;158:261-70).
"That’s the data that’s available. It doesn’t matter how quickly you get the patient to the cath lab within that first period of time. You just need to take them, whether it’s in 2 hours, 6 hours, or 18 hours," Dr. Holmes said.
This has important implications as we think about systems of care. If somebody comes into the hospital late on a Friday night, do you have to take them to the cath lab Friday night, or can you wait electively and take them tomorrow or potentially even Monday morning when everybody’s there?" commented Dr. Holmes, professor of medicine at the Mayo Clinic in Rochester, Minn.
GRACE and CRUSADE
The cornerstone of decision making as to whether to opt for an invasive versus a conservative strategy in a given NSTEMI patient involves application of a formal risk score. A plethora of these risk scoring systems are in use today. Which is the best choice for a cardiologist as an aid to decision making? A meta-analysis involving 36 studies with nearly 117,000 NSTEMI patients has concluded that the GRACE (Global Registry of Acute Cardiac Events) risk score (JAMA 2004;291:2727-33) is the best of the pack. It significantly outperformed the TIMI score, which is the other widely used scoring system, as well as others less widely known (Contemp. Clin. Trials 2012:33:507-14).
"GRACE looks like it performs better. We’ll need better ones in the future, of course. But at the present time, select GRACE for risk stratification," advised the cardiologist, adding that a Grace score app is available.
Despite the fact that physicians are diagnosing and treating NSTEMI earlier in its course, in large part because of the widespread use of troponin assays in the emergency department, NSTEMI is still associated with substantial long-term morbidity and mortality, particularly in the elderly. This was underscored in a recent analysis of 19,336 NSTEMI patients aged 65 years or older who underwent early catheterization and were included in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines) registry.
Twenty-one percent of patients received medical management alone, 60.8% underwent percutaneous coronary intervention, and 18.2% had coronary artery bypass graft surgery. The 5-year unadjusted all-cause mortality rate was 50% in the medically managed group, 33.5% in older patients who underwent PCI, and 24.2% in those who underwent CABG surgery. The unadjusted 5-year rate of a composite of death, readmission for MI, or readmission for stroke was 62.4% with medical management, 44.9% with PCI, and 33% with CABG. The investigators concluded that long-term outcomes in elderly NSTEMI patients appear to be better in this large registry when revascularization is accomplished via CABG than with PCI. This sets the stage for future confirmatory trials (Circ. Cardiovasc. Qual. Outcomes 2013;6:323-32).
Dr. Holmes noted that the incidence of NSTEMI has climbed steadily while that of STEMI has declined over the past couple of decades, not just in the United States but worldwide. In Australia, for example, during 1993-2010 the adjusted incidence of NSTEMI increased by a whopping 315%, from 67 to 182 cases per 100,000 person-years, while the adjusted incidence of STEMI fell by 30% (Am. J. Cardiol. 2013;112:169-73).
"NSTEMI is clearly an annuity for all of cardiology," Dr. Holmes said. "The growth rate is increasing and it will continue to increase as we get older."
He reported having no conflicts of interest.
SNOWMASS, COLO. – An early invasive strategy is particularly beneficial in octogenarians with non–ST-segment elevation myocardial infarction, according to a recent study involving close to 1 million NSTEMI patients aged 80 years or older.
The very eldest are an understudied segment of the NSTEMI population, for whom an initial conservative strategy has been the dominant approach in daily practice.
"This is an important study. We can see that as you get older and older, by virtue of the fact that you have more and more coronary disease, probably you’re going to be better off with an invasive strategy, all other things being equal," Dr. David R. Holmes Jr. commented in highlighting the study at the Annual Cardiovascular Conference at Snowmass.
The study included 968,542 octogenarians hospitalized with NSTEMI during 2003-2010 and entered into the Nationwide Inpatient Sample. Eighty-three percent were managed via an initial conservative approach, with coronary angiography performed only in the event of hemodynamic or electrical instability, refractory angina despite optimal medical therapy, or a test result indicative of high risk. The other 17% underwent an early invasive approach, with angiography within 48 hours of presentation.
Octogenarians managed via an early invasive strategy were more often younger, obese, smokers, dyslipidemic, hypertensive, white, and male, and more likely to have known vascular disease. In a multivariate analysis adjusted for potential confounders, the early invasive strategy group had a 34% reduction in in-hospital mortality compared with the conservatively managed group. They also had a 37% lower rate of acute ischemic stroke, a 40% reduction in intracranial hemorrhage, a 37% lower risk of gastrointestinal bleeding, and a shorter length of stay by an average of half a day. On the other side of the ledger, they had a 2.1-fold increased rate of cardiogenic shock (Am. J. Med. 2013;126:1076-83).
Does time to cath lab matter?
Another recent study looked at the optimal time frame for taking an NSTEMI patient to the cardiac catheterization laboratory as part of an invasive strategy. This was a meta-analysis of seven randomized controlled trials totaling 5,370 NSTEMI patients, along with four observational studies with more than 77,000 NSTEMI patients. The conclusion: There is as yet no persuasive evidence that the time interval makes a difference in outcomes (Ann. Intern. Med. 2013;158:261-70).
"That’s the data that’s available. It doesn’t matter how quickly you get the patient to the cath lab within that first period of time. You just need to take them, whether it’s in 2 hours, 6 hours, or 18 hours," Dr. Holmes said.
This has important implications as we think about systems of care. If somebody comes into the hospital late on a Friday night, do you have to take them to the cath lab Friday night, or can you wait electively and take them tomorrow or potentially even Monday morning when everybody’s there?" commented Dr. Holmes, professor of medicine at the Mayo Clinic in Rochester, Minn.
GRACE and CRUSADE
The cornerstone of decision making as to whether to opt for an invasive versus a conservative strategy in a given NSTEMI patient involves application of a formal risk score. A plethora of these risk scoring systems are in use today. Which is the best choice for a cardiologist as an aid to decision making? A meta-analysis involving 36 studies with nearly 117,000 NSTEMI patients has concluded that the GRACE (Global Registry of Acute Cardiac Events) risk score (JAMA 2004;291:2727-33) is the best of the pack. It significantly outperformed the TIMI score, which is the other widely used scoring system, as well as others less widely known (Contemp. Clin. Trials 2012:33:507-14).
"GRACE looks like it performs better. We’ll need better ones in the future, of course. But at the present time, select GRACE for risk stratification," advised the cardiologist, adding that a Grace score app is available.
Despite the fact that physicians are diagnosing and treating NSTEMI earlier in its course, in large part because of the widespread use of troponin assays in the emergency department, NSTEMI is still associated with substantial long-term morbidity and mortality, particularly in the elderly. This was underscored in a recent analysis of 19,336 NSTEMI patients aged 65 years or older who underwent early catheterization and were included in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines) registry.
Twenty-one percent of patients received medical management alone, 60.8% underwent percutaneous coronary intervention, and 18.2% had coronary artery bypass graft surgery. The 5-year unadjusted all-cause mortality rate was 50% in the medically managed group, 33.5% in older patients who underwent PCI, and 24.2% in those who underwent CABG surgery. The unadjusted 5-year rate of a composite of death, readmission for MI, or readmission for stroke was 62.4% with medical management, 44.9% with PCI, and 33% with CABG. The investigators concluded that long-term outcomes in elderly NSTEMI patients appear to be better in this large registry when revascularization is accomplished via CABG than with PCI. This sets the stage for future confirmatory trials (Circ. Cardiovasc. Qual. Outcomes 2013;6:323-32).
Dr. Holmes noted that the incidence of NSTEMI has climbed steadily while that of STEMI has declined over the past couple of decades, not just in the United States but worldwide. In Australia, for example, during 1993-2010 the adjusted incidence of NSTEMI increased by a whopping 315%, from 67 to 182 cases per 100,000 person-years, while the adjusted incidence of STEMI fell by 30% (Am. J. Cardiol. 2013;112:169-73).
"NSTEMI is clearly an annuity for all of cardiology," Dr. Holmes said. "The growth rate is increasing and it will continue to increase as we get older."
He reported having no conflicts of interest.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Defining patients’ risk helps prevent postop urinary retention
SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.
"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.
Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.
Identify high-risk patients
"For management, identifying the high-risk patient is very important," said Dr. Khemani.
She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.
Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.
"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.
Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.
Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.
Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.
"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.
The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.
Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.
Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.
Complications of postoperative urinary retention can include:
• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.
• Infectious complications – urinary tract infections, sepsis, and joint infections.
• Prolonged need for catheterization.
• Bladder dysfunction.
A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.
"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.
She reported having no financial disclosures.
SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.
"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.
Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.
Identify high-risk patients
"For management, identifying the high-risk patient is very important," said Dr. Khemani.
She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.
Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.
"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.
Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.
Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.
Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.
"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.
The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.
Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.
Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.
Complications of postoperative urinary retention can include:
• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.
• Infectious complications – urinary tract infections, sepsis, and joint infections.
• Prolonged need for catheterization.
• Bladder dysfunction.
A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.
"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.
She reported having no financial disclosures.
SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.
"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.
Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.
Identify high-risk patients
"For management, identifying the high-risk patient is very important," said Dr. Khemani.
She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.
Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.
"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.
Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.
Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.
Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.
"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.
The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.
Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.
Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.
Complications of postoperative urinary retention can include:
• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.
• Infectious complications – urinary tract infections, sepsis, and joint infections.
• Prolonged need for catheterization.
• Bladder dysfunction.
A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.
"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.
She reported having no financial disclosures.
AT THE PERIOPERATIVE MEDICINE SUMMIT
Major finding: The incidence of postoperative urinary retention may be as high as 70% after orthopedic procedures.
Data source: Review of evidence on the risk factors, prevention, and treatment of postoperative urinary retention.
Disclosures: Dr. Khemani reported having no financial disclosures.
High posthepatectomy bilirubin bodes ill for patients
MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.
Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.
She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)
Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.
Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.
Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).
A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,
"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."
Dr. Etra had no financial disclosures.
MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.
Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.
She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)
Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.
Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.
Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).
A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,
"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."
Dr. Etra had no financial disclosures.
MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.
Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.
She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)
Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.
Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.
Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).
A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,
"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."
Dr. Etra had no financial disclosures.
AT AHPBA 2014
Major finding: A high posthepatectomy bilirubin level was associated with an 8-fold increase in the risk of postoperative complications and 90-day mortality.
Data source: A retrospective study of 535 patients.
Disclosures: Dr. Joanna Etra had no financial disclosures.
Team planning cuts pancreatectomy readmissions
MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.
The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.
Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.
In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.
Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.
Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."
As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.
The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.
At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.
"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."
By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:
• Reconcile medications.
• Reconcile discharge plan with national guidelines.
• Make follow-up appointments.
• Follow up on any outstanding tests.
• Arrange for postdischarge services.
• Explain to the patient what do if a problem arises.
• Conduct patient education.
• Communicate discharge information to primary care physician.
• Make a follow-up call within 3 days of discharge.
The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.
Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.
During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.
"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."
Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.
MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.
The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.
Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.
In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.
Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.
Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."
As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.
The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.
At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.
"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."
By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:
• Reconcile medications.
• Reconcile discharge plan with national guidelines.
• Make follow-up appointments.
• Follow up on any outstanding tests.
• Arrange for postdischarge services.
• Explain to the patient what do if a problem arises.
• Conduct patient education.
• Communicate discharge information to primary care physician.
• Make a follow-up call within 3 days of discharge.
The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.
Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.
During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.
"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."
Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.
MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.
The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.
Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.
In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.
Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.
Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."
As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.
The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.
At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.
"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."
By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:
• Reconcile medications.
• Reconcile discharge plan with national guidelines.
• Make follow-up appointments.
• Follow up on any outstanding tests.
• Arrange for postdischarge services.
• Explain to the patient what do if a problem arises.
• Conduct patient education.
• Communicate discharge information to primary care physician.
• Make a follow-up call within 3 days of discharge.
The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.
Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.
During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.
"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."
Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.
AT AHPBA 2014
Major finding: Readmission after pancreatectomy dropped from 24% to 11% after implementation of a multifaceted effort to reduce infections and improve discharge planning,
Data source: A retrospective study of 1,147 patients.
Disclosures: Neither Dr. Ceppa nor Dr. Pitt had any financial disclosures.
Renal insufficiency tied to risk of post–liver surgery problems
MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.
However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.
He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).
Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.
Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.
Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.
Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.
In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).
Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).
Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.
The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).
Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.
"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."
Dr. Squires had no financial disclosures.
MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.
However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.
He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).
Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.
Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.
Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.
Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.
In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).
Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).
Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.
The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).
Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.
"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."
Dr. Squires had no financial disclosures.
MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.
However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.
He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).
Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.
Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.
Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.
Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.
In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).
Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).
Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.
The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).
Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.
"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."
Dr. Squires had no financial disclosures.
AT AHPBA 2014
Major finding: Chronic preoperative renal insufficiency confers a fourfold increase in the risk of major complications after hepatic resection, although it did not increase the risk of 90-day mortality.
Data source: The retrospective study looked at postoperative outcomes in 1,170 patients.
Disclosures: Dr. Squires had no financial disclosures.
Keep mesenteric ischemia on your radar in young patients
CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.
Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.
Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.
The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.
"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."
The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.
Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.
If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.
Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.
Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.
A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.
In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.
During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.
Dr. Dalsing reported having no financial disclosures.
No longer is gastrointestinal ischemia a disease that only gerontologists need know about. Ischemic diseases present in a very wide disease spectrum that may be acute, subacute, or chronic; may involve the mesenteric veins, venules, arterioles, or arteries; small and or large intestine; short segments of bowel or long areas. Moreover, even in young adults, the list of predisposing factors is immense and includes inflammatory diseases, vasculitides, thrombophilic states, surgery, colonoscopy, and medications such as triptans , estrogens, and those that cause constipation; as well as recreational activities such as long-distance running and illicit cocaine use.
To complicate diagnostic matters, the GI tract can evidence disease only in a limited number of ways and so, regardless of etiology, manifestations can mimic those of more common diseases, including abdominal pain, diarrhea, rectal bleeding, and abdominal distention, among others. The CT scan has become a prominent substitute for complete history and physical examination today, but a CT scan does not allow appreciation of the fearful look on a patient's face when a physical exam reveals little and the patient still has severe pain. It is this discrepancy that is still fundamental in recognizing acute mesenteric ischemia early on when the injury is still reversible and the injured bowel can be salvaged by the combined use of intra-arterial papaverine and prompt surgery. Early findings on CT, however, are nonspecific, and findings that are specific - for example, gangrene of the bowel, pneumatosis linearis, and portal mesenteric venous gas - occur too late in the game to help save bowel.
For chronic mesenteric ischemia or intestinal angina, it is important to recognize the classic history of food-associated abdominal pain that tends over time to occur earlier in the meal; lasts longer after the meal; and ultimately, preinfarction, become persistent. Fear of eating, avoidance of meals, and weight loss are characteristic. In such circumstances, splanchnic vascular imaging usually shows two of the three mesenteric vessels to be occluded. Such occlusion does not make the diagnosis, however, as angiography merely shows anatomy that supports or refutes the clinician's diagnosis. A typical clinical history and supportive anatomy prompts either percutaneous or surgical revascularization - probably the latter in a young patient - an otherwise good operative risk.
This was once sure death but can now be treated if diagnosed in time.
Dr. Lawrence J. Brandt, MACG, AGA-F, FASGE, professor of medicine and surgery at Albert Einstein College of Medicine, N.Y., emeritus chief of gastroenterology at Montefiore Medical Center, N.Y. He has no disclosures.
No longer is gastrointestinal ischemia a disease that only gerontologists need know about. Ischemic diseases present in a very wide disease spectrum that may be acute, subacute, or chronic; may involve the mesenteric veins, venules, arterioles, or arteries; small and or large intestine; short segments of bowel or long areas. Moreover, even in young adults, the list of predisposing factors is immense and includes inflammatory diseases, vasculitides, thrombophilic states, surgery, colonoscopy, and medications such as triptans , estrogens, and those that cause constipation; as well as recreational activities such as long-distance running and illicit cocaine use.
To complicate diagnostic matters, the GI tract can evidence disease only in a limited number of ways and so, regardless of etiology, manifestations can mimic those of more common diseases, including abdominal pain, diarrhea, rectal bleeding, and abdominal distention, among others. The CT scan has become a prominent substitute for complete history and physical examination today, but a CT scan does not allow appreciation of the fearful look on a patient's face when a physical exam reveals little and the patient still has severe pain. It is this discrepancy that is still fundamental in recognizing acute mesenteric ischemia early on when the injury is still reversible and the injured bowel can be salvaged by the combined use of intra-arterial papaverine and prompt surgery. Early findings on CT, however, are nonspecific, and findings that are specific - for example, gangrene of the bowel, pneumatosis linearis, and portal mesenteric venous gas - occur too late in the game to help save bowel.
For chronic mesenteric ischemia or intestinal angina, it is important to recognize the classic history of food-associated abdominal pain that tends over time to occur earlier in the meal; lasts longer after the meal; and ultimately, preinfarction, become persistent. Fear of eating, avoidance of meals, and weight loss are characteristic. In such circumstances, splanchnic vascular imaging usually shows two of the three mesenteric vessels to be occluded. Such occlusion does not make the diagnosis, however, as angiography merely shows anatomy that supports or refutes the clinician's diagnosis. A typical clinical history and supportive anatomy prompts either percutaneous or surgical revascularization - probably the latter in a young patient - an otherwise good operative risk.
This was once sure death but can now be treated if diagnosed in time.
Dr. Lawrence J. Brandt, MACG, AGA-F, FASGE, professor of medicine and surgery at Albert Einstein College of Medicine, N.Y., emeritus chief of gastroenterology at Montefiore Medical Center, N.Y. He has no disclosures.
No longer is gastrointestinal ischemia a disease that only gerontologists need know about. Ischemic diseases present in a very wide disease spectrum that may be acute, subacute, or chronic; may involve the mesenteric veins, venules, arterioles, or arteries; small and or large intestine; short segments of bowel or long areas. Moreover, even in young adults, the list of predisposing factors is immense and includes inflammatory diseases, vasculitides, thrombophilic states, surgery, colonoscopy, and medications such as triptans , estrogens, and those that cause constipation; as well as recreational activities such as long-distance running and illicit cocaine use.
To complicate diagnostic matters, the GI tract can evidence disease only in a limited number of ways and so, regardless of etiology, manifestations can mimic those of more common diseases, including abdominal pain, diarrhea, rectal bleeding, and abdominal distention, among others. The CT scan has become a prominent substitute for complete history and physical examination today, but a CT scan does not allow appreciation of the fearful look on a patient's face when a physical exam reveals little and the patient still has severe pain. It is this discrepancy that is still fundamental in recognizing acute mesenteric ischemia early on when the injury is still reversible and the injured bowel can be salvaged by the combined use of intra-arterial papaverine and prompt surgery. Early findings on CT, however, are nonspecific, and findings that are specific - for example, gangrene of the bowel, pneumatosis linearis, and portal mesenteric venous gas - occur too late in the game to help save bowel.
For chronic mesenteric ischemia or intestinal angina, it is important to recognize the classic history of food-associated abdominal pain that tends over time to occur earlier in the meal; lasts longer after the meal; and ultimately, preinfarction, become persistent. Fear of eating, avoidance of meals, and weight loss are characteristic. In such circumstances, splanchnic vascular imaging usually shows two of the three mesenteric vessels to be occluded. Such occlusion does not make the diagnosis, however, as angiography merely shows anatomy that supports or refutes the clinician's diagnosis. A typical clinical history and supportive anatomy prompts either percutaneous or surgical revascularization - probably the latter in a young patient - an otherwise good operative risk.
This was once sure death but can now be treated if diagnosed in time.
Dr. Lawrence J. Brandt, MACG, AGA-F, FASGE, professor of medicine and surgery at Albert Einstein College of Medicine, N.Y., emeritus chief of gastroenterology at Montefiore Medical Center, N.Y. He has no disclosures.
CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.
Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.
Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.
The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.
"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."
The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.
Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.
If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.
Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.
Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.
A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.
In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.
During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.
Dr. Dalsing reported having no financial disclosures.
CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.
Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.
Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.
The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.
"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."
The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.
Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.
If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.
Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.
Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.
A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.
In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.
During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.
Dr. Dalsing reported having no financial disclosures.
AT A VASCULAR SURGERY SYMPOSIUM
Real-world data backs rivaroxaban for postop VTE prevention
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
AT ASH 2013
Major finding: The 30-day VTE event rate was 0.47% for rivaroxaban and 0.81% for low molecular weight heparin (unadjusted RR, 0.58; P = .001).
Data source: Population-based, retrospective cohort study of 24,321 patients undergoing hip or knee arthroplasty
Disclosures: Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
Inpatient safety efforts yield mixed results
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: At least 81,000 adverse events were avoided in a single year in patients hospitalized for acute MI and heart failure.
Data source: A retrospective analysis of data from 61,523 patients in the Medicare Patient Safety Monitoring System.
Disclosures: The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
Give calcium before and after thyroidectomies in gastric bypass patients
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
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Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
|
|
Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
|
|
Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
FROM SURGERY
Major finding: Almost half (42%) of patients who have had gastric bypasses develop recalcitrant, symptomatic hypocalcemia after thyroidectomies. Patients who have not had gastric bypasses do not become symptomatically hypocalcemic.
Data source: A retrospective study of 57 thyroidectomy patients
Disclosures: The work was funded in part by the National Cancer Institute and Massachusetts General Hospital. Investigator disclosures were not available.
FDA panel rejects rivaroxaban again for acute coronary syndrome
SILVER SPRING, MD. – Collection of missing data and additional analyses from a large study on rivaroxaban failed to convince a Food and Drug Administration advisory panel to recommend approval of the anticoagulant drug for acute coronary syndrome.
At a meeting Jan. 16, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10 to 0, with 1 abstention, that the factor Xa inhibitor rivaroxaban (Xarelto) should not be approved as a treatment for acute coronary syndromes (ACS). Rivaroxaban maker Janssen Pharmaceuticals had proposed an indication to reduce the risk of thrombotic cardiovascular events in patients with ACS, based on the results of the ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) trial.
That study compared two doses of rivaroxaban (2.5 mg twice a day, the proposed dose, and 5 mg twice a day) plus standard antiplatelet therapy (aspirin and a thienopyridine) to placebo plus standard therapy in more than 15,000 people with recent ACS. The primary endpoint – the risk of a composite of cardiovascular death, MI, or stroke – was significantly reduced (P = .039) by 15% among patients on the 2.5-mg twice-daily dose, compared with patients on placebo. The difference was primarily driven by a reduction in cardiovascular deaths among rivaroxaban patients.
But in May 2012, the FDA panel voted 4 to 6 against approval of rivaroxaban for the ACS indication, citing safety concerns and the large amount of missing data from the study. In June 2012, the FDA declined to approve the indication, and the agency refused again in March 2013, after Janssen provided more information. The company disputed the decision and continued to pursue approval. Janssen submitted new analyses and proposed that treatment be limited to 90 days.
At the Jan. 16 advisory committee meeting, panel members commended the study investigators and Janssen for that new work. But they still voted against approval, noting that the missing data remained a problem, the P value for the primary endpoint was not low enough to support approval based on a single trial, and concerns continued about bleeding risk.
The additional work "didn’t really add in a substantial way to the primary endpoint analysis," explained advisory panel member Dr. Philip Sager. Overall, the study "wasn’t robust enough in terms of statistical significance to be considered as a positive study," added Dr. Sager, chair of the scientific programs committee at the Cardiac Safety Research Consortium, San Francisco.
The FDA has approved rivaroxaban for several indications, including reduction of the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treatment of deep vein thrombosis, and prevention of deep vein thrombosis after hip or knee replacement surgery.
Janssen will work with the FDA to address the questions raised at the meeting, according to a statement issued by the Johnson & Johnson subsidiary.
In May 2013, European Union drug regulators approved an ACS indication for rivaroxaban, to prevent atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) after an ACS in adults with elevated cardiac biomarkers, at a dose of 2.5 mg twice a day, co-administered with acetylsalicylic acid alone or with acetylsalicylic acid plus clopidogrel or ticlopidine.
The FDA usually follows the recommendations of its advisory panels. Advisory panel members have been cleared of potential conflicts related to the meeting topic. Occasionally, a panelist is given a waiver, but no waivers were given at this meeting.
SILVER SPRING, MD. – Collection of missing data and additional analyses from a large study on rivaroxaban failed to convince a Food and Drug Administration advisory panel to recommend approval of the anticoagulant drug for acute coronary syndrome.
At a meeting Jan. 16, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10 to 0, with 1 abstention, that the factor Xa inhibitor rivaroxaban (Xarelto) should not be approved as a treatment for acute coronary syndromes (ACS). Rivaroxaban maker Janssen Pharmaceuticals had proposed an indication to reduce the risk of thrombotic cardiovascular events in patients with ACS, based on the results of the ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) trial.
That study compared two doses of rivaroxaban (2.5 mg twice a day, the proposed dose, and 5 mg twice a day) plus standard antiplatelet therapy (aspirin and a thienopyridine) to placebo plus standard therapy in more than 15,000 people with recent ACS. The primary endpoint – the risk of a composite of cardiovascular death, MI, or stroke – was significantly reduced (P = .039) by 15% among patients on the 2.5-mg twice-daily dose, compared with patients on placebo. The difference was primarily driven by a reduction in cardiovascular deaths among rivaroxaban patients.
But in May 2012, the FDA panel voted 4 to 6 against approval of rivaroxaban for the ACS indication, citing safety concerns and the large amount of missing data from the study. In June 2012, the FDA declined to approve the indication, and the agency refused again in March 2013, after Janssen provided more information. The company disputed the decision and continued to pursue approval. Janssen submitted new analyses and proposed that treatment be limited to 90 days.
At the Jan. 16 advisory committee meeting, panel members commended the study investigators and Janssen for that new work. But they still voted against approval, noting that the missing data remained a problem, the P value for the primary endpoint was not low enough to support approval based on a single trial, and concerns continued about bleeding risk.
The additional work "didn’t really add in a substantial way to the primary endpoint analysis," explained advisory panel member Dr. Philip Sager. Overall, the study "wasn’t robust enough in terms of statistical significance to be considered as a positive study," added Dr. Sager, chair of the scientific programs committee at the Cardiac Safety Research Consortium, San Francisco.
The FDA has approved rivaroxaban for several indications, including reduction of the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treatment of deep vein thrombosis, and prevention of deep vein thrombosis after hip or knee replacement surgery.
Janssen will work with the FDA to address the questions raised at the meeting, according to a statement issued by the Johnson & Johnson subsidiary.
In May 2013, European Union drug regulators approved an ACS indication for rivaroxaban, to prevent atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) after an ACS in adults with elevated cardiac biomarkers, at a dose of 2.5 mg twice a day, co-administered with acetylsalicylic acid alone or with acetylsalicylic acid plus clopidogrel or ticlopidine.
The FDA usually follows the recommendations of its advisory panels. Advisory panel members have been cleared of potential conflicts related to the meeting topic. Occasionally, a panelist is given a waiver, but no waivers were given at this meeting.
SILVER SPRING, MD. – Collection of missing data and additional analyses from a large study on rivaroxaban failed to convince a Food and Drug Administration advisory panel to recommend approval of the anticoagulant drug for acute coronary syndrome.
At a meeting Jan. 16, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10 to 0, with 1 abstention, that the factor Xa inhibitor rivaroxaban (Xarelto) should not be approved as a treatment for acute coronary syndromes (ACS). Rivaroxaban maker Janssen Pharmaceuticals had proposed an indication to reduce the risk of thrombotic cardiovascular events in patients with ACS, based on the results of the ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) trial.
That study compared two doses of rivaroxaban (2.5 mg twice a day, the proposed dose, and 5 mg twice a day) plus standard antiplatelet therapy (aspirin and a thienopyridine) to placebo plus standard therapy in more than 15,000 people with recent ACS. The primary endpoint – the risk of a composite of cardiovascular death, MI, or stroke – was significantly reduced (P = .039) by 15% among patients on the 2.5-mg twice-daily dose, compared with patients on placebo. The difference was primarily driven by a reduction in cardiovascular deaths among rivaroxaban patients.
But in May 2012, the FDA panel voted 4 to 6 against approval of rivaroxaban for the ACS indication, citing safety concerns and the large amount of missing data from the study. In June 2012, the FDA declined to approve the indication, and the agency refused again in March 2013, after Janssen provided more information. The company disputed the decision and continued to pursue approval. Janssen submitted new analyses and proposed that treatment be limited to 90 days.
At the Jan. 16 advisory committee meeting, panel members commended the study investigators and Janssen for that new work. But they still voted against approval, noting that the missing data remained a problem, the P value for the primary endpoint was not low enough to support approval based on a single trial, and concerns continued about bleeding risk.
The additional work "didn’t really add in a substantial way to the primary endpoint analysis," explained advisory panel member Dr. Philip Sager. Overall, the study "wasn’t robust enough in terms of statistical significance to be considered as a positive study," added Dr. Sager, chair of the scientific programs committee at the Cardiac Safety Research Consortium, San Francisco.
The FDA has approved rivaroxaban for several indications, including reduction of the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treatment of deep vein thrombosis, and prevention of deep vein thrombosis after hip or knee replacement surgery.
Janssen will work with the FDA to address the questions raised at the meeting, according to a statement issued by the Johnson & Johnson subsidiary.
In May 2013, European Union drug regulators approved an ACS indication for rivaroxaban, to prevent atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) after an ACS in adults with elevated cardiac biomarkers, at a dose of 2.5 mg twice a day, co-administered with acetylsalicylic acid alone or with acetylsalicylic acid plus clopidogrel or ticlopidine.
The FDA usually follows the recommendations of its advisory panels. Advisory panel members have been cleared of potential conflicts related to the meeting topic. Occasionally, a panelist is given a waiver, but no waivers were given at this meeting.
FROM AN FDA ADVISORY PANEL MEETING
