- Email: [email protected]
Early North American experience with the INCRAFT device
From the Vascular and Endovascular Surgery Society
Early North American experience with the INCRAFT device Heather L. Gill, MD, MPH,a Robert J. Doonan, MD, PhD,a Abdulmajeed Altoijry, MD, MSc,b Daniel I. Obrand, MD,c Kent S. Mackenzie, MD,a and Oren K. Steinmetz, MD,a Montreal, Quebec, Canada; and Riyadh, Saudi Arabia
ABSTRACT Background: Several low-profile grafts have been created for use in endovascular aneurysm repair in patients with small or difficult to access vessels. Our objective was to evaluate the outcomes of patients undergoing endovascular aneurysm repair with the INCRAFT device in a real-world North American setting. Methods: Consecutive patients undergoing INCRAFT implantation between March 2015 and December 2016 at two McGill University teaching hospitals were enrolled in a prospectively maintained registry. Clinical characteristic and perioperative outcomes were entered into the registry. Two authors performed anatomic measurements from preoperative and postoperative computed tomography angiograms and intraoperative angiograms independently. In cases of disagreement a consensus was reached. Results: We included 61 patients with a median follow-up of 363 days (mean, 344 6 244 days). Minimum left and right access vessel sizes were 7.5 6 1.7 mm and 7.4 6 1.5 mm, respectively. More than 90% of grafts were implanted for aneurysm size or growth. Vessel access was percutaneous in 95% of cases. We had a mean length of stay of 0.88 6 1.8 days with 57.3% of patients discharged the same day. There were 14 procedural type II endoleaks, 10 new type II leaks that were discovered during follow-up, and 11 that resolved for 77% of patients remaining endoleak free during follow-up. There were no 30-day mortalities. Three cancer-related deaths occurred during follow-up. Early complications included one access site repair for bleeding, one access site repair for dissection, and two aortounilateral conversions with femoral-femoral bypass owing to inadvertent ipsilateral gate cannulation. Long-term complications included one graft limb thrombosis, one intervention for type II endoleak with sac expansion that subsequently became infected and was explanted, and one intervention for a type III endoleak for an intervention. During follow-up, 95% of patients remained reintervention free. Conclusions: Use of the INCRAFT device in a real-world North American setting is relatively safe and effective, and is associated with a low rate of perioperative complications. However, we experienced early issues with inadvertent cannulation and deployment of the contralateral limb in the ipsilateral gate. Therefore, we recommend deploying the entire ipsilateral limb before cannulating the contralateral limb. Data with additional follow-up are needed to assess the long-term effectiveness of the INCRAFT device. (J Vasc Surg 2018;-:1-5.) Keywords: Abdominal aortic aneurysm; Endovascular aneurysm repair; Difficult vessel access; INCRAFT
Since its first description, endovascular aortic aneurysm repair (EVAR) has steadily increased in popularity owing to its low perioperative morbidity and mortality,1-3 Since the late 2000s, it has become the most common form of elective repair for infrarenal abdominal aortic aneurysms (AAAs).1,4 Unfortunately, its use remains limited in some patients by hostile anatomic characteristics such as small, calcified, or tortuous access vessels.
The INCRAFT device, an ultralow-profile trimodular graft was designed for implantation in patients with these anatomic characteristics. The graft is available in four sizes: 22, 26, 30, and 34 mm in diameter. The outer diameter of the introducer sheath is 14F for sizes 22 to 30 mm and 16F for the main body size of 34 mm. This compares to 14F to 15F for Ovation, 18F to 20F for the Endurant II, 16F to 18F for the Excluder, and 18F to 22F
From the Division of Vascular Surgery, Department of Surgery, McGill University
The editors and reviewers of this article have no relevant financial relationships to
Health Centre,a and the Division of Vascular Surgery, Department of Surgery,
disclose per the JVS policy that requires reviewers to decline review of any
Jewish General Hospital,c Montreal; and the the Division of Vascular Surgery, Department of Surgery, College of Medicine, King Saud University, Riyadh.b Author conflict of interest: none. Presented at the Vascular and Endovascular Surgery Society Winter Meeting, Vail, Colo, February 4, 2018.
manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2018 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. https://doi.org/10.1016/j.jvs.2018.10.068
Correspondence: Heather L. Gill, MDCM, MPH, FRCSC, Assistant Professor, Vascular and Endovascular Surgery, McGill University, Royal Victoria Hospital, 1001 Decarie Blvd, Montreal, QC H4A 3J1 (e-mail: [email protected]).
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for the Zenith graft. The INCRAFT device is assembled with the main body bifurcated component as well as two iliac limb extensions and can be used to treat aortic necks 17 to 31 mm in diameter and iliac diameters of 7 to 22 mm. Further detailed features of the graft have been reported previously.5-7 It has been approved in Canada and Europe based on the results of the INNOVATION trial, a prospective, multi-institutional study of 60 patients showing safety and efficacy.6 The initial trial reported on 30-day and 1-year outcomes and has since extended its results to 4 years of follow-up.8 There has been very little postmarket data or publications on the graft to date in terms of its safety and efficacy in realworld settings.9,10 Our objective was to evaluate the safety and efficacy of the INCRAFT device in a realworld North American setting.
METHODS Consecutive patients undergoing INCRAFT (Cordis, Vaughan, Ontario, Canada) implantation between March 2015 and December 2016 at two university teaching hospitals in Montreal, Canada, were enrolled in a prospectively collected registry. Patients were eligible to undergo EVAR if they met standard eligibility criteria including AAA size of 5.5 cm or greater in men and 5.0 or greater cm in women, or growth criteria. The INCRAFT device was used according to surgeon preference and not only for difficult anatomic characteristics. However, in patients with challenging vessel access anatomy, including small, calcified, or tortuous access vessels, the INCRAFT device was used preferentially during the study period. The indications for use of the INCRAFT device include femoral access vessels adequate for delivery system, a proximal neck length of 10 mm, aortic neck diameters of 17 to 31 mm, an aortic neck suitable for suprarenal fixation, infrarenal and suprarenal neck angulation of 60 or less, iliac fixation length of 15 mm or greater, iliac diameters of 7 to 22 mm, a minimum overall treatment length of 128 mm or greater, and morphology suitable for aneurysm repair. Clinical and demographic characteristics were collected from charts and patient interview. Anatomic variables were obtained from preoperative computed tomography angiograms, including aneurysm diameter, neck length, diameter and angulation, common iliac artery, external iliac artery, and common femoral artery diameter, as well as calcium and thrombus burden of the aortic neck and common iliac artery, classified as 50% or greater or less than50%. These measurements were obtained from direct measurements and were performed independently by two authors. In cases of disagreement, a consensus was reached. Intraoperative variables collected were type of anesthesia, blood loss, fluoroscopy and procedure times, procedural success, complications, additional intraoperative
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Type of Research: Retrospective analysis of a prospectively maintained registry Take Home Message: In 61 patients who underwent INCRAFT device implantation for endovascular aneurysm repair, there were two early conversions to aortouni-iliac graft owing to inadvertent gate cannulation, one graft thrombosis, and one infection with 95% freedom of reinterventions at a median followup of 363 days Recommendation: INCRAFT seems to be safe and effective at 1 year, but deployment of the ipsilateral limb before cannulating the contralateral limb is helpful to avoid conversions.
procedures, and presence of endoleaks. Thirty-day perioperative complications, emergency room visits, readmissions, reinterventions, and deaths were recorded. Patients were followed postoperatively according to usual clinical practice. Long-term mortality as well as graft related complications, reinterventions, and endoleaks were recorded. This study was approved by the research ethics boards at our participating institutions and written informed consent was not required.
RESULTS We included 61 patients with a median follow-up of 363 days (range, 110-479 days; mean, 344 6 244 days). Patient characteristics are presented in Table I. The mean age of the included patients was 77.1 6 7.7 years with a majority of men (81.9%). Indications for surgery were AAA size/growth in 55 patients (90.1%), symptomatic AAA in 1 patient (1.6%), inflammatory AAA in 1 patient (1.6%), isolated common iliac artery aneurysm in 2 patients (3.2%), and proximal anastomotic pseudoaneurysm after prior open AAA repair in 2 patients (3.2%). There were no ruptured aneurysms that underwent INCRAFT placement. Anatomic variables are presented in Table II. Minimum access vessel diameters were 7.4 6 1.5 mm (range, 4.0-10.6 mm) on the right and 7.5 6 1.7 mm (range, 4.0-11.7 mm) on the left. Procedure characteristics are presented in Table III. The majority of patients underwent spinal anesthesia (93.4%) and ultrasound-guided percutaneous access (95.0%). We also had a same-day discharge rate (no hospital admission) of 57.3% and a mean length of stay of 0.88 6 1.8 days. Endoleak data are presented in Table IV. Fourteen type II leaks (22.9%) were found intraoperatively, 10 type II leaks (16.3%) developed during follow-up, and 11 (18.0%) resolved for 77% of patients remaining endoleak free during follow-up. Three proximal aortic cuffs were placed owing to low graft deployment, giving a 95% technical success before
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Table I. Patient characteristics
Table II. Patient anatomic characteristics Mean 6 SD or No. of patients (%)
Anatomic characteristics
Age, years
77.1 6 7.7
Maximum diameter, mm
56.5 6 11.3
Male sex
50 (81.9)
Neck diameter, mm
23.2 6 3.5
Smoker
16 (26.2)
Neck length, mm
32.7 6 17.2
Ex-smoker
20 (32.7)
Aortic neck calcification $50%
Dyslipidemia
45 (74.0)
Aortic neck thrombus $50%
Coronary artery disease
25 (40.9)
Infrarenal angle,
Chronic obstructive pulmonary disease
17 (27.8)
Suprarenal angle,
Patient characteristics
Mean 6 SD or No. (%)
7 (11.4) 4 (6.5) 25.8 6 23.9
7.3 6 18.2
Common iliac diameter right, mm
14.9 6 8.0 14.8 6 7.8
Diabetes mellitus type II
12 (19.6)
Common iliac diameter left, mm
Hypertension
45 (74.0)
Right common iliac calcification $50%
14 (22.9)
Peripheral arterial disease
5 (8.1)
Right common iliac thrombus $50%
1 (1.6)
Chronic kidney disease
7 (11.4)
Left common iliac calcification $50%
14 (22.9)
4 (6.5)
Left common iliac thrombus $50%
Liver disease Previous abdominal surgery
10 (16.3)
SD, Standard deviation.
the addition of proximal cuffs. During follow-up, 30 patients (49.1%) had a decrease in sac size, 30 patients’ sacs remained stable (49.1%), and 1 patient (1.8%) had an increase in sac size. There were no cases of endotension. Patient complications and outcomes are presented in Table V. There were no deaths within 30 days. Three deaths occurred during follow-up at a mean of 390 days and all were cancer related. Two access site repairs were performed, one owing to bleeding and one owing to dissection. These vessels were 5.0 and 4.8 mm, respectively. We also converted two cases to aortounilateral grafts with femoral-femoral bypasses. These were due to inadvertent cannulation of the ipsilateral gate and deployment of the contralateral limb, early in our experience with the graft. The distance between the contralateral and ipsilateral gate is only 1 cm with the INCRAFT device, making it very easy to inadvertently deploy the ipsilateral gate without knowing. This is particularly true in the context of suboptimal imaging and owing to the fact that there are no radiopaque markers on the ipsilateral gate. After discussion with the manufacturer, we changed our practice and began deploying the ipsilateral limb before cannulation of the contralateral gate to avoid this issue. One of these cases developed a type III endoleak from the contralateral gate during follow-up, which was treated with a plug. In addition, one graft limb thrombosis occurred, which was treated with a femoral-femoral bypass and one patient underwent two attempts at embolization for persistent type II endoleak with sac expansion. The first attempt was unsuccessful. There was a leak from the inferior mesenteric artery, which could not be cannulated by paraendograft access from the groin as well as through superior mesenteric artery collaterals. The patient was
2 (3.2)
Right external iliac artery diameter, mm
7.8 6 1.6
Left external iliac artery diameter, mm
7.8 6 1.7
Right common femoral artery diameter, mm
8.3 6 1.6
Left common femoral artery diameter, mm
8.5 6 2.0
Minimum access vessel diameter right, mm
7.4 6 1.5
Minimum access vessel diameter left, mm
7.5 6 1.7
SD, Standard deviation.
brought back to the radiology suite several weeks later and underwent direct sac puncture, which was successful. However, this same patient later developed a graft infection. Therefore, the graft was explanted and we performed reconstruction with a new aortoiliac system with femoral vein. During follow-up, 95% of patients remained reintervention free.
DISCUSSION This is the first North American series of the INCRAFT device and, to our knowledge, the largest postmarket series in the world. We have found that, in a real-world North American setting, use of the INCRAFT device is relatively safe and effective over a follow-up period of 1 year with a low rate of perioperative morbidity, mortality, and reinterventions comparable with the reported literature.3,11,12 The INCRAFT device was brought to market in an attempt to widen the availability of EVAR to patients with difficult access vessels, given its ultralow profile. Our patients had a mean access vessel size of 7.4 6 1.6 mm (range, 4.0-11.7 mm). These sizes are similar to or smaller than previous studies using the INCRAFT device as well as other low-profile devices.6,9,10,12 In our series, 95% of access was obtained percutaneously with a mean length of stay of 0.88 6 1.80 days, well below the average length of stay seen in other trials.11,13 Furthermore, almost 60% of patients left the same day of the procedure, which we have previously shown to be feasible and safe.14
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Table III. Procedure and hospital characteristics
Table V. Complications and outcomes
Mean 6 SD or No. of patients (%)
Procedure characteristics
Complications and outcomes Mortality
0 (0)
3 (4.9)
Access site repair for bleeding
Spinal
57 (93.4)
Access site repair for dissection
1 (1.6)
Local
1 (1.6)
Aortounilateral conversion
2 (3.2)
Access
1 (1.6)
Bowel obstruction
1 (1.6)
Open
4a (6.5)
Acute kidney injury
1 (1.6)
Percutaneous
58 (95.0)
Pulmonary edema
1 (1.6)
Urinary tract infection
1 (1.6)
Procedure time, minutes
78.1 6 34.5
Contrast volume, mL
60.8 6 37.2
Long term
14.1 6 5.4
Fluoroscopy time, minutes
Mortality during follow-up
125.2 6 131.6
Blood loss, mL Length of stay, days
0.88 6 1.8
Same-day discharge
35 (57.3)
a
No. (%)
30 Day
Anesthesia General anesthesia
2018
One patient had both open and percutaneous access performed. a
3 (4.9)
Graft limb thrombosis
1 (1.6)
Intervention for endoleak
2 (3.2)
Graft infection with explant
1 (1.6)
Total graft-related interventionsa
3 (4.9)
Four total graft related interventions were performed in 3 patients.
Table IV. Endoleaks During follow-up Type
Procedure
New
Resolved
Persistent
Total
I
0
0
0
0
0
II
14
10
11
3
13
III
0
1
0
0
1
IV
0
0
0
0
0
We had two access vessel complications, one cut down for a hematoma and one for a dissection of the femoral artery. Both these patients had no lasting complications secondary to vessel injury and repair. In addition, in both these cases the artery size was at or less than 5 mm. This represents a real-world scenario where device limits are pushed. Indeed, it has been shown that 30% to 60% of EVAR cases are done outside the instructions for use.11 Our technical success of 95% was slightly higher than the 90% achieved in the INNOVATION trial.15 but slightly lower than some published registries using different types of endografts.16-19 Although we left the operating room with no type I or III endoleaks, we did require three proximal aortic cuffs to be placed for low deployment of the grafts, two of which had a type I leak before cuff placement. Most previous studies did not include using a proximal aortic stent as a technical failure. Using a similar definition to previous studies, our technical success rate would be 100%. We had 14 type II endoleaks intraoperatively, 11 of those resolved and 10 new type II endoleaks developed during follow-up. Only one type II leak was associated with sac expansion and underwent embolization procedures. The same patient later developed a graft infection and underwent an explant. These
leak rates are within accepted norms for other endografts and comparable with other studies using the INCRAFT device.3,6,9,12,15 We had two conversions to aortounilateral graft placement with femoral-femoral bypass intraoperatively. These were due to cannulation and placement of both iliac limbs into the ipsilateral aortic limb. This occurred early in our experience with the graft. There is only a 1-cm difference between the contralateral limb and the ipsilateral limb and unintended deployment of the ipsilateral limb happened easily, even when anticipating it. Furthermore, there are no markers on the ipsilateral limb, making visualization of an unintended deployment of the ipsilateral gate difficult. This has been previously noted as a difficulty with the graft.20 After these early cases, to prevent unrecognized inadvertent cannulation of the ipsilateral limb, we have changed our practice and now fully deploy the ipsilateral iliac limb before any attempt to cannulate the contralateral limb. Indeed, this has been since recommended by the device manufacturer. Deployment of the ipsilateral limb could, in some cases, decrease catheter maneuverability and make contralateral gate cannulation more difficult. We did not experience this issue. In these cases, going up and over and snaring the wire would be an option. We also had one limb occlusion approximately 6 weeks after implantation. The patient presented with claudication and underwent a femoral-femoral bypass. Our 30-day mortality was 0% with three deaths (4.9%) occurring during follow-up at a mean of 390 days postoperatively. All deaths were cancer related and there was no aneurysm-related or reintervention-related mortality.
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Our study has several limitations. First, our study is based on a prospectively maintained database with no specific inclusion or exclusion criteria other than standard clinical parameters. This allows for a diverse set of indications for intervention as well as anatomy. However, this is representative of a real-world clinical practice. Because there was no comparison group in this study, we cannot compare directly the outcomes of other grafts used at our clinical sites. Furthermore, Although this is largest series to date using the INCRAFT device, it still includes a relatively small cohort with relatively short follow-up times. Further follow-up is needed to assess the long-term outcomes and durability of the graft in a real-world setting.
CONCLUSIONS This series of 61 patients is the first of its kind in a North American center and is the largest postmarket study of the INCRAFT device available. In our experience, the INCRAFT device is safe and effective with a relatively short and easy learning curve for use. This may allow patients with unfavorable anatomy to be offered EVAR as a treatment option. Further research with longer follow-up is needed to assess long-term outcomes as well as its head-to-head comparison of other lowprofile devices.
AUTHOR CONTRIBUTIONS Conception and design: HG, OS Analysis and interpretation: HG, RD, OS Data collection: HG, RD, MR, DO, KM, OS Writing the article: HG, RD, OS Critical revision of the article: HG, RD, MR, DO, KM, OS Final approval of the article: HG, RD, MR, DO, KM, OS Statistical analysis: Not applicable Obtained funding: Not applicable Overall responsibility: HG
REFERENCES 1. Arko FR 3rd, Murphy EH, Boyes C, Nussbaum T, Lalka SG, Holleman J, et al. Current status of endovascular aneurysm repair: 20 years of learning. Semin Vasc Surg 2012;25:131-5. 2. Hopkins R, Bowen J, Campbell K, Blackhouse G, De Rose G, Novick T, et al. Effects of study design and trends for EVAR versus OSR. Vasc Health Risk Manag 2008;4:1011-22. 3. Steuer J, Lachat M, Veith FJ, Wanhainen A. Endovascular grafts for abdominal aortic aneurysm. Eur Heart J 2016;37: 145-51. 4. Karthikesalingam A, Vidal-Diez A, Holt PJ, Loftus IM, Schermerhorn ML, Soden PA, et al. Thresholds for abdominal aortic aneurysm repair in England and the United States. N Engl J Med 2016;375:2051-9. 5. Bertoglio L, Logaldo D, Marone EM, Rinaldi E, Chiesa R. Technical features of the INCRAFT AAA stent graft system. J Cardiovasc Surg (Torino) 2014;55:705-15.
6. Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, et al. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the innovation trial. J Vasc Surg 2013;57:906-14. 7. Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultralow profile AAA stent-graft system. J Cardiovasc Surg (Torino) 2011;52:661-7. 8. Pratesi G, Pratesi C, Chiesa R, Coppi G, Scheinert D, Brunkwall JS, et al. The innovation trial: four-year safety and effectiveness of the INCRAFT(r) AAA stent-graft system for endovascular repair. J Cardiovasc Surg (Torino) 2017;58: 650-7. 9. Mazzaccaro D, Malacrida G, Amato B, Alessio Angileri S, Ierardi AM, Nano G. Preliminary experience with the use of ultra-low profile endografts. Diagn Interv Radiol 2017;23: 448-53. 10. Sugimoto M, Torsello GF, Torsello GB, Austermann M, Stachmann A, Bisdas T. Postmarket clinical experience with the INCRAFT AAA stent graft system for challenging access routes. Ann Vasc Surg 2017;40:120-7. 11. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009;302:1535-42. 12. Turnbull IC, Criado FJ, Sanchez L, Sadek M, Malik R, Ellozy SH, et al. Five-year results for the talent enhanced low profile system abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg 2010;51: 537-44.e1-2. 13. King EG, Farber A, Rybin D, Doros G, Kalish JA, Eslami MH, et al. Preoperative risk factors predict protracted hospital length of stay after elective endovascular abdominal aortic aneurysm repair. Ann Vasc Surg 2017;43:73-8. 14. Hanley SC, Steinmetz O, Mathieu ES, Obrand D, Mackenzie K, Corriveau MM, et al. Safety and feasibility of endovascular aortic aneurysm repair as day surgery. J Vasc Surg 2018;67:1709-15. 15. Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C. Safety and effectiveness of the INCRAFT AAA stent graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg 2015;61:1-8. 16. Greenberg RK, Chuter TA, Cambria RP, Sternbergh WC 3rd, Fearnot NE. Zenith abdominal aortic aneurysm endovascular graft. J Vasc Surg 2008;48:1-9. 17. Pratesi C, Piffaretti G, Pratesi G, Castelli P. Italian excluder registry and results of gore excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms. J Vasc Surg 2014;59:52-7.e51. 18. Sirignano P, Mansour W, Pranteda C, Siani A, Accrocca F, d’Adamo A, et al. Real-life experience with ovation stent graft: lesson learned from the first one hundred fifty treated patients. Ann Vasc Surg 2017;45:253-61. 19. Stokmans RA, Teijink JA, Forbes TL, Bockler D, Peeters PJ, Riambau V, et al. Early results from the engage registry: realworld performance of the Endurant stent graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg 2012;44:369-75. 20. Mazzaccaro D, Occhiuto MT, Stegher S, Righini P, Malacrida G, Nano G. Tips about the cordis INCRAFT endograft. Ann Vasc Surg 2016;30:205-10.
Submitted Jun 14, 2018; accepted Oct 20, 2018.
Early North American experience with the INCRAFT device Heather L. Gill, MD, MPH,a Robert J. Doonan, MD, PhD,a Abdulmajeed Altoijry, MD, MSc,b Daniel I. Obrand, MD,c Kent S. Mackenzie, MD,a and Oren K. Steinmetz, MD,a Montreal, Quebec, Canada; and Riyadh, Saudi Arabia
ABSTRACT Background: Several low-profile grafts have been created for use in endovascular aneurysm repair in patients with small or difficult to access vessels. Our objective was to evaluate the outcomes of patients undergoing endovascular aneurysm repair with the INCRAFT device in a real-world North American setting. Methods: Consecutive patients undergoing INCRAFT implantation between March 2015 and December 2016 at two McGill University teaching hospitals were enrolled in a prospectively maintained registry. Clinical characteristic and perioperative outcomes were entered into the registry. Two authors performed anatomic measurements from preoperative and postoperative computed tomography angiograms and intraoperative angiograms independently. In cases of disagreement a consensus was reached. Results: We included 61 patients with a median follow-up of 363 days (mean, 344 6 244 days). Minimum left and right access vessel sizes were 7.5 6 1.7 mm and 7.4 6 1.5 mm, respectively. More than 90% of grafts were implanted for aneurysm size or growth. Vessel access was percutaneous in 95% of cases. We had a mean length of stay of 0.88 6 1.8 days with 57.3% of patients discharged the same day. There were 14 procedural type II endoleaks, 10 new type II leaks that were discovered during follow-up, and 11 that resolved for 77% of patients remaining endoleak free during follow-up. There were no 30-day mortalities. Three cancer-related deaths occurred during follow-up. Early complications included one access site repair for bleeding, one access site repair for dissection, and two aortounilateral conversions with femoral-femoral bypass owing to inadvertent ipsilateral gate cannulation. Long-term complications included one graft limb thrombosis, one intervention for type II endoleak with sac expansion that subsequently became infected and was explanted, and one intervention for a type III endoleak for an intervention. During follow-up, 95% of patients remained reintervention free. Conclusions: Use of the INCRAFT device in a real-world North American setting is relatively safe and effective, and is associated with a low rate of perioperative complications. However, we experienced early issues with inadvertent cannulation and deployment of the contralateral limb in the ipsilateral gate. Therefore, we recommend deploying the entire ipsilateral limb before cannulating the contralateral limb. Data with additional follow-up are needed to assess the long-term effectiveness of the INCRAFT device. (J Vasc Surg 2018;-:1-5.) Keywords: Abdominal aortic aneurysm; Endovascular aneurysm repair; Difficult vessel access; INCRAFT
Since its first description, endovascular aortic aneurysm repair (EVAR) has steadily increased in popularity owing to its low perioperative morbidity and mortality,1-3 Since the late 2000s, it has become the most common form of elective repair for infrarenal abdominal aortic aneurysms (AAAs).1,4 Unfortunately, its use remains limited in some patients by hostile anatomic characteristics such as small, calcified, or tortuous access vessels.
The INCRAFT device, an ultralow-profile trimodular graft was designed for implantation in patients with these anatomic characteristics. The graft is available in four sizes: 22, 26, 30, and 34 mm in diameter. The outer diameter of the introducer sheath is 14F for sizes 22 to 30 mm and 16F for the main body size of 34 mm. This compares to 14F to 15F for Ovation, 18F to 20F for the Endurant II, 16F to 18F for the Excluder, and 18F to 22F
From the Division of Vascular Surgery, Department of Surgery, McGill University
The editors and reviewers of this article have no relevant financial relationships to
Health Centre,a and the Division of Vascular Surgery, Department of Surgery,
disclose per the JVS policy that requires reviewers to decline review of any
Jewish General Hospital,c Montreal; and the the Division of Vascular Surgery, Department of Surgery, College of Medicine, King Saud University, Riyadh.b Author conflict of interest: none. Presented at the Vascular and Endovascular Surgery Society Winter Meeting, Vail, Colo, February 4, 2018.
manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2018 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. https://doi.org/10.1016/j.jvs.2018.10.068
Correspondence: Heather L. Gill, MDCM, MPH, FRCSC, Assistant Professor, Vascular and Endovascular Surgery, McGill University, Royal Victoria Hospital, 1001 Decarie Blvd, Montreal, QC H4A 3J1 (e-mail: [email protected]).
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for the Zenith graft. The INCRAFT device is assembled with the main body bifurcated component as well as two iliac limb extensions and can be used to treat aortic necks 17 to 31 mm in diameter and iliac diameters of 7 to 22 mm. Further detailed features of the graft have been reported previously.5-7 It has been approved in Canada and Europe based on the results of the INNOVATION trial, a prospective, multi-institutional study of 60 patients showing safety and efficacy.6 The initial trial reported on 30-day and 1-year outcomes and has since extended its results to 4 years of follow-up.8 There has been very little postmarket data or publications on the graft to date in terms of its safety and efficacy in realworld settings.9,10 Our objective was to evaluate the safety and efficacy of the INCRAFT device in a realworld North American setting.
METHODS Consecutive patients undergoing INCRAFT (Cordis, Vaughan, Ontario, Canada) implantation between March 2015 and December 2016 at two university teaching hospitals in Montreal, Canada, were enrolled in a prospectively collected registry. Patients were eligible to undergo EVAR if they met standard eligibility criteria including AAA size of 5.5 cm or greater in men and 5.0 or greater cm in women, or growth criteria. The INCRAFT device was used according to surgeon preference and not only for difficult anatomic characteristics. However, in patients with challenging vessel access anatomy, including small, calcified, or tortuous access vessels, the INCRAFT device was used preferentially during the study period. The indications for use of the INCRAFT device include femoral access vessels adequate for delivery system, a proximal neck length of 10 mm, aortic neck diameters of 17 to 31 mm, an aortic neck suitable for suprarenal fixation, infrarenal and suprarenal neck angulation of 60 or less, iliac fixation length of 15 mm or greater, iliac diameters of 7 to 22 mm, a minimum overall treatment length of 128 mm or greater, and morphology suitable for aneurysm repair. Clinical and demographic characteristics were collected from charts and patient interview. Anatomic variables were obtained from preoperative computed tomography angiograms, including aneurysm diameter, neck length, diameter and angulation, common iliac artery, external iliac artery, and common femoral artery diameter, as well as calcium and thrombus burden of the aortic neck and common iliac artery, classified as 50% or greater or less than50%. These measurements were obtained from direct measurements and were performed independently by two authors. In cases of disagreement, a consensus was reached. Intraoperative variables collected were type of anesthesia, blood loss, fluoroscopy and procedure times, procedural success, complications, additional intraoperative
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Type of Research: Retrospective analysis of a prospectively maintained registry Take Home Message: In 61 patients who underwent INCRAFT device implantation for endovascular aneurysm repair, there were two early conversions to aortouni-iliac graft owing to inadvertent gate cannulation, one graft thrombosis, and one infection with 95% freedom of reinterventions at a median followup of 363 days Recommendation: INCRAFT seems to be safe and effective at 1 year, but deployment of the ipsilateral limb before cannulating the contralateral limb is helpful to avoid conversions.
procedures, and presence of endoleaks. Thirty-day perioperative complications, emergency room visits, readmissions, reinterventions, and deaths were recorded. Patients were followed postoperatively according to usual clinical practice. Long-term mortality as well as graft related complications, reinterventions, and endoleaks were recorded. This study was approved by the research ethics boards at our participating institutions and written informed consent was not required.
RESULTS We included 61 patients with a median follow-up of 363 days (range, 110-479 days; mean, 344 6 244 days). Patient characteristics are presented in Table I. The mean age of the included patients was 77.1 6 7.7 years with a majority of men (81.9%). Indications for surgery were AAA size/growth in 55 patients (90.1%), symptomatic AAA in 1 patient (1.6%), inflammatory AAA in 1 patient (1.6%), isolated common iliac artery aneurysm in 2 patients (3.2%), and proximal anastomotic pseudoaneurysm after prior open AAA repair in 2 patients (3.2%). There were no ruptured aneurysms that underwent INCRAFT placement. Anatomic variables are presented in Table II. Minimum access vessel diameters were 7.4 6 1.5 mm (range, 4.0-10.6 mm) on the right and 7.5 6 1.7 mm (range, 4.0-11.7 mm) on the left. Procedure characteristics are presented in Table III. The majority of patients underwent spinal anesthesia (93.4%) and ultrasound-guided percutaneous access (95.0%). We also had a same-day discharge rate (no hospital admission) of 57.3% and a mean length of stay of 0.88 6 1.8 days. Endoleak data are presented in Table IV. Fourteen type II leaks (22.9%) were found intraoperatively, 10 type II leaks (16.3%) developed during follow-up, and 11 (18.0%) resolved for 77% of patients remaining endoleak free during follow-up. Three proximal aortic cuffs were placed owing to low graft deployment, giving a 95% technical success before
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Table I. Patient characteristics
Table II. Patient anatomic characteristics Mean 6 SD or No. of patients (%)
Anatomic characteristics
Age, years
77.1 6 7.7
Maximum diameter, mm
56.5 6 11.3
Male sex
50 (81.9)
Neck diameter, mm
23.2 6 3.5
Smoker
16 (26.2)
Neck length, mm
32.7 6 17.2
Ex-smoker
20 (32.7)
Aortic neck calcification $50%
Dyslipidemia
45 (74.0)
Aortic neck thrombus $50%
Coronary artery disease
25 (40.9)
Infrarenal angle,
Chronic obstructive pulmonary disease
17 (27.8)
Suprarenal angle,
Patient characteristics
Mean 6 SD or No. (%)
7 (11.4) 4 (6.5) 25.8 6 23.9
7.3 6 18.2
Common iliac diameter right, mm
14.9 6 8.0 14.8 6 7.8
Diabetes mellitus type II
12 (19.6)
Common iliac diameter left, mm
Hypertension
45 (74.0)
Right common iliac calcification $50%
14 (22.9)
Peripheral arterial disease
5 (8.1)
Right common iliac thrombus $50%
1 (1.6)
Chronic kidney disease
7 (11.4)
Left common iliac calcification $50%
14 (22.9)
4 (6.5)
Left common iliac thrombus $50%
Liver disease Previous abdominal surgery
10 (16.3)
SD, Standard deviation.
the addition of proximal cuffs. During follow-up, 30 patients (49.1%) had a decrease in sac size, 30 patients’ sacs remained stable (49.1%), and 1 patient (1.8%) had an increase in sac size. There were no cases of endotension. Patient complications and outcomes are presented in Table V. There were no deaths within 30 days. Three deaths occurred during follow-up at a mean of 390 days and all were cancer related. Two access site repairs were performed, one owing to bleeding and one owing to dissection. These vessels were 5.0 and 4.8 mm, respectively. We also converted two cases to aortounilateral grafts with femoral-femoral bypasses. These were due to inadvertent cannulation of the ipsilateral gate and deployment of the contralateral limb, early in our experience with the graft. The distance between the contralateral and ipsilateral gate is only 1 cm with the INCRAFT device, making it very easy to inadvertently deploy the ipsilateral gate without knowing. This is particularly true in the context of suboptimal imaging and owing to the fact that there are no radiopaque markers on the ipsilateral gate. After discussion with the manufacturer, we changed our practice and began deploying the ipsilateral limb before cannulation of the contralateral gate to avoid this issue. One of these cases developed a type III endoleak from the contralateral gate during follow-up, which was treated with a plug. In addition, one graft limb thrombosis occurred, which was treated with a femoral-femoral bypass and one patient underwent two attempts at embolization for persistent type II endoleak with sac expansion. The first attempt was unsuccessful. There was a leak from the inferior mesenteric artery, which could not be cannulated by paraendograft access from the groin as well as through superior mesenteric artery collaterals. The patient was
2 (3.2)
Right external iliac artery diameter, mm
7.8 6 1.6
Left external iliac artery diameter, mm
7.8 6 1.7
Right common femoral artery diameter, mm
8.3 6 1.6
Left common femoral artery diameter, mm
8.5 6 2.0
Minimum access vessel diameter right, mm
7.4 6 1.5
Minimum access vessel diameter left, mm
7.5 6 1.7
SD, Standard deviation.
brought back to the radiology suite several weeks later and underwent direct sac puncture, which was successful. However, this same patient later developed a graft infection. Therefore, the graft was explanted and we performed reconstruction with a new aortoiliac system with femoral vein. During follow-up, 95% of patients remained reintervention free.
DISCUSSION This is the first North American series of the INCRAFT device and, to our knowledge, the largest postmarket series in the world. We have found that, in a real-world North American setting, use of the INCRAFT device is relatively safe and effective over a follow-up period of 1 year with a low rate of perioperative morbidity, mortality, and reinterventions comparable with the reported literature.3,11,12 The INCRAFT device was brought to market in an attempt to widen the availability of EVAR to patients with difficult access vessels, given its ultralow profile. Our patients had a mean access vessel size of 7.4 6 1.6 mm (range, 4.0-11.7 mm). These sizes are similar to or smaller than previous studies using the INCRAFT device as well as other low-profile devices.6,9,10,12 In our series, 95% of access was obtained percutaneously with a mean length of stay of 0.88 6 1.80 days, well below the average length of stay seen in other trials.11,13 Furthermore, almost 60% of patients left the same day of the procedure, which we have previously shown to be feasible and safe.14
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Table III. Procedure and hospital characteristics
Table V. Complications and outcomes
Mean 6 SD or No. of patients (%)
Procedure characteristics
Complications and outcomes Mortality
0 (0)
3 (4.9)
Access site repair for bleeding
Spinal
57 (93.4)
Access site repair for dissection
1 (1.6)
Local
1 (1.6)
Aortounilateral conversion
2 (3.2)
Access
1 (1.6)
Bowel obstruction
1 (1.6)
Open
4a (6.5)
Acute kidney injury
1 (1.6)
Percutaneous
58 (95.0)
Pulmonary edema
1 (1.6)
Urinary tract infection
1 (1.6)
Procedure time, minutes
78.1 6 34.5
Contrast volume, mL
60.8 6 37.2
Long term
14.1 6 5.4
Fluoroscopy time, minutes
Mortality during follow-up
125.2 6 131.6
Blood loss, mL Length of stay, days
0.88 6 1.8
Same-day discharge
35 (57.3)
a
No. (%)
30 Day
Anesthesia General anesthesia
2018
One patient had both open and percutaneous access performed. a
3 (4.9)
Graft limb thrombosis
1 (1.6)
Intervention for endoleak
2 (3.2)
Graft infection with explant
1 (1.6)
Total graft-related interventionsa
3 (4.9)
Four total graft related interventions were performed in 3 patients.
Table IV. Endoleaks During follow-up Type
Procedure
New
Resolved
Persistent
Total
I
0
0
0
0
0
II
14
10
11
3
13
III
0
1
0
0
1
IV
0
0
0
0
0
We had two access vessel complications, one cut down for a hematoma and one for a dissection of the femoral artery. Both these patients had no lasting complications secondary to vessel injury and repair. In addition, in both these cases the artery size was at or less than 5 mm. This represents a real-world scenario where device limits are pushed. Indeed, it has been shown that 30% to 60% of EVAR cases are done outside the instructions for use.11 Our technical success of 95% was slightly higher than the 90% achieved in the INNOVATION trial.15 but slightly lower than some published registries using different types of endografts.16-19 Although we left the operating room with no type I or III endoleaks, we did require three proximal aortic cuffs to be placed for low deployment of the grafts, two of which had a type I leak before cuff placement. Most previous studies did not include using a proximal aortic stent as a technical failure. Using a similar definition to previous studies, our technical success rate would be 100%. We had 14 type II endoleaks intraoperatively, 11 of those resolved and 10 new type II endoleaks developed during follow-up. Only one type II leak was associated with sac expansion and underwent embolization procedures. The same patient later developed a graft infection and underwent an explant. These
leak rates are within accepted norms for other endografts and comparable with other studies using the INCRAFT device.3,6,9,12,15 We had two conversions to aortounilateral graft placement with femoral-femoral bypass intraoperatively. These were due to cannulation and placement of both iliac limbs into the ipsilateral aortic limb. This occurred early in our experience with the graft. There is only a 1-cm difference between the contralateral limb and the ipsilateral limb and unintended deployment of the ipsilateral limb happened easily, even when anticipating it. Furthermore, there are no markers on the ipsilateral limb, making visualization of an unintended deployment of the ipsilateral gate difficult. This has been previously noted as a difficulty with the graft.20 After these early cases, to prevent unrecognized inadvertent cannulation of the ipsilateral limb, we have changed our practice and now fully deploy the ipsilateral iliac limb before any attempt to cannulate the contralateral limb. Indeed, this has been since recommended by the device manufacturer. Deployment of the ipsilateral limb could, in some cases, decrease catheter maneuverability and make contralateral gate cannulation more difficult. We did not experience this issue. In these cases, going up and over and snaring the wire would be an option. We also had one limb occlusion approximately 6 weeks after implantation. The patient presented with claudication and underwent a femoral-femoral bypass. Our 30-day mortality was 0% with three deaths (4.9%) occurring during follow-up at a mean of 390 days postoperatively. All deaths were cancer related and there was no aneurysm-related or reintervention-related mortality.
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Our study has several limitations. First, our study is based on a prospectively maintained database with no specific inclusion or exclusion criteria other than standard clinical parameters. This allows for a diverse set of indications for intervention as well as anatomy. However, this is representative of a real-world clinical practice. Because there was no comparison group in this study, we cannot compare directly the outcomes of other grafts used at our clinical sites. Furthermore, Although this is largest series to date using the INCRAFT device, it still includes a relatively small cohort with relatively short follow-up times. Further follow-up is needed to assess the long-term outcomes and durability of the graft in a real-world setting.
CONCLUSIONS This series of 61 patients is the first of its kind in a North American center and is the largest postmarket study of the INCRAFT device available. In our experience, the INCRAFT device is safe and effective with a relatively short and easy learning curve for use. This may allow patients with unfavorable anatomy to be offered EVAR as a treatment option. Further research with longer follow-up is needed to assess long-term outcomes as well as its head-to-head comparison of other lowprofile devices.
AUTHOR CONTRIBUTIONS Conception and design: HG, OS Analysis and interpretation: HG, RD, OS Data collection: HG, RD, MR, DO, KM, OS Writing the article: HG, RD, OS Critical revision of the article: HG, RD, MR, DO, KM, OS Final approval of the article: HG, RD, MR, DO, KM, OS Statistical analysis: Not applicable Obtained funding: Not applicable Overall responsibility: HG
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6. Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, et al. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the innovation trial. J Vasc Surg 2013;57:906-14. 7. Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultralow profile AAA stent-graft system. J Cardiovasc Surg (Torino) 2011;52:661-7. 8. Pratesi G, Pratesi C, Chiesa R, Coppi G, Scheinert D, Brunkwall JS, et al. The innovation trial: four-year safety and effectiveness of the INCRAFT(r) AAA stent-graft system for endovascular repair. J Cardiovasc Surg (Torino) 2017;58: 650-7. 9. Mazzaccaro D, Malacrida G, Amato B, Alessio Angileri S, Ierardi AM, Nano G. Preliminary experience with the use of ultra-low profile endografts. Diagn Interv Radiol 2017;23: 448-53. 10. Sugimoto M, Torsello GF, Torsello GB, Austermann M, Stachmann A, Bisdas T. Postmarket clinical experience with the INCRAFT AAA stent graft system for challenging access routes. Ann Vasc Surg 2017;40:120-7. 11. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009;302:1535-42. 12. Turnbull IC, Criado FJ, Sanchez L, Sadek M, Malik R, Ellozy SH, et al. Five-year results for the talent enhanced low profile system abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg 2010;51: 537-44.e1-2. 13. King EG, Farber A, Rybin D, Doros G, Kalish JA, Eslami MH, et al. Preoperative risk factors predict protracted hospital length of stay after elective endovascular abdominal aortic aneurysm repair. Ann Vasc Surg 2017;43:73-8. 14. Hanley SC, Steinmetz O, Mathieu ES, Obrand D, Mackenzie K, Corriveau MM, et al. Safety and feasibility of endovascular aortic aneurysm repair as day surgery. J Vasc Surg 2018;67:1709-15. 15. Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C. Safety and effectiveness of the INCRAFT AAA stent graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg 2015;61:1-8. 16. Greenberg RK, Chuter TA, Cambria RP, Sternbergh WC 3rd, Fearnot NE. Zenith abdominal aortic aneurysm endovascular graft. J Vasc Surg 2008;48:1-9. 17. Pratesi C, Piffaretti G, Pratesi G, Castelli P. Italian excluder registry and results of gore excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms. J Vasc Surg 2014;59:52-7.e51. 18. Sirignano P, Mansour W, Pranteda C, Siani A, Accrocca F, d’Adamo A, et al. Real-life experience with ovation stent graft: lesson learned from the first one hundred fifty treated patients. Ann Vasc Surg 2017;45:253-61. 19. Stokmans RA, Teijink JA, Forbes TL, Bockler D, Peeters PJ, Riambau V, et al. Early results from the engage registry: realworld performance of the Endurant stent graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg 2012;44:369-75. 20. Mazzaccaro D, Occhiuto MT, Stegher S, Righini P, Malacrida G, Nano G. Tips about the cordis INCRAFT endograft. Ann Vasc Surg 2016;30:205-10.
Submitted Jun 14, 2018; accepted Oct 20, 2018.