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Mesenteric stenting: an evolving therapy
CHICAGO – Mesenteric stenting has replaced open surgery as first-line treatment for chronic mesenteric ischemia, but it is still a therapy in flux.
Controversy exists over single- versus multivessel revascularization when both the celiac artery (CA) and superior mesenteric artery (SMA) are diseased and symptoms are consistent with chronic mesenteric ischemia (CMI), Dr. Jean Panneton said at a symposium on vascular surgery sponsored by Northwestern University.
Some vascular specialists argue that complete revascularization provides better protection when one vessel occludes, while those favoring single-vessel revascularization contend that bypassing only the most problematic vessel avoids a longer, more complex operation in these typically fragile patients.
The data on single- versus multivessel mesenteric bypass is mixed, he said. Some studies have found that two-vessel bypass results in less symptom recurrence, improved patency, and fewer reinterventions than single-vessel bypass. Other studies, however, have found no difference in 1-year patency or freedom from symptom recurrence between the two treatments.
Regardless of the number of vessels treated, no consensus exists as to which artery responds best to stenting, Dr. Panneton, from Eastern Virginia Medical School in Norfolk, said. In their own review of 121 consecutive patients over a 7-year period, there was a major discrepancy between SMA and CA stenting in 1-year primary patency (55% vs. 18%) and 6-month clinical patency (86% vs. 67%).
“In our experience, celiac stenting had much worse ISR [in-stent restenosis] and clinical patency rates than SMA stenting, which questions its utility,” he said.
In the celiac group, stents with a diameter < 6 mm were significantly more likely than larger-caliber stents to lose primary patency, defined as peak systolic velocity < 350 cm/sec.
Interestingly, a subset analysis of patients undergoing two-vessel stenting of the CA and SMA revealed no significant differences in ISR rates or survival free from symptom recurrence, compared with single SMA stenting (J. Vasc. Surg. 2013;57:1062-6).
Surveillance after mesenteric stenting is another area in flux. Duplex ultrasound (DUS) has been validated as an accurate modality for determining native mesenteric artery stenosis, but no firm DUS criteria exist for diagnosing ISR, Dr. Panneton said. Several studies have reported that DUS velocity criteria for native mesenteric stenosis overestimates the percentage of stenosis of stented arteries.
A receiver operator curve (ROC) analysis by Dr. Panneton and his colleagues demonstrated that an SMA peak systolic velocity (PSV) of 445 cm/sec had the highest sensitivity (96%), but only 43% specificity for predicting ISR.
Further prospective validation is needed, although a similar ROC analysis reported 100% sensitivity and 95% sensitivity using a PSV of 412 cm/sec to identify SMA > 70% ISR (J. Vasc. Surg. 2012;55:730-8), he noted.
Intravascular ultrasound (IVUS) is useful as an adjunct to DUS and angiography for the detection of ISR of mesenteric arteries, but isn’t practical for routine surveillance. There is also a dearth of data on outcomes when IVUS is used with other imaging modalities, Dr. Panneton added.
What is clear is that a paradigm shift has occurred in the treatment of CMI, reflected in a threefold increase in the number of mesenteric revascularizations performed in the U.S. during the last 10 years. Still, 5-year survival rates are nearly identical between open surgery and mesenteric stenting, despite primary, secondary, and clinical patency rates seeming to favor open mesenteric bypass.
“Future technology will address the higher ISR and reintervention rates associated with mesenteric stenting and likely improve outcomes,” Dr. Panneton said.
Mesenteric stenting can still be useful, even after bypass, he said, highlighting a 78-year-old woman with a history of aortobifemoral bypass who required endovascular rescue of an SMA graft thrombosis after presenting with acute mesenteric ischemia.
“We were able with a guidewire, to get through the reversed C-loop graft that came from the iliac to the SMA and get into the distal SMA vessel,” he said. “We also used pharmacomechanical thrombectomy to really declot the graft and place a stent at the proximal anastomosis of the iliac-SMA Dacron graft.”
The team has also done mesenteric stenting using a retrograde open mesenteric stenting technique.
“It’s quite useful in acute mesenteric ischemia, but we’ve also used it more recently even in chronic mesenteric ischemia for patients who did not tolerate aortic cross-clamping or did not have any good aorta,” he said. “An example of that would be a porcelain aorta where we don’t want to clamp anything.”
Dr. Panneton is a consultant and serves on the speaker’s bureau for Medtronic.
CHICAGO – Mesenteric stenting has replaced open surgery as first-line treatment for chronic mesenteric ischemia, but it is still a therapy in flux.
Controversy exists over single- versus multivessel revascularization when both the celiac artery (CA) and superior mesenteric artery (SMA) are diseased and symptoms are consistent with chronic mesenteric ischemia (CMI), Dr. Jean Panneton said at a symposium on vascular surgery sponsored by Northwestern University.
Some vascular specialists argue that complete revascularization provides better protection when one vessel occludes, while those favoring single-vessel revascularization contend that bypassing only the most problematic vessel avoids a longer, more complex operation in these typically fragile patients.
The data on single- versus multivessel mesenteric bypass is mixed, he said. Some studies have found that two-vessel bypass results in less symptom recurrence, improved patency, and fewer reinterventions than single-vessel bypass. Other studies, however, have found no difference in 1-year patency or freedom from symptom recurrence between the two treatments.
Regardless of the number of vessels treated, no consensus exists as to which artery responds best to stenting, Dr. Panneton, from Eastern Virginia Medical School in Norfolk, said. In their own review of 121 consecutive patients over a 7-year period, there was a major discrepancy between SMA and CA stenting in 1-year primary patency (55% vs. 18%) and 6-month clinical patency (86% vs. 67%).
“In our experience, celiac stenting had much worse ISR [in-stent restenosis] and clinical patency rates than SMA stenting, which questions its utility,” he said.
In the celiac group, stents with a diameter < 6 mm were significantly more likely than larger-caliber stents to lose primary patency, defined as peak systolic velocity < 350 cm/sec.
Interestingly, a subset analysis of patients undergoing two-vessel stenting of the CA and SMA revealed no significant differences in ISR rates or survival free from symptom recurrence, compared with single SMA stenting (J. Vasc. Surg. 2013;57:1062-6).
Surveillance after mesenteric stenting is another area in flux. Duplex ultrasound (DUS) has been validated as an accurate modality for determining native mesenteric artery stenosis, but no firm DUS criteria exist for diagnosing ISR, Dr. Panneton said. Several studies have reported that DUS velocity criteria for native mesenteric stenosis overestimates the percentage of stenosis of stented arteries.
A receiver operator curve (ROC) analysis by Dr. Panneton and his colleagues demonstrated that an SMA peak systolic velocity (PSV) of 445 cm/sec had the highest sensitivity (96%), but only 43% specificity for predicting ISR.
Further prospective validation is needed, although a similar ROC analysis reported 100% sensitivity and 95% sensitivity using a PSV of 412 cm/sec to identify SMA > 70% ISR (J. Vasc. Surg. 2012;55:730-8), he noted.
Intravascular ultrasound (IVUS) is useful as an adjunct to DUS and angiography for the detection of ISR of mesenteric arteries, but isn’t practical for routine surveillance. There is also a dearth of data on outcomes when IVUS is used with other imaging modalities, Dr. Panneton added.
What is clear is that a paradigm shift has occurred in the treatment of CMI, reflected in a threefold increase in the number of mesenteric revascularizations performed in the U.S. during the last 10 years. Still, 5-year survival rates are nearly identical between open surgery and mesenteric stenting, despite primary, secondary, and clinical patency rates seeming to favor open mesenteric bypass.
“Future technology will address the higher ISR and reintervention rates associated with mesenteric stenting and likely improve outcomes,” Dr. Panneton said.
Mesenteric stenting can still be useful, even after bypass, he said, highlighting a 78-year-old woman with a history of aortobifemoral bypass who required endovascular rescue of an SMA graft thrombosis after presenting with acute mesenteric ischemia.
“We were able with a guidewire, to get through the reversed C-loop graft that came from the iliac to the SMA and get into the distal SMA vessel,” he said. “We also used pharmacomechanical thrombectomy to really declot the graft and place a stent at the proximal anastomosis of the iliac-SMA Dacron graft.”
The team has also done mesenteric stenting using a retrograde open mesenteric stenting technique.
“It’s quite useful in acute mesenteric ischemia, but we’ve also used it more recently even in chronic mesenteric ischemia for patients who did not tolerate aortic cross-clamping or did not have any good aorta,” he said. “An example of that would be a porcelain aorta where we don’t want to clamp anything.”
Dr. Panneton is a consultant and serves on the speaker’s bureau for Medtronic.
CHICAGO – Mesenteric stenting has replaced open surgery as first-line treatment for chronic mesenteric ischemia, but it is still a therapy in flux.
Controversy exists over single- versus multivessel revascularization when both the celiac artery (CA) and superior mesenteric artery (SMA) are diseased and symptoms are consistent with chronic mesenteric ischemia (CMI), Dr. Jean Panneton said at a symposium on vascular surgery sponsored by Northwestern University.
Some vascular specialists argue that complete revascularization provides better protection when one vessel occludes, while those favoring single-vessel revascularization contend that bypassing only the most problematic vessel avoids a longer, more complex operation in these typically fragile patients.
The data on single- versus multivessel mesenteric bypass is mixed, he said. Some studies have found that two-vessel bypass results in less symptom recurrence, improved patency, and fewer reinterventions than single-vessel bypass. Other studies, however, have found no difference in 1-year patency or freedom from symptom recurrence between the two treatments.
Regardless of the number of vessels treated, no consensus exists as to which artery responds best to stenting, Dr. Panneton, from Eastern Virginia Medical School in Norfolk, said. In their own review of 121 consecutive patients over a 7-year period, there was a major discrepancy between SMA and CA stenting in 1-year primary patency (55% vs. 18%) and 6-month clinical patency (86% vs. 67%).
“In our experience, celiac stenting had much worse ISR [in-stent restenosis] and clinical patency rates than SMA stenting, which questions its utility,” he said.
In the celiac group, stents with a diameter < 6 mm were significantly more likely than larger-caliber stents to lose primary patency, defined as peak systolic velocity < 350 cm/sec.
Interestingly, a subset analysis of patients undergoing two-vessel stenting of the CA and SMA revealed no significant differences in ISR rates or survival free from symptom recurrence, compared with single SMA stenting (J. Vasc. Surg. 2013;57:1062-6).
Surveillance after mesenteric stenting is another area in flux. Duplex ultrasound (DUS) has been validated as an accurate modality for determining native mesenteric artery stenosis, but no firm DUS criteria exist for diagnosing ISR, Dr. Panneton said. Several studies have reported that DUS velocity criteria for native mesenteric stenosis overestimates the percentage of stenosis of stented arteries.
A receiver operator curve (ROC) analysis by Dr. Panneton and his colleagues demonstrated that an SMA peak systolic velocity (PSV) of 445 cm/sec had the highest sensitivity (96%), but only 43% specificity for predicting ISR.
Further prospective validation is needed, although a similar ROC analysis reported 100% sensitivity and 95% sensitivity using a PSV of 412 cm/sec to identify SMA > 70% ISR (J. Vasc. Surg. 2012;55:730-8), he noted.
Intravascular ultrasound (IVUS) is useful as an adjunct to DUS and angiography for the detection of ISR of mesenteric arteries, but isn’t practical for routine surveillance. There is also a dearth of data on outcomes when IVUS is used with other imaging modalities, Dr. Panneton added.
What is clear is that a paradigm shift has occurred in the treatment of CMI, reflected in a threefold increase in the number of mesenteric revascularizations performed in the U.S. during the last 10 years. Still, 5-year survival rates are nearly identical between open surgery and mesenteric stenting, despite primary, secondary, and clinical patency rates seeming to favor open mesenteric bypass.
“Future technology will address the higher ISR and reintervention rates associated with mesenteric stenting and likely improve outcomes,” Dr. Panneton said.
Mesenteric stenting can still be useful, even after bypass, he said, highlighting a 78-year-old woman with a history of aortobifemoral bypass who required endovascular rescue of an SMA graft thrombosis after presenting with acute mesenteric ischemia.
“We were able with a guidewire, to get through the reversed C-loop graft that came from the iliac to the SMA and get into the distal SMA vessel,” he said. “We also used pharmacomechanical thrombectomy to really declot the graft and place a stent at the proximal anastomosis of the iliac-SMA Dacron graft.”
The team has also done mesenteric stenting using a retrograde open mesenteric stenting technique.
“It’s quite useful in acute mesenteric ischemia, but we’ve also used it more recently even in chronic mesenteric ischemia for patients who did not tolerate aortic cross-clamping or did not have any good aorta,” he said. “An example of that would be a porcelain aorta where we don’t want to clamp anything.”
Dr. Panneton is a consultant and serves on the speaker’s bureau for Medtronic.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
Acute renal failure biggest short-term risk in I-EVAR explantation
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Acute renal failure occurred postoperatively in one-third of patients who underwent endograft explantation after endovascular abdominal aortic aneurysm repair (EVAR), according to the results of a small retrospective study.
The perioperative infected EVAR (I-EVAR) mortality across the study’s 36 patient records (83% male patients, average age 69 years), culled from four surgery centers’ data from 1997 to 2014, was 8%. The overall mortality was 25%, according to Dr. Victor J. Davila of Mayo Clinic Arizona, Phoenix, and his colleagues. Dr. Davila presented the findings at the Southern Association for Vascular Surgery annual meeting.
“These data show that I-EVAR explantation can be performed safely, with acceptable morbidity and mortality,” said Dr. Davila, who noted that while acceptable, the rates were still high, particularly for acute renal failure.
“We did not find any difference between the patients who developed renal failure and the type of graft, whether or not there was suprarenal fixation, and an incidence of postoperative acute renal failure,” Dr. Davila said, “However, because acute renal failure is multifactorial, we need to minimize aortic clamp time, as well as minimize the aortic intimal disruption around the renal arteries.”
Three deaths occurred within 30 days post operation, all from anastomotic dehiscence. Additional short-term morbidities included respiratory failure that required tracheostomy in three patients, and bleeding and sepsis in two patients each. Six patients required re-exploration because of infected hematoma, lymphatic leak, small-bowel perforation, open abdomen at initial operation, and anastomotic bleeding. Six more deaths occurred at a mean follow-up of 402 days. One death was attributable to a ruptured aneurysm, another to a progressive inflammatory illness, and four deaths were of indeterminate cause.
Only three of the explantations reviewed by Dr. Davila and his colleagues were considered emergent. The rest (92%) were either elective or urgent. Infected patients tended to present with leukocytosis (63%), pain (58%), and fever (56%), usually about 65 days prior to explantation. The average time between EVAR and presentation with infection was 589 days.
Although most underwent total graft excision, two patients underwent partial excision, including one with a distal iliac limb infection that showed no sign of infection within the main portion of the endograft. Nearly three-quarters of patients had in situ reconstruction.
While nearly a third of patients had positive preoperative blood cultures indicating infection, 81% of intraoperative cultures taken from the explanted graft, aneurysm wall, or sac contents indicated infection.
The gram-positive Staphylococcus and Streptococcus were the most common organisms found in cultures (33% and 17%, respectively), although anaerobics were found in a third of patients, gram negatives in a quarter of patients, and fungal infections in 14%. A majority (58%) of patients received long-term suppressive antibiotic therapy.
Surgeons should reserve the option to keep a graft in situ only in infected EVAR patients who likely would not survive surgical explantation and reconstruction, Dr. Davila said. “Although I believe [medical management] is an alternative, the best course of action is to remove the endograft.”
On Twitter @whitneymcknight
AT THE SAVS ANNUAL MEETING
Key clinical point: Minimizing cross-clamp time may reduce the rate of acute renal failure 30 days post op in infected EVAR explantation patients.
Major finding: One-third of I-EVAR patients had postoperative acute renal failure; perioperative mortality in I-EVAR was 8%, and overall mortality was 25%.
Data source: Retrospective analysis of 36 patients with infected EVAR explants performed between 1997 and 2014 across four surgical centers.
Disclosures: Dr. Davila reported he had no relevant disclosures.
CHADS2 predicts postop atrial fibrillation
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
AT THE CRITICAL CARE CONGRESS
Key clinical point: Postop atrial fibrillation is more likely if patients go into surgery with an elevated CHADS 2 score.
Major finding: For every unit increase in baseline CHADS2 score, there is a 17% increase in the risk of new-onset AF following major vascular or thoracic surgery (HR 1.17, 95% CI 1.04-1.31).
Data source: Retrospective chart review of 1,550 adult patients.
Disclosures: The investigators said they had no disclosures. No outside funding was reported for the work.
Genetic blood profiles can estimate risk levels of VTE patients
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Meticulous planning, creativity key to management of EVAR infections
CHICAGO – Successful management of infected aortic endovascular grafts requires careful operative planning and execution, meticulous postoperative care, and a fair bit of creativity.
“Each patient is different, so surgeons have to tailor the reconstructions to the individual patient and with these specific infections, have to be creative,” Dr. Thomas C. Bower, chair of vascular and endovascular surgery at Mayo Clinic, Rochester, Minn., said. “I’ve found the operations to be more challenging and more difficult than explanting portions or total graft excision when the infection has occurred in a hand-sewn graft.”
Unlike the typical bimodal distribution seen with hand-sewn graft infections, infection following endovascular repair of aortic aneurysms (EVAR) occurs from days up to 3 years after implantation. At the Mayo Clinic, a 79-year-old man presented with an infected endograft, psoas abscess, and Salmonella septicemia 4 years after EVAR.
“These infections are uncommon, but we are seeing more of them,” Dr. Bower said at a symposium on vascular surgery sponsored by Northwestern University.
Roughly two-thirds of patients will present with fever, nonspecific abdominal or back pain, malaise, weight loss or night sweats. If time permits, preoperative assessments include echocardiography for left ventricular function, arterial blood gases for pulmonary function since many patients are smokers, and renal ultrasound if creatinine is ≥ 1.5 mg/dL after rehydration. These tests are important because preoperative chronic obstructive pulmonary disease and renal dysfunction correlate with worse postoperative outcomes, he said.
Computed tomography angiography (CTA), however, stands as the single most important step of preoperative preparation, with the sine qua non of infection being air around the graft. Unlike hand-sewn grafts where infections can be localized, typically there is total graft involvement in these cases because the device is left inside the aneurysm sac. Aneurysms or pseudoaneurysms also have been seen above the infected device, including at the top end of suprarenal stents.
“This clearly has an impact on how we approach patients, but what’s become very apparent to me is that CTA often underestimates the amount of periaortic inflammation, especially at the juxta- and pararenal locations,” Dr. Bower said.
The Mayo group initially used in situ antibiotic-soaked prosthetic grafts for explanting EVAR devices, which yielded “acceptable mortality and reinfection rates, but primarily outstanding patency rates.” However, cryopreserved aortoiliac grafts have now become their first choice, Dr. Bower said. An ABO match is not imperative, preparation takes roughly 45 minutes, branch closures done in the lab are buttressed with sutures, and the graft is turned over to keep the lumbar arteries anterior, which offers an easy fix if there is bleeding, rather than having it on the posterior wall. Cryopreserved grafts, however, can dilate 40% and lengthen 10% under pressure.
“I’ve been burned more than once where the graft elongates more than I think, and I end up having to cut a small piece out to foreshorten it,” he said.
Reconstructions are tailored to patient anatomy. Surgeons should have several plans for reconstruction, including routing a graft through a remote path, remembering that CTA will underestimate the amount of periaortic inflammation. Separate bypasses of the renal or visceral arteries are performed first before the aortic clamp is applied to reduce physiologic stress. This requires knowledge of the supraceliac and pararenal aorta exposures, which really begins with the correct choice of incisions, Dr. Bower said. This is based on the aortic segment to be treated, position of the new graft, the aortic clamp site, and patient body habitus.
Most patients with EVAR infections are approached with a midline abdominal incision extended along the xiphoid process, which is the lynch pin for allowing upward and lateral retraction of the abdominal wall, he said. Choosing an incision that allows a more vertical orientation to where the new aortic anastomosis and clamp site will be, rather than operating in a keyhole, is important.
The second step is to open up the pararenal space by moving the viscera out of the way. This begins by ligating the inferior mesenteric vein and adjacent lymphatics, which allows incision of an avascular plane along the base of the left transverse colon. Retractor blades are set to allow the upward and lateral retraction of the small bowel, the left colon, and pancreas. Exposure of the suprarenal or supramesenteric aorta requires mobilization of the left renal vein after ligation and division of its branches.
“If that vein is intensely involved in inflammation, don’t ligate the branches in case you have to divide that vein at the caval confluence. Otherwise, you’ll run into some dysfunction of that left kidney,” Dr. Bower cautioned.
To have a secure place for the aortic cross clamp, the crura must be divided on either side of the diaphragm at or above the supramesenteric aorta, he added.
Key steps in total graft explantation are to drain abscesses prior to surgery to lower the bacterial burden and thus reduce the postoperative inflammatory response, bypass renal/visceral arteries first, if needed, remove the infected graft, debride the aorta to healthy tissue, place the new graft and cover it with omentum, and repair the bowel, if needed.
A piece of the proximal aortic wall should be sent to pathology to ensure the absence of bacteria or microabscesses. Organism-specific antibiotics are administered intravenously for 6-8 weeks followed by lifelong oral antibiotics, he said.
An earlier report involving 24 patients with infected aortic endografts (21 EVARs and 3 thoracic EVARs) treated at Mayo Clinic between 1997 and 2012 revealed polymicrobial infection in 11 patients, with methicillin-resistant Staphylococcus aureus being common. Potential contributors to infection were endovascular reintervention in eight, aortoenteric fistula/erosion in four, and various remote infections (J. Vasc. Surg. 2013;58:371-9).
Rifampin-soaked grafts were used in 15 patients, cryopreserved grafts in 4, femoral vein in 2, and axillofemoral grafts in 3. At a median of 14 months follow-up, patient survival, graft-related complications, and reinfection rates were 79%, 13%, and 4%, respectively, Dr. Bower said.
Dr. Bower reported having no financial disclosures.
The expert opinion from the Northwestern Vascular Symposium regarding the management of EVAR infections reminds us of the importance of appropriate patient selection, proper performance of the planned procedure, and long-term follow-up. As EVAR has become the treatment of choice for more than 80% of patients with infrarenal AAAs in the United States, the rate of patients that return with EVAR infections, although rare, is increasing and their management can be more challenging than that of a primary or aortic graft infection as suggested by Dr. Thomas C. Bower in this opinion. The planning for these cases is critical with multiple options for treatment currently available and endorsed by a variety of investigators. From an evaluation standpoint, CTA is critical for diagnosis and case planning. Air around the graft is considered the “sine qua non” of infection but if it presents in the first month after EVAR it can be due to trapped air introduced into the sac during the intervention.
 |
Dr. Luis A. Sanchez |
Patients with air in the sac at the initial postprocedure evaluation should be considered for early follow-up to make sure this finding resolves. Further assessment that will change the management of the patient includes the type of EVAR device, infra- or suprarenal, since the entire removal of a suprarenal device usually requires supraceliac cross-clamping with its associated morbidity and mortality. Drainage of the infected cavity, as suggested by Dr. Bower, can help lower the bacterial burden and provide information regarding the offending organism. That information will help the vascular surgeon decide if an in-line reconstruction or an extra-anatomical one is more appropriate in the patient’s situation as more virulent organisms tend to be associated with higher reinfection and complication rates when in-line reconstructions are performed.
The different options for aortic access need to be evaluated based on the anatomy of the patient. A transabdominal approach is best for most patients as it allows access to the iliac arteries bilaterally for removal of the entire graft, debridement of the infected bed, aortic and/or visceral reconstruction, and omental coverage of the in-line graft or aortic stump if an extra-anatomical reconstruction is selected. The retroperitoneal approach should be considered for patients that will require extensive perivisceral work, as may be necessary from suprarenal or fenestrated devices, but limitations exist accessing the right iliac system and potentially intraabdominal targets for visceral or renal reconstructions.
The best configuration to reconstruct these patients remains largely undetermined based on the literature. The published experience from the Mayo Clinic (J. Vasc. Surg. 2013;58:371-9), in which some of the opinions of Dr. Bower are based, suggested excellent results in 24 patients mostly treated with rifampin-soaked in-line reconstructions with a periprocedural mortality of 4%. Cryopreserved aortic grafts “have become the conduit of choice for the group at this time,” stated Dr. Bower, to try to further decrease the reinfection rates in their patient population. There are limited data regarding the use of cryopreserved aortoiliac segments for aortic infections and less for EVAR infections. The most recent and largest series (J. Vasc. Surg. 2014;59:669-74) included 220 patients with aortic infections with a perioperative mortality of 9% and cryopreserved graft complications in another 12%-15% of patients.
In summary, aortic infections associated with EVAR are challenging problems that should be addressed in regional centers with experience. Renal and visceral reconstructions as well as supravisceral clamping are associated with significantly higher periprocedural morbidity and mortality based on the extensive experience at the Cleveland Clinic with EVAR explants (J. Vasc. Surg. 2014;59:886-93). The choice of the reconstruction and the material used should be based on the offending organism, type of EVAR device, extent of the infectious process, and the expertise of the treating physician.
Dr. Luis A. Sanchez is chief, section of vascular surgery and Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Washington University, St. Louis, and an associate medical editor for Vascular Specialist. He had no relevant disclosures.
The expert opinion from the Northwestern Vascular Symposium regarding the management of EVAR infections reminds us of the importance of appropriate patient selection, proper performance of the planned procedure, and long-term follow-up. As EVAR has become the treatment of choice for more than 80% of patients with infrarenal AAAs in the United States, the rate of patients that return with EVAR infections, although rare, is increasing and their management can be more challenging than that of a primary or aortic graft infection as suggested by Dr. Thomas C. Bower in this opinion. The planning for these cases is critical with multiple options for treatment currently available and endorsed by a variety of investigators. From an evaluation standpoint, CTA is critical for diagnosis and case planning. Air around the graft is considered the “sine qua non” of infection but if it presents in the first month after EVAR it can be due to trapped air introduced into the sac during the intervention.
|
Dr. Luis A. Sanchez |
Patients with air in the sac at the initial postprocedure evaluation should be considered for early follow-up to make sure this finding resolves. Further assessment that will change the management of the patient includes the type of EVAR device, infra- or suprarenal, since the entire removal of a suprarenal device usually requires supraceliac cross-clamping with its associated morbidity and mortality. Drainage of the infected cavity, as suggested by Dr. Bower, can help lower the bacterial burden and provide information regarding the offending organism. That information will help the vascular surgeon decide if an in-line reconstruction or an extra-anatomical one is more appropriate in the patient’s situation as more virulent organisms tend to be associated with higher reinfection and complication rates when in-line reconstructions are performed.
The different options for aortic access need to be evaluated based on the anatomy of the patient. A transabdominal approach is best for most patients as it allows access to the iliac arteries bilaterally for removal of the entire graft, debridement of the infected bed, aortic and/or visceral reconstruction, and omental coverage of the in-line graft or aortic stump if an extra-anatomical reconstruction is selected. The retroperitoneal approach should be considered for patients that will require extensive perivisceral work, as may be necessary from suprarenal or fenestrated devices, but limitations exist accessing the right iliac system and potentially intraabdominal targets for visceral or renal reconstructions.
The best configuration to reconstruct these patients remains largely undetermined based on the literature. The published experience from the Mayo Clinic (J. Vasc. Surg. 2013;58:371-9), in which some of the opinions of Dr. Bower are based, suggested excellent results in 24 patients mostly treated with rifampin-soaked in-line reconstructions with a periprocedural mortality of 4%. Cryopreserved aortic grafts “have become the conduit of choice for the group at this time,” stated Dr. Bower, to try to further decrease the reinfection rates in their patient population. There are limited data regarding the use of cryopreserved aortoiliac segments for aortic infections and less for EVAR infections. The most recent and largest series (J. Vasc. Surg. 2014;59:669-74) included 220 patients with aortic infections with a perioperative mortality of 9% and cryopreserved graft complications in another 12%-15% of patients.
In summary, aortic infections associated with EVAR are challenging problems that should be addressed in regional centers with experience. Renal and visceral reconstructions as well as supravisceral clamping are associated with significantly higher periprocedural morbidity and mortality based on the extensive experience at the Cleveland Clinic with EVAR explants (J. Vasc. Surg. 2014;59:886-93). The choice of the reconstruction and the material used should be based on the offending organism, type of EVAR device, extent of the infectious process, and the expertise of the treating physician.
Dr. Luis A. Sanchez is chief, section of vascular surgery and Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Washington University, St. Louis, and an associate medical editor for Vascular Specialist. He had no relevant disclosures.
The expert opinion from the Northwestern Vascular Symposium regarding the management of EVAR infections reminds us of the importance of appropriate patient selection, proper performance of the planned procedure, and long-term follow-up. As EVAR has become the treatment of choice for more than 80% of patients with infrarenal AAAs in the United States, the rate of patients that return with EVAR infections, although rare, is increasing and their management can be more challenging than that of a primary or aortic graft infection as suggested by Dr. Thomas C. Bower in this opinion. The planning for these cases is critical with multiple options for treatment currently available and endorsed by a variety of investigators. From an evaluation standpoint, CTA is critical for diagnosis and case planning. Air around the graft is considered the “sine qua non” of infection but if it presents in the first month after EVAR it can be due to trapped air introduced into the sac during the intervention.
|
Dr. Luis A. Sanchez |
Patients with air in the sac at the initial postprocedure evaluation should be considered for early follow-up to make sure this finding resolves. Further assessment that will change the management of the patient includes the type of EVAR device, infra- or suprarenal, since the entire removal of a suprarenal device usually requires supraceliac cross-clamping with its associated morbidity and mortality. Drainage of the infected cavity, as suggested by Dr. Bower, can help lower the bacterial burden and provide information regarding the offending organism. That information will help the vascular surgeon decide if an in-line reconstruction or an extra-anatomical one is more appropriate in the patient’s situation as more virulent organisms tend to be associated with higher reinfection and complication rates when in-line reconstructions are performed.
The different options for aortic access need to be evaluated based on the anatomy of the patient. A transabdominal approach is best for most patients as it allows access to the iliac arteries bilaterally for removal of the entire graft, debridement of the infected bed, aortic and/or visceral reconstruction, and omental coverage of the in-line graft or aortic stump if an extra-anatomical reconstruction is selected. The retroperitoneal approach should be considered for patients that will require extensive perivisceral work, as may be necessary from suprarenal or fenestrated devices, but limitations exist accessing the right iliac system and potentially intraabdominal targets for visceral or renal reconstructions.
The best configuration to reconstruct these patients remains largely undetermined based on the literature. The published experience from the Mayo Clinic (J. Vasc. Surg. 2013;58:371-9), in which some of the opinions of Dr. Bower are based, suggested excellent results in 24 patients mostly treated with rifampin-soaked in-line reconstructions with a periprocedural mortality of 4%. Cryopreserved aortic grafts “have become the conduit of choice for the group at this time,” stated Dr. Bower, to try to further decrease the reinfection rates in their patient population. There are limited data regarding the use of cryopreserved aortoiliac segments for aortic infections and less for EVAR infections. The most recent and largest series (J. Vasc. Surg. 2014;59:669-74) included 220 patients with aortic infections with a perioperative mortality of 9% and cryopreserved graft complications in another 12%-15% of patients.
In summary, aortic infections associated with EVAR are challenging problems that should be addressed in regional centers with experience. Renal and visceral reconstructions as well as supravisceral clamping are associated with significantly higher periprocedural morbidity and mortality based on the extensive experience at the Cleveland Clinic with EVAR explants (J. Vasc. Surg. 2014;59:886-93). The choice of the reconstruction and the material used should be based on the offending organism, type of EVAR device, extent of the infectious process, and the expertise of the treating physician.
Dr. Luis A. Sanchez is chief, section of vascular surgery and Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Washington University, St. Louis, and an associate medical editor for Vascular Specialist. He had no relevant disclosures.
CHICAGO – Successful management of infected aortic endovascular grafts requires careful operative planning and execution, meticulous postoperative care, and a fair bit of creativity.
“Each patient is different, so surgeons have to tailor the reconstructions to the individual patient and with these specific infections, have to be creative,” Dr. Thomas C. Bower, chair of vascular and endovascular surgery at Mayo Clinic, Rochester, Minn., said. “I’ve found the operations to be more challenging and more difficult than explanting portions or total graft excision when the infection has occurred in a hand-sewn graft.”
Unlike the typical bimodal distribution seen with hand-sewn graft infections, infection following endovascular repair of aortic aneurysms (EVAR) occurs from days up to 3 years after implantation. At the Mayo Clinic, a 79-year-old man presented with an infected endograft, psoas abscess, and Salmonella septicemia 4 years after EVAR.
“These infections are uncommon, but we are seeing more of them,” Dr. Bower said at a symposium on vascular surgery sponsored by Northwestern University.
Roughly two-thirds of patients will present with fever, nonspecific abdominal or back pain, malaise, weight loss or night sweats. If time permits, preoperative assessments include echocardiography for left ventricular function, arterial blood gases for pulmonary function since many patients are smokers, and renal ultrasound if creatinine is ≥ 1.5 mg/dL after rehydration. These tests are important because preoperative chronic obstructive pulmonary disease and renal dysfunction correlate with worse postoperative outcomes, he said.
Computed tomography angiography (CTA), however, stands as the single most important step of preoperative preparation, with the sine qua non of infection being air around the graft. Unlike hand-sewn grafts where infections can be localized, typically there is total graft involvement in these cases because the device is left inside the aneurysm sac. Aneurysms or pseudoaneurysms also have been seen above the infected device, including at the top end of suprarenal stents.
“This clearly has an impact on how we approach patients, but what’s become very apparent to me is that CTA often underestimates the amount of periaortic inflammation, especially at the juxta- and pararenal locations,” Dr. Bower said.
The Mayo group initially used in situ antibiotic-soaked prosthetic grafts for explanting EVAR devices, which yielded “acceptable mortality and reinfection rates, but primarily outstanding patency rates.” However, cryopreserved aortoiliac grafts have now become their first choice, Dr. Bower said. An ABO match is not imperative, preparation takes roughly 45 minutes, branch closures done in the lab are buttressed with sutures, and the graft is turned over to keep the lumbar arteries anterior, which offers an easy fix if there is bleeding, rather than having it on the posterior wall. Cryopreserved grafts, however, can dilate 40% and lengthen 10% under pressure.
“I’ve been burned more than once where the graft elongates more than I think, and I end up having to cut a small piece out to foreshorten it,” he said.
Reconstructions are tailored to patient anatomy. Surgeons should have several plans for reconstruction, including routing a graft through a remote path, remembering that CTA will underestimate the amount of periaortic inflammation. Separate bypasses of the renal or visceral arteries are performed first before the aortic clamp is applied to reduce physiologic stress. This requires knowledge of the supraceliac and pararenal aorta exposures, which really begins with the correct choice of incisions, Dr. Bower said. This is based on the aortic segment to be treated, position of the new graft, the aortic clamp site, and patient body habitus.
Most patients with EVAR infections are approached with a midline abdominal incision extended along the xiphoid process, which is the lynch pin for allowing upward and lateral retraction of the abdominal wall, he said. Choosing an incision that allows a more vertical orientation to where the new aortic anastomosis and clamp site will be, rather than operating in a keyhole, is important.
The second step is to open up the pararenal space by moving the viscera out of the way. This begins by ligating the inferior mesenteric vein and adjacent lymphatics, which allows incision of an avascular plane along the base of the left transverse colon. Retractor blades are set to allow the upward and lateral retraction of the small bowel, the left colon, and pancreas. Exposure of the suprarenal or supramesenteric aorta requires mobilization of the left renal vein after ligation and division of its branches.
“If that vein is intensely involved in inflammation, don’t ligate the branches in case you have to divide that vein at the caval confluence. Otherwise, you’ll run into some dysfunction of that left kidney,” Dr. Bower cautioned.
To have a secure place for the aortic cross clamp, the crura must be divided on either side of the diaphragm at or above the supramesenteric aorta, he added.
Key steps in total graft explantation are to drain abscesses prior to surgery to lower the bacterial burden and thus reduce the postoperative inflammatory response, bypass renal/visceral arteries first, if needed, remove the infected graft, debride the aorta to healthy tissue, place the new graft and cover it with omentum, and repair the bowel, if needed.
A piece of the proximal aortic wall should be sent to pathology to ensure the absence of bacteria or microabscesses. Organism-specific antibiotics are administered intravenously for 6-8 weeks followed by lifelong oral antibiotics, he said.
An earlier report involving 24 patients with infected aortic endografts (21 EVARs and 3 thoracic EVARs) treated at Mayo Clinic between 1997 and 2012 revealed polymicrobial infection in 11 patients, with methicillin-resistant Staphylococcus aureus being common. Potential contributors to infection were endovascular reintervention in eight, aortoenteric fistula/erosion in four, and various remote infections (J. Vasc. Surg. 2013;58:371-9).
Rifampin-soaked grafts were used in 15 patients, cryopreserved grafts in 4, femoral vein in 2, and axillofemoral grafts in 3. At a median of 14 months follow-up, patient survival, graft-related complications, and reinfection rates were 79%, 13%, and 4%, respectively, Dr. Bower said.
Dr. Bower reported having no financial disclosures.
CHICAGO – Successful management of infected aortic endovascular grafts requires careful operative planning and execution, meticulous postoperative care, and a fair bit of creativity.
“Each patient is different, so surgeons have to tailor the reconstructions to the individual patient and with these specific infections, have to be creative,” Dr. Thomas C. Bower, chair of vascular and endovascular surgery at Mayo Clinic, Rochester, Minn., said. “I’ve found the operations to be more challenging and more difficult than explanting portions or total graft excision when the infection has occurred in a hand-sewn graft.”
Unlike the typical bimodal distribution seen with hand-sewn graft infections, infection following endovascular repair of aortic aneurysms (EVAR) occurs from days up to 3 years after implantation. At the Mayo Clinic, a 79-year-old man presented with an infected endograft, psoas abscess, and Salmonella septicemia 4 years after EVAR.
“These infections are uncommon, but we are seeing more of them,” Dr. Bower said at a symposium on vascular surgery sponsored by Northwestern University.
Roughly two-thirds of patients will present with fever, nonspecific abdominal or back pain, malaise, weight loss or night sweats. If time permits, preoperative assessments include echocardiography for left ventricular function, arterial blood gases for pulmonary function since many patients are smokers, and renal ultrasound if creatinine is ≥ 1.5 mg/dL after rehydration. These tests are important because preoperative chronic obstructive pulmonary disease and renal dysfunction correlate with worse postoperative outcomes, he said.
Computed tomography angiography (CTA), however, stands as the single most important step of preoperative preparation, with the sine qua non of infection being air around the graft. Unlike hand-sewn grafts where infections can be localized, typically there is total graft involvement in these cases because the device is left inside the aneurysm sac. Aneurysms or pseudoaneurysms also have been seen above the infected device, including at the top end of suprarenal stents.
“This clearly has an impact on how we approach patients, but what’s become very apparent to me is that CTA often underestimates the amount of periaortic inflammation, especially at the juxta- and pararenal locations,” Dr. Bower said.
The Mayo group initially used in situ antibiotic-soaked prosthetic grafts for explanting EVAR devices, which yielded “acceptable mortality and reinfection rates, but primarily outstanding patency rates.” However, cryopreserved aortoiliac grafts have now become their first choice, Dr. Bower said. An ABO match is not imperative, preparation takes roughly 45 minutes, branch closures done in the lab are buttressed with sutures, and the graft is turned over to keep the lumbar arteries anterior, which offers an easy fix if there is bleeding, rather than having it on the posterior wall. Cryopreserved grafts, however, can dilate 40% and lengthen 10% under pressure.
“I’ve been burned more than once where the graft elongates more than I think, and I end up having to cut a small piece out to foreshorten it,” he said.
Reconstructions are tailored to patient anatomy. Surgeons should have several plans for reconstruction, including routing a graft through a remote path, remembering that CTA will underestimate the amount of periaortic inflammation. Separate bypasses of the renal or visceral arteries are performed first before the aortic clamp is applied to reduce physiologic stress. This requires knowledge of the supraceliac and pararenal aorta exposures, which really begins with the correct choice of incisions, Dr. Bower said. This is based on the aortic segment to be treated, position of the new graft, the aortic clamp site, and patient body habitus.
Most patients with EVAR infections are approached with a midline abdominal incision extended along the xiphoid process, which is the lynch pin for allowing upward and lateral retraction of the abdominal wall, he said. Choosing an incision that allows a more vertical orientation to where the new aortic anastomosis and clamp site will be, rather than operating in a keyhole, is important.
The second step is to open up the pararenal space by moving the viscera out of the way. This begins by ligating the inferior mesenteric vein and adjacent lymphatics, which allows incision of an avascular plane along the base of the left transverse colon. Retractor blades are set to allow the upward and lateral retraction of the small bowel, the left colon, and pancreas. Exposure of the suprarenal or supramesenteric aorta requires mobilization of the left renal vein after ligation and division of its branches.
“If that vein is intensely involved in inflammation, don’t ligate the branches in case you have to divide that vein at the caval confluence. Otherwise, you’ll run into some dysfunction of that left kidney,” Dr. Bower cautioned.
To have a secure place for the aortic cross clamp, the crura must be divided on either side of the diaphragm at or above the supramesenteric aorta, he added.
Key steps in total graft explantation are to drain abscesses prior to surgery to lower the bacterial burden and thus reduce the postoperative inflammatory response, bypass renal/visceral arteries first, if needed, remove the infected graft, debride the aorta to healthy tissue, place the new graft and cover it with omentum, and repair the bowel, if needed.
A piece of the proximal aortic wall should be sent to pathology to ensure the absence of bacteria or microabscesses. Organism-specific antibiotics are administered intravenously for 6-8 weeks followed by lifelong oral antibiotics, he said.
An earlier report involving 24 patients with infected aortic endografts (21 EVARs and 3 thoracic EVARs) treated at Mayo Clinic between 1997 and 2012 revealed polymicrobial infection in 11 patients, with methicillin-resistant Staphylococcus aureus being common. Potential contributors to infection were endovascular reintervention in eight, aortoenteric fistula/erosion in four, and various remote infections (J. Vasc. Surg. 2013;58:371-9).
Rifampin-soaked grafts were used in 15 patients, cryopreserved grafts in 4, femoral vein in 2, and axillofemoral grafts in 3. At a median of 14 months follow-up, patient survival, graft-related complications, and reinfection rates were 79%, 13%, and 4%, respectively, Dr. Bower said.
Dr. Bower reported having no financial disclosures.
EXPERT OPINION FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
Does this patient need ultrasonography of the leg to evaluate for deep vein thrombosis?
A 38-year-old woman presents to the emergency department after experiencing several days of swelling and mild discomfort in her left calf. She denies chest pain or shortness of breath. She does not recall antecedent trauma, is a nonsmoker, is healthy, and takes no medications apart from a multivitamin. She has not undergone any surgical procedure, has not been hospitalized recently, and has no history of venous thromboembolic disease. She says she started an aerobics program 1 week ago.
On examination, her left lower leg is mildly swollen, but the difference in calf circumference between the right and left legs is less than 1 cm. There is no erythema, no pitting edema, and only mild and rather diffuse tenderness of the calf. A urine pregnancy test is negative and her D-dimer level is 350 ng/mL (reference range < 500 ng/mL). Does she require ultrasonography of the left leg to evaluate for deep vein thrombosis (DVT)?
This patient does not need confirmatory ultrasonography, as her normal D-dimer level of 350 ng/mL is enough to rule out DVT. Her low probability of having DVT is further supported by her Wells score (Table 1), a tool that can help rule out DVT and reduce the need for further testing. DVT is unlikely if a patient’s Wells score is less than 2, and this patient’s score is –1. She receives 1 point for swelling of her left lower leg, but injury from her recent aerobic exercise is at least as likely as DVT to account for her symptoms (–2 points).
GUIDELINES AND CHOOSING WISELY
Compression ultrasonography is the study most commonly used to evaluate for DVT. The diagnosis is made if either the femoral or popliteal vein is noncompressible.1 In a patient with no history of DVT, the sensitivity of compression ultrasonography is 94%, and its specificity is 98%.
Several guidelines recommend using a clinical decision rule to establish the probability of venous thromboembolic disease before any additional diagnostic testing such as D-dimer measurement or ultrasonography.2–4 A number of clinical decision rules exist for DVT, but the Wells score is the most studied and validated.1 It incorporates the patient’s risk factors, symptoms, and signs to categorize the probability of DVT as low, moderate, or high and has been further modified to classify the risk as either likely or unlikely (Table 1).5
Guidelines from the American College of Chest Physicians (2012), Scottish Intercollegiate Guidelines Network (2010), and American Academy of Family Physicians and American College of Physicians (2007) recommend against performing imaging if a high-sensitivity D-dimer test is negative in a patient in whom the pretest probability of DVT is unlikely.2–4 Enzyme-linked immunofluorescence assays, microplate enzyme-linked immunosorbent assays, and latex quantitative assays are considered high-sensitivity D-dimer tests, having 96%, 94%, and 93% sensitivity, respectively, in ruling out DVT.1 Other D-dimer tests have lower sensitivity and cannot comfortably rule out DVT even if the results are negative.
Since D-dimer measurement is a sensitive but not specific test, it should be used only to rule out DVT—not to rule it in. Moreover, compression ultrasonography may be indicated to rule out other causes of the patient’s symptoms.
The guidelines caution against D-dimer testing if the patient has a comorbid condition that can by itself raise or lower the D-dimer level, leading one to falsely conclude the patient has or does not have DVT (Table 2).1–4 In these instances, the pretest probability of DVT may be higher than calculated by a clinical prediction rule, and compression ultrasonography may be an appropriate initial test.4 Compression ultrasonography is also recommended as a confirmatory test in low-risk patients who have a positive D-dimer test or as an initial test in patients at higher risk for DVT.2–4
If a patient has a low pretest probability of DVT as defined by the Wells score and a normal high-sensitivity D-dimer measurement, then ordering imaging studies is a questionable practice according to statements by the American College of Physicians, American College of Emergency Physicians, European Society of Cardiology, American Academy of Family Physicians, and Scottish Intercollegiate Guidelines Network.
HARMS OF ULTRASONOGRAPHY
Although ultrasonography is generally well tolerated, it may be unnecessary. Combining a prediction rule (to assess the probability) with D-dimer testing (to rule out DVT) can significantly reduce the use of ultrasonography and the associated cost.
Wells et al5 calculated that clinicians could cut back on ultrasonographic testing by 39% by not doing it in those who had a low pretest probability and a negative D-dimer test result.5 In that patient population, fewer than 1% of patients were later found to have DVT.
Ordering compression ultrasonography as additional testing may lead to a false-positive result and to additional unnecessary testing and treatments that would inconvenience the patient, increase the risk of serious complications such as bleeding, and incur increased costs. Cost considerations should include not only the cost of the test and its interpretation, but also the workup and treatment of false-positive results, patient time missed from work while being tested, and potential associated costs for patients who need to be evaluated in the emergency department to obtain same-day testing.
THE CLINICAL BOTTOM LINE
Our patient’s Wells score indicates that DVT is unlikely. A negative D-dimer test is sufficient to rule out DVT, and further testing is unnecessary.
- Huisman MV, Klok FA. Diagnostic management of acute deep vein thrombosis and pulmonary embolism. J Thromb Haemost 2013; 11:412–422.
- Bates SM, Jaeschke R, Stevens EM, et al. Antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e351S–e418S.
- Scottish Intercollegiate Guidelines Network (SIGN). Prevention and management of venous thromboembolism. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2010: http://sign.ac.uk/guidelines/fulltext/122/index.html. Accessed February 6, 2015.
- Qaseem A, Snow V, Barry P, et al. Current diagnosis of venous thromboembolism in primary care: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med 2007; 146:454–458.
- Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003; 349:1227–1235.
A 38-year-old woman presents to the emergency department after experiencing several days of swelling and mild discomfort in her left calf. She denies chest pain or shortness of breath. She does not recall antecedent trauma, is a nonsmoker, is healthy, and takes no medications apart from a multivitamin. She has not undergone any surgical procedure, has not been hospitalized recently, and has no history of venous thromboembolic disease. She says she started an aerobics program 1 week ago.
On examination, her left lower leg is mildly swollen, but the difference in calf circumference between the right and left legs is less than 1 cm. There is no erythema, no pitting edema, and only mild and rather diffuse tenderness of the calf. A urine pregnancy test is negative and her D-dimer level is 350 ng/mL (reference range < 500 ng/mL). Does she require ultrasonography of the left leg to evaluate for deep vein thrombosis (DVT)?
This patient does not need confirmatory ultrasonography, as her normal D-dimer level of 350 ng/mL is enough to rule out DVT. Her low probability of having DVT is further supported by her Wells score (Table 1), a tool that can help rule out DVT and reduce the need for further testing. DVT is unlikely if a patient’s Wells score is less than 2, and this patient’s score is –1. She receives 1 point for swelling of her left lower leg, but injury from her recent aerobic exercise is at least as likely as DVT to account for her symptoms (–2 points).
GUIDELINES AND CHOOSING WISELY
Compression ultrasonography is the study most commonly used to evaluate for DVT. The diagnosis is made if either the femoral or popliteal vein is noncompressible.1 In a patient with no history of DVT, the sensitivity of compression ultrasonography is 94%, and its specificity is 98%.
Several guidelines recommend using a clinical decision rule to establish the probability of venous thromboembolic disease before any additional diagnostic testing such as D-dimer measurement or ultrasonography.2–4 A number of clinical decision rules exist for DVT, but the Wells score is the most studied and validated.1 It incorporates the patient’s risk factors, symptoms, and signs to categorize the probability of DVT as low, moderate, or high and has been further modified to classify the risk as either likely or unlikely (Table 1).5
Guidelines from the American College of Chest Physicians (2012), Scottish Intercollegiate Guidelines Network (2010), and American Academy of Family Physicians and American College of Physicians (2007) recommend against performing imaging if a high-sensitivity D-dimer test is negative in a patient in whom the pretest probability of DVT is unlikely.2–4 Enzyme-linked immunofluorescence assays, microplate enzyme-linked immunosorbent assays, and latex quantitative assays are considered high-sensitivity D-dimer tests, having 96%, 94%, and 93% sensitivity, respectively, in ruling out DVT.1 Other D-dimer tests have lower sensitivity and cannot comfortably rule out DVT even if the results are negative.
Since D-dimer measurement is a sensitive but not specific test, it should be used only to rule out DVT—not to rule it in. Moreover, compression ultrasonography may be indicated to rule out other causes of the patient’s symptoms.
The guidelines caution against D-dimer testing if the patient has a comorbid condition that can by itself raise or lower the D-dimer level, leading one to falsely conclude the patient has or does not have DVT (Table 2).1–4 In these instances, the pretest probability of DVT may be higher than calculated by a clinical prediction rule, and compression ultrasonography may be an appropriate initial test.4 Compression ultrasonography is also recommended as a confirmatory test in low-risk patients who have a positive D-dimer test or as an initial test in patients at higher risk for DVT.2–4
If a patient has a low pretest probability of DVT as defined by the Wells score and a normal high-sensitivity D-dimer measurement, then ordering imaging studies is a questionable practice according to statements by the American College of Physicians, American College of Emergency Physicians, European Society of Cardiology, American Academy of Family Physicians, and Scottish Intercollegiate Guidelines Network.
HARMS OF ULTRASONOGRAPHY
Although ultrasonography is generally well tolerated, it may be unnecessary. Combining a prediction rule (to assess the probability) with D-dimer testing (to rule out DVT) can significantly reduce the use of ultrasonography and the associated cost.
Wells et al5 calculated that clinicians could cut back on ultrasonographic testing by 39% by not doing it in those who had a low pretest probability and a negative D-dimer test result.5 In that patient population, fewer than 1% of patients were later found to have DVT.
Ordering compression ultrasonography as additional testing may lead to a false-positive result and to additional unnecessary testing and treatments that would inconvenience the patient, increase the risk of serious complications such as bleeding, and incur increased costs. Cost considerations should include not only the cost of the test and its interpretation, but also the workup and treatment of false-positive results, patient time missed from work while being tested, and potential associated costs for patients who need to be evaluated in the emergency department to obtain same-day testing.
THE CLINICAL BOTTOM LINE
Our patient’s Wells score indicates that DVT is unlikely. A negative D-dimer test is sufficient to rule out DVT, and further testing is unnecessary.
A 38-year-old woman presents to the emergency department after experiencing several days of swelling and mild discomfort in her left calf. She denies chest pain or shortness of breath. She does not recall antecedent trauma, is a nonsmoker, is healthy, and takes no medications apart from a multivitamin. She has not undergone any surgical procedure, has not been hospitalized recently, and has no history of venous thromboembolic disease. She says she started an aerobics program 1 week ago.
On examination, her left lower leg is mildly swollen, but the difference in calf circumference between the right and left legs is less than 1 cm. There is no erythema, no pitting edema, and only mild and rather diffuse tenderness of the calf. A urine pregnancy test is negative and her D-dimer level is 350 ng/mL (reference range < 500 ng/mL). Does she require ultrasonography of the left leg to evaluate for deep vein thrombosis (DVT)?
This patient does not need confirmatory ultrasonography, as her normal D-dimer level of 350 ng/mL is enough to rule out DVT. Her low probability of having DVT is further supported by her Wells score (Table 1), a tool that can help rule out DVT and reduce the need for further testing. DVT is unlikely if a patient’s Wells score is less than 2, and this patient’s score is –1. She receives 1 point for swelling of her left lower leg, but injury from her recent aerobic exercise is at least as likely as DVT to account for her symptoms (–2 points).
GUIDELINES AND CHOOSING WISELY
Compression ultrasonography is the study most commonly used to evaluate for DVT. The diagnosis is made if either the femoral or popliteal vein is noncompressible.1 In a patient with no history of DVT, the sensitivity of compression ultrasonography is 94%, and its specificity is 98%.
Several guidelines recommend using a clinical decision rule to establish the probability of venous thromboembolic disease before any additional diagnostic testing such as D-dimer measurement or ultrasonography.2–4 A number of clinical decision rules exist for DVT, but the Wells score is the most studied and validated.1 It incorporates the patient’s risk factors, symptoms, and signs to categorize the probability of DVT as low, moderate, or high and has been further modified to classify the risk as either likely or unlikely (Table 1).5
Guidelines from the American College of Chest Physicians (2012), Scottish Intercollegiate Guidelines Network (2010), and American Academy of Family Physicians and American College of Physicians (2007) recommend against performing imaging if a high-sensitivity D-dimer test is negative in a patient in whom the pretest probability of DVT is unlikely.2–4 Enzyme-linked immunofluorescence assays, microplate enzyme-linked immunosorbent assays, and latex quantitative assays are considered high-sensitivity D-dimer tests, having 96%, 94%, and 93% sensitivity, respectively, in ruling out DVT.1 Other D-dimer tests have lower sensitivity and cannot comfortably rule out DVT even if the results are negative.
Since D-dimer measurement is a sensitive but not specific test, it should be used only to rule out DVT—not to rule it in. Moreover, compression ultrasonography may be indicated to rule out other causes of the patient’s symptoms.
The guidelines caution against D-dimer testing if the patient has a comorbid condition that can by itself raise or lower the D-dimer level, leading one to falsely conclude the patient has or does not have DVT (Table 2).1–4 In these instances, the pretest probability of DVT may be higher than calculated by a clinical prediction rule, and compression ultrasonography may be an appropriate initial test.4 Compression ultrasonography is also recommended as a confirmatory test in low-risk patients who have a positive D-dimer test or as an initial test in patients at higher risk for DVT.2–4
If a patient has a low pretest probability of DVT as defined by the Wells score and a normal high-sensitivity D-dimer measurement, then ordering imaging studies is a questionable practice according to statements by the American College of Physicians, American College of Emergency Physicians, European Society of Cardiology, American Academy of Family Physicians, and Scottish Intercollegiate Guidelines Network.
HARMS OF ULTRASONOGRAPHY
Although ultrasonography is generally well tolerated, it may be unnecessary. Combining a prediction rule (to assess the probability) with D-dimer testing (to rule out DVT) can significantly reduce the use of ultrasonography and the associated cost.
Wells et al5 calculated that clinicians could cut back on ultrasonographic testing by 39% by not doing it in those who had a low pretest probability and a negative D-dimer test result.5 In that patient population, fewer than 1% of patients were later found to have DVT.
Ordering compression ultrasonography as additional testing may lead to a false-positive result and to additional unnecessary testing and treatments that would inconvenience the patient, increase the risk of serious complications such as bleeding, and incur increased costs. Cost considerations should include not only the cost of the test and its interpretation, but also the workup and treatment of false-positive results, patient time missed from work while being tested, and potential associated costs for patients who need to be evaluated in the emergency department to obtain same-day testing.
THE CLINICAL BOTTOM LINE
Our patient’s Wells score indicates that DVT is unlikely. A negative D-dimer test is sufficient to rule out DVT, and further testing is unnecessary.
- Huisman MV, Klok FA. Diagnostic management of acute deep vein thrombosis and pulmonary embolism. J Thromb Haemost 2013; 11:412–422.
- Bates SM, Jaeschke R, Stevens EM, et al. Antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e351S–e418S.
- Scottish Intercollegiate Guidelines Network (SIGN). Prevention and management of venous thromboembolism. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2010: http://sign.ac.uk/guidelines/fulltext/122/index.html. Accessed February 6, 2015.
- Qaseem A, Snow V, Barry P, et al. Current diagnosis of venous thromboembolism in primary care: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med 2007; 146:454–458.
- Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003; 349:1227–1235.
- Huisman MV, Klok FA. Diagnostic management of acute deep vein thrombosis and pulmonary embolism. J Thromb Haemost 2013; 11:412–422.
- Bates SM, Jaeschke R, Stevens EM, et al. Antithrombotic therapy and prevention of thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e351S–e418S.
- Scottish Intercollegiate Guidelines Network (SIGN). Prevention and management of venous thromboembolism. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2010: http://sign.ac.uk/guidelines/fulltext/122/index.html. Accessed February 6, 2015.
- Qaseem A, Snow V, Barry P, et al. Current diagnosis of venous thromboembolism in primary care: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med 2007; 146:454–458.
- Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003; 349:1227–1235.
Nonclinical interventions enhance care and outcomes for vascular patients
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The application of simple low-cost interventions and hands-on care, as well as enlisting the patient to participate in care for him or herself, can help vascular specialists achieve favorable outcomes when managing patients in an era of increased regulation.
That was the message of an expert panel assembled to deliver “clinically pertinent information in the midst of a regulatory system that is driving us down a [certain] pathway whether or not we want to go,” panelist Dr. Bruce H. Gray, a vascular surgeon at Greenville (S.C.) Health System, told the audience at this year’s annual meeting of the Southern Association for Vascular Surgery.
Under the Affordable Care Act, there has been “a shift from structure and process to now just outcomes,” according to panelist Dr. John W. Hallett Jr., a clinical professor of surgery at the Medical University of South Carolina and chief medical officer at the Roper St. Francis Vascular Care Center, both in Charleston.
Incentives now penalties
The Patient Quality Reporting System (formerly called the Physicians Quality Reporting Initiative) was the first national program designed by the Centers for Medicare & Medicaid Services to link the reporting of quality data to physician payment. There are six quality strategy domains in the PQRS: effective clinical care; patient safety; communication and care coordination; person- and caregiver-centered experience and outcomes; efficiency and cost reduction; and community and population health. Physicians must satisfy at least three of the six or risk penalties.
Initially intended as an incentive program when it was launched as part of the Tax Relief and Health Care Act of 2006, physicians who voluntarily reported their quality data were awarded a 2% bonus on their yearly CMS payment. Although still referred to by CMS as an incentive program, beginning this year, physician-reported quality data considered by the PQRS criteria as negative will be used to assess a penalty up to 1.5% against their expected CMS payment for that year. In 2016, the penalty is set to increase to 2% of the physician’s CMS payment. “They call the reporting voluntary but now there’s a penalty if you don’t report it,” said panelist Dr. Adam W. Beck, a vascular surgeon at the University of Florida.
Searching for evidence
However, much of the criteria used by the PRQS to evaluate a vascular surgeon’s performance, and thus what he or she will be paid, is not evidence based, according to Dr. Beck. For example, one CMS vascular surgery quality measure in place considers that open repair of a 6 cm or less nonruptured abdominal aortic aneurysm without major complications should result in the patient being discharged postoperatively on day 7.
“The idea is that this is a purely elective operation so in theory, that patient should not die, and should not have major complications, and so can go home on day 7,” Dr. Beck said. “But we don’t really know if that’s true. Some of us are working on figuring out if any of these [measures] are useful or not.”
Similarly, Dr. Gray said that, since its publication in 2005, the BASIL (Bypass vs. Angioplasty in Severe Ischemia of the Leg) trial, which supported surgery over balloon angioplasty for improved long-term outcomes in patients with peripheral artery disease, has been the de facto benchmark for predicting death in this patient cohort, a necessary consideration when choosing a treatment algorithm.
This, despite what he suggested were generalizations gleaned from the data that are not always appropriate, particularly when considering claudication. “Only 11% of those critical limb ischemia patients who were eligible for the trial were randomized to any of the study’s six sites. This trial cannot be extrapolated to our entire heterogeneous CLI population,” Dr. Gray said.
This was true, too, he said, not only because a minority of the patients had angioplasty at multiple levels, but because the patient assessment and mortality rate criteria in the study may not actually coincide with how other specialists assess their patients and predict mortality, as evidenced by a number of studies that have been published since BASIL, all of which relied on different criteria for determining two-year mortality rates.
“The BASIL trial recommendation that we should know the life expectancy of our patients has popped up in the literature more and more, and I have thought long and hard about how that impacts my clinical practice decision tree,” Dr. Gray said, concluding that ultimately, predicting mortality is beside the point. “Mortality is inevitable and sooner in CLI patients. The best care has less to do with predicting mortality, but requires ... the integrity to choose the right procedure for the right patient at the right time.”
Assessing how much muscle and functional mobility a patient has in order to help determine which treatment is best, and not overrelying on electronic health records can also impact outcomes. “You don’t need too many fancy tests to tell what a patient’s functional level is,” he said, adding “there is no substitute for putting your own eyes on the patient.”
Patient participation
Despite the pressure on physicians to perform well on the PQRS, there are many factors beyond their control, such as a patient’s choice to smoke. That’s why using “teachable moments” that remind patients of their own power to improve their chances for recovery is more important than ever, as is clear communication with the patient about what they can expect both pre- and post-surgery, according to Dr. Hallett. “The challenge of taking care of these patients is much more than our technical skill.”
Combining a medical tobacco-cessation program with teletherapeutic programs such as the federally funded 1-800-QUIT-NOW line can be of support to patients, as are phone-based counseling sessions to remind patients to fill their prescriptions and to take them once they do, said Dr. Hallett.
Motivating patients to participate in their recovery should not be left to others, however. Dr. Hallett said has found that leaning on his authority as the surgeon is more effective than leaving the role of adviser to “physician extenders.”
“I can do a teachable moment in less than 5 minutes,” he said in an interview. “For me to say to the patient, ‘Smoking is one of the reasons you have this bad leg. I would really like to help you with stopping. Are you interested?’ Coming from me, it’s much more powerful than from anyone else [on my staff].”
In addition, adhering to low- or no-cost postoperative protocols such as keeping patients warm, and administering both aspirin and a statin at discharge can help improve patient outcomes by as much as 20%, according to Dr. Hallett.
Above all else, Dr. Hallett urged vascular surgeons to focus on the long-term care of patients, or risk not only poor outcomes and lower reimbursements, but also loss of control over the patient’s care.
“If we don’t take care of them, they lose the integrated care they need,” Dr. Hallett said in an interview. “The primary care doctors are too frappin’ busy. I see 15-18 patients a day; they’ll see twice that.”
To that end, he recommended giving patients a thorough cardiovascular exam that includes a complete lipid profile and a review of their medications, particularly since the patient’s primary care doctors aren’t always as attentive to vascular concerns. “You are the long-term cardiovascular doc for these patients. You give the advice, you check their drugs, and you, the surgeon, needs to set their expectations, not someone else,” Dr. Hallett concluded.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE SAVS 2015 ANNUAL MEETING
FDA approves adhesive treatment for superficial varicose veins
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
Transcarotid angioplasty device approved; reverses blood flow to capture embolic debris
The Food and Drug Administration has approved a minimally invasive angioplasty system that enters the carotid artery adjacent to a blockage, and captures embolic debris by extracorporeal filtration of blood near the blockage.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) is inserted into the artery near the stenotic region. As the stent is deployed, the system draws blood down the tube, away from the brain, under high pressure. An extracorporeal filter traps any emboli, and the filtered blood is returned via the femoral vein.
ENROUTE TNS was approved on the basis of the successful ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure). In this study, there was a 3.5% rate of stroke, heart attack, and death among patients treated with the device – significantly lower than the study’s primary outcome goal of 11%. The rate of adverse events was about 14%; these included excessive bleeding or injury at the device insertion site, hypotension, and thrombosis.
The system’s benefits include its minimally invasive approach and the ability to successfully navigate severe carotid tortuosity. It also may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the aortic arch, according to an FDA statement.
Manufactured by Silk Road, Sunnyvale, Calif., the ENROUTE TNS device was approved through a 510(k) submission, which provides an approval pathway for low- to moderate-risk devices that are substantially equivalent to a legally marketed device. According to the FDA statement, ENROUTE TNS is equivalent to a currently marketed flow-reversal system that uses similar technology and has the same intended use, but is designed to be introduced through the groin.
On Twitter @alz_gal
The Food and Drug Administration has approved a minimally invasive angioplasty system that enters the carotid artery adjacent to a blockage, and captures embolic debris by extracorporeal filtration of blood near the blockage.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) is inserted into the artery near the stenotic region. As the stent is deployed, the system draws blood down the tube, away from the brain, under high pressure. An extracorporeal filter traps any emboli, and the filtered blood is returned via the femoral vein.
ENROUTE TNS was approved on the basis of the successful ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure). In this study, there was a 3.5% rate of stroke, heart attack, and death among patients treated with the device – significantly lower than the study’s primary outcome goal of 11%. The rate of adverse events was about 14%; these included excessive bleeding or injury at the device insertion site, hypotension, and thrombosis.
The system’s benefits include its minimally invasive approach and the ability to successfully navigate severe carotid tortuosity. It also may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the aortic arch, according to an FDA statement.
Manufactured by Silk Road, Sunnyvale, Calif., the ENROUTE TNS device was approved through a 510(k) submission, which provides an approval pathway for low- to moderate-risk devices that are substantially equivalent to a legally marketed device. According to the FDA statement, ENROUTE TNS is equivalent to a currently marketed flow-reversal system that uses similar technology and has the same intended use, but is designed to be introduced through the groin.
On Twitter @alz_gal
The Food and Drug Administration has approved a minimally invasive angioplasty system that enters the carotid artery adjacent to a blockage, and captures embolic debris by extracorporeal filtration of blood near the blockage.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) is inserted into the artery near the stenotic region. As the stent is deployed, the system draws blood down the tube, away from the brain, under high pressure. An extracorporeal filter traps any emboli, and the filtered blood is returned via the femoral vein.
ENROUTE TNS was approved on the basis of the successful ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure). In this study, there was a 3.5% rate of stroke, heart attack, and death among patients treated with the device – significantly lower than the study’s primary outcome goal of 11%. The rate of adverse events was about 14%; these included excessive bleeding or injury at the device insertion site, hypotension, and thrombosis.
The system’s benefits include its minimally invasive approach and the ability to successfully navigate severe carotid tortuosity. It also may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the aortic arch, according to an FDA statement.
Manufactured by Silk Road, Sunnyvale, Calif., the ENROUTE TNS device was approved through a 510(k) submission, which provides an approval pathway for low- to moderate-risk devices that are substantially equivalent to a legally marketed device. According to the FDA statement, ENROUTE TNS is equivalent to a currently marketed flow-reversal system that uses similar technology and has the same intended use, but is designed to be introduced through the groin.
On Twitter @alz_gal
Real-world CAS results in Medicare patients not up to trial standards
The presence of competing risks and overall lower levels of provider proficiency appeared to limit the benefits of carotid artery stenting in Medicare beneficiaries, according to the results of a large retrospective cohort study of the Centers for Medicare & Medicaid Services CAS database (2005-2009).
Periprocedural mortality was more than twice the rate in this patient population than in those earlier patients those involved in the pivotal CREST and SAPPHIRE clinical trials, according to a report published online Jan. 12 in JAMA Neurology [doi:10.1001/jamaneurol.2014.3638].
“The higher risk of periprocedural complications and the burden of competing risks owing to age and comorbidity burden must be carefully considered when deciding between carotid stenosis treatments for Medicare beneficiaries,” according to Jessica J. Jalbert, Ph.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues.
Over 22,000 patients were assessed in the study. The mean patient age was just over 76 years, 60.5% were men, and 94% were white. Approximately half were symptomatic, 91.2% were at high surgical risk, and 97.4% had carotid stenosis of at least 70%.
Almost 80% of the patients undergoing carotid artery stenting (CAS) met the SAPPHIRE trial indications and about half met at least one of the SAPPHIRE criteria for high surgical risk.
In the mean follow-up of approximately 2 years, mortality risks exceeded one-third for patients who were 80 years of age or older (41.5% mortality risk), symptomatic (37.3% risk), at high surgical risk with symptomatic carotid stenosis of at least 50% (37.3% risk), or admitted nonelectively (36.2% risk). In addition, among asymptomatic patients, mortality after the periprocedural period exceeded one-third for patients at least 80 years old.
Of particular concern, few of these Medicare beneficiaries undergoing CAS as per the National Coverage Determinations were treated by providers with proficiency levels similar to those required in the clinical trials. This is a potential problem because lower annual volume and early operator experience are associated with increased periprocedural mortality, the authors wrote.
CAS was performed primarily by male physicians (98.4%), specializing in cardiology (52.9%), practicing within a group (79.4%), and residing in the South (42.5%). The mean number of past-year CAS procedures performed was only 13.9 for physicians and 29.8 for hospitals. This translated to more than 80% of the physicians not meeting the minimum CAS volume requirements and/or minimum complication rates of the SAPPHIRE trial, and more than 90% not meeting the requirements of the CREST trial.
“Our results may support concerns about the limited generalizability of [randomized clinical trial] findings,” the researchers stated.
“Real-world observational studies comparing CAS, carotid endarterectomy, and medical management are needed to determine the performance of carotid stenosis treatment options for Medicare beneficiaries,” Dr. Jalbert and her colleagues concluded.
The authors reported no relevant disclosures. The study was funded by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services.
The presence of competing risks and overall lower levels of provider proficiency appeared to limit the benefits of carotid artery stenting in Medicare beneficiaries, according to the results of a large retrospective cohort study of the Centers for Medicare & Medicaid Services CAS database (2005-2009).
Periprocedural mortality was more than twice the rate in this patient population than in those earlier patients those involved in the pivotal CREST and SAPPHIRE clinical trials, according to a report published online Jan. 12 in JAMA Neurology [doi:10.1001/jamaneurol.2014.3638].
“The higher risk of periprocedural complications and the burden of competing risks owing to age and comorbidity burden must be carefully considered when deciding between carotid stenosis treatments for Medicare beneficiaries,” according to Jessica J. Jalbert, Ph.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues.
Over 22,000 patients were assessed in the study. The mean patient age was just over 76 years, 60.5% were men, and 94% were white. Approximately half were symptomatic, 91.2% were at high surgical risk, and 97.4% had carotid stenosis of at least 70%.
Almost 80% of the patients undergoing carotid artery stenting (CAS) met the SAPPHIRE trial indications and about half met at least one of the SAPPHIRE criteria for high surgical risk.
In the mean follow-up of approximately 2 years, mortality risks exceeded one-third for patients who were 80 years of age or older (41.5% mortality risk), symptomatic (37.3% risk), at high surgical risk with symptomatic carotid stenosis of at least 50% (37.3% risk), or admitted nonelectively (36.2% risk). In addition, among asymptomatic patients, mortality after the periprocedural period exceeded one-third for patients at least 80 years old.
Of particular concern, few of these Medicare beneficiaries undergoing CAS as per the National Coverage Determinations were treated by providers with proficiency levels similar to those required in the clinical trials. This is a potential problem because lower annual volume and early operator experience are associated with increased periprocedural mortality, the authors wrote.
CAS was performed primarily by male physicians (98.4%), specializing in cardiology (52.9%), practicing within a group (79.4%), and residing in the South (42.5%). The mean number of past-year CAS procedures performed was only 13.9 for physicians and 29.8 for hospitals. This translated to more than 80% of the physicians not meeting the minimum CAS volume requirements and/or minimum complication rates of the SAPPHIRE trial, and more than 90% not meeting the requirements of the CREST trial.
“Our results may support concerns about the limited generalizability of [randomized clinical trial] findings,” the researchers stated.
“Real-world observational studies comparing CAS, carotid endarterectomy, and medical management are needed to determine the performance of carotid stenosis treatment options for Medicare beneficiaries,” Dr. Jalbert and her colleagues concluded.
The authors reported no relevant disclosures. The study was funded by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services.
The presence of competing risks and overall lower levels of provider proficiency appeared to limit the benefits of carotid artery stenting in Medicare beneficiaries, according to the results of a large retrospective cohort study of the Centers for Medicare & Medicaid Services CAS database (2005-2009).
Periprocedural mortality was more than twice the rate in this patient population than in those earlier patients those involved in the pivotal CREST and SAPPHIRE clinical trials, according to a report published online Jan. 12 in JAMA Neurology [doi:10.1001/jamaneurol.2014.3638].
“The higher risk of periprocedural complications and the burden of competing risks owing to age and comorbidity burden must be carefully considered when deciding between carotid stenosis treatments for Medicare beneficiaries,” according to Jessica J. Jalbert, Ph.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues.
Over 22,000 patients were assessed in the study. The mean patient age was just over 76 years, 60.5% were men, and 94% were white. Approximately half were symptomatic, 91.2% were at high surgical risk, and 97.4% had carotid stenosis of at least 70%.
Almost 80% of the patients undergoing carotid artery stenting (CAS) met the SAPPHIRE trial indications and about half met at least one of the SAPPHIRE criteria for high surgical risk.
In the mean follow-up of approximately 2 years, mortality risks exceeded one-third for patients who were 80 years of age or older (41.5% mortality risk), symptomatic (37.3% risk), at high surgical risk with symptomatic carotid stenosis of at least 50% (37.3% risk), or admitted nonelectively (36.2% risk). In addition, among asymptomatic patients, mortality after the periprocedural period exceeded one-third for patients at least 80 years old.
Of particular concern, few of these Medicare beneficiaries undergoing CAS as per the National Coverage Determinations were treated by providers with proficiency levels similar to those required in the clinical trials. This is a potential problem because lower annual volume and early operator experience are associated with increased periprocedural mortality, the authors wrote.
CAS was performed primarily by male physicians (98.4%), specializing in cardiology (52.9%), practicing within a group (79.4%), and residing in the South (42.5%). The mean number of past-year CAS procedures performed was only 13.9 for physicians and 29.8 for hospitals. This translated to more than 80% of the physicians not meeting the minimum CAS volume requirements and/or minimum complication rates of the SAPPHIRE trial, and more than 90% not meeting the requirements of the CREST trial.
“Our results may support concerns about the limited generalizability of [randomized clinical trial] findings,” the researchers stated.
“Real-world observational studies comparing CAS, carotid endarterectomy, and medical management are needed to determine the performance of carotid stenosis treatment options for Medicare beneficiaries,” Dr. Jalbert and her colleagues concluded.
The authors reported no relevant disclosures. The study was funded by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services.
FROM JAMA NEUROLOGY
Key clinical point: Mortality risks exceeded one-third for patients who were 80 years of age or older, symptomatic, at high surgical risk with symptomatic carotid stenosis of at least 50%, or admitted nonelectively.
Major finding: More than 80% of the physicians performing CAS in the real world did not meet the minimum CAS volume requirements and/or minimum complication rates of the SAPPPHIRE trial.
Data source: Data were obtained from a large retrospective cohort study of the Centers for Medicare and Medicaid Services CAS database (2005-2009).
Disclosures: The authors reported no relevant disclosures.