- Email: [email protected]
Use of Endurant Stent-Graft Aortic Extensions for the Treatment of Focal Aortic Pathology
Clinical Research Use of Endurant Stent-Graft Aortic Extensions for the Treatment of Focal Aortic Pathology Ioakeim T. Giagtzidis, Konstantinos Konstantinidis, Thomas E. Kalogirou, Christos D. Karkos, and Konstantinos O. Papazoglou, Thessaloniki, Greece
Background: To describe our experience with the endovascular treatment of focal abdominal aortic pathology with an adequate distal neck length using Endurant (Medtronic) aortic extension cuffs. Methods: From July 2010 to May 2015, 16 patients (14 male), with a mean age of 73.6 years (range, 59e88), were treated for focal abdominal aortic pathology using only Endurant (Medtronic) aortic cuff extensions. The indication for intervention was a saccular abdominal aortic aneurysm (AAA) in 5 patients, a fusiform aortic aneurysm in 6 patients, abdominal aortic dissection in 2 patients, an aortic juxtarenal rupture in 1 patient, a large anastomotic pseudoaneurysm of previous bifurcated open repair in 1 patient, and a juxtarenal aneurysm above a previous open AAA repair. Aortic lesions had a mean diameter of 52.9 (range, 32e90) mm. All patients were operated under local anesthesia with unilateral femoral exposure. A single 70-mm long Endurant aortic extension was deployed in 5 cases, while in the remaining 11 cases, 2 cuffs were used with the ‘‘telescopic’’ (double tube) technique. A chimney technique was performed in 5 cases (with a bare metal stent in the renal artery in 3 and a stent graft in the celiac artery in 2). Results: The intraoperative technical success was 100% with no endoleaks on completion angiogram. There was no 30-day mortality. One patient developed acute limb ischemia immediately postoperatively and was treated successfully with thrombectomy. During a mean follow-up of 21.9 months, 1 patient died 2 months after the procedure due to cardiac arrest unrelated to his aortic operation. There was 1 early type IIb endoleak (present at the 30-day followup computerized tomography scan), which disappeared 10 months after the procedure. Finally, 1 patient was diagnosed with a type II endoleak and stable diameter 53 months postoperatively, while to date there are no cases of stent-graft migration. Conclusions: The use of Endurant aortic extensions in aneurysms with adequate distal neck is a safe, simple, customizable, and cost-effective method which presents similar early results with standard endovascular aneurysm repair technique.
INTRODUCTION
5th Department of Surgery, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece. Correspondence to: Ioakeim T. Giagtzidis, 5th Department of Surgery, Dimitriou Gounari 8, Thessaloniki 54622, Greece; E-mail: [email protected] Ann Vasc Surg 2016; -: 1–7 http://dx.doi.org/10.1016/j.avsg.2016.03.017 Ó 2016 Elsevier Inc. All rights reserved. Manuscript received: January 4, 2016; manuscript accepted: March 11, 2016; published online: - - -
Endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is counting more than 20 years of use, and it is now accepted as an effective and safe treatment option for infrarenal AAA. Although the first series of EVAR during the 1990s used straight tube endografts,1 nowadays self-expandable bifurcated endoprosthesis is the first option for EVAR. Tubular aortoaortic endograft configuration has been criticized for high-failure rates, whereas a correlation of distal aortic neck length with the 1
2 Giagtzidis et al.
Annals of Vascular Surgery
Table I. Patient details
Gender
Age (years)
Aortic pathology
Maximum diameter (mm)
F M M
75 83 67
Saccular aneurysm Saccular aneurysm Saccular aneurysm
35 45 45
No No No
M
78
32
No
M
64
53
F
59
Infrarenal abdominal aortic dissection Juxtarenal aortic rupture Saccular aneurysm
Abdominal pain No
M
82
M
66
M M M
76 78 88
M M
76 71
M M M
Symptoms
Comorbidities
CAD, HTN CAD, COPD, HTN CAD, HTN, previous carotid stenting HTN, obesity
Elective Elective Elective
HTN
Urgent Elective
Elective Elective Elective
Elective
55
Abdominal pain No
52 61 65
No No No
52 57
No No
HTN, CAD, obesity HTN
Elective Elective
73
Fusiform AAA Fusiform AAA Juxtarenal aneurysm above a previous open AAA repair Fusiform AAA Suprarenal focal abdominal aortic dissection Fusiform AAA
CAD, HTN, previous breast cancer CAD, COPD, CRI, HTN, obesity CRI, Wegener’s granulomatosis, HL HTN, CAD, obesity HTN, CAD HTN
52
No
Elective
72 70
TAAA Saccular aneurysm
65 51
No No
HTN, Benign prostatic hyperplasia HTN CRI, renal transplant, HTN, HL
Anastomotic pseudoaneurysm Fusiform AAA
38
Elective or urgent surgery
92
Urgent Elective
Elective Elective
F, female; M, male; CAD, coronary artery disease; HTN, hypertension; COPD, chronic obstructive airways disease; CRI, chronic renal impairment; HL, hyperlipidemia.
development of type Ib endoleak and distal migration has been established.2 Although the latter is generally accepted for fusiform AAAs, there are several other less frequent focal abdominal aortic pathologies, such as infrarenal aortic dissection, penetrating atherosclerotic ulcer (PAU), intramural hematoma, and saccular aneurysms or pseudoaneurysms, all conditions that can be solved with a tube-graft endovascular approach. In this report, we sought to retrospectively review our experience in using the aortic extension cuffs of the Endurant (Medtronic AVE, Santa Rosa, CA, USA) endovascular stent-graft device for the treatment of focal abdominal aortic pathology with focus on technical feasibility, short-term outcomes, and review of the relevant literature.
METHODS From July 2010 to May 2015, 16 patients (14 male), with a mean age of 73.6 (range, 59e88)
years, were treated for a focal abdominal aortic pathology with an endovascular approach using only aortic cuff extensions of the Endurant stent-graft system. Patient comorbidities are summarized in Table I. Saccular AAAs were present in 5 of them. Two patients had a localized abdominal aortic dissection (Fig. 1), one suffered juxtarenal rupture possibly due to PAU, one patient presented with a large proximal anastomotic pseudoaneurysm after previous open AAA repair with a bifurcated Dacron graft and another developed true pararenal aneurysm after a previous open tube-graft infrarenal AAA repair. Finally, the remaining 6 patients presented with ‘‘typical’’ fusiform-like aortic aneurysm (5 of them infrarenal and 1 thoracoabdominal). The anatomic characteristics of the aortic lesion and operative details are summarized in Table II. The mean maximum diameter of the target lesion was 52.9 mm (range, 32e90 mm). The mean length of proximal neck was 21.06 mm (range, 5e40 mm). The mean distal
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Use of Endurant cuffs for aortic pathology 3
Fig. 1. Focal infrarenal abdominal aortic dissection in a 78-year-old male patient. On table angiography before (A) and postdeployment (B) of a single Endurant aortic
cuff. One can see the dissection flap (white arrows) with the guidewire traversing through the true lumen.
Table II. Aortic lesion anatomy and intraprocedural details
neck length was 24.1 mm (range, 18e28 mm). In addition, proximal and distal neck diameter had a mean value of 26.56 mm (range, 20e33 mm) and 24.57 mm (range, 18e31 mm), respectively. All operations were performed under local anesthesia in an operating room with a portable C-arm (Arcadis Siemens, Germany). One common femoral artery was surgically exposed in standard fashion for delivery of the endograft. The contralateral common femoral artery was percutaneously punctured with Seldinger technique followed by a 7F (35 cm or 45 cm long) sheath over a stiff 0.035in wire, which was introduced up to the level of renal arteries to perform intraoperative angiography. In 5 cases, a single 70-mm-long Endurant aortic extension was deployed, while in the remaining 11 cases 2 cuffs were used with the ‘‘telescopic’’ (double tube) technique and overlapping of approximately 30e40 mm (Fig. 2). The patient who suffered juxtarenal rupture was treated with the ‘‘chimney’’ technique, using a single 32 70 mm2 aortic cuff and a balloon expandable bare metal stent in the left renal artery. ‘‘Open chimney’’ technique was also used in a patient with true aneurysm, where a 5 27 mm2 bare metal stent was deployed to
Variables
Target lesion maximum diameter (mm) Proximal neck diameter (mm) Distal neck diameter (mm) Proximal neck length (mm) Distal neck length (mm) Number of aortic cuffs used (%) One Two Aortic cuff length (mm) 70 49 Aortic cuff diameter (mm) 25 28 32 36 Use of Reliant balloon (%)
N (%) or mean (range)
52.9 (32e90) 26.56 (21e33) 24.57 (18e31) 21.06 (5e40) 24.1 (18e28)
5 (31.25) 11 (68.75) 23 5 2 7 6 11 9 (56.25)
4 Giagtzidis et al.
Fig. 2. Saccular aneurysm localized in the infrarenal abdominal aorta with adequate proximal and distal aortic neck that makes it suitable for tube endografting.
salvage an accessory left renal artery, and, also, in another patient who developed juxtarenal aneurysm 20 years after a previous open AAA repair. In this patient, the left renal artery was salvaged with a balloon expandable 6 37 mm2 stent. In one patient with localized chronic suprarenal aortic dissection, a single 32 70 mm2 cuff was used to seal the false lumen, while the celiac artery was salvaged with a 9 120 mm2 Fluency stent graft (Bard Peripheral Vascular, Tempe, AZ, USA; Fig. 3). Finally, in the patient with a 6.5-cm-diameter thoraco-AAA (TAAA), 2 cuffs (36 70 mm2) were used in the thoracic segment of the aneurysm salvaging the celiac artery with a 9 40 mm2 Fluency stent graft, which was supported from the inside with a self-expandable stent 8 60 mm2. The repair was completed in the infrarenal segment of the aneurysm with a 36 49 mm2 cuff (sandwich technique). In 9 patients, a Reliant balloon (Medtronic AVE, Santa Rosa, CA, USA) was used after deployment for optimum molding of the stent graft. All juxtarenal cases and the single patient with TAAA in this series had been considered as high risk for open surgery. Given the fact that a fenestrated approach is not currently an option in our unit due to reimbursement issues, we considered these patients as candidates for endovascular repair using chimney, telescopic, or sandwich stent-graft techniques. The Endurant aortic extension cuff is a selfexpandable M-shaped nitinol stent sewn to a lowporosity polyester fabric with nonabsorbable sutures. The proximal end of the stent is not covered with fabric, and it consists of anchor pins for fixation. The available diameters are 23, 25, 28, 32,
Annals of Vascular Surgery
Preoperative (A) and postoperative (B) computerized tomography (3-dimensional reconstruction).
Fig. 3. Postoperative plain abdominal X-ray in a 71-yearold man who underwent chimney repair for a localized suprarenal aortic dissection associated with progressive false lumen enlargement. One can see the 32 70 mm2 Endurant aortic cuff (longer white arrow), which was placed in the true lumen to cover the proximal entry tear, and the 9 mm 120 mm2 Fluency chimney stent graft (shorter white arrow) salvaging the celiac artery which was fed by the false lumen.
36 mm, while the covered length can be either 49 or 70 mm long. The delivery device is a single-use catheter with rotating handle for controlled deployment, compatible with a 0.035-in guidewire. It also features a tip capture mechanism for the release of the anchor pins. The catheter outer diameter is available in 18F (for the 23, 25, and 28-mm graft diameter) and 20F (for 32 and 36-mm graft diameter). In our technique, when telescope formation was used, the distal part of the graft was deployed inside the proximal graft where the pins of the proximal-free stent were embedded. The choice of endograft size was based on an approximately 20% oversizing in diameter, which for most
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Use of Endurant cuffs for aortic pathology 5
Table III. Studies reporting results of endovascular tube and double-tube repair of abdominal aortic disease Study (first author)
York et al.
8
Number F-up of pts (months) Stent grafts used
5
6.1
Ruppert et al.9 41
21.9
Saratzis et al.10 53 Mazzaccaro 53 et al.11
24 49
Jones et al.12 Present series
0.7 21.93
8 16
AneuRx
Technical Mortality success (%) (%) Morbidity
100
Zenith (custom), 98 Powerlink EndoFit 100 98.1 Endologix Talent Vanguard Parodi Baxter Lifepath Zenith 100 Endurant 100
0 0 5.7 17.8
0 6.25
Endoleak
One wound 0% dehiscence 12.2% 9.8%
Reintervention
0% 0%
3.8% N/A
5.7% 0% 17.8% 17.8% (single tube) (type I) 4% 3.6% (double tube) (type II)
0% 6.25%
0% 12.5%
0% 0%
Pts, patients; F-up, follow-up; N/A, not available.
chimney cases would practically mean the use of a 32-mm or a 36-mm diameter aortic cuff. Primary technical success was defined as successful deployment of the device without patient mortality, conversion to open repair, type I or III endoleak, and graft occlusion.3 On the other hand, primary clinical success was defined as freedom from aneurysm-related death, rupture, conversion to open surgery, and secondary interventions.3 Follow-up was by means of computerized tomography scan and biplanar abdominal radiograms at 1 month, 6 months, and yearly thereafter. Followup surveillance of the aneurysmal lesions with color Doppler ultrasound or with contrast-enhanced ultrasound scanning was not used as there is no expertise with this diagnostic modality locally.
RESULTS Twelve patients were operated electively, whereas 2 patients, one with rupture and another with an anastomotic pseudoaneurysm, were operated urgently. There was 100% primary technical and clinical success with no endoleaks on completion angiography. There was no 30-day mortality. One patient developed acute limb ischemia immediately after the procedure and was treated successfully with Fogarty thrombectomy (for a complication rate of 6.25%). Apart from that complication, all patients had an uneventful recovery and were discharged the first postoperative day. There was 1 late death during a mean follow-up period of 21.9 months. This patient died 2 months after the procedure due to cardiac arrest, unrelated to his aneurysm. There was a small type IIb endoleak
present in the 30-day follow-up computerized tomography scan, which disappeared 10 months after the procedure. Finally, 1 patient was diagnosed with a late type II endoleak and stable diameter 56 months postprocedure, while to date there are no cases of endograft migration.
DISCUSSION The huge expansion in the use of EVAR technique for the treatment of AAAs over the past years has clearly shown that only a few patients have favorable anatomy for the deployment of aortoaortic stent graft, mainly due to lack of adequate distal neck length.4 However, there are other, relatively uncommon, focal pathologies of the aorta which may be suitable for elective or urgent endovascular treatment with aortoaortic tube stent grafts. Endovascular treatment of saccular abdominal aneurysms, PAUs, intramural hematomas, and anastomotic pseudoaneurysms has been attempted with very good early and midterm results.5e7 In 2002, York et al.8 described the use of ‘‘stacked’’ AneuRx aortic cuffs for the treatment of saccular aneurysms. The authors suggest that the aortoaortic approach with the overlapping cuffs avoids the potential of limb kinking and resulting thrombosis, which may be seen when a bifurcated endograft is used due to the extrinsic compression applied by the nonaneurysmal distal aorta and iliac arteries. Ruppert et al.9 first introduced the term ‘‘trombone’’ technique for 45 patients treated with double-tube stent graft. For these patients, the group used custom-made Zenith and Powerlink stent grafts. They concluded that favorable outcome
6 Giagtzidis et al.
with this technique is met with proper patient selection and aortic anatomic criteria of 10 to 15-mm proximal neck length and minimum distal neck length of 15e20 mm.9 Another group treated 53 patients using Endofit tube stent grafts and made a subgroup analysis of patients receiving 1 stent graft versus those treated with the trombone technique.10 In terms of procedure-related complications, early and late outcomes were significantly better in patients where 2 stent grafts were deployed.10 Similarly, Mazzaccaro et al.11 reviewed 53 patients who were treated with various tube stent grafts, including Endologix, Vanguard, and Talent. They divided the patients into 2 groups according to the number of tube stent grafts used. In the first group, a single-straight endograft was deployed, while in the second group, a double trombone technique was used. Their results suggested that reintervention and endoleaks were more frequent in the group of patients receiving a single endograft.11 Finally, a report of 8 patients with focal infrarenal aortic pathology, which were treated with Zenith tube devices showed excellent early results. The authors concluded that the trombone technique is less invasive and provides better adjustment of length with fewer flow problems in small diameter distal aortas.12 To our knowledge, this is the first report in the literature where Endurant aortic cuffs were used, single or with the telescopic technique, in the abdominal aorta. In cases where 2 aortic cuffs were deployed, 1 might argue that the anchor pins of the inner cuff could compromise the integrity of the fabric of the outer one, leading to type III endoleak. Although this is a report with few patients, no type III endoleak was encountered during the follow-up period. On the contrary, we believe that the technical characteristics of the Endurant cuff increases the stiffness of telescopic construction reducing the likelihood of migration. Tubular devices have a series of advantages over bifurcated grafts. The implantation procedure is less timeconsuming, has less radiation exposure, requires only one femoral surgical exposure, and the overall cost is substantially reduced.10,12 In patients with focal aortic pathology, a bifurcated device can be contraindicated since the limbs of the device would be susceptible to compression, kinking, and thrombosis.11 Furthermore, the availability of different stent-graft sizes in length and diameter can cover up several aortic anatomies by adjusting the overlap between the 2 tubes using the telescopic technique. Accurate proximal and distal deployment of 50-mm and 70-mm length cuffs reach lengths between 100
Annals of Vascular Surgery
and 110 mm which can reliably cover the distance between the renal arteries and aortic bifurcation. It also seems that chimney and sandwich techniques are technically compatible with this stent-graft design with high success rate. This technique also allows the use of local anesthesia reducing the perioperative complications of general anesthesia. Although a direct comparison of the Endurant cuff with other commercially available stent grafts previously published is not intended in this article, Table III summarizes that different stent grafts have comparable results in terms of technical success, mortality, morbidity, endoleak, and reintervention rates proving the safety and efficacy of the method.
CONCLUSIONS In the proper anatomic setting of adequate proximal and distal neck length, covering the affected area with tubular endografts can be a safe, efficient, and cost-effective treatment option. Endurant aortic cuff extensions showed excellent early and midterm results and should be considered as an option when treating focal infrarenal aortic pathology. Follow-up protocol for these patients should be applied as with the standard EVAR technique. Although the midterm results of our patient group are promising and without adverse events, long-term data for reintervention, endoleak, and migration rates are required. Furthermore, since these cases are relatively rare, establishment of a registry would help us draw firm and safe conclusions for the safety of the method. REFERENCES 1. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5:491e9. 2. Faries PL, Briggs VL, Rhee JY, et al. Failure of endovascular aortoaortic tube grafts: a plea for preferential use of bifurcated grafts. J Vasc Surg 2002;35:868e73. 3. Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002;35:1048e60. 4. Katsikas VC, Dalainas I, Martinakis VG, et al. The role of aortouniiliac devices in the treatment of aneurysmal disease. Eur Rev Med Pharmacol Sci 2012;16:1061e71. 5. Taylor BV, Kalman PG. Saccular aortic aneurysms. Ann Vasc Surg 1999;13:555e9. 6. Eggebrecht H, Plicht B, Kahlert P, et al. Intramural hematoma and penetrating ulcers: indications to endovascular treatment. Eur J Vasc Endovac Surg 2009;38:659e65. 7. Zhou W, Bush RL, Bhama JK, et al. Repair of anastomotic abdominal aortic pseudoaneurysm utilizing sequential AneuRx aortic cuffs in an overlapping configuration. Ann Vasc Surg 2006;20:17e22.
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8. York JW, Sternbergh WC, Lepore MR, et al. Endovascular exclusion of saccular AAAs using ‘‘stacked’’ AneuRx aortic cuffs. J Endovasc Ther 2002;9:295e8. 9. Ruppert V, Erz K, B€ urklein D. Double tube stent-grafts for infrarenal aortic aneurysm: a new concept. J Endovasc Ther 2007;14:144e9. 10. Saratzis N, Melas N, Saratzis A, et al. Midterm results of a modified technique for implanting tube grafts during
Use of Endurant cuffs for aortic pathology 7
endovascular abdominal aortic aneurysm repair. J Endovasc Ther 2008;15:433e40. 11. Mazzaccaro D, Occhiuto MT, Malacrida G, et al. Straight aortic endograft in abdominal aortic disease. J Cardiothorac Surg 2013;8:114e20. 12. Jones DW, Meltzer AJ, Graham AR, et al. Endovascular repair of infrarenal focal aortic pathology with limited aortic coverage. Ann Vasc Surg 2014;28:1315e22.
Background: To describe our experience with the endovascular treatment of focal abdominal aortic pathology with an adequate distal neck length using Endurant (Medtronic) aortic extension cuffs. Methods: From July 2010 to May 2015, 16 patients (14 male), with a mean age of 73.6 years (range, 59e88), were treated for focal abdominal aortic pathology using only Endurant (Medtronic) aortic cuff extensions. The indication for intervention was a saccular abdominal aortic aneurysm (AAA) in 5 patients, a fusiform aortic aneurysm in 6 patients, abdominal aortic dissection in 2 patients, an aortic juxtarenal rupture in 1 patient, a large anastomotic pseudoaneurysm of previous bifurcated open repair in 1 patient, and a juxtarenal aneurysm above a previous open AAA repair. Aortic lesions had a mean diameter of 52.9 (range, 32e90) mm. All patients were operated under local anesthesia with unilateral femoral exposure. A single 70-mm long Endurant aortic extension was deployed in 5 cases, while in the remaining 11 cases, 2 cuffs were used with the ‘‘telescopic’’ (double tube) technique. A chimney technique was performed in 5 cases (with a bare metal stent in the renal artery in 3 and a stent graft in the celiac artery in 2). Results: The intraoperative technical success was 100% with no endoleaks on completion angiogram. There was no 30-day mortality. One patient developed acute limb ischemia immediately postoperatively and was treated successfully with thrombectomy. During a mean follow-up of 21.9 months, 1 patient died 2 months after the procedure due to cardiac arrest unrelated to his aortic operation. There was 1 early type IIb endoleak (present at the 30-day followup computerized tomography scan), which disappeared 10 months after the procedure. Finally, 1 patient was diagnosed with a type II endoleak and stable diameter 53 months postoperatively, while to date there are no cases of stent-graft migration. Conclusions: The use of Endurant aortic extensions in aneurysms with adequate distal neck is a safe, simple, customizable, and cost-effective method which presents similar early results with standard endovascular aneurysm repair technique.
INTRODUCTION
5th Department of Surgery, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece. Correspondence to: Ioakeim T. Giagtzidis, 5th Department of Surgery, Dimitriou Gounari 8, Thessaloniki 54622, Greece; E-mail: [email protected] Ann Vasc Surg 2016; -: 1–7 http://dx.doi.org/10.1016/j.avsg.2016.03.017 Ó 2016 Elsevier Inc. All rights reserved. Manuscript received: January 4, 2016; manuscript accepted: March 11, 2016; published online: - - -
Endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is counting more than 20 years of use, and it is now accepted as an effective and safe treatment option for infrarenal AAA. Although the first series of EVAR during the 1990s used straight tube endografts,1 nowadays self-expandable bifurcated endoprosthesis is the first option for EVAR. Tubular aortoaortic endograft configuration has been criticized for high-failure rates, whereas a correlation of distal aortic neck length with the 1
2 Giagtzidis et al.
Annals of Vascular Surgery
Table I. Patient details
Gender
Age (years)
Aortic pathology
Maximum diameter (mm)
F M M
75 83 67
Saccular aneurysm Saccular aneurysm Saccular aneurysm
35 45 45
No No No
M
78
32
No
M
64
53
F
59
Infrarenal abdominal aortic dissection Juxtarenal aortic rupture Saccular aneurysm
Abdominal pain No
M
82
M
66
M M M
76 78 88
M M
76 71
M M M
Symptoms
Comorbidities
CAD, HTN CAD, COPD, HTN CAD, HTN, previous carotid stenting HTN, obesity
Elective Elective Elective
HTN
Urgent Elective
Elective Elective Elective
Elective
55
Abdominal pain No
52 61 65
No No No
52 57
No No
HTN, CAD, obesity HTN
Elective Elective
73
Fusiform AAA Fusiform AAA Juxtarenal aneurysm above a previous open AAA repair Fusiform AAA Suprarenal focal abdominal aortic dissection Fusiform AAA
CAD, HTN, previous breast cancer CAD, COPD, CRI, HTN, obesity CRI, Wegener’s granulomatosis, HL HTN, CAD, obesity HTN, CAD HTN
52
No
Elective
72 70
TAAA Saccular aneurysm
65 51
No No
HTN, Benign prostatic hyperplasia HTN CRI, renal transplant, HTN, HL
Anastomotic pseudoaneurysm Fusiform AAA
38
Elective or urgent surgery
92
Urgent Elective
Elective Elective
F, female; M, male; CAD, coronary artery disease; HTN, hypertension; COPD, chronic obstructive airways disease; CRI, chronic renal impairment; HL, hyperlipidemia.
development of type Ib endoleak and distal migration has been established.2 Although the latter is generally accepted for fusiform AAAs, there are several other less frequent focal abdominal aortic pathologies, such as infrarenal aortic dissection, penetrating atherosclerotic ulcer (PAU), intramural hematoma, and saccular aneurysms or pseudoaneurysms, all conditions that can be solved with a tube-graft endovascular approach. In this report, we sought to retrospectively review our experience in using the aortic extension cuffs of the Endurant (Medtronic AVE, Santa Rosa, CA, USA) endovascular stent-graft device for the treatment of focal abdominal aortic pathology with focus on technical feasibility, short-term outcomes, and review of the relevant literature.
METHODS From July 2010 to May 2015, 16 patients (14 male), with a mean age of 73.6 (range, 59e88)
years, were treated for a focal abdominal aortic pathology with an endovascular approach using only aortic cuff extensions of the Endurant stent-graft system. Patient comorbidities are summarized in Table I. Saccular AAAs were present in 5 of them. Two patients had a localized abdominal aortic dissection (Fig. 1), one suffered juxtarenal rupture possibly due to PAU, one patient presented with a large proximal anastomotic pseudoaneurysm after previous open AAA repair with a bifurcated Dacron graft and another developed true pararenal aneurysm after a previous open tube-graft infrarenal AAA repair. Finally, the remaining 6 patients presented with ‘‘typical’’ fusiform-like aortic aneurysm (5 of them infrarenal and 1 thoracoabdominal). The anatomic characteristics of the aortic lesion and operative details are summarized in Table II. The mean maximum diameter of the target lesion was 52.9 mm (range, 32e90 mm). The mean length of proximal neck was 21.06 mm (range, 5e40 mm). The mean distal
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Use of Endurant cuffs for aortic pathology 3
Fig. 1. Focal infrarenal abdominal aortic dissection in a 78-year-old male patient. On table angiography before (A) and postdeployment (B) of a single Endurant aortic
cuff. One can see the dissection flap (white arrows) with the guidewire traversing through the true lumen.
Table II. Aortic lesion anatomy and intraprocedural details
neck length was 24.1 mm (range, 18e28 mm). In addition, proximal and distal neck diameter had a mean value of 26.56 mm (range, 20e33 mm) and 24.57 mm (range, 18e31 mm), respectively. All operations were performed under local anesthesia in an operating room with a portable C-arm (Arcadis Siemens, Germany). One common femoral artery was surgically exposed in standard fashion for delivery of the endograft. The contralateral common femoral artery was percutaneously punctured with Seldinger technique followed by a 7F (35 cm or 45 cm long) sheath over a stiff 0.035in wire, which was introduced up to the level of renal arteries to perform intraoperative angiography. In 5 cases, a single 70-mm-long Endurant aortic extension was deployed, while in the remaining 11 cases 2 cuffs were used with the ‘‘telescopic’’ (double tube) technique and overlapping of approximately 30e40 mm (Fig. 2). The patient who suffered juxtarenal rupture was treated with the ‘‘chimney’’ technique, using a single 32 70 mm2 aortic cuff and a balloon expandable bare metal stent in the left renal artery. ‘‘Open chimney’’ technique was also used in a patient with true aneurysm, where a 5 27 mm2 bare metal stent was deployed to
Variables
Target lesion maximum diameter (mm) Proximal neck diameter (mm) Distal neck diameter (mm) Proximal neck length (mm) Distal neck length (mm) Number of aortic cuffs used (%) One Two Aortic cuff length (mm) 70 49 Aortic cuff diameter (mm) 25 28 32 36 Use of Reliant balloon (%)
N (%) or mean (range)
52.9 (32e90) 26.56 (21e33) 24.57 (18e31) 21.06 (5e40) 24.1 (18e28)
5 (31.25) 11 (68.75) 23 5 2 7 6 11 9 (56.25)
4 Giagtzidis et al.
Fig. 2. Saccular aneurysm localized in the infrarenal abdominal aorta with adequate proximal and distal aortic neck that makes it suitable for tube endografting.
salvage an accessory left renal artery, and, also, in another patient who developed juxtarenal aneurysm 20 years after a previous open AAA repair. In this patient, the left renal artery was salvaged with a balloon expandable 6 37 mm2 stent. In one patient with localized chronic suprarenal aortic dissection, a single 32 70 mm2 cuff was used to seal the false lumen, while the celiac artery was salvaged with a 9 120 mm2 Fluency stent graft (Bard Peripheral Vascular, Tempe, AZ, USA; Fig. 3). Finally, in the patient with a 6.5-cm-diameter thoraco-AAA (TAAA), 2 cuffs (36 70 mm2) were used in the thoracic segment of the aneurysm salvaging the celiac artery with a 9 40 mm2 Fluency stent graft, which was supported from the inside with a self-expandable stent 8 60 mm2. The repair was completed in the infrarenal segment of the aneurysm with a 36 49 mm2 cuff (sandwich technique). In 9 patients, a Reliant balloon (Medtronic AVE, Santa Rosa, CA, USA) was used after deployment for optimum molding of the stent graft. All juxtarenal cases and the single patient with TAAA in this series had been considered as high risk for open surgery. Given the fact that a fenestrated approach is not currently an option in our unit due to reimbursement issues, we considered these patients as candidates for endovascular repair using chimney, telescopic, or sandwich stent-graft techniques. The Endurant aortic extension cuff is a selfexpandable M-shaped nitinol stent sewn to a lowporosity polyester fabric with nonabsorbable sutures. The proximal end of the stent is not covered with fabric, and it consists of anchor pins for fixation. The available diameters are 23, 25, 28, 32,
Annals of Vascular Surgery
Preoperative (A) and postoperative (B) computerized tomography (3-dimensional reconstruction).
Fig. 3. Postoperative plain abdominal X-ray in a 71-yearold man who underwent chimney repair for a localized suprarenal aortic dissection associated with progressive false lumen enlargement. One can see the 32 70 mm2 Endurant aortic cuff (longer white arrow), which was placed in the true lumen to cover the proximal entry tear, and the 9 mm 120 mm2 Fluency chimney stent graft (shorter white arrow) salvaging the celiac artery which was fed by the false lumen.
36 mm, while the covered length can be either 49 or 70 mm long. The delivery device is a single-use catheter with rotating handle for controlled deployment, compatible with a 0.035-in guidewire. It also features a tip capture mechanism for the release of the anchor pins. The catheter outer diameter is available in 18F (for the 23, 25, and 28-mm graft diameter) and 20F (for 32 and 36-mm graft diameter). In our technique, when telescope formation was used, the distal part of the graft was deployed inside the proximal graft where the pins of the proximal-free stent were embedded. The choice of endograft size was based on an approximately 20% oversizing in diameter, which for most
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Use of Endurant cuffs for aortic pathology 5
Table III. Studies reporting results of endovascular tube and double-tube repair of abdominal aortic disease Study (first author)
York et al.
8
Number F-up of pts (months) Stent grafts used
5
6.1
Ruppert et al.9 41
21.9
Saratzis et al.10 53 Mazzaccaro 53 et al.11
24 49
Jones et al.12 Present series
0.7 21.93
8 16
AneuRx
Technical Mortality success (%) (%) Morbidity
100
Zenith (custom), 98 Powerlink EndoFit 100 98.1 Endologix Talent Vanguard Parodi Baxter Lifepath Zenith 100 Endurant 100
0 0 5.7 17.8
0 6.25
Endoleak
One wound 0% dehiscence 12.2% 9.8%
Reintervention
0% 0%
3.8% N/A
5.7% 0% 17.8% 17.8% (single tube) (type I) 4% 3.6% (double tube) (type II)
0% 6.25%
0% 12.5%
0% 0%
Pts, patients; F-up, follow-up; N/A, not available.
chimney cases would practically mean the use of a 32-mm or a 36-mm diameter aortic cuff. Primary technical success was defined as successful deployment of the device without patient mortality, conversion to open repair, type I or III endoleak, and graft occlusion.3 On the other hand, primary clinical success was defined as freedom from aneurysm-related death, rupture, conversion to open surgery, and secondary interventions.3 Follow-up was by means of computerized tomography scan and biplanar abdominal radiograms at 1 month, 6 months, and yearly thereafter. Followup surveillance of the aneurysmal lesions with color Doppler ultrasound or with contrast-enhanced ultrasound scanning was not used as there is no expertise with this diagnostic modality locally.
RESULTS Twelve patients were operated electively, whereas 2 patients, one with rupture and another with an anastomotic pseudoaneurysm, were operated urgently. There was 100% primary technical and clinical success with no endoleaks on completion angiography. There was no 30-day mortality. One patient developed acute limb ischemia immediately after the procedure and was treated successfully with Fogarty thrombectomy (for a complication rate of 6.25%). Apart from that complication, all patients had an uneventful recovery and were discharged the first postoperative day. There was 1 late death during a mean follow-up period of 21.9 months. This patient died 2 months after the procedure due to cardiac arrest, unrelated to his aneurysm. There was a small type IIb endoleak
present in the 30-day follow-up computerized tomography scan, which disappeared 10 months after the procedure. Finally, 1 patient was diagnosed with a late type II endoleak and stable diameter 56 months postprocedure, while to date there are no cases of endograft migration.
DISCUSSION The huge expansion in the use of EVAR technique for the treatment of AAAs over the past years has clearly shown that only a few patients have favorable anatomy for the deployment of aortoaortic stent graft, mainly due to lack of adequate distal neck length.4 However, there are other, relatively uncommon, focal pathologies of the aorta which may be suitable for elective or urgent endovascular treatment with aortoaortic tube stent grafts. Endovascular treatment of saccular abdominal aneurysms, PAUs, intramural hematomas, and anastomotic pseudoaneurysms has been attempted with very good early and midterm results.5e7 In 2002, York et al.8 described the use of ‘‘stacked’’ AneuRx aortic cuffs for the treatment of saccular aneurysms. The authors suggest that the aortoaortic approach with the overlapping cuffs avoids the potential of limb kinking and resulting thrombosis, which may be seen when a bifurcated endograft is used due to the extrinsic compression applied by the nonaneurysmal distal aorta and iliac arteries. Ruppert et al.9 first introduced the term ‘‘trombone’’ technique for 45 patients treated with double-tube stent graft. For these patients, the group used custom-made Zenith and Powerlink stent grafts. They concluded that favorable outcome
6 Giagtzidis et al.
with this technique is met with proper patient selection and aortic anatomic criteria of 10 to 15-mm proximal neck length and minimum distal neck length of 15e20 mm.9 Another group treated 53 patients using Endofit tube stent grafts and made a subgroup analysis of patients receiving 1 stent graft versus those treated with the trombone technique.10 In terms of procedure-related complications, early and late outcomes were significantly better in patients where 2 stent grafts were deployed.10 Similarly, Mazzaccaro et al.11 reviewed 53 patients who were treated with various tube stent grafts, including Endologix, Vanguard, and Talent. They divided the patients into 2 groups according to the number of tube stent grafts used. In the first group, a single-straight endograft was deployed, while in the second group, a double trombone technique was used. Their results suggested that reintervention and endoleaks were more frequent in the group of patients receiving a single endograft.11 Finally, a report of 8 patients with focal infrarenal aortic pathology, which were treated with Zenith tube devices showed excellent early results. The authors concluded that the trombone technique is less invasive and provides better adjustment of length with fewer flow problems in small diameter distal aortas.12 To our knowledge, this is the first report in the literature where Endurant aortic cuffs were used, single or with the telescopic technique, in the abdominal aorta. In cases where 2 aortic cuffs were deployed, 1 might argue that the anchor pins of the inner cuff could compromise the integrity of the fabric of the outer one, leading to type III endoleak. Although this is a report with few patients, no type III endoleak was encountered during the follow-up period. On the contrary, we believe that the technical characteristics of the Endurant cuff increases the stiffness of telescopic construction reducing the likelihood of migration. Tubular devices have a series of advantages over bifurcated grafts. The implantation procedure is less timeconsuming, has less radiation exposure, requires only one femoral surgical exposure, and the overall cost is substantially reduced.10,12 In patients with focal aortic pathology, a bifurcated device can be contraindicated since the limbs of the device would be susceptible to compression, kinking, and thrombosis.11 Furthermore, the availability of different stent-graft sizes in length and diameter can cover up several aortic anatomies by adjusting the overlap between the 2 tubes using the telescopic technique. Accurate proximal and distal deployment of 50-mm and 70-mm length cuffs reach lengths between 100
Annals of Vascular Surgery
and 110 mm which can reliably cover the distance between the renal arteries and aortic bifurcation. It also seems that chimney and sandwich techniques are technically compatible with this stent-graft design with high success rate. This technique also allows the use of local anesthesia reducing the perioperative complications of general anesthesia. Although a direct comparison of the Endurant cuff with other commercially available stent grafts previously published is not intended in this article, Table III summarizes that different stent grafts have comparable results in terms of technical success, mortality, morbidity, endoleak, and reintervention rates proving the safety and efficacy of the method.
CONCLUSIONS In the proper anatomic setting of adequate proximal and distal neck length, covering the affected area with tubular endografts can be a safe, efficient, and cost-effective treatment option. Endurant aortic cuff extensions showed excellent early and midterm results and should be considered as an option when treating focal infrarenal aortic pathology. Follow-up protocol for these patients should be applied as with the standard EVAR technique. Although the midterm results of our patient group are promising and without adverse events, long-term data for reintervention, endoleak, and migration rates are required. Furthermore, since these cases are relatively rare, establishment of a registry would help us draw firm and safe conclusions for the safety of the method. REFERENCES 1. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5:491e9. 2. Faries PL, Briggs VL, Rhee JY, et al. Failure of endovascular aortoaortic tube grafts: a plea for preferential use of bifurcated grafts. J Vasc Surg 2002;35:868e73. 3. Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002;35:1048e60. 4. Katsikas VC, Dalainas I, Martinakis VG, et al. The role of aortouniiliac devices in the treatment of aneurysmal disease. Eur Rev Med Pharmacol Sci 2012;16:1061e71. 5. Taylor BV, Kalman PG. Saccular aortic aneurysms. Ann Vasc Surg 1999;13:555e9. 6. Eggebrecht H, Plicht B, Kahlert P, et al. Intramural hematoma and penetrating ulcers: indications to endovascular treatment. Eur J Vasc Endovac Surg 2009;38:659e65. 7. Zhou W, Bush RL, Bhama JK, et al. Repair of anastomotic abdominal aortic pseudoaneurysm utilizing sequential AneuRx aortic cuffs in an overlapping configuration. Ann Vasc Surg 2006;20:17e22.
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8. York JW, Sternbergh WC, Lepore MR, et al. Endovascular exclusion of saccular AAAs using ‘‘stacked’’ AneuRx aortic cuffs. J Endovasc Ther 2002;9:295e8. 9. Ruppert V, Erz K, B€ urklein D. Double tube stent-grafts for infrarenal aortic aneurysm: a new concept. J Endovasc Ther 2007;14:144e9. 10. Saratzis N, Melas N, Saratzis A, et al. Midterm results of a modified technique for implanting tube grafts during
Use of Endurant cuffs for aortic pathology 7
endovascular abdominal aortic aneurysm repair. J Endovasc Ther 2008;15:433e40. 11. Mazzaccaro D, Occhiuto MT, Malacrida G, et al. Straight aortic endograft in abdominal aortic disease. J Cardiothorac Surg 2013;8:114e20. 12. Jones DW, Meltzer AJ, Graham AR, et al. Endovascular repair of infrarenal focal aortic pathology with limited aortic coverage. Ann Vasc Surg 2014;28:1315e22.