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Official Newspaper of the American College of Surgeons
Hypertrophic cardiomyopathy: Who should get an ICD?
SNOWMASS, COLO. – Since the 2011 release of the current American College of Cardiology/American Heart Association guidelines on hypertrophic cardiomyopathy, several new evidence-based tools have emerged as being helpful in decision making regarding which patients should receive an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death, Dr. Rick A. Nishimura said at the annual Cardiovascular Conference at Snowmass.
These three tools – gadolinium-enhanced cardiovascular magnetic resonance imaging, a novel European risk score calculator, and a new appreciation of the importance of age-related risk – are most useful in the many cases of hypertrophic cardiomyopathy (HCM) where the cardiologist is on the fence regarding ICD placement because the patient doesn’t clearly meet the conventional major criteria for an ICD, according to Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Nishimura, a member of the writing panel for the current guidelines (Circulation. 2011 Dec 13;124[24]:2761-96), predicted these tools will be incorporated into the next iteration of the HCM guidelines.
Notably absent from Dr. Nishimura’s list of useful tools was genetic testing for assessment of SCD risk in a patient with HCM.
“You should not spend $6,000 to do a genetic study to try to predict who’s at risk for sudden death. It turns out that most mutations are neither inherently benign nor malignant. High-risk mutations come from high-risk families, so you can do just as well by taking a family history,” according to the cardiologist.
Dr. Nishimura explained that the clinical dilemma in trying to evaluate SCD risk in a patient who presents with HCM is that the overall risk is quite low – probably 1% or less per year in the total HCM population – yet HCM is the number-one cause of SCD in younger patients. And it can occur unpredictably years or decades after diagnosis of HCM.
While ICDs are of proven effectiveness in preventing SCD in patients with HCM, reliance solely upon the conventional risk predictors to identify those who should get a device is clearly inadequate. Those criteria have a positive predictive accuracy of less than 15%; in other words, roughly 85% of HCM patients who get an ICD never receive an appropriate, life-saving shock, Dr. Nishimura said.
“We have a lot of work left to do in order to better identify these patients. In our own data from the Mayo Clinic, 20%-25% of patients have inappropriate ICD shocks despite efforts to program the device to prevent such shocks. That’s especially common in younger, active patients with HCM, and when it occurs patients find it absolutely devastating,” according to the cardiologist.
As stated in the current guidelines, the established SCD risk factors that provide a strong indication for an ICD in a patient with HCM are prior documented cardiac arrest, ventricular fibrillation, or hemodynamically significant ventricular tachycardia. Additionally, risk factors which, in Dr. Nishimura’s view, probably warrant insertion of an ICD and, at the very least should trigger a physician-patient discussion about the risks and benefits of preventive device therapy, include a family history of HCM-related sudden death in a first-degree relative, massive left ventricular (LV) hypertrophy as defined by a maximum wall thickness of at least 30 mm, and recent unexplained syncope inconsistent with neurocardiogenic origin.
Less potent risk predictors where savvy clinical judgment becomes imperative include nonsustained ventricular tachycardia on 24-hour Holter monitoring, a hypotensive blood pressure response to exercise, and an increased LV wall thickness in a younger patient that doesn’t rise to the 30-mm standard. These are situations where gadolinium-enhanced MRI, consideration of patient age, and the European risk scoring system can help in the decision-making process, he said.
Gadolinium-enhanced MRI: Contrast-enhanced cardiovascular MRI with late gadolinium enhancement has emerged as a reliable marker of the myocyte disarray and interstitial fibrosis which serves as a substrate for ventricular arrhythmias. In a recent study of 1,293 HCM patients followed for a median of 3.3 years, the incidence of SCD events increased progressively with the extent of late gadolinium enhancement. Extensive late gadolinium enhancement, defined as involving at least 15% of LV mass, was associated with a doubled risk of SCD events in patients otherwise considered at low risk (Circulation. 2014 Aug 5;130[6]:484-95).
“This is probably going to become one of the key markers that can help you when you’re on the fence as to whether or not to put in an ICD. We’re getting MRIs with gadolinium now in all of our HCM patients. What matters is not gadolinium enhancement at the insertion of the left ventricle into the septum – a lot of people have that – but diffuse gadolinium enhancement throughout the septum,” Dr. Nishimura said.
Because SCD risk increases linearly with greater maximal LV wall thickness, gadolinium-enhanced MRI is particularly helpful in assessing risk in a younger patient with a maximal LV wall thickness of, say, 26 mm, he added.
Age: A study by led by Dr. Barry J. Maron, the cochair of the 2011 guideline committee and director of the HCM center at the Minneapolis Heart Institute, provides a new understanding that prophylactic ICD implantation is not warranted in patients with HCM who present at age 60 or older. In their study of 428 consecutive patients presenting with HCM at age 60 or above, the investigators found during 5.8 years of follow-up that the incidence of arrhythmic sudden death events was just 0.2% per year (Circulation. 2013 Feb 5;127[5]:585-93).
“They’ve shown that if you look at patients age 60 or above who have HCM, the risk of sudden cardiac death is almost nonexistent. That’s incredibly important to remember. Sudden death is something that’s going to happen in the younger population, under age 30,” Dr. Nishimura emphasized.
European SCD risk prediction tool: This tool was hailed as a major advance in the current European Society of Cardiology guidelines on HCM (Eur Heart J. 2014;35:2733-2779). The tool was incorporated into the guidelines. It is also available as a smartphone app.
The risk prediction tool (Eur Heart J. 2014 Aug 7;35[30]:2010-20) is a complex equation that incorporates seven predictive factors: age, maximal LV wall thickness, left atrial diameter, LV outflow tract gradient, family history of SCD, nonsustained VT, and unexplained syncope. After input on these seven factors, the equation spits out an individual’s estimated 5-year SCD risk. Based on the study of 3,675 consecutive HCM patients with a median 5.7 years of follow-up that was used to develop the risk equation, the current ESC guidelines state that an ICD is not warranted in HCM patients with a 5-year risk below 4%, device implantation should be considered in those whose risk is 4%-6%, and an ICD should be even more strongly considered in patients with a 5-year risk in excess of 6%.
“A lot of people across the pond are using this risk score. But there are some problems with it,” according to Dr. Nishimura.
In his view, it “doesn’t make much sense” to include left ventricular outflow tract gradient or left atrial diameter in the risk equation. Nor is unexplained syncope carefully defined. Also, the equation would be improved by incorporation of late gadolinium enhancement on MRI, left ventricular dysfunction, and presence or absence of apical aneurysm as predictive variables. But on the plus side, the European equation treats maximal LV wall thickness as a continuous variable, which is more appropriate than the single 30-mm cutoff used in the ACC/AHA guidelines.
The biggest limitation of the European prognostic score, however, is that it hasn’t yet been validated in an independent patient cohort, Dr. Nishimura said. He noted that when Dr. Maron and coworkers recently applied the European SCD risk equation retrospectively to 1,629 consecutive U.S. patients with HCM, the investigators concluded that the risk equation proved unreliable for prediction of future SCD events. Fifty-nine percent of patients who got an appropriate ICD shock or experienced SCD were misclassified as low risk and hence would not have received an ICD under the European guidelines (Am J Cardiol. 2015 Sep 1;116[5]:757-64).
Nonetheless, because of the limited predictive accuracy of today’s standard methods of assessing SCD risk, Dr. Nishimura considers application of the European risk score to be “reasonable” in HCM patients who don’t have any of the strong indications for an ICD.
“If it comes up with an estimated 5-year risk greater than 6%, I think it’s very reasonable to consider implantation of an ICD,” he said.
Dr. Nishimura observed that in addition to assessing SCD risk, cardiologists have two other separate essential tasks when a patient presents with HCM. One is to screen and counsel the first-degree relatives. The other is to determine whether a left ventricular outflow tract obstruction is present in a symptomatic patient and, if so, to improve symptoms by treating the associated hemodynamic abnormalities medically and if need be by septal ablation or septal myectomy.
He reported having no financial conflicts of interest regarding his presentation.
SNOWMASS, COLO. – Since the 2011 release of the current American College of Cardiology/American Heart Association guidelines on hypertrophic cardiomyopathy, several new evidence-based tools have emerged as being helpful in decision making regarding which patients should receive an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death, Dr. Rick A. Nishimura said at the annual Cardiovascular Conference at Snowmass.
These three tools – gadolinium-enhanced cardiovascular magnetic resonance imaging, a novel European risk score calculator, and a new appreciation of the importance of age-related risk – are most useful in the many cases of hypertrophic cardiomyopathy (HCM) where the cardiologist is on the fence regarding ICD placement because the patient doesn’t clearly meet the conventional major criteria for an ICD, according to Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Nishimura, a member of the writing panel for the current guidelines (Circulation. 2011 Dec 13;124[24]:2761-96), predicted these tools will be incorporated into the next iteration of the HCM guidelines.
Notably absent from Dr. Nishimura’s list of useful tools was genetic testing for assessment of SCD risk in a patient with HCM.
“You should not spend $6,000 to do a genetic study to try to predict who’s at risk for sudden death. It turns out that most mutations are neither inherently benign nor malignant. High-risk mutations come from high-risk families, so you can do just as well by taking a family history,” according to the cardiologist.
Dr. Nishimura explained that the clinical dilemma in trying to evaluate SCD risk in a patient who presents with HCM is that the overall risk is quite low – probably 1% or less per year in the total HCM population – yet HCM is the number-one cause of SCD in younger patients. And it can occur unpredictably years or decades after diagnosis of HCM.
While ICDs are of proven effectiveness in preventing SCD in patients with HCM, reliance solely upon the conventional risk predictors to identify those who should get a device is clearly inadequate. Those criteria have a positive predictive accuracy of less than 15%; in other words, roughly 85% of HCM patients who get an ICD never receive an appropriate, life-saving shock, Dr. Nishimura said.
“We have a lot of work left to do in order to better identify these patients. In our own data from the Mayo Clinic, 20%-25% of patients have inappropriate ICD shocks despite efforts to program the device to prevent such shocks. That’s especially common in younger, active patients with HCM, and when it occurs patients find it absolutely devastating,” according to the cardiologist.
As stated in the current guidelines, the established SCD risk factors that provide a strong indication for an ICD in a patient with HCM are prior documented cardiac arrest, ventricular fibrillation, or hemodynamically significant ventricular tachycardia. Additionally, risk factors which, in Dr. Nishimura’s view, probably warrant insertion of an ICD and, at the very least should trigger a physician-patient discussion about the risks and benefits of preventive device therapy, include a family history of HCM-related sudden death in a first-degree relative, massive left ventricular (LV) hypertrophy as defined by a maximum wall thickness of at least 30 mm, and recent unexplained syncope inconsistent with neurocardiogenic origin.
Less potent risk predictors where savvy clinical judgment becomes imperative include nonsustained ventricular tachycardia on 24-hour Holter monitoring, a hypotensive blood pressure response to exercise, and an increased LV wall thickness in a younger patient that doesn’t rise to the 30-mm standard. These are situations where gadolinium-enhanced MRI, consideration of patient age, and the European risk scoring system can help in the decision-making process, he said.
Gadolinium-enhanced MRI: Contrast-enhanced cardiovascular MRI with late gadolinium enhancement has emerged as a reliable marker of the myocyte disarray and interstitial fibrosis which serves as a substrate for ventricular arrhythmias. In a recent study of 1,293 HCM patients followed for a median of 3.3 years, the incidence of SCD events increased progressively with the extent of late gadolinium enhancement. Extensive late gadolinium enhancement, defined as involving at least 15% of LV mass, was associated with a doubled risk of SCD events in patients otherwise considered at low risk (Circulation. 2014 Aug 5;130[6]:484-95).
“This is probably going to become one of the key markers that can help you when you’re on the fence as to whether or not to put in an ICD. We’re getting MRIs with gadolinium now in all of our HCM patients. What matters is not gadolinium enhancement at the insertion of the left ventricle into the septum – a lot of people have that – but diffuse gadolinium enhancement throughout the septum,” Dr. Nishimura said.
Because SCD risk increases linearly with greater maximal LV wall thickness, gadolinium-enhanced MRI is particularly helpful in assessing risk in a younger patient with a maximal LV wall thickness of, say, 26 mm, he added.
Age: A study by led by Dr. Barry J. Maron, the cochair of the 2011 guideline committee and director of the HCM center at the Minneapolis Heart Institute, provides a new understanding that prophylactic ICD implantation is not warranted in patients with HCM who present at age 60 or older. In their study of 428 consecutive patients presenting with HCM at age 60 or above, the investigators found during 5.8 years of follow-up that the incidence of arrhythmic sudden death events was just 0.2% per year (Circulation. 2013 Feb 5;127[5]:585-93).
“They’ve shown that if you look at patients age 60 or above who have HCM, the risk of sudden cardiac death is almost nonexistent. That’s incredibly important to remember. Sudden death is something that’s going to happen in the younger population, under age 30,” Dr. Nishimura emphasized.
European SCD risk prediction tool: This tool was hailed as a major advance in the current European Society of Cardiology guidelines on HCM (Eur Heart J. 2014;35:2733-2779). The tool was incorporated into the guidelines. It is also available as a smartphone app.
The risk prediction tool (Eur Heart J. 2014 Aug 7;35[30]:2010-20) is a complex equation that incorporates seven predictive factors: age, maximal LV wall thickness, left atrial diameter, LV outflow tract gradient, family history of SCD, nonsustained VT, and unexplained syncope. After input on these seven factors, the equation spits out an individual’s estimated 5-year SCD risk. Based on the study of 3,675 consecutive HCM patients with a median 5.7 years of follow-up that was used to develop the risk equation, the current ESC guidelines state that an ICD is not warranted in HCM patients with a 5-year risk below 4%, device implantation should be considered in those whose risk is 4%-6%, and an ICD should be even more strongly considered in patients with a 5-year risk in excess of 6%.
“A lot of people across the pond are using this risk score. But there are some problems with it,” according to Dr. Nishimura.
In his view, it “doesn’t make much sense” to include left ventricular outflow tract gradient or left atrial diameter in the risk equation. Nor is unexplained syncope carefully defined. Also, the equation would be improved by incorporation of late gadolinium enhancement on MRI, left ventricular dysfunction, and presence or absence of apical aneurysm as predictive variables. But on the plus side, the European equation treats maximal LV wall thickness as a continuous variable, which is more appropriate than the single 30-mm cutoff used in the ACC/AHA guidelines.
The biggest limitation of the European prognostic score, however, is that it hasn’t yet been validated in an independent patient cohort, Dr. Nishimura said. He noted that when Dr. Maron and coworkers recently applied the European SCD risk equation retrospectively to 1,629 consecutive U.S. patients with HCM, the investigators concluded that the risk equation proved unreliable for prediction of future SCD events. Fifty-nine percent of patients who got an appropriate ICD shock or experienced SCD were misclassified as low risk and hence would not have received an ICD under the European guidelines (Am J Cardiol. 2015 Sep 1;116[5]:757-64).
Nonetheless, because of the limited predictive accuracy of today’s standard methods of assessing SCD risk, Dr. Nishimura considers application of the European risk score to be “reasonable” in HCM patients who don’t have any of the strong indications for an ICD.
“If it comes up with an estimated 5-year risk greater than 6%, I think it’s very reasonable to consider implantation of an ICD,” he said.
Dr. Nishimura observed that in addition to assessing SCD risk, cardiologists have two other separate essential tasks when a patient presents with HCM. One is to screen and counsel the first-degree relatives. The other is to determine whether a left ventricular outflow tract obstruction is present in a symptomatic patient and, if so, to improve symptoms by treating the associated hemodynamic abnormalities medically and if need be by septal ablation or septal myectomy.
He reported having no financial conflicts of interest regarding his presentation.
SNOWMASS, COLO. – Since the 2011 release of the current American College of Cardiology/American Heart Association guidelines on hypertrophic cardiomyopathy, several new evidence-based tools have emerged as being helpful in decision making regarding which patients should receive an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death, Dr. Rick A. Nishimura said at the annual Cardiovascular Conference at Snowmass.
These three tools – gadolinium-enhanced cardiovascular magnetic resonance imaging, a novel European risk score calculator, and a new appreciation of the importance of age-related risk – are most useful in the many cases of hypertrophic cardiomyopathy (HCM) where the cardiologist is on the fence regarding ICD placement because the patient doesn’t clearly meet the conventional major criteria for an ICD, according to Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Nishimura, a member of the writing panel for the current guidelines (Circulation. 2011 Dec 13;124[24]:2761-96), predicted these tools will be incorporated into the next iteration of the HCM guidelines.
Notably absent from Dr. Nishimura’s list of useful tools was genetic testing for assessment of SCD risk in a patient with HCM.
“You should not spend $6,000 to do a genetic study to try to predict who’s at risk for sudden death. It turns out that most mutations are neither inherently benign nor malignant. High-risk mutations come from high-risk families, so you can do just as well by taking a family history,” according to the cardiologist.
Dr. Nishimura explained that the clinical dilemma in trying to evaluate SCD risk in a patient who presents with HCM is that the overall risk is quite low – probably 1% or less per year in the total HCM population – yet HCM is the number-one cause of SCD in younger patients. And it can occur unpredictably years or decades after diagnosis of HCM.
While ICDs are of proven effectiveness in preventing SCD in patients with HCM, reliance solely upon the conventional risk predictors to identify those who should get a device is clearly inadequate. Those criteria have a positive predictive accuracy of less than 15%; in other words, roughly 85% of HCM patients who get an ICD never receive an appropriate, life-saving shock, Dr. Nishimura said.
“We have a lot of work left to do in order to better identify these patients. In our own data from the Mayo Clinic, 20%-25% of patients have inappropriate ICD shocks despite efforts to program the device to prevent such shocks. That’s especially common in younger, active patients with HCM, and when it occurs patients find it absolutely devastating,” according to the cardiologist.
As stated in the current guidelines, the established SCD risk factors that provide a strong indication for an ICD in a patient with HCM are prior documented cardiac arrest, ventricular fibrillation, or hemodynamically significant ventricular tachycardia. Additionally, risk factors which, in Dr. Nishimura’s view, probably warrant insertion of an ICD and, at the very least should trigger a physician-patient discussion about the risks and benefits of preventive device therapy, include a family history of HCM-related sudden death in a first-degree relative, massive left ventricular (LV) hypertrophy as defined by a maximum wall thickness of at least 30 mm, and recent unexplained syncope inconsistent with neurocardiogenic origin.
Less potent risk predictors where savvy clinical judgment becomes imperative include nonsustained ventricular tachycardia on 24-hour Holter monitoring, a hypotensive blood pressure response to exercise, and an increased LV wall thickness in a younger patient that doesn’t rise to the 30-mm standard. These are situations where gadolinium-enhanced MRI, consideration of patient age, and the European risk scoring system can help in the decision-making process, he said.
Gadolinium-enhanced MRI: Contrast-enhanced cardiovascular MRI with late gadolinium enhancement has emerged as a reliable marker of the myocyte disarray and interstitial fibrosis which serves as a substrate for ventricular arrhythmias. In a recent study of 1,293 HCM patients followed for a median of 3.3 years, the incidence of SCD events increased progressively with the extent of late gadolinium enhancement. Extensive late gadolinium enhancement, defined as involving at least 15% of LV mass, was associated with a doubled risk of SCD events in patients otherwise considered at low risk (Circulation. 2014 Aug 5;130[6]:484-95).
“This is probably going to become one of the key markers that can help you when you’re on the fence as to whether or not to put in an ICD. We’re getting MRIs with gadolinium now in all of our HCM patients. What matters is not gadolinium enhancement at the insertion of the left ventricle into the septum – a lot of people have that – but diffuse gadolinium enhancement throughout the septum,” Dr. Nishimura said.
Because SCD risk increases linearly with greater maximal LV wall thickness, gadolinium-enhanced MRI is particularly helpful in assessing risk in a younger patient with a maximal LV wall thickness of, say, 26 mm, he added.
Age: A study by led by Dr. Barry J. Maron, the cochair of the 2011 guideline committee and director of the HCM center at the Minneapolis Heart Institute, provides a new understanding that prophylactic ICD implantation is not warranted in patients with HCM who present at age 60 or older. In their study of 428 consecutive patients presenting with HCM at age 60 or above, the investigators found during 5.8 years of follow-up that the incidence of arrhythmic sudden death events was just 0.2% per year (Circulation. 2013 Feb 5;127[5]:585-93).
“They’ve shown that if you look at patients age 60 or above who have HCM, the risk of sudden cardiac death is almost nonexistent. That’s incredibly important to remember. Sudden death is something that’s going to happen in the younger population, under age 30,” Dr. Nishimura emphasized.
European SCD risk prediction tool: This tool was hailed as a major advance in the current European Society of Cardiology guidelines on HCM (Eur Heart J. 2014;35:2733-2779). The tool was incorporated into the guidelines. It is also available as a smartphone app.
The risk prediction tool (Eur Heart J. 2014 Aug 7;35[30]:2010-20) is a complex equation that incorporates seven predictive factors: age, maximal LV wall thickness, left atrial diameter, LV outflow tract gradient, family history of SCD, nonsustained VT, and unexplained syncope. After input on these seven factors, the equation spits out an individual’s estimated 5-year SCD risk. Based on the study of 3,675 consecutive HCM patients with a median 5.7 years of follow-up that was used to develop the risk equation, the current ESC guidelines state that an ICD is not warranted in HCM patients with a 5-year risk below 4%, device implantation should be considered in those whose risk is 4%-6%, and an ICD should be even more strongly considered in patients with a 5-year risk in excess of 6%.
“A lot of people across the pond are using this risk score. But there are some problems with it,” according to Dr. Nishimura.
In his view, it “doesn’t make much sense” to include left ventricular outflow tract gradient or left atrial diameter in the risk equation. Nor is unexplained syncope carefully defined. Also, the equation would be improved by incorporation of late gadolinium enhancement on MRI, left ventricular dysfunction, and presence or absence of apical aneurysm as predictive variables. But on the plus side, the European equation treats maximal LV wall thickness as a continuous variable, which is more appropriate than the single 30-mm cutoff used in the ACC/AHA guidelines.
The biggest limitation of the European prognostic score, however, is that it hasn’t yet been validated in an independent patient cohort, Dr. Nishimura said. He noted that when Dr. Maron and coworkers recently applied the European SCD risk equation retrospectively to 1,629 consecutive U.S. patients with HCM, the investigators concluded that the risk equation proved unreliable for prediction of future SCD events. Fifty-nine percent of patients who got an appropriate ICD shock or experienced SCD were misclassified as low risk and hence would not have received an ICD under the European guidelines (Am J Cardiol. 2015 Sep 1;116[5]:757-64).
Nonetheless, because of the limited predictive accuracy of today’s standard methods of assessing SCD risk, Dr. Nishimura considers application of the European risk score to be “reasonable” in HCM patients who don’t have any of the strong indications for an ICD.
“If it comes up with an estimated 5-year risk greater than 6%, I think it’s very reasonable to consider implantation of an ICD,” he said.
Dr. Nishimura observed that in addition to assessing SCD risk, cardiologists have two other separate essential tasks when a patient presents with HCM. One is to screen and counsel the first-degree relatives. The other is to determine whether a left ventricular outflow tract obstruction is present in a symptomatic patient and, if so, to improve symptoms by treating the associated hemodynamic abnormalities medically and if need be by septal ablation or septal myectomy.
He reported having no financial conflicts of interest regarding his presentation.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
CMS releases applications, instructions for 2015 meaningful use hardship exemptions
The Centers for Medicare & Medicaid Services has released the applications for meaningful use hardship exemptions for 2015.
Physicians who qualify for a hardship exemption must apply by March 15; hospitals must apply by April 1 to avoid being penalized in 2017. Exemptions may be granted for those facing infrastructure-related problems, unforeseen circumstances, lack of face-to-face interactions, or lack of available certified electronic health record systems.
As part of the Patient Access and Medicare Protection Act, passed in December 2015, CMS will be able to process blocks of applications instead of on a case-by-case basis, as it was required to do prior to the new law.
Applications and instructions are available here.
The Centers for Medicare & Medicaid Services has released the applications for meaningful use hardship exemptions for 2015.
Physicians who qualify for a hardship exemption must apply by March 15; hospitals must apply by April 1 to avoid being penalized in 2017. Exemptions may be granted for those facing infrastructure-related problems, unforeseen circumstances, lack of face-to-face interactions, or lack of available certified electronic health record systems.
As part of the Patient Access and Medicare Protection Act, passed in December 2015, CMS will be able to process blocks of applications instead of on a case-by-case basis, as it was required to do prior to the new law.
Applications and instructions are available here.
The Centers for Medicare & Medicaid Services has released the applications for meaningful use hardship exemptions for 2015.
Physicians who qualify for a hardship exemption must apply by March 15; hospitals must apply by April 1 to avoid being penalized in 2017. Exemptions may be granted for those facing infrastructure-related problems, unforeseen circumstances, lack of face-to-face interactions, or lack of available certified electronic health record systems.
As part of the Patient Access and Medicare Protection Act, passed in December 2015, CMS will be able to process blocks of applications instead of on a case-by-case basis, as it was required to do prior to the new law.
Applications and instructions are available here.
Early severe-injury DCL fascial closure more likely with postop hypertonic saline
SAN ANTONIO – In massively transfused patients undergoing damage control laparotomy, postop hypertonic saline improves primary fascial closure rates at first take-back, according to investigators from the University of Texas Health Science Center at Houston.
After controlling for age, injury severity, and resuscitation volumes, primary fascial closure (PFC) at first take-back was almost four times as likely in patients who received hypertonic saline (HTS) after bleeding damage control laparotomy (DCL) instead of traditional isotonic maintenance fluids (odds ratio, 3.82; 95% confidence interval, 1.02-14.31; P = .047).
“In a group of seriously injured bleeding trauma patients undergoing DCL, the use of HTS was associated with a lower fluid balance and a higher rate of PFC at the first take-back,” the investigators concluded.
It’s unclear if the results are because of the hypertonic saline drawing off more edema fluid and making early PFC more likely, or because HTS patients in the study received less fluid than their standard maintenance peers – 30 cc/hr of 3% sodium chloride versus 125 cc/hr of traditional isotonic fluids post op.
PFC at first take-back is known to reduce complications. Previous studies have shown that HTS improves PFC rates, but they included moderately injured patients who would have been closed early no matter what postop fluids they received. The investigators wanted to see how well HTS worked in more severely injured patients.
The study compared 54 adult DCL patients from 2010 to 2011 who received traditional isotonic postop maintenance with 41 from 2013 to 2014 on HTS, both for 72 hours or until fascial closure, whichever came first. The university switched to HTS around 2012 based on earlier studies, allowing for the comparison. Patients in both groups received at least three RBC units during surgery, according to investigator Dr. Lindley Folkerson, a surgery resident at the university.
Twenty-seven HTS patients (66%) were closed at first take-back, versus 33 (61%) in the traditional maintenance group. The median time for closure was 29 hours in the HTS group but 38 hours in traditional maintenance patients (P = .035).
There were no between-group demographic or injury severity differences, but because the university has become more conservative with DCL in recent years, the HTS patients were more hypotensive and had greater baseline fluid deficits at emergency department arrival, and received more blood in the operating room. Even so, HTS patients had significantly lower fluid balances at 24 and 48 hours.
The university hasn’t noticed increased kidney injuries with lower-volume HTS, but that might prove to be a problem in a larger study, Dr. Folkerson said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A limitation of the study is that patients were resuscitated as their physicians saw fit, so some in the HTS group likely got isotonic fluids. “We did not restrict fluids because they were on the HTS protocol. Crystalloid, colloid, and blood products were given as deemed necessary by the bedside physician,” she said.
The investigators had no disclosures.
We all agree that fascial closure should be a goal. Many people have many ideas on how best to achieve delayed primary fascial closure. Diuretics decrease visceral edema. The Whitman patch prevents fascial retraction. Patients who return earlier to the operating room are more likely to be closed.
This study describes an institutional effort to improve rates of delayed primary fascial closure which should be commended. Despite patients presenting more critically ill, the rate of closure at first take-back was improved with hypertonic saline. Maybe it is not the hypertonic saline per se but the fact that they gave it instead of all the fluid we used to give.
Dr. Margaret Lauerman is an assistant professor of shock trauma at the University of Maryland Medical Center in Baltimore. She has no disclosures.
We all agree that fascial closure should be a goal. Many people have many ideas on how best to achieve delayed primary fascial closure. Diuretics decrease visceral edema. The Whitman patch prevents fascial retraction. Patients who return earlier to the operating room are more likely to be closed.
This study describes an institutional effort to improve rates of delayed primary fascial closure which should be commended. Despite patients presenting more critically ill, the rate of closure at first take-back was improved with hypertonic saline. Maybe it is not the hypertonic saline per se but the fact that they gave it instead of all the fluid we used to give.
Dr. Margaret Lauerman is an assistant professor of shock trauma at the University of Maryland Medical Center in Baltimore. She has no disclosures.
We all agree that fascial closure should be a goal. Many people have many ideas on how best to achieve delayed primary fascial closure. Diuretics decrease visceral edema. The Whitman patch prevents fascial retraction. Patients who return earlier to the operating room are more likely to be closed.
This study describes an institutional effort to improve rates of delayed primary fascial closure which should be commended. Despite patients presenting more critically ill, the rate of closure at first take-back was improved with hypertonic saline. Maybe it is not the hypertonic saline per se but the fact that they gave it instead of all the fluid we used to give.
Dr. Margaret Lauerman is an assistant professor of shock trauma at the University of Maryland Medical Center in Baltimore. She has no disclosures.
SAN ANTONIO – In massively transfused patients undergoing damage control laparotomy, postop hypertonic saline improves primary fascial closure rates at first take-back, according to investigators from the University of Texas Health Science Center at Houston.
After controlling for age, injury severity, and resuscitation volumes, primary fascial closure (PFC) at first take-back was almost four times as likely in patients who received hypertonic saline (HTS) after bleeding damage control laparotomy (DCL) instead of traditional isotonic maintenance fluids (odds ratio, 3.82; 95% confidence interval, 1.02-14.31; P = .047).
“In a group of seriously injured bleeding trauma patients undergoing DCL, the use of HTS was associated with a lower fluid balance and a higher rate of PFC at the first take-back,” the investigators concluded.
It’s unclear if the results are because of the hypertonic saline drawing off more edema fluid and making early PFC more likely, or because HTS patients in the study received less fluid than their standard maintenance peers – 30 cc/hr of 3% sodium chloride versus 125 cc/hr of traditional isotonic fluids post op.
PFC at first take-back is known to reduce complications. Previous studies have shown that HTS improves PFC rates, but they included moderately injured patients who would have been closed early no matter what postop fluids they received. The investigators wanted to see how well HTS worked in more severely injured patients.
The study compared 54 adult DCL patients from 2010 to 2011 who received traditional isotonic postop maintenance with 41 from 2013 to 2014 on HTS, both for 72 hours or until fascial closure, whichever came first. The university switched to HTS around 2012 based on earlier studies, allowing for the comparison. Patients in both groups received at least three RBC units during surgery, according to investigator Dr. Lindley Folkerson, a surgery resident at the university.
Twenty-seven HTS patients (66%) were closed at first take-back, versus 33 (61%) in the traditional maintenance group. The median time for closure was 29 hours in the HTS group but 38 hours in traditional maintenance patients (P = .035).
There were no between-group demographic or injury severity differences, but because the university has become more conservative with DCL in recent years, the HTS patients were more hypotensive and had greater baseline fluid deficits at emergency department arrival, and received more blood in the operating room. Even so, HTS patients had significantly lower fluid balances at 24 and 48 hours.
The university hasn’t noticed increased kidney injuries with lower-volume HTS, but that might prove to be a problem in a larger study, Dr. Folkerson said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A limitation of the study is that patients were resuscitated as their physicians saw fit, so some in the HTS group likely got isotonic fluids. “We did not restrict fluids because they were on the HTS protocol. Crystalloid, colloid, and blood products were given as deemed necessary by the bedside physician,” she said.
The investigators had no disclosures.
SAN ANTONIO – In massively transfused patients undergoing damage control laparotomy, postop hypertonic saline improves primary fascial closure rates at first take-back, according to investigators from the University of Texas Health Science Center at Houston.
After controlling for age, injury severity, and resuscitation volumes, primary fascial closure (PFC) at first take-back was almost four times as likely in patients who received hypertonic saline (HTS) after bleeding damage control laparotomy (DCL) instead of traditional isotonic maintenance fluids (odds ratio, 3.82; 95% confidence interval, 1.02-14.31; P = .047).
“In a group of seriously injured bleeding trauma patients undergoing DCL, the use of HTS was associated with a lower fluid balance and a higher rate of PFC at the first take-back,” the investigators concluded.
It’s unclear if the results are because of the hypertonic saline drawing off more edema fluid and making early PFC more likely, or because HTS patients in the study received less fluid than their standard maintenance peers – 30 cc/hr of 3% sodium chloride versus 125 cc/hr of traditional isotonic fluids post op.
PFC at first take-back is known to reduce complications. Previous studies have shown that HTS improves PFC rates, but they included moderately injured patients who would have been closed early no matter what postop fluids they received. The investigators wanted to see how well HTS worked in more severely injured patients.
The study compared 54 adult DCL patients from 2010 to 2011 who received traditional isotonic postop maintenance with 41 from 2013 to 2014 on HTS, both for 72 hours or until fascial closure, whichever came first. The university switched to HTS around 2012 based on earlier studies, allowing for the comparison. Patients in both groups received at least three RBC units during surgery, according to investigator Dr. Lindley Folkerson, a surgery resident at the university.
Twenty-seven HTS patients (66%) were closed at first take-back, versus 33 (61%) in the traditional maintenance group. The median time for closure was 29 hours in the HTS group but 38 hours in traditional maintenance patients (P = .035).
There were no between-group demographic or injury severity differences, but because the university has become more conservative with DCL in recent years, the HTS patients were more hypotensive and had greater baseline fluid deficits at emergency department arrival, and received more blood in the operating room. Even so, HTS patients had significantly lower fluid balances at 24 and 48 hours.
The university hasn’t noticed increased kidney injuries with lower-volume HTS, but that might prove to be a problem in a larger study, Dr. Folkerson said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A limitation of the study is that patients were resuscitated as their physicians saw fit, so some in the HTS group likely got isotonic fluids. “We did not restrict fluids because they were on the HTS protocol. Crystalloid, colloid, and blood products were given as deemed necessary by the bedside physician,” she said.
The investigators had no disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: Order 30 cc/hour of 3% sodium chloride after bleeding DCL if you want to close patients in about a day.
Major finding: The median time for fascial closure was 29 hours in the hypertonic saline. group but 38 hours in the traditional fluid maintenance group (P = .035).
Data source: Review of 95 DCL patients.
Disclosures: The investigators had no disclosures.
Patient records requests: New regs clarify physician responsibilities
The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.
New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.
In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.
When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.
In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.
Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.
While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.
To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.
The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.
“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”
The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.
Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.
“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”
Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.
“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”
But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.
“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”
Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.
“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”
On Twitter @legal_med
The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.
New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.
In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.
When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.
In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.
Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.
While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.
To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.
The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.
“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”
The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.
Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.
“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”
Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.
“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”
But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.
“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”
Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.
“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”
On Twitter @legal_med
The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.
New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.
In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.
When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.
In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.
Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.
While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.
To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.
The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.
“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”
The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.
Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.
“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”
Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.
“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”
But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.
“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”
Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.
“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”
On Twitter @legal_med
Limit antibiotics to 4 days for percutaneous abdominal infection drainage
SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.
“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.
The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).
STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.
There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.
The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.
“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.
The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.
“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.
Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm3 or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.
Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.
The investigators have no disclosures.
This project is an important one. We hit [complicated intra-abdominal infection patients] hard and fast, and they do better, but when do we stop?
We all know that we give antibiotics for too long and to the wrong patients, and that this isn’t for free. Increased costs, drug resistance, and C. difficile infections result. But like training wheels and crutches, it’s hard to know when to give them up. The authors tackled this question, but patients without adequate source control were excluded and the study was underpowered. We know shorter courses of antibiotics are probably the right thing, but how do we prove it?
Dr. Jennifer Knight is an acute care surgeon at the West Virginia University in Morgantown. She has no disclosures.
This project is an important one. We hit [complicated intra-abdominal infection patients] hard and fast, and they do better, but when do we stop?
We all know that we give antibiotics for too long and to the wrong patients, and that this isn’t for free. Increased costs, drug resistance, and C. difficile infections result. But like training wheels and crutches, it’s hard to know when to give them up. The authors tackled this question, but patients without adequate source control were excluded and the study was underpowered. We know shorter courses of antibiotics are probably the right thing, but how do we prove it?
Dr. Jennifer Knight is an acute care surgeon at the West Virginia University in Morgantown. She has no disclosures.
This project is an important one. We hit [complicated intra-abdominal infection patients] hard and fast, and they do better, but when do we stop?
We all know that we give antibiotics for too long and to the wrong patients, and that this isn’t for free. Increased costs, drug resistance, and C. difficile infections result. But like training wheels and crutches, it’s hard to know when to give them up. The authors tackled this question, but patients without adequate source control were excluded and the study was underpowered. We know shorter courses of antibiotics are probably the right thing, but how do we prove it?
Dr. Jennifer Knight is an acute care surgeon at the West Virginia University in Morgantown. She has no disclosures.
SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.
“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.
The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).
STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.
There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.
The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.
“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.
The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.
“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.
Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm3 or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.
Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.
The investigators have no disclosures.
SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.
“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.
The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).
STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.
There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.
The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.
“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.
The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.
“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.
Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm3 or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.
Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.
The investigators have no disclosures.
AT The EAST SCIENTIFIC ASSEMBLY
Key clinical point: For patients who aren’t too sick, a 4-day course of antibiotics is adequate for percutaneous drainage of complicated intra-abdominal infections.
Major finding: The rate of recurrent infection is the same whether patients have a 4- or 7-day course (9.7% vs. 10.5%; P = 1.00),
Data source: Posthoc analysis of 129 patients in the STOP-IT trial
Disclosures: The investigators have no disclosures.
Study: Robot-assisted hysterectomy as fast, safe as laparoscopic approach
LAS VEGAS – Robot-assisted laparoscopic hysterectomy is just as quick and safe as standard laparoscopic hysterectomy – at least in the hands of an experienced surgeon, according to a surgical trial of 144 women.
The first prospective, randomized trial comparing the two techniques found no differences in operative time, intraoperative complications, postoperative pain, length of stay, or 12-week complications, Dr. Timothy Deimling reported at a meeting sponsored by the AAGL.
He did caution, however, that the single surgeon who performed all of the procedures was highly experienced with robotic surgery, having performed more than 600 cases in his career.
The trial included 144 women who underwent hysterectomy for benign conditions. There were 72 women in each surgical group. They were consented at the time of consult, but not randomized until the morning of surgery, said Dr. Deimling of the Penn State Milton S. Hershey Medical Center, in Hershey, Pa.
There were no significant between-group differences in any of the baseline characteristics, nor in any of the indications for surgery, with one exception: More women in the laparoscopic group had undergone prior cesarean sections (44% vs. 23%).
The primary outcome was mean operative time, which was considered initial incision to closure. This was similar in the robot-assisted and laparoscopic groups (74 vs. 75 minutes).
Secondary outcomes were also similar, including pain, which was scored on a 1-10 scale. The mean score was 3.9 in the laparoscopic group and 3.8 in the robotic group. Likewise length of stay was similar (mean 19.6 vs. 22 hours).
There was one serious intraoperative complication. A patient in the laparoscopic group experienced a ureteral injury after the insertion of the first trocar, which resulted in termination of the surgery. She later had a successful laparoscopic hysterectomy. Postoperative complications were also similar in the two groups.
But it’s unclear if the results are generalizable. Dr. Deimling noted that the single surgeon who performed all the cases was highly experienced in robotic surgery. Additionally, all cases were assisted by a surgical team of nurses and technicians who were highly trained in both laparoscopic and robotic gynecologic surgery.
Dr. Deimling reported having no relevant financial disclosures.
LAS VEGAS – Robot-assisted laparoscopic hysterectomy is just as quick and safe as standard laparoscopic hysterectomy – at least in the hands of an experienced surgeon, according to a surgical trial of 144 women.
The first prospective, randomized trial comparing the two techniques found no differences in operative time, intraoperative complications, postoperative pain, length of stay, or 12-week complications, Dr. Timothy Deimling reported at a meeting sponsored by the AAGL.
He did caution, however, that the single surgeon who performed all of the procedures was highly experienced with robotic surgery, having performed more than 600 cases in his career.
The trial included 144 women who underwent hysterectomy for benign conditions. There were 72 women in each surgical group. They were consented at the time of consult, but not randomized until the morning of surgery, said Dr. Deimling of the Penn State Milton S. Hershey Medical Center, in Hershey, Pa.
There were no significant between-group differences in any of the baseline characteristics, nor in any of the indications for surgery, with one exception: More women in the laparoscopic group had undergone prior cesarean sections (44% vs. 23%).
The primary outcome was mean operative time, which was considered initial incision to closure. This was similar in the robot-assisted and laparoscopic groups (74 vs. 75 minutes).
Secondary outcomes were also similar, including pain, which was scored on a 1-10 scale. The mean score was 3.9 in the laparoscopic group and 3.8 in the robotic group. Likewise length of stay was similar (mean 19.6 vs. 22 hours).
There was one serious intraoperative complication. A patient in the laparoscopic group experienced a ureteral injury after the insertion of the first trocar, which resulted in termination of the surgery. She later had a successful laparoscopic hysterectomy. Postoperative complications were also similar in the two groups.
But it’s unclear if the results are generalizable. Dr. Deimling noted that the single surgeon who performed all the cases was highly experienced in robotic surgery. Additionally, all cases were assisted by a surgical team of nurses and technicians who were highly trained in both laparoscopic and robotic gynecologic surgery.
Dr. Deimling reported having no relevant financial disclosures.
LAS VEGAS – Robot-assisted laparoscopic hysterectomy is just as quick and safe as standard laparoscopic hysterectomy – at least in the hands of an experienced surgeon, according to a surgical trial of 144 women.
The first prospective, randomized trial comparing the two techniques found no differences in operative time, intraoperative complications, postoperative pain, length of stay, or 12-week complications, Dr. Timothy Deimling reported at a meeting sponsored by the AAGL.
He did caution, however, that the single surgeon who performed all of the procedures was highly experienced with robotic surgery, having performed more than 600 cases in his career.
The trial included 144 women who underwent hysterectomy for benign conditions. There were 72 women in each surgical group. They were consented at the time of consult, but not randomized until the morning of surgery, said Dr. Deimling of the Penn State Milton S. Hershey Medical Center, in Hershey, Pa.
There were no significant between-group differences in any of the baseline characteristics, nor in any of the indications for surgery, with one exception: More women in the laparoscopic group had undergone prior cesarean sections (44% vs. 23%).
The primary outcome was mean operative time, which was considered initial incision to closure. This was similar in the robot-assisted and laparoscopic groups (74 vs. 75 minutes).
Secondary outcomes were also similar, including pain, which was scored on a 1-10 scale. The mean score was 3.9 in the laparoscopic group and 3.8 in the robotic group. Likewise length of stay was similar (mean 19.6 vs. 22 hours).
There was one serious intraoperative complication. A patient in the laparoscopic group experienced a ureteral injury after the insertion of the first trocar, which resulted in termination of the surgery. She later had a successful laparoscopic hysterectomy. Postoperative complications were also similar in the two groups.
But it’s unclear if the results are generalizable. Dr. Deimling noted that the single surgeon who performed all the cases was highly experienced in robotic surgery. Additionally, all cases were assisted by a surgical team of nurses and technicians who were highly trained in both laparoscopic and robotic gynecologic surgery.
Dr. Deimling reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point: Robot-assisted minimally invasive hysterectomy was as quick and as safe as standard laparoscopic surgery.
Major finding: Mean operative time was similar in the robot-assisted hysterectomy and standard laparoscopic groups, at 74 and 75 minutes, respectively.
Data source: The randomized trial included 144 women who underwent hysterectomy for benign conditions.
Disclosures: Dr. Deimling reported having no relevant financial disclosures.
Finding more transplant hearts but not more donors
Heart transplant volumes in the United States have remained static since the start of the century because of improved trauma prevention and treatment, but that has challenged cardiologists to find enough donor hearts for the growing ranks of advanced heart failure patients. So a multidisciplinary team at the University of Washington in Seattle initiated a quality improvement program that doubled transplant volume without any change in transplant-related deaths by accepting hearts they would have otherwise discarded.
The study came about after the researchers determined that a large number of donor hearts from their own organ procurement program were being sent to other transplant centers. So they gathered a multidisciplinary team of transplant surgeons, cardiologists, and members of the organ procurement program to study ways to improve its center-specific organ utilization rate. The endeavor resulted in an increase in utilization rates from 28% to 49% in a year, a rate that has been sustained through a second year, according to study findings published in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:238-43).
“The simple process of systematically reviewing donor turn down events as a group tended to reduce variability [and] increase confidence in expanded criteria donors and resulted in improved donor organ utilization and transplant volumes,” lead author Dr. Jason Smith and colleagues said.
The 30-day and 1-year death rates were similar before and after the quality improvement program started, but the death rates of those on the heart wait list declined from 17.2% to 12%, “which was not statistically significant,” Dr. Smith and coauthors said, “but does show that increasing use of organs that may be outside of the usual pattern has a trend toward improved wait list survival and needs to be considered when assessing donor hearts.”
Because of excellent results of heart transplants in patients with advanced heart failure, a number of investigators have proposed expanding the population of heart donors to include older people, those with higher risk of infectious disease, or with heart disease such as coronary artery disease and left ventricular hypertrophy, Dr. Smith and coauthors said. Their own review found a higher-than-expected rate of donor hearts sent to other centers from the University of Washington organ procurement program.
The multidisciplinary team analyzed the organs the University of Washington surgeons refused and sent to other institutions from July 2012 to June 2013.
For a year after that, the multidisciplinary group did real-time analysis of organ refusal along with quarterly reviews “in a non-confrontational, proactive” setting, as Dr. Smith and his colleagues described it. The group held open discussions on refused organs that were ultimately transplanted elsewhere. “The review process was facilitated to provide a constructive environment to encourage development of best practices and consistency,” the researchers noted. The quality improvement program led to an increase in the unit’s transplant volume despite fewer donor offers.
The researchers acknowledged that donor assessment has been the focus of much controversy. They pointed out that average donor age has increased over the last 20 years from 29 years to 33 years and has since retreated to 31 years, and some programs utilize donors up to their mid-60s. Also, previous studies have advocated for the use of donors who meet the criteria of the Centers for Disease Control and Prevention high risk behavior of infection as well as some drug abusers because of the low-risk of transmission and emerging evidence affirming the safety of hearts of drug users.
“The individual decision to utilize or discard a donor organ is one of the most challenging aspects of transplant medicine,” Dr. Smith and colleagues said. “It requires balancing donor risks against the exigencies of the recipient.”
Today, the multidisciplinary team evaluates each heart offered for donation and is exploring ways to accept even more donor hearts, even discarded hearts. “This represents a large, untapped pool of potential donor hearts that might add to the net number of transplants performed nationally and not merely redistribute organ usage,” Dr. Smith and colleagues said.
Dr. Smith is a consultant for Thoratec and is a primary site investigator for the EXPAND Trial sponsored by TransMedics. Dr. Todd Dardas is supported by the American College of Cardiology/Daiichi Sankyo Career Development Award. Dr. Jay Pal receives grant support from Tenax. Dr. Wayne Levy is a consultant for HeartWare, Novartis, GE Healthcare, Pharmin, and Biotronik. Dr. Claudius Mahr is a consultant for Thoratec, HeartWare and Abiomed. Dr. Nahush Mokadam is a consultant for Thoratec, HeartWare, Syncardia and St. Jude Medical, and has research grants from Thoratec, HeartWare and Syncardia. The other coauthors had no relationships to disclose.
How the University of Washington researchers brought about such a dramatic increase in donor heart utilization raises a number of questions, Dr. Nicholas Smedira of Cleveland Clinic said in his invited commentary (J Thorac Cardiovasc Surg 2016;151:243-4).
“They refer euphemistically to ‘behavioral adaptation’ and ‘frank discussions’ regarding ‘individual and group bias’ as explanations, but understanding exactly how this is accomplished is not easy,” Dr. Smedira said.
Noteworthy is that the researchers used more donors who meet Center for Disease Control and Prevention high risk criteria for infectious disease. However, cardiologists tend to weigh their decision for accepting donor hearts “by the last memorable or distressful experience,” Dr. Smedira said. Hence, many of these donor hearts go unused. At the same time, assessing risk without complete information is challenging, he said.
Besides their thought processes, other factors that influence cardiologists’ decisions on accepting donor hearts include fatigue, scheduling conflicts, reimbursement issues, and outcome metrics. He credited the University of Washington for its “courage” to examine their decision-making process, including exploring biases as well as working “collectively and blamelessly” to support their decisions. “I would encourage more transplant centers to follow a program similar to the University of Washington’s and maybe we will be hearing more yeses and fewer nos,” Dr. Smedira said.
He had no relationships to disclose.
How the University of Washington researchers brought about such a dramatic increase in donor heart utilization raises a number of questions, Dr. Nicholas Smedira of Cleveland Clinic said in his invited commentary (J Thorac Cardiovasc Surg 2016;151:243-4).
“They refer euphemistically to ‘behavioral adaptation’ and ‘frank discussions’ regarding ‘individual and group bias’ as explanations, but understanding exactly how this is accomplished is not easy,” Dr. Smedira said.
Noteworthy is that the researchers used more donors who meet Center for Disease Control and Prevention high risk criteria for infectious disease. However, cardiologists tend to weigh their decision for accepting donor hearts “by the last memorable or distressful experience,” Dr. Smedira said. Hence, many of these donor hearts go unused. At the same time, assessing risk without complete information is challenging, he said.
Besides their thought processes, other factors that influence cardiologists’ decisions on accepting donor hearts include fatigue, scheduling conflicts, reimbursement issues, and outcome metrics. He credited the University of Washington for its “courage” to examine their decision-making process, including exploring biases as well as working “collectively and blamelessly” to support their decisions. “I would encourage more transplant centers to follow a program similar to the University of Washington’s and maybe we will be hearing more yeses and fewer nos,” Dr. Smedira said.
He had no relationships to disclose.
How the University of Washington researchers brought about such a dramatic increase in donor heart utilization raises a number of questions, Dr. Nicholas Smedira of Cleveland Clinic said in his invited commentary (J Thorac Cardiovasc Surg 2016;151:243-4).
“They refer euphemistically to ‘behavioral adaptation’ and ‘frank discussions’ regarding ‘individual and group bias’ as explanations, but understanding exactly how this is accomplished is not easy,” Dr. Smedira said.
Noteworthy is that the researchers used more donors who meet Center for Disease Control and Prevention high risk criteria for infectious disease. However, cardiologists tend to weigh their decision for accepting donor hearts “by the last memorable or distressful experience,” Dr. Smedira said. Hence, many of these donor hearts go unused. At the same time, assessing risk without complete information is challenging, he said.
Besides their thought processes, other factors that influence cardiologists’ decisions on accepting donor hearts include fatigue, scheduling conflicts, reimbursement issues, and outcome metrics. He credited the University of Washington for its “courage” to examine their decision-making process, including exploring biases as well as working “collectively and blamelessly” to support their decisions. “I would encourage more transplant centers to follow a program similar to the University of Washington’s and maybe we will be hearing more yeses and fewer nos,” Dr. Smedira said.
He had no relationships to disclose.
Heart transplant volumes in the United States have remained static since the start of the century because of improved trauma prevention and treatment, but that has challenged cardiologists to find enough donor hearts for the growing ranks of advanced heart failure patients. So a multidisciplinary team at the University of Washington in Seattle initiated a quality improvement program that doubled transplant volume without any change in transplant-related deaths by accepting hearts they would have otherwise discarded.
The study came about after the researchers determined that a large number of donor hearts from their own organ procurement program were being sent to other transplant centers. So they gathered a multidisciplinary team of transplant surgeons, cardiologists, and members of the organ procurement program to study ways to improve its center-specific organ utilization rate. The endeavor resulted in an increase in utilization rates from 28% to 49% in a year, a rate that has been sustained through a second year, according to study findings published in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:238-43).
“The simple process of systematically reviewing donor turn down events as a group tended to reduce variability [and] increase confidence in expanded criteria donors and resulted in improved donor organ utilization and transplant volumes,” lead author Dr. Jason Smith and colleagues said.
The 30-day and 1-year death rates were similar before and after the quality improvement program started, but the death rates of those on the heart wait list declined from 17.2% to 12%, “which was not statistically significant,” Dr. Smith and coauthors said, “but does show that increasing use of organs that may be outside of the usual pattern has a trend toward improved wait list survival and needs to be considered when assessing donor hearts.”
Because of excellent results of heart transplants in patients with advanced heart failure, a number of investigators have proposed expanding the population of heart donors to include older people, those with higher risk of infectious disease, or with heart disease such as coronary artery disease and left ventricular hypertrophy, Dr. Smith and coauthors said. Their own review found a higher-than-expected rate of donor hearts sent to other centers from the University of Washington organ procurement program.
The multidisciplinary team analyzed the organs the University of Washington surgeons refused and sent to other institutions from July 2012 to June 2013.
For a year after that, the multidisciplinary group did real-time analysis of organ refusal along with quarterly reviews “in a non-confrontational, proactive” setting, as Dr. Smith and his colleagues described it. The group held open discussions on refused organs that were ultimately transplanted elsewhere. “The review process was facilitated to provide a constructive environment to encourage development of best practices and consistency,” the researchers noted. The quality improvement program led to an increase in the unit’s transplant volume despite fewer donor offers.
The researchers acknowledged that donor assessment has been the focus of much controversy. They pointed out that average donor age has increased over the last 20 years from 29 years to 33 years and has since retreated to 31 years, and some programs utilize donors up to their mid-60s. Also, previous studies have advocated for the use of donors who meet the criteria of the Centers for Disease Control and Prevention high risk behavior of infection as well as some drug abusers because of the low-risk of transmission and emerging evidence affirming the safety of hearts of drug users.
“The individual decision to utilize or discard a donor organ is one of the most challenging aspects of transplant medicine,” Dr. Smith and colleagues said. “It requires balancing donor risks against the exigencies of the recipient.”
Today, the multidisciplinary team evaluates each heart offered for donation and is exploring ways to accept even more donor hearts, even discarded hearts. “This represents a large, untapped pool of potential donor hearts that might add to the net number of transplants performed nationally and not merely redistribute organ usage,” Dr. Smith and colleagues said.
Dr. Smith is a consultant for Thoratec and is a primary site investigator for the EXPAND Trial sponsored by TransMedics. Dr. Todd Dardas is supported by the American College of Cardiology/Daiichi Sankyo Career Development Award. Dr. Jay Pal receives grant support from Tenax. Dr. Wayne Levy is a consultant for HeartWare, Novartis, GE Healthcare, Pharmin, and Biotronik. Dr. Claudius Mahr is a consultant for Thoratec, HeartWare and Abiomed. Dr. Nahush Mokadam is a consultant for Thoratec, HeartWare, Syncardia and St. Jude Medical, and has research grants from Thoratec, HeartWare and Syncardia. The other coauthors had no relationships to disclose.
Heart transplant volumes in the United States have remained static since the start of the century because of improved trauma prevention and treatment, but that has challenged cardiologists to find enough donor hearts for the growing ranks of advanced heart failure patients. So a multidisciplinary team at the University of Washington in Seattle initiated a quality improvement program that doubled transplant volume without any change in transplant-related deaths by accepting hearts they would have otherwise discarded.
The study came about after the researchers determined that a large number of donor hearts from their own organ procurement program were being sent to other transplant centers. So they gathered a multidisciplinary team of transplant surgeons, cardiologists, and members of the organ procurement program to study ways to improve its center-specific organ utilization rate. The endeavor resulted in an increase in utilization rates from 28% to 49% in a year, a rate that has been sustained through a second year, according to study findings published in the January issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:238-43).
“The simple process of systematically reviewing donor turn down events as a group tended to reduce variability [and] increase confidence in expanded criteria donors and resulted in improved donor organ utilization and transplant volumes,” lead author Dr. Jason Smith and colleagues said.
The 30-day and 1-year death rates were similar before and after the quality improvement program started, but the death rates of those on the heart wait list declined from 17.2% to 12%, “which was not statistically significant,” Dr. Smith and coauthors said, “but does show that increasing use of organs that may be outside of the usual pattern has a trend toward improved wait list survival and needs to be considered when assessing donor hearts.”
Because of excellent results of heart transplants in patients with advanced heart failure, a number of investigators have proposed expanding the population of heart donors to include older people, those with higher risk of infectious disease, or with heart disease such as coronary artery disease and left ventricular hypertrophy, Dr. Smith and coauthors said. Their own review found a higher-than-expected rate of donor hearts sent to other centers from the University of Washington organ procurement program.
The multidisciplinary team analyzed the organs the University of Washington surgeons refused and sent to other institutions from July 2012 to June 2013.
For a year after that, the multidisciplinary group did real-time analysis of organ refusal along with quarterly reviews “in a non-confrontational, proactive” setting, as Dr. Smith and his colleagues described it. The group held open discussions on refused organs that were ultimately transplanted elsewhere. “The review process was facilitated to provide a constructive environment to encourage development of best practices and consistency,” the researchers noted. The quality improvement program led to an increase in the unit’s transplant volume despite fewer donor offers.
The researchers acknowledged that donor assessment has been the focus of much controversy. They pointed out that average donor age has increased over the last 20 years from 29 years to 33 years and has since retreated to 31 years, and some programs utilize donors up to their mid-60s. Also, previous studies have advocated for the use of donors who meet the criteria of the Centers for Disease Control and Prevention high risk behavior of infection as well as some drug abusers because of the low-risk of transmission and emerging evidence affirming the safety of hearts of drug users.
“The individual decision to utilize or discard a donor organ is one of the most challenging aspects of transplant medicine,” Dr. Smith and colleagues said. “It requires balancing donor risks against the exigencies of the recipient.”
Today, the multidisciplinary team evaluates each heart offered for donation and is exploring ways to accept even more donor hearts, even discarded hearts. “This represents a large, untapped pool of potential donor hearts that might add to the net number of transplants performed nationally and not merely redistribute organ usage,” Dr. Smith and colleagues said.
Dr. Smith is a consultant for Thoratec and is a primary site investigator for the EXPAND Trial sponsored by TransMedics. Dr. Todd Dardas is supported by the American College of Cardiology/Daiichi Sankyo Career Development Award. Dr. Jay Pal receives grant support from Tenax. Dr. Wayne Levy is a consultant for HeartWare, Novartis, GE Healthcare, Pharmin, and Biotronik. Dr. Claudius Mahr is a consultant for Thoratec, HeartWare and Abiomed. Dr. Nahush Mokadam is a consultant for Thoratec, HeartWare, Syncardia and St. Jude Medical, and has research grants from Thoratec, HeartWare and Syncardia. The other coauthors had no relationships to disclose.
Key clinical point: A group approach to systematically review rejected donor organs has led to expanded donor criteria and resulted in improved donor organ utilization and transplant volume.
Major finding: Transplant utilization rate increased from 28% to 49% with no significant change in 30-day survival after implementation of a donor review protocol.
Data source: Retrospective review of 293 total donor heart offers at a single center from July 2012 to June 2013 compared with review of 279 heart offers from July 2013 to June 2014.
Disclosures: Lead author Dr. Jason Smith is a consultant for Thoratec and is a primary site investigator for the EXPAND Trial sponsored by TransMedics. Dr. Todd Dardas is supported by the American College of Cardiology/Daiichi Sankyo Career Development Award. Dr. Jay Pal receives grant support from Tenax. Dr. Wayne Levy is a consultant for HeartWare, Novartis, GE Healthcare, Pharmin, and Biotronik. Dr. Claudius Mahr is a consultant for Thoratec, HeartWare and Abiomed. Dr. Nahush Mokadam is a consultant for Thoratec, HeartWare, Syncardia, and St. Jude Medical, and has research grants from Thoratec, HeartWare and Syncardia. The other coauthors had no relationships to disclose.
Fertility preservation in early cervical cancer
Historically, the standard of care for women diagnosed with early cervical cancer has been radical hysterectomy. Thus, young women are not only being confronted with a cancer diagnosis, but may also be forced to cope with the loss of their fertility.
As many young women with cervical cancer were not accepting of this treatment, Dr. Daniel Dargent pioneered the vaginal radical trachelectomy as a fertility-preserving treatment option for early cervical cancer in 1994. There have now been more than 900 vaginal radical trachelectomies performed and they have been shown to have oncologic outcomes similar to those of traditional radical hysterectomy, while sparing a woman’s fertility (Int J Gynecol Cancer. 2013 Jul;23[6]:982-9).
Obstetric outcomes following vaginal radical trachelectomy are acceptable with 17% miscarriage rate in the first trimester (compared to 10%-20% in the general population) and 8% in the second trimester (compared to 1%-5% in the general population) (Am Fam Physician. 2007 Nov 1;76[9]:1341-6). Following vaginal radical trachelectomy, 64% of pregnancies deliver at term.
The usual criteria required to undergo radical trachelectomy include:
1) Reproductive age with desire for fertility.
2) Stage IA1 with LVSI (lymphovascular space invasion), IA2, or IB1 with tumor less than 2 cm.
3) Limited endocervical involvement via preoperative MRI.
4) Negative pelvic lymph nodes.
Preoperative PET scan can be used to evaluate nodal status, but suspicious lymph nodes should be evaluated on frozen section at the time of surgery. The presence of LVSI alone is not a contraindication to trachelectomy.
A key limitation of vaginal radical trachelectomy is the specialized training required to perform this technically challenging procedure. Few surgeons in the United States are trained to perform vaginal radical trachelectomy. In response to this limitation, surgeons began to attempt radical trachelectomy via laparotomy (Gynecol Oncol. 2006 Dec;103[3]:807-13). Oncologic outcomes following fertility-sparing abdominal radical trachelectomy have been reported to be equivalent to radical hysterectomy. Concerns regarding the abdominal approach to radical trachelectomy include higher rates of second trimester loss (19%) when compared to the vaginal approach (8%), higher rate of loss of fertility (30%), and risk of postoperative adhesions.
The advent of minimally invasive surgery, particularly robotic surgery, now offers surgeons the ability to perform a procedure technically similar to radical hysterectomy using a minimally invasive approach. Given the similarity of procedural steps of radical trachelectomy to radical hysterectomy using the robotic platform, this procedure is gaining acceptance in the United States with an associated improved surgeon learning curve (Gynecol Oncol. 2008 Nov;111[2]:255-60). In addition, the use of minimally invasive surgery should result in less adhesion formation facilitating natural fertility options postoperatively.
Obstetric and fertility outcomes are limited following minimally invasive radical trachelectomy via laparoscopy or robotic surgery given the novelty of this procedure. Emerging obstetric outcomes appear reassuring, but further data are needed to fully understand the effects of this procedure on pregnancy outcomes and the need for assisted reproductive techniques to achieve pregnancy.
The management of pregnancies following radical trachelectomy is also an area with limited data, which presents a clinical challenge to obstetricians. Many gynecologic oncologists perform a permanent cerclage at the time of trachelectomy and recommend delivery via scheduled cesarean at term for all subsequent pregnancies prior to labor (usually 37-38 weeks).
At our institution, we recommend the use of progesterone from 16 to 36 weeks despite no clear evidence on the role of progesterone in this setting. Maternal-fetal medicine consultation should be considered to either follow these patients during their pregnancies or to perform a single consultative visit to guide antepartum care.
Some have advocated for less radical surgery, such as simple trachelectomy or large cold knife conization, as the risk of parametrial extension in these patients is low (Gynecol Oncol. 2011 Dec;123[3]:557-60). More data are needed to determine if this is a safe approach. Further, the use of neoadjuvant chemotherapy followed by cold knife conization for fertility preservation in women with larger tumors has been proposed. This may be a feasible option in women with chemo-sensitive tumors, but progression on chemotherapy and increased recurrences have been reported with this approach (Gynecol Oncol. 2008 Dec;111[3]:438-43).
Women of reproductive age diagnosed with early cervical cancer now have multiple options for fertility preservation. Ongoing research regarding obstetric and fertility outcomes is needed; however, oncologic outcomes appear to be equivalent.
Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina, Chapel Hill. Dr. Boggess is an expert in robotic surgery in gynecologic oncology and is a professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no financial disclosures relevant to this column. Email them at obnews@frontlinemedcom.com.
Historically, the standard of care for women diagnosed with early cervical cancer has been radical hysterectomy. Thus, young women are not only being confronted with a cancer diagnosis, but may also be forced to cope with the loss of their fertility.
As many young women with cervical cancer were not accepting of this treatment, Dr. Daniel Dargent pioneered the vaginal radical trachelectomy as a fertility-preserving treatment option for early cervical cancer in 1994. There have now been more than 900 vaginal radical trachelectomies performed and they have been shown to have oncologic outcomes similar to those of traditional radical hysterectomy, while sparing a woman’s fertility (Int J Gynecol Cancer. 2013 Jul;23[6]:982-9).
Obstetric outcomes following vaginal radical trachelectomy are acceptable with 17% miscarriage rate in the first trimester (compared to 10%-20% in the general population) and 8% in the second trimester (compared to 1%-5% in the general population) (Am Fam Physician. 2007 Nov 1;76[9]:1341-6). Following vaginal radical trachelectomy, 64% of pregnancies deliver at term.
The usual criteria required to undergo radical trachelectomy include:
1) Reproductive age with desire for fertility.
2) Stage IA1 with LVSI (lymphovascular space invasion), IA2, or IB1 with tumor less than 2 cm.
3) Limited endocervical involvement via preoperative MRI.
4) Negative pelvic lymph nodes.
Preoperative PET scan can be used to evaluate nodal status, but suspicious lymph nodes should be evaluated on frozen section at the time of surgery. The presence of LVSI alone is not a contraindication to trachelectomy.
A key limitation of vaginal radical trachelectomy is the specialized training required to perform this technically challenging procedure. Few surgeons in the United States are trained to perform vaginal radical trachelectomy. In response to this limitation, surgeons began to attempt radical trachelectomy via laparotomy (Gynecol Oncol. 2006 Dec;103[3]:807-13). Oncologic outcomes following fertility-sparing abdominal radical trachelectomy have been reported to be equivalent to radical hysterectomy. Concerns regarding the abdominal approach to radical trachelectomy include higher rates of second trimester loss (19%) when compared to the vaginal approach (8%), higher rate of loss of fertility (30%), and risk of postoperative adhesions.
The advent of minimally invasive surgery, particularly robotic surgery, now offers surgeons the ability to perform a procedure technically similar to radical hysterectomy using a minimally invasive approach. Given the similarity of procedural steps of radical trachelectomy to radical hysterectomy using the robotic platform, this procedure is gaining acceptance in the United States with an associated improved surgeon learning curve (Gynecol Oncol. 2008 Nov;111[2]:255-60). In addition, the use of minimally invasive surgery should result in less adhesion formation facilitating natural fertility options postoperatively.
Obstetric and fertility outcomes are limited following minimally invasive radical trachelectomy via laparoscopy or robotic surgery given the novelty of this procedure. Emerging obstetric outcomes appear reassuring, but further data are needed to fully understand the effects of this procedure on pregnancy outcomes and the need for assisted reproductive techniques to achieve pregnancy.
The management of pregnancies following radical trachelectomy is also an area with limited data, which presents a clinical challenge to obstetricians. Many gynecologic oncologists perform a permanent cerclage at the time of trachelectomy and recommend delivery via scheduled cesarean at term for all subsequent pregnancies prior to labor (usually 37-38 weeks).
At our institution, we recommend the use of progesterone from 16 to 36 weeks despite no clear evidence on the role of progesterone in this setting. Maternal-fetal medicine consultation should be considered to either follow these patients during their pregnancies or to perform a single consultative visit to guide antepartum care.
Some have advocated for less radical surgery, such as simple trachelectomy or large cold knife conization, as the risk of parametrial extension in these patients is low (Gynecol Oncol. 2011 Dec;123[3]:557-60). More data are needed to determine if this is a safe approach. Further, the use of neoadjuvant chemotherapy followed by cold knife conization for fertility preservation in women with larger tumors has been proposed. This may be a feasible option in women with chemo-sensitive tumors, but progression on chemotherapy and increased recurrences have been reported with this approach (Gynecol Oncol. 2008 Dec;111[3]:438-43).
Women of reproductive age diagnosed with early cervical cancer now have multiple options for fertility preservation. Ongoing research regarding obstetric and fertility outcomes is needed; however, oncologic outcomes appear to be equivalent.
Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina, Chapel Hill. Dr. Boggess is an expert in robotic surgery in gynecologic oncology and is a professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no financial disclosures relevant to this column. Email them at obnews@frontlinemedcom.com.
Historically, the standard of care for women diagnosed with early cervical cancer has been radical hysterectomy. Thus, young women are not only being confronted with a cancer diagnosis, but may also be forced to cope with the loss of their fertility.
As many young women with cervical cancer were not accepting of this treatment, Dr. Daniel Dargent pioneered the vaginal radical trachelectomy as a fertility-preserving treatment option for early cervical cancer in 1994. There have now been more than 900 vaginal radical trachelectomies performed and they have been shown to have oncologic outcomes similar to those of traditional radical hysterectomy, while sparing a woman’s fertility (Int J Gynecol Cancer. 2013 Jul;23[6]:982-9).
Obstetric outcomes following vaginal radical trachelectomy are acceptable with 17% miscarriage rate in the first trimester (compared to 10%-20% in the general population) and 8% in the second trimester (compared to 1%-5% in the general population) (Am Fam Physician. 2007 Nov 1;76[9]:1341-6). Following vaginal radical trachelectomy, 64% of pregnancies deliver at term.
The usual criteria required to undergo radical trachelectomy include:
1) Reproductive age with desire for fertility.
2) Stage IA1 with LVSI (lymphovascular space invasion), IA2, or IB1 with tumor less than 2 cm.
3) Limited endocervical involvement via preoperative MRI.
4) Negative pelvic lymph nodes.
Preoperative PET scan can be used to evaluate nodal status, but suspicious lymph nodes should be evaluated on frozen section at the time of surgery. The presence of LVSI alone is not a contraindication to trachelectomy.
A key limitation of vaginal radical trachelectomy is the specialized training required to perform this technically challenging procedure. Few surgeons in the United States are trained to perform vaginal radical trachelectomy. In response to this limitation, surgeons began to attempt radical trachelectomy via laparotomy (Gynecol Oncol. 2006 Dec;103[3]:807-13). Oncologic outcomes following fertility-sparing abdominal radical trachelectomy have been reported to be equivalent to radical hysterectomy. Concerns regarding the abdominal approach to radical trachelectomy include higher rates of second trimester loss (19%) when compared to the vaginal approach (8%), higher rate of loss of fertility (30%), and risk of postoperative adhesions.
The advent of minimally invasive surgery, particularly robotic surgery, now offers surgeons the ability to perform a procedure technically similar to radical hysterectomy using a minimally invasive approach. Given the similarity of procedural steps of radical trachelectomy to radical hysterectomy using the robotic platform, this procedure is gaining acceptance in the United States with an associated improved surgeon learning curve (Gynecol Oncol. 2008 Nov;111[2]:255-60). In addition, the use of minimally invasive surgery should result in less adhesion formation facilitating natural fertility options postoperatively.
Obstetric and fertility outcomes are limited following minimally invasive radical trachelectomy via laparoscopy or robotic surgery given the novelty of this procedure. Emerging obstetric outcomes appear reassuring, but further data are needed to fully understand the effects of this procedure on pregnancy outcomes and the need for assisted reproductive techniques to achieve pregnancy.
The management of pregnancies following radical trachelectomy is also an area with limited data, which presents a clinical challenge to obstetricians. Many gynecologic oncologists perform a permanent cerclage at the time of trachelectomy and recommend delivery via scheduled cesarean at term for all subsequent pregnancies prior to labor (usually 37-38 weeks).
At our institution, we recommend the use of progesterone from 16 to 36 weeks despite no clear evidence on the role of progesterone in this setting. Maternal-fetal medicine consultation should be considered to either follow these patients during their pregnancies or to perform a single consultative visit to guide antepartum care.
Some have advocated for less radical surgery, such as simple trachelectomy or large cold knife conization, as the risk of parametrial extension in these patients is low (Gynecol Oncol. 2011 Dec;123[3]:557-60). More data are needed to determine if this is a safe approach. Further, the use of neoadjuvant chemotherapy followed by cold knife conization for fertility preservation in women with larger tumors has been proposed. This may be a feasible option in women with chemo-sensitive tumors, but progression on chemotherapy and increased recurrences have been reported with this approach (Gynecol Oncol. 2008 Dec;111[3]:438-43).
Women of reproductive age diagnosed with early cervical cancer now have multiple options for fertility preservation. Ongoing research regarding obstetric and fertility outcomes is needed; however, oncologic outcomes appear to be equivalent.
Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina, Chapel Hill. Dr. Boggess is an expert in robotic surgery in gynecologic oncology and is a professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no financial disclosures relevant to this column. Email them at obnews@frontlinemedcom.com.
FDA approves new biomaterial for hernia repair
The Food and Drug Administration has granted 510K clearance to Gore Medical for a new biomaterial for hernia repair, according to a Gore statement.
Gore describes the product – GORE SYNECOR Biomaterial – as having a “unique structure,” which prevents surgeons from having to choose between using a “permanent material” and an “absorbable, nonpermanent material” when deciding which biomaterial to use for a hernia repair.
GORE SYNECOR Biomaterial is composed of the following:
• Dense monofilament polytetrafluoroethylene macroporous knit.
• GORE BIO-A Web, “a tissue scaffold with proven outcomes in contaminated hernia repair. providing rapid vascularization and ingrowth in complex repairs.”
• Nonporous PGA/TMC film.
No precertification is required for surgeons to implant GORE SYNECOR Biomaterial.
For more information about the new product, visit www.goremedical.com.
The Food and Drug Administration has granted 510K clearance to Gore Medical for a new biomaterial for hernia repair, according to a Gore statement.
Gore describes the product – GORE SYNECOR Biomaterial – as having a “unique structure,” which prevents surgeons from having to choose between using a “permanent material” and an “absorbable, nonpermanent material” when deciding which biomaterial to use for a hernia repair.
GORE SYNECOR Biomaterial is composed of the following:
• Dense monofilament polytetrafluoroethylene macroporous knit.
• GORE BIO-A Web, “a tissue scaffold with proven outcomes in contaminated hernia repair. providing rapid vascularization and ingrowth in complex repairs.”
• Nonporous PGA/TMC film.
No precertification is required for surgeons to implant GORE SYNECOR Biomaterial.
For more information about the new product, visit www.goremedical.com.
The Food and Drug Administration has granted 510K clearance to Gore Medical for a new biomaterial for hernia repair, according to a Gore statement.
Gore describes the product – GORE SYNECOR Biomaterial – as having a “unique structure,” which prevents surgeons from having to choose between using a “permanent material” and an “absorbable, nonpermanent material” when deciding which biomaterial to use for a hernia repair.
GORE SYNECOR Biomaterial is composed of the following:
• Dense monofilament polytetrafluoroethylene macroporous knit.
• GORE BIO-A Web, “a tissue scaffold with proven outcomes in contaminated hernia repair. providing rapid vascularization and ingrowth in complex repairs.”
• Nonporous PGA/TMC film.
No precertification is required for surgeons to implant GORE SYNECOR Biomaterial.
For more information about the new product, visit www.goremedical.com.
Presurgery radiation shows benefit in lung cancer
The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.
Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.
“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.
The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.
The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.
All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.
Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.
The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.
This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.
They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.
The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.
The study authors had no conflicts to disclose.
Implementing the treatment regimen for malignant pleural mesothelioma (MPM) that the Toronto researchers studied poses “several high stakes challenges,” Dr. Valerie Rusch and coauthors at Memorial Sloan-Kettering Cancer Center, New York, said in their invited commentary (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.10.038).
|
Dr. Valerie W. Rusch |
But they noted challenges involved with conventional multi-modality treatment for MPM, namely the 6 months of intensive treatment. However, the experience of the Toronto researchers will be difficult to replicate, they said. “Such outstanding results reflect the expertise of Dr. de Perrot and colleagues in the surgical care of MPM and the excellence of their multidisciplinary program,” Dr. Rusch and coauthors said.
The study results are among the best reported for MPM to date, they added, but they asked why. “Are they solely related to patient selection or do they reflect the true impact of a novel approach to treatment?”
Patients selected for the treatment need to be able to undergo the extrapleural pneumonectomy (EPP) and the surgeon has to be able to predict the resectability of the tumor. But limitations in existing staging methods for MPM make it difficult to predict tumor resectability. “To avoid bronchial stump leaks and other serious complications after EPP requires experience along with meticulous surgical technique and postoperative care,” Dr. Rusch and colleagues said. “Only high-volume centers of excellence could potentially reproduce these results.”
Despite the waning in popularity of EPP, the study results underscore its effectiveness in carefully selected patients – “those with epithelioid tumor histology and no tumor metastases.” To corroborate the findings, reports on other centers’ experience along with human and animal studies rather than a randomized clinical trial are needed. “Dr. de Perrot and colleagues may have been not only bold but SMART,” Dr. Rusch and colleagues said.
Implementing the treatment regimen for malignant pleural mesothelioma (MPM) that the Toronto researchers studied poses “several high stakes challenges,” Dr. Valerie Rusch and coauthors at Memorial Sloan-Kettering Cancer Center, New York, said in their invited commentary (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.10.038).
|
|
Dr. Valerie W. Rusch |
But they noted challenges involved with conventional multi-modality treatment for MPM, namely the 6 months of intensive treatment. However, the experience of the Toronto researchers will be difficult to replicate, they said. “Such outstanding results reflect the expertise of Dr. de Perrot and colleagues in the surgical care of MPM and the excellence of their multidisciplinary program,” Dr. Rusch and coauthors said.
The study results are among the best reported for MPM to date, they added, but they asked why. “Are they solely related to patient selection or do they reflect the true impact of a novel approach to treatment?”
Patients selected for the treatment need to be able to undergo the extrapleural pneumonectomy (EPP) and the surgeon has to be able to predict the resectability of the tumor. But limitations in existing staging methods for MPM make it difficult to predict tumor resectability. “To avoid bronchial stump leaks and other serious complications after EPP requires experience along with meticulous surgical technique and postoperative care,” Dr. Rusch and colleagues said. “Only high-volume centers of excellence could potentially reproduce these results.”
Despite the waning in popularity of EPP, the study results underscore its effectiveness in carefully selected patients – “those with epithelioid tumor histology and no tumor metastases.” To corroborate the findings, reports on other centers’ experience along with human and animal studies rather than a randomized clinical trial are needed. “Dr. de Perrot and colleagues may have been not only bold but SMART,” Dr. Rusch and colleagues said.
Implementing the treatment regimen for malignant pleural mesothelioma (MPM) that the Toronto researchers studied poses “several high stakes challenges,” Dr. Valerie Rusch and coauthors at Memorial Sloan-Kettering Cancer Center, New York, said in their invited commentary (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.10.038).
|
|
Dr. Valerie W. Rusch |
But they noted challenges involved with conventional multi-modality treatment for MPM, namely the 6 months of intensive treatment. However, the experience of the Toronto researchers will be difficult to replicate, they said. “Such outstanding results reflect the expertise of Dr. de Perrot and colleagues in the surgical care of MPM and the excellence of their multidisciplinary program,” Dr. Rusch and coauthors said.
The study results are among the best reported for MPM to date, they added, but they asked why. “Are they solely related to patient selection or do they reflect the true impact of a novel approach to treatment?”
Patients selected for the treatment need to be able to undergo the extrapleural pneumonectomy (EPP) and the surgeon has to be able to predict the resectability of the tumor. But limitations in existing staging methods for MPM make it difficult to predict tumor resectability. “To avoid bronchial stump leaks and other serious complications after EPP requires experience along with meticulous surgical technique and postoperative care,” Dr. Rusch and colleagues said. “Only high-volume centers of excellence could potentially reproduce these results.”
Despite the waning in popularity of EPP, the study results underscore its effectiveness in carefully selected patients – “those with epithelioid tumor histology and no tumor metastases.” To corroborate the findings, reports on other centers’ experience along with human and animal studies rather than a randomized clinical trial are needed. “Dr. de Perrot and colleagues may have been not only bold but SMART,” Dr. Rusch and colleagues said.
The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.
Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.
“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.
The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.
The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.
All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.
Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.
The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.
This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.
They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.
The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.
The study authors had no conflicts to disclose.
The popularity of extrapleural pneumonectomy to treat asbestos-related thoracic mesothelioma has yielded to extended pleurectomy/decortication in recent years, but a recent study suggests that the extrapleural pneumonectomy procedure can achieve good results in a new protocol that involves administering radiation therapy before surgery as opposed the more conventional approach of radiation after surgery.
Researchers at the University of Toronto reported on their protocol that uses accelerated intensity modulated radiation therapy (IMRT) for malignant pleural mesothelioma (MPM) (J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2015.09.129). They call the protocol SMART, for Surgery for Mesothelioma After Radiation Therapy.
“The rationale to develop this protocol was to optimize the delivery of radiation to the whole tumor bed, sterilize the edges of the tumor to limit the risk of spillage at the time of surgery, develop a shorter treatment plan and potentiate the activation of the immune system by using a hypofractionated regimen,” wrote Dr. Marc de Perrot and colleagues.
The protocol involves delivering 25 Gy of radiation in five daily fractions over a week to the entire side of the thorax with 5 Gy boosts based on imaging, followed by extrapleural pneumonectomy (EPP) 4-6 days later. Patients with three or more positive lymph notes (ypN2 disease) also are offered adjuvant chemotherapy.
The researchers performed the protocol on 62 patients from November 2008 to October 2014, which represents 24% of all patients with MPM seen at the institution in that period. Fifty-two patients were men and ages ranged from 41 to 75 years. Clinical stage of cancer ranged from T1N0 in 10 patients, to T2N0 in 35 and T3N0 in 13 (two had T4N0 and two had T3N2). Forty-five had right-side cancers. Six patients received an extended protocol for various reasons, including tumor extending to the chest wall.
All 62 patients completed IMRT and EPP. All but one had resection and reconstruction of the diaphragm, and all but four had resection and reconstruction of the pericardium.
Overall death rate was 4.8% (three patients). Results were better in patients with epithelioid tumors, with a median survival of 51 months and disease-free survival of 47 months. Those with biphasic subtypes had median survival of 10 months and disease-free survival of 8 months. Eight patients had ipsilateral chest recurrence. “This analysis demonstrates that the SMART approach is particularly encouraging for patients with epithelial subtype,” Dr. de Perrot and coauthors said. They no longer perform the SMART protocol on patients with biphasic subtype.
The protocol was not without complications. Twenty-four patients, about 38%, had serious complications that required intervention or worse. Twelve had atrial fibrillation, but none advanced to life-threatening disease. Among other complications, four had empyema – one resulting in death – and three had pulmonary emboli. One other patient in the complications group died from pneumonia, and another died from a heart attack at home.
This is the Toronto researchers’ second attempt at studying the three-modality approach. In their first attempt, only half the patients who started with preoperative chemotherapy went onto complete the radiation after surgery because of difficulties administering it (J Thorac Cardiovasc Surg. 2007;133:111-6; J Clin Oncol. 2009;27:1413-8). Also, about 25% of patients had disease progression during induction chemotherapy and could not go onto surgery.
They designed the most recent trial to deliver radiation before surgery because of the excellent local control of cancer along with evidence that MPM tumors were radio-sensitive. “Considering the risk of disease progression on induction chemotherapy, we felt that switching the order of therapy was potentially a better option for patients with surgically resectable disease,” Dr. de Perrott and colleagues said.
The researchers cited the study’s single-center nature with a single treatment arm, and the lack of longer-term follow-up, as limitations. “However, in our own experience, this approach has been very encouraging and has become our primary option for patients with surgically resectable MPM,” they noted.
The study authors had no conflicts to disclose.
Key clinical point: A new protocol that involves accelerated hemithoracic intensity modulated radiation before surgery for lung mesothelioma delivered encouraging results in patients with epithelioid tumors.
Major finding: Disease-free survival was 47 months in epithelial subtypes compared with 8 months in biphasic subtypes.
Data source: A single-center population of 62 patients with malignant pleural mesothelioma treated between November 2008 and October 2014.
Disclosures: The study authors had no relationships to disclose.
