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IF16. Management of Recurrent Visceral Aortic Patch Aneurysm After Thoracoabdominal Repair: Open, Hybrid, and Endovascular Approach
Journal of Vascular Surgery
Abstracts
41S
Volume 65, Number 6S Table VIII. Comparison of trends in bifurcation true lumen (TL) ratio Odds ratio (95% CI)
P
Yes
1.027 (0.024-44.230)
.989
No
Ref
Parameters
Table I. Patient demographics
Bare stent
Measures 12-months post-op
2.723 (2.555-2.902)
<.001a
6-months post-op
2.707 (2.540-2.884)
<.001a
3-months post-op
2.737 (2.559-2.926)
<.001a
Pre-op
2.726 (0-21,775.822)
Open (n ¼ 14)
Age (years)
71 (68-74) 72.5 (68-75)
Overall (n ¼ 29)
65 (58-72)
71 (67-74)
0
0
1
1
55-69 years
5
3
2
10 18
70-79 years
9
7
2
>80 years
0
0
0
13 (93)
8 (80)
3 (60)
0 24 (83)
I
0
0
0
0
II
5 (35.7)
1 (10)
0
6 (20.7)
III
5 (35.7)
6 (60)
4 (80)
IV
4 (28.6)
3 (30)
1 (20)
8 (27.6)
9.5 (5-14)
11 (8-17)
9 (9-11)
10 (7-15)
<10 points
7 (50)
4 (40)
3 (60)
14 (48)
10-20 points
5 (36)
4 (40)
2 (40)
11 (38)
>20 points
2 (14)
2 (20)
aorta, middle infrarenal aorta, and distal aorta bifurcation, and the true lumen ratio was calculated accordingly. Results: In the no bare-stent group, 5 patients presented with total regression of the false lumen extending from the thoracic to abdominal aorta, 9 with partial regression with total thrombosis of false lumen, and 16 with a patent false lumen. In the bare-stent group, 9 presented with total regression, 7 with partial regression, and 21 with a patent false lumen. There was no significant difference between two groups for any types of aortic remodeling (P ¼ .552 in total regression, P ¼ .390 in partial regression, P ¼ .809 in patent false lumen). The postoperative true lumen area ratio significantly increased in both groups (P < .05). When comparing the degree of postoperative true lumen expansion between the two groups, the true lumen expansion was significantly bigger in bare-stent group than in no bare-stent group at all five levels of the aorta (P < .001). Conclusions: Proximal thoracic stent grafting for coverage of major thoracic dissection inlets with distal bare stenting effectively expands thoracic and abdominal aorta true lumen area but does not promote aortic remodeling in patients with chronic complicated type B aortic dissection.
Median SVS score
Author Disclosures: I. Chen: Nothing to disclose; P. Chen: Nothing to disclose; C. Huang: Nothing to disclose; C. Shih: Nothing to disclose.
Diabetes
IF16. Management of Recurrent Visceral Aortic Patch Aneurysm After Thoracoabdominal Repair: Open, Hybrid, and Endovascular Approach 1
Endovascular (n ¼ 5)
ASA score .827
CI, Confidence interval. a P < .05.
1
Hybrid (n ¼ 10)
<55 years
Male
Ref
Pre-op bifurcation TL ratio
Variablea
0
15 (51.7)
4 (14)
Hypertension 0
1 (7.1)
1 (10)
0
2 (6.9)
1
7 (50)
8 (80)
0
15 (51.7)
2
4 (28.6)
1 (10)
0
5 (17.2)
3
2 (14.3)
0
5 (100)
7 (24.1)
Smoking 0
4 (28.6)
1 (10)
0 (0)
5 (17.2)
1
4 (28.6)
3 (30)
2 (40)
9 (31.0)
2
5 (35.7)
4 (40)
3 (60)
12 (41.4)
3
1 (7.1)
2 (20)
0
13 (92.9)
9 (90)
1
0
1 (10)
2
1 (7.1)
0
3
0
0
0 3 (60) 0 2 (40) 0
3 (10.3) 25 (86.2) 1 (3.4) 2 (6.9) 1 (2.4)
Hyperlipemia
2
Luca Bertoglio, MD, Daniele Mascia, MD, Andrea Kahlberg, MD, Tommaso Cambiaghi, MD,1 Yamume Tshomba, MD,2 Germano Melissano, MD,2 Roberto Chiesa, MD2. 1San Raffaele Scientific Institute, Milano, Italy; 2San Raffaele University, Segrate, Italy
Objectives: This study compared the outcomes of patients with visceral aortic patch (VAP) aneurysms following thoracoabdominal aneurysm (TAAA) open repair treated with three different approaches: open, hybrid, and fenestrated endovascular repair. Methods: Between 1993 and 2016, 29 patients (24 men, median age 71 years; Table I) were referred to our division for recurrent VAP aneurysm (median diameter, 64; range, 58-69) after initial TAAA open repair (median time interval, 6.2 years; range, 4-8 years; Table II) with a prevalence of 2.2% in our open TAAA series (872 cases with the inclusion technique). Four patients (14%) presented connective tissue disorders, and nine patients (31%) had postdissecting aneurysms. Patients were treated by means of redo open repair (O group) in 14 cases (48.3%; Fig 1), hybrid repair (H group) in 10 (34.5%; Fig 2), and endovascular custom-made fenestrated endograft (E group) in 5 (17.2%). Outcomes are reported according to the Society for Vascular Surgery/AASS standards. Patients were evaluated with computed tomography scans in the outpatient clinic at 3, 6, and 12 months and then annually if not otherwise required. Results: Results are summarized in Table III. Technical success (24 hours) was achieved in all cases with a median procedural time of 250 minutes (O: 220 minutes; H: 255 minutes; E: 320 minutes) and median intraoperative estimated blood loss of 1000 mL (O: 1475 mL; H: 550 mL; E: 400 mL). The 30-day mortality was 13.8% (O: 14.3%; H: 20%; E: 0%).
0
2 (14.3)
1 (10)
1
5 (35.7)
3 (30)
3 (60) 0 0
6 (20.7) 8 (27.6)
2
1 (7.1)
0
3
6 (42.9)
6 (60)
1 (3.5)
0
7 (50)
1
4 (28.6)
2
3 (21.4)
3 (30)
0
6 (20.7)
3
0
1 (10)
0
1 (3.4)
2 (40)
15 (51.7)
3 (30)
3 (30)
13 (44.8)
3 (30)
2 (40)
9 (31)
Cardiac status
Pulmonary status 0
2 (14.3)
0
1 (20)
3 (10.3)
1
5 (35.7)
2 (20)
4 (80)
11 (37.9)
2
5 (35.7)
5 (50)
0
10 (34.5)
3
2 (14.3)
3 (30)
0
5 (17.2)
0
7 (50)
6 (60)
1 (20)
14 (48.3)
1
5 (35.7)
3 (30)
3 (60)
11 (37.9)
2
2 (14.3)
1 (10)
3
0
0
Renals status
0 1 (20)
3 (10.3) 1 (3.4)
ASA, American Society of Anesthesiologists; SVS, Society for Vascular Surgery. a Data are presented as median (range) or number (%).
42S
Journal of Vascular Surgery
Abstracts
June Supplement 2017 Table II. Patients’ aortic history Variablea
Open (n ¼ 14)
Hybrid (n ¼ 10)
Endovascular (n ¼ 5) 58 (58-65)
VAP diameter (mm)
62 (58-68)
67 (63-75)
Interval from TAAA repair
5.8 (3-7)
6.5 (4-10)
7 (4-10)
Overall (n ¼ 29) 64 (58-69) 6.2 (4-8)
TAAA extent Type I
0
1 (20)
1 (4)
Type II
6 (43)
0
5 (50)
2 (40)
13 (45)
Type III
6 (43)
4 (40)
2 (40)
12 (41)
Type IV
2 (14)
1 (10)
0
3 (10)
Collagenopathy
2 (14)
2 (20)
0
4 (14)
Postdissecting
5 (36)
2 (20)
2 (40)
9 (31)
TAAA, Thoracoabdominal aortic aneurysm; VAP, visceral aortic patch. a Data are presented as median (range) or number (%).
Table III. Thirty-day and midterm outcomes Hybrid (n ¼ 10)
Endovascular (n ¼ 5)
Operative time (min)
220 (190-260)
255 (193-340)
320 (315-540)
250 (193-320)
Estimated blood loss (mL)
1475 (1000-3400)
550 (380-1450)
400 (300-450)
1000 (450-1700)
Variablea
PRBCs transfusions (No.)
Open (n ¼ 14)
Overall (n ¼ 29)
7.5 (4-12)
4 (3-5)
2 (2-3)
ICU stay (days)
2 (1-3)
3 (1-5)
0 (0-1)
4 (3-7)
Mortality
2 (14.3)
2 (20)
0
Renal
4 (29)
1 (10)
0
5 (17.2)
Cardiac
3 (21)
1 (10)
0
4 (13.8)
Pulmonary
7 (50)
4 (40)
0
11 (37.9)
0
0
0
10 (71.5)
5 (50)
0
2 (1-4) 4 (13.8)
Complications (grade 2-3)
Spinal cord ischemia Any major adverse event Any spinal cord ischemia (any grade) Surgical revision
0 1 (7)
1 (10) 1 (10)
Follow-up (months)
71 (46-89)
Overall survival
10 (71)
1 (20) 0
0 15 (51.7) 2 (6.9) 2 (6.9)
28.5 (19-41)
7 (6-12)
30 (15-75)
4 (40)
4 (100)
16 (55.2)
Related-mortality
0
2
0
2
Unrelated mortality
2
2
0
4
ICU, Intensive care unit; PBRC, packed red blood cells. a Data are presented as median (range) or number (%).
Fig 1. Open repair.
Major (grade 2 and 3) perioperative complications (renal, respiratory, cardiac, or spinal cord) were observed in 51.7% of patients (O: 71.5%; H: 50%; E: 0%). Two patients (6.9%) required a postoperative surgical revision for bleeding (O: 1; H: 1), and in two other patients (6.9%), temporary delayed spinal cord ischemia (grade 1) was observed (H: 1; E: 1). At a mean follow-up of 41.7 6 32 months, the overall survival was 55.2%, with two late aneurysm-related deaths in the hybrid group.
Fig 2. Hybrid repair.
Conclusions: VAP aneurysm occurrence after TAAA repair is rare, and over the years, different techniques have been used to address this complex pathology. Redo open repair is associated with not negligible morbidity and mortality rates, and hybrid repair has proven not to be a possible less invasive alternative and, therefore, has been set aside. Fenestrated endovascular treatment with custom-made device is safe and effective, with promising results and it might be considered as an alternative to standard open repair.
Journal of Vascular Surgery
Abstracts
43S
Volume 65, Number 6S
Fig.
Fig 3. Endovascular repair.
Author Disclosures: L. Bertoglio: Nothing to disclose; T. Cambiaghi: Nothing to disclose; R. Chiesa: Nothing to disclose; A. Kahlberg: Nothing to disclose; D. Mascia: Nothing to disclose; G. Melissano: Nothing to disclose; Y. Tshomba: Nothing to disclose.
S1: WILLIAM J. VON LIEBIG FORUM SS01. Characterization and Outcomes of Reinterventions Following EVAR Alexander S. Fairman, Grace J. Wang, Benjamin M. Jackson, Paul J. Foley, Scott M. Damrauer, Venkat Kalapatapu, Michael A. Golden, Ronald M. Fairman. University of Pennsylvania Health System, Philadelphia, Pa Objectives: Published rates of reintervention after endovascular aneurysm repair (EVAR) range from 10% to 30%. We evaluated a single university center’s experience with reinterventions in the context of trial and United States Food and Drug Administration (FDA)-approved devices. Methods: Retrospective data collection was performed for patients who underwent infrarenal EVAR and required reintervention from 2000 to 2016. Trial EVARs included FDA feasibility and pivotal trials. Time-to-event analysis, predictors of mortality and explant, and survival analysis were performed with Cox regression, logistic regression, and Kaplan-Meier methods. Results: From 2000 to 2016, 1835 EVARs were performed, and 137 patients (116 men; mean age, 72.2 6 10.0 years; 7.5% reintervention
Table. Mean number of reinterventions and mean time to each reintervention, by device
EVAR devices (N ¼ 137)
No
Mean # of Reinterventions (P ¼ 0.009, Trial vs FDA)
Trial devices
37
SS02. 2
3
2.18
3.11
2.62
4.30
3.12
100
1.65
2.13
4.17
6.44
8.10
Ancure
1
3.00
0.83
0.83
2.87
...
Excluder
3
1.67
1.48
3.72
...
...
Endurant
10
1.70
1.8
3.03 0.019 0.15
AFX
8
1.90
1.97
2.46
2.53
0.25
Powerlink
13
1.57
2.02
2.68
2.39
3.22
Talent
3
1.75
2.29
2.34
3.43
3.76
AneuRx
11
1.63
2.32
0.69
5.03
...
Zenith
51
1.72
2.73
3.79
6.17
6.64
Food
and
Drug
EVAR, Endovascular Administration.
aneurysm
repair;
Author Disclosures: S. M. Damrauer: Nothing to disclose; A. S. Fairman: Nothing to disclose; R. M. Fairman: Nothing to disclose; P. J. Foley: Nothing to disclose; M. A. Golden: Nothing to disclose; B. M. Jackson: Nothing to disclose; V. Kalapatapu: Nothing to disclose; G. J. Wang: Nothing to disclose.
Time to Reinterventions (years) 1
FDA-approved devices
rate) underwent reintervention with a mean aneurysm size of 5.9 6 1.2 cm. The median follow-up was 5 years, with an overall survival of 70.1%. Device specific details are outlined in the Table. Most patients (79.5%) underwent two or fewer reinterventions, 20.5% underwent three, and 7.9% underwent four. For all devices, the most common etiology of reintervention was type II endoleak (52.5%), followed by type I endoleak (18.2%), type III endoleak (9.5%), limb kink (7.3%), iliac occlusive disease (5.8%), endotension (1.5%), and other. The Fig compares etiologies between trial and FDA-approved devices. The overall mean time to the first reintervention was 2.3 6 2.5 years, and univariate Cox regression identified male gender (hazard ratio, 1.91; 95% confidence interval [CI], 1.17-3.10; P ¼ .010) and age at the time of EVAR (hazard ratio, 1.03; 95% CI, 1.01-1.05; P ¼ .006) as risk factors for time to first reintervention. Among all patients requiring reintervention, the mean number of reinterventions for trial devices was significantly greater than that for FDAapproved devices (2.18 vs 1.65; P ¼ .009). Trial devices requiring reintervention had a nearly three-fold increase in odds for the need for greater than two reinterventions (odds ratio, 2.88; 95% CI, 1.12-7.37; P ¼ .031). Trial device, etiology of reintervention, and type of reintervention were not predictive of the need for explant or mortality, but the number of reinterventions was significantly associated with the need for explant (odds ratio, 1.86; 95% CI, 1.17-2.96; P ¼ .009). EVAR device and the need for explant did not impact mortality. Conclusions: Despite the rigorous nature of patient enrollment in clinical trials and the development of newer iterations of investigational devices, patients undergoing EVAR with trial devices are more likely to undergo a greater number of reinterventions compared to FDAapproved EVARs. Although mortality and the need for explant were not significantly associated with trial devices, the former finding points to an ethical duty to properly inform patients willing to partake in investigational device trials.
FDA,
4
Standard EVAR in Patients With Dilated Infrarenal Necks Requiring a 34-36 mm Endograft Is Associated With Increased Risk of Type Ia Endoleak and Stent Migration Graeme E. McFarland, Kenneth Tran, Whitt Virgin-Downey, Venita Chandra, Matthew W. Mell, E. John. Harris, Ronald L. Dalman, Jason T. Lee. Stanford University, Stanford, Calif Objectives: Endovascular aneurysm repair (EVAR) has become the standard of care for repair of infrarenal aneurysms. Commercially available endografts are available in proximal diameters up to 36 mm, allowing for proximal seal in necks up to 32 mm. We sought to further investigate clinical outcomes following standard EVAR in patients requiring large main body devices. Methods: We performed a retrospective review of a prospectively maintained database for all patients undergoing elective EVAR for infrarenal abdominal aortic aneurysms at a single institution from 2001 to 2016.
Abstracts
41S
Volume 65, Number 6S Table VIII. Comparison of trends in bifurcation true lumen (TL) ratio Odds ratio (95% CI)
P
Yes
1.027 (0.024-44.230)
.989
No
Ref
Parameters
Table I. Patient demographics
Bare stent
Measures 12-months post-op
2.723 (2.555-2.902)
<.001a
6-months post-op
2.707 (2.540-2.884)
<.001a
3-months post-op
2.737 (2.559-2.926)
<.001a
Pre-op
2.726 (0-21,775.822)
Open (n ¼ 14)
Age (years)
71 (68-74) 72.5 (68-75)
Overall (n ¼ 29)
65 (58-72)
71 (67-74)
0
0
1
1
55-69 years
5
3
2
10 18
70-79 years
9
7
2
>80 years
0
0
0
13 (93)
8 (80)
3 (60)
0 24 (83)
I
0
0
0
0
II
5 (35.7)
1 (10)
0
6 (20.7)
III
5 (35.7)
6 (60)
4 (80)
IV
4 (28.6)
3 (30)
1 (20)
8 (27.6)
9.5 (5-14)
11 (8-17)
9 (9-11)
10 (7-15)
<10 points
7 (50)
4 (40)
3 (60)
14 (48)
10-20 points
5 (36)
4 (40)
2 (40)
11 (38)
>20 points
2 (14)
2 (20)
aorta, middle infrarenal aorta, and distal aorta bifurcation, and the true lumen ratio was calculated accordingly. Results: In the no bare-stent group, 5 patients presented with total regression of the false lumen extending from the thoracic to abdominal aorta, 9 with partial regression with total thrombosis of false lumen, and 16 with a patent false lumen. In the bare-stent group, 9 presented with total regression, 7 with partial regression, and 21 with a patent false lumen. There was no significant difference between two groups for any types of aortic remodeling (P ¼ .552 in total regression, P ¼ .390 in partial regression, P ¼ .809 in patent false lumen). The postoperative true lumen area ratio significantly increased in both groups (P < .05). When comparing the degree of postoperative true lumen expansion between the two groups, the true lumen expansion was significantly bigger in bare-stent group than in no bare-stent group at all five levels of the aorta (P < .001). Conclusions: Proximal thoracic stent grafting for coverage of major thoracic dissection inlets with distal bare stenting effectively expands thoracic and abdominal aorta true lumen area but does not promote aortic remodeling in patients with chronic complicated type B aortic dissection.
Median SVS score
Author Disclosures: I. Chen: Nothing to disclose; P. Chen: Nothing to disclose; C. Huang: Nothing to disclose; C. Shih: Nothing to disclose.
Diabetes
IF16. Management of Recurrent Visceral Aortic Patch Aneurysm After Thoracoabdominal Repair: Open, Hybrid, and Endovascular Approach 1
Endovascular (n ¼ 5)
ASA score .827
CI, Confidence interval. a P < .05.
1
Hybrid (n ¼ 10)
<55 years
Male
Ref
Pre-op bifurcation TL ratio
Variablea
0
15 (51.7)
4 (14)
Hypertension 0
1 (7.1)
1 (10)
0
2 (6.9)
1
7 (50)
8 (80)
0
15 (51.7)
2
4 (28.6)
1 (10)
0
5 (17.2)
3
2 (14.3)
0
5 (100)
7 (24.1)
Smoking 0
4 (28.6)
1 (10)
0 (0)
5 (17.2)
1
4 (28.6)
3 (30)
2 (40)
9 (31.0)
2
5 (35.7)
4 (40)
3 (60)
12 (41.4)
3
1 (7.1)
2 (20)
0
13 (92.9)
9 (90)
1
0
1 (10)
2
1 (7.1)
0
3
0
0
0 3 (60) 0 2 (40) 0
3 (10.3) 25 (86.2) 1 (3.4) 2 (6.9) 1 (2.4)
Hyperlipemia
2
Luca Bertoglio, MD, Daniele Mascia, MD, Andrea Kahlberg, MD, Tommaso Cambiaghi, MD,1 Yamume Tshomba, MD,2 Germano Melissano, MD,2 Roberto Chiesa, MD2. 1San Raffaele Scientific Institute, Milano, Italy; 2San Raffaele University, Segrate, Italy
Objectives: This study compared the outcomes of patients with visceral aortic patch (VAP) aneurysms following thoracoabdominal aneurysm (TAAA) open repair treated with three different approaches: open, hybrid, and fenestrated endovascular repair. Methods: Between 1993 and 2016, 29 patients (24 men, median age 71 years; Table I) were referred to our division for recurrent VAP aneurysm (median diameter, 64; range, 58-69) after initial TAAA open repair (median time interval, 6.2 years; range, 4-8 years; Table II) with a prevalence of 2.2% in our open TAAA series (872 cases with the inclusion technique). Four patients (14%) presented connective tissue disorders, and nine patients (31%) had postdissecting aneurysms. Patients were treated by means of redo open repair (O group) in 14 cases (48.3%; Fig 1), hybrid repair (H group) in 10 (34.5%; Fig 2), and endovascular custom-made fenestrated endograft (E group) in 5 (17.2%). Outcomes are reported according to the Society for Vascular Surgery/AASS standards. Patients were evaluated with computed tomography scans in the outpatient clinic at 3, 6, and 12 months and then annually if not otherwise required. Results: Results are summarized in Table III. Technical success (24 hours) was achieved in all cases with a median procedural time of 250 minutes (O: 220 minutes; H: 255 minutes; E: 320 minutes) and median intraoperative estimated blood loss of 1000 mL (O: 1475 mL; H: 550 mL; E: 400 mL). The 30-day mortality was 13.8% (O: 14.3%; H: 20%; E: 0%).
0
2 (14.3)
1 (10)
1
5 (35.7)
3 (30)
3 (60) 0 0
6 (20.7) 8 (27.6)
2
1 (7.1)
0
3
6 (42.9)
6 (60)
1 (3.5)
0
7 (50)
1
4 (28.6)
2
3 (21.4)
3 (30)
0
6 (20.7)
3
0
1 (10)
0
1 (3.4)
2 (40)
15 (51.7)
3 (30)
3 (30)
13 (44.8)
3 (30)
2 (40)
9 (31)
Cardiac status
Pulmonary status 0
2 (14.3)
0
1 (20)
3 (10.3)
1
5 (35.7)
2 (20)
4 (80)
11 (37.9)
2
5 (35.7)
5 (50)
0
10 (34.5)
3
2 (14.3)
3 (30)
0
5 (17.2)
0
7 (50)
6 (60)
1 (20)
14 (48.3)
1
5 (35.7)
3 (30)
3 (60)
11 (37.9)
2
2 (14.3)
1 (10)
3
0
0
Renals status
0 1 (20)
3 (10.3) 1 (3.4)
ASA, American Society of Anesthesiologists; SVS, Society for Vascular Surgery. a Data are presented as median (range) or number (%).
42S
Journal of Vascular Surgery
Abstracts
June Supplement 2017 Table II. Patients’ aortic history Variablea
Open (n ¼ 14)
Hybrid (n ¼ 10)
Endovascular (n ¼ 5) 58 (58-65)
VAP diameter (mm)
62 (58-68)
67 (63-75)
Interval from TAAA repair
5.8 (3-7)
6.5 (4-10)
7 (4-10)
Overall (n ¼ 29) 64 (58-69) 6.2 (4-8)
TAAA extent Type I
0
1 (20)
1 (4)
Type II
6 (43)
0
5 (50)
2 (40)
13 (45)
Type III
6 (43)
4 (40)
2 (40)
12 (41)
Type IV
2 (14)
1 (10)
0
3 (10)
Collagenopathy
2 (14)
2 (20)
0
4 (14)
Postdissecting
5 (36)
2 (20)
2 (40)
9 (31)
TAAA, Thoracoabdominal aortic aneurysm; VAP, visceral aortic patch. a Data are presented as median (range) or number (%).
Table III. Thirty-day and midterm outcomes Hybrid (n ¼ 10)
Endovascular (n ¼ 5)
Operative time (min)
220 (190-260)
255 (193-340)
320 (315-540)
250 (193-320)
Estimated blood loss (mL)
1475 (1000-3400)
550 (380-1450)
400 (300-450)
1000 (450-1700)
Variablea
PRBCs transfusions (No.)
Open (n ¼ 14)
Overall (n ¼ 29)
7.5 (4-12)
4 (3-5)
2 (2-3)
ICU stay (days)
2 (1-3)
3 (1-5)
0 (0-1)
4 (3-7)
Mortality
2 (14.3)
2 (20)
0
Renal
4 (29)
1 (10)
0
5 (17.2)
Cardiac
3 (21)
1 (10)
0
4 (13.8)
Pulmonary
7 (50)
4 (40)
0
11 (37.9)
0
0
0
10 (71.5)
5 (50)
0
2 (1-4) 4 (13.8)
Complications (grade 2-3)
Spinal cord ischemia Any major adverse event Any spinal cord ischemia (any grade) Surgical revision
0 1 (7)
1 (10) 1 (10)
Follow-up (months)
71 (46-89)
Overall survival
10 (71)
1 (20) 0
0 15 (51.7) 2 (6.9) 2 (6.9)
28.5 (19-41)
7 (6-12)
30 (15-75)
4 (40)
4 (100)
16 (55.2)
Related-mortality
0
2
0
2
Unrelated mortality
2
2
0
4
ICU, Intensive care unit; PBRC, packed red blood cells. a Data are presented as median (range) or number (%).
Fig 1. Open repair.
Major (grade 2 and 3) perioperative complications (renal, respiratory, cardiac, or spinal cord) were observed in 51.7% of patients (O: 71.5%; H: 50%; E: 0%). Two patients (6.9%) required a postoperative surgical revision for bleeding (O: 1; H: 1), and in two other patients (6.9%), temporary delayed spinal cord ischemia (grade 1) was observed (H: 1; E: 1). At a mean follow-up of 41.7 6 32 months, the overall survival was 55.2%, with two late aneurysm-related deaths in the hybrid group.
Fig 2. Hybrid repair.
Conclusions: VAP aneurysm occurrence after TAAA repair is rare, and over the years, different techniques have been used to address this complex pathology. Redo open repair is associated with not negligible morbidity and mortality rates, and hybrid repair has proven not to be a possible less invasive alternative and, therefore, has been set aside. Fenestrated endovascular treatment with custom-made device is safe and effective, with promising results and it might be considered as an alternative to standard open repair.
Journal of Vascular Surgery
Abstracts
43S
Volume 65, Number 6S
Fig.
Fig 3. Endovascular repair.
Author Disclosures: L. Bertoglio: Nothing to disclose; T. Cambiaghi: Nothing to disclose; R. Chiesa: Nothing to disclose; A. Kahlberg: Nothing to disclose; D. Mascia: Nothing to disclose; G. Melissano: Nothing to disclose; Y. Tshomba: Nothing to disclose.
S1: WILLIAM J. VON LIEBIG FORUM SS01. Characterization and Outcomes of Reinterventions Following EVAR Alexander S. Fairman, Grace J. Wang, Benjamin M. Jackson, Paul J. Foley, Scott M. Damrauer, Venkat Kalapatapu, Michael A. Golden, Ronald M. Fairman. University of Pennsylvania Health System, Philadelphia, Pa Objectives: Published rates of reintervention after endovascular aneurysm repair (EVAR) range from 10% to 30%. We evaluated a single university center’s experience with reinterventions in the context of trial and United States Food and Drug Administration (FDA)-approved devices. Methods: Retrospective data collection was performed for patients who underwent infrarenal EVAR and required reintervention from 2000 to 2016. Trial EVARs included FDA feasibility and pivotal trials. Time-to-event analysis, predictors of mortality and explant, and survival analysis were performed with Cox regression, logistic regression, and Kaplan-Meier methods. Results: From 2000 to 2016, 1835 EVARs were performed, and 137 patients (116 men; mean age, 72.2 6 10.0 years; 7.5% reintervention
Table. Mean number of reinterventions and mean time to each reintervention, by device
EVAR devices (N ¼ 137)
No
Mean # of Reinterventions (P ¼ 0.009, Trial vs FDA)
Trial devices
37
SS02. 2
3
2.18
3.11
2.62
4.30
3.12
100
1.65
2.13
4.17
6.44
8.10
Ancure
1
3.00
0.83
0.83
2.87
...
Excluder
3
1.67
1.48
3.72
...
...
Endurant
10
1.70
1.8
3.03 0.019 0.15
AFX
8
1.90
1.97
2.46
2.53
0.25
Powerlink
13
1.57
2.02
2.68
2.39
3.22
Talent
3
1.75
2.29
2.34
3.43
3.76
AneuRx
11
1.63
2.32
0.69
5.03
...
Zenith
51
1.72
2.73
3.79
6.17
6.64
Food
and
Drug
EVAR, Endovascular Administration.
aneurysm
repair;
Author Disclosures: S. M. Damrauer: Nothing to disclose; A. S. Fairman: Nothing to disclose; R. M. Fairman: Nothing to disclose; P. J. Foley: Nothing to disclose; M. A. Golden: Nothing to disclose; B. M. Jackson: Nothing to disclose; V. Kalapatapu: Nothing to disclose; G. J. Wang: Nothing to disclose.
Time to Reinterventions (years) 1
FDA-approved devices
rate) underwent reintervention with a mean aneurysm size of 5.9 6 1.2 cm. The median follow-up was 5 years, with an overall survival of 70.1%. Device specific details are outlined in the Table. Most patients (79.5%) underwent two or fewer reinterventions, 20.5% underwent three, and 7.9% underwent four. For all devices, the most common etiology of reintervention was type II endoleak (52.5%), followed by type I endoleak (18.2%), type III endoleak (9.5%), limb kink (7.3%), iliac occlusive disease (5.8%), endotension (1.5%), and other. The Fig compares etiologies between trial and FDA-approved devices. The overall mean time to the first reintervention was 2.3 6 2.5 years, and univariate Cox regression identified male gender (hazard ratio, 1.91; 95% confidence interval [CI], 1.17-3.10; P ¼ .010) and age at the time of EVAR (hazard ratio, 1.03; 95% CI, 1.01-1.05; P ¼ .006) as risk factors for time to first reintervention. Among all patients requiring reintervention, the mean number of reinterventions for trial devices was significantly greater than that for FDAapproved devices (2.18 vs 1.65; P ¼ .009). Trial devices requiring reintervention had a nearly three-fold increase in odds for the need for greater than two reinterventions (odds ratio, 2.88; 95% CI, 1.12-7.37; P ¼ .031). Trial device, etiology of reintervention, and type of reintervention were not predictive of the need for explant or mortality, but the number of reinterventions was significantly associated with the need for explant (odds ratio, 1.86; 95% CI, 1.17-2.96; P ¼ .009). EVAR device and the need for explant did not impact mortality. Conclusions: Despite the rigorous nature of patient enrollment in clinical trials and the development of newer iterations of investigational devices, patients undergoing EVAR with trial devices are more likely to undergo a greater number of reinterventions compared to FDAapproved EVARs. Although mortality and the need for explant were not significantly associated with trial devices, the former finding points to an ethical duty to properly inform patients willing to partake in investigational device trials.
FDA,
4
Standard EVAR in Patients With Dilated Infrarenal Necks Requiring a 34-36 mm Endograft Is Associated With Increased Risk of Type Ia Endoleak and Stent Migration Graeme E. McFarland, Kenneth Tran, Whitt Virgin-Downey, Venita Chandra, Matthew W. Mell, E. John. Harris, Ronald L. Dalman, Jason T. Lee. Stanford University, Stanford, Calif Objectives: Endovascular aneurysm repair (EVAR) has become the standard of care for repair of infrarenal aneurysms. Commercially available endografts are available in proximal diameters up to 36 mm, allowing for proximal seal in necks up to 32 mm. We sought to further investigate clinical outcomes following standard EVAR in patients requiring large main body devices. Methods: We performed a retrospective review of a prospectively maintained database for all patients undergoing elective EVAR for infrarenal abdominal aortic aneurysms at a single institution from 2001 to 2016.