2013 Vascular Annual Meeting

SAN FRANCISCO – The presence of rupture and the emergent nature of the explantation are two key negative predictors of long-term survival in patients who require explantation of endovascular aneurysm repair endografts, results from a single-center study showed.

"EVAR is now the most common method for treating abdominal aortic aneurysms, and increasing numbers of patients are being observed in long-term follow-up," Dr. Eric J. Turney said at the Society for Vascular Surgery Annual Meeting. "In addition, treatment of patients with indications outside of instructions for use is common."

Dr. Turney and his associates in the vascular surgery department at the Cleveland Clinic set out to evaluate the medical center’s experience with EVAR explants between 1999 and 2012. They identified modes of failure as well as predictors of outcomes. "Furthermore, we examined modes of failure by time since EVAR was implanted: those failing in the first year, those failing within years 1-5, and those failing beyond 5 years," he said. Outcomes included 30-day mortality, cumulative survival, and complications.

He reported on results from explants in 100 patients, making this study the largest single-center study of its kind to date. The majority (91%) of patients were male, and their mean age was 75 years. Coronary artery disease was the most common comorbidity (65%), followed by chronic kidney disease (24%) and chronic obstructive pulmonary disease (COPD) (23%). Suprarenal fixation was present in 37% of patients.

The most common indication for explant was endoleak (82%), followed by infection (13%), acute thrombosis (3%), recurrent thrombosis (1%), and claudication (1%). Fewer than half of patients (40) had type I endoleak, 30 had type II, 22 had type III, none had type IV, 6 had type V, and 16 had multiple endoleaks at the time of explantation.

The majority of endografts (71%) were explanted in an elective setting, with 10% being urgent, 19% being emergent, and 9% with ruptures.

Endografts were excised after a median of 41 months. They failed in 23% of patients within the first year, in 55% of patients between 1 and 5 years, and in 22% of patients beyond 5 years. Overall 30-day mortality was 17%, and it differed by level of acuity. Specifically, 30-day mortality was 9.9% in the elective group, 37% in the emergent group, 38% in the infection group, 56% in the ruptured group, and 60% in the anastomotic fistula group.

Significant predictors of 30-day mortality included visceral revascularization (P = .036), supraceliac clamp (P = .001), emergent explantation (P = .015), the presence of infection (P = .038), and the presence of rupture (P = .006).

Similarly, the negative predictors of long-term survival that reached statistical significance were the presence of rupture (HR, 5.44), the emergent nature of the explantation (HR, 4.07), visceral revascularization (HR, 4.02), the presence of infection (HR, 3.27), the presence of COPD (HR, 2.19), preoperative elevated creatinine (HR, 2.1), and postoperative elevated creatinine (HR, 2.02).

Limitations of the study included its retrospective design "and the fact that it was performed at a single center," Dr. Turney said. "Multiple surgeons performed the explants, with varying preferences in approach. In addition, 61% [of cases] came from an outside facility without preimplant imaging available."

Dr. Turney said that had no relevant financial conflicts to disclose. Other coauthors disclosed receiving research funding or consulting fees from several device manufacturers.

[email protected]

SAN FRANCISCO – The presence of rupture and the emergent nature of the explantation are two key negative predictors of long-term survival in patients who require explantation of endovascular aneurysm repair endografts, results from a single-center study showed.

"EVAR is now the most common method for treating abdominal aortic aneurysms, and increasing numbers of patients are being observed in long-term follow-up," Dr. Eric J. Turney said at the Society for Vascular Surgery Annual Meeting. "In addition, treatment of patients with indications outside of instructions for use is common."

Dr. Turney and his associates in the vascular surgery department at the Cleveland Clinic set out to evaluate the medical center’s experience with EVAR explants between 1999 and 2012. They identified modes of failure as well as predictors of outcomes. "Furthermore, we examined modes of failure by time since EVAR was implanted: those failing in the first year, those failing within years 1-5, and those failing beyond 5 years," he said. Outcomes included 30-day mortality, cumulative survival, and complications.

He reported on results from explants in 100 patients, making this study the largest single-center study of its kind to date. The majority (91%) of patients were male, and their mean age was 75 years. Coronary artery disease was the most common comorbidity (65%), followed by chronic kidney disease (24%) and chronic obstructive pulmonary disease (COPD) (23%). Suprarenal fixation was present in 37% of patients.

The most common indication for explant was endoleak (82%), followed by infection (13%), acute thrombosis (3%), recurrent thrombosis (1%), and claudication (1%). Fewer than half of patients (40) had type I endoleak, 30 had type II, 22 had type III, none had type IV, 6 had type V, and 16 had multiple endoleaks at the time of explantation.

The majority of endografts (71%) were explanted in an elective setting, with 10% being urgent, 19% being emergent, and 9% with ruptures.

Endografts were excised after a median of 41 months. They failed in 23% of patients within the first year, in 55% of patients between 1 and 5 years, and in 22% of patients beyond 5 years. Overall 30-day mortality was 17%, and it differed by level of acuity. Specifically, 30-day mortality was 9.9% in the elective group, 37% in the emergent group, 38% in the infection group, 56% in the ruptured group, and 60% in the anastomotic fistula group.

Significant predictors of 30-day mortality included visceral revascularization (P = .036), supraceliac clamp (P = .001), emergent explantation (P = .015), the presence of infection (P = .038), and the presence of rupture (P = .006).

Similarly, the negative predictors of long-term survival that reached statistical significance were the presence of rupture (HR, 5.44), the emergent nature of the explantation (HR, 4.07), visceral revascularization (HR, 4.02), the presence of infection (HR, 3.27), the presence of COPD (HR, 2.19), preoperative elevated creatinine (HR, 2.1), and postoperative elevated creatinine (HR, 2.02).

Limitations of the study included its retrospective design "and the fact that it was performed at a single center," Dr. Turney said. "Multiple surgeons performed the explants, with varying preferences in approach. In addition, 61% [of cases] came from an outside facility without preimplant imaging available."

Dr. Turney said that had no relevant financial conflicts to disclose. Other coauthors disclosed receiving research funding or consulting fees from several device manufacturers.

[email protected]

SAN FRANCISCO – The presence of rupture and the emergent nature of the explantation are two key negative predictors of long-term survival in patients who require explantation of endovascular aneurysm repair endografts, results from a single-center study showed.

"EVAR is now the most common method for treating abdominal aortic aneurysms, and increasing numbers of patients are being observed in long-term follow-up," Dr. Eric J. Turney said at the Society for Vascular Surgery Annual Meeting. "In addition, treatment of patients with indications outside of instructions for use is common."

Dr. Turney and his associates in the vascular surgery department at the Cleveland Clinic set out to evaluate the medical center’s experience with EVAR explants between 1999 and 2012. They identified modes of failure as well as predictors of outcomes. "Furthermore, we examined modes of failure by time since EVAR was implanted: those failing in the first year, those failing within years 1-5, and those failing beyond 5 years," he said. Outcomes included 30-day mortality, cumulative survival, and complications.

He reported on results from explants in 100 patients, making this study the largest single-center study of its kind to date. The majority (91%) of patients were male, and their mean age was 75 years. Coronary artery disease was the most common comorbidity (65%), followed by chronic kidney disease (24%) and chronic obstructive pulmonary disease (COPD) (23%). Suprarenal fixation was present in 37% of patients.

The most common indication for explant was endoleak (82%), followed by infection (13%), acute thrombosis (3%), recurrent thrombosis (1%), and claudication (1%). Fewer than half of patients (40) had type I endoleak, 30 had type II, 22 had type III, none had type IV, 6 had type V, and 16 had multiple endoleaks at the time of explantation.

The majority of endografts (71%) were explanted in an elective setting, with 10% being urgent, 19% being emergent, and 9% with ruptures.

Endografts were excised after a median of 41 months. They failed in 23% of patients within the first year, in 55% of patients between 1 and 5 years, and in 22% of patients beyond 5 years. Overall 30-day mortality was 17%, and it differed by level of acuity. Specifically, 30-day mortality was 9.9% in the elective group, 37% in the emergent group, 38% in the infection group, 56% in the ruptured group, and 60% in the anastomotic fistula group.

Significant predictors of 30-day mortality included visceral revascularization (P = .036), supraceliac clamp (P = .001), emergent explantation (P = .015), the presence of infection (P = .038), and the presence of rupture (P = .006).

Similarly, the negative predictors of long-term survival that reached statistical significance were the presence of rupture (HR, 5.44), the emergent nature of the explantation (HR, 4.07), visceral revascularization (HR, 4.02), the presence of infection (HR, 3.27), the presence of COPD (HR, 2.19), preoperative elevated creatinine (HR, 2.1), and postoperative elevated creatinine (HR, 2.02).

Limitations of the study included its retrospective design "and the fact that it was performed at a single center," Dr. Turney said. "Multiple surgeons performed the explants, with varying preferences in approach. In addition, 61% [of cases] came from an outside facility without preimplant imaging available."

Dr. Turney said that had no relevant financial conflicts to disclose. Other coauthors disclosed receiving research funding or consulting fees from several device manufacturers.

[email protected]

SAN FRANCISCO – In the opinion of Dr. Larry H. Hollier, multiple organ dysfunction syndrome is a condition "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive.

At the Society for Vascular Surgery Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

The pathophysiology of MODS "is fairly straightforward," he continued. "Some event results in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen-free radicals, tissue damage, and then organ dysfunction." Dr. Hollier discussed these issues as the invited speaker for the prestigious John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m² leads to a severe flulike syndrome (mild SIRS); 26 L/m² leads to multiple organ dysfunction syndrome; and 33 L/m² or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, including steroids, antiendotoxin monoclonal antibodies, IL-1 receptor antagonists, anti-TNF antibodies, antioxidants, inhibition of nitric oxide, and oxygen manipulation in the form of extracorporeal support and perfluorocarbons. "While there is some research experience, in the clinical arena, there has universally not been a treatment that reverses the multiple organ dysfunction syndrome," he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "This is where we have some of the opportunities to improve the situation and possibly prevent the full MODS," Dr. Hollier said. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said. It’s less clear what approach to take for the patient who develops severe cytokine activation and is on course to develop MODS.

"Since high-dose hyperbaric oxygen therapy appears to abort cytokine activation in experimental studies, should we consider hyperbaric oxygen therapy for management of severe cytokine activation postoperatively?" Dr. Hollier asked. "Hyperbaric oxygen therapy has been demonstrated by controlled human studies to be useful in resuscitation and tissue salvage in crush injury and traumatic brain injury. I don’t have the answers to this. These are the areas of investigations that I urge the members of this society and our young students, residents, and fellows to consider."

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "We need research on this to find the answer," he said. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

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

[email protected]

SAN FRANCISCO – In the opinion of Dr. Larry H. Hollier, multiple organ dysfunction syndrome is a condition "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive.

At the Society for Vascular Surgery Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

The pathophysiology of MODS "is fairly straightforward," he continued. "Some event results in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen-free radicals, tissue damage, and then organ dysfunction." Dr. Hollier discussed these issues as the invited speaker for the prestigious John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m² leads to a severe flulike syndrome (mild SIRS); 26 L/m² leads to multiple organ dysfunction syndrome; and 33 L/m² or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, including steroids, antiendotoxin monoclonal antibodies, IL-1 receptor antagonists, anti-TNF antibodies, antioxidants, inhibition of nitric oxide, and oxygen manipulation in the form of extracorporeal support and perfluorocarbons. "While there is some research experience, in the clinical arena, there has universally not been a treatment that reverses the multiple organ dysfunction syndrome," he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "This is where we have some of the opportunities to improve the situation and possibly prevent the full MODS," Dr. Hollier said. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said. It’s less clear what approach to take for the patient who develops severe cytokine activation and is on course to develop MODS.

"Since high-dose hyperbaric oxygen therapy appears to abort cytokine activation in experimental studies, should we consider hyperbaric oxygen therapy for management of severe cytokine activation postoperatively?" Dr. Hollier asked. "Hyperbaric oxygen therapy has been demonstrated by controlled human studies to be useful in resuscitation and tissue salvage in crush injury and traumatic brain injury. I don’t have the answers to this. These are the areas of investigations that I urge the members of this society and our young students, residents, and fellows to consider."

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "We need research on this to find the answer," he said. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

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

[email protected]

SAN FRANCISCO – In the opinion of Dr. Larry H. Hollier, multiple organ dysfunction syndrome is a condition "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive.

At the Society for Vascular Surgery Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

The pathophysiology of MODS "is fairly straightforward," he continued. "Some event results in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen-free radicals, tissue damage, and then organ dysfunction." Dr. Hollier discussed these issues as the invited speaker for the prestigious John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m² leads to a severe flulike syndrome (mild SIRS); 26 L/m² leads to multiple organ dysfunction syndrome; and 33 L/m² or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, including steroids, antiendotoxin monoclonal antibodies, IL-1 receptor antagonists, anti-TNF antibodies, antioxidants, inhibition of nitric oxide, and oxygen manipulation in the form of extracorporeal support and perfluorocarbons. "While there is some research experience, in the clinical arena, there has universally not been a treatment that reverses the multiple organ dysfunction syndrome," he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "This is where we have some of the opportunities to improve the situation and possibly prevent the full MODS," Dr. Hollier said. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said. It’s less clear what approach to take for the patient who develops severe cytokine activation and is on course to develop MODS.

"Since high-dose hyperbaric oxygen therapy appears to abort cytokine activation in experimental studies, should we consider hyperbaric oxygen therapy for management of severe cytokine activation postoperatively?" Dr. Hollier asked. "Hyperbaric oxygen therapy has been demonstrated by controlled human studies to be useful in resuscitation and tissue salvage in crush injury and traumatic brain injury. I don’t have the answers to this. These are the areas of investigations that I urge the members of this society and our young students, residents, and fellows to consider."

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "We need research on this to find the answer," he said. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

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

[email protected]

SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.

"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."

Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."

Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."

In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.

In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.

Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.

A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.

Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).

During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.

The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."

In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."

Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.

[email protected]

SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.

"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."

Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."

Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."

In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.

In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.

Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.

A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.

Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).

During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.

The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."

In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."

Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.

[email protected]

SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.

"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."

Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."

Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."

In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.

In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.

Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.

A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.

Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).

During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.

The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."

In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."

Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.

[email protected]

SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.

"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.

"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."

To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.

Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."

Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.

The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.

"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."

When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).

With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."

She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."

Dr. Desai said that she had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.

"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.

"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."

To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.

Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."

Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.

The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.

"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."

When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).

With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."

She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."

Dr. Desai said that she had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.

"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.

"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."

To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.

Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."

Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.

The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.

"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."

When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).

With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."

She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."

Dr. Desai said that she had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.

However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.

Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.

The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."

Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.

The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.

"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."

The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.

"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."

Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).

Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."

The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.

[email protected]

SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.

However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.

Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.

The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."

Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.

The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.

"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."

The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.

"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."

Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).

Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."

The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.

[email protected]

SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.

However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.

Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.

The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."

Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.

The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.

"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."

The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.

"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."

Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).

Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."

The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.

[email protected]

SAN FRANCISCO – The 30-day unplanned readmission rate following carotid endarterectomy was 6.5% in a single-center study.

In addition, four variables were significantly associated with unplanned readmission: in-hospital postoperative congestive heart failure (CHF) exacerbation; in-hospital postoperative stroke; in-hospital postoperative hematoma; and prior coronary artery bypass graft (CABG).

"Whether these complications are completely avoidable is unknown, but we do identify a group of patients who would probably benefit from more comprehensive discharge planning and careful postdischarge care," Dr. Karen J. Ho said at the Society for Vascular Surgery annual meeting.

According to a study of Medicare claims data from 2003 to 2004, 20% of Medicare beneficiaries discharged from a hospital were rehospitalized within 30 days (N. Eng. J. Med. 2009;360:1418-28). The 30-day rehospitalization rate after vascular surgery was 24%, "the highest of all surgical specialties examined in the study," said Dr. Ho of the surgery department at Brigham and Women’s Hospital, Boston, who was not involved with the published study. "Medicare has started to decrease reimbursements for hospitals with excess readmissions after acute MI, heart failure, and pneumonia. Hip and knee replacements and chronic obstructive pulmonary disease will be added in 2014, and we anticipate that additional surgical procedures will be added thereafter," she said.

In an effort to determine the rate of 30-day unplanned readmission after carotid endarterectomy (CEA), Dr. Ho and her associates conducted a retrospective study of a prospectively collected vascular surgery database at Brigham and Women’s Hospital. The cohort included 896 consecutive CEAs performed between 2002 and 2011. Combined CABG/CEA procedures were excluded.

The primary endpoint was unplanned readmission within 30 days, defined as "any unanticipated, nonelective hospital readmission," she said. The secondary endpoint was 1-year survival.

The mean age of the patients was 70 years, 60% were male, and 95% were white. More than half (65%) had asymptomatic evidence of carotid artery disease.

Dr. Ho reported that the median postoperative length of stay was 1 day and that 9.9% of patients had at least one in-hospital complication. The most frequent in-hospital complication was bleeding/hematoma (4.1%), followed by arrhythmia (2.1%), dysphagia (1.7%), stroke (1.3%), and myocardial infarction (1.2%). Only 3% of patients required a reoperation, while most (94%) were discharged to home. The 30-day stroke rate was 1.7%, while the 30-day death rate was 0.6%.

The overall 30-day readmission rate was 8.6%, while the unplanned 30-day readmission rate was 6.5%. "Most of the overall readmissions (80%) occurred in the first 10 days, and the median time to unplanned readmission was 4 days," Dr. Ho said.

The most common reason for an unplanned readmission was a cardiac complication, followed by headache, bleeding/hematoma, stroke/transient ischemic attack/intracerebral hemorrhage, or other medical emergency. More than one-quarter of patients (27.5%) had more than one reason for an unplanned readmission, while 87.9% of patients had a CEA-related unplanned readmission.

When the researchers performed a univariate analysis followed by analysis with a multivariable Cox model for unplanned readmission, four variables were independently associated with unplanned readmission: in-hospital postoperative CHF exacerbation (hazard ratio, 15.1), in-hospital postoperative stroke (HR, 5.0), in-hospital postoperative hematoma (HR, 3.1), and prior CABG (HR, 2.0).

They also observed a significant difference in survival at 1 year between patients who had an unplanned readmission and those who did not (91% vs. 96%, respectively; P less than .01.) "It’s unclear whether these deaths in the unplanned readmission group were preventable or if they were related to carotid disease or to a procedure-related complication," Dr. Ho said. "Our guess is that the increased overall burden of comorbid disease in these patients, rather than the readmission itself, predicted decreased survival."

Limitations of the study included its retrospective design and the fact that it was conducted at a single center, she said, "but we do know that our unplanned readmission rate is comparable to estimates from recent Medicare data."

Dr. Ho said she had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – The 30-day unplanned readmission rate following carotid endarterectomy was 6.5% in a single-center study.

In addition, four variables were significantly associated with unplanned readmission: in-hospital postoperative congestive heart failure (CHF) exacerbation; in-hospital postoperative stroke; in-hospital postoperative hematoma; and prior coronary artery bypass graft (CABG).

"Whether these complications are completely avoidable is unknown, but we do identify a group of patients who would probably benefit from more comprehensive discharge planning and careful postdischarge care," Dr. Karen J. Ho said at the Society for Vascular Surgery annual meeting.

According to a study of Medicare claims data from 2003 to 2004, 20% of Medicare beneficiaries discharged from a hospital were rehospitalized within 30 days (N. Eng. J. Med. 2009;360:1418-28). The 30-day rehospitalization rate after vascular surgery was 24%, "the highest of all surgical specialties examined in the study," said Dr. Ho of the surgery department at Brigham and Women’s Hospital, Boston, who was not involved with the published study. "Medicare has started to decrease reimbursements for hospitals with excess readmissions after acute MI, heart failure, and pneumonia. Hip and knee replacements and chronic obstructive pulmonary disease will be added in 2014, and we anticipate that additional surgical procedures will be added thereafter," she said.

In an effort to determine the rate of 30-day unplanned readmission after carotid endarterectomy (CEA), Dr. Ho and her associates conducted a retrospective study of a prospectively collected vascular surgery database at Brigham and Women’s Hospital. The cohort included 896 consecutive CEAs performed between 2002 and 2011. Combined CABG/CEA procedures were excluded.

The primary endpoint was unplanned readmission within 30 days, defined as "any unanticipated, nonelective hospital readmission," she said. The secondary endpoint was 1-year survival.

The mean age of the patients was 70 years, 60% were male, and 95% were white. More than half (65%) had asymptomatic evidence of carotid artery disease.

Dr. Ho reported that the median postoperative length of stay was 1 day and that 9.9% of patients had at least one in-hospital complication. The most frequent in-hospital complication was bleeding/hematoma (4.1%), followed by arrhythmia (2.1%), dysphagia (1.7%), stroke (1.3%), and myocardial infarction (1.2%). Only 3% of patients required a reoperation, while most (94%) were discharged to home. The 30-day stroke rate was 1.7%, while the 30-day death rate was 0.6%.

The overall 30-day readmission rate was 8.6%, while the unplanned 30-day readmission rate was 6.5%. "Most of the overall readmissions (80%) occurred in the first 10 days, and the median time to unplanned readmission was 4 days," Dr. Ho said.

The most common reason for an unplanned readmission was a cardiac complication, followed by headache, bleeding/hematoma, stroke/transient ischemic attack/intracerebral hemorrhage, or other medical emergency. More than one-quarter of patients (27.5%) had more than one reason for an unplanned readmission, while 87.9% of patients had a CEA-related unplanned readmission.

When the researchers performed a univariate analysis followed by analysis with a multivariable Cox model for unplanned readmission, four variables were independently associated with unplanned readmission: in-hospital postoperative CHF exacerbation (hazard ratio, 15.1), in-hospital postoperative stroke (HR, 5.0), in-hospital postoperative hematoma (HR, 3.1), and prior CABG (HR, 2.0).

They also observed a significant difference in survival at 1 year between patients who had an unplanned readmission and those who did not (91% vs. 96%, respectively; P less than .01.) "It’s unclear whether these deaths in the unplanned readmission group were preventable or if they were related to carotid disease or to a procedure-related complication," Dr. Ho said. "Our guess is that the increased overall burden of comorbid disease in these patients, rather than the readmission itself, predicted decreased survival."

Limitations of the study included its retrospective design and the fact that it was conducted at a single center, she said, "but we do know that our unplanned readmission rate is comparable to estimates from recent Medicare data."

Dr. Ho said she had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – The 30-day unplanned readmission rate following carotid endarterectomy was 6.5% in a single-center study.

In addition, four variables were significantly associated with unplanned readmission: in-hospital postoperative congestive heart failure (CHF) exacerbation; in-hospital postoperative stroke; in-hospital postoperative hematoma; and prior coronary artery bypass graft (CABG).

"Whether these complications are completely avoidable is unknown, but we do identify a group of patients who would probably benefit from more comprehensive discharge planning and careful postdischarge care," Dr. Karen J. Ho said at the Society for Vascular Surgery annual meeting.

According to a study of Medicare claims data from 2003 to 2004, 20% of Medicare beneficiaries discharged from a hospital were rehospitalized within 30 days (N. Eng. J. Med. 2009;360:1418-28). The 30-day rehospitalization rate after vascular surgery was 24%, "the highest of all surgical specialties examined in the study," said Dr. Ho of the surgery department at Brigham and Women’s Hospital, Boston, who was not involved with the published study. "Medicare has started to decrease reimbursements for hospitals with excess readmissions after acute MI, heart failure, and pneumonia. Hip and knee replacements and chronic obstructive pulmonary disease will be added in 2014, and we anticipate that additional surgical procedures will be added thereafter," she said.

In an effort to determine the rate of 30-day unplanned readmission after carotid endarterectomy (CEA), Dr. Ho and her associates conducted a retrospective study of a prospectively collected vascular surgery database at Brigham and Women’s Hospital. The cohort included 896 consecutive CEAs performed between 2002 and 2011. Combined CABG/CEA procedures were excluded.

The primary endpoint was unplanned readmission within 30 days, defined as "any unanticipated, nonelective hospital readmission," she said. The secondary endpoint was 1-year survival.

The mean age of the patients was 70 years, 60% were male, and 95% were white. More than half (65%) had asymptomatic evidence of carotid artery disease.

Dr. Ho reported that the median postoperative length of stay was 1 day and that 9.9% of patients had at least one in-hospital complication. The most frequent in-hospital complication was bleeding/hematoma (4.1%), followed by arrhythmia (2.1%), dysphagia (1.7%), stroke (1.3%), and myocardial infarction (1.2%). Only 3% of patients required a reoperation, while most (94%) were discharged to home. The 30-day stroke rate was 1.7%, while the 30-day death rate was 0.6%.

The overall 30-day readmission rate was 8.6%, while the unplanned 30-day readmission rate was 6.5%. "Most of the overall readmissions (80%) occurred in the first 10 days, and the median time to unplanned readmission was 4 days," Dr. Ho said.

The most common reason for an unplanned readmission was a cardiac complication, followed by headache, bleeding/hematoma, stroke/transient ischemic attack/intracerebral hemorrhage, or other medical emergency. More than one-quarter of patients (27.5%) had more than one reason for an unplanned readmission, while 87.9% of patients had a CEA-related unplanned readmission.

When the researchers performed a univariate analysis followed by analysis with a multivariable Cox model for unplanned readmission, four variables were independently associated with unplanned readmission: in-hospital postoperative CHF exacerbation (hazard ratio, 15.1), in-hospital postoperative stroke (HR, 5.0), in-hospital postoperative hematoma (HR, 3.1), and prior CABG (HR, 2.0).

They also observed a significant difference in survival at 1 year between patients who had an unplanned readmission and those who did not (91% vs. 96%, respectively; P less than .01.) "It’s unclear whether these deaths in the unplanned readmission group were preventable or if they were related to carotid disease or to a procedure-related complication," Dr. Ho said. "Our guess is that the increased overall burden of comorbid disease in these patients, rather than the readmission itself, predicted decreased survival."

Limitations of the study included its retrospective design and the fact that it was conducted at a single center, she said, "but we do know that our unplanned readmission rate is comparable to estimates from recent Medicare data."

Dr. Ho said she had no relevant financial disclosures.

[email protected]

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]