Doug Brunk

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.

dbrunk@frontlinemedcom.com

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.

dbrunk@frontlinemedcom.com

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.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.

The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."

Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.

The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.

Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.

Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.

Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).

Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.

Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."

Dr. Raux said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the annual meeting of the Society for Vascular Surgery Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said. "Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D the highest-cost device derived the largest market share, while vendors A and B the two lowest-cost devices derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the annual meeting of the Society for Vascular Surgery Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said. "Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D the highest-cost device derived the largest market share, while vendors A and B the two lowest-cost devices derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the annual meeting of the Society for Vascular Surgery Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said. "Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D the highest-cost device derived the largest market share, while vendors A and B the two lowest-cost devices derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.

"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.

The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."

Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."

He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."

Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.

He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.

Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m² vs. a mean of 32 kg/m²), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).

Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.

Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).

In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.

When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.

Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."

Dr. Farber said that he had no disclosures.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.

"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.

The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."

Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."

He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."

Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.

He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.

Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m² vs. a mean of 32 kg/m²), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).

Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.

Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).

In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.

When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.

Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."

Dr. Farber said that he had no disclosures.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.

"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.

The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."

Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."

He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."

Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.

He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.

Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m² vs. a mean of 32 kg/m²), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).

Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.

Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).

In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.

When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.

Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."

Dr. Farber said that he had no disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com