Drugs in vials
Credit: Bill Branson

The French National Health Authority’s Transparency Commission has granted market access for the antineoplastic drug pixantrone (Pixuvri).

The drug is intended for use as monotherapy to treat adult patients with aggressive B-cell non-Hodgkin lymphoma who have failed 2 or 3 prior lines of therapy.

Pixantrone has already gained conditional marketing authorization for this indication within the European Union.

In the fourth quarter of 2012, the drug was made available to patients in 8 countries—Sweden, Denmark, Finland, Austria, Norway, Germany, the UK, and the Netherlands.

And last month, pixantrone was granted market access in Italy.

Now, the drug’s developers, Cell Therapeutics Inc., announced that pixantrone has been granted market access in France.
 
The next steps in France’s pharmaceutical reimbursement process are inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel. And Cell Therapeutics intends to pursue these final goals.

All registered pharmaceuticals in France are subjected to a process known as Evaluation of Therapeutic Benefit, with the resulting evaluation expressed as a classification between 1 and 6. 

The Transparency Commission rated pixantrone at level 5, which allows the drug to be included in the reimbursed drugs list for hospital use. The commission will reassess the rating for the drug within 2 years.

France’s authorization and the European Commission’s conditional marketing authorization are based on data from the phase 3 EXTEND PIX301 trial. Although pixantrone prompted positive results in this trial, the US Food and Drug Administration (FDA) has expressed concerns about the number of patients included.

In fact, the FDA rejected a new drug application for pixantrone in 2010. Cell Therapeutics later resubmitted an application for the drug but withdrew it in January of last year. The company has not confirmed plans to refile with the FDA.

As for the European Commission’s conditional approval of pixantrone, it will be renewed on a yearly basis until Cell Therapeutics fullfills its committment to

provide additional data on patients

treated with pixantrone who previously received rituximab. The company said it expects to

have the results of this research by mid-2015.

Pixantrone is a novel aza-anthracenedione that forms stable DNA adducts. The drug was designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite—both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity.

For full prescribing information for pixantrone, including the safety and efficacy profile in the approved indication, visit www.pixuvri.eu.

Drugs in vials
Credit: Bill Branson

The French National Health Authority’s Transparency Commission has granted market access for the antineoplastic drug pixantrone (Pixuvri).

The drug is intended for use as monotherapy to treat adult patients with aggressive B-cell non-Hodgkin lymphoma who have failed 2 or 3 prior lines of therapy.

Pixantrone has already gained conditional marketing authorization for this indication within the European Union.

In the fourth quarter of 2012, the drug was made available to patients in 8 countries—Sweden, Denmark, Finland, Austria, Norway, Germany, the UK, and the Netherlands.

And last month, pixantrone was granted market access in Italy.

Now, the drug’s developers, Cell Therapeutics Inc., announced that pixantrone has been granted market access in France.
 
The next steps in France’s pharmaceutical reimbursement process are inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel. And Cell Therapeutics intends to pursue these final goals.

All registered pharmaceuticals in France are subjected to a process known as Evaluation of Therapeutic Benefit, with the resulting evaluation expressed as a classification between 1 and 6. 

The Transparency Commission rated pixantrone at level 5, which allows the drug to be included in the reimbursed drugs list for hospital use. The commission will reassess the rating for the drug within 2 years.

France’s authorization and the European Commission’s conditional marketing authorization are based on data from the phase 3 EXTEND PIX301 trial. Although pixantrone prompted positive results in this trial, the US Food and Drug Administration (FDA) has expressed concerns about the number of patients included.

In fact, the FDA rejected a new drug application for pixantrone in 2010. Cell Therapeutics later resubmitted an application for the drug but withdrew it in January of last year. The company has not confirmed plans to refile with the FDA.

As for the European Commission’s conditional approval of pixantrone, it will be renewed on a yearly basis until Cell Therapeutics fullfills its committment to

provide additional data on patients

treated with pixantrone who previously received rituximab. The company said it expects to

have the results of this research by mid-2015.

Pixantrone is a novel aza-anthracenedione that forms stable DNA adducts. The drug was designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite—both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity.

For full prescribing information for pixantrone, including the safety and efficacy profile in the approved indication, visit www.pixuvri.eu.

Drugs in vials
Credit: Bill Branson

The French National Health Authority’s Transparency Commission has granted market access for the antineoplastic drug pixantrone (Pixuvri).

The drug is intended for use as monotherapy to treat adult patients with aggressive B-cell non-Hodgkin lymphoma who have failed 2 or 3 prior lines of therapy.

Pixantrone has already gained conditional marketing authorization for this indication within the European Union.

In the fourth quarter of 2012, the drug was made available to patients in 8 countries—Sweden, Denmark, Finland, Austria, Norway, Germany, the UK, and the Netherlands.

And last month, pixantrone was granted market access in Italy.

Now, the drug’s developers, Cell Therapeutics Inc., announced that pixantrone has been granted market access in France.
 
The next steps in France’s pharmaceutical reimbursement process are inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel. And Cell Therapeutics intends to pursue these final goals.

All registered pharmaceuticals in France are subjected to a process known as Evaluation of Therapeutic Benefit, with the resulting evaluation expressed as a classification between 1 and 6. 

The Transparency Commission rated pixantrone at level 5, which allows the drug to be included in the reimbursed drugs list for hospital use. The commission will reassess the rating for the drug within 2 years.

France’s authorization and the European Commission’s conditional marketing authorization are based on data from the phase 3 EXTEND PIX301 trial. Although pixantrone prompted positive results in this trial, the US Food and Drug Administration (FDA) has expressed concerns about the number of patients included.

In fact, the FDA rejected a new drug application for pixantrone in 2010. Cell Therapeutics later resubmitted an application for the drug but withdrew it in January of last year. The company has not confirmed plans to refile with the FDA.

As for the European Commission’s conditional approval of pixantrone, it will be renewed on a yearly basis until Cell Therapeutics fullfills its committment to

provide additional data on patients

treated with pixantrone who previously received rituximab. The company said it expects to

have the results of this research by mid-2015.

Pixantrone is a novel aza-anthracenedione that forms stable DNA adducts. The drug was designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite—both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity.

For full prescribing information for pixantrone, including the safety and efficacy profile in the approved indication, visit www.pixuvri.eu.

SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.

In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.

In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."

The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.

Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.

The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.

"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.

In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).

"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."

She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."

Dr. Simons said she had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.

In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.

In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."

The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.

Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.

The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.

"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.

In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).

"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."

She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."

Dr. Simons said she had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.

In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.

In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."

The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.

Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.

The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.

"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.

In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).

"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."

She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."

Dr. Simons said she had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.

"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.

Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."

In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.

Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.

Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.

Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).

Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.

The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).

The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).

"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."

Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."

Dr. Gupta said that he had no relevant financial disclosures to make.

[email protected]

SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.

"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.

Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."

In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.

Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.

Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.

Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).

Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.

The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).

The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).

"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."

Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."

Dr. Gupta said that he had no relevant financial disclosures to make.

[email protected]

SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.

"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.

Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."

In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.

Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.

Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.

Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).

Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.

The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).

The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).

"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."

Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."

Dr. Gupta said that he had no relevant financial disclosures to make.

[email protected]

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

This systematic review synthesizes knowledge about the use of complementary and alternative medicine (CAM) among advanced cancer patients. EBSCO and Ovid databases were searched using core concepts, including advanced cancer, CAM, integrative medicine, and decision-making. Articles included in the final review were analyzed using narrative synthesis methods, including thematic analysis, concept mapping, and critical reflection on the synthesis process. Results demonstrate that advanced cancer patients who are younger, female, more educated, have longer duration of disease, and have previously used CAM are more likely to use CAM during this stage of illness. Key themes identified include patterns of and reasons for use; and barriers and facilitators to informed CAM decision-making. Knowledge regarding the use of CAM in advanced cancer remains in its nascent stages. Findings suggest a need for more research on understanding the dynamic process of CAM decision-making in the advanced cancer population from the patients’ perspective.

*For a PDF of the full article, click on the link to the left of this introduction.

This systematic review synthesizes knowledge about the use of complementary and alternative medicine (CAM) among advanced cancer patients. EBSCO and Ovid databases were searched using core concepts, including advanced cancer, CAM, integrative medicine, and decision-making. Articles included in the final review were analyzed using narrative synthesis methods, including thematic analysis, concept mapping, and critical reflection on the synthesis process. Results demonstrate that advanced cancer patients who are younger, female, more educated, have longer duration of disease, and have previously used CAM are more likely to use CAM during this stage of illness. Key themes identified include patterns of and reasons for use; and barriers and facilitators to informed CAM decision-making. Knowledge regarding the use of CAM in advanced cancer remains in its nascent stages. Findings suggest a need for more research on understanding the dynamic process of CAM decision-making in the advanced cancer population from the patients’ perspective.

*For a PDF of the full article, click on the link to the left of this introduction.

This systematic review synthesizes knowledge about the use of complementary and alternative medicine (CAM) among advanced cancer patients. EBSCO and Ovid databases were searched using core concepts, including advanced cancer, CAM, integrative medicine, and decision-making. Articles included in the final review were analyzed using narrative synthesis methods, including thematic analysis, concept mapping, and critical reflection on the synthesis process. Results demonstrate that advanced cancer patients who are younger, female, more educated, have longer duration of disease, and have previously used CAM are more likely to use CAM during this stage of illness. Key themes identified include patterns of and reasons for use; and barriers and facilitators to informed CAM decision-making. Knowledge regarding the use of CAM in advanced cancer remains in its nascent stages. Findings suggest a need for more research on understanding the dynamic process of CAM decision-making in the advanced cancer population from the patients’ perspective.

*For a PDF of the full article, click on the link to the left of this introduction.

Cancer is the leading cause of disease-related death in children and adolescents. Pediatric patients with cancer suffer greatly at the end of life. However, palliative care interventions can reduce suffering and significantly improve the care of these patients and their families. A large percentage of pediatric deaths occur outside of the hospital setting where pediatric palliative resources may not be readily available. This review focuses on the principles of best practice in the provision of palliative care for children and adolescents with cancer.

Click on the PDF icon at the top of this introduction to read the full article.​

Cancer is the leading cause of disease-related death in children and adolescents. Pediatric patients with cancer suffer greatly at the end of life. However, palliative care interventions can reduce suffering and significantly improve the care of these patients and their families. A large percentage of pediatric deaths occur outside of the hospital setting where pediatric palliative resources may not be readily available. This review focuses on the principles of best practice in the provision of palliative care for children and adolescents with cancer.

Click on the PDF icon at the top of this introduction to read the full article.​

Cancer is the leading cause of disease-related death in children and adolescents. Pediatric patients with cancer suffer greatly at the end of life. However, palliative care interventions can reduce suffering and significantly improve the care of these patients and their families. A large percentage of pediatric deaths occur outside of the hospital setting where pediatric palliative resources may not be readily available. This review focuses on the principles of best practice in the provision of palliative care for children and adolescents with cancer.

Click on the PDF icon at the top of this introduction to read the full article.​