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CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.
GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.
The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.
He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.
Noncylindrical neck anatomy
An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.
After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
Large proximal aortic neck
Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.
The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).
Severe neck angulation
Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.
During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.
“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.
Dr. Brinster reported having no conflicts regarding his presentation.
[email protected]
CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.
GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.
The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.
He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.
Noncylindrical neck anatomy
An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.
After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
Large proximal aortic neck
Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.
The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).
Severe neck angulation
Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.
During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.
“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.
Dr. Brinster reported having no conflicts regarding his presentation.
[email protected]
CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.
GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.
The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.
He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.
Noncylindrical neck anatomy
An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.
After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
Large proximal aortic neck
Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.
The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).
Severe neck angulation
Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.
During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.
“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.
Dr. Brinster reported having no conflicts regarding his presentation.
[email protected]
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM