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Collateral bed occlusion linked to spinal cord ischemia
SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.
"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."
Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."
Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."
In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.
In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.
Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.
A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.
Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).
During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.
The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."
In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."
Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.
SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.
"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."
Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."
Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."
In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.
In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.
Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.
A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.
Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).
During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.
The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."
In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."
Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.
SAN FRANCISCO – The occlusion of at least one collateral bed was a significant predictor of immediate-onset spinal cord ischemia and reduced the chances of recovery and survival from the condition, results from a prospective study demonstrated.
"Endovascular aortic repair, particularly thoracoabdominal aortic aneurysm repair, mandates the occlusion of important collateral network vessels, specifically the intercostal and lumbar arteries," Dr. Matthew J. Eagleton said at Society for Vascular Surgery Annual Meeting. "Occlusion of at least one other collateral network vessel, whether that’s the hypogastric artery or the subclavian artery, is associated with early onset SCI, reduced recovery from SCI, and reduced survival."
Dr. Eagleton of the department of vascular surgery at the Cleveland Clinic, described spinal cord ischemia (SCI) as "a devastating complication after aortic surgery. In the past, much effort has been directed toward understanding the pathophysiology of spinal cord ischemia development, developing preventive strategies, and developing treatment strategies."
Endovascular aortic surgery "changes our approach to aortic disease," he continued. "While it offers a potentially less invasive option, there are some caveats to that when it comes to SCI. In many instances, especially in extensive aneurysms, we are unable to preserve important intercostal and lumbar arteries. In comparison to open surgery, we don’t know if spinal cord ischemia develops at the same rate, for the same reasons, with similar presentations and clinical course, or whether our current preventive and treatment algorithms are applicable in this patient population."
In an effort to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair, Dr. Eagleton and his associates evaluated 1,251 patients enrolled in three physician-sponsored investigational device exemption (IDE) trials from 1998 to 2010. They identified patients with confirmed SCI, reviewed their medical records and imaging studies, and used these to supplement prospectively collected data. Outcome measures included the timing of onset of SCI, recovery from SCI, and survival.
In all, 1,251 patients were treated with aortic endografts. Of these, 351 (28%) were infrarenal endografts, 201 (16%) were thoracic endografts, 227 (18%) were fenestrated endografts, and 472 (38%) were visceral branch grafts.
Dr. Eagleton and his associates identified 36 patients with SCI, for a rate of 2.9%. Their mean age was 73 years and 72% were male. The mean aneurysm size in SCI patients was 65 mm; 47% had undergone prior aortic surgery, predominately repair of an infrarenal AAA; and 25% required a conduit. The majority of conduits (78%) were placed at the time of endograft placement while the remainder were placed on an elective basis. The mean percentage length of aorta covered was 67%.
A total of 11 patients (31%) with SCI had at least one occluded collateral vessel. The majority of patients presented with either a motor deficit or a motor and sensory deficit (44% and 47%, respectively). Nearly three-quarters of SCI symptoms (72%) were bilateral in nature.
Onset of symptoms ranged from 0 to 240 hours. Immediate onset occurred in 42% of patients, with delayed onset in the remaining 58%. The one clinical factor that was significantly associated with immediate onset of SCI was the occlusion of at least one collateral bed (P = .021).
During a mean follow-up of 22 months, 30-day survival was 92%, 1-year survival was 56%, and 3-year survival was 45%. Survival was significantly reduced in patients who did not recover from their symptoms of SCI.
The relatively small size of the study cohort "limits extensive statistical analysis," Dr. Eagleton said. "The retrospective nature of clinical data limits more detailed information about clinical presentation and it provides little information about why these patients developed SCI as compared to their counterparts. This will certainly require a more focused evaluation of those who are at higher risk for the development of SCI."
In the meantime, he said, "aggressive efforts need to be made to maintain all collateral flow possible and prevent perioperative complications that diminish spinal cord perfusion. We need to evaluate other methods to augment these preventive strategies."
Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.
AT THE SVS ANNUAL MEETING
Major finding: The sole clinical factor that was significantly associated with the immediate onset of spinal cord ischemia after endovascular aortic aneurysm repair was the occlusion of at least one collateral bed (P = .021).
Data source: An analysis of 1,251 patients enrolled in three physician-sponsored investigational device exemption trials from 1998 to 2010.
Disclosures: Dr. Eagleton disclosed that he is a consultant for Bolton Medical and Cook Medical.
More complications seen in retrievable vs. permanent IVC filters
SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.
"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.
"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."
To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.
Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."
Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.
The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.
"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."
When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).
With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."
She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."
Dr. Desai said that she had no relevant financial conflicts to disclose.
SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.
"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.
"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."
To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.
Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."
Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.
The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.
"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."
When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).
With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."
She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."
Dr. Desai said that she had no relevant financial conflicts to disclose.
SAN FRANCISCO – Significantly higher rates of complications were observed in patients with indwelling retrievable inferior vena cava filters, compared with those who had permanent filters placed, results from a large single-center study showed.
"Venous thromboembolism is a significant cause of morbidity and mortality," Dr. Tina R. Desai said at the Society for Vascular Surgery Annual Meeting. "The primary treatment for this remains anticoagulation. However, since the initial introduction of the Greenfield filter in 1973, there has been a steady increase in the use of inferior vena cava filters." The introduction of retrievable filters in 2003 further contributed to this increase in use of filters, said Dr. Desai, a vascular surgeon at NorthShore University HealthSystem in Skokie, Ill.
"The retrievable filters were approved to be left in place indefinitely, and they have a theoretical advantage of being able to be retrieved when the patient no longer has a significant risk of pulmonary embolism," she said. "Interestingly, if you look at current-day studies, these retrievable filters are quite uncommonly retrieved. In fact, most of them end up being permanent."
To better understand the difference in complications between retrievable and permanent filters, Dr. Desai and her associates conducted a retrospective study of 1,234 patients who had IVC filters placed at NorthShore between 2005 and 2010. Of the 1,234 patients, 449 had retrievable filters placed while 785 had permanent filters placed.
Patients in the permanent filter group were older than those in the indwelling retrievable group (mean age, 75 vs. 64 years, respectively). They were also sicker, with significantly higher rates of cancer, hypertension, diabetes, and coronary artery disease. "Most of our filters were placed for a diagnosis of acute venous thromboembolism, with a relative minority placed for prophylactic reasons," Dr. Desai said. "All filters were placed by an interventional radiologist or a vascular surgeon. The majority of the retrievable filters were Cook Celect filters, and the majority of permanent filters were Braun Vena Tech filters. For our primary analysis, we defined complications as symptomatic events – either periprocedurally or directly related to the filter – that patients experienced."
Of the 449 retrievable filters placed, 67 of them were electively retrieved. This left a group of 382 indwelling retrievable filters. Dr. Desai reported that the rate of symptomatic complications was significantly higher in the indwelling retrievable filter group than in the permanent filter group (8.9% vs. 2.9%; P = .0001). Thrombotic complications were the most common type of symptomatic complication in both groups. They occurred more often in the retrievable filter group than in the permanent filter group (4.2% vs. 1.8%), but this difference did not reach significance.
The researchers did find a statistically significant difference in the number of device-related symptomatic complications that occurred in the indwelling retrievable filter group, compared with the permanent filter group (2.6% vs. 0.5%; P = .006). The number of systemic-related symptomatic complications was higher in the indwelling retrievable filter group than in the permanent filter group (1.3% vs. 0.4%), but this difference did not reach significance.
"In addition to the complications that we saw, we found a number of patient findings such as those shown on CT scan, which shows perforation of filter struts through the wall of the vena cava," Dr. Desai noted. "Others have made similar observations. While we don’t completely understand the significance of these symptomatic findings, it’s hard to ignore these effects when we’re trying to make decisions about whether we should be leaving these retrievable filters in place indefinitely or not."
When the researchers factored both incidental and symptomatic findings into their analysis, the rate of device-related complications was 8.9% in the indwelling retrievable filter group, compared with 0.9% in the permanent filter group, a difference that reached significance (P less than .0001).
With these findings in mind, Dr. Desai recommended that retrievable filters "only be used in conditions where retrieval is highly likely; in all other patients, permanent filters should be used when IVC filters are indicated."
She acknowledged certain limitations of the study, including the fact that its retrospective design "likely results in an underestimation of the number of asymptomatic complications," she said. "Also, we cannot draw meaningful conclusions related to the effects of anticoagulation on thrombotic complications. Organized programs to track and follow patients who receive retrievable filters are necessary to optimize retrieval rates. Further study is needed to determine the significance of asymptomatic device fracture and device penetration through the IVC."
Dr. Desai said that she had no relevant financial conflicts to disclose.
AT THE SVS ANNUAL MEETING
Major finding: The rate of symptomatic complications was significantly higher in patients who received indwelling retrievable inferior vena cava filters than in those who received permanent IVC filters (8.9% vs. 2.9%, respectively; P = .0001).
Data source: A retrospective study of 1,234 patients who had IVC filters placed at NorthShore University HealthSystem in Skokie, Ill., between 2005 and 2010.
Disclosures: Dr. Desai said that she had no relevant financial conflicts to disclose.
Two-year results from STABLE trial unveiled
SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.
However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.
Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.
The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."
Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.
The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.
"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."
The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.
"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."
Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).
Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."
The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.
SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.
However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.
Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.
The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."
Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.
The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.
"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."
The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.
"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."
Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).
Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."
The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.
SAN FRANCISCO – Endovascular repair of complicated type B aortic dissection using a composite device design demonstrates favorable aortic modeling, 2-year results from an ongoing trial showed.
However, patients treated in an acute phase may be prone to aortic growth and require close monitoring, Dr. Joseph V. Lombardi reported at Society for Vascular Surgery Annual Meeting.
Those are key findings the STABLE trial, a prospective, multicenter trial evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical) for the treatment of complicated type B aortic dissection. The system is commercially available in Europe but not in the United States.
The first published results from STABLE, which was comprised of 40 patients, found a 30-day mortality of 5% and a 1-year all-cause mortality of 10% (J. Vasc. Surg. 2012;55:629-40) "Positive aortic modeling was recognized as well," said Dr. Lombardi, chief of vascular surgery at Cooper University Hospital in Camden, N.J., and the principal STABLE investigator. "The goals for complicated type B aortic dissection are to recognize complications promptly, alleviate branch vessel malperfusion, reduce the risk of rupture, and minimize long-term complications."
Dr. Lombardi updated meeting attendees on 2-year data from the STABLE trial, which is being conducted in the United States, Europe, and Australia. He reported on results from 86 patients with a mean age of 59 years. Nearly three-quarters (73%) were male. The primary endpoint is 30-day mortality and follow-up through 5 years is ongoing.
The researchers observed a mean onset to treatment of 17 days. More than half (64%) presented in an acute phase, which they defined as within 0-14 days of symptom onset, while the remainder presented in a non-acute phase defined as greater than 14 days after symptom onset.
"The anatomical extent of the dissections extended through the visceral aorta in 99% of cases and in the common iliac artery or below in 80% of cases," Dr. Lombardi said. "There were a number of device combinations used depending on the patient’s anatomical presentation. Successful device deployment was seen in all patients, with 100% patency."
The all-cause mortality was 12% at 1 year and 15% at 2 years. The 30-day mortality rate for the 86 patients was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.
"There were nine deaths between 1 month and 24 months, four of which were determined to be not related to the dissection," he said. "Combined, this translated into a dissection-related mortality of 11% at 24 months."
Between baseline and 2 years the true lumen diameter increased significantly in the descending thoracic aorta and in the more distal abdominal aorta, with a concomitant decrease in false lumen diameter, Dr. Lombardi said. Transaortic growth of 5 mm or greater was observed in the descending thoracic aorta in 21 patients (24%) and the abdominal aorta in 21 patients (24%).
Generalized linear model analysis revealed that the only significant factor for transaortic growth was duration from symptom onset to treatment (P = .05). "The acute phase treatment is associated with a risk of aortic dilation," Dr. Lombardi said. "Patients in this subgroup need to be closely monitored. Longer-term follow-up on STABLE is needed."
The STABLE Trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.
AT THE SVS ANNUAL MEETING
Major finding: Among patients who underwent endovascular repair of complicated type B aortic dissection with a composite device design, the 30-day mortality rate was 4.7%. Of the 55 patients who had acute presentations, the 30-day mortality rate was 5.5%.
Data source: Results from the ongoing STABLE Trial, a prospective, multicenter study evaluating the safety and effectiveness of a composite endovascular system consisting of TX2 thoracic stent grafts and distal bare metal dissection stents for the treatment of complicated type B aortic dissection.
Disclosures: The STABLE trial was sponsored by Cook Medical. Dr. Lombardi disclosed that he has received research grants from Cook Medical.
Current but not past smokers at extra postoperative risk
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a report published online June 19 in JAMA Surgery.
Current smoking correlates with these adverse outcomes even in patients who don’t have obvious smoking-related disease such cardiovascular disease, chronic pulmonary disorders, or cancer, which suggests that smoking may exert its deleterious effects through acute or subclinical chronic vascular and respiratory pathologic mechanisms, said Dr. Khaled M. Musallam of the American University of Beirut (Lebanon) Medical Center and his associates.
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a recent report published in JAMA Surgery.
Since smoking cessation has clear benefits on morbidity and mortality in the surgical setting, "surgical teams should be more involved in the ongoing efforts to optimize measures for smoking control," they wrote.
"Surgery provides a teachable environment for smoking cessation. Unlike the long-term consequences of smoking, the acute consequences of smoking on patients’ postoperative outcomes can provide a strong motive for quitting," the investigators said.
Dr. Musallam and his colleagues examined the effect of smoking on surgical outcomes using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which includes a registry that provides feedback to participating hospitals regarding 30-day risk-adjusted surgical morbidity and mortality.
For this study, they analyzed data on 607,558 patients undergoing major surgery at more than 200 participating hospitals during a 2-year period in the United States, Canada, Lebanon, and the United Arab Emirates. The mean age of the patients was 56 years (range, 16-90 years); 43% were men and 57% were women.
A total of 125,192 patients (21%) were current smokers and 78,763 (13%) were past smokers who had quit at least 1 year before surgery. The remaining patients had never smoked.
Only current smokers showed an increased likelihood of 30-day mortality. They also were at greater risk for adverse arterial events such as MI or stroke, as well as for adverse respiratory events such as pneumonia, need for intubation, and need for a ventilator, within 30 days of surgery, the investigators said (JAMA Surg. 2013 June 19 [doi:10.1001/jamasurg.2013.2360]).
The higher risk of these adverse outcomes occurred with smokers across all age groups but was particularly notable among those older than age 40 years. It was seen in both sexes, among those undergoing inpatient as well as outpatient procedures, in patients who had general as well as other types of anesthesia, across a variety of surgical subspecialties, and in both elective and emergency surgery cases.
The association between current smoking and adverse outcomes also remained robust in a sensitivity analysis, Dr. Musallam and his associates said.
There was a dose-response effect in an analysis of patients’ smoking history, with the likelihood of adverse arterial and respiratory events increasing in tandem with increasing pack-years of smoking, but even current "light" smokers who had fewer than 10 pack-years of smoking history were at increased risk for postoperative mortality and morbidity.
"These findings encourage ongoing efforts to implement smoking cessation programs," Dr. Musallam and his associates said.
"Early intervention in heavy smokers is warranted, especially because the effect of smoking on postoperative arterial and respiratory morbidity seems to be dose dependent. However, because smokers with a cigarette smoking history of less than 10 pack-years are also at risk of postoperative death, recent and light smokers should also be targeted," they suggested.
Dr. Musallam and his associates reported no financial conflicts of interest.
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a report published online June 19 in JAMA Surgery.
Current smoking correlates with these adverse outcomes even in patients who don’t have obvious smoking-related disease such cardiovascular disease, chronic pulmonary disorders, or cancer, which suggests that smoking may exert its deleterious effects through acute or subclinical chronic vascular and respiratory pathologic mechanisms, said Dr. Khaled M. Musallam of the American University of Beirut (Lebanon) Medical Center and his associates.
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a recent report published in JAMA Surgery.
Since smoking cessation has clear benefits on morbidity and mortality in the surgical setting, "surgical teams should be more involved in the ongoing efforts to optimize measures for smoking control," they wrote.
"Surgery provides a teachable environment for smoking cessation. Unlike the long-term consequences of smoking, the acute consequences of smoking on patients’ postoperative outcomes can provide a strong motive for quitting," the investigators said.
Dr. Musallam and his colleagues examined the effect of smoking on surgical outcomes using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which includes a registry that provides feedback to participating hospitals regarding 30-day risk-adjusted surgical morbidity and mortality.
For this study, they analyzed data on 607,558 patients undergoing major surgery at more than 200 participating hospitals during a 2-year period in the United States, Canada, Lebanon, and the United Arab Emirates. The mean age of the patients was 56 years (range, 16-90 years); 43% were men and 57% were women.
A total of 125,192 patients (21%) were current smokers and 78,763 (13%) were past smokers who had quit at least 1 year before surgery. The remaining patients had never smoked.
Only current smokers showed an increased likelihood of 30-day mortality. They also were at greater risk for adverse arterial events such as MI or stroke, as well as for adverse respiratory events such as pneumonia, need for intubation, and need for a ventilator, within 30 days of surgery, the investigators said (JAMA Surg. 2013 June 19 [doi:10.1001/jamasurg.2013.2360]).
The higher risk of these adverse outcomes occurred with smokers across all age groups but was particularly notable among those older than age 40 years. It was seen in both sexes, among those undergoing inpatient as well as outpatient procedures, in patients who had general as well as other types of anesthesia, across a variety of surgical subspecialties, and in both elective and emergency surgery cases.
The association between current smoking and adverse outcomes also remained robust in a sensitivity analysis, Dr. Musallam and his associates said.
There was a dose-response effect in an analysis of patients’ smoking history, with the likelihood of adverse arterial and respiratory events increasing in tandem with increasing pack-years of smoking, but even current "light" smokers who had fewer than 10 pack-years of smoking history were at increased risk for postoperative mortality and morbidity.
"These findings encourage ongoing efforts to implement smoking cessation programs," Dr. Musallam and his associates said.
"Early intervention in heavy smokers is warranted, especially because the effect of smoking on postoperative arterial and respiratory morbidity seems to be dose dependent. However, because smokers with a cigarette smoking history of less than 10 pack-years are also at risk of postoperative death, recent and light smokers should also be targeted," they suggested.
Dr. Musallam and his associates reported no financial conflicts of interest.
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a report published online June 19 in JAMA Surgery.
Current smoking correlates with these adverse outcomes even in patients who don’t have obvious smoking-related disease such cardiovascular disease, chronic pulmonary disorders, or cancer, which suggests that smoking may exert its deleterious effects through acute or subclinical chronic vascular and respiratory pathologic mechanisms, said Dr. Khaled M. Musallam of the American University of Beirut (Lebanon) Medical Center and his associates.
Current smoking is associated with an increased risk of mortality and other adverse outcomes following major surgery, but past smoking is not, according to a recent report published in JAMA Surgery.
Since smoking cessation has clear benefits on morbidity and mortality in the surgical setting, "surgical teams should be more involved in the ongoing efforts to optimize measures for smoking control," they wrote.
"Surgery provides a teachable environment for smoking cessation. Unlike the long-term consequences of smoking, the acute consequences of smoking on patients’ postoperative outcomes can provide a strong motive for quitting," the investigators said.
Dr. Musallam and his colleagues examined the effect of smoking on surgical outcomes using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which includes a registry that provides feedback to participating hospitals regarding 30-day risk-adjusted surgical morbidity and mortality.
For this study, they analyzed data on 607,558 patients undergoing major surgery at more than 200 participating hospitals during a 2-year period in the United States, Canada, Lebanon, and the United Arab Emirates. The mean age of the patients was 56 years (range, 16-90 years); 43% were men and 57% were women.
A total of 125,192 patients (21%) were current smokers and 78,763 (13%) were past smokers who had quit at least 1 year before surgery. The remaining patients had never smoked.
Only current smokers showed an increased likelihood of 30-day mortality. They also were at greater risk for adverse arterial events such as MI or stroke, as well as for adverse respiratory events such as pneumonia, need for intubation, and need for a ventilator, within 30 days of surgery, the investigators said (JAMA Surg. 2013 June 19 [doi:10.1001/jamasurg.2013.2360]).
The higher risk of these adverse outcomes occurred with smokers across all age groups but was particularly notable among those older than age 40 years. It was seen in both sexes, among those undergoing inpatient as well as outpatient procedures, in patients who had general as well as other types of anesthesia, across a variety of surgical subspecialties, and in both elective and emergency surgery cases.
The association between current smoking and adverse outcomes also remained robust in a sensitivity analysis, Dr. Musallam and his associates said.
There was a dose-response effect in an analysis of patients’ smoking history, with the likelihood of adverse arterial and respiratory events increasing in tandem with increasing pack-years of smoking, but even current "light" smokers who had fewer than 10 pack-years of smoking history were at increased risk for postoperative mortality and morbidity.
"These findings encourage ongoing efforts to implement smoking cessation programs," Dr. Musallam and his associates said.
"Early intervention in heavy smokers is warranted, especially because the effect of smoking on postoperative arterial and respiratory morbidity seems to be dose dependent. However, because smokers with a cigarette smoking history of less than 10 pack-years are also at risk of postoperative death, recent and light smokers should also be targeted," they suggested.
Dr. Musallam and his associates reported no financial conflicts of interest.
FROM JAMA SURGERY
Major Finding: Only current smokers, not past or never smokers, showed an increased likelihood of 30-day mortality, MI, stroke, pneumonia, the need for intubation, and the need for a ventilator.
Data Source: An analysis of data on 30-day mortality and morbidity in 607,558 adults undergoing major surgery in four countries during a 2-year period.
Disclosures: Dr. Musallam and his associates reported no financial conflicts of interest.
Open surgery less risky than FEVAR for some aneurysm repairs
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
AT THE SVS ANNUAL MEETING
Major finding: Compared with patients who underwent open surgical repair of complex abdominal aortic aneurysms, those who underwent fenestrated endovascular aneurysm repair had a higher 30-day mortality (9.5% vs. 2%; P = .038) and a higher occurrence of any complication (42.9% vs. 23.1%; P = .012).
Data source: An analysis 147 open surgery repairs and 42 FEVAR procedures performed at two medical centers between 2001 and 2012.
Disclosures: Dr. Raux said that he had no relevant financial conflicts to disclose.
Open surgery less risky than FEVAR for some aneurysm repairs
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.
AT THE SVS ANNUAL MEETING
Major finding: Compared with patients who underwent open surgical repair of complex abdominal aortic aneurysms, those who underwent fenestrated endovascular aneurysm repair had a higher 30-day mortality (9.5% vs. 2%; P = .038) and a higher occurrence of any complication (42.9% vs. 23.1%; P = .012).
Data source: An analysis 147 open surgery repairs and 42 FEVAR procedures performed at two medical centers between 2001 and 2012.
Disclosures: Dr. Raux said that he had no relevant financial conflicts to disclose.
Postop troponin elevation, MI impact 5-year survival
SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.
In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.
In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."
The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.
Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.
The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.
"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.
In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).
"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."
She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."
Dr. Simons said she had no relevant financial disclosures.
SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.
In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.
In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."
The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.
Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.
The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.
"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.
In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).
"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."
She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."
Dr. Simons said she had no relevant financial disclosures.
SAN FRANCISCO – Postoperative troponin elevation and myocardial infarction both impact 5-year survival following vascular surgery procedures, the results of a large long-term study showed.
In fact, troponin elevation increased the hazard of death by 50% while myocardial infarction increased the hazard of death by nearly threefold, Dr. Jessica P. Simons reported at the annual meeting of the Society for Vascular Surgery. "Future studies are needed to assess the nature of this association as well as the utility of routine postoperative screening for myocardial ischemia," said Dr. Simons of the division of vascular and endovascular surgery at the University of Massachusetts, Worcester.
In a study that she presented on behalf of the Vascular Study Group of New England (VSGNE), Dr. Simons and her associates set out to determine the association of postoperative troponin elevation with long-term survival in patients undergoing vascular surgical procedures. "Postoperative myocardial infarction has been shown to impact short- and long-term mortality," she said. "In addition, troponin elevations have also been shown to negatively impact survival for a wide range of diagnoses. This has been seen in critical care medical literature and also in the general surgical population."
The researchers identified 16,363 VSGNE patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011. The exposure variable of interest was postoperative myocardial ischemia, which was categorized as either no ischemia, troponin elevation, or myocardial infarction. The primary end point was survival during the first 5 years postoperatively. They used Kaplan-Meier analyses and Cox proportional hazards models to evaluate the effect of postoperative troponin elevation and myocardial infarction.
Of the 16,363 patients, 15,888 (97.1%) had no ischemia, 211 (1.3%) had troponin elevation, and 264 (1.6%) had myocardial infarction. When this was broken down by procedure type, open AAA had the highest rates of postoperative myocardial ischemia (9%), troponin elevation (3.9%), and myocardial infarction (5.1%), compared with carotid revascularization, endovascular aneurysm repair, and lower-extremity bypass.
The rate of 5-year survival for all procedures was 73% among those with no ischemia, 54% among those with troponin elevation, and 33% among those with myocardial infarction. This difference reached statistical significance with a P value of less than .0001. After adjusting for covariates, the researchers found a similar trend. In this analysis the rate of 5-year survival was 78% among those with no ischemia, 48% among those with troponin elevation, and 35% among those with myocardial infarction. This also reached statistical significance with a P value of less than .0001.
"We performed a subgroup analysis by procedure type, and the trend was the same across all procedure types," Dr. Simons said.
In Cox modeling the researchers found that postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).
"We have shown an association between postoperative myocardial ischemia and worse survival, but does postoperative myocardial ischemia worsen long-term survival, or does postoperative myocardial ischemia simply identify a high-risk subset of patients?" Dr. Simons asked. "If postoperative myocardial ischemia worsens long-term survival, then efforts should focus on better preoperative medical optimization and perioperative prevention of ischemia. If postoperative myocardial ischemia is simply identifying a high-risk subset of patients, then efforts should focus on better preoperative risk stratification and postoperative medical surveillance."
She concluded that postoperative myocardial ischemia, "whether a troponin elevation or a myocardial infarction, is associated with lower survival. This effect is seen across all procedure types and persists out to 5 years postoperatively."
Dr. Simons said she had no relevant financial disclosures.
AT THE SVS ANNUAL MEETING
Major finding: Postoperative ischemia in the form of a troponin elevation increased the hazard of death at 5 years by 45% (HR, 1.45; P =.01) while myocardial infarction nearly tripled the hazard of death (HR, 2.93; P =.0001).
Data source: A study of 16,363 Vascular Study Group of New England patients who underwent carotid revascularization, open AAA repair, endovascular AAA repair, or lower-extremity bypass between 2003 and 2011.
Disclosures: Dr. Simons said she had no relevant financial disclosures.
Hemodialysis AV graft patency similar for forearm, upper arm
SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.
"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.
The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."
Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."
He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."
Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.
He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.
Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m2 vs. a mean of 32 kg/m2), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).
Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.
Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).
In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.
When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.
Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."
Dr. Farber said that he had no disclosures.
SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.
"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.
The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."
Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."
He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."
Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.
He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.
Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m2 vs. a mean of 32 kg/m2), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).
Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.
Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).
In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.
When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.
Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."
Dr. Farber said that he had no disclosures.
SAN FRANCISCO – Outcomes of forearm and upper arm hemodialysis arteriovenous grafts are similar despite the fact that large caliber outflow veins are often encountered in the upper arm, results from a large trial showed.
"To preserve a maximal number of access sites, forearm location should always be considered before resorting to an upper arm graft," Dr. Alik Farber said at the Society for Vascular Surgery Annual Meeting.
The incidence and prevalence of end-stage renal disease in the United States has grown exponentially in the past 25 years, said Dr. Farber, chief of vascular and endovascular surgery at Boston University Medical Center. "In fact, in 2010 almost 400,000 patients were undergoing hemodialysis," he said. "At the same time, there has been a steady increase in the percent of AV fistulas placed and an associated decline in the percent of AV grafts placed in the United States. In 2010, 20% of patients were undergoing hemodialysis through AV grafts."
Most grafts in the upper extremity are based on the brachial artery. Some are in the forearm while others are in the upper arm. "In the forearm most grafts are looped," Dr. Farber said. "In the upper arm some are looped and some are straight. As it turns out, the optimal graft configuration is unknown. The optimal venous outflow in the upper extremity is unknown. And the optimal location of the first-time AV graft is controversial."
He went on to note that the forearm AV graft "saves the upper arm for a future graft site and has a potential advantage of increasing the suitability of upper arm veins for future native fistula. On the other hand, there is some evidence in the literature that forearm grafts have lower patency rates. The upper arm graft may have higher patency rates because they are ‘sawn into’ large caliber veins. However, surgeons who preferentially place upper arm grafts tend to skip potential distal access sites."
Given the dearth of information on this topic, Dr. Farber and his associates set out to compare outcomes of forearm and upper arm grafts and to evaluate the association between upper extremity AV graft configuration, location, venous outflow, and patency in 649 patients from a multicenter trial conducted by the Dialysis Access Consortium (DAC). This was a randomized, controlled trial of dipyridamole versus placebo in patients with new AV grafts. It found that dipyridamole increased primary unassisted graft patency (N. Engl. J. Med. 2009;360:2191-201). "The important thing for us was that this is the largest randomized, controlled trial of AV grafts conducted to date," Dr. Farber said.
He presented results from 522 patients with AV grafts that were based on the brachial artery. Of the 522 patients, 269 had a forearm graft (fAVG) and 253 had an upper arm graft (uAVG). The primary outcome was loss of primary unassisted patency. "This was defined as a first occurrence of graft thrombosis, an access procedure to correct a greater than 50% stenosis, or other surgical graft modification," Dr. Farber explained. The secondary outcome was cumulative graft failure, "which was defined as the time from randomization to complete loss of access site for dialysis." Kaplan-Meier curves and Cox models were used to examine the effects of access location and configuration on study outcomes.
Compared with patients in the fAVG group, those in the uAVG group were more likely to be male (43% vs. 34%), to be African-American (78% vs. 62%), to have a lower body mass index (mean of 29 kg/m2 vs. a mean of 32 kg/m2), to have a lower baseline systolic blood pressure (139 mm Hg vs. 146 mm Hg), to have hemodialysis initiated before graft placement (80% vs. 64%), and to be on dialysis for a longer period of time (a mean of 2.59 years vs. a mean of 2.51 years).
Unadjusted analyses showed that there was no significant difference in the loss of primary unassisted graft patency or cumulative graft failure between the fAVG and uAVG groups.
Multivariate analyses of outcomes controlled for covariates revealed that the risk of loss of primary unassisted graft patency was not significantly higher in the uAVG group, compared with the fAVG group (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).
In a comparison of straight vs. looped grafts, straight configuration grafts "appeared to have a lower risk of primary and secondary failure, compared with looped figuration grafts, [but] this difference was not statistically significant," he said.
When compared to forearm looped grafts, which were used as a reference, there was no significant difference in the risk of primary and secondary failure among straight fAVGs, straight uAVGs, and looped uAVGs. There was a suggestion of increased risk of failure among upper arm looped grafts (HR 1.47; P = .06). There were also no significant differences between the two groups in adverse events and complications at 30 days.
Dr. Farber acknowledged certain limitations of the study. "Like any observational comparison of treatment groups, analysis was susceptible to uncontrolled confounding [variables]," he said. "We did a post hoc analysis of a randomized trial which did not answer the questions that we posed. Preoperative artery and vein diameters were not recorded and the reasons for graft selection are not known. Lastly, access interventions were followed for only 30 days beyond the occurrence of the primary endpoint, so we couldn’t really use access intervention to thoroughly evaluate the determinants of cumulative graft failure."
Dr. Farber said that he had no disclosures.
AT THE SVS ANNUAL MEETING
Major finding: The risk of loss of primary unassisted graft patency was not significantly higher in patients who had an upper arm arteriovenous graft compared with those who had a forearm AV graft (hazard ratio of 1.24; P = .15). However, there was a suggestion of an association of increased risk of cumulative graft failure among upper arm grafts (HR 1.37; P = .09).
Data source: A study of 522 hemodialysis patients with AV grafts based on the brachial artery. Of these, 269 had a forearm graft and 253 had an upper arm graft.
Disclosures: Dr. Farber said that he had no disclosures.
Postop care program cuts pneumonia, unplanned intubation
A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).
"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.
When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.
BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.
The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.
The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."
The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.
I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.
The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.
Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.
Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.
The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).
These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.
"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.
"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.
While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."
"We believe that a favorable change in practice occurred as a result of our program," they wrote.
The investigators reported having no financial conflicts of interest.
Bruce J. Leavitt, M.D., commented: The reductions in postoperative pneumonia and unplanned intubations fell short of statistical significance in this study, but the investigators still demonstrated many positive outcomes, said Dr. Bruce J. Leavitt.
"Cassidy and his colleagues have shown that creating a multidisciplinary team that implements simple measures involving the pulmonary care of the surgical patient can improve outcomes and lower medical costs," he noted.
Bruce J. Leavitt, M.D., is in the department of surgery at Fletcher Allen Health Care, Burlington, Vt. He reported having no financial conflicts of interest. These remarks were taken from his invited critique accompanying Dr. Cassidy’s report (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.375]).
Bruce J. Leavitt, M.D., commented: The reductions in postoperative pneumonia and unplanned intubations fell short of statistical significance in this study, but the investigators still demonstrated many positive outcomes, said Dr. Bruce J. Leavitt.
"Cassidy and his colleagues have shown that creating a multidisciplinary team that implements simple measures involving the pulmonary care of the surgical patient can improve outcomes and lower medical costs," he noted.
Bruce J. Leavitt, M.D., is in the department of surgery at Fletcher Allen Health Care, Burlington, Vt. He reported having no financial conflicts of interest. These remarks were taken from his invited critique accompanying Dr. Cassidy’s report (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.375]).
Bruce J. Leavitt, M.D., commented: The reductions in postoperative pneumonia and unplanned intubations fell short of statistical significance in this study, but the investigators still demonstrated many positive outcomes, said Dr. Bruce J. Leavitt.
"Cassidy and his colleagues have shown that creating a multidisciplinary team that implements simple measures involving the pulmonary care of the surgical patient can improve outcomes and lower medical costs," he noted.
Bruce J. Leavitt, M.D., is in the department of surgery at Fletcher Allen Health Care, Burlington, Vt. He reported having no financial conflicts of interest. These remarks were taken from his invited critique accompanying Dr. Cassidy’s report (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.375]).
A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).
"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.
When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.
BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.
The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.
The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."
The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.
I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.
The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.
Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.
Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.
The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).
These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.
"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.
"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.
While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."
"We believe that a favorable change in practice occurred as a result of our program," they wrote.
The investigators reported having no financial conflicts of interest.
A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).
"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.
When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.
BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.
The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.
The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."
The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.
I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.
The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.
Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.
Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.
The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).
These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.
"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.
"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.
While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."
"We believe that a favorable change in practice occurred as a result of our program," they wrote.
The investigators reported having no financial conflicts of interest.
FROM JAMA SURGERY
Major finding: Before I COUGH, 52.8% of patients had an incentive spirometer within reach; an unknown number were using it appropriately. Afterward, 77.2% had the device within reach and were using it appropriately.
Data source: A comparison of postoperative complications between 250 patients hospitalized before I COUGH was implemented and 250 hospitalized afterward.
Disclosures: The investigators reported having no financial conflicts of interest.
Better endografts mean fewer reinterventions for endovascular AAA
INDIANAPOLIS – Reintervention rates following endovascular repair of abdominal aortic aneurysms have fallen steadily with the introduction of each successive generation of endografts, while reintervention rates after open surgical repair remained stable during a recent 15-year period.
This was among the key findings from the first in-depth analysis of reinterventions occurring in contemporaneous cohorts of abdominal aortic aneurysm (AAA) patients undergoing endovascular aneurysm repair (EVAR) or open repair. The large single-center retrospective study demonstrated major differences between the two treatment strategies in terms of the incidence, nature, timing, and mortality associated with complications requiring reintervention, Dr. Mustafa Al-Jubouri said at the annual meeting of the American Surgical Association.
Dr. Al-Jubouri of Jobst Vascular Institute, Toledo, Ohio, reported on the 1,144 patients who underwent AAA repair there during 1996-2011. Forty-nine percent had EVAR, 51% open surgical repair. Beginning in 2003, more EVARs than open repairs were done annually at the Toledo institute, consistent with the experience at many major centers in the United States and elsewhere, where EVAR has become the first-line treatment based upon evidence that it offers lower operative mortality, less blood loss, and shorter ICU and hospital lengths of stay.
These advantages come at a cost, however: namely, a greater rate of secondary interventions, mainly due to device migration, failure, or endoleaks. The purpose of Dr. Al-Jubouri’s study was to evaluate the rates and reasons for reintervention over time in the two cohorts, as well as the impact of reintervention on long-term survival.
Reintervention was required in 13.6% of the EVAR group during a mean follow-up of 4.58 years, and in 5.1% of the open surgery group during 6.58 years. A single reintervention occurred in 7.9% of EVAR patients and 3.6% of the open repair group. More than one reintervention was required in 5.8% of EVAR patients compared to just 1.6% of the open repair group.
The types and timing of complications leading to reintervention were very different in the two groups. Sixty-eight percent of reinterventions in the EVAR group were for treatment of endoleaks. Another 11.5% were to address device migration, and an equal number were for occlusion.
In contrast, the three most frequent causes of reintervention in the open repair group were colonic ischemia, accounting for 30.4% of reintervention procedures; severe bleeding, 21.7%; and incisional hernia, which triggered another 21.7% of reinterventions.
Notably, 60% of all reinterventions in the open repair group occurred during the initial hospitalization, while less than 7% of reinterventions in the EVAR patients happened within 1 month of the index procedure and only one-third within the first year, the surgeon continued.
Thirty-day mortality in EVAR patients who underwent reintervention within the first month was zero, compared to a 23.3% mortality rate in open repair patients requiring reintervention within 1 month. However, when patients did not require early reintervention, 30-day mortality rates in the two groups did not differ significantly: 1.9% in EVAR group and in the open repair group. That means when patients in the open surgery group required early reintervention, their mortality rate shot up sevenfold.
After the first 30 days post-index procedure, long-term survival rates in the two groups were similar.
Need for reintervention in the open repair group was strongly related to larger aneurysm size. In contrast, reintervention rates were similar in the EVAR group regardless of aneurysm size.
A first reintervention after EVAR occurred in 23.7% of patients who received a first-generation endograft, such as the Ancure or Talent; in 16.2% of those who got the second-generation AneuRx endograft; and in 9.1% with a third-generation endograft, such as the Excluder, Endurant, Powerlink, or Zenith. The annualized rate of reintervention during the first 3 years of follow-up was 6.8% per year with first-generation devices, 7.2% per year with second-generation endografts, and significantly lower at 3.4% per year with the third-generation.
One major reason reintervention rates in EVAR patients have declined over time is that each newer generation of endograft is lower-profile, easier to deploy, and more durable. Also, many of the surgeons now putting in third-generation endografts were performing EVAR 15 years ago; they’re very experienced operators, Dr. Al-Jubouri noted.
Discussant Dr. James R. Debord proposed another explanation for the decrease in EVAR reinterventions over time.
"Isn’t it much more likely that it’s due to recognition of the fact that many of these type 2 endoleaks that we used to intervene on early on don’t require reintervention unless there’s sac enlargement?" commented Dr. Debord, professor of clinical surgery and chief of vascular surgery at the University of Illinois at Peoria.
Dr. Al-Jubouri concurred that this is an important factor in the declining rate of EVAR reinterventions.
"We saw a significant decrease in reinterventions for type 2 endoleaks between the first, second, and third generations," he said.
Asked how his study findings have changed the follow-up protocols at Jobst Vascular Institute, the surgeon replied that in the early years of the series EVAR patients got a CT scan at 6 weeks, 6 months, 1 year, and annually thereafter. This evaluation has evolved over time. Now EVAR patients get a CT scan at 6-12 weeks, and duplex ultrasounds at 6 months, 1 year, and annually thereafter.
"There is no standardized follow-up for open repair patients. However, most [patients] get an annual duplex ultrasound for their follow-up. A CT scan is not part of the follow-up of patients with open repair. But most if not all of the complications that developed in the open repair group were symptomatic," he explained.
He reported having no financial conflicts.
Dr. Mustafa Al-Jubouri and his colleagues assessed reinterventions and outcomes after EVAR and open AAA repair over a long time period, and found decreasing rates of reintervention after EVAR, which they attribute to improvements in technology from first to third and later-generation devices. I would concur with the one discussant, that some of the decrease may also be due to the understanding that not all type II endoleaks require repair. Further, much of the decrease may be due to physician experience – both with appropriate patient and device selection, and technical expertise, including with deployment. However, regardless of the underlying reason for the improvement in the reintervention rate, it is heartening that reintervention is decreasing as physicians become more facile, and industry provides technological improvements to the devices.
Dr. Linda Harris, FACS, is division chief and program director of vascular surgery at State University of New York, Buffalo. Dr. Harris has no disclosures
Dr. Mustafa Al-Jubouri and his colleagues assessed reinterventions and outcomes after EVAR and open AAA repair over a long time period, and found decreasing rates of reintervention after EVAR, which they attribute to improvements in technology from first to third and later-generation devices. I would concur with the one discussant, that some of the decrease may also be due to the understanding that not all type II endoleaks require repair. Further, much of the decrease may be due to physician experience – both with appropriate patient and device selection, and technical expertise, including with deployment. However, regardless of the underlying reason for the improvement in the reintervention rate, it is heartening that reintervention is decreasing as physicians become more facile, and industry provides technological improvements to the devices.
Dr. Linda Harris, FACS, is division chief and program director of vascular surgery at State University of New York, Buffalo. Dr. Harris has no disclosures
Dr. Mustafa Al-Jubouri and his colleagues assessed reinterventions and outcomes after EVAR and open AAA repair over a long time period, and found decreasing rates of reintervention after EVAR, which they attribute to improvements in technology from first to third and later-generation devices. I would concur with the one discussant, that some of the decrease may also be due to the understanding that not all type II endoleaks require repair. Further, much of the decrease may be due to physician experience – both with appropriate patient and device selection, and technical expertise, including with deployment. However, regardless of the underlying reason for the improvement in the reintervention rate, it is heartening that reintervention is decreasing as physicians become more facile, and industry provides technological improvements to the devices.
Dr. Linda Harris, FACS, is division chief and program director of vascular surgery at State University of New York, Buffalo. Dr. Harris has no disclosures
INDIANAPOLIS – Reintervention rates following endovascular repair of abdominal aortic aneurysms have fallen steadily with the introduction of each successive generation of endografts, while reintervention rates after open surgical repair remained stable during a recent 15-year period.
This was among the key findings from the first in-depth analysis of reinterventions occurring in contemporaneous cohorts of abdominal aortic aneurysm (AAA) patients undergoing endovascular aneurysm repair (EVAR) or open repair. The large single-center retrospective study demonstrated major differences between the two treatment strategies in terms of the incidence, nature, timing, and mortality associated with complications requiring reintervention, Dr. Mustafa Al-Jubouri said at the annual meeting of the American Surgical Association.
Dr. Al-Jubouri of Jobst Vascular Institute, Toledo, Ohio, reported on the 1,144 patients who underwent AAA repair there during 1996-2011. Forty-nine percent had EVAR, 51% open surgical repair. Beginning in 2003, more EVARs than open repairs were done annually at the Toledo institute, consistent with the experience at many major centers in the United States and elsewhere, where EVAR has become the first-line treatment based upon evidence that it offers lower operative mortality, less blood loss, and shorter ICU and hospital lengths of stay.
These advantages come at a cost, however: namely, a greater rate of secondary interventions, mainly due to device migration, failure, or endoleaks. The purpose of Dr. Al-Jubouri’s study was to evaluate the rates and reasons for reintervention over time in the two cohorts, as well as the impact of reintervention on long-term survival.
Reintervention was required in 13.6% of the EVAR group during a mean follow-up of 4.58 years, and in 5.1% of the open surgery group during 6.58 years. A single reintervention occurred in 7.9% of EVAR patients and 3.6% of the open repair group. More than one reintervention was required in 5.8% of EVAR patients compared to just 1.6% of the open repair group.
The types and timing of complications leading to reintervention were very different in the two groups. Sixty-eight percent of reinterventions in the EVAR group were for treatment of endoleaks. Another 11.5% were to address device migration, and an equal number were for occlusion.
In contrast, the three most frequent causes of reintervention in the open repair group were colonic ischemia, accounting for 30.4% of reintervention procedures; severe bleeding, 21.7%; and incisional hernia, which triggered another 21.7% of reinterventions.
Notably, 60% of all reinterventions in the open repair group occurred during the initial hospitalization, while less than 7% of reinterventions in the EVAR patients happened within 1 month of the index procedure and only one-third within the first year, the surgeon continued.
Thirty-day mortality in EVAR patients who underwent reintervention within the first month was zero, compared to a 23.3% mortality rate in open repair patients requiring reintervention within 1 month. However, when patients did not require early reintervention, 30-day mortality rates in the two groups did not differ significantly: 1.9% in EVAR group and in the open repair group. That means when patients in the open surgery group required early reintervention, their mortality rate shot up sevenfold.
After the first 30 days post-index procedure, long-term survival rates in the two groups were similar.
Need for reintervention in the open repair group was strongly related to larger aneurysm size. In contrast, reintervention rates were similar in the EVAR group regardless of aneurysm size.
A first reintervention after EVAR occurred in 23.7% of patients who received a first-generation endograft, such as the Ancure or Talent; in 16.2% of those who got the second-generation AneuRx endograft; and in 9.1% with a third-generation endograft, such as the Excluder, Endurant, Powerlink, or Zenith. The annualized rate of reintervention during the first 3 years of follow-up was 6.8% per year with first-generation devices, 7.2% per year with second-generation endografts, and significantly lower at 3.4% per year with the third-generation.
One major reason reintervention rates in EVAR patients have declined over time is that each newer generation of endograft is lower-profile, easier to deploy, and more durable. Also, many of the surgeons now putting in third-generation endografts were performing EVAR 15 years ago; they’re very experienced operators, Dr. Al-Jubouri noted.
Discussant Dr. James R. Debord proposed another explanation for the decrease in EVAR reinterventions over time.
"Isn’t it much more likely that it’s due to recognition of the fact that many of these type 2 endoleaks that we used to intervene on early on don’t require reintervention unless there’s sac enlargement?" commented Dr. Debord, professor of clinical surgery and chief of vascular surgery at the University of Illinois at Peoria.
Dr. Al-Jubouri concurred that this is an important factor in the declining rate of EVAR reinterventions.
"We saw a significant decrease in reinterventions for type 2 endoleaks between the first, second, and third generations," he said.
Asked how his study findings have changed the follow-up protocols at Jobst Vascular Institute, the surgeon replied that in the early years of the series EVAR patients got a CT scan at 6 weeks, 6 months, 1 year, and annually thereafter. This evaluation has evolved over time. Now EVAR patients get a CT scan at 6-12 weeks, and duplex ultrasounds at 6 months, 1 year, and annually thereafter.
"There is no standardized follow-up for open repair patients. However, most [patients] get an annual duplex ultrasound for their follow-up. A CT scan is not part of the follow-up of patients with open repair. But most if not all of the complications that developed in the open repair group were symptomatic," he explained.
He reported having no financial conflicts.
INDIANAPOLIS – Reintervention rates following endovascular repair of abdominal aortic aneurysms have fallen steadily with the introduction of each successive generation of endografts, while reintervention rates after open surgical repair remained stable during a recent 15-year period.
This was among the key findings from the first in-depth analysis of reinterventions occurring in contemporaneous cohorts of abdominal aortic aneurysm (AAA) patients undergoing endovascular aneurysm repair (EVAR) or open repair. The large single-center retrospective study demonstrated major differences between the two treatment strategies in terms of the incidence, nature, timing, and mortality associated with complications requiring reintervention, Dr. Mustafa Al-Jubouri said at the annual meeting of the American Surgical Association.
Dr. Al-Jubouri of Jobst Vascular Institute, Toledo, Ohio, reported on the 1,144 patients who underwent AAA repair there during 1996-2011. Forty-nine percent had EVAR, 51% open surgical repair. Beginning in 2003, more EVARs than open repairs were done annually at the Toledo institute, consistent with the experience at many major centers in the United States and elsewhere, where EVAR has become the first-line treatment based upon evidence that it offers lower operative mortality, less blood loss, and shorter ICU and hospital lengths of stay.
These advantages come at a cost, however: namely, a greater rate of secondary interventions, mainly due to device migration, failure, or endoleaks. The purpose of Dr. Al-Jubouri’s study was to evaluate the rates and reasons for reintervention over time in the two cohorts, as well as the impact of reintervention on long-term survival.
Reintervention was required in 13.6% of the EVAR group during a mean follow-up of 4.58 years, and in 5.1% of the open surgery group during 6.58 years. A single reintervention occurred in 7.9% of EVAR patients and 3.6% of the open repair group. More than one reintervention was required in 5.8% of EVAR patients compared to just 1.6% of the open repair group.
The types and timing of complications leading to reintervention were very different in the two groups. Sixty-eight percent of reinterventions in the EVAR group were for treatment of endoleaks. Another 11.5% were to address device migration, and an equal number were for occlusion.
In contrast, the three most frequent causes of reintervention in the open repair group were colonic ischemia, accounting for 30.4% of reintervention procedures; severe bleeding, 21.7%; and incisional hernia, which triggered another 21.7% of reinterventions.
Notably, 60% of all reinterventions in the open repair group occurred during the initial hospitalization, while less than 7% of reinterventions in the EVAR patients happened within 1 month of the index procedure and only one-third within the first year, the surgeon continued.
Thirty-day mortality in EVAR patients who underwent reintervention within the first month was zero, compared to a 23.3% mortality rate in open repair patients requiring reintervention within 1 month. However, when patients did not require early reintervention, 30-day mortality rates in the two groups did not differ significantly: 1.9% in EVAR group and in the open repair group. That means when patients in the open surgery group required early reintervention, their mortality rate shot up sevenfold.
After the first 30 days post-index procedure, long-term survival rates in the two groups were similar.
Need for reintervention in the open repair group was strongly related to larger aneurysm size. In contrast, reintervention rates were similar in the EVAR group regardless of aneurysm size.
A first reintervention after EVAR occurred in 23.7% of patients who received a first-generation endograft, such as the Ancure or Talent; in 16.2% of those who got the second-generation AneuRx endograft; and in 9.1% with a third-generation endograft, such as the Excluder, Endurant, Powerlink, or Zenith. The annualized rate of reintervention during the first 3 years of follow-up was 6.8% per year with first-generation devices, 7.2% per year with second-generation endografts, and significantly lower at 3.4% per year with the third-generation.
One major reason reintervention rates in EVAR patients have declined over time is that each newer generation of endograft is lower-profile, easier to deploy, and more durable. Also, many of the surgeons now putting in third-generation endografts were performing EVAR 15 years ago; they’re very experienced operators, Dr. Al-Jubouri noted.
Discussant Dr. James R. Debord proposed another explanation for the decrease in EVAR reinterventions over time.
"Isn’t it much more likely that it’s due to recognition of the fact that many of these type 2 endoleaks that we used to intervene on early on don’t require reintervention unless there’s sac enlargement?" commented Dr. Debord, professor of clinical surgery and chief of vascular surgery at the University of Illinois at Peoria.
Dr. Al-Jubouri concurred that this is an important factor in the declining rate of EVAR reinterventions.
"We saw a significant decrease in reinterventions for type 2 endoleaks between the first, second, and third generations," he said.
Asked how his study findings have changed the follow-up protocols at Jobst Vascular Institute, the surgeon replied that in the early years of the series EVAR patients got a CT scan at 6 weeks, 6 months, 1 year, and annually thereafter. This evaluation has evolved over time. Now EVAR patients get a CT scan at 6-12 weeks, and duplex ultrasounds at 6 months, 1 year, and annually thereafter.
"There is no standardized follow-up for open repair patients. However, most [patients] get an annual duplex ultrasound for their follow-up. A CT scan is not part of the follow-up of patients with open repair. But most if not all of the complications that developed in the open repair group were symptomatic," he explained.
He reported having no financial conflicts.
AT THE ASA ANNUAL MEETING
Major Finding: Reintervention rates were markedly higher following endovascular repair compared with open surgical repair of abdominal aortic aneurysms, but the adverse effects associated with reintervention after open repair were far more serious.
Data Source: A retrospective study of the 15-year experience at a large-volume vascular surgery. It encompassed 1,144 patients who underwent abdominal aortic aneurysm repair and their subsequent reintervention rates.
Disclosures: The presenter reported having no conflicts of interest.